FrancophonIA/ELRC3.0 huggingface dataset:
English: In the 12-month study, Tovanor Breezhaler produced statistically significant improvements in FEV1 compared to tiotropium in the first 4 hours after dosing on day 1 and at week 26, and numerically greater values for FEV1 in the first 4 hours after dosing than tiotropium at week 12 and week 52.
Danish: I studiet på 12 måneder viste Tovanor Breezhaler statistiske signifikante forbedringer i FEV1 sammenlignet med tiotropium i de første 4 timer efter dosering på dag 1 og ved uge 26 samt numerisk højere værdier for FEV1 i de første 4 timer efter dosering end tiotropium ved uge 12 og uge 52.
English: Show the pack of Tovanor Breezhaler.
Danish: Vis dem pakken med Tovanor Breezhaler.
English: After three weeks of treatment the improvement in inspiratory capacity with Tovanor Breezhaler was similar to the first day (200 ml), exercise endurance time however had increased by 89 seconds (an increase of 21%) compared to placebo.
Danish: Efter tre ugers behandling var forbedringen i inspiratorisk kapacitet med Tovanor Breezhaler svarende til den første dag (200 ml), mens fysisk udholdenhedstid var forøget med 89 sekunder (en forøgelse på 21 %) sammenlignet med placebo.
English: The capsules must be administered only using the Tovanor Breezhaler inhaler (see section 6.6).
Danish: Kapslerne må kun tages ved hjælp af Tovanor Breezhaler-inhalatoren (se pkt.
English: At 12 weeks (primary endpoint), Tovanor Breezhaler increased trough FEV1 by 72 ml in patients with the lowest degree of reversibility (<5%) and by 113 ml in those patients with a higher degree of reversibility at baseline (≥5%) compared to placebo (both p<0.05).
Danish: Ved 12 uger (primært endepunkt) øgede Tovanor Breezhaler dal-FEV1 med 72 ml hos patienter med den laveste grad af reversibilitet (<5 %) and med 113 ml i de patienter med en højere grad af reversibilitet ved baseline (≥5 %) sammenlignet med placebo (begge p<0,05).
English: The amount of glycopyrronium delivered is 44 micrograms.
Danish: Mængden af glycopyrronium, som afgives er 44 mikrogram.
English: Tovanor Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index.
Danish: Tovanor Breezhaler reducerede ligeledes åndenød i hvile målt ved Transitional Dyspnoea Index.
English: The pooled analysis also showed fewer patients treated with Tovanor Breezhaler than with placebo experienced an exacerbation requiring hospitalisation (1.7% versus 4.2%, p=0.003).
Danish: Den samlede analyse viste også, at færre patienter på Tovanor Breezhaler sammenlignet med placebo oplevede en eksacerbation, der krævede indlæggelse (1,7 % vs. 4,2 %, p=0,003).
English: Tovanor Breezhaler is a single-dose inhaler.
Danish: Tovanor Breezhaler er en inhalator til enkeltdosering.
English: Only use the capsules with the inhaler provided in this pack (Tovanor
Danish: Brug kun kapslerne sammen med den vedlagte inhalator (Tovanor
English: Tabulated summary of adverse reactions
Danish: Tabuleret resumé af bivirkninger
English: The steady-state mean peak and trough plasma concentrations of glycopyrronium for a 44 micrograms once-daily dosing regimen were 166 picograms/ml and 8 picograms/ml, respectively.
Danish: Gennemsnitlige maksimal og minimum plasmakoncentrationer af glycopyrronium for et dosisregime på 44 mikrogram én gang dagligt ved steady state var henholdsvis 166 picogram/ml og 8 picogram/ml.
English: COPD exacerbations reduction
Danish: Reduktion i KOL-eksacerbationer
English: No specific side effects have been reported when Tovanor Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).
Danish: Der er ikke blevet indberettet yderligere bivirkninger, når Tovanor Breezhaler er blevet brugt sammen med anden medicin til behandling af KOL, som fx behovsinhalatorer (fx salbutamol), methylxanthiner (fx theophyllin) og/eller orale og inhalerede steroider (fx prednisolon).
English: In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Tovanor Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Tovanor Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
Danish: I 6-måneders-studiet var procentdelen af patienter, der oplevede moderate til svære eksacerbationer, 17,5 % for Tovanor Breezhaler og 24,2 % for placebo (hazard ratio: 0,69, p=0,023), og i 12-måneders-studiet var det 32,8 % for Tovanor Breezhaler og 40,2 % for placebo (hazard ratio: 0,66, p=0,001).
English: If you forget to use Tovanor Breezhaler
Danish: Hvis du har glemt at bruge Tovanor Breezhaler
English: - The other ingredients of the inhalation powder are lactose monohydrate and magnesium stearate.
Danish: - Øvrige indholdsstoffer i inhalationspulveret: lactosemonohydrat og magnesiumstearat.
English: For patients receiving tiotropium, 61.0% responded with a 4 point or greater improvement in SGRQ (p=0.004 compared to placebo).
Danish: Hos patienter på tiotropium reagerede 61,0 % med en forbedring på 4 point eller mere i SGRQ (p=0,004 sammenlignet med placebo).
English: Infections and infestations Nasopharyngitis
Danish: Infektioner og parasitære sygdomme Nasofaryngitis
English: What Tovanor Breezhaler contains - The active substance is glycopyrronium bromide.
Danish: Tovanor Breezhaler indeholder - Aktivt stof: glycopyrroniumbromid.
English: In COPD patients both systemic exposure and total urinary excretion of glycopyrronium at pharmacokinetic steady state increased about dose-proportionally over the dose range of 44 to 176 micrograms.
Danish: Hos KOL-patienter øges både systemisk eksponering for og samlet urinudskillelse af glycopyrronium omtrentligt dosisproportionalt i dosisområdet 44 til 176 mikrogram ved farmakokinetisk steady state.
English: Tovanor Breezhaler contains lactose
Danish: Tovanor Breezhaler indeholder lactose
English: What Tovanor Breezhaler looks like and contents of the pack Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder.
Danish: Tovanor Breezhaler 44 mikrogram inhalationspulver, hårde kapsler er gennemsigtige og orange og indeholder et hvidt pulver.
English: • Throat irritation
Danish: • Irritation i halsen
English: No dose adjustment is required in patients with hepatic impairment.
Danish: Dosisjustering er ikke påkrævet hos patienter med nedsat leverfunktion.
English: Tovanor Breezhaler is recommended to be administered, at the same time of the day each day.
Danish: Det anbefales at tage Tovanor Breezhaler på samme tidspunkt hver dag.
English: Each capsule contains 50 micrograms glycopyrronium.
Danish: Hver kapsel indeholder 50 mikrogram glycopyrronium.
English: This belongs to a group of medicines called bronchodilators.
Danish: Tovanor Breezhaler tilhører en gruppe lægemidler, der kaldes bronkodilatorer.
English: - Do not push the capsule through the foil.
Danish: - Tryk ikke kapslen gennem folien.
English: Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules glycopyrronium (as glycopyrronium bromide)
Danish: Tovanor Breezhaler 44 mikrogram inhalationspulver, hårde kapsler glycopyrronium (som glycopyrroniumbromid)
English: Some side effects are common (may affect up to 1 in 10 people)
Danish: Nogle bivirkninger er almindelige (kan forekomme hos flere end 1 ud af 10 patienter)
English: No studies have been conducted in patients with hepatic impairment.
Danish: Der er ikke udført studier i patienter med nedsat leverfunktion.
English: In patients with severe renal impairment or end-stage renal disease requiring dialysis Tovanor Breezhaler should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see sections 4.4 and 5.2).
Danish: Hos patienter med svært nedsat nyrefunktion eller slutstadiet af nyresygdom, som kræver dialyse, må Tovanor Breezhaler udelukkende bruges, hvis den forventede fordel opvejer den potentielle risiko, eftersom den systemiske eksponering for glycopyrronium kan være øget hos denne population (se pkt.
English: At 12 weeks (primary endpoint), Tovanor Breezhaler increased trough FEV1 by 108 ml in the 6-month study and by 97 ml in the 12-month study compared to placebo (both p<0.001).
Danish: Ved 12 uger (primært endepunkt) øgede Tovanor Breezhaler dal-FEV1 med 108 ml i studiet på 6 måneder og med 97 ml i studiet på 12 måneder sammenlignet med placebo (begge med p<0,001).
English: The capsules must only be removed from the blister immediately before use.
Danish: Kapslerne må først tages ud af blisteren umiddelbart inden anvendelse.
English: Tovanor Breezhaler was found to decrease dyspnoea and leg discomfort when exercising as measured using Borg scales.
Danish: Tovanor Breezhaler viste sig at kunne reducere dyspnø og ubehag i benene under motion målt ved Borg-skalaer.
English: Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 55 micrograms of glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium.
Danish: Hver leveret dosis (den dosis, der afgives fra mundstykket af inhalatoren), indeholder 55 mikrogram glycopyrroniumbromid svarende til 44 mikrogram glycopyrronium.
English: In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Tovanor Breezhaler statistically significantly prolonged time to first moderate or severe exacerbation and reduced the rate of moderate or severe COPD exacerbations (0.53 exacerbations/year versus 0.77exacerbations /year, p<0.001).
Danish: I en samlet analyse af de første 6 måneders behandling i studierne på 6 og 12 måneder forlængede Tovanor Breezhaler statistisk signifikant varigheden til første moderate eller svære eksacerbation og reducerede hyppigheden af moderate eller svære KOL-eksacerbationer sammenlignet med placebo (0,53 eksacerbationer/år mod 0,77 eksacerbationer/år, p<0,001).
English: Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules
Danish: Tovanor Breezhaler 44 mikrogram inhalationspulver, hårde kapsler
English: Alfasigma S.p.A. Tel: +39 06 91 39 4666
Danish: Tel: +39 06 91 39 4666
English: In the 6-month study, Tovanor Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p<0.001).
Danish: I studiet på 6 måneder forøgede Tovanor Breezhaler FEV1 efter første dosis med 93 ml inden for 5 minutter og 144 ml inden for 15 minutter fra doseringen sammenlignet med placebo (begge med p<0,001).
English: Some side effects may be serious but are uncommon (may affect up to 1 in 100 people)
Danish: Nogle bivirkninger kan være alvorlige og er ikke almindelige (kan forekomme hos flere end 1 ud af 100 patienter)
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Danish: Dette lægemiddel bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Tovanor Breezhaler 44 mcg inhalation powder glycopyrronium
Danish: Tovanor Breezhaler 44 mikrog inhalationspulver glycopyrronium
English: Some side effects are uncommon (may affect up to 1 in 100 people)
Danish: Nogle bivirkninger er ikke almindelige (kan forekomme hos flere end 1 ud af 100 patienter)
English: Respiratory, thoracic and mediastinal disorders Sinus congestion
Danish: Luftveje, thorax og mediastinum Tilstopning af bihuler
English: • Musculoskeletal pain
Danish: • Muskel- og skeletsmerter
English: The following pack sizes are available: Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.
Danish: Følgende pakningsstørrelser er tilgængelige: Pakninger med 6 x 1, 10 x 1, 12 x 1 og 30 x 1 kapsler og 1 inhalator.
English: What you need to know before you use Tovanor Breezhaler
Danish: Det skal du vide, før du begynder at bruge Tovanor Breezhaler
English: In patients with severe renal impairment (eGFR <30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Tovanor Breezhaler should only be used if the expected benefit outweighs the potential risk (see section 4.4).
Danish: Hos patienter med svært nedsat nyrefunktion (eGFR <30 ml/min/1,73 m2), inklusive dem med slutstadiet af nyresygdom, som kræver dialyse, må Tovanor Breezhaler kun anvendes, hvis den forventede fordel opvejer den potentielle risiko (se pkt.
English: Check capsule is empty
Danish: Tjek at kapslen er tom
English: Instructions for use of Tovanor Breezhaler inhaler
Danish: Brugsanvisning til Tovanor Breezhaler-inhalator
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain
Danish: Knogler, led, muskler og bindevæv Muskuskeletale smerter
English: • Dental caries
Danish: • Huller i tænderne
English: A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Tovanor Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Danish: En samlet analyse af de pivotale studier på 6 og 12 måneder viste, at en statistisk signifikant større procentdel af patienter på Tovanor Breezhaler reagerede med en forbedring på 4 point eller mere i SGRQ sammenlignet med placebo ved uge 26 (henholdsvis 57,8 % og 47,6 %, p<0,001).
English: In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Tovanor Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (58.4% and 46.4% respectively, p<0.001).
Danish: I en samlet analyse af de pivotale studier på 6 og 12 måneder reagerede en statistisk signifikant større procentdel af patienterne, der fik Tovanor Breezhaler, med en forbedring på 1 point eller mere i TDI-fokalscoren ved uge 26 sammenlignet med placebo (henholdsvis 58,4 % og 46,4 %, p<0,001).
English: In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Tovanor Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Danish: Hos patienter med svært nedsat nyrefunktion (estimeret glomerulær filtrationshastighed på under 30 ml/min/1,73 m herunder patienter med slutstadiet af nyresygdom, hvor dialyse er påkrævet, må Tovanor Breezhaler kun bruges, hvis den forventede fordel opvejer den potentielle risiko (se punkt 5.2).
English: In clinical studies with Tovanor Breezhaler, paradoxical bronchospasm was not observed.
Danish: Der er ikke observeret paradoks bronkospasme i kliniske studier med Tovanor Breezhaler.
English: Renal and urinary disorders Urinary tract infection
Danish: Nyrer og urinveje Urinvejsinfektioner
English: Each capsule contains 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms glycopyrronium).
Danish: Hver kapsel indeholder 63 mikrogram glycopyrroniumbromid (svarende til 50 mikrogram glycopyrronium).
English: Musculoskeletal chest pain
Danish: Muskuskeletale brystsmerter
English: • Runny or stuffy nose, sneezing, sore throat
Danish: • Løbende eller tilstoppet næse, nysen, ondt i halsen
English: Each capsule contains 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium.
Danish: Hver kapsel indeholder 63 mikrogram glycopyrroniumbromid svarende til 50 mikrogram glycopyrronium.
English: Although no formal drug interaction studies have been performed, Tovanor Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions.
Danish: Der er ikke udført formelle interaktionsstudier, men Tovanor Breezhaler er blevet anvendt sammen med andre KOL-lægemidler, herunder sympatomimetiske bronkodilatorer, methylxanthiner samt orale og inhalerede steroider, uden kliniske tegn på lægemiddelinteraktioner.
English: Multipack: 90 (3 packs of 30 x 1) capsules + 3 inhalers.
Danish: Multipakning: 90 kapsler (3 pakninger af 30 x 1) + 3 inhalatorer.
English: EXP The inhaler in each pack should be disposed of after all capsules in that pack have been used.
Danish: EXP Smid inhalatoren i hver pakning ud når alle kapsler i pakningen er brugt.
English: Multipack: 96 (4 packs of 24 x 1) capsules + 4 inhalers.
Danish: Multipakning: 96 kapsler (4 pakninger af 24 x 1) + 4 inhalatorer.
English: Multipack comprising 3 packs (30 capsules + 1 inhaler)
Danish: Multipakning bestående af 3 pakninger (30 kapsler + 1 inhalator)
English: Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhalers.
Danish: Multipakning bestående af 96 kapsler (4 pakninger af 24x1) og 4 inhalatorer.
English: 2) Reports have been received from post-approval marketing experience in association with the use of Tovanor Breezhaler.
Danish: 2) Rapporteret efter markedsføring i forbindelse med brug af Tovanor Breezhaler og indberettet frivilligt fra en population af ukendt størrelse.
English: Multipacks containing 90 (3 packs of 30x1) hard capsules and 3 inhalers.
Danish: Multipakning bestående af 90 kapsler (3 pakninger af 30x1) og 3 inhalatorer.
English: What Tovanor Breezhaler is and what it is used for What you need to know before you use Tovanor Breezhaler How to use Tovanor Breezhaler Possible side effects
Danish: Det skal du vide, før du begynder at bruge Tovanor Breezhaler Sådan skal du bruge Tovanor Breezhaler Bivirkninger
English: Multipack: 150 (25 packs of 6 x 1) capsules + 25 inhalers.
Danish: Multipakning: 150 kapsler (25 pakninger af 6 x 1) + 25 inhalatorer.
English: Multipack: 150 (15 packs of 10 x 1) capsules + 15 inhalers.
Danish: Multipakning: 150 kapsler (15 pakninger af 10 x 1) + 15 inhalatorer.
English: PA/Alu/PVC - Alu perforated unit-dose blister Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.
Danish: Pakninger, som indeholder 6x1, 10x1, 12x1 eller 30x1 kapsler og én inhalator.
English: The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 44 micrograms of glycopyrronium.
Danish: som afgives fra mundstykket af inhalatoren) svarer til 44 mikrogram glycopyrronium.
English: How to use Tovanor Breezhaler
Danish: Sådan skal du bruge Tovanor Breezhaler
English: - COPD is a long-term disease and you should use this medicine every day and not only when you have breathing problems or other symptoms of COPD.
Danish: Hvor længe skal du fortsætte med Tovanor Breezhaler-behandling - Fortsæt med at bruge dette lægemiddel, så længe din læge siger, at du skal gøre det. - KOL er en kronisk sygdom, og du skal bruge dette lægemiddel hver dag og ikke blot, når du har åndedrætsbesvær eller andre symptomer på KOL.
English: Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.
