natgillin/translations-raw huggingface dataset:
Corso Vittorio Emanuele Ii, 72 10121 Torino Italy
Corso Vittorio Emanuele Ii, 72 10121 Torino Italia
Aesculapius Farmaceutici Srl Via Cozzaglio, 24 25125 Brescia Italy
Aesculapius Farmaceutici Srl Via Cozzaglio, 24 25125 Brescia Italia
54 Member State
54 Jäsenvaltio
16147 Genova Italy Italy
Via Isonzo, 6 16147 Genova Italia Italia
Via Isonzo, 6 16147 Genova Italy
Via Isonzo, 6 16147 Genova Italia
Effervescent Tablet
Poretabletti
Granules for oral solution
Rakeet oraaliliuosta varten
55 Member State
55 Jäsenvaltio
43100 Parma Italy Italy
Via Palermo 26/ A 43100 Parma Italia
Via Oria, 32 72028 Torre Santa Susanna (Br) Italy
Via Oria, 32 72028 Torre Santa Susanna (Br) Italia
56 Member State
56 Jäsenvaltio
72028 Torre Santa Susanna (Br) Italy Italy
Via Oria, 32 72028 Torre Santa Susanna (Br) Italia Italia
Richard, 7 20143 Milano Italy
Rickova, 7 20143 Milano Italia
57 Member State
57 Jäsenvaltio
20124 Milano Italy Italy
Via Scarlatti Domenico, 31 20124 Milano Italia Italia
Soluble Tablet
Liukeneva tabletti
Epifarma S. R. L Via S. Rocco, 6 85033 Episcopia Pz Italy
Epifarma S. R. L Via S. Rocco, 6 85033 Episcopia Pz Italia
58 Member State
58 Jäsenvaltio
50143 Firenze Italy Italy
Via Di Scandicci, 37 50143 Firenze Italia Italia
Via Privata Maria Teresa, 11 20123 Milano Italy
Via Privata Maria Teresa, 11 20123 Milano Italia
Viale Citta 'D'europa, 681 00100 Roma Italy
Viale Citta 'D' europa, 681 00100 Roma Italia
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)
59 Member State
59 Jäsenvaltio
Italy
Italia Italia
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) Italia
V. Emanuele, 73 88074 Crotone (Kr) Italy
V. Emanuele, 73 88074 Crotone (Kr) Italia
Via Egadi, 7 20144 Milano Italy
Via Egadi, 7 20144 Milano Italia
Via Pavia, 6 20136 Milano
Via Pavia, 6
60 Member State
60 Jäsenvaltio
Italy Italy
20136 Milano Italia Italia
Via Pavia, 6 20136 Milano Italy
Via Pavia, 6 20136 Milano Italia
Strada Solaro, 75/ 77 18038 Villa Sayonara – Sanremo (Im) Italy
Strada Solaro, 75/ 77 18038 Villa Sayonara – Sanremo (Im) Italia
Strada Solaro, 75/ 77 18038 Villa Sayonara – Sanremo (Im) Italy
Strada Solaro, 75/ 77 18038 Villa Sayonara – Sanremo (Im)
61 Member State
61 Jäsenvaltio
Lampugnani Farmaceutici Spa Bianca Maria Visconti, 33 20100 Milano Italy
Lampugnani Farmaceutici Spa Bianca Maria Visconti, 33 20100 Milano Italia
Cutaneous foam
Ihovaahto
Via Giacomo Chiesi 43100 Parma Italy
Via Giacomo Chiesi 43100 Parma
62 Member State
62 Jäsenvaltio
Via Orazio, 20/ 22 80122 Napoli Italy
Via Orazio, 20/ 22 80122 Napoli Italia
Quartiere Varignano, 12 - 13 - 14 55049 Viareggio (Lu) Italy
Quartiere Varignano, 12 - 13 - 14 55049 Viareggio (Lu)
63 Member State
63 Jäsenvaltio
Sublingual Tablet
Resoribletti
156 Km 50 04010 Borgo San Michele (Lt) Italy
156 Km 50 04010 Borgo San Michele (Lt) Italia
156 Km 50 04010 Borgo San Michele (Lt) Italy
156 Km 50 04010 Borgo San Michele (Lt)
64 Member State
64 Jäsenvaltio
Via Palermo, 26/ A 43100 Parma Italy
Via Palermo, 26/ A 43100 Parma Italia
Via Palermo, 26/ A 43100 Parma Italy
Via Palermo, 26/ A 43100 Parma
65 Member State
65 Jäsenvaltio
66 Member State
66 Jäsenvaltio
Ratiopharm Gmbh Graf-Arco Strasse 3 D-89070 Ulm Germany
Ratiopharm Gmbh Graf- Arco Strasse 3 D- 89070 Ulm Saksa
Largo Boccioni, 1 21040 Origgio (Va) Italy
Largo Boccioni, 1 21040 Origgio (Va) Italia
Largo Boccioni, 1 21040 Origgio (Va) Italy
Largo Boccioni, 1 21040 Origgio (Va)
67 Member State
67 Jäsenvaltio
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) Italia
Viale Bodio, 37/ B 20158 Milano Italy
Viale Bodio, 37/ B 20158 Milano Italia
68 Member State
68 Jäsenvaltio
Via Palermo 26/ A 43100 Parma Italy Lithuania
Via Palermo 26/ A 43100 Parma Italia
Boehringer Ingelheim International Gmbh Binger Straβ e 173 55216 Ingelheim Am Rhein Germany
Boehringer InGeeliheim International Gmbh
0,5 g/ 100 g
Geeliheim International Gmbh Finalgel Sport 0, 5 g/ 100 g Geeli
Lithuania
Binger Straβe 173 55216 InGeeliheim Am Rhein Saksa Liettua
Keresztúri Út 30-38 H-1106 Budapest Hungary
Keresztúri Út 30- 38 H- 1106 Budapest Unkari
W. Pola 21 58-500 Jelenia Gora Poland
W. Pola 21 58- 500 Jelenia Gora Puola
Tablet
Tabletti, päällystetty
69 Member State
69 Jäsenvaltio
17, Boulevards De La Plaine B-1050 Bruxelles Belgium Luxembourg
17, Boulevards De La Plaine B- 1050 Bruxelles Belgia
Cutaneous use
Suun kautta
70 Member State
70 Jäsenvaltio
Smb Laboratories 26-28 Rue De La Pastorale B-1080 Bruxelles Belgium
Smb Laboratories 26- 28 Rue De La PastSuun kauttae B- 1080 Bruxelles Belgia
Ambachtenlaan 13h B-3001 Heverlee Belgium
Ambachtenlaan 13h B- 3001 Heverlee Belgia
71 Member State
71 Jäsenvaltio
Postfach 3380 D-89070 Ulm Germany Luxembourg
Rationpharm Gmbh Postfach 3380 D- 89070 Ulm Saksa
Rationpharm Gmbh Postfach 3380 D-89070 Ulm Germany
Rationpharm Gmbh Postfach 3380 D- 89070 Ulm Saksa
Hexal Ag Industriestrasse 25 D-83607 Holzkirchen Germany
Hexal Ag Industriestrasse 25 D- 83607 Holzkirchen Saksa
Cipla (Uk) Limited 53a High Street Esher Surrey Kt10 9qr United Kingdom
Cipla (Uk) Limited 53a High Street Esher Surrey Kt10 9qr Iso- Britannia
Dermal use
Iholle
72 Member State
72 Jäsenvaltio
16 1220 Sofia Bulgaria Latvia
16 1220 Sofia Bulgaria
Wincentego Pola 21 58-500 Jelenia Gora Poland
Wincentego Pola 21 58- 500 Jelenia Gora Puola
Tallinna Farmaatsiatehase As 33 Tondi Street Ee – 11316, Tallinn Estonia
Tallinna Farmaatsiatehase As 33 Tondi Street Ee – 11316, Tallinn Viro
Bruschettini SRL Via Isonzo 4 16147 Genova Italy
Bruschettini SRL Via Isonzo 4 16147 Genova Italia
188 Via Ilderbrando Vivanti 00144 Rome Italy
188 Via Ilderbrando Vivanti 00144 Rome Italia
73 Member State
73 Jäsenvaltio
188 Via Ilderbrando Vivanti 00144 Rome Italy The Netherlands
188 Via Ilderbrando Vivanti 00144 Rome Italia
Postbus 313 3740 Ah Baarn Baarnsche Dijk 1 3741 Ln Baarn The Netherlands
Postbus 313 3740 Ah Baarn Baarnsche Dijk 1 3741 Ln Baarn Alankomaat
Postbus 289 4870 Ag Etten Leur The Netherlands
Postbus 289 4870 Ag Etten Leur Alankomaat
Postbus 289 4870 Ag Etten Leur
Postbus 289
74 Member State
74 Jäsenvaltio
The Netherlands The Netherlands
4870 Ag Etten Leur Alankomaat Alankomaat
Sandoz B. V Veluwezoon 22 1327 Ah Almere The Netherlands
Sandoz B. V Veluwezoon 22 1327 Ah Almere Alankomaat
Dispersible tablet
Dispergoituva tabletti Dispergoituva tabletti
Dispersible tablet
Poretabletti
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 Iso- Britannia
Postbus 408 2300 Ak Leiden The Netherlands
Postbus 408 2300 Ak Leiden Alankomaat
Nikkelstraat 5 4823 Ae Breda The Netherlands
Nikkelstraat 5 4823 Ae Breda Alankomaat
75 Member State
75 Jäsenvaltio
Nikkelstraat 5 4823 Ae Breda The Netherlands The Netherlands
Nikkelstraat 5 4823 Ae Breda Alankomaat
Postbus 552 2003 RN Haarlem The Netherlands
Postbus 552 2003 RN Haarlem Alankomaat
Ratiopharm Nederland Bv, Postbus 2062 1500 Gb Zaandam The Netherlands
Ratiopharm Nederland Bv, Postbus 2062 1500 Gb Zaandam Alankomaat
76 Member State
76 Jäsenvaltio
Postbus 2062 1500 Gb Zaandam The Netherlands
Ratiopharm Nederland Bv, Postbus 2062 1500 Gb Zaandam Alankomaat
Postbus 2043 2800 Bd Gouda The Netherlands
Postbus 2043 2800 Bd Gouda Alankomaat
Hamwells Business Park Unit No.7, Hardicker Street M19 2rb Manchester United Kingdom
Hamwells Business Park Unit No. 7, Kovaicker Street M19 2rb Manchester Iso- Britannia
Pfizer PO Box 3 N-1324 Lysaker
Pfizer PO Box 3
77 Member State
77 Jäsenvaltio
Norway Norway
N- 1324 Lysaker Norja Norja
Box 205, N-1372 Asker 0010 Oslo Norway
Box 205, N- 1372 Asker 0010 Oslo Norja
Oral powder in sachet
Jauhe, annospussi
Box 158 Skøyen N-0212 Oslo Norway
Box 158 Skøyen N- 0212 Oslo Norja
Merck NM P. O. Box 23033 S-10435 Stockholm Sweden
Merck NM P. O. Box 23033 S- 10435 Stockholm Ruotsi
Pfizer Europe MA EEIG Sandwich Kent Ct13 9nj United Kingdom
Pfizer Europe MA EEIG Sandwich Kent Ct13 9nj Iso- Britannia
189
Glaxosmithkline Pharmaceuticals S. A
78 Member State
78 Jäsenvaltio
60-322, Poznań Poland Poland
189 60- 322, Poznań Puola Puola
189 60-322, Poznań Poland
189 60- 322, Poznań Puola
Pola 21 58-500, Jelenia Góra Poland
Pola 21 58- 500, Jelenia Góra Puola
Kereszturi Ut 30-38 H-1106, Budapest Hungary
Kereszturi Ut 30- 38 H- 1106, Budapest Unkari
79 Member State
79 Jäsenvaltio
H-1106, Budapest Hungary Poland
Kereszturi Ut 30- 38 H- 1106, Budapest Unkari Puola
Biala 3 00-895 Warszawa Poland
Biala 3 00- 895 Warszawa Puola
Boehringer Ingelheim International Gmbh Binger Str 173 55216, Ingelheim Am Rhein Germany
Boehringer InGeeliheim International Gmbh Binger Str 173 55216, InGeeliheim Am Rhein Saksa
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 Portugali
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
80 Member State
80 Jäsenvaltio
Portugal
Portugali Portugali
Empreendimento Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal
Empreendimento Lagoas Park Edifício 10 2740- 271 Porto Salvo Portugali
Menarini Portugal - Farmacêutica, S. A.
Menarini Portugali - 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 Portugali
Manuel I - Piso 2
Manuel I - Piso 2 Rua Dos Malhões Nº 1 2770- 071 Paço De Arcos Portugali
Rua Dos Malhões Nº 1 2770-071 Paço De Arcos Portugal Portugal
Portugali
Rua General Ferreira Martins, 8 - 7º Miraflores 1495-137 Algés Portugal
Rua General Ferreira Martins, 8 - 7º Miraflores 1495- 137 Algés Portugali
Via intramuscular
Lihakseen
Estrada Nacional 117-2 Edifícios Azevedos - Alfragide 2724-503 Amadora Portugal
Estrada Nacional 117- 2 Edifícios Azevedos - Alfragide 2724- 503 Amadora Portugali
Rua Quinta Do Pinheiro - Edifício Tejo - 6º Piso 2790-143 Carnaxide Portugal
Rua Quinta Do Pinheiro - Edifício Tejo - 6º Piso 2790- 143 Carnaxide Portugali
Ratiopharm - Comércio E Indústria De Produtos
Ratiopharm - Comércio E Indústria De Produtos Farmacêuticos, Lda.
Piroxicam
Piroxicam Ratiopharm 20 Mg Comprimidos
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 Portugali
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
83 Member State
83 Jäsenvaltio
Portugal Portugal
1070- 325 Lisboa Portugali Portugali
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 Portugali
Rua Do Padrão, 98 3000-312 Coimbra Portugal
Rua Do Padrão, 98 3000- 312 Coimbra Portugali
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 Portugali
Via Isonzo 6 16147 Genova Italy
Via Isonzo 6 16147 Genova Italia
Eye Drops, Solution
Silmätipat, liuos
Ocular
Silmään
Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Hungary
Egis Pharmaceuticals Plc Kereszturi Ut 30- 38 H- 1106 Budapest Unkari
Solution For Injection
Injektioneste
Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9 NJ United Kingdom
Pfizer Europe MA EEIG Ramsgate Road
84 Member State
84 Jäsenvaltio
D-55216 Ingelheim Am Rhein Germany Romania
Binger Strasse 173 D- 55216 InGeeliheim Am Rhein Saksa Romania
Chiesi Farmaceutici Spa, Via Palermo, 26/ A 43100 Parma Italy
Chiesi Farmaceutici Spa, Via Palermo, 26/ A 43100 Parma Italia
Powder For Oral Solution
Jauhe oraaliliuosta varten
53-55 Sector 1, Bucuresti Romania
53- 55 Sector 1, Bucuresti Romania
Piroxsal
Piroxsal Gel
Cutaneous
Iholle
Valea Lupului Nr.1 Iasi Romania
Valea Lupului Nr. 1 Iasi Romania
Local
Vahvuus
Ilfov Romania
Ilfov Romania
Ziduri Intre Vii Nr.22 Sector 2, Bucurest Romania
Ziduri Intre Vii Nr. 22 Sector 2, Bucurest Romania
B-Ul Timisoara Nr.50 Sector 6, Bucuresti Romania
B- Ul Timisoara Nr. 50 Sector 6, Bucuresti Romania
Victor Babes Nr.50 Baia Mare, Jud Maramures Romania
Victor Babes Nr. 50
Romania
Baia Mare, Jud Maramures Romania Romania
Stefan Mihaileanu Nr.31 Etaj 1, Ap.
Stefan Mihaileanu Nr. 31 Etaj 1, Ap.
1
1 Sector 2, Bucuresti Romania
Sector 2, Bucuresti Romania Romania
Romania
Gel
0, 5g% 0, 5g%
0,5g% 0,5g% Gel
Geeli
Piroxicam
Piroxicam 1%
87 Member State
87 Jäsenvaltio
Ozone Laboratories Ltd.
Iso- Britannia Ozone Laboratories Ltd.
United Kingdom Nycomed Ab Box 27264 Se-102 53 Stockholm Sweden
Iso- Britannia Nycomed Ab Box 27264 Se- 102 53 Stockholm Ruotsi
Cream Tablet
Emulsiovoide Tabletti
Cutaneous Oral use
Iholle Suun kautta
Nycomed Ab Box 27264 Se-102 53 Stockholm Sweden
Nycomed Ab Box 27264 Se- 102 53 Stockholm Ruotsi
Merck Nm Ab Box 23033 Se-104 35 Stockholm Sweden
Merck Nm Ab Box 23033 Se- 104 35 Stockholm Ruotsi
Via Palermo 26/ A 43100 Parma Italy
Via Palermo 26/ A
Granulát
Rakeet
Slovakia
43100 Parma Italia Slovakia
Via Palermo 26/ A 43100 Parma
Via Palermo 26/ A 43100 Parma Italia
Tableta
Tabletti
Italy Slovakia
Slovakia
Dermálny krém
Emulsiovoide
topical use
Paikallisesti
Kapsula
Kapseli
Injekč ný roztok
Injektioneste
parenteral use
Parenteraalisesti
Telč ská 114000 Praha 4 Czech Republic
Telčská 114000 Praha 4 Tshekki
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 Slovenia
Krka, Tovarna Zdravil, D. D., Š marješ ka Cesta 6 Si-8501 Novo Mesto Slovenia
Krka, Tovarna Zdravil, D. D., Šmarješka Cesta 6
89 Member State
89 Jäsenvaltio
Slovenia Slovenia
Si- 8501 Novo Mesto Slovenia Slovenia
Capsules 10
Feldene Capsules 10 Mg
Pfizer Limited
Pfizer Limited Walton Oaks, Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Iso- Britannia
20 (20mg
Feldene 20 (20mg Capsules)
Tablet for oral solution
Liukeneva tabletti
Feldene Dispersible Tablets-20 Mg
Feldene Dispersible Tablets- 20 Mg
Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Pfizer Limited Walton Oaks, Dorking Road
Feldene Gel 0.5% W/ W
Feldene Gel 0. 5% W/ W
0.5% w/ w
0, 5% w/ w
90 Member State
90 Jäsenvaltio
Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Walton- 0n- The- Hill Surrey KT20 7NS Iso- Britannia Iso- Britannia
Injection 20mg/ Ml
Lihakseen
Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns United Kingdom
Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns Iso- Britannia
Sandoz Limited Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe United Kingdom
Sandoz Limited
Piroxicam 10 Mg Capsules
Piroxicam 10 Mg
91 Member State
91 Jäsenvaltio
Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe United Kingdom
Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe Iso- Britannia
Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ United Kingdom
Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ Iso- Britannia
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 Iso- Britannia
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 Iso- Britannia
Generics Uk Limited Albany Gate, Darkes Lane, Potters Bar Herts EN6 1AG United Kingdom
Generics Uk Limited
Piroxicam Dispersible Tablets 20mg
Piroxicam
Waymade Plc Sovereign House
Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR Iso- Britannia
Piroxicam 0.5% Gel
Piroxicam 0. 5% Gel
Miles Gray Road Basildon, Essex SS14 3FR United Kingdom United Kingdom
Iso- Britannia
Neolab Limited 57 High Street Odiham, Hampshire RG29 1LF United Kingdom
Neolab Limited 57 High Street Odiham, Hampshire RG29 1LF Iso- Britannia
Piroxicam 0.5%
Piroxicam 0. 5% Gel
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 Iso- Britannia
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 Iso- Britannia
Trinity-Chiesi Pharmaceuticals Limited
Trinity- Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY Iso- Britannia
Brexidol 20 Mg
Brexidol 20 Mg Effervescent Tablets
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB United Kingdom
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB Iso- Britannia
Neots, Cambs PE19 3ET United Kingdom
Neots, Cambs PE19 3ET Iso- Britannia
Tillomed Laboratories Limited
Tillomed Laboratories Limited 3 Howard Road, Eaton Socon St.
Neots, Cambs PE19 3ET United Kingdom United Kingdom
Iso- Britannia
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA Iso- Britannia
Piroxicam 0.5%W/ W
Piroxicam Gel 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 Alankomaat
Flamatrol Capsules
Flamatrol 10mg Capsules
Flamatrol Capsules
Flamatrol 20mg Capsules
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 Iso- Britannia
Feldene P
Feldene P Gel
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
Piroxicam Bp 10mg
Piroxicam Capsules Bp 10mg
94 Member State
94 Jäsenvaltio
Overton, Hampshire RG25 3ED United Kingdom United Kingdom
Overton, Hampshire RG25 3ED Iso- Britannia Iso- Britannia
Strides Arcolab International Limited 201 Jersey Road Isleworth, Middx TW7 4QJ United Kingdom
Strides Arcolab International Limited 201 Jersey Road Isleworth, Middx TW7 4QJ Iso- Britannia
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)
EMEAN TIETEELLISET JOHTOPÄÄTÖKSET JA PERUSTEET VALMISTEYHTEENVETOJEN JA PAKKAUSSELOSTEIDEN MUUTTAMISELLE TIIVISTELMÄ TIETEELLISESTÄ ARVIOINNISTA, JOKA KOSKEE PIROKSIKAAMIA SISÄLTÄVIÄ LÄÄKEVALMISTEITA (katso liite I)
Further to a request from the European Commission the CHMP reviewed safety data on non-selective NSAIDs.
CHMP arvioi ei- selektiivisten tulehduskipulääkkeiden turvallisuustietoja Euroopan komission pyynnöstä.
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.
Nämä keskeiset
These key elements were published on the EMEA website (Doc ref:
(asiakirjaviite:
However a need to further evaluate the benefit/ risk balance of some non-selective NSAIDs including piroxicam was identified.
Arvioinnin yhteydessä katsottiin kuitenkin, että joidenkin ei- selektiivisten tulehduskipulääkkeiden (mukaan lukien piroksikaami) hyöty- riskisuhdetta olisi arvioitava tarkemmin.
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.
Arvioinnissa havaittiin, että puutteelliset epidemiologiset tiedot ja tiedot spontaaneista haittavaikutusilmoituksista olivat merkki kasvaneesta maha- suolikanavan reaktioiden ja ihoreaktioiden riskistä (mukaan lukien hengenvaaralliset rakkulaiset reaktiot) suhteessa muihin ei - selektiivisiin tulehduskipulääkkeisiin.
The CHMP considered that the assessment raised concerns on the benefit/ risk balance of piroxicam and informed the European Commission accordingly.
CHMP katsoi, että arvioinnissa nousi esiin huolenaiheita piroksikaamin hyöty- riskisuhteesta, ja ilmoitti siitä Euroopan komissiolle.
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:
Suositukset julkaistiin Euroopan lääkeviraston kotisivuilla syyskuussa 2006 (asiakirjaviite:
The European Commission considered it to be in the interest of public health to perform a new benefit/ risk assessment of piroxicam.
Tämän vuoksi Euroopan komissio lähetti ilmoituksen, jonka Euroopan lääkevirasto sai 2. elokuuta 2006.
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.
Muutetun direktiivin 2001/ 83/ EY 31 artiklan mukainen menettely aloitettiin 21. syyskuuta 2006.
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.
CHMP totesi 21. kesäkuuta 2007 epidemiologisten tutkimusten osoittavan, että piroksikaamin systeemisiin valmisteisiin liittyy suurempi vakavan maha- suolikanavan myrkytystilan riski suhteessa muihin tulehduskipulääkkeisiin ja suurempi vakavien ihoreaktioiden (SCAR) riski kuin muihin tulehduskipulääkkeisiin, jotka eivät sisällä oksikaamia.
− 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.
− piroksikaamia ei tule käyttää minkään akuutin sairauden hoitoon sen pitkän puoliintumisajan (50 tuntia) ja turvallisuusprofiilin vuoksi, koska yhtä tehokkaita ja turvallisempia hoitoja on saatavilla − piroksikaamin hyödyt ovat sen riskejä suuremmat nivelrikon, nivelreuman tai selkärankareuman oireenmukaisessa lievityksessä − piroksikaami ei ole enää ensisijainen vaihtoehto, jos tulehduskipulääkehoito on aiheellinen − piroksikaamia määräävien lääkäreiden tulee olla perehtyneitä nivelrikon, nivelreuman tai selkärankareuman diagnostiseen arviointiin ja hoitoon − valmisteyhteenvetoon ja pakkausselosteeseen on lisätty uusia vasta- aiheita ja voimakkaampia varoituksia, jotta piroksikaamille altistuminen voidaan rajoittaa niihin potilaisiin, joilla ei ole maha- suolikanavaan ja ihoreaktioihin liittyviä riskitekijöitä − muita riskejä alentavia toimenpiteitä ovat piroksikaamiannoksen rajoittaminen 20 milligrammaan vuorokaudessa sekä suositukset hoitaa potilaita mahdollisimman lyhyen aikaa oireiden lievittämiseksi ja tehdä tarkastus 14 päivän kuluessa.