Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
CYCLOSPORINE
NOVARTIS PHARMACEUTICALS CANADA INC
L04AD01
CICLOSPORIN
100MG
CAPSULE
CYCLOSPORINE 100MG
ORAL
30
Prescription
IMMUNOSUPPRESSIVE AGENTS
Active ingredient group (AIG) number: 0115996001; AHFS:
APPROVED
1997-07-08
_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 ........................................................... Baca dokumen lengkapnya