ASN-FINGOLIMOD CAPSULE

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Dostupné z:

ASCEND LABORATORIES LTD

ATC kód:

L04AA27

INN (Medzinárodný Name):

FINGOLIMOD

Dávkovanie:

0.5MG

Forma lieku:

CAPSULE

Zloženie:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

Immunomodulatory Agents

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2020-06-23

Súhrn charakteristických

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