MED-CYPROTERONE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CYPROTERONE ACETATE

Tilgængelig fra:

GENERIC MEDICAL PARTNERS INC

ATC-kode:

G03HA01

INN (International Name):

CYPROTERONE

Dosering:

50MG

Lægemiddelform:

TABLET

Sammensætning:

CYPROTERONE ACETATE 50MG

Indgivelsesvej:

ORAL

Enheder i pakken:

60/100

Recept type:

Prescription

Terapeutisk område:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0116806001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2012-08-08

Produktets egenskaber

_ _
_Pr_
_MED-CYPROTERONE Product Monograph _
_Page 1 of 34 _
PRODUCT
MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MED-CYPROTERONE
cyproterone acetate
tablets
Tablets, 50
m
g, Oral
Antiandrog en
Generic Medical Partners Inc.:
Date of Initial Authorization:
1500 Don Mills Road, Suite 711
Aug 8, 2012
Toronto, Ontario
M3B 3K4
Date of Revision:
Canada
Dec 2, 2021
Submission Control No.: 255102
_ _
_Pr_
_MED-CYPROTERONE Product Monograph _
_Page 2 of 34 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
12/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
12/2021
7 WARNINGS AND PRECAUTIONS - Carcinogenesis and Mutagenesis
12/2021
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
4
1.
INDICATIONS
.................................................................................................................
4
2.
CONTRAINDICATIONS
.....................................................................................................
4
3.
SERIOUS WARNINGS AND PRECAUTIONS
..........................................................................
4
4.
DOSAGE AND ADMINISTRATION
......................................................................................
4
4.1 Dosing Considerations
................................................................................................
4
4.2 Recommended Dose and Dosage
Adjustment
................................................................ 5
5.
OVERDOSAGE
................................................................................................................
5
6.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.......................................... 5
7.
WARNINGS AND PRECAUTIONS
.......................................