Antisera, other blood fractions and immunological products, whether or not modified or obtained by means of biotechnological processes.

SOLIRIS IS A THERAPY SPECIFICALLY TESTED…

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 justification: 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.

BTI Reference:
GB503331988.
Start date of validity:
.
End date of validity:
2016-12-31.

National keywords: ANTIBODIES IN SOLUTION

A FUSION PROTEIN ENZYME. USED AS A TARGETED…

A FUSION PROTEIN ENZYME. USED AS A TARGETED ENZYME REPLACEMENT THERAPY DESIGNED TO ADDRESS THE UNDERLYING CAUSE OF HYPOPHOSPHATASIA (HPP) BY NORMALIZING THE GENETICALLY DEFECTIVE METABOLIC PROCESS, AND PREVENTING OR REVERSING THE SEVERE AND LIFE-THREATENING COMPLICATIONS OF LIFE-LONG DYSREGULATED MINERAL METABOLISM.

COMPRISED OF THE SOLUBLE CATALYTIC DOMAIN OF HUMAN TISSUE NON-SPECIFIC ALKALINE PHOSPHATE (SALP), THE HUMAN IMMUNOGLOBULIN G1 FC DOMAIN AND OF A DECA ASPARTATE PEPTIDE (D10).

IT IS PRODUCED BY MAMMALIAN CELL CULTURE AND PURIFIED BY STANDARD BIOPROCESS TECHNOLOGY. A CLEAR COLOURLESS PRESERVATIVE-FREE SOLUTION AT 100MG/ML OR 40 MG/ML PACKAGED IN 2ML GLASS VIALS (SEVERAL FILL VOLUMES, BUT SAME VIAL).

IT IS USED AS A FORMULATED MEDICINAL PRODUCT FOR SUBCUTANEOUS INJECTION. IT IS FORMULATED IN 25MM SODIUM PHOSPHATE, 150 MM SODIUM CHLORIDE AT PH 7.4.

THE PREFORMULATED BDS IS SUPPLIED IN A 1L BAG AT A CONCENTRATION OF 100 MG/ML. THE BDS CAN BE FILLED AT THAT CONCENTRATION, OR DILUTED USING THE SAME FORMULATION BUFFER TO 40MG/ML.

Classification justification: CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING:- GENERAL INTERPRETATIVE RULES (GIR)S 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 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300210: ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES CN CODE 30021098 - OTHER THAN ANTISERA, HAEMOGLOBIN, BLOOD GLOBULINS AND SERUM GLOBULINS.

ALSO CLASSIFIED IN ACCORDANCE WITH :- HSENS TO HEADING 3002 (2) (B) REFERS.

BTI Reference:
GB503331890.
Start date of validity:
.
End date of validity:
2016-12-31.

National keywords: ENZYMES ANTIBODIES

A FUSION PROTEIN ENZYME. USED AS A TARGETED…

A FUSION PROTEIN ENZYME. USED AS A TARGETED ENZYME REPLACEMENT THERAPY DESIGNED TO ADDRESS THE UNDERLYING CAUSE OF HYPOPHOSPHATASIA (HPP) BY NORMALIZING THE GENETICALLY DEFECTIVE METABOLIC PROCESS, AND PREVENTING OR REVERSING THE SEVERE AND LIFE-THREATENING COMPLICATIONS OF LIFE-LONG DYSREGULATED MINERAL METABOLISM.

COMPRISED OF THE SOLUBLE CATALYTIC DOMAIN OF HUMAN TISSUE NON-SPECIFIC ALKALINE PHOSPHATASE (SALP), THE HUMAN IMMUNOGLOBULIN G1 FC DOMAIN AND OF A DECA ASPARTATE PEPTIDE (D10).

IT IS PRODUCED BY MAMMALIAN CELL CULTURE AND PURIFIED BY STANDARD BIOPROCESS TECHNOLOGY. A CLEAR COLOURLESS PRESERVATIVE-FREE SOLUTION AT 100MG/ML OR 40 MG/ML PACKAGED IN 2ML GLASS VIALS (SEVERAL FILL VOLUMES, BUT SAME VIAL).

IT IS USED AS A FORMULATED MEDICINAL PRODUCT FOR SUBCUTANEOUS INJECTION. IT IS FORMULATED IN 25MM SODIUM PHOSPHATE, 150 MM SODIUM CHLORIDE AT PH 7.4.

THE PREFORMULATED BDS IS SUPPLIED IN A 1L BAG AT A CONCENTRATION OF 100 MG/ML. THE BDS CAN BE FILLED AT THAT CONCENTRATION, OR DILUTED USING THE SAME FORMULATION BUFFER TO 40MG/ML.

