Oxycan

Hauptinformation

  • Handelsname:
  • Oxycan uno 40 mg Retardtabletten
  • Darreichungsform:
  • Retardtablette
  • Zusammensetzung:
  • Oxycodonhydrochlorid (Ph.Eur.) 40.mg
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Oxycan uno 40 mg Retardtabletten
    Deutschland
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
  • Zulassungsnummer:
  • 88011.00.00
  • Letzte Änderung:
  • 05-11-2018

Packungsbeilage

GEBRAUCHSINFORMATION: INFORMATION FÜR ANWENDER

Oxycan uno 40 mg Retardtabletten

Oxycodonhydrochlorid

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Einnahme dieses

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt oder Apotheker.

Dieses

Arzneimittel

wurde

Ihnen

persönlich

verschrieben.

Geben

nicht

Dritte

weiter.

kann anderen Menschen schaden, auch wenn diese die gleichen Beschwerden haben wie Sie.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt auch

für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Siehe Abschnitt 4.

Was in dieser Packungsbeilage steht

Was ist Oxycan uno und wofür wird es angewendet?

Was sollten Sie vor der Einnahme von Oxycan uno beachten?

Wie ist Oxycan uno einzunehmen?

Welche Nebenwirkungen sind möglich?

Wie ist Oxycan uno aufzubewahren?

Inhalt der Packung und weitere Informationen

1.

Was ist Oxycan uno und wofür wird es angewendet?

Oxycan uno ist

zentral

wirkendes,

starkes

Schmerzmittel

(Analgetikum)

Arzneimittelgruppe

der Opioide.

Oxycan uno wird

angewendet

Behandlung

starken

Schmerzen,

Opioid-Analgetika

angemessen behandelt werden können.

Oxycan uno ist für die Behandlung von Erwachsenen und Jugendlichen ab 12 Jahren angezeigt.

2.

Was sollten Sie vor der Einnahme von Oxycan uno beachten?

Oxycan uno darf nicht eingenommen werden,

wenn Sie allergisch gegen Oxycodonhydrochlorid oder einen der in Abschnitt 6. genannten sonstigen

Bestandteile dieses Arzneimittels sind.

w e n n

Ih r e

A t mu n g

s t a r k

e i n ge s c hr ä n kt

i s t

( A t e md e p r e s s i o n) ,

mi t

w e n i g

S a u e r s t of f

B l u t

(Hypoxie) und/oder zu viel Kohlendioxid im Blut (Hyperkapnie),

wenn Sie an einer schweren chronisch obstruktiven Lungenerkrankung leiden,

w e n n

S i e

C o r

p u l m o n a l e

( H e r z v e r ä n d e r u n g e n

i n f o l g e

e i n e r

c h r o n i s c h e n

Ü b e r l a s t u n g

d e s

Lungenkreislaufs) leiden,

wenn Sie an akutem, schwerem Bronchialasthma leiden,

wenn Sie an einer Darmlähmung (paralytischer Ileus) leiden,

wenn Sie an starken Bauchschmerzen unbekannter Ursache (akutes Abdomen) oder einer verzögerten

Magenentleerung leiden.

Warnhinweise und Vorsichtsmaßnahmen

Bitte

sprechen

Ihrem

Arzt

oder

Apotheker,

bevor

Oxycan uno einnehmen,

wenn

einer

folgenden Punkte auf Sie zutrifft oder in der Vergangenheit zugetroffen hat:

wenn Sie älter oder geschwächt sind,

wenn

Ihre

Lungen-,

Leber- oder

Nierenfunktion

stark

eingeschränkt

(siehe auch Abschnitt 3

„Risikopatienten“),

wenn Sie an einem Myxödem (bestimmte Erkrankung der Schilddrüse), oder einer Funktionsstörung

der Schilddrüse leiden,

wenn Sie an einer Unterfunktion der Nebennierenrinde (Addison-Krankheit) leiden,

wenn Sie an einer Vergrößerung der Prostata (Prostatahypertrophie) leiden,

wenn

alkoholabhängig

sind

oder

sich

einem

Alkoholentzug

unterziehen

Komplikationen

auftreten (z. B. Delirium tremens),

wenn es bei Ihnen infolge einer Vergiftung (z. B. durch Alkohol) zu einer Psychose kommt,

wenn bei Ihnen eine Opioid-Abhängigkeit bekannt ist,

wenn Sie an einer Entzündung der Bauchspeicheldrüse (Pankreatitis) leiden,

wenn Sie an einer Erkrankung der Gallenwege leiden,

wenn Sie an einer entzündlichen Darmerkrankung leiden,

wenn Ihr Blutdruck niedrig oder Ihr Blutvolumen vermindert ist,

wenn bei Ihnen eine Kopfverletzung vorliegt (aufgrund des Risikos für einen erhöhten Hirndruck),

wenn Sie an einer Störung der Kreislaufregulation leiden,

wenn Sie an Epilepsie leiden oder eine Neigung zu Krampfanfällen haben,

wenn Sie MAO-Hemmer (zur Behandlung von Depressionen) einnehmen.

Falsche Anwendung von Oxycan uno

Die Retardtabletten können in zwei Hälften geteilt werden, dürfen jedoch beim Einnehmen nicht zerkaut

oder

zerkleinert

werden,

dies

durch

Aufhebung

Eigenschaften

Retardtablette

einer

schnellen Freisetzung von

Oxycodon führt. Bei der Einnahme von

zerkauten oder zerkleinerten Oxycan

uno Retardtabletten

k o m m t

e i n e r

r a s c h e n

F r e i s e t z u n g

u n d

A u f n a h m e

e i n e r

u n t e r

U m s t ä n d e n

tödlichen

Dosis

Oxycodon

(siehe

Abschnitt

„ Wenn

eine

größere

Menge

Oxycan uno

eingenommen haben, als Sie sollten“).

Eine missbräuchliche Injektion in eine Vene kann ernste und möglicherweise tödlich verlaufende Folgen

haben.

Operationen

Die Anwendung von Oxycan uno vor oder innerhalb von 12-24 Stunden nach einer Operation wird nicht

empfohlen.

Oxycan uno sollte nach einer Darmoperation erst wieder angewendet werden, nachdem sich der Arzt vom

Vorliegen einer normalen Darmfunktion überzeugt hat.

Langzeitbehandlung und Missbrauch

Oxycan uno besitzt

primäres

Abhängigkeitspotential.

Anwendung

über

einen

längeren

Zeitraum

kann es zu einer Gewöhnung an die Wirkung des Arzneimittels kommen, wodurch immer höhere Dosen

erforderlich sind, um die schmerzlindernde Wirkung aufrecht zu erhalten.

Oxycan uno kann

b e i

c h r o n i s c h e r

A n w e n d u n g

e i n e r

k ö r p e r l i c h e n

A b h ä n g i g k e i t

f ü h r e n

u n d

b e i

abruptem

Absetzen

Behandlung

kann

Entzugserscheinungen

kommen.

Wenn

Patient

Behandlung mit Oxycodonhydrochlorid nicht länger benötigt, kann es ratsam sein, die Dosis schrittweise

herabzusetzen, um das Auftreten von Entzugserscheinungen zu vermeiden.

Oxycodon sollte bei Patienten mit früherem oder gegenwärtigem Alkohol- oder Substanzmissbrauch sehr

vorsichtig angewendet werden.

s e h r

s e l t e n e n

F ä l l e n

k a n n

s i c h

e i n e

e r h ö h t e

S c h m e r z e m p f i n d l i c h k e i t

e n t w i c k e l n ,

d i e

n i c h t

a u f

Dosiserhöhungen anspricht. In diesem Fall wird der Arzt Ihre Dosis reduzieren oder Ihre Behandlung auf

ein anderes Schmerzmittel aus der Gruppe der Opioide umstellen.

Wenn Oxycan uno bei chronischen Schmerzen bestimmungsgemäß angewendet wird, ist das Risiko, eine

körperliche oder seelische Abhängigkeit zu entwickeln, jedoch deutlich vermindert und muss gegen den

möglichen Nutzen abgewogen werden. Bitte sprechen Sie darüber mit Ihrem Arzt.

Kinder

Oxycan uno soll

Kindern

unter

Jahren

aufgrund

Bedenken

hinsichtlich

Sicherheit

Wirksamkeit nicht angewendet werden.

Ältere Patienten

Bei älteren Patienten ohne Einschränkung der Nieren- und/oder Leberfunktion ist eine Dosisanpassung in

der Regel nicht erforderlich.

Hinweis zum Fehlgebrauch zu Dopingzwecken

Athleten sollten sich darüber im Klaren sein, dass die Einnahme dieses Arzneimittels zu positiven

Ergebnissen bei Dopingkontrollen führen kann.

