MYLAN-AZATHIOPRINE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

AZATHIOPRINE

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

L04AX01

INN (International Name):

AZATHIOPRINE

Dosering :

50MG

Legemiddelform:

TABLET

Sammensetning:

AZATHIOPRINE 50MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

IMMUNOSUPPRESSIVE AGENTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2017-11-14

Preparatomtale

_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
.....