SANDOZ FINGOLIMOD CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

L04AE01

INN (Διεθνής Όνομα):

FINGOLIMOD

Δοσολογία:

0.5MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

28

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

Immunomodulatory Agents

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2019-03-11

Αρχείο Π.Χ.Π.

_Sandoz Fingolimod _
_Page 1 of 68 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ
® FINGOLIMOD
Fingolimod capsules
Capsule, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral
Sphingosine 1-phosphate receptor modulator
Sandoz Canada Inc.
110, Rue de Lauzon
Boucherville, Québec, Canada
J4B 1E6
Date of Inital Authorization:
October 31, 2019
Date of Revision:
February 23, 2022
Submission Control No: 256559
_Sandoz Fingolimod _
_Page 2 of 68 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
02/2022
4 Dosage and administration
02/2022
7 Warnings and Precautions
02/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
PEDIATRICS
............................................................................................................4
1.2
GERIATRICS
............................................................................................................4
2
CONTRAINDICATIONS ..................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
DOSING
CONSIDERATIONS.........................................................................................5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
.....................................................7
4.4
ADMINISTRATION
....................................................................................................8
4.5
MISSED
DOSE.......................................................................................................