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47 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 Articles 39 and 40 Remove Articles 39 and 40 filter Article 107i procedures Remove Article 107i procedures filter Article 78 Remove Article 78 filter Article 36 referrals (prior to July 2012) Remove Article 36 referrals (prior to July 2012) filter

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Referral: Fenspiride containing medicinal products

fenspiride, Article 107i procedures
Status: CMDh final position, opinion/position date: 29/05/2019, Last updated: 26/06/2019
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Referral: Hydroxyethyl starch (HES) containing medicinal products

hydroxyethyl starch (HES), Article 107i procedures
Status: European Commission final decision, opinion/position date: 26/10/2017, EC decision date: 17/07/2018, Last updated: 27/07/2018
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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: Bayovac IBR Marker Vivum

bovine Herpes Virus type 1 (BHV-1), strain Difivac (IBR-Marker Virus, gE-negative), modified live (attenuated) virus, associated names: Rhinobovin, Marker lebend, Rhinobovin Marker live, RhinobovinMarker Viva, Rhinobovin Marker Attenuato, Rhinobovin Marker Viva Marcada, Article 78
Status: European Commission final decision, opinion/position date: 21/01/2000, EC decision date: 10/07/2000, Last updated: 05/08/2014
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Referral: Methadone medicinal products for oral use containing povidone

methadone, Article 107i procedures
Status: CMDh final position, opinion/position date: 23/07/2014, Last updated: 04/08/2014
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Referral: Hydroxyethyl starch solutions for infusion

hydroxyethyl starch, Article 107i procedures
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 06/03/2014
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Referral: Flupirtine-containing medicines

flupirtine, Article 107i procedures
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 05/09/2013, Last updated: 21/11/2013
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Referral: Vivaglobin

Human normal immunoglobulin, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 16/02/2012, EC decision date: 07/05/2012, Last updated: 18/11/2013
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Referral: Numeta G13%E and Numeta G16%E emulsion for infusion

Article 107i procedures
Status: CMDh final position, opinion/position date: 18/09/2013, Last updated: 27/09/2013
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Referral: Cyproterone- and ethinylestradiol-containing medicines

cyproterone / ethinylestradiol, associated names: Acnemine, Acneson, Chloe, Clairette, Cyprest, Cyprodiol, Diane 35, Dianette, Feminil, Minerva, Zyrona, Article 107i procedures
Status: European Commission final decision, opinion/position date: 29/05/2013, EC decision date: 25/07/2013, Last updated: 05/08/2013
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Referral: Tetrazepam-containing medicines

tetrazepam, associated names: Myolastan and generics, Article 107i procedures
Status: European Commission final decision, opinion/position date: 24/04/2013, EC decision date: 29/05/2013, Last updated: 18/07/2013
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Referral: Ethinylestradiol-Drospirenone 24+4

ethinylestradiol / drospirenone, associated names: Yaz 24+4, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 19/04/2012, EC decision date: 06/07/2012, Last updated: 11/01/2013
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Referral: Yaz 24+4

ethinylestradiol / drospirenone, associated names: Ethinylestradiol-Drospirenone 24+4, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 19/04/2012, EC decision date: 03/07/2012, Last updated: 11/01/2013
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Referral: Valproat Ratiopharm Chrono

valproic acid / valproate, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 25/05/2010, EC decision date: 26/05/2010, Last updated: 23/07/2012
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Referral: Preflucel

influenza vaccine, purified antigen, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 10/12/2012, Last updated: 20/07/2012
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Referral: Goserelin Cell Pharm

goserelin, associated names: Novosis Goserelin, Goserelin Cell Pharm, Novimp and associated names, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 16/09/2011, Last updated: 06/02/2012
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Referral: Novimp

goserelin, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 16/09/2011, Last updated: 06/02/2012
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Referral: Novosis Goserelin

goserelin, associated names: Goserelin Novosis, Gosacin, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 16/09/2011, Last updated: 06/02/2012
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Referral: Hiprabovis Pneumos

Mannheimia haemolytica biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. / inactivated Histophilus somni Bailie strain, Article 78
Status: European Commission final decision, opinion/position date: 14/07/2011, EC decision date: 03/11/2011, Last updated: 12/12/2011
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Referral: Genotropin

somatropin, associated names: Genotonorm, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 24/06/2010, EC decision date: 02/09/2010, Last updated: 26/04/2011
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Referral: Pregsure BVD

Inactivated Bovine Viral Diarrhoea (BVD) type 1 virus, cytopathogenic strain 5960, Article 78
Status: European Commission final decision, opinion/position date: 15/07/2010, EC decision date: 07/10/2010, Last updated: 22/10/2010
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Referral: Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11, Articles 39 and 40
Status: European Commission final decision, opinion/position date: 19/05/2010, EC decision date: 16/08/2010, Last updated: 18/08/2010
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Referral: Porcilis PRRS

Live attenuated PRRS virus strain DV, Articles 39 and 40
Status: European Commission final decision, opinion/position date: 19/05/2010, EC decision date: 16/08/2010, Last updated: 18/08/2010
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Referral: Extraneal

icodextrin, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 22/10/2009, EC decision date: 20/01/2010, Last updated: 27/10/2009
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Referral: Alpha2-adrenoreceptor agonists

Xylazine, Medetomidine, Detomidine, Romifidine, Article 78
Status: European Commission final decision, opinion/position date: 12/11/2008, EC decision date: 30/04/2009, Last updated: 22/06/2009

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47 results

Referral: Fenspiride containing medicinal products

Referral: Hydroxyethyl starch (HES) containing medicinal products

Referral: Closamectin Pour-on Solution and associated names

Referral: Bayovac IBR Marker Vivum

Referral: Methadone medicinal products for oral use containing povidone

Referral: Hydroxyethyl starch solutions for infusion

Referral: Flupirtine-containing medicines

Referral: Vivaglobin

Referral: Numeta G13%E and Numeta G16%E emulsion for infusion

Referral: Cyproterone- and ethinylestradiol-containing medicines

Referral: Tetrazepam-containing medicines

Referral: Ethinylestradiol-Drospirenone 24+4

Referral: Yaz 24+4

Referral: Valproat Ratiopharm Chrono

Referral: Preflucel

Referral: Goserelin Cell Pharm

Referral: Novimp

Referral: Novosis Goserelin

Referral: Hiprabovis Pneumos

Referral: Genotropin

Referral: Pregsure BVD

Referral: Porcilis M Hyo

Referral: Porcilis PRRS

Referral: Extraneal

Referral: Alpha2-adrenoreceptor agonists