Approval · Notice of Compliance 1165 · 2000
PUREGON: Notice of Compliance 1165
Issued June 13, 2000
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
- 1165
- Date
- June 13, 2000
- Company
- Organon Canada Inc.Kirkland, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New liquid formulation and three new strengths
- Therapeutic class
- Human gonadotropin
Products in this notice
Medicinal ingredients
- FOLLITROPIN BETA 50 UNIT per 0.5ML
- FOLLITROPIN BETA 75 UNIT per 0.5ML
- FOLLITROPIN BETA 100 UNIT per 0.5ML
- FOLLITROPIN BETA 150 UNIT per 0.5ML
- FOLLITROPIN BETA 200 UNIT per 0.5ML
- FOLLITROPIN BETA 225 UNIT per 0.5ML
- FOLLITROPIN BETA 250 UNIT per 0.5ML