Die Anwendung von Oxycan

uno als Dopingmittel kann zu einer Gefährdung der Gesundheit führen.

Einnahme von Oxycan

uno zusammen mit anderen Arzneimitteln

Informieren

Ihren

Arzt

oder

Apotheker,

wenn

andere

Arzneimittel

einnehmen,

kürzlich

andere

Arzneimittel eingenommen haben oder beabsichtigen andere Arzneimittel einzunehmen.

Arzneimittel, die das zentrale Nervensystem dämpfen, wie z. B.:

Schlaf- oder Beruhigungsmittel (Sedativa, Hypnotika)

andere Arzneimittel mit Wirkung auf das zentrale Nervensystem (Phenothiazine,

Neuroleptika)

Arzneimittel, die während einer Operation angewendet werden (Anästhetika)

Arzneimittel zur Behandlung von Depressionen

Arzneimittel, die zur Muskelentspannung angewendet werden

Arzneimittel zur Behandlung von Allergien und Erbrechen (Antihistaminika, Antiemetika)

andere Opioide oder Alkohol können die Nebenwirkungen von Oxycodon verstärken, vor

allem die Unterdrückung der Atemfunktion (Atemdepression).

Arzneimittel mit anticholinerger Wirkung, wie z. B.:

andere Arzneimittel, die parasympathische oder cholinerge Nervenfasern blockieren

(psychotrope Arzneimittel)

Arzneimittel zur Behandlung von Allergien (Antihistaminika) und Erbrechen (Antiemetika)

Arzneimittel zur Behandlung der Parkinson-Krankheit können bestimmte Nebenwirkungen

von Oxycodon verstärken (z. B. Verstopfung, Mundtrockenheit oder Störungen beim

Wasserlassen).

Hemmer des Cytochrom-P450-3A4, wie Makrolidantibiotika

(z. B. Clarithromycin, Erythromycin

u n d

Telithromycin),

Azol-Antimykotika

( z .

K e t o c o n a z o l ,

Voriconazol,

I t r a c o n a z o l

u n d

Posaconazol),

Proteaseinhibitoren

( z .

B o c e p r e v i r ,

R i t o n a v i r ,

I n d i n a v i r ,

N e l f i n a v i r

u n d

Saquinavir),

C i m e t i d i n

u n d

Grapefruitsaft,

k ö n n e n

d i e

V e r s t o f f w e c h s e l u n g

v o n

O x y c o d o n

hemmen

Wirkung

Ox ycodon

verstärken. Daher

muss

möglicherweise

Dosis

angepasst werden, wenn Sie solche Mittel einnehmen.

Hemmer

Cytochrom-P450-2D6, wie Chinidin und Paroxetin, können

Stoffwechsel

Oxycodon hemmen.

Einfluss

anderer

Arzneimittel,

Stoffwechsel

Oxycodon

deutlich

beeinflussen

können, wurde nicht untersucht.

M o n o a m i n o x i d a s e - H e m m e r

( M A O - H e m m e r )

k ö n n e n

d i e

N e b e n w i r k u n g e n

v o n

O x y c o d o n

verstärken (z. B. Erregung, Anstieg oder Senkung des Blutdrucks).

E i n z e l f ä l l e n

w u r d e

e i n e

k l i n i s c h

b e d e u t s a m e

v e r s t ä r k t e

o d e r

g e m i n d e r t e

B l u t g e r i n n u n g

b e o b a c h t e t ,

w e n n

Oxycan uno zusammen

m i t

b l u t g e r i n n u n g s h e m m e n d e n

A r z n e i m i t t e l n

v o m

Cumarin-Typ (Antikoagulantien) eingenommen wurde.

Rifampicin,

Carbamazepin,

Phenytoin

oder auch

pflanzliche

Präparat

Johanniskraut

können

d i e

W i r ku n g

v o n

O x y c o d o n

abschwächen. Daher

mu s s

mö gl i c h e r w e i s e

d i e

D o s i s

a n ge p a s s t

werden, wenn Sie solche Mittel einnehmen.

Einnahme von Oxycan uno zusammen mit Alkohol

Einnahme

Alkohol

während

Behandlung

Oxycan uno kann

verstärkter

Schläfrigkeit

führen oder das Risiko schwerwiegender Nebenwirkungen erhöhen, wie flache Atmung

mit dem Risiko

eines Atemstillstands und Bewusstseinsverlust. Es wird empfohlen, während der Einnahme von Oxycan

uno keinen Alkohol zu trinken. Grapefruitsaft kann den Stoffwechsel von Oxycodon hemmen, wodurch

sich

dessen

Wirkung

verstärkt.

Daher

sollte

während

Behandlung

Oxycodon

Grapefruitsaft

verzichtet werden.

Schwangerschaft und Stillzeit

Wenn

schwanger

sind

oder

stillen,

oder

wenn

vermuten,

schwanger

sein

oder

beabsichtigen,

schwanger zu werden, fragen Sie vor der Einnahme dieses Arzneimittels Ihren Arzt oder Apotheker um

Rat.

Schwangerschaft

Oxycan

s o l l t e

w ä h r e n d

d e r

S c h w a n g e r s c h a f t

nicht

e i n g e n o m m e n

w e r d e n .

l i e g e n

k e i n e

ausreichenden Erfahrungen mit der Anwendung von Oxycodon bei Schwangeren vor. Oxycodon gelangt

über die Plazenta in den Organismus des ungeborenen Kindes.

längerfristige

Anwendung

Oxycodon

Schwangerschaft

kann

Entzugserscheinungen

Neugeborenen hervorrufen. Neugeborene, deren Mütter in den letzten drei bis vier Wochen vor der Geburt

mit Oxycodon behandelt wurden, sollten auf eine Unterdrückung der Atemfunktion (Atemdepression) hin

überwacht werden.

Stillzeit

Sie sollten Oxycan uno während der Stillzeit nicht einnehmen,

da Oxycodon in die Muttermilch übergeht

und beim gestillten Kind möglicherweise eine Atemdepression hervorrufen kann.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Oxycodon

kann

Einfluss

Verkehrstüchtigkeit

di e

Fähigkeit

Bedienen

Maschinen

haben.

U n t e r

s t a b i l

e i n g e s t e l l t e r

T h e r a p i e

i s t

e i n

g e n e r e l l e s

F a h r v e r b o t

n i c h t

z w i n g e n d

n o t w e n d i g .

B i t t e

besprechen Sie mit Ihrem Arzt, ob und unter welchen Bedingungen Sie ein Fahrzeug führen dürfen.

Oxycan uno enthält Sucrose

Dieses Arzneimittel enthält Sucrose. Bitte nehmen Sie Oxycan uno erst nach Rücksprache mit Ihrem Arzt

ein, wenn Ihnen bekannt ist, dass Sie unter einer Unverträglichkeit gegenüber bestimmten Zuckern leiden.

3.

Wie ist Oxycan uno einzunehmen?

Nehmen Sie dieses Arzneimittel immer genau nach Absprache mit Ihrem Arzt ein. Fragen Sie bei Ihrem

Arzt oder Apotheker nach, wenn Sie sich nicht sicher sind.

Die empfohlene Dosis beträgt:

Erwachsene und Jugendliche (≥12 Jahre)

Die Anfangsdosis beträgt gewöhnlich einmal täglich 10 mg Oxycodonhydrochlorid. Die Einnahme sollte

möglichst immer zur gleichen Tageszeit erfolgen. Bei einigen Patienten kann eine Anfangsdosis von 5 mg

von Vorteil sein, um die Häufigkeit von Nebenwirkungen so gering wie möglich zu halten.

F ü r

D o s i e r u n g e n ,

d i e

m i t

d i e s e m

A r z n e i m i t t e l

n i c h t

r e a l i s i e r b a r

s i n d ,

s t e h e n

a n d e r e

S t ä r k e n

u n d

Arzneimittel zur Verfügung.

w e i t e r e n

B e h a n d l u n g s v e r l a u f

l e g t

d e r

b e h a n d e l n d e

A r z t

d i e

T a g e s d o s i s

f e s t

u n d

m m t

e i n e

Anpassung der Dosis in Abhängigkeit von der vorhergehenden Dosierung vor. Dosisanpassungen sollten

in Schritten von etwa einem Drittel der Tagesdosis erfolgen, um das Risiko möglicher Nebenwirkungen zu

senken. Im Allgemeinen sollte die zur Schmerzlinderung notwendige niedrigste Dosis gewählt werden.

Patienten,

bereits

Opioiden

behandelt

wurden,

können

Behandlung

einer

höheren

Dosis

beginnen. Dabei sind die Erfahrungen der Patienten mit der Opioid-Behandlung zu berücksichtigen.

M a n c h e

P a t i e n t e n ,

d i e

Oxycan

einnehmen,

b r a u c h e n

s c h n e l l

w i r k s a m e

S c h m e r z m i t t e l

a l s

Bedarfsmedikation zur Behandlung von Durchbruchschmerzen. Oxycan uno ist nicht zur Behandlung von

Durchbruchschmerzen gedacht.

Behandlung

Schmerzen,

nicht

durch

einen

T umor

bedingt

sind,

reicht

ge wöhnl ic h

ei ne

Tagesdosis von 40 mg Oxycodonhydrochlorid aus, es können aber auch höhere Dosierungen erforderlich

s e i n .

Pa ti e nt e n

mi t

T u mo r s c h me r ze n

b e n öt i ge n

d e r

R e ge l

D o si er u n ge n

zw i s c h en

u n d

120 mg

Oxycodonhydrochlorid, die in Einzelfällen auf bis zu 400 mg gesteigert werden können.

Die Behandlung muss regelmäßig hinsichtlich der Schmerzlinderung und anderer Wirkungen kontrolliert

werden,

bestmögliche

Schmerzbehandlung

erreichen,

mögliche

Nebenwirkungen

rechtzeitig

behandeln zu können und zu entscheiden, ob die Behandlung fortgesetzt werden sollte.

Arzt

wird

Ihre

Dosis

anhand

Stärke

Schmerzen

und I hres

Ansprechens

Behandlung

anpassen (siehe Abschnitt 2 „Warnhinweise und Vorsichtsmaßnahmen“).

Risikopatienten

Wenn Ihre Nieren- und/oder Leberfunktion eingeschränkt ist oder wenn Sie ein geringes Körpergewicht

haben, wird Ihr Arzt Ihnen möglicherweise eine niedrigere Anfangsdosis verschreiben.

Anwendung bei Kindern unter 12 Jahren

Oxycan uno darf

Kindern

unter

Jahren

nicht

angewendet

werden,

Bedenken

hinsichtlich

Sicherheit und Wirksamkeit bestehen.

Art der Anwendung

Oxycan uno ist

Einnehmen.

Nehmen

Retardtabletten

einmal

täglich

Ihrem

Arzt

verordnet ein.

N e h m e n

S i e

d i e

R e t a r d t a b l e t t e n

G a n z e n

m i t

a u s r e i c h e n d

F l ü s s i g k e i t

( ½

G l a s

W a s s e r )

o d e r

unabhängig von einer Mahlzeit täglich möglichst zur gleichen Zeit ein.

Retardtabletten

dürfen vorm

Einnehmen

halbiert werden.

Sie dürfen jedoch

weder zerkaut, noch

weiter zerkleinert werden (siehe Abschnitt 2, „Warnhinweise und Vorsichtsmaßnahmen“).

Hinweise zum Öffnen der Blisterpackung

Dieses Arzneimittel ist in einer kindergesicherten Blisterpackung verpackt. Sie können die Retardtabletten

nicht aus der Blisterpackung herausdrücken. Bitte beachten Sie die folgenden Hinweise zum Öffnen der

Blisterpackung:

Trennen Sie eine Einzeldosis entlang der Perforationslinie der Blisterpackung ab.

H i e r d u r c h

w i r d

d e r

S t e l l e ,

d e r

s i c h

d i e

P e r f o r a t i o n s l i n i e n

k r e u z e n ,

e i n

n i c h t

versiegelter Bereich sichtbar.

Ziehen Sie die Deckfolie an der nicht versiegelten „Lasche“ ab.

Wenn Sie eine größere Menge von Oxycan uno eingenommen haben, als Sie sollten

Wenn

eine

größere

Menge

Oxycan uno als

verordnet

eingenommen

haben,

sollten

sofort

I h r e n

A r z t

i n f o r m i e r e n

o d e r

d i e

ö r t l i c h e

G i f t n o t r u f z e n t r a l e

a n r u f e n .

F o l g e n d e

B e s c h w e r d e n

k ö n n e n

a u f t r e t e n :

P u p i l l e n v e r e n g u n g

( M i o s i s ) ,

A t e m d ä m p f u n g

( A t e m d e p r e s s i o n ) ,

S c h l ä f r i g k e i t ,

v e r m i n d e r t e

Spannung der Skelettmuskulatur sowie Abfall des Blutdrucks. In schweren Fällen können Benommenheit,

B e w u s s t l o s i g k e i t

( K o m a ) ,

P u l s v e r l a n g s a m u n g

( B r a d y k a r d i e )

a u f t r e t e n ;

d i e

m i s s b r ä u c h l i c h e

Anwendung hoher Dosen starker Opioide wie Oxycodon kann zum Tode führen.

