Anika Therapeutics S.r.l. withdraws its marketing authorisation application for Hyalograft C autograft

Source: EMA Area: News The European Medicines Agency (EMA) has been formally notified by Anika Therapeutics S.r.l. of its decision to withdraw its application for centralised marketing authorisation for Hyalograft C autograft (cultured autologous chondrocytes on hyaluronan based scaffold), 4 million cells seeded on scaffold, for implantation. It was intended to be used for the surgical repair of symptomatic cartilage defects of the femoral condyle (medial, lateral) or trochlea, caused by acute or repetitive trauma in adults.   Hyalograft C autograft has been used in a number of European Union (EU) countries since before the introduction of the EU regulation on advanced therapies in 2009. This regulation made it compulsory for advanced therapies already available in the EU to undergo evaluation by the Agency in order to obtain an EU-wide marketing authorisation.   Following the withdrawal, Hyalograft C autograft will no longer be available. Health care professionals will need to ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news