MYLAN-AZATHIOPRINE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

AZATHIOPRINE

MAH:

MYLAN PHARMACEUTICALS ULC

ATC_code:

L04AX01

INN:

AZATHIOPRINE

dosage:

50MG

pharmaceutical_form:

TABLET

composition:

AZATHIOPRINE 50MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

IMMUNOSUPPRESSIVE AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0101830001; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2017-11-14

SPC

_Page 1 of 26_
PRODUCT MONOGRAPH
PR
MYLAN-AZATHIOPRINE
Azathioprine Tablets
50 mg
USP
Immunosuppressive Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No.: 179082
Date of Revision: November 06, 2014
_Page 2 of 26_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
15
SPECIAL HANDLING INSTRUCTIONS
......................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 15
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
.........................................................................................................
17
TOXICOLOGY
.....