Key facts

Invented name
Waylivra
Active Substance
Volanesorsen
Therapeutic area
Endocrinology-Gynaecology-Fertility-Metabolism
Decision number
P/0131/2021
PIP number
EMEA-001915-PIP01-15-M03
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
Treatment of familial chylomicronemia syndrome
Route(s) of administration
Subcutaneous use
Contact for public enquiries

Akcea Therapeutics

Tel. +1 6172070202
E-mail: info@akceatx.com

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

Decision

P/0131/2021: EMA decision of 14 April 2021 on the acceptance of a modification of an agreed paediatric investigation plan for volanesorsen (Waylivra), (EMEA-001915-PIP01-15-M03)

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