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Product Information / Maklumat Produk
Product Name :

NERLYNX (neratinib) Film-Coated Tablets 40 mg

Registration No :

MAL20076009ACRZ

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 :

Excella GmbH & Co.KG

Manufacturer Address :

NURNBERGER STR.12, 90537 FEUCHT
GERMANY

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 Neratinib Maleate
 
Packaging Information / Maklumat Bungkusan
No Quantity
1 180 Tablets
 
Consumer Medication Information Leaflet / Risalah Maklumat Ubat Pesakit
No Attachment
1 D4_Consumer Medication Info Leaflet (Malay)_Nerlynx_clean.pdf
2 D4_Consumer Medication Info Leaflet (Eng)_Nerlynx_clean.pdf
 
Label (mock-up) for Immediate Container / Label Dalam Bekas
No Attachment
1 D1 (NER_LBL_58 ver 3.2) 01Jun2020_clean.pdf
 
Label (mock-up) for Outer Carton / Label Luar Bekas
No Attachment
1 D2 (NER_CTN_59 ver 3.3) 01Jun2020_clean.pdf
 
Proposed Package Insert / Sisipan Bungkusan
No Attachment
1 D3_Package Insert_Nerlynx_clean.pdf
 
Technical Evaluation Summary
No Attachment
1 Technical Summary Report Nerlynx July 2020.pdf