Wenn Sie die Einnahme von Oxycan uno vergessen haben

W e n n

S i e

e i n e

E i n n a h m e

v o n

Oxycan uno vergessen

h a b e n ,

i s t

d i e

S c h m e r z l i n d e r u n g

n i c h t

m e h r

ausreichend oder lässt vollständig nach.

können

eine

vergessene

Einnahme

nachholen,

wenn

nächsten

regulären

Einnahme

noch

mindestens

12 S tunden

sind.

können

dann

Einnahme

Oxycan uno wie

verordnet fortsetzen.

Nehmen Sie nicht die doppelte Menge ein, wenn Sie die vorherige Einnahme vergessen haben.

Wenn Sie die Einnahme von Oxycan uno abbrechen

Brechen Sie die Behandlung nicht ohne Rücksprache mit Ihrem Arzt ab.

F a l l s

d i e

B e h a n d l u n g

mi t

Oxycan uno nicht

l ä n g e r

n o t w e n d i g

i s t ,

k a n n

r a t s a m

s e i n ,

d i e

D o s i s

schrittweise zu senken, um Entzugserscheinungen zu vermeiden.

Bei abruptem Absetzen der Behandlung kann ein Entzugssyndrom auftreten. Die Symptome eines solchen

Entzugssyndroms sind in Abschnitt 4 „Welche Nebenwirkungen sind möglich?“ beschrieben.

Wenn Sie weitere Fragen zur Einnahme dieses Arzneimittels haben, wenden Sie sich an Ihren Arzt oder

Apotheker.

4.

Welche Nebenwirkungen sind möglich?

alle

Arzneimittel

kann

auch

dieses

Arzneimittel

Nebenwirkungen

haben,

aber

nicht

jedem

auftreten müssen.

Bedeutsame

Nebenwirkungen

oder

Zeichen,

achten

M aßnahmen,

Auftreten

dieser Nebenwirkungen und Zeichen zu ergreifen sind

Wenn bei Ihnen eine der folgenden Nebenwirkungen auftritt, nehmen Sie Oxycan uno nicht weiter ein und

wenden Sie sich umgehend an Ihren Arzt.

Atemdä mpfung

(Atemdepression)

größte

Risiko

einer

Behandlung

Opioiden

tritt

ehesten

älteren

geschwächten

Patienten

auf.

Folge

kann

entsprechend

veranlagten

Patienten zu einem starken Blutdruckabfall kommen.

Oxycodon

kann

zudem

einer

Pupillenverengung,

einer

Verkrampfung

Atemmuskulatur

glatten Muskulatur sowie zur Unterdrückung des Hustenreflexes führen.

Weitere mögliche Nebenwirkungen

Sehr häufig

(kann mehr als 1 von 10 Behandelten betreffen)

Sedierung (Müdigkeit bis hin zu Benommenheit), Schwindelgefühl, Kopfschmerzen

Verstopfung, Übelkeit und Erbrechen

Juckreiz

Häufig

(kann bis zu 1 von 10 Behandelten betreffen)

verminderter Appetit,

Appetitlosigkeit

verschiedene psychische Nebenwirkungen wie z. B.

Stimmungsveränderungen (z. B. Angst, Verwirrtheitszustände, Depressionen, Schlaflosigkeit,

Nervosität Denkstörungen)

Zittern (Tremor), Lethargie (antriebslos)

Atemdämpfung (Dyspnoe)

Bauchschmerzen, Durchfall, Mundtrockenheit, Schluckauf, Verdauungsstörungen (Dyspepsie)

Hautreaktion/-ausschlag, vermehrtes Schwitzen (Hyperhydrosis)

schmerzhafter Harndrang, Harndrang

Schwächezustände (Asthenie)

Gelegentlich

(kann bis zu 1 von 100 Behandelten betreffen)

allergische Reaktionen

Syndrom der inadäquaten ADH-(antidiuretisches Hormon-)Sekretion, das zu häufigem

Wasserlassen führt

Flüssigkeitsmangel (Dehydratation)

