MYLAN-CYPROTERONE TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
14-09-2010
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
CYPROTERONE ACETATE
Fáanlegur frá:
MYLAN PHARMACEUTICALS ULC
ATC númer:
G03HA01
INN (Alþjóðlegt nafn):
CYPROTERONE
Skammtar:
50MG
Lyfjaform:
TABLET
Samsetning:
CYPROTERONE ACETATE 50MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
60/56/80/168/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
OTHER MISCELLANEOUS THERAPEUTIC AGENTS
Vörulýsing:
Active ingredient group (AIG) number: 0116806001; AHFS:
Leyfisstaða:
CANCELLED POST MARKET
Leyfisdagur:
2011-03-04
Vara einkenni
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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