RENOVA CREAM

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

TRETINOIN

Доступно од:

VALEANT CANADA LP / VALEANT CANADA S.E.C.

АТЦ код:

D10AD01

INN (Међународно име):

TRETINOIN

Дозирање:

0.05%

Фармацеутски облик:

CREAM

Састав:

TRETINOIN 0.05%

Пут администрације:

TOPICAL

Јединице у пакету:

20G

Тип рецептора:

Prescription

Терапеутска област:

CELL STIMULANTS AND PROLIFERANTS

Резиме производа:

Active ingredient group (AIG) number: 0112395001; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2014-07-30

Карактеристике производа

1
PRODUCT MONOGRAPH
Pr
RENOVA
®
Tretinoin Emollient Cream 0.05%, House Std.
Agent for the treatment of photodamaged skin
Valeant Canada LP
4787 Levy
Montreal, Canada
H2R 2P9
DATE OF PREPARATION:
March 21, 2012
Control # 153972
2
PRODUCT MONOGRAPH
PR
RENOVA*
Tretinoin Emollient Cream 0.05%, House Std.
PHARMACOLOGIC CLASSIFICATION
Agent for the treatment of photodamaged skin
CLINICAL PHARMACOLOGY
RENOVA tretinoin emollient cream 0.05% significantly reduces clinical
signs of photodamaged skin such as fine
wrinkles, mottled hyperpigmentation, and roughness.
While the exact mechanism of action of RENOVA emollient cream 0.05% is
unknown, the clinical improvements are
accompanied by the following histologic changes: increased epidermal
and granular layer thickness, reduced melanin
content, and stratum corneum alterations.
INDICATIONS AND CLINICAL USE
RENOVA tretinoin emollient cream 0.05% is indicated for the treatment
of fine wrinkling, mottled hyperpigmentation,
and roughness of the skin. These signs are usually associated with
photodamaged (sun-damaged) skin and intrinsic
aging, but may be associated with other conditions.
The safety and efficacy of RENOVA emollient cream 0.05% for the
prevention or treatment of actinic or solar keratoses
have not been established.
CONTRAINDICATIONS
3
RENOVA tretinoin emollient cream 0.05% is contraindicated in
individuals with a history of sensitivity reactions to any
of its components. It should be discontinued if hypersensitivity to
any of its ingredients is noted.
WARNINGS
RENOVA tretinoin emollient cream 0.05% should be used under medical
supervision as part of a comprehensive skin
protection program, including use of sunscreen products and protective
clothing.
Excessive use of RENOVA emollient cream 0.05% should be avoided.
RENOVA emollient cream 0.05% should be kept
away from the eyes, mouth, angles of the nose, or mucous membranes.
Topical use may induce severe local erythema,
pruritus, burning or stinging, and peeling at the site of application.
If the degree of local irrit