7929 results
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,
, Revision: 14, Authorised, Last updated: 27/07/2023
itabine/Tenofovir disoproxil Mylan Blood-Borne Infections Communicable … itabine/Tenofovir disoproxil Mylan is an HIV medicine that is … Emtricitabine/Tenofovir disoproxil Mylan is also used to help prevent … -
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Referral: Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products
albendazole, Article 35
Status: European Commission final decision, opinion/position date: 05/11/2020, EC decision date: 18/01/2021, Last updated: 22/02/2021associated names, including its generic/hybrid products … associated names, including its generic/hybrid products. The withdrawal … associated names, including its generic/hybrid products Outcome of a procedure … -
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Referral: Baytril injectable and generics
enrofloxacin, Article 35
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 01/09/2014, Last updated: 10/12/2014Baytril injectable and generics … facts Baytril injectable and genericsenrofloxacinEMEA/V/A/097 Article 35 Community interest … Baytril injectable and generics - Art.35 - Background information … -
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Referral: Docetaxel Teva Generics
docetaxel, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/02/2011, EC decision date: 07/07/2011, Last updated: 03/07/2012Docetaxel Teva Generics … the medicine Docetaxel Teva Generics. The Agency's Committee for … benefits of Docetaxel Teva Generics outweigh its risks, and that … -
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Generic and hybrid applications
Last updated: 13/01/2021Generic and hybrid applications … from companies to market A generic medicine is a medicine that … company can only market a generic medicine once the 10-year …
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Generic and hybrid medicines
Last updated: 12/05/2017Generic and hybrid medicines … from companies to market A generic medicine is a medicine that … company can only market a generic medicine once the 10-year …
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Referral: Zanil and associated names, and generic products thereof
oxyclozanide, associated names: Zanil Suspension, Zanil Fluke Drench, Zanil Fluke Drench 34 mg/ml Oral Suspension, Article 35
Status: European Commission final decision, opinion/position date: 13/07/2017, EC decision date: 28/09/2017, Last updated: 25/10/2017and associated names, and generic products thereof … and associated names, and generic products thereof. The Agency's … and associated names, and generic products thereof? The veterinary … -
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Referral: Suanovil 20 / Captalin associated names and generic products thereof
spiramycin, Article 35
Status: European Commission final decision, opinion/position date: 09/09/2014, EC decision date: 11/12/2014, Last updated: 03/02/2015Captalin associated names and generic products thereof … solution for injection and its generic product Spirovet are solutions … and associated names and generic products thereof. The CVMP … -
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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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Referral: Betamox LA 150 mg/ml suspension for injection and associated names, and generics products thereof
Amoxicillin trihydrate, Article 35
Status: European Commission final decision, opinion/position date: 16/07/2020, EC decision date: 12/10/2020, Last updated: 12/11/2020and associated names, and generics products thereof … and associated names, and generic products thereof. The withdrawal … -
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Referral: Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof
azaperone, Article 35
Status: European Commission final decision, opinion/position date: 16/07/2020, EC decision date: 12/10/2020, Last updated: 30/10/2020and associated names, and generic products thereof … -
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Dissolution specification for generic oral immediate release products - Scientific guideline
Last updated: 15/08/2017Dissolution specification for generic oral immediate release products … Dissolution specification for generic oral immediate release products … dissolution specification for generic solid oral immediate release …
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Workshop on good clinical practice for bioequivalence trials/generics
European Medicines Agency, London, UK, 15/10/2015, Last updated: 12/10/2015for bioequivalence trials/generics … for bioequivalence trials/generics … for bioequivalence trials/generics 30 Churchill Place ● … -
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Dissolution specification for generic oral immediate release products
Last updated: 01/01/2015Dissolution specification for generic oral immediate release produc … Dissolution specification for generic oral immediate release produc … dissolution specification for generic oral immediate release products …
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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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Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance
Last updated: 31/12/2009Data exclusivity / Generics / Biosimilars: Regulatory … Data exclusivity / Generics / Biosimilars: Regulatory … between CMDh/RMS and EMA on generics and hybrids 1. Introduction …
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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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Referral: Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof
dinoprost, Article 35
Status: European Commission final decision, opinion/position date: 18/06/2020, EC decision date: 16/09/2020, Last updated: 06/10/2020and associated names, and generic products thereof … -
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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 …