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Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (PDF/753.58 KB) (updated)

First published: 06/08/2020
Last updated: 29/06/2022
EMA/409815/2020 Rev.10
List item

Janus Kinase inhibitors (JAKi) Article-20 referral - Timetable for the procedure (PDF/89.18 KB) (updated)

First published: 11/02/2022
Last updated: 13/06/2022
EMA/PRAC/68282/2022
List item

Janus Kinase inhibitors (JAKi) Article-20 referral - Review started (PDF/123.7 KB) (updated)

First published: 11/02/2022
Last updated: 13/06/2022
EMA/71746/2022
List item

Terlipressin-containing medicinal products Article-31 referral - Timetable for the procedure (PDF/121.25 KB) (updated)

First published: 14/01/2022
Last updated: 10/06/2022
EMA/PRAC/2205/2022 rev2
List item

QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics (Cover page) (DOCX/113.39 KB) (updated)

First published: 27/06/2018
Last updated: 09/06/2022
EMA/295934/2018 v.4
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Isotretinoin (oral formulations) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/202105 (PDF/172.42 KB) (updated)

Last updated: 31/05/2022
Active substance: isotretinoin (oral formulations)
Procedure number: PSUSA/00010488/202105
Regulatory outcome: Variation
Bulgarian
(PDF/269.83 KB)

Croatian
(PDF/39.8 KB)

Czech
(PDF/178.5 KB)

Danish
(PDF/168.46 KB)

Dutch
(PDF/193.1 KB)

Estonian
(PDF/243.64 KB)

Finnish
(PDF/158.17 KB)

French
(PDF/38.02 KB)

German
(PDF/227.2 KB)

Greek
(PDF/342.74 KB)

Hungarian
(PDF/122.72 KB)

Icelandic
(PDF/156.29 KB)

Italian
(PDF/181.64 KB)

Latvian
(PDF/331.18 KB)

Lithuanian
(PDF/132.27 KB)

Maltese
(PDF/182.37 KB)

Norwegian
(PDF/113.01 KB)

Polish
(PDF/258.27 KB)

Portuguese
(PDF/131.59 KB)

Romanian
(PDF/254.52 KB)

Slovak
(PDF/183.34 KB)

Slovenian
(PDF/307.82 KB)

Spanish
(PDF/166.42 KB)

Swedish
(PDF/173.38 KB)
List item

List of signals discussed at PRAC since September 2012 (XLSX/186.83 KB)

Adopted
First published: 08/07/2019
Last updated: 30/05/2022
EMA/PRAC/530804/2013
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Rasilez HCT-H-C-964-A31-0053 : EPAR - Assessment Report - Article 31 (PDF/1.07 MB)

Adopted
First published: 02/10/2014
Last updated: 20/05/2022
EMA/PRAC/294920/2014
List item

Nomegestrol and chlormadinone Article-31 referral - Timetable for the procedure (PDF/138.46 KB)

First published: 01/10/2021
Last updated: 10/05/2022
EMA/PRAC/522598/2021 – Rev. 2
List item

Paracetamol (IV formulation) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002311/202105 (PDF/136.32 KB)

Last updated: 07/04/2022
Active substance: paracetamol (IV formulation)
Procedure number: PSUSA/00002311/202105
Regulatory outcome: Variation
Bulgarian
(PDF/192.3 KB)

Croatian
(PDF/195.36 KB)

Czech
(PDF/159.35 KB)

Danish
(PDF/162.18 KB)

Dutch
(PDF/140.68 KB)

Estonian
(PDF/92.08 KB)

Finnish
(PDF/136.2 KB)

French
(PDF/138.09 KB)

German
(PDF/143.47 KB)

Greek
(PDF/171.42 KB)

Hungarian
(PDF/219.74 KB)

Icelandic
(PDF/134.29 KB)

Italian
(PDF/182.7 KB)

Latvian
(PDF/125.25 KB)

Lithuanian
(PDF/120.98 KB)

Maltese
(PDF/120.5 KB)

Norwegian
(PDF/153.3 KB)

Polish
(PDF/204.5 KB)

Portuguese
(PDF/159.76 KB)

Romanian
(PDF/201.4 KB)

Slovak
(PDF/188.03 KB)

Slovenian
(PDF/230.38 KB)

Spanish
(PDF/154.91 KB)

