International cooperation on therapeutic products
17 June 2022 – On 25 May 2022, Swissmedic granted marketing authorisation for the medicinal product Vabysmo with the active substance faricimab, a solution for injection for intravitreal use for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and for the treatment of diabetic macular oedema (DME), as part of the New Active Substance Work Sharing Initiative (NASWSI) of the Access Consortium in collaboration with the partner authorities. It was the first licence application to be considered by all five access authorities. The Access Consortium is a joint initiative of like-minded regulatory authorities with the purpose of promoting regulatory convergence, exploiting synergies and thus enhancing the efficiency of the regulatory systems and optimising resource requirements.
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