New drug indication approval - June 2022

Product Name

TISSEEL FIBRIN SEALANT VH S/D (FROZEN)

Active Ingredient

Aprotinin (synthetic) (for sealer protein solution); Calcium chloride (for thrombin solution); Fibrinogen (clottable protein) (for sealer protein solution); Thrombin (for thrombin solution)

Product Registrant

BAXTER HEALTHCARE (ASIA) PTE LTD

Date of Approval

02/06/2022

Indications:

Supportive treatment where standard surgical techniques appear insufficient (see section 5.1)

· For improvement of hemostasis

· As a tissue glue to improve wound healing or to support sutures in vascular surgery and in gastrointestinal anastomoses.

· For tissue sealing, to improve adhesion of the separated tissue (e.g. tissue flaps, grafts, split skin grafts [mesh grafts], fixation of subcutaneously implanted lightweight mesh).

The efficacy in fully heparinized patients has been proven.

Product Name

FYCOMPA FILM-COATED TABLET 2MG, 4MG, 8MG

Active Ingredient

Perampanel

Product Registrant

Eisai (Singapore) Pte Ltd

Date of Approval

10/06/2022

Indications:

FYCOMPA is indicated for:

- treatment of partial-onset seizures(POS)with or without secondarily generalised seizures inpatients from 4years of age and older.

- adjunctive treatment of primary generalised tonic-clonic(PGTC)seizures in patients from 7years of age and older with idiopathic generalized epilepsy.

Product Name

DECAPEPTYL INJECTION 0.1 mg/ml

Active Ingredient

TRIPTORELIN

Product Registrant

FERRING PHARMACEUTICALS PRIVATE LIMITED

Date of Approval

10/06/2022

Indications:

DECAPEPTYL® 0.1 mg/1 ml is indicated for downregulation and prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART).

Product Name

JAKAVI TABLET 5MG, 10MG, 15MG, 20MG

Active Ingredient

Ruxolitinib

Product Registrant

Novartis (Singapore) Pte. Ltd

Date of Approval

07/06/2022

Indications:

Myelofibrosis

Jakavi is indicated for the treatment of disease-related splenomegaly and/or symptoms in adult patients with myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

Polycythemia vera

Jakavi is indicated for the treatment of adult patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.