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HSA Approval

TRUMENBA SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

SIN15634P

TRUMENBA SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

TRUMENBA SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

February 21, 2019

PFIZER PRIVATE LIMITED

PFIZER PRIVATE LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantPFIZER PRIVATE LIMITED
Licence HolderPFIZER PRIVATE LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SUSPENSION

**4.2. Posology and method of administration** Posology Standard schedule for routine immunization: Administer 0.5 ml at 0 and 6 months. Schedule for individuals at increased risk of invasive meningococcal disease: Administer 2 doses of 0.5 ml at least 1 month apart, followed by a third dose at least 4 months after the second dose. **Booster Dose** A booster dose should be considered following either dosing regimen for individuals at continued risk of invasive meningococcal disease (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Pediatric Population** Safety and efficacy of Trumenba in children below the age of 10 years of age have not been established. **Elderly** Trumenba has not been studied in adults older than 65 years of age. Method of administration For intramuscular injection only. The preferred site for injection is the deltoid muscle of the upper arm. Separate injection sites and different syringes must be used if more than one vaccine is administered at the same time. There are no data available on the interchangeability of Trumenba with other meningococcal serogroup B vaccines to complete the vaccination series.

INTRAMUSCULAR

Medical Information

**4.1. Therapeutic indications** Trumenba is indicated in individuals 10 years and older for active immunization to prevent invasive meningococcal disease caused by _Neisseria meningitidis_ serogroup B. See section 5.1 for information on protection against specific serogroup B strains – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Dosing of Trumenba should be determined taking into consideration the risk of invasive meningococcal B disease by each country or region. The use of this vaccine should be in accordance with official recommendations.

**4.3. Contraindications** Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Severe allergic reaction (e.g., anaphylaxis) after any previous dose of Trumenba or to any component of this vaccine.

J07AH09

meningococcus B, multicomponent vaccine

Manufacturer Information

PFIZER PRIVATE LIMITED

Pfizer Ireland Pharmaceuticals

Active Ingredients

Neisseria Meningitidis Serogroup B Recombinant LP2086 Subfamily B Protein

0.06 mg/0.5ml

Neisseria Meningitidis Serogroup B Recombinant LP2086 Subfamily A Protein

0.06 mg/0.5ml

Documents

Package Inserts

Trumenba PI.pdf

Approved: November 10, 2021

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