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LifeGlobal Media - Procedural steps and scientific information after initial consultation (PDF/85.22 KB) (new)

First published: 02/03/2021
EMA/CHMP/89049/2021
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Minutes of the CHMP meeting 7-10 December 2020 (PDF/1.2 MB) (new)

Adopted
First published: 02/03/2021
EMA/CHMP/81765/2021
List item

Minutes of the CVMP meeting of 19-20 January 2021 (PDF/317.22 KB) (new)

Adopted
First published: 02/03/2021
EMA/CVMP/99479/2021
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Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines in human medicinal products on the Opinion adopted pursuant to Article 31 of Directive 2001/83/EC (PDF/362.31 KB) (new)

Adopted
First published: 02/03/2021
EMA/47245/2021
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Overview of comments received on the 'Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products - First version' (PDF/604.42 KB) (new)

First published: 01/03/2021
EMA/CVMP/ERA/268948/2020
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Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products - First version (PDF/919.43 KB) (new)

Adopted
First published: 01/03/2021
List item

Minutes - PDCO minutes of the 8-11 December 2020 meeting (PDF/568.6 KB) (new)

Adopted
First published: 01/03/2021
EMA/PDCO/622400/2020
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Lidocaine (bovine): European Public MRL Assessment Report (EPMAR) - Committee for Medicinal Products for Veterinary Use (PDF/224.07 KB) (new)

Adopted
First published: 01/03/2021
EMA/CVMP/94655/2021
List item

Bortezomib Sun-H-C-PSUSA-00000424-202004: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/129.71 KB) (new)

First published: 01/03/2021
EMA/122201/2021
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Praluent-H-C-3882-X-0054-G : EPAR - Assessment report - Variation (PDF/1.14 MB) (new)

Adopted
First published: 01/03/2021
EMA/379767/2020
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Overview of comments received on 'Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version' (PDF/465.69 KB) (new)

First published: 01/03/2021
EMA/CVMP/AWP/902538/2019
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Velcade-H-C-PSUSA-00000424-202004 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/129.71 KB) (new)

First published: 01/03/2021
EMA/122201/2021
List item

Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version (PDF/1.22 MB) (new)

Adopted
First published: 01/03/2021
EMA/CVMP/AWP/842786/2015
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Heplisav B : EPAR - Public assessment report (PDF/1.47 MB) (new)

Adopted
First published: 01/03/2021
EMA/1767/2021
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Bupivacaine (bovine species): European Public MRL Assessment Report (EPMAR) - Committee for Medicinal Products for Veterinary Use (PDF/188.71 KB) (new)

Adopted
First published: 01/03/2021
EMA/CVMP/96709/2021
List item

Byetta-H-C-698-P46-048 : EPAR - Assessment report (PDF/1.36 MB) (new)

Adopted
First published: 01/03/2021
EMA/104840/2021
List item

Byetta-PSUSA-00009147-202003 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/160.62 KB) (new)

First published: 01/03/2021
EMA/120245/2021
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Bydureon-H-C-2020-P46-028 : EPAR - Assessment report (PDF/794.21 KB) (new)

Adopted
First published: 01/03/2021
EMA/94820/2021
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Bydureon-H-C-PSUSA-00009147-202003 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/149.91 KB) (new)

First published: 01/03/2021
EMA/120245/2021
List item

Trimbow-H-C-4257-X-0008-G : EPAR - Assessment Report - Extension (PDF/3.81 MB) (new)

Adopted
First published: 26/02/2021
EMA/667393/2020
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Ogluo : EPAR - Public assessment report (PDF/3.45 MB) (new)

Adopted
First published: 26/02/2021
List item

Ogluo : EPAR - All authorised presentations (PDF/58.73 KB) (new)

First published: 26/02/2021
Bulgarian
(PDF/60.37 KB)

Croatian
(PDF/52.8 KB)

Czech
(PDF/58.4 KB)

Danish
(PDF/55.72 KB)

Dutch
(PDF/51.22 KB)

Estonian
(PDF/51.27 KB)

Finnish
(PDF/49.95 KB)

French
(PDF/53.8 KB)

German
(PDF/54.64 KB)

Greek
(PDF/56.11 KB)

Hungarian
(PDF/57.2 KB)

Icelandic
(PDF/97.54 KB)

Italian
(PDF/52.88 KB)

Latvian
(PDF/64.49 KB)

Lithuanian
(PDF/56.07 KB)

Maltese
(PDF/57.17 KB)

Norwegian
(PDF/98.36 KB)

Polish
(PDF/56.86 KB)

Portuguese
(PDF/53.72 KB)

Romanian
(PDF/54.88 KB)

Slovak
(PDF/57.32 KB)

Slovenian
(PDF/55.29 KB)

Spanish
(PDF/52.58 KB)

Swedish
(PDF/53.91 KB)
List item

CHMP post-authorisation summary of positive opinion for Sarclisa (II-03) (PDF/172.41 KB) (new)

Adopted
First published: 26/02/2021
EMA/CHMP/111163/2021
List item

Ogluo : EPAR - Product information (PDF/1.82 MB) (new)

First published: 26/02/2021
Bulgarian
(PDF/1.92 MB)

Croatian
(PDF/877.54 KB)

Czech
(PDF/922.35 KB)

Danish
(PDF/1.85 MB)

Dutch
(PDF/887.01 KB)

Estonian
(PDF/821.6 KB)

Finnish
(PDF/1.85 MB)

French
(PDF/884.5 KB)

German
(PDF/875.39 KB)

Greek
(PDF/1.47 MB)

Hungarian
(PDF/889.11 KB)

Icelandic
(PDF/1.3 MB)

Italian
(PDF/863.95 KB)

Latvian
(PDF/887.37 KB)

Lithuanian
(PDF/894.96 KB)

Maltese
(PDF/921.81 KB)

Norwegian
(PDF/1.27 MB)

Polish
(PDF/914.55 KB)

Portuguese
(PDF/882.05 KB)

Romanian
(PDF/905.81 KB)

Slovak
(PDF/917.12 KB)

Slovenian
(PDF/891.73 KB)

Spanish
(PDF/1.86 MB)

Swedish
(PDF/852.92 KB)
List item

Ogluo : EPAR - Medicine overview (PDF/131.91 KB) (new)

First published: 26/02/2021
EMA/36/2021
Bulgarian
(PDF/157.12 KB)

Croatian
(PDF/154.31 KB)

Czech
(PDF/154.53 KB)

Danish
(PDF/131.09 KB)

Dutch
(PDF/131.43 KB)

Estonian
(PDF/119.68 KB)

Finnish
(PDF/130.2 KB)

French
(PDF/133.81 KB)

German
(PDF/134.85 KB)

Greek
(PDF/154.71 KB)

Hungarian
(PDF/154.15 KB)

Italian
(PDF/131.28 KB)

Latvian
(PDF/164.62 KB)

Lithuanian
(PDF/155.35 KB)

Maltese
(PDF/156.86 KB)

Polish
(PDF/155.92 KB)

Portuguese
(PDF/132.44 KB)

Romanian
(PDF/152.84 KB)

Slovak
(PDF/154.2 KB)

Slovenian
(PDF/151.75 KB)

Spanish
(PDF/132.57 KB)

Swedish
(PDF/130.72 KB)

26469 results

LifeGlobal Media - Procedural steps and scientific information after initial consultation (PDF/85.22 KB) (new)

Minutes of the CHMP meeting 7-10 December 2020 (PDF/1.2 MB) (new)

Minutes of the CVMP meeting of 19-20 January 2021 (PDF/317.22 KB) (new)

Angiotensin-II-receptor antagonists (sartans) Article 31 referral - CHMP assessment report - Impact of the Article 5(3) scientific opinion on nitrosamines in human medicinal products on the Opinion adopted pursuant to Article 31 of Directive 2001/83/EC (PDF/362.31 KB) (new)

Overview of comments received on the 'Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products - First version' (PDF/604.42 KB) (new)

Reflection paper on antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products - First version (PDF/919.43 KB) (new)

Minutes - PDCO minutes of the 8-11 December 2020 meeting (PDF/568.6 KB) (new)

Lidocaine (bovine): European Public MRL Assessment Report (EPMAR) - Committee for Medicinal Products for Veterinary Use (PDF/224.07 KB) (new)

Bortezomib Sun-H-C-PSUSA-00000424-202004: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/129.71 KB) (new)

Praluent-H-C-3882-X-0054-G : EPAR - Assessment report - Variation (PDF/1.14 MB) (new)

Overview of comments received on 'Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version' (PDF/465.69 KB) (new)

Velcade-H-C-PSUSA-00000424-202004 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/129.71 KB) (new)

Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - First version (PDF/1.22 MB) (new)

Heplisav B : EPAR - Public assessment report (PDF/1.47 MB) (new)

Bupivacaine (bovine species): European Public MRL Assessment Report (EPMAR) - Committee for Medicinal Products for Veterinary Use (PDF/188.71 KB) (new)

Byetta-H-C-698-P46-048 : EPAR - Assessment report (PDF/1.36 MB) (new)

Byetta-PSUSA-00009147-202003 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/160.62 KB) (new)

Bydureon-H-C-2020-P46-028 : EPAR - Assessment report (PDF/794.21 KB) (new)

Bydureon-H-C-PSUSA-00009147-202003 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/149.91 KB) (new)

Trimbow-H-C-4257-X-0008-G : EPAR - Assessment Report - Extension (PDF/3.81 MB) (new)

Ogluo : EPAR - Public assessment report (PDF/3.45 MB) (new)

Ogluo : EPAR - All authorised presentations (PDF/58.73 KB) (new)

CHMP post-authorisation summary of positive opinion for Sarclisa (II-03) (PDF/172.41 KB) (new)

Ogluo : EPAR - Product information (PDF/1.82 MB) (new)

Ogluo : EPAR - Medicine overview (PDF/131.91 KB) (new)