SALOFALK DIN 02112760
Health Canada record
| Active ingredient(s) | MESALAZINE 500 MG |
|---|---|
| Dosage form | Suppository |
| Route | Rectal |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | A07EC02 MESALAZINE |
| Original market date | 31-Dec-1995 |
| Current status date | 10-Jul-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
AbbVie Corporation — licence 101988, currently licensed, last inspection rating C (2023-07-18).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MESALAZINE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02552426 | MESALAMINE | TILLOTTS PHARMA AG | Tablet (Delayed-Release) | MESALAZINE 800 MG | Approved |
| 02297558 | MEZAVANT | TAKEDA CANADA INC | Tablet (Delayed- And Extended-Release) | MESALAZINE 1.2 G | Marketed |
| 02545012 | MEZERA | AVIR PHARMA INC. | Tablet (Delayed-Release) | MESALAZINE 1 G | Marketed |
| 02474026 | MEZERA | AVIR PHARMA INC. | Foam | MESALAZINE 1 G | Marketed |
| 02524481 | MEZERA | AVIR PHARMA INC. | Tablet (Delayed-Release) | MESALAZINE 500 MG | Marketed |
| 02474018 | MEZERA | AVIR PHARMA INC. | Suppository | MESALAZINE 1 G | Marketed |
| 02465752 | OCTASA | TILLOTTS PHARMA AG | Tablet (Delayed-Release) | MESALAZINE 800 MG | Marketed |
| 02529610 | OCTASA | TILLOTTS PHARMA AG | Tablet (Delayed-Release) | MESALAZINE 1600 MG | Marketed |
| 02265257 | PENDO-5 ASA | PENDOPHARM DIVISION OF PHARMASCIENCE INC | Tablet (Enteric-Coated) | MESALAZINE 400 MG | Approved |
| 02153521 | PENTASA | FERRING INC | Suspension | MESALAZINE 1 G | Marketed |
| 02099683 | PENTASA | FERRING INC | Tablet (Extended-Release) | MESALAZINE 500 MG | Marketed |
| 02399466 | PENTASA | FERRING INC | Tablet (Extended-Release) | MESALAZINE 1 G | Marketed |
| 02153556 | PENTASA | FERRING INC | Suspension | MESALAZINE 4 G | Marketed |
| 02153564 | PENTASA | FERRING INC | Suppository | MESALAZINE 1 G | Marketed |
| 02242146 | SALOFALK | ABBVIE CORPORATION | Suppository | MESALAZINE 1000 MG | Marketed |
| 02112809 | SALOFALK | ABBVIE CORPORATION | Suspension | MESALAZINE 4 G | Marketed |
| 02112795 | SALOFALK | ABBVIE CORPORATION | Suspension | MESALAZINE 2 G | Marketed |
| 02112787 | SALOFALK | ABBVIE CORPORATION | Tablet (Delayed-Release) | MESALAZINE 500 MG | Marketed |
| 02171929 | TEVA-5 ASA | TEVA CANADA LIMITED | Tablet (Enteric-Coated) | MESALAZINE 400 MG | Marketed |
| 02562367 | ZDS-MESALAMINE SUPPOSITORIES | ZYDUS LIFESCIENCES LIMITED | Suppository | MESALAZINE 1000 MG | Marketed |
| 02351463 | 5-ASA | SANIS HEALTH INC | Tablet (Enteric-Coated) | MESALAZINE 400 MG | Cancelled Post Market |
| 01997580 | ASACOL | ALLERGAN INC | Tablet (Enteric-Coated) | MESALAZINE 400 MG | Cancelled Post Market |
| 02267217 | ASACOL 800 | ALLERGAN INC | Tablet (Delayed-Release) | MESALAZINE 800 MG | Cancelled Post Market |
| 01914030 | MESASAL | GLAXOSMITHKLINE INC | Tablet (Enteric-Coated) | MESALAZINE 500 MG | Cancelled Post Market |
| 02348063 | NTP-5-AMINOSALICYLIC ACID | TEVA CANADA LIMITED | Tablet (Enteric-Coated) | MESALAZINE 400 MG | Cancelled Pre Market |
| 02153548 | PENTASA ENEMA 2G/100ML | FERRING INC | Enema; Liquid | MESALAZINE 2 G | Cancelled Post Market |
| 02099675 | PENTASA EXTENDED-RELEASE TABLETS 250MG | FERRING INC | Tablet (Extended-Release) | MESALAZINE 250 MG | Cancelled Post Market |
| 02112779 | SALOFALK (R) 5-ASA ENTERIC COATED TAB- 250MG | AXCAN PHARMA INC | Tablet (Enteric-Coated) | MESALAZINE 250 MG | Cancelled Post Market |
| 02112752 | SALOFALK (R) 5-ASA SUPPOSITORIES - 250MG | AXCAN PHARMA INC | Suppository | MESALAZINE 250 MG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 29452 | 2022-11-14 | New Drug Submission (NDS) | Administrative: Change in Product Ownership |
| 12825 | 2011-12-01 | New Drug Submission (NDS) | Manufacturer Name Change |
| 5390 | 1994-07-15 | New Drug Submission (NDS) |
International API supply for MESALAZINE
19 valid EDQM Certificates of Suitability from 19 holders. 1 active FDA Drug Master Files.
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