Dexmedetomidine EVER Pharma

Hauptinformation

  • Handelsname:
  • Dexmedetomidine EVER Pharma Konzentrat zur Herstellung einer Infusionslösung 100 µg-ml
  • Dosierung:
  • 100 µg-ml
  • Darreichungsform:
  • Konzentrat zur Herstellung einer Infusionslösung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Dexmedetomidine EVER Pharma Konzentrat zur Herstellung einer Infusionslösung 100 µg-ml
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • psycholeptica, andere Hypnotika und Sedativa

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE520151
  • Letzte Änderung:
  • 11-04-2018

Packungsbeilage

Gebrauchsinformation: Information für Anwender

Dexmedetomidine EVER Pharma 100 Mikrogramm/ml Konzentrat zur Herstellung

einer Infusionslösung

Dexmedetomidin

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

Arzneimittels begonnen wird, 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 das medizinische

Fachpersonal.

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

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

Was in dieser Packungsbeilage steht

Was ist Dexmedetomidine EVER Pharma und wofür wird es angewendet?

Was sollten Sie vor der Anwendung von Dexmedetomidine EVER Pharma beachten?

Wie ist Dexmedetomidine EVER Pharma anzuwenden?

Welche Nebenwirkungen sind möglich?

Wie ist Dexmedetomidine EVER Pharma aufzubewahren?

Inhalt der Packung und weitere Informationen

1.

Was ist Dexmedetomidine EVER Pharma und wofür wird es angewendet?

Dexmedetomidine EVER Pharma enthält einen Wirkstoff namens Dexmedetomidin, der zu einer

Gruppe von Arzneimitteln gehört, die als Sedativa bezeichnet werden. Es wird angewendet zur

Sedierung (d. h. zur Beruhigung, zum Erreichen eines Dämmerzustandes oder zur Schlafförderung)

von erwachsenen Patienten, die stationär intensivmedizinisch behandelt werden oder zur Sedierung bei

diagnostischen oder chirurgischen Maßnahmen.

2.

Was sollten Sie vor der Anwendung von Dexmedetomidine EVER Pharma beachten?

Dexmedetomidine EVER Pharma darf nicht angewendet werden

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

Bestandteile dieses Arzneimittels sind;

wenn Sie Herzrhythmusstörungen haben (Herzblock 2. oder 3. Grades);

wenn Sie einen sehr niedrigen Blutdruck haben, der auf eine Behandlung nicht anspricht;

wenn Sie vor kurzem einen Schlaganfall oder eine andere ernsthafte Erkrankung hatten, die die

Blutversorgung des Gehirns beeinträchtigt hat.

Warnhinweise und Vorsichtsmaßnahmen

Vor der Behandlung müssen Sie Ihrem Arzt oder dem medizinischen Fachpersonal mitteilen, ob einer

oder mehrere der untenstehenden Punkte auf Sie zutreffen, da die Anwendung von Dexmedetomidine

EVER Pharma dann mit Vorsicht erfolgen muss:

wenn Sie einen auffällig langsamen Herzschlag haben (entweder aufgrund einer Erkrankung oder

weil Sie körperlich gut trainiert sind)

wenn Sie einen niedrigen Blutdruck haben

wenn Sie ein geringes Blutvolumen haben, z. B. nach einer Blutung

wenn Sie bestimmte Herzerkrankungen haben

wenn Sie über 65 Jahre alt sind

wenn Sie eine neurologische Erkrankung haben (beispielsweise eine Kopf- oder

Wirbelsäulenverletzung oder einen Schlaganfall)

wenn Sie schwere Probleme mit der Leber haben

wenn Sie schon einmal nach der Anwendung bestimmter Arzneimittel, insbesondere von

Anästhetika, hohes Fieber entwickelt haben.

Anwendung von Dexmedetomidine EVER Pharma zusammen mit anderen Arzneimitteln

Informieren Sie Ihren Arzt oder das medizinische Fachpersonal, wenn Sie andere Arzneimittel

anwenden bzw. kürzlich andere Arzneimittel angewendet haben oder beabsichtigen andere

Arzneimittel anzuwenden.

