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PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC meeting (PDF/23.84 KB) (new)

Adopted
First published: 01/06/2020
EMA/PRAC/257435/2020
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CVMP post-authorisation summary of positive opinion for Aivlosin (II-0078) (PDF/148.93 KB) (new)

Adopted
First published: 25/05/2020
EMA/CVMP/238731/2020
List item

CVMP post-authorisation summary of positive opinion for Leucofeligen FeLV/RCP (II-0012) (PDF/69.07 KB) (new)

Adopted
First published: 25/05/2020
EMA/CVMP/242131/2020
List item

CVMP post-authorisation summary of positive opinion for Zulvac BTV (II-0004) (PDF/151.13 KB) (new)

Adopted
First published: 25/05/2020
EMA/CVMP/235910/2020
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CVMP summary of positive opinion for Prevexxion RN+HVT+IBD (PDF/143.45 KB) (new)

Adopted
First published: 25/05/2020
EMA/CVMP/240518/2020
List item

CVMP summary of positive opinion for Prevexxion RN (PDF/141 KB) (new)

Adopted
First published: 25/05/2020
EMA/CVMP/240890/2020
List item

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 May 2020 (PDF/158.58 KB) (new)

First published: 25/05/2020
EMA/CVMP/251876/2020
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Medicinal products for human use: monthly figures - April 2020 (PDF/112.4 KB) (new)

First published: 25/05/2020
EMA/272842/2020
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Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201910 (PDF/169.06 KB) (new)

Last updated: 25/05/2020
Active substance: acitretin
Procedure number: PSUSA/00000051/201910
Regulatory outcome: Maintenance
List item

Drospirenone / ethinylestradiol: List of nationally authorised medicinal products - PSUSA/00010217/201909 (PDF/234.08 KB) (new)

Last updated: 20/05/2020
Active substance: Drospirenone, ethinylestradiol
Procedure number: PSUSA/00010217/201909
Regulatory outcome: Maintenance
List item

Betamethasone / tetryzoline: List of nationally authorised medicinal products - PSUSA/00010072/201909 (PDF/97.99 KB) (new)

Last updated: 20/05/2020
Active substance: betamethasone, tetryzoline
Procedure number: PSUSA/00010072/201909
Regulatory outcome: Maintenance
List item

Itopride: List of nationally authorised medicinal products - PSUSA/00010606/201906 (PDF/138.78 KB) (new)

Last updated: 20/05/2020
Active substance: itopride
Procedure number: PSUSA/00010606/201906
Regulatory outcome: Maintenance
List item

Opinion of the CVMP on the establishment of maximum residue limits: Ciclesonide (PDF/193.57 KB) (new)

Adopted
First published: 20/05/2020
EMA/CVMP/101968/2019
List item

Chlorquinaldol (vaginal tablet) / promestriene : List of nationally authorised medicinal products - PSUSA/00009272/201909 (PDF/108.61 KB) (new)

Last updated: 20/05/2020
Active substance: chlorquinaldol, promestriene
Procedure number: PSUSA/00009272/201909
Regulatory outcome: Maintenance
List item

Aminosalicylate sodium: List of nationally authorised medicinal products - PSUSA/00000165/201910 (PDF/121.94 KB) (new)

Last updated: 20/05/2020
Active substance: aminosalicylate sodium
Procedure number: PSUSA/00000165/201910
Regulatory outcome: Maintenance
List item

Clenbuterol: List of nationally authorised medicinal products - PSUSA/00000794/201909 (PDF/106.08 KB) (new)

Last updated: 20/05/2020
Active substance: clenbuterol
Procedure number: PSUSA/00000794/201909
Regulatory outcome: Maintenance
List item

Ambroxol / clenbuterol: List of nationally authorised medicinal products - PSUSA/00000131/201909 (PDF/103.68 KB) (new)

Last updated: 20/05/2020
Active substance: ambroxol, clenbuterol
Procedure number: PSUSA/00000131/201909
Regulatory outcome: Maintenance
List item

Ambroxol : List of nationally authorised medicinal products - PSUSA/00000130/201909 (PDF/452.04 KB) (new)

Last updated: 20/05/2020
Active substance: ambroxol
Procedure number: PSUSA/00000130/201909
Regulatory outcome: Maintenance
List item

Cyproterone Article-31 referral - Annex I (PDF/421.76 KB) (new)

First published: 20/05/2020
Bulgarian
(PDF/466.37 KB)

Croatian
(PDF/448.5 KB)

Czech
(PDF/442.82 KB)

Danish
(PDF/431.09 KB)

Dutch
(PDF/425.97 KB)

Estonian
(PDF/428.91 KB)

Finnish
(PDF/429.3 KB)

French
(PDF/435.7 KB)

German
(PDF/428.45 KB)

Greek
(PDF/447.03 KB)

Hungarian
(PDF/451.46 KB)

Italian
(PDF/436.98 KB)

Latvian
(PDF/447.36 KB)

Lithuanian
(PDF/459.15 KB)

Maltese
(PDF/442.54 KB)

Polish
(PDF/454.37 KB)

Portuguese
(PDF/444.52 KB)

Romanian
(PDF/462.67 KB)

Slovak
(PDF/464.63 KB)

Slovenian
(PDF/449.39 KB)

Spanish
(PDF/436.78 KB)

Swedish
(PDF/419.36 KB)
List item

Cyproterone Article-31 referral - Annex II (PDF/181.09 KB) (new)

First published: 20/05/2020
Bulgarian
(PDF/219.03 KB)

Croatian
(PDF/214.76 KB)

Czech
(PDF/201.79 KB)

Danish
(PDF/185.39 KB)

Dutch
(PDF/164.8 KB)

