PLAN B TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

LEVONORGESTREL

から入手可能:

FOUNDATION CONSUMER HEALTHCARE, LLC

ATCコード:

G03AD01

INN（国際名）:

LEVONORGESTREL

投薬量:

0.75MG

医薬品形態:

TABLET

構図:

LEVONORGESTREL 0.75MG

投与経路:

ORAL

パッケージ内のユニット:

2

処方タイプ:

OTC

治療領域:

CONTRACEPTIVES

製品概要:

Active ingredient group (AIG) number: 0125218002; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2018-05-09

製品の特徴

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_Page 1 of 33_
PRODUCT MONOGRAPH
PLAN B
®
Levonorgestrel Tablets 0.75 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, Québec
April 26, 2018
H4M 2P2
Version 11.0
Submission Control No: 214131
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_Page 2 of 33_
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
............................................................ 13
STORAGE AND STABILITY
.........................................................................................
16
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 16
PART II: SCIENTIFIC INFORMATION
...............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
......................................................................................