Drug Report History
Below you will find the report version history. When a report is updated, a new version of the report is created. The report history allows you to see the changes between versions. You can select two versions of the report to compare. The fields that were changed between versions will be highlighted in yellow.
The translation of reports creates two separate versions which is why some reports may not seem to have any differences. In this case, only the language field below will be highlighted in yellow.
| Version v3-EN | Version v1-EN | |
|---|---|---|
| Language | English | English |
| Date Updated | 2025-08-28 | 2025-07-07 |
| Drug Identification Number | 02361752 | 02361752 |
| Brand name | ZENHALE | ZENHALE |
| Common or Proper name | mometasone furoate & formoterol fumarate dihydrate inhalation aerosol | mometasone furoate & formoterol fumarate dihydrate inhalation aerosol |
| Company Name | ORGANON CANADA INC. | ORGANON CANADA INC. |
| Ingredients | FORMOTEROL FUMARATE DIHYDRATE MOMETASONE FUROATE | FORMOTEROL FUMARATE DIHYDRATE MOMETASONE FUROATE |
| Strength(s) | 5MCG 100MCG | 5MCG 100MCG |
| Dosage form(s) | AEROSOL, METERED DOSE | AEROSOL, METERED DOSE |
| Route of administration | INHALATION INHALATION | INHALATION INHALATION |
| Packaging size | 60 dose | 60 dose |
| ATC code | R03AK | R03AK |
| ATC description | ADRENERGICS, INHALANTS | ADRENERGICS, INHALANTS |
| Reason for discontinuation | Business reasons | Business reasons |
| Anticipated discontinuation date | 2025-09-12 | 2025-09-12 |
| Actual discontinuation date | 2025-08-26 | |
| Remaining supply date | 2025-08-26 | 2025-09-12 |
| Discontinuation status | Discontinued | To be discontinued |
| Discontinuation decision reversal | no | no |
| Tier 3 Status | No | No |
| Information on remaining supply | ||
| Company comments | ZENHALE® 100/5 mcg (DIN 02361752) and ZENHALE® 200/5 mcg (DIN 02361760) remain available in the format of 120 actuations. | ZENHALE® 100/5 mcg (DIN 02361752) and ZENHALE® 200/5 mcg (DIN 02361760) remain available in the format of 120 actuations. |
| Health Canada comments |