ASN-FINGOLIMOD CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Saatavilla:

ASCEND LABORATORIES LTD

ATC-koodi:

L04AA27

INN (Kansainvälinen yleisnimi):

FINGOLIMOD

Annos:

0.5MG

Lääkemuoto:

CAPSULE

Koostumus:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

Immunomodulatory Agents

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0152886001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2020-06-23

Valmisteyhteenveto

_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
.................................