Search the website

Search results

4976 results

Sort by

List item

EudraVigilance access policy for medicines for veterinary use - Revision 2 (PDF/472.2 KB) (new)

Adopted
First published: 18/06/2021
Legal effective date: 01/01/2022
EMA/113700/2008
List item

News: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 2021 (new)

CVMP, Last updated: 18/06/2021
List item

CVMP summary of positive opinion for Tessie (PDF/113.67 KB) (new)

Adopted
First published: 18/06/2021
EMA/CVMP/306774/2021
List item

CVMP summary of positive opinion for Strangvac (PDF/131.49 KB) (new)

Adopted
First published: 18/06/2021
EMA/CVMP/308991/2021
List item

CVMP summary of positive opinion for Fatrovax RHD (PDF/131.04 KB) (new)

Adopted
First published: 18/06/2021
EMA/CVMP/306191/2021
List item

P/0264/2020 : EMA decision of 15 July 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tominersen (EMEA-002546-PIP01-19) (PDF/302.39 KB) (new)

Adopted
First published: 18/06/2021
EMA/366137/2020
List item

Agenda - CVMP agenda of the 15-17 June 2021 meeting (PDF/288.17 KB) (new)

Draft
First published: 15/06/2021
EMA/308464/2021
List item

Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2021 (PDF/260.45 KB) (new)

Adopted
First published: 10/06/2021
EMA/195931/2021
List item

EU VICH adverse event report implementation guide (PDF/680.16 KB) (new)

Draft: consultation open
First published: 04/06/2021
Consultations dates: from 04/06/2021 to 04/08/2021
EMA/186368/2021
List item

Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2021 (PDF/257.84 KB) (new)

Adopted
First published: 04/06/2021
EMA/195931/2021
List item

Phenytoin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002392/202008 (PDF/130.15 KB) (new)

Last updated: 01/06/2021
Active substance: phenytoin
Procedure number: PSUSA/00002392/202008
Regulatory outcome: Variation
Bulgarian
(PDF/135.61 KB)

Croatian
(PDF/141.43 KB)

Czech
(PDF/134.46 KB)

Danish
(PDF/136.96 KB)

Dutch
(PDF/155.15 KB)

Estonian
(PDF/108.9 KB)

Finnish
(PDF/129.67 KB)

French
(PDF/129.75 KB)

German
(PDF/142.7 KB)

Greek
(PDF/136.33 KB)

Hungarian
(PDF/133.66 KB)

Italian
(PDF/151.1 KB)

Latvian
(PDF/134.12 KB)

Lithuanian
(PDF/133.37 KB)

Maltese
(PDF/142.15 KB)

Norwegian
(PDF/129.5 KB)

Polish
(PDF/133.74 KB)

Portuguese
(PDF/138 KB)

Romanian
(PDF/137.51 KB)

Slovak
(PDF/140.17 KB)

Slovenian
(PDF/135.18 KB)

Spanish
(PDF/123.18 KB)

Swedish
(PDF/130.52 KB)
List item

Veterinary Medicines Regulation highlights - Issue 5 (PDF/1.02 MB) (new)

First published: 31/05/2021
Issue 5
List item

Reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products (PDF/341.91 KB) (new)

Draft: consultation open
First published: 25/05/2021
Consultations dates: from 21/05/2021 to 23/07/2021
EMA/CVMP/IWP/251741/2015 Rev. 1
List item

Paromomycin (tissues and eggs of all food producing species): European public MRL assessment report (EPMAR) - CVMP (PDF/273.86 KB) (new)

Adopted
First published: 25/05/2021
EMA/CVMP/56180/2018
List item

News: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 10-12 May 2021

CVMP, Last updated: 17/05/2021
List item

CVMP summary of positive opinion for Bonqat (PDF/137 KB)

Adopted
First published: 17/05/2021
EMA/CVMP/241883/2021
List item

Enteroporc Coli : EPAR - Procedural steps taken and scientific information after the authorisation (PDF/103 KB)

First published: 12/05/2021
List item

Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010271/202007 (PDF/128.84 KB)

Last updated: 11/05/2021
Active substance: Ezetimibe, Rosuvastatin
Procedure number: PSUSA/00010271/202007
Regulatory outcome: Variation
Bulgarian
(PDF/111.32 KB)

Croatian
(PDF/193.12 KB)

Czech
(PDF/151.95 KB)

Danish
(PDF/188.71 KB)

Dutch
(PDF/136.03 KB)

Estonian
(PDF/65.76 KB)

Finnish
(PDF/182.32 KB)

French
(PDF/102.93 KB)

German
(PDF/227.67 KB)

Greek
(PDF/257.75 KB)

Hungarian
(PDF/51.68 KB)

Italian
(PDF/23.21 KB)

Latvian
(PDF/126.73 KB)

Lithuanian
(PDF/143.8 KB)

Maltese
(PDF/272.11 KB)

Norwegian
(PDF/48.06 KB)

Polish
(PDF/226.61 KB)

Portuguese
(PDF/121.92 KB)

Romanian
(PDF/139.38 KB)

Slovak
(PDF/146 KB)

Slovenian
(PDF/107.72 KB)

Spanish
(PDF/50.96 KB)

Swedish
(PDF/51.31 KB)
List item

Agenda - CVMP agenda of the 10-12 May 2021 meeting (PDF/238.03 KB)

Draft
First published: 10/05/2021
EMA/CVMP/242543/2021
List item

OvuGel : EPAR - Public assessment report (PDF/379.24 KB)

Adopted
First published: 07/05/2021
EMA/518898/2020
List item

OvuGel : EPAR - All authorised presentations (PDF/72.88 KB)

First published: 07/05/2021
Bulgarian
(PDF/89.77 KB)

Croatian
(PDF/84.06 KB)

Czech
(PDF/82.07 KB)

Danish
(PDF/73.54 KB)

Dutch
(PDF/73.88 KB)

Estonian
(PDF/81.85 KB)

Finnish
(PDF/93.31 KB)

French
(PDF/74.32 KB)

German
(PDF/75.92 KB)

Greek
(PDF/80.37 KB)

Hungarian
(PDF/83.48 KB)

Icelandic
(PDF/75.17 KB)

Italian
(PDF/73.02 KB)

Latvian
(PDF/90.57 KB)

Lithuanian
(PDF/91.39 KB)

Maltese
(PDF/91.83 KB)

Norwegian
(PDF/74.05 KB)

Polish
(PDF/90.76 KB)

Portuguese
(PDF/73.83 KB)

Romanian
(PDF/81.57 KB)

Slovak
(PDF/90.09 KB)

Slovenian
(PDF/85.93 KB)

Spanish
(PDF/72.87 KB)

Swedish
(PDF/75.29 KB)
List item

OvuGel : EPAR - Product information (PDF/686.36 KB)

First published: 07/05/2021
Bulgarian
(PDF/761.49 KB)

Croatian
(PDF/725.72 KB)

Czech
(PDF/759.85 KB)

Danish
(PDF/314.02 KB)

Dutch
(PDF/706.16 KB)

Estonian
(PDF/667.27 KB)

Finnish
(PDF/656.43 KB)

French
(PDF/677.88 KB)

German
(PDF/685.19 KB)

Greek
(PDF/761.85 KB)

Hungarian
(PDF/759.92 KB)

Icelandic
(PDF/676.6 KB)

Italian
(PDF/301.29 KB)

Latvian
(PDF/380.53 KB)

Lithuanian
(PDF/762.72 KB)

Maltese
(PDF/762.46 KB)

Norwegian
(PDF/686.86 KB)

Polish
(PDF/744.94 KB)

Portuguese
(PDF/678.74 KB)

Romanian
(PDF/761.49 KB)

Slovak
(PDF/771.3 KB)

Slovenian
(PDF/757.44 KB)

Spanish
(PDF/668.56 KB)

Swedish
(PDF/671.86 KB)
List item

OvuGel : EPAR - Medicine overview (DOCX/117.34 KB)

First published: 07/05/2021
EMA/518868/2020
Bulgarian
(PDF/157.25 KB)

Croatian
(PDF/156.87 KB)

Czech
(PDF/153.95 KB)

Danish
(PDF/132.48 KB)

Dutch
(PDF/132.54 KB)

