Approval · Notice of Compliance 35718 · 2025

BUCCOLAM: Notice of Compliance 35718

Issued July 22, 2025

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: 35718
Date: July 22, 2025
Company: Neuraxpharm Pharmaceuticals, S.L.Sant Joan Despi, Barcelona, Spain
Product type: Prescription Pharmaceutical
Submission: New Drug Submission (NDS)
Submission class: Other

Products in this notice

Brand	DIN	Status today
BUCCOLAM	02559579	Marketed
BUCCOLAM	02559587	Marketed
BUCCOLAM	02559595	Marketed
BUCCOLAM	02559609	Marketed

Medicinal ingredients

MIDAZOLAM HYDROCHLORIDE 2.5 MG per 0.5ML
MIDAZOLAM HYDROCHLORIDE 5 MG per ML
MIDAZOLAM HYDROCHLORIDE 7.5 MG per 1.5ML
MIDAZOLAM HYDROCHLORIDE 10 MG per 2ML