FrancophonIA/ELRC3.0 huggingface dataset:
English: As a topical agent, systemic PK/PD relationships cannot be established, however in vitro data show fidaxomicin to have time-dependent bactericidal activity and suggest time over MIC may be the parameter most predicative of clinical efficacy.
Danish: Som lokalt virkende lægemiddel kan det systemiske PK/PD forhold ikke fastlægges, dog har in vitro data vist, at fidaxomicin har tidsafhængig baktericidal aktivitet og tyder på, at tid over MIC (mindste hæmmende koncentration) er den parameter, som er mest prædiktiv for klinisk effekt.
English: Microcrystalline cellulose Pregelatinised starch (maize) Hydroxypropyl cellulose Butylated hydroxytoluene Sodium starch glycolate Magnesium stearate
Danish: Mikrokrystallinsk cellulose Prægelatineret stivelse (majs) Hydroxypropylcellulose Butyleret hydroxytoluen Natriumstivelseglycolat Magnesiumstearat
English: You should not take DIFICLIR if you are pregnant, unless your doctor tells you otherwise.
Danish: De bør ikke tage DIFICLIR, hvis De er gravid, medmindre De har aftalt andet med Deres læge.
English: Fidaxomicin is a narrow spectrum antimicrobial drug with bactericidal activity against C. difficile.
Danish: Fidaxomicin har et smalt antimikrobielt spektrum med baktericidal aktivitet mod C. difficile.
English: Fidaxomicin should be used with caution in patients with a known macrolides allergy.
Danish: Fidaxomicin bør anvendes med forsigtighed hos patienter med kendt allergi overfor makrolider.
English: Hepatobiliary disorders alanine aminotransferase increased
Danish: Lever og galdeveje forhøjet alanin aminotransferase
English: Co-administration of single doses of the P-gp inhibitor cyclosporine A and fidaxomicin in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in a 9.5 and 4-fold increase in Cmax and AUC, respectively, of the main active metabolite OP-1118.
Danish: Samtidig administration af enkeltdoser af P-gp-hæmmeren ciclosporin og fidaxomicin hos raske frivillige forsøgspersoner medførte en 4 og 2 gange stigning i henholdsvis Cmax og AUC for fidaxomicin og en 9,5 og 4 gange stigning i henholdsvis Cmax og AUC for den vigtigste aktive metabolit, OP-1118.
English: A severe allergic reaction may occur, including trouble breathing (dyspnea), swelling of the face or throat (angioedema), severe rash or severe itching (pruritus) (see section 2).
Danish: En alvorlig allergisk reaktion kan forekomme, herunder problemer med at trække vejret (dyspnø), hævelse af ansigt eller svælg (angioødem), alvorligt udslæt eller svær kløe (pruritus) (se punkt 2).
English: Fidaxomicin is an antibiotic belonging to the macrocyclic class of antibacterials.
Danish: Fidaxomicin er et antibiotikum, som tilhører den makrocykliske gruppe af antibakterielle midler.
English: Effect on the intestinal flora
Danish: Effekt på tarmfloraen
English: The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days.
Danish: Den anbefalede dosis er 200 mg (én tablet) to gange dagligt (én gang hver 12. time) i 10 dage.
English: Core tablets:
Danish: Tabletter:
English: Co-administration of 200 mg fidaxomicin twice daily with a single dose of 10 mg rosuvastatin to healthy subjects did not have a clinically significant effect on the AUCinf of rosuvastatin.
Danish: Samtidig administration af 200 mg fidaxomicin 2 gange dagligt og en enkelt dosis på 10 mg rosuvastatin til raske forsøgspersoner havde ingen effekt på rosuvastatins AUCinf.
English: Capsule shaped tablets of 14 mm, white to off-white in colour, debossed with “FDX” on one side and “200” on the other side.
Danish: Kapselformede tabletter på 14 mm, hvid til råhvid, mærket med ”FDX” på den ene side og ”200” på den anden side.
English: In vitro studies showed that fidaxomicin and the metabolite OP-1118 are inhibitors of the transporters BCRP, MRP2 and OATP2B1, but were not found to be substrates.
Danish: In vitro studier viste, at fidaxomicin og metabolitten OP-1118 er hæmmere af transportørerne BCRP, MRP2 og OATP2B1, men blev ikke fundet at være substrater.
English: Fidaxomicin and the metabolite OP-1118 are substrates of P-gp.
Danish: Fidaxomicin og metabolitten OP-1118 er substrater for P-gp.
English: Driving and using machines DIFICLIR is not expected to affect your ability to drive, use tools or machines.
Danish: DIFICLIR forventes ikke at påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: Polyethylene glycol Lecithin (soy)
Danish: Polyethylenglycol Lecithin (soja)
English: You should not use DIFICLIR in combination with one of these medicines, unless your doctor tells you otherwise.
Danish: De bør ikke anvende DIFICLIR i kombination med medicin af denne type, medmindre De har aftalt andet med Deres læge.
English: The safety and efficacy of fidaxomicin in children aged below 18 years has not yet been established.
Danish: Der foreligger endnu ingen information vedrørende sikkerhed og effekt hos børn under 18 år.
English: Fidaxomicin is bactericidal and inhibits RNA synthesis by bacterial RNA polymerase.
Danish: Fidaxomicin er baktericidal og hæmmer RNA syntesen ved bakteriel RNA polymerase.
English: Data from an open label, single arm study in CDI patients with concomitant inflammatory bowel disease (IBD) indicated no major difference in plasma concentrations of fidaxomicin or its main metabolite OP-1118 in patients with IBD as compared with patients without IBD in other studies.
Danish: Data fra et open-label, enkeltarmet studie hos CDI patienter med samtidig inflammatorisk tarmsygdom (IBD) indikerede ingen væsentlig forskel i plasmakoncentrationer af fidaxomicin eller dets hovedmetabolit OP-1118 hos patienter med IBD sammenlignet med patienter uden IBD i andre studier.
English: Immune system disorders rash, pruritus hypersensitivity reactions (angioedema, dyspnea)
Danish: Immunsystemet udslæt, pruritus overfølsomhedsreaktioner (angioødem, dyspnø)
English: Method of administration DIFICLIR is intended for oral use.
Danish: DIFICLIR er til oral anvendelse.
English: Fidaxomicin has been shown to inhibit C. difficile sporulation in vitro.
Danish: Det er påvist, at fidaxomicin hæmmer C. difficile sporedannelse in vitro.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Bivirkningerne er inden for hver frekvensgruppering opstillet efter faldende sværhedsgrad.
English: − The other ingredients are: Tablet core: microcrystalline cellulose, pregelatinised starch, hydroxypropyl cellulose, butylated hydroxytoluene, sodium starch glycolate and magnesium stearate Coating: polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol and lecithin (soy)
Danish: Tablet: Mikrokrystallinsk cellulose, prægelatineret stivelse, hydroxypropylcellulose, butyleret hydroxytoluen, natriumstivelseglycolat og magnesiumstearat Filmovertræk: Polyvinylalkohol, titandioxid (E171), talcum, polyethylenglycol og lecithin (soja)
English: Table 1: Summary of adverse reactions by MedDRA system organ class
Danish: Opsummering af bivirkninger efter MedDRA-systemorganklasse
English: What you need to know before you take DIFICLIR
Danish: Det skal De vide, før De begynder at tage DIFICLIR Tag ikke DIFICLIR
English: Other medicines and DIFICLIR Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis De bruger anden medicin eller har brugt det for nylig.
English: If you feel that you might have a severe allergic reaction such as trouble breathing (dyspnea), swelling of the face or throat (angioedema), severe rash or severe itching (pruritus), stop taking DIFICLIR and seek medical advice urgently from your doctor, pharmacist or at your local hospital emergency department (see section 4).
