FrancophonIA/ELRC3.0 huggingface dataset:
Danish: Ved vurderingen har HMPC gennemgået laboratoriestudier, der har vist, at tilberedninger af anisfrø virker afslappende på muskulaturen i tarmen og luftvejene.
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra għadd ta' studji tal-laboratorji li wrew li l-preparazzjonijiet tal-frotta tal-anisi għandhom effett rilassanti fuq il-muskoli tal-imsaren u l-passaġġi tal-arja.
Danish: Berigtigelse (corrigendum) 1 (19/11/2018)
Maltese: Rettifika (corrigendum) 1 (19/11/2018)
Danish: CAS Nr.
Maltese: CAS No
Danish: Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use' (SANTE-2017-11668) EMA/CHMP/302620/2017/DA corr. 1
Maltese: Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use' (SANTE-2017-11668) EMA/CHMP/302620/2017/MT corr. 1
Danish: Sikkerhedsgrænse
Maltese: Limitu tas-sigurtà
Danish: Coumarin d-Limonen
Maltese: Coumarin d-Limonene
Danish: Latex Naturgummi (latex)
Maltese: Latex Lastku naturali (Latex)
Danish: Topikal, Parenteral Nul
Maltese: Topiku, parenterali
Danish: Produktresumé: Kontraindikation.
Maltese: Kontra- indikazzjoni.
Danish: * 1 mg B (Bor) = 5.7 mg borsyre.
Maltese: * 1 mg B (Boron) = 5.7 mg boric acid.
Danish: 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-on Amylcinnamal
Maltese: 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one Amyl cinnamal
Danish: EMA/CHMP/302620/2017/DA corr. 1
Maltese: EMA/CHMP/302620/2017/MT corr.
Danish: Aspartam (E 951)
Maltese: Aspartame (E 951)
Danish: Parenteral
Maltese: Parenterali
Danish: 1 mmol natrium (Na+) = 23 mg Na+ = 58.4 mg salt (NaCl).
Maltese: 1 mmol ta' sodium (Na) = 23 mg Na = 58.4 mg melħ (NaCl).
Danish: Cyclodextriner f.eks.
Maltese: Cyclodextrins
Danish: Substans
Maltese: Sustanza
Danish: Indeholder x g lactose (svarer til x/2 g glucose og x/2 g galactose) pr. dosis.
Maltese: Fih x g lactose (x 2 g glucose u x/2 g galactose)
Danish: Phenylalanin
Maltese: Phenylalanine
Danish: Chlorcresol
Maltese: Chlorocresol
Danish: <Benzoesyre/benzoat> kan medføre lokal irritation.
Maltese: <Benzoic acid/ benzoate salt> jista' jikkawża irritazzjoni lokali.
Danish: Hydroxymethylpentyl-cyclohexen carboxaldehyd Isoeugenol
Maltese: Hydroxymethylpentyl-cyclohexenecarboxaldehyde Isoeugenol
Danish: Intravenøs (IV) 30 mmol/l
Maltese: 30 mmol/l
Danish: Natriumlaurilsulfat
Maltese: Sodium laurilsulfate
Danish: Tilfældigt methyleret βcyclodextrin (RM-β-CD)
Maltese: Randomly methylated βcyclodextrin (RM-β-CD)
Danish: Energi: 10 kJ (2,3 kcal) pr. g <maltitol><isomalt>.
Maltese: Valur kalorifiku 2.3 kcal/g <maltitol><isomalt>.
Danish: Sorbitol er en kilde til fructose.
Maltese: Sorbitol huwa sors ta' fructose.
