XERMELO

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Estonia, Finland, France, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Spain, UK.

Active ingredients

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

1
UNII 8G388563M7 - TELOTRISTAT ETHYL
 

Both the prodrug (telotristat ethyl) and its active metabolite (telotristat) are inhibitors of L-tryptophan hydroxylases (TPH1 and TPH2, the rate limiting steps in serotonin biosynthesis). Serotonin plays a critical role in regulating several major physiological processes, including secretion, motility, inflammation, and sensation of the gastrointestinal tract, and is over-secreted in patients with carcinoid syndrome. Through inhibition of peripheral TPH1, telotristat reduces the production of serotonin, thus alleviating symptoms associated with carcinoid syndrome.

 
Read more about Telotristat

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 XERMELO 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
A16AX15 A Alimentary tract and metabolism → A16 Other alimentary tract and metabolism products → A16A Other alimentary tract and metabolism products → A16AX Various alimentary tract and metabolism products
Discover more medicines within A16AX15

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 02481553
EE Ravimiamet 1753859, 1753860
ES Centro de información online de medicamentos de la AEMPS 1171224001
FI Lääkealan turvallisuus- ja kehittämiskeskus 403615
FR Base de données publique des médicaments 60705470
GB Medicines & Healthcare Products Regulatory Agency 348419
IL מִשְׂרַד הַבְּרִיאוּת 8459
IT Agenzia del Farmaco 045682010, 045682022
LT Valstybinė vaistų kontrolės tarnyba 1083945, 1083946
NL Z-Index G-Standaard, PRK 148075
PL Rejestru Produktów Leczniczych 100397218
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W69129001, W69129002
US FDA, National Drug Code 70183-125, 70720-125

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