Product information

From Health Canada

New search

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:

2020-07-29

Original market date: See footnote 1

2020-07-29

Product name:

TIBELLA

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:

02488361

Product Monograph/Veterinary Labelling:

Date: 2019-05-09 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

BIOSYENT PHARMA INC
SUITE 402  2476 Argentia Road
Mississauga
Ontario
Canada  L5N 6M1

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Schedule G (CDSA IV)  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

68:16.00   ESTROGENS,ANTIESTROGENS,ESTROGEN AGONIST-ANTAGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

G03CX01  TIBOLONE

Active ingredient group (AIG) number:See footnote 5

0161430001

List of active ingredient(s)
Active ingredient(s) Strength
TIBOLONE 2.5 MG

Risk Management Plans See footnote 7

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

Application information

Related information

Contact us

Version 3.8.0
Date modified: