Extended indication Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (0-18 years) in whom active immunisation is contraindicated or
Registration phase Positive CHMP opinion

Product

Active substance Human normal immunoglobulin
Domain Infectious diseases
Reason of inclusion Indication extension IND
Extended indication Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (0-18 years) in whom active immunisation is contraindicated or not advised. Consideration should also be given to official recommendations on intravenous human immunoglobulin use in measles pre-/post exposure prophylaxis and active immunisation.
Proprietary name Privigen
Manufacturer Cslbehring
Portfolio holder Cslbehring
Route of administration Intravenous
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date November 2025
Expected Registration June 2026
Orphan drug No
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie in april 2026.

Therapeutic value

Expected patient volume per year

Patient volume

Market share is generally not included unless otherwise stated.

Expected cost per patient per year

Potential total cost per year

Off label use

Indication extension

Other information