AG-RANITIDINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-01-2019
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
RANITIDINE (RANITIDINE HYDROCHLORIDE)
Available from:
ANGITA PHARMA 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:
APPROVED
Authorization date:
2019-01-07
Summary of Product characteristics
_Page 1 of 27_
PRODUCT MONOGRAPH
PR
AG-RANITIDINE
Ranitidine Tablets, USP
150 mg & 300 mg ranitidine (as ranitidine hydrochloride)
Histamine H
2
-Receptor Antagonist
Angita Pharma Inc.
Date of Preparation:
1310 rue Nobel
January 4, 2019
Boucherville, Québec
J4B 5H3
Submission Control No.: 221751
_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
...........................................................
Read the complete document
