FrancophonIA/ELRC3.0 huggingface dataset:
English: ILD and worsening of pre-existing ILD have been reported during treatment with leflunomide, the parent compound of teriflunomide.
Lithuanian: Pacientams, gydytiems pirmine teriflunomido medžiaga leflunomidu, buvo pranešta apie IPL arba jau buvusios IPL pasunkėjimo atvejus.
English: Hypertensionb
Lithuanian: Dislipidemija
English: Effect of teriflunomide on organic anion transporter 3 (OAT3) substrates There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of teriflunomide, suggesting that teriflunomide is an inhibitor of OAT3 in vivo.
Lithuanian: Po kartotinių teriflunomido dozių pavartojimo, padidėjo cefakloro vidutinis Cmax ir AUC (atitinkamai 1,43 ir 1,54 karto).
English: Vomiting, Toothache
Lithuanian: Vistor hf.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports (PSURs)
Lithuanian: KITOS SĄLYGOS IR REIKALAVIMAI REGISTRUOTOJUI
English: Headache
Lithuanian: Antr
English: Jaba Recordati, S. A.
Lithuanian: Jaba Recordati, S.
English: FR - France TEVA SANTE Le Palatin 1
Lithuanian: FR - Prancūzija TEVA SANTE Le Palatin 1
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Lithuanian: I priedas Vaistų pavadinimų, vaistų formų, stiprumo, vartojimo būdų ir rinkodaros teisės turėtojų valstybėse narėse sąrašas
English: FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
Lithuanian: FR - Prancūzija EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
English: EL - Greece PHARMACEUTICAL INDUSTRY PROEL EPAM.
Lithuanian: EL - Graikija PHARMACEUTICAL INDUSTRY PROEL EPAM.
English: HU - Hungary Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
Lithuanian: HU - Vengrija Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
English: HU - Hungary sanofi-aventis zrt.
Lithuanian: HU - Vengrija sanofi-aventis zrt.
English: Evropská 846/176a 160 00 Prague Czech republic
Lithuanian: Evropská 846/176a 160 00 Prague
English: Av. Tomás Ribeiro, 43 - Bloco 1, 4º BEdifício Neopark
Lithuanian: Tomás Ribeiro, 43 - Bloco 1, 4º BEdifício Neopark
English: FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Lithuanian: FR - Prancūzija CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
English: EL - Greece ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
Lithuanian: EL - Graikija ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
English: EL - Greece EVAGGELOS KALOFOLIAS & SIA O.E.
Lithuanian: EL - Graikija EVAGGELOS KALOFOLIAS & SIA O.E.
English: BG - Bulgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
Lithuanian: BG - Bulgarija Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
English: Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal
Lithuanian: Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal
English: 25125 Brescia Italy
Lithuanian: 25125 Brescia
English: SK - Slovakia Zentiva k.s., Evropská 846/176a, 160 00, Praha
Lithuanian: SK - Slovakija Zentiva k.s., Evropská 846/176a, 160 00, Praha
English: EL - Greece INTERMED ABEE Kalyftaki 27
Lithuanian: EL - Graikija INTERMED ABEE Kalyftaki 27
English: FR - France THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
Lithuanian: FR - Prancūzija THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
English: BG - Bulgaria Inbiotech Ltd 5A Triaditza str.
Lithuanian: BG - Bulgarija Inbiotech Ltd 5A Triaditza str.
English: BG - Bulgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
Lithuanian: BG - Bulgarija CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.
English: EL - Greece MED-ONE S.A., HELLAS Parnithos Avenue 211
Lithuanian: EL - Graikija MED-ONE S.A., HELLAS Parnithos Avenue 211
English: AT - Austria CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
Lithuanian: AT - Austrija CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
English: RO - Romania LABORATORI GUIDOTTI SpA Via Livornese, 897
Lithuanian: RO - Rumunija LABORATORI GUIDOTTI SpA Via Livornese, 897
English: AT - Austria CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
Lithuanian: AT - Austrija CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
English: RO - Romania S.C.
Lithuanian: RO - Rumunija S.C.
