PRIVA-RANITIDINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-11-2019
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Active ingredient:
RANITIDINE (RANITIDINE HYDROCHLORIDE)
Available from:
PHARMAPAR INC
ATC code:
A02BA02
INN (International Name):
RANITIDINE
Dosage:
150MG
Pharmaceutical form:
TABLET
Composition:
RANITIDINE (RANITIDINE HYDROCHLORIDE) 150MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
HISTAMINE H2-ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0115150002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2022-07-29
Summary of Product characteristics
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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
...........................................................
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