ApprovalTrail

Approval · Notice of Compliance 23824 · 2020

TEPADINA: Notice of Compliance 23824

Issued June 22, 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.

Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
Notice number
23824
Date
June 22, 2020
Company
Adienne SaLugano, Tessin, Switzerland
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Addition of a manufacturing site for the drug substance; a manufacturing site of the drug product; a release-testing site for the drug product; and primary container closure systems for the sterile drug product.
With conditions
Yes (NOC/c)

Products in this notice

BrandDINStatus today
TEPADINANot yet assigned—

Medicinal ingredients