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Trimbow-H-C-4257-X-0012 : EPAR - Assessment report - Extension (PDF/1.65 MB) (new)

Adopted
First published: 09/04/2021
EMA/93446/2021
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Cubicin-H-C-637-P46-035 : EPAR - Assessment report (PDF/999.83 KB) (new)

Adopted
First published: 08/04/2021
EMA/158534/2021
List item

Doptelet-H-C-PSUSA-00010779-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/126.76 KB) (new)

First published: 07/04/2021
EMA/CHMP/197652/2021
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Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010390/202007 (PDF/88.38 KB) (new)

Last updated: 07/04/2021
Active substance: lidocaine hydrochloride, Phenylephrine hydrochloride, Tropicamide
Procedure number: PSUSA/00010390/202007
Regulatory outcome: Variation
Bulgarian
(PDF/180.14 KB)

Croatian
(PDF/218.22 KB)

Czech
(PDF/174.59 KB)

Danish
(PDF/141.87 KB)

Dutch
(PDF/126.43 KB)

Estonian
(PDF/144.91 KB)

Finnish
(PDF/119.17 KB)

French
(PDF/125.9 KB)

German
(PDF/133.01 KB)

Greek
(PDF/151.5 KB)

Hungarian
(PDF/203.12 KB)

Icelandic
(PDF/120.42 KB)

Italian
(PDF/166.66 KB)

Latvian
(PDF/190.42 KB)

Lithuanian
(PDF/208.2 KB)

Maltese
(PDF/180.16 KB)

Norwegian
(PDF/126.34 KB)

Polish
(PDF/185.41 KB)

Portuguese
(PDF/148.73 KB)

Romanian
(PDF/190.16 KB)

Slovak
(PDF/173.9 KB)

Slovenian
(PDF/178.05 KB)

Spanish
(PDF/142.79 KB)

Swedish
(PDF/143.95 KB)
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Primidone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002525/202006 (PDF/213.75 KB) (new)

Last updated: 07/04/2021
Active substance: primidone
Procedure number: PSUSA/00002525/202006
Regulatory outcome: Variation
(PDF/161.21 KB)

Bulgarian
(PDF/230.77 KB)

Croatian
(PDF/280.97 KB)

Czech
(PDF/221.6 KB)

Danish
(PDF/166.97 KB)

Dutch
(PDF/221.45 KB)

Finnish
(PDF/243.13 KB)

French
(PDF/290.07 KB)

German
(PDF/229.03 KB)

Greek
(PDF/225.66 KB)

Hungarian
(PDF/260.39 KB)

Italian
(PDF/237.73 KB)

Latvian
(PDF/337.12 KB)

Lithuanian
(PDF/258.56 KB)

Maltese
(PDF/287.82 KB)

Polish
(PDF/229.29 KB)

Portuguese
(PDF/217.32 KB)

Romanian
(PDF/218.08 KB)

Slovak
(PDF/223.83 KB)

Slovenian
(PDF/279.84 KB)

Spanish
(PDF/68.63 KB)

Swedish
(PDF/66.13 KB)
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Vaxchora-H-C-003876-II-0003-G : EPAR - Assessment report - Variation (PDF/4.5 MB) (new)

Adopted
First published: 07/04/2021
EMA/CHMP/444278/2020
List item

Sunitinib Accord : EPAR - Public assessment report (PDF/891.05 KB) (new)

Adopted
First published: 06/04/2021
EMA/CHMP/2430/2021
List item

Inbrija-H-C-PSUSA-00107800-202006 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/121.67 KB) (new)

First published: 06/04/2021
EMA/191688/2021
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Tysabri-H-C-603-X-0116 : EPAR - Assessment report - Extension (PDF/1.71 MB) (new)

Adopted
First published: 06/04/2021
EMA/CHMP/102816/2021
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CHMP meeting dates 2021, 2022, 2023 and 2024 (PDF/121.18 KB) (new)

First published: 06/04/2021
EMA/90608/2021
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Committee for Medicinal Products for Human Use (CHMP): 24-27 January 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 24/01/2022 to 27/01/2022, Last updated: 06/04/2021
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Committee for Medicinal Products for Human Use (CHMP): 21-24 February 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 21/02/2022 to 24/02/2022, Last updated: 06/04/2021
List item

Committee for Medicinal Products for Human Use (CHMP): 21-24 March 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2022 to 24/03/2022, Last updated: 06/04/2021
List item

Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 19/04/2022 to 22/04/2022, Last updated: 06/04/2021
List item

Committee for Medicinal Products for Human Use (CHMP): 16-19 May 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 16/05/2022 to 19/05/2022, Last updated: 06/04/2021
List item

Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 20/06/2022 to 23/06/2022, Last updated: 06/04/2021
List item

Committee for Medicinal Products for Human Use (CHMP): 18-21 July 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 18/07/2022 to 21/07/2022, Last updated: 06/04/2021
List item

Committee for Medicinal Products for Human Use (CHMP): 16-19 August 2022 (new)

Written procedure, from 16/08/2022 to 19/08/2022, Last updated: 06/04/2021
List item

Committee for Medicinal Products for Human Use (CHMP): 12-15 September 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 12/09/2022 to 15/09/2022, Last updated: 06/04/2021
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Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 10/10/2022 to 13/10/2022, Last updated: 06/04/2021
List item

Committee for Medicinal Products for Human Use (CHMP): 7-10 November 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 07/11/2022 to 10/11/2022, Last updated: 06/04/2021
List item

Committee for Medicinal Products for Human Use (CHMP): 12-15 December 2022 (new)

European Medicines Agency, Amsterdam, the Netherlands, from 12/12/2022 to 15/12/2022, Last updated: 06/04/2021
List item

Truvada : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/97.76 KB) (new)

First published: 31/03/2021
EMA/190145/2021
List item

Vipidia-H-C-2182-PSUSA-00010061-202004: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/145.33 KB) (new)

Adopted
First published: 31/03/2021
EMA/134473/2021
List item

Incresync-H-C-PSUSA-00010061-202004 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/145.33 KB) (new)

First published: 31/03/2021
EMA/134473/2021

17725 results

Trimbow-H-C-4257-X-0012 : EPAR - Assessment report - Extension (PDF/1.65 MB) (new)

Cubicin-H-C-637-P46-035 : EPAR - Assessment report (PDF/999.83 KB) (new)

Doptelet-H-C-PSUSA-00010779-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/126.76 KB) (new)

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010390/202007 (PDF/88.38 KB) (new)

Primidone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002525/202006 (PDF/213.75 KB) (new)

Vaxchora-H-C-003876-II-0003-G : EPAR - Assessment report - Variation (PDF/4.5 MB) (new)

Sunitinib Accord : EPAR - Public assessment report (PDF/891.05 KB) (new)

Inbrija-H-C-PSUSA-00107800-202006 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/121.67 KB) (new)

Tysabri-H-C-603-X-0116 : EPAR - Assessment report - Extension (PDF/1.71 MB) (new)

CHMP meeting dates 2021, 2022, 2023 and 2024 (PDF/121.18 KB) (new)

Committee for Medicinal Products for Human Use (CHMP): 24-27 January 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 21-24 February 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 21-24 March 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 19-22 April 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 16-19 May 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 20-23 June 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 18-21 July 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 16-19 August 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 12-15 September 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 10-13 October 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 7-10 November 2022 (new)

Committee for Medicinal Products for Human Use (CHMP): 12-15 December 2022 (new)

Truvada : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/97.76 KB) (new)

Vipidia-H-C-2182-PSUSA-00010061-202004: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/145.33 KB) (new)

Incresync-H-C-PSUSA-00010061-202004 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/145.33 KB) (new)