NTP-METHYLPHENIDATE ER-C TABLET (EXTENDED-RELEASE)

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

METHYLPHENIDATE HYDROCHLORIDE

Disponibbli minn:

NT PHARMA CANADA LTD

Kodiċi ATC:

N06BA04

INN (Isem Internazzjonali):

METHYLPHENIDATE

Dożaġġ:

36MG

Għamla farmaċewtika:

TABLET (EXTENDED-RELEASE)

Kompożizzjoni:

METHYLPHENIDATE HYDROCHLORIDE 36MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Schedule G (CDSA III)

Żona terapewtika:

Respiratory and CNS Stimulants

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0107548005; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED PRE MARKET

Data ta 'l-awtorizzazzjoni:

2017-08-21

Karatteristiċi tal-prodott

_ _
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..............................................................