ATECTURA BREEZHALER DIN 02498693
Status: Marketed
Holder: NOVARTIS PHARMACEUTICALS CANADA INC
Molecule: INDACATEROL (INDACATEROL ACETATE)
Available to quote
Health Canada record
| Active ingredient(s) | INDACATEROL (INDACATEROL ACETATE) 150 MCG; MOMETASONE FUROATE 320 MCG |
|---|---|
| Dosage form | Capsule |
| Route | Inhalation |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | R03AK14 INDACATEROL AND MOMETASONE |
| Original market date | 19-Aug-2020 |
| Current status date | 19-Aug-2020 |
| Source | Health Canada DPD |
Establishment licence of the holder
Novartis Pharmaceuticals Canada Inc — licence 100273, currently licensed, last inspection rating C (2025-01-14).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing INDACATEROL (INDACATEROL ACETATE)
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02498685 | ATECTURA BREEZHALER | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | INDACATEROL (INDACATEROL ACETATE) 150 MCG; MOMETASONE FUROATE 80 MCG | Marketed |
| 02498707 | ATECTURA BREEZHALER | NOVARTIS PHARMACEUTICALS CANADA INC | Capsule | INDACATEROL (INDACATEROL ACETATE) 150 MCG; MOMETASONE FUROATE 160 MCG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 23552 | 2020-05-06 | New Drug Submission (NDS) |