CIMZIA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1
UNII UMD07X179E - CERTOLIZUMAB PEGOL
 

Certolizumab pegol has a high affinity for human TNFα and binds with a dissociation constant (KD) of 90 pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes. Certolizumab pegol was shown to neutralise membrane associated and soluble human TNFα in a dose-dependent manner. By inhibiting the action of TNFα, certolizumab pegol reduces inflammation and other symptoms in patients with rheumatoid arthritis.

 
Read more about Certolizumab pegol

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 Cimzia 200 mg solution for injection MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)
 CIMZIA Solution for injection 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
L04AB05 Certolizumab pegol L Antineoplastic and immunomodulating agents → L04 Immunosuppressants → L04A Immunosuppressants → L04AB Tumor necrosis factor alpha (TNF-α) inhibitors
Discover more medicines within L04AB05

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 10137M, 10238W, 10892G, 10896L, 10897M, 10904X, 10905Y, 10909E, 11318Q, 11319R, 11320T, 11321W, 11322X, 11323Y, 11324B, 11325C, 11326D, 12005W, 12013G, 12027B, 12028C, 12040Q, 12063X, 3425G
BR Câmara de Regulação do Mercado de Medicamentos 525217050021917, 525217050022017
CA Health Products and Food Branch 02331675, 02465574
DE Bundesinstitut für Arzneimittel und Medizinprodukte 00996241, 01686991, 01751636, 01751978, 06907741, 06907758, 06935186, 07693331, 09245430, 09294291, 10709053, 10709076, 11032322, 11156159, 11514765, 11668132, 12450719, 12450731, 12466293, 12547382, 12547399, 12638044, 13168741, 13425669, 13425675, 13859161, 13859178, 13988964, 14025162, 14025179, 14053230, 14053247, 14055217, 14055223, 14307185, 14367402, 14420119, 14420125, 14445935, 14445964, 16168730, 16168753, 16169089, 16529613, 16808046, 16875628, 16875634
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria H3070113
EE Ravimiamet 1456107, 1456118, 1699320, 1744556, 1744567, 1744578, 1762916, 1762927, 1762938
ES Centro de información online de medicamentos de la AEMPS 109544001, 109544005, 109544008
FI Lääkealan turvallisuus- ja kehittämiskeskus 060812, 066304, 552479
FR Base de données publique des médicaments 64386835, 66661714
GB Medicines & Healthcare Products Regulatory Agency 173161, 335119, 378471
HK Department of Health Drug Office 61805, 67262
IE Health Products Regulatory Authority 88502, 88677
IL מִשְׂרַד הַבְּרִיאוּת 7383
JP 医薬品医療機器総合機構 3999437G1022, 3999437G2029
LT Valstybinė vaistų kontrolės tarnyba 1051600, 1051601, 1072083, 1075875, 1084279, 1084280, 1084281, 1084282, 1084283, 1084284
NL Z-Index G-Standaard, PRK 137219, 143189, 92584
PL Rejestru Produktów Leczniczych 100206939
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W54992001, W54992002
TN Direction de la Pharmacie et du Médicament 3113031H
TR İlaç ve Tıbbi Cihaz Kurumu 8699624950017
US FDA, National Drug Code 50474-710

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