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New drug approvals - May 2018

 

Product Name

VAXIGRIPTETRA SUSPENSION FOR INJECTION IN PREFILLED SYRINGE

Active Ingredient

Influenza Virus (NH) A/California/07/2009 X-179A (H1N1); Influenza Virus (NH) A/Texas/50/2012 (H3N2);

Influenza Virus (NH) B/Brisbane/60/2008;

Influenza Virus (NH) B/Massachusetts/2/2012

Application type

NDA-2: New combination

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

4 May 2018

Registration No.

SIN15477P

Indications:

VaxigripTetra is indicated for active immunisation of adults and children from 3 years of age and older for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.

The use of VaxigripTetra should be based on official recommendations.

 

Product Name

ADACEL-POLIO SUSPENSION FOR INJECTION IN PREFILLED SYRINGE

Active Ingredient

(Acellular pertussis) filamentous haemagglutinin adsorbed (FHA)

(Acelluar pertussis) fimbriae type 2 and 3 adsorbed (FIM)

(Acellular pertussis) pertatctin adsorbed (PRN)

(Acellular pertussis) pertussis toxoid adsorbed (PT)

Diphtheria toxoid adsorbed

Inactivated poliomyelitis vaccine (IPV) type 1 mahoney

Inactivated poliomyelitis vaccine (IPV) type 2 (MEF-1)

Inactivated poliomyelitis vaccine (IPV) type 3 (Saukett)

Tetanus toxoid adsorbed

Application type

NDA-2: New combination

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE LTD

Date of Approval

4 May 2018

Registration No.

SIN15479P

Indications:

ADACEL®-POLIO is indicated for active booster immunization for the prevention of tetanus, diphtheria, pertussis (whooping cough) and poliomyelitis in persons 4 years of age and above.

In children 4 to 6 years of age, ADACEL®-POLIO may be considered as an alternative for the fifth dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine (DTaP-IPV).

Persons who have had tetanus, diphtheria or pertussis should still be immunized since these clinical infections do not always confer immunity. Human Immunodeficiency Virus (HIV)-infected persons, both asymptomatic and symptomatic, should be immunized against tetanus, diphtheria and pertussis according to standard schedules.

ADACEL®-POLIO is not to be used for the treatment of disease caused by Bordetella pertussis, Corynebacterium diphtheriae, Clostridium tetani or poliomyelitis infections.

Pediatrics

ADACEL®-POLIO has been used in clinical studies in children as young as 3 years of age.

Geriatrics

ADACEL®-POLIO has been used in clinical studies in persons up to 91 years of age.

Tetanus Prophylaxis in Wound Management

The need for active immunization with a tetanus toxoid-containing preparation (such as Td Adsorbed vaccine, ADACEL® or ADACEL®-POLIO) with or without passive immunization with Tetanus Immune Globulin, depends on both the condition of the wound and the patient’s vaccination history.

 

Product Name

NOVOMIX 30 PENFILL 100U/ML

Active Ingredient

Insulin Aspart

Application type

NDA-2: New dosage form

Product Registrant

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Date of Approval

9 May 2018

Registration No.

SIN15480P

Indications:

Treatment of patients with diabetes mellitus requiring insulin.

 

Product Name

LONSUF FILM-COATED TABLET 15 MG/6.14 MG AND 20 MG/8.19 MG

Active Ingredient

Tipiracil hydrochloride / trifluridine

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

TAIHO PHARMA SINGAPORE PTE. LTD.

Date of Approval

24 May 2018

Registration No.

SIN15491P and SIN15494P

Indications:

Lonsurf is indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

 

Healthcare professional, Therapeutic Products
Published:

New Drug Approvals