53 results
Keyword Ambroxol Tecnigen Remove keyword
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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: 05/02/2016Ambroxol and bromhexine-containing … Ambroxol and bromhexine-containing … January 2016 EMA/168579/2015 Ambroxol and bromhexine expectorants … -
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Orphan designation: Ambroxol hydrochloride for: Treatment of amyotrophic lateral sclerosis
Date of designation: 25/05/2018, Positive, Last updated: 24/07/2018Ambroxol hydrochloride … opinion on orphan designation Ambroxol hydrochloride for the treatment … opinion on orphan designation Ambroxol hydrochloride for the treatment … -
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Press release: PRAC considers risk of severe allergic reactions with ambroxol- and bromhexine-containing medicines to be small
PRAC, Last updated: 12/01/2015severe allergic reactions with ambroxol- and bromhexine-containing … severe allergic reactions with ambroxol- and bromhexine-containing … allergic reactions with ambroxol- and bromhexine-containing … -
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Press release: Start of review of ambroxol and bromhexine
PRAC, Last updated: 11/04/2014Start of review of ambroxol and bromhexine … Start of review of ambroxol and bromhexine … Start of review of ambroxol and bromhexine The European … -
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Press release: Ambroxol and bromhexine expectorants: safety information to be updated
CMDh, Last updated: 27/02/2015Ambroxol and bromhexine expectorants … the product information for ambroxol- and bromhexine-containing … evaluated available data on ambroxol and bromhexine, including … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 January 2015
PRAC, Last updated: 12/01/2015severe allergic reactions with ambroxol- and bromhexine-containing … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 April 2014
PRAC, Last updated: 11/04/2014Start of review of ambroxol and bromhexine … -
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Human medicine European public assessment report (EPAR): Inovelon
Rufinamide, Epilepsy
Date of authorisation: 16/01/2007, Revision: 23, Authorised, Last updated: 22/02/2023 -
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Referral: Topiramate
topiramate, Article 31 referrals
Status: Under evaluation, Last updated: 20/03/2023 -
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Herbal medicinal product: Hederae helicis folium
Hedera helix L., Ivy leaf, F: Assessment finalised, Last updated: 01/10/2018effective as the medicine ambroxol in improving cough symptoms … -
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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: 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: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023 (updated)
PRAC, Last updated: 22/05/2023 -
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Committee for Orphan Medicinal Products (COMP): 17-19 April 2018
European Medicines Agency, London, UK, from 17/04/2018 to 19/04/2018, Last updated: 16/04/201816 2.2.7. Ambroxol hydrochloride - EMA/OD/236/17 … -
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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): 7-10 April 2014
European Medicines Agency, London, UK, from 07/04/2014 to 10/04/2014, Last updated: 13/08/2013 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 January 2015
European Medicines Agency, London, UK, from 06/01/2015 to 09/01/2015, Last updated: 13/03/2014 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 June 2017
European Medicines Agency, London, UK, from 06/06/2017 to 09/06/2017, Last updated: 13/03/2014 -
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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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COMP: Agendas, minutes and meeting reports (updated)
Last updated: 11/05/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 1-4 December 2014
European Medicines Agency, London, UK, from 01/12/2014 to 04/12/2014, Last updated: 13/08/2013