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News: Europe to boost international cooperation on generics
Last updated: 19/01/2015international cooperation on generics … international cooperation on generics … EMA/789664/2014 International Generic Drug Regulators Programme … -
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News: Europe to boost cooperation with international partners on generics
Last updated: 07/08/2014international partners on generics … assessment of applications for generic medicines as part of the … part of the International Generic Drug Regulators Pilot (IGDRP … -
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Press release: Mylan S.A.S. withdraws its marketing authorisation application for Docetaxel Mylan (docetaxel)
Last updated: 15/03/2010Mylan S.A.S. withdraws its marketing … application for Docetaxel Mylan (docetaxel … been formally notified by Mylan S.A.S. of its decision to … -
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News: Regulatory information – application deadline for participation in information-sharing pilot project for generics extended
Last updated: 21/04/2015information-sharing pilot project for generics extended … information-sharing initiative for generics has been extended to give … part of the International Generic Drug Regulators Pilot (IGDRP … -
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Press release: European Medicines Agency and FDA announce launch of generic medicines application inspections initiative
Last updated: 18/12/2013and FDA announce launch of generic medicines application inspections … and FDA announce launch of generic medicines application inspections … Press release_Joint EMA FDA generic medicines bioequivalence … -
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Press release: Benefits of Diane 35 and generics outweigh risks in specific patient group
PRAC, Last updated: 17/05/2013Benefits of Diane 35 and generics outweigh risks in specific … ethinylestradiol 35 micrograms) and its generics outweigh the risks, provided … failed. Since Diane 35 and its generics are hormonal contraceptives … -
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Press release: European Medicines Agency update on Diane 35 and generics used in the treatment of acne
Last updated: 30/01/2013Agency update on Diane 35 and generics used in the treatment of acne … ethinylestradiol 35 micrograms) and its generics for acne treatment in France … considered that Diane 35 and its generics carry a risk of thromboembolism … -
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Press release: European Medicines Agency starts safety review of Diane 35 and its generics
PRAC, Last updated: 08/02/2013review of Diane 35 and its generics … associated names and its generics at its 4-7 February 2013 … authorisations for Diane 35 and its generics for acne treatment in France … -
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News: European Medicines Agency reiterates PRAC recommendation for Diane 35 and generics
PRAC, Last updated: 17/05/2013recommendation for Diane 35 and generics … benefits of Diane 35 and its generics outweigh the risks in a specific … thromboembolism, Diane 35 and its generics can be used in the treatment … -
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News: Pharmacovigilance Risk Assessment Committee (PRAC) invites stakeholders' feedback in review of Diane 35 and its generics
PRAC, Last updated: 12/02/2013review of Diane 35 and its generics … associated names and its generics at its 4-7 February 2013 … review of Diane 35 and its generics (08/02/2013) European Medicines … -
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Press release: European Medicines Agency recommends authorisation of first generic medicine for human use
Last updated: 19/07/2007recommends authorisation of first generic medicine for human use … marketing authorisation for a generic of a centrally authorised … 10 years, during which no generic medicine can be placed on … -
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Press release: Benefits of Diane 35 and its generics outweigh risks in certain patient groups - PRAC recommendation endorsed by CMDh
CMDh, Last updated: 30/05/2013Benefits of Diane 35 and its generics outweigh risks in certain … Benefits of Diane 35 and its generics outweigh risks in certain … Benefits of Diane 35 and its generics outweigh risks in certain … -
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Press release: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity
Last updated: 19/11/2018Valsartan from Mylan laboratories in India can … Pharmacopoeia Valsartan from Mylan laboratories in India can … PDF icon application/pdf mylan_valsartan_phc_on_cep_suspension_en.pdf 19/11/2018 EMA/809509/2018 Generic Angiotensin-II-receptor antagonists … -
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News: Clinical data for two more medicines now available online
Last updated: 01/02/2017Questions and answers on generic medicines . In future, the … Hospira: EPAR Aripiprazole Mylan: Withdrawn application Related … Clinical data publication Generic medicines External links … -
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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 …