17. February 2012 11:42
Novartis Vaccines and Diagnostics S.r.l. has formally notified the EMA of its intention to withdraw the paediatric-use marketing authorisation (PUMA) for Fluad Paediatric (influenza vaccine, surface antigen, inactivated, adjuvanted with MF59C.1).
The EMA was informed in an official letter that Novartis were unable to address the questions raised by the Committee for Medicinal Products for Human Use (CHMP) within the required timelines.
The European healthcare regulator said the withdrawal does not prejudice the possibility of Novartis making a new application at a later stage.
Fluad Paediatric was intended to be used for the active immunisation against influenza in infants and young children. Its initial application was submitted to the EMA in December 2010. At the time of the withdrawal, it was under evaluation by the CHMP.