MYLAN-CYPROTERONE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
14-09-2010
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Aktiv bestanddel:
CYPROTERONE ACETATE
Tilgængelig fra:
MYLAN PHARMACEUTICALS ULC
ATC-kode:
G03HA01
INN (International Name):
CYPROTERONE
Dosering:
50MG
Lægemiddelform:
TABLET
Sammensætning:
CYPROTERONE ACETATE 50MG
Indgivelsesvej:
ORAL
Enheder i pakken:
60/56/80/168/500
Recept type:
Prescription
Terapeutisk område:
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0116806001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2011-03-04
Produktets egenskaber
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
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