FrancophonIA/ELRC3.0 huggingface dataset:
Danish: Zydus France Zacles Hautes Patures 25 Rue des Peupliers 92752 Nanterre Cedes France
Maltese: Rue des Peupliers 92752 Nanterre Cedes France
Danish: Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland
Maltese: Reykjavikurvegi 76-78 220
Danish: Storbritannien Chanelle Medical Dublin road
Maltese: Ir-Renju Unit Chanelle Medical Dublin road
Danish: Irbesartanas/Hidrochlorot iazidas Torrent
Maltese: Irbesartanas/Hidrochl orotiazidas Torrent
Danish: S-Lab Sp. z o.o.
Maltese: S-Lab Sp. z o.o. ul.
Danish: Chanelle Medical Dublin road Loughrea, Co. Galway Ireland
Maltese: Chanelle Medical Dublin road Loughrea, Co.
Danish: Esomeprazolmagnesium Esomylan 40 mg
Maltese: Esomylan 40 mg
Danish: Trimetazidin
Maltese: Trimetazidina
Danish: Clobazam Sandoz 10 mg, tabletten
Maltese: Klobażam Clobazam Sandoz 10 mg, tabletten
Danish: Tablet
Maltese: Tabletten
Danish: Valsartan/hydrochlorthiaz id "Fair-Med"
Maltese: Valsartan/hydrochlort hiazid "Fair-Med"
Danish: Tramadol/paracetamol
Maltese: Tramadol/paraċeta mol
Danish: Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto Portela de Carnaxide
Maltese: Rua Alto do Montijo, 13 - 1º Dto - Edifício Monsanto Portela de Carnaxide 2790-012 Portela de Carnaxide
Danish: Metforminhydrochlorid Bolamyn/Metabet SR 1000mg Prolonged
Maltese: Bolamyn/Metabet SR 1000mg Prolonged Release Tablets
Danish: Brown & Burk UK, Ltd. 5, Marryat Close Hounslow
Maltese: 5, Marryat Close Hounslow
Danish: Clonazepam 500mcg Tablet
Maltese: Klonażepam Clonazepam 500mcg Tablet
Danish: Desloratadine/Genephar m 5 mg δισκία επικαλυμμένα με υμένιο,
Maltese: Desloratadine/Geneph arm 5 mg δισκία επικαλυμμένα με υμένιο,
Danish: 500 02 Hradec Králové Czech Republic
Maltese: Smetanovo nábřeží 1238/20a 500 02 Hradec Králové Czech Republic
Danish: Tyskland Alfred E. Tiefenbacher GmbH Van-der-Smissen-Strasse 1
Maltese: Tiefenbacher GmbH Van-der-Smissen-Strasse 1
Danish: Desloratadine/Genephar m 2,5 mg δισκία διασπειρόμενα στο στόμα
Maltese: Desloratadine/Geneph arm 2,5 mg δισκία διασπειρόμενα στο στόμα
Danish: Tacpan 1 mg Hartkapseln 1 mg
Maltese: Tacpan 1 mg Hartkapseln
Danish: Rumænien Sandoz Pharma Services SRL
Maltese: Ir-Rumanija Sandoz Pharma Services SRL Calea Floreasca Street
Danish: Tyskland Farmaprojects, S.A.U.
Maltese: Il-Ġermanja Farmaprojects, S.A.U.
Danish: Østrig ratiopharm ArzneimitteiVertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
Maltese: L-Awstrija ratiopharm ArzneimitteiVertriebs-GmbH Albert-Schweitzer-Gasse 3 1140
Danish: Valsartan/hydrochlorthiaz id "Fair-Med" Coated tablets
Maltese: Valsartan/hydrochlort hiazid "Fair-Med" Coated tablets
Danish: Zakłady Farmaceutyczne POLPHARMA S.A. Pelplińska 19 83-200 Starogard Gdański Poland
Maltese: 83-200 Starogard Gdański Poland
Danish: Dipyridamol
Maltese: Dipiridamol
Danish: Alendronat Ranbaxy Veckotablett 70 mg tabletter
Maltese: Aċidu alendroniku Alendronat Ranbaxy Veckotablett 70 mg tabletter
Danish: Metoclopramide Orifarm 10 mg Tablet
Maltese: Metoclopramide Orifarm 10 mg Pillola
Danish: Storbritannien Fannin (UK) Ltd 42-46 Booth Drive Park Farm South Wellingborough
Maltese: Ir-Renju Unit Fannin (UK) Ltd 42-46 Booth Drive Park Farm South
Danish: Holland ratiopharm Nederland B.V.
Maltese: Il-Pajjiżi l-Baxxi ratiopharm Nederland B.V.
Danish: Metoclopramidemonohydr ochloride Accord 10 mg, Tabletten
Maltese: Metoclopramidemono hydrochloride Accord 10 mg, Tabletten
Danish: 1000 mg Tablet
Maltese: 1000 mg Pillola
Danish: Escitalopram Brown 5 mg
Maltese: Exxitalopram Escitalopram Brown 5 mg
Danish: Clobazam TioFarma 20 mg, tabletten
Maltese: Klobażam Clobazam TioFarma 20 mg, tabletten
Danish: Donepezilhydrochlorid DONEPEZIL MYLAN GENERICS ITALIA
Maltese: Donepeżil kloridrat DONEPEZIL MYLAN GENERICS ITALIA
Danish: 320 mg Kapsel
Maltese: 320 mg Kapsula
Danish: Filmovertrukket tablet
Maltese: Film-coated Tablet
Danish: Dexamethasone 2mg Tablets
Maltese: Deksametażon Dexamethasone 2mg Tablets
Danish: Labesfal, Genéricos, S.A. Av. Dr. Afonso Costa, nº
Maltese: Dr. Afonso Costa, nº
Danish: Tramadol/Paracetamol PharmaS 37,5 mg/ 325 mg filmom obložene tablete
Maltese: Tramadol/Paracetamol PharmaS 37,5 mg/ 325 mg filmom obložene tablete mg/325 mg
Danish: G.L.
Maltese: L.U.
Danish: Ácido alendrónico Labesfal
Maltese: Aċidu alendroniku Ácido alendrónico Labesfal
Danish: Apo-trimetazidin 35 mg 35 mg Depottablet
Maltese: Apo-trimetazidin 35 mg
Danish: Cipla Chanelle Generics Limited Athenry Road,
Maltese: Id-Danimarka Cipla Chanelle Generics Limited
Danish: D-20354 Hamburg
Maltese: D-20354
Danish: Holland
Maltese: The Netherlands
Danish: Metforminhydrochlorid Gluforlyn XR 500 mg retard tabletta
Maltese: Gluforlyn XR 500 mg retard tabletta
Danish: Tablets
Maltese: COMPRIMIDOS
Danish: 05-152 Czosnów k. Warszawy Poland
Maltese: 05-152 Czosnów k.
Danish: Venlagamma 37,5 mg retard kemény kapszula
Maltese: 37,5 mg retard kemény kapszula
Danish: PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé
Maltese: PARACETAMOL ZYDUS FRANCE 37,5 mg/325 mg comprimé pelliculé mg/325 mg
Danish: Ewopharma International s.r.o., Hlavna 13
Maltese: Ewopharma International s.r.o.,
Danish: Desloratadine/Genephar m 5 mg δισκία διασπειρόμενα στο στόμα
Maltese: Desloratadine/Geneph arm 5 mg δισκία διασπειρόμενα στο στόμα
Danish: Clonazepam TioFarma 2 mg tabletten, tabletten
Maltese: Klonażepam Clonazepam TioFarma 2 mg tabletten, tabletten
Danish: Fluconazol
Maltese: Flukonażol
Danish: Rumænien Mylan SAS 117 allée des Parcs 69792 Saint-Priest Cedex France
Maltese: Ir-Rumanija Mylan SAS 117 allée des Parcs 69792 Saint-Priest Cedex France
Danish: ESOMEPRAZOL MYLAN 40 mg CAPSULAS GASTRORRESISTENTES EFG
Maltese: ESOMEPRAZOL MYLAN 40 mg CAPSULAS GASTRORRESISTENTE S EFG
Danish: ESOMEPRAZOL MYLAN 20 mg CAPSULAS GASTRORRESISTENTES EFG
Maltese: ESOMEPRAZOL MYLAN 20 mg CAPSULAS GASTRORRESISTENTE S EFG
Danish: COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Maltese: COMPRIMIDOS EFG
Danish: Levodopa/Carbidopa/Enta capone film-coated tablets 150/37.5/200mg
Maltese: Levodopa/Carbidopa/ Entacapone filmcoated tablets 150/37.5/200mg mg/37,5 mg/200 mg
Danish: Clobazam TioFarma 10 mg, tabletten
Maltese: Klobażam Clobazam TioFarma 10 mg, tabletten
Danish: Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain
Maltese: ESPAÑA, S.A. C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta 28108 Alcobendas (Madrid) Spain
Danish: Metforminhydrochlorid Metformin Actavis Retard 750 mg
Maltese: Metformin Actavis Retard 750 mg
Danish: Alendroninsyre alendronic acid 10mg Tablets
Maltese: Aċidu alendroniku alendronic acid 10mg Tablets
Danish: Clonazepam Sandoz 0,5 mg, tabletten
Maltese: Klonażepam Clonazepam Sandoz 0,5 mg, tabletten
Danish: 2,5 mg Tablet
Maltese: 2,5 mg Pillola
Danish: Clonazepam TioFarma 0,5 mg tabletten, tabletten
Maltese: Klonażepam Clonazepam TioFarma 0,5 mg tabletten, tabletten
Danish: Bulgarien Aquachim AD blvd. Prof. Tsvetan Lazarov
Maltese: Prof. Tsvetan Lazarov
Danish: Rumænien Alvogen IPCo S.ar.l.
Maltese: Ir-Rumanija Alvogen IPCo S.ar.l.
Danish: Tyskland ratiopharm GmbH Graf-Arco-Strasse 3
Maltese: Il-Ġermanja ratiopharm GmbH Graf-Arco-Strasse 3
Danish: Acide Alendronique Ranbaxy 70 mg, comprimé
Maltese: Aċidu alendroniku Acide Alendronique Ranbaxy 70 mg, comprimé
Danish: 0,5 mg Tablet
Maltese: 0,5 mg Pillola
Danish: Slovenien Lek farmacevtska družba d.d.
Maltese: Lek farmacevtska družba d.d. Verovškova 57
Danish: Fexofenadina Tevagen 120 mg comprimidos recubiertos con pelicula efg
Maltese: FEXOFENADINA TEVAGEN 120 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
Danish: Alendroninsyre alendronic acid 70mg Once Daily Tablets
Maltese: Aċidu alendroniku alendronic acid 70mg Once Daily Tablets
Danish: Rumænien Glenmark Pharmaceuticals s.r.o.
Maltese: Ir-Rumanija Glenmark Pharmaceuticals s.r.o.
Danish: Storbritannien Morningside Healthcare Limited
Maltese: Ir-Renju Unit Morningside Healthcare Limited
Danish: Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Maltese: Aċidu alendroniku Alendroninezuur 70 Ranbaxy, tabletten 70 mg
Danish: Tacpan 5 mg Hartkapseln 5 mg
Maltese: Tacpan 5 mg Hartkapseln
Danish: Camí Real, 51-57, 08184 Palau-solita i Plegamans (Barcelona)
Maltese: Camí Real, 51-57, 08184
Danish: DESMOPRESSINE MYLAN 240 µg, orodispersible tablet
Maltese: Desmopressina DESMOPRESSINE MYLAN 240 µg, orodispersible tablet
Danish: Clonazepam Sandoz 2 mg, tabletten
Maltese: Klonażepam Clonazepam Sandoz 2 mg, tabletten
Danish: Rizatriptan
Maltese: Riżatriptan
Danish: Aleric Deslo Active
Maltese: Aleric Deslo Active 5 mg
Danish: Thiaminhydrochlorid Tyvera 100mg Tablets 100 mg Tablet
Maltese: Tijamina kloridrata Tyvera 100mg Tablets 100 mg Pillola
Danish: Esomeprazolmagnesium Esomeprazol Mylan 40 mg gyomornedv-ellenálló kemény kapszula
Maltese: Esomeprazol Mylan 40 mg gyomornedvellenálló kemény kapszula
Danish: Thiaminhydrochlorid Tyvera 50mg Tablets 50 mg Tablet
Maltese: Tijamina kloridrata Tyvera 50mg Tablets 50 mg Pillola
Danish: Storbritannien Ranbaxy UK Ltd. Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE
Maltese: Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE
Danish: Levodopa/carbidopa/ent acapon
Maltese: Levodopa/karbidop a/entakapon
Danish: Escitalopram
Maltese: Exxitalopram ESCITALOPRAM
Danish: Levetiracetam Levetiracetam-Hormosan 1000 mg Filmtabletten
Maltese: Levetiraċetam Levetiracetam-Hormosan 1000 mg Filmtabletten
Danish: Laboratórios AnovaProdutos Farmacêuticos, Lda.
Maltese: Laboratórios Anova - Produtos Farmacêuticos, Lda.
Danish: Storbritannien Brown & Burk UK, Ltd. 5, Marryat Close
Maltese: Brown & Burk UK, Ltd.
Danish: Clindamycinhydrochlorid Clindamycin Alternova 150 mg Kapsel, hård Oral anvendelse
Maltese: Clindamycin Alternova 150 mg Kapsula, iebsa
Danish: Levetiracetam Letiramyl 1000 mg potahované tablety
Maltese: Levetiraċetam Letiramyl 1000 mg potahované tablety
Danish: Clopidogrel
Maltese: Klopidogrel
Danish: Levetiracetam LEVETIRACETAM MYLAN GENERICS
Maltese: Levetiraċetam LEVETIRACETAM
Danish: 200 mg Kapsel
Maltese: 200 mg Kapsula
Danish: Fexofenadina Tevagen 180 mg comprimidos recubiertos con pelicula efg
Maltese: FEXOFENADINA TEVAGEN 180 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
Danish: Rumænien Ewopharma International s.r.o., Hlavna 13
Maltese: Ir-Rumanija Ewopharma International s.r.o.,
Danish: Esomeprazolmagnesium Esomeprazol Mylan 20 mg gyomornedv-ellenálló kemény kapszula
Maltese: Esomeprazol Mylan 20 mg gyomornedvellenálló kemény kapszula
Danish: Venlagamma 37,5 mg capsule cu eliberare prelungita
Maltese: 37,5 mg capsule cu eliberare prelungita
Danish: Telmisartan/Hydrochlorot hiazide 80mg/25mg Tablets
Maltese: Telmisartan/Hydrochl orothiazide 80mg/25mg Tablets
Danish: 750 mg Tablet
Maltese: 750 mg Pillola
Danish: Alendromono
Maltese: Aċidu alendroniku Alendromono
Danish: Levetiracetam Levetiracetam-Hormosan 750 mg Filmtabletten
Maltese: Levetiraċetam Levetiracetam-Hormosan 750 mg Filmtabletten
Danish: Levetiracetam Levetiracetam 1000mg film-coated tablets
Maltese: Levetiraċetam Levetiracetam 1000mg film-coated tablets
Danish: Levetiracetam Levetiracetam beta 250 mg, Filmtabletten
Maltese: Levetiraċetam Levetiracetam beta 250 mg, Filmtabletten
Danish: DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
Maltese: Desmopressina DESMOPRESSINE MYLAN 120 µg, orodispersible tablet
Danish: ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS EFG
Maltese: Aċidu alendroniku ACIDO ALENDRONICO SEMANAL PENSA 70 mg COMPRIMIDOS
Danish: Esomeprazolmagnesium Neximyl 40 mg magensaftresistente Hartkapseln
Maltese: Neximyl 40 mg magensaftresistente Hartkapseln
Danish: 50 mg Kapsel
Maltese: 50 mg Kapsula
Danish: 160 mg Kapsel
Maltese: 160 mg Kapsula
Danish: 250 mg Tablet
Maltese: 250 mg Pillola
Danish: Levetiracetam Levetiracetam beta 750 mg, Filmtabletten
Maltese: Levetiraċetam Levetiracetam beta 750 mg, Filmtabletten
Danish: Levetiracetam Levetiracetam beta 500 mg, Filmtabletten
Maltese: Levetiraċetam Levetiracetam beta 500 mg, Filmtabletten
Danish: METOCLOPRAMIDE ACCORD
Maltese: Metoklopramid METOCLOPRAMIDE
Danish: Rizatriptan Mylan 5 mg 5 mg
Maltese: Rizatriptan Mylan 5 mg
Danish: 32 mg tablet
Maltese: 32 mg Pillola
Danish: DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
Maltese: Desmopressina DESMOPRESSINE MYLAN 60 µg, orodispersible tablet
Danish: Storbritannien Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16
Maltese: Il-Ġermanja Lupin (Europe) Limited Victoria Court, Bexton Road Knutsford, Cheshire WA16
Danish: Island ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Maltese: Islanda ratiopharm GmbH Graf-Arco-Strasse 3 D-89079 Ulm Germany
Danish: DK-5260 Odense S Denmark
Maltese: DK-5260
Danish: Metforminhydrochlorid Metformin Actavis Retard 500 mg
Maltese: Metformin Actavis Retard 500 mg
Danish: Valsartan/Hydrochlorothi azide Fair-Med 160 mg/12.5 mg film-coated tablets.
Maltese: Valsartan/Hydrochloro thiazide Fair-Med 160 mg/12.5 mg filmcoated tablets.
Danish: Esomeprazolmagnesium Neximyl 20 mg magensaftresistente Hartkapseln
Maltese: Neximyl 20 mg magensaftresistente Hartkapseln
Danish: 150 mg Kapsel
Maltese: 150 mg Kapsula
Danish: DESLORATADINA APOTEX 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Maltese: DESLORATADINA APOTEX 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
Danish: Escitalopram 20mg Filmcoated tablets
Maltese: Escitalopram 20mg Film-coated tablets
Danish: Levetiracetam Levetiracetam-Hormosan 250 mg Filmtabletten
Maltese: Levetiraċetam Levetiracetam-Hormosan 250 mg Filmtabletten
Danish: 70 mg tablet
Maltese: 70 mg Pillola
Danish: Phenoxymethylpenicillin Phenoxymethylpenicillin 250mg Film-coated
Maltese: Phenoxymethylpenicill in 250mg Film-coated Tablets
Danish: Inaller 5 mg filmtabletta 5 mg
Maltese: Inaller 5 mg filmtabletta
Danish: Levetiracetam Letiramyl 750 mg potahované tablety
Maltese: Levetiraċetam Letiramyl 750 mg potahované tablety
Danish: Alendronato Pensa 70 mg compresse
Maltese: Aċidu alendroniku Alendronato Pensa 70 mg compresse
Danish: Desloratadin
Maltese: Desloratadina
Danish: Storbritannien FDC Pharma Unit 6, Fulcrum 1, Solent Way
Maltese: Ir-Renju Unit FDC Pharma Unit 6, Fulcrum 1, Solent Way Whiteley, Fareham Hampshire PO15 7FE United Kingdom
Danish: Landshuter Allee 8-10 D-80637 München Germany
Maltese: D-80637 München
Danish: 16 July 2015 EMA/466132/2015
Maltese: EMA/466132/2015
Danish: Tlf. +44 (0) 20 3660 8427 E-mail: press@ema.europa.eu
Maltese: 3660 8427 Posta elettronika: press@ema.europa.eu
Danish: Som en følge af CHMP's udtalelse fra januar 2015 og den fornyede overvejelse blev ca. 700 lægemiddelformer og -styrker, der blev undersøgt på Hyderabad-anlægget, anbefalet til suspendering.
Maltese: B'riżultat tal-opinjoni tas-CHMP ta' Jannar 2015 u l-eżaminazzjoni mill-ġdid, madwar 700 forma farmaċewtika u qawwa ta' mediċini studjati fis-sit ta' Hyderabad ġew rakkomandati għal sospensjoni.
Danish: 1 Bivolet (nebivolol), tabletter a 5 mg (indehaver af markedsføringstilladelsen: Neo Balkanika EOOD).
Maltese: 1 Bivolet (nebivolol) pilloli ta' 5 mg (detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
Danish: Gennemgangen blev påbegyndt den 25. september 2014 efter anmodning fra Europa-Kommissionen i henhold til artikel 31 i direktiv 2001/83/EF i forbindelse med det franske lægemiddelagenturs påvisning af manglende overensstemmelse med god klinisk praksis (GCP) på GVK Biosciences' anlæg i Hyderabad, Indien.
Maltese: Ir-rieżami nbeda fil-25 ta' Settembru 2014 fuq talba tal-Kummissjoni Ewropea, skont l-Artikolu 31 tadDirettiva 2001/83/KE, fir-rigward tas-sejbiet mill-aġenzija Franċiża għall-mediċini (ANSM) ta' nuqqas ta' konformtà ma' Prassi Klinika Tajba (PKT) fis-sit ta' GVK Biosciences f'Hyderabad, l-Indja.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) havde vedtaget sin oprindelige anbefaling i januar 2015 efter en inspektion af GVK Biosciences' anlæg i Hyderabad foretaget af det franske lægemiddelagentur (ANSM), der vakte bekymring om, hvordan GVK Biosciences udførte undersøgelser på anlægget, på vegne af indehavere af markedsføringstilladelsen.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bnedmin (CHMP) tal-EMA kien adotta rrakkomandazzjoni oriġinali tiegħu f'Jannar 2015 wara spezzjoni tas-sit ta' GVK Biosciences f'Hyderabad mill-aġenzija Franċiża għall-mediċini (ANSM) li qajmet tħassib dwar kif GVK Biosciences wettqet listudji fis-sit f'isem id-detenturi tal-awtorizazzjoni għat-tqegħid fis-suq.
Danish: Madrid, Spanien transdérmicos EFG
Maltese: Madrid, Spanja transdérmicos EFG
Danish: DE/H/0740/01/MR Frankrig
Maltese: <DE/H/0740/01/MR>
Danish: 8.25 mg/15 cm² som frigiver 50 mikrogram per time
Maltese: 8.25 mg/15 cm² li terħi 50 µg fentanyl fis-siegħa
Danish: DE/H/0740/04/MR Frankrig
Maltese: <DE/H/0740/04/MR>
Danish: DE/H/0740/03/MR Frankrig
Maltese: <DE/H/0740/03/MR>
Danish: fentanyl
Maltese: Anzjani
Danish: Tolerance og fysisk og psykologisk afhængighed kan opstå efter gentagen administration af opioider, men forekommer sjældent under behandling af cancersmerter.
Maltese: Tolleranza u dipendenza fisika u psikoloġika tista' tiżviluppa bl-amministrazzjoni ripetuta tal-opjojdi, iżda huma rari fil-kura ta' l-uġigħ relatat mal-kanċer .
Danish: Transdermal frigivelse af fentanyl (mikrogram/time)
Maltese: Irħir ta' fentanyl transdermali (mikrogramma/siegħa)
Danish: BAGGRUNDSOPLYSNINGER
Maltese: III.
Danish: London, den 23. oktober 2007 EMEA/331678/2007
Maltese: Londra, it-23 ta' Ottubru 2007 EMEA/331678/2007
Danish: Dr. Karl Broich var rapportør, og dr. Eric Abadie var medrapportør.
Maltese: Ir-rapporteur kien Dr Karl Broich u l-Ko-Rapporteur kien Dr Eric Abadie.
Danish: 1 Artikel 29, stk. 4, i direktiv 2001/83/EF, med senere ændringer.
