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PRAC statistics: January 2021 (PDF/638.88 KB) (updated)

First published: 15/01/2021
Last updated: 18/01/2021
List item

COMP meeting report on the review of applications for orphan designation: September 2020 (PDF/465.09 KB) (updated)

Adopted
First published: 21/09/2020
Last updated: 15/01/2021
EMA/COMP/479534/2020 Corr.
List item

Decision of the Executive Director on rules governing the secondment of national experts to the EMA (PDF/298.24 KB) (updated)

First published: 20/12/2019
Last updated: 13/01/2021
EMA/658982/2020
List item

EU/3/18/2060: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene for the treatment of spinal muscular atrophy (PDF/215.54 KB) (updated)

Adopted
First published: 19/12/2018
Last updated: 07/01/2021
EMA/530909/2018
List item

List of signals discussed at PRAC since September 2012 (XLSX/175.02 KB) (updated)

Adopted
First published: 08/07/2019
Last updated: 06/01/2021
EMA/PRAC/530804/2013
List item

PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC meeting (PDF/290.5 KB) (updated)

Adopted
First published: 23/11/2020
Last updated: 05/01/2021
EMA/PRAC/570588/2020 Corr.
List item

CHMP rules of procedure (PDF/237.49 KB)

Adopted
First published: 19/03/2007
Last updated: 22/12/2020
EMEA/MB/87146/2007 - Revised 17 December 2020
List item

Agenda for the 110th meeting of the Management Board: 16-17 December 2020 (PDF/123.31 KB)

Adopted
First published: 15/12/2020
Last updated: 21/12/2020
EMA/MB/547010/2020
List item

EU/3/13/1195: Public summary of opinion on orphan designation:Antisense oligonucleotide targeting the F508delta mutation of CFTR for the treatment of cystic fibrosis (PDF/232.74 KB)

Adopted
First published: 31/10/2013
Last updated: 18/12/2020
EMA/COMP/562059/2013
List item

COMP members interaction with sponsors of orphan designation applications (PDF/169.39 KB)

First published: 12/07/2006
Last updated: 16/12/2020
EMEA/COMP/150409/2006 Rev. 1
List item

EU/3/14/1361: Public summary of opinion on orphan designation: 1-(6-Benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid for the treatment of systemic sclerosis (PDF/237.6 KB)

Adopted
First published: 15/01/2015
Last updated: 14/12/2020
EMA/COMP/646194/2014
List item

Isturisa : Orphan maintenance assessment report (PDF/335.11 KB)

Adopted
First published: 18/02/2020
Last updated: 11/12/2020
EMADOC-2005359794-212453 Rev. 2
List item

Trecondi : Orphan maintenance assessment report (initial authorisation) (PDF/997.21 KB)

Adopted
First published: 22/07/2019
Last updated: 11/12/2020
EMA/235233/2019
List item

EU/3/15/1569: Public summary of opinion on orphan designation: Pentetrazol for the treatment of idiopathic hypersomnia (PDF/221.03 KB)

Adopted
First published: 06/01/2016
Last updated: 10/12/2020
EMA/COMP/699946/2015
List item

EU/3/11/923: Public summary of opinion on orphan designation: L-cysteine, L-leucyl-L-alpha-glutamyl-L-alpha-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-alpha-aspartyl-L-histidyl-S-... (PDF/234.57 KB)

Adopted
First published: 23/11/2011
Last updated: 04/12/2020
EMA/COMP/793868/2011 Rev.1
List item

EU/3/14/1219: Public summary of opinion on orphan designation: Fenfluramine hydrochloride for the treatment of Dravet syndrome (PDF/180.19 KB)

Adopted
First published: 23/01/2014
Last updated: 06/11/2020
EMA/COMP/700717/2013 Corr.
List item

Ifosfamide solutions Article-31 referral - Timetable for the procedure (PDF/138.83 KB)

First published: 13/03/2020
Last updated: 03/11/2020
EMA/PRAC/111338/2020 Rev.2
List item

EU/3/13/1105: Public summary of positive opinion of humanised monoclonal antibody against myostatin for the treatment of Duchenne muscular dystrophy (PDF/215.69 KB)

Adopted
First published: 04/03/2013
Last updated: 23/10/2020
EMA/COMP/34464/2013
List item

EU/3/04/213: Public summary of positive opinion for orphan designation of mepolizumab for the treatment of hypereosinophilic syndrome (PDF/195.84 KB)

Adopted
First published: 23/09/2009
Last updated: 23/10/2020
EMEA/COMP/292/04 Rev. 2
List item

EU/3/13/1116: Public summary of opinion on orphan designation:Mepolizumab for the treatment of Churg-Strauss syndrome (PDF/201.28 KB)

Adopted
First published: 05/04/2013
Last updated: 23/10/2020
EMA/COMP/95498/2013
List item