Die folgenden Arzneimittel können die Wirkung von Dexmedetomidine EVER Pharma verstärken:

Schlaf- oder Beruhigungsmittel (z.B. Midazolam, Propofol)

Starke Schmerzmittel (z. B. Opioide wie Morphin, Codein)

Narkosemittel (z. B. Sevofluran, Isofluran)

Wenn Sie Blutdruck- und Herzfrequenz-senkende Mittel einnehmen, kann die gleichzeitige

Anwendung von Dexmedetomidine EVER Pharma deren Wirkung verstärken. Dexmedetomidine

EVER Pharma darf nicht mit Arzneimitteln angewendet werden, die eine vorübergehende Lähmung

hervorrufen.

Schwangerschaft und Stillzeit

Dexmedetomidine EVER Pharma darf während der Schwangerschaft oder während der Stillzeit nicht

angewendet werden, es sei denn, dass eine Behandlung mit Dexmedetomidine EVER Pharma

aufgrund des klinischen Zustandes der Frau erforderlich ist.

Fragen Sie vor der Anwendung dieses Arzneimittels Ihren Arzt um Rat.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Dexmedetomidine EVER Pharma hat großen Einfluss auf die Verkehrstüchtigkeit und die Fähigkeit

zum Bedienen von Maschinen. Nachdem Ihnen Dexmedetomidine EVER Pharma verabreicht wurde,

dürfen Sie kein Fahrzeug lenken, Maschinen bedienen oder gefährliche Arbeiten verrichten. Fragen

Sie Ihren Arzt, wann Sie diese Tätigkeiten wieder aufnehmen können und wann Sie wieder an Ihren

Arbeitsplatz zurückkehren können.

Dexmedetomidine EVER Pharma enthält Natrium

Dexmedetomidine EVER Pharma enthält Natrium, aber weniger als 1 mmol Natrium pro ml

(3,5 mg/ml).

3.

Wie ist Dexmedetomidine EVER Pharma anzuwenden?

Stationär intensivmedizinische Behandlung

Dexmedetomidine EVER Pharma wird Ihnen von einem Arzt oder medizinischem Fachpersonal

stationär auf der Intensivstation verabreicht.

Sedierung bei ambulanten Eingriffen/Wachsedierung

Dexmedetomidine EVER Pharma wird Ihnen von einem Arzt oder medizinischem Fachpersonal vor

und/oder während diagnostischen oder chirurgischen Maßnahmen verabreicht, die eine Sedierung

erforderlich machen, z.B. zur Sedierung bei ambulanten Eingriffen/Wachsedierung.

Ihr Arzt wird entscheiden, welche Dosis für Sie geeignet ist. Welche Menge Dexmedetomidine EVER

Pharma Sie erhalten, hängt von Ihrem Alter, Ihrer Größe, Ihrem allgemeinen Gesundheitszustand, der

gewünschten Sedierungstiefe und auch davon ab, wie Sie auf das Arzneimittel ansprechen. Ihr Arzt

kann die Dosis erforderlichenfalls anpassen und wird Ihre Herztätigkeit und Ihren Blutdruck während

der Behandlung überwachen.

Dexmedetomidine EVER Pharma wird verdünnt und Ihnen als Infusion („Tropf”) in eine Vene

gegeben.

Nach der Sedierung/Aufwachphase

Ihr Arzt wird Sie nach der Sedierung einige Stunden medizinisch überwachen, um

sicherzustellen, dass es Ihnen gut geht.

Sie dürfen nicht ohne Begleitung nach Hause gehen.

Sie sollten für einige Zeit nach der Anwendung von Dexmedetomidine EVER Pharma keine

Schlaf- und Beruhigungsmittel oder starke Schmerzmittel einnehmen. Sprechen Sie mit Ihrem

Arzt über die Anwendung dieser Mittel und über Alkoholkonsum.

Wenn Sie eine größere Menge von Dexmedetomidine EVER Pharma erhalten haben, als Sie

sollten

Wenn Sie zu viel Dexmedetomidine EVER Pharma erhalten, kann Ihr Blutdruck abfallen, Ihr

Herzschlag langsamer werden und Sie werden möglicherweise übermäßig schläfrig. Ihr Arzt wird

dann entsprechende Gegenmaßnahmen ergreifen.