Danish: Benzylsalicylat
Maltese: Benzyl salicylate
Danish: Hexylcinnamaldehyd
Maltese: Hexyl cinnamaldehyde
Danish: Dimethylsulfoxid
Maltese: Dimethyl sulphoxide
Danish: 1 mmol (23 mg) pr. dosis
Maltese: 1 mmol (23 mg)
Danish: Thiomersal, Phenylmercurinitrat/ acetat/borat
Maltese: Phenylmercuric nitrate/ acetate/borate
Danish: Maltitol (E 965) Isomalt (E 953) Flydende maltitol (hydrogeneret glucosesirup)
Maltese: Maltitol (E 965) Isomalt (E 953) (Isomaltitol)
Danish: 09/10/2017 Parenteral
Maltese: 09/10/2017 Parenterali
Danish: Se Q&A dokument (EMA/CHMP/619104/2013) for yderligere beregninger.
Maltese: (EMA/CHMP/619104/2013) għal aktar kalkoli.
Danish: Forskellige bivirkninger, såsom hyperosmolalitet, lactacidosis; nedsat nyrefunktion (akut tubulær nekrose), akut nyresvigt; kardiotoksicitet (arytmi, hypotension); lidelser i centralnervesystemet (depression, koma, anfald); respiration depression, dyspnø; lever dysfunktion; hæmolytisk reaktion (intravaskulær hæmolyse) og hæmoglobinuri eller generelt nedsat funktion af organer, er rapporteret ved høje doser eller langvarig brug af propylenglycol.
Maltese: (arritmija, pressjoni baxxa); disturbi tas-sistema nervuża ċentrali (depressjoni, koma, aċċessjonijiet); depressjoni respiratorja, qtugħ ta' nifs; disfunzjoni tal-fwied; reazzjoni emolitika (emolisi intravaskulari) u emoglobinurja; jew disfunzjoni multisistemika tal-organi, ġew irrapportati b'dożi għoljin jew użu fit-tul ta'
Danish: 3 mg B/døgn < 18 år** 7 mg B/døgn
Maltese: 1 mg B/jum < 12-il sena 3 mg B/jum < 18-il sena** 7 mg B/jum
Danish: Natriumbenzoat (E 211) Kaliumbenzoat (E 212)
Maltese: Sodium benzoate (E 211) Potassium benzoate (E 212)
Danish: Benzylalkohol kan medføre allergiske reaktioner.
Maltese: Benzyl alcohol jista' jikkawża reazzjonijiet allerġiċi.
Danish: Benzoesyre (E 210) og benzoater f.eks.:
Maltese: Benzoic acid (E 210) and benzoates
Danish: 17 mmol (391 mg) i den maximale daglige dosis
Maltese: 17 mmol (391 mg) huwa bejn wieħed u ieħor
Danish: 5 mg/kg/døgn Sorbitol er en kilde til fructose.
Maltese: 5 mg/kg/jum Sorbitol huwa sors ta' fructose.
Danish: Methylheptincarbonat
Maltese: Methyl heptine carbonate
Danish: Energi: 10 kJ (2,4 kcal) pr. g xylitol.
Maltese: Valur kalorifiku 2.4 kcal/g xylitol.
Danish: Parenteral Luftvejene
Maltese: Parenterali Respiratorji
Danish: Sorbinsyre (E 200) og salte
Maltese: Sorbic acid (E 200) u mlieħ
Danish: Svovldioxid (E 220) Natriumsulfit (E 221) Natriumhydrogensulfit (E
Maltese: Sulphur dioxide (E 220) Sodium sulphite (E 221) Sodium bisulphite (E 222) Sodium metabisulphite (E
Danish: *< >: duftallergener er listet i bilag.
Maltese: *< >: fragrance allergens (allerġeni tal-fwieħa) elenkati fl-appendiċi.
Danish: Benzalkoniumchlorid kan medføre lokal irritation.
Maltese: Benzalkonium chloride jista' jikkawża irritazzjoni lokali.
Danish: På baggrund af de begrænsede data som er tilgængeligt, er der ingen forskel i bivirkningsprofilen hos børn sammenlignet med voksne.
Maltese: Mid-data limita li teżisti, m'hemm l-ebda differenza fl- profil ta' effett avvers fit-tfal meta mqabbla ma' adulti.
Danish: Betadex (E 459)
Maltese: Alfadex Betadex (E 459)
Danish: Dette lægemiddel indeholder duftstof med <allergen(er)>*.
Maltese: Din il-mediċina fiha fwieħa b '<allergen(s)> *.
Danish: Previous version: Natriumlaurilsulfat (E 487)
Maltese: Sodium laurilsulfate (E 487)
Danish: Energi: 9 kJ (2,1 kcal) pr. g lactitol.
Maltese: Valur kalorifiku 2.1 kcal/g lactitol.
Danish: Benzylalkohol
Maltese: Benzyl alcohol
Danish: Se EMEA Public Statement, 8 July 1999, Ref. EMEA/20962/99
Maltese: EMEA/20962/99
Danish: Ricinusolie, polyoxyleret Ricinusolie, polyoxyleret, hydrogeneret
Maltese: Żejt ir-riġnu polyoxyl Żejt ir-riġnu polyoxyl hydrogenated
Danish: 100 mg pr. dosis
Maltese: 100 mg f'kull doża
Danish: Propylparahydroxybenzoat Natriumpropylparahydroxybenzoat Methylparahydroxybenzoat (E 218)
Maltese: Sodium ethyl phydroxybenzoate (E 215) Propyl p-hydroxybenzoate Sodium propyl phydroxybenzoate Methyl p-hydroxybenzoate (E 218)
Danish: Øget risiko som følge af akkumulering hos små børn.
Maltese: Żieda fir-riskju minħabba l-akkumulazzjoni fittfal żgħar.
Danish: Den additive virkning af samtidig administrerede produkter indeholdende fructose (eller sorbitol) og diætindtagelse af fructose (eller sorbitol) bør tages i betragtning.
Maltese: prodotti amministrati b'mod konkomitanti li fihom fructose (jew sorbitol) u l-konsum fid-dieta ta' fructose (jew sorbitol).
Danish: Benzylalkohol er forbundet med risikoen for alvorlige bivirkninger inklusiv åndedrætsbesvær (kaldet "gasping syndrome") hos små børn.
Maltese: Benzyl alcohol gie marbut mar-riskju ta' effetti sekondarji severi inklużi problemi tan-nifs (imsejħa "gasping syndrome ") fi tfal żgħar.
Danish: Må ikke appliceres på slimhinden.
Maltese: Mhux għal applikazzjoni lil-mukoża.
Danish: Natriummethylparahydroxybenzoat (E 219)
Maltese: Sodium methyl phydroxybenzoate (E 219)
Danish: Berigtigelse
Maltese: Rettifika
Danish: Tartrazin (E 102) Sunset yellow FCF (E 110) Azorubin, carmoisin (E 122) Amaranth (E 123) Ponceau 4R red, cochenillerød A (E 124) Brilliant black BN, black PN (E 151)
Maltese: Tartrazine (E 102) Sunset yellow FCF (E 110) Azorubine, carmoisine (E
Danish: Phosphat buffer
Maltese: Buffers tal-fosfat
Danish: 09/10/2017 Oral, parenteral (andet end IV)
Maltese: 09/10/2017 Orali, parenterali (li mhuwiex IV)
Danish: 09/10/2017 Topikal
Maltese: 09/10/2017 Topiku
Danish: Dette er ikke et typisk hjælpestof, men en advarsel anses for at være nødvendig.
Maltese: M'huwiex sustanza mhux attiva tipika, imma twissija hija meqjusa neċessarja.
Danish: Amylcinnamylalkohol
Maltese: Amylcinnamyl alcohol
Danish: Dette lægemiddel indeholder … vol % alkohol, d.v.s. op til … mg pr. <dosis>, svarende til … ml øl, eller … ml vin pr. <dosis>.
Maltese: Dan il-prodott mediċinal fih … vol % ethanol (alcohol), jiġifieri sa' … mg f'kull <doża>, ekwivalenti għal … ml birra, … ml inbid f'kull <doża>.
Danish: 7 mg B/døgn* Må ikke anvendes til børn under 18 år, da dette lægemiddel indeholder bor og kan forringe frugtbarheden i fremtiden.