Estonian
(PDF/131.07 KB)

Finnish
(PDF/131.11 KB)

French
(PDF/134.12 KB)

German
(PDF/136.69 KB)

Greek
(PDF/155.1 KB)

Hungarian
(PDF/156.7 KB)

Italian
(PDF/131.92 KB)

Latvian
(PDF/169.82 KB)

Lithuanian
(PDF/154.6 KB)

Maltese
(PDF/157.25 KB)

Polish
(PDF/157.08 KB)

Portuguese
(PDF/134.92 KB)

Romanian
(PDF/151.06 KB)

Slovak
(PDF/155.61 KB)

Slovenian
(PDF/153.54 KB)

Spanish
(PDF/134.46 KB)

Swedish
(PDF/132.28 KB)
List item

Librela : EPAR - Public assessment report (PDF/445.19 KB)

Adopted
First published: 06/05/2021
EMA/518235/2020
List item

Librela : EPAR - Medicine overview (PDF/132.74 KB)

First published: 06/05/2021
EMA/518254/2020
Bulgarian
(PDF/157.67 KB)

Croatian
(PDF/154.19 KB)

Czech
(PDF/154.82 KB)

Danish
(PDF/131.94 KB)

Dutch
(PDF/131.82 KB)

Estonian
(PDF/131.71 KB)

Finnish
(PDF/130.43 KB)

French
(PDF/132.84 KB)

German
(PDF/134.98 KB)

Greek
(PDF/157.93 KB)

Hungarian
(PDF/152.63 KB)

Italian
(PDF/130.74 KB)

Latvian
(PDF/163.85 KB)

Lithuanian
(PDF/154.02 KB)

Maltese
(PDF/154.99 KB)

Polish
(PDF/154.6 KB)

Portuguese
(PDF/134.06 KB)

Romanian
(PDF/151.69 KB)

Slovak
(PDF/155.06 KB)

Slovenian
(PDF/150.6 KB)

Spanish
(PDF/132.23 KB)

Swedish
(PDF/131.76 KB)

4976 results

EudraVigilance access policy for medicines for veterinary use - Revision 2 (PDF/472.2 KB) (new)

News: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 15-17 June 2021 (new)

CVMP summary of positive opinion for Tessie (PDF/113.67 KB) (new)

CVMP summary of positive opinion for Strangvac (PDF/131.49 KB) (new)

CVMP summary of positive opinion for Fatrovax RHD (PDF/131.04 KB) (new)

P/0264/2020 : EMA decision of 15 July 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for tominersen (EMEA-002546-PIP01-19) (PDF/302.39 KB) (new)

Agenda - CVMP agenda of the 15-17 June 2021 meeting (PDF/288.17 KB) (new)

Monthly report on application procedures, guidelines and related documents for veterinary medicines: April 2021 (PDF/260.45 KB) (new)

EU VICH adverse event report implementation guide (PDF/680.16 KB) (new)

Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2021 (PDF/257.84 KB) (new)

Phenytoin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002392/202008 (PDF/130.15 KB) (new)

Veterinary Medicines Regulation highlights - Issue 5 (PDF/1.02 MB) (new)

Reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products (PDF/341.91 KB) (new)

Paromomycin (tissues and eggs of all food producing species): European public MRL assessment report (EPMAR) - CVMP (PDF/273.86 KB) (new)

News: Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 10-12 May 2021

CVMP summary of positive opinion for Bonqat (PDF/137 KB)

Enteroporc Coli : EPAR - Procedural steps taken and scientific information after the authorisation (PDF/103 KB)

Ezetimibe / rosuvastatin: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010271/202007 (PDF/128.84 KB)

Agenda - CVMP agenda of the 10-12 May 2021 meeting (PDF/238.03 KB)

OvuGel : EPAR - Public assessment report (PDF/379.24 KB)

OvuGel : EPAR - All authorised presentations (PDF/72.88 KB)

OvuGel : EPAR - Product information (PDF/686.36 KB)

OvuGel : EPAR - Medicine overview (DOCX/117.34 KB)

Librela : EPAR - Public assessment report (PDF/445.19 KB)

Librela : EPAR - Medicine overview (PDF/132.74 KB)