natgillin/translations-raw huggingface dataset:
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/126)
Direktiivin 2001/82/EY 35 artiklan mukaisen lausuntopyyntömenettelyn tulos (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.
Siksi helmikuun 5. päivänä 2018 Yhdistynyt kuningaskunta pani vireille direktiivin 2001/82/EY 35 artiklan mukaisen lausuntomenettelyn, joka koski edellä mainittuja eläinlääkkeitä.
Why were solutions for injection containing 50 mg closantel per ml (as a single active substance) reviewed?
Miksi 50 mg klosanteelia millilitrassa (ainoana vaikuttavana aineena) sisältäviä injektionesteitä arvioitiin?
The CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned veterinary medicinal products are required in order to amend the product information accordingly.
Eläinlääkekomitea suositteli, että edellä mainittujen eläinlääkkeiden myyntilupien ehtoja muutetaan ja valmistetiedot muutettaisiin sen mukaisesti.
In addition, cattle may also be treated topically on their skin.
Lisäksi hoito voidaan antaa naudoille myös paikallisesti iholle.
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.
Klosanteeli on tarkoitettu naudoille ja lampaille täysikasvuisten ja kehitysvaiheessa olevien tiehytmatojen, sukkulamatojen ja joidenkin niveljalkaisten toukkamuotojen häätöön ja torjuntaan, ja se annetaan injektiona ihon alle tai oraaliliuoksena.
The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for meat and offal derived from treated sheep.
Eläinlääkekomiteaa pyydettiin arvioimaan kaikki käytettävissä olevat jäämien poistumista koskevat tiedot ja suosittelemaan varoaikoja hoidettujen lampaiden lihaa ja sisäelimiä varten.
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.
Varoajalla tarkoitetaan viimeisestä eläinlääkkeen antamisesta laskettua vähimmäisaikaa, jonka kuluessa teurastetun eläimen lihaa tai muita eläimestä saatuja tuotteita ei saa käyttää elintarvikkeina.
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.
Euroopan lääkevirasto (jäljempänä ”virasto”) sai 21. helmikuuta 2019 päätökseen arvioinnin, joka koski injektionesteenä, liuoksena annettavien 50 mg klosanteelia millilitrassa (ainoana vaikuttavana aineena) sisältävien eläinlääkkeiden lampaille määritettyjen varoaikojen (teurastus) kuluttajaturvallisuutta.
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.
Viraston eläinlääkekomitea (CVMP) katsoi kyseisten valmisteiden yleisen riskihyötysuhteen olevan suotuisa ja suositteli lampaiden osalta muutoksia varoaikoihin kuluttajaturvallisuuden varmistamiseksi.
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.
Yhdistynyt kuningaskunta totesi, että injektionesteenä, liuoksena annettavien klosanteelia sisältävien eläinlääkkeiden lampaita koskevissa (esim. lampaan liha ja sisäelimet) hyväksytyissä varoajoissa on eroavuuksia Euroopan unionin alueella siten, että ne vaihtelevat 28 vuorokaudesta 107 vuorokauteen.
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.
Tällä hetkellä käytettävissä olevien tietojen perusteella eläinlääkekomitea katsoi, että injektionesteenä, liuoksena ihon alle lampaille annettavien 50 mg klosanteelia millilitrassa (ainoana vaikuttavana aineena) sisältävien eläinlääkkeiden yleinen riski-hyötysuhde on suotuisa ja että lampaita koskevat (liha ja sisäelimet) varoajat on yhdenmukaistettava kuluttajaturvallisuuden varmistamiseksi.
20 May 2019
20. toukokuuta 2019 EMA/246018/2019
FR - France TEVA SANTE Le Palatin 1
FR - Ranska TEVA SANTE Le Palatin 1
IT - Italy C.T.
IT - Italia C.T.
EL - Greece SPECIFAR ABEE 28th October str 1
EL - Kreikka SPECIFAR ABEE 28th October str 1
AT - Austria G.L.
AT - Itävalta G.L.
FR - France ETHYPHARM 194, Bureaux de la Colline Bâtiment D
FR - Ranska ETHYPHARM 194, Bureaux de la Colline Bâtiment D
PL - Poland VEDIM Sp. z o.o.
PL - Puola VEDIM Sp. z o.o.
