67 results
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Referral: Valproat Ratiopharm Chrono
valproic acid, valproate, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 25/05/2010, EC decision date: 26/05/2010, Last updated: 23/07/2012various trade names including Depakine/Deprakine, Depakote and Epilim, and … various trade names including Depakine/Deprakine, Depakote and Epilim, and … -
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Referral: Valproate
valproic acid, valproate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/12/2009, EC decision date: 26/08/2010, Last updated: 29/04/2011various trade names including Depakine/Deprakine, Depakote and Epilim, and … various trade names including Depakine/Deprakine, Depakote and Epilim, and … -
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Press release: PRAC recommends new measures to avoid valproate exposure in pregnancy
PRAC, Last updated: 09/02/2018Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … -
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Press release: New measures to avoid valproate exposure in pregnancy endorsed
CMDh, Last updated: 23/03/2018Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … -
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Press release: PRAC recommends strengthening the restrictions on the use of valproate in women and girls
PRAC, Last updated: 10/10/2014Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal … Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal … -
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Referral: Valproate and related substances
sodium valproate, valproic acid, valproate semisodium, valpromide, associated names: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel, Article 31 referrals
Status: CMDh final position, opinion/position date: 19/11/2014, Last updated: 29/01/2015Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal … Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal … -
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Press release: CMDh agrees to strengthen warnings on the use of valproate medicines in women and girls
CMDh, Last updated: 21/11/2014Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal … Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal … -
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National expert: Raffaella Sardelli, Italian Medicines Agency (updated)
- Declaration of interests - 39.64 KB | PDF
- Curriculum Vitae - 31.8 KB | PDF
“Contaminazione da alluminio in soluzioni di albumina umana: un monitoraggio … dell’attivatore della precallicreina in soluzioni di albumina umana” (Abs … -
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National expert: Eraldo Donnarumma, Italian Medicines Agency (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 25.83 KB | PDF
PANORAMI E PERCORSI) “Doping: soluzione o inganno chimico? (BIF n.4/2006 … -
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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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National expert: Armando Magrelli, Italian Medicines Agency (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 50.53 KB | PDF
Country: Italy Employer: Con Soluzioni Con Srl • Start date: 042004 • … -
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Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient
Article 82
Status: European Commission final decision, opinion/position date: 08/12/2022, EC decision date: 28/03/2023, Last updated: 14/04/2023 -
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Referral: Valproate and related substances
sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide, associated names: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/03/2018, EC decision date: 31/05/2018, Last updated: 07/06/2018Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide … -
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Referral: Didanosine
didanosine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/09/2013, EC decision date: 20/11/2013, Last updated: 10/12/2013Aurobindo 200mg capsule rigide gastroresistenti 200 mg Gastro-resistant … Aurobindo 250mg capsule rigide gastroresistenti 250 mg Gastro-resistant … Aurobindo 400mg capsule rigide gastroresistenti 400 mg Gastro-resistant … -
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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: Closamectin Pour-on Solution and associated names
ivermectin, closantel, Article 78
Status: European Commission final decision, opinion/position date: 08/10/2015, EC decision date: 22/03/2016, Last updated: 31/05/2016 -
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Referral: Fiprex
fipronil, Article 33
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 14/07/2014, Last updated: 14/08/2014 -
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Referral: Tylosin injection for mastitis
tylosin, Article 35
Status: European Commission final decision, opinion/position date: 16/03/2017, EC decision date: 10/07/2017, Last updated: 31/07/2017 -
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Referral: Baytril injectable and generics
enrofloxacin, Article 35
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 01/09/2014, Last updated: 10/12/2014 -
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Referral: Injectable veterinary medicinal products containing vitamin A for use in food producing species
Vitamin A (retinol and its esters), Article 35
Status: European Commission final decision, opinion/position date: 12/05/2021, EC decision date: 18/08/2021, Last updated: 27/09/2021 -
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Referral: Moxidectin-containing veterinary medicines used in cattle, sheep and horses
moxidectin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 11/05/2017, Last updated: 24/10/2017 -
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Referral: Veterinary medicinal products containing toltrazuril to be administered orally to chickens
toltrazuril, Article 35
Status: European Commission final decision, opinion/position date: 14/07/2022, EC decision date: 09/11/2022, Last updated: 14/12/2022 -
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Referral: Zyrtec
cetirizine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 30/05/2008, EC decision date: 06/10/2008, Last updated: 16/10/2008 -
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Referral: Altrenogest
altrenogest, Article 35
Status: European Commission final decision, opinion/position date: 19/05/2016, EC decision date: 29/07/2016, Last updated: 08/09/2016