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 24-27 October 2016 (English only) adopted 2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC BG = bălgarski   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC ES = español   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC CS = čeština   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC DA = dansk   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC DE = Deutsch   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC ET = eesti keel   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC EL = elliniká   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC EN = English   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC FR = français   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC IT = italiano   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC LV = latviešu valoda   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC LT = lietuvių kalba   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC HU = magyar   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC MT = Malti   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC NL = Nederlands   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC PL = polski   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC PT = português   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC RO = română   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC SK = slovenčina   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC SL = slovenščina   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC FI = suomi   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC SV = svenska   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC HR = Hrvatski   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC IS = Islenska   2016-11-21    
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2016 PRAC NO = Norsk   2016-11-21    
PRAC recommendations on signals adopted at the PRAC meeting of 26-29 September 2016 (English only) adopted 2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC BG = bălgarski   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC ES = español   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC CS = čeština   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC DA = dansk   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC DE = Deutsch   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC ET = eesti keel   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC EL = elliniká   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC EN = English   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC FR = français   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC IT = italiano   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC LV = latviešu valoda   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC LT = lietuvių kalba   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC HU = magyar   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC MT = Malti   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC NL = Nederlands   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC PL = polski   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC PT = português   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC RO = română   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC SK = slovenčina   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC SL = slovenščina   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC FI = suomi   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC SV = svenska   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC HR = Hrvatski   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC IS = Islenska   2016-10-25    
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2016 PRAC NO = Norsk   2016-10-25    
PRAC recommendations on signals adopted at the PRAC meeting of 30 August-2 September 2016 (English only) adopted 2016-09-26 2016-10-28  
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC BG = bălgarski   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC ES = español   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC CS = čeština   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC DA = dansk   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC DE = Deutsch   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC ET = eesti keel   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC EL = elliniká   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC EN = English   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC FR = français   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC IT = italiano   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC LV = latviešu valoda   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC LT = lietuvių kalba   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC HU = magyar   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC MT = Malti   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC NL = Nederlands   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC PL = polski   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC PT = português   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC RO = română   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC SK = slovenčina   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC SL = slovenščina   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC FI = suomi   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC SV = svenska   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC HR = Hrvatski   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC IS = Islenska   2016-09-26    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August-2 September 2016 PRAC NO = Norsk   2016-09-26    
PRAC recommendations on signals adopted at the PRAC meeting of 4-8 July 2016 (English only) adopted 2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC BG = bălgarski   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC ES = español   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC CS = čeština   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC DA = dansk   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC DE = Deutsch   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC ET = eesti keel   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC EL = elliniká   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC EN = English   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC FR = français   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC IT = italiano   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC LV = latviešu valoda   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC LT = lietuvių kalba   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC HU = magyar   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC MT = Malti   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC NL = Nederlands   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC PL = polski   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC PT = português   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC RO = română   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC SK = slovenčina   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC SL = slovenščina   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC FI = suomi   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC SV = svenska   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC HR = Hrvatski   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC IS = Islenska   2016-08-02    
New product information wording: extracts from PRAC recommendations on signals adopted at the 4-8 July 2016 PRAC NO = Norsk   2016-08-02    
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 June 2016 (English only) adopted 2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC BG = bălgarski   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC ES = español   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC CS = čeština   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC DA = dansk   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC DE = Deutsch   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC ET = eesti keel   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC EL = elliniká   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC EN = English   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC FR = français   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC IT = italiano   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC LV = latviešu valoda   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC LT = lietuvių kalba   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC HU = magyar   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC MT = Malti   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC NL = Nederlands   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC PL = polski   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC PT = português   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC RO = română   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC SK = slovenčina   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC SL = slovenščina   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC FI = suomi   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC SV = svenska   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC HR = Hrvatski   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC IS = Islenska   2016-07-04    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 June 2016 PRAC NO = Norsk   2016-07-04    
