natgillin/translations-raw huggingface dataset:
Diclofenac sodium Diclofenacnatrium Actavis Retard 100 mg, tabletten met gereguleerde afgifte
The Netherlands natrijev diklofenakat Diclofenacnatrium Actavis Retard 100 mg, tabletten met gereguleerde afgifte tableta s prirejenim sproščanjem
Diclofenac sodium Diklofenak Sandoz 25mg
Austria natrijev diklofenakat Diklofenak Sandoz 25mg
Diclofenac sodium Diclostad retard 100 mg Filmtabletten
Austria natrijev diklofenakat Diclostad retard 100 mg Filmtabletten filmsko obložena tableta
Diclofenac sodium Diclo 75 SL - 1 A Pharma
82041 Oberhaching Germany natrijev diklofenakat Diclo 75 SL - 1 A Pharma tableta s podaljšanim sproščanjem
Diclofenac sodium Chatfield Pharms Diclofenac Sodium
Kramer Mews London SW5 9JL United Kingdom natrijev diklofenakat Chatfield Pharms Diclofenac Sodium
Diclofenacum natricum Diclac ID 75 mg modified release tablets
Verovskova 57 SI-1000 Ljubljana Slovenia natrijev diklofenakat Diclac ID 75 mg modified release tablets tableta s prirejenim sproščanjem
Diclofenac sodium Diclofenacnatrium 25 PCH, zetpillen 25 mg
The Netherlands natrijev diklofenakat Diclofenacnatrium 25 PCH, zetpillen 25 mg svečka rektalna uporaba
Diclofenac sodium Sandoz Ltd Rhumalgan SR
Camberley, GUI16 7SR United Kingdom natrijev diklofenakat Sandoz Ltd Rhumalgan SR
Diclofenac sodium Diklofenak Sandoz 50mg
Austria natrijev diklofenakat Diklofenak Sandoz 50mg
Diclofenac sodium Diclofenac SFRotexmedica
22946 Trittau Germany natrijev diklofenakat Diclofenac SFRotexmedica
Diclofenacum natricum DOLMINA 50
Czech Republic natrijev diklofenakat DOLMINA 50
Diclofenac sodium Diclo-CT 50 mg Trinktabletten
Germany natrijev diklofenakat Diclo-CT 50 mg Trinktabletten disperzibilna tableta
Diclofenac sodium DICLOFENACO SANDOZ 100 mg supositorios EFG
28023 Aravaca (Madrid) Spain natrijev diklofenakat DICLOFENACO SANDOZ 100 mg supositorios EFG
Dispersible tablet Oral use
obložena tableta peroralna uporaba
Diclofenac sodium Diclofenac STADA N 75 mg/3 ml
61118 Bad Vilbel Germany natrijev diklofenakat Diclofenac STADA N 75 mg/3 ml
Diclofenac sodium Diclo 100 retard - 1 A Pharma
82041 Oberhaching Germany natrijev diklofenakat Diclo 100 retard - 1 A Pharma tableta s podaljšanim sproščanjem
Diclofenac sodium Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg
1327 AH Almere The Netherlands natrijev diklofenakat Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg
VERAL 75 retard 75mg
VERAL 75 retard 75mg tableta s podaljšanim sproščanjem
76327 Pfinztal-Berghausen Germany
76327 Pfinztal-Berghausen Germany natrijev diklofenakat Diclo KSK 50 mg 50mg
Diclofenac sodium Diclofenac 50 Heumenn Supp.
90449 Nürnberg Germany natrijev diklofenakat Diclofenac 50 Heumenn Supp.
D-83607 Holzkirchen Germany
D-83607 Holzkirchen Germany natrijev diklofenakat Diclac-50
Diclofenac sodium VOLTAREN RETARD 75 mg comprimidos de liberación modificada
08013 Barcelona Spain natrijev diklofenakat VOLTAREN RETARD 75 mg comprimidos de liberación modificada tableta s prirejenim sproščanjem
Voltaren Actigo Extra 25 mg
Voltaren Actigo Extra 25 mg obložena tableta peroralna uporaba
Diclofenacum natricum Diclac 100
Austria natrijev diklofenakat Diclac 100
12,5mg Coated tablet
12,5mg filmsko obložena tableta
Diclofenac sodium Diclofenacnatrium 50 PCH, zetpillen 50 mg
The Netherlands natrijev diklofenakat Diclofenacnatrium 50 PCH, zetpillen 50 mg svečka rektalna uporaba
49, avenue Georges Pompidou 92300 Levallois-Perret France
49, avenue Georges Pompidou 92300 Levallois-Perret France natrijev diklofenakat DICLOFENAC BIOSTABILEX 50 mg, comprimé gastro-résistant
Diclofenac sodium Diclobene 50 mgFilmtabletten
Austria natrijev diklofenakat Diclobene 50 mgFilmtabletten filmsko obložena tableta
The Netherlands Actavis B.V. Baarnsche Dijk 1
Nizozemska Actavis B.V.
Diclofenac sodium Rewodina uno 100 100mg
01445 Radebeul Germany natrijev diklofenakat Rewodina uno 100 100mg capsule
Diclofenac sodium Voltarol 100mg Suppositories
United Kingdom natrijev diklofenakat Voltarol 100mg Suppositories svečka rektalna uporaba
Diclofenacum natricum Diclac ID 150 mg modified release tablets
Verovskova 57 SI-1000 Ljubljana Slovenia natrijev diklofenakat Diclac ID 150 mg modified release tablets tableta s prirejenim sproščanjem
Diclofenac sodium DICLAC INJECTION 75MG/3ML
3301 Lemesos Cyprus natrijev diklofenakat DICLAC INJECTION 75MG/3ML
Diclofenac sodium DICLOFENAC TEVA 50 MG
Belgium natrijev diklofenakat DICLOFENAC TEVA 50 MG
Diclofenac sodium Dexcel-Pharma Dicloflex SR
Armagh BT 63 5AU United Kingdom natrijev diklofenakat Diclomax SR
Diclofenac sodium Diclobene 25 mgFilmtabletten
Austria natrijev diklofenakat Diclobene 25 mgFilmtabletten filmsko obložena tableta
Diclofenac sodium Diclofenacnatrium 100 PCH, zetpillen
The Netherlands natrijev diklofenakat Diclofenacnatrium 100 PCH, zetpillen svečka rektalna uporaba
Diclofenacum kalium Eeze
United Kingdom kalijev diklofenakat
Diclofenac sodium Diclofenacnatrium Apotex 50 mg, maagsapresistente tabletten
The Netherlands natrijev diklofenakat Diclofenacnatrium Apotex 50 mg, maagsapresistente tabletten
Diclofenac sodium DICLOFENAC "S.Med" 25 mg
1220 Vienna Austria natrijev diklofenakat DICLOFENAC "S.Med" 25 mg
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France natrijev diklofenakat DICLOFENAC MYLAN 25 mg, comprimé gastro-résistant
Diclofenac sodium Diclofenacnatrium Apotex 25 mg, maagsapresistente tabletten
The Netherlands natrijev diklofenakat Diclofenacnatrium Apotex 25 mg, maagsapresistente tabletten
75mg/2ml solution for injection
75mg/2ml raztopina za injiciranje intramuskularna uporaba
Gastro-resistent tablet
tableta z gastrorezistentno oblogo
Diclofenac potassium Voltaren Acti
Germany natrijev diklofenakat Voltaren Acti
Belgium RATIOPHARM BELGIUM S.A. Rue Saint-Lambert 141
RATIOPHARM BELGIUM S.A. Rue Saint-Lambert 141 1200 Woluwé-saint-lambert Belgium natrijev diklofenakat DICLOFENACRATIOPHARM 50 MG GASTRO
Diclofenac sodium Voltaren Dispers
Diclofenac Labesfal svečka rektalna uporaba
Diclofenac sodium Diclofenacnatrium Apotex 100 mg, zetpillen
The Netherlands natrijev diklofenakat Diclofenacnatrium Apotex 100 mg, zetpillen svečka rektalna uporaba
Diclofenac potassium Voltaren Akti 12,5 mg film-coated tablets
Diclofenac Actavis 12,5mg filmsko obložena tableta
Diclofenac potassium VOLTAREN DOLO 25 mg lágy kapszula
VOLTAREN DOLO 25 mg lágy kapszula kapsula, mehka peroralna uporaba
Diclofenac sodium DICLAC 75 ID HEXAL SUSTAINED
Industriestraße 25 D-83607 Holzkirchen Germany natrijev diklofenakat DICLAC 75 ID HEXAL SUSTAINED
Diclofenac Sodium Diclostad 50 mg Filmtabletten
Austria natrijev diklofenakat Diclostad 50 mg Filmtabletten filmsko obložena tableta
Diclofenac sodium Almiral 50mg tablets 50mg
Cyprus natrijev diklofenakat Almiral 50mg tablets
Diclofenac sodium Mercury Pharms Econac XL Prolonged
12-16 Addiscombe Road Croydon, Surrey CR0 0XT United Kingdom natrijev diklofenakat Mercury Pharms Econac XL
Diclofenac sodium DOLOTREN supositorios
Spain natrijev diklofenakat DOLOTREN ampollas
Diclofenac sodium Diclofenacratiopharm
Diclofenacratiopharm svečka rektalna uporaba
Diclofenac sodium DICLOFENAC SANDOZ 50 MG
Austria natrijev diklofenakat Diclofenac Sandoz 50 mg
Diclofenacum natricum Diclofenac 50 mg suppositories
Latvia natrijev diklofenakat Diclofenac 50 mg suppositories svečka rektalna uporaba
Diclofenac sodium Diclofenac Genericon 75 mg - Ampullen
Austria natrijev diklofenakat Diclofenac Genericon 75 mgAmpullen
Diclofenac sodium Diclofenacnatrium Apotex 25 mg, zetpillen
The Netherlands natrijev diklofenakat Diclofenacnatrium Apotex 25 mg, zetpillen svečka rektalna uporaba
DICLAC ID 150 MG 150mg
DICLAC ID 150 MG 150mg tableta s prirejenim sproščanjem
Diclofenac sodium Diclofenacnatrium 50 mg, maagsapresistente tabletten
United Kingdom natrijev diklofenakat Diclofenacnatrium 50 mg, maagsapresistente tabletten
Diclofenac potassium Diklotab
Poland natrijev diklofenakat Difadol
VOLTAREN 100 mg retard filmtabletta
VOLTAREN 100 mg retard filmtabletta prolonged-release filmsko obložena tableta
Diclofenac potassium Diclobene rapid 50 mg Filmtabletten
Diclomex Rapid 50mg filmsko obložena tableta
Diclofenac sodium Diclofenacnatrium 25 mg, maagsapresistente tabletten
United Kingdom natrijev diklofenakat Diclofenacnatrium 25 mg, maagsapresistente tabletten
Diclofenac sodium Effekton 100mg Zäpfchen
Italy natrijev diklofenakat Effekton 100mg Zäpfchen svečka rektalna uporaba
Diclofenacum natricum Olfen 100 SR
2740-298 Porto Salvo Portugal natrijev diklofenakat Olfen 100 SR
Diclofenacum natricum Naklofen SR 100 mg prolonged-release tablets
Germany natrijev diklofenakat Voltaren Retard-100 100mg tableta s podaljšanim sproščanjem
Diclofenac potassium Diklok
Belgium kalijev diklofenakat
Diclofenac sodium Diclofenac Natrium HERMES 25 mg
82049 Großhesselohe Germany natrijev diklofenakat Diclofenac Natrium HERMES 25 mg
Diclofenac sodium DICLOFENAC "S.Med" 50 mg
1220 Vienna Austria natrijev diklofenakat DICLOFENAC "S.Med" 50 mg
Diclofenac sodium Diclofenac G.L.
A-8502 Lannach Austria natrijev diklofenakat Diclofenac G.L.
Belgium SOCOBOM N.V. Louizalaan 149 box 24
Luksemburg Socobom S.A Avenue Louise 149 b24 B-1050 Bruxelles Belgium natrijev diklofenakat Polyflam-75
The Netherlands Novartis Consumer Health B.V. Claudius Prinselaan 142
Nizozemska Novartis Consumer Health B.V.
