FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 150 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Danish: Kartoner med 98 tabletter i PVC/PVDC/aluminiumblistere.
English: EU/1/98/086/023 - 14 tablets EU/1/98/086/024 - 28 tablets EU/1/98/086/031 - 30 tablets EU/1/98/086/025 - 56 tablets EU/1/98/086/028 - 56 x 1 tablets EU/1/98/086/026 - 84 tablets EU/1/98/086/034 - 90 tablets EU/1/98/086/027 - 98 tablets
Danish: EU/1/98/086/023 - 14 tabletter EU/1/98/086/024 - 28 tabletter EU/1/98/086/031 - 30 tabletter EU/1/98/086/025 - 56 tabletter EU/1/98/086/028 - 56 x 1 tabletter EU/1/98/086/026 - 84 tabletter EU/1/98/086/034 - 90 tabletter EU/1/98/086/027 - 98 tabletter
English: No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Danish: Dosisjustering er ikke nødvendig til patienter med nedsat nyrefunktion, hvis den renale kreatinin-clearance er  30 ml/min (se pkt.
English: EU/1/98/086/011 - 14 tablets EU/1/98/086/012 - 28 tablets EU/1/98/086/029 - 30 tablets EU/1/98/086/013 - 56 tablets EU/1/98/086/014 - 56 x 1 tablets EU/1/98/086/021 - 84 tablets EU/1/98/086/032 - 90 tablets EU/1/98/086/015 - 98 tablets
Danish: EU/1/98/086/011 - 14 tabletter EU/1/98/086/012 - 28 tabletter EU/1/98/086/029 - 30 tabletter EU/1/98/086/013 - 56 tabletter EU/1/98/086/014 - 56 x 1 tabletter EU/1/98/086/021 - 84 tabletter EU/1/98/086/032 - 90 tabletter EU/1/98/086/015 - 98 tabletter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: What CoAprovel looks like and contents of the pack CoAprovel 300 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Danish: CoAprovel 300 mg/12,5 mg tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2776 på den anden side.
English: Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/12.5 mg combination may respond when uptitrated to 300 mg/25 mg.
Danish: Begrænsede kliniske data (7 patienter ud af 22) tyder på, at patienter, som ikke er tilstrækkelig regulerede med 300 mg/12,5 mg-kombinationen, kan respondere ved dosisøgning til 300/25 mg. Der er hos disse patienter observeret en øgning i blodtryksreduktionen for såvel systolisk blodtryk (SBP) som diastolisk blodtryk (DBP) (henholdsvis 13,3 mmHg og 8,3 mmHg).
English: EU/1/98/086/016 - 14 tablets EU/1/98/086/017 - 28 tablets EU/1/98/086/030 - 30 tablets EU/1/98/086/018 - 56 tablets EU/1/98/086/019 - 56 x 1 tablets EU/1/98/086/022 - 84 tablets EU/1/98/086/033 - 90 tablets EU/1/98/086/020 - 98 tablets
Danish: EU/1/98/086/016 - 14 tabletter EU/1/98/086/017 - 28 tabletter EU/1/98/086/030 - 30 tabletter EU/1/98/086/018 - 56 tabletter EU/1/98/086/019 - 56 x 1 tabletter EU/1/98/086/022 - 84 tabletter EU/1/98/086/033 - 90 tabletter EU/1/98/086/020 - 98 tabletter
English: When necessary, CoAprovel may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Danish: Om nødvendigt kan CoAprovel kombineres med andre antihypertensiva (se pkt.
English: What CoAprovel looks like and contents of the pack CoAprovel 300 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Danish: CoAprovel 300 mg/12,5 mg filmovertrukne tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2876 på den anden side.
English: CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: CoAprovel 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: What CoAprovel looks like and contents of the pack CoAprovel 150 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Danish: CoAprovel 150 mg/12,5 mg filmovertrukne tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2875 på den anden side.
English: What CoAprovel looks like and contents of the pack CoAprovel 150 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Danish: CoAprovel 150 mg/12,5 mg tabletter er ferskenfarvet, bikonvekse, ovalformede med et hjerte præget på den ene side og nummeret 2775 på den anden side.
English: Package leaflet: Information for the patient CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren CoAprovel 300 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
English: CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: CoAprovel 300 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: Package leaflet: Information for the patient CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren CoAprovel 150 mg/12,5 mg tabletter irbesartan/hydrochlorthiazid
English: Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Danish: Kartoner med 90 tabletter i PVC/PVDC/aluminiumblistere.
English: Cartons of 30 film-coated tablets in PVC/PVDC/Aluminium blisters.
Danish: Kartoner med 30 tabletter i PVC/PVDC/aluminiumblistere.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Danish: Ferskenfarvet, bikonveks, oval, med et hjerte præget på den ene side, og nummeret 2776 præget på den anden side.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Danish: Ferskenfarvet, bikonveks, oval, med et hjerte præget på den ene side, og nummeret 2876 præget på den anden side.
English: Package leaflet: Information for the patient CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren CoAprovel 150 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 300 mg irbesartan og 12,5 mg hydrochlorthiazid.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Danish: Ferskenfarvet, bikonveks, oval, med et hjerte præget på den ene side, og nummeret 2775 præget på den anden side.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Danish: Ferskenfarvet, bikonveks, oval, med et hjerte præget på den ene side, og nummeret 2875 præget på den anden side.
English: Posology
Danish: Hoste
English: Package leaflet: Information for the patient CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Danish: Indlægsseddel: Information til brugeren CoAprovel 300 mg/12,5 mg filmovertrukne tabletter irbesartan/hydrochlorthiazid
English: CoAprovel 150 mg/12.5 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN CoAprovel 150 mg/12,5 mg filmovertrukne tabletter.
English: Cartons of 84 film-coated tablets in PVC/PVDC/Aluminium blisters.
Danish: Kartoner med 84 tabletter i PVC/PVDC/aluminiumblistere.
English: cardiac arrhythmias
Danish: Hjertearytmi
English: 37100 Tours - France
Danish: F-75008 Paris - Frankrig
English: Fri
Danish: Lø
English: Sun
Danish: On
English: Thu
Danish: Ti
English: hyperkalaemia
Danish: Magnesiumstearat
English: Treatment is given for 5 to 14 days.
Danish: Behandlingen gives i 5-14 dage.
English: The main measure of effectiveness in both studies was whether the infection was cured.
Danish: Det primære mål for virkning i begge studier var, om infektionen blev kureret.
English: Further information on Quofenix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/quofenix.
Danish: Yderligere information om Quofenix findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/quofenix.
English: Quofenix must not be used in children or adolescents under 18 years of age.
Danish: Quofenix bør ikke bruges til børn eller unge under 18 år.
English: As a result, the bacteria cannot multiply and die.
Danish: Som følge heraf kan bakterierne ikke formere sig, og de dør.
English: It must not be used in women who are pregnant or breast feeding, or women who are able to have children who are not using contraception.
Danish: Det må ikke anvendes hos kvinder, der er gravide eller ammer, eller kvinder, der kan blive gravide, og som ikke bruger prævention.
English: As for all medicines, data on the use of Quofenix are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Quofenix løbende overvåget.
English: After starting with a drip, the doctor may decide to switch to a tablet by mouth once every 12 hours.
Danish: Efter at være startet med indgivelse via drop kan lægen beslutte at skifte til en tablet, der tages gennem munden hver 12. time.
English: It contains the active substance delafloxacin.
Danish: Det indeholder det aktive stof delafloxacin.
English: Fluoroquinolones work by preventing bacteria involved in skin infections from making copies of their DNA (genetic material).
Danish: Fluoroquinoloner virker ved at forhindre de bakterier, der er involveret i hudinfektioner, i at lave kopier af deres dna (genetisk materiale).
English: Other information about Quofenix
Danish: Andre oplysninger om Quofenix
English: What measures are being taken to ensure the safe and effective use of Quofenix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Quofenix?
English: The European Medicines Agency decided that Quofenix's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Quofenix opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Quofenix are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Quofenix vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: Quofenix is available as a powder to be made into a solution for infusion (300 mg) and as tablets (450 mg).
Danish: Quofenix fås som et pulver, der anvendes til at fremstille en injektionsvæske (300 mg), og som tabletter (450 mg).
English: For more information about using Quofenix, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Quofenix, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: The active substance in Quofenix, delafloxacin, belongs to a group of antibiotics called fluoroquinolones.
Danish: Det aktive stof i Quofenix, delafloxacin, tilhører en gruppe antibiotika, der kaldes fluoroquinoloner.
English: Since Quofenix's safety profile was similar to that of other fluoroquinolones, it was considered that, as for other fluoroquinolones, it should be authorised for use only when other antibiotics are not suitable.
Danish: Da Quofenix' sikkerhedsprofil svarede til sikkerhedsprofilen for andre fluoroquinoloner, blev det vurderet, at det ligesom andre fluoroquinoloner kun bør godkendes til brug, når andre antibiotika ikke er egnede.
English: Quofenix is given by infusion (drip) into a vein over one hour every 12 hours.
Danish: Quofenix indgives hver 12. time ved infusion (drop) i en blodåre over et tidsrum på 1 time.
English: The most common side effects with Quofenix (which may affect up to 1 in 10 people) are diarrhoea and nausea (feeling sick), which are mild to moderate.
Danish: De hyppigste bivirkninger ved Quofenix (som kan forekomme hos op til 1 ud af 10 personer) er diarré og kvalme i mild til moderat grad.
English: An overview of Quofenix and why it is authorised in the EU
Danish: En oversigt over Quofenix, og hvorfor det er godkendt i EU
English: Why is Quofenix authorised in the EU?
Danish: Hvorfor er Quofenix godkendt i EU?
English: Quofenix can only be obtained with a prescription and prescribers should take into account official guidance on the use of antibiotics.
Danish: Quofenix fås kun på recept, og den ordinerende læge skal følge de officielle retningslinjer for brug af antibiotika.
English: Persistent and disabling side effects have occurred with fluoroquinolone antibiotics in some patients.
Danish: Vedvarende og invaliderende bivirkninger er observeret med fluoroquinolon-antibiotika hos nogle patienter.
English: Quofenix has a different chemical structure to other fluoroquinolones, which means that it can enter bacterial cells more easily.
Danish: Quofenix har en anden kemisk struktur end andre fluoroquinoloner, og det betyder, at det lettere kan trænge ind i bakterieceller.
English: Quofenix is an antibiotic used in adults to treat bacterial infections of the skin and underlying tissues (acute bacterial skin and skin structure infections) when other medicines are not suitable.
Danish: Quofenix er et antibiotikum, der anvendes hos voksne til behandling af bakterieinfektioner i huden og det underliggende væv (akutte bakterieinfektioner i hud og hudstrukturer), når andre lægemidler ikke er egnede.
English: What is Quofenix and what is it used for?
Danish: Hvad er Quofenix, og hvad anvendes det til?
English: Quofenix must not be used in patients who are hypersensitive (allergic) to quinolone or fluoroquinolone antibiotics or in patients who have had tendon disorders related to treatment with a fluoroquinolone antibiotic.
Danish: Quofenix må ikke anvendes hos patienter, der er overfølsomme over for quinolon- eller fluoroquinolon-antibiotika, eller hos patienter, der har haft seneproblemer som følge af behandling med et fluoroquinolon-antibiotikum.
English: Quofenix was shown to be as effective as alternative antibiotics in two main studies of adults with acute bacterial skin and skin structure infections.
Danish: Det er påvist, at Quofenix er lige så effektivt som andre antibiotika i to hovedstudier med voksne, der havde akutte bakterieinfektioner i hud og hudstrukturer.
English: For the full list of side effects and restrictions with Quofenix, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Quofenix fremgår af indlægssedlen.
English: Quofenix is as effective as alternative antibiotics given into a vein in treating acute bacterial skin and skin structure infections and offers the possibility of switching to treatment by mouth, which may be more convenient for the patient and could reduce hospitalisation costs.
Danish: Quofenix er lige så effektivt som alternative antibiotika, der gives i en blodåre, til behandling af akutte bakterieinfektioner i hud og hudstrukturer, og det giver mulighed for at skifte til behandling gennem munden, hvilket kan være nemmere for patienterne og reducere omkostningerne til hospitalsindlæggelse.
English: After treatment for up to 14 days, 58% of patients who received Quofenix were cured of their infection compared with 60% of patients who received vancomycin and aztreonam.
Danish: Efter behandling i op til 14 dage var 58 % af de patienter, der fik Quofenix, kureret for deres infektion, sammenholdt med 60 % af de patienter, der fik vancomycin og aztreonam.
English: What are the risks associated with Quofenix?
Danish: Hvilke risici er der forbundet med Quofenix?
English: In the first study involving 660 patients, Quofenix given into a vein was compared with vancomycin plus aztreonam (two other antibiotics) both given into a vein.
Danish: I det første studie med 660 patienter blev Quofenix givet i en blodåre og sammenlignet med vancomycin plus aztreonam (to andre antibiotika), som også blev givet i en blodåre.
English: In the second study involving 850 patients, Quofenix given into a vein for 3 days and afterwards given as tablets by mouth was compared with vancomycin plus aztreonam given into a vein.
Danish: I det andet studie med 850 patienter blev Quofenix givet i en blodåre i 3 dage og derefter som tabletter gennem munden; denne behandling blev sammenlignet med vancomycin plus aztreonam givet i en blodåre.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Quofenix 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 Quofenix.
English: How is Quofenix used?
Danish: Hvordan anvendes Quofenix?
English: How does Quofenix work?
Danish: Hvordan virker Quofenix?
English: patients treated with Quofenix were cured of their infection, compared with 51% of patients treated with vancomycin and aztreonam.
Danish: dages behandling var 52 % af de patienter, der fik Quofenix, kureret for deres infektion, sammenholdt med 51 % af de patienter, der fik vancomycin og aztreonam.
English: What benefits of Quofenix have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Quofenix?
English: After up to 14 days of treatment, 52% of
Danish: Efter op til 14
English: The
Danish: To
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC
Danish: Resultatet af en procedure i henhold til artikel 29 i direktiv 2001/83/EF
English: The European Commission issued a decision on 19 November 2012.
