OXYTOCINE EVER Pharma

Information principale

  • Nom commercial:
  • OXYTOCINE EVER Pharma 5 UI/1 ml, solution injectable
  • DCI (Dénomination commune internationale):
  • oxytocin
  • Dosage:
  • 5 UI
  • forme pharmaceutique:
  • solution
  • Composition:
  • composition pour 1 ml de solution injectable > oxytocine : 5 UI
  • Mode d'administration:
  • intra-murale;intramusculaire;intraveineuse
  • Unités en paquet:
  • 1 ampoule(s) en verre de 1 ml
  • Type d'ordonnance:
  • liste II
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • OXYTOCINE EVER Pharma 5 UI/1 ml, solution injectable
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • HORMONE POST-HYPOPHYSAIRE
  • Descriptif du produit:
  • 378 565-1 ou 4009 378 565 1 5 - 1 ampoule(s) en verre de 1 ml - Déclaration de commercialisation non communiquée:;378 566-8 ou 4009 378 566 8 3 - 3 ampoule(s) en verre de 1 ml - Déclaration de commercialisation non communiquée:;570 517-1 ou 4009 570 517 1 6 - 5 ampoule(s) en verre de 1 ml - Déclaration de commercialisation non communiquée:;570 518-8 ou 4009 570 518 8 4 - 10 ampoule(s) en verre de 1 ml - Déclaration de commercialisation:05/05/2017;570 519-4 ou 4009 570 519 4 5 - 50 ampoule(s) en verre de 1 ml - Déclaration de commercialisation non communiquée:;570 520-2 ou 4009 570 520 2 7 - 100 ampoule(s) en verre de 1 ml - Déclaration de commercialisation non communiquée:;

Autres informations

Statut

  • Source:
  • ANSM - Agence Nationale de Sécurité du Médicament et des Produits de Santé
  • Statut de autorisation:
  • Valide
  • Numéro d'autorisation:
  • 66693128
  • Date de l'autorisation:
  • 22-03-2007
  • Dernière mise à jour:
  • 11-08-2017

Notice: composition, indications thérapeutiques, interactions, posologie, effets indésirable, grossesse, allaitement

NOTICE

ANSM - Mis à jour le : 05/07/2016

Dénomination du médicament

OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable

Oxytocine

Encadré

Veuillez lire attentivement cette notice avant de prendre ce médicament car elle contient des informations importantes pour

vous.

Gardez cette notice. Vous pourriez avoir besoin de la relire.

Si vous avez d’autres questions, interrogez votre médecin, ou votre pharmacien.

Ce médicament vous a été personnellement prescrit. Ne le donnez pas à d’autres personnes. Il pourrait leur être nocif,

même si les signes de leur maladie sont identiques aux vôtres.

Si vous ressentez un quelconque effet indésirable, parlez-en à votre médecin, ou votre pharmacien. Ceci s’applique aussi à

tout effet indésirable qui ne serait pas mentionné dans cette notice. Voir rubrique 4.

Que contient cette notice ?

1. Qu'est-ce que OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable et dans quels cas est-il utilisé ?

2. Quelles sont les informations à connaître avant de prendre OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable?

3. Comment prendre OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable?

4. Quels sont les effets indésirables éventuels ?

5. Comment conserver OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable?

6. Contenu de l’emballage et autres informations.

1. QU’EST-CE QUE OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable ET DANS QUELS CAS EST-IL UTILISE ?

Classe pharmacothérapeutique - code ATC :

HORMONE OCYTOCIQUE POST-HYPOPHYSAIRE

Ce médicament est indiqué en cas de :

Insuffisance des contractions utérines, en début ou en cours de travail.

Chirurgie obstétricale (césarienne, interruption de grossesse...).

Hémorragie de la délivrance.

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE OXYTOCINE EVER PHARMA 5 UI/1

ml, solution injectable ?

Ne prenez jamais OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable:

si vous êtes allergique (hypersensible) à la substance active ou à l'un des excipients contenus dans OXYTOCINE EVER

PHARMA 5IU/ml solution injectable.

Accouchement difficile.

Fragilité de l'utérus.

Augmentation du tonus musculaire de l'utérus ou souffrance fœtale quand l'accouchement n'est pas imminent.

Troubles cardiovasculaires sévères et hypertension artérielle sévère en relation avec la grossesse.

Episodes antérieurs de mort fœtale in utero et d'hématome du placenta.

Placenta praevia (anomalie de position du placenta).

Avertissements et précautions

Faites attention avec OXYTOCINE EVER PHARMA 5IU/ml solution injectable:

Mises en garde spéciales

L'induction pharmacologique du travail par dinoprostone ou oxytocine augmente le risque de coagulation intra-vasculaire

disséminée (CIVD) en post-partum, dans de très rares circonstances. Ce risque est augmenté pour les patientes âgées de

35 ans ou plus, ayant eu des complications pendant la grossesse et lorsque que l'âge gestationnel est supérieur à 40

semaines.

Chez ces femmes, l'oxytocine ou toute autre alternative thérapeutique, doivent être utilisées avec précaution. Les praticiens

doivent particulièrement être vigilants aux signes de CIVD.

Précautions d'emploi

OXYTOCINE EVER PHARMA ne doit pas être administré en injection intraveineuse rapide en raison du risque d'une baisse

de la pression artérielle rapide et transitoire accompagnée de flush (rougeur de la peau) et d'une accélération réflexe du

rythme cardiaque.

Afin d'éviter des changements significatifs au niveau de la pression artérielle et du rythme cardiaque, OXYTOCINE EVER

PHARMA doit être utilisé avec prudence chez les patients prédisposés à une diminution de l'apport sanguin au niveau du

cœur due à une maladie cardiovasculaire préexistante.

OXYTOCINE EVER PHARMA doit être administré avec prudence aux patients présentant un « syndrome QT long » ou des

symptômes apparentés.

Ce médicament doit être administré sous contrôle médical très strict (surveillance des contractions utérines et des bruits du

cœur fœtal) en cas d'accouchement dirigé.

Adressez-vous à votre médecin ou à votre pharmacien avant de prendre OXYTOCINE EVER PHARMA 5 UI/1 ml, solution

injectable.

Enfants et adolescents

Sans objet.

Autres médicaments et OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable

Signalez à votre médecin toute prise médicamenteuse (notamment anesthésiques volatils et prostaglandines).

Informez votre médecin ou pharmacien si vous prenez, avez récemment pris ou pourriez prendre tout autre médicament.

OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable avec des aliments, boissons et de l’alcool

Sans objet.

Grossesse et allaitement

Sans objet.

Sportifs

Sans objet.

Conduite de véhicules et utilisation de machines

Sans objet.

OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable contient chlorure de sodium, acétate de sodium trihydraté, acide

acétique glacial, eau pour préparations injectables.

3. COMMENT UTILISER OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable?

Mode d’emploi pour l’ouverture des ampoules :

Une ampoule bouteille de type OPC (One Point Cut) est caractérisée par une zone de fragilité au niveau du col de

l'ampoule, repérée par un point coloré. Pour ouvrir correctement l'ampoule, il est indispensable d'exercer une pression au

niveau de cette zone selon la procédure suivante :

1 - D'une main, tenir fermement le corps de l'ampoule en laissant dépasser la tête de l'ampoule, point coloré face à vous.

2 - De l'autre main, saisir la partie supérieure de l'ampoule, index posé derrière le col de l'ampoule et le pouce sur le point

coloré comme indiqué par le schéma (les deux pouces sont ainsi perpendiculaires).

3 - En tenant fermement chaque partie de l'ampoule, casser d'un coup sec en exerçant une pression vers le bas.

Posologie

Respectez toujours la posologie indiquée par votre médecin. En cas de doute, consultez votre médecin ou votre

pharmacien.

Mode d’administration

Voie injectable.

Si vous avez utilisé plus de OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable que vous n’auriez dû :

Si on administre accidentellement une quantité excessive d'OXYTOCINE EVER PHARMA à une femme, son utérus peut se

contracter trop fortement et causer des lésions ou provoquer une souffrance fœtale.

La prise en charge de ce surdosage consiste en l'arrêt immédiat de l'administration d'OXYTOCINE EVER PHARMA et en la

mise de la mère sous oxygène.

En cas d'intoxication par l'eau, il est essentiel de restreindre la prise de liquide, de corriger le déséquilibre en électrolytes.

Si vous oubliez d’utiliser OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable :

Sans objet.

Si vous arrêtez d’utiliser OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable :

Sans objet.

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

Comme tous les médicaments, ce médicament peut provoquer des effets indésirables, mais ils ne surviennent pas

systématiquement chez tout le monde.

Une injection intraveineuse rapide d'OXYTOCINE EVER PHARMA peut induire une baisse de la pression artérielle rapide

et transitoire accompagnée de flush (rougeur de la peau) et une accélération du rythme cardiaque.

Rarement:

nausées, vomissements,

troubles du rythme cardiaque,

prolongation de la durée de l'intervalle QTc sur l'électrocardiogramme,

anomalie du système de coagulation du sang.

Très rarement :

L'administration trop prolongée d'OXYTOCINE EVER PHARMA peut induire une rétention d'eau pouvant provoquer des

maux de tête, des nausées, des vomissements et des convulsions.

Exceptionnellement :

réactions allergiques.

Déclaration des effets secondaires

Si vous ressentez un quelconque effet indésirable, parlez-en à votre médecin ou votre pharmacien. Ceci s’applique aussi à

tout effet indésirable qui ne serait pas mentionné dans cette notice. Vous pouvez également déclarer les effets indésirables

directement via le système national de déclaration : Agence nationale de sécurité du médicament et des produits de santé

(ANSM) et réseau des Centres Régionaux de Pharmacovigilance - Site internet : www.ansm.sante.fr

En signalant les effets indésirables, vous contribuez à fournir davantage d’informations sur la sécurité du médicament.

5. COMMENT CONSERVER OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable?

Tenir ce médicament hors de la vue et de la portée des enfants.

Ne pas utiliser OXYTOCINE EVER PHARMA 5IU/ml solution injectable après la date de péremption mentionnée sur la

boîte, l’ampoule. La date de péremption fait référence au dernier jour du mois.

A conserver à une température comprise entre +2° C et +8°C.

Ne jetez aucun médicament au tout-à-l’égout ou avec les ordures ménagères. Demandez à votre pharmacien d’éliminer les

médicaments que vous n’utilisez plus. Ces mesures contribueront à protéger l’environnement.

6. CONTENU DE L’EMBALLAGE ET AUTRES INFORMATIONS

Ce que contient OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable

La substance active est :

Oxytocine............................................................................................................................ 5UI

Les autres composants sont :

Chlorure de sodium, acétate de sodium trihydraté, acide acétique glacial, eau pour préparations injectables.

Qu’est-ce que OXYTOCINE EVER PHARMA 5 UI/1 ml, solution injectable et contenu de l’emballage extérieur

Ce médicament se présente sous forme de solution injectable en ampoule. Boîte de 1, 3, 5, 10, 50 ou 100 ampoule(s).

Toutes les présentations peuvent ne pas être commercialisées.

Titulaire de l’autorisation de mise sur le marché

EVER NEURO PHARMA GmbH

OBERBURGAU 3

4866 UNTERACH

AUTRICHE

Exploitant de l’autorisation de mise sur le marché

CENTRE SPECIALITES PHARMACEUTIQUES

76-78 AVENUE DU MIDI

63800 COURNON D’AUVERGNE

Fabricant

EVER PHARMA JENA GmbH

OTTO-SCHOTT-STR. 15

07745 JENA

Allemagne

EVER NEURO PHARMA GmbH

OBERBURGAU 3

4866 UNTERACH

AUTRICHE

Noms du médicament dans les Etats membres de l'Espace Economique Européen

Sans objet.

La dernière date à laquelle cette notice a été révisée est :

[à compléter ultérieurement par le titulaire]

Autres

Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’ANSM (France).

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Pest categorisation of Acrobasis pirivorella

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

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7-9-2018

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

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FDA - U.S. Food and Drug Administration

28-8-2018

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

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20-8-2018

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

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26-11-2018

Wakix (Bioprojet Pharma)

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26-11-2018

Alunbrig (Takeda Pharma A/S)

Alunbrig (Takeda Pharma A/S)

Alunbrig (Active substance: brigatinib) - Centralised - Authorisation - Commission Decision (2018)7976 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4248/

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (Active substance: Setmelanotide) - Orphan designation - Commission Decision (2018)7811 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/143/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Active substance: Glucagon) - Orphan designation - Commission Decision (2018)7801 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/108/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (Active substance: Allogeneic faecal microbiota, pooled) - Orphan designation - Commission Decision (2018)7792 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/123/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

12-11-2018

Neupro (UCB Pharma S.A.)

Neupro (UCB Pharma S.A.)

Neupro (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2018)7551 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

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

29-10-2018

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Active substance: efavirenz) - Centralised - 2-Monthly update - Commission Decision (2018)7252 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/249/II/145/G

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

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

6-8-2018

Kyntheum (Leo Pharma A/S)

Kyntheum (Leo Pharma A/S)

Kyntheum (Active substance: brodalumab) - Centralised - Yearly update - Commission Decision (2018)5383 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety