Approval · Notice of Compliance 16455 · 2014
PRIMENE 10%: Notice of Compliance 16455
Issued December 18, 2014
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
- 16455
- Date
- December 18, 2014
- Company
- Baxter CorporationMississauga, Ontario, Canada
- Product type
- Nonprescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Transfer of drug identification number
- Therapeutic class
- Intravenous nutritive supplement
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PRIMENE 10% | 02236875 | Marketed |
Medicinal ingredients
- L-ALANINE 800 MG per 100ML
- L-ASPARTIC ACID 600 MG per 100ML
- GLUTAMIC ACID 1 G per 100ML
- GLYCINE 400 MG per 100ML
- HISTIDINE 380 MG per 100ML
- L-ARGININE 840 MG per 100ML
- L-CYSTEINE 189 MG per 100ML
- L-ISOLEUCINE 670 MG per 100ML
- L-LEUCINE 1 G per 100ML
- L-ORNITHINE 318 MG per 100ML
- L-PHENYLALANINE 420 MG per 100ML
- L-PROLINE 300 MG per 100ML
- L-THREONINE 370 MG per 100ML
- L-VALINE 760 MG per 100ML
- METHIONINE 240 MG per 100ML
- SERINE 400 MG per 100ML
- TAURINE 60 MG per 100ML
- TRYPTOPHAN 200 MG per 100ML
- L-TYROSINE 45 MG per 100ML
- L-LYSINE 1.1 G per 100ML