EMEA-001136-PIP01-11-M03 - paediatric investigation plan
avatrombopag maleate
PIPHuman
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Key facts
- Invented name
- Doptelet
- Active substance
- avatrombopag maleate
- Therapeutic area
- Blood and lymphatic system disorders
- Haematology-Hemostaseology
- Decision number
- P/0137/2024
- PIP number
- EMEA-001136-PIP01-11-M03
- Pharmaceutical form(s)
- Film-coated tablet
- Powder for oral suspension
- Condition(s) / indication(s)
- Treatment of Idiopathic Thrombocytopenia Purpura (ITP)
- Treatment of Thrombocytopenic Purpura Secondary to Liver Disease
- Route(s) of administration
- Oral use
- Contact for public enquiries
Swedish Orphan Biovitrum AB
E-mail: medical.info@sobi.com
Tel. +46 8697 2000- Decision type
- PM: decision on the application for modification of an agreed PIP
- Decision date
- Compliance check done
- Igen
- Compliance procedure number
- EMEA-C-001136-PIP01-11-M03
- Compliance opinion date
- Compliance outcome
- Positive