US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| INQOVI | 100MG;35MG | tablet · oral | TAIHO ONCOLOGY | Prescription | 7 Jul 2020 |
EMA European Union — centrally authorised medicines
Inaqovi Otsuka Pharmaceutical Netherlands B.V. · Authorised · authorised 15 Sep 2023 · ATC L01BC58
Therapeutic indication (EMA)
Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy. Inaqovi in combination with venetoclax is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| INQOVI | 02501600 | 35 MG; 100 MG | TABLET · ORAL | TAIHO PHARMA CANADA, INC. |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.