PRAC recommendations for regulatory action (i.e. amendment of the product information) are submitted 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:
Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1)
Revision 1 is a major revision with modifications throughout and contains the following:
- Revised definition and process for emerging safety issues, previously addressed in GVP Module VI (IX.A.1.1. and IX.C.2.);
- Streamlined information on scientific aspects of signal management (IX.B.2. to IX.B.4.), statistical aspects now addressed in Addendum I;
English (EN) (283.21 KB - PDF)
Questions and answers on signal management
English (EN) (336.17 KB - PDF)
PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC meeting
English (EN) (289.79 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC
English (EN) (201.34 KB - PDF)
български (BG) (224.54 KB - PDF)
español (ES) (200.64 KB - PDF)
čeština (CS) (235.9 KB - PDF)
dansk (DA) (202.23 KB - PDF)
Deutsch (DE) (209.92 KB - PDF)
eesti keel (ET) (200.81 KB - PDF)
ελληνικά (EL) (226.71 KB - PDF)
français (FR) (203.33 KB - PDF)
hrvatski (HR) (222.16 KB - PDF)
íslenska (IS) (207.1 KB - PDF)
italiano (IT) (200.25 KB - PDF)
latviešu valoda (LV) (233.55 KB - PDF)
lietuvių kalba (LT) (234.21 KB - PDF)
magyar (HU) (237.95 KB - PDF)
Malti (MT) (258.46 KB - PDF)
Nederlands (NL) (203 KB - PDF)
norsk (NO) (205.88 KB - PDF)
polski (PL) (262.14 KB - PDF)
português (PT) (203.43 KB - PDF)
română (RO) (234.86 KB - PDF)
slovenčina (SK) (230.42 KB - PDF)
slovenščina (SL) (229.74 KB - PDF)
Suomi (FI) (216.56 KB - PDF)
svenska (SV) (220.71 KB - PDF)
PRAC recommendations on signals adopted at the 30 September - 3 October 2024 PRAC meeting
English (EN) (137.65 KB - PDF)
PRAC recommendations on signals adopted at the 2-5 September 2024 PRAC meeting
English (EN) (251.06 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals adopted at the 2-5 September 2024 PRAC
English (EN) (204.99 KB - PDF)
български (BG) (221.7 KB - PDF)
español (ES) (190.1 KB - PDF)
čeština (CS) (210.69 KB - PDF)
dansk (DA) (208.03 KB - PDF)
Deutsch (DE) (216.04 KB - PDF)
eesti keel (ET) (224.24 KB - PDF)
ελληνικά (EL) (222.06 KB - PDF)
français (FR) (194.35 KB - PDF)
hrvatski (HR) (199.69 KB - PDF)
íslenska (IS) (179.74 KB - PDF)
italiano (IT) (228.95 KB - PDF)
latviešu valoda (LV) (231.83 KB - PDF)
lietuvių kalba (LT) (211.29 KB - PDF)
magyar (HU) (231.38 KB - PDF)
Malti (MT) (229.24 KB - PDF)
Nederlands (NL) (233.51 KB - PDF)
norsk (NO) (201.91 KB - PDF)
polski (PL) (244.83 KB - PDF)
português (PT) (207.1 KB - PDF)
română (RO) (226.73 KB - PDF)
slovenčina (SK) (223.06 KB - PDF)
slovenščina (SL) (223.62 KB - PDF)
Suomi (FI) (203.06 KB - PDF)
svenska (SV) (204.97 KB - PDF)
PRAC recommendations on signals adopted at the 8-11 July 2024 PRAC meeting
English (EN) (351.03 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals adopted at the 8-11 July 2024 PRAC
English (EN) (203.23 KB - PDF)
български (BG) (268.34 KB - PDF)
español (ES) (223.09 KB - PDF)
čeština (CS) (242.98 KB - PDF)
dansk (DA) (224.47 KB - PDF)
Deutsch (DE) (213.27 KB - PDF)
eesti keel (ET) (205.09 KB - PDF)
ελληνικά (EL) (279.18 KB - PDF)
français (FR) (228.35 KB - PDF)
hrvatski (HR) (243.64 KB - PDF)
íslenska (IS) (211.1 KB - PDF)
italiano (IT) (247.74 KB - PDF)
latviešu valoda (LV) (259.77 KB - PDF)
lietuvių kalba (LT) (227.36 KB - PDF)
magyar (HU) (221.68 KB - PDF)
Malti (MT) (243.26 KB - PDF)
Nederlands (NL) (210.25 KB - PDF)
norsk (NO) (204.08 KB - PDF)
polski (PL) (281.63 KB - PDF)
português (PT) (241.25 KB - PDF)
română (RO) (240.4 KB - PDF)
slovenčina (SK) (240.1 KB - PDF)
slovenščina (SL) (232.74 KB - PDF)
Suomi (FI) (237.52 KB - PDF)
svenska (SV) (221.47 KB - PDF)
PRAC recommendations on signals adopted at the 10-13 June 2024 PRAC meeting
English (EN) (260.31 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals adopted at the 10-13 June 2024 PRAC
English (EN) (252.94 KB - PDF)
български (BG) (296.26 KB - PDF)
español (ES) (260.27 KB - PDF)
čeština (CS) (294.95 KB - PDF)
dansk (DA) (270.01 KB - PDF)
Deutsch (DE) (262.26 KB - PDF)
eesti keel (ET) (256.4 KB - PDF)
