Approval · Notice of Compliance 13642 · 2012
PRADAXA: Notice of Compliance 13642
Issued September 7, 2012
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
- 13642
- Date
- September 7, 2012
- Company
- Boehringer Ingelheim (Canada) Ltd.Burlington, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Product name change
- Therapeutic class
- Anticoagulant
Products in this notice
Medicinal ingredients
- DABIGATRAN ETEXILATE 75 MG per CAP
- DABIGATRAN ETEXILATE 110 MG per CAP
- DABIGATRAN ETEXILATE 150 MG per CAP