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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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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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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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Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance
Last updated: 31/12/2009Data exclusivity / Generics / Biosimilars: Regulatory … European Medicines Agency on generics and hybrids PDF icon application/pdf … 04/12/2012 EMA/234449/2012 Generic European Medicines Agency …
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National expert: Audrey Sultana, Medicines Authority (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 18.44 KB | PDF
affairs Publications Projects Centralised Generic Products: Clinical Assessment … Authorisation Application Duloxetine Mylan -Marketing Authorisation … Application Lopinavir/Ritonavir Mylan -Marketing Authorisation … -
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National expert: John Joseph Borg, Medicines Authority (updated)
- Declaration of interests - 80.14 KB | PDF
- Curriculum Vitae - 27.3 KB | PDF
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National expert: Nicolas Lee, Health Products Regulatory Authority (updated)
- Declaration of interests - 81.3 KB | PDF
- Curriculum Vitae - 17.51 KB | PDF
Ireland) Responsible for R&D (Ireland) of generic medicinal products April … Laboratories Lead role Memantine Mylan Alzheimers Donepezil Mylan Alzheimers Clopidogrel Mylan Anti-clotting Acarbose … -
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National expert: Jeanette Devane, Health Products Regulatory Authority (updated)
- Declaration of interests - 80.45 KB | PDF
- Curriculum Vitae - 18.33 KB | PDF
product RA responsibilities: Generic MA Applications: DCP/MRP … Person (GDP) in Ireland Only. Generic MA Applications: National … Team Leader/ LIMS SuperUser Mylan Damastown (Formerly Rottapharm … -
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Recommendations on medication errors
Last updated: 24/06/202029/08/2018 EMA/133231/2018 Generic Blincyto: measures to avoid … 08/12/2015 EMA/677776/2015 Generic Deferasirox Mylan: Measures to avoid medication …
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National expert: Karina Kuczka, Paul Ehrlich Institute (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 16.79 KB | PDF
Pharma (since Aug 2016 part of Mylan) Clinical assessor (Department … -
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National expert: Saul Faust, European Medicines Agency (updated)
- Declaration of interests - 87.22 KB | PDF
- Curriculum Vitae - 81.46 KB | PDF
Meeting of experts to discuss generic issues related to C Difficile … discussions with PDCO to discuss generic issues regarding age/case … Meeting of experts to discuss generic issues related to C Difficile … -
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National expert: Javier Gisbert, European Medicines Agency (updated)
- Declaration of interests - 81.24 KB | PDF
- Curriculum Vitae - 24.45 KB | PDF
Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz … Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz … Pfizer, Kern Pharma, Biogen, Mylan, Takeda, Janssen, Roche, Sandoz … -
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National expert: Rosa Giuliani, Italian Medicines Agency (updated)
- Declaration of interests - 85.51 KB | PDF
- Curriculum Vitae - 35.88 KB | PDF
cancer 09/2018-09/2018 Mylan Trastuzumab biosimilar breast … -
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National expert: Ciarán Joyce, Health Products Regulatory Authority (updated)
- Declaration of interests - 80.39 KB | PDF
- Curriculum Vitae - 16.69 KB | PDF
2016-August 2016 Sourcing intern Mylan Ireland (Ireland) EDUCATION … consulting Employment/Consultancy Mylan Financial BMS Financial Sigma … -
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National expert: Matjaz Marc, Agency for medicinal products and medical devices of the Republic of Slovenia (updated)
- Declaration of interests - 81.17 KB | PDF
- Curriculum Vitae - 17.74 KB | PDF
2019-January 2020 Marketing manager Mylan Healthcare (Slovenia) January … Indication 06/2019-01/2020 Mylan Cross product responsibility … -
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National expert: Christophe Richez, European Medicines Agency (updated)
- Declaration of interests - 93.37 KB | PDF
- Curriculum Vitae - 19.21 KB | PDF
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National expert: Marcel Maliepaard, Medicines Evaluation Board (updated)
- Declaration of interests - 80.01 KB | PDF
- Curriculum Vitae - 28.16 KB | PDF
PGWP) Co-promotor of a PhD project on generic substitution, in collaboration … oncology & immunosupressants Generic drugs In vitro diagnostics 08/12/2022 … Maliepaard. Reasons for patients' generic drug switching at the pharmacy … -
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National expert: Sheila Ampaire, European Medicines Agency (updated)
- Declaration of interests - 80.09 KB | PDF
- Curriculum Vitae - 20.49 KB | PDF
Limited Spouse works for this generics manufacturer in Uganda 2.9 … -
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National expert: Anthony Serracino-Inglott, Medicines Authority (updated)
- Declaration of interests - 80.64 KB | PDF
- Curriculum Vitae - 101.75 KB | PDF
Lead role Venlafaxine generic Treatment of major depressive … -
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National expert: Liisa Tenkanen, Finnish Medicines Agency (updated)
- Declaration of interests - 81.47 KB | PDF
- Curriculum Vitae - 16.45 KB | PDF
Medical Adviser for certain generic products (Pharmacovigilance … -
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Herbal medicinal product: Citri bergamiae aetheroleum
Citrus bergamia Risso & Poiteau., Bergamot oil, F: Assessment finalised, Last updated: 29/11/202128/08/2012 EMA/HMPC/56155/2011 Generic Final list of references … 28/08/2012 EMA/HMPC/56157/2011 Generic Final public statement on … 28/08/2012 EMA/HMPC/528177/2011 Generic Consultation Draft assessment … -
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National expert: Carmen Ferrajolo, Italian Medicines Agency (updated)
- Declaration of interests - 80.39 KB | PDF
- Curriculum Vitae - 31.34 KB | PDF
AstraZeneca,AbbVie, Servier,Mylan, Gilead, Amgen advisory … -
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Herbal medicinal product: Allii sativi bulbus
Allium sativum L., Garlic, F: Assessment finalised, Last updated: 29/04/202131/10/2016 EMA/HMPC/7685/2013 Generic Draft assessment report on … 25/07/2016 EMA/HMPC/7686/2013 Generic Draft list of references … 25/07/2016 EMA/HMPC/7687/2013 Generic Call for scientific data … -
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National expert: Raúl J. Andrade, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 85.81 KB | PDF
- Curriculum Vitae - 38.85 KB | PDF
expert) 04/2020-(current) Mylan Silimarin NASH, DILI (Kol …