JAMP FINGOLIMOD CAPSULE
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
11-01-2022
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
Inapatikana kutoka:
JAMP PHARMA CORPORATION
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:
15G/50G
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:
2019-08-09
Tabia za bidhaa
_Product Monograph of Jamp Fingolimod Page 1 of 64_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP FINGOLIMOD
Fingolimod Capsules
Capsule, 0.5 mg (as fingolimod hydrochloride), Oral
House Standard
Sphingosine 1-phosphate receptor modulator
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Date of Initial Authorization:
August 9, 2019
Date of Revision:
January 11,2022
Submission Control No: 253082
_Product Monograph of Jamp Fingolimod Page 2 of 64_
_ _
RECENT MAJOR LABEL CHANGES
2 Contraindications
01/ 2022
4 Dosage and Administration
01/ 2022
7 Warnings and Precautions
01/ 2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED .
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES .................................................................................
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
.......................................................................................................
9
5 OVE
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