VAGIFEM VAGINAL TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ESTRADIOL

Διαθέσιμο από:

NOVO NORDISK CANADA INC

Φαρμακολογική κατηγορία (ATC):

G03CA03

INN (Διεθνής Όνομα):

ESTRADIOL

Δοσολογία:

25MCG

Φαρμακοτεχνική μορφή:

VAGINAL TABLET

Σύνθεση:

ESTRADIOL 25MCG

Οδός χορήγησης:

VAGINAL

Μονάδες σε πακέτο:

15 TABLETS WITH APPLICATORS

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ESTROGENS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0106457005; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2014-07-28

Αρχείο Π.Χ.Π.

_ _
_Vagifem_
_®_
_ (estradiol vaginal tablet) _
_Page 1 of 33_
PRODUCT MONOGRAPH
_PR_
VAGIFEM
®
17SS-ESTRADIOL
VAGINAL TABLET WITH APPLICATOR, 25 ΜG
ESTROGEN
Manufacturer’s Standard
Hormone Therapy
_NOVO NORDISK CANADA INC. _
300 – 2680 Skymark Ave.
Mississauga, Ontario
L4W 5L6
DATE OF REVISION:
12 July 2011
SUBMISSION CONTROL NO: 141555
_ _
_Vagifem_
_®_
_ (estradiol vaginal tablet) _
_Page 2 of 33_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS..................................................................................................11
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND
ADMINISTRATION..............................................................................16
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND
STABILITY..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
...............................................................................22
PHARMACEUTICAL
INFORMATION..........................................................................22
CLINICAL
TRIALS...................................................................................