Diclofenac sodium DICLOFENAC BIOGARAN 50 mg, comprimé pelliculé gastrorésistant
92700 Colombes France natrijev diklofenakat DICLOFENAC BIOGARAN 50 mg, comprimé pelliculé gastrorésistant filmsko obložena gastrorezistentna tableta
Diclofenac sodium Almiral 25mg tablets 25mg
Cyprus natrijev diklofenakat Almiral 25mg tablets
Diclofenac sodium VOLTAREN RETARD 100 mg comprimidos de liberación modificada
08013 Barcelona Spain natrijev diklofenakat VOLTAREN RETARD 100 mg comprimidos de liberación modificada tableta s prirejenim sproščanjem
Diclofenac sodium Diclofenacnatrium Actavis 50 mg, maagsapresistente tabletten
The Netherlands natrijev diklofenakat Diclofenacnatrium Actavis 50 mg, maagsapresistente tabletten
Diclofenac sodium Diclofenacnatrium Apotex 50 mg, zetpillen
The Netherlands natrijev diklofenakat Diclofenacnatrium Apotex 50 mg, zetpillen svečka rektalna uporaba
Diclofenac sodium Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg
1327 AH Almere The Netherlands natrijev diklofenakat Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg
DICLAC ID 75 MG 75mg
DICLAC ID 75 MG 75mg tableta s prirejenim sproščanjem
Diclofenacum natricum APO-DICLO 25 MG 25mg
2333 CR Leiden The Netherlands natrijev diklofenakat APO-DICLO 25 MG 25mg
25mg/ml solution for injection
25mg/ml raztopina za injiciranje intramuskularna uporaba
Diclofenac sodium FLEFARMIN
Greece natrijev diklofenakat FLEFARMIN
Diclofenacum natricum Diclofenac GSK
Italy natrijev diklofenakat DICLOFENAC GERMED
Film-coated tablet Oral use
Cataflam obložena tableta peroralna uporaba
Diclofenac sodium Diclofenacnatrium Actavis 100 mg, zetpillen
The Netherlands natrijev diklofenakat Diclofenacnatrium Actavis 100 mg, zetpillen svečka rektalna uporaba
Masate, Milano - 20060 Italy
Masate, Milano - 20060 Italy natrijev diklofenakat NATRIJEV DIKLOFENAKAT BIL
Diclofenac sodium Diclofenacratiopharm 25 mg magensaftresistente Tabletten ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Latvija ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany natrijev diklofenakat Diclofenacratiopharm 25 mg gastro-resistant tablets
Diclofenac sodium Diclofenac Na Pharmacin 100 mg, tabletten met gereguleerde afgifte
3335 LH Zwijndrecht The Netherlands natrijev diklofenakat Diclofenac Na Pharmacin 100 mg, tabletten met gereguleerde afgifte tableta s prirejenim sproščanjem
Prolonged-release film-coated tablet
Diklotab filmsko obložena tableta
Diclofenac sodium Diclofenacratiopharm 50 mg magensaftresistente Tabletten ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Latvija ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany natrijev diklofenakat Diclofenacratiopharm 50 mg gastro-resistant tablets
LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain
Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain natrijev diklofenakat DICLOFENACO NORMON 50 mg comprimidos dispersables EFG
DICLOFENAC AL 50 mg végbélkúp
DICLOFENAC AL 50 mg végbélkúp svečka rektalna uporaba
Diclofenacum natricum VERAL 75
53003 Pardubice Czech Republic natrijev diklofenakat VERAL 75
ARTHROTEC FORTE 75mg 0.2mg
ARTHROTEC FORTE 75mg 0,2mg filmsko obložena tableta
12,5mg Film-coated tablet Oral use
12,5mg obložena tableta peroralna uporaba
Diclofenac sodium Diclofenacnatrium Actavis 25 mg, maagsapresistente tabletten
The Netherlands natrijev diklofenakat Diclofenacnatrium Actavis 25 mg, maagsapresistente tabletten
Diclofenac sodium Dignofenac 25mg 25mg
71034 Böblingen Germany natrijev diklofenakat Dignofenac 25mg 25mg
Diclofenac potassium Dicuno 25 mg filmcoated tablets
Diclofenac potassium 25mg Tablets filmsko obložena tableta
Brausetabletten
zrnca
Diclofenac sodium Diclofenacnatrium Actavis 50 mg, zetpillen
The Netherlands natrijev diklofenakat Diclofenacnatrium Actavis 50 mg, zetpillen svečka rektalna uporaba
Diclofenac sodium Diclofenac Natrium HERMES 50 mg
82049 Großhesselohe Germany natrijev diklofenakat Diclofenac Natrium HERMES 50 mg
The Netherlands Pharmacin B.V. Molenvliet 103
Nizozemska Pharmacin B.V.
Diclofenac sodium Diclofenac Na zetpil CF 100 mg, zetpillen
Poland natrijev diklofenakat Diclofenac GSK 100mg svečka rektalna uporaba
LABORATORIOS LLORENS, S.A. Ciudad de Balaguer, 7-11 08022 Barcelona Spain
Ciudad de Balaguer, 7-11 08022 Barcelona Spain natrijev diklofenakat DICLOFENACO LLORENS 100 mg supositorios EFG
Diclofenac sodium Diclofenac 1A Pharma retard 150 mg - Tabletten
1A Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria natrijev diklofenakat Diclofenac 1A Pharma retard 150 mg - Tabletten tableta s podaljšanim sproščanjem
Diclofenac Lidocaine
Germany kalijev diklofenakat
Diclofenacum natricum Diclac 100 mg modified release tablets
Verovskova 57 SI-1000 Ljubljana Slovenia natrijev diklofenakat Diclac 100 mg modified release tablets tableta s prirejenim sproščanjem
Diclofenac sodium Antigen Diclofenac Sodium Injection
Italy natrijev diklofenakat DICLOFENAC ANGENERICO
Diclofenac potassium Voltaren Akti 25 mg soft capsules
Voltaren Rapid 25 mg kapsula, mehka peroralna uporaba
OLFEN DEPOCAPS 75mg
OLFEN DEPOCAPS 75mg tableta s podaljšanim sproščanjem
Diclofenac sodium DIFEND
Italy natrijev diklofenakat DEFLAMAT
Diclofenac sodium Diclofenacnatrium Actavis 25 mg, zetpillen
The Netherlands natrijev diklofenakat Diclofenacnatrium Actavis 25 mg, zetpillen svečka rektalna uporaba
Diclofenac sodium POLYFLAM EX RUFIMAX EX
Louizalaan 149 box 24 1050 Ixelles Belgium natrijev diklofenakat POLYFLAM EX RUFIMAX EX
Diclofenac sodium Diclac 75 mg Prolonged -Release
Rowex Ltd Bantry, Co. Cork Ireland natrijev diklofenakat Diclac 75 mg Prolonged -Release
Diclofenacum natricum OLFEN-100 SR
2740-298 Porto Salvo Portugal natrijev diklofenakat OLFEN-100 SR
Diclofenacum natricum Dicloberl 100 mg suppositories
Ireland natrijev diklofenakat Difene 100mg Suppositories svečka rektalna uporaba
Croydon, Surrey CR0 0XT United Kingdom
12-16 Addiscombe Road Croydon, Surrey CR0 0XT United Kingdom natrijev diklofenakat Mercury Pharms Econac SR
Diklofenak "Orifarm" 25mg
Diklofenak "Orifarm"
86156 Augsburg Germany
86156 Augsburg Germany natrijev diklofenakat Diclofenbeta 25 25mg
Diclofenacum natricum Diclomelan retard 100 mg sustainedrelease tablets
Germany natrijev diklofenakat Diclo KD retard 100mg tableta s podaljšanim sproščanjem
Diclofenac sodium DOLO-VOLTAREN 50 mg comprimidos dispersables
08013 Barcelona Spain natrijev diklofenakat DOLO-VOLTAREN 50 mg comprimidos dispersables orodisperzibilna tableta
DICLOREUM 100 mg 100mg
DICLOREUM 100 mg 100mg svečka rektalna uporaba
Tratul 50 mgKapseln
Tratul 50 mgKapseln gastrorezistentna kapsula, mehka
Diclofenacum kalium Voltaren Rapid
Voltaren Rapid obložena tableta peroralna uporaba
Latvia ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Slovaška ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Diclofenac sodium Diclo-CT 75mg/2ml Ampullen
Germany natrijev diklofenakat Diclo-CT 75mg/2ml Ampullen raztopina za injiciranje intramuskularna uporaba
Diclofenac potassium Diclofenac T ratiopharm
The Netherlands natrijev diklofenakat Diclofenac Na ratiopharm retard
Diclofenac sodium VURDON
Italy kalijev diklofenakat
Diclofenac sodium Diclofenac Na zetpil CF 50 mg, zetpillen
Poland natrijev diklofenakat Diclofenac GSK 50mg svečka rektalna uporaba
Diclofenac sodium Diclofenac 100 Heumann Supp.
