Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Global Blood Therapeutics Netherlands B.V., Strawinskylaan 3051, 1077ZX Amsterdam, Netherlands
Oxbryta 500 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Light yellow to yellow, oval shaped, biconvex, film-coated tablet of approximately 18 mm × 10 mm, debossed with “GBT 500” on one side. |
Each film-coated tablet contains 500 mg of voxelotor.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Voxelotor |
Voxelotor is a haemoglobin S (HbS) polymerisation inhibitor that binds to HbS with a 1:1 stoichiometry and exhibits preferential partitioning to red blood cells (RBCs). By increasing the affinity of Hb for oxygen, voxelotor demonstrates dose-dependent inhibition of HbS polymerisation. Voxelotor inhibits RBC sickling and improves RBC deformability. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Tablet film-coating: Polyvinyl alcohol (E1203) |
High-density polyethylene (HDPE) bottle with a polypropylene child-resistant cap and an aluminium induction seal. The bottle also contains a silica gel desiccant canister and polyester coil.
Pack-size of 90 film-coated tablets.
Global Blood Therapeutics Netherlands B.V., Strawinskylaan 3051, 1077ZX Amsterdam, Netherlands
| Drug | Countries | |
|---|---|---|
| OXBRYTA | Austria, Estonia, France, Croatia, Ireland, Italy, Lithuania, Poland, United States |
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