Iruzid 10 mg 12 5

Glavna informacija

  • Trgovački naziv:
  • Iruzid 10 mg/12,5 mg tablete
  • Doziranje:
  • 10 mg + 12,5 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 10 mg lizinoprila u obliku lizinopril dihidrata i 12,5 mg hidroklorotiazida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Belupo lijekovi i kozmetika d.d., Koprivnica, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Iruzid 10 mg/12,5 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-169873914-01]; 60 tableta u blisteru, u kutiji [HR-H-169873914-02] Urbroj: 381-12-01/30-16-05

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-169873914
  • Datum autorizacije:
  • 22-12-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

IRUZID 10 mg/12,5 mg tablete

IRUZID 20 mg/12,5 mg tablete

IRUZID 20 mg/25 mg tablete

lizinopril/hidroklorotiazid

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se Vašem liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im naškoditi, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti Vašeg liječnika ili ljekarnika. To

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je IRUZID i za što se koristi?

Što morate znati prije nego počnete uzimati IRUZID?

Kako uzimati IRUZID?

Moguće nuspojave

Kako čuvati IRUZID?

Sadržaj pakiranja i druge informacije

1.

Što je IRUZID i za što se koristi?

Naziv lijeka kojeg uzimate je IRUZID koji kao djelatne tvari sadrži lizinopril i hidroklorotiazid.

IRUZID se primjenjuje u liječenju povišenog krvnog tlaka (hipertenzije). Sadrži dvije djelatne tvari koje

se zovu lizinopril i hidroklorotiazid.

Lizinopril pripada skupini lijekova koji se nazivaju inhibitori angiotenzin konvertirajućeg enzima (ACE-

inhibitori) i djeluje tako da širi krvne žile i time olakšava srcu istiskivanje krvi u sve dijelove tijela.

Hidroklorotiazid

pripada

skupini

lijekova

koji

nazivaju

diuretici

(tablete

mokrenje).

Hidroklorotiazid povećava količinu tekućine koju gubite urinom te se tako smanjuje količina tekućine u

krvnim žilama.

2.

Što morate znati prije nego počnete uzimati IRUZID?

Nemojte uzimati IRUZID:

ako ste alergični na lizinopril, hidroklorotiazid ili bilo koji drugi sastojak ovog lijeka (naveden u

dijelu 6.)

ako ste alergični na druge ACE-inhibitore ili druge derivate sulfonamida. Pitajte svog liječnika

ukoliko niste sigurni

ako ste već prije uzimali lijek iz iste skupine kojoj pripada IRUZID (ACE-inhibitori) i imali

alergijsku reakciju praćenu oticanjem lica, usana, jezika i/ili grla, pri čemu ste otežano gutali ili disali

ako imate dijagnozu nasljednog ili urođenog angioedema (oticanje kože osobito oko očiju, usana,

nosa, jezika, glasnica (larinks) ili ruku. To znači da ste ili rođeni s ovom bolešću ili Vaš liječnik ne

zna što ju uzrokuje.

ako ste trudni više od 3 mjeseca (također je bolje izbjegavati IRUZID i tijekom rane trudnoće) (vidjeti

Trudnoća i dojenje

ako imate ozbiljnih problema s bubrezima

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22-12-2016

O D O B R E N O

ako imate ozbiljnih problema s jetrom

ako ste prestali mokriti

ako imate šećernu bolest ili oštećenu funkciju bubrega i liječite se lijekom za snižavanje krvnog tlaka

koji sadrži aliskiren.

Ako se nešto od gore navedenog odnosi na Vas, nemojte uzimati IRUZID. Ukoliko niste sigurni,

obratite se svome liječniku ili ljekarniku prije nego uzmete ovaj lijek.

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete IRUZID:

obavijestite Vašeg liječnika o bilo kojem zdravstvenom problemu koji imate ili ste imali, kao i o bilo

kojoj alergiji

ako bolujete od bolesti jetre, bubrega ili imate problema sa srcem

ako idete na dijalizu

ako imate presađen bubreg

ako ste nedavno obilno povraćali ili imali proljev

ako su Vam rekli da imate neuobičajene razine sljedećih tvari koje se normalno nalaze u organizmu:

kalija, kalcija, ureje, kreatinina, mokraćne kiseline, kolesterola ili triglicerida

ako imate giht

ako imate stanje koje uzrokuje bolove u zglobovima, kožni osip i vrućicu (naziva se sistemski lupus

eritematozus)

ako razvijete žuticu (žutilo kože i/ili bjeloočnica)

