Europe – EMA : Draft Guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) Rev. 6

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 intravenous administration (IVIg). This guideline should be read in conjunction with the Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) (EMA/CHMP/BPWP/94033/2007 rev. 2). For guidance on the clinical investigation of subcutaneous immunoglobulin products refer to CHMP/BPWP/410415/2011 Rev 1and the coreSPC CPMP/BPWG/143744/2011 Rev. 1…