NEW INDICATION APPROVALS

XTANDI SOFT CAPSULES 40MG

Active Ingredient: Enzalutamide

Licence Holder: Astellas Pharma Singapore Pte. Ltd.

Date of Approval: 5 April 2016

Indications:

Xtandi is indicated for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).

COSENTYX (SECUKINUMAB) POWDER FOR SOLUTION FOR INJECTION 150MG/ML

COSENTYX SOLUTION FOR INJECTION IN PREFILLED SENSOREADY PEN 150MG/ML

COSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 150MG/ML

Active Ingredient: Secukinumab

Licence Holder: Novartis (Singapore) Pte. Ltd.

Date of Approval: 6 April 2016

Indications:

Cosentyx is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Cosentyx can be used alone or in combination with methotrexate.

Cosentyx is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

STELARA SOLUTION FOR INJECTION 45MG/0.5ML

STELARA SOLUTION FOR INJECTION 90MG/1ML

STELARA SOLUTION FOR INJECTION IN

PRE-FILLED SYRINGE 45MG/0.5ML

STELARA SOLUTION FOR INJECTION IN

PRE-FILLED SYRINGE 90MG/1ML

Active Ingredient: Ustekinumab

Licence Holder: Johnson & Johnson Pte. Ltd.

Date of Approval: 19 April 2016

Indications:

Pediatric Plaque Psoriasis

STELARA® is indicated for the treatment of paediatric patients (12 years and older) with moderate to severe plaque psoriasis who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

DYSPORT FOR INJECTION 500 u/vial

Active Ingredient: Clostridium botulinum type A

toxin-haemagglutinin complex

Licence Holder: A. Menarini Singapore Pte. Ltd.

Date of Approval: 20 April 2016

Indications:

Primary axillary hyperhidrosis in adults inadequately managed by topical agents.

IMOJEV POWDER AND DILUENT FOR SUSPENSION FOR INJECTION

Active Ingredient: Japanese encephalitis virus (Live, attenuated, recombinant) 4.0 – 5.8 log PFU/dose

Licence Holder: Sanofi-Aventis Singapore Pte. Ltd.

Date of Approval: 25 April 2016

Indications:

IMOJEV® is indicated for prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 9 months of age and over.

DAKLINZA TABLET 30 MG AND 60 MG

Active Ingredient: Daclatasvir

Licence Holder: Bristol-Myers Squibb (Singapore)

Pte. Ltd.

Date of Approval: 25 Apr 2016

Indications:

DAKLINZA is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).

For HCV genotype specific activity, see sections 4.4 and 5.1.

PREVENAR 13 SUSPENSION FOR INJECTION

Active Ingredient: Pneumococcal polysaccharide serotype 1, 14, 18C, 19A, 19F, 23F, 3, 4, 5, 6A, 6B, 7F, 9V

Licence Holder: Pfizer Private Limited

Date of Approval: 6 May 2016

Indications:

Active immunisation for the prevention of invasive disease and pneumonia caused by S. pneumoniae in adults ≥18 to 49 years of age.

VIREAD TABLETS 300 MG

Active Ingredient: Tenofovir disoproxil fumarate

Licence Holder: Gilead Sciences Singapore Pte. Ltd.

Date of Approval: 6 May 2016

Indications:

Chronic Hepatitis B

VIREAD is indicated for the treatment of chronic hepatitis B in adults. The following points should be considered when initiating therapy with VIREAD for the treatment of HBV infection:

• The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Studies (13.2)].

• VIREAD was evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease. [See Adverse Reactions (6.1), Clinical Studies (13.2)].

• The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy [See Microbiology (11.3), Clinical Studies (13.2)].

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