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

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

METHYLPHENIDATE HYDROCHLORIDE

Dostopno od:

TEVA CANADA LIMITED

Koda artikla:

N06BA04

INN (mednarodno ime):

METHYLPHENIDATE

Odmerek:

27MG

Farmacevtska oblika:

TABLET (EXTENDED-RELEASE)

Sestava:

METHYLPHENIDATE HYDROCHLORIDE 27MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Schedule G (CDSA III)

Terapevtsko območje:

Respiratory and CNS Stimulants

Povzetek izdelek:

Active ingredient group (AIG) number: 0107548007; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2023-03-21

Lastnosti izdelka

_ _
PRODUCT MONOGRAPH
TEVA-METHYLPHENIDATE ER-C
(Methylphenidate Hydrochloride)
Extended-release Tablets 18 mg, 27 mg, 36 mg, and 54 mg
Teva Standard
CNS Stimulant
Teva Canada Limited
Date of Revision:
30 Novopharm Court
December 19, 2019
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No: 233639
C
_Teva-Methylphenidate ER-C_
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 28
PART II: SCIENTIFIC INFORMATION
....................................................................................
30
PHARMACEUTICAL INFORMATION
.................................................................................
30
CLINICAL TRIALS
.....................