Вы искали: kongerigedet (Датский - Английский)

det forenede kongerigedet forenede kongerige
the netherlands

det forenede kongerigedet forenede kongerigecpmp/423/04astrazeneca uk limited 600 capability green luton bedfordshire lu1 3lu astrazeneca uk limited 600 capability green luton bedfordshire lu1 3lu astrazeneca uk limited 600 capability green luton bedfordshire lu1 3lu astrazeneca uk limited 600 capability green luton bedfordshire lu1 3lu
ukastrazeneca uk limited 600 capability green luton bedfordshire lu1 3lu astrazeneca uk limited 600 capability green luton bedfordshire lu1 3lu astrazeneca uk limited 600 capability green luton bedfordshire lu1 3lu

filmovertrukket tabletoral anvendelseoral anvendelseoral anvendelseoral anvendelseoral anvendelseoral anvendelseoral anvendelsemedlemsstatmarkedsføringstill delseansøgersærnavnstyrkerlægemiddelformindgivelsesvejroute de versailles, 78163 marly-le-roi cedex, francedet forenede kongerigedet forenede kongerigelaboratoire glaxosmithkline, 100 route de versailles, 78163 marly-le-roi cedex, france laboratoire glaxosmithkline, 100 route de versailles, 78163 marly-le-roi cedex, franceadartreladartrel161, 0 mg2, 0 mgfilmovertrukket tabletfilmovertrukket tabletoral anvendelseoral anvendelsebilag iifaglige konklusioner og begrundelser for Ændring af produktresumeer, etikettering og indlÆgssedler fremlagt af emea9 faglige konklusionersamlet resumÉ af den faglige vurdering af adartrel (se bilag i)der blev udstedt en markedsføringstilladelse for ropirinol af frankrig den 30. juni 2004.inden afslutningen af den gensidige anerkendelses-procedure indbragte spanien og nederlandene en sag for emea ud fra den betragtning, at dette lægemiddel muligvis udgør en risiko for folkesundheden, eftersom sikkerhed og virkning for ropinirol til langtidsbehandling af restless legs syndrome (rls) efter deres opfattelse ikke er påvist.de spørgsmål, der blev drøftet, vedrørte oplysninger om virkning i de kliniske undersøgelser, navnlig hos andelen af patienter med en funktionel påvirkning samt langtidsvirkningen, sikkerheden og benefit/risk-forholdet.markedsføringsindehaveren har defineret svær idiopatisk rsl som en tilstand hos patienter, der har opnået et scoringsresultat ved baseline på 24 point eller mere på den internationale rls -graderingsskala (irls) .chmp er imidlertid af den opfattelse, at denne patientpopulations tilstand bør defineres som moderat til svær idiopatisk rsl.tolerabilitetsprofilen for ropinirol skal i denne patientpopulation ifølge dokumentationen analyseres på baggrund af den fysiske tilstand, som i væsentlig grad påvirker patienternes livskvalitet, hvilket navnlig skyldes, at rls-patienter lider af kronisk søvnløshed.på denne baggrund viser de kliniske undersøgelsesdata om sikkerhed, at ropinirol har en acceptabel tolerabilitet og sikkerhedsprofil hos rsl-patienter over det relevante dosisområde 0, 25 -4mg/dag.bivirkninger som kvalme, svimmelhed, søvntrang og opkastning forekom hyppigere ved behandling med ropinirol end med placebo, men bivirkningerne hos størstedelen af patienterne var af mild til moderat sværhedsgrad.disse bivirkninger blev generelt først indberettet i løbet af de første to uger af behandlingen, og seponeringsraten for behandling med ropinirol var lav og svarede til den for behandling med placebo.arten af disse bivirkninger er i overensstemmelse med den etablerede sikkerhedsprofil for ropinirol og lægemiddelklassen af dopaminagonister.der er blevet fremlagt en indgående vurdering af de mest almindelige bivirkninger i målgruppen (scoringsresultat ved baseline på 24-40 point) .de bivirkninger, der er specifikke for rls-patienter, såsom augmentation og reboundeffekter, er blevet drøftet.
ropirinol has been granted a marketing authorisation by france on 30 june 2004.before the end of a mutual recognition procedure, spain and the netherlands, presented to the emea a referral considering that this medicinal product might present a risk to public health since they were of the opinion that safety and efficacy in long-term treatment of ropinirole in restless legs syndrome had not been demonstrated.the issues discussed included the efficacy data provided in the clinical trials, particularly in the subset of patients having a functional impact and the long-term efficacy and safety as well as the benefit-risk ratio.the mah has defined severe idiopathic rls as those patients who have an international restless legs syndrome rating scale (irls) baseline score of 24 points or more.however, for the chmp, this population of patients should be defined as moderate to severe idiopathic rls.according to the literature, the tolerability profile of ropinirole in this population of patients must be analysed in the context of a physical condition that significantly affects the quality of life of patients mainly due to the fact that rls patients suffer with chronic insomnia.in this context the clinical trial safety data demonstrate that ropinirole has an acceptable tolerability and safety profile in rls patients over the dose range 0.25 -4mg/day.whilst the adverse events of nausea, vomiting, dizziness and somnolence occurred more frequently with ropinirole treatment than with placebo, the majority of patients had events that were mild to moderate in severity.these events were generally first reported during the initial two weeks of treatment and the rate of discontinuation from ropinirole treatment was low and similar to that from placebo treatment.the nature of these events is consistent with the established safety profile of ropinirole and the dopamine agonist class of drugs.a detailed assessment of the most common adverse events in the target population (irls baseline score 24-40 points) has been provided.the adverse events that are specific to rls patients, such as augmentation and rebound effects have been discussed.the analysis of serious adverse events (sae) was unremarkable in the overall group of patients enrolled in the ropinirole clinical studies.a recent study has been conducted by the mah in healthy volunteers on the effects of ropinirole on cardiac conduction.no clinically significant effect on the qt interval was observed.the data generated from the ropinirole clinical trial programme with studies of up to 52-week duration of ropinirole treatment is reassuring as far as the clinical significance of potential episodes of augmentation reported.the reported rates in the literature of augmentation associated with dopamine agonists including ropinirole are generally lower than the ones reported for levodopa.more importantly the majority of the ropinirole episodes of augmentation had limited clinical significance as generally patients continued on ropinirole treatment without discontinuation and, in the majority of the events the investigators did not increase the dose of ropinirole as a result of the augmentation.a rebound phenomenon following discontinuation of ropinirole treatment (end of treatment rebound) cannot be excluded.in clinical trials, although the average irls total scores 7-10 days after withdrawal of therapy were higher in ropinirole-treated patients than in placebo-treated patients, the severity of symptoms following withdrawal of therapy generally did not exceed the baseline assessment in ropinirole-treated patients.the mah agreed to revise the spc, sections 4.2 and 5.1, to specify that ropinirole is indicated in moderate to severe idiopathic restless legs syndrome.the mah agreed to revise also section 5.1, to specify that ropinirole treated patients had higher irls scores at follow up assessment compared to placebo treated patients.in the moderate to severe rls population the benefit of treating with ropinirole is seen in all outcomes measured in a consistent way.the safety profile although pledged by uncomfortable adverse events like nausea and vomiting is mostly a problem in the early phase of the treatment and is considered19/94 manageable.the benefit-risk assessment is considered favourable for the moderate to severe rls as defined in the spc.therefore the chmp has recommended that there are no objections for the granting of the marketing authorisation for adartel, in the treatment of symptomatic treatment of moderate to severe idiopathic restless legs syndrome.this marketing authorisation is subject to conditions considered essential for the safe and effective use of the medicinal product, which are that a long-term, double-blind, placebo controlled trial should be conducted as a post-marketing commitment (see annexe iv) .the amended spc is endorsed by the chmp.grounds for amendment of the summary of product characteristicswhereas,-the scope of the referral was that the safety and efficacy in long-term treatment of ropinirole inrestless legs syndrome should be demonstrated,-based on the documentation submitted and the scientific discussion within the committee, thesummary of products characteristic proposed by the applicant has been amended as set out in annexe iii.20/94 annex iiisummary of product characteristics, labelling and package leaflet21/94 a.summary of product characteristics22/94 1 name of the medicinal productadartrel 0.25 mg film-coated tablets.2 qualitative and quantitative compositioneach film-coated tablet contains 0.25 mg of ropinirole (as hydrochloride) .excipient(s):lactose for a full list of excipients, see section 6.1.3 pharmaceutical form film-coated tablet.white oval-shaped, marked " gs " on one side and " mle " on the other.4 clinical particulars4.1 therapeutic indicationsadartrel is indicated for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome (see section 5.1) .4.2 posology and method of administrationoral use.adultsindividual dose titration against efficacy and tolerability is recommended.ropinirole should be taken just before bedtime, however the dose can be taken up to 3 hours before retiring.ropinirole may be taken with food, to improve gastrointestinal tolerance.treatment initiation (week 1)the recommended initial dose is 0.25 mg once daily (administered as above) for 2 days.if this dose is well tolerated the dose should be increased to 0.5 mg once daily for the remainder of week 1.therapeutic regimen (week 2 onwards)following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved.the average dose in clinical trials, in patients with moderate to severe restless legs syndrome, was 2 mg once a day.