MYLAN-CYPROTERONE TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

CYPROTERONE ACETATE

Saadav alates:

MYLAN PHARMACEUTICALS ULC

ATC kood:

G03HA01

INN (Rahvusvaheline Nimetus):

CYPROTERONE

Annus:

50MG

Ravimvorm:

TABLET

Koostis:

CYPROTERONE ACETATE 50MG

Manustamisviis:

ORAL

Ühikuid pakis:

60/56/80/168/500

Retsepti tüüp:

Prescription

Terapeutiline ala:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2011-03-04

Toote omadused

PRODUCT MONOGRAPH
MYLAN-CYPROTERONE
Cyproterone Acetate Tablets
50 MG
House standard
ANTIANDROGEN
MYLAN PHARMACEUTICALS ULC
85 ADVANCE RD.
ETOBICOKE, ONTARIO
Date of revision: September 9, 2010
M8Z 2S6
Submission Control No.: 139740
1
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION................................. 2
SUMMARY PRODUCT INFORMATION
............................................... 2
INDICATIONS AND CLINICAL
USE..................................................... 2
CONTRAINDICATIONS
..........................................................................
2
WARNINGS AND
PRECAUTIONS......................................................... 3
ADVERSE
REACTIONS...........................................................................
7
DRUG INTERACTIONS
...........................................................................
9
DOSAGE AND
ADMINISTRATION.......................................................
9
OVERDOSAGE
.......................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY ...................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING .................... 11
PART II: SCIENTIFIC INFORMATION
....................................................... 12
PHARMACEUTICAL
INFORMATION................................................. 12
CLINICAL
TRIALS.................................................................................
14
DETAILED
PHARMACOLOGY............................................................
19
TOXICOLOGY
........................................................................................
22
REFERENCES
.........................................................................................
27
PART III: CONSUMER INFORMATION
.................................................................. 30
2
MYLAN-CYPROTERONE
Cyproterone Acetate Tablets, House
50 MG
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
TABLE 1 – PRODUCT INFORMATION SUMMARY
ROUTE OF
ADMINISTRATION
DOSAGE FORM