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:
Approved
Current status date:
2018-01-04
Product name:
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS 28
DIN:
02424460
Product Monograph/Veterinary Labelling:
Date:
2018-01-03
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MYLAN PHARMACEUTICALS ULC
85 Advance Road
Etobicoke
Ontario
Canada
M8Z 2S6
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
2
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
68:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
G03AA12 DROSPIRENONE AND ESTROGEN
Active ingredient group (AIG) number:See footnote5
0250430001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| DROSPIRENONE | 3 MG |
| ETHINYL ESTRADIOL | 0.03 MG |