30 November 2017 EMA/806830/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: piroxicam
Procedure no.: PSUSA/00002438/201704
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product full name (in authorisation country) FELDEN® 10 mg – Kapseln
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
16.690
AT
FELDEN 0,5% - Gel
not available
1-18971
FELDEN® 20 mg – lösbare Tabletten
not available
1-18280
FELDEN® 20 mg – Ampullen
not available
1-18967
FELDEN® Quick-Solve 20 mg – Lyotabletten
not available
1-20748
FELDEN® 20 mg – Kapseln
not available
17.048
Piroxicam EG 20 mg dispergeerbare tabletten Piroxicam EG 20 mg/ml oplossing voor injectie Piroxicam EG 20 mg Tabletten zur Herstellung einer Suspension zum Einnehmen Piroxicam EG 20 mg/ml Injektionslösung Piroxicam EG 20 mg comprimés dispersibles Piroxicam EG 20 mg capsules Piroxicam EG 20 mg/ml solution injectable Piroxicam EG 20 mg Kapseln Piroxicam EG 20 mg gélules
not available
BE167115
PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. PFIZER CORPORATION AUSTRIA GESELLSCHAFT M.B.H. EUROGENERICS N.V./S.A.
not available
BE228076
EUROGENERICS N.V./S.A.
BE
not available
BE167115
EUROGENERICS N.V./S.A.
BE
not available
BE228076
EUROGENERICS N.V./S.A.
BE
not available
BE167115
EUROGENERICS N.V./S.A.
BE
not available
BE167054
EUROGENERICS N.V./S.A.
BE
not available
BE228076
EUROGENERICS N.V./S.A.
BE
not available not available
BE167054 BE167054
EUROGENERICS N.V./S.A. EUROGENERICS N.V./S.A.
BE BE
List of nationally authorised medicinal products EMA/806830/2017
AT AT AT AT AT BE
Page 2/13
Product full name (in authorisation country) Feldene 20 mg Hartkapseln Feldene 10 mg Hartkapseln Feldene 20 mg Zäpfchen Feldene Lyotabs 20 mg Schmelztabletten Feldene IM 20 mg/ml Injektionslösung Feldene 0,5% Gel Feldene Dispersal 20 mg Tabletten zur Herstellung einer Suspension zum Einnehmen Feldene 20 mg suppositoires Feldene 20 mg gélules FELDENE 0,5 % gel Feldene Lyotabs 20 mg comprimés orodispersibles Feldene 10 mg gélules Feldene Dispersal 20 mg comprimés dispersibles Feldene IM 20 mg/ml solution injectable Feldene 10 mg harde capsules Feldene 20 mg harde capsules Feldene Dispersal 20 mg Dispergeerbare tabletten Feldene Lyotabs 20 mg Orodispergeerbare tabletten FELDENE 0,5% gel Feldene 20 mg zetpillen Feldene IM 20 mg/ml oplossing voor injectie
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not not not not
available available available available
BE115726 BE115735 BE127915 BE248936
PFIZER PFIZER PFIZER PFIZER
(BELGIUM) (BELGIUM) (BELGIUM) (BELGIUM)
BE BE BE BE
not available
BE137672
PFIZER S.A. (BELGIUM)
BE
not available not available
BE137864 BE254161
PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM)
BE BE
not not not not
available available available available
BE127915 BE115726 BE137864 BE248936
PFIZER PFIZER PFIZER PFIZER
(BELGIUM) (BELGIUM) (BELGIUM) (BELGIUM)
BE BE BE BE
not available not available
BE115735 BE254161
PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM)
BE BE
not available
BE137672
PFIZER S.A. (BELGIUM)
BE
not available
BE115735
PFIZER S.A. (BELGIUM)
BE
not available
BE115726
PFIZER S.A. (BELGIUM)
BE
not available
BE254161
PFIZER S.A. (BELGIUM)
BE
not available
BE248936
PFIZER S.A. (BELGIUM)
BE
not available not available not available
BE137864 BE127915 BE137672
PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM)
BE BE BE
List of nationally authorised medicinal products EMA/806830/2017
S.A. S.A. S.A. S.A.
S.A. S.A. S.A. S.A.
Page 3/13
Product full name (in authorisation country) BREXINE®-DRYFIZ® 20 mg BRAUSETABLETTEN (Brausetabletten) BREXINE-DRYFIZ 20 mg BRUISTABLETTEN BREXINE®-DRYFIZ® 20 mg COMPRIMÉS EFFERVESCENTS BREXINE® 20 mg TABLETTEN BREXINE 20 mg TABLETTEN BREXINE® 20 mg COMPRIMÉS ????????? 20 mg ???????? FELDENE® FELDENE® FELDENE® BREXIN® 20 mg tablets
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
BE161296
CHIESI SA/NV
BE
not available
BE161296
CHIESI SA/NV
BE
not available
BE161296
CHIESI SA/NV
BE
not available
BE157586
CHIESI SA/NV
BE
not available not available
BE157586 BE157586
CHIESI SA/NV CHIESI SA/NV
BE BE
not not not not not
20000196 12075 12074 13022 14762
BG CY CY CY CY
FLAMEXIN, TABLETY
not available
29/116/96-C
Pirox-CT 20 mg Tabletten Piroxicam-ratiopharm 20 mg Injektionslösung Felden, gel Felden, dispergible tabletter FELDENE, 0,5% geel BREXIN, 20 mg suukaudse lahuse pulber BREXIN, 20 mg tabletid FELDENE 20 mg/ml, Solución inyectable FELDENE FLAS 20 mg, liofilizado oral FELDENE 10 mg, cápsulas duras
not available not available
6156699.01.01 6362849.00.00
PROMEDICA S.R.L. PFIZER HELLAS, A.E. PFIZER HELLAS, A.E. PFIZER HELLAS, A.E. VARNAVAS HADJIPANAYIS LTD. (LATSIA) CHIESI FARMACEUTICI S.P.A. ABZ-PHARMA GMBH RATIOPHARM GMBH
not not not not
available available available available
12337 12061 196498 313900
PFIZER APS PFIZER APS PFIZER EUROPE MA EEIG NORAMEDA UAB
DK DK EE EE
not available not available
313800 58.085
NORAMEDA UAB PFIZER, S.L.
EE ES
not available
60.070
PFIZER, S.L.
ES
not available
55.382
PFIZER, S.L.
ES
available available available available available
List of nationally authorised medicinal products EMA/806830/2017
CZ DE DE
Page 4/13
Product full name (in authorisation country) FELDENE 20 mg, cápsulas duras FELDEGEL Piroxicam Gel al 0.5% Uso Cutáneo Salvacam 5 mg/g Gel
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
55.806
PFIZER, S.L.
ES
not available
57797
PFIZER, S.L.
ES
not available
58.986
ES
SASULEN 5 mg/g gel Felden 0,5 % gel FELDEN 0,5 % geeli BREXIN 20 mg, comprimé sécable BREXIN 20 mg, comprimé effervescent BREXIN 20 mg, comprimé sécable BREXIN 20 mg, comprimé effervescent BREXIN 20 mg, comprimé effervescent BREXIN 20 mg, comprimé effervescent FELDENE DISPERSIBLE 20 mg, comprimé sécable FELDENE DISPERSIBLE 20 mg, comprimé sécable FELDENE DISPERSIBLE 20 mg, comprimé sécable FELDENE 20 mg/1 ml, solution injectable en ampoule (IM) FELDENE 20 mg, gélule
not not not not
available available available available
58.708 10158 10158 335 411-2
LABORATORIOS SALVAT, S.A. LABORATORIOS VERIS, S.A. PFIZER OY PFIZER OY PIERRE FABRE MEDICAMENT
not available
348 777-0
FR
not available
335 959-8
SAS PIERRE FABRE MEDICAMENT PIERRE FABRE MEDICAMENT
not available
348 778-7
FR
not available
348 779-3
not available
348 780-1
not available
34009 331 938 6 7
SAS PIERRE FABRE MEDICAMENT SAS PIERRE FABRE MEDICAMENT SAS PIERRE FABRE MEDICAMENT PFIZER HOLDING FRANCE
not available
34009 331 936 3 8
FR
not available
34009 331 939 2 8
not available
328 610.3
PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.)
not available
34009 326 369 7 6
FR
FELDENE DISPERSIBLE 20 mg, comprimé sécable
not available
34009 342 241 1 9
PFIZER HOLDING FRANCE (S.C.A.) PFIZER HOLDING FRANCE (S.C.A.)
List of nationally authorised medicinal products EMA/806830/2017
ES FI FI FR
FR
FR FR FR
FR FR
FR
Page 5/13
Product full name (in authorisation country) FELDENE 20 mg/1 ml, solution injectable en ampoule (IM) FELDENE 10 mg, gélule
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
328 609.5
PFIZER HOLDING FRANCE (S.C.A.)
FR
not available
34009 324 221 2 8
FRANCE
FR
FELDENE 20 mg, gélule
not available
34009 326 679 6 3
FRANCE
FR
GELDENE 0,5 POUR CENT, gel pour application locale GELDENE 0,5 POUR CENT, gel pour application locale FELDENE 20 mg, suppositoire FELDENE 20 mg, suppositoire CYCLADOL 20 mg, comprimé effervescent CYCLADOL 20 mg, comprimé sécable CYCLADOL 20 mg, comprimé sécable CYCLADOL 20 mg, comprimé sécable CYCLADOL 20 mg, comprimé sécable CYCLADOL 20 mg, comprimé effervescent CYCLADOL 20 mg, comprimé effervescent CYCLADOL 20 mg, comprimé effervescent FELDENE 0,5% (w/w) γέλη Feldene 10 mg διασπειρόμενα δισκία Feldene 20 mg διασπειρόμενα δισκία
not available
331 669-5
FRANCE
FR
not available
331 670-3
FRANCE
FR
not available
34009 326 680 4 5
FRANCE
FR
not available
34009 326 382 3 9
FRANCE
FR
not available
3400934877353
PFIZER HOLDING (S.C.A.) PFIZER HOLDING (S.C.A.) PFIZER HOLDING (S.C.A.) PFIZER HOLDING (S.C.A.) PFIZER HOLDING (S.C.A.) PFIZER HOLDING (S.C.A.) CHIESI S.A.S.
not available
3400933609573
CHIESI S.A.S.
FR
not available
3400933609405
CHIESI S.A.S.
FR
not available
3400933609344
CHIESI S.A.S.
FR
not available
3400933609283
CHIESI S.A.S.
FR
not available
3400934877414
CHIESI S.A.S.
FR
not available
3400934877582
CHIESI S.A.S.
FR
not available
3400934877643
CHIESI S.A.S.
FR
not available not available
41098/10/31-05-2011 41095/10/31-05-2011
PFIZER HELLAS, A.E. PFIZER HELLAS, A.E.
GR GR
not available
41097/10/31-05-2011
PFIZER HELLAS, A.E.
GR
List of nationally authorised medicinal products EMA/806830/2017
FR
Page 6/13
Product full name (in authorisation country) BREXIN® Dref 20 mg, αναβράζοντα δισκία BREXIN® 20 mg, κοκκία μιας δόσης για πόσιμο υγρό σε φακελίσκους BREXIN® 20 mg, δισκία Feldene Dispersal 20 mg diszpergálódó tabletta Feldene Dispersal 20 mg diszpergálódó tabletta Feldene kemény kapszula Feldene kemény kapszula Feldene Dispersal 20 mg diszpergálódó tabletta Feldene Dispersal 20 mg diszpergálódó tabletta Brexin 20 mg pezsgőtabletta
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
5247/10-02-99
CHIESI HELLAS A.E.B.E.
GR
not available
21244/91/26-03-92
CHIESI HELLAS A.E.B.E.
GR
not available not available
20011/91/26-03-92 OGYI-T-1141/05
CHIESI HELLAS A.E.B.E. PFIZER KFT.
GR HU
not available
OGYI-T-1141/07
PFIZER KFT.
HU
not available not available not available
OGYI-T-1141/02 OGYI-T-1141/01 OGYI-T-1141/06
PFIZER KFT. PFIZER KFT. PFIZER KFT.
HU HU HU
not available
OGYI-T-1141/08
PFIZER KFT.
HU
not available
OGYI-T-8393/05
PHARMACEUTICALS
HU
Brexin 20 mg pezsgőtabletta
not available
OGYI-T-8393/07
PHARMACEUTICALS
HU
Brexin 20 mg pezsgőtabletta
not available
OGYI-T-8393/08
PHARMACEUTICALS
HU
Brexin 20 mg tabletta
not available
OGYI-T-8393/03
PHARMACEUTICALS
HU
Feldene 20 mg capsules, hard Feldene 10 mg capsules, hard Feldene 5 mg/g Gel Felden 20 mg dreifitöflur Felden 0,5% hlaup SINARTROL 30 mg compresse SINARTROL INFIAMMAZIONE E DOLORE 1,5% crema
not available
PA 19/24/3
CHIESI GMBH CHIESI GMBH CHIESI GMBH CHIESI GMBH PFIZER
LIMITED
IE
not available
PA 19/24/2
PFIZER LIMITED
IE
not not not not
available available available available
PA 19/24/8 960064 930143 026396046
IE IS IS IT
not available
042579019
PFIZER LIMITED PFIZER APS PFIZER APS SPA – SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A. SPA – SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A.
List of nationally authorised medicinal products EMA/806830/2017
IT
Page 7/13
Product full name (in authorisation country) SINARTROL 1,5% crema
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
026396059
IT
PIROFTAL FELDENE 20 mg compresse solubili FELDENE Fast 20 mg compresse sublinguali FELDENE 20 mg capsule rigide FELDENE 20 mg/1 ml soluzione iniettabile per uso intramuscolare FELDENE Fast 20 mg compresse sublinguali FELDENE 20 mg supposte FELDENE CREMADOL 1% crema PIROFTAL BREXIN 20 mg compresse effervescenti CICLADOL 20 mg compresse CICLADOL 20 mg compresse CICLADOL 20 mg compresse CICLADOL 20 mg compresse effervescenti CICLADOL 20 mg compresse effervescenti CICLADOL 20 mg compresse effervescenti CICLADOL 20 mg compresse effervescenti CICLADOL 20 mg granulato per soluzione orale BREXIN 20 mg compresse effervescenti
not available not available
025986011 024249056
SPA – SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A. BRUSCHETTINI S.R.L PFIZER ITALIA S.R.L.
not available
028437034
PFIZER ITALIA S.R.L.
IT
not available
024249029
PFIZER ITALIA S.R.L.
IT
not available
024249068
PFIZER ITALIA S.R.L.
IT
not available
028437022
PFIZER ITALIA S.R.L.
IT
not available not available
024249031 035443011
PFIZER ITALIA S.R.L. PFIZER ITALIA S.R.L.
IT IT
not available not available
025986011 026446070
BRUSCHETTINI S.R.L PROMEDICA S.R.L.
IT IT
not not not not
available available available available
026447110 026447122 026447058 026447072
MASTER MASTER MASTER MASTER
S.R.L. S.R.L. S.R.L. S.R.L.
IT IT IT IT
not available
026447084
MASTER PHARMA S.R.L.
IT
not available
026447096
MASTER PHARMA S.R.L.
IT
not available
026447108
MASTER PHARMA S.R.L.
IT
not available
026447033
MASTER PHARMA S.R.L.
IT
not available
026446094
PROMEDICA S.R.L.
IT
List of nationally authorised medicinal products EMA/806830/2017
PHARMA PHARMA PHARMA PHARMA
IT IT
Page 8/13
Product full name (in authorisation country) BREXIN 20 mg compresse effervescenti BREXIN 20 mg granulato per soluzione orale BREXIVEL 20 mg/1 ml Soluzione iniettabile per uso intramuscolare BREXIN 20 mg compresse BREXIN 20 mg compresse BREXIN 20 mg supposte CICLADOL 20 mg supposte LENOTAC 14 mg cerotto medicato LENOTAC 14 mg cerotto medicato LENOSPREAD CREMA ANTIFLOG 1% Gel
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
026446106
PROMEDICA S.R.L.
IT
not available
026446031
PROMEDICA S.R.L.
IT
not available
027371071
PROMEDICA S.R.L.
IT
not not not not not
available available available available available
026446118 026446120 026446043 026447045 038356022
PROMEDICA S.R.L. PROMEDICA S.R.L. PROMEDICA S.R.L. MASTER PHARMA S.R.L. I.B.N. SAVIO S.R.L.
IT IT IT IT IT
not available
038356010
I.B.N. SAVIO S.R.L.
IT
not available not available
025496062 025069067
IT IT
SCANNING 14 mg cerotto medicato SCANNING 14 mg cerotto medicato PIROFTAL CLEVIAN 1% GEL
not available
038354027
I.B.N. SAVIO S.R.L. FABBRICA ITALIANA RITROVATI MEDICINALI ED AFFINI F.I.R.M.A. - S.P.A. IBSA FARMACEUTICI ITALIA
not available
038354015
IBSA FARMACEUTICI ITALIA
IT
not available not available
025986011 027224031
IT IT
LENOSPREAD CREMA Brexin 20 mg tabletės Brexin 20 mg milteliai geriamajam tirpalui Piroxicam EG 20 mg comprimés dispersibles Piroxicam EG 20 mg/ml solution injectable Piroxicam EG 20 mg gélules
not available not available not available
025496062 LT/1/2000/1566/001 LT/1/2000/1566/002
BRUSCHETTINI S.R.L AESCULAPIUS FARMACEUTICI S.R.L. I.B.N. SAVIO S.R.L. NORAMEDA UAB NORAMEDA UAB
not available
2007060016
EUROGENERICS N.V./S.A.
LU
not available
2007060015
EUROGENERICS N.V./S.A.
LU
not available
2007060014
EUROGENERICS N.V./S.A.
LU
List of nationally authorised medicinal products EMA/806830/2017
IT
IT LT LT
Page 9/13
Product full name (in authorisation country) Feldene Dispersal 20 mg Tabletten zur Herstellung einer Suspension zum Einnehmen Feldene 20 mg Zäpfchen Feldene IM 20 mg/ml Injektionslösung Feldene 0,5% Gel Feldene Lyotabs 20 mg Schmelztabletten Feldene 20 mg Hartkapseln Feldene 10 mg Hartkapseln FELDENE 0,5 % gel Feldene 20 mg suppositoires Feldene Dispersal 20 mg comprimés dispersibles Feldene Lyotabs 20 mg comprimés orodispersibles Feldene 10 mg Gélules Feldene 20 mg Gélules Feldene IM 20 mg/ml solution injectable BREXINE® 20 mg COMPRIMÉS BREXIN 20 mg tabletes BREXIN 20 mg pulveris iekškigi lietojama škiduma pagatavošanai Brexidol 20 mg tabletter
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
2005078260
PFIZER S.A. (BELGIUM)
LU
not available not available
2005078261 2005078262
PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM)
LU LU
not available not available
2005118296 2005078259
PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM)
LU LU
not not not not not
available available available available available
2005078258 2005078257 2005118296 2005078261 2005078260
PFIZER PFIZER PFIZER PFIZER PFIZER
(BELGIUM) (BELGIUM) (BELGIUM) (BELGIUM) (BELGIUM)
LU LU LU LU LU
not available
2005078259
PFIZER S.A. (BELGIUM)
LU
not available not available not available
2005078257 2005078258 2005078262
PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM) PFIZER S.A. (BELGIUM)
LU LU LU
not available
0430/10080830
CHIESI SA/NV
LU
not available not available
03-0566 03-0567
NORAMEDA UAB NORAMEDA UAB
LV LV
not available
8013
NO
FELDENE, roztwór do wstrzykiwań, 20 mg/ml Flamexin, 191,2 mg, tabletki
not available
R/2346
CHIESI FARMACEUTICI S.P.A. PFIZER EUROPE MA EEIG
not available
9222
PL
Flexar 20 mg/1 ml solução injectável
not available
2065894
CHIESI PHARMACEUTICALS GMBH A. MENARINI PORTUGAL, FARMACÊUTICA, S.A.
List of nationally authorised medicinal products EMA/806830/2017
S.A. S.A. S.A. S.A. S.A.
PL
PT
Page 10/13
Product full name (in authorisation country) Feldene 20 mg comprimidos dispersíveis Feldene 20 mg comprimidos dispersíveis Feldene 20 mg comprimidos dispersíveis Feldene 20 mg comprimidos dispersíveis Feldene 20 mg comprimidos dispersíveis Feldene 20 mg/1 ml solução injectável Feldene 20 mg cápsulas
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
5201215
PT
not available
5201231
not available
5201256
not available
5201249
not available
5201223
not available
5378021
not available
8515619
Feldene 20 mg comprimidos dispersíveis Feldene 20 mg/1 ml solução injectável Feldene 20 mg comprimidos dispersíveis Feldene 20 mg comprimidos dispersíveis Feldene 20 mg comprimidos dispersíveis Feldene 20 mg comprimidos dispersíveis Feldene 20 mg cápsulas
not available
5892286
not available
8675405
not available
8665729
not available
5892385
not available
8665752
not available
4534681
not available
8515635
Feldene 5 mg/g gel
not available
8675512
Feldene 20 mg supositórios
not available
8563924
BREXIN 20 mg comprimidos
not available
4615795
BREXIN 20 mg comprimidos
not available
4615894
LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. LABORATÓRIOS PFIZER, LDA. CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A.
List of nationally authorised medicinal products EMA/806830/2017
PT PT PT PT PT PT PT PT PT PT PT PT PT PT PT PT PT
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Product full name (in authorisation country) BREXIN 20 mg granulado
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
4615993
PT
BREXIN 20 mg granulado
not available
5718093
BREXIN 20 mg granulado
not available
4616090
BREXIN 20 mg comprimidos efervescentes BREXIN 20 mg comprimidos efervescentes Flexar 5 mg/g gel
not available
4616199
not available
4616298
not available
2583599
Flexar 20 mg supositórios
not available
9702902
Flexar 20 mg cápsulas
not available
5878491
Flexar 20 mg cápsulas
not available
5878590
Bruxicam 0,5%, picături oftalmice, soluţie Bruxicam 0,5%, picături oftalmice, soluţie Flamexin, comprimate efervescente, 20 mg Flamexin, comprimate efervescente, 20 mg Flamexin, comprimate efervescente, 20 mg Flamexin, 20 mg, pulbere pentru soluţie orală Flamexin, 20 mg, pulbere pentru soluţie orală Flamexin, 20 mg, pulbere pentru soluţie orală Flamexin, 20 mg, pulbere pentru soluţie orală
not available
455/2007/01
CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. A. MENARINI PORTUGAL, FARMACÊUTICA, S.A. A. MENARINI PORTUGAL, FARMACÊUTICA, S.A. A. MENARINI PORTUGAL, FARMACÊUTICA, S.A. A. MENARINI PORTUGAL, FARMACÊUTICA, S.A. BRUSCHETTINI S.R.L
not available
455/2007/01
BRUSCHETTINI S.R.L
RO
not available
7147/2006/01
FARMACEUTICI
RO
not available
7147/2006/02
FARMACEUTICI
RO
not available
7147/2006/03
FARMACEUTICI
RO
not available
7597/2006/01
FARMACEUTICI
RO
not available
7597/2006/02
FARMACEUTICI
RO
not available
7597/2006/03
FARMACEUTICI
RO
not available
7597/2006/04
CHIESI S.P.A. CHIESI S.P.A. CHIESI S.P.A. CHIESI S.P.A. CHIESI S.P.A. CHIESI S.P.A. CHIESI S.P.A.
FARMACEUTICI
RO
List of nationally authorised medicinal products EMA/806830/2017
PT PT PT PT PT PT PT PT RO
Page 12/13
Product full name (in authorisation country) 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 Brexidol 20 mg tabletter
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the Member State
Member State where product is authorised
not available
7597/2006/05
RO
not available
7597/2006/06
not available
7146/2006/01
not available
7146/2006/02
not available
7146/2006/03
not available
455/2007/01
CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. BRUSCHETTINI S.R.L
not available
11844
SE
Flamexin 20 mg granulát
not available
29/0115/99-S
Flamexin 20 mg tablety
not available
29/0114/99-S
Piroxicam 0.5% Gel
not available
PL 17507-0029
Piroxicam Manx 0.5% w/w Gel FELDENE 20mg CAPSULES Feldene Melt 20mg FELDENE 10mg CAPSULES FELDENE GEL Piroxicam Capsules 10mg
not available
PL 14251/0028
CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. AUDEN MCKENZIE (PHARMA DIVISION) LTD MANX HEALTHCARE LTD
not not not not not
PL PL PL PL PL
UK UK UK UK UK
Piroxicam Capsules 20mg
not available
PL 20416/0138
Piroxicam 0.5% w/w Gel
-
PL40378/0179
PFIZER LIMITED PFIZER LIMITED PFIZER LIMITED PFIZER LIMITED CRESCENT PHARMA LIMITED CRESCENT PHARMA LIMITED TORRENT PHARMA LTD.
available available available available available
List of nationally authorised medicinal products EMA/806830/2017
00057/0146 00057/0352 00057/0145 00057/0284 20416/0137
RO RO RO RO RO
SK SK UK UK
UK UK
Page 13/13