ελληνικά (EL) (291.44 KB - PDF)
français (FR) (261.36 KB - PDF)
hrvatski (HR) (291.09 KB - PDF)
íslenska (IS) (240.99 KB - PDF)
italiano (IT) (272.63 KB - PDF)
latviešu valoda (LV) (298.2 KB - PDF)
lietuvių kalba (LT) (295.35 KB - PDF)
magyar (HU) (288.81 KB - PDF)
Malti (MT) (289.2 KB - PDF)
Nederlands (NL) (257.63 KB - PDF)
norsk (NO) (242.05 KB - PDF)
polski (PL) (310.99 KB - PDF)
português (PT) (265.3 KB - PDF)
română (RO) (285.53 KB - PDF)
slovenčina (SK) (298.97 KB - PDF)
slovenščina (SL) (294.66 KB - PDF)
Suomi (FI) (253.72 KB - PDF)
svenska (SV) (254.29 KB - PDF)
PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC meeting
English (EN) (262.57 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC
English (EN) (219.9 KB - PDF)
български (BG) (237.51 KB - PDF)
español (ES) (201.79 KB - PDF)
čeština (CS) (234.67 KB - PDF)
dansk (DA) (218.77 KB - PDF)
Deutsch (DE) (203.83 KB - PDF)
eesti keel (ET) (199.5 KB - PDF)
ελληνικά (EL) (240.61 KB - PDF)
français (FR) (201.96 KB - PDF)
hrvatski (HR) (232.4 KB - PDF)
íslenska (IS) (234.76 KB - PDF)
italiano (IT) (199.29 KB - PDF)
latviešu valoda (LV) (245.47 KB - PDF)
lietuvių kalba (LT) (238.43 KB - PDF)
magyar (HU) (233.41 KB - PDF)
Malti (MT) (239.27 KB - PDF)
Nederlands (NL) (200.42 KB - PDF)
norsk (NO) (217.52 KB - PDF)
polski (PL) (234.91 KB - PDF)
português (PT) (201.41 KB - PDF)
română (RO) (233.39 KB - PDF)
slovenčina (SK) (255.25 KB - PDF)
slovenščina (SL) (230.58 KB - PDF)
Suomi (FI) (199.34 KB - PDF)
svenska (SV) (197.96 KB - PDF)
PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meeting
English (EN) (388.56 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC
English (EN) (389.78 KB - PDF)
български (BG) (447.7 KB - PDF)
español (ES) (367.77 KB - PDF)
čeština (CS) (433.54 KB - PDF)
dansk (DA) (362.31 KB - PDF)
Deutsch (DE) (407.27 KB - PDF)
eesti keel (ET) (368.16 KB - PDF)
ελληνικά (EL) (441.79 KB - PDF)
français (FR) (416.24 KB - PDF)
hrvatski (HR) (425.66 KB - PDF)
íslenska (IS) (403.92 KB - PDF)
italiano (IT) (381.1 KB - PDF)
latviešu valoda (LV) (454.89 KB - PDF)
lietuvių kalba (LT) (427.05 KB - PDF)
magyar (HU) (426.66 KB - PDF)
Malti (MT) (454.48 KB - PDF)
Nederlands (NL) (376.96 KB - PDF)
norsk (NO) (331.89 KB - PDF)
polski (PL) (458.97 KB - PDF)
português (PT) (413.16 KB - PDF)
română (RO) (424.02 KB - PDF)
slovenčina (SK) (404.42 KB - PDF)
slovenščina (SL) (436.28 KB - PDF)
Suomi (FI) (374.93 KB - PDF)
svenska (SV) (381.19 KB - PDF)
PRAC recommendations on signals adopted at the 4-7 March 2024 PRAC meeting
English (EN) (230.14 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals adopted at the 4-7 March 2024 PRAC
English (EN) (172.98 KB - PDF)
български (BG) (194.29 KB - PDF)
español (ES) (173.71 KB - PDF)
čeština (CS) (200.97 KB - PDF)
dansk (DA) (174.57 KB - PDF)
Deutsch (DE) (176.1 KB - PDF)
eesti keel (ET) (173.19 KB - PDF)
ελληνικά (EL) (194.53 KB - PDF)
français (FR) (174.52 KB - PDF)
hrvatski (HR) (203.33 KB - PDF)
íslenska (IS) (197.33 KB - PDF)
italiano (IT) (189.71 KB - PDF)
latviešu valoda (LV) (204.93 KB - PDF)
lietuvių kalba (LT) (204.57 KB - PDF)
magyar (HU) (200.01 KB - PDF)
Malti (MT) (213.97 KB - PDF)
Nederlands (NL) (186.61 KB - PDF)
norsk (NO) (197.34 KB - PDF)
polski (PL) (195.11 KB - PDF)
português (PT) (193.11 KB - PDF)
română (RO) (199.73 KB - PDF)
slovenčina (SK) (201.16 KB - PDF)
slovenščina (SL) (200.53 KB - PDF)
Suomi (FI) (171.89 KB - PDF)
svenska (SV) (173.96 KB - PDF)
PRAC recommendations on signals adopted at the 5-8 February 2024 PRAC meeting
English (EN) (160.8 KB - PDF)
PRAC recommendations on signals adopted at the 8-11 January 2024 PRAC meeting
English (EN) (289.57 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals adopted at the 8-11 January 2024 PRAC
English (EN) (236.18 KB - PDF)
български (BG) (268.09 KB - PDF)
español (ES) (240.06 KB - PDF)
čeština (CS) (274.08 KB - PDF)
dansk (DA) (235.55 KB - PDF)
Deutsch (DE) (242.16 KB - PDF)
eesti keel (ET) (235.06 KB - PDF)
ελληνικά (EL) (280.45 KB - PDF)
français (FR) (257.12 KB - PDF)
hrvatski (HR) (271.98 KB - PDF)
íslenska (IS) (243.21 KB - PDF)
