Approval · Notice of Compliance 13853 · 2012
HERCEPTIN: Notice of Compliance 13853
Issued November 16, 2012
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
- 13853
- Date
- November 16, 2012
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Indication extensin: Herceptin (trastuzumab) is indicated for the treatment of patients with early stage breasta acnacer with ECOG 0-1 status whose romours overexpress HER2 following surgery and after chemotherapy; following adjuvant chemotherapy consisting of socorubicin and cylophosphamide, in combination with paclitaxel or doxetaxel; in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HERCEPTIN | Not yet assigned | — |
Medicinal ingredients
- TRASTUZUMAB 440 MG per VIAL