BICALUTAMIDE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

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Hent Produktets egenskaber (SPC)
23-01-2018

Aktiv bestanddel:

BICALUTAMIDE

Tilgængelig fra:

SIVEM PHARMACEUTICALS ULC

ATC-kode:

L02BB03

INN (International Name):

BICALUTAMIDE

Dosering:

50MG

Lægemiddelform:

TABLET

Sammensætning:

BICALUTAMIDE 50MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/100

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0127996001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2020-01-22

Produktets egenskaber

                                PRODUCT MONOGRAPH
PR
BICALUTAMIDE
Bicalutamide tablets, USP
50 mg Tablets
Non-Steroidal Anti-androgen
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec
H4R 2P7
www.sivem.ca
Date of Revision:
January 23, 2018
Submission Control No.: 212723
_BICALUTAMIDE Product Monograph_
Page 2 of 34
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
................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 13
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 14
PART II: SCIENTIFIC INFORMATION
................................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
.........................................................................................................
16
DETAILED
PHARMACOLOGY.............................................
                                
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Produktets egenskaber Produktets egenskaber fransk 23-01-2018

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