Oxyglobin

Hauptinformation

  • Handelsname:
  • Oxyglobin
  • Verwenden für:
  • Tiere
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Oxyglobin
    Europäische Union
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Hunde
  • Therapiebereich:
  • BLUT-ERSATZSTOFFE UND PERFUSION LÖSUNGEN
  • Anwendungsgebiete:
  • Oxyglobin liefert Sauerstoff tragende Unterstützung für Hunde, die Verbesserung der klinischen Zeichen der Anämie für mindestens 24 Stunden, unabhängig von der zugrunde liegenden Erkrankung.
  • Produktbesonderheiten:
  • Revision: 14

Weitere Informationen

Status

  • Quelle:
  • EMA - European Medicines Agency
  • Berechtigungsstatus:
  • Autorisiert
  • Zulassungsnummer:
  • EMEA/V/C/000045
  • Berechtigungsdatum:
  • 29-11-1999
  • EMEA-Code:
  • EMEA/V/C/000045
  • Letzte Änderung:
  • 18-01-2019

Öffentlichen Beurteilungsberichts

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8447

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

EMA/499068/2007

EMEA/V/C/000045

Zusammenfassung des EPAR für die Öffentlichkeit

Oxyglobin

Hämoglobin-Glutamer 200

Das vorliegende Dokument ist eine Zusammenfassung des Europäischen Öffentlichen

Beurteilungsberichts (EPAR), in dem erläutert wird, wie der Ausschuss für Tierarzneimittel (CVMP)

aufgrund der Beurteilung der vorgelegten Unterlagen zu den Empfehlungen bezüglich der

Anwendung des Tierarzneimittels gelangt ist.

Dieses Dokument kann das persönliche Gespräch mit dem Tierarzt nicht ersetzen. Wenn Sie

weitere Informationen über den Gesundheitszustand oder die Behandlung Ihres Tieres benötigen,

wenden Sie sich bitte an Ihren Tierarzt. Wenn Sie weitere Informationen zur Grundlage der

Empfehlungen des CVMP wünschen, lesen Sie bitte die wissenschaftliche Diskussion (ebenfalls Teil

des EPAR).

Was ist Oxyglobin?

Oxyglobin enthält Hämoglobin-Glutamer 200 vom Rind (in einer Stärke von 130 mg/ml), das zu

einer Klasse von Arzneimitteln mit sauerstofftragender Funktion gehört. Oxyglobin ist eine Lösung

zur Infusion (Tropf in eine Vene).

Wofür wird Oxyglobin angewendet?

Oxyglobin wird angewendet, um den Sauerstoffgehalt des Blutes bei Hunden mit Anämie

(Blutarmut, d. h. Mangel an roten Blutkörperchen oder rotem Blutfarbstoff) zu steigern. Oxyglobin

sollte für mindestens 24 Stunden angewendet werden.

Oxyglobin wird zuerst auf 37°C erwärmt und anschließend in einer Dosierung von 30 ml pro

Kilogramm Körpergewicht mit einer Infusionsgeschwindigkeit von bis zu 10 ml/kg pro Stunde

verabreicht. Die optimale Dosis richtet sich danach, wie schwer die Anämie ist und wie lange sie

bereits besteht sowie nach der gewünschten Wirkungsdauer des Arzneimittels. Oxyglobin ist nur

für die einmalige Anwendung bestimmt. Die Verträglichkeit von Oxyglobin mit dem Blut des

Oxyglobin

EMA/499068/2007

Page 2/3

Hundes muss vor der Anwendung nicht überprüft werden. Nähere Informationen siehe

Packungsbeilage.

Wie wirkt Oxyglobin?

Oxyglobin ist eine auf Hämoglobin basierende sauerstofftragende Lösung. Es enthält Hämoglobin-

Glutamer 200, das aus Hämoglobin (dem Eiweißstoff in den roten Blutkörperchen, der den

Sauerstoff durch den Körper transportiert) aus dem Blut von Kühen hergestellt und in einer

Standardlösung (Ringer-Lactat) verdünnt wird, um fehlendes Blutvolumen zu ersetzen. Nach

Verabreichung an Hunde steigert Oxyglobin die Hämoglobinmenge im Blut und das Blutvolumen im

Körper. Dies führt dazu, dass mehr Sauerstoff im Blut durch die Arterien transportiert wird, und

lindert dadurch die Symptome der Anämie.

Wie wurde Oxyglobin untersucht?

Oxyglobin wurde in einer Studie an Hunden mit kurzfristiger oder lang anhaltender Anämie infolge

von Blutverlust, krankhaftem Abbau von roten Blutkörperchen oder unzureichender Bildung neuer

roter Blutkörperchen untersucht. In der Studie wurden die Wirkungen von Oxyglobin mit dem

Verlauf ohne Behandlung verglichen.

Welchen Nutzen hat Oxyglobin in diesen Studien gezeigt?

In der Hauptstudie an Hunden benötigten 95 % der mit Oxyglobin behandelten Tiere nach

24 Stunden keine Behandlung mit anderen Sauerstoffträgern, verglichen mit 32 % der Hunde, die

nicht mit Oxyglobin behandelt wurden. Bei den mit Oxyglobin behandelten Hunden dauerte es

länger, bis eine zusätzliche Behandlung erforderlich war. Das Arzneimittel steigerte zudem die

Hämoglobinkonzentrationen im Blut und verbesserte die körperliche Verfassung der Hunde.

Weitere Studien untermauerten diese Ergebnisse und zeigten, dass Oxyglobin bei anderen Tieren

als Kühen Sauerstoff aufnehmen, transportieren und abgeben kann. Dieser Sauerstoff kann dann

Gewebe wie z. B. Muskelgewebe versorgen.

Welches Risiko ist mit Oxyglobin verbunden?

Die mit Oxyglobin beobachteten Nebenwirkungen werden sowohl durch das Medikament als auch

durch die zugrundeliegende Ursache der Anämie hervorgerufen. Sie umfassen eine Verfärbung von

Haut, Schleimhäuten (Auskleidung von Körperhöhlen) und Sklera (weiße Augenhaut), dunklen Kot

und verfärbten oder trüben Urin. Eine häufige Nebenwirkung ist die „Kreislaufüberladung“

(Blutflüssigkeit tritt aus den Blutgefäßen aus), die zu Tachypnoe (beschleunigter Atmung),

Dyspnoe (Kurzatmigkeit), verschärften Lungengeräuschen und Lungenödem

(Flüssigkeitsansammlung in den Lungen) führt. Weitere häufige Nebenwirkungen sind Erbrechen,

Appetitlosigkeit und Fieber. Die vollständige Auflistung der im Zusammenhang mit Oxyglobin

berichteten Nebenwirkungen ist der Packungsbeilage zu entnehmen.

Oxyglobin darf nicht angewendet werden bei Tieren, die bereits früher mit Oxyglobin behandelt

wurden, oder bei Hunden mit erhöhtem Risiko einer Kreislaufüberladung wie etwa bei Oligurie oder

Anurie (verminderte oder fehlende Urinausscheidung) oder fortgeschrittener Herzkrankheit.

Oxyglobin

EMA/499068/2007

Page 3/3

Welche Vorsichtsmaßnahmen müssen von Personen, die das

Arzneimittel verabreichen oder mit dem Tier in Kontakt kommen,

getroffen werden?

Es sind keine Vorsichtsmaßnahmen erforderlich.

Warum wurde Oxyglobin zugelassen?

Der Ausschuss für Tierarzneimittel (CVMP) gelangte zu dem Schluss, dass die Vorteile von

Oxyglobin bei der Verabreichung zusätzlicher Sauerstoffträger zur Verbesserung der klinischen

Zeichen der Anämie für mindestens 24 Stunden unabhängig von der zugrundeliegenden

Erkrankung gegenüber den Risiken überwiegen, und empfahl, die Genehmigung für das

Inverkehrbringen von Oxyglobin zu erteilen. Das Nutzen-Risiko-Verhältnis ist im Modul zur

wissenschaftlichen Diskussion dieses EPAR zu finden.

Weitere Informationen über Oxyglobin:

Am 14. Juli 1999 erteilte die Europäische Kommission eine Genehmigung für das Inverkehrbringen

von Oxyglobin in der gesamten Europäischen Union. Informationen über den Verschreibungsstatus

dieses Arzneimittels finden Sie auf dem Etikett der Faltschachtel.

Diese Zusammenfassung wurde zuletzt im März 2012 aktualisiert.

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

B. PACKUNGSBEILAGE

GEBRAUCHSINFORMATION

Oxyglobin 130 mg/ml Infusionslösung für Hunde

1.

NAME UND ANSCHRIFT DES ZULASSUNGSINHABERS UND, WENN

UNTERSCHIEDLICH, DES HERSTELLERS, DER FÜR DIE CHARGENFREIGABE

VERANTWORTLICH IST

Zulassungsinhaber :

Teleportboulevard 140

1043EJ

Amsterdam

The Netherlands

Für die Chargenfreigabe verantwortlicher Hersteller:

Dales Pharmaceutical Ltd.

Snaygill Industrial Estate

Keighley Road

Skipton

North Yorkshire, BD23 2RW United Kingdom

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

Oxyglobin 130 mg/ml Infusionslösung für Hunde

3.

WIRKSTOFF(E) UND SONSTIGE BESTANDTEILE

Hämoglobin-Glutamer 200 (vom Rind) – 130 mg/ml

4.

ANWENDUNGSGEBIET(E)

Oxyglobin liefert Hunden zusätzliche Sauerstoffträger, die die klinischen Anzeichen von Anämie,

unabhängig von der zugrundeliegenden Erkrankung für die Dauer von mindestens 24 Stunden

verbessern.

5.

GEGENANZEIGEN

Nicht anwenden bei Tieren, die bereits früher mit Oxyglobin behandelt wurden.

Plasmaexpander wie Oxyglobin dürfen nicht an für Kreislaufüberladung anfällige Hunde verabreicht

werden, wie etwa Hunde mit Oligurie oder Anurie oder mit fortgeschrittenen Herzleiden (z.B.

kongestive Herzerkrankungen) oder mit anderen ernsten Störungen der Herzfunktionen.

Oxyglobin ist ausschließlich für die einmalige Anwendung vorgesehen.

6.

NEBENWIRKUNGEN

Während der Untersuchungen zur klinischen Verträglichkeit und Wirksamkeit wurden unerwünschte

Wirkungen festgestellt, die möglicherweise auf Oxyglobin und/oder die der Anämie zugrundeliegende

Erkrankung zurückzuführen waren. Die beobachteten unerwünschten Wirkungen umfassen eine

geringfügige bis mittlere Verfärbung der Schleimhäute, der Skleren sowie des Urins aufgrund der

Metabolisierung und/oder der Ausscheidung von Hämoglobin. Häufig beobachtete Nebenwirkungen

waren Erbrechen, Appetitlosigkeit, Fieber und Kreislaufüberladung mit den entsprechenden klinischen

Symptomen wie Tachypnoe, Dyspnoe, verschärfte Atemgeräusche und Lungenödem. Die

Kreislaufüberladung konnte durch Herabsetzen der Infusionsgeschwindigkeit kontrolliert werden.

Gelegentlich festgestellte Nebenwirkungen waren Durchfall, Hautverfärbung und

Herzrhythmusstörungen. Sehr selten wird Nystagmus beobachtet.

Falls Sie eine Nebenwirkung bei Ihrem Tier/Ihren Tieren feststellen, die nicht in der Packungsbeilage

aufgeführt ist, teilen Sie diese Ihrem Tierarzt oder Apotheker mit.

7.

ZIELTIERART

Hund

8.

DOSIERUNG FÜR JEDE TIERART, ART UND DAUER DER ANWENDUNG

Die empfohlene Dosierung für Oxyglobin beträgt 30 ml/kg Körpergewicht zur intravenösen

Verabreichung bei einer empfohlenen Infusionsgeschwindigkeit von bis zu 10 ml/kg/Std.

In bestimmten klinischen Situationen kann eine Dosis von 15 – 30 ml/kg KG angemessen sein. Die

optimale Dosierung richtet sich nach dem Schweregrad und der Chronizität der Anämie sowie nach der

gewünschten Wirkungsdauer. (Siehe Tabelle A: Pharmakokinetische Parameter)

Tabelle A: Pharmakokinetische Parameter bei verschiedenen Dosierungen nach einer einmaligen

Oxyglobin-Infusion

Dosis

(ml/kg)

Plasmakonzentratio n

unmittelbar nach

Infusion*

(g/dl)

Dauer (Stunden):

Oxyglobin-Spiegel über

1 g/dl

Elimination aus dem

Plasma*** (Tage)

2.0–2.5

23–39

4–6

3.4–4.3

66–70

5–7

3.6–4.8

74–82

5–9**

* Bereich basiert auf Mittelwert ± Standardabweichung

** Bereich basiert auf geschätztem Mittelwert innerhalb eines 95 %igen Vorhersageintervalls

*** Bereich basiert auf 5 addierten Halbwertzeiten

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Die Umverpackung ist vor der Verwendung zu entfernen. Innerhalb von 24 Stunden verwenden.

Oxyglobin ist unter aseptischen Bedingungen mit Hilfe eines üblichen intravenösen Infusionsbesteckes

und eines Katheters zu verabreichen.

Wie jede intravenöse Infusion sollte Oxyglobin vor der Verabreichung auf 37 ° C erwärmt werden.

Nicht in dem Mikrowellenofen erwärmen. Nicht überhitzen.

Nicht gleichzeitig mit anderen Flüssigkeiten oder Arzneimitteln über dieselbe Infusionsvorrichtung

verabreichen. Dem Infusionsbeutel keine Arzneimittel oder Lösungen zugeben. Nicht den Inhalt

mehrerer Infusionsbeutel mischen.

10.

WARTEZEIT

Nicht zutreffend.

11.

BESONDERE LAGERUNGSHINWEISE

Arzneimittel unzugänglich für Kinder aufbewahren.

Nicht über 30

C lagern. Nicht einfrieren. Nach dem Entfernen der Umverpackung innerhalb von 24

Stunden verwenden.

Sie dürfen das Arzneimittel nach dem auf dem Etikett angegebenen Verfalldatum nicht mehr anwenden.

12.

BESONDERE WARNHINWEISE

Nicht anwenden bei Tieren, die bereits früher mit Oxyglobin behandelt wurden.

Eine gleichzeitige Behandlung der Anämieursachen sollte eingeleitet werden.

Das Tier sollte vor der Verabreichung nicht zu viel Wasser aufnehmen. Aufgrund der

plasmaexpandierenden Eigenschaften von Oxyglobin sollte die Möglichkeit einer Kreislaufüberladung

berücksichtigt werden, insbesondere wenn zusätzliche Infusionen, speziell kolloidale Lösungen,

verabreicht werden. Jegliche Anzeichen einer Kreislaufüberladung müssen sorgfältig überwacht werden

oder der zentrale Venendruck (ZVD) gemessen werden. Bei Anzeichen einer Kreislaufüberladung oder

wenn der ZVD einen klinisch nicht mehr vertretbaren Wert erreicht, ist die Oxyglobin-Infusion

zeitweilig auszusetzen und kann im Anschluss an das Abklingen der Anzeichen und/oder nach Senkung

des ZVD mit geringerer Tropfgeschwindigkeit wieder aufgenommen werden.

Die Behandlung mit Oxyglobin hat eine geringfügige Senkung des Hämatokrit unmittelbar im

Anschluss an die Infusion zur Folge.

Verträglichkeit und Wirksamkeit von Oxyglobin bei Hunden mit Thrombozytopenie begleitet von

Spontanblutungen, sowie bei Hunden mit Oligurie oder mit Anurie oder fortgeschrittenen Herzleiden

bisher nicht untersucht.

Die Unbedenklichkeit von Oxyglobin bei trächtigen oder säugenden Hündinnen wurde nicht geprüft.

