ASERVO EQUIHALER DIN 02498634
Status: Cancelled Post Market
Holder: BOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
Molecule: CICLESONIDE
Health Canada record
| Active ingredient(s) | CICLESONIDE 343 MCG |
|---|---|
| Dosage form | Solution |
| Route | Inhalation |
| Schedule | PRESCRIPTION |
| Class | Veterinary |
| ATC | |
| Original market date | 08-Dec-2020 |
| Current status date | 25-Jun-2024 |
| Source | Health Canada DPD |
Establishment licence of the holder
Boehringer Ingelheim (Canada) Ltd Ltee — licence 100187, currently licensed, last inspection rating C (2025-03-03).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing CICLESONIDE
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02285606 | ALVESCO | COVIS PHARMA GMBH | Aerosol (Metered-Dose) | CICLESONIDE 100 MCG | Marketed |
| 02285614 | ALVESCO | COVIS PHARMA GMBH | Aerosol (Metered-Dose) | CICLESONIDE 200 MCG | Marketed |
| 02303671 | OMNARIS | COVIS PHARMA GMBH | Spray (Metered-Dose) | CICLESONIDE 50 MCG | Marketed |
| 02285592 | ALVESCO | TAKEDA CANADA INC | Aerosol (Metered-Dose) | CICLESONIDE 50 MCG | Cancelled Pre Market |
| 02417316 | APO-CICLESONIDE | APOTEX INC | Spray (Metered-Dose) | CICLESONIDE 50 MCG | Dormant |
| 02404311 | OMNARIS HFA | TAKEDA CANADA INC | Aerosol (Metered-Dose) | CICLESONIDE 50 MCG | Cancelled Post Market |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 24958 | 2021-01-07 | Supplement to a New Drug Submission (SNDS) | ADDITION OF DRUG SUBSTANCE MANUFACTURING SITE |
| 23533 | 2020-04-30 | New Drug Submission (NDS) |
International API supply for CICLESONIDE
3 valid EDQM Certificates of Suitability from 3 holders. 7 active FDA Drug Master Files.
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