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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015
CHMP, Last updated: 24/04/2015Duloxetine Mylan INN duloxetine Marketing-authorisation … Marketing-authorisation applicant Generics UK Limited Therapeutic indication … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 June 2021
CHMP, Last updated: 25/06/202101/07/2021 EMA/235088/2021 Generic Scientific advice and protocol … EMA/CHMP/SAWP/355768/2021 Generic Overview of invented names … 25/06/2021 EMA/354021/2021 Generic Abecma: EPAR Abiraterone … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2016
CHMP, Last updated: 11/11/2016Tadalafil Generics INN tadalafil Marketing-authorisation … Marketing-authorisation applicant MYLAN S.A.S Therapeutic indication … of opinion for Tadalafil Generics … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 2016
CHMP, Last updated: 29/01/2016orphan designation. Three generic medicines received a positive … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020
CHMP, Last updated: 31/01/2020EMA/CHMP/SAWP/47592/2020 Generic Recommendations on eligibility … 11/02/2020 EMA/634510/2019 Generic Ameluz: EPAR Arsenic trioxide … Ameluz: EPAR Arsenic trioxide Mylan: EPAR Azacitidine betapharm … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
CHMP, Last updated: 29/05/202004/06/2020 EMA/194047/2020 Generic Overview of invented names … 29/05/2020 EMA/280671/2020 Generic Scientific advice and protocol … 29/05/2020 EMA/CHMP/SAWP//2020 Generic Apixaban Accord: EPAR Hepcludex … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2019
CHMP, Last updated: 26/04/201926/04/2019 EMA/CHMP/208938/2019 Generic Name of medicine Dovato … 29/04/2019 EMA/CHMP/213099/2019 Generic Name of medicine Esperoct … 26/04/2019 EMA/CHMP/170114/2019 Generic Name of medicine Libtayo … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019
CHMP, Last updated: 26/07/201931/07/2019 EMA/317956/2019 Generic Scientific advice and protocol … EMA/CHMP/SAWP/420885/2019 Generic Deferasirox Mylan: EPAR Empliciti: EPAR Epidyolex … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016
CHMP, Last updated: 14/10/2016neuroendrocrine tumours. Three generic medicines were recommended … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021
CHMP, Last updated: 17/09/202122/09/2021 EMA/324180/2021 Generic Scientific advice and protocol … EMA/CHMP/SAWP/519377/2021 Generic Adempas: EPAR Artesunate … Raylumis: EPAR Rivaroxaban Mylan: EPAR Segluromet: EPAR Steglatro … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022
CHMP, Last updated: 19/09/2022EMA/CHMP/SAWP/769857/2022 Generic Recommendations on eligibility … 21/09/2022 EMA/68000/2022 Generic Adtralza: EPAR Biktarvy … EC decision Teriflunomide Mylan: Pending EC decision Vaxneuvance … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 December 2017
CHMP, Last updated: 15/12/2017breast and gastric cancer. Two generic medicines received a positive … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2019 (updated)
CHMP, Last updated: 15/11/201921/11/2019 EMA/506363/2019 Generic Scientific advice and protocol … EMA/CHMP/SAWP/643843/2019 Generic Clopidogrel / Acetylsalicylic … Clopidogrel / Acetylsalicylic acid Mylan: EPAR Deferasirox Accord … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2017
CHMP, Last updated: 23/06/2017authorised for use. Two A generic medicine is a medicine that … company can only market a generic medicine once the 10-year … information can be found under Generic and hybrid medicines … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017
CHMP, Last updated: 21/04/2017authorised for use. Two A generic medicine is a medicine that … company can only market a generic medicine once the 10-year … information can be found under Generic and hybrid medicines … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018
CHMP, Last updated: 23/03/2018arthritis and psoriasis. Two generic medicines received a positive … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017
CHMP, Last updated: 10/11/2017carcinoma of the cervix. Three generic medicines received a positive … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
CHMP, Last updated: 21/07/2017non-small cell lung cancer. Three generic medicines received a positive … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2016
CHMP, Last updated: 24/06/2016eosinophilic asthma. The A generic medicine is a medicine that … company can only market a generic medicine once the 10-year … information can be found under Generic and hybrid medicines … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2015
CHMP, Last updated: 22/05/2015replacement surgery. Two generic medicines received positive … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018
CHMP, Last updated: 27/07/2018marketing authorisation for three generic medicines … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 September 2014
CHMP, Last updated: 26/09/2014Tadalafil Mylan INN tadalafil Marketing-authorisation … Marketing-authorisation applicant Generics (UK) Limited Therapeutic … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
CHMP, Last updated: 17/12/202117/12/2021 EMA/751669/2021 Generic Apexxnar: EPAR Entyvio: EPAR … Metformin hydrochloride Mylan: EPAR Teysuno: EPAR Veklury … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022
CHMP, Last updated: 25/02/202225/02/2022 EMA/CHMP/SAWP/12021 Generic Beovu: EPAR Delstrigo: EPAR … Delstrigo: EPAR Dimethyl fumarate Mylan: EPAR Dimethyl fumarate Neuraxpharm … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 November 2011
CHMP, Last updated: 18/11/2011Positive opinions on generics …