90449 Nürnberg Germany natrijev diklofenakat Diclofenac 100 Heumann Supp.
Film-coated sustained release tablet
filmsko obložena tableta s podaljšanim sproščanjem
Diclofenacum kalium Diclofenac Rapid Orifarm
Diclofenac Rapid Orifarm filmsko obložena tableta
VERAL 100 retard 100mg
VERAL 100 mg 100mg svečka rektalna uporaba
Box 51166 3502 Lemesos Cyprus
P.O. Box 51706 Lemesos Cyprus natrijev diklofenakat REMETHAN SUSTAINED
Prolonged-release tablet
Retardtabletten tableta s podaljšanim sproščanjem
Diclofenac sodium Mercury Pharms Diclofenac Sodium
12-16 Addiscombe Road Croydon, Surrey CR0 0XT United Kingdom natrijev diklofenakat Mercury Pharms Diclofenac Sodium
Diclofenac sodium Diclofenbeta 25 25mg betapharm Arzneimittel GmbH Kobelweg 95
Belgium natrijev diklofenakat Diclofenac EG-25 25mg obložena tableta peroralna uporaba
Estonia ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany
Estonija ratiopharm GmbH Graf Arco Strasse 3 D-89079 Ulm Germany dikofenak
Modified-Release Capsule, Hard
kapsula s prirejenim sproščanjem, trda
Diclofenac sodium Diclo KD 75 akut
Germany natrijev diklofenakat Diclo KD 75 akut kapsula s prirejenim sproščanjem, trda
Diclofenac sodium Diclofenac 50 Heumann
90449 Nürnberg Germany natrijev diklofenakat Diclofenac 50 Heumann
Diclofenac sodium Voltaren 100 mg Zäpfchen
DICLOFENAC SODIC 100 mg svečka rektalna uporaba
Diclofenac potassium Diclofen Kalium KPC 25 mg Filmtabletten
Diclofen Kalium KPC 25 mg Filmtabletten filmsko obložena tableta
Diclofenac sodium Tratul retard 100 mg - Filmtabletten
A-1160 Vienna Austria natrijev diklofenakat Tratul retard 100 mg - Filmtabletten filmsko obložena tableta
12 February 2013
12. februar 2013
The Committee appointed Ms H. Jukes as rapporteur and Mr G. J. Schefferlie as co-rapporteur.
Odbor je za poročevalko imenoval H. Jukes, za soporočevalca pa G. J. Schefferlieja.
The final opinion was converted into a Decision by the European Commission on 12 February 2013.
Končno mnenje je bilo dne 12. februarja 2013 spremenjeno v sklep Evropske komisije.
The decentralised procedure (NL/V/0164/003/DC) started on 17 June 2011.
Decentralizirani postopek (NL/V/0164/003/DC) se je začel 17. junija 2011.
The application was submitted to the Netherlands as reference Member State and Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Poland, Spain and the United Kingdom as concerned Member States.
Vloga je bila predložena Nizozemski kot referenčni državi članici ter Avstriji, Belgiji, Češki republiki, Danski, Franciji, Nemčiji, Madžarski, Irski, Italiji, Poljski, Španiji in Združenem kraljestvu kot zadevnim državam članicam.
The referral procedure started on 11 July 2012.
Napotitveni postopek se je začel 11. julija 2012.
International non-proprietary name (INN): meloxicam
Mednarodno nelastniško ime (INN): meloksikam
Written explanations were provided by the applicant on 11 September 2012.
Predlagatelj je pisna pojasnila predložil 11. septembra 2012.
Veterinary Medicines and Product Data Management
Zdravila za uporabo v veterinarski medicini in upravljanje podatkov o zdravilih
Meloxicam is a Non-Steroidal Anti-Inflammatory Drug.
Meloksikam je nesteroidno protivnetno zdravilo.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amendments to the Summary of Product Characteristics, labelling and package leaflet in the Annex III.
Seznam zadevnih imen zdravila je na voljo v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami povzetka glavnih značilnosti zdravila in navodila za uporabo v Prilogi III.
Potential serious risks were identified during the decentralised procedure by two concerned Member States, Ireland and the United Kingdom, regarding the bioequivalence for the target species pigs.
Med decentraliziranim postopkom sta dve zadevni državi članici, Irska in Združeno kraljestvo, opozorili na morebitna resna tveganja v zvezi z bioekvivalenco za ciljno vrsto prašiči.
Based on the evaluation of the currently available data, the CVMP considered that the particulars concerning the target species pigs that were submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC, and consequently do not satisfy the criteria for authorisation in respect of safety and efficacy for the target species pigs.
Odbor CVMP je na podlagi ocene trenutno razpoložljivih podatkov menil, da podatki o ciljni vrsti prašiči, ki so bili posredovani v podporo vlogi, niso skladni s členom 13 Direktive 2011/82/ES in posledično ne izpolnjujejo meril za odobritev, kar zadeva varnost in učinkovitost za ciljno vrsto prašiči.
The active substance is included in veterinary medicinal products currently authorised in the European Union via the centralised authorisation procedure, as well as nationally, for use in cattle, pigs, horses, dogs and cats.
To zdravilno učinkovino vsebujejo zdravila za uporabo v veterinarski medicini, ki so trenutno v Evropski uniji odobrena tako po centraliziranem postopku pridobitve dovoljenja za promet kot po nacionalnih postopkih, in sicer za uporabo pri govedu, prašičih, konjih, psih in mačkah.
On 29 June 2012 the reference Member State, the Netherlands, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Referenčna država članica, Nizozemska, je 29. junija 2012 Evropsko agencijo za zdravila obvestila, da CMD(v) ni dosegla soglasja o zdravilu in da je v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotila na odbor CVMP.
Therefore, the Committee adopted a negative opinion on 8 November 2012 recommending the refusal of the granting of the marketing authorisation for Melosolute 40 mg/ml solution for injection for the target species pigs.
Odbor je zato 8. novembra 2012 sprejel negativno mnenje in priporočil zavrnitev vloge za izdajo dovoljenja za promet za zdravilo Melosolute 40 mg/ml raztopina za injiciranje za ciljno vrsto prašiči.
On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started on 2 May 2012.
Ker ti pomisleki na 210. dan postopka še vedno niso bili rešeni, je bila zadeva 2. maja 2012 v skladu s členom 33(1) Direktive 2001/82/ES napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek (zdravila za uporabo v veterinarski medicini) (CMD(v)).
Day 60 of the CMD(v) procedure was on 29 June 2012, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Na šestdeseti dan postopka CMD(v) dne 29. junija 2012 zadevne države članice niso dosegle soglasja o zdravilu, zato je bil postopek napoten na odbor CVMP.
This is a ‘hybrid' application according to Article 13(3) Directive 2001/82/EC, as amended, referring to the centrally authorised reference product Metacam 20 mg/ml solution for injection for cattle, pigs and horses (EU/2/97/004).
Gre za hibridno vlogo v skladu s členom 13(3) Direktive 2001/82/ES, kakor je bila spremenjena, pri čemer je referenčno zdravilo, odobreno po centraliziranem postopku, zdravilo Metacam 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje (EU/2/97/004).