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Product Information / Maklumat Produk
Product Name :

BLINCYTO (Blinatumomab) for injection 35 mcg/vial

Registration No :

MAL16105053ACZ

Holder :

Amgen Biopharmaceuticals Malaysia Sdn Bhd

Holder Address :

COMMON GROUND, 1 POWERHOUSE, HORIZON PENTHOUSE, NO. 1, PERSIARAN BANDAR UTAMA, BANDAR UTAMA,
47800
PETALING JAYA
MALAYSIA

Phone No :

1800 818 227

Manufacturer :

Amgen Manufacturing Limited LLC

Manufacturer Address :

STATE ROAD 31, KM 24.6 JUNCOS, PUERTO RICO 00777-4060,
UNITED STATES

Importer :

Amgen Biopharmaceuticals Malaysia Sdn Bhd

Importer Address :

HORIZON PENTHOUSE, 1 POWERHOUSE
1, PERSIARAN BANDAR UTAMA, BANDAR UTAMA
47800
PETALING JAYA
MALAYSIA

Ingredients Information / Maklumat Bahan Aktif
No Active Ingredient
1 Blinatumomab
 
Packaging Information / Maklumat Bungkusan
No Quantity
1 35µg/mcg mcg/mL
2 10ml mL
 
Label (mock-up) for Immediate Container / Label Dalam Bekas
No Attachment
1 D1 Proposed Blincyto vial label.pdf
2 D1 Proposed IVSS vial label.pdf
 
Label (mock-up) for Outer Carton / Label Luar Bekas
No Attachment
1 D2 1033822 ART MCK05939 ART Blincyto Carton_ADL and BIP.pdf