FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel Teva Generics B.V. to Teva Generics B.V. on 28 October 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Teva Generics B.V.
English: The Committee recommended that Clopidogrel Teva Generics B.V. be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Teva Generics B.V.
English: Clopidogrel Teva Generics B.V. can be given to the following groups of patients:
Danish: kan gives til følgende patientgrupper:
English: What are the benefit and risk of Clopidogrel Teva Generics B.V.?
Danish: Hvad er risk/benefit-forholdet for Clopidogrel Teva Generics B.V.
English: Other information about Clopidogrel Teva Generics B.V.:
Danish: Andre oplysninger om Clopidogrel Teva Generics B.V.
English: Clopidogrel Teva Generics B.V. is a medicine that contains the active substance clopidogrel.
Danish: er et lægemiddel, som indeholder det aktive stof clopidogrel.
English: Clopidogrel Teva Generics B.V. is converted into its active form in the body.
Danish: omdannes til sin aktive form i kroppen.
English: What is Clopidogrel Teva Generics B.V.?
Danish: Hvad er Clopidogrel Teva Generics B.V.
English: How does Clopidogrel Teva Generics B.V. work?
Danish: Hvordan virker Clopidogrel Teva Generics B.V.
English: How is Clopidogrel Teva Generics B.V. used?
Danish: Hvordan anvendes Clopidogrel Teva Generics B.V.
English: Why has Clopidogrel Teva Generics B.V. been approved?
Danish: Hvorfor blev Clopidogrel Teva Generics B.V.
English: June 2008
Danish: Juni 2008
English: 19 March 2009
Danish: 19. marts 2009
English: The European Commission issued a decision on 26 May 2009.
Danish: Europa-Kommissionen traf en afgørelse den 26. maj 2009.
English: Second and third trimester of pregnancy (section 4.4 and 4.6).
Danish: Graviditet i andet og tredje trimester (afsnit 4.4 og 4.6).
English: Ref. EMEA/CHMP/335293/2009 EMEA/H/A-30/1000
Danish: EMEA/CHMP/356528/2009 EMEA/H/A-30/1000
English: Company responses provided on: 27 October 2008, 16 February 2009 Opinion date:
Danish: Virksomhedens svar afgivet den: 27. oktober 2008, 16, februar 2009 Dato for udtalelsen:
English: Dr Liv Mathiesen (Norway)
Danish: Liv Mathiesen (Norge)
English: Diovan Comp and associated names are authorised in the EU via national procedures.
Danish: Diovan Comp og tilknyttede navne er godkendt i EU efter nationale procedurer.
English: The review was carried out under an ‘Article 30' referral1.
Danish: Undersøgelsen blev gennemført som følge af en sag indbragt i henhold til artikel 301.
English: London, 28 May 2009 Doc.
Danish: London, den 28. maj 2009 Ref. dok.
English: In addition, before prescribing higher strengths of Diovan Comp, doctors should consider that in most patients maximal effects are observed within four weeks, but in some patients four to eight weeks treatment may be required.
Danish: Desuden bør lægerne, inden der ordineres højere dosisstyrker af Diovan Comp, tage i betragtning, at den maksimale effekt ses inden for fire uger hos de fleste patienter, men hos nogle patienter kan det være nødvendigt med fire til otte ugers behandling.
English: What is Diovan Comp?
Danish: Hvad er Diovan Comp?
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Danish: 1 Artikel 30 i direktiv 2001/83/EF, med senere ændringer, indbringelse, fordi medlemsstaterne har vedtaget indbyrdes afvigende afgørelser.
English: Severe renal impairment (creatinine clearance <30 ml/min), anuria.
Danish: Alvorlig nyreinsufficiens (kreatininclearance <30 ml/min), anuria.
English: The Committee also removed a contraindication for women who are breastfeeding because it considered that the amount of hydrochlorothiazide found in breast milk was very low.
Danish: Udvalget fjernede også en kontraindikation for kvinder, der ammer, da det fandt, at mængden af hydrochlorthiazid fundet i brystmælk var meget lav.
English: The new wording clarifies the possible interactions with Diovan Comp, and identifies which interactions are linked to each, or to both, active substances.
Danish: Den nye formulering tydeliggør de eventuelle interaktioner med Diovan Comp og påviser, hvilke interaktioner der er knyttet til hvert enkelt eller begge de aktive stoffer.
English: Questions and answers on the referral for Diovan Comp and associated names tablets containing valsartan (80, 160 or 320 mg) and hydrochlorothiazide (12.5 or 25 mg)
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Diovan Comp og tilknyttede navne tabletter indeholdende valsartan (80, 160 eller 320 mg) og hydrochlorthiazid (12,5 eller 25 mg).
English: Diovan Comp is used to treat patients with hypertension (high blood pressure), and is also available in the EU under other trade names: Co-Angiosan, Co-Angiosane, Co-Dalzad, Co-Diovan, Co-Diovane, Co-Novasan, Co-Novocard, Cordinate Plus, Corixil, Co-Tareg, Cotareg, Diovan HCT, Kalpress Plus, Levetix, Mitten Plus, Nazzec, Provas Comp, Provas Plus, and Valsartan/Hydroklortiazide.
Danish: Diovan Comp anvendes til behandling af patienter med hypertension (forhøjet blodtryk) og findes også i EU under andre handelsnavne: Co-Angiosan, Co-Angiosane, Co-Dalzad, Co-Diovan, CoDiovane, Co-Novasan, Co-Novocard, Cordinate Plus, Corixil, Co-Tareg, Cotareg, Diovan HCT, Kalpress Plus, Levetix, Mitten Plus, Nazzec, Provas Comp, Provas Plus og Valsartan/Hydroklortiazid.
English: The new wording also means that in all member states Diovan Comp will also be used in patients previously treated with hydrochlorothiazide.
Danish: Den nye formulering betyder ligeledes, at Diovan Comp i alle medlemsstater også vil blive anvendt til patienter, som tidligere er blevet behandlet med hydrochlorthiazid.
English: Diovan Comp contains two active substances, valsartan and hydrochlorothiazide.
Danish: Diovan Comp indeholder de to aktive stoffer valsartan og hydrochlorthiazid.
English: The Committee also harmonised the SPC section on interactions with other medicines.
Danish: Udvalget harmoniserede ligeledes afsnittet i produktresuméet om interaktion med andre lægemidler.
English: The CHMP agreed on a harmonised indication (the disease for which the medicine may be used): “Treatment of essential hypertension in adults.
Danish: CVMP godkendte en harmoniseret indikation (den sygdom, som lægemidlet kan anvendes til): "Behandling af essentiel hypertension hos voksne.
English: Valsartan works by blocking the effect of angiotensin II.
Danish: Valsartan virker ved at blokere virkningen af angiotensin II.
English: Why was Diovan Comp reviewed?
Danish: Hvorfor blev Diovan Comp vurderet?
English: The European Medicines Agency (EMEA) has completed a review of Diovan Comp and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har foretaget en vurdering af Diovan Comp og tilknyttede navne.
English: This has led to differences in the way the medicine can be used in the different member states where the medicine is marketed, as reflected in the Summaries of Product Characteristics (SPCs), labelling and package leaflets.
Danish: Dette har medført forskelle i lægemidlets anvendelsesmåde i de forskellige medlemsstater, hvor lægemidlet markedsføres, hvilket fremgår af forskelle i produktresuméer, etikettering og indlægssedler.
English: On 27 May 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Diovan Comp and associated names in the EU and the EEA.
Danish: Den 27. maj 2008 henviste Europa-Kommissionen sagen til Udvalget for Humanmedicinske Lægemidler med henblik på harmonisering af markedsføringstilladelserne for Diovan Comp og tilknyttede navne i EU og EØS.
English: The CHMP recommended wordings for the dosage section giving more precise instructions on how to switch to Diovan Comp.
Danish: CHMP anbefalede ordlyden til doseringsafsnittet indeholdende mere præcise instruktioner om, hvordan skiftet til Diovan Comp skal ske.
English: Valsartan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure.
Danish: Valsartan tilhører en gruppe lægemidler kaldet angiotensin II-receptorantagonister, som medvirker til at kontrollere højt blodtryk.
English: The contraindications removed were: hepatic encephalopathy, biliary obstruction, gout and Addison's disease.
Danish: De kontraindikationer, der blev fjernet, var: leverencefalopati, biliær obstruktion, urinsyregigt og Addisons sygdom.
English: Severe hepatic impairment, biliary cirrhosis and cholestasis.
Danish: Alvorlig leverinsufficiens, biliær cirrhose og cholestasis.
English: Angiotensin II is a substance in the body that causes vessels to tighten, thus causing blood pressure to increase.
Danish: Angiotensin II er et stof i kroppen, der medfører forsnævring af blodkarrene og dermed en stigning i blodtrykket.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diovan Comp in the European Union (EU) and the European Economic Area (EEA).
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) er af den opfattelse, at der er behov for at harmonisere ordinationsoplysningerne for Diovan Comp i Den Europæiske Union (EU) og Det Europæiske Økonomiske Samarbejdsområde (EØS).
English: The CHMP also agreed on a harmonised wording for the contra-indications (situations where the medicine must not be used): Hypersensitivity to valsartan, hydrochlorothiazide, other sulfonamide-derived medicinal products or to any of the excipients.
Danish: CHMP godkendte også en harmoniseret formulering af kontraindikationer (situationer, hvor lægemidlet ikke må anvendes): Overfølsomhed over for valsartan, hydrochlorthiazid, andre sulfonamid-afledte lægemidler eller over for et eller flere af hjælpestofferne.
English: In particular, the CHMP agreed that patients not adequately controlled with valsartan or hydrochlorothiazide can be switched directly to Diovan Comp as long as the new treatment is in line with the recommended dosages for the individual active substances.
Danish: CHMP nåede navnlig til enighed om, at patienter, som ikke opnår tilstrækkelig blodtrykskontrol med valsartan eller hydrochlorthiazid, kan skifte direkte til Diovan Comp, når blot den nye behandling er i overensstemmelse med de anbefalede doser for de enkelte aktive stoffer.
English: The CHMP discussed how Diovan Comp, which is a fixed-dose combination of two active substances, should be introduced in to the treatment of patients whose blood pressure is not controlled with either of the active substances used alone.
Danish: CHMP drøftede, hvordan Diovan Comp, der er en fastdosiskombination af to aktive stoffer, skulle indføres i behandlingen af patienter, som ikke opnår tilstrækkelig blodtrykskontrol med et af de aktive stoffer alene.
English: The CHMP harmonised the SPC section on special warnings and included warnings about photosensitivity and problems with the function of the parathyroid glands in patients taking ‘thiazide' diuretics such as hydrochlorothiazide.
Danish: CHMP harmoniserede afsnittet i produktresuméet om særlige advarsler og medtog advarsler om lysfølsomhed og problemer med biskjoldbruskkirtlernes funktion hos patienter, der tager thiaziddiuretika, herunder hydrochlorthiazid.
English: The CHMP discussed the use of Diovan Comp in patients previously treated with other angiotensin II receptor antagonists and agreed that the switch to Diovan Comp should only be for patients previously treated with valsartan.
Danish: CHMP drøftede brugen af Diovan Comp til patienter, der tidligere er blevet behandlet med andre angiotensin II-receptorantagonister, og nåede til enighed om, at patienter, der tidligere er blevet behandlet med valsartan, skulle kunne skifte til Diovan Comp.
English: patients whose blood pressure is not adequately controlled on valsartan or hydrochlorotiazide monotherapy”
Danish: Diovan Comp fastdosiskombination er indiceret til patienter, hvis blodtryk ikke kan bringes tilfredsstillende under kontrol med valsartan eller hydrochlorthiazid monoterapi".
English: Diovan Comp was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det blev bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentrale procedurer (CMD(h)), at Diovan Comp skulle harmoniseres.
English: Refractory hypokalaemia, hyponatraemia, hypercalcaemia, and symptomatic hyperuricaemia.” The Committee noted that some contra-indications that were included in the SPC in some member states could be removed, as they were now covered by the harmonised wording.
Danish: Udvalget bemærkede, at nogle kontraindikationer i produktresuméet i nogle medlemsstater kunne fjernes, da de nu var omfattet af den harmoniserede formulering.
English: This can be possibly attributed to different algorithms/specifications of the model or similar reasons.
Danish: Dette kan muligvis tilskrives modellens forskellige algoritmer/specifikationer eller lignende årsager.
English: This approach has generally been accepted and supported by other EU and non-EU authorities as well.
Danish: Denne tilgang er generelt accepteret og understøttet af myndigheder i både andre EU- og ikke-EUlande.
English: Local irritation potential
Danish: Risiko for lokal irritation
English: The results the Applicant obtained for the treatment effect using this model are as follows:
Danish: De resultater, som ansøgeren opnåede for behandlingseffekten ved hjælp af denne model, er som følger:
English: The legal basis for this application refers to: Article 10(1) of Directive 2001/83/EC, as amended.
Danish: Retsgrundlaget for denne ansøgning er artikel 10, stk. 1, i direktiv 2001/83/EF, med senere ændringer.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF FENTRIX AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF FENTRIX OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Belgium20097 Hamburg
Danish: 20097 Hamburg
English: Skin reactions with a score 1 were not included in the analysis because these are very mild and could be found in any transdermal product in the market.
Danish: Hudreaktioner med en score på 1 blev ikke medtaget i analysen, da disse er meget milde og kunne ses ved et hvilket som helst transdermalt produkt på markedet.
English: Initially, the Applicant submitted the data comparing the adverse events without any statistical analysis and a statistical comparison was requested.
Danish: Indledningsvis indsendte ansøgeren data, der sammenlignede bivirkningerne uden nogen statistisk analyse, og der blev anmodet om en statistisk sammenligning.
English: Single dose: OR estimate: 5.67, 95 % CI [1.12; 28.78] p = 0.0371 Multiple dose: OR estimate: 1.41, 95 % CI [0.97; 2.05] p = 0.0716
Danish: Enkeltdosis: OR-estimat: 5,67, 95 % CI [1,12; 28,78] p=0,0371 Flerdosis: OR-estimat: 1,41, 95 % CI [0,97; 2,05] p=0,0716
English: It was therefore argued that specific dermal irritation studies are required according to the guidelines mentioned above.
Danish: Det blev derfor fremført, at specifikke undersøgelser af dermal irritation er påkrævet i henhold til de retningslinjer, der henvises til i det ovenstående.
English: Fentanyl is 75-100 times more potent than parenteral morphine.
Danish: Fentanyl er 75-100 gange stærkere end parenteral morfin.
English: For this reason, it was considered reliable to assume that further investigations would not substantially add to this favourable safety profile and should hence be avoided for reasons of animal welfare as has been common practice in other European procedures in the past.
Danish: Derfor blev det vurderet som sikkert at antage, at yderligere undersøgelser ikke ville bibringe væsentlige nye oplysninger til denne positive sikkerhedsprofil, og derfor burde de undgås af hensyn til dyrevelfærden, som det har været almindelig praksis ved andre europæiske procedurer gennem tiden.
English: - Non-clinical issues
Danish: - Ikkekliniske aspekter
English: Therefore, the objecting MS were of the view that the difference was not only statistically significant but that the difference was also considered to be clinically relevant.
Danish: De medlemsstater, der havde gjort indsigelser, var derfor af den overbevisning, at forskellen ikke kun var statistisk signifikant, men at forskellen også var klinisk relevant.
English: It was therefore argued that this could not be used as supportive of a similar safety profile as required by the guideline.
Danish: Det blev derfor fremført, at de ikke kunne anvendes som understøttelse af en lignende sikkerhedsprofil, som det kræves i retningslinjerne.
English: As there is currently no explicit EU guidance available on the evaluation of local tolerability of transdermal systems, and considering previous experience with marketing authorisations of several other transdermal patches in the EU, the CHMP noted that skin tolerability had always been assessed as part of the pharmacokinetic studies.
Danish: Da der på nuværende tidspunkt ikke findes nogen specifikke europæiske retningslinjer for vurderingen af transdermale systemers lokale tolerabilitet, og set i lyset af den tidligere erfaring med markedsføringstilladelser for flere andre depotplastre i EU, bemærkede CHMP, at hudtolerabilitet altid var blevet vurderet som en del af de farmakokinetiske undersøgelser.
English: The Applicant acknowledged that only non-clinical single dose studies have been performed.
Danish: Ansøgeren erkendte, at der kun er blevet udført ikkekliniske enkeltdosisundersøgelser.
English: These findings have been corroborated by a comparable tolerability profile determined in clinical studies (see below).
Danish: Disse resultater er blevet bekræftet af en sammenlignelig tolerabilitetsprofil, som er fastlagt gennem kliniske undersøgelser (se nedenfor).
English: Consequently, the requirements set in these regulations have been taken rather as recommendations by European Member States and applicants in the past than absolute requirements.
Danish: Derfor er de krav, der er indeholdt i disse bestemmelser, blevet betragtet som anbefalinger snarere end deciderede krav af de europæiske medlemsstater og ansøgere.
English: The objecting MS were of the view that the study results needed to be reanalysed because initially the irritation data had not been appropriately assessed.
Danish: De medlemsstater, der havde gjort indsigelser, var af den opfattelse, at undersøgelsesresultaterne skulle analyseres på ny, fordi irritationsdataene oprindelig ikke var blevet vurderet tilstrækkelig grundigt.
English: The guideline on non-clinical investigations of local tolerance was developed before the introduction of transdermal systems.
Danish: Retningslinjerne for ikkekliniske undersøgelser af lokal tolerance blev udviklet, før transdermale systemer blev indført.
