Approval · Notice of Compliance 19224 · 2017

ACTONEL: Notice of Compliance 19224

Issued May 1, 2017

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: 19224
Date: May 1, 2017
Company: Warner Chilcott Canada CoMarkham, Ontario, Canada
Product type: Prescription Pharmaceutical
Submission: Supplement to a New Drug Submission (SNDS), supplement
Submission class: Other
Reason: Update to the product monograph regarding osteonecrosis of the jaw (onj) in response to an advisement letter

Products in this notice

Brand	DIN	Status today
ACTONEL	02242518	Cancelled Post Market
ACTONEL	02239146	Cancelled Post Market
ACTONEL	02246896	Marketed
ACTONEL	02316838	Marketed
ACTONEL	02370417	Marketed
ACTONEL DR	Not yet assigned	—

Medicinal ingredients

RISEDRONATE SODIUM 5 MG per MG
RISEDRONATE SODIUM 30 MG per MG
RISEDRONATE SODIUM 75 MG per MG
RISEDRONATE SODIUM 150 MG per MG
RISEDRONATE SODIUM 35 MG per MG