KOVALTRY

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey

Active ingredients

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

1 Octocog alfa UNII P89DR4NY54 - ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT

Octocog alfa (Full length recombinant human coagulation factor VIII (rDNA)) is a purified protein that has 2,332 amino acids. It is produced by recombinant DNA technology in baby hamster kidney cells (BHK) into which the human factor VIII gene has been introduced. Read about Octocog alfa

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
KOVALTRY Powder and solvent for solution for injection	European Medicines Agency (EU)	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: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 538920050030607, 538920050030707, 538920050030807, 538920050030907, 538920050031007
Country: CA	Health Products and Food Branch	Identifier(s): 02451441, 02451468, 02451476, 02451484, 02451492
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 180-MBE-0421, 185-MBE-0421, 207-MBE-0721
Country: EE	Ravimiamet	Identifier(s): 1713372, 1713383, 1713394, 1713406, 1713417
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1151076002, 1151076004, 1151076006, 1151076008, 1151076010
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 049119, 096660, 389337, 531926, 578050
Country: FR	Base de données publique des médicaments	Identifier(s): 60797807, 64966902, 65700541, 66206474, 68686890
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8168, 8169, 9305
Country: IT	Agenzia del Farmaco	Identifier(s): 044726014, 044726026, 044726038, 044726040, 044726053, 044726065, 044726077, 044726089, 044726091, 044726103, 044726115, 044726127, 044726139, 044726141, 044726154, 044726166, 044726178, 044726180, 044726192, 044726204, 044726216, 044726228, 044726230, 044726242
Country: JP	医薬品医療機器総合機構	Identifier(s): 6343447D1025, 6343447D2021, 6343447D3028, 6343447D4024, 6343447D5020
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1079695, 1079849, 1079851, 1079853, 1079855, 1086340, 1086341, 1086342, 1089283, 1089284, 1089285, 1089286, 1089287, 1089288, 1089289, 1089290
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 57673, 57681, 57703, 85731
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 18739, 18754, 18756, 18757, 18758
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100367045, 100367051, 100367068, 100367074, 100367080
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W64713001, W64714001, W64715001, W64716001
Country: SG	Health Sciences Authority	Identifier(s): 15586P, 15587P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699546790074, 8699546790081, 8699546790098, 8699546790104, 8699546790111