EU/3/07/441: Public summary of positive opinion for orphan designation of hydrocortisone (modified release tablet) for the treatment of adrenal insufficiency (PDF/196.39 KB)

Adopted
First published: 21/09/2009
Last updated: 20/10/2020
EMEA/COMP/57720/2007 Rev.4
List item

PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC meeting (PDF/424.87 KB)

Adopted
First published: 23/06/2020
Last updated: 16/10/2020
EMA/PRAC/257435/2020 Corr.4
List item

Decision of EMA on rules relating to Articles 11, 11a and 13 of the Staff Regulations concerning the handling of declared interests of staff members of the European Medicines Agency and candidates before recruitment (PDF/332.75 KB)

Adopted
First published: 26/10/2016
Last updated: 05/10/2020
Legal effective date: 01/01/2019
EMA/259494/2016 Rev.4
List item

Agenda of the 109th meeting of the Management Board: 1 October 2020 (PDF/118.08 KB)

Adopted
First published: 30/09/2020
Last updated: 05/10/2020
EMA/MB/388242/2020
List item

EU/3/16/1643: Public summary of opinion on orphan designation: Autologous stromal vascular cell fraction from adipose tissue for the treatment of systemic sclerosis (PDF/204.81 KB)

Adopted
First published: 31/05/2016
Last updated: 13/08/2020
EMA/COMP/236625/2016

4974 results

PRAC statistics: January 2021 (PDF/638.88 KB) (updated)

COMP meeting report on the review of applications for orphan designation: September 2020 (PDF/465.09 KB) (updated)

Decision of the Executive Director on rules governing the secondment of national experts to the EMA (PDF/298.24 KB) (updated)

EU/3/18/2060: Public summary of opinion on orphan designation: Adeno-associated viral vector serotype hu68 containing the human SMN1 gene for the treatment of spinal muscular atrophy (PDF/215.54 KB) (updated)

List of signals discussed at PRAC since September 2012 (XLSX/175.02 KB) (updated)

PRAC recommendations on signals adopted at the 26-29 October 2020 PRAC meeting (PDF/290.5 KB) (updated)

CHMP rules of procedure (PDF/237.49 KB)

Agenda for the 110th meeting of the Management Board: 16-17 December 2020 (PDF/123.31 KB)

EU/3/13/1195: Public summary of opinion on orphan designation:Antisense oligonucleotide targeting the F508delta mutation of CFTR for the treatment of cystic fibrosis (PDF/232.74 KB)

COMP members interaction with sponsors of orphan designation applications (PDF/169.39 KB)

EU/3/14/1361: Public summary of opinion on orphan designation: 1-(6-Benzothiazolylsulfonyl)-5-chloro-1H-indole-2-butanoic acid for the treatment of systemic sclerosis (PDF/237.6 KB)

Isturisa : Orphan maintenance assessment report (PDF/335.11 KB)

Trecondi : Orphan maintenance assessment report (initial authorisation) (PDF/997.21 KB)

EU/3/15/1569: Public summary of opinion on orphan designation: Pentetrazol for the treatment of idiopathic hypersomnia (PDF/221.03 KB)

EU/3/11/923: Public summary of opinion on orphan designation: L-cysteine, L-leucyl-L-alpha-glutamyl-L-alpha-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-alpha-aspartyl-L-histidyl-S-... (PDF/234.57 KB)

EU/3/14/1219: Public summary of opinion on orphan designation: Fenfluramine hydrochloride for the treatment of Dravet syndrome (PDF/180.19 KB)

Ifosfamide solutions Article-31 referral - Timetable for the procedure (PDF/138.83 KB)

EU/3/13/1105: Public summary of positive opinion of humanised monoclonal antibody against myostatin for the treatment of Duchenne muscular dystrophy (PDF/215.69 KB)

EU/3/04/213: Public summary of positive opinion for orphan designation of mepolizumab for the treatment of hypereosinophilic syndrome (PDF/195.84 KB)

EU/3/13/1116: Public summary of opinion on orphan designation:Mepolizumab for the treatment of Churg-Strauss syndrome (PDF/201.28 KB)

EU/3/07/441: Public summary of positive opinion for orphan designation of hydrocortisone (modified release tablet) for the treatment of adrenal insufficiency (PDF/196.39 KB)

PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC meeting (PDF/424.87 KB)

Decision of EMA on rules relating to Articles 11, 11a and 13 of the Staff Regulations concerning the handling of declared interests of staff members of the European Medicines Agency and candidates before recruitment (PDF/332.75 KB)

Agenda of the 109th meeting of the Management Board: 1 October 2020 (PDF/118.08 KB)

EU/3/16/1643: Public summary of opinion on orphan designation: Autologous stromal vascular cell fraction from adipose tissue for the treatment of systemic sclerosis (PDF/204.81 KB)