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13/12/2018 |
Overview of comments: Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)
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13/12/2018 |
Scientific guideline: Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance
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13/12/2018 |
Overview of comments: Overview of comments received on 'Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance' (EMA/CHMP/291450/2018)
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13/12/2018 |
Aliskiren product-specific bioequivalence guidance (updated) |
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13/12/2018 |
Human medicines European public assessment report (EPAR): elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide, Genvoya, elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide, HIV Infections, 19/11/2015, 18, Authorised (updated) |
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13/12/2018 |
Template or form: Template 2 - Translations required with the submission of an application for transfer of orphan medicinal product designation
(updated) |
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13/12/2018 |
Human medicines European public assessment report (EPAR): entacapone, Entacapone Teva, entacapone, Parkinson Disease, 18/02/2011, 8, Authorised (updated) |
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13/12/2018 |
Template or form: Translations required with the submission of an application for orphan medicinal product designation
(updated) |
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13/12/2018 |
Human medicines European public assessment report (EPAR): ferric maltol, Feraccru, ferric maltol, Anemia, Iron-Deficiency, 18/02/2016, 7, Authorised (updated) |
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13/12/2018 |
Report: Wheat starch (containing gluten) used as an excipient - Report published in support of the ‘Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use’
(updated) |
