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Work plan for the Pharmacovigilance Inspectors Working Group for 2020 (PDF/117.13 KB) (new)

Adopted
First published: 03/07/2020
EMA/INS/PhV/359174/2020
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Minutes - PDCO minutes of the 09-11 December 2019 meeting (PDF/463.91 KB) (new)

Adopted
First published: 02/07/2020
EMA/PDCO/682483/2019
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Minutes - PDCO minutes of the 28-31 January 2020 meeting (PDF/1.57 MB) (new)

Draft
First published: 02/07/2020
EMA/PDCO/52138/2020
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Annual report of the Pharmacovigilance Inspectors Working Group for 2018 (PDF/162.02 KB) (new)

Adopted
First published: 02/07/2020
EMA/INS/PhV/569203/2019
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Ketoprofen (Bovine, Porcine and Equidae): European public maximum-residue-limit assessment report (EPMAR) - CVMP (PDF/273.06 KB) (new)

Adopted
First published: 02/07/2020
EMA/CVMP/94885/2020
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CVMP strategy on antimicrobials 2021-2025 (PDF/325.1 KB) (new)

Draft: consultation open
First published: 01/07/2020
Consultations dates: from 01/07/2020 to 30/09/2020
EMA/CVMP/179874/2020
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Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs) (PDF/187.75 KB) (new)

First published: 26/06/2020
EMA/CVMP/IWP/669993/2019
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Tulissin : EPAR - Public assessment report (PDF/310.01 KB) (new)

Adopted
First published: 26/06/2020
EMA/94821/2020
List item

Tulaven : EPAR - Public assessment report (PDF/305.44 KB) (new)

Adopted
First published: 26/06/2020
EMA/94834/2020
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Minutes of the CVMP meeting of 18-20 May 2020 (PDF/266.05 KB) (new)

Adopted
First published: 26/06/2020
EMA/CVMP/326595/2020
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Agenda - PDCO agenda of the 23-26 June 2020 meeting (PDF/440.71 KB) (new)

Draft
First published: 24/06/2020
EMA/PDCO/302368/2020
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Monthly report on application procedures, guidelines and related documents for veterinary medicines: May 2020 (PDF/240.34 KB) (new)

Adopted
First published: 23/06/2020
EMA/298881/2020
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PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC meeting (PDF/393.26 KB) (new)

Adopted
First published: 23/06/2020
EMA/PRAC/257435/2020
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New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC (PDF/304.06 KB) (new)

First published: 23/06/2020
EMA/PRAC/257439/2020
Bulgarian
(PDF/361 KB)

Croatian
(PDF/353.7 KB)

Czech
(PDF/361.51 KB)

Danish
(PDF/309.84 KB)

Dutch
(PDF/317.37 KB)

Estonian
(PDF/309.98 KB)

Finnish
(PDF/308.59 KB)

French
(PDF/315.83 KB)

German
(PDF/302.53 KB)

Greek
(PDF/371.78 KB)

Hungarian
(PDF/368.39 KB)

Icelandic
(PDF/330.14 KB)

Italian
(PDF/309.73 KB)

Latvian
(PDF/360.14 KB)

Lithuanian
(PDF/363.81 KB)

Maltese
(PDF/372.17 KB)

Norwegian
(PDF/295.5 KB)

Polish
(PDF/354.54 KB)

Portuguese
(PDF/310.02 KB)

Romanian
(PDF/351.33 KB)

Slovak
(PDF/365.97 KB)

Slovenian
(PDF/357.14 KB)

Spanish
(PDF/309.12 KB)

Swedish
(PDF/306.21 KB)
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Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020 (PDF/163.73 KB) (new)

First published: 19/06/2020
EMA/CVMP/302233/2020
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CVMP post-authorisation summary of positive opinion for Bluevac BTV (PDF/127.82 KB) (new)

Adopted
First published: 19/06/2020
EMA/CVMP/307513/2020
List item

Bupivacaine - Summary opinion of the CVMP on the establishment of maximum residue limits (PDF/121.83 KB) (new)

Adopted
First published: 19/06/2020
EMA/CVMP/278195/2020
List item

Press release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020

CVMP, Last updated: 19/06/2020
List item

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905 (PDF/129.27 KB) (new)

Last updated: 18/06/2020
Active substance: Methoxyflurane
Procedure number: PSUSA/00010484/201905
Regulatory outcome: Maintenance
List item

Isoflurane: List of nationally authorised medicinal products - PSUSA/00001786/201910 (PDF/190.54 KB) (new)

Last updated: 17/06/2020
Active substance: isoniazid
Procedure number: PSUSA/00001786/201910
Regulatory outcome: Maintenance
List item

Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa (PDF/151.37 KB) (new)

First published: 17/06/2020
Dissemination date: 17/06/2020
List item

Tixocortol, chlorhexidine gluconate / tixocortol pivalate: List of nationally authorised medicinal products - PSUSA/00010333/201911 (PDF/114.82 KB) (new)

Last updated: 17/06/2020
Active substance: tixocortol, chlorhexidine gluconate / tixocortol pivalate
Procedure number: PSUSA/00010333/201911
Regulatory outcome: Maintenance
List item

Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201911 (PDF/127.2 KB) (new)

Last updated: 17/06/2020
Active substance: Ozenoxacin
Procedure number: PSUSA/00010651/201911
Regulatory outcome: Maintenance
List item

Isoniazid: List of nationally authorised medicinal products - PSUSA/00001789/201911 (PDF/117.03 KB) (new)

Last updated: 17/06/2020
Active substance: isoniazid
Procedure number: PSUSA/00001789/201911
Regulatory outcome: Maintenance
List item

Felbamate: List of nationally authorised medicinal products - PSUSA/00010155/201909 (PDF/133.83 KB) (new)

Last updated: 16/06/2020
Active substance: felbamate
Procedure number: PSUSA/00010155/201909
Regulatory outcome: Maintenance

11204 results

Work plan for the Pharmacovigilance Inspectors Working Group for 2020 (PDF/117.13 KB) (new)

Minutes - PDCO minutes of the 09-11 December 2019 meeting (PDF/463.91 KB) (new)

Minutes - PDCO minutes of the 28-31 January 2020 meeting (PDF/1.57 MB) (new)

Annual report of the Pharmacovigilance Inspectors Working Group for 2018 (PDF/162.02 KB) (new)

Ketoprofen (Bovine, Porcine and Equidae): European public maximum-residue-limit assessment report (EPMAR) - CVMP (PDF/273.06 KB) (new)

CVMP strategy on antimicrobials 2021-2025 (PDF/325.1 KB) (new)

Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs) (PDF/187.75 KB) (new)

Tulissin : EPAR - Public assessment report (PDF/310.01 KB) (new)

Tulaven : EPAR - Public assessment report (PDF/305.44 KB) (new)

Minutes of the CVMP meeting of 18-20 May 2020 (PDF/266.05 KB) (new)

Agenda - PDCO agenda of the 23-26 June 2020 meeting (PDF/440.71 KB) (new)

Monthly report on application procedures, guidelines and related documents for veterinary medicines: May 2020 (PDF/240.34 KB) (new)

PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC meeting (PDF/393.26 KB) (new)

New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC (PDF/304.06 KB) (new)

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020 (PDF/163.73 KB) (new)

CVMP post-authorisation summary of positive opinion for Bluevac BTV (PDF/127.82 KB) (new)

Bupivacaine - Summary opinion of the CVMP on the establishment of maximum residue limits (PDF/121.83 KB) (new)

Press release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 June 2020

Methoxyflurane: List of nationally authorised medicinal products - PSUSA/00010484/201905 (PDF/129.27 KB) (new)

Isoflurane: List of nationally authorised medicinal products - PSUSA/00001786/201910 (PDF/190.54 KB) (new)

Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa (PDF/151.37 KB) (new)

Tixocortol, chlorhexidine gluconate / tixocortol pivalate: List of nationally authorised medicinal products - PSUSA/00010333/201911 (PDF/114.82 KB) (new)

Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/201911 (PDF/127.2 KB) (new)

Isoniazid: List of nationally authorised medicinal products - PSUSA/00001789/201911 (PDF/117.03 KB) (new)

Felbamate: List of nationally authorised medicinal products - PSUSA/00010155/201909 (PDF/133.83 KB) (new)