PRAC recommendations on safety signals

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Each month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines.

PRAC recommendations for regulatory action (i.e. amendment of the product information) are submitted to:

  • the Committee for Medicinal Products for Human Use (CHMP), for endorsement, if the signal concerns a centrally authorised medicine. At the time of publication, the PRAC recommendations have been endorsed by the CHMP;
  • the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), for information, if the signal concerns a nationally authorised medicine. It is the responsibility of the medicines regulatory authorities in the Member States to oversee that these PRAC recommendations are adhered to.

Marketing-authorisation holders are expected to take action according to the recommendations. They should monitor the information on this page regularly to keep informed about the PRAC recommendations concerning their products.

The presence of a safety signal does not mean that a medicine has caused the reported adverse event. The adverse event could be a symptom of another illness or caused by another medicine taken by the patient.

The overview of PRAC recommendations is published after each month's CHMP and CMDh meeting. The first list was published in October 2013 and lists the recommendations from the September 2013 PRAC meeting. A cumulative list of all signals discussed at the PRAC since September 2012 is also available below.

Starting from the January 2015 PRAC meeting, the Agency now publishes recommendations for updates of product information translated into all official European Union (EU) languages.

The Agency publishes these translations in all official EU languages, as well as Norwegian and Icelandic, in the table below after review of their quality by the national regulatory authorities in EU Member States.

Marketing-authorisation holders can use these translations to update their product information.

The Agency expects this initiative to accelerate the implementation of changes to product information and to ensure consistency across EU countries, thus leading to better information for patients on their medicines.

For more information on how safety signals are assessed in the EU, see:

Table of contents


PRAC recommendations on safety signals: monthly overviews

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Document(s) Language Status First published Last updated Effective Date
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 June 2016 (English only) adopted 04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC BG = bălgarski   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC ES = español   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC CS = čeština   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC DA = dansk   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC DE = Deutsch   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC ET = eesti keel   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC EL = elliniká   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC EN = English   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC FR = français   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC IT = italiano   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC LV = latviešu valoda   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC LT = lietuvių kalba   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC HU = magyar   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC MT = Malti   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC NL = Nederlands   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC PL = polski   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC PT = português   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC RO = română   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC SK = slovenčina   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC SL = slovenščina   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC FI = suomi   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC SV = svenska   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC HR = Hrvatski   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC IS = Islenska   04/07/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC NO = Norsk   04/07/2016    
PRAC recommendations on signals adopted at the PRAC meeting of 10-13 May 2016 (English only) adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC BG = bălgarski adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC ES = español adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC CS = čeština adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC DA = dansk adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC DE = Deutsch adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC ET = eesti keel adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC EL = elliniká adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC EN = English adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC FR = français adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC IT = italiano adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC LV = latviešu valoda adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC LT = lietuvių kalba adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC HU = magyar adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC MT = Malti adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC NL = Nederlands adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC PL = polski adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC PT = português adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC RO = română adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC SK = slovenčina adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC SL = slovenščina adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC FI = suomi adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC SV = svenska adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC HR = Hrvatski adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC IS = Islenska adopted 06/06/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC NO = Norsk adopted 06/06/2016    
PRAC recommendations on signals adopted at the PRAC meeting of 11-14 April 2016 (English only) adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC BG = bălgarski adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC ES = español adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC CS = čeština adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC DA = dansk adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC DE = Deutsch adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC ET = eesti keel adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC EL = elliniká adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC EN = English adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC FR = français adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC IT = italiano adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC LV = latviešu valoda adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC LT = lietuvių kalba adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC HU = magyar adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC MT = Malti adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC NL = Nederlands adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC PL = polski adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC PT = português adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC RO = română adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC SK = slovenčina adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC SL = slovenščina adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC FI = suomi adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC SV = svenska adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC HR = Hrvatski adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC IS = Islenska adopted 10/05/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC NO = Norsk adopted 10/05/2016    
PRAC recommendations on signals adopted at the PRAC meeting of 14-17 March 2016 (English only) adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC BG = bălgarski adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC ES = español adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC CS = čeština adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC DA = dansk adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC DE = Deutsch adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC ET = eesti keel adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC EL = elliniká adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC EN = English adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC FR = français adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC IT = italiano adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC LV = latviešu valoda adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC LT = lietuvių kalba adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC HU = magyar adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC MT = Malti adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC NL = Nederlands adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC PL = polski adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC PT = português adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC RO = română adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC SK = slovenčina adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC SL = slovenščina adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC FI = suomi adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC SV = svenska adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC HR = Hrvatski adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC IS = Islenska adopted 11/04/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC NO = Norsk adopted 11/04/2016    
PRAC recommendations on signals adopted at the PRAC meeting of 8-11 February 2016 (English only) adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC BG = bălgarski adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC ES = español adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC CS = čeština adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC DA = dansk adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC DE = Deutsch adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC ET = eesti keel adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC EL = elliniká adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC EN = English adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC FR = français adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC IT = italiano adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC LV = latviešu valoda adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC LT = lietuvių kalba adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC HU = magyar adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC MT = Malti adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC NL = Nederlands adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC PL = polski adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC PT = português adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC RO = română adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC SK = slovenčina adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC SL = slovenščina adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC FI = suomi adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC SV = svenska adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC HR = Hrvatski adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC IS = Islenska adopted 07/03/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC NO = Norsk adopted 07/03/2016    
PRAC recommendations on signals adopted at the PRAC meeting of 11-14 January 2016 (English only) adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC BG = bălgarski adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC ES = español adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC CS = čeština adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC DA = dansk adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC DE = Deutsch adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC ET = eesti keel adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC EL = elliniká adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC EN = English adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC FR = français adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC IT = italiano adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC LV = latviešu valoda adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC LT = lietuvių kalba adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC HU = magyar adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC MT = Malti adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC NL = Nederlands adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC PL = polski adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC PT = português adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC RO = română adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC SK = slovenčina adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC SL = slovenščina adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC FI = suomi adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC SV = svenska adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC HR = Hrvatski adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC IS = Islenska adopted 08/02/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC NO = Norsk adopted 08/02/2016    
PRAC recommendations on signals adopted at the PRAC meeting of 30 November - 3 December 2015 (English only) adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC BG = bălgarski adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC ES = español adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC CS = čeština adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC DA = dansk adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC DE = Deutsch adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC ET = eesti keel adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC EL = elliniká adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC EN = English adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC FR = français adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC IT = italiano adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC LV = latviešu valoda adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC LT = lietuvių kalba adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC HU = magyar adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC MT = Malti adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC NL = Nederlands adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC PL = polski adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC PT = português adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC RO = română adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC SK = slovenčina adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC SL = slovenščina adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC FI = suomi adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC SV = svenska adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC HR = Hrvatski adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC IS = Islenska adopted 06/01/2016    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC NO = Norsk adopted 06/01/2016    
PRAC recommendations on signals adopted at the PRAC meeting of 3-6 November 2015 (English only) adopted 30/11/2015    
PRAC recommendations on signals adopted at the PRAC meeting of 5-8 October 2015 (English only) adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC BG = bălgarski adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC ES = español adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC CS = čeština adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC DA = dansk adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC DE = Deutsch adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC ET = eesti keel adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC EL = elliniká adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC EN = English adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC FR = français adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC IT = italiano adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC LV = latviešu valoda adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC LT = lietuvių kalba adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC HU = magyar adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC MT = Malti adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC NL = Nederlands adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC PL = polski adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC PT = português adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC RO = română adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC SK = slovenčina adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC SL = slovenščina adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC FI = suomi adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC SV = svenska adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC HR = Hrvatski adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC IS = Islenska adopted 03/11/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC NO = Norsk adopted 03/11/2015    
