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Product Name
ASADIN INJECTION 1 MG/ML
Active Ingredient
Arsenic Trioxide
Application type
NDA-1: New chemical entity
Product Registrant
PHARM-D SINGAPORE PTE LTD
Date of Approval
02/11/2022
Registration No.
SIN16634P
Indications:
1.1. Newly-Diagnosed Low-to-Intermediate-Risk Acute promyelocytic leukaemia
Arsenic Trioxide is indicated in combination with tretinoin for treatment of adults with newly-diagnosed low-to-intermediate risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
1.2. Relapsed or Refractory Acute promyelocytic leukaemia
For the induction of remission and consolidation in patients with acute promyelocytic leukaemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.
HIBRUKA TABLET 50 MG
Orelabrutinib
LABCORP DEVELOPMENT (ASIA) PTE. LTD.
22/11/2022
SIN16645P
HIBRUKA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
APEXXNAR SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML
Pneumococcal polysaccharide of serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F conjugated to CRM197 carrier protein, adsorbed on aluminium phosphate.
NDA-1: New biological entity
PFIZER PRIVATE LIMITED
30/11/2022
SIN16648P
Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
See Section 5.1 for information on protection against specific pneumococcal serotypes.
APEXXNAR should be used in accordance with official recommendations.
New Drug Approvals