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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:

2018-11-21

Original market date: See footnote 1

2010-04-12

Product name:

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE INJECTION

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

DIN:

02339536

Product Monograph/Veterinary Labelling:

Date: 2018-04-16 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

PIERREL PHARMA S.R.L.
Strada Statale Appia 7 Bis N. 46/48
Capua
Caserta
Italy  81043

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Block/Infiltration

Number of active ingredient(s):

2

Schedule(s):

Ethical  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

72:00.00   LOCAL ANESTHETICS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N01BB58  ARTICAINE, COMBINATIONS

Active ingredient group (AIG) number:See footnote 5

0252683001

List of active ingredient(s)
Active ingredient(s) Strength
ARTICAINE HYDROCHLORIDE 40 MG / ML
EPINEPHRINE BITARTRATE 0.009 MG / ML

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