Страна: Канада
мова: англійська
Джерело: Health Canada
APREMILAST; APREMILAST; APREMILAST
GLENMARK PHARMACEUTICALS CANADA INC.
L04AA32
APREMILAST
10MG; 20MG; 30MG
TABLET
APREMILAST 10MG; APREMILAST 20MG; APREMILAST 30MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0356230001; AHFS:
APPROVED
2022-11-14
_Pr_ _GLN-APREMILAST (Apremilast Tablets 10 mg, 20 mg, 30 mg) _ _Page 1 of 37_ PRODUCT MONOGRAPH PR GLN-APREMILAST apremilast tablets 10 mg, 20 mg, and 30 mg Selective Immunosuppressant Glenmark Pharmaceuticals Canada Inc. 1600 Steeles Ave. West, Suite 407, Concord, ON L4K 4M2 Date of Preparation: August 06, 2021 Submission Control No: 243974 _Pr_ _GLN-APREMILAST (Apremilast Tablets 10 mg, 20 mg, 30 mg) _ _Page 2 of 37_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION.................................................... 3 SUMMARY PRODUCT INFORMATION ........................................................................ 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS.................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS .................................................................................................. 7 DRUG INTERACTIONS ................................................................................................ 11 DOSAGE AND ADMINISTRATION ............................................................................. 14 OVERDOSAGE.............................................................................................................. 15 ACTION AND CLINICAL PHARMACOLOGY ............................................................. 15 STORAGE AND STABILITY ........................................................................................ 18 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................... 18 PART II: SCIENTIFIC INFORMATION ........................................................................ 20 PHARMACEUTICAL INFORMATION ......................................................................... 20 CLINICAL TRIALS............................................................................ Прочитайте повний документ