33 results
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Press release: European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
Last updated: 19/11/2013allopurinol, benzerapide/levodopa, bromazepam, calcitriol, carvedilol, ceftriaxone … allopurinol, benzerapide/levodopa, bromazepam, calcitriol, carvedilol, ceftriaxone … -
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Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 50, Authorised, Last updated: 13/03/2023 -
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Human medicine European public assessment report (EPAR): Ocrevus
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018, Revision: 17, Authorised, Last updated: 13/04/2023 -
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Human medicine European public assessment report (EPAR): Impulsor
milnacipran, Fibromyalgia
Date of refusal: 08/04/2010, Refused, Last updated: 26/04/2010 -
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Human medicine European public assessment report (EPAR): Milnacipran Pierre Fabre Medicament
milnacipran, Fibromyalgia
Date of refusal: 08/04/2010, Refused, Last updated: 26/04/2010 -
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Human medicine European public assessment report (EPAR): Comirnaty
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,
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, Revision: 41, Authorised, Last updated: 24/03/2023
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Referral: Topiramate
topiramate, Article 31 referrals
Status: Under evaluation, Last updated: 20/03/2023 -
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Referral: Ranitidine-containing medicinal products
ranitidine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/09/2020, EC decision date: 24/11/2020, Last updated: 17/02/2021 -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014 -
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Referral: Ambroxol and bromhexine-containing medicines
ambroxol, bromhexine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2015, EC decision date: 14/01/2016, Last updated: 05/02/2016 -
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Referral: Aggrastat
Tirofiban, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 26/03/1999, EC decision date: 18/06/1999, Last updated: 18/06/1999 -
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Referral: Tetrazepam-containing medicines
tetrazepam, associated names: Myolastan and generics, Article 107i procedures
Status: European Commission final decision, opinion/position date: 24/04/2013, EC decision date: 29/05/2013, Last updated: 18/07/2013 -
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Referral: Bisphosphonates
alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, associated names: Actonel, Aredia, Bonefos, Didronel, Fosamax, Nerixia, Skelid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 13/07/2011, Last updated: 28/10/2011 -
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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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Public data from Article 57 database
Last updated: 17/10/2022 -
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News: European Commission closes infringement procedure against Roche
Last updated: 15/12/2017allopurinol, benzerapide/levodopa, bromazepam, calcitriol, carvedilol … -
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Press release: European Medicines Agency starts infringement procedure to investigate Roche's alleged non-compliance with pharmacovigilance obligations
Last updated: 23/10/2012allopurinol, benzerapide/levodopa, bromazepam, calcitriol, carvedilol … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 14-17 May 2018
European Medicines Agency, London, UK, from 14/05/2018 to 17/05/2018, Last updated: 14/05/2018 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 March 2017
European Medicines Agency, London, UK, from 20/03/2017 to 23/03/2017, Last updated: 20/03/2017 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 April 2021
European Medicines Agency, Amsterdam, the Netherlands, from 06/04/2021 to 09/04/2021, Last updated: 27/02/2018 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 24-27 October 2016
European Medicines Agency, London, UK, from 24/10/2016 to 27/10/2016, Last updated: 13/03/2014 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 17/05/2023 -
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News: EMA's medical literature monitoring enters into full operation
Last updated: 01/09/2015 -
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News: Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups
Last updated: 12/05/2015 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 April 2021
PRAC, Last updated: 09/04/2021