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Agenda - PDCO agenda of the 23-26 February 2021 meeting (PDF/360.47 KB) (new)

Adopted
First published: 23/02/2021
EMA/PDCO/67461/2021
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P/0365/2020: EMA decision of 9 September 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mitapivat (EMEA-002684-PIP01-19) (PDF/298.77 KB) (new)

Adopted
First published: 16/02/2021
EMA/415913/2020
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P/0059/2021: EMA decision of 5 February 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for COVID-19 vaccine (Ad26.COV2-S (recombinant)) (EMEA-002880-PIP01-20) (PDF/210.39 KB) (new)

Draft
First published: 16/02/2021
List item

P/0060/2021: EMA decision of 5 February 2021 on the acceptance of a modification of an agreed paediatric investigation plan for remdesivir (Veklury), (EMEA-002826-PIP01-20-M01) (PDF/167.33 KB) (new)

Adopted
First published: 16/02/2021
EMA/71518/2021
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P/0062/2021: EMA decision of 5 February 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for baricitinib (Olumiant), (EMEA-001220-PIP07-20) (PDF/199.65 KB) (new)

Adopted
First published: 16/02/2021
EMA/501874/2008
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Addendum to Assessment report on Lavandula angustifolia Mill. (L. officinalis Chaix), flos (PDF/216.77 KB) (new)

First published: 11/02/2021
EMA/HMPC/487394/2020
List item

Call for scientific data for the periodic review of the monograph on Arnica montana L., flos (PDF/109.92 KB) (new)

Draft: consultation open
First published: 02/02/2021
Consultations dates: from 01/02/2021 to 30/04/2021
EMA/HMPC/58504/2021
List item

Call for scientific data for the periodic review of the monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium (PDF/110.11 KB) (new)

Draft: consultation open
First published: 02/02/2021
Consultations dates: from 01/02/2021 to 30/04/2021
EMA/HMPC/58633/2021
List item

Call for scientific data for the periodic review of the monograph on Cichorium intybus L., radix (PDF/110.63 KB) (new)

Draft: consultation open
First published: 02/02/2021
Consultations dates: from 01/02/2021 to 30/04/2021
EMA/HMPC/58690/2021
List item

Call for scientific data for the periodic review of the monograph on Cucurbita pepo L., semen (PDF/110.07 KB) (new)

Draft: consultation open
First published: 02/02/2021
Consultations dates: from 01/02/2021 to 30/04/2021
EMA/HMPC/58701/2021
List item

Call for scientific data for the periodic review of the monograph on Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich), rhizoma (PDF/110.83 KB) (new)

Draft: consultation open
First published: 02/02/2021
Consultations dates: from 01/02/2021 to 30/04/2021
EMA/HMPC/58738/2021
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Minutes of the HMPC 16-18 November 2020 meeting (PDF/352.46 KB) (new)

Adopted
First published: 01/02/2021
EMA/HMPC/654096/2020
List item

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 11-13 January 2021 (PDF/108.62 KB) (new)

Adopted
First published: 01/02/2021
EMA/HMPC/35098/2021
List item

Draft public statement on Salvia miltiorrhiza Bunge, radix et rhizoma - First version (PDF/133.61 KB) (new)

Draft: consultation open
First published: 01/02/2021
Consultations dates: from 29/01/2021 to 30/04/2021
EMA/HMPC/509927/2019
List item

Draft list of references supporting the assessment of Salvia miltiorrhiza Bunge, radix et rhizoma - First version (PDF/226.09 KB) (new)

Draft
First published: 01/02/2021
EMA/HMPC/509927/2019
List item

Draft assessment report on Salvia miltiorrhiza Bunge, radix et rhizoma - First version (PDF/1.14 MB) (new)

Draft
First published: 01/02/2021
EMA/HMPC/509932/2019
List item

Draft European Union herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1 (PDF/263.14 KB) (new)

Draft: consultation open
First published: 01/02/2021
Consultations dates: from 01/02/2021 to 30/04/2021
EMA/HMPC/486551/2020
List item

Draft assessment report on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1 (PDF/543.87 KB) (new)

Draft
First published: 01/02/2021
EMA/HMPC/486549/2020
List item

Draft list of references supporting the assessment of Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1 (PDF/153.74 KB) (new)

