Granted marketing authorisation
WebJul 20, 2024 · SOUTH PLAINFIELD, N.J., July 20, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Upstaza™ (eladocagene exuparvovec) … WebWe publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005. This is based on the MHRA assessment...
Granted marketing authorisation
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WebICH: “The date of first marketing authorisation for a company’s new medicinal product in any country in the world”; date on which the first regulatory authority granted marketing authorisation of a new drug; the “EU birth date” is the date it was first was authorised in the EU (these may be the same date); the “birth date” triggers the submission … WebMar 17, 2024 · On March 16, 2024 the Court of Justice of the European Union (CJEU) rendered an important judgment for the pharmaceutical industry as it brings some clarification on the test to assess if two products have the ‘same active substance’ and therefore belong to the same Global Marketing Authorisation (GMA). This is a crucial …
WebJun 22, 2024 · Copenhagen, Denmark; June 22, 2024 – Genmab A/S (Nasdaq: GMAB) announced today that the European Commission (EC) has granted marketing authorization for the daratumumab subcutaneous (SC)...
WebApr 12, 2024 · Moximed, a medical device company on a mission to improve the standard of care for people with knee osteoarthritis (OA), announced that the US Food and Drug Administration (FDA) granted marketing authorization of the MISHA Knee System, an implantable shock absorber (ISA) for the knee. WebAug 22, 2024 · FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted Marketing Authorization for Sunlenca ® (lenacapavir) injection and tablets for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV …
Web29 April 2024. Market authorisation is the approval given to supply a therapeutic good in Australia, and, in most cases, involves entry on the Australian Register of Therapeutic …
WebJul 1, 2024 · NEW BRUNSWICK, N.J.-- ( BUSINESS WIRE )--Johnson & Johnson today announced that the European Commission (EC) has granted Marketing Authorisation for its Janssen Pharmaceutical Companies’ Ebola... ifood incluiWebApr 7, 2024 · On 30 March 2024, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product sodium thiosulfate (Pedmarqsi), intended for the prevention of ototoxicity induced by cisplatin chemotherapy … ifood igarassuWebJul 1, 2024 · NEW BRUNSWICK, N.J., 1 July 2024 – Johnson & Johnson today announced that the European Commission (EC) has granted Marketing Authorisation for its … is stockfish open sourceWebMar 17, 2024 · Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and... is stockfish machine learningWebFeb 15, 2024 · Marketing authorisations granted from 15 - 31 October 2024. PDF, 47.8 KB, 2 pages. This file may not be suitable for users of assistive technology. Request an … is stockfish safeWebDec 8, 2024 · OSAKA, Japan, and CAMBRIDGE, Massachusetts, December 8, 2024 – Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) granted marketing authorization for … ifood imagensWebMar 11, 2024 · NEW BRUNSWICK, N.J., March 11, 2024 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Commission (EC) has granted a Conditional Marketing Authorization (CMA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), … ifood impressora