DOMPERIDONE Dakota Pharm

Information principale

  • Nom commercial:
  • DOMPERIDONE Dakota Pharm 10 mg, comprimé pelliculé
  • Dosage:
  • 10 mg
  • forme pharmaceutique:
  • comprimé
  • Composition:
  • composition pour un comprimé > dompéridone : 10 mg
  • Mode d'administration:
  • orale
  • Unités en paquet:
  • plaquette(s) thermoformée(s) PVC-Aluminium de 20 comprimé(s)
  • Type d'ordonnance:
  • liste II
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • DOMPERIDONE Dakota Pharm 10 mg, comprimé pelliculé
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • STIMULANTS DE LA MOTRICITE INTESTINALE
  • Descriptif du produit:
  • 363 132-7 ou 4009 363 132 7 9 - plaquette(s) thermoformée(s) PVC-Aluminium de 20 comprimé(s) - Déclaration de commercialisation non communiquée:;363 133-3 ou 4009 363 133 3 0 - plaquette(s) thermoformée(s) PVC-Aluminium de 30 comprimé(s) - Déclaration de commercialisation non communiquée:;363 135-6 ou 4009 363 135 6 9 - plaquette(s) thermoformée(s) PVC-Aluminium de 40 comprimé(s) - Déclaration de commercialisation non communiquée:;565 088-9 ou 4009 565 088 9 1 - plaquette(s) thermoformée(s) PVC-Aluminium de 100 comprimé(s) - Déclaration de commercialisation non communiquée:;

Autres informations

Statut

  • Source:
  • ANSM - Agence Nationale de Sécurité du Médicament et des Produits de Santé
  • Statut de autorisation:
  • Archivée
  • Numéro d'autorisation:
  • 62169256
  • Date de l'autorisation:
  • 24-11-2003
  • Dernière mise à jour:
  • 10-08-2017

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

NOTICE

ANSM - Mis à jour le : 21/12/2007

Dénomination du médicament

DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé

Encadré

Veuillez lire attentivement l'intégralité de cette notice avant de prendre ce médicament.

Gardez cette notice, vous pourriez avoir besoin de la relire.

Si vous avez toute autre question, si vous avez un doute, demandez plus d'informations à votre médecin ou à votre

pharmacien.

Ce médicament vous a été personnellement prescrit. Ne le donnez jamais à quelqu'un d'autre, même en cas de symptômes

identiques, cela pourrait lui être nocif.

Si l'un des effets indésirables devient grave ou si vous remarquez un effet indésirable non mentionné dans cette notice,

parlez-en à votre médecin ou à votre pharmacien.

Sommaire notice

Dans cette notice :

1. QU'EST-CE QUE DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé ET DANS QUELS CAS EST-IL

UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE DOMPERIDONE DAKOTA PHARM 10

mg, comprimé pelliculé ?

3. COMMENT PRENDRE DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé ET DANS QUELS CAS EST-IL

UTILISE ?

Classe pharmacothérapeutique

Sans objet.

Indications thérapeutiques

Ce médicament contient du dompéridone, substance appartenant à la famille des antagonistes de la dopamine. Il agit sur la

motricité intestinale.

Chez l'adulte et l'adolescent (plus de 12 ans et plus de 35 kg), ce médicament est indiqué dans le soulagement des nausées

et vomissements, sensations de ballonnements, gênes ou régurgitations gastriques (remontées du contenu de l'estomac

dans la bouche).

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE DOMPERIDONE DAKOTA PHARM 10

mg, comprimé pelliculé ?

Liste des informations nécessaires avant la prise du médicament

Sans objet.

Contre-indications

Ne prenez jamais DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé dans les cas suivants:

Allergie connue au dompéridone ou à l'un des autres composants de ce médicament,

prolactinome (maladie de la glande hypophysaire),

saignements de l'estomac ou de l'intestin, obstruction mécanique ou perforation digestive.

EN CAS DE DOUTE, IL EST INDISPENSABLE DE DEMANDER L'AVIS DE VOTRE MEDECIN OU DE VOTRE

PHARMACIEN.

Précautions d'emploi ; mises en garde spéciales

Faites attention avec DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé:

En raison de la présence de lactose, ce médicament ne doit pas être utilisé en cas de galactosémie, de syndrome de

malabsorption du glucose et du galactose ou de déficit en lactase (maladies métaboliques rares).

Prévenir votre médecin en cas d'insuffisance hépatique (défaillance des fonctions du foie).

Ce médicament sera utilisé AVEC PRECAUTION en cas d'insuffisance rénale (défaillance des fonctions du rein). En cas de

traitement prolongé, votre médecin sera amené à vous suivre régulièrement.

EN CAS DE DOUTE, NE PAS HESITER A DEMANDER L'AVIS DE VOTRE MEDECIN OU DE VOTRE PHARMACIEN.

Interactions avec d'autres médicaments

Prise ou utilisation d'autres médicaments

Si vous prenez ou avez pris récemment un autre médicament, y compris un médicament obtenu sans ordonnance, parlez-en

à votre médecin ou à votre pharmacien.

Interactions avec les aliments et les boissons

Sans objet.

Interactions avec les produits de phytothérapie ou thérapies alternatives

Sans objet.

Utilisation pendant la grossesse et l'allaitement

Grossesse et allaitement

Il est préférable de ne pas utiliser ce médicament pendant la grossesse.

Si ce médicament vous est prescrit au cours de la grossesse, respectez la posologie et la durée du traitement établies par

votre médecin.

Si vous découvrez que vous êtes enceinte pendant le traitement, consultez votre médecin car lui seul peut juger de la

nécessité de le poursuivre.

L'utilisation de ce médicament au cours de l'allaitement est déconseillée.

Demandez conseil à votre médecin ou à votre pharmacien avant de prendre tout médicament.

Sportifs

Sans objet.

Effets sur l'aptitude à conduire des véhicules ou à utiliser des machines

Conduite de véhicules et utilisation de machines

Ce médicament n'altère pas (ou de façon négligeable) la capacité à conduire ou à utiliser des machines.

Liste des excipients à effet notoire

Liste des excipients à effet notoire:lactose.

3. COMMENT PRENDRE DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé ?

Instructions pour un bon usage

Sans objet.

Posologie, Mode et/ou voie(s) d'administration, Fréquence d'administration et Durée du traitement

Adultes et adolescents (plus de 12 ans et plus de 35 kg): 1 à 2 comprimés, 3 à 4 fois par jour, sans dépasser 8

comprimés par jour.

La forme comprimé n'est pas adaptée aux enfants pesant moins de 35 kg. Les enfants seront traités préférentiellement avec

une forme suspension buvable à 1 mg/ml.

Voie orale.

Il est recommandé de prendre ce médicament avant les repas. Si le médicament est pris après les repas, son absorption est

quelque peu retardée.

La durée initiale du traitement est de quatre semaines. Si les symptômes persistent après 4 semaines, consultez votre

médecin qui évaluera la nécessité de poursuivre le traitement.

DANS TOUS LES CAS, RESPECTEZ STRICTEMENT L'ORDONNANCE DE VOTRE MEDECIN.

Symptômes et instructions en cas de surdosage

Si vous avez pris plus de DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé que vous n'auriez dû:

Consultez immédiatement votre médecin ou votre pharmacien.

Instructions en cas d'omission d'une ou de plusieurs doses

Si vous oubliez de prendre DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé:

Ne prenez pas de dose double pour compenser la dose simple que vous avez oublié de prendre.

Risque de syndrome de sevrage

Sans objet.

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

Description des effets indésirables

Comme tous les médicaments, DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé est susceptible d'avoir des

effets indésirables, bien que tout le monde n'y soit pas sujet:

Très rares: réaction allergique, effets secondaires extrapyramidaux (modification de la tonicité des muscles et de la

régulation des mouvements involontaires et automatiques), urticaire.

Rares: augmentation des taux de prolactine (hormone qui provoque la lactation), galactorrhée (écoulement de lait en

dehors des périodes d'allaitement), gynécomastie (développement anormal des seins chez l'homme), aménorrhée (troubles

des règles), troubles gastro-intestinaux, y compris des crampes intestinales très rares et passagères.

Si vous remarquez des effets indésirables non mentionnés dans cette notice, ou si certains effets indésirables deviennent

graves, veuillez en informer votre médecin ou votre pharmacien.

5. COMMENT CONSERVER DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé ?

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

Date de péremption

Ne pas utiliser DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé après la date de péremption mentionnée sur

la boîte.

Conditions de conservation

Pas de précautions particulières de conservation.

Si nécessaire, mises en garde contre certains signes visibles de détérioration

Les médicaments ne doivent pas être jetés au tout à l'égout ou avec les ordures ménagères. Demandez à votre pharmacien

ce qu'il faut faire des médicaments inutilisés. Ces mesures permettront de protéger l'environnement.

6. INFORMATIONS SUPPLEMENTAIRES

Liste complète des substances actives et des excipients

Que contient DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé ?

La substance active est:

Dompéridone ..................................................................................................................................... 10 mg

Pour un comprimé pelliculé.

Les autres composants sont:

Noyau: amidon de maïs, lactose monohydraté, povidone K30, stéarate de magnésium, laurilsulfate de sodium, huiles

végétales hydrogénées, cellulose microcristalline, crospovidone.

Pelliculage: hypromellose, macrogol 6000.

Forme pharmaceutique et contenu

Qu'est-ce que DOMPERIDONE DAKOTA PHARM 10 mg, comprimé pelliculé et contenu de l'emballage extérieur ?

Ce médicament se présente sous forme de comprimé pelliculé. Boîte de 20, 30, 40 ou 100.

Nom et adresse du titulaire de l'autorisation de mise sur le marché et du titulaire de l'autorisation de fabrication responsable

de la libération des lots, si différent

Titulaire

SANOFI-AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Exploitant

LABORATOIRES IREX - Groupe SANOFI-SYNTHELABO

11, rue Salomon de Rothschild

92150 SURESNES

Fabricant

LABORATOIRES BTT

Zone industrielle de Krafft

67150 ERSTEIN

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

Sans objet.

Date d’approbation de la notice

La dernière date à laquelle cette notice a été approuvée est le {date}.

AMM sous circonstances exceptionnelles

Sans objet.

Informations Internet

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

Informations réservées aux professionnels de santé

Sans objet.

Autres

Sans objet.

4-12-2018

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8-11-2018

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3-11-2018

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22-10-2018

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18-10-2018

October 18, 2018: Pharmacist Indicted for Taking Drugs, Carrying Firearm in Violation of Court Order

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28-9-2018

Debate on research dissemination at the Danish Medicines Agency

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Danish Medicines Agency

17-9-2018

September 11, 2018: Columbus Pharmacist Sentenced for Health Care Fraud Scheme

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FDA - U.S. Food and Drug Administration

11-9-2018

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11-9-2018

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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4-9-2018

Safer prescription of blood thinning agents

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Danish Medicines Agency

28-8-2018

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

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Danish Medicines Agency

23-8-2018

August 22, 2018: Louisiana Pharmacist Convicted of Trafficking and Selling Stolen Medication

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FDA - U.S. Food and Drug Administration

20-8-2018

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

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FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

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FDA - U.S. Food and Drug Administration

18-7-2018

FDA Investigating Multistate Outbreak of Salmonella Sandiego Infections Linked to Hy-Vee Spring Pasta Salad

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FDA - U.S. Food and Drug Administration

18-7-2018

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

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FDA - U.S. Food and Drug Administration

13-7-2018

Scientific guideline:  Guideline on good pharmacogenomic practice - First version, adopted

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11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

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11-7-2018

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

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FDA - U.S. Food and Drug Administration

15-6-2018

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1-6-2018

Demulen 30 birth control pills: Packages containing broken or chipped pills

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1-6-2018

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11-5-2018

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FDA - U.S. Food and Drug Administration

10-5-2018

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

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FDA - U.S. Food and Drug Administration

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

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FDA - U.S. Food and Drug Administration

16-4-2018

Women taking birth control pills reminded to return any packages for replacement if the pills are missing or look unusual

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16-4-2018

Les femmes qui prennent des pilules anticonceptionnelles doivent retourner les emballages pour les faire remplacer s’il manque des comprimés ou s’ils ont un aspect inhabituel

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28-3-2018

DKMA Update March 2018

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Danish Medicines Agency

8-3-2018

Recommandation de suspension immédiate et rappel du Zinbryta®, médicament utilisé dans le traitement de la sclérose en plaques

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Ministère de la Santé - Luxembourg

25-1-2018

How to Buy Medicines Safely From an Online Pharmacy

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FDA - U.S. Food and Drug Administration

22-12-2017

Retrait des produits infantiles PICOT et MILUMEL

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Ministère de la Santé - Luxembourg

3-11-2017

New Director of Division for Pharmacovigilance & Medical Devices

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Danish Medicines Agency

12-9-2017

E2B acknowledgment format change

E2B acknowledgment format change

Companies that use the Danish Medicines Agency's Pharmacovigilance System should be aware that we have changed the MessageFormatRelease value from 2.0 to 1.0.

Danish Medicines Agency

11-9-2017

DKMA Update

DKMA Update

Our newsletter Danish Pharmacovigilance Update changes name to DKMA Update and will from now on contain information about medicinal products in general, patient safety and life science.

Danish Medicines Agency

1-8-2017

Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg

Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg

German and Danish parallel importers and the Danish Medicines Agency are now withdrawing the fourth batch of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batch contains counterfeit packs.

Danish Medicines Agency

27-7-2017

Counterfeit packs of the schizophrenia medicine Xeplion 150 mg

Counterfeit packs of the schizophrenia medicine Xeplion 150 mg

One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.

Danish Medicines Agency

8-6-2017

Danish Pharmacovigilance Update, May 2017

Danish Pharmacovigilance Update, May 2017

The May issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

22-5-2017

Danish Pharmacovigilance Update, April 2017

Danish Pharmacovigilance Update, April 2017

The April issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

18-4-2017

Danish Pharmacovigilance Update, March 2017

Danish Pharmacovigilance Update, March 2017

The March issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

6-3-2017

Danish Pharmacovigilance Update, February 2017

Danish Pharmacovigilance Update, February 2017

The February issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

3-2-2017

Danish Pharmacovigilance Update, January 2017

Danish Pharmacovigilance Update, January 2017

The January issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

6-1-2017

Danish Pharmacovigilance Update, December 2016

Danish Pharmacovigilance Update, December 2016

The December issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

20-12-2016

New chair of PhVWP-V

New chair of PhVWP-V

Lisbet Vesterager Borge, veterinarian, has been elected chair of the European Pharmacovigilance Working Party Veterinary (PhVWP-V).

Danish Medicines Agency

9-12-2016

Danish Pharmacovigilance Update, November 2016

Danish Pharmacovigilance Update, November 2016

The November issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

15-11-2016

Danish Pharmacovigilance Update, October 2016

Danish Pharmacovigilance Update, October 2016

The October issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

3-11-2016

Danish Pharmacovigilance Update, September 2016

Danish Pharmacovigilance Update, September 2016

The September issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

7-10-2016

Experts for the European Pharmacopoeia's groups of experts and working parties

Experts for the European Pharmacopoeia's groups of experts and working parties

A very large part of the work related to the drafting of new monographs for the European Pharmacopoeia (EDQM) is carried out by external experts in 75 groups of experts and working parties. Experts for the groups are appointed for a period of three years, and the EDQM is now seeking experts for the period from 2017 to 2019.

Danish Medicines Agency

13-9-2016

Danish Pharmacovigilance Update, August 2016

Danish Pharmacovigilance Update, August 2016

The August issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

5-7-2016

Danish Pharmacovigilance Update, June 2016

Danish Pharmacovigilance Update, June 2016

The June issue of Danish Pharmacovigilance Update.

Danish Medicines Agency

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

30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

30-8-2018

Modified release paracetamol

Modified release paracetamol

Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'

Therapeutic Goods Administration - Australia

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (TurnKey PharmaConsulting Ireland Limited)

EU/3/18/1991 (Active substance: Docosahexaenoic acid ethyl ester) - Orphan designation - Commission Decision (2018)1880 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/235/17

Europe -DG Health and Food Safety

23-3-2018

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

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

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

Europe -DG Health and Food Safety

23-3-2018

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

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

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

Europe -DG Health and Food Safety