ANGELIQ TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DROSPIRENONE; ESTRADIOL

Διαθέσιμο από:

BAYER INC

Φαρμακολογική κατηγορία (ATC):

G03FA17

INN (Διεθνής Όνομα):

DROSPIRENONE AND ESTROGEN

Δοσολογία:

1.0MG; 1.0MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

DROSPIRENONE 1.0MG; ESTRADIOL 1.0MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

28

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PROGESTINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0251181001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2005-07-08

Αρχείο Π.Χ.Π.

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_Page 1 of 47 _
PRODUCT MONOGRAPH
PR
ANGELIQ
®
Drospirenone and Estradiol-17β tablet
1/1 mg
Progestin – Estrogen
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
http://www.bayer.ca
Date of Revision:
February 17, 2016
Submission Control No: 189314
© 2016, Bayer Inc.
® TM see www.bayer.ca/tm-mc
_ _
_Page 2 of 47 _
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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................27
PART II: SCIENTIFIC INFORMATION
................................................................................28
PHARMACEUTICAL INFORMATION
..........................................................................28
CLINICAL TRIALS
..........................................................................................................30
DETAILED PHARMACOLOGY
..........