natgillin/translations-raw huggingface dataset:
These additional studies showed that protection against Japanese encephalitis virus lasted for at least 2 to 3 years in most people vaccinated with Ixiaro. 
Te dodatne študije so pokazale, da je zaščita proti virusu japonskega encefalitisa pri večini ljudi, cepljenih s cepivom Ixiaro, trajala vsaj dve do tri leta.
What is Ixiaro and what is it used for? 
Kaj je zdravilo Ixiaro in za kaj se uporablja?
Four weeks after the final injection, 96% of these people who received both doses of Ixiaro had developed protective levels of antibodies (352 out of 365). 
Štiri tedne po zadnjem injiciranju so se pri 96 % (352 od 365) oseb, ki so prejele oba odmerka cepiva Ixiaro, razvile zaščitne ravni protiteles.
What benefit of Ixiaro have been shown in studies? 
Kakšne koristi je zdravilo Ixiaro izkazalo v študijah?
What are the risks associated with Ixiaro? 
Kakšna tveganja so povezana z zdravilom Ixiaro?
Ixiaro contains small amounts of the virus that causes Japanese encephalitis, which has been inactivated (killed) so that it cannot cause the disease. 
Cepivo Ixiaro vsebuje majhne količine virusa, ki povzroča japonski encefalitis in ki je bil inaktiviran (uničen), tako da ne more povzročiti bolezni.
In adults, the second dose can be given up to 11 months after the first. 
Pri odraslih se lahko drugi odmerek injicira najpozneje 11 mesecev po prejemu prvega odmerka.
Adults from 18-65 years who are likely to be exposed to the Japanese encephalitis virus again or who are at continuous risk of the disease should receive a booster dose of Ixiaro one to two years later and a second booster dose 10 years after the first booster. 
Odrasli, stari med 18 in 65 let, pri katerih obstaja verjetnost ponovne izpostavljenosti virusu japonskega encefalitisa, ali tiste osebe, ki so bolezni nenehno izpostavljene, morajo obnovitveni odmerek cepiva Ixiaro prejeti eno ali dve leti po drugem odmerku in drugi obnovitveni odmerek deset let po prvem obnovitvenem odmerku.
In adults, including those aged above 65 years, and children aged 3 years and older, a full dose of Ixiaro (0.5 ml) should be given, and an additional 0.5 ml dose should be given four weeks later. 
Pri odraslih, vključno s starejšimi od 65 let, in otrocih, starejših od treh let, je treba uporabiti celotni odmerek cepiva Ixiaro (0,5 ml), ki mu sledi še en 0,5-mililitrski odmerek štiri tedne kasneje.
Ixiaro has been shown to trigger the production of antibodies against the Japanese encephalitis virus in 3 main studies: 
Cepivo Ixiaro je spodbudilo nastajanje protiteles proti virusu japonskega encefalitisa v treh glavnih študijah:
Adults from 18 to 65 years can also receive a rapid vaccination course, where the second dose is given seven days after the first dose. 
Odrasli med 18. in 65. letom starosti se lahko cepijo po hitri shemi cepljenja, pri kateri prejmejo drugi odmerek cepiva sedem dni po prvem.
It is recommended that individuals who receive the first dose of Ixiaro should receive both doses. 
Priporočeno je, da osebe, ki prejmejo prvi odmerek cepiva Ixiaro, prejmejo tudi drugi odmerek.
In children aged between 2 months and 3 years, half the adult dose of Ixiaro (0.25 ml) should be given, and an additional 0.25 ml dose should be given four weeks later. 
Pri otrocih, starih od dveh mesecev do treh let, je treba uporabiti polovični odmerek cepiva Ixiaro (0,25 ml), ki mu sledi še en 0,25-mililitrski odmerek štiri tedne kasneje.
Ixiaro is a vaccine that helps protect adults and children aged 2 months and older against Japanese encephalitis, a disease that causes inflammation of the brain. 
Cepivo Ixiaro se uporablja za zaščito odraslih in otrok, starejših od dveh mesecev, pred japonskim encefalitisom, tj. boleznijo, ki povzroča vnetje možganov.