ako imate šećernu bolest (Vaš liječnik će Vas možda htjeti nadzirati prvih mjesec dana liječenja)

ako mislite da ste trudni (ili planirate trudnoću). Uzimanje lijeka IRUZID ne preporučuje se u ranoj

trudnoći i ne smijete ga uzimati ako ste trudni više od 3 mjeseca zbog toga što može uzrokovati teška

oštećenja Vašeg djeteta (vidjeti dio

Trudnoća i dojenje

Obavijestite Vašeg liječnika ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za

liječenje visokog krvnog tlaka:

blokator angiotenzin II receptora (ARB) (nazivaju se i sartanima – primjerice valsartan, telmisartan,

irbesartan), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću

aliskiren.

Liječnik Vam može provjeravati bubrežnu funkciju, krvni tlak i količinu elektrolita (npr. kalija) u krvi u

redovitim intervalima.

Vidjeti također informacije u dijelu

Nemojte uzimati IRUZID

Ukoliko započinjete tretmane desenzibilizacije, to su tretmani koji se koriste za smanjenje alergijskih

reakcija na ubode ose ili pčele, obavijestite liječnika koji provodi postupak da uzimate IRUZID.

Ukoliko započinjete tretman za uklanjanje kolesterola iz Vaše krvi (naziva se LDL afereza), obavijestite

liječnika koji provodi postupak da uzimate IRUZID.

Ako idete na operaciju

Prije kirurškog zahvata i anestezije (čak i one kod stomatologa) obavijestite liječnika ili stomatologa da

uzimate IRUZID jer je moguć iznenadni pad krvnog tlaka.

Djeca i adolescenti

IRUZID nije namijenjen za primjenu u djece.

Drugi lijekovi i IRUZID

Obavijestite Vašeg liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje

druge lijekove, uključujući i one koje nabavljate bez recepta.

Neki lijekovi mogu utjecati na djelovanje drugih lijekova.

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O D O B R E N O

Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza:

ako uzimate neki blokator angiotenzin II receptora (ARB) ili aliskiren (vidjeti također dijelove

Nemojte uzimati IRUZID

Upozorenja i mjere opreza

Osobito je važno da obavijestite Vašeg liječnika ako uzimate lijekove za:

liječenje šećerne bolesti kao što su inzulin ili tablete za snižavanje razine šećera u krvi (npr. aliskiren)

liječenje mentalnih poremećaja kao što su litij ili antipsihotici

liječenje gihta (kao što je alopurinol)

liječenje raka uključujući tzv. mTOR inhibitore (npr., temsirolimus, sirolimus, everolimus)

liječenje poremećaja srčanog ritma (npr. prokainamid ili sotalol)

probavne smetnje (npr. antacidi)

snižavanje krvnog tlaka, za liječenje šoka, zatajenja srca, astme ili alergija (npr. efedrin, noradrenalin

ili epinefrin (adrenalin)

nesanicu ili smanjenje tjeskobe (sedativi)

povišen kolesterol (lijekovi koji se nazivaju kolestiramin ili kolestipol).

Ili ako uzimate:

diuretike (tablete za mokrenje). Ako već uzimate diuretike, Vaš liječnik će Vam možda reći da

smanjite dozu diuretika, ili čak prestanete uzimati diuretik, prije nego počnete uzimati IRUZID.

steroide za liječenje raznih stanja uključujući reumatizam, artritis, alergijska stanja, određene kožne

bolesti, astmu ili poremećaje krvi

nesteroidne protuupalne lijekove (vrsta lijekova protiv boli, npr. indometacin)

opioidne lijekove protiv bolova (npr. kodein, dekstropopoksifen, diamorfin, morfin, pentazocin,

petidin)

lijekove koji suprimiraju Vaš imunološki sustav nakon operacije (npr. ciklosporin) ili neki autoimuni

poremećaj kao što je reumatoidni artritis

ACTH kako biste saznali radi li Vaša nadbubrežna žlijezda ispravno

nadomjeske kalija, lijekove koji štede kalij, nadomjeske soli koji sadrže kalij ili ako ste na dijeti sa

smanjenim unosom soli

antidepresive i/ili antipsihotike

soli zlata za liječenje artritisa

lijekove za opuštanje mišića koji se koriste pri operacijama (npr., tubokurarinklorid)

trimetoprim (za liječenje urinarnih infekcija).

Uzimanje lijeka IRUZID može utjecati na neke nalaze testova krvi i urina. Napomenite Vašem liječniku

da uzimate IRUZID ako ćete raditi neku od ovih pretraga.

