TRIKAFTA DIN 02542285
Status: Marketed
Holder: VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
Molecule: ELEXACAFTOR
Available to quote
Health Canada record
| Active ingredient(s) | ELEXACAFTOR 80 MG; TEZACAFTOR 40 MG; IVACAFTOR 60 MG; IVACAFTOR 59.5 MG |
|---|---|
| Dosage form | Granules |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | R07AX32 IVACAFTOR, TEZACAFTOR AND ELEXACAFTOR |
| Original market date | 27-Oct-2023 |
| Current status date | 27-Oct-2023 |
| Source | Health Canada DPD |
Establishment licence of the holder
Vertex Pharmaceuticals (Canada) Incorporated — licence 101886, currently licensed, last inspection rating C (2024-07-30).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing ELEXACAFTOR
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02517140 | TRIKAFTA | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Tablet | ELEXACAFTOR 100 MG; TEZACAFTOR 50 MG; IVACAFTOR 75 MG; IVACAFTOR 150 MG | Marketed |
| 02526670 | TRIKAFTA | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Tablet | ELEXACAFTOR 50 MG; TEZACAFTOR 25 MG; IVACAFTOR 37.5 MG; IVACAFTOR 75 MG | Marketed |
| 02542277 | TRIKAFTA | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Granules | ELEXACAFTOR 100 MG; TEZACAFTOR 50 MG; IVACAFTOR 75 MG; IVACAFTOR 75 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 31866 | 2023-10-16 | Supplement to a New Drug Submission (SNDS) | Expand indication. Addition of new dosage form . Addition of new strengths |