NTP-METHYLPHENIDATE ER-C TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-03-2010
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Active ingredient:
METHYLPHENIDATE HYDROCHLORIDE
Available from:
NT PHARMA CANADA LTD
ATC code:
N06BA04
INN (International Name):
METHYLPHENIDATE
Dosage:
27MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
METHYLPHENIDATE HYDROCHLORIDE 27MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Schedule G (CDSA III)
Therapeutic area:
Respiratory and CNS Stimulants
Product summary:
Active ingredient group (AIG) number: 0107548007; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2017-08-21
Summary of Product characteristics
_ _
PRODUCT MONOGRAPH
NTP-METHYLPHENIDATE ER-C
(Methylphenidate Hydrochloride)
Extended-release Tablets 18 mg, 27 mg, 36 mg, and 54 mg
NT Pharma Standard
CNS Stimulant
NT Pharma Canada Limited
Date of Preparation:
5691 Main Street
March 18, 2010
Stouffville, Ontario
Canada, L4A 1H5
Submission Control No: 136744
C
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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...........................................................................................................
9
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND
ADMINISTRATION.....................................................................................
16
OVERDOSAGE
.......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 19
STORAGE AND
STABILITY.................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 24
PART II: SCIENTIFIC
INFORMATION....................................................................................
25
PHARMACEUTICAL
INFORMATION.................................................................................
25
CLINICAL
TRIALS..............................................................
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