EMEA-002449-PIP02-18-M01

Table of contents

Key facts

Active substance
Berotralstat
Therapeutic area
Pneumology-allergology
Decision number
P/0353/2021
PIP number
EMEA-002449-PIP02-18-M01
Pharmaceutical form(s)
  • Capsule, hard
  • Age-appropriate oral solid formulation
Condition(s) / indication(s)
Treatment of hereditary angioedema
Route(s) of administration
Oral use
Contact for public enquiries
BioCryst Ireland Limited

E-mail: medinfo@biocryst.com
Tel: (1) 919-859-1302

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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