Danish: Hvis De føler, at De måske får en alvorlig allergisk reaktion, såsom åndedrætsbesvær, hævelse af ansigt eller svælg (angioødem), alvorligt udslæt eller svær kløe, skal De stoppe med at tage DIFICLIR og straks kontakte Deres læge eller Deres lokale skadestue (se punkt 4).
English: Due to limited clinical data, fidaxomicin should be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI.
Danish: På grund af begrænset antal kliniske data bør fidaxomicin anvendes med forsigtighed hos patienter med pseudomembranøs colitis, fulminant eller livstruende CDI.
English: The maximum fidaxomicin and OP-1118 plasma levels in CDI patients with concomitant IBD were within the range of levels found in CDI patients without IBD.
Danish: Maksimale plasmakoncentrationer af fidaxomicin og OP-1118 hos CDI patienter med samtidig IBD var inden for området af plasmakoncentrationer fundet hos CDI patienter uden IBD.
English: Effect of fidaxomicin on P-gp substrates
Danish: Fidaxomicins effekt på P-gp-substrater
English: In CDI patients, average peak plasma levels of fidaxomicin and its main metabolite OP-1118 tend to be 2- to 6-fold higher than in healthy adults.
Danish: Hos CDI patienter tenderer den gennemsnitlige peak plasmakoncentration af fidaxomicin og den primære metabolit OP-1118 til at være 2 til 6 gange højere end hos raske voksne.
English: Acute hypersensitivity reactions, such as angioedema and dyspnea, have been reported during post-marketing (see section 4.3 and 4.4).
Danish: Akutte overfølsomhedsreaktioner, såsom angioødem og dyspnø, er blevet rapporteret efter markedsføring (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/733/003-004
Danish: EU/1/11/733/003-004
English: Fidaxomicin may be a mild to moderate inhibitor of intestinal P-gp.
Danish: Fidaxomicin kan være en svag til moderat hæmmer af intestinal P-gp.
English: Danmark Astellas Pharma a/s Tlf: +45 43430355
Danish: Astellas Pharma a/s Tlf: +45 43430355
English: Fidaxomicin does not have a clinically significant effect on the exposure of rosuvastatin, a substrate for the transporters OATP2B1 and BCRP.
Danish: Fidaxomicin har ikke en klinisk relevant effekt på eksponeringen for rosuvastatin, et substrat for transportørerne OATP2B1 og BCRP.
English: If you are allergic to macrolides (a class of antibiotics), ask your doctor for advice before using this medicine.
Danish: Hvis De er overfølsom overfor makrolider (en type af antibiotika), skal De spørge Deres læge til råds, inden De tager denne medicin.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with fidaxomicin in one or more subsets of the paediatric population in enterocolitis caused by C. difficile (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med fidaxomicin i alle undergrupper af den pædiatriske population med enterrocolitis forårsaget af C. difficile (se pkt.
English: Gram negative organisms are intrinsically not susceptible to fidaxomicin.
Danish: Gram-negative organismer er ikke modtagelige over for fidaxomicin.
English: − This medicine has been prescribed for you only.
Danish: - Lægen har ordineret dette lægemiddel til Dem personligt.
English: Effect of P-gp inhibitors on fidaxomicin
Danish: P-gp-hæmmeres effekt på fidaxomicin
English: Hypersensitivity reactions including severe angioedema have been reported (see section 4.8).
Danish: Overfølsomhedsreaktioner, herunder svær angioødem, er blevet rapporteret (se pkt.
English: Do not stop taking DIFICLIR, unless your doctor has advised you to do so. Keep taking this medicine until the course is finished, even if you feel better.
Danish: Bliv ved med at tage medicinen, indtil kuren er færdig, også selvom De har det bedre.
English: This is because it is not known whether fidaxomicin can harm your baby.
Danish: Man ved ikke, om DIFICLIR kan skade Deres barn.
English: What DIFICLIR looks like and contents of the pack DIFICLIR 200 mg film-coated tablets are capsule shaped tablets, white to off-white in colour, with “FDX” on one side and “200” on the other side.
Danish: DIFICLIR 200 mg filmovertrukne tabletter er kapselformede tabletter, hvide til råhvide med ”FDX” på den ene side og ”200” på den anden side.
English: 100 x 1 film-coated tablet in alu/alu perforated unit dose blisters.
Danish: 100 x 1 filmovertrukken tablet i alu/alu perforerede enkeltdosisblistre.
English: The most common side effects (may affect up to 1 in 10 people) are vomiting, nausea and constipation.
Danish: De mest almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter), er opkastning,
English: As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see section 4.4 and 5.2).
Danish: Da den kliniske relevans af denne stigning i eksponering er uklar, frarådes samtidig administration af potente P-gp-hæmmere, såsom ciclosporin, ketoconazol, erythromycin, clarithromycin, verapamil, dronedaron og amiodaron (se pkt.
English: DIFICLIR is used in adults to treat infections of the lining of the colon (large intestine) with certain bacteria called Clostridium difficile.
Danish: DIFICLIR anvendes til behandling af voksne med infektioner i tarmvæggen (tyktarmen) forårsaget af bakterien Clostridium difficile.
English: Limited data from patients with an active history of chronic hepatic cirrhosis in the Phase 3 studies showed that median plasma levels of fidaxomicin and OP-1118 may be approximately 2- and 3-fold higher, respectively, than in non-cirrhotic patients.
Danish: Begrænsede data fra patienter med en aktiv historie med kronisk levercirrose i Fase 3 studier viste, at median-plasmakoncentrationen af fidaxomicin og OP-1118 hos disse patienter i gennemsnit var henholdsvis 2 og 3 gange højere end hos patienter uden levercirrose.
English: Under conditions of clinical use, fidaxomicin has no clinically relevant effect on the exposure of rosuvastatin, a substrate for OATP2B1 and BCRP (see section 4.5).
Danish: Under forhold sammenlignelige med klinisk anvendelse har fidaxomicin ingen klinisk relevant effekt på eksponeringen for rosuvastatin, et substrat for OATP2B1 og BCRP (se pkt.
English: There are limited data available on the use of fidaxomicin in severe cases of the disease (e.g. pseudomembranous colitis).
Danish: Den aktuelle viden om brug af fidaxomicin i svære sygdomstilfælde (f.eks. pseudomembranøs kolitis) er begrænset.
English: 20 x 1 film-coated tablet in alu/alu perforated unit dose blisters.
Danish: 20 x 1 filmovertrukken tablet i alu/alu perforerede enkeltdosisblistre.
English: If such reaction occurs, stop taking DIFICLIR and seek medical advice urgently from your doctor, pharmacist or at your local hospital emergency department.
Danish: Stop med at tage DIFICLIR, hvis en sådan reaktion opstår og kontakt straks Deres læge, apotekspersonalet eller Deres lokale skadestue.
English: Gastrointestinal disorders vomiting, nausea, constipation abdominal distention, flatulence, dry mouth
Danish: Mave-tarm-kanalen opkastning, kvalme, konstipation abdominal oppustethed, flatulens, mundtørhed
English: Co-administration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see sections 4.5 and 5.2).
Danish: Samtidig administration af potentielle P-glycoprotein-hæmmere såsom ciclosporin, ketoconazol, erythromycin, clarithromycin, verapamil, dronedaron og amiodaron anbefales ikke (se pkt.
English: Busuttil Ltd. Tel: +356 21 447184
Danish: E.J. Busuttil Ltd. Tel: +356 21 447184
English: − certain blood tests might show changed levels, e.g. increased liver enzymes (alanine aminotransferase)
Danish: − Bestemte blodprøver kan vise ændret koncentration, f.eks. forhøjede leverenzymer
English: Magyarország Astellas Pharma Kft. Tel.: +36 1577 8200
Danish: Astellas Pharma Kft. Tel.: +36 1577 8200
English: Patients with fulminant colitis and patients with multiple episodes (defined as more than one prior episode within the previous 3 months) of CDI were excluded in the studies.
