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:
2021-02-22
Original market date: See footnote 1
2021-02-22
Product name:
GLEOLAN
Description:
SINGLE DOSE VIAL
DIN:
02504928
Product Monograph/Veterinary Labelling:
Date:
2020-09-08
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MEDEXUS PHARMACEUTICALS INC.
35 Nixon Road, Unit 10
Bolton
Ontario
Canada
L7E 1K1
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
36:68.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01XD04 AMINOLEVULINIC ACID
Active ingredient group (AIG) number:See footnote5
0143983002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| AMINOLEVULINIC ACID HYDROCHLORIDE | 1.5 G / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |