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Azamethiphos (extension to fin fish): European public maximum-residue-limit assessment report (EPMAR) (PDF/258 KB) (updated)

Adopted
First published: 11/06/2012
Last updated: 23/11/2023
EMA/CVMP/88291/2011-corr 1
List item

Chemical-unlike biological substances considered as not requiring an MRL evaluation as per Regulation (EU) No. 2018/782, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (PDF/133.12 KB) (updated)

First published: 29/05/2020
Last updated: 23/11/2023
EMA/CVMP/572629/2019 Rev. 2
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Veterinary Scientific Advice procedure - submission deadlines 2024 (PDF/97.74 KB) (updated)

First published: 05/11/2021
Last updated: 23/11/2023
EMA/CVMP/SAWP/492656/2023
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Malta - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022 (PDF/265.28 KB) (updated)

First published: 20/11/2023
Last updated: 20/11/2023
List item

EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information (PDF/1.66 MB) (updated)

Adopted
First published: 21/01/2021
Last updated: 03/11/2023
EMA/772581/2022
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CaniLeish : EPAR - Public assessment report (PDF/730.18 KB)

First published: 06/04/2011
Last updated: 24/10/2023
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CVMP summary of positive opinion for Canileish (PDF/80.53 KB)

Adopted
First published: 14/01/2011
Last updated: 24/10/2023
EMA/CVMP/296014/2010
List item

CaniLeish : EPAR - All Authorised presentations (PDF/58.49 KB)

First published: 06/04/2011
Last updated: 24/10/2023
Bulgarian
(PDF/122.86 KB)

Czech
(PDF/105.51 KB)

Danish
(PDF/55.54 KB)

Dutch
(PDF/55.85 KB)

Estonian
(PDF/57.9 KB)

Finnish
(PDF/58.6 KB)

French
(PDF/55.93 KB)

German
(PDF/65.09 KB)

Greek
(PDF/124.83 KB)

Hungarian
(PDF/96.57 KB)

Icelandic
(PDF/57.08 KB)

Italian
(PDF/58.32 KB)

Latvian
(PDF/106.77 KB)

Lithuanian
(PDF/101.46 KB)

Maltese
(PDF/103.95 KB)

Norwegian
(PDF/52 KB)

Polish
(PDF/98.5 KB)

Portuguese
(PDF/59.32 KB)

Romanian
(PDF/96.81 KB)

Slovak
(PDF/105.93 KB)

Slovenian
(PDF/87.46 KB)

Spanish
(PDF/56.46 KB)

Swedish
(PDF/56.33 KB)
List item

CaniLeish : EPAR - Summary for the public (PDF/97.39 KB)

First published: 06/04/2011
Last updated: 24/10/2023
Bulgarian
(PDF/279.52 KB)

Czech
(PDF/143.38 KB)

Danish
(PDF/98.61 KB)

Dutch
(PDF/99.79 KB)

Estonian
(PDF/160.37 KB)

Finnish
(PDF/163.9 KB)

French
(PDF/163.73 KB)

German
(PDF/163.28 KB)

Greek
(PDF/304.63 KB)

Hungarian
(PDF/126.09 KB)

Italian
(PDF/102.6 KB)

Latvian
(PDF/220.7 KB)

Lithuanian
(PDF/203.83 KB)

Maltese
(PDF/157.76 KB)

Polish
(PDF/147 KB)

Portuguese
(PDF/97.25 KB)

Romanian
(PDF/158.19 KB)

Slovak
(PDF/195.36 KB)

Slovenian
(PDF/125.11 KB)

Spanish
(PDF/117.04 KB)

Swedish
(PDF/96.48 KB)
List item

CaniLeish : EPAR - Product Information (PDF/807.96 KB)

First published: 06/04/2011
Last updated: 24/10/2023
Bulgarian
(PDF/806.53 KB)

Croatian
(PDF/750.72 KB)

Czech
(PDF/874.83 KB)

Danish
(PDF/814.05 KB)

Dutch
(PDF/792.81 KB)

Estonian
(PDF/764.47 KB)

Finnish
(PDF/738.32 KB)

French
(PDF/763.41 KB)

German
(PDF/718.44 KB)

Greek
(PDF/952.17 KB)

Hungarian
(PDF/790.22 KB)

Icelandic
(PDF/683.5 KB)

Italian
(PDF/688.64 KB)

Latvian
(PDF/1001.02 KB)

Lithuanian
(PDF/878.17 KB)

Maltese
(PDF/966.19 KB)

Norwegian
(PDF/887.59 KB)

Polish
(PDF/765.13 KB)

Portuguese
(PDF/784.26 KB)

Romanian
(PDF/760.68 KB)

Slovak
(PDF/1.02 MB)

Slovenian
(PDF/852.11 KB)

Spanish
(PDF/690.86 KB)

Swedish
(PDF/705.65 KB)
List item

Guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominators and indicators (PDF/949.61 KB)

Adopted
First published: 23/06/2023
Last updated: 13/10/2023
Legal effective date: 05/10/2023
Consultations dates: from 23/06/2023 to 31/07/2023
EMA/CVMP/882931/2022
List item

Guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy (PDF/510.5 KB)

Adopted
First published: 27/01/2023
Last updated: 13/10/2023
Legal effective date: 13/10/2023
Consultations dates: from 27/01/2023 to 31/05/2023
EMA/CVMP/NTWP/32862/2022
List item

Tevimbra : EPAR - Orphan maintenance assessment report (PDF/313.79 KB)

Adopted
First published: 02/10/2023
Last updated: 10/10/2023
EMA/OD/0000129253
List item

Sweden - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/295.98 KB)

First published: 18/11/2022
Last updated: 05/10/2023
List item

Czechia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/288.71 KB)

First published: 18/11/2022
Last updated: 05/10/2023
List item

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products (PDF/149.15 KB)

Adopted
First published: 22/07/2009
Last updated: 29/09/2023
Legal effective date: 01/10/2021
EMA/CVMP/PhVWP/10418/2009 Rev.14 corr.
List item

Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Votubia (everolimus) for the treatment of tuberous sclerosis (PDF/111.28 KB)

Adopted
First published: 10/10/2011
Last updated: 15/09/2023
EMA/COMP/518763/2011
List item

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2023 (PDF/152.57 KB)

First published: 31/03/2023
Last updated: 15/09/2023
EMA/CVMP/PhVWP/137199/2023
List item

EU/3/10/764: Public summary of opinion on orphan designation of everolimus for the treatment of tuberous sclerosis (PDF/185.32 KB)

Adopted
First published: 11/08/2010
Last updated: 15/09/2023
EMA/COMP/306721/2010 Rev. 3
List item

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data (PDF/1.28 MB)

First published: 16/12/2021
Last updated: 14/09/2023
EMA/772580/2022
List item

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Pomalidomide Celgene (pomalidomide) for the treatment of multiple myeloma (PDF/107.6 KB)

Adopted
First published: 20/08/2013
Last updated: 13/09/2023
EMA/351975/2013 Rev.1
List item

EU/3/09/672: Public summary of opinion on orphan designation for pomalidomide for the treatment of multiple myeloma (PDF/181.27 KB)

Adopted
First published: 20/10/2009
Last updated: 13/09/2023
EMEA/COMP/474084/2009 Rev.3
List item

Imnovid: Orphan maintenance assessment report (post-authorisation) (PDF/752.93 KB)

Adopted
First published: 18/06/2019
Last updated: 13/09/2023
EMA/275155/2019
List item

EU/3/07/442: Public summary of positive opinion for orphan designation of enzastraurin hydrochloride for the treatment of diffuse large B cell lymphoma (PDF/305.53 KB)

Adopted
First published: 10/07/2008
Last updated: 12/09/2023
EMEA/COMP/94131/2008
List item

Evrysdi : Orphan maintenance assessment report (initial authorisation) (PDF/513.15 KB)

Adopted
First published: 04/05/2021
Last updated: 12/09/2023
EMA/OD/0000039037

7816 results

Azamethiphos (extension to fin fish): European public maximum-residue-limit assessment report (EPMAR) (PDF/258 KB) (updated)

Chemical-unlike biological substances considered as not requiring an MRL evaluation as per Regulation (EU) No. 2018/782, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (PDF/133.12 KB) (updated)

Veterinary Scientific Advice procedure - submission deadlines 2024 (PDF/97.74 KB) (updated)

Malta - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2022 (PDF/265.28 KB) (updated)

EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information (PDF/1.66 MB) (updated)

CaniLeish : EPAR - Public assessment report (PDF/730.18 KB)

CVMP summary of positive opinion for Canileish (PDF/80.53 KB)

CaniLeish : EPAR - All Authorised presentations (PDF/58.49 KB)

CaniLeish : EPAR - Summary for the public (PDF/97.39 KB)

CaniLeish : EPAR - Product Information (PDF/807.96 KB)

Guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominators and indicators (PDF/949.61 KB)

Guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy (PDF/510.5 KB)

Tevimbra : EPAR - Orphan maintenance assessment report (PDF/313.79 KB)

Sweden - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/295.98 KB)

Czechia - Sales trends (mg/PCU) of antibiotic veterinary medicinal products for food-producing animals from 2010 to 2021 (PDF/288.71 KB)

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse events in animals and humans to veterinary medicinal products (PDF/149.15 KB)

Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Votubia (everolimus) for the treatment of tuberous sclerosis (PDF/111.28 KB)

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2023 (PDF/152.57 KB)

EU/3/10/764: Public summary of opinion on orphan designation of everolimus for the treatment of tuberous sclerosis (PDF/185.32 KB)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data (PDF/1.28 MB)

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Pomalidomide Celgene (pomalidomide) for the treatment of multiple myeloma (PDF/107.6 KB)

EU/3/09/672: Public summary of opinion on orphan designation for pomalidomide for the treatment of multiple myeloma (PDF/181.27 KB)

Imnovid: Orphan maintenance assessment report (post-authorisation) (PDF/752.93 KB)

EU/3/07/442: Public summary of positive opinion for orphan designation of enzastraurin hydrochloride for the treatment of diffuse large B cell lymphoma (PDF/305.53 KB)

Evrysdi : Orphan maintenance assessment report (initial authorisation) (PDF/513.15 KB)