MHRA-101718-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Human alpha-1-proteinase inhibitor immunoglobulin G fusion protein, recombinant
Invented Name
Not yet available
PIP Number MHRA-101718-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
Therapeutic area:
  • Pneumology - Allergology
Conditions / Indications
Conditions / Indications:
  • Treatment of emphysema secondary to congenital deficiency of alpha-1 antitrypsin
Route(s) of administration
Route(s) of administration:
  • All routes of administration
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Human alpha-1-proteinase inhibitor immunoglobulin G fusion protein, recombinant.pdf
Published Date 23/06/2025