Tardyferon

Hauptinformation

  • Handelsname:
  • Tardyferon Retardtabletten
  • Darreichungsform:
  • Retardtabletten
  • Zusammensetzung:
  • Eisen(II) 80 mg als ferrosi sulfas dessiccatus, excipiens pro compresso Dunst.
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • Biologische Medizin

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Tardyferon Retardtabletten
    Schweiz
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Synthetika
  • Therapiebereich:
  • Eisenmangelanämie bei nachgewiesenem Eisenmangel

Weitere Informationen

Status

  • Quelle:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Zulassungsnummer:
  • 37448
  • Berechtigungsdatum:
  • 01-09-1972
  • Letzte Änderung:
  • 24-10-2018

Packungsbeilage

Patienteninformation

Vorsichtsmassnahmen

Information für Patientinnen und Patienten

Tardyferon

Was ist Tardyferon und wann wird es angewendet?

Tardyferon ist ein Eisenpräparat, welches zur Behandlung von Eisenmangel im Blut ("Blutarmut")

angewendet wird.

Eisenmangelzustände können entstehen:

- bei Blutverlusten (z. B. durch Magen-Darm-Krankheiten, nach Magen-Darm-Operationen oder bei

häufigen und starken Regelblutungen) und Infekten;

- in der Schwangerschaft, im Wochenbett und beim Stillen;

- in den Wachstumsphasen bei Kleinkindern und Kindern;

- bei Störungen der Eisenaufnahme aus der Nahrung (z. B. bei verminderter Magensäurebildung, im

höheren Lebensalter).

Tardyferon enthält sogenannte "Mucoproteose" als Hilfsstoff. Mucoproteose trägt zu einer

gleichmässigen und langsamen Freisetzung des in Tardyferon enthaltenen Eisens bei, wodurch die

Verträglichkeit verbessert wird. Durch die verzögerte Freisetzung wird auch die Aufnahme des

Eisens im Darm günstig beeinflusst.

Bei leichtem, sogenannt latentem Eisenmangel, das heisst noch vor Ausbildung einer sogenannten

Eisenmangelanämie (Blutarmut) werden die normalen Reserven des Körpereisens fast vollständig für

die Bildung des roten Blutfarbstoffes (Hämoglobin) verwendet. Die Verarmung an Eisen kann

bereits jetzt zu allgemeinen Beschwerden wie vermindertem Appetit und schnellem Ermüden führen.

Eine solche Situation kann häufig während der Schwangerschaft auftreten.

Erst bei schwerem Eisenmangel, d.h. wenn das Eisen für die notwendige Bildung des Hämoglobins

nicht mehr ausreicht, entsteht der sogenannte manifeste Eisenmangel mit Blutarmut (Anämie).

Was sollte dazu beachtet werden?

Bevor Sie mit der Behandlung beginnen, sollte der zu niedrige Gehalt des Blutes an Eisen und

Blutfarbstoff (Hämoglobin) vom Arzt oder der Ärztin durch geeignete Untersuchungen bestätigt

worden sein, denn wenn die Blutarmut nicht durch Eisenmangel bedingt ist, ist Tardyferon

wirkungslos. In solchen Fällen kann eine Verabreichung sogar zu einer Eisenüberladung führen.

Wann darf Tardyferon nicht eingenommen/angewendet werden?

Wenn Sie auf einen der Inhaltsstoffe gemäss Zusammensetzung von Tardyferon überempfindlich

reagieren. Bei einer selten vorkommenden krankhaften Eisenablagerung in den Geweben

(sogenannte Eisenspeicherkrankheit), bei sogenannten Eisenverwertungsstörungen (wenn die

"Blutarmut" z.B. auf einer mangelhaften Verwertung des Eisens beruht), bei "Blutarmut", die nicht

auf Eisenmangel, sondern z.B. auf einem Mangel an Vitamin B12 beruht, bei begründeter

Unverträglichkeit (z.B. bei schweren entzündlichen Veränderungen im Magen und im Darm) sowie

bei schweren Leber- und Nierenerkrankungen darf Tardyferon nicht angewendet werden.

Kinder unter 10 Jahren dürfen nicht mit Tardyferon behandelt werden, sondern nur mit einem

Arzneimittel, das weniger Eisen enthält.

Wann ist bei der Einnahme/Anwendung von Tardyferon Vorsicht geboten?

Bei entzündlichen Magen- oder Darmerkrankungen, bei krankhaft verzögerter Magenentleerung und

bei gewissen anderen Krankheiten des Magen-Darm-Kanals sollten Sie Eisenpräparate mit Vorsicht

und nur nach Rücksprache mit dem Arzt bzw. der Ärztin einnehmen.

