Approval · Notice of Compliance 3844 · 1997
HAVRIX: Notice of Compliance 3844
Issued July 8, 1997
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
- 3844
- Date
- July 8, 1997
- Company
- Smithkline Beecham Pharma, Division Of Smithkline Beecham Inc.Mississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- An alternate site for production of concentrated sterile bulk, scale up of manufacturing process
- Therapeutic class
- Active immunizing agent
Products in this notice
Medicinal ingredients
- HEPATITIS A VACCINE, INACTIVATED 720 UNIT per 0.5ML
- HEPATITIS A VACCINE, INACTIVATED 1,440 UNIT per ML