MYLAN-NAPROXEN EC TABLET (ENTERIC-COATED)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
26-03-2015
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Active ingredient:
NAPROXEN
Available from:
MYLAN PHARMACEUTICALS ULC
ATC code:
M01AE02
INN (International Name):
NAPROXEN
Dosage:
375MG
Pharmaceutical form:
TABLET (ENTERIC-COATED)
Composition:
NAPROXEN 375MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Product summary:
Active ingredient group (AIG) number: 0109634004; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-07-12
Summary of Product characteristics
_ _
_Page 1 of 40_
PRODUCT MONOGRAPH
PR
MYLAN-NAPROXEN EC
Naproxen Enteric-Coated Tablet
250 mg, 375 mg and 500 mg
Pharmaceutical Standard: Professed
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
Canada M8Z 2S6
Submission Control No.: 181728
Date of Revision: March 10, 2015
_ _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
13
DRUG INTERACTIONS
.........................................................................................................
17
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 23
PART II: SCIENTIFIC INFORMATION
...............................................................................
24
PHARMACEUTICAL INFORMATION
.................................................................................
24
CLINICAL TRIALS
....................................
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