IRUZID s hranom i pićem

IRUZID tablete možete uzimati neovisno o obroku.

Trudnoća i dojenje

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se svom liječniku

ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Liječnik će preporučiti prestanak primjene IRUZID tableta prije nego zatrudnite ili odmah nakon potvrde

trudnoće te Vam savjetovati da umjesto IRUZID tableta uzmete drugi lijek. Ne preporučuje se primjena

IRUZID tableta u ranoj trudnoći. Ako ste trudni dulje od 3 mjeseca, ne smijete uzimati IRUZID jer

njegova primjena nakon trećeg mjeseca trudnoće može izazvati teško oštećenje djeteta.

Obavijestite liječnika ako dojite ili planirate dojiti. Ne preporučuje se primjena IRUZID tableta u dojilja.

Ako želite dojiti (osobito ako se radi o novorođenčetu ili nedonoščetu), liječnik može izabrati drugu

terapiju.

Upravljanje vozilima i strojevima

Ovaj lijek može ponekad uzrokovati omaglicu i umor što može utjecati na sposobnost upravljanja

vozilima i strojevima, posebno na početku liječenja, tijekom prilagodbe doze ili pri istodobnoj primjeni s

alkoholom. U slučaju reakcije na lijek, nemojte voziti niti koristiti alate ili strojeve.

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O D O B R E N O

Prije navedenih aktivnosti preporučuje se da utvrdite kako reagirate na uzimanje ovog lijeka.

3.

Kako uzimati IRUZID?

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik. Provjerite s Vašim liječnikom ako

niste sigurni.

Preporučena doza je jedna IRUZID tableta jedanput na dan.

IRUZID se može uzimati u bilo koje doba dana, prije, tijekom ili nakon obroka. Odaberite vrijeme za

uzimanje tablete koje Vam najviše odgovara te uzimajte tabletu svaki dan u to vrijeme.

Budite posebno oprezni nakon uzimanja prve doze lijeka ili nakon povećanja doze. Ukoliko osjetite

omaglicu ili ošamućenost hitno se javite svom liječniku.

Učinak IRUZID tableta traje 24 sata stoga trebate uzimati samo jednu tabletu jedanput na dan.

Uzimajte IRUZID onoliko dugo koliko je odredio Vaš liječnik.

Ako uzmete više IRUZID tableta nego što ste trebali

Ako ste uzeli previše tableta, odmah zatražite medicinsku pomoć. Simptomi koji bi se najvjerojatnije

javili u slučaju predoziranja su ošamućenost ili omaglica zbog pada krvnog tlaka.

Ako ste zaboravili uzeti IRUZID

Ako zaboravite uzeti lijek, NE BRINITE

- samo uzmite tabletu sljedeći dan prema uobičajenom

rasporedu. NEMOJTE uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka, obratite se svom

liječniku ili ljekarniku.

4.

Moguće nuspojave

Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće razviti kod svakoga.

Prestanite uzimati tablete i odmah se javite liječniku ukoliko Vam se javi bilo koji od sljedećih

simptoma: oticanje lica, usana, jezika i/ili grla, zbog čega disanje ili gutanje može biti otežano. Ovo

mogu biti znakovi alergijske reakcije.

Prijavljene su i sljedeće nuspojave:

Često (javljaju se u do 1 na 10 bolesnika):

omaglica, glavobolja, osjećaj ošamućenosti nakon naglog ustajanja zbog pada krvnog tlaka (ortostatska

hipotenzija) što može uzrokovati nesvjesticu, kašalj, proljev, povraćanje te bubrežne tegobe.

Manje često (javljaju se u do 1 na 100 bolesnika):

neuobičajeni osjećaj kao trnci i bockanje, osjećaj vrtnje, promjene osjeta okusa, promjene raspoloženja,

poteškoće sa spavanjem, srčani ili moždani udar u nekih bolesnika (koji je možda bio uzrokovan padom

krvnog tlaka), brzi ili nepravilni otkucaji srca, Reynaudov sindrom (simptomi uključuju hladne prste na

rukama i nogama), kihanje, mučnina, bol u trbuhu, probavne tegobe, osip, svrbež, impotencija, slabost i

umor, promjene nekih krvnih nalaza.

Rijetko (javljaju se u do 1 na 1000 bolesnika):

mentalna smetenost, suha usta, koprivnjača i svrbež, gubitak kose, crvenilo kože, visoke razine ureje u

krvi, bubrežne tegobe ili zatajenje bubrega, povećanje dojki u muškaraca, niske razine natrija u krvi koji

može uzrokovati slabost, umor, glavobolju, mučninu, povraćanje i grčeve.

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Vrlo rijetko (javljaju se u do 1 na 10 000 bolesnika uključujući izolirane slučajeve):

vrlo rijetko su prijavljeni slučajevi poremećaja krvi koji mogu uzrokovati vrućicu ili zimicu, bolove u

grlu, ranice u ustima ili grlu, neuobičajeno krvarenje ili neobjašnjive modrice. Otečeni limfni čvorovi,

nizak šećer u krvi, bronhitis, bol u sinusima, otežano disanje, upala gušterače, hepatitis (koji uzrokuje

mučninu, vrućicu i tamno obojan urin), žutica (žuto obojana koža i/ili bjeloočnice), zatajenje jetre,

izrazito znojenje, mjehurići na koži, kožne tegobe uključujući crvenilo i ljuštenje kože i bolna područja,

promjene u količini urina.

Vrlo rijetko u nekih bolesnika je prijavljen neželjeni razvoj hepatitisa koji je napredovao do zatajenja

jetre. Ukoliko se razvije žutica, odmah obavijestite Vašeg liječnika.

Prijavljeno je i stanje sa skupinom simptoma koji uključuju vrućicu, bolove u mišićima i zglobovima te

upalu krvnih žila. Također se može javiti osjetljivost kože na svjetlost te osip.

Ostale nuspojave (nepoznate učestalosti):

depresija, bol i oticanje žlijezda slinovnica, gubitak apetita (anoreksija), prisutnost šećera u urinu, povišen

kolesterol, giht, nemir, prolazno zamućenje vida, vrtoglavica (osjećaj vrtnje), nakupljanje tekućine u

plućima, zatvor, osjetljivost na svjetlost, neuobičajeno krvarenje ili modrice ispod kože.

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. Ovo uključuje i svaku

moguću

nuspojavu

koja

nije

navedena

ovoj

uputi.

Nuspojave

možete

prijaviti

izravno

putem

nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati IRUZID?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 25

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju. Rok valjanosti

odnosi se na zadnji dan navedenog mjeseca.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika kako baciti

lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranja i druge informacije

Što IRUZID sadrži?

Jedna IRUZID 10 mg/12,5 mg tableta sadrži 10 mg lizinoprila u obliku lizinopril dihidrata i 12,5 mg

hidroklorotiazida.

Jedna IRUZID 20 mg/12,5 mg tableta sadrži 20 mg lizinoprila u obliku lizinopril dihidrata i 12,5 mg

hidroklorotiazida.

Jedna IRUZID 20 mg/25 mg tableta sadrži 20 mg lizinoprila u obliku lizinopril dihidrata i 25 mg

hidroklorotiazida.

Pomoćne tvari su:

IRUZID 10 mg/12,5 mg: manitol (E421); kalcijev hidrogenfosfat dihidrat; kukuruzni škrob; škrob,

prethodno geliran; magnezijev stearat; boja indigo carmine (E132).

IRUZID 20 mg/12,5 mg: manitol (E421); kalcijev hidrogenfosfat dihidrat; kukuruzni škrob; škrob,

prethodno geliran; magnezijev stearat; željezov oksid, žuti (E172).

IRUZID

mg/25

manitol

(E421);

kalcijev

hidrogenfosfat

dihidrat;

kukuruzni

škrob;

škrob,

prethodno geliran; magnezijev stearat; željezov oksid, crveni (E172).

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Kako IRUZID izgleda i sadržaj pakiranja?

IRUZID 10 mg/12,5 mg: plave, bikonveksne i heksagonalne tablete, promjera oko 7 mm.

IRUZID 20 mg/12,5 mg: žute, bikonveksne i heksagonalne tablete, promjera oko 9 mm.

IRUZID 20 mg/25 mg: svijetlo roze, bikonveksne i okrugle tablete, promjera oko 8 mm.

IRUZID 10 mg/12,5 mg; 20 mg/12,5 mg i 20 mg/25 mg: 30 (1x30) i 60 (2x30) tableta u PVC/PVDC/Al

blisteru, u kutiji.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

BELUPO lijekovi i kozmetika d.d.

Ulica Danica 5

48 000 Koprivnica

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u prosincu 2016.

H A L M E D

22-12-2016

O D O B R E N O

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Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

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

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

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

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

FDA - U.S. Food and Drug Administration

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

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

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

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

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

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

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

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

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

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

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

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

Recently Updated Records for the Week of September 12, 2018 Last Modified Date: Friday, September 07, 2018

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

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

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

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

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety