FrancophonIA/ELRC3.0 huggingface dataset:
English: FR - France THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
Maltese: THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
English: FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Maltese: Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03 France
English: EL - Greece PHARMACEUTICAL INDUSTRY PROEL EPAM.
Maltese: INDUSTRY PROEL EPAM.
English: CY - Cyprus CODAL SYNTO LTD 33 Thekla Lysioti str.
Maltese: CODAL SYNTO LTD 33 Thekla Lysioti str.
English: RO - Romania CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
Maltese: RO - Ir-Rumanija CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
English: Magis Farmaceutici Spa Via Cacciamali, 34-36-38/B 25125 Brescia Italy
Maltese: Magis Farmaceutici Spa Via Cacciamali, 34-36-38/B 25125
English: EL - Greece INTERMED ABEE Kalyftaki 27
Maltese: INTERMED ABEE Kalyftaki 27
English: AT - Austria CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
Maltese: CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
English: Arrowblue Produtos Farmacêuticos S.A. Av. D. João II,
Maltese: Arrowblue Produtos Farmacêuticos S.A. Av. D.
English: SI - Slovenia CSC Pharma d.o.o.
Maltese: SI - Is-Slovenja CSC Pharma d.o.o. Jana
English: EL - Greece VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
Maltese: VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
Maltese: Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
English: EL - Greece PHARMACYPRIA HELLAS A.E. Paster 6
Maltese: PHARMACYPRIA HELLAS A.E. Paster 6
English: EL - Greece MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
Maltese: MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
English: Viale Papiniano, 22/B 20100 Milano Italy
Maltese: Viale Papiniano, 22/B 20100
English: EL - Greece FARMANIC CHEMIPHARMA S.A. Fylis 137
Maltese: FARMANIC CHEMIPHARMA S.A. Fylis 137
English: AT - Austria CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
Maltese: CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190
English: EL - Greece PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
Maltese: PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
English: Farmac.Damor Spa Via Emilio Scaglione, 27 80145 Napoli Italy
Maltese: Farmac.Damor Spa Via Emilio Scaglione, 27 80145
English: RO - Romania Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
Maltese: RO - Ir-Rumanija Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
English: EL - Greece DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
Maltese: 21ST Km National Highway Athens-Lamia 14565 Greece
English: EL - Greece MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
Maltese: MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
English: EL - Greece VOCATE PHARMAKEFTIKI A.E. Gounari 150
Maltese: VOCATE PHARMAKEFTIKI A.E. Gounari 150
English: EL - Greece NORMA HELLAS A.E. Menandrou 54
Maltese: NORMA HELLAS A.E. Menandrou 54
English: Farmac.Caber Spa Viale Città D'Europa, 681 00144 Roma Italy
Maltese: Farmac.Caber Spa Viale Città D'Europa, 681 00144
English: Via Domenico Scarlatti, 31 20124 Milano Italy
Maltese: Via Domenico Scarlatti, 31 20124
English: Ratiopharm GmbH Graf-Arcostrasse, 2 ULM D-89070
Maltese: Ratiopharm GmbH Graf-Arcostrasse, 2 ULM
English: Almus Srl Via Cesarea, 11/10 16121 Genova Italy
Maltese: Via Cesarea, 11/10 16121 Genova Italy
English: Zentiva k.s.
Maltese: Zentiva a.s.
English: EL - Greece REMEK PHARMACEUTICALS ABEE Pentelis 34
Maltese: REMEK PHARMACEUTICALS ABEE Pentelis 34
English: CY - Cyprus CHR. K. UNIMED LTD 21 Davlou
Maltese: K. UNIMED LTD 21 Davlou
English: RO - Romania S.C.
Maltese: RO - Ir-Rumanija S.C.