Draft
First published: 01/02/2021
EMA/HMPC/486553/2020
List item

Addendum - Final assessment report on Syzygium aromaticum (L.) Merill et L.M. Perry, flos and Syzygium aromaticum (L.) Merill et L.M. Perry, floris aetheroleum (PDF/170.14 KB)

Adopted
First published: 28/01/2021
EMA/HMPC/475451/2020
List item

Paediatric Committee (PDCO): 23-26 March 2021

Virtual meeting, from 23/03/2021 to 26/03/2021, Last updated: 27/01/2021
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Paediatric Committee (PDCO): 20-23 April 2021

Virtual meeting, from 20/04/2021 to 23/04/2021, Last updated: 27/01/2021
List item

Paediatric Committee (PDCO): 18-21 May 2021

Virtual meeting, from 18/05/2021 to 21/05/2021, Last updated: 27/01/2021
List item

Paediatric Committee (PDCO): 22-25 June 2021

Virtual meeting, from 22/06/2021 to 25/06/2021, Last updated: 27/01/2021
List item

Paediatric Committee (PDCO): 20-23 July 2021

Virtual meeting, from 20/07/2021 to 23/07/2021, Last updated: 27/01/2021

7347 results

Agenda - PDCO agenda of the 23-26 February 2021 meeting (PDF/360.47 KB) (new)

P/0365/2020: EMA decision of 9 September 2020 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for mitapivat (EMEA-002684-PIP01-19) (PDF/298.77 KB) (new)

P/0059/2021: EMA decision of 5 February 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral for COVID-19 vaccine (Ad26.COV2-S (recombinant)) (EMEA-002880-PIP01-20) (PDF/210.39 KB) (new)

P/0060/2021: EMA decision of 5 February 2021 on the acceptance of a modification of an agreed paediatric investigation plan for remdesivir (Veklury), (EMEA-002826-PIP01-20-M01) (PDF/167.33 KB) (new)

P/0062/2021: EMA decision of 5 February 2021 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for baricitinib (Olumiant), (EMEA-001220-PIP07-20) (PDF/199.65 KB) (new)

Addendum to Assessment report on Lavandula angustifolia Mill. (L. officinalis Chaix), flos (PDF/216.77 KB) (new)

Call for scientific data for the periodic review of the monograph on Arnica montana L., flos (PDF/109.92 KB) (new)

Call for scientific data for the periodic review of the monograph on Camellia sinensis (L.) Kuntze, non fermentatum folium (PDF/110.11 KB) (new)

Call for scientific data for the periodic review of the monograph on Cichorium intybus L., radix (PDF/110.63 KB) (new)

Call for scientific data for the periodic review of the monograph on Cucurbita pepo L., semen (PDF/110.07 KB) (new)

Call for scientific data for the periodic review of the monograph on Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich), rhizoma (PDF/110.83 KB) (new)

Minutes of the HMPC 16-18 November 2020 meeting (PDF/352.46 KB) (new)

HMPC meeting report on European Union herbal monographs, guidelines and other activities - 11-13 January 2021 (PDF/108.62 KB) (new)

Draft public statement on Salvia miltiorrhiza Bunge, radix et rhizoma - First version (PDF/133.61 KB) (new)

Draft list of references supporting the assessment of Salvia miltiorrhiza Bunge, radix et rhizoma - First version (PDF/226.09 KB) (new)

Draft assessment report on Salvia miltiorrhiza Bunge, radix et rhizoma - First version (PDF/1.14 MB) (new)

Draft European Union herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1 (PDF/263.14 KB) (new)

Draft assessment report on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1 (PDF/543.87 KB) (new)

Draft list of references supporting the assessment of Orthosiphon aristatus (Blume) Miq. var. aristatus, folium - Revision 1 (PDF/153.74 KB) (new)

Addendum - Final assessment report on Syzygium aromaticum (L.) Merill et L.M. Perry, flos and Syzygium aromaticum (L.) Merill et L.M. Perry, floris aetheroleum (PDF/170.14 KB)

Paediatric Committee (PDCO): 23-26 March 2021

Paediatric Committee (PDCO): 20-23 April 2021

Paediatric Committee (PDCO): 18-21 May 2021

Paediatric Committee (PDCO): 22-25 June 2021

Paediatric Committee (PDCO): 20-23 July 2021