CAS NO. 1174277-80-5

Classification justification: CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING:- GENERAL INTERPRETATIVE RULES (GIR)S 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 300210 - ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES CN CODE 30021098 - OTHER THAN ANTISERA, HAEMOGLOBIN, BLOOD GLOBULINS AND SERUM GLOBULINS.

ALSO CLASSIFIED IN ACCORDANCE WITH: HSENS TO HEADING 3002 (2) (B)

BTI Reference:
GB503320016.
Start date of validity:
.
End date of validity:
2016-12-31.

National keywords: ENZYMES ANTIBODIES

SOLIRIS IS A THERAPY SPECIFICALLY TESTED…

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 300MG/30ML IS A FORMULATION OF ECULIZUMAB WHICH IS RECOMBINANT HUMANIZED MONOCLONAL LGG2/4;&#954 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 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.

CAS NO. 219685-50-4.

Classification justification: 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.

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.

BTI Reference:
GB503319972.
Start date of validity:
.
End date of validity:
2016-12-31.

National keywords: ANTIBODIES IN SOLUTION

TEST KIT CONSISTING OF BLOOD GROUPING REAGENTS…

TEST KIT CONSISTING OF BLOOD GROUPING REAGENTS AND 12 X 8 STRIPS OF MICROWELLS COATED WITH ANTI PLATELET ANTIBODIES

Classification justification: GENERAL INTERPRETATIVE RULES 1 & 6 TEXT TO CODES 3002 & 3002 10 91 00 HARMONISED SYSTEM EXPLANATORY NOTES TO HEADING 3002 REF: R00A1216 STATE LABORATORY ADVICE EUROPEAN COURT OF JUSTICE CASE C-191/91

BTI Reference:
IE13NT-14-1647-04.
Start date of validity:
.
End date of validity:
2016-12-31.

National keywords: DIAGNOSTIC REAGENTS ANTIBODIES MONOCLONAL

EACH VIAL CONTAINS 40 MG OF DIGOXIN IMMUNE…

EACH VIAL CONTAINS 40 MG OF DIGOXIN IMMUNE DIGIFAB IS A STERILE, LYOPHILIZED PREPARATION OF DIGOXIN-IMMUNE OVINE FAB (MONOVALENT) IMMUNOGLOBULIN FRAGMENTS.

THESE FRAGMENTS ARE OBTAINED FROM THE BLOOD OF HEALTHY SHEEP IMMUNIZED WITH A DIGOXIN DERIVATIVE, DIGOXIN DICARBOXYMETHOXYLAMINE (DDMA), A DIGOXIN ANALOGUE WHICH CONTAINS THE FUNCTIONALLY ESSENTIAL CYCLOPENTAPERHYDROPHENANTHRENE: LACTONE RING MOIETY COUPLED TO KEYHOLE LIMPET HEMOCYANIN (KLH).

THE FINAL PRODUCT IS PREPARED BY ISOLATING THE IMMUNOGLOBULIN FRACTION OF THE OVINE SERUM, DIGESTING IT WITH PAPAIN AND ISOLATING THE DIGOXIN-SPECIFIC FAB FRAGMENTS BY AFFINITY CHROMATOGRAPHY

Classification justification: 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 300210 - ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES ALSO CLASSIFIED IN ACCORDANCE WITH: HSENs TO 3002 AND CNENs TO 3002 HS Explanatory Notes to heading 3002, (C), (1), third paragraph.

BTI Reference:
GB503263975.
Start date of validity:
.
End date of validity:
2019-10-30.

National keywords: SHEEP BLOOD FRACTIONS

ORENCIA 250MG/15CC VIALS IMPORTED FOR ANALYTICAL…

ORENCIA 250MG/15CC VIALS IMPORTED FOR ANALYTICAL TESTING. ORENCIA IS A FINISHED PHARMACEUTICAL PRODUCT. THE ACTIVE INGREDIENT/DRUG SUBSTANCE CONTAINED WITH OTHER EXCIPIENTS IN THE IMPORTED ORENCIA VIAL IS CALLED ABATACEPT (CAS NUMBER 332348-12-6).

Classification justification: GENERAL INTERPRETATIVE RULES 1 & 6 NOTES TO HEADING 30 AND 3002 10 98 00 HARMONISED SYSTEM EXPLANATORY NOTES TO HEADING 3002 ADVICE FROM STATE LAB R16A0100

BTI Reference:
IE16NT-14-4235-1.
Start date of validity:
.
End date of validity:
2019-08-15.

National keywords: FOR MEDICINAL PURPOSES STERILE IN SOLUTION PHARMACEUTICAL PRODUCTS

A FUSION PROTEIN ENZYME. USED AS A TARGETED…

A FUSION PROTEIN ENZYME. USED AS A TARGETED ENZYME REPLACEMENT THERAPY DESIGNED TO ADDRESS THE UNDERLYING CAUSE OF HYPOPHOSPHATASIA (HPP) BY NORMALIZING THE GENETICALLY DEFECTIVE METABOLIC PROCESS, AND PREVENTING OR REVERSING THE SEVERE AND LIFE-THREATENING COMPLICATIONS OF LIFE-LONG DYSREGULATED MINERAL METABOLISM.

COMPRISED OF THE SOLUBLE CATALYTIC DOMAIN OF HUMAN TISSUE NON-SPECIFIC ALKALINE PHOSPHATE (SALP), THE HUMAN IMMUNOGLOBULIN G1 FC DOMAIN AND OF A DECA ASPARTATE PEPTIDE (D10).

IT IS PRODUCED BY MAMMALIAN CELL CULTURE AND PURIFIED BY STANDARD BIOPROCESS TECHNOLOGY. A CLEAR COLOURLESS PRESERVATIVE-FREE SOLUTION AT 100MG/ML OR 40 MG/ML PACKAGED IN 2ML GLASS VIALS (SEVERAL FILL VOLUMES, BUT SAME VIAL).

IT IS USED AS A FORMULATED MEDICINAL PRODUCT FOR SUBCUTANEOUS INJECTION. IT IS FORMULATED IN 25MM SODIUM PHOSPHATE, 150 MM SODIUM CHLORIDE AT PH 7.4.

THE PREFORMULATED BDS IS SUPPLIED IN A 1L BAG AT A CONCENTRATION OF 100 MG/ML. THE BDS CAN BE FILLED AT THAT CONCENTRATION, OR DILUTED USING THE SAME FORMULATION BUFFER TO 40MG/ML.

Classification justification: CLASSIFICATION HAS BEEN DETERMINED IN ACCORDANCE WITH THE FOLLOWING:- GENERAL INTERPRETATIVE RULES (GIR)S 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 6 HAS BEEN USED TO CLASSIFY THE GOODS TO SUBHEADING LEVEL 300210: ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES CN CODE 30021098 - OTHER THAN ANTISERA, HAEMOGLOBIN, BLOOD GLOBULINS AND SERUM GLOBULINS.

ALSO CLASSIFIED IN ACCORDANCE WITH :- HSENS TO HEADING 3002 (2) (B) REFERS.

BTI Reference:
GB502962655.
Start date of validity:
.
End date of validity:
2022-04-18.

National keywords: ENZYMES ANTIBODIES

SOLIRIS IS A THERAPY SPECIFICALLY TESTED…

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 justification: 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.

BTI Reference:
GB502962459.
Start date of validity:
.
End date of validity:
2022-04-14.

National keywords: ANTIBODIES IN SOLUTION

A STERILE NONPYROGENIC, PURIFIED, LYOPHILIZED…

A STERILE NONPYROGENIC, PURIFIED, LYOPHILIZED PREPARATION OF OVINE FAB (MONOVALENT) IMMUNOGLOBULIN FRAGMENTS OBTAINED FROM THE BLOOD OF HEALTHY SHEEP FLOCKS IMMUNIZED WITH ONE OF THE FOLLOWING NORTH AMERICAN SNAKE VENOMS. (WESTERN DIAMONDBACK RATTLESNAKE, EASTERN DIAMONDBACK RATTLESNAKE, MOJAVE RATTLESNAKE OR WATER MOCCASIN).

TO OBTAIN THE FINAL ANTIVENIN PRODUCT, THE FOUR DIFFERENT MONOSPECIFIC ANTIVENINS ARE MIXED.

EACH MONOSPECIFIC ANTIVENIN IS PREPARED BY FRACTIONATING THE IMMUNOGLOBULIN FROM THE OVINE SERUM, DIGESTING IT WITH PAPAIN AND ISOLATING THE VENOM SPECIFIC FAB FRAGMENTS ON ION EXCHANGE AND AFFINITY CHROMATOGRAPHY COLUMNS.

EACH VIAL CONTAINS UP TO 1G OF TOTAL PROTEIN AND NOT LESS THAN THE INDICATED NUMBER OF MOUSE LD50 NEUTRALIZING UNITS PER VIAL.

USED FOR THE MANAGEMENT OF PATIENTS WITH NORTH AMERICAN CROTALID ENVENOMATION.

Classification justification: 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 300210 - ANTISERA, OTHER BLOOD FRACTIONS AND IMMUNOLOGICAL PRODUCTS, WHETHER OR NOT MODIFIED OR OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES ALSO CLASSIFIED IN ACCORDANCE WITH: HSENs TO 3002 AND CNENs TO 3002

BTI Reference:
GB502804874.
Start date of validity:
.
End date of validity:
2022-01-04.

National keywords: SHEEP BLOOD FRACTIONS