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Bacterial lysate medicines Article 31 referral - CHMP assessment report (PDF/430.83 KB)

Adopted
First published: 16/09/2019
EMA/457345/2019
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Bacterial lysate medicines Article 31 referral - Annex IV (PDF/13.44 KB)

First published: 16/09/2019
Bulgarian
(PDF/51.4 KB)

Croatian
(PDF/33 KB)

Czech
(PDF/46.43 KB)

Dutch
(PDF/13.08 KB)

Estonian
(PDF/10.73 KB)

Finnish
(PDF/10.8 KB)

French
(PDF/13.25 KB)

German
(PDF/13.3 KB)

Greek
(PDF/55.83 KB)

Hungarian
(PDF/34.51 KB)

Italian
(PDF/13.27 KB)

Latvian
(PDF/47.33 KB)

Lithuanian
(PDF/47.71 KB)

Maltese
(PDF/47.71 KB)

Polish
(PDF/47.18 KB)

Portuguese
(PDF/13.06 KB)

Romanian
(PDF/45.12 KB)

Slovak
(PDF/35.57 KB)

Slovenian
(PDF/33.23 KB)

Spanish
(PDF/13.07 KB)

Swedish
(PDF/13.12 KB)
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Bacterial lysate medicines Article 31 referral - Annex II (PDF/44.85 KB)

First published: 16/09/2019
Bulgarian
(PDF/89.09 KB)

Croatian
(PDF/80.78 KB)

Czech
(PDF/92.98 KB)

Danish
(PDF/41.1 KB)

Dutch
(PDF/43.54 KB)

Estonian
(PDF/40.72 KB)

Finnish
(PDF/45.73 KB)

French
(PDF/47.62 KB)

German
(PDF/50.95 KB)

Greek
(PDF/97.63 KB)

Hungarian
(PDF/78.83 KB)

Italian
(PDF/42.92 KB)

Latvian
(PDF/85.52 KB)

Lithuanian
(PDF/89.89 KB)

Maltese
(PDF/92.75 KB)

Polish
(PDF/79 KB)

Portuguese
(PDF/45.34 KB)

Romanian
(PDF/86.6 KB)

Slovak
(PDF/75.8 KB)

Slovenian
(PDF/79.53 KB)

Spanish
(PDF/44.77 KB)

Swedish
(PDF/46.42 KB)
List item

Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2019 (PDF/227.6 KB)

First published: 16/09/2019
EMA/438093/2019
List item

Agenda - Workshop on the use of registries for tumour histology-independent cancer therapies (PDF/77.4 KB)

Draft
First published: 16/09/2019
EMA/499786/2019
List item

Workshop on the use of registries for tumour histology-independent cancer therapies

European Medicines Agency, Amsterdam, the Netherlands, 29/11/2019, Last updated: 16/09/2019
List item

Ciclosporin (systemic use): List of nationally authorised products - PSUSA/00000745/201812 (PDF/578.14 KB)

Last updated: 16/09/2019
Active substance: ciclosporin (systemic use)
Procedure number: PSUSA/00000745/201812
Regulatory outcome: Maintenance
List item

Camellia sinensis, Leaf, Dry extract refined (derived from Camellia sinensis, L. O.KUNTZE) (topical use): List of nationally authorised products - PSUSA/00010569/201812

Last updated: 16/09/2019
Active substance: Camellia sinensis, Leaf, Dry extract refined (derived from Camellia sinensis, L. O.KUNTZE) (topical use)
Procedure number: PSUSA/00010569/201812
Regulatory outcome: Maintenance
List item

Caffeine / ergotamine: List of nationally authorised products - PSUSA/00000485/201811 (PDF/88.1 KB)

Last updated: 16/09/2019
Active substance: caffeine / ergotamine
Procedure number: PSUSA/00000485/201811
Regulatory outcome: Maintenance
List item

Agenda - CHMP agenda of the 16-19 September 2019 meeting (PDF/810.75 KB)

Draft
First published: 16/09/2019
EMA/CHMP/502557/2019
List item

Bisoprolol / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000420/201811 (PDF/151.52 KB)

Last updated: 13/09/2019
Active substance: bisoprolol, hydrochlorothiazide
Procedure number: PSUSA/00000420/201811
Regulatory outcome: Maintenance
List item

CVMP post-authorisation summary of positive opinion Vectra Felis (II/0009) (PDF/137.48 KB)

Adopted
First published: 13/09/2019
EMA/CVMP/450607/2019
List item

Summary of opinion: Vectra Felis

pyriproxyfen / dinotefuran, opinion date: 13/09/2019, Positive, Last updated: 13/09/2019
List item

CVMP post-authorisation summary of positive opinion for Bravecto (II/0033/G, II/0036) (PDF/149.32 KB)

Adopted
First published: 13/09/2019
EMA/CVMP/465180/2019
List item

Summary of opinion: Bravecto

fluralaner, opinion date: 13/09/2019, Positive, Last updated: 13/09/2019
List item

CVMP post-authorisation summary of negative opinion for Velactis (II/0004) (PDF/127.67 KB)

Adopted
First published: 13/09/2019
EMA/CVMP/455277/2019
List item

Summary of opinion: Velactis

cabergoline, opinion date: 13/09/2019, Negative, Last updated: 13/09/2019
List item

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2019 (PDF/145.45 KB)

First published: 13/09/2019
EMA/CVMP/474767/2019
List item

Press release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2019

CVMP, Last updated: 13/09/2019
List item

Summary of opinion: Gumbohatch

avian infectious bursal disease vaccine (live), opinion date: 12/09/2019, Positive, Last updated: 13/09/2019
List item

Summary of opinion: Nobivac Myxo-RHD Plus

myxomatosis and rabbit haemorrhagic viral disease vaccine (live recombinant), opinion date: 12/09/2019, Positive, Last updated: 13/09/2019
List item

Levodopa/Carbidopa/Entacapone Orion-H-C-PSUSA-00000547-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/82.2 KB)

First published: 13/09/2019
EMA/308741/2019
List item

EMA to provide guidance on avoiding nitrosamines in human medicines (PDF/107.06 KB)

First published: 13/09/2019
EMA/500009/2019
List item

Press release: EMA to provide guidance on avoiding nitrosamines in human medicines

Last updated: 13/09/2019
List item

Press release: EMA to review ranitidine medicines following detection of NDMA

Last updated: 13/09/2019

56601 results

Bacterial lysate medicines Article 31 referral - CHMP assessment report (PDF/430.83 KB)

Bacterial lysate medicines Article 31 referral - Annex IV (PDF/13.44 KB)

Bacterial lysate medicines Article 31 referral - Annex II (PDF/44.85 KB)

Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2019 (PDF/227.6 KB)

Agenda - Workshop on the use of registries for tumour histology-independent cancer therapies (PDF/77.4 KB)

Workshop on the use of registries for tumour histology-independent cancer therapies

Ciclosporin (systemic use): List of nationally authorised products - PSUSA/00000745/201812 (PDF/578.14 KB)

Camellia sinensis, Leaf, Dry extract refined (derived from Camellia sinensis, L. O.KUNTZE) (topical use): List of nationally authorised products - PSUSA/00010569/201812

Caffeine / ergotamine: List of nationally authorised products - PSUSA/00000485/201811 (PDF/88.1 KB)

Agenda - CHMP agenda of the 16-19 September 2019 meeting (PDF/810.75 KB)

Bisoprolol / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000420/201811 (PDF/151.52 KB)

CVMP post-authorisation summary of positive opinion Vectra Felis (II/0009) (PDF/137.48 KB)

Summary of opinion: Vectra Felis

CVMP post-authorisation summary of positive opinion for Bravecto (II/0033/G, II/0036) (PDF/149.32 KB)

Summary of opinion: Bravecto

CVMP post-authorisation summary of negative opinion for Velactis (II/0004) (PDF/127.67 KB)

Summary of opinion: Velactis

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2019 (PDF/145.45 KB)

Press release: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 September 2019

Summary of opinion: Gumbohatch

Summary of opinion: Nobivac Myxo-RHD Plus

Levodopa/Carbidopa/Entacapone Orion-H-C-PSUSA-00000547-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/82.2 KB)

EMA to provide guidance on avoiding nitrosamines in human medicines (PDF/107.06 KB)

Press release: EMA to provide guidance on avoiding nitrosamines in human medicines

Press release: EMA to review ranitidine medicines following detection of NDMA