New drug indication approval - June 2021

Product Name

FIBRYGA POWDER AND SOVENT FOR SOLUTION FOR INJECTION OR INFUSION 1G/VIAL

Active Ingredient

HUMAN FIBRINOGEN

Product Registrant

WELLCHEM PHARMACEUTICALS PTE LTD

Date of Approval

01/06/2021

Indications:

As complementary therapy to management of uncontrolled severe haemorrhage in patients with acquired hypofibrinogenaemia in the course of surgical intervention.

Product Name

DYSPORT FOR INJECTION 300U AND 500U/VIAL

Active Ingredient

Clostridium botulinum type a toxin-haemagglutinin complex

Product Registrant

Zuellig Pharma Pte Ltd

Date of Approval

17/06/2021

Indications:

Dysport is indicated for symptomatic treatment of focal spasticity of upper limbs in paediatric cerebral palsy patients, two years of age or older.

Product Name

MENVEO POWDER AND SOLUTION FOR SOLUTION FOR INJECTION

Active Ingredient

(MenA Lyo) Meningococcal Group A oligosaccharide conjugated to CRM197 protein; (MenCWY) Meningococcal Group C oligosaccharide conjugated to CRM197 protein; (MenCWY) Meningococcal Group W-135 oligosaccharide conjugated to CRM197 protein; (MenCWY) Meningococcal Group Y oligosaccharide conjugated to CRM197 protein

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

30/06/2021

Indications:

Menveo is indicated for active immunization of children (from 2 months of age), adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y, to prevent invasive disease.

The use of this vaccine should be in accordance with official recommendations.