English: PL - Poland Zentiva a.s. U Kabelovny 130
Maltese: BG - Il-Bulgarija Zentiva k.s. U kabelovny 130
English: EL - Greece FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
Maltese: FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
English: Agia Varvara 12351
Maltese: Varvara 12351 Greece
English: Palaio Faliro Attikis 17564
Maltese: Palaio Faliro Attikis 17564 Greece
English: RO - Romania LABORATORI GUIDOTTI SpA Via Livornese, 897
Maltese: RO - Ir-Rumanija LABORATORI GUIDOTTI SpA Via Livornese, 897
English: Via Livornese, 897 I-56010 La VettolaPisa
Maltese: Via Livornese, 897 I-56010
English: Doc Generici Srl Via Manuzio, 7 20124 Milano Italy
Maltese: Doc Generici Srl Via Manuzio, 7 20124
English: Sofar Spa Via Isonzo, 8 20100 Milano Italy
Maltese: Sofar Spa Via Isonzo, 8 20100
English: SK - Slovakia Medicom International s.r.o.
Maltese: SK - Is-Slovakkja Medicom International s.r.o.
English: 3508 Lemessos
Maltese: 3508 Lemessos Cyprus
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
Maltese: LTD 1-10 Constantinoupoleos str. P.O.Box 51409
English: BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
Maltese: BG - Il-Bulgarija Sopharma AD 16 Iliensko shosse str.
English: AULIN, granule pentru suspensie orală, 100 mg/plic mg/sachet
Maltese: AULIN, granule pentru suspensie orală, 100 mg/plic
English: Pensa Pharma Spa Via Rosellini Ippolito, 12 20124 Milano Italy
Maltese: Pensa Pharma Spa Via Rosellini Ippolito, 12 20124
English: 3505 Lemessos
Maltese: 3505 Lemessos Cyprus
English: BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
Maltese: BG - Il-Bulgarija Actavis EAD 29 Atanas Dukov str.
English: SI-1000 Ljubljana
Maltese: SI-1000
English: EL - Greece KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
Maltese: Parnithos Avenue 189 Aharnai Attikis 13671 Greece
English: EL - Greece REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
Maltese: REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451 Greece
English: EL - Greece BROS EPE Avgis & Gallinis 15
Maltese: BROS EPE Avgis & Gallinis 15 N.
English: EL - Greece ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
Maltese: ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A Holargos 15562
English: Kamatero Attikis 13451
Maltese: Kamatero Attikis 13451 Greece
English: NIMESULIDE / B.I.
Maltese: NIMESULIDE / B.I. FARMA
English: FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
Maltese: EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A 12, rue Danjou
English: Mylan Spa Via Vittor Pisani, 20 20124 Milano Italy
Maltese: Mylan Spa Via Vittor Pisani, 20 20124
English: So.Se.Pharm Srl Via dei Castelli Romani, 22 00040 Pomezia (Roma) Italy
Maltese: So.Se.Pharm Srl Via dei Castelli Romani, 22 00040
English: Rua João Chagas, 53 - 3º 1499-040 Cruz QuebradaDafundo
Maltese: Rua João Chagas, 53 - 3º 1499-040
English: Via Padre G. Semeria, 5 - 16131 Genova Italy
Maltese: Semeria, 5 - 16131 Genova Italy
English: EL - Greece MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Maltese: Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
English: 56010 PISA La Vettola Italy
Maltese: 56010 PISA La Vettola
English: N. Psychiko 15451
Maltese: Psychiko 15451 Greece
English: Dorom Srl Via Messina, 38 20154 Milano Italy
Maltese: Dorom Srl Via Messina, 38 20154
English: EL - Greece BIOMEDICA-CHEMICA A.E. G. Lyra 25
Maltese: BIOMEDICA-CHEMICA A.E. G.
English: Teva Italia Srl Via Messina, 38 20154 Milano Italy
Maltese: Italia Srl Via Messina, 38 20154
English: Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Maltese: Viale Fulvio Testi, 330 20126 Milano Italy
English: Agips Farmaceutici Srl Via Amendola, 4 16035 Rapallo (GE) Italy
Maltese: Agips Farmaceutici Srl Via Amendola, 4 16035
English: HU - Hungary PannonPharma Kft. Pannonpharma út 1.
Maltese: PannonPharma Kft. Pannonpharma út 1. 7720, Pécsvárad Hungary
English: EL - Greece VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
Maltese: Ethnikis Antistaseos & Trifyllias Aharnai 13671
English: PL - Poland Laboratori Guidotti S.p.A. (Menarini Group) Via Livornese 897
Maltese: Laboratori Guidotti S.p.A (Menarini Group). Via Livornese 897
English: EL - Greece BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
Maltese: 30 Km Athens-Lavrion Markopoulo 19003 Greece
English: G. KORONIS
Maltese: KORONIS
English: Laboratórios Basi - Indústria Farmacêutica, S.A. Rua do Padrão, 98
Maltese: Laboratórios Basi - Indústria Farmacêutica, S.A.
English: 95-200 Pabianice
Maltese: Piłsudskiego 5, 95-200
English: PHARM O.E.
Maltese: FARMEDIA A.E.
English: NIMESIL, granule pentru suspensie orală, 100 mg mg/sachet
Maltese: NIMESIL, granule pentru suspensie orală, 100 mg
English: Savio Srl Via E. Bazzano, 14 16019 Ronco Scrivia (GE) Italy
Maltese: Bazzano, 14 16019 Ronco Scrivia (GE) Italy
English: Ecobi Farmaceutici sas Via E. Bazzano, 26 16019 Ronco Scrivia (GE) Italy
Maltese: Bazzano, 26 16019 Ronco Scrivia (GE) Italy
English: PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
Maltese: Pabianickie Zakłady Farmaceutyczne Polfa S.A.
English: Limassol, CY-3505
Maltese: P.O. Box 51409 Limassol, CY-3505 Cyprus
English: EL - Greece RAFARM AEBE Korintou 12
Maltese: AEBE Korintou 12
English: EL - Greece COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
Maltese: COUP ABEE Agias Varvaras 53-55
English: RO - Romania S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
Maltese: LABORMED PHARMA S.A. B-dul Theodor Pallady nr.
English: EL - Greece MED-ONE S.A., HELLAS Parnithos Avenue 211
Maltese: MED-ONE S.A., HELLAS Parnithos Avenue 211 Aharnai 13671
English: EL - Greece FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
Maltese: Athinas 22 & Apollonos Gerakas Attikis 15344 Greece
English: EL - Greece EVAGGELOS KALOFOLIAS & SIA O.E.
Maltese: EVAGGELOS KALOFOLIAS &
English: CZ - Czech Republic
Maltese: CZ - Ir-Repubblika Ċeka
English: RO - Romania Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
Maltese: Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
English: EL - Greece ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
Maltese: INDUSTRY, Marathonos Avenue 95
English: EL - Greece GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
Maltese: 18th Km Marathonos Avenue Pallini Attikis 15351
English: EL - Greece ANTOR EPE P. Mavromihali 1
Maltese: ANTOR EPE P. Mavromihali 1 Vrilissia 15235 Greece
English: 1045 Budapest
Maltese: Budapest Hungary
English: FR - France TEVA SANTE Le Palatin 1
Maltese: Le Palatin 1
English: Athens 10438
Maltese: Favierou 48 Athens 10438
English: Ranbaxy Portugal - Comércio e Desenvol.
Maltese: Ranbaxy Portugal - Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda.
English: N. Kifissia 14564
Maltese: Kifissia 14564
English: CY - Cyprus CDL PHARMACEUTICAL LTD 5 Diomedous str.
Maltese: CDL PHARMACEUTICAL LTD 5
English: EL - Greece BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
Maltese: Km Marathonos Avenue Pallini 15344
English: RO - Romania S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
Maltese: Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
English: 200 MG/SUPP Suppository
Maltese: MG/SUPPOSITORJU
English: Largo Boccioni 1 21040 Origgio Varese Italy
Maltese: Origgio Varese Italy
English: Menandrou 54
Maltese: SIA O.E. Menandrou 54
English: EL - Greece BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
Maltese: HELLAS S.A. Ellinikou 2
English: Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua da Tapada Grande, 2 - Abrunheira
Maltese: Rua da Tapada Grande, 2 - Abrunheira
English: FARMA A.E. Aristotelous 73
Maltese: B.I. FARMA A.E. Aristotelous 73 Athens 10434 Greece
English: Helsinn Birex Pharmaceutical Ltd. Damastown, Mulhuddart Dublin-15
Maltese: HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart Dublin 15
English: MG/SACHET
Maltese: MG/5ML
English: Piam Farmaceutici Spa Via Padre G. Semeria, 5 16131 Genova Italy
Maltese: Semeria, 5 16131 Genova Italy
English: HU - Hungary Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
Maltese: BV Laan Copes van Cattenbruch 74. 2585
English: Farmoz - Sociedade Técnico Medicinal, S.A. Rua da Tapada Grande, 2, Abrunheira
Maltese: Farmoz - Sociedade Técnico Medicinal, S.A.
English: NIMM TABLETS 100mg 100mg
Maltese: TABLETS 100mg 100mg
English: LT - Lithuania Zentiva k.s.
Maltese: LT - Il-Litwanja
English: Coated tablet
Maltese: MG TABLETY
English: RO - Romania ANFARM HELLAS S.A. Perikleous 53-57
Maltese: RO - Ir-Rumanija ANFARM HELLAS S.A.
English: RO - Romania MEDOCHEMIE LTD. - CYPRUS, P.O.
Maltese: RO - Ir-Rumanija MEDOCHEMIE
English: Box 51409
Maltese: - CYPRUS, P.O. Box 51409
English: I.B.N.
Maltese: S.R.L.
English: RO - Romania S.C. MAGISTRA C&C S.R.L.
Maltese: RO - Ir-Rumanija S.C. ARENA GROUP S.A. Str.
English: EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
Maltese: HELLAS S.A. Perikleous 53-57 Gerakas Attikis 153 44 Greece
English: Granules for oral solution in sachet
Maltese: Granuli għal soluzzjoni orali
English: Paiania Attikis 19002
Maltese: HELLAS A.E. Agias Marinas Paiania Attikis 19002 Greece
English: 100mg/sachet Granules for oral suspension
Maltese: 100 MG/QARTAS Granuli għal soluzzjoni orali
English: Athens 11855
Maltese: .E. Agias Markellis 17 Athens 11855
English: Aulin 100 mg tablete 100 mg
Maltese: Aulin 100 mg tablete
English: FARMA
Maltese: PHARMACEUTICAL
English: 100 MG/TAB Effervescent tablet Oral use
Maltese: 100 MG/PILLOLA Pillola effervexxenti
English: Arkoleon 11
Maltese: Valaoritou 10
English: Sandoz Spa Largo U. Boccioni, 1 21040 Origgio (VA) Italy
Maltese: Sandoz Spa Largo U.
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.
Maltese: Stat Membru kkonċernat (CMS): l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Islanda, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, irRumanija, is-Slovakkja, is-Slovenja u Spanja.
English: Member State EU/EEA
Maltese: Stat Membru tal-UE/ŻEE
English: 4 Åkerblom et al. (2008), Deltamethrin toxicity to the midge Chironomus riparius Meigen - Effects of exposure scenario and sediment quality.
Maltese: (2008), Deltamethrin toxicity to the midge Chironomus riparius Meigen - Effects of exposure scenario and sediment quality.
English: Ecotox.
Maltese: Ecotox. Environm.
English: Route of administration
Maltese: Mod ta' amministrazzj oni
English: The applications in question, submitted via the decentralised procedure, are generic applications according to Art. 13(3) of Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose authorised in the United Kingdom.
Maltese: L-applikazzjonijiet inkwistjoni, ippreżentati permezz tal-proċedura deċentralizzata, huma applikazzjonijiet ġeneriċi skont l-Artikolu 13(3) tad-Direttiva 2001/82/EC, kif emendata, li jirreferu għall-prodotti ta' referenza Pfizer Insettiċida li Titferra' 1% w/v Soluzzjoni għall-Ġilda u Pfizer Insettiċida għall-Użu Lokalizzat 1% w/v Soluzzjoni għall-Ġilda b'ħafna dożi, awtorizzati fir-Renju Unit.
English: Overall deltamethrin was not considered to be a PBT compound.
Maltese: B'mod globali, deltamethrin ma tqiesx li huwa kompost PBT.
English: 1 VICH GL6: Guideline on Environmental Impact Assessment (EIAS) for Veterinary Medicinal Products - Phase I
Maltese: 1 VICH GL6: Linja gwida dwar il-Valutazzjoni tal-Impatt Ambjentali (EIAS) għal Prodotti Mediċinali Veterinarji - Fażi I
English: Consequently in order to mitigate the risk for dung insects RMMs were included in the SPC in sections 4.5.iii and 5 (Environmental properties).
Maltese: RMMs fis-Sommarju tal-Karatteristiċi tal-Prodott fis-sezzjonijiet 4.5.iii u 5 (Proprjetajiet ambjentali).
English: New acute OECD studies were carried out on aquatic organisms followed by an OECD chronic study with daphnia.
Maltese: Saru studji akuti ġodda tal-OECD fuq organiżmi akkwatiċi segwiti minn studju kroniku tal-OECD bid-dafnja.
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.
Maltese: Dan ir-riferiment skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE sar minħabba tħassib li lapplikant ma kienx wera b'mod sodisfaċenti s-sigurtà ambjentali ta' Deltanil 10 mg/ml Soluzzjoni li Titferra' għall-ifrat u n-nagħaġ u ta' Deltanil 100 mg Soluzzjoni għall-Użu Lokalizzat għall-ifrat minħabba n-nuqqas ta' dejta essenzjali li mingħajrha mhuwiex possibbli tintlaħaq konklużjoni dwar is-sigurtà ambjentali tal-prodotti.
English: Data from an acceptable study gave a bioconcentration factor of 510 l/kg which is below the value of 2000 l/kg which would indicate a potential to bioaccumulate.
Maltese: Dejta minn studju aċċettabbli tat fattur ta' bijokonċentrazzjoni ta' 510 l/kg li huwa aktar baxx mill-valur ta' 2000 l/kg li jindika potenzjal ta' bijoakkumulazzjoni.
English: GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004386.pdf
Maltese: II (CVMP/VICH/790/03)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004393.pdf 3 Linja gwida tas-CVMP dwar il-valutazzjoni tal-impatt ambjentali għal prodotti mediċinali veterinarji b'appoġġ għal linji gwida GL6 u GL38 tal-VICH (EMEA/CVMP/ERA/418282/2005)
English: Acceptable data on the acute toxicity of deltamethrin to dung fly larvae and adult beetles were provided which indicated that RQ values for dung insects were in the order of 90 - 10 000.
Maltese: Kienet ipprovduta dejta aċċettabbli dwar l-effett tossiku akut ta' deltamethrin għal-larvi taddubbiena tad-demel u għall-ħanfus adult li indikat li l-valuri RQ għall-insetti tad-demel kienu madwar 90 - 10 000.
English: Potential serious risks were identified during the decentralised procedure by Germany and the Netherlands who considered no acceptable data in the environmental risk assessment has been provided on: n-octanol:water partition coefficient (KOW); soil adsorption coefficient (KOC); soil degradation; bioaccumulation (BCF); toxicity to dung insects, and therefore the environmental risk assessment cannot be finalised.
Maltese: Matul il-proċedura deċentralizzata kienu identifikati riskji serji potenzjali mill-Ġermanja u l-Pajjiżi l-Baxxi li kkunsidraw li ma kienet ġiet ipprovduta l-ebda dejta aċċettabbli fil-valutazzjoni tar-riskju ambjentali dwar: n-octanol: il-koeffiċjent ta' separazzjoni tal-ilma (KOW); il-koeffiċjent ta' assorbiment mill-ħamrija (KOC); id-degradazzjoni fil-ħamrija; il-bijoakkumulazzjoni (BCF); l-effett tossiku għall-insetti tad-demel, u għalhekk il-valutazzjoni tar-riskju ambjentali ma tistax tiġi finalizzata.
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.
Maltese: Billi deltamethrin għandu koeffiċjent ta' separazzjoni n-octanol/ilma (KOW, espress bħala logKOW) ta' >5.1, il-potenzjal ta' bijoakkumulazzjoni tiegħu, il-potenzjal tiegħu li jitqies bħala kompost persistenti, bijoakkumulattiv u tossiku (PBT) u l-avvelenament sekondarju kienu indirizzati kif meħtieġ mil-linji gwida tal-VICH u tas-CVMP.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Maltese: Lista ta' ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, razez tal-annimali, mod ta' amministrazzjoni, applikant fl-Istati Membri
English: In order to address the concerns raised by the referral, the applicant provided an environmental risk assessment (ERA) in accordance with VICH guidelines GL61 and GL382 and in accordance with the CVMP guideline in support of VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)3.
Maltese: b'appoġġ għal-linji gwida GL6 u GL38 tal-VICH (EMEA/CVMP/ERA/418282/2005)3.
English: The active substance is well known and is included in veterinary medicinal products currently authorised in the EU.
Maltese: Is-sustanza attiva hija magħrufa sewwa u hija inkluża fi prodotti mediċinali veterinarji attwalment awtorizzati fl-UE.
English: A risk for dung insects was identified by the ERA and RMMs were proposed to address the risk.
Maltese: L-ERA identifikat riskju għall-insetti tad-demel u kienu proposti RMMs sabiex jindirizzaw ir-riskju.
English: Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin, a synthetic pyrethroid.
Maltese: Deltanil 10 mg/ml Soluzzjoni li Titferra' għall-ifrat u n-nagħaġ u Deltanil 100 mg Soluzzjoni għallUżu Lokalizzat għall-ifrat fihom deltamethrin, pyrethroid sintetiku.
English: Deltamethrin was shown to have a half-life in soil of 72 days based on acceptable published data.
Maltese: Deltamethrin intwera li għandu half-life fil-ħamrija ta' 72 jum abbażi ta' dejta ppubblikata aċċettabbli.
English: On the basis of the ERA no other RMMs were proposed by the applicant.
Maltese: RMMs oħra mill-applikant.
English: The reference member state (RMS) is the United Kingdom for both products.
Maltese: L-Istat Membru ta' referenza (SMR) huwa r-Renju Unit għaż-żewġ prodotti.
English: Add, where applicable, “Deltamethrin is toxic to aquatic organisms and honey bees and may accumulate in sediment.”
Maltese: Żid, fejn japplika, “Id-deltametrin huwa tossiku għal organiżmi akwatiċi u naħal tal-għasel u jista' jakkumula fis-sediment.
English: The benefit of the products is that treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs can be carried out using the products.
Maltese: Il-benefiċċju tal-prodotti huwa li l-kura u l-prevenzjoni ta' infestazzjonijiet mill-furrax u d-dubbien fuq l-ifrat; qurdien, furrax, keds u blowfly strike stabbilit fuq in-nagħaġ u furrax u qurdien fuq ilħrief, jistgħu jitwettqu bl-użu tal-prodotti.
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.
Maltese: Kienet ipprovduta ERA skont il-linji gwida tal-VICH u tas-CVMP li kienet tinkludi taħlita ta' studji ppubblikati u studji magħmulin apposta mill-applikant u li indirizzat l-aspetti kollha tar-riskju ambjentali.
English: No degradation rate for deltamethrin in sediment was required in order to complete the ERA, but some information in the published literature suggests that in some sediments degradation occurs with a half-life in soil of about 10 days (Åkerblom et al. 2008)4.
Maltese: Ma kienet meħtieġa l-ebda rata ta' degradazzjoni għal deltamethrin fis-sediment sabiex issir l-ERA, iżda xi informazzjoni fil-letteratura ppubblikata tissuġġerixxi li f'xi sedimenti sseħħ degradazzjoni b'ħalf-life fil-ħamrija ta' madwar 10 ijiem (Åkerblom et al. 2008)4.
English: Strength Pharmaceutical form
Maltese: Karatterisitiċi ambjentali
English: Based on acceptable published data for sediment species the RQ for sediment was <1.
Maltese: Abbażi ta' dejta ppubblikata aċċettabbli għall-ispeċijiet tas-sediment, l-RQ għas-sediment kien <1.
English: The ERA was complete in terms of data requirements and quality of data.
Maltese: L-ERA kienet kompleta f'termini tar-rekwiżiti tad-dejta u tal-kwalità tad-dejta.