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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:

2020-06-02

Original market date: See footnote 1

2020-06-02

Lot number: See footnote 2

.

Product name:

METHOTREXATE SUBCUTANEOUS

Description:

SINGLE-USE, PRE-FILLED SYRINGE

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:

02491311

Product Monograph/Veterinary Labelling:

Date: 2019-08-02 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ACCORD HEALTHCARE INC
3535 Boulevard St-Charles, Suite 704
Kirkland
Quebec
Canada  H9H 5B9

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Subcutaneous

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

10:00.00   ANTINEOPLASTIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

L04AX03  METHOTREXATE

Active ingredient group (AIG) number:See footnote 5

0107545005

List of active ingredient(s)
Active ingredient(s) Strength
METHOTREXATE (METHOTREXATE SODIUM) 15 MG / 0.3 ML

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