Folgende Arzneimittel können in ihrer Wirkung beeinträchtigt werden, wenn sie gleichzeitig mit

Tardyferon eingenommen werden: Bestimmte Antibiotika (Tetracycline und Chinolone), bestimmte

Parkinson-Mittel (Methyldopa, Levodopa und Carbidopa), Arzneimittel zur Behandlung der

Osteoporose (Bisphosphonate) sowie Schilddrüsenhormone.

Folgende Arzneimittel können die Wirkung von Tardyferon vermindern: Bestimmte Antibiotika

(Tetracycline, Chloramphenicol), Aluminium-, Magnesium- und Calcium-haltige Arzneimittel zur

Bindung von Magensäure (Antazida) und Cholestyramin (ein Mittel zur Senkung des Blutfettes)

sowie andere Arzneimittel mit Calcium, Phosphat oder Zink.

Falls eine gleichzeitige Therapie mit diesen Arzneimitteln nicht vermieden werden kann, sollte bei

der Einnahme ein zeitlicher Abstand von mindestens 3 Stunden eingehalten werden.

Die schleimhautreizende Wirkung von Eisenpräparaten in Magen und Darm kann durch die

gleichzeitige Einnahme gewisser entzündungshemmender Arzneimittel, z.B. gegen rheumatische

Erkrankungen, verstärkt werden. Deshalb sollte die Einnahme dieser Arzneimittel mindestens 3 bis 4

Stunden auseinander liegen.

Durch die Therapie mit Tardyferon wird die Aufnahme von Phosphaten aus der Nahrung

herabgesetzt.

Bei der Einnahme von Tardyferon sollte auf gleichzeitigen Konsum von Milch und Milchprodukten,

Schwarztee, Kaffee und Eiern verzichtet werden, da die Wirksamkeit des Arzneimittels dadurch

eingeschränkt wird.

Chronischer Alkoholmissbrauch kann durch Erhöhung der Eisenaufnahme zu einer Eisenüberladung

führen.

Aufgrund der Gefahr von entzündlich bedingten Schleimhautdefekten im Mund sowie

Zahnverfärbungen dürfen die Depot-Dragées nicht gelutscht, zerkaut oder länger im Mund gelassen

werden, sondern müssen mit einem Glas Wasser sofort als Ganzes geschluckt werden.

Dieses Arzneimittel enthält Saccharose. Bitte nehmen Sie Tardyferon erst nach Rücksprache mit

Ihrem Arzt oder Ihrer Ärztin ein, wenn Ihnen bekannt ist, dass Sie unter einer Unverträglichkeit

gegenüber bestimmten Zuckern leiden.

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie

-an anderen Krankheiten leiden,

-Allergien haben oder

-andere Arzneimittel (auch selbstgekaufte!) einnehmen oder äusserlich anwenden.

Darf Tardyferon während einer Schwangerschaft oder in der Stillzeit eingenommen/angewendet

werden?

Tardyferon wird auch bei Eisenmangelzuständen in der Schwangerschaft und in der Stillzeit

verschrieben. Sie sollten unbedingt mit Ihrem Arzt oder Ihrer Ärztin sprechen, bevor Sie mit der

Einnahme von Tardyferon beginnen.

Wie verwenden Sie Tardyferon?

Die Depot-Dragées werden vor den Mahlzeiten mit etwas Flüssigkeit eingenommen und dürfen nicht

gelutscht, zerkaut oder länger im Mund gelassen werden, sondern sollen sofort mit einem Glas

Wasser als Ganzes geschluckt werden.

• Bei leichter Blutarmut und verstecktem (latentem) Eisenmangel:

Erwachsene: 1 x täglich 1 Depot-Dragée morgens

Kinder und Jugendliche ab 10 Jahren: 1 x täglich 1 Depot-Dragée morgens.

• Bei schwerer Blutarmut:

Erwachsene: 2 x täglich 1 Depot-Dragée morgens und abends

Kinder und Jugendliche ab 10 Jahren: täglich 1 Depot-Dragée morgens bis 2 Depot-Dragées täglich

(je 1 Depot-Dragée morgens und abends), falls dies die Maximaldosis für Kinder und Jugendliche

von 6 mg(Fe2+)/kg KG/d nicht überschreitet.

Ihr Arzt bzw. Ihre Ärztin kann diese Empfehlung jedoch Ihren Bedürfnissen anpassen.

Die Behandlungsdauer richtet sich nach dem Ausmass des bestehenden Eisenmangels. Die

Anwendung sollte etwa 2 bis 3 Monate über das Verschwinden der Eisenmangelsymptome hinaus

fortgesetzt werden, um auch die Eisenspeicher aufzufüllen.

Bei versehentlicher Einnahme einer grossen Überdosis können Eisenvergiftungserscheinungen

auftreten. Sie beginnen mit Übelkeit, Magenschmerzen, Erbrechen von schwärzlichem Mageninhalt

("Kaffeesatz") und Durchfall.

Nach einiger Zeit kann es zu beschleunigtem Puls, Schwindel, Atemnot und Blauwerden der Lippen

und des Gesichts, in schweren Fällen zu unregelmässiger Atmung, Krämpfen und

Lähmungserscheinungen kommen.

Erzwungenes Erbrechen trägt zur Entfernung einer soeben geschluckten Übermenge an Eisen bei.

Als Gegenmittel wird die Einnahme von rohen Eiern und Milch empfohlen. Schnelle ärztliche

Behandlung ist in jedem Vergiftungsfall notwendig.

Obwohl das Arzneimittel Tardyferon nicht für Kinder unter 10 Jahren bestimmt ist, sei darauf

hingewiesen, dass Kinder auf eine Überdosis Eisen erheblich empfindlicher als Erwachsene

reagieren. Bei Kleinkindern kann eine Gesamtdosis von etwa 0,5 g Eisen (= 6 Dragées Tardyferon)

bereits zu einem lebensbedrohlichen Zustand führen.

Halten Sie sich an die in der Packungsbeilage angegebene oder vom Arzt oder der Ärztin

verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so

sprechen Sie mit Ihrem Arzt oder Apotheker bzw. mit Ihrer Ärztin oder Apothekerin.

Welche Nebenwirkungen kann Tardyferon haben?

Folgende Nebenwirkungen können bei der Einnahme von Tardyferon auftreten:

Häufig: kommt es zu Übelkeit, Völlegefühl, Magenschmerzen, Durchfall, Verstopfung.

Gelegentlich kommt es zu Dunkelfärbung des Stuhls, Magenschleim-hautentzündung (Gastritis),

Oberbauchbeschwerden (Dyspepsie), Erbrechen, Kehlkopfentzündung, Juckreiz, Ausschlag mit

Hautrötungen.

Häufigkeit nicht bekannt: Reversible Zahnverfärbungen, entzündlich bedingte Schleimhautdefekte

im Mund (bei falscher Anwendung), Überempfindlichkeitsreaktionen und Nesselfieber.

Bei Auftreten solcher Symptome ist unverzüglich der Arzt oder die Ärztin zu informieren.

Wenn Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder

Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Was ist ferner zu beachten?

Da bereits die kleinste Packung mit 30 Depot-Dragées Tardyferon eine Gesamtdosis Eisen enthält,

die auf einmal eingenommen vor allem bei Kleinkindern zu einer lebensbedrohlichen Vergiftung

führen kann, muss dieses Arzneimittel unbedingt ausserhalb der Reichweite von Kindern aufbewahrt

werden.

Bei Raumtemperatur (15-25ºC) aufbewahren.

Das Arzneimittel darf nur bis zu dem auf dem Behälter mit "EXP" bezeichneten Verfalldatum

verwendet werden.

Arzneimittel, die Sie nicht mehr einnehmen oder deren Datum abgelaufen ist, bringen Sie am besten

zur Entsorgung in die Apotheke.

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese

Personen verfügen über die ausführliche Fachinformation.

Was ist in Tardyferon enthalten?

1 Depot-Dragée enthält den Wirkstoff: 80 mg zweiwertiges Eisen in Form von Eisen(II)-sulfat,

Hilfsstoffe: Mucoproteose, Saccharose, den Farbstoff Erythrosin (E 127) sowie andere Hilfsstoffe.

Der Hilfsstoff Mucoproteose ist tierischer Herkunft.

Zulassungsnummer

37448 (Swissmedic)

Wo erhalten Sie Tardyferon? Welche Packungen sind erhältlich?

In Apotheken, ohne ärztliche Verschreibung. Packungen zu 30 und 100 Depot-Dragées.

Zulassungsinhaberin

Pierre Fabre Pharma AG, 4123 Allschwil

Diese Packungsbeilage wurde im August 2017 letztmals durch die Arzneimittelbehörde

(Swissmedic) geprüft.

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Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

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

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

14-8-2018

Koehler-Bright Star recalls WorkSafe 3-D cell flashlights

Koehler-Bright Star recalls WorkSafe 3-D cell flashlights

The flashlights are missing an encapsulation on the circuit board component which could allow the flashlight to ignite in an explosive environment, posing a burn hazard and risk of personal injury to the user or bystander.

Health Canada

9-8-2018

Dringende Sicherheitsinformation zu GENESIS II NON POROUS C/R FEMORAL SIZE 6 RIGHT von Smith & Nephew Orthopaedics GmbH

Dringende Sicherheitsinformation zu GENESIS II NON POROUS C/R FEMORAL SIZE 6 RIGHT von Smith & Nephew Orthopaedics GmbH

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

14-7-2018

Dringende Sicherheitsinformation zu Vitamin D total II, Elecsys Vitamin D total II von Roche Diagnostics GmbH

Dringende Sicherheitsinformation zu Vitamin D total II, Elecsys Vitamin D total II von Roche Diagnostics GmbH

Weitere Informationen sowie Details zum Produkt entnehmen Sie bitte der anliegenden Kundeninformation des Herstellers.

Deutschland - BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte

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

9-10-2018

Testoviron®-Depot-250

Rote - Liste

14-9-2018

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here:  http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

FDA - U.S. Food and Drug Administration

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

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

4-9-2018

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5857 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/726/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Binocrit (Sandoz GmbH)

Binocrit (Sandoz GmbH)

Binocrit (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5856 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/725/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Spinraza (Biogen Idec Limited)

Spinraza (Biogen Idec Limited)

Spinraza (Active substance: nusinersen) - Centralised - 2-Monthly update - Commission Decision (2018)5862 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/II/4

Europe -DG Health and Food Safety

3-9-2018

Apis/Levisticum II

Rote - Liste

30-8-2018

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (Active substance: influenza vaccine (live attenuated, nasal)) - Centralised - Variation - Commission Decision (2018)5815 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2617/II/82

Europe -DG Health and Food Safety

29-8-2018

Coagadex (Bio Products Laboratory Ltd)

Coagadex (Bio Products Laboratory Ltd)

Coagadex (Active substance: human coagulation factor X) - Centralised - 2-Monthly update - Commission Decision (2018)5772 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3855/II/07

Europe -DG Health and Food Safety

29-8-2018

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (Active substance: mepolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5770 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3860/II/13/G

Europe -DG Health and Food Safety

27-8-2018

RoActemra (Roche Registration GmbH)

RoActemra (Roche Registration GmbH)

RoActemra (Active substance: tocilizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5687 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/955/II/78

Europe -DG Health and Food Safety

22-8-2018

Lenvima (Eisai Europe Limited)

Lenvima (Eisai Europe Limited)

Lenvima (Active substance: lenvatinib) - Centralised - 2-Monthly update - Commission Decision (2018)5627 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3727/II/11/G

Europe -DG Health and Food Safety

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

7-8-2018

Inovelon (Eisai Limited)

Inovelon (Eisai Limited)

Inovelon (Active substance: Rufinamide) - Centralised - 2-Monthly update - Commission Decision (2018)5424 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/II/45

Europe -DG Health and Food Safety

6-8-2018

Rapamune (Pfizer Limited)

Rapamune (Pfizer Limited)

Rapamune (Active substance: sirolimus) - Centralised - 2-Monthly update - Commission Decision (2018)5384 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/273/II/164

Europe -DG Health and Food Safety

6-8-2018

Dexdor (Orion Corporation)

Dexdor (Orion Corporation)

Dexdor (Active substance: dexmedetomidine) - Centralised - 2-Monthly update - Commission Decision (2018)5377 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2268/II/26

Europe -DG Health and Food Safety

3-8-2018

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (MeiraGTx UK II Limited)

EU/3/18/2042 (Active substance: Adenovirus associated viral vector serotype 2/8 containing the human CNGA3 gene) - Orphan designation - Commission Decision (2018)5274 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/18

Europe -DG Health and Food Safety

1-8-2018

Eylea (Bayer AG)

Eylea (Bayer AG)

Eylea (Active substance: aflibercept) - Centralised - 2-Monthly update - Commission Decision (2018)5222 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2392/II/45

Europe -DG Health and Food Safety

1-8-2018

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Active substance: nivolumab) - Centralised - 2-Monthly update - Commission Decision (2018)5204 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3985/II/41

Europe -DG Health and Food Safety

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Scientific guideline: Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency

13-7-2018

Briviact (UCB Pharma S.A.)

Briviact (UCB Pharma S.A.)

Briviact (Active substance: brivaracetam) - Centralised - 2-Monthly update - Commission Decision (2018)4715 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3898/II/10/G

Europe -DG Health and Food Safety

9-7-2018

Pexion (Boehringer Ingelheim Vetmedica GmbH)

Pexion (Boehringer Ingelheim Vetmedica GmbH)

Pexion (Active substance: Imepitoin) - Centralised - 2-Monthly update - Commission Decision (2018)4433 of Mon, 09 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2543/II/11/G

Europe -DG Health and Food Safety