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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data (PDF/393.5 KB) (updated)

First published: 16/12/2021
Last updated: 20/05/2022
EMA/717215/2021
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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/1.61 MB) (updated)

Adopted
First published: 21/01/2021
Last updated: 20/05/2022
EMA/444352/2021
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Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2022 (PDF/156.28 KB) (updated)

First published: 04/02/2022
Last updated: 20/05/2022
EMA/CVMP/PhVWP/48138/2022
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EU/3/17/1856: Public summary of opinion on orphan designation: Inebilizumab for the treatment of neuromyelitis optica spectrum disorders (PDF/200.88 KB) (updated)

Adopted
First published: 05/05/2017
Last updated: 19/05/2022
EMA/144977/2017
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EU/3/15/1555: Public summary of opinion on orphan designation: Synthetic hepcidin for the treatment of beta thalassaemia intermedia and major (PDF/185.88 KB) (updated)

Adopted
First published: 16/11/2015
Last updated: 18/05/2022
EMA/COMP/615273/2015
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EU/3/07/478: Public summary of positive opinion for orphan designation of N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide for the treatment of Hodgkin's lymphoma (PDF/317.04 KB) (updated)

Adopted
First published: 23/09/2009
Last updated: 10/05/2022
EMEA/COMP/389996/2007 Rev.1
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EU/3/13/1228: Public summary of opinion on orphan designation: Obeticholic acid for the treatment of primary sclerosing cholangitis (PDF/187.38 KB) (updated)

Adopted
First published: 24/03/2014
Last updated: 10/05/2022
EMA/COMP/18109/2014
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Recommended submission dates for veterinary medicinal products (PDF/656.81 KB) (updated)

Adopted
First published: 01/07/2009
Last updated: 06/05/2022
EMA/587410/2021 Rev.4
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Change of applicant checklist - pre-submission guidance (veterinary) (PDF/178.27 KB) (updated)

First published: 01/10/2018
Last updated: 03/05/2022
EMA/603587/2018
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Change of applicant - Cover letter standard text (veterinary) (DOCX/20.88 KB) (updated)

First published: 01/10/2018
Last updated: 03/05/2022
List item

CHMP post-authorisation summary of positive opinion for Tecfidera (II-0073) (PDF/129.75 KB)

Adopted
First published: 28/01/2022
Last updated: 22/04/2022
EMA/CHMP/691024/2021 Rev.2
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Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6 (PDF/277.29 KB)

First published: 17/07/2006
Last updated: 22/04/2022
EMA/CVMP/32995/2006 Rev. 1
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Purevax RCPCh FeLV : EPAR - Product Information (PDF/146.78 KB)

First published: 26/01/2010
Last updated: 11/04/2022
Bulgarian
(PDF/269.98 KB)

Croatian
(PDF/231.33 KB)

Czech
(PDF/233.16 KB)

Danish
(PDF/151.77 KB)

Dutch
(PDF/140.98 KB)

Estonian
(PDF/173.89 KB)

Finnish
(PDF/137.83 KB)

French
(PDF/143.16 KB)

German
(PDF/142.6 KB)

Greek
(PDF/268.83 KB)

Hungarian
(PDF/234.28 KB)

Icelandic
(PDF/155.14 KB)

Italian
(PDF/147.15 KB)

Latvian
(PDF/230.42 KB)

Lithuanian
(PDF/234.66 KB)

Maltese
(PDF/231.3 KB)

Norwegian
(PDF/136.49 KB)

Portuguese
(PDF/170.8 KB)

Romanian
(PDF/238.97 KB)

Slovak
(PDF/234.74 KB)

Slovenian
(PDF/228.45 KB)

Spanish
(PDF/141.87 KB)

Swedish
(PDF/153.56 KB)
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Purevax RCP FeLV : EPAR - Procedural steps taken and scientific information after authorisation (PDF/166.15 KB)

First published: 26/01/2010
Last updated: 07/04/2022
List item

Purevax RCP FeLV : EPAR - Product Information (PDF/114.63 KB)

First published: 26/01/2010
Last updated: 07/04/2022
Bulgarian
(PDF/235.4 KB)

Croatian
(PDF/199.95 KB)

Czech
(PDF/201.17 KB)

Danish
(PDF/121.93 KB)

Dutch
(PDF/108.59 KB)

Estonian
(PDF/138.34 KB)

Finnish
(PDF/110.95 KB)

German
(PDF/109.42 KB)

Greek
(PDF/228.17 KB)

Hungarian
(PDF/202.59 KB)

Icelandic
(PDF/124.9 KB)

Italian
(PDF/114.45 KB)

Latvian
(PDF/199.31 KB)

Lithuanian
(PDF/199.8 KB)

Maltese
(PDF/211.51 KB)

Norwegian
(PDF/111.63 KB)

Polish
(PDF/210.23 KB)

Portuguese
(PDF/147.04 KB)

Romanian
(PDF/211.92 KB)

Slovak
(PDF/201.29 KB)

Slovenian
(PDF/197.24 KB)

Spanish
(PDF/109.63 KB)

Swedish
(PDF/106.92 KB)
List item

EU/3/16/1666: Public summary of opinion on orphan designation: Rimiducid for treatment of graft-versus-host disease (PDF/194.23 KB)

Adopted
First published: 23/06/2016
Last updated: 07/04/2022
EMA/COMP/308001/2016
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EU/3/16/1674: Public summary of opinion on orphan designation: Allogeneic donor-derived ex-vivo expanded T lymphocytes transduced with a retroviral vector containing inducible caspase 9 and truncated CD19 for treatment i... (PDF/216.9 KB)

Adopted
First published: 26/07/2016
Last updated: 07/04/2022
EMA/COMP/388379/2016
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Purevax RCP : EPAR - Product information (PDF/136.1 KB)

First published: 20/02/2009
Last updated: 06/04/2022
Bulgarian
(PDF/254.72 KB)

Croatian
(PDF/217.04 KB)

Czech
(PDF/222.44 KB)

Danish
(PDF/124.95 KB)

Dutch
(PDF/128.81 KB)

Estonian
(PDF/161.36 KB)

Finnish
(PDF/126.29 KB)

French
(PDF/129.61 KB)

German
(PDF/128.75 KB)

Greek
(PDF/245.3 KB)

Hungarian
(PDF/215.01 KB)

Icelandic
(PDF/143.57 KB)

Italian
(PDF/132.88 KB)

Latvian
(PDF/219.67 KB)

Lithuanian
(PDF/225.21 KB)

Maltese
(PDF/249.99 KB)

Norwegian
(PDF/125.03 KB)

Polish
(PDF/226.13 KB)

Portuguese
(PDF/142.87 KB)

Romanian
(PDF/226.98 KB)

Slovak
(PDF/224.36 KB)

Slovenian
(PDF/215.01 KB)

Spanish
(PDF/131.65 KB)

Swedish
(PDF/125.94 KB)
List item

Purevax RCPCh FeLV : EPAR - Procedural steps taken and scientific information after authorisation (PDF/175.91 KB)

First published: 26/01/2010
Last updated: 06/04/2022
List item

Purevax RCPCh : EPAR - Product Information (PDF/141.25 KB)

First published: 26/01/2010
Last updated: 06/04/2022
Bulgarian
(PDF/267.1 KB)

Croatian
(PDF/234.44 KB)

Czech
(PDF/229.09 KB)

Danish
(PDF/134.39 KB)

Dutch
(PDF/141.17 KB)

Estonian
(PDF/166.68 KB)

Finnish
(PDF/133.71 KB)

French
(PDF/136.6 KB)

German
(PDF/136.3 KB)

Greek
(PDF/259.72 KB)

Hungarian
(PDF/226.12 KB)

Icelandic
(PDF/151.29 KB)

Italian
(PDF/142.64 KB)

Latvian
(PDF/228.21 KB)

Lithuanian
(PDF/227.94 KB)

Maltese
(PDF/226.62 KB)

Norwegian
(PDF/132.9 KB)

Polish
(PDF/235.38 KB)

Portuguese
(PDF/145.15 KB)

Romanian
(PDF/243.97 KB)

Slovak
(PDF/232.2 KB)

Slovenian
(PDF/221.04 KB)

Spanish
(PDF/138.62 KB)

Swedish
(PDF/133.68 KB)
List item

Purevax RCPCh : EPAR - Procedural steps taken and scientific information after authorisation (PDF/175.87 KB)

First published: 22/01/2010
Last updated: 06/04/2022
List item

Orphan medicines figures 2000-2021 (PDF/259.86 KB)

First published: 16/04/2015
Last updated: 06/04/2022
List item

EU/3/11/896: Public summary of opinion on orphan designation: Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol f... (PDF/214.36 KB)

Adopted
First published: 21/09/2011
Last updated: 06/04/2022
EMA/COMP/512931/2011
List item

Improvac : EPAR - Procedural steps taken and scientific information after authorisation (PDF/196.73 KB)

First published: 27/11/2009
Last updated: 05/04/2022
List item

Improvac : EPAR - Product Information (PDF/232.65 KB)

First published: 23/11/2009
Last updated: 05/04/2022
Bulgarian
(PDF/275.76 KB)

Croatian
(PDF/246.69 KB)

Czech
(PDF/249.85 KB)

Danish
(PDF/230.5 KB)

Dutch
(PDF/262.11 KB)

Estonian
(PDF/236.54 KB)

Finnish
(PDF/248.8 KB)

French
(PDF/242.9 KB)

German
(PDF/246.07 KB)

Greek
(PDF/280.75 KB)

Hungarian
(PDF/243.43 KB)

Icelandic
(PDF/236.71 KB)

Italian
(PDF/239.31 KB)

Latvian
(PDF/266.73 KB)

Lithuanian
(PDF/259.88 KB)

Maltese
(PDF/269.99 KB)

Norwegian
(PDF/246.08 KB)

Polish
(PDF/259.27 KB)

Portuguese
(PDF/230.66 KB)

Romanian
(PDF/264.35 KB)

Slovak
(PDF/251.63 KB)

Slovenian
(PDF/241.62 KB)

Spanish
(PDF/240.66 KB)

Swedish
(PDF/249.13 KB)

7651 results

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data (PDF/393.5 KB) (updated)

EU Implementation Guide (IG) on veterinary medicines product data - Chapter 2: Format for the electronic submission of veterinary medicinal product information (PDF/1.61 MB) (updated)

Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2022 (PDF/156.28 KB) (updated)

EU/3/17/1856: Public summary of opinion on orphan designation: Inebilizumab for the treatment of neuromyelitis optica spectrum disorders (PDF/200.88 KB) (updated)

EU/3/15/1555: Public summary of opinion on orphan designation: Synthetic hepcidin for the treatment of beta thalassaemia intermedia and major (PDF/185.88 KB) (updated)

EU/3/07/478: Public summary of positive opinion for orphan designation of N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-ylamino)-methyl] benzamide for the treatment of Hodgkin's lymphoma (PDF/317.04 KB) (updated)

EU/3/13/1228: Public summary of opinion on orphan designation: Obeticholic acid for the treatment of primary sclerosing cholangitis (PDF/187.38 KB) (updated)

Recommended submission dates for veterinary medicinal products (PDF/656.81 KB) (updated)

Change of applicant checklist - pre-submission guidance (veterinary) (PDF/178.27 KB) (updated)

Change of applicant - Cover letter standard text (veterinary) (DOCX/20.88 KB) (updated)

CHMP post-authorisation summary of positive opinion for Tecfidera (II-0073) (PDF/129.75 KB)

Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6 (PDF/277.29 KB)

Purevax RCPCh FeLV : EPAR - Product Information (PDF/146.78 KB)

Purevax RCP FeLV : EPAR - Procedural steps taken and scientific information after authorisation (PDF/166.15 KB)

Purevax RCP FeLV : EPAR - Product Information (PDF/114.63 KB)

EU/3/16/1666: Public summary of opinion on orphan designation: Rimiducid for treatment of graft-versus-host disease (PDF/194.23 KB)

EU/3/16/1674: Public summary of opinion on orphan designation: Allogeneic donor-derived ex-vivo expanded T lymphocytes transduced with a retroviral vector containing inducible caspase 9 and truncated CD19 for treatment i... (PDF/216.9 KB)

Purevax RCP : EPAR - Product information (PDF/136.1 KB)

Purevax RCPCh FeLV : EPAR - Procedural steps taken and scientific information after authorisation (PDF/175.91 KB)

Purevax RCPCh : EPAR - Product Information (PDF/141.25 KB)

Purevax RCPCh : EPAR - Procedural steps taken and scientific information after authorisation (PDF/175.87 KB)

Orphan medicines figures 2000-2021 (PDF/259.86 KB)

EU/3/11/896: Public summary of opinion on orphan designation: Multilamellar microvesicle comprising phosphatidylcholine, sphingomyelin, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol and cholesterol f... (PDF/214.36 KB)

Improvac : EPAR - Procedural steps taken and scientific information after authorisation (PDF/196.73 KB)

Improvac : EPAR - Product Information (PDF/232.65 KB)