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Product Information / Maklumat Produk
Product Name :

VAXNEUVANCE (Pneumococcal 15-Valent Conjugate Vaccine) Suspension For Injection Prefilled Syringe

 Registration No :

MAL23126010AZ
Holder :

MERCK SHARP & DOHME (MALAYSIA) SDN. BHD.

 Holder Address :

LOT NO. B-22-1 & B-22-2, LEVEL 22
THE ASCENT, PARADIGM NO. 1
JALAN SS 7/26A, KELANA JAYA
47301
PETALING JAYA
MALAYSIA
Phone No :

03-74991600
Manufacturer :

MERCK SHARP & DOHME B.V.

 Manufacturer Address :

WAARDERWEG 39, HAARLEM, 2031 BN
NETHERLANDS
Importer :

MERCK SHARP & DOHME (MALAYSIA) SDN. BHD.

 Importer Address :

LOT NO. B-22-1 & B-22-2, LEVEL 22
THE ASCENT, PARADIGM NO. 1
JALAN SS 7/26A, KELANA JAYA
47301
PETALING JAYA
MALAYSIA
Ingredients Information / Maklumat Bahan Aktif
No Active Ingredient
1 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 1
2 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 3
3 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 4
4 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 5
5 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 6A
6 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 6B
7 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 7F
8 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 9V
9 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 14
10 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 18C
11 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 19A
12 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 19F
13 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 22F
14 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 23F
15 Monovalent Conjugate Bulk - Pneumococcal Polysaccharide Serotype 33F
 
Packaging Information / Maklumat Bungkusan
No Quantity
1 10 Pre-Filled Syringes
2 1 Pre-Filled Syringes
 
Label (mock-up) for Immediate Container / Label Dalam Bekas
No Attachment
1 D1_Vaxneuvance_Inj_inner label_clean.pdf
 
Label (mock-up) for Outer Carton / Label Luar Bekas
No Attachment
1 D2_Vaxneuvance_Inj_outer carton 10s_clean.pdf
2 D2_Vaxneuvance_Inj_outer carton 1s_clean.pdf
 
Technical Evaluation Summary
No Attachment
1 Technical Summary Report Vavneuvance (DCA Dec 2023) FINAL (1).pdf