PROMETRIUM CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-03-2021
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Active ingredient:
PROGESTERONE
Available from:
ORGANON CANADA INC.
ATC code:
G03DA04
INN (International Name):
PROGESTERONE
Dosage:
100MG
Pharmaceutical form:
CAPSULE
Composition:
PROGESTERONE 100MG
Administration route:
ORAL
Units in package:
28/100
Prescription type:
Prescription
Therapeutic area:
PROGESTINS
Product summary:
Active ingredient group (AIG) number: 0106327002; AHFS:
Authorization status:
APPROVED
Authorization date:
2011-02-17
Summary of Product characteristics
Page 1 of 34
PRODUCT MONOGRAPH
PROMETRIUM
®
Progesterone capsules
100 mg
Progestin
Organon Canada Inc.
16766 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.organon.ca
Date of Revision:
March 29, 2021
Submission Control No: 249484
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Page 2 of 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................17
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL INFORMATION
..........................................................................20
CLINICAL TRIALS
..........................................................................................................21
TOXICOLOGY
..............................................................................................................
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