BICALUTAMIDE TABLETS
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
17-10-2017
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Aktiv bestanddel:
BICALUTAMIDE
Tilgængelig fra:
FRESENIUS KABI CANADA LTD
ATC-kode:
L02BB03
INN (International Name):
BICALUTAMIDE
Dosering:
50MG
Lægemiddelform:
TABLET
Sammensætning:
BICALUTAMIDE 50MG
Indgivelsesvej:
ORAL
Enheder i pakken:
10/30
Recept type:
Prescription
Terapeutisk område:
ANTINEOPLASTIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0127996001; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2023-03-10
Produktets egenskaber
PRODUCT MONOGRAPH PR
BICALUTAMIDE TABLETS
bicalutamide
50 mg
USP
Non-Steroidal Antiandrogen
FRESENIUS KABI CANADA LTD. DATE OF REVISION:
165 Galaxy Blvd, Suite 100 October 17, 2017
Toronto, ON, M9W 0C8
SUBMISSION CONTROL NO. 209416
Bicalutamide Tablets – Product Monograph
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
...............................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
................................................................................................
8
DRUG INTERACTIONS
..............................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................
13
OVERDOSAGE
............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 14
STORAGE AND STABILITY
......................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 15
PART II: SCIENTIFIC INFORMATION
............................................................................
16
PHARMACEUTICAL INFORMATION
......................................................................
16
CLINICAL TRIALS
......................................................................................................
16
DETAILED PHARMACOLOGY
.................................................................................
19
TOXICOLOGY
....
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