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Stelara-H-C-958-II-0073 : EPAR - Assessment Report - Variation (PDF/4.03 MB)

Adopted
First published: 22/01/2020
EMA/12150/2020
List item

Stelara : EPAR - Paediatric investigation plan compliance statement (PDF/129.39 KB)

Adopted
First published: 22/01/2020
EMA/22261/2020
List item

EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 1 (PDF/304.7 KB)

Adopted
First published: 21/01/2020
Legal effective date: 21/01/2020
EMA/CHMP/578661/2010 Rev .1
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Agenda - CVMP agenda of the 21-23 January 2020 meeting (PDF/244.76 KB)

First published: 21/01/2020
EMA/28170/2020
List item

Kadcyla : EPAR -H-C-2389-II-0045 : EPAR - Assessment Report - Variation (PDF/5.77 MB)

Adopted
First published: 20/01/2020
EMA/652550/2019
List item

Flurbiprofen Geiser Article 29(4) referral - Annex II (PDF/77.17 KB)

First published: 20/01/2020
Bulgarian
(PDF/118.08 KB)

Croatian
(PDF/92.04 KB)

Czech
(PDF/95.95 KB)

Danish
(PDF/80.81 KB)

Dutch
(PDF/79.43 KB)

Estonian
(PDF/74.99 KB)

Finnish
(PDF/74.69 KB)

French
(PDF/71.97 KB)

German
(PDF/82.87 KB)

Greek
(PDF/111.57 KB)

Hungarian
(PDF/84.17 KB)

Italian
(PDF/77.23 KB)

Latvian
(PDF/97.1 KB)

Lithuanian
(PDF/95.17 KB)

Maltese
(PDF/96.68 KB)

Polish
(PDF/91.9 KB)

Portuguese
(PDF/78.78 KB)

Romanian
(PDF/94.69 KB)

Slovak
(PDF/85.43 KB)

Slovenian
(PDF/89.97 KB)

Spanish
(PDF/76.72 KB)

Swedish
(PDF/76.55 KB)
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Flurbiprofen Geiser Article 29(4) referral - Annex I (PDF/56.52 KB)

First published: 20/01/2020
Bulgarian
(PDF/80.37 KB)

Croatian
(PDF/70.41 KB)

Czech
(PDF/72.71 KB)

Danish
(PDF/58.45 KB)

Dutch
(PDF/57.52 KB)

Estonian
(PDF/54.83 KB)

Finnish
(PDF/55.25 KB)

French
(PDF/57.48 KB)

German
(PDF/58.83 KB)

Greek
(PDF/79.76 KB)

Hungarian
(PDF/69.39 KB)

Italian
(PDF/56.61 KB)

Latvian
(PDF/72.3 KB)

Lithuanian
(PDF/72.88 KB)

Maltese
(PDF/74.49 KB)

Polish
(PDF/73.54 KB)

Portuguese
(PDF/57.22 KB)

Romanian
(PDF/71.07 KB)

Slovak
(PDF/71.37 KB)

Slovenian
(PDF/69.67 KB)

Spanish
(PDF/56.37 KB)

Swedish
(PDF/56.87 KB)
List item

Orencia-H-C-701-II-0134 : EPAR - Assessment Report - Variation (PDF/418.06 KB)

Adopted
First published: 17/01/2020
EMA/692959/2019
List item

Applications for new human medicines under evaluation by the CHMP: January 2020 (PDF/101.17 KB)

First published: 17/01/2020
EMA/4760/2020
List item

Remsima-H-C-2576-X-0062 : EPAR - Assessment Report - Variation (PDF/4.17 MB)

Adopted
First published: 16/01/2020
EMA/CHMP/548703/2019
List item

Tecfidera-H-C-PSUSA-00010143-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/141.1 KB)

First published: 15/01/2020
EMA/689907/2019
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Minutes of the CAT meeting 11-13 September 2019 (PDF/435.41 KB)

Adopted
First published: 15/01/2020
EMA/CAT/14825/2020
List item

Revlimid-H-C-717-II-0107 : EPAR - Assessment Report - Variation (PDF/7.34 MB)

Adopted
First published: 15/01/2020
EMA/CHMP/693880/2019
List item

Poteligeo : EPAR - Procedural steps taken and scientific information after authorisation (PDF/144.96 KB)

First published: 10/01/2020
EMA/695324/2019
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Firmagon-H-C-PSUSA-00000944-201902: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/163.32 KB)

Adopted
First published: 10/01/2020
EMA/617518/2019
List item

Mepact-H-C-PSUSA-00002059-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/132.23 KB)

First published: 09/01/2020
EMA/692996/2019
List item

Human medicines highlights 2019 (PDF/2.1 MB)

First published: 09/01/2020
List item

Neptra : EPAR - Public assessment report (PDF/520.18 KB)

Adopted
First published: 09/01/2020
EMA/562522/2019
List item

Neptra : EPAR - Medicine overview (PDF/119.06 KB)

First published: 09/01/2020
EMA/560411/2019
Bulgarian
(PDF/143.74 KB)

Croatian
(PDF/139.84 KB)

Czech
(PDF/141.47 KB)

Danish
(PDF/117.54 KB)

Dutch
(PDF/119.49 KB)

Estonian
(PDF/116.66 KB)

Finnish
(PDF/116.76 KB)

French
(PDF/120.96 KB)

German
(PDF/122.26 KB)

Greek
(PDF/144.92 KB)

Hungarian
(PDF/141.12 KB)

Italian
(PDF/118.35 KB)

Latvian
(PDF/148.42 KB)

Lithuanian
(PDF/142.13 KB)

Maltese
(PDF/142.7 KB)

Polish
(PDF/141.79 KB)

Portuguese
(PDF/148.95 KB)

Romanian
(PDF/140.09 KB)

Slovak
(PDF/141.34 KB)

Slovenian
(PDF/137.75 KB)

Spanish
(PDF/119.48 KB)

Swedish
(PDF/117.5 KB)
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Mirataz : EPAR - Public assessment report (PDF/400.48 KB)

Adopted
First published: 08/01/2020
EMA/562416/2019
List item

Mirataz : EPAR - Medicine overview (PDF/118.96 KB)

First published: 08/01/2020
EMA/546639/2019
Bulgarian
(PDF/131.98 KB)

Croatian
(PDF/130.43 KB)

Czech
(PDF/130.21 KB)

Danish
(PDF/108.57 KB)

Dutch
(PDF/108.21 KB)

Estonian
(PDF/105.88 KB)

Finnish
(PDF/133 KB)

French
(PDF/109.69 KB)

German
(PDF/111.56 KB)

Greek
(PDF/132.83 KB)

Hungarian
(PDF/128.21 KB)

Italian
(PDF/106.97 KB)

Latvian
(PDF/146.86 KB)

Lithuanian
(PDF/129.69 KB)

Maltese
(PDF/131.29 KB)

Polish
(PDF/130.72 KB)

Portuguese
(PDF/108.7 KB)

Romanian
(PDF/127.75 KB)

Slovak
(PDF/130.48 KB)

Slovenian
(PDF/127.35 KB)

Spanish
(PDF/108.53 KB)

Swedish
(PDF/107.51 KB)
List item

Darzalex-H-C-4077-II-0029 : EPAR - Assessment Report - Variation (PDF/916.69 KB)

Adopted
First published: 08/01/2020
EMA/CHMP/622108/2019
List item

Senshio-H-C-PSUSA-00010340-201902 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/117.79 KB)

Adopted
First published: 07/01/2020
EMA/691595/2019
List item

Tasigna-H-C-PSUSA-00002162-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/129.68 KB)

Adopted
First published: 07/01/2020
EMA/691903/2019
List item

Kyprolis-H-C-PSUSA-00010448-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/71.07 KB)

First published: 07/01/2020
EMA/573870/2019

20727 results

Stelara-H-C-958-II-0073 : EPAR - Assessment Report - Variation (PDF/4.03 MB)

Stelara : EPAR - Paediatric investigation plan compliance statement (PDF/129.39 KB)

EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 1 (PDF/304.7 KB)

Agenda - CVMP agenda of the 21-23 January 2020 meeting (PDF/244.76 KB)

Kadcyla : EPAR -H-C-2389-II-0045 : EPAR - Assessment Report - Variation (PDF/5.77 MB)

Flurbiprofen Geiser Article 29(4) referral - Annex II (PDF/77.17 KB)

Flurbiprofen Geiser Article 29(4) referral - Annex I (PDF/56.52 KB)

Orencia-H-C-701-II-0134 : EPAR - Assessment Report - Variation (PDF/418.06 KB)

Applications for new human medicines under evaluation by the CHMP: January 2020 (PDF/101.17 KB)

Remsima-H-C-2576-X-0062 : EPAR - Assessment Report - Variation (PDF/4.17 MB)

Tecfidera-H-C-PSUSA-00010143-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/141.1 KB)

Minutes of the CAT meeting 11-13 September 2019 (PDF/435.41 KB)

Revlimid-H-C-717-II-0107 : EPAR - Assessment Report - Variation (PDF/7.34 MB)

Poteligeo : EPAR - Procedural steps taken and scientific information after authorisation (PDF/144.96 KB)

Firmagon-H-C-PSUSA-00000944-201902: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/163.32 KB)

Mepact-H-C-PSUSA-00002059-201903 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/132.23 KB)

Human medicines highlights 2019 (PDF/2.1 MB)

Neptra : EPAR - Public assessment report (PDF/520.18 KB)

Neptra : EPAR - Medicine overview (PDF/119.06 KB)

Mirataz : EPAR - Public assessment report (PDF/400.48 KB)

Mirataz : EPAR - Medicine overview (PDF/118.96 KB)

Darzalex-H-C-4077-II-0029 : EPAR - Assessment Report - Variation (PDF/916.69 KB)

Senshio-H-C-PSUSA-00010340-201902 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/117.79 KB)

Tasigna-H-C-PSUSA-00002162-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/129.68 KB)

Kyprolis-H-C-PSUSA-00010448-201901 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/71.07 KB)