Search the website

Search results

7761 results

Sort by

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) (updated)

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) (updated)

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) (updated)

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) (updated)

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) (updated)

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) (updated)

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) (updated)

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) (updated)

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) (updated)

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

EU/3/19/2145: Public summary of opinion on orphan designation for risdiplam for the treatment of spinal muscular atrophy (PDF/183.64 KB) (updated)

Adopted
First published: 09/04/2019
Last updated: 12/09/2023
EMADOC-628903358-446
List item

Nobivac Myxo-RHD : EPAR - Public assessment report (PDF/299.3 KB) (updated)

Adopted
First published: 26/09/2011
Last updated: 12/09/2023
EMA/646849/2011 Rev. 1
List item

CVMP summary of positive opinion for Nobivac Myxo-RHD (PDF/78.78 KB) (updated)

Adopted
First published: 15/07/2011
Last updated: 12/09/2023
MA/CVMP/504724/2011
List item

Nobivac Myxo-RHD : EPAR - Procedural steps taken and scientific information after authorisation (PDF/265.32 KB) (updated)

First published: 23/04/2014
Last updated: 12/09/2023
List item

Nobivac Myxo-RHD : EPAR - Summary for the public (PDF/82.78 KB) (updated)

First published: 26/09/2011
Last updated: 12/09/2023
EMA/632740/2011
Bulgarian
(PDF/171.03 KB)

Czech
(PDF/119.57 KB)

Danish
(PDF/101.51 KB)

Dutch
(PDF/84.09 KB)

Estonian
(PDF/98.5 KB)

Finnish
(PDF/83.59 KB)

French
(PDF/87.59 KB)

German
(PDF/165.02 KB)

Greek
(PDF/179.69 KB)

Hungarian
(PDF/168.78 KB)

Italian
(PDF/164.96 KB)

Latvian
(PDF/202.32 KB)

Lithuanian
(PDF/118.59 KB)

Maltese
(PDF/123.05 KB)

Polish
(PDF/121.2 KB)

Portuguese
(PDF/143.92 KB)

Romanian
(PDF/121.28 KB)

Slovak
(PDF/172.34 KB)

Slovenian
(PDF/168.64 KB)

Spanish
(PDF/85.69 KB)

Swedish
(PDF/81.55 KB)
List item

EU/3/17/1955: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene for the treatment of mucopolysaccharidosis t... (PDF/201.59 KB) (updated)

Adopted
First published: 12/03/2018
Last updated: 12/09/2023
EMA/839607/2017
List item

EU/3/17/1956: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene for the treatment of mucopolysaccharidosis... (PDF/205.64 KB) (updated)

Adopted
First published: 13/03/2018
Last updated: 12/09/2023
EMA/843195/2017
List item

Adakveo: Orphan maintenance assessment report (initial authorisation) (PDF/619.53 KB)

Adopted
First published: 11/08/2020
Last updated: 21/08/2023
EMADOC-1700519818-516929
List item

EU/3/18/2109: Public summary of opinion on orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase for the treatment of phenylalanine hydroxylase deficiency (PDF/198.35 KB)

Adopted
First published: 08/03/2019
Last updated: 08/08/2023
EMA/830775/2018
List item

EU/3/06/384: Public summary of positive opinion for orphan designation ofhuman telomerase reverse transcriptase peptide (611-626) for the treatment of pancreatic cancer (PDF/206.93 KB)

Adopted
First published: 21/09/2009
Last updated: 08/08/2023
EMEA/COMP/177332/2008 Rev.2
List item

Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Tobi Podhaler (tobramycin) for the treatment of Pseudomonas aeruginosa lung infection in cys... (PDF/122.63 KB)

Adopted
First published: 10/10/2011
Last updated: 31/07/2023
EMA/COMP/624961/2010
List item

EU/3/03/140: Public summary of positive opinion for orphan designation of tobramycin (inhalation powder) for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis (PDF/244.6 KB)

Adopted
First published: 07/03/2007
Last updated: 31/07/2023
EMEA/COMP/4684/03 Rev.3
List item

Guideline on Stability Testing: Stability testing of existing active substances and related finished products (PDF/410.11 KB)

Adopted
First published: 20/02/2023
Last updated: 21/07/2023
Legal effective date: 17/02/2023
EMA/CVMP/QWP/709423/2022,Corr.1
List item

EU/3/19/2150: Public summary of opinion on orphan designation: Codon-optimised human cystic fibrosis transmembrane conductance (PDF/208.43 KB)

Adopted
First published: 07/05/2019
Last updated: 21/07/2023
EMADOC-628903358-642
List item

EU/3/20/2297: Public summary of opinion on orphan designation for Adeno-associated virus serotype HSC15 expressing human arylsulfatase A gene for the treatment of metachromatic leukodystrophy (PDF/217.09 KB)

Adopted
First published: 24/09/2020
Last updated: 21/07/2023
EMADOC-628903358-2485
List item

Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1 (PDF/314.71 KB)

Adopted
First published: 16/12/2021
Last updated: 19/07/2023
Legal effective date: 01/07/2022
EMA/CVMP/EWP/170208/2005 Rev.1 Corr1

7761 results

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) (updated)

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

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

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) (updated)

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) (updated)

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

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

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) (updated)

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

EU/3/19/2145: Public summary of opinion on orphan designation for risdiplam for the treatment of spinal muscular atrophy (PDF/183.64 KB) (updated)

Nobivac Myxo-RHD : EPAR - Public assessment report (PDF/299.3 KB) (updated)

CVMP summary of positive opinion for Nobivac Myxo-RHD (PDF/78.78 KB) (updated)

Nobivac Myxo-RHD : EPAR - Procedural steps taken and scientific information after authorisation (PDF/265.32 KB) (updated)

Nobivac Myxo-RHD : EPAR - Summary for the public (PDF/82.78 KB) (updated)

EU/3/17/1955: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human alpha L-iduronidase gene for the treatment of mucopolysaccharidosis t... (PDF/201.59 KB) (updated)

EU/3/17/1956: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype 2/6 encoding zinc-finger nucleases and the human iduronate 2-sulfatase gene for the treatment of mucopolysaccharidosis... (PDF/205.64 KB) (updated)

Adakveo: Orphan maintenance assessment report (initial authorisation) (PDF/619.53 KB)

EU/3/18/2109: Public summary of opinion on orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase for the treatment of phenylalanine hydroxylase deficiency (PDF/198.35 KB)

EU/3/06/384: Public summary of positive opinion for orphan designation ofhuman telomerase reverse transcriptase peptide (611-626) for the treatment of pancreatic cancer (PDF/206.93 KB)

Recommendation for maintenance of orphan designation at the time of addition of new indications to the marketing authorisation: Tobi Podhaler (tobramycin) for the treatment of Pseudomonas aeruginosa lung infection in cys... (PDF/122.63 KB)

EU/3/03/140: Public summary of positive opinion for orphan designation of tobramycin (inhalation powder) for the treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis (PDF/244.6 KB)

Guideline on Stability Testing: Stability testing of existing active substances and related finished products (PDF/410.11 KB)

EU/3/19/2150: Public summary of opinion on orphan designation: Codon-optimised human cystic fibrosis transmembrane conductance (PDF/208.43 KB)

EU/3/20/2297: Public summary of opinion on orphan designation for Adeno-associated virus serotype HSC15 expressing human arylsulfatase A gene for the treatment of metachromatic leukodystrophy (PDF/217.09 KB)

Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1 (PDF/314.71 KB)