Maltese: 1 Artikolu 29(4) tad-Direttiva 2001/83/KE, kif emendata.
Danish: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Danish: Referencemedlemsstaten var Tyskland, og de berørte medlemsstater var Østrig, Frankrig, Nederlandene, Spanien og Det Forenede Kongerige.
Maltese: L-Istat Membru ta' Referenza kien il-Ġermanja u l-Istati Membri Konċernati kienu l-Awstrija, Franza, l-Olanda, Spanja u r-Renju Unit.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 13. april 2007.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda spjegazzjonijiet bil-miktub fit-13 ta' April ta' l-2007.
Danish: Fentanyl-ratiopharm 25/50/75/100 µg/h TTS og tilknyttede navne er et opioidanalgetikum, der er indiceret til svære kroniske smerter, som kun kan behandles tilfredsstillende med opioidanalgetika.
Maltese: Fentanyl-ratiopharm 25/50/75/100 µg/h TTS u ismijiet assoċjati, hu analġesiku opioid li hu indikat għal uġigħ kroniku sever li jkun jista' jiġi ġestit adegwatament biss b'analġesiċi opioid.
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 41, OM Fentanyl-ratiopharm 25/50/75/100 µg/h TTS og tilknyttede navne Internationalt fællesnavn (INN): fentanyl
Maltese: OPINJONI LI SSEGWI L-ARTIKOLU 29(4)1 RERERENZA GĦAL Fentanyl-ratiopharm 25/50/75/100 µg/h TTS u assoċjati
Danish: Ratiopharm GmbH indgav ansøgninger om gensidig anerkendelse af Fentanyl-ratiopharm 25/50/75/100 µg/h TTS og tilknyttede navne, depotplaster, baseret på den markedsføringstilladelse, der var udstedt af Tyskland den 4. april 2006.
Maltese: Ratiopharm GmbH ippreżentat applikazzjonijiet għal għarfien reċiproku għal Fentanyl-ratiopharm 25/50/75/100 µg/h TTS u ismijiet assoċjati, stikka transdermali skond l-awtorizzazzjoni għat-tqegħid fis-suq mogħtija mill-Ġermanja fl-4 ta' April ta' l-2006.
Danish: Indgivelsesvej Emballage Indhold Pakningsst ørrelse
Maltese: Ippakkjar Kontenut Daqs talpakkett
Danish: EUnummer
Maltese: Speċi filmira
Danish: Særnavn Styrke Lægemidd elform
Maltese: Qawwa Għamla Farmaċewtika
Danish: ATCvet-kode: QP51AX08.
Maltese: QP51AX08.
Danish: Halofuginone ingen Kvæg 10 μg/kg
Maltese: BOVINI 10 μg/kg
Danish: Det farmakologisk aktive stof
Maltese: Sustanza farmakoloġikament attiva
Danish: Tartrazin (E102)
Maltese: Tartrażin (E102)
Danish: Benzoesyre (E210) Mælkesyre (E270) Tartrazin (E102)
Maltese: Aċidu benżojku (E210) Aċidu lattiku (E270) Tartrażin (E102
Danish: 08503 Gurb-Vic, Barcelona Spanien
Maltese: 08503 Gurb-Vic, Barcelona
Danish: Dato for første markedsføringstilladelse: 13/12/2016
Maltese: Data tal-ewwel awtorizazzjoni: 13/12/2016
Danish: EXP {måned/år}
Maltese: EXP{xahar/sena}
Danish: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgien
Maltese: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten
Danish: Det formodede fordelingsvolumen er 10 l/kg.
Maltese: Il-volum apparenti ta'distrubuzzjoni huwa ta' 10 litri/kilogramma.
Danish: Benzoesyre (E210)
Maltese: Aċidu benżojku (E210)
Danish: 0,50 mg Svarende til 0,6086 mg halofuginonelaktat
Maltese: 0.50 mg Ekwivalenti għal 0.6086 mg ta' halofuginone lactate
Danish: Panon VetPharma Kft.
