ApprovalTrail

Drug · DIN 02520125

HYPERHEP B

NEONATAL, PREFILLED SYRINGE

Yes: authorized and sold in Canada

Authorized, and the company reports that it sells it in Canada.

Status Marketed since August 16, 2022; first marketed August 16, 2022.
Drug Identification Number (DIN)
02520125
Company (DIN owner)
Grifols Therapeutics LlcClayton, North Carolina, United States
Schedule
Schedule d
Dosage form
Solution
Route
Intramuscular
Therapeutic class (ATC)
Hepatitis b immunoglobulin J06BB04
Class
Human
Record last updated
August 24, 2026

Active ingredients

As listed in the Drug Product Database.

IngredientStrengthPer
HEPATITIS B IMMUNOGLOBULIN (HUMAN)110 UNIT0.5 ML

Notices of Compliance

Health Canada approvals that name this DIN.

  • September 8, 2021: NOC 26653Supplement to a New Drug Submission (SNDS) · Changes to the manufacturing process, to the description of the drug product and new presentation

Other DINs named HYPERHEP B