List of nationally authorised medicinal products

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1 30 November 2017 EMA/806830/2017 Human Medicines Evaluation Division Active substance: piroxicam Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 FELDEN 10 mg Kapseln not available PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. FELDEN 0,5% - Gel not available PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. FELDEN 20 mg lösbare Tabletten not available PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. FELDEN 20 mg Ampullen not available PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. FELDEN Quick-Solve 20 mg Lyotabletten not available PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. FELDEN 20 mg Kapseln not available PFIZER CORPORATION AT AUSTRIA GESELLSCHAFT M.B.H. Piroxicam EG 20 mg not available BE EUROGENERICS N.V./S.A. BE dispergeerbare tabletten Piroxicam EG 20 mg/ml not available BE EUROGENERICS N.V./S.A. BE oplossing voor injectie Piroxicam EG 20 mg not available BE EUROGENERICS N.V./S.A. BE Tabletten zur Herstellung einer Suspension zum Einnehmen Piroxicam EG 20 mg/ml not available BE EUROGENERICS N.V./S.A. BE Injektionslösung Piroxicam EG 20 mg not available BE EUROGENERICS N.V./S.A. BE comprimés dispersibles Piroxicam EG 20 mg not available BE EUROGENERICS N.V./S.A. BE capsules Piroxicam EG 20 mg/ml not available BE EUROGENERICS N.V./S.A. BE solution injectable Piroxicam EG 20 mg Kapseln not available BE EUROGENERICS N.V./S.A. BE Piroxicam EG 20 mg gélules not available BE EUROGENERICS N.V./S.A. BE where AT AT AT AT AT EMA/806830/2017 Page 2/13

3 Feldene 20 mg Hartkapseln not available BE PFIZER S.A. (BELGIUM) BE Feldene 10 mg Hartkapseln not available BE PFIZER S.A. (BELGIUM) BE Feldene 20 mg Zäpfchen not available BE PFIZER S.A. (BELGIUM) BE Feldene Lyotabs 20 mg not available BE PFIZER S.A. (BELGIUM) BE Schmelztabletten Feldene IM 20 mg/ml not available BE PFIZER S.A. (BELGIUM) BE Injektionslösung Feldene 0,5% Gel not available BE PFIZER S.A. (BELGIUM) BE Feldene Dispersal 20 mg not available BE PFIZER S.A. (BELGIUM) BE Tabletten zur Herstellung einer Suspension zum Einnehmen Feldene 20 mg suppositoires not available BE PFIZER S.A. (BELGIUM) BE Feldene 20 mg gélules not available BE PFIZER S.A. (BELGIUM) BE FELDENE 0,5 % gel not available BE PFIZER S.A. (BELGIUM) BE Feldene Lyotabs 20 mg not available BE PFIZER S.A. (BELGIUM) BE comprimés orodispersibles Feldene 10 mg gélules not available BE PFIZER S.A. (BELGIUM) BE Feldene Dispersal 20 mg not available BE PFIZER S.A. (BELGIUM) BE comprimés dispersibles Feldene IM 20 mg/ml not available BE PFIZER S.A. (BELGIUM) BE solution injectable Feldene 10 mg harde not available BE PFIZER S.A. (BELGIUM) BE capsules Feldene 20 mg harde not available BE PFIZER S.A. (BELGIUM) BE capsules Feldene Dispersal 20 mg not available BE PFIZER S.A. (BELGIUM) BE Dispergeerbare tabletten Feldene Lyotabs 20 mg not available BE PFIZER S.A. (BELGIUM) BE Orodispergeerbare tabletten FELDENE 0,5% gel not available BE PFIZER S.A. (BELGIUM) BE Feldene 20 mg zetpillen not available BE PFIZER S.A. (BELGIUM) BE Feldene IM 20 mg/ml oplossing voor injectie not available BE PFIZER S.A. (BELGIUM) BE where EMA/806830/2017 Page 3/13

4 BREXINE -DRYFIZ 20 mg BRAUSETABLETTEN (Brausetabletten) BREXINE-DRYFIZ 20 mg BRUISTABLETTEN BREXINE -DRYFIZ 20 mg COMPRIMÉS EFFERVESCENTS BREXINE 20 mg TABLETTEN not available BE CHIESI SA/NV BE not available BE CHIESI SA/NV BE not available BE CHIESI SA/NV BE not available BE CHIESI SA/NV BE BREXINE 20 mg TABLETTEN not available BE CHIESI SA/NV BE BREXINE 20 mg not available BE CHIESI SA/NV BE COMPRIMÉS????????? 20 mg???????? not available PROMEDICA S.R.L. BG FELDENE not available PFIZER HELLAS, A.E. CY FELDENE not available PFIZER HELLAS, A.E. CY FELDENE not available PFIZER HELLAS, A.E. CY BREXIN 20 mg tablets not available VARNAVAS HADJIPANAYIS CY LTD. (LATSIA) FLAMEXIN, TABLETY not available 29/116/96-C CHIESI FARMACEUTICI CZ Pirox-CT 20 mg Tabletten not available ABZ-PHARMA GMBH DE Piroxicam-ratiopharm 20 mg not available RATIOPHARM GMBH DE Injektionslösung Felden, gel not available PFIZER APS DK Felden, dispergible tabletter not available PFIZER APS DK FELDENE, 0,5% geel not available PFIZER EUROPE MA EEIG EE BREXIN, 20 mg suukaudse not available NORAMEDA UAB EE lahuse pulber BREXIN, 20 mg tabletid not available NORAMEDA UAB EE FELDENE 20 mg/ml, not available PFIZER, S.L. ES Solución inyectable FELDENE FLAS 20 mg, not available PFIZER, S.L. ES liofilizado oral FELDENE 10 mg, cápsulas duras not available PFIZER, S.L. ES where EMA/806830/2017 Page 4/13

5 FELDENE 20 mg, cápsulas duras FELDEGEL Piroxicam Gel al 0.5% Uso Cutáneo not available PFIZER, S.L. ES not available PFIZER, S.L. ES Salvacam 5 mg/g Gel not available LABORATORIOS SALVAT, ES S.A. SASULEN 5 mg/g gel not available LABORATORIOS VERIS, S.A. ES Felden 0,5 % gel not available PFIZER OY FI FELDEN 0,5 % geeli not available PFIZER OY FI BREXIN 20 mg, comprimé not available PIERRE FABRE MEDICAMENT sécable BREXIN 20 mg, comprimé not available SAS PIERRE FABRE effervescent MEDICAMENT BREXIN 20 mg, comprimé not available PIERRE FABRE MEDICAMENT sécable BREXIN 20 mg, comprimé not available SAS PIERRE FABRE effervescent MEDICAMENT BREXIN 20 mg, comprimé not available SAS PIERRE FABRE effervescent MEDICAMENT BREXIN 20 mg, comprimé not available SAS PIERRE FABRE effervescent MEDICAMENT FELDENE DISPERSIBLE 20 not available PFIZER HOLDING ANCE mg, comprimé sécable FELDENE DISPERSIBLE 20 not available PFIZER HOLDING ANCE mg, comprimé sécable FELDENE DISPERSIBLE 20 not available PFIZER HOLDING ANCE mg, comprimé sécable FELDENE 20 mg/1 ml, not available PFIZER HOLDING ANCE solution injectable en ampoule (IM) FELDENE 20 mg, gélule not available PFIZER HOLDING ANCE FELDENE DISPERSIBLE 20 mg, comprimé sécable not available PFIZER HOLDING ANCE where EMA/806830/2017 Page 5/13

6 FELDENE 20 mg/1 ml, solution injectable en ampoule (IM) not available PFIZER HOLDING ANCE FELDENE 10 mg, gélule not available PFIZER HOLDING ANCE FELDENE 20 mg, gélule not available PFIZER HOLDING ANCE GELDENE 0,5 POUR CENT, not available PFIZER HOLDING ANCE gel pour application locale GELDENE 0,5 POUR CENT, not available PFIZER HOLDING ANCE gel pour application locale FELDENE 20 mg, not available PFIZER HOLDING ANCE suppositoire FELDENE 20 mg, not available PFIZER HOLDING ANCE suppositoire not available CHIESI S.A.S. comprimé effervescent not available CHIESI S.A.S. comprimé sécable not available CHIESI S.A.S. comprimé sécable not available CHIESI S.A.S. comprimé sécable not available CHIESI S.A.S. comprimé sécable not available CHIESI S.A.S. comprimé effervescent not available CHIESI S.A.S. comprimé effervescent not available CHIESI S.A.S. comprimé effervescent FELDENE 0,5% (w/w) γέλη not available 41098/10/ PFIZER HELLAS, A.E. GR Feldene 10 mg not available 41095/10/ PFIZER HELLAS, A.E. GR διασπειρόμενα δισκία Feldene 20 mg διασπειρόμενα δισκία not available 41097/10/ PFIZER HELLAS, A.E. GR where EMA/806830/2017 Page 6/13

7 BREXIN Dref 20 mg, αναβράζοντα δισκία BREXIN 20 mg, κοκκία μιας δόσης για πόσιμο υγρό σε φακελίσκους not available 5247/ CHIESI HELLAS A.E.B.E. GR not available 21244/91/ CHIESI HELLAS A.E.B.E. GR BREXIN 20 mg, δισκία not available 20011/91/ CHIESI HELLAS A.E.B.E. GR Feldene Dispersal 20 mg not available OGYI-T-1141/05 PFIZER KFT. HU diszpergálódó tabletta Feldene Dispersal 20 mg not available OGYI-T-1141/07 PFIZER KFT. HU diszpergálódó tabletta Feldene kemény kapszula not available OGYI-T-1141/02 PFIZER KFT. HU Feldene kemény kapszula not available OGYI-T-1141/01 PFIZER KFT. HU Feldene Dispersal 20 mg not available OGYI-T-1141/06 PFIZER KFT. HU diszpergálódó tabletta Feldene Dispersal 20 mg not available OGYI-T-1141/08 PFIZER KFT. HU diszpergálódó tabletta Brexin 20 mg pezsgőtabletta not available OGYI-T-8393/05 CHIESI PHARMACEUTICALS HU GMBH Brexin 20 mg pezsgőtabletta not available OGYI-T-8393/07 CHIESI PHARMACEUTICALS HU GMBH Brexin 20 mg pezsgőtabletta not available OGYI-T-8393/08 CHIESI PHARMACEUTICALS HU GMBH Brexin 20 mg tabletta not available OGYI-T-8393/03 CHIESI PHARMACEUTICALS HU GMBH Feldene 20 mg capsules, not available PA 19/24/3 PFIZER LIMITED IE hard Feldene 10 mg capsules, not available PA 19/24/2 PFIZER LIMITED IE hard Feldene 5 mg/g Gel not available PA 19/24/8 PFIZER LIMITED IE Felden 20 mg dreifitöflur not available PFIZER APS IS Felden 0,5% hlaup not available PFIZER APS IS SINARTROL 30 mg not available SPA SOCIETÀ PRODOTTI IT compresse ANTIBIOTICI SINARTROL INFIAMMAZIONE E DOLORE 1,5% crema not available SPA SOCIETÀ PRODOTTI ANTIBIOTICI IT where EMA/806830/2017 Page 7/13

8 SINARTROL 1,5% crema not available SPA SOCIETÀ PRODOTTI IT ANTIBIOTICI PIROFTAL not available BRUSCHETTINI S.R.L IT FELDENE 20 mg compresse not available PFIZER ITALIA S.R.L. IT solubili FELDENE Fast 20 mg not available PFIZER ITALIA S.R.L. IT compresse sublinguali FELDENE 20 mg capsule not available PFIZER ITALIA S.R.L. IT rigide FELDENE 20 mg/1 ml not available PFIZER ITALIA S.R.L. IT soluzione iniettabile per uso intramuscolare FELDENE Fast 20 mg not available PFIZER ITALIA S.R.L. IT compresse sublinguali FELDENE 20 mg supposte not available PFIZER ITALIA S.R.L. IT FELDENE CREMADOL 1% not available PFIZER ITALIA S.R.L. IT crema PIROFTAL not available BRUSCHETTINI S.R.L IT BREXIN 20 mg compresse not available PROMEDICA S.R.L. IT CICLADOL 20 mg compresse not available MASTER PHARMA S.R.L. IT CICLADOL 20 mg compresse not available MASTER PHARMA S.R.L. IT CICLADOL 20 mg compresse not available MASTER PHARMA S.R.L. IT CICLADOL 20 mg compresse not available MASTER PHARMA S.R.L. IT CICLADOL 20 mg compresse not available MASTER PHARMA S.R.L. IT CICLADOL 20 mg compresse not available MASTER PHARMA S.R.L. IT CICLADOL 20 mg compresse not available MASTER PHARMA S.R.L. IT CICLADOL 20 mg granulato not available MASTER PHARMA S.R.L. IT per soluzione orale BREXIN 20 mg compresse not available PROMEDICA S.R.L. IT where EMA/806830/2017 Page 8/13

