ACCUTANE ROCHE CAPSULE

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

ISOTRETINOIN

Tillgänglig från:

HOFFMANN-LA ROCHE LIMITED

ATC-kod:

D10BA01

INN (International namn):

ISOTRETINOIN

Dos:

10MG

Läkemedelsform:

CAPSULE

Sammansättning:

ISOTRETINOIN 10MG

Administreringssätt:

ORAL

Enheter i paketet:

30

Receptbelagda typ:

Prescription

Terapiområde:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Produktsammanfattning:

Active ingredient group (AIG) number: 0115751001; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2001-04-02

Produktens egenskaper

_Pr_
_ACCUTANE™ ROCHE_
_®_
_ (isotretinoin) _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACCUTANE™ ROCHE
®
isotretinoin
Capsule, USP
10 mg, 40 mg
Retinoid for Treatment of Acne
ATC Code: D10BA01
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, ON L5N 5M8
www.rochecanada.com
Date of Initial Approval:
December 02, 1982
Date of Revision:
August 21, 2019
Submission Control No: 226870
ACCUTANE™ ROCHE
®
trade-mark of Hoffmann-La Roche Limited
©
Copyright 1982 – 2019 Hoffmann-La Roche Limited
_ _
_Pr_
_ACCUTANE™ ROCHE_
_®_
_ (isotretinoin) _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
ADVERSE REACTIONS, Clinical Trial Adverse Reaction [8.2]
Nov-2016
TABLE OF CONTENTS
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
..................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 6
4
DOSAGE AND ADMINISTRATION
................................................................................
6
4.1
Dosing Considerations
...........................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
....................................................... 7
4.3
Administration
......