REDDY-PROGESTERONE CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PROGESTERONE

Tersedia dari:

DR. REDDY'S LABORATORIES INC

Kode ATC:

G03DA04

INN (Nama Internasional):

PROGESTERONE

Dosis:

100MG

Bentuk farmasi:

CAPSULE

Komposisi:

PROGESTERONE 100MG

Rute administrasi :

ORAL

Unit dalam paket:

2X15

Jenis Resep:

Prescription

Area terapi:

PROGESTINS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2017-04-20

Karakteristik produk

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.........................................................................................................