NB-PRAMIPEXOLE DIN 02566214
Health Canada record
| Active ingredient(s) | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | N04BC05 PRAMIPEXOLE |
| Original market date | |
| Current status date | 25-Feb-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
NB Pharma Inc. — licence 3-002798, currently licensed, last inspection rating C (2025-12-05).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02297337 | ACT PRAMIPEXOLE | TEVA CANADA LIMITED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Marketed |
| 02297302 | ACT PRAMIPEXOLE | TEVA CANADA LIMITED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Marketed |
| 02297310 | ACT PRAMIPEXOLE | TEVA CANADA LIMITED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Marketed |
| 02297329 | ACT PRAMIPEXOLE | TEVA CANADA LIMITED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG | Marketed |
| 02347342 | APO-PRAMIPEXOLE | APOTEX INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.125 MG | Approved |
| 02292386 | APO-PRAMIPEXOLE | APOTEX INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Marketed |
| 02292394 | APO-PRAMIPEXOLE | APOTEX INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.0 MG | Marketed |
| 02292408 | APO-PRAMIPEXOLE | APOTEX INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Marketed |
| 02347350 | APO-PRAMIPEXOLE | APOTEX INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.75 MG | Approved |
| 02292378 | APO-PRAMIPEXOLE | APOTEX INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Marketed |
| 02297256 | MIRAPEX | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.125 MG | Marketed |
| 02237145 | MIRAPEX | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Marketed |
| 02367610 | PRAMIPEXOLE | SANIS HEALTH INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Marketed |
| 02367602 | PRAMIPEXOLE | SANIS HEALTH INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Marketed |
| 02325802 | PRAMIPEXOLE | PRO DOC LIMITEE | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Marketed |
| 02325810 | PRAMIPEXOLE | PRO DOC LIMITEE | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Marketed |
| 02309157 | PRAMIPEXOLE | SIVEM PHARMACEUTICALS ULC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Marketed |
| 02309149 | PRAMIPEXOLE | SIVEM PHARMACEUTICALS ULC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG | Marketed |
| 02309130 | PRAMIPEXOLE | SIVEM PHARMACEUTICALS ULC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Marketed |
| 02309122 | PRAMIPEXOLE | SIVEM PHARMACEUTICALS ULC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Marketed |
| 02325837 | PRAMIPEXOLE | PRO DOC LIMITEE | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Marketed |
| 02325829 | PRAMIPEXOLE | PRO DOC LIMITEE | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG | Marketed |
| 02367629 | PRAMIPEXOLE | SANIS HEALTH INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG | Marketed |
| 02315270 | SANDOZ PRAMIPEXOLE | SANDOZ CANADA INCORPORATED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Marketed |
| 02315297 | SANDOZ PRAMIPEXOLE | SANDOZ CANADA INCORPORATED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Marketed |
| 02315262 | SANDOZ PRAMIPEXOLE | SANDOZ CANADA INCORPORATED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Marketed |
| 02315289 | SANDOZ PRAMIPEXOLE | SANDOZ CANADA INCORPORATED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG | Marketed |
| 02363321 | AVA-PRAMIPEXOLE | AVANSTRA INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.0 MG | Cancelled Post Market |
| 02363348 | AVA-PRAMIPEXOLE | AVANSTRA INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Cancelled Post Market |
| 02363305 | AVA-PRAMIPEXOLE | AVANSTRA INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Cancelled Post Market |
| 02363313 | AVA-PRAMIPEXOLE | AVANSTRA INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Cancelled Post Market |
| 02309033 | DOM-PRAMIPEXOLE | DOMINION PHARMACAL | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.0 MG | Cancelled Pre Market |
| 02309017 | DOM-PRAMIPEXOLE | DOMINION PHARMACAL | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Cancelled Post Market |
| 02309025 | DOM-PRAMIPEXOLE | DOMINION PHARMACAL | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Cancelled Pre Market |
| 02309041 | DOM-PRAMIPEXOLE | DOMINION PHARMACAL | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Cancelled Pre Market |
| 02241594 | MIRAPEX | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Cancelled Post Market |
| 02237146 | MIRAPEX | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG | Cancelled Post Market |
| 02237147 | MIRAPEX | BOEHRINGER INGELHEIM (CANADA) LTD LTEE | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Cancelled Post Market |
| 02376350 | MYLAN-PRAMIPEXOLE | MYLAN PHARMACEUTICALS ULC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Cancelled Post Market |
| 02376369 | MYLAN-PRAMIPEXOLE | MYLAN PHARMACEUTICALS ULC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Cancelled Post Market |
| 02376385 | MYLAN-PRAMIPEXOLE | MYLAN PHARMACEUTICALS ULC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Cancelled Post Market |
| 02376377 | MYLAN-PRAMIPEXOLE | MYLAN PHARMACEUTICALS ULC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG | Cancelled Post Market |
| 02362317 | NTP-PRAMIPEXOLE | NT PHARMA CANADA LTD | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Cancelled Pre Market |
| 02362287 | NTP-PRAMIPEXOLE | NT PHARMA CANADA LTD | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Cancelled Pre Market |
| 02362295 | NTP-PRAMIPEXOLE | NT PHARMA CANADA LTD | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Cancelled Pre Market |
| 02362309 | NTP-PRAMIPEXOLE | NT PHARMA CANADA LTD | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.0 MG | Cancelled Pre Market |
| 02335778 | NU-PRAMIPEXOLE | NU-PHARM INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Cancelled (Unreturned Annual) |
| 02290154 | PMS-PRAMIPEXOLE | PHARMASCIENCE INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Cancelled Post Market |
| 02290146 | PMS-PRAMIPEXOLE | PHARMASCIENCE INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.0 MG | Cancelled Post Market |
| 02290138 | PMS-PRAMIPEXOLE | PHARMASCIENCE INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.50 MG | Cancelled Post Market |
| 02290111 | PMS-PRAMIPEXOLE | PHARMASCIENCE INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Cancelled Post Market |
| 02344289 | PRAMIPEXOLE | COBALT PHARMACEUTICALS COMPANY | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Cancelled Pre Market |
| 02344270 | PRAMIPEXOLE | COBALT PHARMACEUTICALS COMPANY | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Cancelled Pre Market |
| 02344300 | PRAMIPEXOLE | COBALT PHARMACEUTICALS COMPANY | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Cancelled Pre Market |
| 02344297 | PRAMIPEXOLE | COBALT PHARMACEUTICALS COMPANY | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.0 MG | Cancelled Pre Market |
| 02367645 | PRAMIPEXOLE | SANIS HEALTH INC | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Dormant |
| 02269317 | TEVA-PRAMIPEXOLE | TEVA CANADA LIMITED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5 MG | Cancelled Post Market |
| 02269333 | TEVA-PRAMIPEXOLE | TEVA CANADA LIMITED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5 MG | Cancelled Post Market |
| 02269325 | TEVA-PRAMIPEXOLE | TEVA CANADA LIMITED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1 MG | Cancelled Post Market |
| 02269309 | TEVA-PRAMIPEXOLE | TEVA CANADA LIMITED | Tablet | PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 36973 | 2026-02-25 | Abbreviated New Drug Submission (ANDS) | Administrative: Licensing Agreement between two manufacturers |
International API supply for PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
13 valid EDQM Certificates of Suitability from 13 holders. 12 active FDA Drug Master Files.
Request a quote for NB-PRAMIPEXOLE