9 BREXIN 20 mg compresse BREXIN 20 mg granulato per soluzione orale BREXIVEL 20 mg/1 ml Soluzione iniettabile per uso intramuscolare not available PROMEDICA S.R.L. IT not available PROMEDICA S.R.L. IT not available PROMEDICA S.R.L. IT BREXIN 20 mg compresse not available PROMEDICA S.R.L. IT BREXIN 20 mg compresse not available PROMEDICA S.R.L. IT BREXIN 20 mg supposte not available PROMEDICA S.R.L. IT CICLADOL 20 mg supposte not available MASTER PHARMA S.R.L. IT LENOTAC 14 mg cerotto not available I.B.N. SAVIO S.R.L. IT medicato LENOTAC 14 mg cerotto not available I.B.N. SAVIO S.R.L. IT medicato LENOSPREAD CREMA not available I.B.N. SAVIO S.R.L. IT ANTIFLOG 1% Gel not available FABBRICA ITALIANA IT RITROVATI MEDICINALI ED AFFINI F.I.R.M.A. - SCANNING 14 mg cerotto not available IBSA FARMACEUTICI ITALIA IT medicato SCANNING 14 mg cerotto not available IBSA FARMACEUTICI ITALIA IT medicato PIROFTAL not available BRUSCHETTINI S.R.L IT CLEVIAN 1% GEL not available AESCULAPIUS IT FARMACEUTICI S.R.L. LENOSPREAD CREMA not available I.B.N. SAVIO S.R.L. IT Brexin 20 mg tabletės not available LT/1/2000/1566/001 NORAMEDA UAB LT Brexin 20 mg milteliai not available LT/1/2000/1566/002 NORAMEDA UAB LT geriamajam tirpalui Piroxicam EG 20 mg not available EUROGENERICS N.V./S.A. LU comprimés dispersibles Piroxicam EG 20 mg/ml not available EUROGENERICS N.V./S.A. LU solution injectable Piroxicam EG 20 mg gélules not available EUROGENERICS N.V./S.A. LU where EMA/806830/2017 Page 9/13

10 Feldene Dispersal 20 mg Tabletten zur Herstellung einer Suspension zum Einnehmen not available PFIZER S.A. (BELGIUM) LU Feldene 20 mg Zäpfchen not available PFIZER S.A. (BELGIUM) LU Feldene IM 20 mg/ml not available PFIZER S.A. (BELGIUM) LU Injektionslösung Feldene 0,5% Gel not available PFIZER S.A. (BELGIUM) LU Feldene Lyotabs 20 mg not available PFIZER S.A. (BELGIUM) LU Schmelztabletten Feldene 20 mg Hartkapseln not available PFIZER S.A. (BELGIUM) LU Feldene 10 mg Hartkapseln not available PFIZER S.A. (BELGIUM) LU FELDENE 0,5 % gel not available PFIZER S.A. (BELGIUM) LU Feldene 20 mg suppositoires not available PFIZER S.A. (BELGIUM) LU Feldene Dispersal 20 mg not available PFIZER S.A. (BELGIUM) LU comprimés dispersibles Feldene Lyotabs 20 mg not available PFIZER S.A. (BELGIUM) LU comprimés orodispersibles Feldene 10 mg Gélules not available PFIZER S.A. (BELGIUM) LU Feldene 20 mg Gélules not available PFIZER S.A. (BELGIUM) LU Feldene IM 20 mg/ml not available PFIZER S.A. (BELGIUM) LU solution injectable BREXINE 20 mg not available 0430/ CHIESI SA/NV LU COMPRIMÉS BREXIN 20 mg tabletes not available NORAMEDA UAB LV BREXIN 20 mg pulveris not available NORAMEDA UAB LV iekškigi lietojama škiduma pagatavošanai Brexidol 20 mg tabletter not available 8013 CHIESI FARMACEUTICI NO FELDENE, roztwór do not available R/2346 PFIZER EUROPE MA EEIG PL wstrzykiwań, 20 mg/ml Flamexin, 191,2 mg, tabletki not available 9222 CHIESI PHARMACEUTICALS PL GMBH Flexar 20 mg/1 ml solução injectável not available A. MENARINI PORTUGAL, FARMACÊUTICA, S.A. where EMA/806830/2017 Page 10/13

11 Feldene 20 mg comprimidos Feldene 20 mg comprimidos Feldene 20 mg comprimidos Feldene 20 mg comprimidos Feldene 20 mg comprimidos Feldene 20 mg/1 ml solução injectável not available LABORATÓRIOS PFIZER, not available LABORATÓRIOS PFIZER, not available LABORATÓRIOS PFIZER, not available LABORATÓRIOS PFIZER, not available LABORATÓRIOS PFIZER, not available LABORATÓRIOS PFIZER, Feldene 20 mg cápsulas not available LABORATÓRIOS PFIZER, Feldene 20 mg comprimidos not available LABORATÓRIOS PFIZER, Feldene 20 mg/1 ml solução not available LABORATÓRIOS PFIZER, injectável Feldene 20 mg comprimidos not available LABORATÓRIOS PFIZER, Feldene 20 mg comprimidos not available LABORATÓRIOS PFIZER, Feldene 20 mg comprimidos not available LABORATÓRIOS PFIZER, Feldene 20 mg comprimidos not available LABORATÓRIOS PFIZER, Feldene 20 mg cápsulas not available LABORATÓRIOS PFIZER, Feldene 5 mg/g gel not available LABORATÓRIOS PFIZER, Feldene 20 mg supositórios not available LABORATÓRIOS PFIZER, BREXIN 20 mg comprimidos not available CHIESI FARMACEUTICI BREXIN 20 mg comprimidos not available CHIESI FARMACEUTICI where EMA/806830/2017 Page 11/13

12 BREXIN 20 mg granulado not available CHIESI FARMACEUTICI BREXIN 20 mg granulado not available CHIESI FARMACEUTICI BREXIN 20 mg granulado not available CHIESI FARMACEUTICI BREXIN 20 mg comprimidos not available CHIESI FARMACEUTICI efervescentes BREXIN 20 mg comprimidos not available CHIESI FARMACEUTICI efervescentes Flexar 5 mg/g gel not available A. MENARINI PORTUGAL, FARMACÊUTICA, S.A. Flexar 20 mg supositórios not available A. MENARINI PORTUGAL, FARMACÊUTICA, S.A. Flexar 20 mg cápsulas not available A. MENARINI PORTUGAL, FARMACÊUTICA, S.A. Flexar 20 mg cápsulas not available A. MENARINI PORTUGAL, FARMACÊUTICA, S.A. Bruxicam 0,5%, picături not available 455/2007/01 BRUSCHETTINI S.R.L RO oftalmice, soluţie Bruxicam 0,5%, picături not available 455/2007/01 BRUSCHETTINI S.R.L RO oftalmice, soluţie Flamexin, comprimate not available 7147/2006/01 CHIESI FARMACEUTICI RO efervescente, 20 mg Flamexin, comprimate not available 7147/2006/02 CHIESI FARMACEUTICI RO efervescente, 20 mg Flamexin, comprimate not available 7147/2006/03 CHIESI FARMACEUTICI RO efervescente, 20 mg Flamexin, 20 mg, pulbere not available 7597/2006/01 CHIESI FARMACEUTICI RO pentru soluţie orală Flamexin, 20 mg, pulbere not available 7597/2006/02 CHIESI FARMACEUTICI RO pentru soluţie orală Flamexin, 20 mg, pulbere not available 7597/2006/03 CHIESI FARMACEUTICI RO pentru soluţie orală Flamexin, 20 mg, pulbere pentru soluţie orală not available 7597/2006/04 CHIESI FARMACEUTICI RO where EMA/806830/2017 Page 12/13

13 Flamexin, 20 mg, pulbere pentru soluţie orală Flamexin, 20 mg, pulbere pentru soluţie orală Flamexin, 20 mg, comprimate Flamexin, 20 mg, comprimate Flamexin, 20 mg, comprimate Bruxicam 0,5%, picături oftalmice, soluţie not available 7597/2006/05 CHIESI FARMACEUTICI RO not available 7597/2006/06 CHIESI FARMACEUTICI RO not available 7146/2006/01 CHIESI FARMACEUTICI RO not available 7146/2006/02 CHIESI FARMACEUTICI RO not available 7146/2006/03 CHIESI FARMACEUTICI RO not available 455/2007/01 BRUSCHETTINI S.R.L RO Brexidol 20 mg tabletter not available CHIESI FARMACEUTICI SE Flamexin 20 mg granulát not available 29/0115/99-S CHIESI FARMACEUTICI SK Flamexin 20 mg tablety not available 29/0114/99-S CHIESI FARMACEUTICI SK Piroxicam 0.5% Gel not available PL AUDEN MCKENZIE (PHARMA UK DIVISION) LTD Piroxicam Manx 0.5% w/w not available PL 14251/0028 MANX HEALTHCARE LTD UK Gel FELDENE 20mg CAPSULES not available PL 00057/0146 PFIZER LIMITED UK Feldene Melt 20mg not available PL 00057/0352 PFIZER LIMITED UK FELDENE 10mg CAPSULES not available PL 00057/0145 PFIZER LIMITED UK FELDENE GEL not available PL 00057/0284 PFIZER LIMITED UK Piroxicam Capsules 10mg not available PL 20416/0137 CRESCENT PHARMA UK LIMITED Piroxicam Capsules 20mg not available PL 20416/0138 CRESCENT PHARMA UK LIMITED Piroxicam 0.5% w/w Gel - PL40378/0179 TORRENT PHARMA LTD. UK where EMA/806830/2017 Page 13/13