Product Dossier
IMOJEV
Product Dossier for IMOJEV (Japanese encephalitis virus, Biocelect). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Biocelect
- Active ingredient: Japanese encephalitis virus
- Therapeutic area: Infectious Disease
- Related brand: JESPECT
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
IMOJEV is a Japanese encephalitis vaccine, live attenuated, supplied as powder for injection in a vial plus diluent vial.
Approved indications
— Prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus in individuals from 12 months of age and over.
Dosing overview
IMOJEV includes a booster dose recommendation for paediatric populations.
Regulatory history
IMOJEV was first listed on the ARTG on 23 August 2010 under licence category RE. On 11 December 2013, the TGA approved a major variation submission for IMOJEV, which amended the dosage schedule to include a booster dose for paediatric populations and updated the Product Information with long-term adult follow-up data.