FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon (may affect up to 1 in 100 people) torsade de pointes (life threatening irregular heart beat) hypersensitivity (allergic reaction) anorexia (loss of appetite), weight loss, weight gain depression, anxiety, sleep disorder disorientation, amnesia (loss of memory) peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs) syncope (fainting), hypertension (high blood pressure) dyspnoea (shortness of breath) pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores) hepatitis (inflammation of the liver) angioedema (severe swelling of the skin and other tissues most often the lips or the eyes) urticaria (itchy rash), alopecia (unusual hair loss or thinning), pruritus (itching) muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles) nephrolithiasis (formation of kidney stones), interstitial nephritis (kidney inflammation), hematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination), chronic kidney disease (how well your kidneys work) gynaecomastia (breast enlargement in men) chest pain, malaise (generally feeling unwell), fever asthenia (unusual tiredness or weakness) serious skin rashes (allergic reactions including rash, a high temperature, increased levels of liver enzymes seen in blood tests, an increase in a type of white blood cell [esosinophilia] and/or enlarged lymph nodes) (see section 2) gallbladder disorders (gallstones and gallbladder inflammation)
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) livstruende uregelmæssige hjerteslag (puls) (torsades de pointes) overfølsomhed (allergisk reaktion) manglende appetit, vægttab, vægtstigning depression, angst, søvnforstyrrelser desorientering, hukommelsestab (amnesi) følelsesløshed, svaghed, prikken eller smerter i arme og ben (perifer neuropati) besvimelse (synkope), højt blodtryk (hypertension) åndenød betændelse i bugspytkirtlen (pankreatitis), irritation af slimhinden i mavesækken (gastritis), sår i munden og forkølelsessår leverbetændelse (hepatitis) angioødem (voldsom hævelse af hud og andre steder, som oftest læber og øjne) nældefeber (kløende udslæt), hårtab eller -udtynding (alopeci), kløe (pruritus) svind af muskelmasse (atrofi), ledsmerter (artralgi), muskelsmerter (myalgi)
English: Adverse Reactions uncommon myalgia, muscle atrophy, arthralgia rare myopathy
Danish: Knogler, led, muskler og bindevæv ikke almindelig myalgi, muskelatrofi, artralgi sjælden myopati
English: Rifabutin 150 mg twice weekly (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Danish: Rifabutin 150 mg to gange ugentligt (atazanavir 300 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt)
English: Efavirenz 600 mg once daily (atazanavir 400 mg once daily)
Danish: Efavirenz 600 mg 1 gang dagligt (atazanavir 400 mg 1 gang dagligt)
English: The mechanism of interaction is CYP3A4 and UGT1A1 inhibition by atazanavir.
Danish: Interaktionsmekanismen er atazanavirs CYP3A4- og UGT1A1hæmning.
English: Omeprazole 40 mg once daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily, 2 hours after omeprazole)
Danish: Omeprazol 40 mg 1 gang dagligt (atazanavir 300 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt, 2 timer efter omeprazol)
English: If drospirenone/ethinyloestradiol is co-administered with atazanavir/cobicistat clinical monitoring is recommended due to the potential for hyperkalemia.
Danish: Klinisk monitorering anbefales hvis drospirenon/ethinylestradiol administreres samtidig med atazanavir/cobicistat, grundet potentiel hyperkaliæmi.
English: The mechanism of interaction is CYP3A and/or P-glycoprotein inhibition by atazanavir and cobicistat.
Danish: Interaktionsmekanismen er atazanavirs og cobicistats CYP3Aog/eller P-glycoprotein-hæmning.
English: triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety) simvastatin and lovastatin (used to lower blood cholesterol) avanafil (used to treat erectile dysfunction) colchicine (used to treat gout), if you have kidney and/or liver problems ticagrelor (used to reduce the blood clots) grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination, and glecaprevir/pibrentasvir fixed dose combination (used to treat chronic hepatitis C infection)
Danish: triazolam og oralt (indtaget gennem munden) midazolam (bruges som sovemedicin og/eller til at behandle angst) simvastatin og lovastatin (bruges til at sænke mængden af kolesterol i blodet) avanil (bruges til at behandle erektil dysfunktion (impotens)).
English: The mechanism of interaction is CYP3A inhibition.
Danish: Interaktionsmekanismen er CYP3A-hæmning.
English: The mechanism of interaction is CYP3A4 induction by rifampicin.
Danish: Interaktionsmekanismen er rifampicins CYP3A4-induktion.
English: Omeprazole 20 mg once daily am (atazanavir 300 mg once daily with ritonavir 100 mg once daily pm, 12 hours after omeprazole)
Danish: Omeprazol 20 mg 1 gang dagligt om morgenen (atazanavir 300 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt om aftenen, 12 timer efter omeprazol)
English: Co-administration with the following medicinal products that are strong inducers of the CYP3A4 isoform of cytochrome P450 due to the potential for loss of therapeutic effect (see section 4.5): carbamazepine, phenobarbital, phenytoin (antiepileptics) St John's wort (Hypericum perforatum) (herbal product) rifampicin (antimycobacterial)
Danish: Samtidig administration af følgende lægemidler, som er kraftige induktorer af CYP3A4-isoformen af cytochrom-P450 på grund af den potentielle risiko for tab af terapeutisk virkning (se pkt.
English: The mechanism of interaction is CYP3A4 and P-gp inhibition by cobicistat.
Danish: Interaktionsmekanismen er cobicistats CYP3A4- og P-gp-hæmning.
English: Elbasvir 50 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily
Danish: Elbasvir 50 mg 1 gang dagligt (atazanavir 300 mg/ritonavir 100 mg 1 gang dagligt)
English: Boceprevir 800 mg three times daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Danish: Boceprevir 800 mg tre gange dagligt (atazanavir 300 mg/ritonavir 100 mg 1 gang dagligt)
English: Plasma concentrations of atorvastatin are increased when coadministered with atazanavir/cobicistat
Danish: Plasmakoncentrationerne af atorvastatin øges ved samtidig administration med atazanavir/cobicistat
English: Plasma concentrations of pitavastatin may be increased if co-administered with EVOTAZ.
Danish: Plasmakoncentrationerne af pitavastatin kan øges ved samtidig administration af EVOTAZ.
English: The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or cobicistat and clarithromycin.
Danish: Interaktionsmekanismen er atazanavirs og/eller cobicistats og clarithromycins
English: Rifampicin 600 mg once daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Danish: Rifampicin 600 mg 1 gang dagligt (atazanavir 300 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt)
English: Plasma concentrations of rosuvastatin are increased when coadministered with atazanavir/cobicistat.
Danish: Plasmakoncentrationerne af rosuvastatin øges ved samtidig administration med atazanavir/cobicistat.
English: Nevirapine 200 mg twice daily (atazanavir 300 mg once daily with ritonavir 100 mg once daily)
Danish: Nevirapin 200 mg to gange dagligt (atazanavir 300 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt)
English: There have been reports of unusual heart beat in patients taking atazanavir-containing regimen.
Danish: Der er set unormal hjerterytme (puls) hos patienter, som anvender lægemidler med atazanavir.
English: The mechanism of interaction is induction of CYP3A4 by bosentan.
Danish: Interaktionsmekanismen er bosentans CYP3A4-induktion.
English: Tenofovir alafenamide 10 mg once daily (atazanavir 300 mg once daily with cobicistat 150 mg once daily)
Danish: Tenofoviralafenamid 10 mg 1 gang dagligt (atazanavir 300 mg 1 gang dagligt og cobicistat 150 mg 1 gang dagligt)
English: ANTIGOUT Colchicine
Danish: Osteonekrose
English: Elbasvir concentrations were increased when co-administered with atazanavir/ritonavir
Danish: Koncentrationerne for elbasvir steg betydeligt ved samtidig administration med atazanavir/ritonavir.
English: The mechanism of interaction is CYP3A inhibition by atazanavir and cobicistat.
Danish: Interaktionsmekanismen er atazanavirs og cobicistats CYP3A-hæmning.
English: Nevirapine Cmin ↑32% (↑22%
Danish: Nevirapin Cmax ↑17% (↑9% ↑25%) Nevirapin Cmin ↑32% (↑22% ↑43%)
English: The mechanism of interaction is inhibition of CYP3A4 by cobicistat.
Danish: Interaktionsmekanismen er cobicistats CYP3A4-hæmning.
English: Do not double the next dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: 12 hours at steady state following a dose of 300 mg daily with ritonavir 100 mg once daily with a light meal.
Danish: Gennemsnitlig halveringstid var, inden for atazanavirs dosisinterval, hos hiv-inficerede voksne patienter (n=33, kombinerede studier) 12 timer ved steady-state efter en dosis på 300 mg dagligt med 100 mg ritonavir én gang dagligt med et let måltid.
English: Renal impairment Atazanavir
Danish: Nedsat nyrefunktion Atazanavir
English: Plasma concentrations of trazodone may be increased when co-administered with EVOTAZ.
Danish: Trazodons plasmakoncentrationer kan øges ved samtidig administration af EVOTAZ.
English: What EVOTAZ is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: If you miss a dose of EVOTAZ by 12 hours or less, take it right away with food and then take your next scheduled dose at the usual time.
Danish: Hvis du har glemt at tage en dosis inden for 12 timer efter det tidspunkt, du normalt tager EVOTAZ, skal du tage tabletten med mad så hurtigt som muligt.
English: Concentrations of beta-blockers may be increased when co-administered with EVOTAZ.
Danish: Koncentrationen af betablokkere kan øges ved samtidig administration af EVOTAZ.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Danish: Autoimmune lidelser (såsom Graves sygdom og autoimmun hepatitis) er også rapporteret i forbindelse med immunreaktivering.
English: The mechanism of interaction is inhibition of CYP3A4 by atazanavir and cobicistat.
Danish: Interaktionsmekanismen er atazanavirs og cobicistats CYP3A4-hæmning.
English: EVOTAZ is not recommended for patients undergoing haemodialysis (see sections 4.4 and 5.2).
Danish: EVOTAZ frarådes til patienter i hæmodialyse (se pkt.
English: Co-administration with the following medicinal products due to the potential for serious and/or lifethreatening adverse reactions (see section 4.5): colchicine, when used in patients with renal and/or hepatic impairment (antigout) (see section 4.5) sildenafil - when used for the treatment of pulmonary arterial hypertension (see sections 4.4 and 4.5 for co-administration for the treatment of erectile dysfunction), avanafil (PDE5 inhibitors) simvastatin and lovastatin (HMG-CoA reductase inhibitors) (see section 4.5) grazoprevir-containing products, including elbasvir/grazoprevir fixed dose combination (used to treat chronic hepatitis C infection) (see section 4.5) glecaprevir/pibrentasvir fixed dose combination (see section 4.5)
Danish: 4.4 og 4.5 for samtidig adminstration ved behandling af erektil dysfunktion), avanafil (PDE5-hæmmere) simvastatin og lovastatin (HMG-CoA reduktasehæmmere) (se pkt.
English: Integrase Inhibitors
Danish: Integrasehæmmere
English: If you have any further questions, ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: ‘Essential' means that the disease has no obvious cause.
Danish: "Essentiel" betyder, at sygdommen ikke har nogen åbenlys årsag.
English: Results are normally seen within 2 or 3 weeks of starting treatment.
Danish: Resultater ses sædvanligvis inden for to til tre uger efter påbegyndt behandling.
English: This is a summary of the European public assessment report (EPAR) for Anagrelide Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Anagrelide Mylan.
English: The full EPAR for Anagrelide Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Anagrelide Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After a week, the dose is increased every week by 0.5 mg a day, until the platelet count is below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the level usually seen in healthy people).
Danish: Efter en uge øges dosis hver uge med 0,5 mg dagligt, indtil blodpladetallet er under 600 mio. blodplader pr. ml og ideelt mellem 150 og 400 mio./ml (det antal, der normalt observeres hos sunde personer).
English: Treatment should only be started by a doctor who has experience in treating essential thrombocythaemia.
Danish: Behandling bør kun iværksættes af en læge med erfaring i behandling af essentiel trombocytæmi.
English: The Agency recommended that Anagrelide Mylan be approved for use in the EU.
Danish: Agenturet anbefalede, at Anagrelide Mylan godkendes til anvendelse i EU.
English: As for every medicine, the company provided studies on the quality of Anagrelide Mylan.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Anagrelide Mylan.
