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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:

2018-06-13

Original market date: See footnote 1

2018-06-13

Product name:

PENTHROX

Description:

SINGLE DOSE BOTTLE

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:

02474719

Product Monograph/Veterinary Labelling:

Date: 2018-04-06 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

PURDUE PHARMA
575 Granite Court
Pickering
Ontario
Canada  L1W 3W8

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Inhalation

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

28:08.92   MISCELLANEOUS ANALGESICS AND ANTIPYRETICS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N02BG09  METHOXYFLURANE

Active ingredient group (AIG) number:See footnote 5

0102114001

List of active ingredient(s)
Active ingredient(s) Strength
METHOXYFLURANE 99.9 %
Additional Risk Minimization Measures
Healthcare Professional Education

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