English: EL - Greece B.I.
Lithuanian: EL - Graikija B.I.
English: EL - Greece DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
Lithuanian: EL - Graikija DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
English: Dolni Mecholupy Praha 10, CZ-10237 Czech Republic
Lithuanian: Dolni Mecholupy Praha 10, CZ-10237
English: EL - Greece RAFARM AEBE Korintou 12
Lithuanian: EL - Graikija RAFARM AEBE Korintou 12
English: RO - Romania CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
Lithuanian: RO - Rumunija CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
English: EL - Greece HELP ABEE Valaoritou 10
Lithuanian: EL - Graikija HELP ABEE Valaoritou 10
English: EL - Greece COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
Lithuanian: EL - Graikija COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
English: EL - Greece KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
Lithuanian: EL - Graikija KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
English: EL - Greece BROS EPE Avgis & Gallinis 15
Lithuanian: EL - Graikija BROS EPE Avgis & Gallinis 15
English: CY - Cyprus CODAL SYNTO LTD 33 Thekla Lysioti str.
Lithuanian: CY - Kipras CODAL SYNTO LTD 33 Thekla Lysioti str.
English: EL - Greece VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
Lithuanian: EL - Graikija VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
English: RO - Romania Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
Lithuanian: RO - Rumunija Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
English: EL - Greece S.J.A.
Lithuanian: EL - Graikija S.J.A.
English: EL - Greece BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
Lithuanian: EL - Graikija BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
English: EL - Greece MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
Lithuanian: EL - Graikija MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
English: Constantinoupoleos Str. 1-10 Limassol, CY-3011
Lithuanian: 1-10 Limassol, CY-3011
English: S.A. Rua João Chagas, 53 - 3º 1495-764 Cruz Quebrada Portugal
Lithuanian: Rua João Chagas, 53 - 3º 1495-764 Cruz Quebrada Portugal
English: CY - Cyprus CDL PHARMACEUTICAL LTD 5 Diomedous str.
Lithuanian: CY - Kipras CDL PHARMACEUTICAL LTD 5 Diomedous str.
English: EL - Greece REMEK PHARMACEUTICALS ABEE Pentelis 34
Lithuanian: EL - Graikija REMEK PHARMACEUTICALS ABEE Pentelis 34
English: N. Psychiko 15451
Lithuanian: Psychiko 15451
English: Laboratori Guidotti S.p.A (Menarini Group).
Lithuanian: CZ - Čekija Laboratori Guidotti S.p.A (Menarini Group).
English: Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora PORTUGAL
Lithuanian: Rua João de Deus, 19 2700-487 Amadora PORTUGAL
English: EL - Greece VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
Lithuanian: EL - Graikija VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
English: Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal
Lithuanian: Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal
English: EL - Greece FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
Lithuanian: EL - Graikija FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
English: BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
Lithuanian: BG - Bulgarija Sopharma AD 16 Iliensko shosse str.
English: EL - Greece BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
Lithuanian: EL - Graikija BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
English: HU - Hungary PannonPharma Kft. Pannonpharma út 1.
Lithuanian: HU - Vengrija PannonPharma Kft.
English: Almus Srl Via Cesarea, 11/10 16121 Genova Italy
Lithuanian: Via Cesarea, 11/10 16121 Genova Italy
English: EL - Greece FARMILIA E.E.
Lithuanian: EL - Graikija FARMILIA E.E.
English: NIMESIL, granule pentru suspensie orală, 100 mg mg/sachet
Lithuanian: NIMESIL, granule pentru suspensie orală, 100 mg mg/paketėlis
English: EL - Greece REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
Lithuanian: EL - Graikija REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
English: AULIN, granule pentru suspensie orală, 100 mg/plic mg/sachet
Lithuanian: AULIN, granule pentru suspensie orală, 100 mg/plic mg/paketėlis
English: HU - Hungary Lab. Guidotti S.p.A.
Lithuanian: HU - Vengrija Lab. Guidotti S.p.A.
English: CY - Cyprus CHR. K. UNIMED LTD 21 Davlou
Lithuanian: K. UNIMED LTD 21 Davlou
English: EL - Greece LEOVAN, M. LEWN & SIA EE Argonafton 22
Lithuanian: LEWN & SIA EE Argonafton 22
English: Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros
Lithuanian: Zona Industrial do Lagedo 3465-157 Santiago de Besteiros
English: BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
Lithuanian: BG - Bulgarija Actavis EAD 29 Atanas Dukov str.
English: PL - Poland Medicom International s.r.o.
Lithuanian: PL - Lenkija Medicom International s.r.o.
English: PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
Lithuanian: PL - Lenkija Pabianickie Zakłady Farmaceutyczne Polfa S.A.
English: Arrowblue Produtos Farmacêuticos S.A. Av. D. João II,
Lithuanian: Arrowblue Produtos Farmacêuticos S.A.
English: SK - Slovakia Medicom International s.r.o.
Lithuanian: SK - Slovakija Medicom International s.r.o.
English: 50 MG/5ML Oral suspension Oral use
Lithuanian: 50 MG/5ML Geriamoji suspensija Vartoti per burną
English: de Produtos Farmacêuticos, Unip., Lda.
Lithuanian: de Produtos Farmacêuticos, Unip.
English: B-dul Aurel Vlaicu nr. 82 A, Constanţa
Lithuanian: 82 A, Constanţa
English: EL - Greece BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
Lithuanian: EL - Graikija BOEHRINGER INGELHEIM HELLAS S.A.
English: Via Padre G. Semeria, 5 - 16131 Genova Italy
Lithuanian: Semeria, 5 - 16131 Genova Italy
English: RO - Romania S.C. MAGISTRA C&C S.R.L.
Lithuanian: MAGISTRA C&C S.R.L.
English: EL - Greece MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Lithuanian: 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
English: U Kabelovny 130, 102 37, Prague 10, Dolni Mecholupy Czech Republic
Lithuanian: LT - Lietuva Zentiva k.s. U Kabelovny 130, 102 37, Prague 10, Dolni Mecholupy Czech Republic
English: PL - Poland Zentiva a.s. U Kabelovny 130
Lithuanian: BG - Bulgarija Zentiva k.s. U kabelovny 130
English: EL - Greece FARMANIC CHEMIPHARMA S.A. Fylis 137
Lithuanian: EL - Graikija FARMANIC CHEMIPHARMA S.A.
English: Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Lithuanian: Viale Fulvio Testi, 330 20126 Milano Italy
English: BG - Bulgaria Laboratori Guidotti S.p.A.
Lithuanian: BG - Bulgarija Laboratori Guidotti S.p.A.
English: G. KORONIS
Lithuanian: KORONIS
English: Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98
Lithuanian: Laboratórios Basi - Indústria Farmacêutica, S.
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
Lithuanian: 31, Sector 2, Bucureşti,
English: SK - Slovakia Laboratori Guidotti S.p.A.
Lithuanian: SK - Slovakija Laboratori Guidotti S.p.A.
English: EL - Greece BIOMEDICA-CHEMICA A.E. G. Lyra 25
Lithuanian: EL - Graikija BIOMEDICA-CHEMICA A.E.
English: SI - Slovenia CSC Pharma d.o.o.
Lithuanian: SI - Slovėnija CSC Pharma d.o.o. Jana Husa 1a
English: RO - Romania MEDOCHEMIE LTD. - CYPRUS, P.O.
Lithuanian: RO - Rumunija MEDOCHEMIE LTD.
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
Lithuanian: CY - Kipras MEDOCHEMIE LTD 1-10 Constantinoupoleos str.
English: LT - Lithuania Medochemie Ltd. P.O.
Lithuanian: LT - Lietuva Medochemie Ltd.
English: EL - Greece ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
Lithuanian: PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
English: EL - Greece ALET PHARMACEUTICALS M. Alexander 121
Lithuanian: EL - Graikija ALET PHARMACEUTICALS M.
