MYLAN-AZATHIOPRINE TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
24-11-2014

Viambatanisho vya kazi:

AZATHIOPRINE

Inapatikana kutoka:

MYLAN PHARMACEUTICALS ULC

ATC kanuni:

L04AX01

INN (Jina la Kimataifa):

AZATHIOPRINE

Kipimo:

50MG

Dawa fomu:

TABLET

Tungo:

AZATHIOPRINE 50MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100

Dawa ya aina:

Prescription

Eneo la matibabu:

IMMUNOSUPPRESSIVE AGENTS

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2017-11-14

Tabia za bidhaa

                                _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
.....
                                
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