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:
2018-06-01
Original market date: See footnote 1
1991-12-31
Product name:
EMLA CREAM
DIN:
00886858
Product Monograph/Veterinary Labelling:
Date:
2022-04-20
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ASPEN PHARMACARE CANADA INC.
Unit 8, 1155 North Service Road West
Oakville
Ontario
Canada
L6M 3E3
Class:
Human
Dosage form(s):
Cream
Route(s) of administration:
Topical
Number of active ingredient(s):
2
Schedule(s):
Ethical
American Hospital Formulary Service (AHFS): See footnote 3
72:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
N01BB54 PRILOCAINE, COMBINATIONS
Active ingredient group (AIG) number:See footnote5
0222447001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| LIDOCAINE | 2.5 % |
| PRILOCAINE | 2.5 % |