ApprovalTrail

Approval · Notice of Compliance 16231 · 2014

ELAPRASE: Notice of Compliance 16231

Issued October 29, 2014

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
16231
Date
October 29, 2014
Company
Shire Human Genetic Therapies IncLexington, Massachusetts, United States
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
Updates to the product monograph
Therapeutic class
Enzyme replacement therapy

Products in this notice

BrandDINStatus today
ELAPRASENot yet assigned—

Medicinal ingredients