ABSORICA LD CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ISOTRETINOIN

Available from:

SUN PHARMACEUTICAL INDUSTRIES LIMITED

ATC code:

D10BA01

INN (International Name):

ISOTRETINOIN

Dosage:

16MG

Pharmaceutical form:

CAPSULE

Composition:

ISOTRETINOIN 16MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0115751007; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-06-22

Summary of Product characteristics

_Absorica LD_
_®_
_ (isotretinoin) Product Monograph _
_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ABSORICA LD®
Isotretinoin Capsules
Micronized formulation
Capsules, 8 mg, 16 mg, 24 mg, and 32 mg, Oral
USP
Retinoid for treatment of acne
Sun Pharmaceutical Industries Limited
Sun House, Plot 201 B/1
Western Express Highway, Goregaon (E)
Mumbai - 400 063
Maharashtra, India
Date of Initial Authorization:
June 22, 2023
Imported and Distributed by:
Sun Pharma Canada Inc.
Brampton, ON L6T 1C1
Submission Control Number: 263460
Absorica LD and C-A-R-E are trademarks of Sun Pharma, or its
affiliates and subsidiaries.
© 2023 Sun Pharma, or its subsidiaries and affiliates. All rights
reserved.
_Absorica LD_
_®_
_ (isotretinoin) Product Monograph _
_Page 2 of 49_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
7
4.1
Dosing Considerations
.......................................................................................
7
4.2
Recommended Dose and Dosage
Adjustment.............................