国: カナダ
言語: 英語
ソース: Health Canada
APREMILAST; APREMILAST; APREMILAST
MARCAN PHARMACEUTICALS 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
_Page 1 of 35 _ PRODUCT MONOGRAPH PR MAR-APREMILAST apremilast tablets 10 mg, 20 mg, and 30 mg Selective Immunosuppressant MARCAN PHARMACEUTICALS INC. 2 Gurdwara Road, Suite #112, Ottawa, ON, K2E 1A2 SUBMISSION CONTROL NO.: 246219 DATE OF PREPARATION: June 22, 2022 _Page 2 of 35 _ 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 ........................................................................................................... 6 DRUG INTERACTIONS ......................................................................................................... 11 DOSAGE AND ADMINISTRATION ......................................................................................... 13 OVERDOSAGE ..................................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY........................................................................... 14 STORAGE AND STABILITY ................................................................................................... 17 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................... 17 PART II: SCIENTIFIC INFORMATION ................................................................................... 18 PHARMACEUTICAL INFORMATION ..................................................................................... 18 CLINICAL TRIALS ............................................................. 完全なドキュメントを読む