SOLIRIS IS A THERAPY SPECIFICALLY TESTED AND APPROVED FOR THE TREATMENT OF PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) AN ULTRA-RARE LIFE THREATENING BLOOD DISORDER. SOLIRIS HAS BEEN APPROVED FOR THE TREATMENT OF PATIENTS WITH PNH IN NEARLY 50 COUNTRIES WORLDWIDE. SOLIRIS 300MG/30ML IS A FORMULATION OF ECULIZUMAB WHICH IS RECOMBINANT HUMANIZED MONOCLONAL LGG2/4;&#954 ANTIBODY PRODUCED BY MURINE MYELOMA CELL CULTUREAND PURIFIED BY STANDARD BIOPROCESS TECHNOLOGY. ECULIZUMAB CONTAINS HUMAN CONSTANT REGIONS FROM HUMAN IMMUNOGLOBULIN G2 SEQUENCES AND HUMAN IMMUNOGLOBULIN G4 SEQUENCES AND MURINE COMPLEMENTARITY DETERMINING REGIONS GRAFTED ONTO THE HUMAN FRAMEWORK LIGHT AND HEAVY CHAIN VARIABLE REGIONS. ECULIZUMAB IS COMPOSED OF TWO 448 AMINO ACID HEAVY CHAINS AND TWO 214 AMINO ACID LIGHT CHAINS AND HAS A MOLECULAR WEIGHT OF APPROXIMATELY 148 KDA. SOLIRIS 300 MG/30ML IS A STERILE COLOURLESS PRESERVATIVE-FREE SOLUTION FOR INTRAVENOUS INFUSION AND IS SUPPLIED IN 30ML SINGLE USE VIALS. THE PRODUCT IS FORMULATED AT PH7 AND EACH VIAL CONTAINS 300 MG OF ECULIZUMAB 13.8 MG SODIUM PHOSPHATE MONOBASIC. 53.4 MG SODIUM PHOSPHATE DIBASIC 263.1 MG SODIUM CHLORIDE, 6.6 MG POLYSORBATE 80 (VEGETABLE ORIGIN) AND WATER FOR INJECTION. THE DP AND FP ARE SUPPLIED IN VIALS, HOWEVER BDS IS SUPPLIED IN 100L BAGS . THE COMPOSITION OF THE PRODUCT IS THE SAME WHETHER BDS DP OR FP.

CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING :- GENERAL INTERPRETATIVE RULES (GIRs) GIR 1 HAS BEEN USED TO CLASSIFY THIS PRODUCT BY THE TERMS OF HEADING 3002: HUMAN BLOOD, ANIMAL BLOOD PREPARED FOR THE THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS,CULTURES OF MICRO-ORGANISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS. GIR 3B HAS BEEN USED AS THE ECULIZUMAB IS THE ESSENTIAL CHARACTER. GIR 5B HAS BEEN USED TO IDENTIFY THE TYPE OF PACKAGING - VIALS AND 100L BAGS. GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300210 : ANTISERA AND OTHER BLOOD FRACTIONS AND MODIFIED IMMUNOLOGICAL PRODUCTS, CN CODE 30021091 : HAEMOGLOBIN, BLOOD GLOBULINS AND SERUM GLOBULINS. ALSO CLASSIFIED IN ACCORDANCE WITH : HSEN NOTE (C) (2) TO HEADING 3002.