JAMP-OXCARBAZEPINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

OXCARBAZEPINE

Διαθέσιμο από:

JAMP PHARMA CORPORATION

Φαρμακολογική κατηγορία (ATC):

N03AF02

INN (Διεθνής Όνομα):

OXCARBAZEPINE

Δοσολογία:

300MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

OXCARBAZEPINE 300MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS ANTICONVULSANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0140461002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2022-09-06

Αρχείο Π.Χ.Π.

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PRODUCT MONOGRAPH
PR
JAMP-OXCARBAZEPINE
Oxcarbazepine Tablets
150 mg, 300 mg and 600 mg
Manufacturer’s Standard
Antiepileptic
JAMP PHARMA CORPORATION
1380-203 NEWTON STREET
BOUCHERVILLE, QUEBEC
J4B-5H2
SUBMISSION CONTROL NO: 183866
Date of Preparation:
May 1, 2015
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.......................................................
3
SUMMARY PRODUCT
INFORMATION................................................................................
3
INDICATIONS AND CLINICAL
USE......................................................................................
3
CONTRAINDICATIONS...........................................................................................................
3
WARNINGS AND
PRECAUTIONS..........................................................................................
3
ADVERSE
REACTIONS...........................................................................................................
14
DRUG
INTERACTIONS............................................................................................................
24
DOSAGE AND
ADMINISTRATION........................................................................................
26
OVERDOSAGE..........................................................................................................................
29
ACTION AND CLINICAL
PHARMACOLOGY......................................................................
29
STORAGE AND
STABILITY...................................................................................................
31
DOSAGE FORMS, COMPOSITION AND
PACKAGING.......................................................
32
PART II: SCIENTIFIC
INFORMATI