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Ezetimibe product-specific bioequivalence guidance
Last updated: 15/10/2019Ezetimibe product-specific bioequivalence … of the bioequivalence of ezetimibe tablet 10 mg …
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National expert: Mirna Galovic, Agency for Medicinal Products and Medical Devices of Croatia (updated)
- Declaration of interests - 80.61 KB | PDF
- Curriculum Vitae - 17.19 KB | PDF
Head of quality department Krka-farma d.o.o. (Croatia) Establishment … director for Quality Management Krka-farma d.o.o. (Croatia) Management … Indication 08/2004-11/2018 KRKA-FARMA d.o.o. Cross product responsibility … -
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National expert: Monika Posega, Agency for medicinal products and medical devices of the Republic of Slovenia (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 16.72 KB | PDF
2006-June 2009 Sales agent KRKA, d.d., Novo mesto (Slovenia) Marketing … Promotion of sales of medicines KRKA, d.d., Novo mesto (Slovenia) Pharmacodynamic … -
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National expert: Audrey Sultana, Medicines Authority (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 18.19 KB | PDF
Authorisation Application Darunavir Krka Marketing Authorisation Application Duloxetine … Application Efavirenz/ Emtricitabine/Tenofovir Krka Marketing Authorisation Application Emtricitabine/Tenofovir … Application Emtricitabine/Tenofovir Krka Marketing Authorisation Application Lopinavir/Ritonavir … -
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National expert: John Joseph Borg, Medicines Authority (updated)
- Declaration of interests - 80.02 KB | PDF
- Curriculum Vitae - 25.52 KB | PDF
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National expert: Helene Ly, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 16.48 KB | PDF
procedures (Instanyl, Clopidogrel KRKA, Zylt, PecFent, Tafamidis … -
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National expert: Ladislava Nejezchlebova, Institute for State Control of Veterinary Biologicals and Medicaments
- Declaration of interests - 79.09 KB | PDF
- Curriculum Vitae - 16.85 KB | PDF
pharmaceutical representative Krka, Novo mesto (Czechia) promotion … -
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National expert: Svetoslav Valentinov Branchev, Bulgarian Food Safety Agency (updated)
- Declaration of interests - 80.12 KB | PDF
- Curriculum Vitae - 74.42 KB | PDF
Type of Interest Declared KRKA My wife started working in … regulatory affairs department in KRKA Bulgaria 2.9 Repurposing … -
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National expert: Rajko Kenda, Agency for medicinal products and medical devices of the Republic of Slovenia (updated)
- Declaration of interests - 80.08 KB | PDF
- Curriculum Vitae - 53.88 KB | PDF
Type of Interest Declared KRKA, pharmaceutical company Slovenia … -
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National expert: Biljana Temova, Agency for medicinal products and medical devices of the Republic of Slovenia (updated)
- Declaration of interests - 80.31 KB | PDF
- Curriculum Vitae - 16.28 KB | PDF
Quality Assurance Manager Krka d.d. Novo mesto (Slovenia) EDUCATION … Indication 05/2013-01/2018 KRKA d.d. Novo mesto Cross … -
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National expert: Sara Brandel, Medical Products Agency (updated)
- Declaration of interests - 80.14 KB | PDF
- Curriculum Vitae - 16.19 KB | PDF
Regulatory Affairs Manager Krka Sverige AB (Sweden) May … -
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National expert: Barbara Bridget Byrne Habic, Agency for medicinal products and medical devices of the Republic of Slovenia (updated)
- Declaration of interests - 80.14 KB | PDF
- Curriculum Vitae - 16.85 KB | PDF
Type of Interest Declared Krka Current Financial interest 2.9 … -
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National expert: Urska Hajnrih, Agency for medicinal products and medical devices of the Republic of Slovenia (updated)
- Declaration of interests - 80.77 KB | PDF
- Curriculum Vitae - 16.64 KB | PDF
Type of Interest Declared Krka d.d. Current financial interest 2.9 … -
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National expert: Gasper Marc, Agency for medicinal products and medical devices of the Republic of Slovenia (updated)
- Declaration of interests - 80.87 KB | PDF
- Curriculum Vitae - 18.28 KB | PDF
Type of Interest Declared Krka shares Roche shares 2.9 … -
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National expert: Daniela Planinsek, Agency for medicinal products and medical devices of the Republic of Slovenia (updated)
- Declaration of interests - 80.05 KB | PDF
- Curriculum Vitae - 18.35 KB | PDF
Type of Interest Declared KRKA current financial interests 2.9 … -
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Product-specific bioequivalence guidance
Last updated: 06/10/2015product-specific bioequivalence guidance Ezetimibe product-specific bioequivalence …
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Herbal medicinal product: Lichen islandicus (updated)
Cetraria islandica (L.) Acharius s.l., Iceland moss, C: ongoing call for scientific data, Last updated: 07/04/2021 -
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Herbal medicinal product: Sabalis serrulatae fructus
Serenoa repens (W. Bartram) Small (Sabal serrulata (Michaux) Nichols), Saw Palmetto Fruit, F: Assessment finalised, Last updated: 02/12/2020 -
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Combination Herbal medicinal product: Thymi herba and Primulae radix
Combination: Thymus vulgaris L.; Thymus zygis L. and Primula veris L.; Primula elatior (L.) Hill, Thyme and Primula root, F: Assessment finalised, Last updated: 23/06/2016 -
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Herbal medicinal product: Echinaceae purpureae herba
Echinacea purpurea (L.) Moench, Purple Coneflower Herb, F: Assessment finalised, Last updated: 17/02/2016 -
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Public data from Article 57 database
Last updated: 16/02/2021 -
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Deadlines for placing paediatric medicines on the market
Last updated: 10/08/2015 -
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PDCO: Agendas, minutes and meeting reports
Last updated: 11/11/2020 -
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PRAC: Agendas, minutes and highlights
Last updated: 16/02/2021 -
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CHMP: Agendas, minutes and highlights
Last updated: 29/01/2021