BERIATE

This brand name is authorized in Austria, Ecuador, Estonia, Spain, Hong Kong, Lithuania, Malta, Poland, Romania, Singapore, Tunisia, Turkey

Active ingredients

The drug BERIATE contains one active pharmaceutical ingredient (API):

1 Coagulation factor VIII UNII 839MOZ74GK - ANTIHEMOPHILIC FACTOR HUMAN

Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X (factor Xa). Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. Read about Coagulation factor VIII

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
BERIATE Powder and solvent for solution for injection / infusion	Medicines Authority (MT)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
B02BD02	Coagulation factor VIII	B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BD Blood coagulation factors
Discover more medicines within B02BD02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 228-MBE-0122, 229-MBE-0122, 230-MBE-0122
Country: EE	Ravimiamet	Identifier(s): 1799286, 1799297, 1799309, 1799310
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 63009, 63023
Country: HK	Department of Health Drug Office	Identifier(s): 64213, 64214, 64215
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1089042, 1089043, 1089044, 1089045
Country: MT	Medicines Authority	Identifier(s): MA665/01101, MA665/01102, MA665/01103, MA665/01104
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100339310, 100339333, 100339340, 100339356
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W61670001, W61671001, W61672001, W61673001
Country: SG	Health Sciences Authority	Identifier(s): 15771P, 15772P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 8143111H, 8143112H
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8681624980019, 8681624980026