412 results
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Press release: EMA reviewing cancer medicine docetaxel
PRAC, Last updated: 10/03/2017EMA reviewing cancer medicine docetaxel … investigating the cancer medicine docetaxel following cases of neutropenic … known and rare side effect of docetaxel (which may affect up to one … -
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Press release: PRAC concludes there is no evidence of a change in known risk of neutropenic enterocolitis with docetaxel
PRAC, Last updated: 09/06/2017neutropenic enterocolitis with docetaxel … Doctors advised to follow recommendations … neutropenic enterocolitis with docetaxel 30 Churchill Place … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 7-10 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 07/06/2021 to 10/06/2021, Last updated: 07/06/2021medicines for human use. Documents Agenda - PRAC draft agenda … this agenda is a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the agenda cannot … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021
PRAC, Last updated: 17/09/2021whether any changes to the Documents providing officially approved … this agenda is a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the agenda cannot … -
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Committee for Orphan Medicinal Products (COMP): 13-15 April 2021
European Medicines Agency, Amsterdam, the Netherlands, from 13/04/2021 to 15/04/2021, Last updated: 11/06/2021treatment of rare diseases. Documents COMP meeting report on the … -
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Committee for Orphan Medicinal Products (COMP): 15-17 June 2021
European Medicines Agency, Amsterdam, the Netherlands, from 15/06/2021 to 17/06/2021, Last updated: 24/06/2021Documents … this agenda is a working document primarily designed for COMP … undertakes. Note on access to documents Some documents mentioned in the agenda cannot … -
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Committee for Orphan Medicinal Products (COMP): 10-12 May 2021
European Medicines Agency, Amsterdam, the Netherlands, from 10/05/2021 to 12/05/2021, Last updated: 10/05/2021Documents … this agenda is a working document primarily designed for COMP … undertakes. Note on access to documents Some documents mentioned in the agenda cannot … -
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Committee for Orphan Medicinal Products (COMP): 16-18 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 16/02/2021 to 18/02/2021, Last updated: 01/03/2021treatment of rare diseases. Documents Agenda - COMP agenda of the … this agenda is a working document primarily designed for COMP … undertakes. Note on access to documents Some documents mentioned in the agenda cannot … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 8-11 February 2021
European Medicines Agency, Amsterdam, the Netherlands, from 08/02/2021 to 11/02/2021, Last updated: 08/02/2021medicines for human use. Documents Agenda - PRAC draft agenda … this agenda is a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the agenda cannot … -
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Committee for Orphan Medicinal Products (COMP): 19-21 January 2021
European Medicines Agency, Amsterdam, the Netherlands, from 19/01/2021 to 21/01/2021, Last updated: 03/02/2021Documents … set of minutes is a working document primarily designed for COMP … found at the end of this document. Note on access to documents Some documents mentioned in the minutes … -
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Committee for Orphan Medicinal Products (COMP): 3-5 November 2020
Virtual meeting, from 03/11/2020 to 05/11/2020, Last updated: 03/02/2021treatment of rare diseases. Documents Agenda - COMP agenda of the … set of minutes is a working document primarily designed for COMP … found at the end of this document. Note on access to documents Some documents mentioned in the minutes … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 26-29 October 2020
Virtual meeting, from 26/10/2020 to 29/10/2020, Last updated: 08/01/2021medicines for human use. Documents Minutes of the PRAC meeting … the minutes are a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the minutes … -
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News: Call for independent scientific experts to join EMA's Pharmacovigilance Risk Assessment Committee (PRAC) - deadline extended
PRAC, Last updated: 20/11/2020examining and commenting on documents. Working for the Committee … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 July 2020
European Medicines Agency, Amsterdam, the Netherlands, from 06/07/2020 to 09/07/2020, Last updated: 10/12/2020Documents … the minutes are a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the minutes … -
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Workshop on support for orphan medicines development
Virtual event, 30/11/2020, Last updated: 25/02/2021Documents … covered at the end of this document. The workshop was targeted … regulation and related guidance documents published by the European … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 23-26 November 2020
Virtual meeting, from 23/11/2020 to 26/11/2020, Last updated: 27/11/2020medicines for human use. Documents Minutes of the PRAC meeting … the minutes are a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the minutes … -
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Committee for Orphan Medicinal Products (COMP): 14-16 July 2020
European Medicines Agency, Amsterdam, the Netherlands, from 14/07/2020 to 16/07/2020, Last updated: 14/10/2020treatment of rare diseases. Documents Minutes of the COMP meeting … -
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Committee for Orphan Medicinal Products (COMP): 6-8 October 2020
Virtual meeting, from 06/10/2020 to 08/10/2020, Last updated: 08/10/2020treatment of rare diseases. Documents Agenda - COMP agenda of the … set of minutes is a working document primarily designed for COMP … undertakes. Note on access to documents Some documents mentioned in the minutes … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 28 September-1 October 2020
Virtual meeting, from 28/09/2020 to 01/10/2020, Last updated: 29/09/2020medicines for human use. Documents Agenda - PRAC draft agenda … the minutes are a working document primarily designed for PRAC … undertakes. Note on access to documents Some documents mentioned in the minutes … -
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Committee for Orphan Medicinal Products (COMP): 16-18 June 2020
European Medicines Agency, Amsterdam, the Netherlands, from 16/06/2020 to 18/06/2020, Last updated: 07/08/2020treatment of rare diseases. Documents Minutes of the COMP meeting … -
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Committee for Orphan Medicinal Products (COMP): 18-20 May 2020
European Medicines Agency, Amsterdam, the Netherlands, from 18/05/2020 to 20/05/2020, Last updated: 25/06/2020treatment of rare diseases. Documents Agenda - COMP agenda of the … -
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Committee for Orphan Medicinal Products (COMP): 17-19 March 2020
European Medicines Agency, Amsterdam, the Netherlands, from 17/03/2020 to 19/03/2020, Last updated: 15/05/2020treatment of rare diseases. Documents Minutes of the COMP meeting … -
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News: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets
PRAC, Last updated: 19/03/2021on a new or incompletely documented adverse event that is potentially … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 9-12 March 2020
from 09/03/2020 to 12/03/2020, Last updated: 06/03/2020medicines for human use. Documents Agenda - PRAC draft agenda … -
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Pharmacovigilance Risk Assessment Committee (PRAC): 13-16 January 2020
European Medicines Agency, Spark building, Orlyplein 24, Amsterdam 1043 DP, The Netherlands, from 13/01/2020 to 16/01/2020, Last updated: 13/01/2020EMA/PRAC/297855/2020 Generic Related documents Related content Meeting highlights …