Approval · Notice of Compliance 9725 · 2008
COSMEGEN: Notice of Compliance 9725
Issued August 20, 2008
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
- 9725
- Date
- August 20, 2008
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Removal of indications: 1) cosmegen, as part of a combination therapy and/or multi-modality treatment regimen indicated for treatment of metastatic, nonseminomatous testicular cancer. 2) cosmegen, as a component of regional perfusion in combination with melphalan, indicated for palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies. revision to the product monograph sections: warnings and precautions, adverse reactions, dosage and administration, and clinical trials
- Therapeutic class
- Actinomycin antibiotic / antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| COSMEGEN | Not yet assigned | — |
Medicinal ingredients
- DACTINOMYCIN 0.5 MG per VIAL