italiano (IT) (235.79 KB - PDF)
latviešu valoda (LV) (285.69 KB - PDF)
lietuvių kalba (LT) (276.59 KB - PDF)
magyar (HU) (274.96 KB - PDF)
Malti (MT) (278.63 KB - PDF)
Nederlands (NL) (254.09 KB - PDF)
norsk (NO) (229.68 KB - PDF)
polski (PL) (275.63 KB - PDF)
português (PT) (239.08 KB - PDF)
română (RO) (269.78 KB - PDF)
slovenčina (SK) (279.66 KB - PDF)
slovenščina (SL) (270.47 KB - PDF)
Suomi (FI) (234.27 KB - PDF)
svenska (SV) (234.34 KB - PDF)
PRAC recommendations on signals adopted at the 27-30 November 2023 PRAC meeting
English (EN) (272.34 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals adopted at the 27-30 November 2023 PRAC
English (EN) (204.6 KB - PDF)
български (BG) (241.17 KB - PDF)
español (ES) (205.71 KB - PDF)
čeština (CS) (238.04 KB - PDF)
dansk (DA) (205.44 KB - PDF)
Deutsch (DE) (210.59 KB - PDF)
eesti keel (ET) (204.03 KB - PDF)
ελληνικά (EL) (243.42 KB - PDF)
français (FR) (210.44 KB - PDF)
hrvatski (HR) (230.92 KB - PDF)
íslenska (IS) (210.19 KB - PDF)
italiano (IT) (205.76 KB - PDF)
latviešu valoda (LV) (235.93 KB - PDF)
lietuvių kalba (LT) (242.29 KB - PDF)
magyar (HU) (229.7 KB - PDF)
Malti (MT) (241.88 KB - PDF)
Nederlands (NL) (206.33 KB - PDF)
norsk (NO) (201.08 KB - PDF)
polski (PL) (244.56 KB - PDF)
português (PT) (207.34 KB - PDF)
română (RO) (230.02 KB - PDF)
slovenčina (SK) (239.6 KB - PDF)
slovenščina (SL) (227.8 KB - PDF)
Suomi (FI) (203.45 KB - PDF)
svenska (SV) (204.74 KB - PDF)
PRAC recommendations on signals adopted at the 23-26 October 2023 PRAC
English (EN) (199.17 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals adopted at the 23-26 October PRAC
English (EN) (165.6 KB - PDF)
български (BG) (202.4 KB - PDF)
español (ES) (185.06 KB - PDF)
čeština (CS) (213.04 KB - PDF)
dansk (DA) (185.6 KB - PDF)
Deutsch (DE) (188.74 KB - PDF)
eesti keel (ET) (184.37 KB - PDF)
ελληνικά (EL) (205.57 KB - PDF)
français (FR) (184.84 KB - PDF)
hrvatski (HR) (202.44 KB - PDF)
íslenska (IS) (170.47 KB - PDF)
italiano (IT) (184.08 KB - PDF)
latviešu valoda (LV) (211.64 KB - PDF)
lietuvių kalba (LT) (213.69 KB - PDF)
magyar (HU) (212.47 KB - PDF)
Malti (MT) (212.56 KB - PDF)
Nederlands (NL) (185.01 KB - PDF)
norsk (NO) (167.41 KB - PDF)
polski (PL) (215.69 KB - PDF)
português (PT) (187.11 KB - PDF)
română (RO) (208.78 KB - PDF)
slovenčina (SK) (215.29 KB - PDF)
slovenščina (SL) (211.28 KB - PDF)
Suomi (FI) (184.42 KB - PDF)
svenska (SV) (185.24 KB - PDF)
PRAC recommendations on signals adopted at the 25-28 September 2023 PRAC
English (EN) (146.79 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 25-28 September 2023 PRAC
English (EN) (158.31 KB - PDF)
български (BG) (175.03 KB - PDF)
español (ES) (159.33 KB - PDF)
čeština (CS) (177.38 KB - PDF)
dansk (DA) (151.42 KB - PDF)
Deutsch (DE) (143.68 KB - PDF)
eesti keel (ET) (150.35 KB - PDF)
ελληνικά (EL) (178.27 KB - PDF)
français (FR) (159.57 KB - PDF)
hrvatski (HR) (174.93 KB - PDF)
íslenska (IS) (164.56 KB - PDF)
italiano (IT) (158.3 KB - PDF)
latviešu valoda (LV) (176.45 KB - PDF)
lietuvių kalba (LT) (175.38 KB - PDF)
magyar (HU) (167.4 KB - PDF)
Malti (MT) (177.96 KB - PDF)
Nederlands (NL) (156.03 KB - PDF)
norsk (NO) (151.11 KB - PDF)
polski (PL) (178.22 KB - PDF)
português (PT) (160.77 KB - PDF)
română (RO) (166.25 KB - PDF)
slovenčina (SK) (170.29 KB - PDF)
slovenščina (SL) (167.36 KB - PDF)
Suomi (FI) (157.98 KB - PDF)
svenska (SV) (158.35 KB - PDF)
PRAC recommendations on signals adopted at the 28-31 August 2023 PRAC meeting
English (EN) (194.43 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 28-31 August 2023 PRAC meeting
English (EN) (165.22 KB - PDF)
български (BG) (183.92 KB - PDF)
español (ES) (166.98 KB - PDF)
čeština (CS) (195.78 KB - PDF)
dansk (DA) (168.75 KB - PDF)
Deutsch (DE) (169.93 KB - PDF)
eesti keel (ET) (167.36 KB - PDF)
ελληνικά (EL) (196.91 KB - PDF)
français (FR) (168.14 KB - PDF)
hrvatski (HR) (194.11 KB - PDF)
íslenska (IS) (170.94 KB - PDF)
italiano (IT) (182.96 KB - PDF)
latviešu valoda (LV) (192.49 KB - PDF)
lietuvių kalba (LT) (193.72 KB - PDF)
magyar (HU) (192.02 KB - PDF)
Malti (MT) (195.05 KB - PDF)
Nederlands (NL) (167.99 KB - PDF)
norsk (NO) (166.72 KB - PDF)
polski (PL) (187.39 KB - PDF)
português (PT) (168.59 KB - PDF)
română (RO) (191.14 KB - PDF)
slovenčina (SK) (186.14 KB - PDF)
slovenščina (SL) (182.23 KB - PDF)
Suomi (FI) (164.81 KB - PDF)
svenska (SV) (167 KB - PDF)
PRAC recommendations on signals adopted at the 3-6 July 2023 PRAC meeting
English (EN) (202.46 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2023 PRAC meeting
English (EN) (208.23 KB - PDF)
български (BG) (220.66 KB - PDF)
español (ES) (203.33 KB - PDF)
čeština (CS) (220.6 KB - PDF)
dansk (DA) (219.4 KB - PDF)
Deutsch (DE) (202.58 KB - PDF)
eesti keel (ET) (200.97 KB - PDF)
ελληνικά (EL) (223.39 KB - PDF)
français (FR) (200.9 KB - PDF)
hrvatski (HR) (229.07 KB - PDF)
íslenska (IS) (214.15 KB - PDF)
italiano (IT) (209.21 KB - PDF)
latviešu valoda (LV) (232.48 KB - PDF)
lietuvių kalba (LT) (228.79 KB - PDF)
magyar (HU) (198.77 KB - PDF)
Malti (MT) (230.5 KB - PDF)
Nederlands (NL) (200.9 KB - PDF)
norsk (NO) (198 KB - PDF)
polski (PL) (222.26 KB - PDF)
português (PT) (218.64 KB - PDF)
română (RO) (218.36 KB - PDF)
slovenčina (SK) (221.53 KB - PDF)
slovenščina (SL) (219.73 KB - PDF)
Suomi (FI) (217.95 KB - PDF)
svenska (SV) (200.99 KB - PDF)
PRAC recommendations on signals adopted at the 5-8 June 2023 PRAC meeting
English (EN) (213.41 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 June 2023 PRAC meeting
English (EN) (159.72 KB - PDF)
български (BG) (170.57 KB - PDF)
español (ES) (152.12 KB - PDF)
čeština (CS) (171.99 KB - PDF)
dansk (DA) (170.18 KB - PDF)
Deutsch (DE) (154.44 KB - PDF)
eesti keel (ET) (153.34 KB - PDF)
ελληνικά (EL) (174.07 KB - PDF)
français (FR) (152.63 KB - PDF)
hrvatski (HR) (169.47 KB - PDF)
íslenska (IS) (183.88 KB - PDF)
italiano (IT) (151.57 KB - PDF)
latviešu valoda (LV) (171.02 KB - PDF)
lietuvių kalba (LT) (179.82 KB - PDF)
magyar (HU) (169.65 KB - PDF)
Malti (MT) (174.38 KB - PDF)
Nederlands (NL) (153.03 KB - PDF)
norsk (NO) (153.56 KB - PDF)
polski (PL) (195.7 KB - PDF)
português (PT) (153.89 KB - PDF)
română (RO) (167.72 KB - PDF)
slovenčina (SK) (173.51 KB - PDF)
slovenščina (SL) (171.16 KB - PDF)
Suomi (FI) (151.43 KB - PDF)
svenska (SV) (152.62 KB - PDF)
PRAC recommendations on signals adopted at the 10-12 May 2023 PRAC meeting
English (EN) (269.98 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-12 May 2023 PRAC meeting
English (EN) (180.72 KB - PDF)
български (BG) (191.08 KB - PDF)
español (ES) (173.26 KB - PDF)
čeština (CS) (192.54 KB - PDF)
dansk (DA) (174.9 KB - PDF)
Deutsch (DE) (175.14 KB - PDF)
eesti keel (ET) (174.31 KB - PDF)
ελληνικά (EL) (195.14 KB - PDF)
français (FR) (173.61 KB - PDF)
hrvatski (HR) (189.77 KB - PDF)
íslenska (IS) (186.41 KB - PDF)
italiano (IT) (173.14 KB - PDF)
latviešu valoda (LV) (201.86 KB - PDF)
lietuvių kalba (LT) (207.93 KB - PDF)
magyar (HU) (191.43 KB - PDF)
Malti (MT) (193.97 KB - PDF)
Nederlands (NL) (174.21 KB - PDF)
norsk (NO) (167.27 KB - PDF)
polski (PL) (216.95 KB - PDF)
português (PT) (175.04 KB - PDF)
română (RO) (191.16 KB - PDF)
slovenčina (SK) (194.02 KB - PDF)
slovenščina (SL) (192.14 KB - PDF)
Suomi (FI) (172.83 KB - PDF)
svenska (SV) (173.97 KB - PDF)
PRAC recommendations on signals adopted at the 11-14 April 2023 PRAC meeting
English (EN) (155.71 KB - PDF)
PRAC recommendations on signals adopted at the 13-16 March 2023 PRAC meeting
English (EN) (217.48 KB - PDF)
New product information wording : extracts from PRAC recommendations on signals adopted at the 13-16 March 2023 PRAC
English (EN) (195.63 KB - PDF)
български (BG) (213.92 KB - PDF)
español (ES) (195.82 KB - PDF)
čeština (CS) (217.62 KB - PDF)
dansk (DA) (195.81 KB - PDF)
Deutsch (DE) (216.23 KB - PDF)
eesti keel (ET) (195.35 KB - PDF)
ελληνικά (EL) (217.15 KB - PDF)
français (FR) (195.91 KB - PDF)
hrvatski (HR) (214.22 KB - PDF)
íslenska (IS) (199.66 KB - PDF)
italiano (IT) (211.14 KB - PDF)
latviešu valoda (LV) (221.68 KB - PDF)
lietuvių kalba (LT) (225.53 KB - PDF)
magyar (HU) (217.26 KB - PDF)
Malti (MT) (217.41 KB - PDF)
Nederlands (NL) (196.8 KB - PDF)
norsk (NO) (207.69 KB - PDF)
