PLAN B TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LEVONORGESTREL

Disponibil de la:

FOUNDATION CONSUMER HEALTHCARE, LLC

Codul ATC:

G03AD01

INN (nume internaţional):

LEVONORGESTREL

Dozare:

1.5MG

Forma farmaceutică:

TABLET

Compoziție:

LEVONORGESTREL 1.5MG

Calea de administrare:

ORAL

Unități în pachet:

1

Tip de prescriptie medicala:

OTC

Zonă Terapeutică:

CONTRACEPTIVES

Rezumat produs:

Active ingredient group (AIG) number: 0125218004; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-05-09

Caracteristicilor produsului

PRODUCT MONOGRAPH
PLAN B
®
Levonorgestrel Tablet
1.5 mg
Manufacturer’s Standard
EMERGENCY CONTRACEPTION
Foundation Consumer Healthcare, LLC
1190 Omega Drive
Pittsburgh, PA 15205. USA
Paladin Labs Inc.
Date of Preparation:
100 Blvd. Alexis Nihon, Suite 600
Saint-Laurent, Quebec
April 26, 2018
H4M 2P2
Version 12.0
Submission Control No: 214131
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_Page 2 of 36_
TABLE OF CONTENTS
PART I: HEALTH CARE PROFESSIONAL INFORMATION
............................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG
INTERACTIONS..................................................................................................
11
DOSAGE AND ADMINISTRATION
.............................................................................
13
OVERDOSAGE
................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 14
STORAGE AND STABILITY
.........................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 16
PART II: SCIENTIFIC INFORMATION
................................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
.........................................................................................................
18
DETAILED