Anyone who has an allergic reaction after the first dose of Ixiaro should not receive the second dose. 
Posamezniki, pri katerih se po prejemu prvega odmerka cepiva Ixiaro pokaže alergijska reakcija, ne smejo prejeti drugega odmerka.
Ixiaro (given as 2 doses 4 weeks apart) was as effective as the comparator vaccine at triggering the production of antibodies against the Japanese encephalitis virus. 
Cepivo Ixiaro (dano v dveh odmerkih v razmiku štirih tednov) je bilo pri spodbujanju nastanka protiteles proti virusu japonskega encefalitisa enako učinkovito kot primerjalno cepivo.
99% to 100% of children who received both doses of Ixiaro had developed protective levels of antibodies against the Japanese encephalitis virus 4 weeks after the final injection. 
V njej je 99 % do 100 % otrok, ki so prejeli oba odmerka cepiva Ixiaro, štiri tedne po zadnjem cepljenju razvilo zaščitne ravni protiteles proti virusu japonskega encefalitisa.
In future, the immune system will be able to produce antibodies quickly and in large numbers when it is exposed to Japanese encephalitis virus again. 
Ob ponovni izpostavitvi virusu japonskega encefalitisa v prihodnosti jih bo imunski sistem lahko tvoril hitreje in v večjem številu.
How is Ixiaro used? 
Kako se zdravilo Ixiaro uporablja?
For the full list of side effects of Ixiaro, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Ixiaro, glejte navodilo za uporabo.
In children, fever, diarrhoea, influenza-like illness, irritability, and reactions at the injection site (such as redness, 
Pri otrocih so bili najpogostejši neželeni učinki (ki se lahko pojavijo pri več kot 1 otroku od 10) povišana telesna temperatura, driska, gripi podobna bolezen, razdražljivost in reakcije na mestu injiciranja (kot so pordelost, bolečina in občutljivost).
Ixiaro can only be obtained with a prescription. 
Predpisovanje in izdaja cepiva Ixiaro je le na recept.
How does Ixiaro work? 
Kako zdravilo Ixiaro deluje?
Ixiaro can be injected under the skin in people who have a bleeding disorder such as low blood platelet counts or haemophilia. 
Pri ljudeh s hemoragičnimi motnjami, kot sta majhno število trombocitov ali hemofilija, se cepivo Ixiaro lahko injicira v podkožje.
What is closantel? 
Kaj je klozantel?
In addition, cattle may also be treated topically on their skin. 
Poleg tega je govedo mogoče zdraviti tudi topično na koži.
20 May 2019 
20. maj 2019
The European Commission issued a decision on 20 May 2019. 
Evropska komisija je sklep izdala 20. maja 2019.
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/126) 
Izid napotitvenega postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/126)
Consequently, on 5 February 2018, the United Kingdom initiated a procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products. 
Zato je Združeno kraljestvo 5. februarja 2018 v skladu s členom 35 Direktive 2001/82/ES sprožilo postopek za zgoraj navedena zdravila za uporabo v veterinarski medicini.
Closantel is intended for use in cattle and sheep for the treatment and control of adult and immature flukes, nematodes and larval stages of some arthropods and is administered subcutaneously by injection or as an oral solution. 
Klozantel je namenjen za uporabo pri govedu in ovcah za zdravljenje in obvladovanje odraslih in nezrelih metljajev, nematodov in larvalnih faz nekaterih členonožcev ter se daje subkutano z injekcijo ali kot peroralna raztopina.
Withdrawal period refers to the minimum period of time from administering the last dose of veterinary medicinal product and the production of meat or other animal-derived products for food. 
Karenca se nanaša na najkrajši čas, ki mora miniti od zadnjega odmerka zdravila za uporabo v veterinarski medicini do proizvodnje mesa ali drugih izdelkov živalskega izvora za prehrano.
The United Kingdom noted that, for veterinary medicinal products containing closantel presented as solutions for injection, there are different approved withdrawal periods for sheep across the European Union e.g. sheep meat and offal, from 28 days to 107 days. 
Združeno kraljestvo je ugotovilo, da za zdravila za uporabo v veterinarski medicini, ki vsebujejo klozantel, v obliki raztopin za injiciranje, v Evropski uniji obstajajo različne odobrene karence za ovce, npr. za ovčje mesto in organe, v razponu od 28 dni do 107 dni.
The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for meat and offal derived from treated sheep. 
Odbor CVMP je bil zaprošen, naj pregleda vse razpoložljive podatke o izločanju ostankov in priporoči karenco za meso in organe, pridobljene iz zdravljenih ovc.
On 21 February 2019, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods (meat and offal) for sheep for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection. 
Evropska agencija za zdravila (agencija) je 21. februarja 2019 zaključila pregled varnosti potrošnikov glede karenc za ovce (meso in organi) za zdravila za uporabo v veterinarski medicini, ki vsebujejo 50 mg klozantela na ml (kot edino učinkovino) in so v obliki raztopine za injiciranje.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the concerned products is positive and recommended amendments to the withdrawal periods for sheep to provide assurance for consumer safety. 
Odbor za zdravila za uporabo v veterinarskih medicini (CVMP) pri agenciji je sklenil, da je splošno razmerje med tveganji in koristmi za zadevna zdravila pozitivno, in je zaradi zagotavljanja varnosti potrošnikov priporočil spremembe karenc za ovce.
Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep, is positive and agreed that the withdrawal periods (meat and offal) for sheep should be harmonised and amended to provide assurance for consumer safety. 
Na podlagi vrednotenja trenutno razpoložljivih podatkov je odbor CVMP zaključil, da je splošno razmerje med tveganji in koristmi za zdravila za uporabo v veterinarski medicini, ki vsebujejo 50 mg klozantela na ml (kot edino učinkovino) in so v obliki raztopine za injiciranje za subkutano uporabo pri ovcah, pozitivno ter je soglašal, da je treba karence za ovce (meso in organi) zaradi varnosti potrošnikov poenotiti in spremeniti.
Proprietary data and scientific references on residue depletion were provided by the marketing authorisation holders. 
Imetniki dovoljenja za promet z zdravili so predložili zaščitene podatke in znanstvena vire o izločanju ostankov.
Why were solutions for injection containing 50 mg closantel per ml (as a single active substance) reviewed? 
Zakaj so bile raztopine za injiciranje, ki vsebujejo 50 mg klozantela na ml
FR - France TEVA SANTE Le Palatin 1 
FR - Francija TEVA SANTE Le Palatin 1
Greece 17456 
Grčija 17456
de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID Spain 
de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID Španija
capsules (with micronised powder) 
kapsula (z mikroniziranim praškom)
1800 Vilvoorde Belgium 
1800 Vilvoorde Belgija
1507 CC Zaandam The Netherlands 
1507 CC Zaandam The Nizozemska
Agios Dimitrios 17341 Greece 
Agios Dimitrios 17341 Grčija
Markopoulo Mesogeion 19003 Greece 
Markopoulo Mesogeion 19003 Grčija
ES - Spain BEXAL FARMACEUTICA, S.ACentro Empresarial Osa Mayor. 
ES - Španija BEXAL FARMACEUTICA, S.ACentro Empresarial Osa Mayor.
2700-327 Amadora Portugal 
2700-327 Amadora Portugalska
4870 AG Etten-Leur The Netherlands 
4870 AG Etten-Leur The Nizozemska
Rivium Westlaan 142 2909 LD Capelle a/d Ijssel The Netherlands 
Rivium Westlaan 142 2909 LD Capelle a/d Ijssel The Nizozemska
S.C. VIM SPECTRUM S.R.L., Şoseaua Sighişoarei, Nr. 409, Corunca, jud Mureş Romania 
S.C. VIM SPECTRUM S.R.L., Şoseaua Sighişoarei, Nr. 409, Corunca, jud Mureş Romunija
MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium 
MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgija
Veluwezoom 22 1327 AH Almere The Netherlands 
Veluwezoom 22 1327 AH Almere The Nizozemska
3752 LB Bunschoten The Netherlands 
3752 LB Bunschoten The Nizozemska
Osa Mayor, 4Area BAravaca 28023 (Madrid) Spain 
Osa Mayor, 4Area BAravaca 28023 (Madrid) Španija
Alpharma ApS Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal 
Alpharma ApS Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugalska
TECHNOLOGY S.A. Rue du Parc Industriel 39 6900 Marche-en-Famenne Belgium 
TECHNOLOGY S.A. Rue du Parc Industriel 39 6900 Marche-en-Famenne Belgija
1504 Lefkosia 
1504 Lefkosia Ciper
Bezalip® Retard depo tablet 
Bezalip® Retard depo tableta
LV - Latvia Sanofi-aventis Latvia SIA Kr.Valdemara Str. 33-8 
LV - Latvija Sanofi-aventis Latvija SIA Kr.Valdemara Str. 33-8
Pharmachemie BV P.O.Box 552, 2003 RN Haarlem The Netherlands 
Pharmachemie BV P.O.Box 552, 2003 RN Haarlem The Nizozemska
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states 
Seznam imen, farmacevtskih oblik, jakosti, poti uporabe zdravila in imetnikov dovoljenja za promet z zdravili v državah članicah
Rua João Chagas, 53 Piso 3 1495-764 Cruz Quebrada - Dafundo Portugal 
Rua João Chagas, 53 Piso 3 1495-764 Cruz Quebrada - Dafundo Portugalska
Eurogenerics SA Esplanade Heysel, B22 B- 1020 Bruxelles Belgium 
Eurogenerics SA Esplanade Heysel, B22 B- 1020 Bruxelles Belgija
ET - Estonia Sanofi-Aventis Estonia 
ET - Estonija Sanofi-Aventis Estonia
2333 CR Leiden The Netherlands 
2333 CR Leiden The Nizozemska
97-107 Uxbridge Road EALING, LONDON W5 5TL United Kingdom 
97-107 Uxbridge Road EALING, LONDON W5 5TL Velika Britanija
ACTAVIS UK LIMITED WHIDDON VALLEY BARNSTAPLE DEVON EX32 8NS United Kingdom 
ACTAVIS UK LIMITED WHIDDON VALLEY BARNSTAPLE DEVON EX32 8NS Velika Britanija
UAB PharmaSwiss Šeimyniškių 21B LT-09200 Vilnius Lithuania 
UAB PharmaSwiss Šeimyniškių 21B LT-09200 Vilnius Litva
United Kingdom, 
Velika Britanija,
SANDOZ LIMITED 37 Woolmer Way, Borden, Hampshire GU35 9QE United Kingdom 
SANDOZ LIMITED 37 Woolmer Way, Borden, Hampshire GU35 9QE Velika Britanija
IS - Iceland Pfizer Aps Lautrupsvang 8 
IS - Islandija Pfizer Aps Lautrupsvang 8
EL - Greece Sanofi-Aventis Aebe Syngrou Avenue 348, Building A, 
Sanofi-Aventis Aebe Syngrou Avenue 348, Building A,
UAB Sanofi - Aventis Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania 
UAB Sanofi - Aventis Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Litva
Quinta da Beloura 2710-444 Sintra Portugal 
Quinta da Beloura 2710-444 Sintra Portugalska
Generics (Uk) Limited Station Close Potters Bar, HERTS EN6 1TL United Kingdom 
Generics (Uk) Limited Station Close Potters Bar, HERTS EN6 1TL Velika Britanija
FR - France Pfizer Holding France 23-25, avenue du Docteur Lannelongue 
FR - Francija Pfizer Holding Francija 23-25, avenue du Docteur Lannelongue
ES - Spain ACTAVIS SPAIN S.A.Rivera del Loira 46 - Bussines Centre Regus Office 525 Madrid Spain 
ES - Španija ACTAVIS ŠPANIJA S.A.Rivera del Loira 46 - Bussines Centre Regus Office 525 Madrid
A-8502 Lannach 
A-8502 Lannach Avstrija
ES - Spain ACTAVIS SPAIN, S.A. Perú 8 
ES - Španija ACTAVIS ŠPANIJA, S.A. Perú 8
ES - Spain LABORATORIO STADA, S.L.Frederic Mompou, 5 Sant Just Desvern08960 
ES - Španija LABORATORIO STADA, S.L.Frederic Mompou, 5 Sant Just Desvern08960
Genus Pharmaceuticals Limited Park View House 65 London Road NEWBURY, BERKS RG14 1JN United Kingdom 
Genus Pharmaceuticals Limited Park View House 65 London Road NEWBURY, BERKS RG14 1JN Velika Britanija
Korinthos 20100 
Korinthos 20100 Grčija
ES - Spain USO RACIONAL S.L.Ferraz, 10 - 1º Izda. 
ES - Španija USO RACIONAL S.L.Ferraz, 10 - 1º Izda.
Teva Uk Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom 
Teva Uk Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG Velika Britanija
1045 Budapest Hungary 
1045 Budapest Madžarska
Archimedes Pharma Uk Limited Bishops Weald House Albion Way, Horsham, West Sussex RH12 1AH United Kingdom 
Archimedes Pharma Uk Limited Bishops Weald House Albion Way, Horsham, West Sussex RH12 1AH Velika Britanija
E. Demunterlaan 3 1090 Bruxelles Belgium 
E. Demunterlaan 3 1090 Bruxelles Belgija
ES - Spain USO RACIONAL S.L.Ferraz, 10 - 1º Izda.28008 Madrid 
ES - Španija USO RACIONAL S.L.Ferraz, 10 - 1º Izda.28008 Madrid
ES - Spain BIAL INDUSTRIAL FARMACEUTICA S.A.Alameda de Urquijo 
ES - Španija BIAL INDUSTRIAL FARMACEUTICA S.A.Alameda de Urquijo
1a D-17498 Mesekenhagen Germany 
1a D-17498 Mesekenhagen Nemčija
Diagonal 507 Barcelona 
Diagonal 507 BARCELONA Španija
D-82041 Oberhaching Germany 
D-82041 Oberhaching Nemčija
Solvay Healthcare Limited Mansbridge Road, West End, SOUTHAMPTON SO18 3JD United Kingdom 
Solvay Healthcare Limited Mansbridge Road, West End, SOUTHAMPTON SO18 3JD Velika Britanija
1074 Budapest Hungary 
1074 Budapest Madžarska
AT - Austria 1A Pharma GmbH Stella-Klein-Löw-Weg 17, A1020 Wien 
AT - Avstrija 1A Pharma GmbH Stella-Klein-Löw-Weg 17, A1020 Wien
HANTS GU32 3QB United Kingdom 
HANTS GU32 3QB Velika Britanija
D-56218 Mülheim-Kärlich Germany 
D-56218 Mülheim-Kärlich Nemčija
IS- 220 Hafnarfjördur Iceland 
IS- 220 Hafnarfjördur Islandija
13 D-24941 Flensburg Germany 
13 D-24941 Flensburg Nemčija
FR - France ACTAVIS France La Boursidière Centre d'Affaires 92357 Le Plessis Robinson FRANCE 
ACTAVIS Francija La Boursidière Centre d'Affaires 92357 Le Plessis Robinson Francija
EL - Greece LABORATOIRES SMB S.A., BELGIUM 
LABORATOIRES SMB S.A., BELGIJA
PETERSFIELD, HANTSGU32 3QB United Kingdom 
PETERSFIELD, HANTSGU32 3QB Velika Britanija
Chanaux) 93330 Neuilly-sur-Seine France 
Chanaux) 93330 Neuilly-sur-Seine Francija
AT - Austria Ratiopharm Arzneimittel Vertriebs-GmbH 
AT - Avstrija Ratiopharm Arzneimittel Vertriebs-GmbH
HUHungary sanofi-aventis zrt. 
HUMadžarska sanofi-aventis zrt.
One Onslow Street Guildford, Surrey GU1 4YS United Kingdom 
One Onslow Street Guildford, Surrey GU1 4YS Velika Britanija
HR8 2DX Herefordshire United Kingdom 
HR8 2DX Herefordshire Velika Britanija
E. Demunter 3 B- 1090 Bruxelles Belgium 
E. Demunter 3 B- 1090 Bruxelles Belgija
ES - Spain PARKE DAVIS, Avda. 