Maltese: Panon VetPharma
Danish: Den koncentration, der skal til for at dræbe henholdsvis 50 % og 90 % af parasitterne i et in vitro testsystem er IC50 < 0,1 µg/ml og IC90 på 4,5 µg/ml.
Maltese: Il-konċentrazzjoni sabiex tinpedixxi 50% u 90% tal-parassiti f'testijiet li saru in vitro huwa ta' IC50 < 0.1 μg/ml u IC90 ta' 4.5 μg/ml, rispettivament.
Danish: Vand, destilleret
Maltese: Ilma, Ippurifikat
Danish: Det aktive stof i HALAGON er et tilladt stof som beskrevet i tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010:
Maltese: Is-sustanza attiva f'HALAGON hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness għarRegolament tal-Kummissjoni (UE) Nru 37/2010:
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Maltese: Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
Danish: Oral opløsning.
Maltese: Soluzzjoni orali
Danish: Træk to henholdsvis tre gange for at indgive den ønskede mængde (8 ml for kalve på 35-45 kg og 12 ml for kalve på 45-60 kg).
Maltese: Iġbed darbtejn jew tlieta, rispettivament, għall-amminstrazzjoni tal-volum mixtieq (8 ml għall għoġġiela ta' 35 - 45 kg u 12 ml għall-għoġġiela ta' 45 - 60 kg, rispettivament).
Danish: • 35 kg < kalve ≤ 45 kg: 8 ml HALAGON én gang dagligt i 7 på hinanden følgende dage
Maltese: • 35kg < għoġġiela ≤ 45kg : 8 ml HALAGON darba kuljum għal sebat ijiem konsekuttivi.
Danish: Dosering er: 100 µg halofuginone / kg legemsvægt / 1 gang dagligt i 7 på hinanden følgende dage, svarende til 4 ml HALAGON / 20 kg legemsvægt / 1 gang dagligt i 7 på hinanden følgende dage.
Maltese: Id-dożaġġ huwa ta': 100 μg ta' halofuginone/kg piż tal-ġisem/ darba kuljum għal 7 ijiem konsekuttivi, jiġifieri 4 ml ta' HALAGON / 20 kg piż tal-ġisem/ darba kuljum għal 7 ijiem konsekuttivi.
Danish: MRL Målvæv Andre bestemmelser
Maltese: MRL Tessuti mmirati
Danish: Farmakoterapeutisk gruppe: Andre antiprotozomidler, halofuginone.
Maltese: Aġenti anti-protożoiċi oħrajn, halofuginone Kodici ATĊ veterinarja:
Danish: 71 08503 Gurb-Vic, Barcelona Spanien
Maltese: Sant Hipolit, Km. 71 08503 Gurb-Vic, Barcelona Spanja
Danish: Halofuginone (laktatsalt)
Maltese: Halofuginone
Danish: Hver pakke indeholder også en doseringspumpe til doser a 4 ml, som består af flere enkeltdele fremstillet af LDPE, HDPE, LLDPE, polypropylen, rustfrit stål og silicone.
Maltese: Kull pakkett fih ukoll pompa talkejl ta' 4 ml li tikkonsisti minn diversi komponenti magħmula minn poli-etilin ta' densità għolja, baxxa u lineari b'densità baxxa, poli-propilen, azzar inossidabbli u silikonu.
Danish: Arnika Veterina d.o.o.
Maltese: Arnika Veterina d.o.o. Vidikovac 20, 10000
Danish: • Forebyggelse af diarré forårsaget af diagnosticeret Cryptosporidium parvum-infektion i besætninger, der har haft cryptosporidiosis.
Maltese: • Prevenzjoni kontra dijareja kkawżata mill-infezzjoni Cryptosoridium pavarum,f'irziezet li għandhom storja ta' kriptosporidjosi.
Danish: Kød og indmad: 13 dage.
Maltese: PERJODU TA' TIŻMIM Laħam u intern :13-il ġurnata.
Danish: HALAGON 0,5 mg/ml, oral opløsning halufuginone
Maltese: HALAGON 0.5mg/ml soluzzjoni orali. halofuginone