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Referral: Denagard 45%
Tiamulin hydrogen fumarate, associated names: Tiamutin 45%, Denagard 450 mg/g, Denagard vet 450 mg/g, Article 34
Status: European Commission final decision, opinion/position date: 12/04/2017, EC decision date: 14/07/2017, Last updated: 11/08/2017 -
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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: 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: 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: Closamectin Pour-on Solution and associated names
Ivermectin, closantel, Article 78
Status: European Commission final decision, opinion/position date: 08/10/2015, EC decision date: 22/03/2016, Last updated: 31/05/2016 -
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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: 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: Dectomax injectable solution and its associated names
doramectin, associated names: Dectomax 1% Injektionslösung für Rinder und Schafe, Dectomax Vet, Dectomax 1%, Dectomax 1% Injectable Solution, Prontax, Dectomax solution injectable, Dectomax Injectable Solution for Cattle and Sheep, Article 34
Status: European Commission final decision, opinion/position date: 08/12/2004, EC decision date: 29/03/2005, Last updated: 13/08/2014 -
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Referral: Eprinex pour-on and its associated names
eprinomectin, associated names: Eprinex - Lösung zum Auftragen auf die Haut für Rinder, Eprinex Vet, Eprinex pour-on vet, Eprinex pour on pour bovins, Eprinex Pour-On for beef and dairy cattle, Ivomec-Eprinex Pour On voor vlees- en melkvee, Article 34
Status: European Commission final decision, opinion/position date: 11/02/2004, EC decision date: 11/08/2004, Last updated: 11/08/2014 -
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Referral: Caustinerf arsenical and Yranicid arsenical
ephedrine hydrochloride, lidocaine and arsenous anhydride, Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/04/2014, EC decision date: 11/07/2014, Last updated: 06/08/2014