Swedish
(PDF/172.08 KB)
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Remifentanil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002617/202105 (PDF/147.75 KB)

Last updated: 06/04/2022
Active substance: remifentanil
Procedure number: PSUSA/00002617/202105
Regulatory outcome: Variation
Bulgarian
(PDF/337.89 KB)

Croatian
(PDF/268.55 KB)

Czech
(PDF/443.34 KB)

Danish
(PDF/388.37 KB)

Dutch
(PDF/328.14 KB)

Estonian
(PDF/271.48 KB)

Finnish
(PDF/321.82 KB)

French
(PDF/336.01 KB)

German
(PDF/330.82 KB)

Greek
(PDF/335.2 KB)

Hungarian
(PDF/468.29 KB)

Italian
(PDF/378.5 KB)

Latvian
(PDF/522.33 KB)

Lithuanian
(PDF/270.09 KB)

Maltese
(PDF/367.96 KB)

Norwegian
(PDF/325.44 KB)

Polish
(PDF/370.65 KB)

Portuguese
(PDF/370.07 KB)

Romanian
(PDF/331.4 KB)

Slovak
(PDF/277.26 KB)

Slovenian
(PDF/436.65 KB)

Spanish
(PDF/370.98 KB)

Swedish
(PDF/366.23 KB)
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Minutes of the PRAC meeting 6-9 April 2021 (PDF/892.71 KB)

First published: 10/02/2022
Last updated: 21/03/2022
EMA/PRAC/89475/2022 Corr.1
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PRAC work plan 2022 (PDF/228 KB)

First published: 23/08/2021
Last updated: 16/03/2022
EMA/PRAC/576527/2021
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Dobutamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001151/202103 (PDF/91.49 KB)

Last updated: 09/03/2022
Active substance: Dobutamine
Procedure number: PSUSA/00001151/202103
Regulatory outcome: Variation
Bulgarian
(PDF/175.59 KB)

Croatian
(PDF/181.04 KB)

Czech
(PDF/195.41 KB)

Danish
(PDF/143.34 KB)

Dutch
(PDF/153.59 KB)

Estonian
(PDF/145.68 KB)

Finnish
(PDF/138.67 KB)

French
(PDF/144.97 KB)

German
(PDF/158.06 KB)

Greek
(PDF/178.29 KB)

Hungarian
(PDF/187.06 KB)

Icelandic
(PDF/154.4 KB)

Italian
(PDF/152.06 KB)

Latvian
(PDF/188.95 KB)

Lithuanian
(PDF/181.58 KB)

Maltese
(PDF/190.13 KB)

Norwegian
(PDF/142.4 KB)

Polish
(PDF/187.4 KB)

Portuguese
(PDF/145.15 KB)

Romanian
(PDF/188.56 KB)

Slovak
(PDF/190.87 KB)

Slovenian
(PDF/178.39 KB)

Spanish
(PDF/146.18 KB)

Swedish
(PDF/142.39 KB)
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Terlipressin-containing medicinal products Article-31 referral - Annex I (PDF/174.12 KB)

First published: 14/01/2022
Last updated: 21/02/2022
EMA/10268/2022 Rev. 1
List item

Quinapril : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002591/202104 (PDF/80.07 KB)

Last updated: 15/02/2022
Active substance: quinapril
Procedure number: PSUSA/00002591/202104
Regulatory outcome: Variation
Bulgarian
(PDF/81.1 KB)

Croatian
(PDF/103.14 KB)

Czech
(PDF/82.44 KB)

Danish
(PDF/82.97 KB)

Dutch
(PDF/94.26 KB)

Estonian
(PDF/102.53 KB)

Finnish
(PDF/83.63 KB)

French
(PDF/82.76 KB)

German
(PDF/89.59 KB)

Greek
(PDF/80.16 KB)

Hungarian
(PDF/81.46 KB)

Italian
(PDF/101.42 KB)

Latvian
(PDF/112.01 KB)

Lithuanian
(PDF/88.64 KB)

Maltese
(PDF/110.28 KB)

Polish
(PDF/105.59 KB)

Portuguese
(PDF/91.38 KB)

Romanian
(PDF/80.24 KB)

Slovak
(PDF/84.34 KB)

Slovenian
(PDF/108.57 KB)

Spanish
(PDF/81.17 KB)

Swedish
(PDF/80.89 KB)
List item

Consideration on core requirements for RMPs of COVID-19 vaccines (PDF/607.45 KB)

First published: 13/11/2020
Last updated: 10/02/2022
EMA/PRAC/73244/2022
List item

Oxycodone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/202104 (PDF/205.51 KB)

Last updated: 01/02/2022
Active substance: oxycodone
Procedure number: PSUSA/00002254/202104
Regulatory outcome: Variation
Bulgarian
(PDF/292.01 KB)

Croatian
(PDF/287.67 KB)

Czech
(PDF/161.83 KB)

Danish
(PDF/214.08 KB)

Dutch
(PDF/208.28 KB)

Estonian
(PDF/200.93 KB)

Finnish
(PDF/201.41 KB)

French
(PDF/227.02 KB)

German
(PDF/242.89 KB)

Greek
(PDF/268.51 KB)

Hungarian
(PDF/313.38 KB)

Icelandic
(PDF/213.35 KB)

Italian
(PDF/213.47 KB)

Latvian
(PDF/296.66 KB)

Lithuanian
(PDF/286.49 KB)

Maltese
(PDF/241.3 KB)

Norwegian
(PDF/204.07 KB)

Polish
(PDF/247.98 KB)

Portuguese
(PDF/311.01 KB)

Romanian
(PDF/390.27 KB)

Slovak
(PDF/287.18 KB)

Slovenian
(PDF/284.3 KB)

Spanish
(PDF/210.22 KB)

Swedish
(PDF/194.95 KB)
List item

Glatiramer - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00001529-202011 (PDF/33.83 KB)

Last updated: 20/01/2022
Active substance: glatiramer
Regulatory outcome: Variation
Bulgarian
(PDF/80.29 KB)

Croatian
(PDF/73.59 KB)

Czech
(PDF/134.01 KB)

Danish
(PDF/34.48 KB)

Dutch
(PDF/36.33 KB)

Estonian
(PDF/30.2 KB)

Finnish
(PDF/86.42 KB)

French
(PDF/34.28 KB)

German
(PDF/155.78 KB)

Greek
(PDF/84.1 KB)

Hungarian
(PDF/153.76 KB)

Icelandic
(PDF/36.15 KB)

Italian
(PDF/36.54 KB)

Latvian
(PDF/76.32 KB)

Lithuanian
(PDF/77.31 KB)

Maltese
(PDF/78.4 KB)

Norwegian
(PDF/30.64 KB)

Polish
(PDF/80.05 KB)

Portuguese
(PDF/34.25 KB)

Romanian
(PDF/66.96 KB)

Slovak
(PDF/77.46 KB)

Slovenian
(PDF/66.22 KB)

Spanish
(PDF/35.56 KB)

Swedish
(PDF/34.46 KB)
List item

Zytiga-H-C-002321-II-0004-G : EPAR - Assessment Report - Variation (PDF/1.07 MB)

Adopted
First published: 24/01/2013
Last updated: 17/01/2022
EMA/CHMP/755312/2012
List item

Nafarelin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002105/202102 (PDF/72.61 KB)

Last updated: 14/01/2022
Active substance: nafarelin
Procedure number: PSUSA/00002105/202102
Regulatory outcome: Variation
Bulgarian
(PDF/80.31 KB)

Croatian
(PDF/82.51 KB)

Czech
(PDF/209.8 KB)

Danish
(PDF/76.43 KB)

Dutch
(PDF/74.54 KB)

Estonian
(PDF/79.54 KB)

Finnish
(PDF/68.38 KB)

French
(PDF/82.06 KB)

German
(PDF/80.72 KB)

Greek
(PDF/72.09 KB)

Hungarian
(PDF/72.76 KB)

Icelandic
(PDF/74.93 KB)

Italian
(PDF/101.18 KB)

Latvian
(PDF/95.19 KB)

Lithuanian
(PDF/88.44 KB)

Maltese
(PDF/92.6 KB)

Norwegian
(PDF/71.68 KB)

Polish
(PDF/91.25 KB)

Portuguese
(PDF/90.53 KB)

Romanian
(PDF/79.05 KB)

Slovak
(PDF/83.76 KB)

Slovenian
(PDF/83.27 KB)

Spanish
(PDF/80.73 KB)

Swedish
(PDF/84.17 KB)
List item

PRAC recommendations on signals adopted at the 25-28 October 2021 PRAC meeting (PDF/247.24 KB)

Adopted
First published: 22/11/2021
Last updated: 10/12/2021
EMA/PRAC/605613/2021 1 Corr2
List item

Amfepramone-containing medicinal products Article-31 referral - Timetable for the procedure (PDF/130.97 KB)

First published: 12/02/2021
Last updated: 03/12/2021
EMA/PRAC/51714/2021 Rev.4
List item

Nomegestrol and chlormadinone Article-31 referral - Annex A and Annex I (PDF/182.91 KB)

Draft
First published: 01/10/2021
Last updated: 04/11/2021
List item

New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting (PDF/241.88 KB)

Adopted
First published: 02/08/2021
Last updated: 26/10/2021
EMA/PRAC/380228/2021 Corr. 2
Bulgarian
(PDF/242.41 KB)

Croatian
(PDF/253.47 KB)

Czech
(PDF/252.52 KB)

Danish
(PDF/221.69 KB)

Dutch
(PDF/225.04 KB)

Estonian
(PDF/224.83 KB)

Finnish
(PDF/222.83 KB)

French
(PDF/227.99 KB)

German
(PDF/230.93 KB)

Greek
(PDF/260.04 KB)

Hungarian
(PDF/276.5 KB)

Icelandic
(PDF/252.3 KB)

Italian
(PDF/221.75 KB)

Latvian
(PDF/255.79 KB)

Lithuanian
(PDF/257.06 KB)

Maltese
(PDF/261.54 KB)

Norwegian
(PDF/229.82 KB)

Polish
(PDF/258 KB)

Portuguese
(PDF/226.97 KB)

Romanian
(PDF/268.11 KB)

Slovak
(PDF/254.5 KB)

Slovenian
(PDF/249.32 KB)

Spanish
(PDF/214.23 KB)

Swedish
(PDF/221.44 KB)

2608 results

Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (PDF/753.58 KB) (updated)

Janus Kinase inhibitors (JAKi) Article-20 referral - Timetable for the procedure (PDF/89.18 KB) (updated)

Janus Kinase inhibitors (JAKi) Article-20 referral - Review started (PDF/123.7 KB) (updated)

Terlipressin-containing medicinal products Article-31 referral - Timetable for the procedure (PDF/121.25 KB) (updated)

QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics (Cover page) (DOCX/113.39 KB) (updated)

Isotretinoin (oral formulations) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/202105 (PDF/172.42 KB) (updated)

List of signals discussed at PRAC since September 2012 (XLSX/186.83 KB)

Rasilez HCT-H-C-964-A31-0053 : EPAR - Assessment Report - Article 31 (PDF/1.07 MB)

Nomegestrol and chlormadinone Article-31 referral - Timetable for the procedure (PDF/138.46 KB)

Paracetamol (IV formulation) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002311/202105 (PDF/136.32 KB)

Remifentanil : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002617/202105 (PDF/147.75 KB)

Minutes of the PRAC meeting 6-9 April 2021 (PDF/892.71 KB)

PRAC work plan 2022 (PDF/228 KB)

Dobutamine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001151/202103 (PDF/91.49 KB)

Terlipressin-containing medicinal products Article-31 referral - Annex I (PDF/174.12 KB)

Quinapril : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002591/202104 (PDF/80.07 KB)

Consideration on core requirements for RMPs of COVID-19 vaccines (PDF/607.45 KB)

Oxycodone : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/202104 (PDF/205.51 KB)

Glatiramer - Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation - PSUSA-00001529-202011 (PDF/33.83 KB)

Zytiga-H-C-002321-II-0004-G : EPAR - Assessment Report - Variation (PDF/1.07 MB)

Nafarelin: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002105/202102 (PDF/72.61 KB)

PRAC recommendations on signals adopted at the 25-28 October 2021 PRAC meeting (PDF/247.24 KB)

Amfepramone-containing medicinal products Article-31 referral - Timetable for the procedure (PDF/130.97 KB)

Nomegestrol and chlormadinone Article-31 referral - Annex A and Annex I (PDF/182.91 KB)

New product information wording: extracts from PRAC recommendations on signals adopted at the 5-8 July 2021 PRAC meeting (PDF/241.88 KB)