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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:

2017-03-17

Original market date: See footnote 1

2016-01-28

Product name:

DIMENHYDRINATE INJECTION USP

Description:

SINGLE-USE AMPOULE, PRESERVATIVE-FREE

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:

02428954

Product Monograph/Veterinary Labelling:

Date: 2014-07-29 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

TELIGENT OU
Akadeemia Tee 21/5
Tallinn
Harju County
Estonia  12618

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intravenous,  Intramuscular

Number of active ingredient(s):

1

Schedule(s):

Ethical  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

56:22.08   ANTIHISTAMINES

Anatomical Therapeutic Chemical (ATC): See footnote 4

R06AA02  DIPHENHYDRAMINE

Active ingredient group (AIG) number:See footnote 5

0102747004

List of active ingredient(s)
Active ingredient(s) Strength
DIMENHYDRINATE 50 MG / ML

Application information

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