Granodex 1mgml Solution for Injection or Infusion

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

GRANISETRON HYDROCHLORIDE

Dostopno od:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (mednarodno ime):

GRANISETRON HYDROCHLORIDE

Enote v paketu:

5 ampoules x 3 ml; 5 ampoules x 1 ml

Izdeluje:

PT Ferron Par Pharmaceuticals

Lastnosti izdelka

SpecPacGen008154/3
Author(s):
12.11.2021, Gina Sonya, Specialist, Assistant (Packaging),
Reviewed by:
Approved by:
Effective date
:
12.11.2021
12.11.2021, Riski Amanda Tambunan, Supervisor Packaging Design,
12.11.2021, RA Officer 02, Regulatory Affairs Officer,
Specification Packaging Material
E-63140-00, LEAFLET GRANODEX INJECTION
MALAYSIA
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
SpecPacGen008154/3
Approved :RA Officer 02, Regulatory Affairs Officer,
Effective date: 12.11.2021
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
SpecPacGen008154/3
Approved :RA Officer 02, Regulatory Affairs Officer,
Effective date: 12.11.2021
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
NO.
PARAMETERS
SPECIFICATION
1.
Material
HVS (Lihat CoA / See CoA)
2.
Gramatur / Grammature
54 – 66 gsm
3.
Dimensi panjang / Length dimension
239 – 241 mm
4.
Dimensi lebar / Width dimension
179 – 181 mm
5.
Arah serat / Fiber direction
Vertikal / Vertical
6.
Warna / Colour
Lihat proof print / See proof print
7.
Redaksional / Redactional
Lihat proof print / See proof print
SpecPacGen008154/3
Approved :RA Officer 02, Regulatory Affairs Officer,
Effective date: 12.11.2021
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
HISTORY
REVISION
NO.
REVISION
DATE
DETAILS
REASON
00
-
Dokumen
baru
menggantikan
Specpacgen006668/1,
d6ngan
perubahan :
-
Perubahan bentuk sediaan menjadi
“Solution for injection or infusion”
-
Perubahan
redaksional
sesuai
PI
terbaru
CMCOthRec075034/1
01
10 Sep
2021
Penghilangan
redaksional
mengikuti
PI terakhir
-
CMCOthRec075035/2
-
CMCOthRec077297/1
02
11 Nov
2021
-
Perubahan ukuran font redaksional
menjadi 7pt
-
Penambahan
kotak
keterangan
ukuran
dan
jenis
font
yang
digunakan pada redaksional
CMCOthRec079634/1
SpecPacGen008154/3
Approved :RA Officer 02, Regulatory Affairs Officer,
Effective date: 12.11.2021
CONFIDENTIAL