RATIO-VALPROIC CAPSULE
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
12-10-2016
Nekateri dokumenti za ta izdelek trenutno niso na voljo, pošljete lahko zahtevo v našo stranko in obvestili vas bomo takoj, ko jih bomo lahko pridobili.
Pošlji zahtevo.
Pošlji zahtevo.
Aktivna sestavina:
VALPROIC ACID
Dostopno od:
TEVA CANADA LIMITED
Koda artikla:
N03AG01
INN (mednarodno ime):
VALPROIC ACID
Odmerek:
250MG
Farmacevtska oblika:
CAPSULE
Sestava:
VALPROIC ACID 250MG
Pot uporabe:
ORAL
Enote v paketu:
100/500
Tip zastaranja:
Prescription
Terapevtsko območje:
MISCELLANEOUS ANTICONVULSANTS
Povzetek izdelek:
Active ingredient group (AIG) number: 0112996001; AHFS:
Status dovoljenje:
CANCELLED POST MARKET
Datum dovoljenje:
2018-05-18
Lastnosti izdelka
PRODUCT MONOGRAPH
PR
RATIO-VALPROIC
(VALPROIC ACID)
Capsules
Capsules (250 mg and 500 mg)
USP
Antiepileptic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Preparation :
July 24, 2013
Submission Control No: 166248
2
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
.........................................................................................................
16
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
26
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND STABILITY
.................................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC INFORMATION
....................................................................................
33
PHARMACEUTICAL INFORMATION
.................................................................................
33
CLINICAL TRIALS
.................................................................................................................
Preberite celoten dokument
