Approval · Notice of Compliance 11780 · 2010
TYKERB: Notice of Compliance 11780
Issued September 30, 2010
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 11780
- Date
- September 30, 2010
- Company
- Glaxosmithkline IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: In combination with letrozole for the treatment of post-menopausal patients with hormone receptor positive metastatic breast cancer, whose tumours over express the ErbB2 (HER2) receptor, and who are suitable for endocrine therapy
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TYKERB | Not yet assigned | — |
Medicinal ingredients
- LAPATINIB DITOSYLATE MONOHYDRATE 250 MG per TAB