BERIPLEX

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Spain, Hong Kong, Ireland, Malta, Netherlands, New Zealand, Poland, Romania, Tunisia, Turkey, United Kingdom

Active ingredients

The drug BERIPLEX contains a combination of these active pharmaceutical ingredients (APIs):

1 Factor II (Prothrombin)
UNII 8FB1K07F16 - PROTHROMBIN
Read about Thrombin
2 Factor VII (proconvertin)
UNII 4156XVB4QD - COAGULATION FACTOR VII HUMAN
Read about Coagulation factor VII
3 Factor IX (monoclonal antibody purified)
UNII 6U90Y1795T - COAGULATION FACTOR IX HUMAN

Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It is a vitamin-K dependent coagulation factor and it is synthesised in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X.

Read about Coagulation factor IX
4 Factor X Stuart-Prower factor
UNII 0P94UQE6SY - COAGULATION FACTOR X HUMAN

Coagulation factor X is derived from human plasma and used as a replacement for the naturally existing coagulation factor X in patients with hereditary factor X deficiency.

Read about Coagulation factor X
5 Protein C
UNII 3Z6S89TXPW - PROTEIN C

Protein C is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor protein S. Protein C exerts its effect by the inactivation of the activated forms of factors V and VIII which leads to a decrease in thrombin formation. Protein C has also been shown to have profibrinolytic effects.

Read about Protein C
6 Protein S
UNII 90J3F6N5FN - PROTEIN S HUMAN
Read about Protein S

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
B02BD01 Coagulation factor IX, II, VII and X in combination B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors
Discover more medicines within B02BD01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 502600704155416, 502618080008107
Country: CA Health Products and Food Branch Identifier(s): 02359251, 02410826
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 69890, 76961
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 109230, 109234, 223222
Country: HK Department of Health Drug Office Identifier(s): 58741
Country: MT Medicines Authority Identifier(s): MA665/00301, MA665/00302
Country: NL Z-Index G-Standaard Identifier(s): 15353397, 15353400
Country: NL Z-Index G-Standaard, PRK Identifier(s): 71927, 71935
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 20416, 20498, 20499
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100116573, 100204018, 100204024
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W62579001, W62580001
Country: TN Direction de la Pharmacie et du Médicament Identifier(s): 8143081H
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8681624980187, 8681624980194

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