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150 results
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Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)
daclatasvir, dasabuvir, sofosbuvir, ledipasvir, simeprevir, ombitasvir, paritaprevir, ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017 -
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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: 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: Zydelig
idelalisib, associated names: Zydelig, Article 20 procedures
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 15/09/2016, Last updated: 03/10/2016 -
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Referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease
beclometasone, budesonide, flunisolide, fluticasone propionate, fluticasone furoate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 28/04/2016, EC decision date: 29/06/2016, Last updated: 15/07/2016 -
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Referral: SGLT2 inhibitors
canagliflozin, dapagliflozin, empagliflozin, associated names: Edistride, Ebymect, Xigduo, Vokanamet, Synjardy, Jardiance, Invokana, Forxiga, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 28/04/2016, Last updated: 18/05/2016 -
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Referral: Tysabri
natalizumab, associated names: Tysabri, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 25/04/2016, Last updated: 12/05/2016 -
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Referral: Fusafungine containing medicinal products for oromucosal and nasal use
fusafungine, Article 31 referrals
Status: CMDh final position, opinion/position date: 31/03/2016, Last updated: 14/04/2016 -
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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: Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard
bivalent HPV vaccine (types 16, 18), quadrivalent HPV vaccine (types 6, 11, 16, 18), 9-valent HPV vaccine (types 6, 11, 16, 18, 31, 33, 45, 52 and 58), associated names: Cervarix, Gardasil, Gardasil 9, Silgard, Article 20 procedures
Status: European Commission final decision, opinion/position date: 19/11/2015, EC decision date: 12/01/2016, Last updated: 20/01/2016 -
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Referral: Inductos
dibotermin alfa, associated names: Inductos, Article 20 procedures
Status: European Commission final decision, opinion/position date: 22/10/2015, EC decision date: 20/11/2015, Last updated: 07/12/2015 -
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Referral: Adrenaline auto-injectors
adrenaline (epinephrine), Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/06/2015, EC decision date: 14/08/2015, Last updated: 26/08/2015 -
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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: Iclusig
ponatinib, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 15/01/2015, Last updated: 02/03/2015 -
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Referral: Corlentor and Procoralan
ivabradine, associated names: Corlentor and Procoralan, Article 20 procedures
Status: European Commission final decision, opinion/position date: 20/11/2014, EC decision date: 15/01/2015, Last updated: 16/02/2015 -
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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: 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