FR - France GALENIX DEVELOPPEMENT Les Palanques
FR - Ranska GALENIX DEVELOPPEMENT Les Palanques
IT - Italy Farmaceutici Caber Spa Viale Città D'Europa, 681
IT - Italia Farmaceutici Caber Spa Viale Città D'Europa, 681
1080 Brussels
1080 Bruxelles
FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou
FR - Ranska EG LABO - Laboratoires EuroGenerics "Le Quintet" - bâtiment A 12, rue Danjou
ES - Spain BEXAL FARMACEUTICA, S.ACentro Empresarial Osa Mayor.
BEXAL FARMACEUTICA, S.ACentro Empresarial Osa Mayor.
EL - Greece MED-ONE AFBEE Agiou Petrou 30 and Epameinonda
EL - Kreikka MED-ONE AFBEE Agiou Petrou 30 and Epameinonda
28290 Las Matas
28290 Las Matas Madrid
PL - Poland Grodziskie Zakłady Farmaceutyczne "Polfa" Sp. z o.o.
PL - Puola Grodziskie Zakłady Farmaceutyczne "Polfa" Sp. z o.o.
IE - Ireland Pfizer Healthcare Ireland 9 Riverwalk
Pfizer Healthcare Ireland 9 Riverwalk
IT - Italy Vecchi & Piam Sapa Via Padre Semeria, 5
IT - Italia Vecchi & Piam Sapa Via Padre Semeria, 5
IT - Italy Francia Farmaceutici Industria Farmaco Biologica Srl
IT - Italia Francia Farmaceutici Industria Farmaco Biologica Srl
FR - France RANBAXY PHARMACIE GENERIQUES
FR - Ranska RANBAXY PHARMACIE GENERIQUES
FR - France SUBSTIPHARM 8, rue Bellini
FR - Ranska SUBSTIPHARM 8, rue Bellini
IT - Italy Salus Researches Spa Via Aurelia, 58
IT - Italia Salus Researches Spa Via Aurelia, 58
EL - Greece Sanofi-Aventis Aebe Syngrou Avenue 348, Building A,
EL - Kreikka Sanofi-Aventis Aebe Syngrou Avenue 348, Building A,
ES - Spain NOVARTIS FARMACEUTICA, S.A. Gran Via de les Corts Catalanes 764 Barcelona
NOVARTIS FARMACEUTICA, S.A. Gran Via de les Corts Catalanes 764 Barcelona
FR - France AJC INVEST 6, rue de la Rochefoucauld 16000 Angoulême FRANCE
FR - Ranska AJC INVEST 6, rue de la Rochefoucauld 16000 Angoulême FRANCE
ET - Estonia Pharmaswiss Eesti OÜ Tammsaare tee 47
ET - Viro Pharmaswiss Eesti OÜ Tammsaare tee 47
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Luettelo lääkevalmisteen nimistä, lääkemuodoista, vahvuuksista, antoreiteistä ja myyntiluvan haltijoista jäsenvaltioissa
Diagonal 507 Barcelona
Diagonal 507 BARCELONA Spain
FR - France BOUCHARA RECORDATI 68, rue Marjolin
FR - Ranska BOUCHARA RECORDATI 68, rue Marjolin
IT - Italy Winthrop Pharmaceuticals Italia Srl
IT - Italia Winthrop Pharmaceuticals Italia Srl
ES - Spain LABORATORIOS RANBAXY S.L.Passeig de Gracia 9 Barcelona
LABORATORIOS RANBAXY S.L.Passeig de Gracia 9 Barcelona
IT - Italy Get Srl Via Dante Alighieri, 73 18038 Sanremo - IMPERIA Italy
IT - Italia Get Srl Via Dante Alighieri, 73 18038 Sanremo - IMPERIA Italy
08918 BARCELONA
08918 BARCELONA Spain
ARENA GROUP S.A. Str. Ştefan Mihăileanu Nr.31, Sector 2
S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu Nr.31, Sector 2
MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
BE - Belgia MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
IT - Italy Solvay Pharma Spa Via della Libertà 30
IT - Italia Solvay Pharma Spa Via della Libertà 30
ES - Spain USO RACIONAL S.L.Ferraz, 10 - 1º Izda.
