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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:

2017-11-06

Original market date: See footnote 1

2017-11-06

Product name:

TEPADINA

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:

02462680

Product Monograph/Veterinary Labelling:

Date: 2020-06-15 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ADIENNE SA
Via Zurigo 46
Lugano
Tessin
Switzerland  6900

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

10:00.00   ANTINEOPLASTIC AGENTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

L01AC01  THIOTEPA

Active ingredient group (AIG) number:See footnote 5

0107649001

List of active ingredient(s)
Active ingredient(s) Strength
THIOTEPA 15 MG / VIAL

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

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