CEFSPAN

Country: Индонезија

Језик: Индонежански

Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Активни састојак:

CEFIXIME TRIHYDRATE

Доступно од:

KALBE FARMA - Indonesia

INN (Међународно име):

CEFIXIME TRIHYDRATE

Дозирање:

224 MG

Фармацеутски облик:

KAPLET SALUT SELAPUT

Јединице у пакету:

DUS, 3 STRIP @ 10 KAPLET SALUT SELAPUT

Произведен од:

DANKOS FARMA - Indonesia

Датум одобрења:

2020-03-25

Карактеристике производа

Specification (Packaging Material)
SpecContDP000442/2
This document has been electronically signed
Approved by: Weta Surtantya, QA, 15 Jun 2020, Seimtiarti Wijaya
Kusumanti
Dewi, R&D, 15 Jun 2020
CEFSPAN 200 MG FILM-COATED TABLET
(Indonesia) Leaflet Specification
Effective date:15 Jun 2020
In house
Page 3 of 5
DISETUJUI OLEH BPOM: 15/10/2020
ID: EREG100221VR12000157
Specification (Packaging Material)
SpecContDP000442/2
This document has been electronically signed
Approved by: Weta Surtantya, QA, 15 Jun 2020, Seimtiarti Wijaya
Kusumanti
Dewi, R&D, 15 Jun 2020
CEFSPAN 200 MG FILM-COATED TABLET
(Indonesia) Leaflet Specification
Effective date:15 Jun 2020
In house
Page 4 of 5
DISETUJUI OLEH BPOM: 15/10/2020
ID: EREG100221VR12000157
REVISION HISTORY
DATE
DOCUMENT NUMBER
DESCRIPTION OF CHANGES
29 Apr 2020
SpecContDP000442/1
Design refers to BPOM Approval, 25 Mar
2020
15 Jun 2020
SpecContDP000442/2
-
Design changes refers to Change Request
No.
01365/CR/11/2019/DF:
Change
text
under lisence from “Astellas Pharma Inc”
to “Otsuka Chemical Co., Ltd.,”.
-
Design changes refers to Change Request
No.
00604/CR/05/2020/DF:
Change
content from 3 strips to 1 strip.
Specification (Packaging Material)
SpecContDP000442/2
This document has been electronically signed
Approved by: Weta Surtantya, QA, 15 Jun 2020, Seimtiarti Wijaya
Kusumanti
Dewi, R&D, 15 Jun 2020
CEFSPAN 200 MG FILM-COATED TABLET
(Indonesia) Leaflet Specification
Effective date:15 Jun 2020
In house
Page 5 of 5
DISETUJUI OLEH BPOM: 15/10/2020
ID: EREG100221VR12000157