NEORAL CAPSULE

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

CYCLOSPORINE

Fáanlegur frá:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC númer:

L04AD01

INN (Alþjóðlegt nafn):

CICLOSPORIN

Skammtar:

50MG

Lyfjaform:

CAPSULE

Samsetning:

CYCLOSPORINE 50MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

30

Gerð lyfseðils:

Prescription

Lækningarsvæði:

IMMUNOSUPPRESSIVE AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0115996003; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2014-07-11

Vara einkenni

_NEORAL_
®
_ (Cyclosporine) capsules, oral solution for microemulsion _
_SANDIMMUNE_
®
_ (Cyclosporine) concentrate for solution for infusion_
_ _
_Page 1 of 73_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NEORAL
®
(CYCLOSPORINE CAPSULES FOR MICROEMULSION)
(CYCLOSPORINE ORAL SOLUTION FOR MICROEMULSION)
Soft gelatin capsules, 10, 25, 50 and 100 mg and oral use
Solution, 100 mg/mL and oral use
PR
SANDIMMUNE
® I.V.
(CYCLOSPORINE FOR INJECTION)
Concentrate for solution for infusion, 50 mg/mL and Intravenous
Immunosuppressant
ATC code L04A D01
Novartis Pharmaceuticals Canada Inc.
700 Saint-Hubert St., Suite 100
Montreal, Quebec
H2Y 0C1
www.novartis.ca
Submission Control No: 268008
Date of Initial Authorization:
NEORAL: January 13, 1995
SANDIMMUNE: March 23,1984
Date of Revision:
February 23, 2023
NEORAL and SANDIMMUNE are registered trademarks.
_ _
_NEORAL_
®
_ (Cyclosporine) capsules, oral solution for microemulsion _
_SANDIMMUNE_
®
_ (Cyclosporine) concentrate for solution for infusion_
_ _
_Page 2 of 73_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Driving and
Operating Machinery
02/2023
7 WARNINGS AND PRECAUTIONS, 7.1 Special
Population, 7.1.1 Pregnant Women and 7.1.2 Breast
Feeding
02/2023
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
...........................................................