Basic Information
Rebif Solution for Injection in Cartridge 44mcg/0.5ml
INJECTION, SOLUTION
Regulatory Information
SIN13975P
June 17, 2011
Prescription Only
Therapeutic
SUBCUTANEOUS
August 10, 2023
June 3, 2025
XL03AB07
Company Information
Active Ingredients
Strength: 44mcg/0.5ml
Detailed Information
Contraindications
**4.3 Contraindications** - Hypersensitivity to natural or recombinant interferon-β, or to any excipients. - Current severe depression and/or suicidal ideation (see sections 4.4 and 4.8 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Indication Information
**4.1 Therapeutic indications** Rebif is indicated for the treatment of - patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing relapsing multiple sclerosis (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - patients with relapsing multiple sclerosis. In clinical trials, this was characterised by two or more acute exacerbations in the previous two years (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).