OTEZLA

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

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 more about Apremilast

Medication package inserts

Below package inserts are available for further reading:

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