NOVO-VALPROIC CAPSULE

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
19-06-2014

Viambatanisho vya kazi:

VALPROIC ACID

Inapatikana kutoka:

TEVA CANADA LIMITED

ATC kanuni:

N03AG01

INN (Jina la Kimataifa):

VALPROIC ACID

Kipimo:

250MG

Dawa fomu:

CAPSULE

Tungo:

VALPROIC ACID 250MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100/500

Dawa ya aina:

Prescription

Eneo la matibabu:

MISCELLANEOUS ANTICONVULSANTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0112996001; AHFS:

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2018-05-02

Tabia za bidhaa

                                PRODUCT MONOGRAPH
PR
NOVO-VALPROIC
(Valproic Acid)
250 mg Capsules, USP Standard
500 mg Enteric Coated Capsules, Teva Standard
Antiepileptic
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
June 19, 2014
Toronto, Ontario
M1B 2K9
CONTROL NO.: 174447
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
.....................................................................................
25
OVERDOSAGE
.......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 28
STORAGE AND STABILITY
.................................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 31
PART II: SCIENTIFIC INFORMATION
....................................................................................
32
PHARMACEUTICAL INFORMATION
.................................................................................
32
CLINICAL TRIALS
.................................................................................................................
33
D
                                
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