TARO-CLOBETASOL SPRAY

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CLOBETASOL PROPIONATE

Tilgjengelig fra:

TARO PHARMACEUTICALS INC

ATC-kode:

D07AD01

INN (International Name):

CLOBETASOL

Dosering :

0.05%

Legemiddelform:

SPRAY

Sammensetning:

CLOBETASOL PROPIONATE 0.05%

Administreringsrute:

TOPICAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

ANTI-INFLAMMATORY AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0110995001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2019-06-18

Preparatomtale

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_TARO-CLOBETASOL SPRAY (Clobetasol Propionate Spray) _Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TARO-CLOBETASOL SPRAY
Clobetasol Propionate Spray
Solution,
0.05% w/w, Topical
Topical Corticosteroid
Taro Pharmaceuticals Inc.
130 East Drive, Brampton, ON
L6T 1C1
Date of Initial Authorization:
June 18, 2019
Date of Revision:
February 2, 2023
Submission Control Number: 266329
_ _
_TARO-CLOBETASOL SPRAY (Clobetasol Propionate Spray) _Page 2 of 28
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
02/2023
1 INDICATIONS, 1.1 Pediatrics
02/2023
1 INDICTIONS, 1.2 Geriatrics
02/2023
2 CONTRAINDICATIONS
02/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
02/2023
4 DOSING AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
02/2023
4 DOSING AND ADMINISTRATION, 4. 4 Administration, How to use Taro-
Clobetasol Spray
06/2021
7
WARNINGS AND PRECAUTIONS, General
02/2023
7
WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
06/2021
7
WARNINGS AND PRECAUTIONS, Immune
02/2023
7
WARNINGS AND PRECAUTIONS, Musculoskeletal
02/2023
7
WARNINGS AND PRECAUTIONS, Ophthalmologic
06/2021
7
WARNINGS AND PRECAUTIONS, Sensitivity/Resistance
02/2023
7
WARNINGS AND PRECAUTIONS, Skin
02/2023
7
WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
02/2023
7
WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
06/2021
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
...........................................................................................