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243 results

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Referral type Article 31 referrals Remove Article 31 referrals filter Article 29(4) referrals Remove Article 29(4) referrals filter

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Referral: Cyproterone-containing medicinal products

cyproterone, Article 31 referrals
Status: CMDh final position, opinion/position date: 25/03/2020, Last updated: 20/05/2020
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Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use

estradiol, associated names: Linoladiol, Linoladiol N, Linoladiol Estradiol, Estradiol Wolff, Montadiol, Article 31 referrals
Status: CMDh final position, opinion/position date: 30/01/2020, Last updated: 08/04/2020
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Referral: Flurbiprofen Geiser

flurbiprofen, associated names: Flurbiprofen Sejmet, Mentocaína Spray, Flurbiprofeno Geiser, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/10/2019, EC decision date: 16/12/2019, Last updated: 20/01/2020
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Referral: Methotrexate containing medicinal products

methotrexate, associated names: Nordimet, Jylamvo, Ledertrexate, Maxtrex, Metex, Metoject, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/08/2019, EC decision date: 21/10/2019, Last updated: 31/10/2019
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Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions

Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2019, EC decision date: 09/09/2019, Last updated: 16/09/2019
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Referral: Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction

Omega-3 fatty acid ethyl esters, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2018, EC decision date: 06/06/2019, Last updated: 13/06/2019
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Referral: Syner-Kinase and associated names

urokinase, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 28/02/2019, EC decision date: 16/05/2019, Last updated: 03/06/2019
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Referral: Metamizole containing medicinal products

metamizole, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2018, EC decision date: 20/03/2019, Last updated: 28/03/2019
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Referral: Quinolone- and fluoroquinolone-containing medicinal products

nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin, associated names: Quinsair, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 11/03/2019, Last updated: 19/03/2019
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Referral: Diotop capsules

diclofenac, omeprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 31/01/2019, Last updated: 15/02/2019
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Referral: Diclofenac Sodium Spray Gel 4%

diclofenac sodium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 18/01/2019, Last updated: 14/02/2019
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Referral: Perlinring and associated names

etonogestrel, ethinylestradiol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/10/2018, EC decision date: 18/12/2018, Last updated: 21/01/2019
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Referral: Paclitaxel Hetero and associated names

paclitaxel, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/10/2018, EC decision date: 11/01/2019, Last updated: 21/01/2019
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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: Alcover and associated names

sodium oxybate, associated names: n/a, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 26/01/2017, EC decision date: 18/12/2017, 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: Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets

paracetamol, ibuprofen, associated names: Paracomb, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 07/08/2017, Last updated: 18/08/2017

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243 results

Referral: Cyproterone-containing medicinal products

Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use

Referral: Flurbiprofen Geiser

Referral: Methotrexate containing medicinal products

Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions

Referral: Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction

Referral: Syner-Kinase and associated names

Referral: Metamizole containing medicinal products

Referral: Quinolone- and fluoroquinolone-containing medicinal products

Referral: Diotop capsules

Referral: Diclofenac Sodium Spray Gel 4%

Referral: Perlinring and associated names

Referral: Paclitaxel Hetero and associated names

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: Alcover and associated names

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: Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets