CO MYCOPHENOLATE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

MYCOPHENOLATE MOFETIL

Commercializzato da:

COBALT PHARMACEUTICALS COMPANY

Codice ATC:

L04AA06

INN (Nome Internazionale):

MYCOPHENOLIC ACID

Dosaggio:

500MG

Forma farmaceutica:

TABLET

Composizione:

MYCOPHENOLATE MOFETIL 500MG

Via di somministrazione:

ORAL

Confezione:

50/100

Tipo di ricetta:

Prescription

Area terapeutica:

IMMUNOSUPPRESSIVE AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0128158002; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2018-05-07

Scheda tecnica

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_Page 1 of 55_
PRODUCT MONOGRAPH
PR
_CO_ MYCOPHENOLATE
Mycophenolate Mofetil Tablets USP
500 mg
Immunosuppressive Agent
Cobalt Pharmaceuticals Company
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
SUBMISSION CONTROL NO: 168316
Date of Revision:
October 16, 2013
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_Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
15
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
......................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 27
PART II: SCIENTIFIC INFORMATION
..............................................................................
28
PHARMACEUTICAL INFORMATION
.........................................................................
28
CLINICAL TRIALS
.........................................................................................................
29
DETAILED PHARMACOLOGY
.............................................................................