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Response from SWP to CMDh questions regarding Genotoxicity and Contraception (PDF/1.24 MB) (new)

First published: 01/04/2020
EMA/CHMP/SWP/74077/2020
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Etonogestrel and ethinylestradiol vaginal delivery system 0.12 mg/0.015 mg/day product-specific bioequivalence guidance (PDF/144.63 KB) (new)

Adopted
First published: 01/04/2020
Legal effective date: 01/09/2020
EMA/CHMP/97470/2019
List item

Azacitidine betapharm : EPAR - All authorised presentations (PDF/13.22 KB) (new)

Adopted
First published: 01/04/2020
Bulgarian
(PDF/69.57 KB)

Croatian
(PDF/48.03 KB)

Czech
(PDF/69.19 KB)

Danish
(PDF/13.1 KB)

Dutch
(PDF/15.24 KB)

Estonian
(PDF/14.97 KB)

Finnish
(PDF/13.13 KB)

French
(PDF/15.08 KB)

German
(PDF/15.15 KB)

Greek
(PDF/35.86 KB)

Hungarian
(PDF/29.92 KB)

Icelandic
(PDF/13.13 KB)

Italian
(PDF/15.18 KB)

Latvian
(PDF/48.47 KB)

Lithuanian
(PDF/30.27 KB)

Maltese
(PDF/48.86 KB)

Norwegian
(PDF/15.07 KB)

Polish
(PDF/49.23 KB)

Portuguese
(PDF/15.16 KB)

Romanian
(PDF/47.6 KB)

Slovak
(PDF/49.13 KB)

Slovenian
(PDF/29.69 KB)

Spanish
(PDF/15.32 KB)

Swedish
(PDF/14.99 KB)
List item

Azacitidine betapharm : EPAR - Medicine overview (PDF/170.35 KB) (new)

Adopted
First published: 01/04/2020
EMA/66667/2020
Bulgarian
(PDF/185.42 KB)

Croatian
(PDF/190.29 KB)

Czech
(PDF/192.37 KB)

Danish
(PDF/168.72 KB)

Dutch
(PDF/169.35 KB)

Estonian
(PDF/158.46 KB)

Finnish
(PDF/167.39 KB)

French
(PDF/171.19 KB)

German
(PDF/172.89 KB)

Greek
(PDF/194.64 KB)

Hungarian
(PDF/193.09 KB)

Italian
(PDF/168.54 KB)

Latvian
(PDF/208.25 KB)

Lithuanian
(PDF/191.34 KB)

Maltese
(PDF/192.95 KB)

Polish
(PDF/193.44 KB)

Portuguese
(PDF/170.28 KB)

Romanian
(PDF/187.62 KB)

Slovak
(PDF/191.45 KB)

Slovenian
(PDF/190.18 KB)

Spanish
(PDF/169.83 KB)

Swedish
(PDF/168.8 KB)
List item

Azacitidine betapharm : EPAR - Public assessment report (PDF/439.81 KB) (new)

Adopted
First published: 01/04/2020
EMA/CHMP/91461/2020
List item

Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2020/2021 (PDF/190.18 KB) (new)

Adopted
First published: 01/04/2020
EMA/CHMP/BWP/134670/2020
List item

News: EU recommendations for 2020/2021 seasonal flu vaccine composition

CHMP, Last updated: 01/04/2020
List item

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 March 2020 (PDF/158.84 KB) (new)

Adopted
First published: 01/04/2020
List item

Nubeqa : EPAR - Medicine overview (PDF/118.2 KB) (new)

First published: 01/04/2020
EMA/58296/2020
Bulgarian
(PDF/142.06 KB)

Croatian
(PDF/138.79 KB)

Czech
(PDF/139.84 KB)

Danish
(PDF/118.08 KB)

Dutch
(PDF/117.76 KB)

Estonian
(PDF/107.12 KB)

Finnish
(PDF/116.51 KB)

French
(PDF/119.36 KB)

German
(PDF/121.06 KB)

Greek
(PDF/140.2 KB)

Hungarian
(PDF/137.1 KB)

Italian
(PDF/117.81 KB)

Latvian
(PDF/155.82 KB)

Lithuanian
(PDF/140.53 KB)

Maltese
(PDF/141.14 KB)

Polish
(PDF/141.77 KB)

Portuguese
(PDF/118.87 KB)

Romanian
(PDF/136.35 KB)

Slovak
(PDF/141.38 KB)

Slovenian
(PDF/138.06 KB)

Spanish
(PDF/118.62 KB)

Swedish
(PDF/117.82 KB)
List item

Cyproterone Article-31 referral - PRAC assessment report (PDF/493.5 KB) (new)

Adopted
First published: 01/04/2020
EMA/134740/2020
List item

ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5 (PDF/1.24 MB) (new)

Adopted
First published: 01/04/2020
Legal effective date: 26/09/2020
EMA/CHMP/ICH/616110/2018
List item

Kymriah : EPAR - Procedural steps taken and scientific information after authorisation (PDF/173.44 KB) (new)

First published: 01/04/2020
List item

CHMP summary of positive opinion for Bemrist Breezhaler (PDF/122.32 KB) (new)

Adopted
First published: 31/03/2020
EMA/CHMP/138090/2020
List item

CHMP summary of positive opinion for Atectura Breezhaler (PDF/122.21 KB) (new)

Adopted
First published: 31/03/2020
EMA/CHMP/74496/2020
List item

Epclusa-H-C-PSUSA-00010524-201906 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/121.74 KB) (new)

First published: 31/03/2020
List item

Fosfomycin Article-31 referral - Annex III (PDF/373.23 KB) (new)

First published: 31/03/2020
List item

P/0413/2019: EMA decision of 6 December 2019 on the agreement of a paediatric investigation plan and on the granting of a waiver for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16) (PDF/260.38 KB) (new)

Adopted
First published: 30/03/2020
List item

Questions and answers on the withdrawal of application for the marketing authorisation of Rituximab Mabion (PDF/141.7 KB) (new)

First published: 30/03/2020
EMA/163447/2020
List item

CHMP ORGAM minutes for the meeting on 2 December 2019 (PDF/242.1 KB) (new)

Adopted
First published: 30/03/2020
EMA/CHMP/654738/2019
List item

CHMP ORGAM agenda for the meeting on 2 December 2019 (PDF/304.8 KB) (new)

Adopted
First published: 30/03/2020
EMA/CHMP/614413/2019
List item

Qtrilmet : EPAR - Procedural steps taken and scientific information after authorisation (PDF/145.28 KB) (new)

First published: 30/03/2020
List item

Start of Union reviews - CHMP meeting of 23-26 March 2020 (PDF/119.53 KB) (new)

Adopted
First published: 27/03/2020
EMA/153417/2020
List item

No change to product information for breast cancer medicine Tyverb following re-assessment of data (PDF/128.11 KB) (new)

First published: 27/03/2020
EMA/147884/2020
List item

CHMP summary of positive opinion for Zolgensma (PDF/133.25 KB) (new)

Adopted
First published: 27/03/2020
EMA/106773/2020
List item

Press release: No change to product information for breast cancer medicine Tyverb following re-assessment of data

CHMP, Last updated: 27/03/2020

17904 results

Response from SWP to CMDh questions regarding Genotoxicity and Contraception (PDF/1.24 MB) (new)

Etonogestrel and ethinylestradiol vaginal delivery system 0.12 mg/0.015 mg/day product-specific bioequivalence guidance (PDF/144.63 KB) (new)

Azacitidine betapharm : EPAR - All authorised presentations (PDF/13.22 KB) (new)

Azacitidine betapharm : EPAR - Medicine overview (PDF/170.35 KB) (new)

Azacitidine betapharm : EPAR - Public assessment report (PDF/439.81 KB) (new)

Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2020/2021 (PDF/190.18 KB) (new)

News: EU recommendations for 2020/2021 seasonal flu vaccine composition

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 23-26 March 2020 (PDF/158.84 KB) (new)

Nubeqa : EPAR - Medicine overview (PDF/118.2 KB) (new)

Cyproterone Article-31 referral - PRAC assessment report (PDF/493.5 KB) (new)

ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5 (PDF/1.24 MB) (new)

Kymriah : EPAR - Procedural steps taken and scientific information after authorisation (PDF/173.44 KB) (new)

CHMP summary of positive opinion for Bemrist Breezhaler (PDF/122.32 KB) (new)

CHMP summary of positive opinion for Atectura Breezhaler (PDF/122.21 KB) (new)

Epclusa-H-C-PSUSA-00010524-201906 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/121.74 KB) (new)

Fosfomycin Article-31 referral - Annex III (PDF/373.23 KB) (new)

P/0413/2019: EMA decision of 6 December 2019 on the agreement of a paediatric investigation plan and on the granting of a waiver for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16) (PDF/260.38 KB) (new)

Questions and answers on the withdrawal of application for the marketing authorisation of Rituximab Mabion (PDF/141.7 KB) (new)

CHMP ORGAM minutes for the meeting on 2 December 2019 (PDF/242.1 KB) (new)

CHMP ORGAM agenda for the meeting on 2 December 2019 (PDF/304.8 KB) (new)

Qtrilmet : EPAR - Procedural steps taken and scientific information after authorisation (PDF/145.28 KB) (new)

Start of Union reviews - CHMP meeting of 23-26 March 2020 (PDF/119.53 KB) (new)

No change to product information for breast cancer medicine Tyverb following re-assessment of data (PDF/128.11 KB) (new)

CHMP summary of positive opinion for Zolgensma (PDF/133.25 KB) (new)

Press release: No change to product information for breast cancer medicine Tyverb following re-assessment of data