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334 results

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

Referral status European Commission final decision Remove European Commission final decision filter Opinion provided by Committee for Medicinal Products for Human Use Remove Opinion provided by Committee for Medicinal Products for Human Use filter

Referral type Article 5(11) referrals (prior to January 2010) Remove Article 5(11) referrals (prior to January 2010) filter Article 29(4) referrals Remove Article 29(4) referrals filter Article 30 referrals Remove Article 30 referrals filter Article 13 referrals Remove Article 13 referrals filter Article 31 referrals Remove Article 31 referrals filter Article 6(13) referrals (prior to January 2010) Remove Article 6(13) referrals (prior to January 2010) filter

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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: Basiron AC and associated names

benzoyl peroxide, Article 13 referrals
Status: European Commission final decision, opinion/position date: 28/03/2019, EC decision date: 04/07/2019, Last updated: 19/07/2019
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Referral: Septanest and associated names

articaine (hydrochloride), adrenaline (tartrate), Article 30 referrals
Status: European Commission final decision, opinion/position date: 28/06/2018, EC decision date: 28/03/2019, Last updated: 19/06/2019
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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: 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: Scandonest and associated names

mepivacaine, associated names: Biocaine, Scandicaine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 31/05/2018, EC decision date: 02/08/2018, Last updated: 07/08/2018
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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: 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: 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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Referral: Cardioxane

dexrazoxane, Article 13 referrals
Status: European Commission final decision, opinion/position date: 19/07/2017, EC decision date: 19/07/2017, Last updated: 26/07/2017
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Referral: Vepesid

etoposide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2017, EC decision date: 26/06/2017, Last updated: 14/07/2017
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Referral: Etopophos

etoposide phosphate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2017, EC decision date: 26/06/2017, Last updated: 14/07/2017
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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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334 results

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

Referral: Basiron AC and associated names

Referral: Septanest and associated names

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: Diotop capsules

Referral: Diclofenac Sodium Spray Gel 4%

Referral: Perlinring and associated names

Referral: Paclitaxel Hetero and associated names

Referral: Scandonest and associated names

Referral: Retinoid-containing medicinal products

Referral: Valproate and related substances

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

Referral: Cardioxane

Referral: Vepesid

Referral: Etopophos

Referral: Micro Therapeutic Research