English: Anagrelide Mylan is used when the patient's current treatment does not work well enough or has unacceptable side effects, and when they are ‘at risk' because of their age (over 60 years), very high platelet counts or previous clotting problems.
Danish: Anagrelide Mylan anvendes, når patientens hidtidige behandling ikke virker godt nok eller medfører uacceptable bivirkninger, og når patienten tilhører "risikogruppen" enten på grund af alder (over 60 år), meget højt blodpladetal eller tidligere størkningsproblemer.
English: This means that Anagrelide Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Xagrid.
Danish: Det betyder, at Anagrelide Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Xagrid.
English: Anagrelide Mylan is available as capsules (0.5 and 1 mg).
Danish: Anagrelide Mylan fås som kapsler (0,5 og 1 mg).
English: The European Medicines Agency concluded that, in accordance with EU requirements, Anagrelide Mylan has been shown to have comparable quality and to be bioequivalent to Xagrid.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Anagrelide Mylan er af sammenlignelig kvalitet og er bioækvivalent med Xagrid.
English: The recommended starting dose is one 0.5 mg capsule twice a day.
Danish: Den anbefalede startdosis er én 0,5-mg-kapsel to gange dagligt.
English: Anagrelide Mylan is also a ‘hybrid medicine' because it is available in an additional strength.
Danish: Anagrelide Mylan er også et "hybridt lægemiddel", idet det fås i en yderligere styrke.
English: This reduces the platelet count, helping to improve symptoms in patients with the disease.
Danish: Dette nedsætter blodpladetallet, hvorved symptomerne mindskes hos patienter med sygdommen.
English: The maximum recommended dose of Anagrelide Mylan is 2.5 mg at a time.
Danish: Den maksimale, anbefalede dosis Anagrelide Mylan er 2,5 mg ad gangen.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Xagrid, and do not need to be repeated for Anagrelide Mylan.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i den godkendte anvendelse med referencelægemidlet, Xagrid, og det er ikke nødvendigt at gentage disse for Anagrelide Mylan.
English: What are the benefits and risks of Anagrelide Mylan?
Danish: Hvilke fordele og risici er der forbundet med Anagrelide Mylan?
English: What is Anagrelide Mylan and what is it used for?
Danish: Hvad er Anagrelide Mylan, og hvad anvendes det til?
English: Anagrelide Mylan is a medicine used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets circulating in the blood).
Danish: Anagrelide Mylan er et lægemiddel, der anvendes til at mindske antallet af blodplader (bestanddele, der hjælper blodet til at størkne) hos patienter med essentiel trombocytæmi (en sygdom, hvor der er for mange blodplader i blodet).
English: What measures are being taken to ensure the safe and effective use of Anagrelide Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Anagrelide Mylan?
English: This puts the patient at risk of developing blood clots or bleeding problems.
Danish: Dette medfører øget risiko for blodpropper eller blødningsproblemer.
English: Anagrelide Mylan can only be obtained with a prescription.
Danish: Anagrelide Mylan udleveres kun efter recept.
English: Other information about Anagrelide Mylan
Danish: Andre oplysninger om Anagrelide Mylan
English: For more information about treatment with Anagrelide Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Anagrelide Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Because Anagrelide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Anagrelide Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Anagrelide Mylan, anagrelide, blocks the development and growth of cells in the bone marrow called ‘megakaryocytes', which produce platelets.
Danish: Det aktive stof i Anagrelide Mylan, anagrelid, blokerer udviklingen og væksten af celler i knoglemarven kaldet "megakaryocytter", som producerer blodplader.
English: It is not intended to provide practical advice on how to use Anagrelide Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Anagrelide Mylan bør anvendes.
English: Therefore, the Agency's view was that, as for Xagrid, the benefit outweighs the identified risk.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Xagrid.
English: Essential thrombocythaemia is a disease in which the bone marrow produces too many platelets.
Danish: Essentiel trombocytæmi er en sygdom, hvor knoglemarven producerer for mange blodplader.
English: Why is Anagrelide Mylan approved?
Danish: Hvorfor blev Anagrelide Mylan godkendt?
English: Anagrelide Mylan anagrelide
Danish: Anagrelide Mylan anagrelid
English: For practical information about using Anagrelide Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Anagrelide Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Anagrelide Mylan have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Anagrelide Mylan.
English: How is Anagrelide Mylan used?
Danish: Hvordan anvendes Anagrelide Mylan?
English: How has Anagrelide Mylan been studied?
Danish: Hvordan blev Anagrelide Mylan undersøgt?
English: Anagrelide Mylan contains the active substance anagrelide and is a ‘generic medicine'.
Danish: Anagrelide Mylan indeholder det aktive stof anagrelid.
English: How does Anagrelide Mylan work?
Danish: Hvordan virker Anagrelide Mylan?
English: Annex I List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Danish: Bilag I Liste over særnavne, lægemiddelformer, lægemidlernes styrker, administrationsveje, indehavere af markedsføringstilladelse i medlemsstaterne
English: United Kingdom Genus Pharmaceuticals Holdings Limited, Park View House, 65
Danish: Storbritannien Genus Pharmaceuticals Holdings Limited, Park View House, 65
English: United Kingdom Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, CY-1060
Danish: Storbritannien Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, CY-1060
English: 2 g of meprobamate (in combination with magnesium oxide, magnesium sulphate, kaolin, sterculia gum)
Danish: 2 g meprobamat (i kombination med magnesiumoxid, magnesiumsufat, kaolin, sterculiagummi)
English: 400 mg of meprobamate (in combination with aceprometazine)
Danish: 400 mg meprobamat (i kombination med aceprometazin)
English: 200 mg of meprobamate (in combination with medroxyprogesterone acetate bendroflumethiazide)
Danish: 200 mg meprobamat (i kombination med medroxyprogesteronacetat og bendroflumethiazid)
English: 150 mg of meprobamate (in combination with quinine)
Danish: 150 mg meprobamat (i kombination med kinin)
English: ANDAXIN tabletta
Danish: ANDAXIN tabletta 200 mg
English: Clinical/safety
Danish: Klinisk/sikkerhed
English: Conditions to the marketing authorisations
Danish: Betingelser for markedsføringstilladelserne
English: 2015:pilot study 31 December 2016: main cohort (1 year results)
Danish: 31. marts 2015: pilotundersøgelse 31. december hovedkohorte (resultater efter 1 år)
English: Within 30 days after Commission Decision
Danish: Senest 30 dage efter
English: DHPC Communication circulation according to the CHMP agreed action plan and conditions.
Danish: Udsendelse af DHPC-meddelelse ifølge den handlingsplan og de betingelser, som CHMP har vedtaget.
English: The MAH will perform a PASS study to address all important, potential and identified risks, particularly Parkinsonism.
Danish: Indehaveren af markedsføringstilladelsen skal udføre et PASS-undersøgelse med henblik på at håndtere alle vigtige, potentielle og identificerede risici, især parkinsonisme.
English: The full study protocol for the nested case-control study within the European Society of Cardiology cohort, to investigate the potential association between extrapyramidal symptoms (EPS) and trimetazidine will be submitted to the MSs/RMS within 60 days after Commission Decision to be finalised prior to starting the study.
Danish: Den komplette undersøgelsesprotokol for den indlejrede case-kontrolundersøgelse inden for kohorten af »European Society of Cardiology« til undersøgelse af den potentielle forbindelse mellem ekstrapyramidale symptomer (EPS) og trimetazidin skal indsendes til medlemslandene/referencelandene senest 60 dage efter Kommissionens afgørelse og færdiggøres, inden undersøgelsen påbegyndes.
English: The MAH should perform a drug utilization study to verify the compliance of prescribers regarding the restricted indication after marketing authorisation changes.
Danish: Indehaveren af markedsføringstilladelsen skal udføre en undersøgelse af lægemiddelanvendelse med henblik på at bekræfte receptudstederes overholdelse af den indskrænkede indikation efter ændringerne til markedsføringstilladelsen.
English: The final study protocol will be submitted within 60 days from Commission decision to MSs/RMS to be finally agreed prior to starting the study.
Danish: Den endelige undersøgelsesprotokol skal indsendes senest 60 dage efter Kommissionens afgørelse til medlemslandene/referencelandene med endelig vedtagelse, inden undersøgelsen påbegyndes.