English: FR - France HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
Lithuanian: FR - Prancūzija HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
English: FARMA A.E. Aristotelous 73
Lithuanian: Aristotelous 73
English: Savio Srl Via E. Bazzano, 14 16019 Ronco Scrivia (GE) Italy
Lithuanian: Bazzano, 14 16019 Ronco Scrivia (GE) Italy
English: EL - Greece MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
Lithuanian: EL - Graikija MINERVA PHARMAKEFTIKI A.E.
English: RO - Romania S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
Lithuanian: 30, Pipera Voluntari, Jud.
English: N. Kifissia 14564
Lithuanian: Kifissia 14564
English: BG - Bulgaria Zentiva k.s.
Lithuanian: CZ - Čekija Zentiva k.s.
English: EL - Greece PHARMACYPRIA HELLAS A.E. Paster 6
Lithuanian: EL - Graikija PHARMACYPRIA HELLAS A.E.
English: EL - Greece LAVIPHARM HELLAS A.E. Agias Marinas
Lithuanian: EL - Graikija LAVIPHARM HELLAS A.E.
English: EL - Greece FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
Lithuanian: Athinas 22 & Apollonos Gerakas Attikis 15344
English: Orodispersible tablet Oral use
Lithuanian: Burnoje disperguojamoji tabletė
English: VECCHI & C. PIAM s.a.p.a.
Lithuanian: VECCHI & C.
English: LT - Lithuania Laboratori Guidotti S.p.A.
Lithuanian: LT - Lietuva Laboratori Guidotti S.p.A.
English: EL - Greece NORMA HELLAS A.E. Menandrou 54
Lithuanian: EL - Graikija NORMA HELLAS A.E.
English: EL - Greece PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
Lithuanian: EL - Graikija PHARMATHEN INTERNATIONAL S.A.
English: EL - Greece ANTOR EPE P. Mavromihali 1
Lithuanian: EL - Graikija ANTOR EPE P.
English: MG/SACHET
Lithuanian: MG/PAKETĖLIS
English: Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 - Abrunheira
Lithuanian: Rua da Tapada Grande, 2 - Abrunheira
English: Medicom International, s.r.o.
Lithuanian: CZ - Čekija Medicom International, s.r.o.
English: RO - Romania ANFARM HELLAS S.A. Perikleous 53-57
Lithuanian: RO - Rumunija ANFARM HELLAS S.A.
English: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira
Lithuanian: Farmoz - Sociedade Técnico Medicinal, S.A.
English: EL - Greece GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
Lithuanian: 18th Km Marathonos Avenue Pallini Attikis 15351
English: LT - Lithuania Zentiva k.s.
Lithuanian: PL - Lenkija Zentiva a.s.
English: EL - Greece ARMEDICA A.E. Agias Markellis 17
Lithuanian: EL - Graikija ARMEDICA A.E.
English: EL - Greece VOCATE PHARMAKEFTIKI A.E. Gounari 150
Lithuanian: EL - Graikija VOCATE PHARMAKEFTIKI A.E.
English: PL - Poland Laboratori Guidotti S.p.A. (Menarini Group) Via Livornese 897
Lithuanian: (Menarini Group) Via Livornese 897
English: ES - Spain HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
Lithuanian: ES - Ispanija HELSINN BIREX PHARMACEUTICALS LTD.
English: LT - Lithuania Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart
Lithuanian: LT - Lietuva Helsinn Birex Pharmaceuticals Ltd.
English: RO - Romania Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
Lithuanian: 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
English: RO - Romania S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
Lithuanian: 44B sector 3, Bucuresti
English: The warnings are appropriate.
Lithuanian: Įspėjimai yra tinkami.
English: The active substance is well known and is included in veterinary medicinal products currently authorised in the EU.
Lithuanian: Veiklioji medžiaga gerai žinoma ir yra veterinarinių vaistų, kuriais šiuo metu leidžiama prekiauti ES, sudėtyje.
