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News: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 2021

CVMP, Last updated: 22/01/2021
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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database (PDF/239.24 KB) (new)

Draft: consultation open
First published: 21/01/2021
Consultations dates: from 21/01/2021 to 21/03/2021
EMA/536780/2020
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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 1: Registration and data access requirements for the User Interface (UI) and Application Programming Interface (API) (PDF/225.65 KB) (new)

Draft: consultation open
First published: 21/01/2021
Consultations dates: from 21/01/2021 to 21/03/2021
EMA/562455/2020
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EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information (PDF/1.47 MB) (new)

Draft: consultation open
First published: 21/01/2021
Consultations dates: from 21/01/2021 to 21/03/2021
EMA/106051/2020
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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 3: Process for the initial submission and maintenance of veterinary medicinal products information (PDF/259.69 KB) (new)

Draft: consultation open
First published: 21/01/2021
Consultations dates: from 21/01/2021 to 21/03/2021
EMA/590669/2020
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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 4: Process and format for the submission of legacy data on veterinary medicinal products (PDF/560.28 KB) (new)

Draft: consultation open
First published: 21/01/2021
Consultations dates: from 21/01/2021 to 21/03/2021
EMA/557461/2020
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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications (PDF/213.63 KB) (new)

Draft: consultation open
First published: 21/01/2021
Consultations dates: from 21/01/2021 to 21/03/2021
EMA/597691/2020
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Agenda - CVMP agenda of the 19-21 January 2021 meeting (PDF/272.57 KB) (new)

Draft
First published: 19/01/2021
EMA/32304/2021
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Overview of comments received on ''Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation" (PDF/1.29 MB) (new)

Adopted
First published: 13/01/2021
EMA/CVMP/117410/2019
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Reflection paper on dose review and adjustment of established veterinary antibiotics in the context of SPC harmonisation - First version (PDF/2.25 MB) (new)

Adopted
First published: 13/01/2021
EMA/CVMP/849775/2017
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EudraVigilance access policy for medicines for veterinary use - Revision 2 (PDF/445.39 KB) (new)

Draft: consultation open
First published: 12/01/2021
Consultations dates: from 12/01/2021 to 12/03/2021
EMA/113700/2008 Rev.2
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Minutes of the CVMP meeting of 3-5 November 2020 (PDF/338.83 KB) (new)

Adopted
First published: 07/01/2021
EMA/CVMP/666630/2020
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VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use (PDF/384.03 KB)

Adopted
First published: 22/12/2020
EMA/CVMP/VICH/677723/2016
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European Medicines Agency/AnimalhealthEurope veterinary medicines info day 2021: first announcement - save this date in your diary! (PDF/191.45 KB)

First published: 21/12/2020
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European Medicines Agency/AnimalhealthEurope veterinary medicines info day 2021

Virtual meeting, 25/03/2021, Last updated: 21/12/2020
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Increxxa : EPAR - Public assessment report (PDF/352.51 KB)

Adopted
First published: 17/12/2020
EMA/457503/2020
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Increxxa : EPAR - Medicine overview (PDF/173.46 KB)

First published: 17/12/2020
EMA/508992/2020
Bulgarian
(PDF/207.9 KB)

Croatian
(PDF/193.8 KB)

Czech
(PDF/196.73 KB)

Danish
(PDF/173.43 KB)

Dutch
(PDF/173.8 KB)

Estonian
(PDF/171.59 KB)

Finnish
(PDF/171.53 KB)

French
(PDF/174.79 KB)

German
(PDF/177.04 KB)

Greek
(PDF/207.87 KB)

Hungarian
(PDF/196.81 KB)

Italian
(PDF/173.19 KB)

Latvian
(PDF/208.9 KB)

Lithuanian
(PDF/195 KB)

Maltese
(PDF/196.92 KB)

Polish
(PDF/197.78 KB)

Portuguese
(PDF/174.66 KB)

Romanian
(PDF/203.65 KB)

Slovak
(PDF/197.22 KB)

Slovenian
(PDF/194.81 KB)

Spanish
(PDF/174.48 KB)

Swedish
(PDF/172.92 KB)
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CVMP summary of positive opinion for Solensia (PDF/129.54 KB)

Adopted
First published: 11/12/2020
EMA/631469/2020
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News: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 8-10 December 2020

CVMP, Last updated: 11/12/2020
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Tulinovet : EPAR - Public assessment report (PDF/289.01 KB)

Adopted
First published: 09/12/2020
EMA/457567/2020
List item

Tulinovet : EPAR - Product information (PDF/266.18 KB)

First published: 09/12/2020
Bulgarian
(PDF/359.96 KB)

Croatian
(PDF/257.84 KB)

Czech
(PDF/297.52 KB)

Danish
(PDF/316.38 KB)

Dutch
(PDF/304.55 KB)

Estonian
(PDF/291.73 KB)

Finnish
(PDF/257.25 KB)

French
(PDF/281.78 KB)

German
(PDF/302.96 KB)

Greek
(PDF/351.52 KB)

Hungarian
(PDF/319.98 KB)

Icelandic
(PDF/242.06 KB)

Italian
(PDF/258.6 KB)

Latvian
(PDF/314.26 KB)

Lithuanian
(PDF/293.9 KB)

Maltese
(PDF/313.91 KB)

Norwegian
(PDF/308.66 KB)

Polish
(PDF/267.95 KB)

Portuguese
(PDF/287.45 KB)

Romanian
(PDF/285.12 KB)

Slovak
(PDF/286.16 KB)

Slovenian
(PDF/273.93 KB)

Spanish
(PDF/297.3 KB)

Swedish
(PDF/302.63 KB)
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Agenda - CVMP agenda of the 8-10 December 2020 meeting (PDF/295.6 KB)

Draft
First published: 08/12/2020
EMA/661799/2020
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Monthly report on application procedures, guidelines and related documents for veterinary medicines: October 2020 (PDF/274.7 KB)

Adopted
First published: 08/12/2020
EMA/587476/2020
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Chanhold : EPAR - Procedural steps taken and scientific information after authorisation (PDF/83.93 KB)

First published: 26/11/2020
List item

Betamox LA and generics Article-35 referral - Questions and answers on the review of withdrawal periods for Betamox LA 150 mg/ml suspension for injection and associated names, and generic products thereof (PDF/133.62 KB)

First published: 12/11/2020
EMA/502239/2020
Bulgarian
(PDF/136.76 KB)

Croatian
(PDF/136.77 KB)

Czech
(PDF/136.01 KB)

Danish
(PDF/125.67 KB)

Dutch
(PDF/123.99 KB)

Estonian
(PDF/112.29 KB)

Finnish
(PDF/123.2 KB)

French
(PDF/127.61 KB)

German
(PDF/127.39 KB)

Greek
(PDF/138.21 KB)

Hungarian
(PDF/133.58 KB)

Italian
(PDF/113.98 KB)

Latvian
(PDF/155.19 KB)

Lithuanian
(PDF/137.94 KB)

Maltese
(PDF/157.35 KB)

Polish
(PDF/136.87 KB)

Portuguese
(PDF/127.22 KB)

Romanian
(PDF/134.3 KB)

Slovak
(PDF/137.13 KB)

Slovenian
(PDF/121.95 KB)

Spanish
(PDF/122.31 KB)

Swedish
(PDF/111.85 KB)

4730 results

News: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 19-20 January 2021

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database (PDF/239.24 KB) (new)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 1: Registration and data access requirements for the User Interface (UI) and Application Programming Interface (API) (PDF/225.65 KB) (new)

EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information (PDF/1.47 MB) (new)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 3: Process for the initial submission and maintenance of veterinary medicinal products information (PDF/259.69 KB) (new)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 4: Process and format for the submission of legacy data on veterinary medicinal products (PDF/560.28 KB) (new)

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 5: Technical specifications (PDF/213.63 KB) (new)

Agenda - CVMP agenda of the 19-21 January 2021 meeting (PDF/272.57 KB) (new)

Overview of comments received on ''Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation" (PDF/1.29 MB) (new)

Reflection paper on dose review and adjustment of established veterinary antibiotics in the context of SPC harmonisation - First version (PDF/2.25 MB) (new)

EudraVigilance access policy for medicines for veterinary use - Revision 2 (PDF/445.39 KB) (new)

Minutes of the CVMP meeting of 3-5 November 2020 (PDF/338.83 KB) (new)

VICH GL59 Harmonisation of criteria to waive laboratory animal batch safety testing for vaccines for veterinary use (PDF/384.03 KB)

European Medicines Agency/AnimalhealthEurope veterinary medicines info day 2021: first announcement - save this date in your diary! (PDF/191.45 KB)

European Medicines Agency/AnimalhealthEurope veterinary medicines info day 2021

Increxxa : EPAR - Public assessment report (PDF/352.51 KB)

Increxxa : EPAR - Medicine overview (PDF/173.46 KB)

CVMP summary of positive opinion for Solensia (PDF/129.54 KB)

News: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 8-10 December 2020

Tulinovet : EPAR - Public assessment report (PDF/289.01 KB)

Tulinovet : EPAR - Product information (PDF/266.18 KB)

Agenda - CVMP agenda of the 8-10 December 2020 meeting (PDF/295.6 KB)

Monthly report on application procedures, guidelines and related documents for veterinary medicines: October 2020 (PDF/274.7 KB)

Chanhold : EPAR - Procedural steps taken and scientific information after authorisation (PDF/83.93 KB)

Betamox LA and generics Article-35 referral - Questions and answers on the review of withdrawal periods for Betamox LA 150 mg/ml suspension for injection and associated names, and generic products thereof (PDF/133.62 KB)