Danish: Europa-Kommissionen traf en afgørelse den 19. november 2012.
English: EMA/480596/2012 rev1 EMEA/H/A-29/1338
Danish: Den 19. november 2012 EMA/480596/2012 rev1 EMEA/H/A-29/1338
English: However, the Member States were not able to reach an agreement and the Portuguese medicines agency referred the matter to the CHMP for arbitration on 31 May 2012.
Danish: Medlemsstaterne kunne imidlertid ikke nå til enighed, og den portugisiske lægemiddelmyndighed indbragte sagen for CHMP med henblik på voldgift den 31. maj 2012.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Danish: lægemidler er bioækvivalente, når de frembringer samme mængde af det aktive stof i kroppen.
English: As a result, blood glucose is reduced and this helps to control type 2 diabetes.
Danish: Derved nedsættes blodsukkeret, hvilket medvirker til at regulere type 2-diabetes.
English: The active substance, glimepiride, stimulates the pancreas to produce more insulin.
Danish: Det aktive stof, glimepirid, stimulerer bugspytkirtlen til at producere mere insulin.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Portugal) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Cyprus, France, Germany, Italy, Sweden and the United Kingdom).
Danish: Ved denne procedure vurderer én medlemsstat ("referencemedlemsstaten", her Portugal) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land samt i andre medlemsstater (de "berørte medlemsstater", her Cypern, Frankrig, Tyskland, Italien, Sverige og Det Forenede Kongerige).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Glimepirida Parke-Davis outweigh its risks, and that the marketing authorisation can be granted in Portugal and in the following Member States of the EU: Cyprus, France, Germany, Italy, Sweden and the United Kingdom.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Glimepirida Parke-Davis opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Portugal og i følgende EU-medlemsstater: Cypern, Frankrig, Tyskland, Italien, Sverige og Det Forenede Kongerige.
English: Glimepirida Parke-Davis is a medicine used to treat type 2 diabetes (a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively).
Danish: Glimepirida Parke-Davis er et lægemiddel, der anvendes til behandling af type 2-diabetes (en sygdom, hvor bugspytkirtlen enten ikke producerer nok insulin til at regulere blodsukkeret, eller hvor kroppen ikke er i stand til at udnytte insulinet tilstrækkeligt).
English: What is Glimepirida Parke-Davis?
Danish: Hvad er Glimepirida Parke-Davis?
English: On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Glimepirida Parke-Davis (glimepiride, tablets 2, 3 and 4 mg).
Danish: Den 19. juli 2012 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) vedrørende godkendelsen af lægemidlet Glimepirida Parke-Davis (glimepirid, tabletter, 2, 3 og 4 mg).
English: Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) EMA/480596/2012 rev1
Danish: Spørgsmål og svar om Glimepirida Parke-Davis (glimepirid, tabletter, 2, 3 og 4 mg) EMA/480596/2012 rev1
English: Why was Glimepirida Parke-Davis reviewed?
Danish: Hvorfor blev Glimepirida Parke-Davis vurderet igen?
English: Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg)
Danish: Spørgsmål og svar om Glimepirida Parke-Davis (glimepirid, tabletter, 2, 3 og 4 mg)
English: bioequivalence study submitted by the company was carried out using 1 mg of Glimepirida ParkeDavis, and the results were applied to the higher strengths.
Danish: Den bioækvivalensundersøgelse, der blev forelagt af virksomheden, blev udført med 1 mg Glimepirida Parke-Davis, og resultaterne heraf blev anvendt på de højere styrker.
English: Glimepirida Parke-Davis is a ‘generic medicine', which means that it is similar to a ‘reference medicine', already authorised in the EU, called Amaryl.
Danish: Det betyder, at Glimepirida Parke-Davis svarer til et referencelægemiddel, som allerede er godkendt i EU (Amaryl).
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the bioequivalence study conducted with the 1 mg tablet is adequate to show that the higher strengths of Glimepirida Parke-Davis and Amaryl are also bioequivalent.
Danish: På baggrund af vurderingen af de aktuelt foreliggende data var og den videnskabelige drøftelse i udvalget besluttede CHMP, at den bioækvivalensundersøgelse, der blev udført med 1-mg-tabletten, var tilstrækkelig til at påvise, at Glimepirida Parke-Davis og Amaryl også er bioækvivalente i de højere styrker.
English: The CHMP therefore concluded that, as Glimepirida Parke-Davis 2, 3 and 4 mg strengths are bioequivalent to the reference medicine, marketing authorisation should be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at Glimepirida Parke-Davis i styrkerne 2, 3 og 4 mg, er bioækvivalent med referencelægemidlet, og anbefalede udstedelse af markedsføringstilladelse i de berørte medlemsstater.