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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:

2011-11-17

Original market date: See footnote 1

2011-11-17

Product name:

JALYN

Description:

MODIFIED-RELEASE CAPSULE (DUTASTERIDE: IMMEDIATE RELEASE, AND TAMSULOSIN HCL: EXTENDED RELEASE)

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:

02372010

Product Monograph/Veterinary Labelling:

Date: 2016-05-04 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

GLAXOSMITHKLINE INC
7333 Mississauga Road
Mississauga
Ontario
Canada  L5N 6L4

Class: 

Human

Dosage form(s):

Capsule (Immediate And Extended Release)

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

92:08.00   5 ALFA REDUCTASE INHIBITORS ,  12:16.04.12   Selective Alfa-1-Adrenergic Blocking Agents

Anatomical Therapeutic Chemical (ATC): See footnote 4

G04CA52  TAMSULOSIN AND DUTASTERIDE

Active ingredient group (AIG) number:See footnote 5

0252960001

List of active ingredient(s)
Active ingredient(s) Strength
DUTASTERIDE 0.5 MG
TAMSULOSIN HYDROCHLORIDE 0.4 MG

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