PRAC recommendations on signals adopted at the PRAC meeting of 10-13 May 2016 (English only) adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC BG = bălgarski adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC ES = español adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC CS = čeština adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC DA = dansk adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC DE = Deutsch adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC ET = eesti keel adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC EL = elliniká adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC EN = English adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC FR = français adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC IT = italiano adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC LV = latviešu valoda adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC LT = lietuvių kalba adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC HU = magyar adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC MT = Malti adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC NL = Nederlands adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC PL = polski adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC PT = português adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC RO = română adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC SK = slovenčina adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC SL = slovenščina adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC FI = suomi adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC SV = svenska adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC HR = Hrvatski adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC IS = Islenska adopted 2016-06-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 May 2016 PRAC NO = Norsk adopted 2016-06-06    
PRAC recommendations on signals adopted at the PRAC meeting of 11-14 April 2016 (English only) adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC BG = bălgarski adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC ES = español adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC CS = čeština adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC DA = dansk adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC DE = Deutsch adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC ET = eesti keel adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC EL = elliniká adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC EN = English adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC FR = français adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC IT = italiano adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC LV = latviešu valoda adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC LT = lietuvių kalba adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC HU = magyar adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC MT = Malti adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC NL = Nederlands adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC PL = polski adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC PT = português adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC RO = română adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC SK = slovenčina adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC SL = slovenščina adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC FI = suomi adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC SV = svenska adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC HR = Hrvatski adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC IS = Islenska adopted 2016-05-10    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 April 2016 PRAC NO = Norsk adopted 2016-05-10    
PRAC recommendations on signals adopted at the PRAC meeting of 14-17 March 2016 (English only) adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC BG = bălgarski adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC ES = español adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC CS = čeština adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC DA = dansk adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC DE = Deutsch adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC ET = eesti keel adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC EL = elliniká adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC EN = English adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC FR = français adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC IT = italiano adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC LV = latviešu valoda adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC LT = lietuvių kalba adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC HU = magyar adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC MT = Malti adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC NL = Nederlands adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC PL = polski adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC PT = português adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC RO = română adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC SK = slovenčina adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC SL = slovenščina adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC FI = suomi adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC SV = svenska adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC HR = Hrvatski adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC IS = Islenska adopted 2016-04-11    
New product information wording: extracts from PRAC recommendations on signals adopted at the 14-17 March 2016 PRAC NO = Norsk adopted 2016-04-11    
PRAC recommendations on signals adopted at the PRAC meeting of 8-11 February 2016 (English only) adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC BG = bălgarski adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC ES = español adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC CS = čeština adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC DA = dansk adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC DE = Deutsch adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC ET = eesti keel adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC EL = elliniká adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC EN = English adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC FR = français adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC IT = italiano adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC LV = latviešu valoda adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC LT = lietuvių kalba adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC HU = magyar adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC MT = Malti adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC NL = Nederlands adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC PL = polski adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC PT = português adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC RO = română adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC SK = slovenčina adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC SL = slovenščina adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC FI = suomi adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC SV = svenska adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC HR = Hrvatski adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC IS = Islenska adopted 2016-03-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 8-11 February 2016 PRAC NO = Norsk adopted 2016-03-07    
PRAC recommendations on signals adopted at the PRAC meeting of 11-14 January 2016 (English only) adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC BG = bălgarski adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC ES = español adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC CS = čeština adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC DA = dansk adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC DE = Deutsch adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC ET = eesti keel adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC EL = elliniká adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC EN = English adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC FR = français adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC IT = italiano adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC LV = latviešu valoda adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC LT = lietuvių kalba adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC HU = magyar adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC MT = Malti adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC NL = Nederlands adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC PL = polski adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC PT = português adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC RO = română adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC SK = slovenčina adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC SL = slovenščina adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC FI = suomi adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC SV = svenska adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC HR = Hrvatski adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC IS = Islenska adopted 2016-02-08    
New product information wording: extracts from PRAC recommendations on signals adopted at the 11-14 January 2016 PRAC NO = Norsk adopted 2016-02-08    
