SOHONOS CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PALOVAROTENE

Available from:

IPSEN BIOPHARMACEUTICALS CANADA INC

ATC code:

M09AX11

INN (International Name):

PALOVAROTENE

Dosage:

10MG

Pharmaceutical form:

CAPSULE

Composition:

PALOVAROTENE 10MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0163378005; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-01-21

Summary of Product characteristics

_SOHONOS_
_®_
_ (palovarotene capsule) _
_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SOHONOS
®
palovarotene capsules
Capsules, 1 mg, 1.5 mg, 2.5 mg, 5 mg, 10 mg, Oral
Retinoid/Retinoic acid receptor gamma (RAR

) selective agonist
Ipsen Biopharmaceuticals Canada Inc.
5050 Satellite Drive, Suite 500
Mississauga ON
L4W 0G1
www.ipsen.ca
Date of Initial Authorization:
JAN 20, 2022
Date of Revision:
NOV 17, 2023
Submission Control Number: 268140
SOHONOS is a registered trademark of Clementia Pharmaceuticals Inc.
©2021. All rights
reserved.
_ _
_SOHONOS_
_®_
_ (palovarotene capsule) _
_Page 2 of 46 _
RECENT MAJOR LABEL CHANGES
1 Indications
11/2023
3 Serious Warnings and Precautions
11/2023
4 Dosage and Administration
11/2023
7 Warnings and Precautions
11/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...................................................... 4
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
..................................................