Approval · Notice of Compliance 2969 · 1998
TWINRIX JUNIOR: Notice of Compliance 2969
Issued March 6, 1998
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
- 2969
- Date
- March 6, 1998
- 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
- New strength and new dosage regimen for infants, children and adolescents 1 through 18 years of age
- Therapeutic class
- Active immunizing agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TWINRIX JUNIOR | 02237548 | Marketed |
Medicinal ingredients
- HEPATITIS A VACCINE, INACTIVATED 360 UNIT per 0.5ML
- HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCG per 0.5ML