MYLAN-PREGABALIN CAPSULE
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
14-03-2017
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Verzend verzoek.
Werkstoffen:
PREGABALIN
Beschikbaar vanaf:
MYLAN PHARMACEUTICALS ULC
ATC-code:
N02BF02
INN (Algemene Internationale Benaming):
PREGABALIN
Dosering:
225MG
farmaceutische vorm:
CAPSULE
Samenstelling:
PREGABALIN 225MG
Toedieningsweg:
ORAL
Eenheden in pakket:
60/100
Prescription-type:
Prescription
Therapeutisch gebied:
MISCELLANEOUS ANTICONVULSANTS
Product samenvatting:
Active ingredient group (AIG) number: 0151121007; AHFS:
Autorisatie-status:
CANCELLED PRE MARKET
Autorisatie datum:
2018-07-04
Productkenmerken
_MYLAN-PREGABALIN (PREGABALIN) PRODUCT MONOGRAPH_
_PAGE 1 _
_OF 81_
PRODUCT MONOGRAPH
PR
MYLAN-PREGABALIN
PREGABALIN CAPSULES
25 MG, 50 MG, 75 MG, 150 MG, 225 MG, 300 MG
ANALGESIC AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision: March 1, 2017
_SUBMISSION CONTROL NO: _202862
_MYLAN-PREGABALIN (PREGABALIN) PRODUCT MONOGRAPH_
_PAGE 2 _
_OF 81_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ..................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................ 3
INDICATIONS
AND
CLINICAL
USE
............................................... 3
CONTRAINDICATIONS
.......................................................... 4
WARNINGS
AND
PRECAUTIONS
................................................... 4
ADVERSE
REACTIONS
......................................................... 19
DRUG
INTERACTIONS
......................................................... 41
DOSAGE
AND
ADMINISTRATION
................................................. 44
OVERDOSAGE
................................................................ 48
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................... 49
STORAGE
AND
STABILITY
..................................................... 54
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
................................... 54
PART II: SCIENTIFIC INFORMATION ............................................ 56
PHARMACEUTICAL
INFORMATION
................................................ 56
CLINICAL
TRIALS
........................................................... 57
DETAILED
PHARMACOLOGY
..................................................... 68
TOXICOLOGY
................................................................ 71
REFERENCES
................................................................ 75
PART III: CONSUMER INFORMATION ............................................. 78
_MYLAN-PREGABALIN (PREGABALIN) PRODUCT MONOGRAPH_
_PAGE 3 _
_OF 81_
PR MYLAN-PREGABALIN
P
REGABALIN CAPSULES
PART I: HEALTH PROFESSIONAL IN
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