MYLAN-CYPROTERONE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CYPROTERONE ACETATE

Διαθέσιμο από:

MYLAN PHARMACEUTICALS ULC

Φαρμακολογική κατηγορία (ATC):

G03HA01

INN (Διεθνής Όνομα):

CYPROTERONE

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

CYPROTERONE ACETATE 50MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

60/56/80/168/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2011-03-04

Αρχείο Π.Χ.Π.

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