ORKAMBI DIN 02483831
Status: Marketed
Holder: VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
Molecule: LUMACAFTOR
Available to quote
Health Canada record
| Active ingredient(s) | LUMACAFTOR 100 MG; IVACAFTOR 125 MG |
|---|---|
| Dosage form | Granules |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | R07AX30 IVACAFTOR AND LUMACAFTOR |
| Original market date | 14-Dec-2018 |
| Current status date | 14-Dec-2018 |
| 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 LUMACAFTOR
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02483858 | ORKAMBI | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Granules | LUMACAFTOR 150 MG; IVACAFTOR 188 MG | Marketed |
| 02537087 | ORKAMBI | VERTEX PHARMACEUTICALS (CANADA) INCORPORATED | Granules | LUMACAFTOR 75 MG; IVACAFTOR 94 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 21622 | 2018-12-11 | Supplement to a New Drug Submission (SNDS) | TO EXPAND THE INDICATION OFR ORKAMBI (LUMACAFTOR/VACAFTOR) FOR THE TREATMENT OF CYSTIC FIBROSIS (CF) IN PATIENTS AGED 2 THROUGH 5 YEARS WHO ARE HOMOZYGOUS FOR THE F5D8DEL MUTATION IN THE CYCTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATORY (CFTR) GENE. A NEW DOSAGE FORM, GRANULES, IS ALSO BEING PROPOSED FOR THIS PATIENT POPULATION |
International API supply for LUMACAFTOR
1 active FDA Drug Master Files.
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