FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipientwith known effect: each film-coated tablet contains 73.80 mg lactose (as monohydrate).
Danish: Hjælpestof med kendt effekt: hver filmovertrukken tablet indeholder 73,80 mg lactose (som monohydrat)
English: NAME OF THE MEDICINAL PRODUCT Memantine Accord 5 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Memantin Accord 10 mg filmovertrukne tabletter.
English: Memantine Accordbelongs to a group of medicines known as anti-dementia medicines.
Danish: Memantin Accordtilhører gruppen af medicin kaldet antidemensmedicin (medicin til behandling af demens).
English: How does Memantine Accord work
Danish: Hvordan virker Memantin Accord?
English: EU/1/13/880/020 14 x 1 film-coated tablets EU/1/13/880/021 28 x 1 film-coated tablets EU/1/13/880/022 56 x 1 film-coated tablets EU/1/13/880/023 98 x 1 film-coated tablets
Danish: EU/1/13/880/020 14 x 1 filmovertrukne tabletter EU/1/13/880/021 28 x 1 filmovertrukne tabletter EU/1/13/880/022 56 x 1 filmovertrukne tabletter EU/1/13/880/023 98 x 1 filmovertrukne tabletter
English: EU/1/13/880/016 14 x 1 film-coated tablets EU/1/13/880/017 28 x 1 film-coated tablets EU/1/13/880/018 56 x 1film-coated tablets EU/1/13/880/019 98 x 1film-coated tablets
Danish: EU/1/13/880/016 14 x 1 filmovertrukne tabletter EU/1/13/880/017 28 x 1 filmovertrukne tabletter EU/1/13/880/018 56 x 1 filmovertrukne tabletter EU/1/13/880/019 98 x 1 filmovertrukne tabletter
English: Memantine Accord 20 mg tablets are also available in perforated unit dose calendar blister in packsizes of 14x1, 28x1, 56x1 or 98x1 tablet.
Danish: Memantin Accord 20 mg tabletter fås også i perforeret enhedsdosiskalenderblisterpakning i pakningsstørrelser med 14 x 1, 28 x 1, 56 x 1 eller 98 x 1 tabletter.
English: Do not take Memantine Accord:
Danish: Memantin Accordindeholder:
English: Excipientwith known effect: each film-coated tablet contains 295.18 mg lactose (as monohydrate).
Danish: Hjælpestof med kendt effekt: hver filmovertrukken tablet indeholder 295,18 mg lactose (som monohydrat).
English: Uncommon Confusion Uncommon Hallucinations1
Danish: Hallucinationer1
English: The patient should take one 20 mg film-coated tablet per day for 7 days.
Danish: Patienten bør indtage en filmovertrukken 20 mg-tablet dagligt i 7 dage.
English: Biotransformation:
Danish: Dosistilpasning:
English: Memantine Accord 20 mg film-coated tablets
Danish: Memantin Accord 20 mg filmovertrukne tabletter.
English: Memantine Accord film-coated tablets are also available in perforated unit dose calendar blister in pack-sizes of 14x1, 28x1, 56x1 or 98x1 tablet.
Danish: Memantin Accord filmovertrukne tabletter fås også i perforeret enhedsdosiskalenderblisterpakning i pakningsstørrelser med 14 x 1, 28 x 1, 56 x 1 eller 98 x 1 tabletter.
English: Excipientwith known effect: each film coated tablet contains 183.13 mg lactose (as monohydrate).
Danish: Hjælpestof med kendt effekt: hver filmovertrukken tablet indeholder 183,13 mg lactose (som monohydrat)
English: Memantine Accord 15 mg film-coated tablets are presented as orange to grey-orange, oblong, coated tablet, debossed with “MT” on one side and “15” on the other side.
Danish: Memantin Accord 15 mg filmovertrukne tabletter er orange til gråligt orange, aflange, overtrukne tabletter præget med ”MT” delt af kærven på den ene side og ”15” delt af kærven på den anden side.
English: Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine - The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, all in the tablet core; hypromellose, polysorbate 80, macrogol 400, titanium dioxide (E 171), all in the tablet coating
Danish: Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, kolloid vandfri silica, crospovidone, magnesiumstearat, som alle findes i tablettens kerne; hypromellose, polysorbat 80, macrogol 400, titandioxid (E 171), som alle findes i tablettens overtræk.
English: Memantine Accord 5 mg film-coated tablets are presented as white, oblong, coated tablet, debossed with “MT” on one side and “5” on the other side.
Danish: Memantin Accord 5 mg filmovertrukne tabletter er hvide, aflange overtrukne tabletter præget med ”MT” på den ene side og ”5” på den anden side.
English: The 5 mg film-coated tablets are white, oblong, coated tablets, debossed with "MT" on one side and "5" on the other side.
Danish: De hvide filmovertrukne tabletter på 5 mg er aflange tabletter præget med ”MT” på den ene side og ”5” på den anden side.
English: A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores <20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Danish: En metaanalyse af patienter med moderat til svær Alzheimers sygdom (med en samlet MMSE-score < 20) fra de seks fase III, placebokontrollerede undersøgelser af 6 måneders varighed (inkl.
English: Memantine Accord 20 mg film-coated tablets are presented as pale red to greyred, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and “20” divided by the score on the other side.
Danish: Memantin Accord 20 mg filmovertrukne tabletter er svagt røde til gråligt røde, aflange, overtrukne tabletter med delekærv, præget med ”MT” delt af kærven på den ene side og ”20” delt af kærven på den anden side.
English: White, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and "10" divided by the score on the other side.
Danish: Hvid, aflang, filmovertrukket tablet med delekærv og præget ” MT” delt af kærven på den ene side og ”10” delt af kærven på den anden side.
English: The 10 mg film-coated tablets are white, oblong, coated and scored tablets, debossed with "MT" divided by the score on one side and "10" divided by the score on the other side.
Danish: De hvide filmovertrukne tabletter på 10 mg er aflange tabletter med delekærv og præget med ”MT” delt af kærven på den ene side og ”10” delt af kærven på den anden side.
English: The 15 mg film-coated tablets are orange to grey-orange, oblong, coated tablets debossedwith "MT" on one side and "15" on the other side.
Danish: De orange til gråligorange filmovertrukne tabletter på 15 mg er aflange tabletter præget med ”MT” på den ene side og ”15” på den anden side.
English: Memantine Accord 10 mg film-coated tablets are presented as white, oblong, coated and scored tablet, debossed with “MT” divided by the score on one side and “10” divided by the score on the other side.
Danish: Memantin Accord 10 mg filmovertrukne tabletter er hvide, aflange, overtrukne tabletter med delekærv, præget med ”MT” delt af kærven på den ene side og ”1 0” delt af kærven på den anden side.
English: Memantine Accord film-coated tablets are presented as white, oblong, coated and scored tablet,debossed with "MT" divided by the score on one side and “10” divided by the score on the other side.
Danish: Memantin Accord filmovertrukne tabletter er hvide, aflange, overtrukne med delkærv, præget med ”MT” delt af kærven på den ene side og ”10” delt af kærven på den anden side.
English: The patient should take one 15 mg film-coated tablet per day for 7 days.
Danish: Patienten bør indtage en 5 mg filmovertrukket tablet dagligt (hvid) i 7 dage.
English: Elevated liver function test Not known Hepatitis
Danish: Forhøjet leverfunktionstest Hepatitis
English: Memantine Accord film-coated tablets are presented as pale red to greyred, oblong, coated and scored tablet, debossed with "MT" divided by the score on one side and “20” divided by the score on the other side.
Danish: Memantin Accord filmovertrukne tabletter er svagt røde til gråligrøde, aflange, overtrukne tabletter med delekærv, præget med ”MT” delt af kærven på den ene side og ”20” delt af kærven på den anden side.
English: Memantine Accord 5 mg film-coated tablets Memantine Accord 10 mg film-coated tablets Memantine Accord 15 mg film-coated tablets Memantine Accord 20 mg film-coated tablets memantine hydrochloride
Danish: Memantin Accord 5 mg filmovertrukne tabletter Memantin Accord 10 mg filmovertrukne tabletter Memantin Accord 15 mg filmovertrukne tabletter Memantin Accord 20 mg filmovertrukne tabletter memantinhydrochlorid
English: 15 mg tablet week 4 and beyond 20 mg tablets once a day Maintenance dose
Danish: En tablet à 20 mg én gang dagligt
English: Somnolence
Danish: Hypertension
English: If you take more Memantine Accord than you should
Danish: Hvis du har taget for meget Memantin Accord
English: Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
Danish: 3. uge (dag 15-21): Patienten bør indtage en filmovertrukken 15 mg-tablet dagligt i 7 dage.
English: PVC/PE/PVDC-aluminium blister.
Danish: 6.5 Emballagetype og pakningsstørrelser PVC/PE/PVDC-aluminiumsblister).
English: Memantine Accord 5 mg film-coated tablets Memantine Accord 10 mg film-coated tablets Memantine Accord 15 mg film-coated tablets Memantine Accord 20 mg film-coated tablets
Danish: Memantin Accord 5 mg filmovertrukne tabletter Memantin Accord 10 mg filmovertrukne tabletter Memantin Accord 15 mg filmovertrukne tabletter Memantin Accord 20 mg filmovertrukne tabletter
English: Pale red to grey-red, oblong, scored, coated tablet, debossed with “MT” divided by the score on one side and "20" divided by the score on the other side.
Danish: Svagt røde til gråligrøde, aflange filmovertrukne tabletter, præget med ”MT” delt af kærven på den ene side og ”20” delt af kærven på den anden side.
English: Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet per day (white, scored) for 7 days.
Danish: 2. uge (dag 8-14): Patienten bør indtage en filmovertrukken 10 mg-tablet dagligt i 7 dage.
English: The 20 mg film-coated tablets are pale red to grey-red, oblong, scored, coated tablets, debossed with "MT" divided by the score on one side and "20" divided by the score on the other side.
Danish: De svagt røde til gråligrøde filmovertrukne tabletter på 20 mg er aflange tabletter præget med ”MT” delt af kærven på den ene side og ”20” delt af kærven på den anden side.
English: Uncommon Confusion Uncommon Hallucinations1 Not known Psychotic reactions2
Danish: Almindelig Ikke almindelig Ikke almindelig Ikke kendt
English: The expiry date refers to the last day of that month.
Danish: Brug ikke Memantin Accordefter den udløbsdato, der står på pakningen og blisteret efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: one and a half 10 mg tablet week 4 and beyond two 10 mg tablets once a day
Danish: To tabletter à 10 mg én gang dagligt
English: The patient should take one 10 mg film-coated tablet per day for 7 days.
Danish: Patienten bør indtage én filmovertrukken 10 mg-tablet dagligt (hvid med delekærv) i 7 dage.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Memantin Accordnøjagtigt efter lægens anvisning.
English: 14 x 1 film-coated tablets 28 x 1 film-coated tablets 56 x 1 film-coated tablets 98 x 1 film-coated tablets
Danish: 28 x 1 filmovertrukne tabletter
English: Marketing Authorisation Holder
Danish: Indehaveren af markedsføringstilladelsen
English: 7 film-coated tablets, Memantine Accord 5 mg 7 film-coated tablets, Memantine Accord 10 mg 7 film-coated tablets, Memantine Accord 15 mg 7 film-coated tablets, Memantine Accord 20 mg
Danish: Memantin Accord 5 mg, filmovertrukne tabletter Memantin Accord 10 mg, filmovertrukne tabletter Memantin Accord 15 mg, filmovertrukne tabletter Memantin Accord 20 mg, filmovertrukne tabletter memantinhydrochlorid
English: Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 20 mg memantinhydrochlorid svarende til 16,62 mg memantin.
English: Furthermore, memantine has minor to moderate influenceon the ability to drive and use machines such that outpatients should be warned to take special care.
Danish: Derudover kan Memantin Accordpåvirke din reaktionsevne, så det ikke er hensigtsmæssigt at køre bil eller betjene maskiner.
English: The full EPAR for Docetaxel Kabi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Docetaxel Kabi findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Kabi on 22 May 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Docetaxel Kabi den 22. maj 2012.
English: This is a summary of the European public assessment report (EPAR) for Docetaxel Kabi.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Docetaxel Kabi.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Docetaxel Kabi.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Docetaxel Kabi.
English: The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated.
Danish: Dosis, behandlingsvarighed og anvendelse sammen med andre lægemidler afhænger af, hvilken kræftform der behandles.
English: • non-small-cell lung cancer.
Danish: • ikke-småcellet lungekræft.
English: It is available as a concentrate to be made up into a solution for infusion (drip into a vein).
Danish: Det fås som et koncentrat til fremstilling af en opløsning til infusion (drop i en vene).
English: Docetaxel Kabi is given as a one-hour infusion every three weeks.
Danish: Docetaxel Kabi gives hver tredje uge ved en infusion, der varer en time.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
Danish: Docetaxel påvirker også andre celler end kræftcellerne såsom blodcellerne, hvilket kan medføre bivirkninger.
English: For more information about treatment with Docetaxel Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Docetaxel Kabi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Docetaxel Kabi is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Danish: Docetaxel Kabi må kun bruges, når neutrofiltallet (koncentrationen af en form for hvide blodlegemer) er normalt (mindst 1 500 celler/mm3).
English: The CHMP concluded that, in accordance with EU requirements, Docetaxel Kabi has been shown to be comparable to Taxotere.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Docetaxel Kabi er sammenligneligt med Taxotere.
English: This means that Docetaxel Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere.
Danish: Det betyder, at Docetaxel Kabi er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union kaldet Taxotere.
English: Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply.
Danish: Docetaxel blokerer cellernes evne til at nedbryde det indvendige ‘celleskelet' og dermed deres evne til at dele og formere sig.
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Danish: • gastrisk adenocarcinom (en form for mavekræft) hos patienter, der endnu ikke har fået nogen behandling mod deres kræft.
English: Docetaxel Kabi is used to treat the following types of cancer:
Danish: Docetaxel Kabi anvendes til behandling af følgende kræftformer:
English: Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Taxotere.
English: • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread).
Danish: • kræft i hoved- og halsregionen hos patienter, hvis kræft er fremskreden (er begyndt at sprede sig).
English: • prostate cancer, when the cancer does not respond to hormonal treatment.
Danish: • prostatakræft, når hormonbehandling ikke virker på sygdommen.
English: No additional studies were needed as Docetaxel Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.
Danish: Der krævedes ingen supplerende undersøgelser, da Docetaxel Kabi er et generisk lægemiddel, der gives ved infusion og indeholder det samme aktive stof som referencelægemidlet Taxotere.
English: Docetaxel Kabi is a ‘generic medicine'.
Danish: Docetaxel Kabi er et ‘generisk lægemiddel'.
English: The company also showed that the Docetaxel Kabi solution for infusion has comparable quality to that of Taxotere.
Danish: Virksomheden påviste også, at Docetaxel Kabi-opløsningen til infusion var af en kvalitet, som er sammenlignelig med kvaliteten af Taxotere.
English: Docetaxel Kabi is used with prednisone or prednisolone (anti-inflammatory medicines);
Danish: Docetaxel Kabi anvendes sammen med prednison eller prednisolon (antiinflammatoriske lægemidler).
English: Docetaxel Kabi can be used on its own after other treatments have failed.
Danish: Docetaxel Kabi kan bruges som eneste behandling, når andre lægemidler har været uden virkning.
English: The active substance in Docetaxel Kabi, docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Danish: Det aktive stof i Docetaxel Kabi, docetaxel, tilhører en gruppe lægemidler mod kræft, der kaldes taxaner.
English: Because Docetaxel Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Docetaxel Kabi er et generisk lægemiddel, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The company provided data from published literature on docetaxel.
Danish: Virksomheden fremlagde data om docetaxel fra den offentliggjorte faglitteratur.
English: It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer;
Danish: Det kan også bruges sammen med cisplatin (et andet lægemiddel mod kræft) til patienter, der endnu ikke har fået nogen behandling mod deres kræftsygdom,
English: Docetaxel Kabi is used with cisplatin and 5-fluorouracil.
Danish: Docetaxel Kabi anvendes sammen med cisplatin og 5-fluorouracil.
English: What are the benefits and risks of Docetaxel Kabi?
Danish: Hvilke fordele og risici er der forbundet med Docetaxel Kabi?
English: Docetaxel Kabi should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Danish: Docetaxel Kabi bør kun anvendes på afdelinger, der er specialiseret i kemoterapi, under overvågning af en læge, der er specialiseret i brug af kemoterapi.
English: Other information about Docetaxel Kabi
Danish: Andre oplysninger om Docetaxel Kabi
English: The Committee recommended that Docetaxel Kabi be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Docetaxel Kabi.
English: Docetaxel Kabi is a medicine that contains the active substance docetaxel.
Danish: Docetaxel Kabi er et lægemiddel, der indeholder det aktive stof docetaxel.
English: Docetaxel Kabi is used with cisplatin and 5-fluorouracil (other anticancer medicines);
Danish: Docetaxel Kabi anvendes sammen med cisplatin og 5-fluorouracil (andre lægemidler mod kræft),
English: For full details, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet, der også er en del af denne EPAR.
English: For more information, see the summary of product characteristics.
Danish: De nærmere oplysninger fremgår af produktresuméet.
English: It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Danish: Afhængigt af brystkræftens art og stadium kan det også anvendes sammen med andre midler mod kræft (doxorubicin, cyclophosphamid, trastuzumab eller capecitabin) til patienter, der endnu ikke har fået nogen behandling mod deres kræftsygdom, eller hos hvem andre behandlinger har været uden effekt,
English: Why has Docetaxel Kabi been approved?
Danish: Hvorfor blev Docetaxel Kabi godkendt?
English: An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Kabi infusion.
Danish: Dagen før infusionen med Docetaxel Kabi gives patienten endvidere et antiinflammatorisk lægemiddel såsom dexamethason.
English: What is Docetaxel Kabi?
Danish: Hvad er Docetaxel Kabi?
English: How has Docetaxel Kabi been studied?
Danish: Hvordan blev Docetaxel Kabi undersøgt?
English: What is Docetaxel Kabi used for?
Danish: Hvad anvendes Docetaxel Kabi til?
English: How is Docetaxel Kabi used?
Danish: Hvordan anvendes Docetaxel Kabi?
English: How does Docetaxel Kabi work?
Danish: Hvordan virker Docetaxel Kabi?
English: This summary was last updated in December 2014.
Danish: Dette sammendrag blev senest ajourført i december 2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Suvaxyn CSF Marker on 10/02/2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Suvaxyn CSF Marker den 10/02/2015.
English: The vaccine is given to pigs from seven weeks of age as a single injection into the muscle.
Danish: Vaccinen gives til svin fra 7-ugers alderen som en enkelt injektion i en muskel.
English: Protection lasted at least six months after vaccination.
Danish: Beskyttelsen varede mindst seks måneder efter vaccinationen.
English: The main measure of effectiveness was development of antibodies against E2 protein 14 days after vaccination.
Danish: Effektiviteten blev hovedsagelig bedømt på dannelsen af antistoffer mod E2-proteinet 14 dage efter vaccinationen.
English: Classical swine fever vaccine (live recombinant)
Danish: Klassisk svinefeber vaccine (levende, rekombinant)
English: Protection starts two weeks after vaccination and lasts for at least six months.
Danish: Beskyttelsen indtræder to uger efter vaccinationen og varer mindst seks måneder.
English: The effectiveness of Suvaxyn CSF Marker was further investigated in a small scale study with 30 eight-week-old piglets.
Danish: Effektiviteten af Suvaxyn CSF Marker blev nærmere undersøgt i en lille undersøgelse med 30 otte uger gamle smågrise.
English: The purpose of these studies was to establish how long it took for pigs to be fully protected and the length of time protection lasts against CSFV.
Danish: Formålet med undersøgelserne var at fastslå, hvor lang tid det tog for svin at opnå fuld beskyttelse, og hvor længe de var beskyttet mod klassisk svinefebervirus.
English: The CVMP concluded that the benefits of Suvaxyn CSF Marker exceed the risks for the approved indication and recommended that Suvaxyn CSF Marker be given a marketing authorisation.
Danish: CVMP konkluderede, at fordelene ved Suvaxyn CSF Marker overstiger risiciene til den anbefalede anvendelse, og anbefalede udstedelse af markedsføringstilladelse for Suvaxyn CSF Marker.