JAMP-BICALUTAMIDE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BICALUTAMIDE

Διαθέσιμο από:

JAMP PHARMA CORPORATION

Φαρμακολογική κατηγορία (ATC):

L02BB03

INN (Διεθνής Όνομα):

BICALUTAMIDE

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

BICALUTAMIDE 50MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0127996001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2016-02-01

Αρχείο Π.Χ.Π.

_Page 1 of 33 _
PRODUCT MONOGRAPH
PR JAMP-
BICALUTAMIDE
Bicalutamide Tablets, USP
50 mg
Non-Steroidal Antiandrogen
Jamp Pharma Corporation
1310 Rue Nobel
Boucherville, Quebec, Canada
J4B 5H3
DATE OF REVISION:
July 5, 2018
Submission Control No.: 211343
_Page 2 of 33 _
T A B L E O F C O N T E N T S
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
..................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
11
DOSAGE AND ADMINISTRATION
....................................................................................
13
OVERDOSAGE
........................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 14
STORAGE AND STABILITY
................................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 14
P A R T II: S C I E N T I F I C I N F O R M A T I O N
............................................................ 16
P H A R M A C E U T I C A L IN F O R M A T I O N
.............................................................. 16
C L I N I C A L TRIALS
...........................................................................................................
16
DETAILED PHARMACOLOGY
...