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EU/3/12/1002: Public summary of opinion on orphan designation: Adenovirus-associated vector containing human Fas-c gene for the treatment of glioma (PDF/213.68 KB) (updated)

Adopted
First published: 04/07/2012
Last updated: 26/09/2022
EMA/COMP/268035/2012
List item

EU/3/17/1926: Public summary of opinion on orphan designation : Ofranergene obadenovec for the treatment of ovarian cancer (PDF/194.9 KB) (updated)

First published: 08/01/2018
Last updated: 26/09/2022
EMA/632137/2017
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Minutes of the COMP meeting on 15-17 March 2022 (PDF/505.22 KB) (updated)

Adopted
First published: 13/06/2022
Last updated: 22/09/2022
EMA/COMP/157930/2022
List item

EU/3/14/1382: Public summary of positive opinion for orphan designation: Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist for the treatment of acute lymphoblastic leukaemia (PDF/223.74 KB) (updated)

Adopted
First published: 26/02/2015
Last updated: 16/09/2022
EMA/COMP/724271/2014
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EU/3/20/2356: Public summary of opinion on orphan designation - Autologous CD34+ cells transduced ex vivo with a lentiviral vector containing a modified gamma-globin gene for the treatment of sickle cell disease (PDF/189.71 KB) (updated)

First published: 15/02/2021
Last updated: 16/09/2022
EMADOC-628903358-3459
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Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (PDF/215.3 KB) (updated)

Adopted
First published: 23/09/2009
Last updated: 16/09/2022
EMA/CVMP/519714/2009 Rev. 54
List item

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (PDF/3.88 MB) (updated)

Adopted
First published: 22/07/2009
Last updated: 15/09/2022
Legal effective date: 01/10/2021
EMA/CVMP/PhVWP/10418/2009 Rev.13 Corr.
List item

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (Excel) (XLS/559 KB) (updated)

Adopted
First published: 22/07/2009
Last updated: 15/09/2022
EMA/CVMP/PhVWP/10418/2009 Rev.13 Corr.
List item

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products (PDF/726.06 KB) (updated)

Adopted
First published: 19/07/2010
Last updated: 15/09/2022
EMA/CVMP/PhVWP/237953/2022 Corr.
List item

Minutes of the COMP meeting on 12-14 July 2022 (PDF/550.66 KB) (updated)

First published: 12/09/2022
Last updated: 12/09/2022
EMA/COMP/646322/2022
List item

EU/3/10/752: Public summary of positive opinion for Velaglucerase alfa for the treatment of Gaucher disease (PDF/181.91 KB) (updated)

Adopted
First published: 23/06/2010
Last updated: 09/09/2022
EMA/COMP/169787/2010 Rev. 1
List item

Recommendation for maintenance of orphan designation at the time of marketing authorisation for Vpriv (velaglucerase alfa) for the treatment of Gaucher disease (PDF/116.32 KB) (updated)

Adopted
First published: 13/09/2010
Last updated: 09/09/2022
EMA/COMP/433831/2010
List item

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Revestive (teduglutide) for the treatment of short-bowel syndrome (PDF/111.78 KB) (updated)

Adopted
First published: 26/09/2012
Last updated: 09/09/2022
EMA/COMP/452266/2012
List item

EU/3/01/077: Public summary of positive opinion for orphan designation of [gly2]-recombinant human glucagon-like peptide for the treatment of short-bowel syndrome (PDF/193.8 KB) (updated)

Adopted
First published: 15/05/2009
Last updated: 09/09/2022
EMA/COMP/247424/2008 Rev.1
List item

Procaine benzylpenicillin Article-82 referral - Annex I (PDF/616.82 KB) (updated)

First published: 23/02/2022
Last updated: 08/09/2022
EMA/116259/2022
List item

EU/3/11/898: Public summary of opinion on orphan designation: Sirolimus for the treatment of chronic non-infectious uveitis (PDF/213.47 KB) (updated)

Adopted
First published: 21/09/2011
Last updated: 30/08/2022
EMA/COMP/508827/2011
List item

EU/3/13/1205: Public summary of opinion on orphan designation: Human monoclonal antibody against human interleukin 13 for the treatment of eosinophilic oesophagitis (PDF/195.1 KB) (updated)

Adopted
First published: 02/12/2013
Last updated: 30/08/2022
EMA/COMP/637681/2013 Rev. 1
List item

EU/3/18/2009: Public summary of opinion on orphan designation: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo for the treatment of ovarian cancer (PDF/208.29 KB)

Adopted
First published: 17/05/2018
Last updated: 17/08/2022
EMA/198204/2018
List item

Kalydeco : Orphan maintenance assessment report (post-authorisation) (II-0089) (PDF/394.32 KB)

Adopted
First published: 12/05/2021
Last updated: 10/08/2022
EMA/OD/0000042076
List item

