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Product Name
NUFILONG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 6MG/0.6ML
Active Ingredient
Pegfilgrastim
Application type
NDA-2: Biosimilar
Product Registrant
PHARMA TO MARKET PTE. LTD
Date of Approval
07/12/2021
Registration No.
SIN16393P
Indications:
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in
patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic
myeloid leukaemia and myelodysplastic syndromes).
COMIRNATY DISPERSION FOR INJECTION 30MCG/DOSE
COMIRNATY CONCENTRATE FOR DISPERSION FOR INJECTION 10MCG/DOSE
Tozinameran
NDA-1/2: New biological entity
BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE LTD
10/12/2021
SIN16396P, SIN16397P
COMIRNATY is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
ONCASPAR POWDER FOR SOLUTION FOR INJECTION / INFUSION 750 U/ML
Pegaspargase
NDA-1: New biological entity
SERVIER (S) PTE LTD
27/12/2021
SIN16408P
Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL).
New Drug Approvals