Danish: (defineret som mere end én tidligere episode inden for de sidste 3 måneder) blev ekskluderet fra forsøgene.
English: − dizziness, headache
Danish: − Udslæt, kløe
English: Each film-coated tablet contains 200 mg of fidaxomicin.
Danish: Hver filmovertrukken tablet indeholder 200 mg fidaxomicin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MÆRKNING, DER SKAL ANFØRES PÅ BLISTEREMBALLAGE BLISTER
English: 4.7 Effects on ability to drive and use machines DIFICLIR has no or negligible influence on the ability to drive and use machines.
Danish: DIFICLIR påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: If you have kidney or liver problems, ask your doctor for advice before using this medicine.
Danish: Hvis De har nyreproblemer eller leverproblemer, skal De spørge Deres læge til råds, inden De bruger denne medicin.
English: Deutschland Astellas Pharma GmbH Tel: +49 (0)89 454401
Danish: Astellas Pharma GmbH Tel: +49 (0)89 454401
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 December 2011
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Fidaxomicin is a substrate of P-gp.
Danish: Fidaxomicin er substrat for P-gp.
English: The most common adverse reactions are vomiting, nausea and constipation.
Danish: Resumé af sikkerhedsprofilen De hyppigst forekommende bivirkninger er opkastning, kvalme og konstipation.
English: Suomi/Finland Astellas Pharma Puh/Tel: +358 (0)9 85606000
Danish: Astellas Pharma Puh/Tel: +358 (0)9 85606000
English: DIFICLIR 200 mg film-coated tablets
Danish: DIFICLIR 200 mg filmovertrukne tabletter
English: If you are pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De bruger dette lægemiddel.
English: 20 x 1 film-coated tablet.
Danish: 100 x 1 filmovertrukne tabletter 20 x 1 filmovertrukne tabletter
English: DIFICLIR 200 mg film-coated tablets Fidaxomicin
Danish: DIFICLIR 200 mg filmovertrukne tabletter fidaxomicin
English: − If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller apotekspersonalet.
English: Warnings and precautions Talk to your doctor or pharmacist before taking DIFICLIR.
Danish: Kontakt lægen eller apotekspersonalet, før De tager DIFICLIR.
English: Tel: +354 535 7000
Danish: Vistor hf. Tel: +354 535 7000
English: If you are breastfeeding ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De ammer, skal De spørge Deres læge eller apotekspersonalet til råds, før De bruger dette lægemiddel.
English: − bloated feeling, wind (flatulence)
Danish: − Oppustethed, flatulens
English: − dry mouth, altered taste (dysgeusia)
Danish: − Mundtørhed, ændret smagssans
English: If you use one of these medicines, please ask your doctor for advice before taking this medicine.
Danish: Hvis De tager medicin af denne type, bedes De tale med Deres læge, inden De bruger denne medicin.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid dette lægemiddel nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment (see section 5.2).
Danish: På grund af begrænset antal kliniske data bør fidaxomicin anvendes med forsigtighed hos patienter med svært nedsat nyrefunktion eller moderat til svært nedsat leverfunktion (se pkt.
English: Nervous system disorders dizziness, headache, dysgeusia
Danish: Nervesystemet svimmelhed, hovedpine, smagsforstyrrelser
English: The rate of recurrence (including relapses) was significantly lower with fidaxomicin (14.1% versus 26.0% with a 95% CI of [-16.8%, -6.8%]), however these trials were not prospectively designed to prove prevention of reinfection with a new strain.
Danish: % vs. 26,0 % med et 95 % CI på [-16,8 %, -6,8 %]).
English: − erythromycin (a medicine used to treat ear, nose, throat, chest and skin infections)
Danish: brystkasse og hud) - clarithromycin (et lægemiddel, der anvendes til at behandle infektioner i brystkasse, hals,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 200 mg of fidaxomicin.
Danish: - Det aktive stof er fidaxomicin, og hver filmovertrukken tablet indeholder 200 mg fidaxomicin.
English: Description of the patient population in clinical trials
Danish: Patienter med fulminant kolit og patienter med multiple CDI-episoder
English: − verapamil (a medicine used to treat high blood pressure or to prevent chest pain attacks, or used following a heart attack to prevent another one)
Danish: bihuler, hud og væv samt infektioner med Helicobacter pylori i forbindelse med sår på tolvfingertarmen eller mavesår) - verapamil (et lægemiddel, der anvendes til behandling af for højt blodtryk eller til at forebygge anfald af brystsmerter eller anvendes efter et hjerteanfald for at forebygge et nyt) - dronedaron og amiodaron (lægemidler, der anvendes til at styre hjerterytmen) - dabigatranetexilat (et lægemiddel, der anvendes til at forebygge blodpropper efter operationer til udskiftning af hofte eller knæ).
English: België/Belgique/Belgien Astellas Pharma B.V.
Danish: België/Belgique/Belgien
English: − clarithromycin (a medicine used to treat chest infections, throat and sinus infections, skin and tissue infections and Helicobacter pylori infections associated with duodenal or stomach ulcer)
Danish: anvendes efter en organ- eller knoglemarvstransplantation, mod psoriasis eller eksem, eller mod leddegigt eller nefrotisk syndrom) - ketoconazol (et lægemiddel, der anvendes til behandling af svampeinfektioner) - erythromycin (et lægemiddel, der anvendes til behandling af infektioner i øre, næse, hals,
English: NAME OF THE MEDICINAL PRODUCT DIFICLIR 200 mg film-coated tablets fidaxomicin
Danish: Indlægsseddel: Information til brugeren DIFICLIR 200 mg filmovertrukne tabletter fidaxomicin
English: DIFICLIR is available in:
Danish: DIFICLIR fås i:
English: Hepatic impairment
Danish: − Svimmelhed, hovedpine
English: Due to the limited clinical data in this population, DIFICLIR should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Danish: På grund af begrænset antal kliniske data bør DIFICLIR anvendes med forsigtighed til patienter med moderat til svært nedsat leverfunktion (se pkt.
English: Tabulated summary of adverse reactions
Danish: Opsummering af bivirkninger i tabelform
English: Due to the limited clinical data in this population, DIFICLIR should be used with caution in patients with severe renal impairment (see sections 4.4 and
Danish: På grund af begrænset antal kliniske data bør DIFICLIR anvendes med forsigtighed til patienter med svært nedsat nyrefunktion (se pkt.
English: Tel: +44 (0) 203 379 8700
Danish: Astellas Pharma Ltd. Tel: +44 (0) 203 379 8700
English: Astellas Pharma B.V. Tel: +31 (0)71 5455745
Danish: Tel: +31 (0)71 5455745
English: Astellas Pharma S.p.A. Tel: +39 02 921381
Danish: Tel: +39 02 921381
English: − ketoconazole (a medicine used to treat fungal infections)
Danish: Disse lægemidler er blandt andre: - ciclosporin (et lægemiddel, der anvendes til at dæmpe kroppens immunforsvar, og som f.eks.
English: Luxembourg/Luxemburg Astellas Pharma B.V.
Danish: Astellas Pharma B.V.
English: Examples of such medicines are:
Danish: - Øvrige indholdsstoffer:
English: 18 October 2012
Danish: Den 18. oktober 2012
English: The company that applied for authorisation is H. Lundbeck A/S, Denmark.
Danish: Den virksomhed, der har indgivet ansøgningen, er H. Lundbeck A/S, Danmark.
English: It was expected to be available as tablets (20 mg/10 mg).
Danish: Det forventedes leveret som tabletter (20 mg/10 mg).
English: The company did not carry out any new studies in patients with Alzheimer's disease.
Danish: Virksomheden udførte ikke nye undersøgelser hos patienter med Alzheimers sygdom.