Unruhe (Agitiertheit), extrem emotionales Verhalten (Affektlabilität), euphorische Stimmung,

Halluzinationen, Störungen der Sexualfunktion (vermindertes sexuelles Verlangen), körperliche

(physische) Abhängigkeit mit Entzugssymptomen

Amnesie, Krampfanfälle (insbesondere bei Personen mit Epilepsie oder Neigung zu

Krampfanfällen), Konzentrationsstörungen, Migräne

erhöhte Muskelspannung, herabgesetzter Tastsinn (Hypästhesie), unwillkürliche

Muskelzuckungen, Sprachstörungen, Ohnmacht, Empfindungsstörungen (Parästhesie)

Geschmacksstörungen

Pupillenverengung, Sehstörungen

Schwindel, abnorm gesteigertes Hörempfinden (Hyperakusis)

beschleunigter Puls, Empfindung von unregelmäßigen Herzschlägen und starkem Herzklopfen (im

Zusammenhang mit Absetzreaktionen), Gefäßerweiterung (Vasodilatation)

Dämpfung der Atmung, vermehrtes Husten, Veränderung der

Stimme

Schluckbeschwerden, Blähungen, Aufstoßen, verminderte Bewegung des Darms (Ileus)

Mundgeschwüre, Entzündung der Mundschleimhaut (Stomatitis)

Erhöhte Leberenzymwerte

trockene Haut

Harnverhalten

Erektile Dysfunktion, Keimdrüsenunterfunktion

Schüttelfrost, Entzugserscheinungen, Unwohlsein, Wasseransammlungen im Gewebe (Ödeme,

periphere Ödeme), Arzneimitteltoleranz,

Durst

Verletzungen durch Unfälle

Selten

(kann bis zu 1 von 1.000 Behandelten betreffen)

Herpes simplex

Erkrankung der Lymphknoten (Lymphadenopathie)

Krampfanfälle, vor allem bei Patienten, die an Epilepsie oder einer Neigung zu Krampfanfällen

leiden

Zahnfleischbluten, dunkel gefärbter Stuhl, Zahnerkrankungen

Nesselsucht (Urticaria)

Gewichtsveränderungen (Zu- oder Abnahme)

Sehr selten

(kann bis zu 1 von 10.000 Behandelten betreffen)

erhöhtes Schmerzempfinden (Hyperalgesie)

Nicht bekannt

(Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar)

schwere allergische Reaktionen (anaphylaktische/anaphylaktoide Reaktionen)

Aggressivität

Karies

Gallenstauung (Cholestase), Gallenkoliken

Ausbleiben der Regelblutung (Amenorrhoe)

Arzneimittelentzugssyndrom bei Neugeborenen

Gegenmaßnahmen

Wenn bei Ihnen eine der oben genannten Nebenwirkungen auftritt, wird Ihr Arzt geeignete Maßnahmen

ergreifen.

Nebenwirkung

Verstopfung

können

durch

vorbeugende

Maßnahmen

(wie

z.B.

viel

trinken,

ballaststoffreiche

Ernährung)

entgegenwirken.

Wenn

Ihnen

übel

oder

erbrechen

müssen,

wird Ihnen Ihr Arzt ein Arzneimittel dagegen verschreiben.

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt auch für

Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind.

Sie können Nebenwirkungen auch direkt dem Bundesinstitut für Arzneimittel und Medizinprodukte, Abt.

P h a r ma k o v i g i l a n z ,

K u r t -G e o r g -K i e s i n g e r -A l l e e

D -5 3 1 7 5

B o n n ,

W e b s i t e :

w w w . b f a r m. d e

anzeigen.

In d e m

S i e

N e b e n w i r ku n g e n

me l d e n ,

kö n n e n

Si e

d a z u

b e i t r a g e n ,

d a s s

me h r

In f o r ma t i o n e n

ü be r

di e

Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5.

Wie ist Oxycan uno aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

dürfen dieses Arzneimittel nach dem auf der Blisterpackung und de m Umkarton nach „Verwendbar

bis“ angegebenen Verfalldatum nicht mehr verwenden. Das Verfalldatum bezieht sich auf den letzten Tag

des angegebenen Monats.

Für dieses Arzneimittel sind keine besonderen Lagerungsbedingungen erforderlich.

Entsorgen Sie Arzneimittel nicht im Abwasser oder Haushaltsabfall. Fragen Sie Ihren Apotheker, wie das

Arzneimittel

entsorgen

ist,

wenn

nicht

mehr

verwenden.

tragen

damit

Schutz

Umwelt bei.

