Summary of opinion(1) (initial authorisation) Lamzede (velmanase alfa)
15 February 2018 – The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lamzede, intended for the treatment of patients with non-neurological manifestations of mild to moderate alpha-mannosidosis. Lamzede was designated as an orphan medicinal product on 26 January 2005. The applicant for this medicinal product is Chiesi Farmaceutici S.p.A. Lamzede will be available as 10 mg powder for solution for infusion. The active substance of Lamzede is velmanase alfa, a recombinant