polski (PL) (218.7 KB - PDF)
português (PT) (197.04 KB - PDF)
română (RO) (219.13 KB - PDF)
slovenčina (SK) (217.84 KB - PDF)
slovenščina (SL) (213.89 KB - PDF)
Suomi (FI) (194.13 KB - PDF)
svenska (SV) (195.28 KB - PDF)
PRAC recommendations on signals adopted at the 6-9 February 2023 PRAC meeting
English (EN) (211.21 KB - PDF)
New product information wording : extracts from PRAC recommendations on signals adopted at the 6-9 February 2023 PRAC meeting
English (EN) (165.1 KB - PDF)
български (BG) (207.59 KB - PDF)
español (ES) (188.76 KB - PDF)
čeština (CS) (211.06 KB - PDF)
dansk (DA) (188.97 KB - PDF)
Deutsch (DE) (191.29 KB - PDF)
eesti keel (ET) (187.83 KB - PDF)
ελληνικά (EL) (212.54 KB - PDF)
français (FR) (189.9 KB - PDF)
hrvatski (HR) (209.04 KB - PDF)
íslenska (IS) (161.55 KB - PDF)
italiano (IT) (194.18 KB - PDF)
latviešu valoda (LV) (198.5 KB - PDF)
lietuvių kalba (LT) (198.27 KB - PDF)
magyar (HU) (207.76 KB - PDF)
Malti (MT) (211.18 KB - PDF)
Nederlands (NL) (178.97 KB - PDF)
norsk (NO) (155.78 KB - PDF)
polski (PL) (210.42 KB - PDF)
português (PT) (189.2 KB - PDF)
română (RO) (205.58 KB - PDF)
slovenčina (SK) (210.2 KB - PDF)
slovenščina (SL) (205.13 KB - PDF)
Suomi (FI) (187.67 KB - PDF)
svenska (SV) (187.17 KB - PDF)
PRAC recommendations on signals adopted at the 9-12 January 2023 PRAC meeting
English (EN) (227.11 KB - PDF)
New product information wording : extracts from PRAC recommendations on signals adopted at the 9-12 January 2023 PRAC meeting
English (EN) (201 KB - PDF)
български (BG) (285.71 KB - PDF)
español (ES) (245.38 KB - PDF)
čeština (CS) (285.61 KB - PDF)
dansk (DA) (245.15 KB - PDF)
Deutsch (DE) (255.64 KB - PDF)
eesti keel (ET) (245.71 KB - PDF)
ελληνικά (EL) (290.09 KB - PDF)
français (FR) (248.8 KB - PDF)
hrvatski (HR) (273.21 KB - PDF)
íslenska (IS) (209.08 KB - PDF)
italiano (IT) (244.63 KB - PDF)
latviešu valoda (LV) (284.66 KB - PDF)
lietuvių kalba (LT) (288.8 KB - PDF)
magyar (HU) (274.42 KB - PDF)
Malti (MT) (288.48 KB - PDF)
Nederlands (NL) (263.25 KB - PDF)
norsk (NO) (296.78 KB - PDF)
polski (PL) (284.16 KB - PDF)
português (PT) (264.17 KB - PDF)
română (RO) (283.66 KB - PDF)
slovenčina (SK) (282.82 KB - PDF)
slovenščina (SL) (279.87 KB - PDF)
Suomi (FI) (243.71 KB - PDF)
svenska (SV) (248.84 KB - PDF)
PRAC recommendations on signals adopted at the 28 November - 1 December 2022 PRAC meeting
English (EN) (159.21 KB - PDF)
PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC meeting
English (EN) (288.84 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 24-27 October 2022 PRAC meeting
English (EN) (217.94 KB - PDF)
български (BG) (233.6 KB - PDF)
español (ES) (200.02 KB - PDF)
čeština (CS) (239.37 KB - PDF)
dansk (DA) (218.22 KB - PDF)
Deutsch (DE) (220.97 KB - PDF)
eesti keel (ET) (210.81 KB - PDF)
ελληνικά (EL) (245.43 KB - PDF)
français (FR) (218.73 KB - PDF)
hrvatski (HR) (233.19 KB - PDF)
íslenska (IS) (224.01 KB - PDF)
italiano (IT) (217.66 KB - PDF)
latviešu valoda (LV) (247.36 KB - PDF)
lietuvių kalba (LT) (242.43 KB - PDF)
magyar (HU) (229.72 KB - PDF)
Malti (MT) (245.49 KB - PDF)
Nederlands (NL) (220.24 KB - PDF)
norsk (NO) (211.77 KB - PDF)
polski (PL) (242.63 KB - PDF)
português (PT) (211.74 KB - PDF)
română (RO) (231.79 KB - PDF)
slovenčina (SK) (242.89 KB - PDF)
slovenščina (SL) (238.95 KB - PDF)
Suomi (FI) (216.94 KB - PDF)
svenska (SV) (217.97 KB - PDF)
PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting
English (EN) (236.53 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 September 2022 PRAC meeting
English (EN) (202.61 KB - PDF)
български (BG) (243.42 KB - PDF)
español (ES) (204.32 KB - PDF)
čeština (CS) (228.06 KB - PDF)
dansk (DA) (203.86 KB - PDF)
Deutsch (DE) (208.25 KB - PDF)
eesti keel (ET) (205.32 KB - PDF)
ελληνικά (EL) (238.52 KB - PDF)
français (FR) (205.97 KB - PDF)
hrvatski (HR) (235.73 KB - PDF)
íslenska (IS) (205.1 KB - PDF)
italiano (IT) (203.81 KB - PDF)
latviešu valoda (LV) (237.38 KB - PDF)
lietuvių kalba (LT) (244.12 KB - PDF)
magyar (HU) (227.95 KB - PDF)
Malti (MT) (243.57 KB - PDF)
Nederlands (NL) (218.16 KB - PDF)
norsk (NO) (204.59 KB - PDF)
