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EU/3/18/2052: Public summary of opinion on orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl... (PDF/225.47 KB)

Adopted
First published: 20/12/2018
Last updated: 21/10/2022
EMA/530846/2018
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Signal assessment report - template (DOCX/125 KB)

First published: 29/10/2014
Last updated: 21/10/2022
List item

Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101 (PDF/156.56 KB)

Last updated: 18/10/2022
Active substance: betamethasone
Procedure number: PSUSA/00000391/202101
Regulatory outcome: Variation
Bulgarian
(PDF/126.38 KB)

Croatian
(PDF/218.18 KB)

Czech
(PDF/411.72 KB)

Danish
(PDF/156.89 KB)

Dutch
(PDF/135.15 KB)

Estonian
(PDF/150.55 KB)

Finnish
(PDF/113.87 KB)

French
(PDF/192.49 KB)

German
(PDF/107.8 KB)

Greek
(PDF/126.78 KB)

Hungarian
(PDF/215.99 KB)

Icelandic
(PDF/125.77 KB)

Italian
(PDF/123.46 KB)

Latvian
(PDF/165.6 KB)

Lithuanian
(PDF/429.9 KB)

Maltese
(PDF/90.56 KB)

Norwegian
(PDF/182.53 KB)

Polish
(PDF/206.42 KB)

Portuguese
(PDF/156.53 KB)

Romanian
(PDF/130.4 KB)

Slovak
(PDF/125.51 KB)

Slovenian
(PDF/198.26 KB)

Spanish
(PDF/157.21 KB)

Swedish
(PDF/175.82 KB)
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EU/3/15/1599: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype rh10 containing the human factor IX gene for the treatment of haemophilia B (PDF/204.79 KB)

Adopted
First published: 03/02/2016
Last updated: 11/10/2022
EMA/COMP/776835/2015
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Template - Translations required with the submission of an application for orphan medicinal product designation (DOC/71 KB)

First published: 10/12/2009
Last updated: 06/10/2022
List item

Pholcodine-containing medicinal products Article-107i referral - Annex I (PDF/129.33 KB)

Draft
First published: 02/09/2022
Last updated: 04/10/2022
EMA/722200/2022 Rev. 1
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Terlipressin-containing medicinal products Article-31 referral - New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome (PDF/158.27 KB)

First published: 14/01/2022
Last updated: 30/09/2022
EMA/781753/2022
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Topiramate Article-31 referral - Annex I (PDF/562.38 KB)

Draft
First published: 02/09/2022
Last updated: 29/09/2022
EMA/722981/2022 rev.1
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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)

Adopted
First published: 04/07/2012
Last updated: 26/09/2022
EMA/COMP/268035/2012
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EU/3/17/1926: Public summary of opinion on orphan designation : Ofranergene obadenovec for the treatment of ovarian cancer (PDF/194.9 KB)

First published: 08/01/2018
Last updated: 26/09/2022
EMA/632137/2017
List item

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

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)

Adopted
First published: 26/02/2015
Last updated: 16/09/2022
EMA/COMP/724271/2014
List item

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)

First published: 15/02/2021
Last updated: 16/09/2022
EMADOC-628903358-3459
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EU/3/10/752: Public summary of positive opinion for Velaglucerase alfa for the treatment of Gaucher disease (PDF/181.91 KB)

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)

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)

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)

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

Amfepramone-containing medicinal products Article-31 referral - Timetable for the procedure (PDF/116.87 KB)

First published: 12/02/2021
Last updated: 02/09/2022
EMA/PRAC/51714/2021 Rev.5
List item

Consideration on core requirements for RMPs of COVID-19 vaccines (PDF/339.77 KB)

First published: 13/11/2020
Last updated: 01/09/2022
EMA/PRAC/73244/2022
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EU/3/11/898: Public summary of opinion on orphan designation: Sirolimus for the treatment of chronic non-infectious uveitis (PDF/213.47 KB)

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

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

5459 results

EU/3/18/2052: Public summary of opinion on orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl... (PDF/225.47 KB)

Signal assessment report - template (DOCX/125 KB)

Betamethasone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000391/202101 (PDF/156.56 KB)

EU/3/15/1599: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype rh10 containing the human factor IX gene for the treatment of haemophilia B (PDF/204.79 KB)

Template - Translations required with the submission of an application for orphan medicinal product designation (DOC/71 KB)

Pholcodine-containing medicinal products Article-107i referral - Annex I (PDF/129.33 KB)

Terlipressin-containing medicinal products Article-31 referral - New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome (PDF/158.27 KB)

Topiramate Article-31 referral - Annex I (PDF/562.38 KB)

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)

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

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

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)

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)

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

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)

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)

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)

Amfepramone-containing medicinal products Article-31 referral - Timetable for the procedure (PDF/116.87 KB)

Consideration on core requirements for RMPs of COVID-19 vaccines (PDF/339.77 KB)

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

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)

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)