Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
2026-02-20
Original market date: See footnote 1
2026-02-20
Product name:
BUCCOLAM
Description:
SINGLE-USE PREFILLED SYRINGE
DIN:
02559595
Product Monograph/Veterinary Labelling:
Date:
2025-07-22
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
NEURAXPHARM PHARMACEUTICALS, S.L.
Avenida De Barcelona, 69
Sant Joan Despi
Barcelona
Spain
08970
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Buccal
Number of active ingredient(s):
1
Schedule(s):
TARGETED SUBSTANCES (CDSA IV)
Anatomical Therapeutic Chemical (ATC): See footnote 4
N05CD08 MIDAZOLAM
Active ingredient group (AIG) number:See footnote5
0119935001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MIDAZOLAM (MIDAZOLAM HYDROCHLORIDE) | 7.5 MG / 1.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Patient Education |