USO RACIONAL S.L.Ferraz, 10 - 1º Izda.
FR - France Pfizer Holding France 23-25, avenue du Docteur Lannelongue
FR - Ranska Pfizer Holding France 23-25, avenue du Docteur Lannelongue
ES - Spain ACTAVIS SPAIN S.A.Rivera del Loira 46 - Bussines Centre Regus Office 525 Madrid Spain
ACTAVIS SPAIN S.A.Rivera del Loira 46 - Bussines Centre Regus Office 525 Madrid Spain
FR - France Laboratoires LEURQUIN MEDIOLANUM
FR - Ranska Laboratoires LEURQUIN MEDIOLANUM
IT - Italy Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio - VARESE Italy
IT - Italia Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio - VARESE Italy
FR - France LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf
FR - Ranska LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf
EL - Greece KLEVA AFBEE Parnithos Avenue 189 Aharnes Attikis 136 75 Greece
EL - Kreikka KLEVA AFBEE Parnithos Avenue 189 Aharnes Attikis 136 75 Greece
ES - Spain ACTAVIS SPAIN, S.A. Perú 8
ACTAVIS SPAIN, S.A. Perú 8
FR - France WYVERN MEDICAL LTD Sterling House - 3A New Street Ledbury
FR - Ranska WYVERN MEDICAL LTD Sterling House - 3A New Street Ledbury
AT - Austria Solvay Pharma GmbH Dresdner Straße 91/C2/Top 12 A- 1200 Wien
AT - Itävalta Solvay Pharma GmbH Dresdner Straße 91/C2/Top 12 A- 1200 Wien
AT - Austria Pfizer Corporation Austria GmbH
AT - Itävalta Pfizer Corporation Austria GmbH
FR - France WYVERN MEWYVERN MEDICAL LTD
FR - Ranska WYVERN MEWYVERN MEDICAL LTD
ES - Spain PARKE DAVIS, Avda.
PARKE DAVIS, Avda.
EL - Greece MEDICHROM S.A. 6th Km Markopolou-Koropi Avenue
EL - Kreikka MEDICHROM S.A. 6th Km Markopolou-Koropi Avenue
ES - Spain BIAL INDUSTRIAL FARMACEUTICA S.A.Alameda de Urquijo
BIAL INDUSTRIAL FARMACEUTICA S.A.Alameda de Urquijo
EL - Greece ACTAVIS GROUP PTC EHF., ICELAND
EL - Kreikka ACTAVIS GROUP PTC EHF., ICELAND
EL - Greece LABORATOIRES SMB S.A., BELGIUM
EL - Kreikka LABORATOIRES SMB S.A., BELGIUM
UAB PharmaSwiss Šeimyniškių 21B LT-09200 Vilnius Lithuania
LT - Liettua UAB PharmaSwiss Šeimyniškių 21B LT-09200 Vilnius Lithuania
EL - Greece PHARMACEUTICAL INDUSTRY E.G. KORONIS S.A.
EL - Kreikka PHARMACEUTICAL INDUSTRY E.G. KORONIS S.A.
EL - Greece SOLVAY PHARMA Μ.Ε.Π.Ε Agiou DIMITRIOU 63
EL - Kreikka SOLVAY PHARMA Μ.Ε.Π.Ε Agiou DIMITRIOU 63
IT - Italy Eg Spa Via Scarlatti Domenico, 31 20124 MILANO Italy
IT - Italia Eg Spa Via Scarlatti Domenico, 31 20124 MILANO Italy
AT - Austria Ratiopharm Arzneimittel Vertriebs-GmbH
AT - Itävalta Ratiopharm Arzneimittel Vertriebs-GmbH
IT - Italy Teva Italia Srl Via Messina, 38
IT - Italia Teva Italia Srl Via Messina, 38
FR - France Société FERLUX SA 24, avenue d'Aubière BP 151
FR - Ranska Société FERLUX SA 24, avenue d'Aubière BP 151
FR - France ACTAVIS France La Boursidière Centre d'Affaires 92357 Le Plessis Robinson FRANCE
FR - Ranska ACTAVIS France La Boursidière Centre d'Affaires 92357 Le Plessis Robinson FRANCE
IT - Italy Biores Italia Srl Via Vittorio Grassi, 13La Rustica
IT - Italia Biores Italia Srl Via Vittorio Grassi, 13La Rustica
AT - Austria 1A Pharma GmbH Stella-Klein-Löw-Weg 17, A1020 Wien
AT - Itävalta 1A Pharma GmbH Stella-Klein-Löw-Weg 17, A1020 Wien
IT - Italy Boniscontro & Gazzone Srl Via Pavia, 6
IT - Italia Boniscontro & Gazzone Srl Via Pavia, 6
ES - Spain USO RACIONAL S.L.Ferraz, 10 - 1º Izda.28008 Madrid
USO RACIONAL S.L.Ferraz, 10 - 1º Izda.28008 Madrid
CY - Cyprus SANOFI AVENTIS CYPRUS LTD Charalambou Mouskou 14
CY - Kypros SANOFI AVENTIS CYPRUS LTD Charalambou Mouskou 14
IT - Italy Doc Generici Srl Via Manuzio, 7
IT - Italia Doc Generici Srl Via Manuzio, 7
EL - Greece GAP S.A. Agisilaou 46
EL - Kreikka GAP S.A. Agisilaou 46
EL - Greece PFIZER HELLAS S.A. Messogion Avenue 243
EL - Kreikka PFIZER HELLAS S.A. Messogion Avenue 243
CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany
DE - Saksa CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin
1 A Pharma GmbH Keltenring 1 + 3
DE - Saksa 1 A Pharma GmbH Keltenring 1 + 3
EL - Greece FINIXPHARM EPE Dervenakion 38 and Sahini str Gerakas Attikis 153 44 Greece
EL - Kreikka FINIXPHARM EPE Dervenakion 38 and Sahini str Gerakas Attikis 153 44 Greece
AT - Austria Stada Arzneimittel GmbH Muthgasse 36
AT - Itävalta Stada Arzneimittel GmbH Muthgasse 36
ES - Spain LABORATORIO STADA, S.L.Frederic Mompou, 5 Sant Just Desvern08960
LABORATORIO STADA, S.L.Frederic Mompou, 5 Sant Just Desvern08960 BARCELONA
FR - France Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux
FR - Ranska Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux
EL - Greece HRISPA ALFA PHARMACEUTICALS S.A.
EL - Kreikka HRISPA ALFA PHARMACEUTICALS S.A.
CY - Cyprus REMEDICA LTD Aharnon street
CY - Kypros REMEDICA LTD Aharnon street
IT - Italy Pfizer Italia Srl Via Isonzo, 71
IT - Italia Pfizer Italia Srl Via Isonzo, 71
1a D-17498 Mesekenhagen Germany
D-17498 Mesekenhagen Germany
EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
EL - Kreikka ANFARM HELLAS S.A. Perikleous 53-57
EL - Greece BIOSPRAY ABEE 18th Km Marathonos Avenue Pallini Attikis 153 44
EL - Kreikka BIOSPRAY ABEE 18th Km Marathonos Avenue Pallini Attikis 153 44
IT - Italy Actavis Italy Spa Viale Luigi Pasteur, 10Nerviano
IT - Italia Actavis Italy Spa Viale Luigi Pasteur, 10Nerviano
IT - Italy Teofarma Srl Via Fratelli Cervi, 8Valle Salimbene 27010 Pavia
IT - Italia Teofarma Srl Via Fratelli Cervi, 8Valle Salimbene 27010 Pavia
ES - Spain LABORATORIOS MENARINI S.A Alfonso XII
LABORATORIOS MENARINI S.A Alfonso XII
Mylan dura GmbH Wittichstr.
DE - Saksa Mylan dura GmbH Wittichstr.
21079 Dijon Cedex
21079 Dijon Cedex France
IT - Italy Teofarma Srl Via Fratelli Cervi, 8 - Valle Salimbene
IT - Italia Teofarma Srl Via Fratelli Cervi, 8 - Valle Salimbene
Sandoz Pharmaceuticals GmbH Raiffeisenstr.
DE - Saksa Sandoz Pharmaceuticals GmbH Raiffeisenstr.
