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Aivlosin-V-C-83-II-0078 : EPAR - Assessment Report - Variation (PDF/427.42 KB) (new)

Adopted
First published: 19/10/2020
EMA/296009/2020
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Minutes of the CVMP meeting of 8-9 September 2020 meeting (PDF/339.41 KB) (new)

Adopted
First published: 16/10/2020
EMA/CVMP/527316/2020
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News: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-7 October 2020

CVMP, Last updated: 09/10/2020
List item

CVMP summary of positive opinion for Vectormune FP ILT (PDF/132.19 KB) (new)

Adopted
First published: 09/10/2020
EMA/CVMP/505185/2020
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CVMP post-authorisation summary of positive opinion for Innovax-ND-IBD (II/0004) (PDF/129.06 KB) (new)

Adopted
First published: 09/10/2020
EMA/CVMP/507630/2020
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CVMP summary of positive opinion for Rexxolide (PDF/65.72 KB) (new)

Adopted
First published: 09/10/2020
EMA/CVMP/496850/2020
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CVMP summary of positive opinion for Nobivac DP Plus (PDF/121.49 KB) (new)

Adopted
First published: 09/10/2020
EMA/CVMP/500514/2020
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CVMP summary of positive opinion for Enteroporc Coli AC (PDF/136.36 KB) (new)

Adopted
First published: 09/10/2020
EMA/CVMP/489228/2020
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CVMP summary of positive opinion for CircoMax Myco (PDF/66.58 KB) (new)

Adopted
First published: 09/10/2020
EMA/CVMP/495892/2020
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Agenda - CVMP agenda of the 6-8 October 2020 meeting (PDF/284.04 KB) (new)

Draft
First published: 06/10/2020
EMA/523278/2020 draft 3
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Dinolytic and generics Article-35 referral - Annex I-III (PDF/163.37 KB) (new)

First published: 06/10/2020
Bulgarian
(PDF/223.78 KB)

Croatian
(PDF/193.5 KB)

Czech
(PDF/195.78 KB)

Danish
(PDF/151.46 KB)

Dutch
(PDF/170.22 KB)

Estonian
(PDF/166.23 KB)

Finnish
(PDF/163.13 KB)

French
(PDF/170.08 KB)

German
(PDF/169.9 KB)

Greek
(PDF/237.45 KB)

Hungarian
(PDF/194.53 KB)

Icelandic
(PDF/161.63 KB)

Italian
(PDF/167.8 KB)

Latvian
(PDF/207.01 KB)

Lithuanian
(PDF/202.5 KB)

Maltese
(PDF/201.08 KB)

Norwegian
(PDF/165.82 KB)

Polish
(PDF/205.78 KB)

Portuguese
(PDF/167.29 KB)

Romanian
(PDF/199.3 KB)

Slovak
(PDF/191.75 KB)

Slovenian
(PDF/189.16 KB)

Spanish
(PDF/151.06 KB)

Swedish
(PDF/166.73 KB)
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Dinolytic and generics Article-35 referral - Questions and answers on the review of withdrawal periods for Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof (PDF/75.34 KB) (new)

First published: 06/10/2020
EMA/451685/2020
Bulgarian
(PDF/97.71 KB)

Croatian
(PDF/78.73 KB)

Czech
(PDF/81.73 KB)

Danish
(PDF/75.52 KB)

Dutch
(PDF/76.16 KB)

Estonian
(PDF/74.15 KB)

Finnish
(PDF/74.02 KB)

French
(PDF/78.15 KB)

German
(PDF/79.33 KB)

Greek
(PDF/93.12 KB)

Hungarian
(PDF/78.79 KB)

Italian
(PDF/76.59 KB)

Latvian
(PDF/82.21 KB)

Lithuanian
(PDF/81.95 KB)

Maltese
(PDF/82.85 KB)

Polish
(PDF/82.58 KB)

Portuguese
(PDF/76.13 KB)

Romanian
(PDF/79.96 KB)

Slovak
(PDF/80.25 KB)

Slovenian
(PDF/90.79 KB)

Spanish
(PDF/76.38 KB)

Swedish
(PDF/74.53 KB)
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Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2020 (PDF/276.11 KB) (new)

Adopted
First published: 29/09/2020
EMA/402999/2020
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Clynav-V-C-2390-II-0010 : EPAR - Assessment report - Variation (PDF/281.29 KB) (new)

Adopted
First published: 25/09/2020
EMA/101438/2020
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Minutes of the CVMP meeting of 14-16 July 2020 meeting (PDF/339.68 KB)

Adopted
First published: 18/09/2020
EMA/CVMP/473597/2020
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Advice on implementing measures under Article 106 (6) of Regulation (EU) 2019/6 on veterinary medicinal products – scientific problem analysis and recommendations to ensure a safe and efficient administration of oral veterinary medicinal products via rout (PDF/1.06 MB)

Adopted
First published: 16/09/2020
EMA/CVMP/508559/2019
List item

News: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-9 September 2020

CVMP, Last updated: 11/09/2020
List item

Imidacloprid (Fin fish) - Summary opinion of the CVMP on the establishment of maximum residue limits (PDF/68.44 KB)

Adopted
First published: 11/09/2020
EMA/CVMP/446875/2020
List item

CVMP post-authorisation summary of positive opinion for Cytopoint (II-0009) (PDF/139.68 KB)

Adopted
First published: 11/09/2020
EMA/CVMP/446877/2020
List item

CVMP summary of positive opinion for OvuGel (PDF/136.42 KB)

Adopted
First published: 11/09/2020
EMA/CVMP/430527/2020
List item

CVMP summary of positive opinion for Librela (PDF/133.73 KB)

Adopted
First published: 11/09/2020
EMA/CVMP/438128/2020
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Bacillus clausii multi-antibioresistant spores: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000284/201911 (PDF/95.16 KB)

Last updated: 11/09/2020
Active substance: bacillus clausii multi-antibioresistant spores
Procedure number: PSUSA/00000284/201911
Regulatory outcome: Variation
Bulgarian
(PDF/135.38 KB)

Croatian
(PDF/120.04 KB)

Czech
(PDF/132.37 KB)

Danish
(PDF/102.68 KB)

Dutch
(PDF/101.53 KB)

Estonian
(PDF/98.38 KB)

Finnish
(PDF/100.13 KB)

French
(PDF/102.62 KB)

German
(PDF/116.88 KB)

Greek
(PDF/126.84 KB)

Hungarian
(PDF/135.09 KB)

Italian
(PDF/92.22 KB)

Latvian
(PDF/123.2 KB)

Lithuanian
(PDF/123.72 KB)

Maltese
(PDF/92.65 KB)

Polish
(PDF/117.29 KB)

Portuguese
(PDF/102.92 KB)

Romanian
(PDF/121.72 KB)

Slovak
(PDF/0 bytes)

Slovenian
(PDF/0 bytes)

Spanish
(PDF/103.61 KB)

Swedish
(PDF/0 bytes)
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Vectormune FP ILT + AE : EPAR - Procedural steps taken and scientific information after the authorisation (PDF/70.34 KB)

First published: 09/09/2020
List item

Agenda - CVMP agenda of the 8-10 September 2020 meeting (PDF/242.38 KB)

Draft
First published: 08/09/2020
EMA/469339/2020
List item

Iron (parenteral preparations, except for iron dextran): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010236/202001 (PDF/27.64 KB)

Last updated: 07/09/2020
Active substance: iron (parenteral preparations, except for iron dextran)
Procedure number: PSUSA/00010236/202001
Regulatory outcome: Variation
Bulgarian
(PDF/76.13 KB)

Croatian
(PDF/65.09 KB)

Czech
(PDF/59.24 KB)

Danish
(PDF/27.87 KB)

Dutch
(PDF/28.21 KB)

Estonian
(PDF/27.8 KB)

Finnish
(PDF/26.7 KB)

French
(PDF/28.65 KB)

German
(PDF/29.5 KB)

Greek
(PDF/132.29 KB)

Hungarian
(PDF/57.1 KB)

Icelandic
(PDF/27.78 KB)

Italian
(PDF/28.84 KB)

Latvian
(PDF/81.43 KB)

Lithuanian
(PDF/74.33 KB)

Maltese
(PDF/70.47 KB)

Norwegian
(PDF/28.4 KB)

Polish
(PDF/61.32 KB)

Portuguese
(PDF/28.01 KB)

Romanian
(PDF/66.42 KB)

Slovak
(PDF/58.98 KB)

Slovenian
(PDF/65.5 KB)

Spanish
(PDF/28.52 KB)

Swedish
(PDF/27.31 KB)

4809 results

Aivlosin-V-C-83-II-0078 : EPAR - Assessment Report - Variation (PDF/427.42 KB) (new)

Minutes of the CVMP meeting of 8-9 September 2020 meeting (PDF/339.41 KB) (new)

News: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 6-7 October 2020

CVMP summary of positive opinion for Vectormune FP ILT (PDF/132.19 KB) (new)

CVMP post-authorisation summary of positive opinion for Innovax-ND-IBD (II/0004) (PDF/129.06 KB) (new)

CVMP summary of positive opinion for Rexxolide (PDF/65.72 KB) (new)

CVMP summary of positive opinion for Nobivac DP Plus (PDF/121.49 KB) (new)

CVMP summary of positive opinion for Enteroporc Coli AC (PDF/136.36 KB) (new)

CVMP summary of positive opinion for CircoMax Myco (PDF/66.58 KB) (new)

Agenda - CVMP agenda of the 6-8 October 2020 meeting (PDF/284.04 KB) (new)

Dinolytic and generics Article-35 referral - Annex I-III (PDF/163.37 KB) (new)

Dinolytic and generics Article-35 referral - Questions and answers on the review of withdrawal periods for Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof (PDF/75.34 KB) (new)

Monthly report on application procedures, guidelines and related documents for veterinary medicines: July 2020 (PDF/276.11 KB) (new)

Clynav-V-C-2390-II-0010 : EPAR - Assessment report - Variation (PDF/281.29 KB) (new)

Minutes of the CVMP meeting of 14-16 July 2020 meeting (PDF/339.68 KB)

Advice on implementing measures under Article 106 (6) of Regulation (EU) 2019/6 on veterinary medicinal products – scientific problem analysis and recommendations to ensure a safe and efficient administration of oral veterinary medicinal products via rout (PDF/1.06 MB)

News: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-9 September 2020

Imidacloprid (Fin fish) - Summary opinion of the CVMP on the establishment of maximum residue limits (PDF/68.44 KB)

CVMP post-authorisation summary of positive opinion for Cytopoint (II-0009) (PDF/139.68 KB)

CVMP summary of positive opinion for OvuGel (PDF/136.42 KB)

CVMP summary of positive opinion for Librela (PDF/133.73 KB)

Bacillus clausii multi-antibioresistant spores: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000284/201911 (PDF/95.16 KB)

Vectormune FP ILT + AE : EPAR - Procedural steps taken and scientific information after the authorisation (PDF/70.34 KB)

Agenda - CVMP agenda of the 8-10 September 2020 meeting (PDF/242.38 KB)

Iron (parenteral preparations, except for iron dextran): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010236/202001 (PDF/27.64 KB)