REDDY-PROGESTERONE CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PROGESTERONE

제공처:

DR. REDDY'S LABORATORIES INC

ATC 코드:

G03DA04

INN (국제 이름):

PROGESTERONE

복용량:

100MG

약제 형태:

CAPSULE

구성:

PROGESTERONE 100MG

관리 경로:

ORAL

패키지 단위:

2X15

처방전 유형:

Prescription

치료 영역:

PROGESTINS

제품 요약:

Active ingredient group (AIG) number: 0106327002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2017-04-20

제품 특성 요약

1
PRODUCT MONOGRAPH
PR
REDDY-PROGESTERONE
Progesterone capsules 100 mg
Progestin
MANUFACTURED BY:
DR. REDDY’S LABORATORIES, INC.
Princeton, NJ – 08540 USA
IMPORTED AND DISTRIBUTED BY:
DR. REDDY’S LABORATORIES CANADA INC.
Mississauga, ON L4W 4Y1
CANADA
Date of Revision:
Nov 4, 2022
Submission
Control No: 264364
2
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.........................................................................................................