SANDOZ MYCOPHENOLIC ACID TABLET (ENTERIC-COATED)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
04-07-2018
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Aktiva substanser:
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM)
Tillgänglig från:
SANDOZ CANADA INCORPORATED
ATC-kod:
L04AA06
INN (International namn):
MYCOPHENOLIC ACID
Dos:
360MG
Läkemedelsform:
TABLET (ENTERIC-COATED)
Sammansättning:
MYCOPHENOLIC ACID (MYCOPHENOLATE SODIUM) 360MG
Administreringssätt:
ORAL
Enheter i paketet:
120
Receptbelagda typ:
Prescription
Terapiområde:
IMMUNOSUPPRESSIVE AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0150521002; AHFS:
Bemyndigande status:
CANCELLED PRE MARKET
Tillstånd datum:
2019-08-01
Produktens egenskaper
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PRODUCT MONOGRAPH
PR
SANDOZ MYCOPHENOLIC ACID
Mycophenolic acid enteric-coated tablets 180 mg, 360 mg
(as mycophenolate sodium)
Manufacturer’s Standard
Immunosuppressant
Sandoz Canada Inc.
145 Jules-Leger street
Boucherville, Quebec
J4B 7K8
Date of Preparation:
August 27, 2018
Submission Control No: 218020
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_Sandoz Mycophenolic Acid _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
TOXICOLOGY
..............................................................................................................
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