FEMHRT TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

NORETHINDRONE ACETATE; ETHINYL ESTRADIOL

זמין מ:

WARNER CHILCOTT CANADA CO

קוד ATC:

G03FA01

INN (שם בינלאומי):

NORETHISTERONE AND ESTROGEN

כמות:

1MG; 5MCG

טופס פרצבטיות:

TABLET

הרכב:

NORETHINDRONE ACETATE 1MG; ETHINYL ESTRADIOL 5MCG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

5X28

סוג מרשם:

Prescription

איזור תרפויטי:

CONTRACEPTIVES

leaflet_short:

Active ingredient group (AIG) number: 0206375004; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2016-08-05

מאפייני מוצר

PRODUCT MONOGRAPH
FEMHRT
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS)
1 MG AND 5 ΜG
FEMHRT LO
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS)
0.5 MG AND 2.5 ΜG
ESTROGEN-PROGESTIN COMBINATION
Warner Chilcott Canada Co.
Date of Preparation: March 4, 2011
Toronto, Ontario M5W 3N7
Control #: 143937
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TABLE OF CONTENTS
PAGE
PART I: HEALTH PROFESSIONAL INFORMATION
............................................ 3
SUMMARY PRODUCT INFORMATION
.................................................................. 3
INDICATIONS AND CLINICAL
USE........................................................................
3
CONTRAINDICATIONS.............................................................................................
4
WARNINGS AND
PRECAUTIONS............................................................................
4
ADVERSE REACTIONS
...........................................................................................
12
DRUG
INTERACTIONS............................................................................................
14
DOSAGE AND
ADMINISTRATION........................................................................
16
OVERDOSAGE..........................................................................................................
17
ACTIONS AND CLINICAL PHARMACOLOGY
.................................................... 17
STORAGE AND STABILITY
...................................................................................
22
DOSAGE FORMS, COMPOSITION, AND
PACKAGING....................................... 22
PART II: SCIENTIFIC INFORMATION
.................................................................. 24
PHARMACEUTICAL
INFORMATION....................................................................
24
CLINICAL TRIALS
...................................................................................................
25
REFERENCES............................................................................................................
40
PART III: CONSUMER
INFORMATION...