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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 3-6 July 2017 PRAC meeting (PDF/161.01 KB)

Adopted
First published: 07/08/2017
Last updated: 07/08/2017
EMA/PRAC/406987/2017
List item

New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC (PDF/122.33 KB)

3. Darbepoetin alfa; epoetin alfa epoetin beta epoetin theta epoetin zeta; methoxy polyethylene …

First published: 07/08/2017
Last updated: 07/08/2017
EMA/PRAC/406976/2017
Bulgarian
(PDF/188.27 KB)

Croatian
(PDF/170.46 KB)

Czech
(PDF/172.79 KB)

Danish
(PDF/120.68 KB)

Dutch
(PDF/125.57 KB)

Estonian
(PDF/123.07 KB)

Finnish
(PDF/124.27 KB)

French
(PDF/129.42 KB)

German
(PDF/130.9 KB)

Greek
(PDF/192.01 KB)

Hungarian
(PDF/165.44 KB)

Icelandic
(PDF/128.38 KB)

Italian
(PDF/126.79 KB)

Latvian
(PDF/179.39 KB)

Lithuanian
(PDF/183.44 KB)

Maltese
(PDF/186.73 KB)

Norwegian
(PDF/131.2 KB)

Polish
(PDF/187.01 KB)

Portuguese
(PDF/124 KB)

Romanian
(PDF/178.59 KB)

Slovak
(PDF/169.92 KB)

Slovenian
(PDF/161.59 KB)

Spanish
(PDF/125.86 KB)

Swedish
(PDF/125.46 KB)
List item

Minutes of the PRAC meeting 3-6 July 2017 (PDF/860.9 KB)

Adopted
First published: 22/09/2017
Last updated: 22/09/2017
EMA/PRAC/631448/2017
List item

Minutes of the PRAC meeting 6-9 February 2017 (PDF/919.18 KB)

Adopted
First published: 05/05/2017
Last updated: 05/05/2017
EMA/PRAC/286717/2017
List item

Agenda - PRAC draft agenda of meeting 3-6 July 2017 (PDF/635.35 KB)

Draft
First published: 03/07/2017
Last updated: 03/07/2017
EMA/PRAC/423016/2017
List item

Agenda - PRAC draft agenda of meeting 6-9 February 2017 (PDF/590.01 KB)

Draft
First published: 06/02/2017
Last updated: 06/02/2017
EMA/PRAC/35833/2017
List item

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 February 2017 (PDF/101.26 KB)

Adopted
First published: 06/03/2017
Last updated: 06/03/2017
EMA/PRAC/68642/2017
List item

Agenda - PRAC draft agenda of meeting 9-12 July 2018 (PDF/729.91 KB)

Draft
First published: 09/07/2018
Last updated: 09/07/2018
EMA/PRAC/470871/2018
List item

Agenda - PRAC draft agenda of meeting 9-12 March 2015 (PDF/503.52 KB)

Draft
First published: 10/03/2015
Last updated: 10/03/2015
EMA/PRAC/644853/2014
List item

Agenda - PRAC draft agenda of meeting 9-12 February 2015 (PDF/512.61 KB)

Draft
First published: 10/02/2015
Last updated: 10/02/2015
EMA/PRAC/92670/2015
List item

Minutes of the PRAC meeting 9-12 February 2015 (PDF/768.13 KB)

Adopted
First published: 27/03/2015
Last updated: 27/03/2015
EMA/PRAC/147021/2015
List item

Agenda - PRAC draft agenda of meeting 13-16 May 2013 (PDF/339.38 KB)

Draft
First published: 14/05/2013
Last updated: 14/05/2013
EMA/PRAC/291178/2013
List item

Agenda - PRAC draft agenda of meeting 7-10 July 2014 (PDF/487.98 KB)

Draft
First published: 07/07/2014
Last updated: 07/07/2014
EMA/PRAC/412722/2014
List item

Agenda - PRAC draft agenda of meeting 8-11 April 2013 (PDF/286.52 KB)

Draft
First published: 11/04/2013
Last updated: 11/04/2013
EMA/218110/2013
List item

Minutes of the PRAC meeting 2-5 December 2013 (PDF/527.85 KB)

Adopted
First published: 17/01/2014
Last updated: 29/01/2014
EMA/PRAC/807963/2013 Corr
List item

