TARO-ADAPALENE/BENZOYL PEROXIDE GEL

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ADAPALENE; BENZOYL PEROXIDE

Pieejams no:

TARO PHARMACEUTICALS INC

ATĶ kods:

D10AD53

SNN (starptautisko nepatentēto nosaukumu):

ADAPALENE, COMBINATIONS

Deva:

0.1%; 2.5%

Zāļu forma:

GEL

Kompozīcija:

ADAPALENE 0.1%; BENZOYL PEROXIDE 2.5%

Ievadīšanas:

TOPICAL

Vienības iepakojumā:

60G/70G

Receptes veids:

Prescription

Ārstniecības joma:

KERATOLYTIC AGENTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2019-09-27

Produkta apraksts

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
.................................