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Product Information / Maklumat Produk
Product Name :

Dupixent 300 mg Solution for Injection in Pre-filled Syringe

 Registration No :

MAL19056001AZ
Holder :

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

 Holder Address :

UNIT TB-18-1, LEVEL 18, TOWER B, PLAZA 33,
NO.1, JALAN KEMAJUAN, SEKSYEN 13,
46200
PETALING JAYA
MALAYSIA
Phone No :

03-76510800
Manufacturer :

Sanofi Winthrop Industrie

 Manufacturer Address :

1051 BOULEVARD INDUSTRIEL,
76580 LE TRAIT,
FRANCE
Importer :

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

 Importer Address :

UNIT TB-18-1, LEVEL 18, TOWER B, PLAZA 33,
NO.1, JALAN KEMAJUAN, SEKSYEN 13,
46200
PETALING JAYA
MALAYSIA
Ingredients Information / Maklumat Bahan Aktif
No Active Ingredient
1 DUPILUMAB
 
Packaging Information / Maklumat Bungkusan
No Quantity
1 2 Pre-Filled Syringes
2 2 Pre-Filled Syringes
 
Label (mock-up) for Immediate Container / Label Dalam Bekas
No Attachment
1 D1 Dupixent label 718015 (PFS-S) - NEW.pdf
2 D1 Dupixent label (PFS).pdf.pdf
 
Label (mock-up) for Outer Carton / Label Luar Bekas
No Attachment
1 D2 Dupixent Carton 740987 (PFS-S) V2.pdf.pdf
2 D2 Dupixent Carton (PFS-S)- Waterford V2.pdf.pdf
3 D2 Dupixent carton (PFS) Waterford -V2.pdf.pdf
4 D2 Dupixent carton (PFS) V2.pdf.pdf
5 D2 Dupixent carton (PFS) Cook -V2.pdf.pdf
 
Technical Evaluation Summary
No Attachment
1 Technical Summary Report Dupixent May 2019_Published.pdf