EMEA-002449-PIP02-18-M02 - paediatric investigation plan
Berotralstat
PIPHuman
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Key facts
- Invented name
- Orladeyo
- Active substance
- Berotralstat
- Therapeutic area
- Congenital, familial and genetic disorders
- Decision number
- P/0151/2024
- PIP number
- EMEA-002449-PIP02-18-M02
- Pharmaceutical form(s)
- Capsule, hard
- Age appropriate oral solid dosage form
- Condition(s) / indication(s)
- Treatment of hereditary angioedema
- Route(s) of administration
- Oral use
- Contact for public enquiries
Biocryst Ireland Limited
E-mail: eurow_ra@biocryst.com
Tel.: +49 (0)15172444722- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Nej