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Dinoprostone : List of nationally authorised medicinal products - PSUSA/00001104/202209 (PDF/200.01 KB) (new)

Last updated: 01/06/2023
Active substance: dinoprostone
Procedure number: PSUSA/00001104/202209
Regulatory outcome: Maintenance
List item

Mandate, objectives and rules of procedure for the European Sales and Use of Antimicrobials for veterinary medicine Working Group (ESUAvet WG) (PDF/469.02 KB) (new)

First published: 01/06/2023
List item

Minutes of the CVMP meeting of 18-20 April 2023 (PDF/337.22 KB) (new)

Adopted
First published: 26/05/2023
EMA/CVMP/221092/2023
List item

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 10-12 May 2023 (PDF/104.07 KB) (new)

First published: 25/05/2023
EMA/HMPC/220353/2023
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Etomidate : List of nationally authorised medicinal products - PSUSA/00001330/202209 (PDF/167.72 KB) (new)

Last updated: 24/05/2023
Active substance: etomidate
Procedure number: PSUSA/00001330/202209
Regulatory outcome: Maintenance
List item

Felbamate : List of nationally authorised medicinal products - PSUSA/00010155/202209 (PDF/179.06 KB) (new)

Last updated: 24/05/2023
Active substance: felbamate
Procedure number: PSUSA/00010155/202209
Regulatory outcome: Maintenance
List item

Agenda of the PDCO meeting 23-26 May 2023 (PDF/382.25 KB) (new)

Draft
First published: 23/05/2023
EMA/PDCO/227981/2023
List item

News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 2023 (new)

CVMP, Last updated: 22/05/2023
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Janus Kinase inhibitors (JAKi) Article-20 procedure - Annex - Scientific conclusions (PDF/139.86 KB) (new)

First published: 22/05/2023
Bulgarian
(PDF/203.66 KB)

Croatian
(PDF/208.34 KB)

Czech
(PDF/217.54 KB)

Danish
(PDF/182.81 KB)

Dutch
(PDF/185.49 KB)

Estonian
(PDF/172.43 KB)

Finnish
(PDF/169.26 KB)

French
(PDF/178.06 KB)

German
(PDF/192.42 KB)

Greek
(PDF/202.37 KB)

Hungarian
(PDF/215.29 KB)

Icelandic
(PDF/189.22 KB)

Italian
(PDF/180.64 KB)

Latvian
(PDF/202.23 KB)

Lithuanian
(PDF/225.26 KB)

Maltese
(PDF/226.94 KB)

Norwegian
(PDF/180 KB)

Polish
(PDF/211.18 KB)

Portuguese
(PDF/181.57 KB)

Romanian
(PDF/221.05 KB)

Slovak
(PDF/199.58 KB)

Slovenian
(PDF/222.12 KB)

Spanish
(PDF/180.84 KB)

Swedish
(PDF/182.3 KB)
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Janus Kinase inhibitors (JAKi) Article-20 procedure - EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders (PDF/144.53 KB) (new)

First published: 22/05/2023
EMA/142279/2023
Bulgarian
(PDF/171.95 KB)

Croatian
(PDF/163.55 KB)

Czech
(PDF/169.94 KB)

Danish
(PDF/143.34 KB)

Dutch
(PDF/144.92 KB)

Estonian
(PDF/147.68 KB)

Finnish
(PDF/142.31 KB)

French
(PDF/146.19 KB)

German
(PDF/147.72 KB)

Greek
(PDF/173.18 KB)

Hungarian
(PDF/168.99 KB)

Italian
(PDF/143.21 KB)

Latvian
(PDF/169.62 KB)

Lithuanian
(PDF/167.59 KB)

Maltese
(PDF/170.99 KB)

Polish
(PDF/166.82 KB)

Portuguese
(PDF/143.95 KB)

Romanian
(PDF/166.7 KB)

Slovak
(PDF/179.25 KB)

Slovenian
(PDF/166.02 KB)

Spanish
(PDF/144.12 KB)

Swedish
(PDF/144.4 KB)
List item

Derivative of 4Hpyrazolo[3,4-d]pyrimidin-4-one (BI409306) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/80.15 KB) (new)

First published: 22/05/2023
EMEA-001742-PIP01-14
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Minutes of the PRAC meeting 6-9 February 2023 (PDF/876.31 KB) (new)

Adopted
First published: 17/05/2023
EMA/PRAC/185211/2023
List item

P/0185/2022 : EMA decision on 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for avibactam / aztreonam (EMEA-002283-PIP01-17-M03) (PDF/274.43 KB) (new)

Adopted
First published: 17/05/2023
EMA/640003/2008
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P/0187/2022 : EMA decision on 25 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga), (EMEA-000597-PIP03-15-M05) (PDF/257.47 KB) (new)

Adopted
First published: 17/05/2023
EMA/274001/2022
List item

P/0180/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for brincidofovir (EMEA- 001904-PIP03-18-M02) (PDF/209.5 KB) (new)

Adopted
First published: 17/05/2023
EMA/205675/2022
List item

P/0179/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cemiplimab (Libtayo), (EMEA-002007-PIP02-17-M02) (PDF/269.91 KB) (new)

Adopted
First published: 17/05/2023
EMA/205775/2022
List item

P/0177/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16-M01) (PDF/210.29 KB) (new)

Adopted
First published: 17/05/2023
EMA/205591/2022
List item

P/0175/2022 : EMA decision of 13 May 2022 on the refusal of a modification of an agreed paediatric investigation plan for betibeglogene autotemcel (Zynteglo), (EMEA-001665-PIP01-14-M06) (PDF/236.14 KB) (new)

Adopted
First published: 16/05/2023
EMA/206734/2022
List item

P/0174/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (EMEA- 002360-PIP01-18-M02) (PDF/229.81 KB) (new)

Adopted
First published: 16/05/2023
EMA/207913/2022
List item

P/0168/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for human, recombinant, non-fucosylated IgG1k monoclonal antibody...(EMEA-002886-PIP01-20-M01) (PDF/199.5 KB) (new)

Adopted
First published: 16/05/2023
EMA/204358/2022
List item

P/0170/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for remibrutinib (EMEA-002582-PIP01-19-M01) (PDF/173.16 KB) (new)

Adopted
First published: 16/05/2023
EMA/204227/2022
List item

P/0164/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bis-choline tetrathiomolybdate (EMEA-002232-PIP02-19-M02) (PDF/222.26 KB) (new)

Adopted
First published: 16/05/2023
EMA/207916/2022
List item

P/0163/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cefiderocol (Fetcroja), (EMEA-002133-PIP01-17-M02) (PDF/224.67 KB) (new)

Adopted
First published: 16/05/2023
EMA/207939/2022
List item

Pombiliti : EPAR - Risk management plan summary (PDF/394.94 KB) (new)

First published: 16/05/2023
List item

Aminosalicylic acid - List of nationally authorised medicinal products - PSUSA/00000165/202210 (PDF/128.13 KB) (new)

Last updated: 16/05/2023
Active substance: Aminosalicylic acid
Procedure number: PSUSA/00000165/202210
Regulatory outcome: Maintenance

14534 results

Dinoprostone : List of nationally authorised medicinal products - PSUSA/00001104/202209 (PDF/200.01 KB) (new)

Mandate, objectives and rules of procedure for the European Sales and Use of Antimicrobials for veterinary medicine Working Group (ESUAvet WG) (PDF/469.02 KB) (new)

Minutes of the CVMP meeting of 18-20 April 2023 (PDF/337.22 KB) (new)

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 10-12 May 2023 (PDF/104.07 KB) (new)

Etomidate : List of nationally authorised medicinal products - PSUSA/00001330/202209 (PDF/167.72 KB) (new)

Felbamate : List of nationally authorised medicinal products - PSUSA/00010155/202209 (PDF/179.06 KB) (new)

Agenda of the PDCO meeting 23-26 May 2023 (PDF/382.25 KB) (new)

News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 May 2023 (new)

Janus Kinase inhibitors (JAKi) Article-20 procedure - Annex - Scientific conclusions (PDF/139.86 KB) (new)

Janus Kinase inhibitors (JAKi) Article-20 procedure - EMA confirms measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders (PDF/144.53 KB) (new)

Derivative of 4Hpyrazolo[3,4-d]pyrimidin-4-one (BI409306) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/80.15 KB) (new)

Minutes of the PRAC meeting 6-9 February 2023 (PDF/876.31 KB) (new)

P/0185/2022 : EMA decision on 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for avibactam / aztreonam (EMEA-002283-PIP01-17-M03) (PDF/274.43 KB) (new)

P/0187/2022 : EMA decision on 25 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for mirabegron (Betmiga), (EMEA-000597-PIP03-15-M05) (PDF/257.47 KB) (new)

P/0180/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for brincidofovir (EMEA- 001904-PIP03-18-M02) (PDF/209.5 KB) (new)

P/0179/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cemiplimab (Libtayo), (EMEA-002007-PIP02-17-M02) (PDF/269.91 KB) (new)

P/0177/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for sufentanil (citrate) / ketamine (hydrochloride) (EMEA-001739-PIP02-16-M01) (PDF/210.29 KB) (new)

P/0175/2022 : EMA decision of 13 May 2022 on the refusal of a modification of an agreed paediatric investigation plan for betibeglogene autotemcel (Zynteglo), (EMEA-001665-PIP01-14-M06) (PDF/236.14 KB) (new)

P/0174/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for tirzepatide (EMEA- 002360-PIP01-18-M02) (PDF/229.81 KB) (new)

P/0168/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for human, recombinant, non-fucosylated IgG1k monoclonal antibody...(EMEA-002886-PIP01-20-M01) (PDF/199.5 KB) (new)

P/0170/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for remibrutinib (EMEA-002582-PIP01-19-M01) (PDF/173.16 KB) (new)

P/0164/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for bis-choline tetrathiomolybdate (EMEA-002232-PIP02-19-M02) (PDF/222.26 KB) (new)

P/0163/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for cefiderocol (Fetcroja), (EMEA-002133-PIP01-17-M02) (PDF/224.67 KB) (new)

Pombiliti : EPAR - Risk management plan summary (PDF/394.94 KB) (new)

Aminosalicylic acid - List of nationally authorised medicinal products - PSUSA/00000165/202210 (PDF/128.13 KB) (new)