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Committee for Herbal Medicinal Products (HMPC): 18-20 July 2022 (updated)

from 18/07/2022 to 20/07/2022, Last updated: 10/08/2022
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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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Assessment report on Saccharomyces cerevisiae CBS 5926 (PDF/1.42 MB) (new)

Adopted
First published: 08/08/2022
EMA/HMPC/625623/2015
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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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Final public statement on Saccharomyces cerevisiae CBS 5926 (PDF/131.9 KB) (new)

Adopted
First published: 08/08/2022
EMA/HMPC/483588/2020
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Public statement on Salvia miltiorrhiza Bunge, radix et rhizoma (PDF/127.13 KB) (new)

First published: 03/08/2022
EMA/HMPC/509931/2019
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List of references supporting the assessment of Salvia miltiorrhiza Bunge, radix et rhizoma (PDF/234.37 KB) (new)

Adopted
First published: 03/08/2022
EMA/HMPC/509927/2019
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Assessment report on Salvia miltiorrhiza Bunge, radix et rhizoma (PDF/1.04 MB) (new)

Adopted
First published: 03/08/2022
EMA/HMPC/509932/2019
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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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CAT quarterly highlights and approved ATMPs - July 2022 (PDF/450.51 KB) (new)

First published: 29/07/2022
EMA/CAT/654429/2022
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HMPC: overview of assessment work - priority list (PDF/788.07 KB) (updated)

Adopted
First published: 26/10/2009
Last updated: 26/07/2022
EMA/HMPC/561868/2021
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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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Committee for Advanced Therapies (CAT): 15-17 June 2022 (updated)

European Medicines Agency, Amsterdam, the Netherlands, from 15/06/2022 to 17/06/2022, Last updated: 22/07/2022
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Minutes of the CAT meeting 15-17 June 2022 (PDF/461.52 KB) (new)

First published: 22/07/2022
EMA/CAT/600000/2022

9182 results

Committee for Herbal Medicinal Products (HMPC): 18-20 July 2022 (updated)

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

Assessment report on Saccharomyces cerevisiae CBS 5926 (PDF/1.42 MB) (new)

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

Final public statement on Saccharomyces cerevisiae CBS 5926 (PDF/131.9 KB) (new)

Public statement on Salvia miltiorrhiza Bunge, radix et rhizoma (PDF/127.13 KB) (new)

List of references supporting the assessment of Salvia miltiorrhiza Bunge, radix et rhizoma (PDF/234.37 KB) (new)

Assessment report on Salvia miltiorrhiza Bunge, radix et rhizoma (PDF/1.04 MB) (new)

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

CAT quarterly highlights and approved ATMPs - July 2022 (PDF/450.51 KB) (new)

HMPC: overview of assessment work - priority list (PDF/788.07 KB) (updated)

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)

Committee for Advanced Therapies (CAT): 15-17 June 2022 (updated)

Minutes of the CAT meeting 15-17 June 2022 (PDF/461.52 KB) (new)