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Product Information / Maklumat Produk
Product Name :

QDENGA powder and solvent for solution for injection in prefilled syringe (Dengue tetravalent vaccine (live, attenuated))

 Registration No :

MAL24026010ACZ
Holder :

Takeda Malaysia Sdn Bhd

 Holder Address :

UNIT TB-L 13-1, LEVEL 13
TOWER B, PLAZA 33
NO.1, JALAN KEMAJUAN, SEKSYEN 13
46200
PETALING JAYA
MALAYSIA
Phone No :

60379533100
Manufacturer :

Takeda GmBH

 Manufacturer Address :

TAKEDA (WERK SINGEN),
ROBERT-BOSCH-STR.8,
78224 SINGEN,
GERMANY
Importer :

Takeda Malaysia Sdn Bhd

 Importer Address :

UNIT TB-L 13-1, LEVEL 13,
TOWER B, PLAZA 33
NO.1, JALAN KEMAJUAN, SEKSYEN 13
46200
PETALING JAYA
MALAYSIA
Ingredients Information / Maklumat Bahan Aktif
No Active Ingredient
1 Dengue virus serotype 3 (live, attenuated)
2 Dengue virus serotype 1 (live, attenuated)
3 Dengue virus serotype 2 (live, attenuated)
4 Dengue virus serotype 4 (live, attenuated)
 
Packaging Information / Maklumat Bungkusan
No Quantity
1 1 Vials
2 5 Vials
 
Label (mock-up) for Immediate Container / Label Dalam Bekas
No Attachment
1 D1_LA Qdenga DP Vial_MYS.pdf
 
Label (mock-up) for Outer Carton / Label Luar Bekas
No Attachment
1 D2_CN Qdenga_Kombi Pack without needles.pdf
2 D2_CN Qdenga_Kombi Pack_(with needle).pdf
3 D2_CN Qdenga vial_PFS Blister Pack (whitout needles).pdf
4 D2_CN Qdenga vial_PFS Blister Pack (with needle).pdf
 
Technical Evaluation Summary
NO INFORMATION DETAIL