32 results
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Withdrawn application: Doxorubicin Hydrochloride Tillomed
doxorubicin, date of withdrawal: 02/03/2020, Initial authorisation, Last updated: 27/07/2020Doxorubicin Hydrochloride Tillomed: Withdrawn application … Doxorubicin Hydrochloride Tillomed: Withdrawal of the marketing … Doxorubicin hydrochloride Tillomed (doxorubicin hydrochloride … -
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Referral: Carbamazepin Tillomed
carbamazepin, associated names: Carbamazepin Tillomed, Carbamazepina Tillomed, Karbamazepin Tillomed, Karbamazepina Tillomed, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 25/06/2020, Last updated: 21/07/2020Carbamazepin Tillomed … authorisation of Carbamazepin Tillomed (carbamazepine, 200 and 400 … -
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Orphan designation: acetazolamide for: Treatment of periodic paralysis
Date of designation: 21/08/2019, Positive, Last updated: 14/01/2020Commission to Laboratorios Tillomed Spain, S.L.U, Spain, for … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)
CHMP, Last updated: 27/03/2020Doxorubicin Hydrochloride Tillomed … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
CHMP, Last updated: 30/04/2020Carbamazepin Tillomed … -
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Referral: Synchron
Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/05/2022, EC decision date: 28/11/2022, Last updated: 16/12/2022 -
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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: 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: Metformin and metformin-containing medicines
metformin, associated names: Xigduo, Vipdomet, Velmetia, Synjardy, Ristfor, Komboglyze, Jentadueto, Janumet, Icandra (previously Vildagliptin / metformin hydrochloride Novartis), Glubrava, Eucreas, Efficib, Ebymect, Competact, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/10/2016, EC decision date: 12/12/2016, Last updated: 21/12/2016 -
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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: Codeine-containing medicines
codeine, Article 31 referrals
Status: CMDh final position, opinion/position date: 26/06/2013, Last updated: 02/08/2013 -
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Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005 -
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Referral: Piroxicam
piroxicam, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/06/2007, EC decision date: 07/09/2007, Last updated: 31/01/2008 -
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Referral: Fibrates
bezafibrate, ciprofibrate, fenofibrate, gemfibrozil, associated names: Bezalip, Lipanor, Lipanthyl, Lopid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/10/2010, EC decision date: 28/02/2011, Last updated: 03/04/2013 -
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Referral: Zolpidem-containing medicines
zolpidem, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 23/06/2014, Last updated: 04/08/2014 -
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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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Public data from Article 57 database
Last updated: 17/10/2022 -
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EudraVigilance: electronic reporting
Last updated: 15/02/2022 -
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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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PRAC recommendations on safety signals (updated)
Last updated: 06/03/2023 -
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PRAC: Agendas, minutes and highlights (updated)
Last updated: 31/03/2023 -
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Committee for Orphan Medicinal Products (COMP): 16-18 July 2019
European Medicines Agency, Amsterdam, the Netherlands, from 16/07/2019 to 18/07/2019, Last updated: 19/12/2019 -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
PRAC, Last updated: 17/09/2021 -
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COMP: Agendas, minutes and meeting reports (updated)
Last updated: 17/03/2023 -
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Pharmacovigilance Risk Assessment Committee (PRAC): 3-6 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 03/05/2021 to 06/05/2021, Last updated: 27/02/2018