Maa: Kanada
Kieli: englanti
Lähde: Health Canada
LOMITAPIDE (LOMITAPIDE MESYLATE)
CHIESI FARMACEUTICI S.P.A.
C10AX12
LOMITAPIDE
5MG
CAPSULE
LOMITAPIDE (LOMITAPIDE MESYLATE) 5MG
ORAL
28
Prescription
MISCELLANEOUS ANTILIPEMIC AGENTS
Active ingredient group (AIG) number: 0155310001; AHFS:
APPROVED
2014-02-04
_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 ........................................................ Lue koko asiakirja