Kalydeco : Orphan maintenance assessment report (post-authorisation) (II-0085) (PDF/349.34 KB)

Adopted
First published: 26/10/2020
Last updated: 10/08/2022
EMA/OD/0000036247
List item

Kalydeco : Orphan maintenance assessment report (post-authorisation) (II-0063) (PDF/530.67 KB)

Adopted
First published: 08/11/2018
Last updated: 10/08/2022
EMA/716663/2018
List item

EU/3/08/556: Public summary of positive opinion for orphan designation of N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide for the treatment of cystic fibrosis (PDF/207.66 KB)

Adopted
First published: 02/04/2009
Last updated: 10/08/2022
EMA/COMP/272429/2008 Rev.3
List item

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Kalydeco (ivacaftor) for the treatment of cystic fibrosis (PDF/118.72 KB)

Adopted
First published: 31/08/2012
Last updated: 10/08/2022
EMA/COMP/394533/2012
List item

Draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides residues in food of animal origin (PDF/1.47 MB)

Draft: consultation closed
First published: 30/06/2022
Last updated: 01/08/2022
Consultations dates: from 30/06/2022 to 13/09/2022
EMA/CVMP/499555/2021
List item

EU/3/15/1463: Public summary of positive opinion for orphan designation of melphalan flufenamide for the treatment of plasma cell myeloma (PDF/180.79 KB)

Adopted
First published: 11/05/2015
Last updated: 28/07/2022
EMA/COMP/132969/2015

7561 results

EU/3/12/1002: Public summary of opinion on orphan designation: Adenovirus-associated vector containing human Fas-c gene for the treatment of glioma (PDF/213.68 KB) (updated)

EU/3/17/1926: Public summary of opinion on orphan designation : Ofranergene obadenovec for the treatment of ovarian cancer (PDF/194.9 KB) (updated)

Minutes of the COMP meeting on 15-17 March 2022 (PDF/505.22 KB) (updated)

EU/3/14/1382: Public summary of positive opinion for orphan designation: Allogeneic CD34+ cells expanded ex vivo with an aryl hydrocarbon receptor antagonist for the treatment of acute lymphoblastic leukaemia (PDF/223.74 KB) (updated)

EU/3/20/2356: Public summary of opinion on orphan designation - Autologous CD34+ cells transduced ex vivo with a lentiviral vector containing a modified gamma-globin gene for the treatment of sickle cell disease (PDF/189.71 KB) (updated)

Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin (PDF/215.3 KB) (updated)

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (PDF/3.88 MB) (updated)

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (Excel) (XLS/559 KB) (updated)

List of changes to combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animal and humans to veterinary medicinal products (PDF/726.06 KB) (updated)

Minutes of the COMP meeting on 12-14 July 2022 (PDF/550.66 KB) (updated)

EU/3/10/752: Public summary of positive opinion for Velaglucerase alfa for the treatment of Gaucher disease (PDF/181.91 KB) (updated)

Recommendation for maintenance of orphan designation at the time of marketing authorisation for Vpriv (velaglucerase alfa) for the treatment of Gaucher disease (PDF/116.32 KB) (updated)

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Revestive (teduglutide) for the treatment of short-bowel syndrome (PDF/111.78 KB) (updated)

EU/3/01/077: Public summary of positive opinion for orphan designation of [gly2]-recombinant human glucagon-like peptide for the treatment of short-bowel syndrome (PDF/193.8 KB) (updated)

Procaine benzylpenicillin Article-82 referral - Annex I (PDF/616.82 KB) (updated)

EU/3/11/898: Public summary of opinion on orphan designation: Sirolimus for the treatment of chronic non-infectious uveitis (PDF/213.47 KB) (updated)

EU/3/13/1205: Public summary of opinion on orphan designation: Human monoclonal antibody against human interleukin 13 for the treatment of eosinophilic oesophagitis (PDF/195.1 KB) (updated)

EU/3/18/2009: Public summary of opinion on orphan designation: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo for the treatment of ovarian cancer (PDF/208.29 KB)

Kalydeco : Orphan maintenance assessment report (post-authorisation) (II-0089) (PDF/394.32 KB)

Kalydeco : Orphan maintenance assessment report (post-authorisation) (II-0085) (PDF/349.34 KB)

Kalydeco : Orphan maintenance assessment report (post-authorisation) (II-0063) (PDF/530.67 KB)

EU/3/08/556: Public summary of positive opinion for orphan designation of N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide for the treatment of cystic fibrosis (PDF/207.66 KB)

Recommendation for maintenance of orphan designation at the time of marketing authorisation: Kalydeco (ivacaftor) for the treatment of cystic fibrosis (PDF/118.72 KB)

Draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides residues in food of animal origin (PDF/1.47 MB)

EU/3/15/1463: Public summary of positive opinion for orphan designation of melphalan flufenamide for the treatment of plasma cell myeloma (PDF/180.79 KB)