OTEZLA

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa

Active ingredients

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

1 Apremilast UNII UP7QBP99PN - APREMILAST

Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, IL-17 and other inflammatory cytokines. Read about Apremilast

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
OTEZLA Film-coated tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
L04AA32		L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AA Selective immunosuppressants
Discover more medicines within L04AA32

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 12218C, 12223H
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 544120110005217, 544120110005317, 562418090000602
Country: CA	Health Products and Food Branch	Identifier(s): 02434318, 02434334
Country: EE	Ravimiamet	Identifier(s): 1674682, 1674693, 1674705
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 114981001, 114981002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 077988, 181713
Country: FR	Base de données publique des médicaments	Identifier(s): 60418716, 63257093
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 287707, 287710, 287713, 287715, 287718
Country: HK	Department of Health Drug Office	Identifier(s): 64859, 64860
Country: IE	Health Products Regulatory Authority	Identifier(s): 88872, 88873
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7625, 7626
Country: IT	Agenzia del Farmaco	Identifier(s): 043867011, 043867023, 043867035
Country: JP	医薬品医療機器総合機構	Identifier(s): 3999042F1025, 3999042F2021, 3999042F3028
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1075467, 1075468, 1075469
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 125709, 125717
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 17715, 17716
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100332101, 100332118
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W66652001, W66653001, W66653002
Country: SG	Health Sciences Authority	Identifier(s): 15202P, 15203P
Country: US	FDA, National Drug Code	Identifier(s): 55513-137, 59572-631
Country: ZA	Health Products Regulatory Authority	Identifier(s): 51/32/0864, 51/32/0865, 51/32/0866