Product Dossier
VEYVONDI
Product Dossier for VEYVONDI (vonicog alfa, Takeda Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Takeda Pharmaceuticals
- Active ingredient: vonicog alfa
- Therapeutic area: Haematology
- Same area: REVOLADE
- Same area: NOVICRIT
What it is
VEYVONDI is a powder for injection containing vonicog alfa, available in two strengths: 650 IU and 1300 IU, supplied with solvent vials.
Approved indications
— Treatment of haemorrhage in adults aged 18 years and older with von Willebrand Disease when desmopressin (DDAVP) treatment alone is ineffective or not indicated. — Treatment of surgical bleeding in adults aged 18 years and older with von Willebrand Disease when desmopressin (DDAVP) treatment alone is ineffective or not indicated. — Prevention of surgical bleeding in adults aged 18 years and older with von Willebrand Disease when desmopressin (DDAVP) treatment alone is ineffective or not indicated.
Key safety warnings
VEYVONDI should not be used in the treatment of Haemophilia A.
Regulatory history
The TGA approved VEYVONDI (vonicog alfa) for registration on 15 April 2020, following a 173 working day evaluation under the COR-B process. VEYVONDI was first listed on the ARTG on 20 April 2020 in both the 650 IU and 1300 IU strengths.