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Product Information / Maklumat Produk
Product Name :

YONDELIS 1MG FOR INJECTION

Registration No :

MAL20091970ACRZ

Holder :

ZUELLIG PHARMA SDN BHD

Holder Address :

NO. 15, PERSIARAN PASAK BUMI, SEK. U8
PERINDUSTRIAN BUKIT JELUTONG
40150
SHAH ALAM
MALAYSIA

Phone No :

03-55662288

Manufacturer :

BAXTER ONCOLOGY GMBH

Manufacturer Address :

KANTSTRASSE 2, 33790 HALLE/WESTFALEN,
GERMANY

Importer :

JOHNSON & JOHNSON SDN BHD

Importer Address :

LEVEL 8, THE PINNACLE,
PERSIARAN LAGOON,
BANDAR SUNWAY,
46150
PETALING JAYA
MALAYSIA

Importer :

ZUELLIG PHARMA SDN BHD

Importer Address :

NO. 15, PERSIARAN PASAK BUMI,
SEKSYEN U8,
PERINDUSTRIAN BUKIT JELUTONG,
40150
SHAH ALAM
MALAYSIA

Ingredients Information / Maklumat Bahan Aktif
No Active Ingredient
1 TRABECTEDIN
 
Packaging Information / Maklumat Bungkusan
No Quantity
1 1Units Units
 
Consumer Medication Information Leaflet / Risalah Maklumat Ubat Pesakit
No Attachment
 
Label (mock-up) for Immediate Container / Label Dalam Bekas
No Attachment
1 D1 Inner label Yondelis_AW_134730_3.pdf
2 YON.LBL.9801.V5.pdf
 
Label (mock-up) for Outer Carton / Label Luar Bekas
No Attachment
1 D2 Outer carton Yondelis_AW_134729_2.pdf
2 YON.CTN.9701.V5.pdf
 
Proposed Package Insert / Sisipan Bungkusan
No Attachment
1 D3 Package insert_Yondelis_CCDSvMar2019_clean.pdf
2 D3 Yondelis Leaflet YON.LEA.9901.V3 6Oct2020.pdf
 
Technical Evaluation Summary
NO INFORMATION DETAIL