Danish: Multipakning bestående af 150 kapsler (25 pakninger af 6x1) og 25 inhalatorer.
English: Dental caries
Danish: Hjerte Atrieflimren
English: The usual dose is to inhale the content of one capsule each day.
Danish: Så meget Tovanor Breezhaler skal du tage Den sædvanlige dosis er inhalation af én kapsel dagligt.
English: Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.
Danish: Multipakning bestående af 150 kapsler (15 pakninger af 10x1) og 15 inhalatorer.
English: 30 x 1 capsules + 1 inhaler.
Danish: 30 x 1 kapsler + 1 inhalator.
English: • Numbness
Danish: • Kløe
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid Tovanor Breezhaler nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: • Irregular heart beat
Danish: Uregelmæssig hjerterytme
English: Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene.
Danish: Selve inhalatoren og hætten er fremstillet af acrylonitrilbutadienstyren.
English: • Difficulty and pain when passing urine
Danish: • Vanskelig og smertefuld vandladning
English: The inhaler in each pack should be disposed of after all capsules in that pack have been used.
Danish: - Smid inhalatoren i hver pakning ud efter alle kapsler i pakningen er brugt.
English: Do not remove from the blister until immediately before use.
Danish: Må først tages ud af blisteren lige før brug.
English: Your Seebri Breezhaler Inhaler pack contains: • One Seebri Breezhaler inhaler
Danish: Din Tovanor Breezhaler inhalatorpakning indeholder:
English: • Cough with sputum
Danish: • Hoste med opspyt
English: • Dry mouth
Danish: • Næseblod
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: - Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: Excipients
Danish: • Udslæt
English: How long to continue your treatment with Tovanor Breezhaler - Keep using this medicine for as long as your doctor tells you.
Danish: Brug af anden medicin sammen med Tovanor Breezhaler Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Administratio n
English: Immediate Packaging Content (concentration)
Danish: Indhold (Koncent ration)
English: Contribute to the creation of an environment that stimulates innovation
Danish: Bidrage til at skabe et miljø, der stimulerer innovation
English: This will be done within the context of the 7th Framework Programme.
Danish: Dette vil blive gjort inden for rammerne af det syvende rammeprogram.
English: NATIONAL COMPETENT AUTHORITIES 4,000 EUROPEAN EXPERTS
Danish: NATIONALE KOMPETENTE MYNDIGHEDER 4 000 EUROPÆISKE EKSPERTER
English: Participate in international standardisation activities.
Danish: Deltage i internationale standardiseringsaktiviteter.
English: The certificate of compliance is valid throughout the European Community.
Danish: Overensstemmelsescertifikatet er gyldigt i hele Det Europæiske Fællesskab.
English: This situation is expected to continue for 2008.
Danish: Denne situation forventes at fortsætte i 2008.
English: A number of activities are underway with this goal in mind.
Danish: En række aktiviteter er undervejs med dette mål for øje.
English: This will be done in collaboration with the national competent authorities.
Danish: Dette vil ske i samarbejde med de nationale kompetente myndigheder.
English: The documents will be improved in the light of stakeholders' expectations.
Danish: Disse dokumenter vil blive forbedret i lyset af interessenternes forventninger.
English: The number of variations is growing every year.
Danish: Antallet af ændringer stiger år for år.
English: This document is a summary of the Agency's work programme for 2008.
Danish: Dette dokument er et sammendrag af agenturets arbejdsprogram for 2008.
English: Please note that figures for 2008 are estimates only.
Danish: Bemærk, at tallene for 2008 blot er skøn.
English: Head: David Mackay
Danish: Leder: David Mackay
English: Consequently, the number of new veterinary pharmaceutical medicines for food-producing animals will remain at a low level.
Danish: Som følge heraf vil antallet af nye veterinærmedicinske lægemidler til fødevareproducerende dyr forblive på et lavt niveau.
English: The HMPC plans to establish 20 monographs and 10 list entries this year.
Danish: HMPC planlægger at udarbejde 20 monografier og foretage 10 listeopførelser i år.
English: The number of applications for initial marketing authorisation has doubled over the last four years.
Danish: Antallet af ansøgninger om oprindelige markedsføringstilladelser er fordoblet i løbet af de seneste fire år.
English: 1.6. International cooperation
Danish: 1.6 Internationalt samarbejde
English: Further interaction will develop in the areas specified by the European Commission.
Danish: Der vil blive udviklet et yderligere samarbejde på de områder, Europa-Kommissionen har specificeret.