Approval · Notice of Compliance 28758 · 2022
REACTINE (10 MG): Notice of Compliance 28758
Issued August 15, 2022
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 28758
- Date
- August 15, 2022
- Company
- McNeil Consumer Healthcare, division of Johnson & Johnson Inc.Markham, Ontario, Canada
- Product type
- Nonprescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph to comply with the 2020 PM template. Updates to Labelling Materials . Addition of packaging size
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REACTINE (10 MG) | Not yet assigned | — |
| REACTINE (5 MG) | Not yet assigned | — |
| REACTINE (CHILDREN'S SYRUP) | 02238337 | Marketed |
| REACTINE ALLERGY | Not yet assigned | — |
| REACTINE ALLERGY LIQUID GELS | Not yet assigned | — |
| REACTINE FAST MELT JUNIOR | Not yet assigned | — |
| REACTINE RAPID DISSOLVE | Not yet assigned | — |
Medicinal ingredients
- CETIRIZINE HYDROCHLORIDE 10 MG per TAB
- CETIRIZINE HYDROCHLORIDE 5 MG per TAB
- CETIRIZINE HYDROCHLORIDE 5 MG per 5ML
- CETIRIZINE HYDROCHLORIDE 10 MG per CAP