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 300 MG/30ML IS A FORMULATION OF ECULIZUMAB WHICH IS A RECOMBINANT HUMANIZED MONOCLONAL IGG2/4;κ ANTIBODY PRODUCED BY MURINE MYELOMA CELL CULTURE AND 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, CLEAR, COLORLESS, PRESERVATIVE-FREE SOLUTION FOR INTRAVENOUS INFUSION AND IS SUPPLIED IN 30-ML SINGLE-USE VIALS. THE PRODUCT IS FORMULATED AT PH 7 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 FP IS SUPPLIED IN VIALS AS DESCRIBED ABOVE.

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 THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS, CULTURES OF MICRO-ORGANISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS GIR 5B HAS BEEN USED TO IDENTIFY THE TYPE OF PACKAGING. GIR 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300215 - ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; IMMUNOLOGICAL PRODUCTS, PUT UP IN MEASURED DOSES OR IN FORMS OR PACKINGS FOR RETAIL SALE ALSO CLASSIFIED IN ACCORDANCE WITH CHAPTER NOTE 2 TO CHAPTER 30 HSENs TO 3002