ApprovalTrail

Approval · Notice of Compliance 7688 · 2006

TRACLEER: Notice of Compliance 7688

Issued January 12, 2006

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
7688
Date
January 12, 2006
Company
Actelion Pharmaceuticals LtdAllschwil, Basel-Landschaft, Switzerland
Product type
Prescription Pharmaceutical
Submission
Supplement to a New Drug Submission (SNDS), supplement
Submission class
Other
Reason
New indication for pulmonary hypertension secondary to human immunodeficiency virus in patients who did not respond adequately to conventional therapy
Therapeutic class
Endothelin receptor antagonist

Products in this notice

BrandDINStatus today
TRACLEERNot yet assigned—

Medicinal ingredients