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Article 31 referrals Remove Article 31 referrals filter Article 33 Remove Article 33 filter Article 6(12) referrals (prior to January 2010) Remove Article 6(12) referrals (prior to January 2010) filter Article 34 Remove Article 34 filter Article 107i procedures Remove Article 107i procedures filter Article 29(4) referrals (116) Apply Article 29(4) referrals filter Article 30 referrals (93) Apply Article 30 referrals filter Article 35 (42) Apply Article 35 filter Article 20 procedures (22) Apply Article 20 procedures filter Article 107 procedures (prior to July 2012) (15) Apply Article 107 procedures (prior to July 2012) filter Article 29 paediatrics (9) Apply Article 29 paediatrics filter Article 36 referrals (prior to July 2012) (9) Apply Article 36 referrals (prior to July 2012) filter Article 13 (6) Apply Article 13 filter Article 13 referrals (6) Apply Article 13 referrals filter Article 6(13) referrals (prior to January 2010) (5) Apply Article 6(13) referrals (prior to January 2010) filter Article 78 (5) Apply Article 78 filter Articles 39 and 40 (4) Apply Articles 39 and 40 filter Article 5(11) referrals (prior to January 2010) (2) Apply Article 5(11) referrals (prior to January 2010) filter

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187 results

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

Referral type Article 6(12) referrals (prior to January 2010) Remove Article 6(12) referrals (prior to January 2010) filter Article 34 Remove Article 34 filter Article 31 referrals Remove Article 31 referrals filter Article 107i procedures Remove Article 107i procedures filter Article 33 Remove Article 33 filter

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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: 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: 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: CattleMarker IBR Inactivated

Infectious bovine rhinotracheitis vaccine (inactivated), Article 33
Status: European Commission final decision, opinion/position date: 17/03/2016, EC decision date: 10/06/2016, Last updated: 19/07/2016
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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: Ambroxol and bromhexine-containing medicines

ambroxol and 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: Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys

Amoxicillin (as trihydrate), Article 33
Status: European Commission final decision, opinion/position date: 04/11/2015, EC decision date: 07/01/2016, Last updated: 05/02/2016
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Referral: Gutal

Zinc oxide, Article 33
Status: European Commission final decision, opinion/position date: 06/05/2015, EC decision date: 22/10/2015, Last updated: 26/11/2015
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Referral: Coglapix suspension for injection for pigs

inactivated porcine actinobacillosis vaccine, Article 33
Status: European Commission final decision, opinion/position date: 03/06/2015, EC decision date: 28/08/2015, Last updated: 02/10/2015
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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

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: 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: Baytril injectable

enrofloxacin, Article 34
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 01/09/2014, Last updated: 10/12/2014
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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: Linco-Spectin 100 and associated names

lincomycin and spectinomycin, Article 34
Status: European Commission final decision, opinion/position date: 10/04/2014, EC decision date: 11/07/2014, Last updated: 04/09/2014
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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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187 results

Referral: Micro Therapeutic Research

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

Referral: Intravenous iron-containing medicinal products

Referral: Metformin and metformin-containing medicines

Referral: Pharmaceutics International Inc.

Referral: Semler

Referral: Alkem

Referral: CattleMarker IBR Inactivated

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

Referral: Ambroxol and bromhexine-containing medicines

Referral: Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys

Referral: Gutal

Referral: Coglapix suspension for injection for pigs

Referral: Adrenaline auto-injectors

Referral: GVK Biosciences

Referral: Polymyxin-containing medicines

Referral: Baytril injectable

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: Linco-Spectin 100 and associated names

Referral: Fiprex