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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

Agenda - HMPC agenda of the 11-13 January 2021 meeting (PDF/187.58 KB) (new)

Adopted
First published: 15/01/2021
EMA/HMPC/668124/2020
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PRAC statistics: January 2021 (PDF/639.23 KB) (new)

First published: 15/01/2021
List item

Brintellix-H-C-2717-II-0025 : EPAR - Assessment report - Variation (PDF/2.28 MB) (new)

Adopted
First published: 15/01/2021
EMA/638238/2020
List item

Public statement on Sebivo: Withdrawal of the marketing authorisation in the European Union (PDF/152.83 KB) (new)

First published: 14/01/2021
EMA/594353/2020
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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

Mayzent-PSUSA-00010818-202003: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/131.25 KB) (new)

First published: 14/01/2021
EMA/666450/2020
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Zonegran-H-C-PSUSA-00003152-202003: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) (PDF/150.04 KB) (new)

First published: 14/01/2021
EMA/615671/2020
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Phesgo : EPAR - Public assessment report (PDF/4.86 MB) (new)

Adopted
First published: 13/01/2021
EMA/CHMP/646782/2020
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Fycompa-H-C-2434-II-0047 : EPAR - Assessment Report - Variation (PDF/3.81 MB) (new)

Adopted
First published: 13/01/2021
EMA/695418/2020
List item

Hexyon-H-C-2702-WS-0676: EPAR - Assessment Report - Variation (PDF/868.29 KB) (new)

Adopted
First published: 13/01/2021
EMA/707880/2020
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Comirnaty : EPAR - Procedural steps taken and scientific information after authorisation (PDF/150.81 KB) (new)

First published: 12/01/2021
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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
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Public statement on Panretin (SRD): Withdrawal of the marketing authorisation in the European Union (PDF/118.8 KB) (new)

First published: 11/01/2021
EMA/652257/2020
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Ozempic-PSUSA-00010671-201911 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/120.95 KB) (new)

First published: 11/01/2021
EMA/11051/2021
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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

Applications for new human medicines under evaluation by the CHMP: January 2021 (PDF/104.11 KB) (new)

First published: 11/01/2021
EMA/1722/2021
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
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Daurismo : EPAR - Procedural steps taken and scientific information after the authorisation (PDF/108.77 KB) (new)

First published: 08/01/2021
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

Comirnaty - Product Information as approved by the CHMP on 8 January 2021, pending endorsement by the European Commission (PDF/888.12 KB) (new)

First published: 08/01/2021
List item

Fintepla : EPAR - Public assessment report (PDF/1.89 MB) (new)

Adopted
First published: 08/01/2021
EMA/639853/2020
List item

Fintepla : EPAR - Product information (PDF/892.16 KB) (new)

First published: 08/01/2021
Bulgarian
(PDF/855.32 KB)

Croatian
(PDF/834.38 KB)

Czech
(PDF/820.42 KB)

Danish
(PDF/788.69 KB)

Dutch
(PDF/786.25 KB)

Estonian
(PDF/769.4 KB)

Finnish
(PDF/772.42 KB)

French
(PDF/800.56 KB)

German
(PDF/805.92 KB)

Greek
(PDF/852.34 KB)

Hungarian
(PDF/853.71 KB)

Icelandic
(PDF/932.29 KB)

Italian
(PDF/781.43 KB)

Latvian
(PDF/822.86 KB)

Lithuanian
(PDF/838.88 KB)

Maltese
(PDF/869.56 KB)

Norwegian
(PDF/848.65 KB)

Polish
(PDF/849.33 KB)

Portuguese
(PDF/773.09 KB)

Romanian
(PDF/857.84 KB)

Slovak
(PDF/854.25 KB)

Slovenian
(PDF/835.17 KB)

Spanish
(PDF/776.48 KB)

Swedish
(PDF/767.92 KB)
List item

Prevenar 13-H-C-1104-PSUSA-00009263-202001: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/132.23 KB) (new)

Adopted
First published: 08/01/2021
EMA/10426/2021

20625 results

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

Agenda - HMPC agenda of the 11-13 January 2021 meeting (PDF/187.58 KB) (new)

PRAC statistics: January 2021 (PDF/639.23 KB) (new)

Brintellix-H-C-2717-II-0025 : EPAR - Assessment report - Variation (PDF/2.28 MB) (new)

Public statement on Sebivo: Withdrawal of the marketing authorisation in the European Union (PDF/152.83 KB) (new)

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

Mayzent-PSUSA-00010818-202003: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/131.25 KB) (new)

Zonegran-H-C-PSUSA-00003152-202003: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) (PDF/150.04 KB) (new)

Phesgo : EPAR - Public assessment report (PDF/4.86 MB) (new)

Fycompa-H-C-2434-II-0047 : EPAR - Assessment Report - Variation (PDF/3.81 MB) (new)

Hexyon-H-C-2702-WS-0676: EPAR - Assessment Report - Variation (PDF/868.29 KB) (new)

Comirnaty : EPAR - Procedural steps taken and scientific information after authorisation (PDF/150.81 KB) (new)

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

Public statement on Panretin (SRD): Withdrawal of the marketing authorisation in the European Union (PDF/118.8 KB) (new)

Ozempic-PSUSA-00010671-201911 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/120.95 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)

Applications for new human medicines under evaluation by the CHMP: January 2021 (PDF/104.11 KB) (new)

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

Daurismo : EPAR - Procedural steps taken and scientific information after the authorisation (PDF/108.77 KB) (new)

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

Comirnaty - Product Information as approved by the CHMP on 8 January 2021, pending endorsement by the European Commission (PDF/888.12 KB) (new)

Fintepla : EPAR - Public assessment report (PDF/1.89 MB) (new)

Fintepla : EPAR - Product information (PDF/892.16 KB) (new)

Prevenar 13-H-C-1104-PSUSA-00009263-202001: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/132.23 KB) (new)