Approval · Notice of Compliance 36263 · 2025
HYPERRHO: Notice of Compliance 36263
Issued October 27, 2025
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
- 36263
- Date
- October 27, 2025
- Company
- Grifols Therapeutics LlcClayton, North Carolina, United States
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Revised brand name. Alternate drug substance manufacturing facility. Drug substance manufacturing process change. New strength
Products in this notice
Medicinal ingredients
- ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 1,500 UNIT per ML
- ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 250 UNIT per ML