Wenn Sie zu viel Dexmedetomidine EVER Pharma erhalten, nehmen Sie sofort Kontakt mit Ihren

Arzt, Apotheker oder der Giftnotrufzentrale auf (070/245.245).

Wenn Sie weitere Fragen zur Anwendung dieses Arzneimittels haben, wenden Sie sich an Ihren Arzt.

4.

Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei jedem

auftreten müssen.

Sehr häufig (kann mehr als 1 von 10 Behandelten betreffen):

Verlangsamter Herzschlag

Blutdruckabfall oder -anstieg

veränderte Atmung oder Atemstillstand.

Häufig (kann bis zu 1 von 10 Behandelten betreffen):

Schmerzen in der Brust oder Herzanfall

beschleunigter Herzschlag

erniedrigter oder erhöhter Blutzucker

Übelkeit, Erbrechen oder Mundtrockenheit

Unruhe

Beschwerden nach Absetzen des Arzneimittels

Überwärmung des Körpers.

Gelegentlich (kann bis zu 1 von 100 Behandelten betreffen):

Übersäuerung des Organismus

niedriger Albuminspiegel im Blut

Halluzinationen

Herzschwäche

Kurzatmigkeit und Abflachung der Atmung

mangelnde Wirksamkeit des Arzneimittels

Blähbauch

Durst.

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt, Apotheker oder das

medizinische Fachpersonal. Dies gilt auch für Nebenwirkungen, die nicht in dieser Packungsbeilage

angegeben sind. Sie können Nebenwirkungen auch direkt anzeigen über die Föderalagentur für

Arzneimittel und Gesundheitsprodukte, Abteilung Vigilanz, EUROSTATION II, Victor Hortaplein

40/40, B-1060 Brussel

Website: www.fagg-afmps.be

E-Mail: patientinfo@fagg-afmps.be

Indem Sie Nebenwirkungen melden, können Sie dazu beitragen, dass mehr Informationen über die

Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5.

Wie ist Dexmedetomidine EVER Pharma aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf dem Etikett und dem Umkarton nach EXP angegebenen

Verfalldatum nicht mehr verwenden.

Für dieses Arzneimittel sind bezüglich der Temperatur keine besonderen Lagerungsbedingungen

erforderlich. Die Ampullen oder die Durchstechflaschen im Umkarton aufbewahren, um den Inhalt vor

Licht zu schützen.

6.

Inhalt der Packung und weitere Informationen

Was Dexmedetomidine EVER Pharma enthält

Der Wirkstoff ist Dexmedetomidin. 1 ml Konzentrat enthält Dexmedetomidinhydrochlorid

entsprechend 100 Mikrogramm Dexmedetomidin.

Die sonstigen Bestandteile sind Natriumchlorid und Wasser für Injektionszwecke.

Jede 2 ml-Ampulle enthält 200 Mikrogramm Dexmedetomidin (als Hydrochlorid).

Jede 2 ml-Durchstechflasche enthält 200 Mikrogramm Dexmedetomidin (als Hydrochlorid).

Jede 4 ml-Durchstechflasche enthält 400 Mikrogramm Dexmedetomidin (als Hydrochlorid).

Jede 10 ml-Durchstechflasche enthält 1.000 Mikrogramm Dexmedetomidin (als Hydrochlorid).

Die Konzentration der gebrauchsfertigen Zubereitung nach der Verdünnung beträgt entweder

4 Mikrogramm/ml oder 8 Mikrogramm/ml.

Wie Dexmedetomidine EVER Pharma aussieht und Inhalt der Packung

Konzentrat zur Herstellung einer Infusionslösung (steriles Konzentrat).

Das Konzentrat ist eine klare, farblose Lösung.

Behältnisse

2 ml-Ampullen aus farblosem Glas

2 ml-, 5 ml- oder 10 ml-Durchstechflaschen aus farblosem Glas

Packungsgrößen

5 x 2 ml-Ampullen

25 x 2 ml-Ampullen

5 x 2 ml-Durchstechflaschen

4 x 4 ml-Durchstechflaschen

5 x 4 ml-Durchstechflaschen

4 x 10 ml-Durchstechflaschen

5 x 10 ml-Durchstechflaschen

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer

EVER Valinject GmbH, Oberburgau 3, 4866 Unterach am Attersee, Österreich

Hersteller

EVER Pharma Jena GmbH, Otto-Schott-Straße 15, 07745 Jena, Deutschland

Zulassungsnummer

2 ml-Ampulle: BE520124

2 ml-Durchstechflasche: BE520133

4 ml-Durchstechflasche: BE520142

10 ml-Durchstechflasche: BE520151

Art der Abgabe

Verschreibungspflichtig.

Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR)

unter den folgenden Bezeichnungen zugelassen:

Dexmedetomidin EVER Pharma 100 Mikrogramm/ml Konzentrat zur Herstellung einer

Infusionslösung

Dexmedetomidine EVER Pharma 100 Mikrogramm/ml Konzentrat zur Herstellung einer

Infusionslösung

Dexmedetomidine EVER Pharma

Dexmedetomidin EVER Valinject 100 Mikrogramm/ml Konzentrat zur Herstellung einer

Infusionslösung

Dexmedetomidin EVER Pharma 100 mikrogram/ml koncentrat til infusionsvæske, opløsning

Dexmedetomidina EVER Pharma 100 microgramos/ml concentrado para solución para

perfusión

Dexmedetodimina EVER Pharma

Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion

Dexmedetomidine EVER Pharma 100 microgram/ml concentraat voor oplossing voor infusie

Dexmedetomidine EVER Pharma

Dexmedetomidine EVER Pharma

Dexmedetomidine EVER Pharma 100 mikrogram/ml koncentrat till infusionsvätska, lösning

Dexmedetomidine EVER Pharma 100 mikrogramov/ml infúzny koncentrát

Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion

Diese Packungsbeilage wurde zuletzt genehmigt im 11/2017.

Die folgenden Informationen sind für medizinisches Fachpersonal bestimmt:

Dexmedetomidine EVER Pharma 100 Mikrogramm/ml Konzentrat zur Herstellung einer

Infusionslösung

Art der Anwendung

Die Anwendung von Dexmedetomidine EVER Pharma muss durch Ärzte/medizinisches Fachpersonal

erfolgen, die für das Management von intensivmedizinisch behandelten Patienten oder die

anästhetische Versorgung von Patienten im Operationssaal qualifiziert sind. Dexmedetomidine EVER

Pharma darf nur als verdünnte intravenöse Infusion unter Verwendung einer kontrollierten

Infusionspumpe gegeben werden.

Herstellung der Infusionslösung

Dexmedetomidine EVER Pharma kann mit Glukoselösung 50 mg/ml (5 %), Ringerlösung,

Mannitollösung oder Natriumchlorid 9 mg/ml (0,9 %) Injektionslösung verdünnt werden, um die

erforderliche Konzentration von 4 Mikrogramm/ml oder 8 Mikrogramm/ml vor der Anwendung zu

erreichen. Untenstehenden Tabellen sind die für die Herstellung der Infusion benötigten Volumina zu

entnehmen.

Falls die erforderliche Konzentration 4 Mikrogramm/ml beträgt:

Volumen von Dexmedetomidin

EVER Valinject

100 Mikrogramm/ml Konzentrat zur

Herstellung einer Infusionslösung

Volumen des

Verdünnungsmittels

Infusionsvolumen

gesamt

2 ml

48 ml

50 ml

4 ml

96 ml

100 ml

10 ml

240 ml

250 ml

20 ml

480 ml

500 ml

Falls die erforderliche Konzentration 8 Mikrogramm/ml beträgt:

Volumen von Dexmedetomidin

EVER Valinject

100 Mikrogramm/ml Konzentrat zur

Herstellung einer Infusionslösung

Volumen des

Verdünnungsmittels

Infusionsvolumen

gesamt

4 ml

46 ml

50 ml

8 ml

92 ml

100 ml

20 ml

230 ml

250 ml

40 ml

460 ml

500 ml

Die Lösung vorsichtig schütteln, um eine gute Durchmischung zu erreichen.

Dexmedetomidine EVER Pharma muss vor der Gabe visuell auf feste Bestandteile und Verfärbungen

kontrolliert werden.

Es konnte gezeigt werden, dass Dexmedetomidine EVER Pharma mit den folgenden

Infusionslösungen und Arzneimitteln kompatibel ist:

Ringer-Lactat-Lösung, Glukoselösung 50 mg/ml (5 %), Natriumchlorid 9 mg/ml (0,9 %)

Injektionslösung, Mannitol 200 mg/ml (20 %) Injektionslösung, Thiopental-Natrium, Etomidat,

Vecuroniumbromid, Pancuroniumbromid, Succinylcholin, Atracuriumbesylat, Mivacuriumchlorid,

Rocuroniumbromid, Glycopyrrolatbromid, Phenylephrin-HCl, Atropinsulfat, Dopamin, Noradrenalin,

Dobutamin, Midazolam, Morphinsulfat, Fentanylcitrat und Plasmaersatz.

Kompatiblitätsstudien haben ein Potential für die Adsorption von Dexmedetomidin an manche Arten

von natürlichem Gummi ergeben. Obwohl Dexmedetomidin nach Wirkung dosiert wird, empfiehlt es

sich, nur Komponenten mit Dichtungen aus synthetischem Gummi oder beschichtetem natürlichen

Gummi zu benutzen.

Haltbarkeit

Nach der Verdünnung:

Die chemische und physikalische Stabilität der gebrauchsfertigen Zubereitung wurde für 48 Stunden

bei 25 °C und bei Kühlschranktemperatur (2 °C - 8°C) nachgewiesen.

Aus mikrobiologischer Sicht sollte die gebrauchsfertige Zubereitung sofort verwendet werden. Wenn

die gebrauchsfertige Zubereitung nicht sofort eingesetzt wird, ist der Anwender für die Dauer und die

Bedingungen der Aufbewahrung verantwortlich. Sofern die Herstellung der gebrauchsfertigen

Zubereitung nicht unter kontrollierten und validierten aseptischen Bedingungen erfolgt, ist diese nicht

länger als 24 Stunden bei 2°C bis 8°C aufzubewahren.

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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

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

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

28-9-2018

Debate on research dissemination at the Danish Medicines Agency

Debate on research dissemination at the Danish Medicines Agency

On 1 October, the Danish Medicines Agency and the Danish Society for Pharmacoepidemiology have invited a number of researchers, doctors and communication officers from research institutions throughout Denmark to a debate on how the findings of new health research can be disseminated most responsibly. The debate meeting can be followed live on the Danish Medicines Agency’s Facebook profile.

Danish Medicines Agency

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

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

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

13-9-2018

Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

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

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

27-8-2018

Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks

Health Canada is advising Canadians that several unauthorized products seized from Vitality Health Foods in Drayton Valley, AB, may pose serious health risks. The 11products include vitamins, dietary supplements, workout supplements and decongestants. Seized products were labelled to contain various ingredients, including prescription drugs and controlled substances.

Health Canada

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

1-11-2018

Protopic (Leo Pharma A/S)

Protopic (Leo Pharma A/S)

Protopic (Active substance: Tacrolimus) - Centralised - Yearly update - Commission Decision (2018)7343 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

2-10-2018

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2018)6476 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (Active substance: vigabatrin) - Centralised - Authorisation - Commission Decision (2018)6224 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4534

Europe -DG Health and Food Safety

24-9-2018

INCRELEX (Ipsen Pharma)

INCRELEX (Ipsen Pharma)

INCRELEX (Active substance: Mecasermin) - Centralised - Yearly update - Commission Decision (2018)6240 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

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

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

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

We will always remember those who have fallen and the heroes who risked their lives to treat and save others. #September11, #NeverForgetpic.twitter.com/LJrMEBE2SU

We will always remember those who have fallen and the heroes who risked their lives to treat and save others. #September11, #NeverForgetpic.twitter.com/LJrMEBE2SU

We will always remember those who have fallen and the heroes who risked their lives to treat and save others. #September11, #NeverForget pic.twitter.com/LJrMEBE2SU

FDA - U.S. Food and Drug Administration

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety