PMS-PROGESTERONE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-05-2018
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Active ingredient:
PROGESTERONE
Available from:
PHARMASCIENCE INC
ATC code:
G03DA04
INN (International Name):
PROGESTERONE
Dosage:
100MG
Pharmaceutical form:
CAPSULE
Composition:
PROGESTERONE 100MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
PROGESTINS
Product summary:
Active ingredient group (AIG) number: 0106327002; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-06-01
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
PMS-PROGESTERONE
Progesterone Capsules
100 mg
PROGESTIN
PHARMASCIENCE INC.
DATE OF PREPARATION:
6111 Ave. Royalmount
May 29, 2018
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control No: 208866
_pms-PROGESTERONE Product Monograph Page 2 of 33_
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
..................................................................................................
14
DOSAGE AND ADMINISTRATION
..............................................................................
15
OVERDOSAGE
................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 16
STORAGE AND STABILITY
.........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL INFORMATION
.........................................................................
19
CLINICAL TRIALS
..........................................................................................................
20
TOXICOLOGY
..............................................................................
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