17 results
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Referral: Topiramate (updated)
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: Lansoprazol-ratiopharm 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 21/02/2006, Last updated: 25/02/2006 -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015 -
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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: 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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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Expired, Last updated: 25/11/2021 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021 -
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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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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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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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Public data from Article 57 database
Last updated: 17/10/2022 -
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Outcomes of imposed non-interventional post-authorisation safety studies
Last updated: 27/06/2022 -
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Press release: GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies
CHMP, Last updated: 23/01/2015 -
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CHMP: meeting archive 2016-2018
Last updated: 26/02/2020 -
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Guidance documents
Last updated: 19/07/2022