English: For the pour-on product 24 concerned member states (CMS) are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Lithuanian: Dėl užpilamojo preparato šioje procedūroje dalyvauja 24 susijusios valstybės narės: Austrija, Belgija, Bulgarija, Kipras, Čekija, Danija, Estija, Prancūzija, Vokietija, Graikija, Vengrija, Islandija, Airija, Italija, Latvija, Lietuva, Liuksemburgas, Nyderlandai, Lenkija, Portugalija, Rumunija, Slovakija, Slovėnija ir Ispanija.
English: The efficacy of Deltanil has been demonstrated according to current rules during the decentralised procedure.
Lithuanian: Deltanil veiksmingumas buvo įrodytas vadovaujantis šiuo metu galiojančiomis taisyklėmis decentralizuotos procedūros metu.
English: No additional studies were carried out in order to further refine the risk as guidance in this area is not currently available.
Lithuanian: Jokių papildomų tyrimų siekiant išsamiau ištirti šią riziką nebuvo atlikta, nes šiuo metu šiuo klausimu nėra parengta jokių gairių.
English: Quality, target animal safety, user safety and residues were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Lithuanian: Kokybė, paskirties gyvūnų saugumas, naudotojų saugumas ir likučiai nebuvo vertinami šios kreipimosi procedūros metu, kadangi referencinė valstybė narė nepranešė apie jokius su tuo susijusius nerimą keliančius klausimus.
English: It provided all the information required to be able to make a conclusion on the environmental risk presented by the use of the products.
Lithuanian: Jame pateikta visa informacija, kurios reikia, kad būtų galima padaryti išvadą dėl šių preparatų naudojimo keliamos rizikos aplinkai.
English: Efficacy was not assessed in this referral procedure.
Lithuanian: Šios kreipimosi procedūros metu veiksmingumas nebuvo vertinamas.
English: Package leaflet:
Lithuanian: Informacinis Lapelis:
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Lithuanian: Veterinarinio vaisto pavadinimų, vaisto formų, stiprumų, gyvūnų rūšių, naudojimo būdų ir pareiškėjų valstybėse narėse sąrašas
English: Using these data PNECs were derived using the appropriate assessment factors.
Lithuanian: Remiantis šiais duomenis, taikant atitinkamus vertinimo faktorius, buvo nustatytos PNEC reikšmės.
English: The benefit-risk for the products can be considered to be positive.
Lithuanian: Šių preparatų naudos ir rizikos santykį galima laikyti teigiamu.
English: Overall deltamethrin was not considered to be a PBT compound.
Lithuanian: Apskritai, deltametrinas nebuvo priskirtas prie PBT junginių.
English: As the active substance is an ectoparasiticide a Phase II ERA was presented.
Lithuanian: Kadangi ši veiklioji medžiaga yra ektoparaziticidas, buvo pateiktas II fazės RAV.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany and the Netherlands.
Lithuanian: Atsižvelgdamas į pateiktus duomenis, dėl iš Vokietijos ir Nyderlandų gautame pranešime iškeltų klausimų komitetas padarė toliau pateikiamas išvadas.
English: Scientific justifications were provided for the cases of deviations from guidelines and a number of peer reviewed publications were submitted.
Lithuanian: Buvo pateiktas kelių nukrypimo nuo gairių atvejų mokslinis pagrindimasir keletas ekspertų recenzuotų publikacijų.
English: 4 Åkerblom et al. (2008), Deltamethrin toxicity to the midge Chironomus riparius Meigen - Effects of exposure scenario and sediment quality.
Lithuanian: (2008), Deltamethrin toxicity to the midge Chironomus riparius Meigen - Effects of exposure scenario and sediment quality.
English: However, it was considered that information on the possible accumulation of deltamethrin in sediments should be communicated to the user in the product information.
Lithuanian: Tačiau nuspręsta, kad informaciją apie galimą deltametrino kaupimąsi nuosėdose reikėtų naudotojams pateikti informaciniame lapelyje.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Lithuanian: Galiojanti veterinarinio vaisto aprašo, ženklinimo ir informacinio lapelio versija yra paskutinė versija, dėl kurios buvo susitarta Koordinacinės grupės procedūrų metu su šiais papildymais:
English: As the PECgroundwater was below 0.1 µg/l no further assessment for the water compartment was required.
Lithuanian: Kadangi požeminio vandens PEC buvo mažesnė, nei 0,1 µg/l, toliau vertinti vandens aplinkai keliamos rizikos nereikėjo.
English: Add, where applicable, “Deltamethrin is toxic to aquatic organisms and honey bees and may accumulate in sediment.”
Lithuanian: Pridėti, kur reikia, „Deltametrinas yra toksiškas vandens organizmams bei naminėms bitėms ir gali kauptis nuosėdose.
English: Environmental risk
Lithuanian: Aplinkai keliama rizika
English: The use of the products was not expected to pose a risk for soil, groundwater and surface water.
Lithuanian: Nustatyta, kad šie preparatai neturėtų kelti pavojaus dirvožemiui ir požeminiam ar paviršiniam vandeniui.
English: The reference member state (RMS) is the United Kingdom for both products.
Lithuanian: Abiejų preparatų atveju referencinė valstybė narė yra Jungtinė Karalystė.
English: As deltamethrin has a n-octanol/water partition coefficient (KOW, expressed as logKOW) of >5.1, its bioaccumulation potential, potential for being considered a persistent, bioaccumulative and toxic (PBT) compound and secondary poisoning were addressed as required by the VICH and CVMP guidelines.
Lithuanian: Kadangi deltametrino pasiskirstymo n-oktanolyje ir vandenyje koeficientas (KOW, išreikštas pasiskirstymo n-oktanolyje ir vandenyje koeficiento logaritmu (logKOW) yra >5,1, jo bioakumuliacinio potencialo, galimybės laikyti jį patvaria, bioakumuliacine ir toksiška (PBT) medžiaga bei antrinio nuodijimo klausimai buvo išspręsti taip, kaip to reikalaujama pagal VICH ir CVMP gaires.
English: This referral under Article 33(4) of Directive 2001/82/EC was made due to concerns that the applicant had not satisfactorily demonstrated the environmental safety of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle due to lack of pivotal data without which it is not possible to conclude on the environmental safety of the products.
Lithuanian: Ši Direktyvos 2001/82/EB 33 straipsnio 4 dalyje numatyta kreipimosi procedūra pradėta suabejojus, ar pareiškėjas tinkamai įrodė Deltanil 10 mg/ml užpilamojo tirpalo galvijams ir avims bei Deltanil 100 mg užtepamojo tirpalo galvijams saugumą aplinkai, nes nebuvo pateikta pagrindinių duomenų, be kurių neįmanoma padaryti išvados dėl preparatų saugumo aplinkai.
English: An ERA was provided for the Deltanil products, which was in accordance with VICH and CVMP guidelines.
Lithuanian: Buvo pateiktas Deltanil preparatų keliamos rizikos aplinkai vertinimas, kuris atitiko VICH ir CVMP gaires.
English: An ERA in accordance with VICH and CVMP guidelines was provided which contained a mixture of published and bespoke studies from the applicant and addressed all aspects of environmental risk.
Lithuanian: Vadovaujantis VICH ir CVMP gairėmis, buvo pateiktas RAV, kuriame buvo cituojami įvairūs pareiškėjo publikuoti ir pagal užsakymą atlikti tyrimai bei aptarti visi rizikos aplinkai aspektai.
English: For the spot-on product Belgium, France, Germany and the Netherlands are involved as CMS.
Lithuanian: Dėl užtepamojo preparato - susijusios valstybės narės Belgija, Prancūzija, Vokietija ir Nyderlandai.
English: The RQ values for surface water were <1 for all target animal types.
Lithuanian: Visų paskirties rūšių gyvūnų atveju RQ paviršiniam vandeniui buvo <1.
English: Deltamethrin residues will be introduced into the environment following direct excretion onto pasture.
Lithuanian: Deltametrino likučiai patenka į aplinką gyvūnų išmatoms tiesiogiai patekus ant ganyklos žolės.
English: 5 Environmental properties
Lithuanian: 5 Savybės aplinkoje