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HMPC meeting report on European Union herbal monographs, guidelines and other activities - 18-20 July 2022 (PDF/107.14 KB) (new)

First published: 10/08/2022
EMA/HMPC/658338/20222
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Diclofenac (systemic formulations) : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00001048/202109 (PDF/130.68 KB) (new)

Last updated: 08/08/2022
Active substance: Diclofenac
Procedure number: PSUSA/00001048/202109
Regulatory outcome: Variation
Bulgarian
(PDF/150.99 KB)

Croatian
(PDF/153.41 KB)

Czech
(PDF/170.32 KB)

Danish
(PDF/123.31 KB)

Dutch
(PDF/114.2 KB)

Estonian
(PDF/121.81 KB)

Finnish
(PDF/111.8 KB)

French
(PDF/138.36 KB)

German
(PDF/128.04 KB)

Greek
(PDF/136.41 KB)

Hungarian
(PDF/150.82 KB)

Icelandic
(PDF/137.76 KB)

Italian
(PDF/171.11 KB)

Latvian
(PDF/174.83 KB)

Lithuanian
(PDF/153.2 KB)

Maltese
(PDF/143.1 KB)

Norwegian
(PDF/200.84 KB)

Polish
(PDF/155.97 KB)

Portuguese
(PDF/123.92 KB)

Romanian
(PDF/133.34 KB)

Slovak
(PDF/135.09 KB)

Slovenian
(PDF/151.41 KB)

Spanish
(PDF/132.78 KB)

Swedish
(PDF/112.59 KB)
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List of references supporting the assessment of Saccharomyces cerevisiae CBS 5926 (PDF/245.49 KB) (new)

Adopted
First published: 08/08/2022
EMA/HMPC/625624/2015
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Minutes - PCDO minutes of the 21-24 June 2022 meeting (PDF/514.37 KB) (new)

First published: 02/08/2022
EMA/PDCO/625532/2022
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Minutes of the PRAC meeting 25-28 October 2021 (PDF/960.77 KB) (new)

Adopted
First published: 02/08/2022
EMA/PRAC/648171/2022
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Rabeprazole : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00002601/202110 (PDF/81.29 KB) (new)

Last updated: 01/08/2022
Active substance: Rabeprazole
Procedure number: PSUSA/00002601/202110
Regulatory outcome: Variation
(PDF/124.01 KB)

Bulgarian
(PDF/120.78 KB)

Croatian
(PDF/116.6 KB)

Czech
(PDF/121.68 KB)

Danish
(PDF/81.05 KB)

Estonian
(PDF/75.81 KB)

Finnish
(PDF/77.17 KB)

French
(PDF/128.88 KB)

German
(PDF/84.13 KB)

Greek
(PDF/114.47 KB)

Hungarian
(PDF/120.28 KB)

Icelandic
(PDF/83 KB)

Italian
(PDF/125.71 KB)

Latvian
(PDF/154.14 KB)

Lithuanian
(PDF/142.33 KB)

Maltese
(PDF/126.84 KB)

Polish
(PDF/122.28 KB)

Portuguese
(PDF/80.53 KB)

Romanian
(PDF/115.13 KB)

Slovak
(PDF/124.47 KB)

Slovenian
(PDF/116.49 KB)

Spanish
(PDF/88.35 KB)

Swedish
(PDF/80.68 KB)
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Rabeprazole : List of nationally authorised medicinal products - PSUSA/00002601/202110 (PDF/172.27 KB) (new)

Last updated: 01/08/2022
Active substance: Rabeprazole
Procedure number: PSUSA/00002601/202110
Regulatory outcome: Variation
List item

PRAC recommendations on signals adopted at the 4-7 July 2022 PRAC meeting (PDF/160.13 KB) (new)

Adopted
First published: 01/08/2022
EMA/PRAC/610990/2022
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Soybean phospholipids (oral use) : List of nationally authorised medicinal products - PSUSA/00010707/202110 (PDF/167.82 KB) (new)

Last updated: 01/08/2022
Active substance: Soybean phospholipids (oral use)
Procedure number: PSUSA/00010707/202110
Regulatory outcome: Variation
List item

News: EMA Paediatric Committee elects Brian Aylward as its new Chair (new)

PDCO, Last updated: 25/07/2022
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P/0282/2021: EMA decision of 19 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cabozantinib (Cometriq, Cabometyx), (EMEA-001143-PIP01-11-M03) (PDF/256.28 KB) (new)

First published: 25/07/2022
EMA/394138/2021
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P/0254/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat (Rezolsta), (EMEA-001280-PIP01-12-M04) (PDF/245.37 KB) (new)

First published: 25/07/2022
EMA/357657/2021
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P/0250/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP03-18-M01) (PDF/215.45 KB) (new)

First published: 22/07/2022
EMA/640003/2008
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P/0269/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir alafenamide (Vemlidy), (EMEA-001584-PIP01-13-M06) (PDF/236.26 KB) (new)

First published: 22/07/2022
EMA/358271/2021
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P/0253/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for nemolizumab (EMEA- 001624-PIP01-14-M03) (PDF/228.97 KB) (new)

First published: 22/07/2022
EMA/358444/2021
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P/0244/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ralinepag (EMEA-002432-PIP02-20) (PDF/209.62 KB) (new)

First published: 22/07/2022
EMA/318092/2021
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P/0280/2021: EMA decision of 16 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bardoxolone (methyl) (EMEA-002488-PIP01-18) (PDF/258.34 KB) (new)

First published: 22/07/2022
EMA/384669/2021
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P/0243/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for finerenone (EMEA-001623-PIP03-20) (PDF/215.51 KB) (new)

First published: 22/07/2022
EMA/357803/2021
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P/0255/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for romosozumab (Evenity), (EMEA-001075-PIP04-15-M03) (PDF/251.68 KB) (new)

Adopted
First published: 22/07/2022
EMA/359907/2021
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P/0267/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir (Tivicay),(EMEA-000409-PIP01-08-M06) (PDF/228.21 KB) (new)

Adopted
First published: 22/07/2022
EMA/359351/2021
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P/0268/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (Invokana), (EMEA-001030-PIP01-10-M09) (PDF/220.73 KB) (new)

Adopted
First published: 22/07/2022
EMA/359518/2021
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Concept paper on the revision of the guideline for veterinary medicinal products for zootechnical purposes - Revision 1 (in progress) (PDF/205.05 KB) (new)

Draft: consultation open
First published: 22/07/2022
Consultations dates: from 22/07/2022 to 31/10/2022
EMA/CVMP/EWP/222080/2022
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P/0245/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan for maralixibat chloride (EMEA-001475-PIP04-20) (PDF/194.54 KB) (new)

First published: 22/07/2022
EMA/358055/2021
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P/0265/2021: EMA decision of 7 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for autologous selected renal cells (EMEA-002844-PIP01-20) (PDF/271.76 KB) (new)

First published: 22/07/2022
EMA/315803/2021
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Draft guideline on the application of Article 34 of Regulation (EU) 2019/6 - Classification of veterinary medicinal products (prescription status) (PDF/387.49 KB) (new)

Draft: consultation open
First published: 22/07/2022
Consultations dates: from 22/07/2022 to 31/10/2022
EMA/CVMP/273040/2022

13445 results

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 18-20 July 2022 (PDF/107.14 KB) (new)

Diclofenac (systemic formulations) : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00001048/202109 (PDF/130.68 KB) (new)

List of references supporting the assessment of Saccharomyces cerevisiae CBS 5926 (PDF/245.49 KB) (new)

Minutes - PCDO minutes of the 21-24 June 2022 meeting (PDF/514.37 KB) (new)

Minutes of the PRAC meeting 25-28 October 2021 (PDF/960.77 KB) (new)

Rabeprazole : Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisation(s) - PSUSA/00002601/202110 (PDF/81.29 KB) (new)

Rabeprazole : List of nationally authorised medicinal products - PSUSA/00002601/202110 (PDF/172.27 KB) (new)

PRAC recommendations on signals adopted at the 4-7 July 2022 PRAC meeting (PDF/160.13 KB) (new)

Soybean phospholipids (oral use) : List of nationally authorised medicinal products - PSUSA/00010707/202110 (PDF/167.82 KB) (new)

News: EMA Paediatric Committee elects Brian Aylward as its new Chair (new)

P/0282/2021: EMA decision of 19 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cabozantinib (Cometriq, Cabometyx), (EMEA-001143-PIP01-11-M03) (PDF/256.28 KB) (new)

P/0254/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for darunavir / cobicistat (Rezolsta), (EMEA-001280-PIP01-12-M04) (PDF/245.37 KB) (new)

P/0250/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for guselkumab (Tremfya), (EMEA-001523-PIP03-18-M01) (PDF/215.45 KB) (new)

P/0269/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for tenofovir alafenamide (Vemlidy), (EMEA-001584-PIP01-13-M06) (PDF/236.26 KB) (new)

P/0253/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for nemolizumab (EMEA- 001624-PIP01-14-M03) (PDF/228.97 KB) (new)

P/0244/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ralinepag (EMEA-002432-PIP02-20) (PDF/209.62 KB) (new)

P/0280/2021: EMA decision of 16 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bardoxolone (methyl) (EMEA-002488-PIP01-18) (PDF/258.34 KB) (new)

P/0243/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for finerenone (EMEA-001623-PIP03-20) (PDF/215.51 KB) (new)

P/0255/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for romosozumab (Evenity), (EMEA-001075-PIP04-15-M03) (PDF/251.68 KB) (new)

P/0267/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dolutegravir (Tivicay),(EMEA-000409-PIP01-08-M06) (PDF/228.21 KB) (new)

P/0268/2021: EMA decision of 9 July 2021 on the acceptance of a modification of an agreed paediatric investigation plan for canagliflozin (Invokana), (EMEA-001030-PIP01-10-M09) (PDF/220.73 KB) (new)

Concept paper on the revision of the guideline for veterinary medicinal products for zootechnical purposes - Revision 1 (in progress) (PDF/205.05 KB) (new)

P/0245/2021: EMA decision of 9 July 2021 on the agreement of a paediatric investigation plan for maralixibat chloride (EMEA-001475-PIP04-20) (PDF/194.54 KB) (new)

P/0265/2021: EMA decision of 7 July 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for autologous selected renal cells (EMEA-002844-PIP01-20) (PDF/271.76 KB) (new)

Draft guideline on the application of Article 34 of Regulation (EU) 2019/6 - Classification of veterinary medicinal products (prescription status) (PDF/387.49 KB) (new)