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65 results

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Categories Human Remove Human filter Veterinary Remove Veterinary filter

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 36 referrals (prior to July 2012) Remove Article 36 referrals (prior to July 2012) filter Article 35 Remove Article 35 filter Article 13 referrals Remove Article 13 referrals filter Article 6(13) referrals (prior to January 2010) Remove Article 6(13) referrals (prior to January 2010) filter Article 107i procedures Remove Article 107i procedures filter

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Referral: All pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits

tilmicosin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 07/03/2012, EC decision date: 14/06/2012, Last updated: 19/07/2012
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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: Baytril injectable and generics

enrofloxacin, Article 35
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: Benzathine benzylpenicillin intended for administration to food-producing species

benzathine benzylpenicillin, associated names: See annex I, Article 35
Status: European Commission final decision, opinion/position date: 15/01/2003, EC decision date: 22/04/2003, Last updated: 26/07/2016
List item

Referral: Betamox LA 150 mg/ml suspension for injection and associated names, and generics products thereof

Amoxicillin trihydrate, Article 35
Status: European Commission final decision, opinion/position date: 16/07/2020, EC decision date: 12/10/2020, Last updated: 12/11/2020
List item

Referral: Bupropion hydrochloride

bupropion, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 25/07/2002, EC decision date: 25/10/2002, Last updated: 06/12/2002
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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: Cephalosporins

ceftiofur and cefquinome, associated names: Cobactan, Cefenil, Ceftiocyl, Cevaxel, Eficur, Excenel, Readycef, Virbacef, Truleva, Ceftiomax, Ceftiosan, Actionis, Cemay, Article 35
Status: European Commission final decision, opinion/position date: 13/10/2011, EC decision date: 13/01/2012, Last updated: 01/02/2012
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Referral: Cerivastatin

cerivastatin, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 21/03/2002, EC decision date: 22/08/2002, Last updated: 20/12/2002
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Referral: Closantel

closantel, Article 35
Status: European Commission final decision, opinion/position date: 21/02/2019, EC decision date: 20/05/2019, Last updated: 27/06/2019
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Referral: Colistin

Colistin sulfate, Article 35
Status: European Commission final decision, opinion/position date: 10/02/2010, EC decision date: 10/06/2010, Last updated: 24/06/2010
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Referral: Colistin oral

colistin, Article 35
Status: European Commission final decision, opinion/position date: 11/12/2014, EC decision date: 16/03/2015, Last updated: 13/04/2015
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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
List item

Referral: Dexadreson

dexamethasone, Article 35
Status: European Commission final decision, opinion/position date: 18/07/2013, EC decision date: 18/10/2013, Last updated: 27/11/2013
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Referral: Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof

Dinoprost, Article 35
Status: European Commission final decision, opinion/position date: 18/06/2020, EC decision date: 16/09/2020, Last updated: 06/10/2020
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Referral: Doramectin

doramectin, Article 35
Status: European Commission final decision, opinion/position date: 12/06/2013, EC decision date: 06/09/2013, Last updated: 18/10/2013
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Referral: Doxycycline hyclate

Doxycycline hyclate, Article 35
Status: European Commission final decision, opinion/position date: 11/02/2010, EC decision date: 14/06/2010, Last updated: 28/06/2011
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Referral: Flukicides for which no maximum residue limit has been established in milk and which are intended for use in ruminants producing milk for human consumption

clorsulon, closantel, nitroxinil, rafoxanide, triclabendazole, Article 35
Status: European Commission final decision, opinion/position date: 14/06/2012, EC decision date: 19/11/2012, Last updated: 18/01/2013
List item

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: Gadograf, Gadovist

gadobutrol, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 17/11/2006, EC decision date: 13/04/2007, Last updated: 09/11/2007
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Referral: Gentamicin

gentamicin, Article 35
Status: European Commission final decision, opinion/position date: 06/11/2014, EC decision date: 11/02/2015, Last updated: 10/04/2015
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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
List item

Referral: Hipralona Enro-S

enrofloxacin, Article 35
Status: European Commission final decision, opinion/position date: 13/09/2012, EC decision date: 17/12/2012, Last updated: 04/02/2013
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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
List item

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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65 results

Referral: All pre-mixes for medicated feedingstuff containing 40 g, 100 g or 200 g tilmicosin per kg pre-mix and administered to rabbits

Referral: Basiron AC and associated names

Referral: Baytril injectable and generics

Referral: Benzathine benzylpenicillin intended for administration to food-producing species

Referral: Betamox LA 150 mg/ml suspension for injection and associated names, and generics products thereof

Referral: Bupropion hydrochloride

Referral: Cardioxane

Referral: Cephalosporins

Referral: Cerivastatin

Referral: Closantel

Referral: Colistin

Referral: Colistin oral

Referral: Cyproterone- and ethinylestradiol-containing medicines

Referral: Dexadreson

Referral: Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof

Referral: Doramectin

Referral: Doxycycline hyclate

Referral: Flukicides for which no maximum residue limit has been established in milk and which are intended for use in ruminants producing milk for human consumption

Referral: Flupirtine-containing medicines

Referral: Gadograf, Gadovist

Referral: Gentamicin

Referral: Goserelin Cell Pharm

Referral: Hipralona Enro-S

Referral: Hydroxyethyl starch (HES) containing medicinal products

Referral: Hydroxyethyl starch solutions for infusion