CELEBREX

This brand name is authorized in United States. It is also authorized in Australia, Austria, Canada, Cyprus, Ecuador, Estonia, France, Germany, Hong Kong SAR China, Ireland, Italy, Lithuania, Malta, Mexico, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1
UNII JCX84Q7J1L - CELECOXIB
 

Celecoxib is an oral, selective, cyclooxygenase-2 (COX-2) inhibitor within the clinical dose range (200-400 mg daily). No statistically significant inhibition of COX-1 (assessed as ex vivo inhibition of thromboxane B2 [TxB2] formation) was observed in this dose range in healthy volunteers.

 
Read more about Celecoxib

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 CELEBREX Capsule MPI, US: SPL/PLR FDA, National Drug Code (US)
 CELEBREX Capsule, hard MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

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

ATC Group Classification
M01AH01 Celecoxib M Musculo-skeletal system → M01 Antiinflammatory and antirheumatic products → M01A Antiinflammatory and antirheumatic products, non-steroids → M01AH Coxibs
Discover more medicines within M01AH01

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 8439E, 8440F
CA Health Products and Food Branch 02239941, 02239942
DE Bundesinstitut für Arzneimittel und Medizinprodukte 00033152, 00033169, 00566078, 00566084, 00566090, 00566109, 00566138, 00566144, 00566150, 01135251, 01135529, 01713558, 01743832, 03162140, 03162157, 04656134, 04656140, 04656246, 04656252, 04656269, 05458212, 05506454, 05506460, 05506483, 06058880, 06058897, 06058905, 06058911, 06058928, 06058934, 06574848, 06574854, 07544683, 08882382, 08882399, 08882548, 09154302, 09154325, 09154331, 09154348, 10111574, 10111580, 10111597, 10297900, 10297917
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria 1614-MEE-0116
EE Ravimiamet 1073641, 1073652, 1073663, 1073674, 1073685, 1073696, 1073708, 1073719, 1073731, 1073742, 1073753, 1073764, 1073775, 1073786, 1073797, 1073809, 1073810, 1842342, 1842353, 1842364, 1852376, 1852387, 1852398
ES Centro de información online de medicamentos de la AEMPS 034824460, 3400935437068, 63072, 63073
FR Base de données publique des médicaments 66150367, 68952704
GB Medicines & Healthcare Products Regulatory Agency 138473, 138475, 144925, 144926, 144929, 161476, 196926, 20087, 20089
HK Department of Health Drug Office 44730, 44731, 52866
IE Health Products Regulatory Authority 16863, 16963, 17019, 17030, 17066, 17094, 17304, 17390
IT Agenzia del Farmaco 034624460
LT Valstybinė vaistų kontrolės tarnyba 1004062, 1004063, 1010159, 1010160, 1010161, 1010162
MT Medicines Authority MA1396/00401, MA1396/00402, PI1438/08501A, PI1438/08502A, PI770/12801A, PI770/12802A, PI908/05303A, PI908/05304A
MX Comisión Federal para la Protección contra Riesgos Sanitarios 031M99
NG Registered Drug Product Database 04-2108
Switch country to Nigeria in order to find specific presentations of CELEBREX
NL Z-Index G-Standaard, PRK 58998, 59005
NZ Medicines and Medical Devices Safety Authority 11684, 20389, 20418, 8515, 8542
PL Rejestru Produktów Leczniczych 100092708, 100188437
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W67264006, W67264007, W67264008, W67265004, W67265006, W67265008
SG Health Sciences Authority 11240P, 11241P, 13653P
TN Direction de la Pharmacie et du Médicament 9243101, 9243102, 9243104
TR İlaç ve Tıbbi Cihaz Kurumu 8699532151384, 8699532151605
US FDA, National Drug Code 0025-1515, 0025-1520, 0025-1525, 0025-1530, 55289-451, 55289-475, 61919-046, 63187-079, 63629-3021, 80425-0037, 80425-0039, 80425-0040
ZA Health Products Regulatory Authority 33/3.1/0332, 33/3.1/0333

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