Winthrop Arzneimittel GmbH Urmitzer Str. 5
DE - Saksa Winthrop Arzneimittel GmbH Urmitzer Str. 5
AT - Austria Arcana Arzneimittel GmbH Hütteldorfer Straße 299
AT - Itävalta Arcana Arzneimittel GmbH Hütteldorfer Straße 299
AT - Austria Genericon Pharma GmbH Hafnerstraße 211
AT - Itävalta Genericon Pharma GmbH Hafnerstraße 211
IT - Italy Actavis Italy Spa Viale Luigi Pasteur 10 - Nerviano - 20014 MILANO
IT - Italia Actavis Italy Spa Viale Luigi Pasteur 10 - Nerviano - 20014 MILANO
DEGermany betapharm Arzneimittel GmbH Kobelweg 95
DE - Saksa betapharm Arzneimittel GmbH Kobelweg 95
145 mg pour 1 comprimé tablet
145 mg pour 1 comprimé
FR - France CLL PHARMA Nice Premier - Arénas 455, Promenade des Anglais 06299 Nice Cedex 03 France
FR - Ranska CLL PHARMA Nice Premier - Arénas 455, Promenade des Anglais 06299 Nice Cedex 03 France
FR - France CLL PHARMA Nice Premier - Arénas 455, Promenade des Anglais 06299 Nice Cedex 03 FRANCE
FR - Ranska CLL PHARMA Nice Premier - Arénas 455, Promenade des Anglais 06299 Nice Cedex 03 FRANCE
LULuxembourg
LULuxemburg
CY - Cyprus Varnavas Hadjipanayis Ltd, 7 Androcleous street
CY - Kypros Varnavas Hadjipanayis Ltd, 7 Androcleous street
ES - Spain QUIMIFAR, S.A.Comadran, 37 Barbera del Valles 08210 BARCELONA
QUIMIFAR, S.A.Comadran, 37 Barbera del Valles 08210 BARCELONA Spain
ES - Spain FERMON, S.L.Alfonso XII, 587 Badalona
FERMON, S.L.Alfonso XII, 587 Badalona
Heumann Pharma GmbH & Co. Generica KG
DE - Saksa Heumann Pharma GmbH & Co. Generica KG
Juta Pharma GmbH Gutenbergstr.
DE - Saksa Juta Pharma GmbH Gutenbergstr.
HUHungary sanofi-aventis zrt.
HU - Unkari sanofi-aventis zrt.
TAD Pharma GmbH Heinz-Lohmann-Str. 5D 27472 Cuxhaven Germany
DE - Saksa TAD Pharma GmbH Heinz-Lohmann-Str. 5D 27472 Cuxhaven
Stadapharm GmbH Stadastr.
DE - Saksa Stadapharm GmbH Stadastr.
FR - France Laboratoire Ratiopharm 19, Bd Paul Vaillant Couturier 94200 Ivry sur Seine France
FR - Ranska Laboratoire Ratiopharm 19, Bd Paul Vaillant Couturier 94200 Ivry sur Seine France
FR - France Arrow 26, avenue Tony Garnier 69007 Lyon
FR - Ranska Arrow 26, avenue Tony Garnier 69007 Lyon
CHEPLAPHARM Arzneimittel GmbH
DE - Saksa CHEPLAPHARM Arzneimittel GmbH
CY - Cyprus Varnavas Hadjipanayis Ltd 7 Androcleous street P.O.Box 21229
CY - Kypros Varnavas Hadjipanayis Ltd 7 Androcleous street P.O.Box 21229
Pfizer Pharma GmbH Linkstr.
DE - Saksa Pfizer Pharma GmbH Linkstr.
FR - France ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE
FR - Ranska ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France
FR - France ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France
FR - Ranska ZYDUS France 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE
FR - France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
FR - Ranska ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
EL - Greece COSMOPHARM EPE P.O.
