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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:

2020-01-02

Original market date: See footnote 1

1958-12-31

Product name:

FUNGIZONE

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:

00029149

Product Monograph/Veterinary Labelling:

Date: 2019-12-12 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

CHEPLAPHARM ARZNEIMITTEL GMBH
Ziegelhof 24
Greifswald
Mecklenburg - West Pomerania
Germany  17489

Class: 

Human

Dosage form(s):

Powder For Solution

Route(s) of administration:

Intravenous

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

08:14.28   POLYENES

Anatomical Therapeutic Chemical (ATC): See footnote 4

J02AA01  AMPHOTERICIN B

Active ingredient group (AIG) number:See footnote 5

0105864001

List of active ingredient(s)
Active ingredient(s) Strength
AMPHOTERICIN B 50 MG / VIAL

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