ELIDEL CREAM

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PIMECROLIMUS

Beschikbaar vanaf:

BAUSCH HEALTH, CANADA INC.

ATC-code:

D11AH02

INN (Algemene Internationale Benaming):

PIMECROLIMUS

Dosering:

1%

farmaceutische vorm:

CREAM

Samenstelling:

PIMECROLIMUS 1%

Toedieningsweg:

TOPICAL

Eenheden in pakket:

30/60/100G

Prescription-type:

Prescription

Therapeutisch gebied:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0149001001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2011-12-02

Productkenmerken

_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ELIDEL

(Pimecrolimus)
Cream, 1%
Topical Calcineurin Inhibitor
BAUSCH HEALTH, CANADA INC.
2150 St-Elzear Blvd. West
Laval, Quebec H7L 4A8
Canada
Date of Initial Approval:
November 3, 2011
Date of Revision:
January 16, 2020
Submission Control No: 233261

is a registered trademark of Meda Pharma sarl used under license by
Bausch Health
Companies.
_ _
_ELIDEL_
_®_
_ Product Monograph _
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
INDICATIONS, Pediatrics (1.1) 09-2019
SERIOUS WARNING AND PRECAUTIONS BOX (3) [Removed] 09-2019
WARNINGS AND PRECAUTIONS, Carcinogenesis (6.0), Special Populations,
Pediatrics
(6.1.3) 09-2019
TABLE OF CONTENTS
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
.......................................................................................
4
3
DOSAGE AND ADMINISTRATION
.....................................................................
4
3.1
Recommended Dose and Dosage Adjustment
............................................ 4
4
OVERDOSAGE
....................................................................................................
5
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 5
6
WARNINGS AND PRECAUTIONS
......................................................................
5
6.1
Special Populations
...................................................