6.

Inhalt der Packung und weitere Informationen

Was Oxycan uno enthält

Der Wirkstoff ist Oxycodonhydrochlorid.

Jede Retardtablette enthält 40 mg Oxycodonhydrochlorid entsprechend 35,87 mg Oxycodon.

Die sonstigen Bestandteile sind:

T a b l e t t e n k e r n :

Z u c k e r - S t ä r k e - P e l l e t s

( S u c r o s e ,

M a i s s t ä r k e ) ,

H y p r o m e l l o s e ,

T a l k u m ,

E t h y l c e l l u l o s e ,

Hyprolose, Propylenglycol, Carmellose-Natrium (Ph.Eur.), Mikrokristalline Cellulose, Magnesiumstearat

(Ph.Eur.), Hochdisperses Siliciumdioxid

Filmüberzug: Opadry II Weiß (bestehend aus Polyvinylalkohol, Talkum, Titandioxid (E171), Macrogol

3350) und Opadry II Rot (bestehend aus Polyvinylalkohol, Talkum, Macrogol 3350, Eisen(III)-oxid

(E172)).

Wie Oxycan uno aussieht und Inhalt der Packung

Rosafarbene,

längliche,

bikonvexe

Retardtabletten

einem

Durchmesser

12,3 mm

x 5,8 mm

einer Bruchkerbe auf beiden Seiten.

Die Tablette kann in gleiche Dosen geteilt werden.

Packungsgrößen:

20 x 1 Einzeldosis, 50 x 1 Einzeldosis und 100 x 1 Einzeldosis in kindergesicherten perforierten Blistern

zur Abgabe von Einzeldosen.

Pharmazeutischer Unternehmer und Hersteller

Hormosan Pharma GmbH

Wilhelmshöher Straße 106

60389 Frankfurt am Main

Tel. 0 69/47 87 30

Fax 0 69/47 87 316

E-Mail: info@hormosan.de

www.hormosan.de

Diese Packungsbeilage wurde zuletzt überarbeitet im Januar 2018.

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

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21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

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20-11-2018

Relevance of new scientific information (Santos‐Vigil et al., 2018*) in relation to the risk assessment of genetically modified crops with Cry1Ac

Relevance of new scientific information (Santos‐Vigil et al., 2018*) in relation to the risk assessment of genetically modified crops with Cry1Ac

Published on: Wed, 14 Nov 2018 Following a request from the European Commission, EFSA assessed the scientific publication by Santos‐Vigil et al. (2018). The outstanding question was whether or not the new scientific information contains elements that could lead the EFSA GMO Panel to reconsider the outcome of its previous risk assessments on genetically modified crops expressing Cry1Ac protein. Santos‐Vigil et al. (2018) investigated the allergenic potential and immunological effects of the Cry1Ac protei...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of (EZ)‐1,3‐dichloropropene ...

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17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

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17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

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15-11-2018

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Published on: Wed, 14 Nov 2018 The technical report reflects the outcome of the discussions and agreements that were reached in the pesticides peer review meeting on residues and maximum residue levels regarding the principles and guidance for application of the proportionality concept in the risk assessment methodologies used at European level for the estimation of the maximum residue levels for pesticides. In addition, practical experiences on the use of the proportionality approach gained by EFSA hav...

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15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

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15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

12-11-2018

European Antibiotic Awareness Day 2018

European Antibiotic Awareness Day 2018

European Antibiotic Awareness Day 2018

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. Th...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

15-10-2018

EFSA Focal Points: a decade of networking for European food safety

EFSA Focal Points: a decade of networking for European food safety

EFSA Focal Points: a decade of networking for European food safety

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Danish Medicines Agency aces European benchmark survey

Danish Medicines Agency aces European benchmark survey

The Danish Medicines Agency has just scored 4.5 of a possible 5 in the common-European survey known as the Benchmarking of European Medicines Agencies (BEMA). ”It's a really good result that will benefit all of us and may help raise the standard throughout Europe,” said the Danish health minister.

Danish Medicines Agency

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep-2018

This Patients' and Consumers' Working Party (PCWP) plenary meeting will include discussions on patient engagement along the regulatory lifecycle and visibility of patient input throughout scientific procedures. Feedback will also be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

13-9-2018

 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...

Europe - EMA - European Medicines Agency

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency