BIO-H-TIN Vitamin H

Hauptinformation

  • Handelsname:
  • BIO-H-TIN Vitamin H 5 mg - Tabletten
  • INN (Internationale Bezeichnung):
  • BIOTIN
  • Einheiten im Paket:
  • 30 Stück, Laufzeit: 36 Monate,120 Stück, Laufzeit: 36 Monate,60 Stück, Laufzeit: 36 Monate
  • Verschreibungstyp:
  • Arzneimittel zur Abgabe ohne aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • BIO-H-TIN Vitamin H 5 mg - Tabletten
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiebereich:
  • Biotin
  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 1-23369
  • Berechtigungsdatum:
  • 01-12-1999
  • Letzte Änderung:
  • 09-08-2017

Öffentlichen Beurteilungsberichts

Für diese Arzneispezialität steht kein NPAR zur Verfügung. Alle relevanten

Änderungen seit 01.07.2011 finden sich in der Life – Cycle Tabelle.

Relevante Änderungen

Art der Änderung

Genehmigungs-

Datum

Fachinformation

Gebrauchsinformation

Kennzeichnung

betroffen

Zusammenfassung der

Änderung bzw.

wissenschaftliche

Information

Änderung der

pharmakologischen

Eigenschaften

06.02.2013

FI GI

Aktualisierung

Änderung der

Bezeichnung

06.02.2013

FI GI KE

Änderung der Bezeichnung

auf: BIO-H-TIN Vitamin H

5 mg - Tabletten

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

942785_F_GI_14-05-23_BIO-H-TIN 5 mg

Wortlaut der für die Packungsbeilage vorgesehenen Angaben

Gebrauchsinformation: Information für Anwender

BIO-H-TIN® Vitamin H 5 mg Tabletten

Wirkstoff: Vitamin H (Biotin)

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

Einnahme dieses Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Nehmen Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage

beschrieben bzw. genau nach Anweisung Ihres Arztes oder Apothekers ein.

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

lesen.

Fragen Sie Ihren Apotheker, wenn Sie weitere Informationen oder einen Rat

benötigen.

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

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

angegeben sind.

Wenn Sie sich nicht besser oder gar schlechter fühlen, wenden Sie sich an Ihren

Arzt.

Was in dieser Packungsbeilage steht:

Was ist BIO-H-TIN® Vitamin H 5 mg und wofür wird es angewendet?

Was sollten Sie vor der Einnahme von BIO-H-TIN® Vitamin H 5 mg beachten?

Wie ist BIO-H-TIN® Vitamin H 5 mg einzunehmen?

Welche Nebenwirkungen sind möglich?

Wie ist BIO-H-TIN® Vitamin H 5 mg aufzubewahren?

Inhalt der Packung und weitere Informationen

942785_F_GI_14-05-23_BIO-H-TIN 5 mg

1.

Was ist BIO-H-TIN Vitamin H 5 mg und wofür wird es angewendet?

BIO-H-TIN Vitamin H 5 mg Tabletten sind ein Vitaminpräparat.

Biotin, auch als Vitamin B

oder Vitamin H bezeichnet, ist ein wasserlösliches Vitamin

und gehört zu den Vitaminen der B-Gruppe. Dieses Vitamin kann in der Darmflora

gebildet und zusätzlich über die Nahrung aufgenommen werden. Es kommt im

menschlichen Körper in verschiedenen Organen und Geweben vor.

Vitamin H spielt eine wichtige Rolle bei Stoffwechselprozessen (Kohlenhydrat-, Fett-,

und Eiweißstoffwechsel).

BIO-H-TIN Vitamin H 5 mg Tabletten werden angewendet zur

Vorbeugung und Behandlung eines Vitamin H-Mangels, der durch eine

verminderte Vitamin H-Versorgung oder einen erhöhten Vitamin H-Bedarf des

Körpers gekennzeichnet ist. Solche Vitamin H-Mangelzustände machen sich

insbesondere durch Veränderungen der Haare (Haarausfall) und der Haut

(Schuppungen, Rötungen) sowie als Störungen des Nagelwachstums

bemerkbar.

Behandlung eines Vitamin H-Mangels beim sehr seltenen Biotin-abhängigen,

multiplen

Carboxylasemangel

(eine

Erbkrankheit,

Enzym

Aufspaltung des Vitamin H aus der Nahrung fehlt).

2.

Was sollten Sie vor der Einnahme von BIO-H-TIN Vitamin H 5 mg beachten?

BIO-H-TIN Vitamin H 5 mg darf nicht eingenommen werden

wenn Sie allergisch gegen Vitamin H oder einen der in Abschnitt 6 genannten

sonstigen Bestandteile dieses Arzneimittels sind.

Einnahme von BIO-H-TIN Vitamin H 5 mg zusammen mit anderen Arzneimitteln

Informieren

Ihren

Arzt

oder

Apotheker,

wenn

andere

Arzneimittel

einnehmen/anwenden,

kürzlich

andere

Arzneimittel

eingenommen/angewendet

haben oder beabsichtigen andere Arzneimittel einzunehmen/anzuwenden.

Falls

regelmäßig

Antiepileptika

einnehmen,

beachten

bitte,

dass

diese

Medikamente den Vitamin H-Blutspiegel senken können.

Einnahme von BIO-H-TIN Vitamin H 5 mg zusammen mit Nahrungsmitteln

Bei gleichzeitiger Einnahme von Vitamin H mit großen Mengen von rohem

Hühnereiweiß über einen längeren Zeitraum kann die Aufnahme von Vitamin H stark

eingeschränkt sein. Auf den Verzehr von rohem oder ungenügend erhitztem Eiklar

sollte daher während einer Behandlung mit Vitamin H verzichtet werden.

Schwangerschaft und Stillzeit

Bei bestimmungsgemäßer Anwendung gibt es keine Einschränkungen. Vitamin H ist

placentagängig und geht in die Muttermilch über.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Es sind keine Beeinträchtigungen bekannt.

942785_F_GI_14-05-23_BIO-H-TIN 5 mg

BIO-H-TIN Vitamin H 5 mg enthält Lactose (Milchzucker)

Bitte nehmen Sie BIO-H-TIN Vitamin H 5 mg daher erst nach Rücksprache mit

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

gegenüber bestimmten Zuckern leiden.

3.

Wie ist BIO-H-TIN Vitamin H 5 mg einzunehmen?

Nehmen Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage

beschrieben bzw. genau nach der mit Ihrem Arzt oder Apotheker getroffenen

Absprache ein. Fragen Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie sich

nicht sicher sind.

Die empfohlene Dosis beträgt:

Tablette

BIO-H-TIN

Vitamin

täglich

ausreichend

Flüssigkeit

einnehmen.

Zur Prophylaxe sind weniger als 0,2 mg pro Tag ausreichend.

Hinweis:

Zum Teilen der Tablette

diese mit der Bruchkerbe

nach oben auf eine feste

Unterlage

legen

kräftig

Daumen

darauf drücken.

Zur Therapie des multiplen Carboxylasemangels: täglich 1 bis 2 Tabletten (5 – 10

mg Vitamin H).

Die Dauer der Anwendung ist abhängig vom Verlauf der Grunderkrankung.

Anwendung bei Kindern und Jugendlichen

Anwendung

Kindern

Jugendlichen

sollte

bedingt

durch

eingeschränkte Datenlage nur nach ärztlicher Verordnung erfolgen.

Wenn Sie eine größere Menge von BIO-H-TIN Vitamin H 5 mg eingenommen

haben, als Sie sollten:

Vergiftungen und Überdosierungserscheinungen sind nicht bekannt.

Wenn Sie die Einnahme von BIO-H-TIN Vitamin H 5 mg vergessen haben:

Nehmen Sie nicht die doppelte Menge ein, wenn Sie die vorherige Einnahme

vergessen

haben,

sondern

führen

Einnahme,

Dosierungsanleitung beschrieben bzw. vom Arzt verordnet, fort.

Wenn Sie die Einnahme von BIO-H-TIN Vitamin H 5 mg abbrechen:

Hier sind bei bestimmungsgemäßer Anwendung von BIO-H-TIN Vitamin H 5 mg

keine Besonderheiten zu beachten.

942785_F_GI_14-05-23_BIO-H-TIN 5 mg

Wenn Sie weitere Fragen zur Einnahme dieses Arzneimittels haben, wenden Sie

sich an Ihren Arzt oder Apotheker.

4.

Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die

aber nicht bei jedem auftreten müssen.

Sehr seltene Nebenwirkungen (betrifft bis zu 1 von 10.000 Behandelten):

Allergische Reaktionen

Ausschlag

(Rash),

Juckreiz

(Pruritus),

Nesselsucht

(Urtikaria),

Hautrötung

(Erythem)

Meldung von Nebenwirkungen

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

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

angegeben sind. Sie können Nebenwirkungen auch direkt dem Bundesamt für

Sicherheit im Gesundheitswesen, Traisengasse 5, 1200 Wien, ÖSTERREICH, Fax: +

43 (0) 50 555 36207, Website: www.basg.gv.at anzeigen.

Indem Sie Nebenwirkungen melden, können Sie dazu beitragen, dass mehr

Informationen über die Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5.

Wie ist BIO-H-TIN Vitamin H 5 mg aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf dem Umkarton und dem Behältnis

angegebenen Verfalldatum nicht mehr verwenden.

Das Verfalldatum bezieht sich auf den letzten Tag des angegebenen Monats.

Die Durchdrückpackung im Umkarton aufbewahren, um den Inhalt vor Licht zu

schützen.

6.

Inhalt der Packung und weitere Informationen

Was eine Tablette BIO-H-TIN Vitamin H 5 mg enthält:

Der Wirkstoff ist: 5 mg Vitamin H (Biotin)

Die sonstigen Bestandteile sind: Mikrokristalline Cellulose, Lactose-Monohydrat,

Croscarmellose-Natrium, Magnesiumstearat (Ph. Eur.) [pflanzlich], hochdisperses

Siliciumdioxid.

Wie BIO-H-TIN Vitamin H 5 mg aussieht und Inhalt der Packung:

Weiße, runde, mit Hilfe einer Bruchkerbe (SNAP TAB) in gleiche Hälften teilbare

Tablette; Packungen mit 30, 60 und 120 Tabletten.

Pharmazeutischer Unternehmer

BIO-H-TIN Pharma GmbH & Co. KG, Emil-Kemmer-Straße 33, D-96103 Hallstadt,

Deutschland, Telefon: + 49 (0)951/6043-0, Telefax: + 49 (0)951/604329.

942785_F_GI_14-05-23_BIO-H-TIN 5 mg

Hersteller

Dr. R. Pfleger Chemische Fabrik GmbH, D-96045 Bamberg, Deutschland, Telefon:

+ 49 (0)951/6043-0, Telefax: + 49 (0)951/604329.

E-Mail: info@dr-pfleger.de

Zul.Nr.: 1-23369

Diese Packungsbeilage wurde zuletzt überarbeitet im Mai 2014.

6-12-2018

Kroger Louisville Division Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

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FDA - U.S. Food and Drug Administration

6-12-2018

King Soopers and City Market Recalls Abound Chicken and Brown Rice Dog Food Because of Elevated Vitamin D Levels

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Following a recall by Sunshine Mills, Inc., King Soopers announced it has removed from sale Abound Chicken & Brown Rice Recipe dog food produced by Sunshine Mills, Inc. sold in King Soopers and City Market stores, located in Colorado, Utah, New Mexico and Wyoming. Only Abound Chicken & Brown Rice Recipe dog food with the listed UPC numbers and Best by Dates are affected by this recall. The recall was initiated because the product had the potential to contain an elevated level of Vitamin D, which may caus...

FDA - U.S. Food and Drug Administration

6-12-2018

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3-12-2018

FDA Alerts Pet Owners about Potentially Toxic Levels of Vitamin D in Several Dry Pet Foods

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1-12-2018

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29-11-2018

ELM Pet Foods Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

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FDA - U.S. Food and Drug Administration

29-11-2018

Glyphosate: ANSES launches a comparative assessment with the available alternatives

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France - Agence Nationale du Médicament Vétérinaire

28-11-2018

ANF Pet Inc. Issues Voluntary Precautionary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

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FDA - U.S. Food and Drug Administration

28-11-2018

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

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FDA - U.S. Food and Drug Administration

27-11-2018

Sunshine Mills, Inc. Issues Voluntary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D

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FDA - U.S. Food and Drug Administration

20-11-2018

FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder

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16-11-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs

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FDA - U.S. Food and Drug Administration

14-11-2018

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IMA - Icelandic Medicines Agency

14-11-2018

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13-11-2018

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9-11-2018

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FDA - U.S. Food and Drug Administration

9-11-2018

Natural Life Pet Products Expands Recall of Dry Food Due to Elevated Levels of Vitamin D

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FDA - U.S. Food and Drug Administration

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

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France - Agence Nationale du Médicament Vétérinaire

3-11-2018

Nutrisca Issues Recall of Dry Dog Food Due to Elevated Levels of Vitamin D

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Nutrisca, of Saint Louis, Missouri is voluntarily recalling one formula of Nutrisca dry dog food (described below) due to it containing elevated levels of vitamin D.

FDA - U.S. Food and Drug Administration

3-11-2018

Natural Life Pet Products Issues Recall of Dry Food Due to Elevated Levels of Vitamin D

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FDA - U.S. Food and Drug Administration

2-11-2018

FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

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FDA - U.S. Food and Drug Administration

26-10-2018

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24-10-2018

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

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16-10-2018

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During an implementation period of maximum two years, it will be permitted to sell released packs on which a UK marketing authorisation holder or a representative is indicted as well as packs on which an EEA marketing authorisation holder or a representative is indicated for the concerned D.Sp.No. (Danish speciality number).

Danish Medicines Agency

30-11-2018

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more:  https://go.usa.gov/xPMPk pic.twitter.com/6rRnfSyLy4

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FDA - U.S. Food and Drug Administration

29-11-2018

alli (GlaxoSmithKline Dungarvan Limited)

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alli (Active substance: Orlistat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8041 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/854/T/59

Europe -DG Health and Food Safety

28-11-2018

Docetaxel Zentiva (Zentiva k.s.)

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Europe -DG Health and Food Safety

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (Active substance: Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8044 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/242/T/73

Europe -DG Health and Food Safety

28-11-2018

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8042 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3954/T/39

Europe -DG Health and Food Safety

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

28-11-2018

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Active substance: ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8047 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/T/71

Europe -DG Health and Food Safety

26-11-2018

Nyxoid (Mundipharma Corporation (Ireland) Limited)

Nyxoid (Mundipharma Corporation (Ireland) Limited)

Nyxoid (Active substance: naloxone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7966 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4325/T/04

Europe -DG Health and Food Safety

26-11-2018

Kentera (Teva B.V.)

Kentera (Teva B.V.)

Kentera (Active substance: Oxybutynin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7967 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/532/T/49

Europe -DG Health and Food Safety

26-11-2018

Levetiracetam Hospira (Pfizer Europe MA EEIG)

Levetiracetam Hospira (Pfizer Europe MA EEIG)

Levetiracetam Hospira (Active substance: levetiracetam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7985 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2783/T/19

Europe -DG Health and Food Safety

22-11-2018

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7876 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2809/T/22

Europe -DG Health and Food Safety

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

16-11-2018

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Active substance: daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7678 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004310/T/0008

Europe -DG Health and Food Safety

16-11-2018

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (Active substance: belimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7679 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2015/T/60

Europe -DG Health and Food Safety

16-11-2018

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7673 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3754/T/26

Europe -DG Health and Food Safety

16-11-2018

Ontruzant (Samsung Bioepis NL B.V.)

Ontruzant (Samsung Bioepis NL B.V.)

Ontruzant (Active substance: trastuzumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7553 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004323/T/0012

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Active substance: Itacitinib) - Transfer of orphan designation - Commission Decision (2018)7573 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/169/17/T/01

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

12-11-2018

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Zentiva k.s.)

Irbesartan HCT Zentiva (Active substance: irbesartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7555 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Pfizer Europe MA EEIG)

Xeljanz (Active substance: Tofacitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7554 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004214/T/0015

Europe -DG Health and Food Safety

12-11-2018

Tracleer (Janssen-Cilag International NV)

Tracleer (Janssen-Cilag International NV)

Tracleer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7556 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000401/T/0088

Europe -DG Health and Food Safety

6-11-2018

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7419 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/T/36

Europe -DG Health and Food Safety

1-11-2018

Zolvix (Elanco GmbH)

Zolvix (Elanco GmbH)

Zolvix (Active substance: monepantel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7383 of Thu, 01 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/000154/T/0024

Europe -DG Health and Food Safety

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

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

Europe -DG Health and Food Safety

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

18-10-2018

Leflunomide Zentiva (Zentiva k.s.)

Leflunomide Zentiva (Zentiva k.s.)

Leflunomide Zentiva (Active substance: leflunomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6923 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/001129/T/0032

Europe -DG Health and Food Safety

18-10-2018

Sutent (Pfizer Europe MA EEIG)

Sutent (Pfizer Europe MA EEIG)

Sutent (Active substance: sunitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6922 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/687/T/72

Europe -DG Health and Food Safety

18-10-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6925 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002755/T/0026

Europe -DG Health and Food Safety

18-10-2018

Rapamune (Pfizer Europe MA EEIG)

Rapamune (Pfizer Europe MA EEIG)

Rapamune (Active substance: sirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6921 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/273/T/168

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

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

Europe -DG Health and Food Safety