Die Verabreichung an solche Tiere wird nicht empfohlen.

13.

BESONDERE VORSICHTSMASSNAHMEN FÜR DIE ENTSORGUNG VON NICHT

VERWENDETEM ARZNEIMITTEL ODER VON ABFALLMATERIALIEN, SOFERN

ERFORDERLICH

Nicht verwendete Tierarzneimittel oder davon stammende Abfallmaterialien sind entsprechend den

örtlichen Vorschriften zu entsorgen.

14.

GENEHMIGUNGSDATUM DER PACKUNGSBEILAGE

Detaillierte Angaben zu diesem Tierarzneimittel finden Sie auf der Website der Europäischen

Arzneimittel-Agentur (EMA) unter

http://www.ema.europa.eu/.

15.

WEITERE ANGABEN

Laboruntersuchungen

Klinische Chemie: Im Serum enthaltenes Oxyglobin kann kolorometrische Messergebnisse

beeinflussen. Bei der chemischen Untersuchung des Serums ermittelte Messergebnisse können in

Abhängigkeit von der angewandten Dosis, der Zeitspanne seit der Infusion, dem Typ des

Analysegerätes sowie der verwendeten Reagenzien entweder künstlich erhöht oder erniedrigt sein. (Die

Vertriebsfirma liefert Ihnen spezifische Daten).

Hämatologie: Keine artifizielle Beeinflussung der Messergebnisse. Stellen Sie sicher, dass

Hämoglobin direkt gemessen und nicht über die Zahl der Erythrozyten berechnet wird.

Blutgerinnung: Die Prothrombinzeit (PT) und die aktivierte partielle Thromboplastinzeit (aPTT)

können durch mechanische, magnetische und Lichtstreuungs-Methoden genau bestimmt werden.

Photometrische Verfahren zur Bestimmung der Koagulation sind bei Vorhandensein von Oxyglobin

nicht zuverlässig.

Harnuntersuchung: Die Ergebnisse der Sedimentuntersuchung werden nicht beeinflusst. Die Resultate

klinisch-chemischer Harnuntersuchungen (z.B. mit Teststreifen auf pH, Glukose, Ketonkörper, Protein)

sind bei deutlicher Urinverfärbung unzuverlässig.

60 ml Infusionsbeutel.

125 ml Infusionsbeutel.

Es werden möglicherweise nicht alle Packungsgrößen in Verkehr gebracht.

Falls weitere Informationen über das Tierarzneimittel gewünscht werden, setzen Sie sich bitte mit dem

örtlichen Vertreter des Zulassungsinhabers in Verbindung

Deutschland

Albrecht GmbH

Hauptstr. 6-8

88326 Aulendorf

Tel.: +49 (0) 752 52 05 10

Fax: +49 (0) 752 57 00 5

United Kingdom

Dechra Veterinary Products Limited

Sansaw Business Park, Hadnall,

Shrewsbury, Shropshire, SY4 4AS

Tel.: +44 (0) 19 39 21 12 00

Fax: +44 (0) 19 39 21 12 01

France

Dechra Veterinary Products SAS

60, Avenue du Centre,

78180 Montigny-le-Bretonneux

Tel: +33 1 3048 7140

Fax: +33 1 3081 9963

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

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

Published on: Mon, 17 Dec 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 pencycuron. To assess the occurrence of pencycuron 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 States (incl...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Thu, 13 Dec 2018 Following a request from the European Commission, EFSA was asked to review the comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments originating from the applicant (Han‐Biotech GmbH) were submitted to EFSA via the E...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

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...

Europe - EFSA - European Food Safety Authority Publications

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...

Europe - EFSA - European Food Safety Authority Publications

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

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

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

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

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

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

29-8-2018

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

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

Published on: Tue, 28 Aug 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 sintofen. To assess the occurrence of sintofen 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 ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 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 prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 Aug 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 napropamide. To assess the occurrence of napropamide 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 (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 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 myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-3-2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007.

Danish Medicines Agency

18-12-2018


Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Europe - EMA - European Medicines Agency

5-12-2018


Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety