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175 results

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Medicine European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter Referrals Remove Referrals filter

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Referral status European Commission final decision Remove European Commission final decision filter CMDh final position Remove CMDh final position filter Under evaluation Remove Under evaluation filter

Referral type Article 107i procedures Remove Article 107i procedures filter Article 31 referrals Remove Article 31 referrals filter Article 20 procedures Remove Article 20 procedures filter Article 6(12) referrals (prior to January 2010) Remove Article 6(12) referrals (prior to January 2010) filter Article 29 paediatrics Remove Article 29 paediatrics filter

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Referral: Zinbryta

daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, EC decision date: 27/03/2018, Last updated: 11/07/2018
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Referral: Maci

matrix-applied characterised autologous cultured chondrocytes, associated names: Maci, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/09/2014, EC decision date: 19/11/2014, Last updated: 05/07/2018
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Referral: Retinoid-containing medicinal products

acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene, associated names: Targretin, Panretin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/03/2018, EC decision date: 21/06/2018, Last updated: 02/07/2018
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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: 07/06/2018
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Referral: Flupirtine-containing medicinal products

flupirtine, Article 31 referrals
Status: CMDh final position, opinion/position date: 21/03/2018, Last updated: 04/05/2018
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Referral: Paracetamol modified-release

paracetamol, associated names: Alvedon, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2017, EC decision date: 19/02/2018, Last updated: 01/03/2018
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Referral: Hydroxyethyl starch solutions for infusion

hydroxyethyl starch, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 12/01/2018
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Referral: Zinbryta

daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, opinion/position date: 09/11/2017, EC decision date: 08/01/2018, Last updated: 12/01/2018
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Referral: Factor VIII

associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017
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Referral: Gadolinium-containing contrast agents

gadobenic acid / gadobutrol / gadodiamide / gadopentetic acid / gadoteric acid / gadoteridol / gadoversetamide / gadoxetic acid, associated names: Optimark, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/07/2017, EC decision date: 23/11/2017, Last updated: 04/12/2017
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Referral: Vancomycin-containing medicines

vancomycin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 21/09/2017, Last updated: 17/11/2017
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Referral: Symbioflor 2

Escherichia coli bacteria (cells and autolysate), associated names: Symbioflor E. Coli, Symbioflor® 2, Symbioflor Escherichia, Article 31 referrals
Status: European Commission final decision, EC decision date: 22/06/2017, Last updated: 07/09/2017
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Referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions

methylprednisolone, Article 31 referrals
Status: CMDh final position, opinion/position date: 31/07/2017, Last updated: 04/09/2017
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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: SGLT2 inhibitors (previously canagliflozin)

canagliflozin, empagliflozin, dapagliflozin, canagliflozin / metformin, empagliflozin / metformin, dapagliflozin / metformin, associated names: Xigduo, Ebymect, Edistride, Synjardy, Forxiga, Jardiance, Vokanamet, Invokana, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 04/05/2017, Last updated: 08/05/2017
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Referral: Dienogest/ethinylestradiol-containing medicinal products indicated in acne

dienogest / ethinylestradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/01/2017, EC decision date: 22/03/2017, Last updated: 24/03/2017
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Referral: Intravenous iron-containing medicinal products

ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside, iron sucrose, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 13/09/2013, Last updated: 22/03/2017
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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.

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

beclomethasone, 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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175 results

Referral: Zinbryta

Referral: Maci

Referral: Retinoid-containing medicinal products

Referral: Valproate and related substances

Referral: Flupirtine-containing medicinal products

Referral: Paracetamol modified-release

Referral: Hydroxyethyl starch solutions for infusion

Referral: Zinbryta

Referral: Factor VIII

Referral: Gadolinium-containing contrast agents

Referral: Vancomycin-containing medicines

Referral: Symbioflor 2

Referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions

Referral: Micro Therapeutic Research

Referral: SGLT2 inhibitors (previously canagliflozin)

Referral: Dienogest/ethinylestradiol-containing medicinal products indicated in acne

Referral: Intravenous iron-containing medicinal products

Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)

Referral: Metformin and metformin-containing medicines

Referral: Pharmaceutics International Inc.

Referral: Semler

Referral: Alkem

Referral: Zydelig

Referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease

Referral: SGLT2 inhibitors