English: The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Danish: CHMP vurderede dossieret og de tilgængelige data, herunder de spørgsmål, der var rejst af de berørte medlemsstater, der havde gjort indsigelse.
English: Fentanyl has been marketed as iv anaesthetic since the 1960s.
Danish: Fentanyl er blevet markedsført som intravenøs bedøvelse siden 1960'erne.
English: If it can be agreed that irritation scores at or below 1 are without clinical relevance and that more than 90 % of the reported incidences are well within this accepted range, it would consequently be erroneous to base the decision about a potential serious risk solely on a small portion (less than 4 % (SD) respectively 9 % (MD)) of the entity.
Danish: Hvis der kan opnås enighed om, at irritationsscorer på eller under 1 er uden klinisk relevans, og at mere end 90 % af de rapporterede forekomster ligger inden for dette godkendte interval, ville det som en følge heraf være fejlagtigt udelukkende at basere beslutningen om en potentiel alvorlig risiko på en lille andel (mindre end 4 % (enkeltdosis) henholdsvis 9 % (flerdosis)) af enheden.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, INDGIVELSESVEJ, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Danish: Det gyldige produktresumé, etiketteringen og indlægssedlen er de endelige versioner, der er opnået under koordinationsgruppens procedure.
English: Hence, efficacy and systemic tolerability of the active substance remains unaffected.
Danish: Det aktive stofs effekt og systemiske tolerabilitet forbliver således uændret.
English: More importantly, the Applicant reproduced the statistically significant product effect for the single dose study (p= 0.0371), whereas for the multiple dose study the differences were not statistically significant (p=0.0716).
Danish: Det er vigtigt at understrege, at ansøgeren genskabte den statistisk signifikante produkteffekt for enkeltdosisundersøgelsen (p=0,0371), mens forskellene for flerdosisundersøgelsen ikke var statistisk signifikante (p=0,0716).
English: The objecting MS argued that although this study was neither designed nor powered to assess the tolerability profile, its results suggest a worse safety profile for the test product.
Danish: De medlemsstater, der havde gjort indsigelser, fremførte, at selv om denne undersøgelse hverken var udformet eller havde tilstrækkelig statistisk styrke til at vurdere tolerabilitetsprofilen, tyder dens resultater på en dårligere sikkerhedsprofil for testproduktet.
English: Due to the mechanical stressing during the detachment of the adhesive layer from the upper skin area, irritation is unavoidable; therefore slight skin irritation is always induced by the repetitive use of transdermal patches.
Danish: På grund af den mekaniske belastning under fjernelse af det klæbende lag fra overhuden er irritation uundgåelig, hvorfor en smule hudirritation altid vil forekomme ved gentagen anvendelse af depotplastre.
English: - Clinical issues
Danish: - Kliniske aspekter
English: The reference medicinal product is Dorogesic 25 - 100 µg/h, (MAH Janssen-Cilag, Neuss, Germany).
Danish: Referencelægemidlet er Dorogesic 25-100 µg/h, (MAH Janssen-Cilag, Neuss, Tyskland).
English: This proves that even the visually inspected, slightly increased incidence of skin irritations obviously has no further influence on the permeability of the drug substance, if compared to the reference medicinal product.
Danish: Dette beviser, at selv den visuelt påviste mindre stigning i forekomsterne af hudirritation tydeligvis ikke har nogen indvirkning på lægemiddelstoffets permeabilitet i sammenligning med referencelægemidlet.
English: In order to assess the applicability of this objection, the CHMP took into account that the subsequent points:
Danish: Med henblik på at bedømme denne indsigelses anvendelighed overvejede CHMP nedenstående punkter:
English: To clarify the clinical relevance of these concerns and to assess the significance of the statistical analysis performed by the CMS, the following points were considered by the CHMP:
Danish: For at klarlægge disse betænkeligheders kliniske relevans og vurdere signifikansen af den statistiske analyse udført af de berørte medlemsstater blev følgende punkter taget i betragtning af CHMP:
English: This reservoir was introduced between the layer exposed to the skin (donor layer) and the backing film.
Danish: Dette reservoir er lagt ind mellem det lag, der er i kontakt med huden (donorlaget) og filmen på bagsiden.
English: The analgesic and sedative action of fentanyl is proposed to be mediated mainly through µ-opioid-receptors.
Danish: Fentanyls smertestillende og beroligende effekt foreslås medieret hovedsagelig gennem µ-opioid-receptorer.