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:

2018-06-18

Original market date: See footnote 1

2018-06-18

Product name:

MELPHALAN FOR INJECTION

Description:

SINGLE USE VIAL

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:

02473348

Product Monograph/Veterinary Labelling:

Date: 2023-02-13 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

MARCAN PHARMACEUTICALS INC
2 Gurdwara Rd., Suite 112
Ottawa
Ontario
Canada K2E 1A2

Class:

Human

Dosage form(s):

Powder For Solution ,  Solution ,  Kit

Route(s) of administration:

Intravenous ,  Intra-Arterial

Number of active ingredient(s):

2

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

10:00.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

L01AA03 MELPHALAN

Active ingredient group (AIG) number:See footnote5

0225962001

List of active ingredient(s)
Active ingredient(s) Strength
BUFFER SOLUTION 10 ML / VIAL
MELPHALAN (MELPHALAN HYDROCHLORIDE) 50 MG / VIAL
Version 4.0.2
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