WebFeb 11, 2024 · Please note that this product (marketed as marketed as Tecvayli) was withdrawn from the Union Register of orphan medicinal products in month & year upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.. On 19 October 2024, orphan designation EU/3/20/2331 was granted by … WebMar 21, 2024 · European Commission. European Commission; Live, work, travel in the EU ... Public Health - Union Register of medicinal products. Medicinal products authorised under Article 126a of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code relating to medicinal products …
Authorisation procedures - The centralised procedure - Public Health
WebOn 28 August 2006, orphan designation (EU/3/06/391) was granted by the European Commission to Nektar Therapeutics UK Ltd, United Kingdom, for amphotericin B (for inhalation use) for the prevention of pulmonary fungal infections in patients deemed at risk. The sponsorship was transferred to Kendle International Ltd, United Kingdom, in August ... WebPlease note that this product was withdrawn from the Community Register of designated orphan medicinal products in November 2015. ... (EU/3/01/035) was granted by the European Commission to NeoPharma Production AB, Sweden, for levodopa / carbidopa (gastroenteral use) ... stereorec top
Union Register - Public Health
WebSep 11, 2011 · The Commission has established a Register of all food enzymes' applications to be considered for inclusion in the first Union list. The Register contains all applications which were submitted within the mentioned period (11 September 2011 – 11 March 2015) and which comply with the validity criteria laid down in Article 12 of … WebMay 20, 2004 · The Commission's Secretariat-General then notifies the decision to the marketing authorisation holder. The decision is subsequently published in the Union Register. Marketing authorisations are initially valid for five years. Applications for renewal must be made to the EMA at least six months before this five-year period expires. … WebAug 27, 2024 · European Community - EC: The European Community is one of the three pillars of the European Union (EU). The pillars represent the three different areas of … stereo repair in york pa