Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**Dosage and method of administration** Posology The recommended dose of Aremed for adults including the elderly in one 1 mg tablet once a day. _Special populations_ Paediatric population: Aremed is not recommended for use in children and adolescents due to insufficient data on safety and efficacy. _Renal impairment:_ No dose change is recommended in patients with mild or moderate renal impairment. _Hepatic impairment:_ No dose change is recommended in patients with mild hepatic disease. Method of administration Oral administration.
ORAL
Medical Information
**Indications** Aremed is indicated for the treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.
**Contraindications** Aremed is contra-indicated in: - premenopausal women. - pregnant or breast-feeding women. - patients with severe renal impairment (creatinine clearance <20ml/min). - patients with moderate or severe hepatic disease. - hypersensitivity to the active substance(s) or to any of the excipients listed in section List of excipients. - concurrent oestrogen-containing therapies. - concurrent tamoxifen therapy.
L02BG03
anastrozole
Manufacturer Information
GOLDPLUS UNIVERSAL PTE LTD
REMEDICA LTD