ORKAMBI DIN 02463040
Status: Marketed
Holder: VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
Molecule: IVACAFTOR
Available to quote
Health Canada record
| Active ingredient(s) | IVACAFTOR 125 MG; LUMACAFTOR 100 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | R07AX30 IVACAFTOR AND LUMACAFTOR |
| Original market date | 03-May-2017 |
| Current status date | 03-May-2017 |
| 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 IVACAFTOR
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02397412 | KALYDECO | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Tablet | IVACAFTOR 150 MG | Marketed |
| 02442612 | KALYDECO | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Granules | IVACAFTOR 50 MG | Marketed |
| 02442620 | KALYDECO | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Granules | IVACAFTOR 75 MG | Marketed |
| 02519364 | KALYDECO | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Granules | IVACAFTOR 25 MG | Marketed |
| 02543451 | KALYDECO | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Granules | IVACAFTOR 13.4 MG | Marketed |
| 02451379 | ORKAMBI | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Tablet | IVACAFTOR 125 MG; LUMACAFTOR 200 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 19186 | 2017-04-18 | Supplement to a New Drug Submission (SNDS) | NEW INDICATION: FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS 6 YEARS OF AGE AND OLDER WHO ARE HOMOZYGOUS FOR THE F08DEL MUTATION IN THE CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATORT (CFTR) GENE. NEW STRENGTH: 100 MG LUMACAFTOR/125 MG IVACAFTOR |
International API supply for IVACAFTOR
15 active FDA Drug Master Files.
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