MYLAN-FINGOLIMOD CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Διαθέσιμο από:

MYLAN PHARMACEUTICALS ULC

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:

28/30/90/500

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.

_MYLAN-FINGOLIMOD (Fingolimod Capsules) _
_Page 1 of 59_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MYLAN-FINGOLIMOD
Fingolimod Capsules
Capsule, 0.5 mg fingolimod (as fingolimod hydrochloride), Oral
Sphingosine 1-phosphate receptor modulator
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
MAR 11, 2019
Date of Revision:
MAR 23, 2023
Submission Control Number: 269036
_ _
_MYLAN-FINGOLIMOD (Fingolimod Capsules) _
_Page 2 of 59_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
02/2020
4 DOSAGE AND ADMINISTRATION
03/2023
7 WARNINGS AND PRECAUTIONS
03/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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
........................................................................