104 results
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Referral: Micro Therapeutic Research
Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/03/2017, EC decision date: 23/06/2017, Last updated: 10/07/2017 -
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Referral: Pharmaceutics International Inc.
sodium phenylbutyrate, progesterone, dutasteride, colecalciferol, associated names: Ammonaps, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/09/2016, EC decision date: 05/12/2016, Last updated: 14/12/2016 -
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Referral: Semler
Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 22/09/2016, Last updated: 17/11/2016 -
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Referral: Alkem
Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2016, EC decision date: 08/09/2016, Last updated: 07/10/2016 -
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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: Cozaar
irbesartan, associated names: Loortan, Loortan Cardio Start, Cozaar Startpakkle, Cardopal Start, Lorzaar, Lorzaar start, Lorzaar Protect, Pinzaar, Lorzaar Varipharmstart, Lortaan, Neo-Lotan, Losaprex, Cozaar IC, Lortaar IC, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 23/10/2008, EC decision date: 22/01/2009, Last updated: 13/01/2012 -
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Referral: Xalatan
latanoprost, associated names: Latanoprost Pharmacia & Upjohn, Xalatan 50 mikrogramov/ml kaplijice za oko, raztopina, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 22/07/2010, EC decision date: 15/10/2010, Last updated: 08/12/2010 -
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Referral: Diovan
valsartan, associated names: Angiosan, Diovane, Tareg, Cordinate, Provas, Dalzad, Rixil, Kalpress Cardio, Diovan Cardio, Miten Cardio, Valsartan Novartis, Kalpress, Miten, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 15/12/2009, EC decision date: 19/04/2010, Last updated: 31/05/2010 -
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Referral: Diovan
valsartan, associated names: Angiosan, Diovane, Tareg, Cordinate, Provas, Dalzad, Rixil, Kalpress Cardio, Diovan Cardio, Miten Cardio, Valsartan Novartis, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 15/12/2009, EC decision date: 19/04/2010, Last updated: 31/05/2010 -
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Referral: Arimidex
anastrozole, Article 29 paediatrics
Status: European Commission final decision, EC decision date: 06/11/2009, Last updated: 28/05/2010 -
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Referral: Methoxasol-T
trimethoprim, sulfamethoxazole, Article 34
Status: European Commission final decision, opinion/position date: 11/10/2007, EC decision date: 11/01/2008, Last updated: 09/10/2008 -
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Referral: Vigabatrin
vigabatrin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/05/1999, EC decision date: 05/10/1999, Last updated: 12/10/1998 -
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Referral: Terfenadine
terfenadine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/11/1997, EC decision date: 22/09/1998, Last updated: 22/01/1998 -
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Orphan designation: Trientine tetrahydrochloride for: Treatment of Wilson's disease
Date of designation: 19/03/2015, Withdrawn, -
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Orphan designation: Sodium phenylbutyrate for: Treatment of 5q spinal muscular atrophy
Date of designation: 11/01/2012, Withdrawn, Last updated: 17/07/2017 -
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Q&A: Good clinical practice (GCP) (updated)
Last updated: 08/06/2023 -
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Mutual recognition agreements (MRA) (updated)
Last updated: 31/05/2023 -
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Good clinical practice
Last updated: 04/05/2023 -
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Joint Audit Programme
Last updated: 14/03/2023 -
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International collaboration on GMP inspections
Last updated: 01/02/2023 -
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Coordination of pharmacovigilance inspections
Last updated: 12/01/2023 -
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Guidance on good manufacturing practice and good distribution practice: Questions and answers
Last updated: 05/01/2023 -
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Pharmacovigilance inspection procedures: human
Last updated: 29/11/2022 -
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GMP/GDP Inspectors Working Group
Last updated: 05/08/2022 -
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Good clinical practice (GCP) inspection procedures
Last updated: 13/07/2022