ES - Španija PARKE DAVIS, Avda.
Generis Farmacêutica S.A. Office Park da Beloura Edifício 4, Quinta da Belou 2710-444 Sinta Portugal 
Generis Farmacêutica S.A. Office Park da Beloura Edifício 4, Quinta da Belou 2710-444 Sinta Portugalska
EL - Greece KLEVA AFBEE Parnithos Avenue 189 Aharnes Attikis 136 75 Greece 
KLEVA AFBEE Parnithos Avenue 189 Aharnes Attikis 136 75 Grčija
92213 Saint-Cloud Cedex France 
92213 Saint-Cloud Cedex Francija
16th Km Marathonos Avenue Pallini Attikis 153 44 Greece 
16th Km Marathonos Avenue Pallini Attikis 153 44 Grčija
AT - Austria Stada Arzneimittel GmbH Muthgasse 36 
AT - Avstrija Stada Arzneimittel GmbH Muthgasse 36
IT - Italy Actavis Italy Spa Viale Luigi Pasteur, 10Nerviano 
Actavis Italija Spa Viale Luigi Pasteur, 10Nerviano
1 A Pharma GmbH Keltenring 1 + 3 
DE - Nemčija 1 A Pharma GmbH Keltenring 1 + 3
ES - Spain LABORATORIOS MENARINI S.A Alfonso XII 
ES - Španija LABORATORIOS MENARINI S.A Alfonso XII
ES - Spain PARKE DAVIS Avda. 
ES - Španija PARKE DAVIS Avda.
Abbott Arzneimittel GmbH Hans-Boeckler-Allee 20 D-30173 Hannover Germany 
Abbott Arzneimittel GmbH Hans-Boeckler-Allee 20 D-30173 Hannover Nemčija
CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany 
CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Nemčija
Lek farmacevtska družba d.d., Verovškova 57 
SI - Slovenija Lek farmacevtska družba d.d., Verovškova 57
21079 Dijon Cedex 
21079 Dijon Cedex Francija
IT - Italy Actavis Italy Spa Viale Luigi Pasteur 10 - Nerviano - 20014 MILANO 
Actavis Italija Spa Viale Luigi Pasteur 10 - Nerviano - 20014 MILANO
94200 Ivry sur Seine FRANCE 
94200 Ivry sur Seine Francija
AT - Austria Pfizer Corporation Austria GmbH 
AT - Avstrija Pfizer Corporation Avstrija GmbH
D-90449 Nürnberg Germany 
D-90449 Nürnberg Nemčija
FR - France CLL PHARMA Nice Premier - Arénas 455, Promenade des Anglais 06299 Nice Cedex 03 FRANCE 
Nice Premier - Arénas 455, Promenade des Anglais 06299 Nice Cedex 03 Francija
63804 Cournon d'Auvergne Cedex France 
63804 Cournon d'Auvergne Cedex Francija
Pharmaceuticals Uk Limited One Onslow Street Guildford, Surrey GU1 4YS United Kingdom 
Pharmaceuticals Uk Limited One Onslow Street Guildford, Surrey GU1 4YS Velika Britanija
DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven Belgium 
Ambachtenlaan 13H 3001 Leuven Belgija
IT - Italy Get Srl Via Dante Alighieri, 73 18038 Sanremo - IMPERIA Italy 
Via Dante Alighieri, 73 18038 Sanremo - IMPERIA Italija
AT - Austria Arcana Arzneimittel GmbH Hütteldorfer Straße 299 
AT - Avstrija Arcana Arzneimittel GmbH Hütteldorfer Straße 299
20014 MILANO 
20014 MILANO Italija
IT - Italy Teofarma Srl Via Fratelli Cervi, 8Valle Salimbene 27010 Pavia 
Teofarma Srl Via Fratelli Cervi, 8Valle Salimbene 27010 Pavia Italija
FR - France AJC INVEST 6, rue de la Rochefoucauld 16000 Angoulême FRANCE 
6, rue de la Rochefoucauld 16000 Angoulême Francija
FR - France ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France 
ZYDUS Francija 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre Francija
BGBulgaria 
BG - Bolgarija
IT - Italy Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio - VARESE Italy 
Largo Umberto Boccioni, 1 21040 Origgio - VARESE Italija
EL - Greece FINIXPHARM EPE Dervenakion 38 and Sahini str Gerakas Attikis 153 44 Greece 
FINIXPHARM EPE Dervenakion 38 and Sahini str Gerakas Attikis 153 44 Grčija
AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany 
AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Nemčija
8 Kruczkowskiego St., 00-308 Warsaw Poland 
8 Kruczkowskiego St., 00-308 Warsaw Poljska
AT - Austria Genericon Pharma GmbH Hafnerstraße 211 
AT - Avstrija Genericon Pharma GmbH Hafnerstraße 211
ES - Spain FERMON, S.L.Alfonso XII, 587 Badalona 
ES - Španija FERMON, S.L.Alfonso XII, 587 Badalona
00165 ROMA 
00165 ROMA Italija
IT - Italy Eg Spa Via Scarlatti Domenico, 31 20124 MILANO Italy 
Via Scarlatti Domenico, 31 20124 MILANO Italija
65439 Flörsheim 
65439 Flörsheim Nemčija
00155 ROMA 
00155 ROMA Italija
ES - Spain LABORATORIOS MENARINI S.A Alfonso XII, 587 Badalona 08918 BARCELONA 
ES - Španija LABORATORIOS MENARINI S.A Alfonso XII, 587 Badalona 08918 BARCELONA
CZ - Czech Republic sanofi-aventis s.r.o. 
CZ - Češka sanofi-aventis s.r.o.
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany 
ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 D-89150 Laichingen Nemčija
92302 Levallois-Perret Cedex FRANCE 
92302 Levallois-Perret Cedex Francija
EL - Greece ACTAVIS GROUP PTC EHF., ICELAND 
ACTAVIS GROUP PTC EHF., ICELAND
Elmogan 450 mg filmsko obložene tablete 
Elmogan 450 mg Filmsko obložena tableta
DEGermany betapharm Arzneimittel GmbH Kobelweg 95 
DE - Nemčija betapharm Arzneimittel GmbH Kobelweg 95
FR - France Arrow 26, avenue Tony Garnier 69007 Lyon 
FR - Francija Arrow 26, avenue Tony Garnier 69007 Lyon
5 ks. J. Poniatowskiego St. 05-825 Grodzisk Mazowiecki Poland 
5 ks. J. Poniatowskiego St. 05-825 Grodzisk Mazowiecki Poljska
5 ks. J. Poniatowskiego St., 05-825 Grodzisk Mazowiecki Poland 
5 ks. J. Poniatowskiego St., 05-825 Grodzisk Mazowiecki Poljska
FR - France Laboratoire Ratiopharm 19, Bd Paul Vaillant Couturier 94200 Ivry sur Seine France 
FR - Francija Laboratoire Ratiopharm 19, Bd Paul Vaillant Couturier 94200 Ivry sur Seine Francija
191 90 Sollentuna Sweden 
SE - Švedska Pfizer AB 191 90 Sollentuna Sweden
PTPortugal 
PTPortugalska
Laboratoires Fournier SA 28 boulevard Clèmenceau BP 27912 21079 DIJON Cedex France 
Laboratoires Fournier SA 28 boulevard Clèmenceau BP 27912 21079 DIJON Cedex Francija
HEXAL AG Industriestraße 25 83607 Holzkirchen Germany 
HEXAL AG Industriestraße 25 83607 Holzkirchen Nemčija
FR - France CRISTERS 22 quai Gallieni 92150 Suresnes France 
CRISTERS 22 quai Gallieni 92150 Suresnes Francija
SKSlovakia sanofi-aventis Slovakia s.r.o. 
SK - Slovaška sanofi-aventis Slovaška s.r.o.
1200 mg Granules 
1200 mg zrnca
CY - Cyprus SANOFI AVENTIS CYPRUS LTD Charalambou Mouskou 14 
SANOFI AVENTIS CIPER LTD Charalambou Mouskou 14 2015 Strovolos Ciper