PRIVA-RANITIDINE TABLET

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

RANITIDINE (RANITIDINE HYDROCHLORIDE)

Disponibbli minn:

PHARMAPAR INC

Kodiċi ATC:

A02BA02

INN (Isem Internazzjonali):

RANITIDINE

Dożaġġ:

150MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

HISTAMINE H2-ANTAGONISTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0115150002; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED PRE MARKET

Data ta 'l-awtorizzazzjoni:

2022-07-29

Karatteristiċi tal-prodott

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_Page 1 of 27 _
PRODUCT MONOGRAPH
PR
PRIVA-RANITIDINE
Ranitidine Tablets, USP
150 mg & 300 mg ranitidine (as ranitidine hydrochloride)
Histamine H
2
-Receptor Antagonist
PHARMAPAR INC.
Date of Approval:
1565, Boul. Lionel-Boulet
November 20, 2019
Varennes, Quebec, J3X 1P7
Canada
Submission Control No: 231367
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_Page 2 of 27 _
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..........................................................................................................5
DRUG
INTERACTIONS..........................................................................................................7
DOSAGE AND
ADMINISTRATION......................................................................................8
OVERDOSAGE.......................................................................................................................10
ACTION AND CLINICAL
PHARMACOLOGY...................................................................10
STORAGE AND
STABILITY................................................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................11
PART II: SCIENTIFIC INFORMATION
......................................................................................12
PHARMACEUTICAL INFORMATION
...............................................................................12
CLINICAL TRIALS
...........................................................