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Article 31 referrals Remove Article 31 referrals filter Article 30 referrals Remove Article 30 referrals filter Article 29 paediatrics Remove Article 29 paediatrics filter Article 13 referrals Remove Article 13 referrals filter Article 34 Remove Article 34 filter Article 29(4) referrals (116) Apply Article 29(4) referrals filter Article 20 procedures (22) Apply Article 20 procedures filter Article 6(12) referrals (prior to January 2010) (21) Apply Article 6(12) referrals (prior to January 2010) filter Article 107 procedures (prior to July 2012) (15) Apply Article 107 procedures (prior to July 2012) filter Article 36 referrals (prior to July 2012) (9) Apply Article 36 referrals (prior to July 2012) filter Article 107i procedures (8) Apply Article 107i procedures filter Article 6(13) referrals (prior to January 2010) (5) Apply Article 6(13) referrals (prior to January 2010) filter Article 5(11) referrals (prior to January 2010) (2) Apply Article 5(11) referrals (prior to January 2010) filter

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222 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 34 Remove Article 34 filter Article 31 referrals Remove Article 31 referrals filter Article 13 referrals Remove Article 13 referrals filter Article 30 referrals Remove Article 30 referrals filter Article 29 paediatrics Remove Article 29 paediatrics filter

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

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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: Ibuprofen- and dexibuprofen-containing medicines

ibuprofen and dexibuprofen, Article 31 referrals
Status: CMDh final position, opinion/position date: 20/05/2015, Last updated: 14/07/2015
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Referral: Ikorel and Dancor

nicorandil, Article 30 referrals
Status: European Commission final decision, opinion/position date: 26/03/2015, EC decision date: 05/06/2015, Last updated: 30/06/2015
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Referral: Hydroxyzine

hydroxyzine, associated names: Atarax, Article 31 referrals
Status: CMDh final position, opinion/position date: 25/03/2015, Last updated: 08/06/2015
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Referral: Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients

codeine, Article 31 referrals
Status: CMDh final position, opinion/position date: 22/04/2015, Last updated: 18/05/2015
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Referral: Plendil and associated names

felodipine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 16/12/2014, Last updated: 30/03/2015
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Referral: Nasonex

mometasone furoate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 20/11/2014, EC decision date: 19/01/2015, Last updated: 03/02/2015
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Referral: Valproate and related substances

sodium valproate, valproic acid, valproate semisodium, valpromide, associated names: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel, Article 31 referrals
Status: CMDh final position, opinion/position date: 19/11/2014, Last updated: 29/01/2015
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Referral: Oxynal Targin and associated names

oxycodone hydrochloride / naloxone hydrochloride, Article 13 referrals
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 22/12/2014, Last updated: 27/01/2015
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Referral: EMLA cream and associated names

lidocaine / prilocaine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/09/2014, EC decision date: 28/11/2014, Last updated: 15/01/2015
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Referral: Testosterone-containing medicines

testosterone, Article 31 referrals
Status: CMDh final position, opinion/position date: 19/11/2014, Last updated: 08/01/2015
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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: 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: Seroquel / Seroquel XR and associated names

quetiapine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 06/08/2014, Last updated: 09/09/2014
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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
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Referral: Zolpidem-containing medicines

zolpidem, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 23/06/2014, Last updated: 04/08/2014
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Referral: Crestor and associated names

rosuvastatin, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 30/06/2014, Last updated: 01/08/2014
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Referral: Sandostatin and associated names

octreotide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 26/06/2014, EC decision date: 26/06/2014, Last updated: 27/06/2014

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222 results

Referral: Ambroxol and bromhexine-containing medicines

Referral: Adrenaline auto-injectors

Referral: GVK Biosciences

Referral: Ibuprofen- and dexibuprofen-containing medicines

Referral: Ikorel and Dancor

Referral: Hydroxyzine

Referral: Codeine-containing medicinal products for the treatment of cough or cold in paediatric patients

Referral: Plendil and associated names

Referral: Nasonex

Referral: Valproate and related substances

Referral: Oxynal Targin and associated names

Referral: EMLA cream and associated names

Referral: Testosterone-containing medicines

Referral: Polymyxin-containing medicines

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: Seroquel / Seroquel XR and associated names

Referral: Caustinerf arsenical and Yranicid arsenical

Referral: Zolpidem-containing medicines

Referral: Crestor and associated names

Referral: Sandostatin and associated names