MYLAN-VALPROIC CAPSULE

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

VALPROIC ACID

Sẵn có từ:

MYLAN PHARMACEUTICALS ULC

Mã ATC:

N03AG01

INN (Tên quốc tế):

VALPROIC ACID

Liều dùng:

250MG

Dạng dược phẩm:

CAPSULE

Thành phần:

VALPROIC ACID 250MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS ANTICONVULSANTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2016-06-28

Đặc tính sản phẩm

1
_ _
_ _
PRODUCT MONOGRAPH
PR
MYLAN-VALPROIC
Valproic Acid Capsules, USP
250 mg
Antiepileptic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke Ontario
M8Z 2S6
Date of Revision: May 7, 2015
Submission Control No.: 184065
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
...........................................................................................................
20
DRUG INTERACTIONS
...........................................................................................................
24
DOSAGE AND ADMINISTRATION
......................................................................................
34
OVERDOSAGE
..........................................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
37
STORAGE AND STABILITY
...................................................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 40
PART II: SCIENTIFIC INFORMATION ...................................................................................
41
PHARMACEUTICAL INFORMATION
..................................................................................
41
CLINICAL TRIALS
.....................................................................................................................
42
DETAILED P