Approval · Notice of Compliance 24737 · 2020
HADLIMA: Notice of Compliance 24737
Issued November 26, 2020
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
- 24737
- Date
- November 26, 2020
- Company
- Samsung Bioepis Co., LtdIncheon, Incheon, Korea, Republic Of
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- PRODUCT MONOGRAPH UPDATES AND NEW INDICATIONS: HIDRADENITIS SUPPURATIVA - TREATMENT OF ACTVE TO SEVERE HIDRADENITIS SUPPURATIVA IN ADULT AN ADOLESCENT POPULATIONS (12 TO 17 YEARS OF AGE WIGHING >30 KG) WHO HAVE NOT RESPONDED TO CONVENTIONAL THERAPY (INCLUDING SYTEMIC ANTIBIOTICS) pEDIATRIC uVEITIS - TREATMENT OF CHRONIC NON-INFECTIOUS ANTERIOR UVEITIS IN PEDIATRIC PATIENTS FROM 2 YEARS OF AGE WHO HAVE HAD AN INADEQUATE RESPONSE TO OR ARE INTOLERANT TO CONVENTIONAL THERAPY, OR IN WHOM CONVENTIONAL THERAPY IS INAPPROPRIATE. HADLIMA AND HADLIMA PUSHTOUCH ARE AVAILABLE FOR PEDIATRIC UVEITIS PATIENTS WHO REQUIRE THE FULL 40 MG DOSE BASED ON BODY WEIGHT
- Canadian reference product
- HUMIRA
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| HADLIMA | Not yet assigned | — |
| HADLIMA PUSHTOUCH | Not yet assigned | — |
Medicinal ingredients
- ADALIMUMAB 40 MG per 0.8ML