polski (PL) (237.49 KB - PDF)
português (PT) (206.24 KB - PDF)
română (RO) (236.02 KB - PDF)
slovenčina (SK) (235.27 KB - PDF)
slovenščina (SL) (225.04 KB - PDF)
Suomi (FI) (202.03 KB - PDF)
svenska (SV) (202.52 KB - PDF)
PRAC recommendations on signals adopted at the 29 August - 1 September 2022 PRAC meeting
English (EN) (200.74 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 29 August - 1 September 2022 PRAC
English (EN) (162.15 KB - PDF)
български (BG) (200.28 KB - PDF)
español (ES) (173.2 KB - PDF)
čeština (CS) (201 KB - PDF)
dansk (DA) (173.26 KB - PDF)
Deutsch (DE) (175.23 KB - PDF)
eesti keel (ET) (181.71 KB - PDF)
ελληνικά (EL) (199.4 KB - PDF)
français (FR) (181.74 KB - PDF)
hrvatski (HR) (197.65 KB - PDF)
íslenska (IS) (167.61 KB - PDF)
italiano (IT) (197.02 KB - PDF)
latviešu valoda (LV) (199.55 KB - PDF)
lietuvių kalba (LT) (200.83 KB - PDF)
magyar (HU) (180.4 KB - PDF)
Malti (MT) (203.9 KB - PDF)
Nederlands (NL) (183.29 KB - PDF)
norsk (NO) (181.35 KB - PDF)
polski (PL) (223.84 KB - PDF)
português (PT) (182.59 KB - PDF)
română (RO) (189.47 KB - PDF)
slovenčina (SK) (193.11 KB - PDF)
slovenščina (SL) (181.76 KB - PDF)
Suomi (FI) (172.63 KB - PDF)
svenska (SV) (189.28 KB - PDF)
PRAC recommendations on signals adopted at the 4-7 July 2022 PRAC meeting
English (EN) (160.13 KB - PDF)
PRAC recommendations on signals adopted at the 7-10 June 2022 PRAC meeting
English (EN) (154.79 KB - PDF)
PRAC recommendations on signals adopted at the 2-5 May 2022 PRAC meeting
English (EN) (136.03 KB - PDF)
PRAC recommendations on signals adopted at the 4-7 April 2022 PRAC meeting
English (EN) (145.74 KB - PDF)
PRAC recommendations on signals adopted at the 7-10 March 2022 PRAC meeting
English (EN) (317.17 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 March 2022 PRAC
English (EN) (271.85 KB - PDF)
български (BG) (317.97 KB - PDF)
español (ES) (280.36 KB - PDF)
čeština (CS) (297.25 KB - PDF)
dansk (DA) (276.5 KB - PDF)
Deutsch (DE) (305.23 KB - PDF)
eesti keel (ET) (271.93 KB - PDF)
ελληνικά (EL) (321.95 KB - PDF)
français (FR) (280.11 KB - PDF)
hrvatski (HR) (315.11 KB - PDF)
íslenska (IS) (278.41 KB - PDF)
italiano (IT) (275.94 KB - PDF)
latviešu valoda (LV) (317.29 KB - PDF)
lietuvių kalba (LT) (317.01 KB - PDF)
magyar (HU) (315.43 KB - PDF)
Malti (MT) (327.73 KB - PDF)
Nederlands (NL) (277.62 KB - PDF)
norsk (NO) (269.91 KB - PDF)
polski (PL) (321.64 KB - PDF)
português (PT) (276.18 KB - PDF)
română (RO) (321.34 KB - PDF)
slovenčina (SK) (316.72 KB - PDF)
slovenščina (SL) (306.44 KB - PDF)
Suomi (FI) (272.18 KB - PDF)
svenska (SV) (273.92 KB - PDF)
PRAC recommendations on signals adopted at the 7-10 February 2022 PRAC meeting
English (EN) (229.36 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 February 2022 PRAC
English (EN) (169.92 KB - PDF)
български (BG) (205.11 KB - PDF)
español (ES) (188.64 KB - PDF)
čeština (CS) (194.54 KB - PDF)
dansk (DA) (171.03 KB - PDF)
Deutsch (DE) (174.82 KB - PDF)
eesti keel (ET) (172.43 KB - PDF)
ελληνικά (EL) (206.06 KB - PDF)
français (FR) (172.76 KB - PDF)
hrvatski (HR) (195.19 KB - PDF)
íslenska (IS) (176.77 KB - PDF)
italiano (IT) (187.52 KB - PDF)
latviešu valoda (LV) (197.88 KB - PDF)
lietuvių kalba (LT) (201.2 KB - PDF)
magyar (HU) (193.31 KB - PDF)
Malti (MT) (195.85 KB - PDF)
Nederlands (NL) (201.81 KB - PDF)
norsk (NO) (174.81 KB - PDF)
polski (PL) (217.72 KB - PDF)
português (PT) (172.68 KB - PDF)
română (RO) (191.89 KB - PDF)
slovenčina (SK) (195 KB - PDF)
slovenščina (SL) (193.31 KB - PDF)
Suomi (FI) (170.34 KB - PDF)
svenska (SV) (187.41 KB - PDF)
PRAC recommendations on signals adopted at the 10-13 January 2022 PRAC meeting
English (EN) (228.07 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 10-13 January 2022 PRAC
English (EN) (190.89 KB - PDF)
български (BG) (222.97 KB - PDF)
español (ES) (193.57 KB - PDF)
čeština (CS) (213.94 KB - PDF)
dansk (DA) (192.97 KB - PDF)
Deutsch (DE) (197.97 KB - PDF)
eesti keel (ET) (193.74 KB - PDF)
ελληνικά (EL) (217.28 KB - PDF)
français (FR) (193.88 KB - PDF)
hrvatski (HR) (214.55 KB - PDF)
íslenska (IS) (197.02 KB - PDF)
italiano (IT) (192.29 KB - PDF)
latviešu valoda (LV) (215.46 KB - PDF)
lietuvių kalba (LT) (214.43 KB - PDF)
magyar (HU) (213.11 KB - PDF)
Malti (MT) (219.99 KB - PDF)
Nederlands (NL) (222.24 KB - PDF)
norsk (NO) (175.59 KB - PDF)
polski (PL) (217 KB - PDF)
português (PT) (193.84 KB - PDF)
română (RO) (212.6 KB - PDF)
slovenčina (SK) (216.47 KB - PDF)
slovenščina (SL) (213.05 KB - PDF)
Suomi (FI) (191.35 KB - PDF)
svenska (SV) (192.38 KB - PDF)
PRAC recommendations on signals adopted at the 29 November-2 December 2021 PRAC meeting
Adopted at the 29 November - 2 December 2021 PRAC meeting
English (EN) (249.21 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 29 November - 2 December 2021 PRAC meeting
English (EN) (161.49 KB - PDF)
български (BG) (190.42 KB - PDF)
español (ES) (173.43 KB - PDF)
čeština (CS) (200.75 KB - PDF)
dansk (DA) (182.01 KB - PDF)
Deutsch (DE) (184.04 KB - PDF)
eesti keel (ET) (172.31 KB - PDF)
ελληνικά (EL) (200.24 KB - PDF)
français (FR) (181.48 KB - PDF)
hrvatski (HR) (189.67 KB - PDF)
íslenska (IS) (168.33 KB - PDF)
italiano (IT) (196.69 KB - PDF)
latviešu valoda (LV) (199.85 KB - PDF)
lietuvių kalba (LT) (199.37 KB - PDF)
magyar (HU) (190.12 KB - PDF)
Malti (MT) (200.67 KB - PDF)
Nederlands (NL) (181.69 KB - PDF)
norsk (NO) (147.52 KB - PDF)
polski (PL) (200.86 KB - PDF)
português (PT) (192.58 KB - PDF)
română (RO) (189.49 KB - PDF)
slovenčina (SK) (201.06 KB - PDF)
slovenščina (SL) (198.38 KB - PDF)
Suomi (FI) (179.78 KB - PDF)
svenska (SV) (181.02 KB - PDF)
PRAC recommendations on signals adopted at the 25-28 October 2021 PRAC meeting
English (EN) (247.24 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 25-28 October 2021 PRAC meeting
English (EN) (212.86 KB - PDF)
български (BG) (211.11 KB - PDF)
español (ES) (192.84 KB - PDF)
čeština (CS) (220.3 KB - PDF)
dansk (DA) (208.45 KB - PDF)
Deutsch (DE) (194.88 KB - PDF)
eesti keel (ET) (193.02 KB - PDF)
ελληνικά (EL) (222.15 KB - PDF)
français (FR) (192.44 KB - PDF)
hrvatski (HR) (211.58 KB - PDF)
íslenska (IS) (196.59 KB - PDF)
italiano (IT) (208.27 KB - PDF)
latviešu valoda (LV) (213.45 KB - PDF)
lietuvių kalba (LT) (221.75 KB - PDF)
magyar (HU) (219.39 KB - PDF)
Malti (MT) (216.71 KB - PDF)
Nederlands (NL) (209.73 KB - PDF)
norsk (NO) (191.62 KB - PDF)
polski (PL) (221.7 KB - PDF)
português (PT) (193.48 KB - PDF)
română (RO) (210.11 KB - PDF)
slovenčina (SK) (214.05 KB - PDF)
slovenščina (SL) (217.82 KB - PDF)
Suomi (FI) (191.03 KB - PDF)
svenska (SV) (191.98 KB - PDF)
PRAC recommendations on signals adopted at the 27-30 September 2021 PRAC meeting
Adopted at the 27-30 September 2021 PRAC meeting
English (EN) (350.7 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals - Part 2 - adopted at the 27-30 September 2021 PRAC
English (EN) (175.48 KB - PDF)
български (BG) (206.58 KB - PDF)
español (ES) (172.45 KB - PDF)
čeština (CS) (180.17 KB - PDF)
dansk (DA) (155.42 KB - PDF)
Deutsch (DE) (158.56 KB - PDF)
eesti keel (ET) (147.89 KB - PDF)
ελληνικά (EL) (201.29 KB - PDF)
français (FR) (157.15 KB - PDF)
hrvatski (HR) (177.23 KB - PDF)
íslenska (IS) (213.63 KB - PDF)
italiano (IT) (155.33 KB - PDF)
latviešu valoda (LV) (220.31 KB - PDF)
lietuvių kalba (LT) (177.71 KB - PDF)
magyar (HU) (187.37 KB - PDF)
Malti (MT) (206.73 KB - PDF)
Nederlands (NL) (186.35 KB - PDF)
norsk (NO) (171.46 KB - PDF)
polski (PL) (198.12 KB - PDF)
português (PT) (167.61 KB - PDF)
română (RO) (167.28 KB - PDF)
slovenčina (SK) (180.22 KB - PDF)
slovenščina (SL) (173.63 KB - PDF)
Suomi (FI) (154.33 KB - PDF)
svenska (SV) (172.62 KB - PDF)
New product information wording – Extracts from PRAC recommendations on signals – Part 1 – Vaxzevria - adopted at the PRAC meeting of 27-30 September 2021
English (EN) (199.55 KB - PDF)
български (BG) (208.54 KB - PDF)
español (ES) (195.96 KB - PDF)
čeština (CS) (210.96 KB - PDF)
dansk (DA) (200.53 KB - PDF)
Deutsch (DE) (199.55 KB - PDF)
eesti keel (ET) (199.04 KB - PDF)
ελληνικά (EL) (213.39 KB - PDF)
français (FR) (189.26 KB - PDF)
hrvatski (HR) (213.68 KB - PDF)
íslenska (IS) (192.76 KB - PDF)
italiano (IT) (199.88 KB - PDF)
latviešu valoda (LV) (227.31 KB - PDF)
lietuvių kalba (LT) (210.63 KB - PDF)
magyar (HU) (206.43 KB - PDF)
Malti (MT) (211.67 KB - PDF)
Nederlands (NL) (225.59 KB - PDF)
norsk (NO) (198.08 KB - PDF)
polski (PL) (210.97 KB - PDF)
português (PT) (194.74 KB - PDF)
română (RO) (206.83 KB - PDF)
slovenčina (SK) (211.42 KB - PDF)
slovenščina (SL) (207.37 KB - PDF)
Suomi (FI) (186.61 KB - PDF)
svenska (SV) (198.89 KB - PDF)
PRAC recommendations on signals adopted at the 30 August - 2 September 2021 PRAC meeting
English (EN) (229.8 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 30 August - 2 September 2021 PRAC
English (EN) (187.73 KB - PDF)
български (BG) (198.86 KB - PDF)
español (ES) (181.19 KB - PDF)
čeština (CS) (209.2 KB - PDF)
dansk (DA) (188.57 KB - PDF)
Deutsch (DE) (190.87 KB - PDF)
eesti keel (ET) (180.99 KB - PDF)
ελληνικά (EL) (208.85 KB - PDF)
français (FR) (189.04 KB - PDF)
hrvatski (HR) (197.36 KB - PDF)
íslenska (IS) (194.19 KB - PDF)
italiano (IT) (204.02 KB - PDF)
latviešu valoda (LV) (208.47 KB - PDF)
lietuvių kalba (LT) (207.82 KB - PDF)
magyar (HU) (200.36 KB - PDF)
Malti (MT) (209.6 KB - PDF)
Nederlands (NL) (189.25 KB - PDF)
norsk (NO) (183.32 KB - PDF)
polski (PL) (211.29 KB - PDF)
português (PT) (181.18 KB - PDF)
română (RO) (199.66 KB - PDF)
slovenčina (SK) (212.41 KB - PDF)
slovenščina (SL) (206.66 KB - PDF)
Suomi (FI) (187.44 KB - PDF)
svenska (SV) (187.92 KB - PDF)
PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting
English (EN) (315.1 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting
English (EN) (241.88 KB - PDF)
български (BG) (242.41 KB - PDF)
español (ES) (214.23 KB - PDF)
čeština (CS) (252.52 KB - PDF)
dansk (DA) (221.69 KB - PDF)
Deutsch (DE) (230.93 KB - PDF)
eesti keel (ET) (224.83 KB - PDF)
ελληνικά (EL) (260.04 KB - PDF)
français (FR) (227.99 KB - PDF)
hrvatski (HR) (253.47 KB - PDF)
íslenska (IS) (252.3 KB - PDF)
italiano (IT) (221.75 KB - PDF)
latviešu valoda (LV) (255.79 KB - PDF)
lietuvių kalba (LT) (257.06 KB - PDF)
magyar (HU) (276.5 KB - PDF)
Malti (MT) (261.54 KB - PDF)
Nederlands (NL) (225.04 KB - PDF)
norsk (NO) (229.82 KB - PDF)
polski (PL) (258 KB - PDF)
português (PT) (226.97 KB - PDF)
română (RO) (268.11 KB - PDF)
slovenčina (SK) (254.5 KB - PDF)
slovenščina (SL) (249.32 KB - PDF)
Suomi (FI) (222.83 KB - PDF)
svenska (SV) (221.44 KB - PDF)
PRAC recommendations on signals adopted at the 7-10 June 2021 PRAC meeting
English (EN) (418.49 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals - Part 2 - adopted at the PRAC meeting of 7-10 June 2021
English (EN) (347.41 KB - PDF)
български (BG) (405.91 KB - PDF)
español (ES) (352.31 KB - PDF)
čeština (CS) (413.53 KB - PDF)
dansk (DA) (349.32 KB - PDF)
Deutsch (DE) (344.58 KB - PDF)
eesti keel (ET) (345.82 KB - PDF)
ελληνικά (EL) (418.89 KB - PDF)
français (FR) (347.2 KB - PDF)
hrvatski (HR) (415.89 KB - PDF)
íslenska (IS) (356.06 KB - PDF)
italiano (IT) (358.3 KB - PDF)
latviešu valoda (LV) (417.2 KB - PDF)
lietuvių kalba (LT) (419.93 KB - PDF)
magyar (HU) (423.88 KB - PDF)
Malti (MT) (439.82 KB - PDF)
Nederlands (NL) (345.36 KB - PDF)
norsk (NO) (477.28 KB - PDF)
polski (PL) (419.36 KB - PDF)
português (PT) (351.84 KB - PDF)
română (RO) (420.01 KB - PDF)
slovenčina (SK) (420.68 KB - PDF)
slovenščina (SL) (418.19 KB - PDF)
Suomi (FI) (345.78 KB - PDF)
svenska (SV) (348.59 KB - PDF)
New product information wording: extracts from PRAC recommendations on signals - Part 1 - adopted at the PRAC meeting of 7-10 June 2021
English (EN) (141.28 KB - PDF)
български (BG) (165.8 KB - PDF)
español (ES) (143.5 KB - PDF)
čeština (CS) (164.48 KB - PDF)
dansk (DA) (142.99 KB - PDF)
Deutsch (DE) (144.16 KB - PDF)
eesti keel (ET) (143.19 KB - PDF)
ελληνικά (EL) (167.82 KB - PDF)
français (FR) (143.87 KB - PDF)
hrvatski (HR) (160.11 KB - PDF)
íslenska (IS) (164.07 KB - PDF)
italiano (IT) (157.69 KB - PDF)
latviešu valoda (LV) (183.37 KB - PDF)
lietuvių kalba (LT) (188.62 KB - PDF)
magyar (HU) (162.13 KB - PDF)
Malti (MT) (165.05 KB - PDF)
Nederlands (NL) (142.11 KB - PDF)
norsk (NO) (165.57 KB - PDF)
polski (PL) (174.73 KB - PDF)