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180 results

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Categories Human Remove Human filter Veterinary Remove Veterinary filter

Referral type Article 5(11) referrals (prior to January 2010) Remove Article 5(11) referrals (prior to January 2010) filter Article 13 Remove Article 13 filter Article 107i procedures Remove Article 107i procedures filter Article 31 referrals Remove Article 31 referrals filter Article 33 Remove Article 33 filter

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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: 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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Referral: Hydroxyzine

hydroxyzine, associated names: Atarax, Article 31 referrals
Status: CMDh final position, opinion/position date: 25/03/2015, Last updated: 08/06/2015
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Referral: Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients

Article 31 referrals
Status: CMDh final position, opinion/position date: 22/04/2015, Last updated: 18/05/2015
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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: 29/01/2015
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Referral: Resflor solution injectable and associated names

florfenicol, flunixin, Article 13
Status: European Commission final decision, opinion/position date: 07/10/2014, EC decision date: 05/12/2014, Last updated: 09/01/2015
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Referral: Testosterone-containing medicines

testosterone, Article 31 referrals
Status: CMDh final position, opinion/position date: 19/11/2014, Last updated: 08/01/2015
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Referral: Polymyxin-containing medicines

colistimethate sodium, associated names: Colobreathe, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 16/12/2014, Last updated: 05/01/2015
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Referral: Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum

bromocriptine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/08/2014, EC decision date: 30/10/2014, Last updated: 08/12/2014
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Referral: Emergency contraceptives

levonorgestrel, ulipristal acetate, associated names: Norlevo, Levonelle/Postinor and Levodonna, ellaOne, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/07/2014, EC decision date: 30/09/2014, Last updated: 24/10/2014
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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: Diacerein-containing medicines for oral administration

diacerein, associated names: Zondar, Article 31 referrals
Status: European Commission final decision, EC decision date: 04/09/2014, Last updated: 19/09/2014
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Referral: Linoladiol N and Linoladiol HN

estradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/04/2014, EC decision date: 19/08/2014, Last updated: 11/09/2014
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Referral: Domperidone-containing medicines

domperidone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 01/09/2014, Last updated: 11/09/2014
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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: Vasotop P

ramipril, Article 13
Status: European Commission final decision, opinion/position date: 08/12/2009, EC decision date: 27/04/2010, Last updated: 14/08/2014
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Referral: Porcimectin Injection and its associated names

ivermectin, associated names: Porcimec P, Article 33
Status: European Commission final decision, opinion/position date: 12/06/2002, EC decision date: 12/09/2002, Last updated: 13/08/2014
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Referral: Bovimectin Injection and its associated names

ivermectin, associated names: Bovimec B, Article 33
Status: European Commission final decision, opinion/position date: 12/06/2002, EC decision date: 19/09/2002, Last updated: 13/08/2014
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Referral: Cobactan DC and its associated names

cefquinome, associated names: Cephaguard DC, Cobactan DC intramam Susp. Ad us. Vet, Cobactan DC suspension intramammaire, Article 13
Status: European Commission final decision, opinion/position date: 20/07/2006, EC decision date: 13/10/2006, Last updated: 12/08/2014
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Referral: Cobactan IV 4.5% powder and solvent for solution for injection and its associated names

cefquinome, associated names: Cobactan, Cobactan Vet., Cobactan 4.5%, Cobactan IV IM 4.5%, Cobactan IV 4.5% A.U.V., Cephaguard IV IM 4.5%, Article 33
Status: European Commission final decision, opinion/position date: 17/05/2006, EC decision date: 21/08/2006, Last updated: 12/08/2014
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Referral: Orbax

orbifloxacin, Article 33
Status: European Commission final decision, opinion/position date: 15/01/2003, EC decision date: 16/04/2003, Last updated: 11/08/2014
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Referral: Caustinerf arsenical and Yranicid arsenical

ephedrine hydrochloride, lidocaine, arsenous anhydride, Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/04/2014, EC decision date: 11/07/2014, Last updated: 06/08/2014
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Referral: Avinew

live Newcastle disease virus, VG/GA strain, Article 33
Status: European Commission final decision, opinion/position date: 12/09/2001, EC decision date: 04/02/2002, Last updated: 05/08/2014
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Referral: Methadone medicinal products for oral use containing povidone

methadone, Article 107i procedures
Status: CMDh final position, opinion/position date: 23/07/2014, Last updated: 04/08/2014
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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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180 results

Referral: GVK Biosciences

Referral: Ibuprofen- and dexibuprofen-containing medicines

Referral: Hydroxyzine

Referral: Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients

Referral: Valproate and related substances

Referral: Resflor solution injectable and associated names

Referral: Testosterone-containing medicines

Referral: Polymyxin-containing medicines

Referral: Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum

Referral: Emergency contraceptives

Referral: Renin-angiotensin-system (RAS)-acting agents

Referral: Diacerein-containing medicines for oral administration

Referral: Linoladiol N and Linoladiol HN

Referral: Domperidone-containing medicines

Referral: Fiprex

Referral: Vasotop P

Referral: Porcimectin Injection and its associated names

Referral: Bovimectin Injection and its associated names

Referral: Cobactan DC and its associated names

Referral: Cobactan IV 4.5% powder and solvent for solution for injection and its associated names

Referral: Orbax

Referral: Caustinerf arsenical and Yranicid arsenical

Referral: Avinew

Referral: Methadone medicinal products for oral use containing povidone

Referral: Zolpidem-containing medicines