FrancophonIA/ELRC3.0 huggingface dataset:
English: Fampyra is not recommended during breast-feeding.
Danish: Fampyra anbefales ikke under graviditet.
English: Patients with renal impairment:
Danish: Patienter med nyreinsufficiens:
English: Baseline 69.27 (2.22) Average change -0.01 (1.46) Difference p-value LEMMT (mean, sem) (Lower Extremity Manual Muscle Test) Baseline 3.92 (0.070) Average change 0.05 (0.024) Difference p-value Ashworth Score (A test for muscle spasticity)
Danish: MSWS-12-score (gennemsnit, SEM) Baseline 69,27 (2,22) Gennemsnitlig ændring -0,01 (1,46) Forskel p-værdi LEMMT (gennemsnit M SEM, ) (Manuel muskeltest for underekstremiteter) Baseline 3,92 (0,070) Gennemsnitlig ændring 0,05 (0,024) Forskel p-værdi
English: Infections were seen in the clinical studies (see section 4.8) and increased infection rate and impairment of the immune response cannot be excluded.
Danish: 4.8) og en øget infektionshyppighed samt et nedsat immunrespons kan ikke udelukkes.
English: Biogen Netherlands B.V. Prins Mauritslaan 13
Danish: Prins Mauritslaan 13
English: • Flu (influenza)
Danish: • Influenza
English: Fampyra is primarily excreted unchanged by the kidneys, and with creatinine clearance known to decrease with age, monitoring of renal function in older patients should be considered (see section 4.2).
Danish: Fampyra udskilles overvejende uændret gennem nyrerne, og da det er kendt, at kreatininclearance øges med alderen, bør overvågning af nyrefunktionen hos ældre patienter overvejes (se pkt.
English: Baseline Endpoint Change Difference p-value Average % Change Difference p-value MSWS-12-score (mean, sem)
Danish: Baseline Endepunkt Ændring Forskel p-værdi Gennemsnitlig %-ændring Forskel p-værdi
English: Fampyra should be discontinued if patients no longer receive walking benefit.
Danish: Fampyra bør seponeres, såfremt patienten ikke længere oplever nogen fordel af behandlingen.
English: If your Fampyra is supplied in bottles, only one bottle should be opened at a time.
Danish: Får du Fampyra i en tabletbeholder, bør du kun åbne én beholder ad gangen.
English: Acute symptoms of overdose with Fampyra were consistent with central nervous system excitation and included confusion, tremulousness, diaphoresis, seizure, and amnesia.
Danish: Akutte symptomer på overdosering med Fampyra var overensstemmende med stimulering af centralnervesystemet og inkluderede forvirring, rysten, diaforese, krampeanfald og amnesi.
English: Fampyra is primarily excreted unchanged by the kidneys.
Danish: Fampyra udskilles uændret og primært gennem nyrerne.
English: Caution is required when Fampyra is prescribed concurrently with medicinal products that are substrates of OCT2 for example, carvedilol, propanolol and metformin.
Danish: Der bør udvises forsigtighed, når Fampyra ordineres samtidig med lægemidler, som er substrater for OCT2, f.eks. carvedilol, propranolol og metformin.
English: Package leaflet: information for the user Fampyra 10mg prolonged-release tablets fampridine
Danish: Indlægsseddel: Information til brugeren Fampyra 10 mg depottabletter fampridin
English: EU/1/11/699/001 28 tablets EU/1/11/699/002 56 tablets
Danish: EU/1/11/699/001 28 tabletter EU/1/11/699/002 56 tabletter
English: • Common cold (nasopharyngitis)
Danish: • Forkølelse (nasofaryngitis)
English: Each bottle contains 14 tablets and a silica gel desiccant.
Danish: Hver beholder indeholder 14 tabletter og en kapsel med silicagel.
English: In patients with renal impairment, accumulation occurs relative to the degree of impairment.
Danish: Hos patienter med nyreinsufficiens ses ophobningen i forhold til graden af nyreinsufficiens.
English: Adverse reactions identified are mostly neurological and include seizure, insomnia, anxiety, balance disorder, dizziness, paraesthesia, tremor, headache and asthenia.
Danish: De identificerede bivirkninger er overvejende neurologiske og inkluderer krampeanfald, søvnløshed, angst, balanceforstyrrelse, svimmelhed, paræsthesi, rysten, hovedpine og slaphed.
English: Ft per sec
Danish: Fod pr. sek.
English: EU/1/11/699/003 28 tablets EU/1/11/699/004 56 tablets
Danish: EU/1/11/699/003 28 tabletter EU/1/11/699/004 56 tabletter
English: • Difficulty breathing (shortness of breath)
Danish: • Åndedrætsbesvær (kortåndethed)
English: Fampyra comes in foil blisters of 14 tablets each.
Danish: Fampyra leveres i folieblisterkort med 14 tabletter i hver.
English: Fampyra must not be administered to patients with mild, moderate and severe renal impairment (see section 4.3).
Danish: Fampyra må ikke administreres til patienter med mild, moderat og alvorlig nyreinsufficiens (se pkt.
English: Swallow each tablet whole, with a drink of water.
Danish: Tabletterne skal synkes hele med lidt vand.
English: You must always leave 12 hours between each tablet.
Danish: Du skal altid lade 12 timer gå mellem hver tablet.
English: 14 prolonged-release tablets
Danish: 14 depottabletter
English: Fampyra is an off-white, film coated, oval biconvex 13 x 8 mm prolonged-release tablet with A10 on one side.
Danish: Fampyra er en cremefarvet, filmovertrukket, oval bikonveks 13 x 8 mm depottablet mærket med A10 på den ene side.
English: Fampyra should be discontinued in patients who experience a seizure while on treatment.
Danish: Behandlingen med Fampyra bør afbrydes i patienter, som får et krampeanfald under behandlingen.
English: • Heartbeat that you can feel (palpitations)
Danish: • Hjertebanken, du kan mærke dine hjerteslag (palpitationer)
English: Insomnia Anxiety
Danish: Søvnløshed Angst
English: Patients with hepatic impairment No dose adjustment is required for patients with hepatic impairment.
Danish: Patienter med leverinsufficiens Det er ikke nødvendigt at justere dosis hos patienter med leverinsufficiens.
English: Gait abnormalities and hyper-excitability were also observed.
Danish: Der blev også observeret anormal gang og øget irritabilitet.
English: Leave the desiccant in the bottle, do not swallow it.
Danish: Lad silicakapslen ligge i beholderen, den må ikke indtages.
English: Treatment with fampridine increases seizure risk (see section 4.8).
Danish: Behandling med fampridin øger risikoen for krampeanfald (se pkt.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Fampyra in all subsets of the paediatric population in treatment of multiple sclerosis with walking disability (see section 4.2 for information on paediatric use).
Danish: *Intent to treat-population = 633; LMS = Mindste kvadraters gennemsnit (Least Square Mean) Det Europæiske Lægemiddelagentur har afstået fra kravet om indsendelse af resultater fra studier med Fampyra i alle pædiatriske undergrupper i behandling af multipel sklerose med gangbesvær (se pkt 4.2 for information om brugen hos børn).
English: Studies MS-F203 and MS-F204
Danish: Studierne MS-F203 og MS-F204
English: If you are pregnant, or are planning to become pregnant, tell your doctor before you take Fampyra Fampyra is not recommended during pregnancy.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid,
English: LSM: -1.36
Danish: LMS: -1,36
English: In overdose you may notice sweating, minor shaking (tremor), confusion, memory loss (amnesia) and fits (seizure).
Danish: Ved en overdosis kan du opleve sveden, små ufrivillige, rystende, rytmiske bevægelser (tremor), forvirring, hukommelsessvigt og krampeanfald.
English: Hypersensitivity to fampridine or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for fampridin eller over for et eller flere af hjælpestofferne anført i pkt.
English: • Minor shaking (tremor)
Danish: • Små ufrivillige, rystende, rytmiske bevægelser (tremor)
English: Common Common Common Common Common Uncommon Uncommon
Danish: Almindelig Almindelig Almindelig Almindelig Almindelig Ikke almindelig Ikke almindelig
English: • This medicine has been prescribed for you only.
Danish: • Lægen har ordineret Fampyra til dig personligt.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER MÆRKNING PÅ BEHOLDEREN
English: leave 12 hours between each tablet
Danish: Der skal gå 12 timer mellem hver tablet
English: In post-marketing experience, serious hypersensitivity reactions (including anaphylactic reaction) have been reported, the majority of these cases occurred within the first week of treatment.
Danish: Efter markedsføringen er der indberettet alvorlige overfølsomhedsreaktioner (herunder anafylaktisk reaktion).
English: Fampyra is supplied in either bottles or blister packs.
Danish: Fampyra leveres enten i tabletbeholdere eller i blisterpakninger
English: Fampyra should not be administered to patients with renal impairment (creatinine clearance <80 ml/min) (see section 4.3).
Danish: Fampyra bør ikke administreres til patienter med nyreinsufficiens (kreatininclearance <80 ml/min.)
English: What Fampyra contains − The active substance is fampridine.
Danish: − Det aktive stof er fampridin.
English: Walking speed Feet/sec
Danish: P-værdi Ganghastighed fod/sek.
English: Treatment with Fampyra is restricted to prescription and supervision by physicians experienced in the management of MS.
Danish: Behandling med Fampyra er receptbelagt og skal forestås af læger med særligt kendskab til behandling af MS.
English: Each tablet contains 10 mg of fampridine.
Danish: Hver tablet indeholder 10 mg fampridin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERPAKNINGER
English: Τηλ: +30 210 8771500
Danish: Genesis Pharma SA Τηλ: +30 210 8771500
English: If your Fampyra is supplied in bottles, the bottle will also contain a desiccant.
Danish: Hvis du får din Fampyra i en beholder, er der en silicakapsel i beholderen.
English: The primary endpoint in studies MS-F203 and MS-F204 was the responder rate in walking speed as measured by the Timed 25-foot Walk (T25FW).
Danish: Det primære endepunkt i studierne MS-F203 og MS-F204 var forbedring af ganghastighed målt ved T25FW, dvs. den tid det tager at gå ca. 7,5 m. En responder blev defineret som en patient, som konsistent havde hurtigere ganghastighed ved mindst tre besøg ud af fire i den dobbeltblinde periode sammenlignet med den maksimale ganghastighed blandt fem besøg uden behandling.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen, på apoteket eller sygeplejersken hvis der er noget, du er i tvivl om.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED BEHOLDERE
English: Common Common Common Common
Danish: Almindelig Almindelig Almindelig Almindelig
English: Sun.
Danish: Teл.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BLISTER CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE MED BLISTERPAKNINGER
English: ТП ЕВОФАРМА Teл.
Danish: България ТП ЕВОФАРМА
English: Fampyra is only available by prescription and under the supervision of doctors experienced in MS.
Danish: Fampyra er receptpligtigt og behandlingen skal forestås af læger med erfaring i behandling af MS.
English: Fampyra is contraindicated in patients with mild, moderate and severe renal impairment (creatinine clearances <80 ml/min) (see section 4.3).
Danish: Fampyra er kontraindiceret til patienter med let, moderat og alvorlig nyreinsufficiens (kreatininclearance <80 ml/min.)
English: Each pack contains 28 tablets (2 blisters) or 56 tablets (4 blisters).
Danish: En pakke indeholder 28 tabletter (2 blisterkort) eller 56 tabletter (4 blisterkort).
English: The Fampyra dose was 10 mg BID.
Danish: Dosis af Fampyra var 10 mg 2 gange dagligt.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Thus, the concomitant use of fampridine with medicinal products that are inhibitors of OCT2 for example, cimetidine are contraindicated (see section 4.3) and concomitant use of fampridine with medicinal products that are substrates of OCT2 for example, carvedilol, propanolol and metformin is cautioned (see section 4.4.)
Danish: 4.3) og samtidig brug af fampridin sammen med andre lægemidler der er substrater af OCT2 eksempelvis carvedilol, propranolol og metformin (se pkt 4.4) bør ske med forsigtighed.
English: Fampyra 10 mg prolonged-release tablets
Danish: Fampyra 10 mg depottabletter
English: Respiratory, thoracic and mediastinal disorders
Danish: Luftveje, thorax og mediastinum Dyspnø Smerter i svælget
English: Each pack contains 28 tablets (2 bottles) or 56 tablets (4 bottles).
Danish: En pakke indeholder 28 tabletter (2 beholdere) eller 56 tabletter (4 beholdere).
English: 28 prolonged-release tablets (2 blisters of 14 tablets each) 56 prolonged-release tablets (4 blisters of 14 tablets each)
Danish: 28 depottabletter (2 blisterpakninger med 14 tabletter i hver) 56 depottabletter (4 blisterpakninger med 14 tabletter i hver)
English: Fampyra 10 mg prolonged-release tablets fampridine
Danish: Fampyra 10 mg depottabletter fampridin
English: Pack size of 28 (2 blisters of 14) tablets.
Danish: Pakningsstørrelse på 28 (2 blisterpakninger á 14) tabletter.
English: For further information on seizure risk, please refer to sections 4.3 and 4.4.
Danish: 4.3 og 4.4 for yderligere information om risikoen for krampeanfald.
English: − Each prolonged-release tablet contains 10 mg of fampridine
Danish: − Hver depottablet indeholder 10 mg fampridin
English: Pack size of 56 (4 blisters of 14) tablets.
Danish: Pakningsstørrelse på 56 (4 blisterpakninger á 14) tabletter.
English: Each prolonged-release tablet contains 10 mg of fampridine.
Danish: Hver depottablet indeholder 10 mg fampridin.
English: For further information on hypersensitivity reactions, please refer to sections 4.3 and 4.4.
Danish: For yderligere information om overfølsomhedsreaktioner, se pkt.
English: Uncommon Uncommon Uncommon
Danish: Ikke almindelig Ikke almindelig Ikke almindelig
English: Pack size of 28 (2 bottles of 14) tablets.
Danish: Pakningsstørrelse på 28 (2 beholdere á 14) tabletter.
English: 28 prolonged-release tablets (2 bottles of 14 tablets each) 56 prolonged-release tablets (4 bottles of 14 tablets each)
Danish: 28 depottabletter (2 beholdere med 14 tabletter i hver) 56 depottabletter (4 beholdere med 14 tabletter i hver)
English: Pack size of 56 (4 bottles of 14) tablets.
Danish: Pakningsstørrelse på 56 (4 beholdere á 14) tabletter.
English: This may increase your risk of serious side effects Tell your doctor and do not take Fampyra if any of these apply to you.
Danish: Tal med din læge og lad være med at tage Fampyra, hvis noget af dette gælder for dig.
English: Monitoring renal function to detect any renal impairment is recommended in older people (see section 4.4).
Danish: Det anbefales at overvåge nyrefunktionen hos ældre patienter med henblik på registrering af eventuel nyresvækkelse (se pkt.
English: Anaphylaxis Angioedema Hypersensitivity
Danish: Anafylaksi Angioødem Overfølsomhed
English: After first opening a bottle, use within 7 days.
Danish: Brug inden 7 dage efter en beholder er åbnet første gang.
English: Palpitations
Danish: Blisterpakninger
English: Seizure
Danish: Opbevaring
English: Tachycardia
Danish: Palpitationer Takykardi
English: Nausea Vomiting Constipation Dyspepsia
Danish: Opkastning Forstoppelse Fordøjelsesbesvær
English: Τηλ: +357 22 765740
Danish: Genesis Pharma (Cyprus) Ltd Τηλ: +357 22 765740
English: Wed. Thu.
Danish: 1 Se pkt.
English: What Fampyra is and what it is used for What you need to know before you take Fampyra How to take Fampyra
Danish: Det skal du vide, før du begynder at tage Fampyra Sådan skal du tage Fampyra Bivirkninger
English: Fampyra 10 mg BID
Danish: Fampyra 10 mg 2 gange dagligt
English: Pharmaceutic al Form
Danish: Lægemiddelform
English: Name
Danish: Særnavn Styrke
English: London, 19 February 2009 Doc.
Danish: London, den 19. februar 2009 Dok.
English: The Committee was concerned over the way the main study was designed.
Danish: Udvalget var betænkeligt over den måde, hvorpå hovedundersøgelsen var udformet.
English: In addition, the study did not look at how long the patients survived.
Danish: I undersøgelsen havde man endvidere ikke set nærmere på, hvor længe patienterne overlevede.
English: The application was at day 206 when the company withdrew.
Danish: Ansøgningen var på dag 206, da firmaet trak den tilbage.
English: International non-proprietary name (INN): vorinostat
Danish: Internationalt fællesnavn (INN): vorinostat
English: This was expected to lead to a reduction in the growth and division of the T-cells.
Danish: Dette forventedes at føre til et fald i væksten og delingen af T-cellerne.
English: All of the patients had progressive, persistent or recurrent disease and had received two other systemic treatments.
Danish: Alle patienterne havde fremskreden, persisterende eller recidiverende sygdom og havde fået to andre systemiske behandlinger.
English: Following the Committee's opinion, it usually takes around two months for the European Commission to grant a licence.
Danish: Efter at udvalget har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. to måneder om at udstede tilladelsen.
English: The main measure of effectiveness was based on the change in how much of the skin was affected by the disease and the severity of the skin lesions.
Danish: Det primære effektmål var forandringen i, hvor meget huden var berørt af sygdommen, og hudlæsionernes sværhedsgrad.
English: If you are in a clinical trial, compassionate use programme or a named patient programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse, i et program for anvendelse med særlig udleveringstilladelse eller i et program for navngivne patienter og har behov for yderligere oplysninger om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: Vorinostat MSD was to be used in patients whose cancer was progressive (getting worse), persistent (not responding to treatment) or recurrent (kept on coming back), and had not responded to at least two other systemic (whole-body) treatments.
