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Referral: Pseudoephedrine-containing medicinal products (updated)
pseudoephedrine, Article 31 referrals
Status: Under evaluation, Last updated: 05/09/2023various trade names, including Actifed, Aerinaze, Aspirin Complex … various trade names, including Actifed, Aerinaze, Aspirin Complex … -
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News: PRAC starts safety review of pseudoephedrine-containing medicines
Last updated: 10/02/2023various trade names, including Actifed, Aerinaze, Aspirin Complex … -
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National expert: Michael Denkinger, European Medicines Agency (updated)
- Declaration of interests - 40.73 KB | PDF
- Curriculum Vitae - 65.02 KB | PDF
Dallmeier D, Rothenbacher D; ActiFE Study Group. Association … biomarkers in older adults: the ActiFE_study. Sci Rep. 2020 Jul 17;10(1):11862 … -
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National expert: Aurélie Demarcq, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 39.41 KB | PDF
- Curriculum Vitae - 24.1 KB | PDF
ingrédients pharmaceutiques actifs (API) pour l’industrie … ingrédients pharmaceutiques actifs (API) pour l’industrie … Ingrédients Pharmaceutiques Actifs (IPA) pour l’industrie … -
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Human medicine European public assessment report (EPAR): Insuman
insulin human, Diabetes Mellitus
Date of authorisation: 21/02/1997, Revision: 33, Authorised, Last updated: 12/07/2023 -
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Human medicine European public assessment report (EPAR): Evicel
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 05/10/2008, Revision: 18, Authorised, Last updated: 11/05/2023 -
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Human medicine European public assessment report (EPAR): Taxotere
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 27/11/1995, Revision: 50, Authorised, Last updated: 24/03/2023 -
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National expert: Hugues Malonne, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 41.98 KB | PDF
- Curriculum Vitae - 46.94 KB | PDF
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Referral: Pholcodine-containing medicinal products
pholcodine, Article 107i procedures
Status: European Commission final decision, opinion/position date: 14/12/2022, EC decision date: 06/03/2023, Last updated: 29/03/2023 -
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Referral: Zyrtec
cetirizine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 30/05/2008, EC decision date: 06/10/2008, Last updated: 16/10/2008Lannelongue 75668 Paris cedex 14 ACTIFED ALLERGIE CETIRIZINE 10MG … -
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Referral: Pholcodine
pholcodine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/12/2011, EC decision date: 17/02/2012, Last updated: 28/03/2012 -
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Referral: Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients
Article 31 referrals
Status: CMDh final position, opinion/position date: 22/04/2015, Last updated: 18/05/2015 -
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Guidance for the application of Article 34 of Regulation (EU) 2019/6 - prescription status
Last updated: 27/01/2023 -
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Public data from Article 57 database
Last updated: 30/06/2023 -
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EudraVigilance
Last updated: 25/03/2020