Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Blueprint Medicines (Netherlands) B.V., Gustav Mahlerplein 2, 1082 MA Amsterdam, Netherlands
AYVAKYT 100 mg film-coated tablets.
AYVAKYT 200 mg film-coated tablets.
AYVAKYT 300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. AYVAKYT 100 mg film-coated tablets: Round, white film-coated tablet of 9 mm diameter, printed with blue ink “BLU” on one side and “100” on the other. AYVAKYT 200 mg film-coated tablets: Oval, white film-coated tablet of 16 mm in length and 8 mm in width, printed with blue ink “BLU” on one side and “200” on the other. AYVAKYT 300 mg film-coated tablets: Oval, white film-coated tablet of 18 mm in length and 9 mm in width, printed with blue ink “BLU” on one side and “300” on the other. |
AYVAKYT 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of avapritinib.
AYVAKYT 200 mg film-coated tablets: Each film-coated tablet contains 200 mg of avapritinib.
AYVAKYT 300 mg film-coated tablets: Each film-coated tablet contains 300 mg of avapritinib.
For the full list of excipients, see section 6.1.
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Tablet coat: Talc Printing ink: Shellac glaze 45% (20% esterified) in ethanol |
High-density polyethylene (HDPE) bottle with child-resistant cap with foiled induction seal liner and a desiccant in canister.
Each carton contains one bottle with 30 film-coated tablets.
Blueprint Medicines (Netherlands) B.V., Gustav Mahlerplein 2, 1082 MA Amsterdam, Netherlands
AYVAKYT 100 mg film-coated tablets: EU/1/20/1473/001
AYVAKYT 200 mg film-coated tablets: EU/1/20/1473/002
AYVAKYT 300 mg film-coated tablets: EU/1/20/1473/003
Date of first authorization: 24 September 2020
| Drug | Countries | |
|---|---|---|
| AYVAKYT | Austria, Estonia, France, Croatia, Ireland, Lithuania, Poland, Romania, United Kingdom |
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