FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 322 (38.1%) of all patients were not evaluable for MMR at 60 months (99 in the nilotinib 300 mg twice daily group, 93 in the nilotinib 400 mg twice daily group and 130 in the imatinib group) due to missing/unevaluable PCR assessments (n=9), atypical transcripts at baseline (n=8) or discontinuation prior to the 60-month time point (n=305).
Danish: I alt 322 (38,1 %) af alle patienter var ikke evaluerbare for MMR efter 60 måneder (99 i nilotinib 300 mg to gange dagligt gruppen, 93 i nilotinib 400 mg to gange dagligt gruppen og 130 i imatinib-gruppen) på grund af manglende / ikke evaluerbare PCR-vurderinger (n=9), atypiske transkripter ved baseline (n=8) eller seponering forud for 60-måneders tidspunktet (n=305).
English: Component of a multipack comprising 4 cartons.
Danish: Delpakning af multipakning med 4 pakninger.
English: Multipack: 112 (4 packs of 28) hard capsules.
Danish: Multipakning: 112 (4 pakninger med 28) hårde kapsler.
English: Discontinuation due to adverse drug reactions was observed in 10% of patients.
Danish: 10 % af patienterne seponerede Tasigna på grund af bivirkninger.
English: • Multipacks containing 112 (4 packs of 28) hard capsules.
Danish: • Multipakninger indeholdende 112 (4 pakninger med 28) hårde kapsler.
English: A total of 395 (46.7%) of all patients were not evaluable for MMR at 72 months (130 in the nilotinib 300 mg twice daily group, 110 in the nilotinib 400 mg twice daily group and 155 in the imatinib group) due to missing/unevaluable PCR assessments (n=25), atypical transcripts at baseline (n=8) or discontinuation prior to the 72-month time point (n=362).
Danish: I alt 395 (46,7 %) af alle patienter var ikke evaluerbare for MMR efter 72 måneder (130 i nilotinib 300 mg to gange dagligt gruppen, 110 i nilotinib 400 mg to gange dagligt gruppen og 155 i imatinib-gruppen) på grund af manglende / ikke evaluerbare PCR-vurderinger (n=25), atypiske transkripter ved baseline (n=8) eller seponering forud for 72-måneders tidspunktet (n=362).
English: PVC/PVDC/Alu [in carton] 40 hard capsules
Danish: PVC/PVDC/Alu [i karton] 40 hårde kapsler
English: Ejection fraction decrease, pericardial effusion, pericarditis, diastolic dysfunction, left bundle branch block
Danish: Nedsat uddrivningsfraktion, perikardiel effusion, perikarditis, diastolisk dysfunktion, ventresidig grenblok Vaskulære sygdomme Almindelig:
English: CMLAP n=137 Grade
Danish: CML-AP n=137 Grad 3-4
English: The majority of patients had a long history of CML that included extensive prior treatment with other antineoplastic agents, including imatinib, hydroxyurea, interferon, and some had even failed organ transplant (Table 11).
Danish: De fleste af patienterne havde et langt forløb med CML med ekstensiv forudgående behandling med andre antineoplastiske stoffer, inkl.
English: PVC/PVDC/Alu [in carton] 120 hard capsules
Danish: PVC/PVDC/Alu [i karton] 120 hårde kapsler
English: CMLCP n=321 Grade
Danish: CML-C P n=321 Grad
English: PVC/PVDC/Alu [in carton] 112 hard capsules
Danish: PVC/PVDC/Alu [i karton] 112 hårde kapsler
English: 1 Common
Danish: Almindelig 6
English: For patients who fail to achieve MMR after three months of treatment re-initiation, BCR-ABL kinase domain mutation testing should be performed.
Danish: BCR-ABL kinase-domæne-mutationstest skal udføres hos patienter, der ikke kan opretholde MMR 3 måneder efter genoptagelse af behandlingen.
English: Adult Philadelphia chromosome positive CML patients in chronic phase who have been treated with nilotinib as first-line therapy and who achieved a sustained deep molecular response (MR4.5) Discontinuation of treatment may be considered in eligible adult Philadelphia chromosome positive (Ph+) CML patients in chronic phase who have been treated with nilotinib at 300 mg twice daily for a minimum of 3 years if a deep molecular response is sustained for a minimum of one year immediately prior to discontinuation of therapy.
Danish: Det kan overvejes at seponere behandling af egnede voksne Philadelphiakromosom-positive (Ph+) CML-patienter i kronisk fase, som er blevet behandlet med 300 mg nilotinib to gange dagligt i mindst 3 år, hvis et dybt molekylært respons har været opretholdt i mindst et år umiddelbart før seponering af behandlingen.