Estonian
(PDF/185.88 KB)

Finnish
(PDF/162.83 KB)

French
(PDF/182.85 KB)

German
(PDF/172.56 KB)

Greek
(PDF/218.1 KB)

Hungarian
(PDF/192.38 KB)

Italian
(PDF/163.75 KB)

Latvian
(PDF/231.3 KB)

Lithuanian
(PDF/222.72 KB)

Maltese
(PDF/234.17 KB)

Polish
(PDF/208.72 KB)

Portuguese
(PDF/167.12 KB)

Romanian
(PDF/220.72 KB)

Slovak
(PDF/203.96 KB)

Slovenian
(PDF/218.28 KB)

Spanish
(PDF/182.26 KB)

Swedish
(PDF/165.53 KB)
List item

Cyproterone Article-31 referral - Annex IV (PDF/84.48 KB) (new)

First published: 20/05/2020
Bulgarian
(PDF/140.94 KB)

Croatian
(PDF/143.67 KB)

Czech
(PDF/132.82 KB)

Danish
(PDF/124.93 KB)

Dutch
(PDF/120.03 KB)

Estonian
(PDF/118.48 KB)

Finnish
(PDF/117.4 KB)

French
(PDF/120.86 KB)

German
(PDF/126.01 KB)

Greek
(PDF/132.89 KB)

Hungarian
(PDF/138.83 KB)

Italian
(PDF/117.61 KB)

Latvian
(PDF/145.77 KB)

Lithuanian
(PDF/152.03 KB)

Maltese
(PDF/142.52 KB)

Polish
(PDF/156.95 KB)

Portuguese
(PDF/121.55 KB)

Romanian
(PDF/146.52 KB)

Slovak
(PDF/152.45 KB)

Slovenian
(PDF/148.37 KB)

Spanish
(PDF/119.83 KB)

Swedish
(PDF/120.95 KB)
List item

Pharmacovigilance regulatory recommendations for centrally authorised veterinary medicinal products during 2020 (PDF/125.34 KB) (new)

First published: 20/05/2020
EMA/112926/2020
List item

Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2020 (PDF/232.39 KB) (new)

Adopted
First published: 19/05/2020
EMA/191989/2020
List item

Valsartan / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010735/201910 (PDF/230.02 KB) (new)

Last updated: 19/05/2020
Active substance: valsartan, Rosuvastatin
Procedure number: PSUSA/00010735/201910
Regulatory outcome: Maintenance
List item

Dinoprostone: List of nationally authorised medicinal products - PSUSA/00001104/201909 (PDF/167.95 KB) (new)

Last updated: 19/05/2020
Active substance: dinoprostone
Procedure number: PSUSA/00001104/201909
Regulatory outcome: Maintenance

25802 results

PRAC recommendations on signals adopted at the 11-14 May 2020 PRAC meeting (PDF/23.84 KB) (new)

CVMP post-authorisation summary of positive opinion for Aivlosin (II-0078) (PDF/148.93 KB) (new)

CVMP post-authorisation summary of positive opinion for Leucofeligen FeLV/RCP (II-0012) (PDF/69.07 KB) (new)

CVMP post-authorisation summary of positive opinion for Zulvac BTV (II-0004) (PDF/151.13 KB) (new)

CVMP summary of positive opinion for Prevexxion RN+HVT+IBD (PDF/143.45 KB) (new)

CVMP summary of positive opinion for Prevexxion RN (PDF/141 KB) (new)

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 May 2020 (PDF/158.58 KB) (new)

Medicinal products for human use: monthly figures - April 2020 (PDF/112.4 KB) (new)

Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201910 (PDF/169.06 KB) (new)

Drospirenone / ethinylestradiol: List of nationally authorised medicinal products - PSUSA/00010217/201909 (PDF/234.08 KB) (new)

Betamethasone / tetryzoline: List of nationally authorised medicinal products - PSUSA/00010072/201909 (PDF/97.99 KB) (new)

Itopride: List of nationally authorised medicinal products - PSUSA/00010606/201906 (PDF/138.78 KB) (new)

Opinion of the CVMP on the establishment of maximum residue limits: Ciclesonide (PDF/193.57 KB) (new)

Chlorquinaldol (vaginal tablet) / promestriene : List of nationally authorised medicinal products - PSUSA/00009272/201909 (PDF/108.61 KB) (new)

Aminosalicylate sodium: List of nationally authorised medicinal products - PSUSA/00000165/201910 (PDF/121.94 KB) (new)

Clenbuterol: List of nationally authorised medicinal products - PSUSA/00000794/201909 (PDF/106.08 KB) (new)

Ambroxol / clenbuterol: List of nationally authorised medicinal products - PSUSA/00000131/201909 (PDF/103.68 KB) (new)

Ambroxol : List of nationally authorised medicinal products - PSUSA/00000130/201909 (PDF/452.04 KB) (new)

Cyproterone Article-31 referral - Annex I (PDF/421.76 KB) (new)

Cyproterone Article-31 referral - Annex II (PDF/181.09 KB) (new)

Cyproterone Article-31 referral - Annex IV (PDF/84.48 KB) (new)

Pharmacovigilance regulatory recommendations for centrally authorised veterinary medicinal products during 2020 (PDF/125.34 KB) (new)

Monthly report on application procedures, guidelines and related documents for veterinary medicines: March 2020 (PDF/232.39 KB) (new)

Valsartan / rosuvastatin: List of nationally authorised medicinal products - PSUSA/00010735/201910 (PDF/230.02 KB) (new)

Dinoprostone: List of nationally authorised medicinal products - PSUSA/00001104/201909 (PDF/167.95 KB) (new)