Notice of Amendment: Addition of Metamizole (Dipyrone) to the Prescription Drug List (PDL)
Date: July 18, 2022
Our file number: 22-108325-965
The purpose of this Notice of Amendment is to announce that metamizole (also known as 'dipyrone') has been added to the veterinary part of the Prescription Drug List (PDL).
| Drugs containing any of the following: | Including (but not limited to): | Qualifier | Effective Date |
|---|---|---|---|
| Metamizole (dipyrone) or its salts | n/a | n/a | 2022-07-18 |
Rationale
As indicated in the Notice of Intent to Amend published on January 18th 2022, Health Canada received a veterinary drug submission for metamizole (also known as 'dipyrone'), a pyrazolone non-steroidal anti-inflammatory drug (NSAID). Upon review of the safety and efficacy evidence submitted to Health Canada, it was determined that metamizole meets the criteria outlined in section C.01.040.3 of the Food and Drug Regulations. More information can be found in the Notice of Consultation.
As a result of this PDL amendment, a veterinary product containing metamizole (dipyrone) or its salts will be considered a prescription drug subject to the Food and Drug Regulations (FDR).
Health Canada has notified the sponsors of the following Drug Identification Number (DIN) products that their products will be affected by this switch:
- 02229855
- 00319406
- 02279843
- 02231658
- 02500086
Should you have any questions on this update to the Prescription Drug List, please contact:
Health Canada
Pharmaceutical Drugs Directorate
Office of Science
E-mail: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
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