natgillin/translations-raw huggingface dataset:
Pfizer Holding France 23-25, Avenue Du Docteur Lannelongue 75014 Paris France
Pfizer Holding Franţa 23- 25, Avenue Du Docteur Lannelongue 75014 Paris Franţa
Piroxicam Beral 10 Mg, Gélule
Piroxicam Beral 10
Piroxicam Beral 0,5 Pour Cent, Gel
Piroxicam Beral 0, 5
Pierre Fabre Medicament 45, Place Abel Gance 92654 Boulogne Cedex France
Pierre Fabre Medicament
Brexin 20 Mg, Suppositoire
Brexin 20 Mg,
Brexin 20 Mg, Comprimé Sécable
Brexin 20 Mg,
47 Member State
47 Statul Membru
Sandoz 49, Avenue Georges Pompidou 92300 Levallois-Perret France
Sandoz
Piroxicam Sandoz 20 Mg, Gélule
Piroxicam Sandoz 20
Sandoz 49, Avenue Georges Pompidou 92300 Levallois-Perret France
49, Avenue Georges Pompidou 92300 Levallois- Perret Franţa
Piroxicam Gnr 10 Mg, Gélule
Piroxicam Gnr 10
Teva Classics Le Palatin 1, 1, Cours Du Triangle, 92936 Paris La Défense Cedex France
Teva Classics
Piroxicam Teva 10 Mg, Gélule
Piroxicam Teva 10
Teva Classics Le Palatin 1, 1, Cours Du Triangle, 92936 Paris La Défense Cedex France
Le Palatin 1, 1, Cours Du Triangle, 92936 Paris La Défense Cedex Franţa
Piroxicam Teva 20 Mg, Gélule
Piroxicam Teva 20
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 Franţa
Teva Pharma Bv Industrieweg 23 Po Box 217, 3640 Ae Mijdrecht The Netherlands
Teva Pharma Bv Industrieweg 23 Po Box 217, 3640 Ae Mijdrecht Olanda
48 Member State
48 Statul Membru
3640 Ae Mijdrecht The Netherlands France
Industrieweg 23 Po Box 217, 3640 Ae Mijdrecht Olanda
Meda Pharma 25, Boulevard de l’ Amiral Bruix 75016 Paris France
Meda Pharma 25, Boulevard de l’ Amiral Bruix 75016 Paris Franţa
Meda Pharma 25, Boulevard de l’ Amiral Bruix 75016 Paris France
Meda Pharma
Flexirox 20 Mg, Gélule
Flexirox 20 Mg,
Flexirox 10 Mg, Gélule
Flexirox 10 Mg,
Winthrop Medicaments 1/ 13, Boulevard Romain Rolland 75014 Paris France
Winthrop Medicaments
Piroxicam Winthrop 20 Mg, Gélule
20 mg
Piroxicam Winthrop 10 Mg, Gélule
Piroxicam Winthrop
Winthrop Medicaments 1/ 13, Boulevard Romain Rolland
1/ 13, Boulevard Romain Rolland 75014 Paris Franţa
49 Member State
49 Statul Membru
75014 Paris France France
Winthrop Medicaments 1/ 13, Boulevard Romain Rolland 75014 Paris Franţa
Winthrop Medicaments 1/ 13, Boulevard Romain Rolland 75014 Paris France
Winthrop Medicaments 1/ 13, Boulevard Romain Rolland 75014 Paris Franţa
Zydus France 25, Rue Des Peupliers, Zac Les Hautes Pâtures - Parc D’ activités Des Peupliers, 92000 Nanterre France
Zydus Franţa
Piroxicam Zydus 20 Mg, Gélule
Piroxicam Zydus 20
Zydus France 25, Rue Des Peupliers, Zac Les Hautes Pâtures - Parc D’ activités Des Peupliers, 92000 Nanterre France
25, Rue Des Peupliers, Zac Les Hautes Pâtures - Parc D’ activités Des Peupliers, 92000 Nanterre Franţa
Piroxicam Zydus 10 Mg, Gélule
Piroxicam Zydus 10
19 89150 Laichingen Germany
19 89150 Laichingen Germania
50 Member State
50 Statul Membru
Hungary
1010 Viena Austria Ungaria
30-38 1106 Budapest Hungary
30- 38 1106 Budapesta Ungaria
Topical use
Administrare locală
1034 Budapest, Tímár U.
1034 Budapesta, Tímár U.
51 Member State
51 Statul Membru
5/ C 1133 Budapest Hungary
1133 Budapesta Ungaria Ungaria
Feldene Dispersal
Feldene
5/ C 1133 Budapest Hungary
5/ C 1133 Budapesta Ungaria
70-72 1074 Budapest Hungary
70- 72 1074 Budapesta Ungaria
13 4042 Debrecen Hungary
13 4042 Debrecen Ungaria
52 Member State
52 Statul Membru
Ireland
Highfield, Cheadle Sk8 3gy Marea Britanie Irlanda
Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy United Kingdom
Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy Marea Britanie
Feldene 10 Mg Capsules
Feldene 10 Mg
Feldene 20mg Capsules
Feldene 20mg
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 Marea Britanie
Pfizer Healthcare Ireland 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Ireland
Pfizer Healthcare Irlanda 9 Riverwalk National Digital Park Citywest Business Campus Dublin 24 Irlanda
53 Member State
53 Statul Membru
Dk 2750 Ballerup Denmark Iceland
Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Danemarca
Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Denmark
Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Danemarca
Topical use
Administrare
Via Isonzo, 6
Via Isonzo, 6 16147 Genova Italia
16147 Genova Italy Italy
Italia
Eye drops, solution
Picături oftalmice,
Ocular use
Administrare
Effervescent Tablet
Comprimate
Granules for oral solution
Gramule pentru soluţie
55 Member State
55 Statul Membru
Via Oria, 32
Via Oria, 32 72028 Torre Santa Susanna (Br) Italia
72028 Torre Santa Susanna (Br) Italy Italy
Italia
Doc Generici Srl Via Manuzio, 7 20124 Milano Italy
Doc Generici Srl
Piroxicam Doc Generici
Piroxicam Doc
Richard, 7 20143 Milano Italy
Richard, 7 20143 Milano Italia
Via Scarlatti Domenico, 31
Via Scarlatti Domenico, 31 20124 Milano Italia
20124 Milano Italy Italy
Italia
Soluble Tablet
Comprimate solubile
Via Di Scandicci, 37
Via Di Scandicci, 37 50143 Firenze Italia
50143 Firenze Italy Italy
Italia
59 Member State
59 Statul Membru
Italy
20041 Agrate Brianza (Mi) Italia Italia
60 Member State
60 Statul Membru
Italy Italy
Via Pavia, 6 20136 Milano Italia Italia
61 Member State
61 Statul Membru
Italy
18038 Villa Sayonara – Sanremo (Im) Italia Italia
Cutaneous foam
Spumă cutanată
Granules for oral solution
Granule pentru soluţie
62 Member State
62 Statul Membru
Italy
43100 Parma Italia Italia
63 Member State
63 Statul Membru
Italy
55049 Viareggio (Lu) Italia Italia
Sublingual Tablet
Comprimate
64 Member State
64 Statul Membru
Italy
04010 Borgo San Michele (Lt) Italia Italia
65 Member State
65 Statul Membru
Via Palermo, 26/ A 43100 Parma Italy
43100 Parma Italia Italia
66 Member State
66 Statul Membru
Ratiopharm Gmbh Graf-Arco Strasse 3 D-89070 Ulm Germany
Ratiopharm Gmbh
67 Member State
67 Statul Membru
Italy
21040 Origgio (Va) Italia Italia
68 Member State
68 Statul Membru
Via Palermo 26/ A 43100 Parma Italy Lithuania
Italia Lituania
Boehringer Ingelheim International Gmbh Binger Straβ e 173 55216 Ingelheim Am Rhein Germany
Boehringer Ingelheim International Gmbh Binger Straβe 173 55216 Ingelheim Am Rhein Germania
Keresztúri Út 30-38 H-1106 Budapest Hungary
Keresztúri Út 30- 38 H- 1106 Budapesta Ungaria
W. Pola 21 58-500 Jelenia Gora Poland
W. Pola 21 58- 500 Jelenia Gora Polonia
Coated tablet
Drajee
Tablet
Drajee
69 Member State
69 Statul Membru
Cutaneous use
Administrare orală
70 Member State
70 Statul Membru
Nycomed Belgium S. A.
Nycomed Belgia 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 Belgia
Rationpharm Gmbh
Ambachtenlaan 13h B- 3001 Heverlee
Piroxicam-Rpm
dispersabile
71 Member State
71 Statul Membru
Postfach 3380 D-89070 Ulm Germany Luxembourg
Rationpharm Gmbh Postfach 3380 D- 89070 Ulm Germania
Rationpharm Gmbh Postfach 3380 D-89070 Ulm Germany
Rationpharm Gmbh Postfach 3380 D- 89070 Ulm Germania
Hexal Ag Industriestrasse 25 D-83607 Holzkirchen Germany
Hexal Ag Industriestrasse 25 D- 83607 Holzkirchen Germania
Cipla (Uk) Limited 53a High Street Esher Surrey Kt10 9qr United Kingdom
Cipla (Uk) Limited 53a High Street Esher Surrey Kt10 9qr Marea Britanie
Dermal use
Administrare cutanată
20 mg
Pirox- 20
Piroxicam
20 mg
72 Member State
72 Statul Membru
Wincentego Pola 21 58-500 Jelenia Gora Poland
Wincentego Pola 21 58- 500 Jelenia Gora Polonia
73 Member State
73 Statul Membru
Postbus 313 3740 Ah Baarn Baarnsche Dijk 1 3741 Ln Baarn The Netherlands
Piroxicam Actavis
Piroxicam Actavis Disper 20 mg
20 mg
20 mg
Disper 20 mg
Piroxicam Actavis 10 mg
Piroxicam Actavis 10
Piroxicam Actavis 20 mg
Piroxicam Actavis 20
Postbus 289 4870 Ag Etten Leur The Netherlands
Postbus 289 4870 Ag Etten Leur Olanda
74 Member State
74 Statul Membru
The Netherlands The Netherlands
Postbus 289 4870 Ag Etten Leur Olanda
Sandoz B. V Veluwezoon 22 1327 Ah Almere The Netherlands
Sandoz B. V
Piroxicam Sandoz Disper 10 mg
10 mg
10 mg
Disper 10 mg
Piroxicam Sandoz Disper 20 mg
20 mg
Piroxicam Sandoz 20 Mg Zetpil
Piroxicam Sandoz 20
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 Marea Britanie
Piroxicam Katwijk 20 Mg Dispers Tabletten
Piroxicam Katwijk
The Netherlands
Postbus 408 2300 Ak Leiden Olanda
20 mg
20 Mg Dispers Tabletten
Effervescent tablet
dispersabile
Brexine
Brexine Bruis
Oral powder
Administrare
75 Member State
75 Statul Membru
Nikkelstraat 5 4823 Ae Breda The Netherlands The Netherlands
Nikkelstraat 5 4823 Ae Breda Olanda
Nikkelstraat 5 4823 Ae Breda The Netherlands
Nikkelstraat 5 4823 Ae Breda Olanda
Postbus 552 2003 RN Haarlem The Netherlands
Postbus 552 2003 RN Haarlem Olanda
Ratiopharm Nederland Bv, Postbus 2062 1500 Gb Zaandam The Netherlands
Ratiopharm Nederland Bv,
Piroxicam Ratiopharm Dispergeerbaar 20 Mg
20 mg
20 mg
Ratiopharm Dispergeerbaar 20 Mg
Piroxicam Ratiopharm 10 Mg
Piroxicam
Ratiopharm Nederland Bv,
Postbus 2062 1500 Gb Zaandam
76 Member State
76 Statul Membru
Postbus 2062 1500 Gb Zaandam The Netherlands
Olanda Olanda
The Netherlands
Administrare
Ratiopharm Nederland Bv, Postbus 2062 1500 Gb Zaandam The Netherlands
Postbus 2062 1500 Gb Zaandam Olanda
Piroxicam Ratiopharm 20 Mg
20 mg
20 mg
Ratiopharm 20 Mg
Piroxicam Albic 10 Mg
Piroxicam Albic 10
Postbus 2043 2800 Bd Gouda The Netherlands
Postbus 2043 2800 Bd Gouda Olanda
Piroxicam Albic 20 Mg
Piroxicam Albic 20
Hamwells Business Park Unit No.7, Hardicker Street M19 2rb Manchester United Kingdom
Hamwells Business Park Unit No. 7, Hardicker Street M19 2rb Manchester Marea Britanie
77 Member State
77 Statul Membru
Norway Norway
orală PO Box 3 N- 1324 Lysaker Norvegia Norvegia
Box 205, N-1372 Asker 0010 Oslo Norway
Box 205, N- 1372 Asker 0010 Oslo Norvegia
Oral powder in sachet
Pulbere pentru administrare orală în plic
Box 158 Skøyen N-0212 Oslo Norway
Box 158 Skøyen N- 0212 Oslo Norvegia
Merck NM P. O. Box 23033 S-10435 Stockholm Sweden
Merck NM P. O. Box 23033 S- 10435 Stockholm Suedia
Pfizer Europe MA EEIG Sandwich Kent Ct13 9nj United Kingdom
Pfizer Europe MA EEIG Sandwich Kent Ct13 9nj Marea Britanie
189
189 60- 322, Poznań Polonia
60-322, Poznań Poland Poland
Polonia
189 60-322, Poznań Poland
189 60- 322, Poznań Polonia
Pola 21 58-500, Jelenia Góra Poland
Pola 21 58- 500, Jelenia Góra Polonia
Kereszturi Ut 30-38 H-1106, Budapest Hungary
Kereszturi Ut 30- 38 H- 1106, Budapesta Ungaria
Kereszturi Ut 30-38
Kereszturi Ut 30- 38 H- 1106, Budapesta Ungaria
H-1106, Budapest Hungary Poland
Polonia
Torrex Chiesi Polska Sp. z o. o. ul.
Torrex Chiesi Polska Sp. z o. o.
Powder for solution for injection
Pulbere pentru soluţie
Biala 3 00-895 Warszawa Poland
Biala 3 00- 895 Varşovia Polonia
Boehringer Ingelheim International Gmbh Binger Str 173 55216, Ingelheim Am Rhein Germany
Boehringer Ingelheim International Gmbh Binger Str 173 55216, Ingelheim Am Rhein Germania
João Ii Lote 1.02.2.1 D - 2º 1990-090 Lisboa Portugal
João Ii Lote 1. 02. 2. 1 D - 2º 1990- 090 Lisabona Portugalia
Av.
Neo- Farmacêutica, Lda.
80 Member State
80 Statul Membru
Portugal
1990- 090 Lisabona Portugalia Portugalia
Empreendimento Lagoas Park Edifício 10 2740-271 Porto Salvo Portugal
Empreendimento Lagoas Park Edifício 10 2740- 271 Porto Salvo Portugalia
Menarini Portugal - Farmacêutica, S. A.
Menarini Portugalia - 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
Portugal
Portugalia Portugalia
Manuel I - Piso 2
Manuel I - Piso 2 Rua Dos Malhões Nº 1 2770- 071 Paço De Arcos Portugalia
Rua Dos Malhões Nº 1 2770-071 Paço De Arcos Portugal Portugal
Portugalia
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 Portugalia
Rua General Ferreira Martins, 8 - 7º Miraflores 1495-137 Algés Portugal
Rua General Ferreira Martins, 8 - 7º Miraflores 1495- 137 Algés Portugalia
Via intramuscular
Administrare intramusculară
Estrada Nacional 117-2 Edifícios Azevedos - Alfragide 2724-503 Amadora Portugal
Estrada Nacional 117- 2 Edifícios Azevedos - Alfragide 2724- 503 Amadora Portugalia
Estrada Nacional 117-2 Edifícios Azevedos - Alfragide 2724-503 Amadora Portugal
Estrada Nacional 117- 2 Edifícios Azevedos - Alfragide 2724- 503 Amadora
Rua Quinta Do Pinheiro - Edifício Tejo - 6º Piso 2790-143 Carnaxide Portugal
Rua Quinta Do Pinheiro - Edifício Tejo - 6º Piso 2790- 143 Carnaxide Portugalia
20 mg
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 Portugalia
José Malhoa - Edifício Malhoa Plaza Nº 2, Piso-Escritório 2.2 1070-325 Lisboa Portugal
José Malhoa - Edifício Malhoa Plaza Nº 2,
Portugal
Piso- Escritório 2. 2 1070- 325 Lisboa Portugalia Portugalia
Rua Manuel Ribeiro De Pavia, 1 - 1º - Venda Nova 2700-547 Amadora
Rua Manuel Ribeiro De Pavia, 1 - 1º - Venda Nova 2700- 547 Amadora Portugalia
Portugal Portugal
Portugalia
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 Portugalia
Rua Do Padrão, 98 3000-312 Coimbra Portugal
Rua Do Padrão, 98 3000- 312 Coimbra Portugalia
Av.
Cinfa Portugalia, Lda.
Piroxicam Cinfa 20 Mg Comprimidos Dispersíveis
Piroxicam Cinfa 20
Eye Drops, Solution
Picături oftalmice, soluţie
Ocular
Administrare oftalmică
Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Hungary
Egis Pharmaceuticals Plc Kereszturi Ut 30- 38 H- 1106 Budapesta Ungaria
Solution For Injection
Soluţie injectabilă
Pfizer Europe MA EEIG Ramsgate Road Sandwich Kent CT 13 9 NJ United Kingdom
Pfizer Europe MA EEIG
20mg/ Ml - 1ml
20mg/ Ml -
Intramuscular
Administrare
84 Member State
84 Statul Membru
D-55216 Ingelheim Am Rhein Germany Romania
Boehringer Ingelheim Pharma Gmbh & Co. Kg, Binger Strasse 173 D- 55216 Ingelheim Am Rhein Germania
Chiesi Farmaceutici Spa, Via Palermo, 26/ A 43100 Parma Italy
Chiesi Farmaceutici Spa,
Chiesi Farmaceutici Spa, Via Palermo, 26/ A 43100 Parma Italy
Via Palermo, 26/ A 43100 Parma Italia
Powder For Oral Solution
Pulbere pentru soluţie
Cutaneous
Administrare cutanată
Valea Lupului Nr.1 Iasi Romania
Valea Lupului Nr. 1 Iasi
Local
Concentraţia
Romania
Romania Romania
Romania
orală Str.
0,5g% 0,5g% Gel
0, 5g% 0, 5g% Gel
United Kingdom
Marea Britanie Ozone Laboratories Ltd.
Cutaneous
cutanată
Ozone Laboratories Ltd.
Marea Britanie Ozone Laboratories Ltd.
Oral
20mg
Invented name
Comprimate
Strength
orală
38 Princes Court 88 Brompton Road Knightsbridge, SW3 1ES London United Kingdom Romania
Knightsbridge, SW3 1ES London
Ozone Laboratories Ltd.
Administrare
United Kingdom Nycomed Ab Box 27264 Se-102 53 Stockholm Sweden
Marea Britanie Nycomed Ab Box 27264 Se- 102 53 Stockholm Suedia
Cream Tablet
Cremă Comprimate
Cutaneous Oral use
cutanată Administrare orală
Nycomed Ab Box 27264 Se-102 53 Stockholm Sweden
Nycomed Ab Box 27264 Se- 102 53 Stockholm Suedia
Merck Nm Ab Box 23033 Se-104 35 Stockholm Sweden
Merck Nm Ab Box 23033 Se- 104 35 Stockholm Suedia
Granulát
Granule
Slovakia
orală Via Palermo 26/ A 43100 Parma Italia Slovacia
Tableta
Comprimate
Italy Slovakia
Slovacia
Dermálny krém
Cremă
topical use
Administrare locală
Kapsula
Capsule
Injekč ný roztok
Soluţie injectabilă
parenteral use
Administrare parenterală
Telč ská 114000 Praha 4 Czech Republic
Telčská 114000 Praga 4 Republica Cehă
Krka, Tovarna Zdravil, D. D., Š marješ ka Cesta 6 Si-8501 Novo Mesto Slovenia
Krka, Tovarna Zdravil, D. D.,
89 Member State
89 Statul Membru
Slovenia Slovenia
cutanată Šmarješka Cesta 6 Si- 8501 Novo Mesto Slovenia Slovenia
Capsules 10
Capsules 10
Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Walton Oaks, Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Marea Britanie
Capsules)
Capsules)
Feldene Dispersable Tablets 10mg
Feldene Dispersable
Tablet for oral solution
Comprimate
Feldene Dispersible Tablets-20 Mg
Feldene Dispersible
Feldene Gel 0.5% W/ W
Feldene Gel 0. 5%
90 Member State
90 Statul Membru
Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Walton Oaks, Dorking Road Walton- 0n- The- Hill Surrey KT20 7NS Marea Britanie
Injection 20mg/ Ml
cutanată
Feldene Melt 20mg Tablets
Feldene Melt 20mg
Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns United Kingdom
Actavis Uk Limited
Piroxicam Capsules 10mg
Piroxicam Capsules
Piroxicam Capsules 20mg
Piroxicam Capsules
Clonmel Healthcare Limited Waterford Road Clonmel, Co.
Clonmel Healthcare Limited
Kentene, Piroflam, Piroflex
Kentene, Piroflam,
Sandoz Limited Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe United Kingdom
Sandoz Limited Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe Marea Britanie
Piroxicam 10 Mg Capsules
10 Mg
Sandoz Limited
Sandoz Limited
Piroxicam 20 Mg
20 Mg
Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe United Kingdom
Unit 37, Woolmer Way Bordon Hampshire Gu35 9qe Marea Britanie
Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ United Kingdom
Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ Marea Britanie
Pharmvit Limited Unit 13, Metropolitan Centre Derby Road, Greenford Middlesex UB6 8UJ United Kingdom
Pharmvit Limited
Piroxicam 20mg Capsules Bp
Piroxicam 20mg
Piroxicam Dispersible Tablets 10mg
Piroxicam
Waymade Plc Sovereign House
Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR Marea Britanie
Miles Gray Road Basildon, Essex SS14 3FR United Kingdom United Kingdom
Marea Britanie
Neolab Limited 57 High Street Odiham, Hampshire RG29 1LF United Kingdom
Neolab Limited 57 High Street Odiham, Hampshire RG29 1LF Marea Britanie
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 Marea Britanie
Trinity-Chiesi Pharmaceuticals Limited Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY United Kingdom
Trinity- Chiesi Pharmaceuticals Limited
Brexidol 20mg Tablets
Brexidol 20mg
Effervescent tablet
Comprimate
Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY United Kingdom
Cheadlw Royal Business Park Highfield, Cheadle SK8 3GY Marea Britanie
Effervescent Tablets
efervescente
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB United Kingdom
Pliva Pharma Limited Vision House, Bedford Road Petersfield, Hampsire GU32 3QB
United Kingdom
Marea Britanie Marea Britanie
Neots, Cambs PE19 3ET United Kingdom
Neots, Cambs PE19 3ET Marea Britanie
Neots, Cambs PE19 3ET United Kingdom United Kingdom
Marea Britanie
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom
Manx Healthcare
Gel
Piroxicam Gel
Teva Pharma Bv Industrieweg 23 Po Box 217 3640 Ae Mijdrecht The Netherlands
Teva Pharma Bv
10mg
Flamatrol 10mg
Teva Pharma Bv Industrieweg 23 Po Box 217 3640 Ae Mijdrecht The Netherlands
Industrieweg 23 Po Box 217 3640 Ae Mijdrecht Olanda
Flamatrol Capsules
Capsules
20mg
Flamatrol 20mg
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 Marea Britanie
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
94 Member State
94 Statul Membru
Overton, Hampshire RG25 3ED United Kingdom United Kingdom
Polhampton Lane Overton, Hampshire RG25 3ED Marea Britanie Marea Britanie
Strides Arcolab International Limited 201 Jersey Road Isleworth, Middx TW7 4QJ United Kingdom
Crescent Pharma Limited
10mg 10mg
20mg
Strides Arcolab International Limited 201 Jersey Road Isleworth, Middx TW7 4QJ United Kingdom
201 Jersey Road Isleworth, Middx TW7 4QJ Marea Britanie
95 ANNEX II
95 ANEXA 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)
CONCLUZII ŞTIINŢIFICE ŞI MOTIVE PENTRU MODIFICAREA REZUMATELOR CARACTERISTICILOR PRODUSULUI ŞI A PROSPECTELOR PREZENTATE DE EMEA REZUMAT GENERAL AL EVALUĂRII ŞTIINŢIFICE PENTRU PRODUSELE MEDICAMENTOASE CARE CONŢIN PIROXICAM (vezi Anexa I)
This review, which concluded in October 2005, did not reveal any new safety concerns for the class of NSAIDs as a whole.
Această reexaminare, care s- a încheiat în octombrie 2005, nu a constatat alte noi motive de îngrijorare privind siguranţa clasei AINS privită în ansamblu.
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.
Cu toate acestea, în timpul acestei reexaminări, Comitetul a adoptat recomandări privitoare la modificarea informaţiilor despre produsul sau aşa- numitele „ elemente cheie ”, ceea ce reflectă o poziţie comună asupra unor aspecte bine cunoscute privind siguranţa in cadrul informaţiilor despre produs referitoare la AINS neselective.
These key elements were published on the EMEA website (Doc ref:
Aceste elemente cheie au fost publicate pe site- ul web EMEA (Doc ref:
However a need to further evaluate the benefit/ risk balance of some non-selective NSAIDs including piroxicam was identified.
Cu toate acestea, a fost identificată nevoia suplimentară de evaluare a raportului beneficiu/ risc privind anumite AINS neselective, inclusiv a piroxicamului.
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.
Reexaminarea a constatat că datele epidemiologice limitate şi datele privind reacţia adversă spontană la medicament au constituit un semnal cu privire la riscul crescut de reacţii gastrointestinale şi cutanate (inclusiv erupţiile buloase ce pot fi letale) legate de alte AINS neselective.
The CHMP considered that the assessment raised concerns on the benefit/ risk balance of piroxicam and informed the European Commission accordingly.
CHMP a considerat că evaluarea a dat naştere la motive de îngrijorare cu privire la raportul beneficiu/ risc privind piroxicamul şi, ca urmare, a informat Comisia Europeană.
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:
De asemenea, CHMP a recomandat modificările sau aşa- numitele „ elemente cheie ”, care urmează a fi incluse în informaţiile despre produs aplicabile piroxicamului, precum şi altor AINS neselective, care au fost publicate pe site- ul web EMEA în luna septembrie 2006 (Doc ref:
The European Commission considered it to be in the interest of public health to perform a new benefit/ risk assessment of piroxicam.
Comisia Europeană a considerat că efectuarea unei noi evaluări beneficiu/ risc pentru piroxicam este, din punctul de vedere al sănătăţii, de interes public.
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.
Prin urmare, Comisia Europeană a trimis o notificare care a fost primită de EMEA pe 2 august 2006 şi, conform articolului 31 din Directiva (CE) 2001/ 83/ CE, astfel cum a fost astfel cum a fost modificată, a fost iniţiată o sesizare pe data de 21 septembrie 2006.