PRAC recommendations on signals adopted at the PRAC meeting of 7-10 September 2015 (English only) adopted 06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC BG = bălgarski   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC ES = español   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC CS = čeština   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC DA = dansk   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC DE = Deutsch   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC ET = eesti keel   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC EL = elliniká   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC EN = English   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC FR = français   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC IT = italiano   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC LV = latviešu valoda   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC LT = lietuvių kalba   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC HU = magyar   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC MT = Malti   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC NL = Nederlands   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC PL = polski   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC PT = português   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC RO = română   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC SK = slovenčina   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC SL = slovenščina   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC FI = suomi   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC SV = svenska   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC HR = Hrvatski   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC IS = Islenska   06/10/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC NO = Norsk   06/10/2015    
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 July 2015 (English only) adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC BG = bălgarski adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC ES = español adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC CS = čeština adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC DA = dansk adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC DE = Deutsch adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC ET = eesti keel adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC EL = elliniká adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC EN = English adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC FR = français adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC IT = italiano adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC LV = latviešu valoda adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC LT = lietuvių kalba adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC HU = magyar adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC MT = Malti adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC NL = Nederlands adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC PL = polski adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC PT = português adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC RO = română adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC SK = slovenčina adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC SL = slovenščina adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC FI = suomi adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC SV = svenska adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC HR = Hrvatski adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC IS = Islenska adopted 07/08/2015    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC NO = Norsk adopted 07/08/2015    
PRAC recommendations on signals adopted at the PRAC meeting of 8-11 June 2015 (English only) adopted 30/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC BG = bălgarski adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC ES = español adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC CS = čeština adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC DA = dansk adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC DE = Deutsch adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC ET = eesti keel adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC EL = elliniká adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC EN = English adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC FR = français adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC IT = italiano adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC LV = latviešu valoda adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC LT = lietuvių kalba adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC HU = magyar adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC MT = Malti adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC NL = Nederlands adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC PL = polski adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC PT = português adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC RO = română adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC SK = slovenčina adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC SL = slovenščina adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC FI = suomi adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC SV = svenska adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC HR = Hrvatski adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC IS = Islenska adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC NO = Norsk adopted 01/06/2015    
PRAC recommendations on signals adopted at the PRAC meeting of 4-7 May 2015 (English only) adopted 01/06/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC BG = bălgarski adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC ES = español adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC CS = čeština adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC DA = dansk adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC DE = Deutsch adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC ET = eesti keel adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC EL = elliniká adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC EN = English adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC FR = français adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC IT = italiano adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC LV = latviešu valoda adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC LT = lietuvių kalba adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC HU = magyar adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC MT = Malti adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC NL = Nederlands adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC PL = polski adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC PT = português adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC RO = română adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC SK = slovenčina adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC SL = slovenščina adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC FI = suomi adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC SV = svenska adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC HR = Hrvatski adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC IS = Islenska adopted 13/05/2015    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC NO = Norsk adopted 13/05/2015    
PRAC recommendations on signals adopted at the PRAC meeting of 7-10 April 2015 (English only) adopted 28/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 BG = bălgarski adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 ES = español adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 CS = čeština adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 DA = dansk adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 DE = Deutsch adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 ET = eesti keel adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 EL = elliniká adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 EN = English adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 FR = français adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 IT = italiano adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 LV = latviešu valoda adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 LT = lietuvių kalba adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 HU = magyar adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 MT = Malti adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 NL = Nederlands adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 PL = polski adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 PT = português adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 RO = română adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 SK = slovenčina adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 SL = slovenščina adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 FI = suomi adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 SV = svenska adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 HR = Hrvatski adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 IS = Islenska adopted 22/04/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 NO = Norsk adopted 22/04/2015    
PRAC recommendations on signals adopted at the PRAC meeting of 9-12 March 2015 (English only) adopted 31/03/2015 09/04/2015  
PRAC recommendations on signals adopted at the PRAC meeting of 9-12 February 2015 (English only) adopted 03/03/2015 19/03/2015  
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 BG = bălgarski adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 ES = español adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 CS = čeština adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 DA = dansk adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 DE = Deutsch adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 ET = eesti keel adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 EL = elliniká adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 EN = English adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 FR = français adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 IT = italiano adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 LV = latviešu valoda adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 LT = lietuvių kalba adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 HU = magyar adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 MT = Malti adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 NL = Nederlands adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 PL = polski adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 PT = português adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 RO = română adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 SK = slovenčina adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 SL = slovenščina adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 FI = suomi adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 SV = svenska adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 HR = Hrvatski adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 IS = Islenska adopted 23/03/2015    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 NO = Norsk adopted 23/03/2015    
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 January 2015 (English only) adopted 27/01/2015 05/02/2015  
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 BG = bălgarski adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 ES = español adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 CS = čeština adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 DA = dansk adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 DE = Deutsch adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 ET = eesti keel adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 EL = elliniká adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 EN = English adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 FR = français adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 IT = italiano adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 LV = latviešu valoda adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 LT = lietuvių kalba adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 HU = magyar adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 MT = Malti adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 NL = Nederlands adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 PL = polski adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 PT = português adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 RO = română adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 SK = slovenčina adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 SL = slovenščina adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 FI = suomi adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 SV = svenska adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 HR = Hrvatski adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 IS = Islenska adopted 18/02/2015    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 NO = Norsk adopted 18/02/2015    
PRAC recommendations on signals adopted at the PRAC meeting of 1-4 December 2014 (English only) adopted 22/12/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 3-6 November 2014 (English only) adopted 25/11/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 October 2014 (English only) adopted 28/10/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 8-11 September 2014 (English only) adopted 30/09/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 7-10 July 2014 (English only) adopted 29/07/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 10-13 June 2014 (English only) adopted 01/07/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 5-8 May 2014 (English only) adopted 27/05/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 7-10 April 2014 (English only) adopted 29/04/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 3-6 March 2014 (English only) adopted 25/03/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 3-6 February 2014 (English only) adopted 25/02/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 January 2014 (English only) adopted 28/01/2014    
PRAC recommendations on signals adopted at the PRAC meeting of 2-5 December 2013 (English only) adopted 17/12/2013    
PRAC recommendations on signals adopted at the PRAC meeting of 4-7 November 2013 (English only) adopted 28/11/2013    
PRAC recommendations on signals adopted at the PRAC meeting of 7-10 October 2013 (English only) adopted 06/11/2013 18/11/2013  
PRAC recommendations on signals adopted at the PRAC meeting of 2-5 September 2013 (English only) adopted 04/10/2013    
PRAC signal recommendations requesting an update of the product information – September 2012 to July 2013 (English only) adopted 28/11/2013 21/01/2014  

List of safety signals discussed since September 2012

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Document(s) Language Status First published Last updated Effective Date
List of signals discussed at the PRAC since September 2012 (English only)   04/10/2013 04/07/2016