On 1 October 2014 the European Medicines Agency (“EMA”) opened a consultation on revisions to its guideline on core summary of product characteristics (“SmPC”) for human plasma derived and recombinant coagulation factor IX products (the “Guidelines”).
The Guidelines are intended to provide harmonised guidance to applicants and regulators regarding the information that is to be included in the SmPC for human plasma derived and recombinant coagulation factor IX products, which are indicated for use in the treatment of prophylaxis of bleeding in patients with haemophilia B.
The original core SmPC came into effect in December 2000 and has been revised twice. This third revision to the Guidelines is to include minor updates. In particular, additional information concerning the appropriate determination of factor IX levels to guide dosage has been added to the Posology section.
Other proposed revisions to the Guidelines include the addition of cardiovascular events to the list of Special Warnings and Special Precautions for Use, and the inclusion of adverse event reporting in the Undesirable Effects section.
The deadline for comments on the revisions to the Guidelines is 31 October 2014.