JUXTAPID CAPSULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LOMITAPIDE (LOMITAPIDE MESYLATE)

Disponibil de la:

CHIESI FARMACEUTICI S.P.A.

Codul ATC:

C10AX12

INN (nume internaţional):

LOMITAPIDE

Dozare:

5MG

Forma farmaceutică:

CAPSULE

Compoziție:

LOMITAPIDE (LOMITAPIDE MESYLATE) 5MG

Calea de administrare:

ORAL

Unități în pachet:

28

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISCELLANEOUS ANTILIPEMIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0155310001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-02-04

Caracteristicilor produsului

_JUXTAPID (Lomitapide) Product Monograph _
_Page 1 of 36 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
JUXTAPID
®
Lomitapide Capsules
Capsules, 5 mg, 10 mg and 20 mg, Lomitapide (as lomitapide mesylate),
for oral use
Microsomal Triglyceride Transfer Protein Inhibitor
MANUFACTURER:
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A, 43122 Parma, Italy
IMPORTED BY:
Medison Pharma Canada Inc.
One Dundas Street West, Suite 2500
Toronto, Ontario
Canada, M5G 1Z3
Submission Control Number: 283104
Date of
Initial
Authorization:
FEB 23, 2024
_ _
_Product Monograph JUXTAPID (Lomitapide) _
_Page 2 of 36 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Reproductive Health: Female and Male
Potential
03/2022
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
..................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................