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Generic and hybrid applications
Last updated: 13/01/2021Generic and hybrid applications … from companies to market generic medicines in the European … marketing authorisation for generic or hybrid medicines typically …
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Dissolution specification for generic oral immediate release products
Last updated: 15/08/2017Dissolution specification for generic oral immediate release produc … dissolution of orally administered generic drug products with immediate … dissolution specification for generic solid oral immediate release …
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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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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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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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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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Herbal medicinal product: Polypodii rhizoma
Polypodium vulgare L., Polypody Rhizome, F: Assessment finalised, Last updated: 22/08/201922/08/2019 EMA/164380/2019 Generic Key facts Polypodii rhizomaPolypody … 16/08/2018 EMA/HMPC/627591/2017 Generic Final community herbal monograph … 06/11/2008 EMEA/HMPC/600668/2007 Generic Opinion of the Committee … -
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Herbal medicinal product: Menthae piperitae aetheroleum
Mentha x piperita L., Peppermint oil, F: Assessment finalised, Last updated: 24/07/202016/09/2020 EMA/55625/2020 Generic Key facts Menthae piperitae … -
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Herbal medicinal product: Herniariae herba
Herniaria glabra L.; Herniaria hirsuta L.; Herniaria incana Lam., Rupturewort, F: Assessment finalised, Last updated: 14/10/202014/10/2020 EMA/382941/2020 Generic Key facts Herniariae herbaRupturewortHerniaria … -
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Herbal medicinal product: Fragariae folium
Fragaria vesca L.; Fragaria moschata Weston; Fragaria viridis Weston; Fragaria x ananassa (Weston) Duchesne ex Rozier , Wild Strawberry Leaf, F: Assessment finalised, Last updated: 22/08/201922/08/2019 EMA/833739/2018 Generic Key facts Fragariae foliumWild … -
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Herbal medicinal product: Tribuli terrestris herba
Tribulus terrestris L., Tribulus herb , C: ongoing call for scientific data, Last updated: 15/06/202115/09/2021 EMA/HMPC/291056/2021 Generic Herbal medicinal products … -
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Herbal medicinal product: Arnicae flos
Arnica montana L., Arnica flower, F: Assessment finalised, Last updated: 02/02/202102/12/2016 EMA/654173/2016 Generic Key facts Arnicae flosArnica … -
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Herbal medicinal product: Rosae flos
Rosa centifolia L.; Rosa gallica L.; Rosa damascena Mill., Rose flower, F: Assessment finalised, Last updated: 13/04/202206/07/2017 EMA/237220/2017 Generic Key facts Rosae flosRose … -
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Herbal medicinal product: Sideritis herba
Sideritis scardica Griseb.; Sideritis clandestina (Bory & Chaub.) Hayek; Sideritis raeseri Boiss. &, Ironwort, F: Assessment finalised, Last updated: 13/04/202211/11/2016 EMA/115825/2016 Generic Key facts Sideritis herbaIronwortSideritis … -
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Herbal medicinal product: Cichorii intybi radix
Cichorium intybus L., Chicory root, F: Assessment finalised, Last updated: 18/03/2022 -
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Herbal medicinal product: Fucus
Fucus vesiculosus L., Bladderwrack, F: Assessment finalised, Last updated: 16/03/202202/12/2016 EMA/661584/2016 Generic Key facts FucusBladderwrackFucus … -
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Herbal medicinal product: Ononidis radix
Ononis spinosa L., Restharrow root, F: Assessment finalised, Last updated: 15/03/202209/03/2017 EMA/815130/2016 Generic Key facts Ononidis radixRestharrow … -
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Herbal medicinal product: Myrtilli fructus siccus
Vaccinium myrtillus L., Dried Bilberry fruit, F: Assessment finalised, Last updated: 15/03/2022 -
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Herbal medicinal product: Origani majoranae herba
Origanum majorana L., Majoram, F: Assessment finalised, Last updated: 15/03/202202/12/2016 EMA/653011/2016 Generic Key facts Origani majoranae … -
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Herbal medicinal product: Pilosellae herba cum radice
Hieracium pilosella L., Mouse-ear hawkweed, F: Assessment finalised, Last updated: 15/03/2022 -
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Herbal medicinal product: Myrtilli fructus recens
Vaccinium myrtillus L., Fresh Bilberry fruit, F: Assessment finalised, Last updated: 15/03/2022 -
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Herbal medicinal product: Eschscholziae herba
Eschscholzia california Cham., California poppy, F: Assessment finalised, Last updated: 15/02/2022 -
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Combination Herbal medicinal product: Species sedativae
Herbal tea combinations for use as sedatives, F: Assessment finalised, Last updated: 28/10/202128/10/2021 EMA/645615/2020 Generic Key facts Combination: Species … -
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Herbal medicinal product: Ricini oleum
Ricinus communis L., Castor oil, F: Assessment finalised, Last updated: 13/04/2022 -
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Herbal medicinal product: Sennae folium
Cassia senna L.; Cassia angustifolia Vahl, Senna leaf, F: Assessment finalised, Last updated: 13/04/2022