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National expert: Gabriele Balciunaite Murziene, State Medicines Control Agency (updated)
- Declaration of interests - 39.34 KB | PDF
- Curriculum Vitae - 29.51 KB | PDF
laboratorijų kompetencijai keliami bendieji reikalavimai” Page … -
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Withdrawn application: Garenoxacin mesylate
date of withdrawal: 25/07/2007, Initial authorisation, Last updated: 26/07/2007 -
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Withdrawn application: Winfuran
date of withdrawal: 17/01/2014, Initial authorisation, Last updated: 11/03/2014 -
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Orphan designation: Humanised monoclonal IgG4 antibody against tissue-factor-pathway inhibitor (concizumab) for: Treatment of haemophilia A
Date of designation: 10/10/2012, Withdrawn, Last updated: 14/12/2022 -
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Orphan designation: Human monoclonal IgG1 antibody against tissue factor pathway inhibitor for: Treatment of haemophilia A
Date of designation: 14/10/2016, Positive, Last updated: 14/11/2016 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022 -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Guidance documents
Last updated: 19/07/2022