PRAC recommendations on signals adopted at the PRAC meeting of 30 November - 3 December 2015 (English only) adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC BG = bălgarski adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC ES = español adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC CS = čeština adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC DA = dansk adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC DE = Deutsch adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC ET = eesti keel adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC EL = elliniká adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC EN = English adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC FR = français adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC IT = italiano adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC LV = latviešu valoda adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC LT = lietuvių kalba adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC HU = magyar adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC MT = Malti adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC NL = Nederlands adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC PL = polski adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC PT = português adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC RO = română adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC SK = slovenčina adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC SL = slovenščina adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC FI = suomi adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC SV = svenska adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC HR = Hrvatski adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC IS = Islenska adopted 2016-01-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 November-3 December PRAC NO = Norsk adopted 2016-01-06    
PRAC recommendations on signals adopted at the PRAC meeting of 3-6 November 2015 (English only) adopted 2015-11-30    
PRAC recommendations on signals adopted at the PRAC meeting of 5-8 October 2015 (English only) adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC BG = bălgarski adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC ES = español adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC CS = čeština adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC DA = dansk adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC DE = Deutsch adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC ET = eesti keel adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC EL = elliniká adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC EN = English adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC FR = français adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC IT = italiano adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC LV = latviešu valoda adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC LT = lietuvių kalba adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC HU = magyar adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC MT = Malti adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC NL = Nederlands adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC PL = polski adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC PT = português adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC RO = română adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC SK = slovenčina adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC SL = slovenščina adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC FI = suomi adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC SV = svenska adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC HR = Hrvatski adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC IS = Islenska adopted 2015-11-03    
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 October 2015 PRAC NO = Norsk adopted 2015-11-03    
PRAC recommendations on signals adopted at the PRAC meeting of 7-10 September 2015 (English only) adopted 2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC BG = bălgarski   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC ES = español   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC CS = čeština   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC DA = dansk   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC DE = Deutsch   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC ET = eesti keel   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC EL = elliniká   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC EN = English   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC FR = français   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC IT = italiano   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC LV = latviešu valoda   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC LT = lietuvių kalba   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC HU = magyar   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC MT = Malti   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC NL = Nederlands   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC PL = polski   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC PT = português   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC RO = română   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC SK = slovenčina   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC SL = slovenščina   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC FI = suomi   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC SV = svenska   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC HR = Hrvatski   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC IS = Islenska   2015-10-06    
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 September 2015 PRAC NO = Norsk   2015-10-06    
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 July 2015 (English only) adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC BG = bălgarski adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC ES = español adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC CS = čeština adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC DA = dansk adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC DE = Deutsch adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC ET = eesti keel adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC EL = elliniká adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC EN = English adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC FR = français adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC IT = italiano adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC LV = latviešu valoda adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC LT = lietuvių kalba adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC HU = magyar adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC MT = Malti adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC NL = Nederlands adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC PL = polski adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC PT = português adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC RO = română adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC SK = slovenčina adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC SL = slovenščina adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC FI = suomi adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC SV = svenska adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC HR = Hrvatski adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC IS = Islenska adopted 2015-08-07    
New product information wording: extracts from PRAC recommendations on signals adopted at the 6-9 July 2015 PRAC NO = Norsk adopted 2015-08-07    
PRAC recommendations on signals adopted at the PRAC meeting of 8-11 June 2015 (English only) adopted 2015-06-30    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC BG = bălgarski adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC ES = español adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC CS = čeština adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC DA = dansk adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC DE = Deutsch adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC ET = eesti keel adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC EL = elliniká adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC EN = English adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC FR = français adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC IT = italiano adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC LV = latviešu valoda adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC LT = lietuvių kalba adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC HU = magyar adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC MT = Malti adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC NL = Nederlands adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC PL = polski adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC PT = português adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC RO = română adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC SK = slovenčina adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC SL = slovenščina adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC FI = suomi adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC SV = svenska adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC HR = Hrvatski adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC IS = Islenska adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 4-7 May 2015 PRAC NO = Norsk adopted 2015-06-01    
