Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, DELAYED RELEASE
**4.2 Posology and method of administration** Mezavant XL is intended for once daily, oral administration. The tablets must not be crushed or chewed and should be taken with food. Adults, including the elderly (>65 years) For induction of remission: 2.4 to 4.8 g (two to four tablets) should be taken once daily. The highest dose of 4.8 g/day is recommended for patients not responding to lower doses of mesalazine. When using the highest dose (4.8 g/day), the effect of the treatment should be evaluated at 8 weeks. For maintenance of remission: 2.4 g (two tablets) should be taken once daily. Children and adolescents Mezavant XL is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy. Specific studies have not been performed to investigate Mezavant XL in patients with hepatic or renal impairment (see sections 4.3 and 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
ORAL
Medical Information
**4.1 Therapeutic indications** For the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis. For maintenance of remission.
**4.3 Contraindications** History of hypersensitivity to salicylates (including mesalazine) or any of the excipients of Mezavant XL. Severe renal impairment (GFR <30 ml/min/1.73m2) and/or severe hepatic impairment.
A07EC02
mesalazine
Manufacturer Information
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
COSMO S.P.A.
Active Ingredients
Documents
Package Inserts
Mezavant XL Tablet PI.pdf
Approved: April 12, 2023