CO MYCOPHENOLATE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
22-10-2013
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Aktívna zložka:
MYCOPHENOLATE MOFETIL
Dostupné z:
COBALT PHARMACEUTICALS COMPANY
ATC kód:
L04AA06
INN (Medzinárodný Name):
MYCOPHENOLIC ACID
Dávkovanie:
500MG
Forma lieku:
TABLET
Zloženie:
MYCOPHENOLATE MOFETIL 500MG
Spôsob podávania:
ORAL
Počet v balení:
50/100
Typ predpisu:
Prescription
Terapeutické oblasti:
IMMUNOSUPPRESSIVE AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0128158002; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2018-05-07
Súhrn charakteristických
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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
.............................................................................
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