ApprovalTrail

Drug · DIN 02520133

HYPERHEP B

PREFILLED SYRINGE

Authorized, not yet reported as sold

Authorized for sale in Canada; the company has not yet told Health Canada that it is on the market.

Status Approved since September 10, 2021.
Drug Identification Number (DIN)
02520133
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
July 31, 2026

Active ingredients

As listed in the Drug Product Database.

IngredientStrengthPer
HEPATITIS B IMMUNOGLOBULIN (HUMAN)220 UNITML

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