Approval · Notice of Compliance 11062 · 2010

ACTONEL: Notice of Compliance 11062

Issued February 18, 2010

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: 11062
Date: February 18, 2010
Company: Warner Chilcott Canada CoMarkham, Ontario, Canada
Product type: Prescription Pharmaceutical
Submission: New Drug Submission (NDS)
Submission class: Admin
Reason: Manufacturer name change
Therapeutic class: Bone metabolism regulator

Products in this notice

Brand	DIN	Status today
ACTONEL	02242518	Cancelled Post Market
ACTONEL	02239146	Cancelled Post Market
ACTONEL	02246896	Marketed
ACTONEL	02297787	Cancelled Post Market
ACTONEL	02316838	Marketed

Medicinal ingredients

RISEDRONATE SODIUM HEMI-PENTAHYDRATE 5 MG per TAB
RISEDRONATE SODIUM HEMI-PENTAHYDRATE 30 MG per TAB
RISEDRONATE SODIUM HEMI-PENTAHYDRATE 35 MG per TAB
RISEDRONATE SODIUM HEMI-PENTAHYDRATE 75 MG per TAB
RISEDRONATE SODIUM HEMI-PENTAHYDRATE 150 MG per TAB