AG-QUETIAPINE FUMARATE TABLET (IMMEDIATE RELEASE)
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
11-06-2021
Některé dokumenty pro tento produkt momentálně nejsou k dispozici, můžete poslat požadavek našemu zákaznickému servisu a my vás upozorníme, jakmile je dokážeme získat.
Poslat žádost.
Poslat žádost.
Aktivní složka:
QUETIAPINE (QUETIAPINE FUMARATE)
Dostupné s:
ANGITA PHARMA INC.
ATC kód:
N05AH04
INN (Mezinárodní Name):
QUETIAPINE
Dávkování:
100MG
Léková forma:
TABLET (IMMEDIATE RELEASE)
Složení:
QUETIAPINE (QUETIAPINE FUMARATE) 100MG
Podání:
ORAL
Jednotky v balení:
15G/50G
Druh předpisu:
Prescription
Terapeutické oblasti:
ATYPICAL ANTIPSYCHOTICS
Přehled produktů:
Active ingredient group (AIG) number: 0131858002; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2021-06-14
Charakteristika produktu
Page 1 of 59
PRODUCT MONOGRAPH
PR
AG-QUETIAPINE FUMARATE
Quetiapine Tablets USP
25 mg, 100 mg, 200 mg and 300 mg
quetiapine (as quetiapine fumarate)
Antipsychotic Agent
_ANGITA PHARMA INC. _
_DATE OF REVISION:_
1310 rue Nobel
June 11, 2021
Boucherville, Québec
J4B 5H3
Submission Control No.: 252148
Page 2 of 59
TABLE OF CONTENTS
PRODUCT MONOGRAPH
....................................................................................................
1
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
...............................................................................................
15
DRUG INTERACTIONS
...............................................................................................
31
DOSAGE AND ADMINISTRATION
...........................................................................
33
OVERDOSAGE
.............................................................................................................
35
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 36
STORAGE AND STABILITY
.......................................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 38
PART II: SCIENTIFIC INFORMATION
.............................................................................
39
PHARMACEUTICAL INFORMATION
.......................................................................
39
CLINICAL TRIALS
..........................................................................
Přečtěte si celý dokument
