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Simvastatin: List of nationally authorised medicinal products - PSUSA/00002709/202004 (PDF/286.06 KB) (new)

Last updated: 18/01/2021
Active substance: simvastatin
Procedure number: PSUSA/00002709/202004
Regulatory outcome: Maintenance
List item

Teicoplanin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0025 (PDF/190.6 KB) (new)

Last updated: 18/01/2021
Active substance: Teicoplanin
Procedure number: EMEA/H/N/PSR/S/0025
Regulatory outcome: Variation
Bulgarian
(PDF/144.44 KB)

Croatian
(PDF/183.23 KB)

Czech
(PDF/110.83 KB)

Danish
(PDF/160.66 KB)

Dutch
(PDF/201.55 KB)

Finnish
(PDF/148.94 KB)

French
(PDF/113.79 KB)

German
(PDF/242.18 KB)

Greek
(PDF/218.62 KB)

Hungarian
(PDF/71.35 KB)

Italian
(PDF/237.87 KB)

Maltese
(PDF/269.46 KB)

Polish
(PDF/254.79 KB)

Romanian
(PDF/263.23 KB)

Slovak
(PDF/118.14 KB)

Slovenian
(PDF/115.39 KB)

Spanish
(PDF/234.82 KB)

Swedish
(PDF/69.31 KB)
List item

Teicoplanin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0025 (PDF/120.29 KB) (new)

Last updated: 18/01/2021
Active substance: Teicoplanin
Procedure number: EMEA/H/N/PSR/S/0025
Regulatory outcome: Variation
List item

Cyproterone / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000906/202005 (PDF/151.58 KB) (new)

Last updated: 18/01/2021
Active substance: cyproterone, ethinylestradiol
Procedure number: PSUSA/00000906/202005
Regulatory outcome: Maintenance
List item

Ivabradine / metoprolol : List of nationally authorised medicinal products - PSUSA/00010381/202004 (PDF/223.63 KB) (new)

Last updated: 18/01/2021
Active substance: ivabradine, metoprolol
Procedure number: PSUSA/00010381/202004
Regulatory outcome: Maintenance
List item

Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004 (PDF/350.15 KB) (new)

Last updated: 18/01/2021
Active substance: Azithromycin
Procedure number: PSUSA/00010491/202004
Regulatory outcome: Maintenance
List item

Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004 (PDF/350.15 KB) (new)

Last updated: 18/01/2021
Active substance: Azithromycin
Procedure number: PSUSA/00010491/202004
Regulatory outcome: Maintenance
List item

Gadodiamide: List of nationally authorised medicinal products - PSUSA/00001503/202004 (PDF/335.61 KB) (new)

Last updated: 18/01/2021
Active substance: gadodiamide
Procedure number: PSUSA/00001503/202004
Regulatory outcome: Maintenance
List item

Captopril: List of nationally authorised medicinal products - PSUSA/00000535/202004 (PDF/123.38 KB) (new)

Last updated: 18/01/2021
Active substance: Captopril
Procedure number: PSUSA/00000535/202004
Regulatory outcome: Maintenance
List item

Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/202005 (PDF/104.73 KB) (new)

Last updated: 15/01/2021
Active substance: Ozenoxacin
Procedure number: PSUSA/00010651/202005
Regulatory outcome: Maintenance
List item

PRAC statistics: January 2021 (PDF/638.88 KB) (updated)

First published: 15/01/2021
Last updated: 18/01/2021
List item

News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021

PRAC, Last updated: 15/01/2021
List item

Ulipristal acetate 5mg medicinal products Article-31 referral - CHMP scientific conclusions and PRAC assessment report (PDF/617.57 KB) (new)

Adopted
First published: 14/01/2021
EMA/524073/2020
List item

Overview of comments received on ''Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation" (PDF/1.29 MB) (new)

Adopted
First published: 13/01/2021
EMA/CVMP/117410/2019
List item

Reflection paper on dose review and adjustment of established veterinary antibiotics in the context of SPC harmonisation - First version (PDF/2.25 MB) (new)

Adopted
First published: 13/01/2021
EMA/CVMP/849775/2017
List item

EudraVigilance access policy for medicines for veterinary use - Revision 2 (PDF/445.39 KB) (new)

Draft: consultation open
First published: 12/01/2021
Consultations dates: from 12/01/2021 to 12/03/2021
EMA/113700/2008 Rev.2
List item

Agenda - PRAC draft agenda of meeting 11-14 January 2021 (PDF/689.63 KB) (new)

Draft
First published: 11/01/2021
EMA/PRAC/17329/2021
List item

Flucloxacillin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001402/202003 (PDF/120.73 KB) (new)

Last updated: 11/01/2021
Active substance: flucloxacillin
Procedure number: PSUSA/00001402/202003
Regulatory outcome: Variation
Bulgarian
(PDF/168.95 KB)

Croatian
(PDF/154.91 KB)

Czech
(PDF/162.85 KB)

Danish
(PDF/157.2 KB)

Dutch
(PDF/146.76 KB)

Estonian
(PDF/140.74 KB)

Finnish
(PDF/142.26 KB)

French
(PDF/139.26 KB)

German
(PDF/149.49 KB)

Greek
(PDF/157.12 KB)

Hungarian
(PDF/163.85 KB)

Icelandic
(PDF/159.27 KB)

Italian
(PDF/167.63 KB)

Latvian
(PDF/157.5 KB)

Lithuanian
(PDF/194.82 KB)

Maltese
(PDF/174.08 KB)

Polish
(PDF/155.21 KB)

Portuguese
(PDF/143.73 KB)

Romanian
(PDF/157.82 KB)

Slovak
(PDF/178.7 KB)

Slovenian
(PDF/94.69 KB)

Spanish
(PDF/143.17 KB)

Swedish
(PDF/142.44 KB)
List item

Flucloxacillin: List of nationally authorised medicinal products - PSUSA/00001402/202003 (PDF/295.42 KB) (new)

Last updated: 11/01/2021
Active substance: flucloxacillin
Procedure number: PSUSA/00001402/202003
Regulatory outcome: Variation
List item

Minutes of the PRAC meeting 26-29 October 2020 (PDF/827.93 KB) (new)

Adopted
First published: 08/01/2021
EMA/PRAC/12790/2021
List item

Ethosuximide: List of nationally authorised medicinal products - PSUSA/00001316/202003 (PDF/128.93 KB) (new)

Last updated: 08/01/2021
Active substance: ethosuximide
Procedure number: PSUSA/00001316/202003
Regulatory outcome: Variation
List item

Minutes of the CVMP meeting of 3-5 November 2020 (PDF/338.83 KB) (new)

Adopted
First published: 07/01/2021
EMA/CVMP/666630/2020
List item

New product information wording: extracts from PRAC recommendations on signals adopted at the 23-26 November 2020 PRAC (PDF/210.69 KB) (new)

Adopted
First published: 06/01/2021
EMA/PRAC/654443/2020
Bulgarian
(PDF/238.71 KB)

Croatian
(PDF/233.59 KB)

Czech
(PDF/242.82 KB)

Danish
(PDF/210.69 KB)

Dutch
(PDF/231.29 KB)

Estonian
(PDF/209.83 KB)

Finnish
(PDF/231.94 KB)

French
(PDF/231.07 KB)

German
(PDF/215.2 KB)

Greek
(PDF/278.17 KB)

Hungarian
(PDF/240.65 KB)

Icelandic
(PDF/216.58 KB)

Italian
(PDF/226.5 KB)

Latvian
(PDF/247.44 KB)

Lithuanian
(PDF/267.59 KB)

Maltese
(PDF/245.63 KB)

Norwegian
(PDF/213.43 KB)

Polish
(PDF/269.42 KB)

Portuguese
(PDF/213.28 KB)

Romanian
(PDF/244.13 KB)

Slovak
(PDF/245.42 KB)

Slovenian
(PDF/238.35 KB)

Spanish
(PDF/209.19 KB)

Swedish
(PDF/208.66 KB)
List item

PRAC recommendations on signals adopted at the 23-26 November 2020 PRAC meeting (PDF/319.34 KB) (new)

Adopted
First published: 06/01/2021
EMA/PRAC/630091/2020
List item

P/0003/2021: EMA decision of 5 January 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222) (EMEA-002862-PIP01-20) (PDF/185.1 KB) (new)

Adopted
First published: 05/01/2021
EMA/1708/2021

11535 results

Simvastatin: List of nationally authorised medicinal products - PSUSA/00002709/202004 (PDF/286.06 KB) (new)

Teicoplanin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - EMEA/H/N/PSR/S/0025 (PDF/190.6 KB) (new)

Teicoplanin : List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0025 (PDF/120.29 KB) (new)

Cyproterone / ethinylestradiol : List of nationally authorised medicinal products - PSUSA/00000906/202005 (PDF/151.58 KB) (new)

Ivabradine / metoprolol : List of nationally authorised medicinal products - PSUSA/00010381/202004 (PDF/223.63 KB) (new)

Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004 (PDF/350.15 KB) (new)

Azithromycin: List of nationally authorised medicinal products - PSUSA/00010491/202004 (PDF/350.15 KB) (new)

Gadodiamide: List of nationally authorised medicinal products - PSUSA/00001503/202004 (PDF/335.61 KB) (new)

Captopril: List of nationally authorised medicinal products - PSUSA/00000535/202004 (PDF/123.38 KB) (new)

Ozenoxacin: List of nationally authorised medicinal products - PSUSA/00010651/202005 (PDF/104.73 KB) (new)

PRAC statistics: January 2021 (PDF/638.88 KB) (updated)

News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021

Ulipristal acetate 5mg medicinal products Article-31 referral - CHMP scientific conclusions and PRAC assessment report (PDF/617.57 KB) (new)

Overview of comments received on ''Reflection paper on dose optimisation of established veterinary antibiotics in the context of SPC harmonisation" (PDF/1.29 MB) (new)

Reflection paper on dose review and adjustment of established veterinary antibiotics in the context of SPC harmonisation - First version (PDF/2.25 MB) (new)

EudraVigilance access policy for medicines for veterinary use - Revision 2 (PDF/445.39 KB) (new)

Agenda - PRAC draft agenda of meeting 11-14 January 2021 (PDF/689.63 KB) (new)

Flucloxacillin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001402/202003 (PDF/120.73 KB) (new)

Flucloxacillin: List of nationally authorised medicinal products - PSUSA/00001402/202003 (PDF/295.42 KB) (new)

Minutes of the PRAC meeting 26-29 October 2020 (PDF/827.93 KB) (new)

Ethosuximide: List of nationally authorised medicinal products - PSUSA/00001316/202003 (PDF/128.93 KB) (new)

Minutes of the CVMP meeting of 3-5 November 2020 (PDF/338.83 KB) (new)

New product information wording: extracts from PRAC recommendations on signals adopted at the 23-26 November 2020 PRAC (PDF/210.69 KB) (new)

PRAC recommendations on signals adopted at the 23-26 November 2020 PRAC meeting (PDF/319.34 KB) (new)

P/0003/2021: EMA decision of 5 January 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222) (EMEA-002862-PIP01-20) (PDF/185.1 KB) (new)