New drug approvals - Jan 2020

Product Name

Active Ingredient

Bilastine

Application type

Product Registrant

A. MENARINI SINGAPORE PTE. LTD.

Date of Approval

Registration No.

Indications: 

Symptomatic treatment of allergic rhino-conjunctivitis and urticaria. Bilaxten is indicated in children aged 6 to 11 years with a body weight of at least 20 kg.

Product Name

Active Ingredients

Application type

Product Registrant

Date of Approval

Registration No.

Indications:
Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies.

Product Name

Active Ingredients

Application type

Product Registrant

Date of Approval

Registration No.

Indications:
Treatment of erectile dysfunction in adult men.                                                                
In order for Spedra to be effective, sexual stimulation is required

Product Name

Active Ingredients

Application type

Product Registrant

Date of Approval

Registration No.

Indications:

Rapamune (sirolimus) is indicated for the prophylaxis of organ rejection in patients receiving renal transplants.
In patients at low to moderate immunologic risk, it is recommended that Rapamune be used initially in a regimen with cyclosporine and corticosteroids.
Cyclosporine should be withdrawn 2 to 4 months after transplantation and the Rapamune dose should be increased to reach recommended blood concentrations (see Section 4.2. Posology and method of administration). Cyclosporine withdrawal has not been studied in patients with Banff 93 Grade III acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, or with serum creatinine >4.5 mg/dL, Black patients, re-transplants, multi-organ transplants, or patients with high-panel reactive antibodies (see Section 5. PHARMACOLOGICAL PROPERTIES - Clinical trials data on efficacy).