FrancophonIA/ELRC3.0 huggingface dataset:
English: Sevocalm received a marketing authorisation valid throughout the EU on 21/06/2016.
Danish: Sevohale fik en markedsføringstilladelse med gyldighed i hele EU den 21. juni 2016.
English: Sevohale is a ‘generic medicine'.
Danish: Sevohale er et "generisk lægemiddel".
English: What is Sevohale and what is it used for?
Danish: Hvad er Sevohale, og hvad anvendes det til?
English: The European Medicines Agency concluded that, in accordance with EU requirements, Sevohale has been shown to be comparable to SevoFlo.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Sevohale kan sammenlignes med SevoFlo.
English: An overview of Sevohale and why it is authorised in the EU
Danish: Oversigt over Sevohale, og hvorfor det er godkendt i EU
English: This means that Sevohale contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called SevoFlo.
Danish: Det betyder, at Sevohale indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder SevoFlo.
English: Sevohale is given using specialised anaesthetic equipment, usually in a carefully controlled mixture including oxygen.
Danish: Sevohale gives ved hjælp af specielt bedøvelsesudstyr, normalt i en nøje kontrolleret blanding med ilt.
English: Why is Sevohale authorised in the EU?
Danish: Hvorfor blev Sevohale godkendt i EU?
English: It contains the active substance sevoflurane, a chemical which is a liquid at room temperature, but when heated becomes a gas (vaporises).
Danish: Det indeholder det aktive stof sevofluran, som er et kemisk stof, der har væskeform ved rumtemperatur, men som bliver til en gas (fordamper), når det opvarmes.
English: The dog or cat breathes in this gas mixture, which causes it to become unconscious.
Danish: Hunden eller katten indånder gasblandingen og bliver derved bevidstløs.
English: Sevoflurane mimics the action of GABA, a substance that naturally reduces brain activity, and blocks the action of glutamate, which stimulates the action of the brain.
Danish: Sevofluran efterligner virkningen af GABA, der er et stof, som naturligt reducerer hjerneaktiviteten, og blokerer virkningen af glutamat, der stimulerer hjernen.
English: No additional studies were needed as Sevohale is a generic medicine that is given by inhalation and contains the same active substance as the reference medicine, SevoFlo.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom Sevohale er et generisk lægemiddel, der indgives ved inhalation og indeholder det samme aktive stof som referencelægemidlet SevoFlo.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Sevohale, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Sevohale, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: The precautions are the same as for the reference medicine since Sevohale is a generic medicine.
Danish: Disse forholdsregler er de samme som for referencelægemidlet, eftersom Sevohale er et generisk lægemiddel.
English: For more information about using Sevohale, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Sevohale, kan du læse indlægssedlen eller kontakte dyrlægen eller dit apotek.
English: Therefore, the Agency's view was that, as for SevoFlo, the benefits outweigh the identified risks and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Sevohale opvejer de identificerede risici, som for SevoFlo, og at det kan godkendes til anvendelse i EU.
English: Sevohale is a general anaesthetic for dogs and cats.
Danish: Sevohale anvendes til fuld bedøvelse af hunde og katte.
English: Because Sevohale is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Sevohale er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: How has Sevohale been studied?
Danish: Hvordan blev Sevohale undersøgt?
English: Sevohale is used to bring about and maintain general anaesthesia (loss of consciousness).
Danish: Sevohale anvendes både til at fremkalde og vedligeholde fuld bedøvelse (bevidstløshed).
English: How is Sevohale used?
Danish: Hvordan anvendes Sevohale?
English: How does Sevohale work?
Danish: Hvordan virker Sevohale?
English: Revaccination: every six months.
Danish: Revaccination: hver 6. måned.
English: In trials the following has been demonstrated:
Danish: I studier er følgende blevet vist:
English: ATCvet code: QI02AA04.
Danish: ATCvet-kode: QI02AA04
English: Date of first authorisation: 15/07/2013 Date of last renewal: 14/06/2018
Danish: Dato for første markedsføringstilladelse: 15/07/2013 Dato for seneste fornyelse af markedsføringstilladelse: 14/06/2018
English: Following repeated administration at short intervals, the intensity and frequency of these reactions may be increased.
Danish: Efter gentagne administrationer med korte intervaller kan intensiteten og frekvensen af disse reaktioner blive forøget.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of foot-and-mouth disease.
Danish: Anvendelse af dette veterinærlægemiddel er kun tilladt under de særlige betingelser fastsat i den Europæiske Unions lovgivning vedrørende kontrol af mund- og klovsyge.
English: Mannide mono-oleate Polysorbate 80
Danish: Mannide monooleat Polysorbat 80
English: In some cases ulceration may occur at the injection site.
Danish: Sårdannelse kan i nogle tilfælde forekomme på injektionsstedet.
English: Maternal antibodies may interfere with vaccination.
Danish: Maternelle antistoffer kan have indvirkning på vaccinationen.
English: Schedule should be adjusted accordingly (see section 4.9).
Danish: Planlægning af vaccination bør justeres herefter (se afsnit 4.9).
English: Do not mix the vaccine by vigorous shaking because it leads to entrapment of air bubbles.
Danish: Vaccinen må ikke blandes ved at ryste den voldsomt, fordi dette fører til indeslutning af luftbobler.
English: Avoid accidental contamination of the vaccine after first broaching and during use.
Danish: Undgå utilsigtet forurening af vaccinen efter første anbrud og ved brug.
English: Each dose of 2 ml of emulsion contains:
Danish: En dosis på 2 ml emulsion indeholder:
English: BOEHRINGER INGELHEIM ANIMAL HEALTH Netherlands B.V. Houtribweg 39
Danish: BOEHRINGER INGELHEIM ANIMAL HEALTH Netherlands B.V.
English: In cattle, the antibody levels measured were above those shown to be protective.
Danish: Hos kvæg var de målte niveauer af antistoffer over det nødvendige for at yde beskyttelse.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Danish: I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan en medlemsstat i overensstemmelse med medlemsstatens nationale lovgivning forbyde fremstilling, indførsel, besiddelse salg, levering og/eller anvendelse af immunologiske veterinærlægemidler på hele eller en del af sit område, hvis det godtgøres:
English: Pigs: 4 weeks after vaccination.
Danish: Svin: 4 uger efter vaccination.
English: 10 doses 25 doses
Danish: 10 doser 25 doser
English: These local reactions normally resolve over a period of four weeks post vaccination, but may persist for longer in a small number of animals.
Danish: Disse lokalreaktioner vil sædvanligvis forsvinde inden for en periode på fire uger efter vaccination, men kan vare i længere tid hos et lille antal dyr.
English: The number and type of strains included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.
Danish: Antal og type af stammer, der er indeholdt i det færdige produkt, vil blive tilpasset den øjeblikkelige epidemiologiske situation på det tidspunkt det færdige lægemiddel bliver produceret og vil angives på etiketten.
English: Schedule should be adjusted accordingly (see section “dosage”).
Danish: Planlægning af vaccination bør justeres herefter (se afsnit om ”dosering”).
English: Do not warm the product before use.
Danish: Lægemidlet må ikke varmes før brug.
English: Onset of immunity:
Danish: Indtræden af immunitet:
English: Liquid paraffin 537 mg. White emulsion after shaking.
Danish: Flydende paraffinolie 537 mg. Hvid emulsion efter omrystning.
English: The safety of the veterinary medicinal product has not been established during lactation.
Danish: Veterinærlægemidlets sikkerhed under laktation er ikke fastlagt.
English: EXP {month/year} Once broached use immediately.
Danish: EXP{måneder/år} Efter anbrud anvendes straks.
English: * PD50 - 50% protective dose in cattle as described in Ph. Eur.
Danish: *PD50: 50% beskyttende dosis hos kvæg som beskrevet i Ph.Eur monograph 0063.
English: Pharmaceutical group: inactivated viral vaccine, foot-and-mouth disease virus.
Danish: Farmakoterapeutisk gruppe: inaktiveret viral vaccine, mund- og klovsyge virus.
English: Cattle and sheep: 7 days after vaccination.
Danish: Kvæg og får: 7 dage efter vaccination.
English: Swellings (diameter of up to 12 cm in ruminants and 4 cm in pigs) occurred very commonly in most animals after administration of a dose of vaccine.
Danish: Hævelser (op til 12 cm i diameter hos drøvtyggere og 4 cm hos svin) var meget almindelige hos de fleste dyr efter administration af en vaccinedosis.
English: Polypropylene bottle with a nitrile elastomer closure and sealed with an aluminium cap.
Danish: Polypropylenflaske med en nitrylelastomer prop der er forseglet med en aluminiumshætte.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten EXP. Udløbsdatoen refererer til den sidste dag i den pågældende måned.
English: A slight increase of rectal temperature of up to 1.2 °C for 4 days post-vaccination with no other generalised clinical signs is commonly observed.
Danish: En let rectal temperaturforhøjelse på op til 1,2 °C i op til 4 dage efter vaccination uden andre kliniske symptomer er almindelig.
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ
English: 10 doses 25 doses 50 doses 100 doses 150 doses 10 x 10 doses 10 x 25 doses 10 x 50 doses 10 x 100 doses 10 x 150 doses
Danish: 10 doser 25 doser 50 doser 100 doser 150 doser 10 x10 doser 10 x 25 doser 10 x 50 doser 10 x100 doser 10 x 150 doser
English: Sodium chloride Potassium dihydrogen phosphate Potassium chloride Disodium phosphate anhydrous Potassium hydroxide Water for injections.
Danish: Natriumchlorid Kaliumdihydrogenphosphat Kaliumchlorid Dinatriumphosphat, vandfrit Kaliumhydroxid Vand til injektionsvæsker
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Den aktive substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009 når det anvendes som i dette veterinære lægemiddel.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated ) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelig (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).
English: Major incompatibilities: Do not mix with any other veterinary medicinal product.
Danish: Væsentlige uforligeligheder: Dette lægemiddel må ikke blandes med andre lægemidler.
English: Primary vaccination: Cattle from 2 weeks of age:
Danish: Basisvaccination: Kvæg fra 2-ugersalderen:
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERAF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: No antibodies to NSP were detected using the PrioCHECK FMDV NS test kit:
Danish: Der blev ikke fundet antistoffer til NSP ved anvendelse af PrioCHECK
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER
English: Inactivated foot-and-mouth disease antigens are purified and do not contain sufficient amounts of non-structural proteins (NSP) to induce an antibody response following administration of a trivalent vaccine containing an amount of antigen corresponding with at least 15 PD50 per strain per dose of 2 ml.
Danish: Inaktiveret mund- og klovsygeantigener bliver renset og indeholder ikke tilstrækkelige mængder af ikke-strukturerede proteiner (NSP) til at inducere et antistofsvar efter administration af en trivalent vaccine, der indeholder en antigenmængde, svarende til mindst 15 PD50 pr stamme pr. dosis på 2 ml.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 10 or 25 doses
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Flaske á 10 og 25 doser
English: Store and transport refrigerated.
Danish: Opbevares og transporteres koldt Må ikke nedfryses.
English: 50 doses 100 doses 150 doses
Danish: 50 doser 100 doser 150 doser
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double dose to calves, lambs and piglets.
Danish: Der har ikke været observeret andre bivirkninger end de, der er nævnt i pkt 4.6, efter administration af en dobbeltdosis til kalve, lam og smågrise.
English: White emulsion after shaking.
Danish: Hvid emulsion efter omrystning.
English: Shelf life of the veterinary medicinal product not containing strain Asia1 Shamir as packaged for sale: 6 months.
Danish: Opbevaringstid for veterinærlægemidlet, der ikke indeholder stammen Asia1 Shamir, er i salgspakning: 6 måneder.
English: Maximum three of the following purified, inactivated foot-and-mouth disease virus strains:
Danish: Maksimalt tre af følgende rensede, inaktiverede antigener af mund- ogklovsygevirusstammer:
English: Duration of immunity: vaccination of cattle, sheep and pigs induced the production of neutralising antibodies that persisted for at least 6 months.
Danish: Varighed af immunitet: Vaccination af kvæg, får og svin inducerede produktion af neutraliserende antistoffer, der varede ved i mindst 6 måneder.
English: Pigs from 2 weeks of age:
Danish: Svin fra 2-ugersalderen:
English: The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in a Member State on the whole or part of its territory, see package leaflet for further information.
Danish: Indførsel, besiddelse, salg, levering og/eller anvendelse af dette veterinærlægemiddel kan være forbudt i en medlemsstat på dele af eller hele dens område.
English: Vaccination of cattle with strains O1 Manisa, O1 BFS, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia1 Shamir and SAT2 Saudi Arabia resulted in a reduction of clinical signs in animals exposed to infection.
Danish: Vaccination af kvæg med stammerne O1 Manisa, O1 BFS, A22 Iraq, A24 Cruzeiro, A Turkey 14/98 ,Asia1 Shamir og SAT2 Saudi Arabia resulterede i en reduktion af kliniske symptomer hos dyr der var udsat for infektion.
English: Do not mix with any other veterinary medicinal product.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler.
English: Shelf life of the veterinary medicinal product containing strain Asia1 Shamir as packaged for sale: 2 months.
Danish: Opbevaringstid for veterinærlægemidlet, der indeholder stammen Asia1 Shamir, er i salgspakning: 2 måneder.
English: No adverse reactions except those mentioned in section “adverse reactions” were observed after the administration of a double dose to calves, lambs and piglets.
Danish: Der har ikke været observeret andre bivirkninger end de, der er nævnt under ”Bivirkninger”, efter administration af en dobbeltdosis til kalve, lam og smågrise.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE
English: Cattle, sheep: SC. Pigs: IM.
Danish: Kvæg og får: SC Svin: IM
English: Vaccination of pigs with strains O Taiwan 3/97 and A22 Iraq resulted in a reduction of clinical signs in animals exposed to infection.
Danish: Vaccination af svin med stammerne O Taiwan 3/97 og A22 Iraq resulterede i en reduktion af kliniske symptomer hos dyr der var udsat for infektion.
English: Vaccination of sheep with strain O1 Manisa resulted in a reduction of clinical signs in animals exposed to infection.
Danish: Vaccination af får med stammen O1 Manisa resulterede i en reduktion af kliniske symptomer hos dyr der var udsat for infektion.
English: one dose of 2 ml, by subcutaneous route.
Danish: en dosis på 2 ml, subkutan administration.
English: Cattle and sheep: for subcutaneous use.
Danish: Kvæg og får: subkutan administration.
English: To stimulate active immunity of cattle, sheep and pigs against purified, inactivated foot-and-mouth disease virus strain antigens related to those contained in the vaccine.
Danish: Stimulering af aktiv immunitet hos kvæg, får og svin mod rensede, inaktiverede antigener af mund- og klovsygevirusstammer svarende til dem, der er i vaccinen.
English: When animals have to be vaccinated in presence of maternal antibodies, revaccination at 8-10 weeks is recommended.
Danish: Når dyr vaccineres i nærvær af maternelle antistoffer, bør revaccination finde sted ved 8-10ugersalderen.
English: FMD antigen ≥ 6 PD50 per strain
Danish: FMD antigen ≥ 6 PD50 pr stamme.
English: Vaccination of pigs with strain Asia1 Shamir resulted in a reduction of clinical signs and virus shedding in animals exposed to infection.
Danish: Vaccination af svin med stammen Asia1 Shamir resulterede i en reduktion af kliniske symptomer og viral shedding hos dyr der var udsat for infektion.
English: Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.
Danish: Aktiv immunisering af kvæg,får og svin fra 2ugers alderen for at reducere kliniske symptomer fra mund- og klovsyge.
English: - in pigs following administration of a double dose followed by a single dose 3 weeks later and a third vaccination with a single dose 7 weeks after the second dose.
Danish: - Hos svin efter administration af en dobbeltdosis efterfulgt af en enkeltdosis 3 uger senere og en tredje vaccination med en enkelt dosis 7 uger efter den anden dosis.
English: When very young pigs (at 2 weeks old) have to be vaccinated, revaccination at 8-10 weeks is recommended.
Danish: Når meget unge svin (2 uger gamle) skal vaccineres, bør revaccination finde sted ved 8-10ugersalderen.
English: Cattle and sheep: SC.
Danish: Kvæg, får: s.c.
English: Inactivated FMD antigen, ≥ 6 cattle PD50 per strain.
Danish: Renset inaktiveret FMD antigen, ≥6 kvæg PD50 pr. stamme.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 50, 100 and 150 doses
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Flaske á 50/100 og 150 doser
English: Sheep from 2 weeks of age:
Danish: Får fra 2-ugersalderen:
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: BILAG II A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG BRUG.
English: The use of a multiple injection device is recommended.
Danish: en dosis på 2 ml, intramuskulær administration Det anbefales at anvende multidoseringssprøjte.
English: AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs
Danish: AFTOVAXPUR DOE injektionsvæske, emulsion til kvæg, får og svin
English: Homogenize the content of the vial by gentle mixing before the insertion of needle.
Danish: Indholdet af hætteglasset homogeniseres ved forsigtigt at blande det, før nålen sættes i. Dette opnås bedst ved at vende hætteglassets bund over dets top flere gange.
English: Pack sizes: - Cardboard box with 1 bottle of 10, 25, 50, 100 or 150 doses; - Cardboard box with 10 bottles of 10, 25, 50, 100 or 150 doses.
Danish: Pakningsstørrelser: - Papæske med 1 flaske á 10, 25, 50, 100 eller 150 doser.
English: - in cattle following administration of a double dose followed by a single dose 7 weeks later and a third vaccination with a single dose 13 weeks after the second dose, - in sheep following administration of a double dose followed by a single dose 5 weeks later and a third vaccination with a single dose 7 weeks after the second dose,
Danish: - Hos kvæg efter administration af en dobbeltdosis efterfulgt af en enkeltdosis 7 uger senere og en tredje vaccination med en enkelt dosis 13 uger efter den anden dosis.
English: Cardboard box with 1 bottle of 10, 25, 50, 100 or 150 doses Cardboard box with 10 bottles of 10, 25, 50, 100 or 150 doses
Danish: Pakning med 1 flaske med 10, 25, 50, 100 eller 150 doser.
English: - in cattle following administration of a double dose followed by a single dose 7 weeks later and a third vaccination with a single dose 13 weeks after the second dose, - in sheep following administration of a double dose followed by a single dose 5 weeks later and a third vaccination with a single dose 7 weeks after the second dose, - in pigs following administration of a double dose followed by a single dose 3 weeks later and a third vaccination with a single dose 7 weeks after the second dose.
Danish: - Hos får efter administration af en dobbeltdosis efterfulgt af en enkeltdosis 5 uger senere og en tredje vaccination med en enkelt dosis 7 uger efter den anden dosis.
English: METHOD AND ROUTES OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Pigs: for intramuscular use.
Danish: intramuskulær administration Læs indlægssedlen inden brug.
English: Purified, inactivated foot-and-mouth disease virus strain antigens, at least 6 PD50* per strain.
Danish: Rensede inaktiverede mund- og klovsygevirusantigener, min 6 PD50 pr stamme.
English: Paraffin, liquid
Danish: Injektionsvæske, emulsion
English: (*) equivalent to titre prior to inactivation (log 10)
Danish: (*) svarende til titer før inaktivering (log 10)
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Danish: Fortegnelse over lægemidlernes navne, lægemiddelformer, styrker, indgivelsesvej, indehavere af markedsføringstilladelser i medlemsstaterne
English: 15, boulevard Charles de Gaulle
Danish: BIOGARAN 15, boulevard Charles de Gaulle
English: S.C. VIM SPECTRUM S.R.L., Şos.
Danish: S.C. VIM SPECTRUM S.R.L.,
English: EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Danish: LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex