ASN-FINGOLIMOD CAPSULE
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
18-06-2020
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Aktiv bestanddel:
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
Tilgængelig fra:
ASCEND LABORATORIES LTD
ATC-kode:
L04AA27
INN (International Name):
FINGOLIMOD
Dosering:
0.5MG
Lægemiddelform:
CAPSULE
Sammensætning:
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
Immunomodulatory Agents
Produkt oversigt:
Active ingredient group (AIG) number: 0152886001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2020-06-23
Produktets egenskaber
_Page 1 of 64 _
PRODUCT MONOGRAPH
PR
ASN-FINGOLIMOD
Fingolimod capsules
0.5 mg fingolimod capsules (as fingolimod hydrochloride)
Sphingosine 1-phosphate receptor modulator
Ascend Laboratories Ltd.
35 Nixon Road, Unit 10
Caledon, Ontario
L7E 1K1
Date of Approval:
June 18, 2020
Submission Control No: 231582
_Page 2 of 64 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................25
DRUG INTERACTIONS
..................................................................................................33
DOSAGE AND ADMINISTRATION
..............................................................................36
OVERDOSAGE
................................................................................................................39
ACTION AND CLINICAL PHARMACOLOGY
............................................................40
STORAGE AND STABILITY
..........................................................................................45
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................45
PART II: SCIENTIFIC INFORMATION
...............................................................................46
PHARMACEUTICAL INFORMATION
..........................................................................46
CLINICAL TRIALS
..........................................................................................................47
DETAILED PHARMACOLOGY
.................................
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