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:
Cancelled Pre Market
Current status date:
2023-07-10
Original market date: See footnote 1
Product name:
NATAZIA
Description:
BLISTER PACK OF 28 TABS, 3MG ESTRADIOL VALERATE, 2MG ESTRADIOL VAL. AND 2MG DIENOGEST,2MG ESTRADIOL VAL. AND 3MG DIENOGEST,1MG ESTRADIOL VAL. 2PLACEBO
DIN:
02379112
Product Monograph/Veterinary Labelling:
Date:
2019-08-19
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BAYER INC
2920 Matheson Blvd East
Mississauga
Ontario
Canada
L4W 5R6
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
6
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
68:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
G03AB08 DIENOGEST AND ESTROGEN
Active ingredient group (AIG) number:See footnote5
0653087001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DIENOGEST | 2 MG |
| DIENOGEST | 3 MG |
| ESTRADIOL VALERATE | 1 MG |
| ESTRADIOL VALERATE | 2 MG |
| ESTRADIOL VALERATE | 2 MG |
| ESTRADIOL VALERATE | 3 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.