FrancophonIA/ELRC3.0 huggingface dataset:
English: Please ask your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: In the first week, Skilarence 30 mg is taken once daily (1 tablet in the evening).
Danish: Den første uge tages Skilarence 30 mg én gang dagligt (1 tablet om aftenen).
English: Constipation Abdominal discomfort
Danish: Forstoppelse Abdominalt ubehag Flatulens
English: No specific studies have been performed in patients with renal impairment.
Danish: Der er ikke udført specifikke studier hos patienter med nedsat nyrefunktion.
English: Tablet strength
Danish: Tabletstyrke
English: - Pregnancy and breast-feeding.
Danish: - Graviditet og amning.
English: - Severe hepatic or renal impairment.
Danish: - Svært nedsat lever- eller nyrefunktion.
English: Skilarence contains lactose.
Danish: Skilarence indeholder laktose.
English: - the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171), simethicone, indigo carmine (E132) and sodium hydroxide.
Danish: croscarmellosenatrium, silica, kolloid vandfri, magnesiumstearat, methacrylsyre-ethylacrylatcopolymer (1:1), talkum, triethylcitrat, titandioxid (E171), simethicon, indigokarmin (E132) og natriumhydroxid.
English: At week 16 of treatment, 13/175 (7.4%) of patients were noted to have lymphocyte levels <0.7x 10
Danish: I uge 16 (behandlingsafslutning) var der ingen yderligere nedgang i lymfocyttallet.I behandlingsuge 16 viste 13/175 (7,4 %) af patienterne sig at have lymfocytniveauer <0,7x109/l.
English: Pack sizes: 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 and 400 gastro-resistant tablets.
Danish: Skilarence 120 mg: Blister (PVC/PVDC-aluminium): 40, 70, 90, 100, 120, 180, 200, 240, 300, 360 og 400 enterotabletter
English: What Skilarence 30 mg looks like and contents of the pack Skilarence 30 mg is a white, round tablet with a diameter of approximately 6.8 mm.
Danish: Skilarence 30 mg er en hvid, rund tablet med en diameter på cirka 6,8 mm.
English: EU/1/17/1201/001 42 tablets EU/1/17/1201/013 70 tablets EU/1/17/1201/014 210 tablets
Danish: EU/1/17/1201/001 42 tabletter EU/1/17/1201/013 70 tabletter EU/1/17/1201/014 210 tabletter
English: EU/1/17/1201/002 40 tablets EU/1/17/1201/003 70 tablets EU/1/17/1201/004 90 tablets EU/1/17/1201/005 100 tablets EU/1/17/1201/006 120 tablets EU/1/17/1201/007 180 tablets EU/1/17/1201/008 200 tablets EU/1/17/1201/009 240 tablets EU/1/17/1201/012 300 tablets EU/1/17/1201/010 360 tablets EU/1/17/1201/011 400 tablets
Danish: EU/1/17/1201/002 40 tabletter EU/1/17/1201/003 70 tabletter EU/1/17/1201/004 90 tabletter EU/1/17/1201/005 100 tabletter EU/1/17/1201/006 120 tabletter EU/1/17/1201/007 180 tabletter EU/1/17/1201/008 200 tabletter EU/1/17/1201/009 240 tabletter EU/1/17/1201/012 300 tabletter EU/1/17/1201/010 360 tabletter EU/1/17/1201/011 400 tabletter
English: In the second week, Skilarence 30 mg is taken twice daily (1 tablet in the morning and 1 in the evening).
Danish: Den anden uge tages Skilarence 30 mg to gange dagligt (1 tablet om morgenen og 1 tablet om aftenen).
English: Skilarence contains lactose
Danish: Skilarence indeholder laktose
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Industrias Farmaceuticas Almirall, S.A.
English: PASI 75 and PGA score clear or almost clear and non-inferior (using a non-inferiority margin of -15%) to the active comparator (p<0.0003) based on PASI 75.
Danish: Efter 16 ugers behandling viste Skilarence sig at være bedre end placebo (p<0,0001) baseret på PASI 75 og PGA-scoren helet (clear) eller næsten helet (almost clear) og non-inferior (med en noninferioritetsmargin på 15 %) i forhold til den aktive komparator (p<0,0003) baseret på PASI 75.
English: - the other ingredients are: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), talc, triethyl citrate, titanium dioxide (E171) and simethicone.
Danish: croscarmellosenatrium, silica, kolloid vandfri, magnesiumstearat, methacrylsyre-ethylacrylat copolymer (1:1), talcum, triethylcitrat, titandioxid (E171) og simethicon.
English: No dose adjustment is needed in patients with mild to moderate renal impairment (see section 5.2).
Danish: Der er ikke behov for dosisjustering hos patienter med mild til moderat nedsat nyrefunktion (se pkt.
English: If you take more Skilarence than you should If you think you have taken too many Skilarence tablets, talk to your doctor or pharmacist.
Danish: Hvis du mener, at du har taget for mange Skilarence-tabletter, skal du tale med din læge eller apotekspersonalet.
English: Breakfast
Danish: Middag
English: Skilarence 30 mg 42, 70 and 210 gastro-resistant tablets in PVC/PVDC-aluminium blister packs.
Danish: Skilarence 30 mg: Blister (PVC/PVDC-aluminium): 42, 70 og 210 enterotabletter
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Skilarence Fortæl lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: 40 gastro-resistant tablets 70 gastro-resistant tablets 90 gastro-resistant tablets 100 gastro-resistant tablets 120 gastro-resistant tablets 180 gastro-resistant tablets 200 gastro-resistant tablets 240 gastro-resistant tablets 300 gastro-resistant tablets 360 gastro-resistant tablets 400 gastro-resistant tablets
Danish: 40 enterotabletter 70 enterotabletter 90 enterotabletter 100 enterotabletter 120 enterotabletter 180 enterotabletter 200 enterotabletter 240 enterotabletter 300 enterotabletter 360 enterotabletter 400 enterotabletter
English: What Skilarence 120 mg contains - the active substance is dimethyl fumarate.
Danish: Skilarence 120 mg indeholder - Aktivt stof: dimethylfumarat.
English: Do not crush, break, dissolve or chew the tablet.
Danish: Tabletten må ikke knuses, deles, opløses eller tygges.
English: For monitoring recommendations and clinical management of adverse reactions, see section 4.4.
Danish: Anbefalinger vedrørende overvågning og klinisk behandling af bivirkninger er beskrevet i pkt.
English: Carcinogenicity
Danish: Kræftfremkaldende egenskaber
English: Skilarence 30 mg gastro-resistant tablets dimethyl fumarate
Danish: Skilarence 30 mg enterotabletter dimethylfumarat
English: What Skilarence 30 mg contains - the active substance is dimethyl fumarate.
Danish: Skilarence 30 mg indeholder: - Aktivt stof: dimethylfumarat.
English: Skilarence 120 mg gastro-resistant tablets dimethyl fumarate
Danish: Skilarence 120 mg enterotabletter dimethylfumarat
English: Other medicines and Skilarence
Danish: ETIKETTERING OG INDLÆGSSEDDEL
English: For monitoring recommendations and clinical management of haematological adverse reactions, see section 4.4.
Danish: Anbefalinger vedrørende overvågning og klinisk behandling af hæmatologiske bivirkninger er beskrevet i pkt.
English: Skilarence has not been studied in patients with severe renal impairment, and use of Skilarence is contraindicated in these patients (see section 4.3).
Danish: Skilarence er ikke blevet undersøgt hos patienter med alvorligt nedsat leverfunktion, og brug af Skilarence er kontraindiceret hos disse patienter (se pkt.
English: - constipation - gas (flatulence), stomach discomfort, indigestion - decreased appetite - headache - feeling tired - weakness - feeling hot - abnormal sensations of the skin, such as itching, burning, stinging, tickling or tingling - pink or red blotches on the skin (erythema)
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 personer): - stigning i alle hvide blodlegemer (leukocytose) - stigning i bestemte hvide blodlegemer kaldet eosinofile blodceller - stigning i visse enzymer i blodet (bruges til at kontrollere, hvordan din lever har det) - opkastning - forstoppelse - luft i maven (flatulens), maveubehag, fordøjelsesbesvær - nedsat appetit - hovedpine - træthedsfornemmelse - svaghed - varmefornemmelse - unormale fornemmelser i huden, såsom kløe, brændende, stikkende, kildrende eller snurrende fornemmelser - lyserøde eller røde pletter på huden (erytem)
English: Coating:
Danish: Overtræk:
English: Other haematological disorders
Danish: Andre hæmatologiske lidelser:
English: 9/L or other pathological results are identified.
Danish: 9/l, lymfopeni under 1,0x10 9/l, eller hvis der konstateres andre patologiske resultater.
English: There are no data available with Skilarence in paediatric patients.
Danish: Der foreligger ingen data med Skilarence hos børn og unge.
English: Exhalation of CO2 resulting from the metabolism of monomethyl fumarate is the primary route of elimination; only small amounts of intact monomethyl fumarate are excreted through urine or faeces.
Danish: Den primære eliminationsvej er udånding af CO2 som følge af metabolismen af monomethylfumarat.
English: Skin burning sensation Pruritus
Danish: Hud og subkutane væv Erytem Brændende fornemmelse i huden
English: OUTER CARTON - SKILARENCE 30 mg GASTRO RESISTANT TABLETS
Danish: YDRE KARTON - SKILARENCE 30 mg ENTEROTABLETTER
English: How to take Skilarence
Danish: Sådan skal du tage Skilarence
English: Hence, Skilarence is contraindicated in patients with severe renal impairment (see section 4.3).
Danish: Skilarence er derfor kontraindiceret hos patienter med svært nedsat nyrefunktion (se pkt.
English: OUTER CARTON - SKILARENCE 120 mg GASTRO RESISTANT TABLETS
Danish: YDRE KARTON - SKILARENCE 120 mg ENTEROTABLETTER
English: BLISTER FOIL - SKILARENCE 30 mg GASTRO RESISTANT TABLETS
Danish: BLISTERFOLIE - SKILARENCE 30 mg ENTEROTABLETTER
English: Skilarence has not been studied in patients with severe hepatic impairment and is contraindicated in these patients (see section 4.3).
Danish: Skilarence er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion og er kontraindiceret hos disse patienter (se pkt.
English: Skilarence 30 mg gastro-resistant tablets Skilarence 120 mg gastro-resistant tablets
Danish: Skilarence 30 mg enterotabletter Skilarence 120 mg enterotabletter
English: BLISTER FOIL - SKILARENCE 120 mg GASTRO RESISTANT TABLETS
Danish: BLISTERFOLIE - SKILARENCE 120 mg ENTEROTABLETTER
English: Therefore, Skilarence is contraindicated during breastfeeding (see section 4.3).
Danish: Skilarence er derfor kontraindiceret til ammende kvinder (se pkt.
English: Treatment week
Danish: Behandlingsuge
English: Very common side effects (may affect more than 1 in 10 people): - decrease in white blood cells called lymphocytes (lymphopenia)
Danish: Meget almindelige bivirkninger (kan påvirke mere end 1 ud af 10 personer): - fald i hvide blodlegemer kaldet lymfocytter (lymfopeni) - fald i alle hvide blodlegemer (leukopeni) - rødfarvning af ansigtet eller kroppen (rødmen) - diarré
English: Common Common Common Rare
Danish: Almindelig Sjælden
English: Each tablet contains 30 mg dimethyl fumarate.
Danish: Hver tablet indeholder 30 mg dimethylfumarat.
English: Each tablet contains 120 mg dimethyl fumarate.
Danish: Hver tablet indeholder 120 mg dimethylfumarat.
English: One tablet contains 120 mg dimethyl fumarate.
Danish: En tablet indeholder 120 mg dimethylfumarat.
English: Hepatic impairment
Danish: Varmefornemmelse Asteni
English: 13.3, 35.5 a
Danish: 4.2 og 5.2).
English: What Skilarence is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: One tablet contains 30 mg dimethyl fumarate.
Danish: En tablet indeholder 30 mg dimethylfumarat.
English: Each gastro-resistant tablet contains 30 mg dimethyl fumarate.
Danish: Hver enterotablet indeholder 30 mg dimethylfumarat.
English: Each gastro-resistant tablet contains 120 mg dimethyl fumarate.
Danish: Hver enterotablet indeholder 120 mg dimethylfumarat.
English: decrease in all white blood cells (leukopenia) - reddening of the face or body (flushing) - diarrhoea - bloating, stomach pain or stomach cramps - feeling sick (nausea)
Danish: Meget almindelige bivirkninger (kan påvirke mere end 1 ud af 10 personer): - fald i bestemte hvide blodlegemer kaldet lymfocytter (lymfopeni) - fald i alle hvide blodlegemer (leukopeni) - rødfarvning af ansigtet eller kroppen (rødmen) - diarré - oppustet mave, mavesmerter eller mavekramper - følelse af at skulle kaste op (kvalme)
English: Lunch Evening meal
Danish: Morgen Middag Aften
English: Paraesthesia
Danish: Paræstesi
English: How to store Skilarence 6.
Danish: Oversigt over indlægssedlen 1.
English: Flatulence
Danish: Simeticon
English: Lymphopenia
Danish: PRODUKTRESUMÉ
English: MARKETING AUTHORISATION NUMBERS
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE)
English: - Severe gastrointestinal disorders.
Danish: - Svære lidelser i mave-tarm-kanalen.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 July 2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21.
English: The committee considered that the study failed to show beneficial effects in the population studied.
Danish: Udvalget var af den opfattelse, at undersøgelsen ikke viste gavnlige virkninger hos den undersøgte population.
English: What is Infinia?
Danish: Hvad er Infinia?
English: The company presented results of a main study in 168 patients looking at the effects of the medicine on exacerbations (sudden worsening of symptoms) of the disease.
Danish: Virksomheden fremlagde resultater af en hovedundersøgelse hos 168 patienter vedrørende dette lægemiddels virkninger på exacerbationer af sygdommen (pludselig forværring af symptomerne).
English: What was Infinia expected to be used for?
Danish: Hvad forventedes Infinia anvendt til?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it needed more time to collect additional information that the CHMP requested in relation to this application.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den havde brug for mere tid til at indsamle de supplerende oplysninger, som CHMP anmodede om i forbindelse med denne ansøgning.
English: If you are in a clinical trial or compassionate use 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 eller i et program for anvendelse med særlig udleveringstilladelse og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der behandler dig.
English: A lack of this enzyme can cause damage to the lungs (such as emphysema and airway obstruction) which leads to breathing problems.
Danish: En mangel på dette enzym kan medføre skader på lungerne (såsom emfysem og luftvejsobstruktion), der giver vejrtrækningsproblemer.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Infinia did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Infinia ikke opvejede risiciene.
English: There were also concerns that patients taking Infinia may produce antibodies against it which could reduce its effects or make patients more prone to allergic reactions.
Danish: Der var ligeledes betænkeligheder med hensyn til risikoen for, at patienter, der tager Infinia, danner antistoffer mod det, hvilket kunne mindske dets virkning eller gøre patienterne mere udsat for allergiske reaktioner.
English: Other medicines containing alpha-1-antitrypsin are authorised in the EU for the same disease but are given as an infusion (drip) into a vein.
Danish: Andre lægemidler, der indeholder alfa-1-antitrypsin, er godkendt i EU til den samme sygdom, men gives som infusion (drop i en vene).
English: In addition, there were concerns about the tolerability and safety profile of the medicine, since patients who were taking Infinia had to stop treatment due to side effects more often than patients taking placebo.
Danish: Endvidere var der betænkeligheder med hensyn til lægemidlets tolerabilitet og sikkerhedsprofil, eftersom patienter, der tog Infinia, oftere måtte stoppe behandlingen på grund af bivirkninger end patienter, der tog placebo.
English: The medicine was compared with placebo (a dummy treatment) and the main measure of effectiveness was the length of time patients went without having an exacerbation.
Danish: Lægemidlet blev sammenlignet med placebo (en uvirksom behandling), og hovedeffektmålet var længden af det tidsrum, hvor patienterne ikke havde nogen exacerbationer.
English: It is obtained from human blood and was intended to replace the missing protein in the lungs of patients with alpha-1-antitrypsin deficiency.
Danish: Det udvindes af humant blod og var beregnet på at erstatte det manglende protein i lungerne hos patienter med alfa-1-antitrypsinmangel.
English: Further information on the orphan designation can be found here.
Danish: Yderligere oplysninger om udpegelsen som lægemiddel til sjældne sygdomme findes her.
English: On 21 June 2017, Kamada BioPharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Infinia, for the treatment of adults with lung disease due to congenital deficiency of alpha-1antitrypsin.
Danish: Den 21. juni 2017 meddelte Kamada BioPharma Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Infinia til behandling af voksne med lungesygdom, der skyldes medfødt alfa-1antitrypsinmangel.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Infinia.
Danish: Virksomheden har til CHMP oplyst, at der ikke er nogen konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser eller i programmer for anvendelse af Infinia med særlig udleveringstilladelse.
English: The active substance in Infinia, alpha-1-antitrypsin, is a protein in the blood which protects lung tissue from damage.
Danish: Det aktive stof i Infinia, alfa-1-antitrypsin, er et protein i blodet, der beskytter lungevævet mod skader.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Infinia could not have been approved for the treatment of adults with lung disease due to congenital deficiency of alpha-1-antitrypsin.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Infinia ikke kunne være blevet godkendt til behandling af voksne med lungesygdom, der skyldes medfødt alfa-1-antitrypsinmangel.
English: Infinia is a medicine containing the active substance alpha-1-antitrypsin (also known as alpha1proteinase inhibitor).
Danish: Infinia er et lægemiddel, der indeholder det aktive stof alfa-1-antitrypsin (også kendt som alfa1proteasehæmmer).
English: How does Infinia work?
Danish: Hvordan virker Infinia?
English: Infinia was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 16 November 2004 for the treatment of emphysema due to congenital alpha-1-antitrypsin deficiency.
Danish: Infinia blev udpeget som "lægemiddel til sjældne sygdomme" den 16. november 2004 til behandling af emfysem, der skyldes medfødt alfa-1-antitrypsinmangel.
English: It was to be available as a solution to be inhaled.
Danish: Det var meningen, at det skulle kunne fås som inhalationsvæske, opløsning.
English: The medicine was expected to be used for treating lung disease in adults with congenital (inborn) deficiency of alpha-1-antitrypsin.
Danish: Lægemidlet forventedes anvendt til behandling af lungesygdom hos voksne med medfødt alfa-1antitrypsinmangel.
English: Page 2/2
Danish: juli 2017
English: In addition, the company will perform a study to further investigate the risk of blood clots.
Danish: Virksomheden vil desuden gennemføre en undersøgelse for at undersøge risikoen for blodpropper yderligere.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoely on 27 July 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zoely den 27. juli 2011.
English: A lower Pearl Index represents a lower chance of getting pregnant.
Danish: Et lavere Pearl Index viser en lavere sandsynlighed for at blive gravid.
English: Other information about Zoely
Danish: Andre oplysninger om Zoely
English: Zoely was investigated in two main studies involving a total of 4,433 women aged 18 to 50 years old.
Danish: Zoely blev undersøgt i to hovedundersøgelser, der omfattede i alt 4 433 kvinder i alderen 18 til 50 år.
English: The full EPAR for Zoely can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Zoely findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a summary of the European public assessment report (EPAR) for Zoely.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zoely.
English: Zoely nomegestrol acetate / estradiol
Danish: Zoely nomegestrolacetat / estradiol
English: A risk management plan has been developed to ensure that Zoely is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Zoely anvendes så sikkert som muligt.
English: Zoely is a contraceptive pill.
Danish: Zoely er en p-pille.
English: In women aged 18 to 35, the Pearl Index was around 0.4 with Zoely and 0.8 with the comparator medicine in the first study, and around 1.2 with Zoely and 1.9 with the comparator medicine in the second study.
Danish: Hos kvinder i alderen 18 til 35 år var Pearl Index ca. 0,4 med Zoely og 0,8 med sammenligningslægemidlet i den første undersøgelse, og det var ca. 1,2 med Zoely og 1,9 med sammenligningslægemidlet i den anden undersøgelse.
English: No clinical study data on Zoely are available in adolescents under 18 years old.
Danish: Der foreligger ingen data fra kliniske undersøgelser af Zoely hos unge under 18 år.
English: One tablet a day is taken for as long as contraception is required, starting with an active tablet on the first day of the cycle.
Danish: Der tages en tablet om dagen, lige så længe svangerskabsforebyggelse er nødvendig, og der startes med en aktiv tablet på menstruationens første dag.
English: What measures are being taken to ensure the safe and effective use of Zoely?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zoely?
English: Zoely must not be used when a woman has, or has had, blood clots in the veins or arteries or when a woman has some of the risk factors for blood clots.
Danish: Zoely må ikke anvendes, hvis en kvinde har eller har haft blodpropper i arterierne eller venerne, eller hvis hun har nogle af risikofaktorerne for blodpropper.
English: The Pearl Index is a standard way of measuring the effectiveness of contraceptives, which measures how many unwanted pregnancies occur in 100 women-years (corresponding to 1,300 menstrual cycles).
Danish: Pearl Index er en standardmetode til at måle svangerskabsforebyggende midlers effektivitet, hvor man måler, hvor mange uønskede graviditeter der forekommer i 100 kvindeår (svarende til 1 300 menstruationscyklusser).
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 Zoely.
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, hvordan Zoely skal anvendes.