Maltese: 7 mg B/jum* Tagħtix lil tifel / tifla ta' inqas minn 18-il sena peress li din il-mediċina fiha boron u tista' tfixkel il fertilità fil-futur.
Danish: Indeholder x g galactose pr. dosis.
Maltese: Fih x g galactose f'kull doża.
Danish: Butylhydroxytoluen (BHT) (E321)
Maltese: Butylated hydroxytoluene (E 321)
Danish: 09/10/2017 Intravenøs (IV) Nul
Maltese: 09/10/2017 Ġol-vina (IV)
Danish: Benzyl akohol
Maltese: Benzyl benzoate
Danish: Monitorering er påkrævet hos patienter med nedsat nyre- eller leverfunktion, fordi der er rapporteret adskillige bivirkninger, der skyldes propylenglycol, såsom renal dysfunktion (akut tubulær nekrose), akut nyresvigt og nedsat nyreleverfunktion.
Maltese: Monitoraġġ mediku huwa meħtieġ f'pazjenti b'funzjonijiet renali jew epatiċi indeboliti minħabba li ġew irrappurtati diversi episodji avversi attribwiti għal propylene glycol bħal disfunzjoni renali (nekrożi tubulari akuta), insuffiċjenza renali akuta u disfunzjoni tal-fwied.
Danish: Phenylalanin kan være skadeligt, hvis du har phenylketonuri (PKU, Føllings sygdom), en sjælden genetisk lidelse, hvor phenylalanin ophobes, fordi kroppen ikke kan fjerne det ordentligt.
Maltese: Phenylalanine jista' jkun ta' ħsara jekk inti għandek fenilketonurja (phenylketonuria , PKU), disturb ġenetiku rari fejn il-phenylalanine jakkumula għaliex il-ġisem ma jistax ineħħih sewwa.
Danish: Dette lægemiddel indeholder x mmol (eller y mg) kalium pr. dosis.
Maltese: Din il-mediċina fiha x mmol (jew y mg) ta' potassium f'kull <doża>.
Danish: 3 mg B/døgn* Må ikke anvendes til børn under 12 år, da dette lægemiddel indeholder bor og kan forringe frugtbarheden i fremtiden.
Maltese: 3 mg B/jum* Tagħtix lil tifel / tifla ta' inqas minn 12-il sena peress li din il-mediċina fiha boron u tista' tfixkel il fertilità fil-futur.
Danish: Sodium-containing effervescent, dispersible and soluble medicines - Cardiovascular events " (EMA/PRAC/234960/2015).
Maltese: "1.3. Sodium-containing effervescent, dispersible and soluble medicinesCardiovascular events " (EMA/PRAC/234960/2015).
Danish: EMA/CHMP/302620/2017/DA Rev. 1
Maltese: EMA/CHMP/302620/2017/MT Rev.
Danish: Forskellige bivirkninger, såsom hyperosmolalitet, lactacidosis; nedsat nyrefunktion (akut tubulær nekrose), akut nyresvigt; kardiotoksicitet (arytmi, hypotension); lidelser i centralnervesystemet (depression, koma, anfald); respirationsdepression, dyspnø; leverdysfunktion; hæmolytisk reaktion (intravaskulær hæmolyse) og hæmoglobinuri eller generelt nedsat funktion af organer, er rapporteret ved høje doser eller langvarig brug af propylenglycol.
Maltese: Episodji avversi varji, bħal iperosmolalità, aċidożi lattika; disfunzjoni renali (nekrożi tubulari akuta), insuffiċjenza renali akuta; kardjotossiċità (arritmija, pressjoni baxxa); disturbi tas-sistema nervuża ċentrali (depressjoni, koma, aċċessjonijiet); depressjoni respiratorja, qtugħ ta' nifs; disfunzjoni tal-fwied; reazzjoni emolitika (emolisi intravaskulari) u emoglobinurja; jew disfunzjoni multisistemika tal-organi, ġew irrapportati b'dożi għoljin jew użu fit-tul ta' propylene glycol.
Danish: Indeholder x g lactose (svarer til x/2 g glucose og x/2 g galactose) pr. dosis.
Maltese: Fih x g lactose (x 2 g glucose u x/2 g galactose) f'kull doża.
Danish: Se Q&A dokument (EMA/CHMP/619104/2013) for yderligere beregninger.
Maltese: Ara d-dokument Q & A (EMA/CHMP/619104/2013) għal aktar kalkoli.
Danish: Betadex (E 459) γ-cyclodextrin Sulfobutyl-ether-βcyclodextrin (SBE-β-CD) Hydroxypropyl betadex Tilfældigt methyleret βcyclodextrin (RM-β-CD)
Maltese: Betadex (E 459) γ-cyclodextrin Sulfobutyl-ether-βcyclodextrin (SBE-β-CD) Hydroxypropyl betadex Randomly methylated βcyclodextrin (RM-β-CD)
Danish: 3 mg B/døgn < 18 år** 7 mg B/døgn ≥ 18 år** 10 mg B/døgn
Maltese: 1 mg B/jum < 12-il sena 3 mg B/jum < 18-il sena** 7 mg B/jum ≥ 18-il sena** 10 mg B/jum
Danish: En dosis på (vælg maksimal dosis) af dette lægemiddel givet til (et barn i alderen A, der vejer B kg eller en voksen, der vejer 70 kg) resulterer i en eksponering for ethanol på C mg/kg, hvilket kan forårsage en stigning i koncentrationen af ethanol i blodet på ca. D mg/100 ml (se rapporten EMA/CHMP/43486/2018, bilag 1).
Maltese: Doża ta' (agħżel doża massima) ta' din il-mediċina mogħtija lil (tifel ta' A età ta' sena u li tiżen B kg jew adult li jiżen 70 kg) tirriżulta f'espożizzjoni għal C mg / kg ta' ethanol li jista' jikkawża żieda fl-alkoħol fid-demm konċentrazzjoni (BAC) ta' madwar D mg / 100 ml (ara lAppendiċi 1 tar-rapport EMA / CHMP / 43486/2018).
Danish: Forslag til information i SPC´et:
Maltese: Proposta għall-SPC:
Danish: 17 mmol (391 mg) i den maximale daglige dosis
Maltese: 17 mmol (391 mg) fid-doża massima ta' kuljum
Danish: 22/11/2019 Kutan
Maltese: 22/11/2019 Użu għall-ġilda Żero
Danish: Parenteral Inhalation
Maltese: Parenterali Respiratorji
Danish: 75 mg/kg pr. dosis
Maltese: 75 mg/kg f'kull doża
Danish: 1 mmol (23 mg) pr. dosis
Maltese: 1 mmol (23 mg) f'kull doża
Danish: 17 mmol (391 mg) svarer til ca. 20% af den WHO anbefalede maximale daglige indtagelse af 2 g natrium og anses som "højdosis" natrium.
Maltese: 17 mmol (391 mg) huwa bejn wieħed u ieħor 20% talammont massimu rakkomandat mill-WHO ta' 2 g sodium li għandu jittieħed mad-dieta kuljum minn adult u huwa meqjus li jirrappreżenta sodium "għoli".
Danish: 15 mg/kg pr. dosis
Maltese: 15 mg/kg f'kull doża
Danish: Ved beregning af den tilsvarende øl- og vinmængde antages det, at øl indeholder 5% v/v (alkohol per. volumen) ethanol, svarende til 4% w/v, og at vin indeholder 12,5% v/v eller 10% w/v (ethanols massefylde er anslået til 0,8) ethanol.
Maltese: Biex tikkalkula l-volum ekwivalenti ta' birra u inbid, assumi li l-kontenut ta' etanol ta' birra huwa ta' 5% v / v (alkoħol skond il-volum, ABV), li huwa ekwivalenti għal 4% w / v, u ta nbid huwa ta' 12.5% v / v jew 10% w / v (il-gravità speċifika ta' l-ethanol ġiet approssimata bħala
Danish: På baggrund af de begrænsede tilgængelige data er der ingen forskel i bivirkningsprofilen hos børn sammenlignet med voksne.
Maltese: Mid-data limita li teżisti, m'hemm l-ebda differenza flprofil ta' effett avvers fit-tfal meta mqabbla ma' adulti.
Danish: 200 mg/kg/døgn Cyclodextriner kan medføre fordøjelsesproblemer som diarré.
Maltese: 200 mg/kg/jum Cyclodextrins jista' jikkawżaw problemi diġestivi bħal dijarea.
Danish: Rektal
Maltese: Rettifika
Danish: [* Angivelsen »glutenfri« gælder kun hvis glutenindholdet i lægemidlet er mindre end 20 ppm.]
Maltese: [*Id-dikjarazzjoni "mingħajr gluten" tapplika biss jekk il-kontenut ta' gluten fil-prodott mediċinali huwa anqas minn 20 ppm.]
Danish: Monitorering er påkrævet hos patienter med nedsat nyreeller leverfunktion, fordi der er rapporteret adskillige bivirkninger, der skyldes propylenglycol, såsom renal dysfunktion (akut tubulær nekrose), akut nyresvigt og nedsat nyreleverfunktion.
Maltese: Monitoraġġ mediku huwa meħtieġ f'pazjenti b'funzjonijiet renali jew epatiċi indeboliti minħabba li ġew irrappurtati diversi episodji avversi attribwiti għal propylene glycol bħal disfunzjoni renali (nekrożi tubulari akuta), insuffiċjenza renali akuta u disfunzjoni tal-fwied.
Danish: Benzylalkohol er forbundet med risiko for alvorlige bivirkninger inklusive åndedrætsbesvær (kaldet "gasping syndrome") hos små børn.
Maltese: Benzyl alcohol gie marbut mar-riskju ta' effetti sekondarji severi inklużi problemi tan-nifs (imsejħa "gasping syndrome ") fi tfal żgħar.
Danish: Til sammenligning antages stigningen i koncentrationen af ethanol i blodet at være ca. 50 mg/100 ml for en voksen, der drikker et glas vin eller 500 ml øl.
Maltese: Għall-paragun, għal adult li jixrob tazza inbid jew 500 ml birra, il-BAC x'aktarx ikun ta' madwar 50 mg / 100 ml.
Danish: Øl- og vinmængder (A og B) skal rundes op til næste hele tal.
Maltese: Il-volumi tal-birra u l-inbid (A u B) għandhom jiġu aġġustati għan-numru sħiħ li jmiss.
Danish: 09/10/2017 Okulær
Maltese: 09/10/2017 Topiku
Danish: Anisylalkohol
Maltese: Anisyl alcohol
Danish: 140 mg/kg/døgn Sorbitol kan medføre gastrointestinalt ubehag og en mild afførende virkning.
Maltese: 140 mg/kg/jum Sorbitol jista' jikkawża skumdita' gastrointestinali u effett lassattiv ħafif.
Danish: Ministry of Agriculture, Natural Resources and Environment
Maltese: Ministry of Agriculture, Natural Resources u Environment
Danish: 2.10 Paralleldistribution
Maltese: 2.10 Distribuzzjoni parallela
Danish: Sandsynlighed for godkendelse (%)
Maltese: Probabbilta' ta' approvazzjoni (%)
Danish: PSUR FUM - SO
Maltese: PSURs FUM - SO
Danish: IQM-rådgiver:
Maltese: Konsulenta IQM:
Danish: Annex II to Note for guidance on process validation: non-standard processes
Maltese: Anness II to Note for guidance on process validation: non-standard processes
Danish: Swedish Orphan International AB
Maltese: Swedish Orfni International AB
Danish: Websteder:
Maltese: Websites:
Danish: An EU veterinary suspected adverse reaction report form for veterinarians and health professionals
Maltese: An UE veterinary suspected adverse reaction report form for veterinarians and health professionals
Danish: Konkurrerende risikoanalyse, P-værdi = 0.02
Maltese: Analizi tar-riskju ta' kompetizzjoni P-valur = 0.02
Danish: Orphan Europe SARL
Maltese: Orfni Europe SARL
Danish: CY - 1417 Nicosia
Maltese: Street CY - 1417 Nicosia
Danish: Personale og budget
Maltese: Personal u budget
Danish: Division de la Pharmacie et des Médicaments Villa Louvigny - 1er étage Parc de la Ville - Allée Marconi L - 2120 Luxembourg
Maltese: Division de la Pharmacie et des Médicaments Villa Louvigny - 1er étage Parc de la Ville - Allée Marconi L - 2120
Danish: Ravila Str 19
Maltese: Str 19
Danish: ICH S7B - The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals
Maltese: ICH S7B - The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by
Danish: Head of Veterinary Medicinal Product Unit Ministry for Food, Agriculture and Fisheries Albertown
Maltese: Head of Veterinary Medicinal Product Unit Ministry for Food, Agriculture u Fisheries Albertown
Danish: Homoharringtonine Stragen France SAS
Maltese: Homoharringtonine Stragen Franza SAS
Danish: Position paper on the data requirements for removing the target animal batch safety test for immunological veterinary medicinal products in the EU
Maltese: Position paper on the data requirements for removing the target animal batch safety test for immunological veterinary medicinal products in the UE
Danish: Fergus SWEENEY (formand)
Maltese: Fergus SWEENEY (President)
Danish: Interesserede parter
Maltese: Partijiet interessati
Danish: Danmark 3,57 % Estland 0,77 % Finland 2,04 % Frankrig
Maltese: Id-Danimarka 3.57 % L-Estonja 0.77 %Il-Finlandja 2.04 % Franza
Danish: • José Félix Olalla Marañón (Spanien)
Maltese: • José Félix Olalla Marañón (Spanja)
Danish: • Harrie J J Seeverens (Nederlandene)
Maltese: • Harrie J J Seeverens (Olanda)
Danish: • Martin Možina (Slovenien)
Maltese: • Martin Možina (Slovenja)
Danish: 1417 Athalassas Street
Maltese: 1417 Athalassas
Danish: 6.1 Administration
Maltese: 6.1 Amministrazzjoni
Danish: Position paper on control of impurities of pharmacopoeial substances: Compliance with the European Pharmacopoeia general monograph ‘Substances for pharmaceutical use' and general chapter ‘Control of impurities in substances for pharmaceutical use'
Maltese: Compliance with the European Pharmacopoeia general monograph ‘Substances for pharmaceutical use' and general chapter ‘Control of impurities in substances for pharmaceutical use'
Danish: Formand: Harrie SEEVERENS/Jean-Hugues TROUVIN
Maltese: Harrie SEEVERENS/Jean-Hugues TROUVIN
Danish: Personalets geografiske fordeling i EMEA - 31. december 2004
Maltese: Distribuzzjoni geografika ta' l-EMEA - 31 ta' Dicembru 2004
Danish: • Sigurður B Thorsteinsson (Island)
Maltese: • Sigurður B Thorsteinsson (Islanda)
Danish: Agnès SAINT-RAYMOND (fra medio oktober 2004)
Maltese: Agnès SAINT-RAYMOND (from mid-October 2004)
Danish: Mechanisms to Trigger Investigations of the Safety of Veterinary Medicinal Products by EU Competent Authorities
Maltese: Mechanisms to Trigger Investigations of the Safety of Veterinary Medicinal Products by UE Competent Authorities
Danish: Emer COOKE (formand)
Maltese: Emer COOKE (President)
Danish: Fendrix Hepatitis B virus surface antigen (rDNA) (S protein) Part A
Maltese: Fendrix Hepatitis B virus surface antigen (rDNA) (S protein)
Danish: • Patrick SALMON2 (Irland)
Maltese: • Patrick SALMON2 (Irlanda)
Danish: Videnskabelig rådgivning (n=48)
Maltese: Parir xjentifiku (n=48)
Danish: Gloria GARCÍA LORENTE (Spanien) suppleant: Adela Velázquez
Maltese: Gloria GARCÍA LORENTE (Spanja) Sostituta: Adela Velázquez
Danish: Infrastruktur
Maltese: Infrastruttura
Danish: • José Manuel Toscano Rico (Portugal)
Maltese: • José Manuel Toscano Rico (Portugall)
Danish: Treatment to mobilise progenitor cells prior to stemcell transplantation
Maltese: Treatment to mobilise progenitor cells prior to stem-cell transplantation
Danish: • Barbara VAN ZWIETEN-BOOT (Nederlandene) suppleant: Frits LEKKERKERKER
Maltese: • Barbara VAN ZWIETEN-BOOT (Olanda) Sostitut: Frits LEKKERKERKER
Danish: suppleant: Jens ERSBØLL7
Maltese: Jens ERSBØLL7
Danish: Fælles Eudraadresseliste (Eudra Common Directory, ECD)
Maltese: Direttorju Komuni Eudra (ECD)
Danish: 1.7 Virksomhedsledelse - Integreret styringssystem
Maltese: 1.7 Il-Governanza Korporattiva - sistema ta' ġestjoni integrata
Danish: ICH S8 - Immunotoxicology studies
Maltese: Status human pharmaceuticals ICH S8 - Immunotoxicology studies
Danish: • Patricia VELLA BONANNO9 (Malta) suppleant: John Joseph BORG10
Maltese: • Patricia VELLA BONANNO9 (Malta) Sostitut: John Joseph BORG10
Danish: Medlemmer
Maltese: Membri
Danish: • Veijo Saano (Finland)
Maltese: • Veijo Saano (Finlandja)
Danish: • Gonzalo CALVO ROJAS (Spanien) suppleant: Fernando DE ANDRÉS-TRELLES
Maltese: • Gonzalo CALVO ROJAS (Spanja) Sostitut: Fernando DE ANDRÉS-TRELLES
Danish: Guideline on submission of marketing authorisation applications for pandemic influenza vaccines through the centralised procedure
Maltese: Guideline on submission of market authorisation applications for pandemic influenza vaccines through the centralised procedure
Danish: MT - CMR 02 Marsa
Maltese: MT - CMR 02 Marsa Tel.
Danish: • Jean-Louis ROBERT1 (Luxembourg)
Maltese: • Jean-Louis ROBERT1 (Lussemburgu)
Danish: • Heidrun Bosch Traberg (Danmark)
Maltese: • Heidrun Bosch Traberg (Danimarka)
Danish: Christian Cuschieri (Malta) suppleant: Caroline ATTARD
Maltese: Christian Cuschieri (Malta) Sostituta: Caroline ATTARD
Danish: Guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application
Maltese: Guideline on dossier structure and content for pandemic influenza vaccine market authorisation application
Danish: • Pekka KURKI1 (Finland) (indvalgt)
Maltese: • Pekka KURKI1 (Finlandja) (co-opted)
Danish: Slovakiet 1,79 % Portugal
Maltese: Spanja 9.69 % Ir-Repubblika Slovakka 1.79 % Il-Portugall
Danish: Wojciech DYMOWSKI (Polen) suppleant: Elżbieta WOJTASIK
Maltese: Wojciech DYMOWSKI (Polonja) Sostituta: Elżbieta WOJTASIK
Danish: • Henri METZ (Luxembourg)
Maltese: • Henri METZ (Lussemburgu)
Danish: • George STATHOPOULOS (Grækenland)
Maltese: • George STATHOPOULOS (Greċja)
Danish: • Steffen THIRSTRUP6 (Danmark)
Maltese: • Steffen THIRSTRUP6 (Danimarka)
Danish: • Domenica TARUSCIO (Italien)
Maltese: • Domenica TARUSCIO (Italja)