Pays: Canada
Langue: anglais
Source: Health Canada
BICALUTAMIDE
JAMP PHARMA CORPORATION
L02BB03
BICALUTAMIDE
50MG
TABLET
BICALUTAMIDE 50MG
ORAL
30/100
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0127996001; AHFS:
APPROVED
2016-02-01
_Page 1 of 33 _ PRODUCT MONOGRAPH PR JAMP- BICALUTAMIDE Bicalutamide Tablets, USP 50 mg Non-Steroidal Antiandrogen Jamp Pharma Corporation 1310 Rue Nobel Boucherville, Quebec, Canada J4B 5H3 DATE OF REVISION: July 5, 2018 Submission Control No.: 211343 _Page 2 of 33 _ T A B L E O F C O N T E N T S PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................. 3 INDICATIONS AND CLINICAL USE .................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 3 WARNINGS AND PRECAUTIONS ............................................................................. 4 ADVERSE REACTIONS .................................................................................................. 7 DRUG INTERACTIONS ................................................................................................. 11 DOSAGE AND ADMINISTRATION .................................................................................... 13 OVERDOSAGE ........................................................................................................................ 13 ACTION AND CLINICAL PHARMACOLOGY ................................................................. 14 STORAGE AND STABILITY ................................................................................................ 14 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................. 14 P A R T II: S C I E N T I F I C I N F O R M A T I O N ............................................................ 16 P H A R M A C E U T I C A L IN F O R M A T I O N .............................................................. 16 C L I N I C A L TRIALS ........................................................................................................... 16 DETAILED PHARMACOLOGY ... Lire le document complet