KOVALTRY

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

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
KOVALTRY Powder and solvent for solution for injection	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

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