Aug 1, 2012

EMA launches consultation on the SmPC for immunoglobulin (SC & IM)

The European Medicines Agency has recently launched a consultation on their Draft guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration.

The purpose of this core SmPC is to provide applicants and regulators with harmonised guidance on the information to be included in the Summary of product characteristics (SmPC) for a human normal immunoglobulin for subcutaneous and/or intramuscular administration.

The deadline for comments for this concept paper is 31 January 2013. The document is available for consultation by clicking here.


World PI Week
IPOPI would be grateful for any support to the important work for primary immunodeficiencies.

Read all

Executive Director: Johan Prevot
Tel/Fax: +351 21 407 5720
UK office
Firside Main Road Downderry
Cornwall PL11 3LE
United Kingdom

Tel: +44 1503 250 668
Fax: +44 1503 250 961
IPOPI is a charity registered in the UK.
Registration No. 1058005