14 results
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Veterinary medicine European public assessment report (EPAR): Cardalis
benazepril hydrochloride, spironolactone, Dogs
Date of authorisation: 23/07/2012, Revision: 4, Authorised, Last updated: 04/11/2021 -
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Human medicine European public assessment report (EPAR): Tracleer
bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary
Date of authorisation: 14/05/2002, Revision: 42, Authorised, Last updated: 13/02/2023 -
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Human medicine European public assessment report (EPAR): Xarelto
rivaroxaban, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 30/09/2008, Revision: 39, Authorised, Last updated: 23/02/2023 -
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Human medicine European public assessment report (EPAR): Thelin
sitaxentan sodium, Hypertension, Pulmonary
Date of authorisation: 10/08/2006, Revision: 13, Withdrawn, Last updated: 02/03/2011 -
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Withdrawn application: Heplisav
date of withdrawal: 10/02/2014, Initial authorisation, Last updated: 26/05/2014 -
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Referral: Pseudoephedrine-containing medicinal products (updated)
pseudoephedrine, Article 31 referrals
Status: Under evaluation, Last updated: 12/05/2023 -
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Referral: Veterinary medicinal products containing tylosin to be administered orally via feed or the drinking water to pigs
tylosin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 08/05/2014, EC decision date: 31/07/2014, Last updated: 05/09/2014 -
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Referral: Ibuprofen- and dexibuprofen-containing medicines
ibuprofen, dexibuprofen, Article 31 referrals
Status: CMDh final position, opinion/position date: 20/05/2015, Last updated: 14/07/2015 -
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Press release: European Medicines Agency review concludes positive benefit-risk balance for non-selective NSAIDs
CHMP, Last updated: 24/10/2006 -
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Manufacture of the finished dosage form (veterinary) - Scientific guideline
Last updated: 23/07/2021 -
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Article 5(3) opinions
Last updated: 24/02/2023 -
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Manufacture of the finished dosage form (human) - Scientific guideline
Last updated: 17/11/2017 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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CHMP: meeting archive 2001-2009
Last updated: 18/11/2013