EL - Kreikka COSMOPHARM EPE P.O. Box 42
ES - Spain LABORATORIOS MENARINI S.A Alfonso XII, 587 Badalona 08918 BARCELONA
LABORATORIOS MENARINI S.A Alfonso XII, 587 Badalona 08918 BARCELONA Spain
JUBILANT PHARMACEUTICALS NV Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke
Guldensporenpark 22 - Block C 9820 Merelbeke
Hennig Arzneimittel GmbH & Co.KG
DE - Saksa Hennig Arzneimittel GmbH & Co.KG
LACROMID 200 FC TABLETS 200mg tablets
LACROMID 200 FC TABLETS 200mg
FR - France CRISTERS 22 quai Gallieni 92150 Suresnes France
FR - Ranska CRISTERS 22 quai Gallieni 92150 Suresnes France
Box 313, 3740 AH Baarn, The Netherlands
Actavis BV P.O. Box 313, 3740 AH Baarn, The Netherlands
Box 313, 3740 AH Baarn The Netherlands
Actavis BV P.O. Box 313, 3740 AH Baarn The Netherlands
PL - Poland Laboratoires Fournier S.A. Bd Clemenceau 28
PL - Puola Laboratoires Fournier S.A. Bd Clemenceau 28
DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven Belgium
Ambachtenlaan 13H 3001 Leuven
PL - Poland Apotex Europe B.V. Darwinweg 20
PL - Puola Apotex Europe B.V.
PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
PL - Puola ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
Fenofibrato KernPharma 160 mg capsules
Fenofibrato KernPharma 160 mg
CZ - Czech Republic sanofi-aventis s.r.o.
CZTshekki sanofi-aventis s.r.o.
FR - France Laboratoire RATIOPHARM 19, boulevard Paul Vaillant Couturier
FR - Ranska LABORATOIRE RATIOPHARM 19, boulevard Paul Vaillant Couturier
ZAFIBRAL FC TABLETS 200mg tablets
ZAFIBRAL FC TABLETS 200mg
LIPANTHYL 67 M capsule 67 mg capsules
LIPANTHYL 67 M capsule 67 mg
LIPANTHYL 267 M capsule 267 mg capsules
LIPANTHYL 267 M capsule 267 mg
FR - France Sandoz 49, av. Pompidou 92300 Levallois-Perret France
FR - Ranska Sandoz 49, av. Pompidou 92300 Levallois-Perret France
LIPIDIL MICRONISED HARD CAPSULES 267mg capsules
LIPIDIL MICRONISED HARD CAPSULES 267mg
SANDOZ N.V.
BE - Belgia SANDOZ N.V.
ES - Spain KERN PHARMA S.L.
KERN PHARMA S.L.
Abbott Arzneimittel GmbH Hans-Boeckler-Allee 20 D-30173 Hannover Germany
DE - Saksa Abbott Arzneimittel GmbH Hans-Boeckler-Allee 20
6D 64295 Darmstadt Germany
64295 Darmstadt Germany
MODALIM TABLETS 100mg 100mg tablets
MODALIM TABLETS 100mg 100mg
Pliva Pharma Limited Vision House Bedford Road Petersfield
Pliva Pharma Limited Vision House Bedford Road Petersfield HANTS GU32 3QB United Kingdom
Bezalip modified-release filmcoated tablet
Bezalip modified-release depottabletti, kalvopäällysteinen
Alternova A/S Lodhusvej 11 4230 Skælskør Denmark
4230 Skælskør Denmark
ES - Spain SOLVAY PHARMA S.A. Avda.
SOLVAY PHARMA S.A. Avda.
TECHNOLOGY S.A. Rue du Parc Industriel 39 6900 Marche-en-Famenne Belgium
TECHNOLOGY S.A. Rue du Parc Industriel 39
Lopid 600 mg film-coated tablets film-coated tablets oral use
Lopid 600 mg film-coated tablets
FENOFIBRATE RATIOPHARM 145 mg, comprimé tablet
FENOFIBRATE RATIOPHARM 145 mg, comprimé
FR - France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
FR - Ranska SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France
LIPIDIL MICRONISED HARD CAPSULES 200mg capsules
LIPIDIL MICRONISED HARD CAPSULES 200mg
FR - France Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
FR - Ranska Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
Ciprofibrate containing medicinal products with Marketing Authorisation in the European Union
Ciprofibrate sisältävät lääkevalmisteet, joille on myönnetty myyntilupa Euroopan Unionissa
Berlin-Chemie AG Glienicker Weg 125 D-12489 Berlin Germany
DE - Saksa Berlin-Chemie AG Glienicker Weg 125
FI - Finland Laboratoires SMB S.A. Rue de la Pastorale 26-28
S.A. Rue De La Pastorale 26-28
PL - Poland Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
PL - Puola Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée
400 mg, comprimé enrobé à libération prolongée
LIPOFOR CAPSULES 600mg 600mg capsules
LIPOFOR CAPSULES 600mg 600mg
1200 mg Granules
1200 mg Rakeet
400 MG/TAB PROLONGED RELEASE TABLETS
400 MG/TAB Depottabletti
IT - Italy Ratiopharm Gmbh Graf-Arco Strasse 3
IT - Italia Ratiopharm GmbH Graf-Arco Strasse 3
IT - Italy Ratiopharm GmbH Graf-Arco Strasse 3
IT - Italia Ratiopharm Gmbh Graf-Arco Strasse 3
FR - France Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
FR - Ranska Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
FENOFIBRATE EXPANPHARM 67 mg, comprimé tablet
FENOFIBRATE EXPANPHARM 67 mg, comprimé
AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
DE - Saksa AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7
PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3
PL - Puola ratiopharm GmbH Graf-Arco-Strasse 3
FENOFIBRATE EXPANPHARM 200 mg, comprimé tablet
FENOFIBRATE EXPANPHARM 200 mg, comprimé
FENOFIBRATE RATIOPHARM 160 mg, comprimé tablet
FENOFIBRATE RATIOPHARM 160 mg, comprimé
LIPIPHARM 145 mg, comprimé tablet
LIPIPHARM 145 mg, comprimé
BEZAFIBRAT ARENA 200 mg 200 mg tablets
BEZAFIBRAT ARENA 200 mg 200 mg
FENOFIBRATE QUALIMED 145 mg, comprimé tablet
FENOFIBRATE QUALIMED 145 mg, comprimé
IPOLIPID CAPSULES 600mg 600mg capsules
IPOLIPID CAPSULES 600mg 600mg
AT - Austria Actavis Group PTC ehf Reykjavikurvegur 76-78
AT - Itävalta Actavis Group PTC ehf Reykjavikurvegur 76-78
FR - France Actavis Group PTC ehf Reykjavikurvegi 76-78
FR - Ranska Actavis Group PTC ehf Reykjavikurvegi 76-78
GEMLIPID-MEDICHROM 600 MG/TAB Film coated tablet
GEMLIPID-MEDICHROM 600 MG/TAB Tabletti, kalvopäällysteinen
FENOFIBRATE ALTER 160 mg, comprimé tablet
FENOFIBRATE ALTER 160 mg, comprimé
S.A. Rue De La Pastorale 26-28 1080 Bruxelles Belgium
Laboratoires SMB S.A. Rue de la Pastorale 26-28 1080 Brussels Belgium
FENOFIBRATE TEVA 160 mg, comprimé tablet
FENOFIBRATE TEVA 160 mg, comprimé
FENOFIBRATE SANDOZ 145 mg, comprimé tablet
FENOFIBRATE SANDOZ 145 mg, comprimé
NLNetherlands
NLAlankomaat
Lipantil Supra 145mg filmcoated tablets film-coated tablets oral use
Lipantil Supra 145mg filmcoated tablets
BEZAFIBRAT SLAVIA 200 mg tablets
BEZAFIBRAT SLAVIA 200 mg
FENOFIBRATE CRISTERS 160 mg, comprimé tablet
FENOFIBRATE CRISTERS 160 mg, comprimé
Bezafibrat "ratiopharm" retard 400 mgFilmtabletten prolonged-release tablet
Bezafibrat "ratiopharm" retard 400 mgFilmtabletten
CY - Cyprus MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
CY - Kypros MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
FENOFIBRATE WINTHROP 145 mg, comprimé tablet
FENOFIBRATE WINTHROP 145 mg, comprimé
CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
CY - Kypros MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
400 mg tablet
600 mg Tabletti
Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union
Gemfibrotsiilia sisältävät lääkevalmisteet, joille on myönnetty myyntilupa Euroopan Unionissa
FENOFIBRATE ACTAVIS 160 mg, comprimé tablet
FENOFIBRATE ACTAVIS 160 mg, comprimé
Lipantil Micro 200 mg capsules, hard hard capsules
Lipantil Micro 200 mg capsules, hard
FENOFIBRATE BIOGARAN 145 mg, comprimé tablet
FENOFIBRATE BIOGARAN 145 mg, comprimé