Drug · DIN 02269198
ACLASTA
Yes: authorized and sold in Canada
Authorized, and the company reports that it sells it in Canada.
Status Marketed since December 13, 2022; first marketed August 22, 2005.
- Drug Identification Number (DIN)
- 02269198
- Company (DIN owner)
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Schedule
- Prescription
- Dosage form
- Solution
- Route
- Intravenous
- Therapeutic class (ATC)
- Zoledronic acid M05BA08
- Class
- Human
- Record last updated
- March 22, 2025
Active ingredients
As listed in the Drug Product Database.
| Ingredient | Strength | Per |
|---|---|---|
| ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) | 5 MG | 100 ML |
Notices of Compliance
Health Canada approvals that name this DIN.
- December 13, 2022: NOC 29690New Drug Submission (NDS) · Administrative: Change in Product Ownership
- April 11, 2017: NOC 19153Supplement to a New Drug Submission (SNDS) · Update to the product monograph regarding osteonecrosis of the jaw (onj) in response to an advisement letter
- June 30, 2005: NOC 7193New Drug Submission (NDS)
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “aclasta”. A notice may cover another product or only some lots: read it to see what it covers.
- ACLASTA (zoledronic acid 5 mg/100 mL) - Volume overfill in vials of solution for intravenous infusion - For Health ProfessionalsJuly 8, 2013 · Drugs · Product safety
- Bisphosphonate osteoporosis drugs (Aclasta, Actonel, Didrocal, Fosamax, Fosavance): Small but increased risk of unusual thigh bone fracturesDecember 19, 2011 · Drugs
- ACLASTA (zoledronic acid 5mg/100mL) solution for intravenous infusion - Association with renal dysfunction - For the PublicOctober 14, 2010 · Drugs
- ACLASTA (zoledronic acid 5mg/100mL) solution for intravenous infusion - Association with renal dysfunction - For Health ProfessionalsOctober 14, 2010 · Drugs