MYLAN-FINGOLIMOD CAPSULE

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)

Inapatikana kutoka:

MYLAN PHARMACEUTICALS ULC

ATC kanuni:

L04AE01

INN (Jina la Kimataifa):

FINGOLIMOD

Kipimo:

0.5MG

Dawa fomu:

CAPSULE

Tungo:

FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE) 0.5MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

28/30/90/500

Dawa ya aina:

Prescription

Eneo la matibabu:

Immunomodulatory Agents

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2019-03-11

Tabia za bidhaa

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