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New drug indication approval - May 2022

Product Name

ROMIPLATE POWDER FOR SOLUTION FOR INJECTION 250µG/VIAL

Active Ingredient

Romiplostim

Product Registrant

KYOWA KIRIN ASIA PACIFIC PTE. LTD.

Date of Approval

05/05/2015

Indications:

Romiplate® is indicated for adults with moderate to severe aplastic anaemia refractory to conventional therapies.

Product Name

SAXENDA® SOLUTION FOR INJECTION IN PRE-FILLED PEN 6MG/ML

Active Ingredient

Liraglutide

Product Registrant

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Date of Approval

19/05/2022

Indications:

Adolescents (≥12 years)

Saxenda® can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with:

• an inadequate response to reduced calorie diet and increased physical activity alone, and

• obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points) and

• body weight above 60 kg.

Limitations of Use: The safety and effectiveness of Saxenda® in pediatric patients with type 2 diabetes have not been established.

Treatment with Saxenda® should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose.

Product Name

SKYRIZI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 75MG/0.83ML

Active Ingredient

Risankizumab

Product Registrant

ABBVIE PTE. LTD.

Date of Approval

24/05/2022

Indications:

SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults who have an inadequate response or who have been intolerant to at least one prior disease-modifying antirheumatic drug (DMARD) therapy.

*Evaluated via Access

Product Name

ENTRESTO FILM COATED TABLET 50MG

ENTRESTO FILM COATED TABLET 100MG

ENTRESTO FILM COATED TABLET 200MG

Active Ingredient

Sacubitril/Valsartan sodium salt complex

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

26/05/2022

Indications:

Entresto is indicated for the treatment of essential hypertension.

 

Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Indication Approvals