qanastek/EMEA-V3 huggingface dataset:
Finalgel
Finalgell
Via Palermo 26 A 43100, Parma Italy
Via Palermo 26 A 43100, Parma L- Italja
11 Member State
11 Stat Membru
Egis Pharmaceuticals Public Limited Company Kereszturi ut 30-38 H-1106 Budapest Hungary
Egis Pharmaceuticals Public Limited Company Kereszturi ut 30- 38 H- 1106 Budapest L- Ungerija
Hotemin Injection
Hotemin Injezzjoni
Rectal use
Użu gor- rektum
Psychiko Greece
Psychiko Il- Greċja
12 Member State
12 Stat Membru
Rectal use
Użu ġor- rektum
External use
Użu fuq barra
Pobox 21229 1504 Lefkosia Cyprus
Pobox 21229 1504 Lefkosia Ċipru
Medochemie Ltd Pobox 51409, 3505 Lemesos, Cyprus
Medochemie Ltd Pobox 51409, 3505 Lemesos, Ċipru
13 Member State
13 Stat Membru
Cyprus Cyprus
Ċipru Ċipru
P. O Box 51706 3508 Limassol Cyprus
P. O Box 51706 3508 Limassol Ċipru
Keresztúri Út 30-38 1106 Budapest Hungary
Keresztúri Út 30- 38 1106 Budapest L- Ungerija
Cutaneous use
Użu ġol- ġilda
14 Member State
14 Stat Membru
Czech Republic Czech Republic
Ir- Repubblika Ċeka Ir- Repubblika Ċeka
Telč ská 1 14000 Praha 4 Czech Republic
Telčská 1 14000 Praha 4 Ir- Repubblika Ċeka
Gottlieb-Daimler-Strasse 19 891 50 Laichingen Germany
Gottlieb- Daimler- Strasse 19 891 50 Laichingen Il- Ġermanja
Via Palermo 26/ A 43100 Parma Italy
Via Palermo 26/ A 43100 Parma L- Italja
Granules
Granuli
Effervescent tablet
Pillola li tfexfex
7 D-89143 Blaubeuren Germany
7 D- 89143 Blaubeuren Il- Ġermanja
Piroxicam Acis 20mg Tabs 29562.00.00
Piroxicam Acis 20mg Pillolas 29562. 00. 00
15 Member State
15 Stat Membru
Germany Germany
Il- Ġermanja Il- Ġermanja
19 D-89150 Laichingen Germany
19 D- 89150 Laichingen Il- Ġermanja
Effervescent tablet
Pillola Effervexxenti
6 D-22761 Hamburg Germany
6 D- 22761 Hamburg Il- Ġermanja
16 Member State
16 Stat Membru
Bc Biochemie Pharma Gmbh Carl-Zeiss-Ring 3 D- 85737 Ismaning Germany
Bc Biochemie Pharma Gmbh Carl- Zeiss- Ring 3 D - 85737 Ismaning Il- Ġermanja
Betapharm Arzneimittel Gmbh Kobelweg 95 D-86156 Augsburg Germany
Betapharm Arzneimittel Gmbh Kobelweg 95 D- 86156 Augsburg Il- Ġermanja
42a D-13407 Berlin Germany
42a D- 13407 Berlin Il- Ġermanja
Injection
Injezzjoni
83 D-76327 Pfinztal Germany
83 D- 76327 Pfinztal Il- Ġermanja
17 Member State
17 Stat Membru
2 D-12277 Berlin Germany
2 D- 12277 Berlin Il- Ġermanja
Generica Kg Südwestpark 50 D-90449 Nürnberg Germany
Generica Kg Südwestpark 50 D- 90449 Nürnberg Il- Ġermanja
25 D-83607 Holzkirchen Germany
25 D- 83607 Holzkirchen Il- Ġermanja
18 Member State
18 Stat Membru
Suppository
Suppożitorji
19 Member State
19 Stat Membru
Kohne Pharma Gmbh Schallbruch 1 D-42781 Haan Germany
Kohne Pharma Gmbh Schallbruch 1 D- 42781 Haan Il- Ġermanja
19 D-64289 Darmstadt Germany
19 D- 64289 Darmstadt Il- Ġermanja
15 D- 06796 Brehna Germany
15 D - 06796 Brehna Il- Ġermanja
20 Member State
20 Stat Membru
15 D-07745 Jena Germany
15 D- 07745 Jena Il- Ġermanja
21 Member State
21 Stat Membru
Oral use
Jittieħed
1 D-76139 Karlsruhe Germany
1 D- 76139 Karlsruhe Il- Ġermanja
3 D-89079 Ulm Germany
3 D- 89079 Ulm Il- Ġermanja
Sandoz Pharmaceuticals Gmbh Carl-Zeiss-Ring 3 D-85737 Ismaning Germany
Sandoz Pharmaceuticals Gmbh Carl- Zeiss- Ring 3 D- 85737 Ismaning Il- Ġermanja
22 Member State
22 Stat Membru
78D- 56130 Bad Ems Germany
78D - 56130 Bad Ems Il- Ġermanja
78 D-56130 Bad Ems Germany
78 D- 56130 Bad Ems Il- Ġermanja
2-18 D-61118 Bad Vilbel Germany
2- 18 D- 61118 Bad Vilbel Il- Ġermanja
Piroxi 10 Stada Tabs 44091.00.00
Piroxi 10 Stada Pillolas 44091. 00. 00
Piroxi 20 Stada Tabs 44091.01.00
Piroxi 20 Stada Pillolas 44091. 01. 00
Piroxicam Stada 10mg Tabs 6068067.00.00
Piroxicam Stada 10mg Pillolas 6068067. 00. 00
23 Member State
23 Stat Membru
Pxi-10 Stada Tabs 28449.00.00
Pxi- 10 Stada Pillolas 28449. 00. 00
5 D-27472 Cuxhaven Germany
5 D- 27472 Cuxhaven Il- Ġermanja
24 Member State
24 Stat Membru
9626.00.00
mill- ħalq
Weimer Pharma Gmbh Im Steingerüst 30 D- 76437 Rastatt Germany
Weimer Pharma Gmbh Im Steingerüst 30 D - 76437 Rastatt Il- Ġermanja
Wieb Pharm Vertriebs Gmbh & Co. Kg Diestraat 15 D-25870 Norderfriedrichskoog Germany
Wieb Pharm Vertriebs Gmbh & Co. Kg Diestraat 15 D- 25870 Norderfriedrichskoog Il- Ġermanja
25 Member State
25 Stat Membru
10 D-82256 Fürstenfeldbruck Germany
10 D- 82256 Fürstenfeldbruck Il- Ġermanja
Merck NM AB Ynglingagatan 14 11347, Post Box 23033 SE-10435 Stockholm Sweden
Merck NM AB Ynglingagatan 14 11347, Post Box 23033 SE- 10435 Stockholm L- Isvezja
26 Member State
26 Stat Membru
Sweden Denmark
L- Isvezja Id- Danimarka
Pfizer Aps Lautrupvang 8 Dk-2750 Ballerup Denmark
Pfizer Aps Lautrupvang 8 Dk- 2750 Ballerup Id- Danimarka
Dispersible Tablet
Pillola li tinħall
Cutaneous use
Użu għall- ġilda.
Tietgens Boulevard 40 DK-5220 Odense SØ Denmark
Tietgens Boulevard 40 DK- 5220 Odense SØ Id- Danimarka
Hexal A/ S Kanalholmen 8-12 Dk-2650 Hvidovre Denmark
Hexal A/ S Kanalholmen 8- 12 Dk- 2650 Hvidovre Id- Danimarka
10 mg/ tab
10 mg/ pillola
Gastro resistant tablet
Pillola gastro reżistenti
Oral
Mill- ħalq
27 Member State
27 Stat Membru
Athens-Lamia 14565 Greece Greece
Athens- Lamia 14565 Il- Greċja Il- Greċja
DEMO ABEE 21st Km National Road Athens-Lamia 14565 Greece
DEMO ABEE 21st Km National Road Athens- Lamia 14565 Il- Greċja
20 mg/ tab
20 mg/ pillola
Gastro resistant tablet
Pillola reżistenti għall- istonku
Inj sol
Soluzzjoni għall- injezzjoni
Intramuscular
Ġol- muskolu
14565 Greece
14565 Il- Greċja
External
Fuq barra
Pfizer Hellas Ae Mesogeion 243 New Psychiko 15451 Greece
Pfizer Hellas Ae Mesogeion 243 New Psychiko 15451 Il- Greċja
Rectal
Ġor- rektum
28 Member State
28 Stat Membru
New Psychiko 15451 Greece Greece
New Psychiko 15451 Il- Greċja Il- Greċja
Tabs rapid
Pilloli rapidi
Lyra 25, Kato Kifissia Greece
Lyra 25, Kato Kifissia Il- Greċja
10 mg/ cap
10 mg/ kap
20 mg/ cap
20 mg/ kap
Remedina Gounari 25 & Areos Kamatero Attiki 13451 Greece
Remedina Gounari 25 & Areos Kamatero Attiki 13451 Il- Greċja
29 Member State
29 Stat Membru
Peristeri 12134 Greece Greece
Peristeri 12134 Il- Greċja Il- Greċja
Koronis Dilou 9 Peristeri 12134 Greece
Koronis Dilou 9 Peristeri 12134 Il- Greċja
Help Aebe Valaoritou 10 Metamorfosi Attiki 14452 Greece
Help Aebe Valaoritou 10 Metamorfosi Attiki 14452 Il- Greċja
Rafarm Aebe Korinthou 12 New Psychiko 15451 Greece
Rafarm Aebe Korinthou 12 New Psychiko 15451 Il- Greċja
30 Member State
30 Stat Membru
Vilco Ae Pefkon 121 Neo Irakleio 14122 Greece
Vilco Ae Pefkon 121 Neo Irakleio 14122 Il- Greċja
Faran Abee Achaias & Troizinias New Kifissia 14564 Greece
Faran Abee Achaias & Troizinias New Kifissia 14564 Il- Greċja
MENTINOVA AE 16th Km Marathonos Avenue Pallini Attiki 15344 Greece
MENTINOVA AE 16th Km Marathonos Avenue Pallini Attiki 15344 Il- Greċja
Tabs
Pilloli
31 Member State
31 Stat Membru
Pallini Attiki 15351 Greece Greece
Pallini Attiki 15351 Il- Greċja Il- Greċja
GENEPHARM AE 18th Km Marathonos Avenue Pallini Attiki 15351 Greece
GENEPHARM AE 18th Km Marathonos Avenue Pallini Attiki 15351 Il- Greċja
Coup Oe Kouparoussos & Sia Agias Varvaras 53 Dafni 17235 Greece
Coup Oe Kouparoussos & Sia Agias Varvaras 53 Dafni 17235 Il- Greċja
Kleva Epe Parnithos Avenue 189 Acharnai Attiki 13671 Greece
Kleva Epe Parnithos Avenue 189 Acharnai Attiki 13671 Il- Greċja
32 Member State
32 Stat Membru
Acharnai Attiki 13671 Greece Greece
Acharnai Attiki 13671 Il- Greċja Il- Greċja
Norma Hellas Ae Menandrou 54 Athens 10431 Greece
Norma Hellas Ae Menandrou 54 Athens 10431 Il- Greċja
Palaiologou & Perikleous 27 Chalandri 15232 Greece
Palaiologou & Perikleous 27 Chalandri 15232 Il- Greċja
33 Member State
33 Stat Membru
Chalandri 15232 Greece Greece
Chalandri 15232 Il- Greċja Il- Greċja
Gap Ae Agisilaou 46 Agios Dimitrios 17341 Greece
Gap Ae Agisilaou 46 Agios Dimitrios 17341 Il- Greċja
Chiesi Hellas Aebe Anapafseos Avenue 30 Vrilissia 15235 Greece
Chiesi Hellas Aebe Anapafseos Avenue 30 Vrilissia 15235 Il- Greċja
20 mg/ sachet
20 mg/ qartas
Grannules for oral solution
Granijiet għal soluzzjoni orali
Effervescent tablets
Pillola Effervexxenti
Pharmanel Pharmaceutical Ae Marathonos 106 Gerakas 15344 Greece
Pharmanel Pharmaceutical Ae Marathonos 106 Gerakas 15344 Il- Greċja
15 mg/ tab
15 mg/ pillola
30 mg/ tab
30 mg/ pillola
34 Member State
34 Stat Membru
Gerakas 15344 Greece Spain
Gerakas 15344 Il- Greċja Spanja
De Europa, 20 B 28108 Alcobendas Madrid Spain
De Europa, 20 B 28108 Alcobendas Madrid Spanja
Liophilised
Lijofilizzat
Feldegel
Feldegell
Cutaneous use
Jittieħed minn fuq il- ġilda
35 Member State
35 Stat Membru
08029 Barcelona Spain Spain
08029 Barcelona Spanja Spanja
Berlin, 38-48 7ª Planta 08029 Barcelona Spain
Berlin, 38- 48 7ª Planta 08029 Barcelona Spanja
Powder for oral solution
Trab għal soluzzjoni Mill- ħalqi
Comadran 37 Barbera Del Valles 08210 Barcelona Spain
Comadran 37 Barbera Del Valles 08210 Barcelona Spanja
36 Member State
36 Stat Membru
Carretera De Barcelona 2 46132 Almacera Spain
Carretera De Barcelona 2 46132 Almacera Spanja
Areta 31620 Huarte Pamplona Spain
Areta 31620 Huarte Pamplona Spanja
37 Member State
37 Stat Membru
Las Matas 28290 Madrid Spain Spain
Las Matas 28290 Madrid Spanja Spanja
08007 Barcelona Spain
08007 Barcelona Spanja
De Burgos 16 D - 5ª Planta 28036 Madrid Spain
De Burgos 16 D - 5ª Planta 28036 Madrid Spanja
Laboratorios Salvat S. A. Gallo, 30-36 08950 Barcelona Spain
Laboratorios Salvat S. A. Gallo, 30- 36 08950 Barcelona Spanja
Cutaneous use
Jinfirex fuq il- ġilda
Laboratorios faes Farma Sa maximo Aguirre, 14 48940 Lamiaco-Lejona Spain
Laboratorios faes Farma Sa maximo Aguirre, 14 48940 Lamiaco- Lejona Spanja
Laboratorios Faes Farma Sa Maximo Aguirre, 14 48940 Lamiaco-Lejona Spain
Laboratorios Faes Farma Sa Maximo Aguirre, 14 48940 Lamiaco- Lejona Spanja
Cutaneous use
Jinfirex fuq
38 Member State
38 Stat Membru
Route of administration
Maximo Aguirre, 14 48940 Lamiaco- Lejona Spanja
Maximo Aguirre, 14 48940 Lamiaco-Lejona Spain Spain
Spanja
Gran Via Carlos Iii 94 08028 Barcelona Spain
Gran Via Carlos Iii 94 08028 Barcelona Spanja
39 Member State
39 Stat Membru
Pfizer Europe Ma Eeig Ramsgate Road Sandwich Kent Ct13 9nj United Kingdom
Pfizer Europe Ma Eeig Ramsgate Road Sandwich Kent Ct13 9nj Ir- Renju Unit
Pfizer Oy Tietokuja 3 00330 Helsinki Finland
Pfizer Oy Tietokuja 3 00330 Helsinki Il- Finlandja
Alpharma A/ S Harbitzalleen 3 158 Skoyen 0212 Oslo Norway
Alpharma A/ S Harbitzalleen 3 158 Skoyen 0212 Oslo In- Norveġja
Box 1161 89143 Blaubeuren Germany
Box 1161 89143 Blaubeuren Il- Ġermanja
Rectal use
Jittieħed
40 Member State
40 Stat Membru
18, Rue Du Docteur Ragnaud 16000 Angoulême France
18, Rue Du Docteur Ragnaud 16000 Angoulême Franza
Biogaran 15, Boulevard Charles De Gaulle 92707 Colombes Cedex France
Biogaran 15, Boulevard Charles De Gaulle 92707 Colombes Cedex Franza
Laboratoire Pharmy II 26 rue des Gaudines 78100 Saint-Germain-Laye France
Laboratoire Pharmy II 26 rue des Gaudines 78100 Saint- Germain- Laye Franza
Cephalon France 20, Rue Charles Martigny 94701 Maisons-Alfort Cedex France
Cephalon Franza 20, Rue Charles Martigny 94701 Maisons- Alfort Cedex Franza
41 Member State
41 Stat Membru
11, Avenue Dubonnet 92400 Courbevoie France
11, Avenue Dubonnet 92400 Courbevoie Franza
Chiesi 11, Avenue Dubonnet 92400 Courbevoie France
Chiesi 11, Avenue Dubonnet 92400 Courbevoie Franza
Dexo 179, Bureaux De La Colline 92213 Saint-Cloud Cedex France
Dexo 179, Bureaux De La Colline 92213 Saint- Cloud Cedex Franza
Eg Labo - Laboratoires Eurogenerics "Le Quintet" - Bâtiment A 12, Rue Danjou 92517 Boulogne Billancourt Cedex France
Eg Labo - Laboratoires Eurogenerics "Le Quintet" - Bâtiment A 12, Rue Danjou 92517 Boulogne Billancourt Cedex Franza
42 Member State
42 Stat Membru
Expanpharm International 6, rue de la Rochefoucauld 16000 Angouleme France
Expanpharm International 6, rue de la Rochefoucauld 16000 Angouleme Franza
28, Boulevard Clemenceau 21000 Dijon France
42, Rue De Longvic 21300 Chenove Franza
Innotech International 7-9, Avenue François-Vincent Raspail Bp 32, 94111 Arcueil Cedex France
Innotech International 7- 9, Avenue François- Vincent Raspail Bp 32, 94111 Arcueil Cedex Franza
France
Franza Franza
Innotech International
Innotech International 7- 9, Avenue François- Vincent Raspail Bp 32, 94111 Arcueil Cedex Franza
Ivax Pharmaceuticals 34, Avenue Franklin Roosevelt 92150 Suresnes France
Ivax Pharmaceuticals 34, Avenue Franklin Roosevelt 92150 Suresnes Franza
Laboratoire Rpg - Ranbaxy Pharmacie Generiques 4, Place Louis Armand, 75012 Paris France
Laboratoire Rpg - Ranbaxy Pharmacie Generiques 4, Place Louis Armand, 75012 Paris Franza
44 Member State
44 Stat Membru
Route of administration
Franza Franza
34, Rue Saint-Romain, 69359 Lyon Cedex 08 France
Merck Generiques 34, Rue Saint- Romain, 69359 Lyon Cedex 08 Franza
Merck Generiques 34, Rue Saint-Romain, 69359 Lyon Cedex 08 France
Merck Generiques 34, Rue Saint- Romain, 69359 Lyon Cedex 08 Franza
Palbian Eurasanté - Parc Galénis, 85 C Rue Nelson Mandela 59120 Loos France
Palbian Eurasanté - Parc Galénis, 85 C Rue Nelson Mandela 59120 Loos Franza
45 Member State
45 Stat Membru
Route of administration
mill- ħalq
France France
Franza
Pfizer 23-25, Avenue Du Docteur Lannelongue 75668 Paris Cedex 14 France
Pfizer 23- 25, Avenue Du Docteur Lannelongue 75668 Paris Cedex 14 Franza
Feldene 20 Mg/ 1 Ml, Solution Injectable En Ampoule (Im)
Feldene 20 Mg/ 1 Ml, Solution Injectable En Ampulla (Im)
Pfizer 23-25, Avenue Du Docteur Lannelongue 75668 Paris Cedex 14 France
Pfizer 23- 25, Avenue Du Docteur Lannelongue 75668 Paris Cedex 14Franza
Geldene 0,5 Pour Cent, Gel Pour Application Locale
Ġelldene 0, 5 Pour Cent, Ġell Pour Application Locale
Pfizer Holding France 23-25, Avenue Du Docteur Lannelongue 75014 Paris France
Pfizer Holding Franza 23- 25, Avenue Du Docteur Lannelongue 75014 Paris Franza
Pfizer Holding France 23-25, Avenue Du Docteur Lannelongue 75014 Paris
Pfizer Holding Franza 23- 25, Avenue Du Docteur Lannelongue 75014 Paris Franza
Piroxicam Beral Dispersible 20 Mg, Comprimé
Piroxicam Beral 20
Tablet
Soluzzjoni
46 Member State
46 Stat Membru
Pfizer Holding France 23-25, Avenue Du Docteur Lannelongue 75014 Paris France
23- 25, Avenue Du Docteur Lannelongue 75014 Paris Franza
Piroxicam Beral 20 Mg/ 1 Ml, Solution Injectable En Ampoule (Im)
Mg/ 1 Ml, Solution Injectable En Ampoule (Im)
Solution for injection
għall- injezzjoni
Intramuscular use
ġol- muskolu
Piroxicam Beral 0,5 Pour Cent, Gel
Piroxicam Beral 0, 5 Pour Cent, Gell
Pierre Fabre Medicament 45, Place Abel Gance 92654 Boulogne Cedex France
Pierre Fabre Medicament 45, Place Abel Gance 92654 Boulogne Cedex Franza
Ratiopharm 5, Rue Charles Martigny, Bp 42, 94702 Maisons-Alfort Cedex
Ratiopharm 5, Rue Charles Martigny, Bp 42, 94702 Maisons- Alfort Cedex Franza
Piroxicam- Ratiopharm 20 Mg, Gélule
20 mg
47 Member State
47 Stat Membru
Sandoz 49, Avenue Georges Pompidou 92300 Levallois-Perret France
49, Avenue Georges Pompidou 92300 Levallois- Perret Franza
Piroxicam Sandoz 20 Mg, Gélule
Mg, Gélule
Capsule, hard
mill- ħalq
Sandoz 49, Avenue Georges Pompidou 92300 Levallois-Perret France
Sandoz 49, Avenue Georges Pompidou 92300 Levallois- Perret Franza
Teva Classics Le Palatin 1, 1, Cours Du Triangle, 92936 Paris La Défense Cedex France
Teva Classics Le Palatin 1, 1, Cours Du Triangle, 92936 Paris La Défense Cedex Franza
Teva Pharma Bv Industrieweg 23 Po Box 217, 3640 Ae Mijdrecht The Netherlands
Teva Pharma Bv Industrieweg 23 Po Box 217, 3640 Ae Mijdrecht L- Olanda
Teva Pharma Bv Industrieweg 23 Po Box 217,
Teva Pharma Bv Industrieweg 23 Po Box 217, 3640 Ae Mijdrecht L- Olanda
48 Member State
48 Stat Membru
3640 Ae Mijdrecht The Netherlands France
Franza
Meda Pharma 25, Boulevard de l’ Amiral Bruix 75016 Paris France
Meda Pharma 25, Boulevard de l’ Amiral Bruix 75016 Paris Franza
Suspension
Suspensjoni
Winthrop Medicaments 1/ 13, Boulevard Romain Rolland 75014 Paris France
Winthrop Medicaments 1/ 13, Boulevard Romain Rolland 75014 Paris Franza
Winthrop Medicaments 1/ 13, Boulevard Romain Rolland
Winthrop Medicaments 1/ 13, Boulevard Romain Rolland 75014 Paris Franza
49 Member State
49 Stat Membru
75014 Paris France France
Franza
Zydus France 25, Rue Des Peupliers, Zac Les Hautes Pâtures - Parc D’ activités Des Peupliers, 92000 Nanterre France
Zydus France 25, Rue Des Peupliers, Zac Les Hautes Pâtures - Parc D’ activités Des Peupliers, 92000 Nanterre Franza
19 89150 Laichingen Germany
19 89150 Laichingen Il- Ġermanja
Torrex Chiesi Pharma Gmbh Gonzagagasse 16/ 16 1010 Vienna Austria
Torrex Chiesi Pharma Gmbh Gonzagagasse 16/ 16 1010 Vienna l- Awstrija
Oral use
Jittieħed mir- rektum
50 Member State
50 Stat Membru
30-38 1106 Budapest Hungary
1106 Budapest L- Ungerija L- Ungerija
30-38 1106 Budapest Hungary
30- 38 1106 Budapest L- Ungerija
5/ C 1133 Budapest Hungary
5/ C 1133 Budapest L- Ungerija
51 Member State
51 Stat Membru
5/ C 1133 Budapest Hungary
1133 Budapest L- Ungerija L- Ungerija
Sublingual use
Użu għal taħt l- ilsien
70-72 1074 Budapest Hungary
70- 72 1074 Budapest L- Ungerija
13 4042 Debrecen Hungary
13 4042 Debrecen L- Ungerija
Slovakofarma As Nitrianská 100 92027 Hlomovec Hungary
Slovakofarma As Nitrianská 100 92027 Hlomovec L- Ungerija
Trinity Chiesi Pharmaceuticals Ltd Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy United Kingdom
Trinity Chiesi Pharmaceuticals Ltd Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy Ir- Renju Unit
Brexidol 20mg Tablets
Brexidol 20mg Pillola
Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy United Kingdom
Cheadle Royal Business Park
Effervescent Tablets
Pillola Effervexxenti
Ireland
Highfield, Cheadle Sk8 3gy Ir- Renju Unit L- Irlanda
Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Pfizer Limited Walton Oaks, Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Ir- Renju Unit
Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland
Pfizer Healthcare L- Irlanda 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 L- Irlanda
Pfizer Aps Lautrupvang 8
Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Id- Danimarka
53 Member State
53 Stat Membru
Route of administration
L- Islanda
Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Denmark
Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Id- Danimarka
Felden
Felden gel
Corso Vittorio Emanuele Ii, 72 10121 Torino Italy
Corso Vittorio Emanuele Ii, 72 10121 Torino L- Italja
Aesculapius Farmaceutici Srl Via Cozzaglio, 24 25125 Brescia Italy
Aesculapius Farmaceutici Srl Via Cozzaglio, 24 25125 Brescia L- Italja
Via Aurelia, 58 00165 Roma Italy
Via Aurelia, 58 00165 Roma L- Italja
Via Isonzo, 6
Via Isonzo, 6 16147 Genova L- Italja
54 Member State
54 Stat Membru
16147 Genova Italy Italy
L- Italja
Via Isonzo, 6 16147 Genova Italy
Via Isonzo, 6 16147 Genova L- Italja
Ocular use
Użu għall - għajnejn
Effervescent Tablet
Pillola Effervexxenti
Granules for oral solution
Granuli for Mill- ħalq solution
Via Palermo 26/ A
Via Palermo 26/ A 43100 Parma L- Italja
Powder and solvent for solution for injection
Trab u solvent għal solzzjoni għall- injezzjoni
55 Member State
55 Stat Membru
43100 Parma Italy Italy
L- Italja
Via Oria, 32 72028 Torre Santa Susanna (Br) Italy
Via Oria, 32 72028 Torre Santa Susanna (Br) L- Italja
Via Oria, 32
Via Oria, 32 72028 Torre Santa Susanna (Br) L- Italja
56 Member State
56 Stat Membru
72028 Torre Santa Susanna (Br) Italy Italy
L- Italja
Doc Generici Srl Via Manuzio, 7 20124 Milano Italy
Doc Generici Srl Via Manuzio, 7 20124 Milano L- Italja
Richard, 7 20143 Milano Italy
Riciebsa, 7 20143 Milano L- Italja
Via Scarlatti Domenico, 31
Via Scarlatti Domenico, 31 20124 Milano L- Italja
57 Member State
57 Stat Membru
20124 Milano Italy Italy
L- Italja
Via Scarlatti Domenico, 31 20124 Milano Italy
Via Scarlatti Domenico, 31 20124 Milano L- Italja
Epifarma S. R. L Via S. Rocco, 6 85033 Episcopia Pz Italy
Epifarma S. R. L Via S. Rocco, 6 85033 Episcopia Pz L- Italja
Soluble Tablet
Soluble Pillola
Via Di Scandicci, 37 50143 Firenze Italy
Via Di Scandicci, 37 50143 Firenze L- Italja
Capsule, soft
Kapsula, ratba
Via Di Scandicci, 37
Via Di Scandicci, 37 50143 Firenze L- Italja
58 Member State
58 Stat Membru
50143 Firenze Italy Italy
L- Italja
Via Privata Maria Teresa, 11 20123 Milano Italy
Via Privata Maria Teresa, 11 20123 Milano L- Italja
Viale Citta 'D'europa, 681 00100 Roma Italy
Viale Citta 'D' europa, 681 00100 Roma L- Italja
Centro Direzionale Colleoni Palazzo Andromeda Via Paracelso, 16 20041 Agrate Brianza (Mi) Italy
Centro Direzionale Colleoni Palazzo Andromeda Via Paracelso, 16 20041 Agrate Brianza (Mi) L- Italja
Via Mario Lalli, 8 56127 Pisa Italy
Via Mario Lalli, 8 56127 Pisa L- Italja
V. Emanuele, 73 88074 Crotone (Kr) Italy
V. Emanuele, 73 88074 Crotone (Kr) L- Italja
Via Egadi, 7 20144 Milano Italy
Via Egadi, 7 20144 Milano L- Italja
Intramuscular use
Ġol- muskolu use
Via Pavia, 6 20136 Milano
Via Pavia, 6 20136 Milano L- Italja
60 Member State
60 Stat Membru
Italy Italy
S. R. L.
Via Pavia, 6 20136 Milano Italy
Via Pavia, 6 20136 Milano L- Italja
Rectal use
mir- rektum
Strada Solaro, 75/ 77 18038 Villa Sayonara – Sanremo (Im) Italy
Strada Solaro, 75/ 77 18038 Villa Sayonara – Sanremo (Im) L- Italja
Lampugnani Farmaceutici Spa Bianca Maria Visconti, 33 20100 Milano Italy
Lampugnani Farmaceutici Spa Bianca Maria Visconti, 33
Italy
20100 Milano L- Italja L- Italja
Lampugnani Farmaceutici Spa Bianca Maria Visconti, 33 20100 Milano Italy
Lampugnani Farmaceutici Spa Bianca Maria Visconti, 33 20100 Milano L- Italja
Cutaneous foam
Sustanza kimika li tagħmel ir- ragħwa għall- ġilda
Via Giacomo Chiesi 43100 Parma Italy
Via Giacomo Chiesi 43100 Parma L- Italja
Granules for oral solution
Granijiet għal soluzzjoni orali
Italy
43100 Parma L- Italja L- Italja
Via Orazio, 20/ 22 80122 Napoli Italy
Via Orazio, 20/ 22 80122 Napoli L- Italja
Quartiere Varignano, 12 - 13 - 14 55049 Viareggio (Lu) Italy
Quartiere Varignano, 12 - 13 - 14 55049 Viareggio (Lu) L- Italja
Italy
55049 Viareggio (Lu) L- Italja L- Italja
Strada Statale 156 Km 50 04010 Borgo San Michele (Lt) Italy
Strada Statale 156 Km 50 04010 Borgo San Michele (Lt) L- Italja
Sublingual Tablet
Sublingual Pillola
156 Km 50 04010 Borgo San Michele (Lt) Italy
156 Km 50 04010 Borgo San Michele (Lt) L- Italja
Sublingual Tablet
Pillola ta ’ taħt l- ilsien
Via Tranquillo Cremona 10 20092 Cinisello Balsamo (Mi) Italy
Via Tranquillo Cremona 10 20092 Cinisello Balsamo (Mi) L- Italja
Via Palermo, 26/ A 43100 Parma Italy
Via Palermo, 26/ A 43100 Parma L- Italja
Granules for oral solution
Granuli għal soluzzjoni Mill- ħalqi
Ratiopharm Gmbh Graf-Arco Strasse 3 D-89070 Ulm Germany
Ratiopharm Gmbh Graf- Arco Strasse 3 D- 89070 Ulm Il- Ġermanja
Largo Boccioni, 1 21040 Origgio (Va) Italy
Largo Boccioni, 1 21040 Origgio (Va) L- Italja
Societa 'Di Servizio Per L'industria Farmaceutica Ed Affini Via Dei Castelli Romani, 22 00040 Pomezia (Rm) Italy
Societa 'Di Servizio Per L' industria Farmaceutica Ed Affini
Societa 'Di Servizio Per L'industria Farmaceutica Ed Affini Via Dei Castelli Romani, 22 00040 Pomezia (Rm) Italy
Societa 'Di Servizio Per L' industria Farmaceutica Ed Affini Via Dei Castelli Romani, 22 00040 Pomezia (Rm) L- Italja
Topical use
Użu topikali
Cutaneous foam
Fowm tal- ġilda
Via Felice Casati, 16 20124 Milano Italy
Via Felice Casati, 16 20124 Milano L- Italja
Viale Bodio, 37/ B 20158 Milano Italy
Viale Bodio, 37/ B 20158 Milano L- Italja
68 Member State
68 Stat Membru
Via Palermo 26/ A 43100 Parma Italy Lithuania
L- Italja Il- Litwanja
Granules for oral solution
Granuli għal soluzzjoni
Boehringer Ingelheim International Gmbh Binger Straβ e 173 55216 Ingelheim Am Rhein Germany
Boehringer InĠellheim International Gmbh
0,5 g/ 100 g
Ġellheim International Gmbh Finalgel Sport 0, 5 g/ 100 g Ġell
Gel
Jinfirex fuq
Cutaneous use
il- ġilda
Keresztúri Út 30-38 H-1106 Budapest Hungary
Keresztúri Út 30- 38 H- 1106 Budapest L- Ungerija
W. Pola 21 58-500 Jelenia Gora Poland
W. Pola 21 58- 500 Jelenia Gora Il- Polonja
Coated tablet
Pillola Miksija
69 Member State
69 Stat Membru
17, Boulevards De La Plaine B-1050 Bruxelles Belgium Luxembourg
Il- Belġju Il- Lussemburgu
17, Boulevards De La Plaine B-1050 Bruxelles Belgium
17, Boulevards De La Plaine B- 1050 Bruxelles Il- Belġju
Esplanade Heysel, B 22 B-1020 Bruxelles Belgium
Esplanade Heysel, B 22 B- 1020 Bruxelles Il- Belġju
70 Member State
70 Stat Membru
Esplanade Heysel B 22 B-1020 Bruxelles Belgium Luxembourg
Il- Belġju Il- Lussemburgu
615, Chaussee De Gand B-1080 Bruxelles Belgium
615, Chaussee De Gand B- 1080 Bruxelles Il- Belġju
Nycomed Belgium S. A.
Nycomed Il- Belġju S. A.
Smb Laboratories 26-28 Rue De La Pastorale B-1080 Bruxelles Belgium
Smb Laboratories 26- 28 Rue De La Pastorale B- 1080 Bruxelles Il- Belġju
Ambachtenlaan 13h B-3001 Heverlee Belgium
Ambachtenlaan 13h B- 3001 Heverlee Il- Belġju
Rationpharm Gmbh
Rationpharm Gmbh Postfach 3380 D- 89070 Ulm
71 Member State
71 Stat Membru
Postfach 3380 D-89070 Ulm Germany Luxembourg
Il- Ġermanja Il- Lussemburgu
Rationpharm Gmbh Postfach 3380 D-89070 Ulm Germany
Rationpharm Gmbh Postfach 3380 D- 89070 Ulm Il- Ġermanja
Hexal Ag Industriestrasse 25 D-83607 Holzkirchen Germany
Hexal Ag Industriestrasse 25 D- 83607 Holzkirchen Il- Ġermanja
Cipla (Uk) Limited 53a High Street Esher Surrey Kt10 9qr United Kingdom
Cipla (Uk) Limited 53a High Street Esher Surrey Kt10 9qr Ir- Renju Unit
Pirox Gel
Pirox Ġell
Dermal use
Għal użu fuq il- ġilda
72 Member State
72 Stat Membru
16 1220 Sofia Bulgaria Latvia
Il- Bulgarija Il- Latvija
16 1220 Sofia Bulgaria
16 1220 Sofia Il- Bulgarija
Wincentego Pola 21 58-500 Jelenia Gora Poland
Wincentego Pola 21 58- 500 Jelenia Gora Il- Polonja
Film-coated tablet
Pillola Miksija b’ Rita
Tallinna Farmaatsiatehase As 33 Tondi Street Ee – 11316, Tallinn Estonia
Tallinna Farmaatsiatehase As 33 Tondi Street Ee – 11316, Tallinn L- Estonja
Bruschettini SRL Via Isonzo 4 16147 Genova Italy
Bruschettini SRL Via Isonzo 4 16147 Genova L- Italja
188 Via Ilderbrando Vivanti 00144 Rome Italy
188 Via Ilderbrando Vivanti 00144 Rome L- Italja
73 Member State
73 Stat Membru
188 Via Ilderbrando Vivanti 00144 Rome Italy The Netherlands
L- Italja L- Olanda
Postbus 313 3740 Ah Baarn Baarnsche Dijk 1 3741 Ln Baarn The Netherlands
Postbus 313 3740 Ah Baarn Baarnsche Dijk 1 3741 Ln Baarn L- Olanda
Postbus 289 4870 Ag Etten Leur The Netherlands
Postbus 289 4870 Ag Etten Leur L- Olanda
Postbus 289 4870 Ag Etten Leur
Postbus 289 4870 Ag Etten Leur L- Olanda
74 Member State
74 Stat Membru
Sandoz B. V Veluwezoon 22 1327 Ah Almere The Netherlands
Veluwezoon 22 1327 Ah Almere L- Olanda
Oral use
mill- ħalq
Sandoz B. V Veluwezoon 22 1327 Ah Almere The Netherlands
Sandoz B. V Veluwezoon 22 1327 Ah Almere L- Olanda
Karib Ltd, Karib House 63-65 Imperial Way Cr9 4qy Croydon, Surrey United Kingdom
Karib Ltd, Karib House 63- 65 Imperial Way Cr9 4qy Croydon, Surrey Ir- Renju Unit
Postbus 408 2300 Ak Leiden The Netherlands
Postbus 408 2300 Ak Leiden L- Olanda
Nikkelstraat 5 4823 Ae Breda The Netherlands
Nikkelstraat 5 4823 Ae Breda L- Olanda
75 Member State
75 Stat Membru
Nikkelstraat 5 4823 Ae Breda The Netherlands The Netherlands
L- Olanda L- Olanda
Postbus 552 2003 RN Haarlem The Netherlands
Postbus 552 2003 RN Haarlem L- Olanda
Ratiopharm Nederland Bv, Postbus 2062 1500 Gb Zaandam The Netherlands
Ratiopharm Nederland Bv, Postbus 2062 1500 Gb Zaandam L- Olanda
76 Member State
76 Stat Membru
The Netherlands
L- Olanda L- Olanda
Postbus 2043 2800 Bd Gouda The Netherlands
Postbus 2043 2800 Bd Gouda L- Olanda
Hamwells Business Park Unit No.7, Hardicker Street M19 2rb Manchester United Kingdom
Hamwells Business Park Unit No. 7, Iebsaicker Street M19 2rb Manchester Ir- Renju Unit
Pfizer PO Box 3 N-1324 Lysaker
Pfizer PO Box 3 N- 1324 Lysaker In- Norveġja
Norway Norway
In- Norveġja
Nycomed Pharma As P. O.
Nycomed Pharma As
Box 205, N-1372 Asker 0010 Oslo Norway
Box 205, N- 1372 Asker 0010 Oslo In- Norveġja
Oral powder in sachet
Trab Orali f’ qartas
Box 158 Skøyen N-0212 Oslo Norway
Box 158 Skøyen N- 0212 Oslo In- Norveġja
Merck NM P. O. Box 23033 S-10435 Stockholm Sweden
Merck NM P. O. Box 23033 S- 10435 Stockholm L- Isvezja
Pfizer Europe MA EEIG Sandwich Kent Ct13 9nj United Kingdom
Pfizer Europe MA EEIG Sandwich Kent Ct13 9nj Ir- Renju Unit
189
189 60- 322, Poznań Il- Polonja
78 Member State
78 Stat Membru
60-322, Poznań Poland Poland
Il- Polonja
189 60-322, Poznań Poland
189 60- 322, Poznań Il- Polonja
Pola 21 58-500, Jelenia Góra Poland
Pola 21 58- 500, Jelenia Góra Il- Polonja
Kereszturi Ut 30-38 H-1106, Budapest Hungary
Kereszturi Ut 30- 38 H- 1106, Budapest L- Ungerija
Kereszturi Ut 30-38
Kereszturi Ut 30- 38 H- 1106, Budapest L- Ungerija
79 Member State
79 Stat Membru
H-1106, Budapest Hungary Poland
Il- Polonja
Biala 3 00-895 Warszawa Poland
Biala 3 00- 895 Warszawa Il- Polonja
Powder for solution for injection
Trab għal Soluzzjoni għall- injezzjoni
Boehringer Ingelheim International Gmbh Binger Str 173 55216, Ingelheim Am Rhein Germany
Boehringer InĠellheim International Gmbh Binger Str 173 55216, InĠellheim Am Rhein Il- Ġermanja
Cutaneous use
Jittieħed mill- ħalq
João Ii Lote 1.02.2.1 D - 2º 1990-090 Lisboa Portugal
João Ii Lote 1. 02. 2. 1 D - 2º 1990- 090 Lisboa Il- Portugall
Portugal
Edifício 10 2740- 271 Porto Salvo Il- Portugall Il- Portugall
Empreendimento Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal
Empreendimento Lagoas Park Edifício 10 2740- 271 Porto Salvo Il- Portugall
Menarini Portugal - Farmacêutica, S. A.
Menarini Il- Portugall - Farmacêutica, S. A.
Manuel I - Piso 2 Rua Dos Malhões Nº 1 2770-071 Paço De Arcos Portugal
Manuel I - Piso 2 Rua Dos Malhões Nº 1 2770- 071 Paço De Arcos Il- Portugall
Manuel I - Piso 2
Manuel I - Piso 2
81 Member State
81 Stat Membru
Rua Dos Malhões Nº 1 2770-071 Paço De Arcos Portugal Portugal
Rua Dos Malhões Nº 1 2770- 071 Paço De Arcos Il- Portugall Il- Portugall
Cutaneous use
Jinfirex fuq il - ġilda
Rua General Ferreira Martins, 8 - 7º Miraflores 1495-137 Algés Portugal
Rua General Ferreira Martins, 8 - 7º Miraflores 1495- 137 Algés Il- Portugall
Via intramuscular
Jittieħed ġol- muskolu
Estrada Nacional 117-2 Edifícios Azevedos - Alfragide 2724-503 Amadora Portugal
Estrada Nacional 117- 2 Edifícios Azevedos - Alfragide 2724- 503 Amadora Il- Portugall
82 Member State
82 Stat Membru
Route of administration
Carnaxide Il- Portugall Il- Portugall
Rua Quinta Do Pinheiro - Edifício Tejo - 6º Piso 2790-143 Carnaxide Portugal
Rua Quinta Do Pinheiro - Edifício Tejo - 6º Piso 2790- 143 Carnaxide Il- Portugall
Rua Manuel Ribeiro De Pavia, 1 - 1º Venda Nova 2700-547 Amadora Portugal
Rua Manuel Ribeiro De Pavia, 1 - 1º Venda Nova 2700- 547 Amadora Il- Portugall
José Malhoa - Edifício Malhoa Plaza Nº 2, Piso-Escritório 2.2 1070-325 Lisboa Portugal
José Malhoa - Edifício Malhoa Plaza Nº 2, Piso- Escritório 2. 2 1070- 325 Lisboa Il- Portugall
Solution for injection
Soluzzjoni
Intramuscular use
Jittieħed
83 Member State
83 Stat Membru
Route of administration
għall- injezzjoni
Portugal Portugal
Il- Portugall
Rua Manuel Ribeiro De Pavia, 1 - 1º - Venda Nova 2700-547 Amadora Portugal
Rua Manuel Ribeiro De Pavia, 1 - 1º - Venda Nova 2700- 547 Amadora Il- Portugall
Rua Do Padrão, 98 3000-312 Coimbra Portugal
Rua Do Padrão, 98 3000- 312 Coimbra Il- Portugall
Cinfa Portugal, Lda.
Cinfa Il- Portugall, Lda.
Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal
Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790- 221 Carnaxide Il- Portugall
Via Isonzo 6 16147 Genova Italy
Via Isonzo 6 16147 Genova L- Italja
Eye Drops, Solution
Soluzzjoni għat- taqtir ta ’ l- għajnejn
Ocular
Fl- għajnejn
Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Hungary
Egis Pharmaceuticals Plc Kereszturi Ut 30- 38 H- 1106 Budapest L- Ungerija
Solution For Injection
Soluzzjoni għall- injezzjoni
Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9 NJ United Kingdom
Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9 NJ Ir- Renju Unit
84 Member State
84 Stat Membru
Route of administration
Ir- Rumanija
D-55216 Ingelheim Am Rhein Germany Romania
Boehringer Ingellheim Pharma Gmbh & Co. Kg, Binger Strasse 173 D- 55216 InĠellheim Am Rhein Il- Ġermanja
Chiesi Farmaceutici Spa, Via Palermo, 26/ A 43100 Parma Italy
Chiesi Farmaceutici Spa, Via Palermo, 26/ A 43100 Parma L- Italja
Powder For Oral Solution
Trab għal soluzzjoni Mill- ħalqi
53-55 Sector 1, Bucuresti Romania
53- 55 Sector 1, Bucuresti Ir- Rumanija
Cutaneous
Jinfirex fuq il- ġilda
Maramures Romania
Maramures Ir- Rumanija
Valea Lupului Nr.1 Iasi Romania
Valea Lupului Nr. 1 Iasi Ir- Rumanija
Local
Lokali
85 Member State
85 Stat Membru
Romania
Ilfov Ir- Rumanija Ir- Rumanija
Ziduri Intre Vii Nr.22 Sector 2, Bucurest Romania
Ziduri Intre Vii Nr. 22 Sector 2, Bucurest Ir- Rumanija
Cluj Romania
Cluj Ir- Rumanija
B-Ul Timisoara Nr.50 Sector 6, Bucuresti Romania
B- Ul Timisoara Nr. 50 Sector 6, Bucuresti Ir- Rumanija
Victor Babes Nr.50 Baia Mare, Jud Maramures Romania
Victor Babes Nr. 50 Baia Mare, Jud Maramures Ir- Rumanija
86 Member State
86 Stat Membru
Sector 2, Bucuresti Romania Romania
1 Sector 2, Bucuresti Ir- Rumanija Ir- Rumanija
319e Sector 6, Bucuresti Romania
319e Sector 6, Bucuresti Ir- Rumanija
35 Iasi, Jud Iasi Romania
35 Iasi, Jud Iasi Ir- Rumanija
0,5g% 0,5g% Gel
Ġell
United Kingdom
Jinfirex fuq il- ġilda
87 Member State
87 Stat Membru
Route of administration
Ir- Renju Unit Ir- Rumanija
Ozone Laboratories Ltd.
Ir- Renju Unit Ozone Laboratories Ltd.
Sweden
Pillola
United Kingdom Nycomed Ab Box 27264 Se-102 53 Stockholm Sweden
Ir- Renju Unit
Piroxicam Brexidol
Piroxicam
3% 20 mg
20 mg
Cream Tablet
Pillola
Cutaneous Oral use
Jittieħed mill- ħalq
Nycomed Ab Box 27264 Se-102 53 Stockholm Sweden
Nycomed Ab Box 27264 Se- 102 53 Stockholm L- Isvezja
Merck Nm Ab Box 23033 Se-104 35 Stockholm Sweden
Merck Nm Ab Box 23033 Se- 104 35 Stockholm L- Isvezja
Tableta
Pillolaa
oral use
Jittieħed
88 Member State
88 Stat Membru
Route of administration
Via Palermo 26/ A 43100 Parma L- Italja
Italy Slovakia
Is- Slovakja
topical use
Użu topiku
parenteral use
Użu parenterali
Telč ská 114000 Praha 4 Czech Republic
Telčská 114000 Praha 4 Ir- Repubblika Ċeka
Krka, Tovarna Zdravil, D. D., Š marješ ka Cesta 6 Si-8501 Novo Mesto Slovenia
Krka, Tovarna Zdravil, D. D., Šmarješka Cesta 6 Si- 8501 Novo Mesto Is- Slovenja
89 Member State
89 Stat Membru
Route of administration
Šmarješka Cesta 6 Si- 8501 Novo Mesto Is- Slovenja
Slovenia Slovenia
Is- Slovenja
Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Walton Oaks, Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Ir- Renju Unit
Feldene Dispersable Tablets 10mg
Feldene Dispersable tablets 10mg
Tablet for oral solution
Pillola għal soluzzjoni Mill- ħalqi
Feldene Dispersible Tablets-20 Mg
Feldene Dispersable tablets- 20 Mg
90 Member State
90 Stat Membru
Route of administration
Ir- Renju Unit
Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Pfizer Limited Walton Oaks, Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Ir- Renju Unit
Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns United Kingdom
Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns Ir- Renju Unit
Tipperary, Ireland
Tipperary, L- Irlanda
91 Member State
91 Stat Membru
Route of administration
Ir- Renju Unit Ir- Renju Unit
Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe United Kingdom
Sandoz Limited Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe Ir- Renju Unit
Capsules
Piroxicam Kapsulas
Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ United Kingdom
Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ Ir- Renju Unit
Pharmvit Limited Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ United Kingdom
Pharmvit Limited Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ Ir- Renju Unit
Generics Uk Limited Albany Gate, Darkes Lane, Potters Bar Herts EN6 1AG United Kingdom
Generics Uk Limited Albany Gate, Darkes Lane, Potters Bar Herts EN6 1AG Ir- Renju Unit
Piroxicam Dispersible Tablets 10mg
Piroxicam Pillola li tinħall 10mg
Tablet for oral solution
Pillola għal soluzzjoni
Piroxicam Dispersible Tablets 20mg
Piroxicam Pillola li tinħall 20mg
Waymade Plc Sovereign House
Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR Ir- Renju Unit
Invented name
Ir- Renju Unit
Neolab Limited 57 High Street Odiham, Hampshire RG29 1LF United Kingdom
Neolab Limited 57 High Street Odiham, Hampshire RG29 1LF Ir- Renju Unit
Dr Reddy's Laboratories (Uk) Limited 6 Riverview Road Beverley, E Yorks HU17 0LD United Kingdom
Dr Reddy' s Laboratories (Uk) Limited 6 Riverview Road Beverley, E Yorks HU17 0LD Ir- Renju Unit
Trinity-Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY United Kingdom
Trinity- Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY Ir- Renju Unit
Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY United Kingdom
Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY Ir- Renju Unit
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB United Kingdom
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB Ir- Renju Unit
Piroxicam 0.5% Gel
Piroxicam 0. 5% Ġell
93 Member State
93 Stat Membru
Neots, Cambs PE19 3ET United Kingdom United Kingdom
Neots, Cambs PE19 3ET Ir- Renju Unit
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA Ir- Renju Unit
Piroxicam 0.5%W/ W
Piroxicam Ġell 0. 5% W/ W
Teva Pharma Bv Industrieweg 23 Po Box 217 3640 Ae Mijdrecht The Netherlands
Teva Pharma Bv Industrieweg 23 Po Box 217 3640 Ae Mijdrecht L- Olanda
Pfizer Consumer Healthcare Walton Oaks Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Pfizer Consumer Healthcare Walton Oaks Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Ir- Renju Unit
Feldene P
Feldene P Ġell
Crescent Pharma Limited Units 3 & 4, Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED United Kingdom
Crescent Pharma Limited Units 3 & 4, Quidhampton Business Units Polhampton Lane Overton, Hampshire RG25 3ED Ir- Renju Unit
94 Member State
94 Stat Membru
Overton, Hampshire RG25 3ED United Kingdom United Kingdom
Ir- Renju Unit
Strides Arcolab International Limited 201 Jersey Road Isleworth, Middx TW7 4QJ United Kingdom
Strides Arcolab International Limited 201 Jersey Road Isleworth, Middx TW7 4QJ Ir- Renju Unit
95 ANNEX II
95 ANNESS II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PIROXICAM CONTAINING MEDICINAL PRODUCTS (see Annex I)
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDAR TAS- SOMMARJI TAL- KARATTERISTIĊI TAL- PRODOTT U L- FULJETTI TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA SOMMARJU ĠENERALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ PRODOTTI MEDIĊINALI LI FIHOM PIROXICAM (ara Anness I)
Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic properties.
Piroxicam huwa mediċina anti- infjammatorja mhux sterojdi (NSAID) bi kwalitajiet anti- infjammatorji, analġeżiċi u kontra d- deni.
Piroxicam is authorised in the European Union following national marketing procedures.
Piroxicam huwa awtorizzat fl- Unjoni Ewropea wara proċeduri nazzjonali għat- tqegħid fis- suq.
Further to a request from the European Commission the CHMP reviewed safety data on non-selective NSAIDs.
B’ referenza għal talba mill- Kummissjoni Ewropea l- CHMP evalwa informazzjoni ta ’ sigurtà dwar NSAIDs mhux selettivi.
This review, which concluded in October 2005, did not reveal any new safety concerns for the class of NSAIDs as a whole.
Din l- evalwazzjoni, li ġiet konkluża f’ Ottubru 2005, ma żvelat l- ebda tħassib ta ’ sigurtà ġdid għall- klassi ta ’ NSAIDs b’ mod ġenerali.
However the Committee adopted recommendations for changes to the product information, or so called “ key elements” during this review which reflect a common position on well known safety issues in the product information of the non-selective NSAIDs.
Madankollu l- Kumitat adotta rakkomandazzjonijiet għal tibdil fl- informazzjoni dwar il- prodott, jew l- hekk imsejħa “ elementi prinċipali ” matul din l- evalwazzjoni li jirriflettu pożizzjoni komuni dwar kwistjonijiet magħrufa ta ’ sigurtà fl- informazzjoni dwar il- prodott ta ’ NSAIDs mhux selettivi.
These key elements were published on the EMEA website (Doc ref:
Dawn l- elementi prinċipali ġew ippubblikati fuq il- websajt ta ’ l- EMEA (Dok Ref:
However a need to further evaluate the benefit/ risk balance of some non-selective NSAIDs including piroxicam was identified.
Madankollu kienet identifikata l- ħtieġa li jiġi evalwat aktar il- bilanċ bejn il- benefiċċju u r- riskju ta ’ xi NSAIDs mhux selettivi fosthom piroxicam.
This review was finalised in June 2006.
Din l- evalwazzjoni ġiet finalizzata f’ Ġunju 2006.
The review found that limited epidemiological data and spontaneous adverse drug reaction data provided a signal of increased risk of gastrointestinal and skin reactions (including life-threatening bullous reactions) relative to other non- selective NSAIDs.
L - evalwazzjoni sabet li informazzjoni epidemjoloġika limitata u informazzjoni spontanja dwar ir - reazzjoni tal- mediċina pprovdiet sinjal ta ’ riskju akbar ta ’ reazzjonijiet gastro- intestinali u tal- ġilda (fosthom reazzjonijiet bullużi ta ’ periklu għall- ħajja) relattiv għal NSAIDs oħra mhux selettivi.
The CHMP considered that the assessment raised concerns on the benefit/ risk balance of piroxicam and informed the European Commission accordingly.
Il - CHMP qies li l- evalwazzjoni qajmet tħassib dwar il- bilanċ bejn il- benefiċċju u r- riskju ta ’ piroxicam u informa lill- Kummissjoni Ewropea f’ dak ir- rigward.
The CHMP also made recommendations for changes, or so called “ key elements”, to be included in the product information of piroxicam, as well as for some other non-selective NSAIDs which were published on the EMEA website in September 2006 (Doc ref:
Il- CHMP għamel ukoll rakkomandazzjonijiet għal bidliet, jew hekk imsejħa “ elementi prinċipali ”, li għandhom jiġu inklużi fl- informazzjoni dwar il - prodott ta ’ piroxicam, kif ukoll għal xi NSAIDs oħra mhux selettivi li ġew ippubblikati fuq il- websajt ta ’ l- EMEA f’ Settembru 2006 (Dok ref:
The European Commission considered it to be in the interest of public health to perform a new benefit/ risk assessment of piroxicam.
Il- Kummissjoni Ewropea ħasset li huwa fl- interess tas- saħħa pubblika li twettaq evalwazzjoni ġdida tal- benefiċċju/ riskju ta ’ piroxicam.
Therefore, the European Commission sent a notification that was received by the EMEA on 2 August 2006 and a referral under Article 31 of Directive 2001/ 83/ EC, as amended was started on 21 September 2006.
Għalhekk, il- Kummissjoni Ewropea bagħtet notifikazzjoni li kienet riċevuta mill- EMEA fit- 2 ta ’ Awwissu 2006 u referenza taħt l- Artikolu 31 tad- Direttiva 2001/ 83/ KE, kif emendat ġiet mibdija fil- 21 ta ’ Settembru 2006.
The European Commission requested the CHMP to give its opinion on whether the marketing authorisations for medicinal products containing piroxicam should be maintained, varied, suspended or revoked.
Il- Kummissjoni Ewropea talbet lill- CHMP biex jagħti l- opinjoni tiegħu dwar jekk l- awtorizzazzjonijiet għat- tqegħid fis- suq ta ’ prodotti li fihom piroxicam għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
The CHMP reviewed the data submitted by Marketing Authorisation Holders from clinical trials, epidemiological studies, and spontaneous reporting of adverse drug reactions.
Il- CHMP evalwa l- informazzjoni sottomessa mid- Detenturi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis - Suq minn provi kliniċi, studji epidemjoloġiċi, u rappurtar spontanju ta ’ reazzjonijiet avversi tal - mediċina.
The CHMP concluded on 21 June 2007 that epidemiological studies suggest that systemic formulations of piroxicam are associated with a higher risk of serious gastrointestinal toxicity, relative to other NSAIDs, and a higher risk of serious skin reactions (SCAR) than other non-oxicam NSAIDs.
Fil- 21 ta ’ Ġunju 2007 il- CHMP ikkonkluda li studji epidemjoloġiċi jissuġġerixxu li l- formulazzjonijiet sistemiċi ta ’ piroxicam huma assoċjati ma ’ riskju akbar ta ’ tossiċità gastro- intestinali serja, meta mqabbla ma ’ NSAIDs oħra, u riskju akbar ta ’ reazzjonijiet serji tal- ġilda (SCAR) minn NSAIDS mhux oxicam oħra.
Therefore the Committee has made a number of recommendations as outlined below.
Għalhekk il- Kumitat għamel numru ta ’ rakkomandazzjonijiet kif spjegat fil- qosor hawn taħt.
These recommendations build on the previous key elements published for piroxicam in September 2006 and must be implemented in the product information.
Dawn ir- rakkomandazzjonijiet jibnu fuq l- elementi prinċipali preċedenti ppubblikati għal piroxicam f’ Settembru 2006 u jridu jiġu implimentati fl- informazzjoni dwar il- prodott.
With regards to topical formulations of piroxicam, the CHMP agreed that no restrictions were necessary.
Dwar il- formulazzjonijiet topiċi ta ’ piroxicam, il- CHMP qabel li m’ hemmx bżonn restrizzjonijiet.
The use of topical NSAIDs is accompanied by a markedly reduced systemic exposure compared to systemic dosing and therefore a lower rate of systemic adverse events is expected with use of topical formulations.
L - użu ta ’ NSAIDs topiċi huwa akkumpanjat minn esponiment sistemiku mnaqqas ħafna meta mqabbel ma ’ dożaġġ sistemiku u għalhekk hija mistennija rata aktar baxxa ta ’ episodji avversi sistemiċi bl- użu ta ’ formulazzjonijiet topiċi.
As such the below outlined recommendations only apply to systemic formulations of piroxicam:
Fil- fatt ir- rakkomandazzjonijiet ta ’ hawn isfel japplikaw biss għal formulazzjonijiet sistemiċi ta ’ piroxicam:
− piroxicam should not be used for treatment of any acute condition due to the long half life of 50 hours and the safety profile, since equally effective and safer therapies are available; − the benefits of piroxicam outweigh the risks in the symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; − piroxicam is no longer a first line option should an NSAID be indicated; − prescription of piroxicam should only be initiated by those physicians with experience in diagnostic evaluation and treatment of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis; − new contraindications and strengthened warnings have been added to the Summary of Product characteristics and Package Leaflet in order to limit exposure of piroxicam to those patients without risk factors for gastrointestinal and skin reactions; − further risk minimisation measures include limitation of the dose of piroxicam to 20 mg per day, and recommendations to treat patients for the shortest time possible to relieve symptoms with review within 14 days.
− piroxicam m’ għandux jintuża għat- trattament ta ’ xi kondizzjoni akuta minħabba l- half life twila ta ’ 50 siegħa u l- profil tas- sigurtà, billi huma disponibbli terapiji effettivi daqsu u aktar siguri; − il- vantaġġi ta ’ piroxicam huma akbar mir- riskji fis- solliev sintomatiku ta ’ l- osteoartrite, l - artrite rewmatika jew spondilite li tagħqad bl- ankilosi; − piroxicam m’ għadux aktar l- ewwel għażla jekk tkun indikata NSAID; − il- preskrizzjoni ta ’ piroxicam għandha tinbeda biss minn tobba li għandhom esperjenza fl - evalwazzjoni dijanjostika u t- trattament ta ’ osteoartrite, artrite rewmatika jew spondilite li tagħqad bl- ankilosi; − ġew miżjuda kontra- indikazzjonijiet ġodda u twissijiet aktar b’ saħħithom fis- Sommarju tal - Karatteristiċi tal- Prodott u l- Fuljett ta ’ Tagħrif bil- għan li jitnaqqas l- esponiment ta ’ piroxicam għal dawk il- pazjenti mingħajr fatturi ta ’ riskju għal reazzjonijiet gastro- intestinali u tal- ġilda; − miżuri oħra sabiex jitnaqqas ir- riskju jinkludu l- limitazzjoni tad- doża ta ’ piroxicam għal 20 mg kuljum, u rakkomandazzjonijiet sabiex il- pazjenti jiġu trattati għall- iqsar żmien possibbli biex jittaffew is- sintomi b’ eżami mill- ġdid fi żmien 14- il ġurnata.
Combination therapy with gastro-protective agents (e. g. misoprostol or proton pump inhibitors) should also be carefully considered for all patients and in particular for the elderly.
It- terapija kombinata b’ sustanzi gastro- protettivi (eż. misoprostol jew inibituri tal- proton pump) għandha tiġi wkoll ikkunsidrata sewwa għall- pazjenti kollha u b’ mod partikolari għall- anzjani.
The CHMP agreed that the recommendations of article 5(3) of regulation (EC) no 726/ 2004 issued in October 2006 and published on the EMEA website (Doc.
Il- CHMP qabel li r- rakkomandazzjonijiet ta ’ l- artikolu 5( 3) tar- regolament (KE) nru 726/ 2004 maħruġa f’ Ottubru 2006 u ppubblikati fuq il- websajt ta ’ l- EMEA (Dok.
EMEA/ 413136/ 2006) remain valid for piroxicam containing medicinal products.
EMEA/ 413136/ 2006) jibqgħu validi għal prodotti mediċinali li fihom piroxicam.