MHRA-102015-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Alvelestat tosylate
Invented Name
Not yet available
PIP Number MHRA-102015-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical form.
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of alpha-1 antitrypsin deficiency.
Route(s) of administration
Route(s) of administration:
  • All route 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):Alvelestat tosylate.pdf
Published Date 24/10/2025