ANGELIQ TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DROSPIRENONE; ESTRADIOL

Commercializzato da:

BAYER INC

Codice ATC:

G03FA17

INN (Nome Internazionale):

DROSPIRENONE AND ESTROGEN

Dosaggio:

1.0MG; 1.0MG

Forma farmaceutica:

TABLET

Composizione:

DROSPIRENONE 1.0MG; ESTRADIOL 1.0MG

Via di somministrazione:

ORAL

Confezione:

28

Tipo di ricetta:

Prescription

Area terapeutica:

PROGESTINS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2005-07-08

Scheda tecnica

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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
..........