DERMATOP EMOLLIENT CREAM

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PREDNICARBATE

Διαθέσιμο από:

BAUSCH HEALTH, CANADA INC.

Φαρμακολογική κατηγορία (ATC):

D07AC18

INN (Διεθνής Όνομα):

PREDNICARBATE

Δοσολογία:

0.1%

Φαρμακοτεχνική μορφή:

CREAM

Σύνθεση:

PREDNICARBATE 0.1%

Οδός χορήγησης:

TOPICAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTI-INFLAMMATORY AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0120996001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2020-12-03

Αρχείο Π.Χ.Π.

_Pr_
_DERMATOP _
_®_
_ OINTMENT and _
_Pr_
_DERMATOP _
_®_
_ EMOLLIENT CREAM Prednicarbate Ointment and _
_Prednicarbate Cream _
_Product Monograph Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DERMATOP
® OINTMENT
Prednicarbate Ointment
Ointment, 0.1% w/w, Topical
Mfr. Std.
PR
DERMATOP
® EMOLLIENT CREAM
Prednicarbate Cream
Cream, 0.1% w/w, Topical
Mfr. Std.
Topical Corticosteroid
ATC: D07AC18
Bausch Health, Canada Inc.
2150 St-Elzear Blvd. West
Laval, Quebec
H7L 4A8
Date of Initial Authorization:
August 12, 1996
Date of Revision:
April 27, 2022
Submission Control Number: 259325
_ _
_Pr_
_DERMATOP _
_®_
_ OINTMENT and _
_Pr_
_DERMATOP _
_®_
_ EMOLLIENT CREAM Prednicarbate Ointment and _
_Prednicarbate Cream _
_Product Monograph Page 2 of 28_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
04/2022
1 INDICATIONS, 1.1 Pediatrics
04/2022
1 INDICATIONS, 1.2 Geriatrics
04/2022
4 DOSAGE AND ADMINISTRATION
04/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing
Considerations
04/2022
7 WARNINGS AND PRECAUTIONS
04/2022
7 WARNINGS AND PRECAUTIONS, Endocrine and
Metabolism
04/2022
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
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................