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Product Information / Maklumat Produk
Product Name :

Octaplex Powder and Solvent for Solution for Infusion

Registration No :

MAL20081743AZ

Holder :

Pharmaniaga Marketing Sdn Bhd

Holder Address :

7 LORONG KELULI 1B, KAW. PERINDUSTRIAN BUKIT RAJA SELATAN, SEKSYEN 7,
40000
SHAH ALAM
MALAYSIA

Phone No :

03-33429999

Manufacturer :

OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES.M.B.H.

Manufacturer Address :

OBERLAAERSTRASSE 235, A-1100 VIENNA, AUSTRIA
AUSTRIA

Importer :

PHARMANIAGA LOGISTICS SDN. BHD.

Importer Address :

NO. 7, LORONG KELULI 1B,
KAWASAN PERINDUSTRIAN BUKIT RAJA SELATAN,
SEKSYEN 7,
40000
SHAH ALAM
MALAYSIA

Ingredients Information / Maklumat Bahan Aktif
No Active Ingredient
1 PROTEIN S
2 Protein C
3 Human coagulation factor IX
4 HUMAN COAGULATION FACTOR II
5 HUMAN COAGULATION FACTOR VII
6 HUMAN COAGULATION FACTOR X
 
Packaging Information / Maklumat Bungkusan
No Quantity
1 20mlUnits mL
2 1 Vials
 
Label (mock-up) for Immediate Container / Label Terdekat
No Attachment
1 D1 Label_Octaplex Austria Apr 2022.pdf
 
Label (mock-up) for Outer Carton / Label Luar
No Attachment
1 D2 Outer Carton_Octaplex Austria Apr 2022.pdf
 
Technical Evaluation Summary
NO INFORMATION DETAIL