ROZEREM

This brand name is authorized in Brazil, Japan, United States

Active ingredients

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

1 Ramelteon UNII 901AS54I69 - RAMELTEON

Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT1 and MT2 receptors and relative selectivity over the MT3 receptor. The activity of ramelteon at the MT1 and MT2receptors is believed to contribute to its sleep-promoting properties, as these receptors, acted upon by endogenous melatonin, are thought to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle. Read about Ramelteon

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
ROZEREM Film-coated tablet	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

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

ATC code	Group title	Classification
N05CH02	Ramelteon	N Nervous system → N05 Psycholeptics → N05C Hypnotics and sedatives → N05CH Melatonin receptor agonists
Discover more medicines within N05CH02

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): 501117110028902, 501117110029002, 501117110029102
Country: JP	医薬品医療機器総合機構	Identifier(s): 1190016F1024
Country: US	FDA, National Drug Code	Identifier(s): 64764-805