NEW HSA Drug Approvals Source: HSA (http://www.hsa.gov.sg, April – May 2016)

Active Ingredient:
Licence Holder:
Date of Approval:

OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/ML

Active Ingredient: Nivolumab

Licence Holder: Bristol-Myers Squibb (Singapore)

Pte. Ltd.

Date of Approval: 4 April 2016

Indications:

Melanoma

OPDIVO as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.

Non-Small Cell Lung Cancer (NSCLC)

OPDIVO as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.

MALTOFER FILM COATED TABLETS 100MG

Active Ingredient: Iron (III)-Hydroxide 

polymaltose complex

Licence Holder: Vifor Pharma Asia Pacific Pte. Ltd.

Date of Approval: 6 April 2016

Indications:

Maltofer is used to treat iron deficiency and prevent iron deficiency during pregnancy.

LENVIMA HARD CAPSULE 4 MG AND 10MG

Active Ingredient: Lenvatinib mesilate

Licence Holder: Eisai (Singapore) Pte. Ltd.

Date of Approval: 7 April 2016

Indications:

LENVIMA is indicated for the treatment of patients with locally re-current or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer.

BIOFLOR CAPSULE 250MG

Active Ingredient: Saccharomyces boulardii (lyophilised)

Licence Holder: United Italian Trading Corporation (Private) Limited

Date of Approval: 8 April 2016

Indications:

Helps to reduce the risk of antibiotic-associated diarrhea in adults.

MISODEL VAGINAL DELIVERY SYSTEM 200MCG

Active Ingredient: Misoprostol

Licence Holder: Ferring Pharmaceuticals Pte. Ltd.

Date of Approval: 19 April 2016

Indications:

MISODELTM is indicated for induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated.

MEZAVANT XL GASTRO-RESISTANT PROLONGED RELEASE TABLET 1200MG

Active Ingredient: Mesalazine

Licence Holder: LF Asia Distribution

Date of Approval: 3 May 2016

Indications:

For the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis. For maintenance

of remission.

ENDOMETRIN VAGINAL TABLETS 100MG

Active Ingredient: Progesterone, micronised

Licence Holder: Ferring Pharmaceuticals Pte. Ltd.

Date of Approval: 12 May 2016

Indications:

ENDOMETRIN® is indicated for luteal support as part of an

Assisted Reproductive Technology (ART) treatment program for infertile women.

TRIPLIXAM FILM COATED TABLET

2.5MG / 0.625MG / 5MG

TRIPLIXAM FILM COATED TABLET

5MG / 1.25MG / 5MG

TRIPLIXAM FILM COATED TABLET

5MG / 1.25MG / 10MG

TRIPLIXAM FILM COATED TABLET

10MG / 2.5MG / 5MG

TRIPLIXAM FILM COATED TABLET

10MG / 2.5MG / 10MG

Active Ingredient: Perindopril arginine / Indapamide / Amlodipine

Licence Holder: Servier (S) Pte. Ltd.

Date of Approval: 23 May 2016

Indications:

Triplixam is indicated as substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril/indapamide fixed dose combination and amlodipine, taken at the same dose level.

ARNUITY ELLIPTA INHALATION POWDER

100MCG/DOSE AND 200MCG/DOSE

Active Ingredient: Fluticasone furoate (micronised)

Licence Holder: Glaxosmithkline Pte. Ltd.

Date of Approval: 27 May 2016

Indications:

ARNUITY ELLIPTA is indicated for the maintenance treatment

of asthma.

Disclaimer: Regulatory approval by the HSA does not imply that a product has been launched and/or is available in the market. Please contact the license holder or your local distributor for more information.

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