MedPath
HSA Product

SPRYCEL TABLETS 70MG

Product approved by Health Sciences Authority (SG)

Basic Information

SPRYCEL TABLETS 70MG

TABLET, FILM COATED

Regulatory Information

SIN13352P

September 14, 2007

Prescription Only

Therapeutic

ORAL

August 10, 2023

June 3, 2025

Company Information

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

Active Ingredients

DASATINIB

Strength: 70mg/tab

Detailed Information

Contraindications

**4 CONTRAINDICATIONS** Hypersensitivity to the active substance or to any of the excipients.

Indication Information

**1 INDICATIONS AND USAGE** SPRYCEL® (dasatinib) is indicated for the treatment of adult patients with - newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. - chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy including imatinib. - Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. SPRYCEL® (dasatinib) is indicated for the treatment of pediatric patients with - newly diagnosed Ph+ CML in chronic phase or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. - newly diagnosed Ph+ ALL in combination with chemotherapy.

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