ROZEREM

This brand name is authorized in United States. It is also authorized in Brazil, Japan.

Active ingredients

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

1
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 more about Ramelteon

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group 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)
BR Câmara de Regulação do Mercado de Medicamentos 501117110028902, 501117110029002, 501117110029102
JP 医薬品医療機器総合機構 1190016F1024
US FDA, National Drug Code 64764-805

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