Danish: Vorinostat MSD skulle have været anvendt til patienter, hvis kræft var progredierende (i forværring), persisterende (ikke reagerede på behandlingen) eller recidiverende (blev ved med at vende tilbage), og som ikke havde reageret på mindst to andre systemiske (hele kroppen) behandlinger.
English: Based on the review of the initial documentation, the Committee prepares a list of questions at day 120, which is sent to the company.
Danish: Efter gennemgang af den oprindelige dokumentation udarbejder udvalget på dag 120 en liste over spørgsmål, som sendes til virksomheden.
English: The effects of Vorinostat MSD were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Vorinostat MSD blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Questions and answers on the withdrawal of the marketing application for Vorinostat MSD
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Vorinostat MSD
English: Once the company has supplied responses to the questions, the Committee reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når virksomheden har besvaret spørgsmålene, gennemgår udvalget besvarelsen og kan, inden udvalget afgiver en udtalelse, stille eventuelle supplerende spørgsmål til virksomheden på dag 180.
English: CTCL is a rare type of lymphoma (cancer of the lymph tissue) where some white blood cells (T-cells) grow in the skin.
Danish: CTCL er en sjælden form for lymfon (kræft i lymfevævet), hvor der er visse hvide blodlegemer (T-celler), som vokser i huden.
English: Vorinostat MSD is a medicine that contains the active substance vorinostat.
Danish: Vorinostat MSD er et lægemiddel, som indeholder det aktive stof vorinostat.
English: The company presented the results of one main study in which 74 adults with advanced CTCL were given Vorinostat MSD.
Danish: Firmaet fremlagde resultaterne af en hovedundersøgelse, hvori 74 voksne med fremskreden CTCL blev givet Vorinostat MSD.
English: Therefore, at the time of the withdrawal, the Committee's view was that a benefit of Vorinostat MSD had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor udvalgets opfattelse, at fordelene ved Vorinostat MSD ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: Vorinostat MSD was designated as an orphan medicinal product on 21 June 2004.
Danish: Vorinostat MSD blev udpeget som lægemiddel til sjældne sygdomme den 21. juni 2004.
English: On 13 February 2009 Merck Sharp & Dohme Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vorinostat MSD, for the treatment of adults with advanced cutaneous T-cell lymphoma.
Danish: Den 13. februar 2009 meddelte Merck Sharp & Dohme Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Vorinostat MSD til behandling af voksne med fremskreden kutant T-celle lymfon.
English: In particular, the CHMP was concerned about the risk of thromboembolic events (problems caused by the formation of clots in the blood vessels) in patients taking Vorinostat MSD.
Danish: CHMP var især betænkelig over risikoen for tromboemboliske komplikationer (problemer forårsaget af dannelsen af blodpropper i blodkarrene) hos patienter, som tog Vorinostat MSD.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the Committee had some concerns and was of the provisional opinion that Vorinostat MSD could not have been approved for the treatment of advanced CTCL.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde udvalget visse betænkeligheder og var af den foreløbige opfattelse, at Vorinostat MSD ikke kunne have været godkendt til behandling af fremskreden CTCL.
English: Vorinostat MSD was not compared with any other treatment.
Danish: Vorinostat MSD blev ikke sammenlignet med nogen anden behandling.
English: What is Vorinostat MSD?
Danish: Hvad er Vorinostat MSD?
English: The active substance in Vorinostat MSD, vorinostat, blocks the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells.
Danish: Det aktive stof i Vorinostat MSD, vorinostat, blokerer aktiviteten af proteiner kaldet histone deacetylases, som medvirker til at ”tænde” og ”slukke” for gener i celler.
English: Vorinostat MSD was expected to be used to treat adults with advanced cutaneous T-cell lymphoma (CTCL).
Danish: Vorinostat MSD forventedes anvendt til at behandle voksne med fremskreden kutant T-celle lymfon (CTCL).
English: In CTCL, Vorinostat MSD was expected to stop the genes that suppress the division and growth of the tumour cells from being turned off at the appropriate times.
Danish: Ved CTCL forventedes Vorinostat MSD at stoppe de gener, som forhindrer, at delingen og væksten af tumorceller bliver slukket på de rette tidspunkter.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Vorinostat MSD?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser eller i programmer for anvendelse af Vorinostat MSD med særlig udleveringstilladelse?