MYLAN-CYPROTERONE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
14-09-2010
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
CYPROTERONE ACETATE
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
G03HA01
INN (International Name):
CYPROTERONE
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
CYPROTERONE ACETATE 50MG
Administration route:
ORAL
Units in package:
60/56/80/168/500
Prescription type:
Prescription
Therapeutic area:
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0116806001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2011-03-04
Summary of Product characteristics
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
Read the complete document
