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

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

METHYLPHENIDATE HYDROCHLORIDE

Διαθέσιμο από:

NT PHARMA CANADA LTD

Φαρμακολογική κατηγορία (ATC):

N06BA04

INN (Διεθνής Όνομα):

METHYLPHENIDATE

Δοσολογία:

18MG

Φαρμακοτεχνική μορφή:

TABLET (EXTENDED-RELEASE)

Σύνθεση:

METHYLPHENIDATE HYDROCHLORIDE 18MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Schedule G (CDSA III)

Θεραπευτική περιοχή:

Respiratory and CNS Stimulants

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0107548004; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2017-08-21

Αρχείο Π.Χ.Π.

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