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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:

2021-06-15

Original market date: See footnote 1

2021-06-15

Product name:

NEXTSTELLIS

Description:

24 PINK ACTIVE TABLETS + 4 WHITE INERT TABLETS

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:

02513218

Product Monograph/Veterinary Labelling:

Date: 2021-03-05 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

SEARCHLIGHT PHARMA INC
1600 Rue Notre Dame Ouest, Suite 312
Montreal
Quebec
Canada  H3J 1M1

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

2

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

68:12.00   CONTRACEPTIVES

Anatomical Therapeutic Chemical (ATC): See footnote 4

G03AA18  DROSPIRENONE AND ESTETROL

Active ingredient group (AIG) number:See footnote 5

0262789001

List of active ingredient(s)
Active ingredient(s) Strength
DROSPIRENONE 3 MG
ESTETROL MONOHYDRATE 15 MG

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