Agenda - PRAC draft agenda of meeting 2-5 December 2013 (PDF/333.05 KB)

Draft
First published: 02/12/2013
Last updated: 02/12/2013
EMA/PRAC/748572/2013
List item

Minutes of the PRAC meeting 8-11 April 2013 (PDF/676.26 KB)

Adopted
First published: 05/06/2013
Last updated: 05/06/2013
EMA/PRAC/332071/2013
List item

Agenda - PRAC draft agenda of meeting 3-6 February 2014 (PDF/437.17 KB)

Draft
First published: 05/02/2014
Last updated: 05/02/2014
EMA/PRAC/66008/2014
List item

Minutes of the PRAC meeting 9-12 March 2015 (PDF/1016.94 KB)

Adopted
First published: 20/04/2015
Last updated: 20/04/2015
EMA/PRAC/257790/2015
List item

Agenda - PRAC draft agenda of meeting 29-31 October 2012 (PDF/208.48 KB)

Draft
First published: 29/10/2012
Last updated: 29/10/2012
EMA/PRAC/519417/2012
List item

Minutes of the PRAC meeting 13-16 May 2013 (PDF/763.91 KB)

Adopted
First published: 24/06/2013
Last updated: 24/06/2013
EMA/PRAC/336080/2013
List item

Agenda - PRAC draft agenda of meeting 8-11 June 2015 (PDF/478.68 KB)

Draft
First published: 09/06/2015
Last updated: 09/06/2015
EMA/PRAC/386470/2015
List item

Minutes of the PRAC meeting 7-10 July 2014 (PDF/841.61 KB)

Adopted
First published: 22/09/2014
Last updated: 22/09/2014
EMA/PRAC/501208/2014
List item

Agenda - PRAC draft agenda of meeting 4 -7 March 2013 (PDF/298.62 KB)

Draft
First published: 06/03/2013
Last updated: 06/03/2013
EMA/PRAC/141813/2013

63 results

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

PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC meeting (PDF/161.01 KB)

New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC (PDF/122.33 KB)

Minutes of the PRAC meeting 3-6 July 2017 (PDF/860.9 KB)

Minutes of the PRAC meeting 6-9 February 2017 (PDF/919.18 KB)

Agenda - PRAC draft agenda of meeting 3-6 July 2017 (PDF/635.35 KB)

Agenda - PRAC draft agenda of meeting 6-9 February 2017 (PDF/590.01 KB)

PRAC recommendations on signals adopted at the PRAC meeting of 6-9 February 2017 (PDF/101.26 KB)

Agenda - PRAC draft agenda of meeting 9-12 July 2018 (PDF/729.91 KB)

Agenda - PRAC draft agenda of meeting 9-12 March 2015 (PDF/503.52 KB)

Agenda - PRAC draft agenda of meeting 9-12 February 2015 (PDF/512.61 KB)

Minutes of the PRAC meeting 9-12 February 2015 (PDF/768.13 KB)

Agenda - PRAC draft agenda of meeting 13-16 May 2013 (PDF/339.38 KB)

Agenda - PRAC draft agenda of meeting 7-10 July 2014 (PDF/487.98 KB)

Agenda - PRAC draft agenda of meeting 8-11 April 2013 (PDF/286.52 KB)

Minutes of the PRAC meeting 2-5 December 2013 (PDF/527.85 KB)

Agenda - PRAC draft agenda of meeting 2-5 December 2013 (PDF/333.05 KB)

Minutes of the PRAC meeting 8-11 April 2013 (PDF/676.26 KB)

Agenda - PRAC draft agenda of meeting 3-6 February 2014 (PDF/437.17 KB)

Minutes of the PRAC meeting 9-12 March 2015 (PDF/1016.94 KB)

Agenda - PRAC draft agenda of meeting 29-31 October 2012 (PDF/208.48 KB)

Minutes of the PRAC meeting 13-16 May 2013 (PDF/763.91 KB)

Agenda - PRAC draft agenda of meeting 8-11 June 2015 (PDF/478.68 KB)

Minutes of the PRAC meeting 7-10 July 2014 (PDF/841.61 KB)

Agenda - PRAC draft agenda of meeting 4 -7 March 2013 (PDF/298.62 KB)