Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**4.2 Posology and method of administration** Route of administration: Oral. **Adults (including elderly)** The dosage range is 20 to 40 mg daily, given either in divided doses twice daily or as a single dose once daily. **Use in children** The use of NOLVADEX is not recommended in children, as safety and efficacy have not been established (see Pharmacodynamic and Pharmacokinetics properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
ORAL
Medical Information
**4.1 Therapeutic indication** NOLVADEX is indicated for the treatment of breast cancer.
**4.3 Contraindications** **_Pregnancy:_** NOLVADEX must not be given during pregnancy. Premenopausal patients must be carefully examined before treatment to exclude the possibility of pregnancy (see also Pregnancy and lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). NOLVADEX should not be given to patients who have experienced hypersensitivity to the product or any of its ingredients.
L02BA01
tamoxifen
Manufacturer Information
ASTRAZENECA SINGAPORE PTE LTD
ASTRAZENECA UK LTD
Active Ingredients
Documents
Package Inserts
Nolvadex Tablet PI.pdf
Approved: August 12, 2022