PREVYMIS

This brand name is authorized in Austria, Canada, Croatia, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Turkey, UK, United States.

Active ingredients

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

1	Letermovir UNII 1H09Y5WO1F - LETERMOVIR
	Letermovir inhibits the CMV DNA terminase complex which is required for cleavage and packaging of viral progeny DNA. Letermovir affects the formation of proper unit length genomes and interferes with virion maturation. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease.
	Read more about Letermovir

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
PREVYMIS Film-coated tablet	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
J05AX18		J Antiinfectives for systemic use → J05 Antivirals for systemic use → J05A Direct acting antivirals → J05AX Other antivirals
Discover more medicines within J05AX18

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
CA	Health Products and Food Branch	02469367, 02469375, 02469383, 02469405
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	7116-MEE-0322, 7118-MEE-0322
EE	Ravimiamet	1762523, 1762534, 1762545, 1762556
ES	Centro de información online de medicamentos de la AEMPS	1171245001, 1171245002
FI	Lääkealan turvallisuus- ja kehittämiskeskus	196318, 529781
FR	Base de données publique des médicaments	62944394, 64591854, 67334530, 67601314
GB	Medicines & Healthcare Products Regulatory Agency	365798, 388859
HK	Department of Health Drug Office	66122, 66123, 66124, 66125
IE	Health Products Regulatory Authority	89063, 89064
IL	מִשְׂרַד הַבְּרִיאוּת	8529, 8530
IT	Agenzia del Farmaco	045890011, 045890023, 045890035, 045890047
JP	医薬品医療機器総合機構	6250048F1027, 6250406A1029
LT	Valstybinė vaistų kontrolės tarnyba	1084801, 1084802, 1084803, 1084804
NL	Z-Index G-Standaard, PRK	196525, 196533, 196762
NZ	Medicines and Medical Devices Safety Authority	20358, 20359, 20360, 20361
PL	Rejestru Produktów Leczniczych	100400682, 100400707, 100413489, 100413495
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W65647001, W65648001
SG	Health Sciences Authority	15757P, 15758P, 15759P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699636091463, 8699636091470, 8699636261446, 8699636261453
US	FDA, National Drug Code	0006-3075, 0006-3076, 0006-5003, 0006-5004