DexaMedica Meropenem 1 g Powder for Injection

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

MEROPENEM TRIHYDRATE

Dostupno od:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (International ime):

MEROPENEM TRIHYDRATE

Jedinice u paketu:

Box, 1 g x 10 Vials

Proizveden od:

PT DEXA MEDICA

Svojstava lijeka

SpecPacGen002902/5
Author(s):
24.08.2022, Helen Fransiska Manurung, Artwork Management Officer -
BTR,
Reviewed by:
Approved by:
Effective date
:
24.08.2022
24.08.2022, Riski Amanda Tambunan, Supervisor Packaging Design,
24.08.2022, RA Officer 03, Regulatory Affairs Officer,
Specification Packaging Material
E-61927-00, LEAFLET DEXAMEDICA MEROPENEM
POWDER FOR INJECTION MALAYSIA
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
SpecPacGen002902/5
Approved :RA Officer 03, Regulatory Affairs Officer,
Effective date: 24.08.2022
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
SpecPacGen002902/5
Approved :RA Officer 03, Regulatory Affairs Officer,
Effective date: 24.08.2022
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
NO.
PARAMETERS
SPECIFICATION
1.
Material
HVS (Lihat CoA / _See CoA_)
2.
Gramature / _Grammature _(gsm)
54 – 66 gsm
3.
Dimensi panjang / _Length Dimension_ (mm)
248 – 252 mm
4.
Dimensi Lebar / _Width Dimension_ (mm)
148 – 152 mm
5.
Warna / _Colour_
Lihat proof print / _See proof print_
6.
Redaksional / _Redactional_
Lihat proof print / _See proof print_
SpecPacGen002902/5
Approved :RA Officer 03, Regulatory Affairs Officer,
Effective date: 24.08.2022
CONFIDENTIAL
_DIS-FORM-RND-187 (Rev.00) eff.date 08 Jan. 2016_
HISTORY
REVISION NO.
REVISION DATE
DETAILS
REASON
00
-
Dokumen baru
Email RA tanggal 9-Des-2016
Email RA tanggal 21-Des-2016
01
5-Jan-2017
Perubahan tanggal revisi terakhir
Feedback distributor
02
12-Jan-2017
Perubahan tanggal revisi terakhir pada AW hal.1
Feedback RA
03
05 Agustus 2021

Perubahan branded menjadi OGB (Meropenem)

Perubahan packsize dari 1 vial menjadi 10 vial
CMCOthRec075867/1
(Email RA)
04
23 Agustus 2022
-
Perubahan dimensi menjadi 250 x 150 mm
-
Perubahan desain kemasan mengikuti acuan manual
terupdate
-
Perubahan nama brand
-
Penambahan redaksional
CMCOthRec090571/1
CMCOthRec090572/1
SpecPacGen002902/5
Approved :RA Officer 03, Regulatory Affairs Officer,
Effective date: 24.08.2022
CONFIDENTIAL