PRAC recommendations on signals adopted at the PRAC meeting of 4-7 May 2015 (English only) adopted 2015-06-01    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC BG = bălgarski adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC ES = español adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC CS = čeština adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC DA = dansk adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC DE = Deutsch adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC ET = eesti keel adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC EL = elliniká adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC EN = English adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC FR = français adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC IT = italiano adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC LV = latviešu valoda adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC LT = lietuvių kalba adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC HU = magyar adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC MT = Malti adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC NL = Nederlands adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC PL = polski adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC PT = português adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC RO = română adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC SK = slovenčina adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC SL = slovenščina adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC FI = suomi adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC SV = svenska adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC HR = Hrvatski adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC IS = Islenska adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted at the 7-10 April 2015 PRAC NO = Norsk adopted 2015-05-13    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 BG = bălgarski adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 ES = español adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 CS = čeština adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 DA = dansk adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 DE = Deutsch adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 ET = eesti keel adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 EL = elliniká adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 EN = English adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 FR = français adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 IT = italiano adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 LV = latviešu valoda adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 LT = lietuvių kalba adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 HU = magyar adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 MT = Malti adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 NL = Nederlands adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 PL = polski adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 PT = português adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 RO = română adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 SK = slovenčina adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 SL = slovenščina adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 FI = suomi adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 SV = svenska adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 HR = Hrvatski adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 IS = Islenska adopted 2015-04-22    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 March 2015 NO = Norsk adopted 2015-04-22    
PRAC recommendations on signals adopted at the PRAC meeting of 9-12 March 2015 (English only) adopted 2015-03-31 2015-04-09  
PRAC recommendations on signals adopted at the PRAC meeting of 9-12 February 2015 (English only) adopted 2015-03-03 2015-03-19  
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 BG = bălgarski adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 ES = español adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 CS = čeština adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 DA = dansk adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 DE = Deutsch adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 ET = eesti keel adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 EL = elliniká adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 EN = English adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 FR = français adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 IT = italiano adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 LV = latviešu valoda adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 LT = lietuvių kalba adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 HU = magyar adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 MT = Malti adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 NL = Nederlands adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 PL = polski adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 PT = português adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 RO = română adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 SK = slovenčina adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 SL = slovenščina adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 FI = suomi adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 SV = svenska adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 HR = Hrvatski adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 IS = Islenska adopted 2015-03-23    
PRAC recommendations on signals for update of the product information adopted by PRAC at the 9-12 February 2015 NO = Norsk adopted 2015-03-23    
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 January 2015 (English only) adopted 2015-01-27 2015-02-05  
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 BG = bălgarski adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 ES = español adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 CS = čeština adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 DA = dansk adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 DE = Deutsch adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 ET = eesti keel adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 EL = elliniká adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 EN = English adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 FR = français adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 IT = italiano adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 LV = latviešu valoda adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 LT = lietuvių kalba adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 HU = magyar adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 MT = Malti adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 NL = Nederlands adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 PL = polski adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 PT = português adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 RO = română adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 SK = slovenčina adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 SL = slovenščina adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 FI = suomi adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 SV = svenska adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 HR = Hrvatski adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 IS = Islenska adopted 2015-02-18    
PRAC recommendations on signals for update of the product information adopted at the PRAC meeting of 6-9 January 2015 NO = Norsk adopted 2015-02-18    
PRAC recommendations on signals adopted at the PRAC meeting of 1-4 December 2014 (English only) adopted 2014-12-22    
PRAC recommendations on signals adopted at the PRAC meeting of 3-6 November 2014 (English only) adopted 2014-11-25    
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 October 2014 (English only) adopted 2014-10-28    
PRAC recommendations on signals adopted at the PRAC meeting of 8-11 September 2014 (English only) adopted 2014-09-30    
PRAC recommendations on signals adopted at the PRAC meeting of 7-10 July 2014 (English only) adopted 2014-07-29    
PRAC recommendations on signals adopted at the PRAC meeting of 10-13 June 2014 (English only) adopted 2014-07-01    
PRAC recommendations on signals adopted at the PRAC meeting of 5-8 May 2014 (English only) adopted 2014-05-27    
PRAC recommendations on signals adopted at the PRAC meeting of 7-10 April 2014 (English only) adopted 2014-04-29    
PRAC recommendations on signals adopted at the PRAC meeting of 3-6 March 2014 (English only) adopted 2014-03-25    
PRAC recommendations on signals adopted at the PRAC meeting of 3-6 February 2014 (English only) adopted 2014-02-25    
PRAC recommendations on signals adopted at the PRAC meeting of 6-9 January 2014 (English only) adopted 2014-01-28    
PRAC recommendations on signals adopted at the PRAC meeting of 2-5 December 2013 (English only) adopted 2013-12-17    
PRAC recommendations on signals adopted at the PRAC meeting of 4-7 November 2013 (English only) adopted 2013-11-28    
PRAC recommendations on signals adopted at the PRAC meeting of 7-10 October 2013 (English only) adopted 2013-11-06 2013-11-18  
PRAC recommendations on signals adopted at the PRAC meeting of 2-5 September 2013 (English only) adopted 2013-10-04    
PRAC signal recommendations requesting an update of the product information – September 2012 to July 2013 (English only) adopted 2013-11-28 2014-01-21  

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)   2013-10-04 2016-11-21