TARO-ADAPALENE/BENZOYL PEROXIDE GEL

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ADAPALENE; BENZOYL PEROXIDE

Fáanlegur frá:

TARO PHARMACEUTICALS INC

ATC númer:

D10AD53

INN (Alþjóðlegt nafn):

ADAPALENE, COMBINATIONS

Skammtar:

0.1%; 2.5%

Lyfjaform:

GEL

Samsetning:

ADAPALENE 0.1%; BENZOYL PEROXIDE 2.5%

Stjórnsýsluleið:

TOPICAL

Einingar í pakka:

60G/70G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

KERATOLYTIC AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0252888001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2019-09-27

Vara einkenni

PRODUCT MONOGRAPH
Pr
TARO-ADAPALENE / BENZOYL PEROXIDE
Adapalene and Benzoyl Peroxide Topical Gel, 0.1% / 2.5% w/w
Pr
TARO-ADAPALENE / BENZOYL PEROXIDE FORTE
Adapalene and Benzoyl Peroxide Topical Gel, 0.3% / 2.5% w/w
Acne Therapy
Taro Pharmaceuticals Inc.
Date of Preparation:
130 East Drive
September 11, 2020
Brampton, ON
L6T 1C1
Submission
Control No: 235710
Page 2 of 46
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
...............................................................................................4
WARNINGS AND PRECAUTIONS
...............................................................................4
ADVERSE
REACTIONS................................................................................................6
DRUG INTERACTIONS
..............................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................
14
OVERDOSAGE
.............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
......................................................................................
18
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
20
PHARMACEUTICAL INFORMATION
.......................................................................
20
CLINICAL TRIALS
.................................