8 results
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Human medicine European public assessment report (EPAR): Simbrinza
brinzolamide, brimonidine tartrate, Ocular Hypertension; Glaucoma, Open-Angle
Date of authorisation: 18/07/2014, Revision: 10, Authorised, Last updated: 19/12/2022 -
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Referral: Singulair
montelukast, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/04/2008, EC decision date: 11/07/2008, Last updated: 05/08/2008 -
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Orphan designation: hydrocortisone for: Treatment of adrenal insufficiency
Date of designation: 22/05/2006, Expired, Last updated: 25/11/2021 -
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Orphan designation: hydrocortisone for: Treatment of congenital adrenal hyperplasia
Date of designation: 27/07/2005, Positive, Last updated: 14/06/2021 -
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Orphan designation: dexamethasone for: Treatment of multiple myeloma
Date of designation: 09/06/2010, Withdrawn, Last updated: 12/02/2018kezelése Italian Desametasone (compressa da 40 mg) Trattamento del … -
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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: 09/10/2023 -
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Guidance documents related to data submission for authorised medicines
Last updated: 19/07/2022