English: QTcF increase from baseline exceeding 60 msec was observed in <1% of patients while on the study medicinal product.
Danish: QTcF-øgning fra baseline på mere end 60 msek.
English: Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.
Danish: - pædiatriske patienter med Philadelphiakromosom-positiv CML, i kronisk fase, som er resistent eller intolerant over for tidligere behandling, herunder imatinib.
English: Adult Philadelphia chromosome positive CML patients in chronic phase who have achieved a sustained deep molecular response (MR 4.5) on nilotinib following prior imatinib therapy Discontinuation of treatment may be considered in eligible adult Philadelphia chromosome positive (Ph+) CML patients in chronic phase who have been treated with nilotinib for a minimum of 3 years if a deep molecular response is sustained for a minimum of one year immediately prior to discontinuation of therapy.
Danish: Det kan overvejes at seponere behandling af egnede voksne Philadelphiakromosom-positive (Ph+) CML-patienter i kronisk fase, som er blevet behandlet med nilotinib i mindst 3 år, hvis et dybt molekylært respons har været opretholdt i mindst et år umiddelbart før seponering af behandlingen.
English: The change from baseline in mean time-averaged QTcF interval at steady state was 6 msec. No patient had an absolute QTcF >500 msec while on the study medicinal product.
Danish: Ændringen i baseline i tid for det gennemsnitlige QTcF-interval ved steady-state var 6 msek.
English: PVC/PVDC/Alu [in wallet] 112 hard capsules
Danish: PVC/PVDC/Alu [i folder] 112 hårde kapsler
English: Titanium dioxide (E171) Red iron oxide (E172) Yellow iron oxide (E172)
Danish: Titandioxid (E 171) Jernoxid, rød (E 172) Jernoxid, gul (E 172)
English: A total of 305 (36.1%) of all patients were not evaluable for MMR at 48 months (98 in the nilotinib 300 mg twice daily group, 88 in the nilotinib 400 mg twice daily group and 119 in the imatinib group) due to missing/unevaluable PCR assessments (n=18), atypical transcripts at baseline (n=8), or discontinuation prior to the 48-month time point (n=279).
Danish: I alt 305 (36,1 %) af alle patienter var ikke evaluerbare for MMR ved 48 måneder (98 i nilotinib-gruppen, der fik 300 mg 2 gange dagligt, 88 i nilotinib-gruppen, der fik 400 mg 2 gange dagligt, og 119 i imatinib-gruppen) på grund af manglende/ikke evaluerbare PCR-vurderinger (n=18), atypiske transkriptioner ved baseline (n=8) eller ophør før 48-måneder (n=279).
English: Musculoskeletal stiffness, joint swelling
Danish: Muskuloskeletale smerter, lændesmerter
English: INTERMEDIATE CARTON
Danish: KARTON MED DELPAKNINGER
English: Most frequently reported adverse reactions in Tasigna clinical studies Non-haematological adverse reactions (excluding laboratory abnormalities) that are reported in at least 5% of the adult patients in Tasigna clinical studies that serve as the basis for the approved indications are shown in Table 3.
Danish: laboratorieabnormaliteter), som rapporteres hos mindst 5 % af de voksne patienter i kliniske studier af Tasigna, som ligger til grund for de godkendte indikationer, er vist i tabel 3.
English: - increased skin sensitivity - bleeding, tender or enlarged gums - nose bleed - dry mouth, sore throat, mouth sores - frequent urine output - haemorrhoids, anal abscess - enterocolitis (inflammation of the bowel) - herpes virus infection - feeling of hardening in the breasts, heavy periods, nipple swelling - appetite disorder, weight decreased - breast enlargement in men - symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
Danish: nældefeber, svampeinfektion på fødderne - fortykkede hudpletter med rød/sølvfarvet hud (tegn på psoriasis) - øget hudoverfølsomhed - blødning, ømme eller hævede gummer - næseblod - tør mund, ondt i halsen, sår i munden - hyppig vandladning - hæmorroider, bylder i endetarmen - betændelse i tarmene (enterocolitis) - herpes virus infektion - følelse af spændte bryster, kraftige menstruationer, hævelse af brystvorterne - spiseforstyrrelse, vægttab - forstørrelse af bryster hos mænd - symptomer på restless legs syndrom (en uimodståelig trang til at bevæge en del af kroppen, som regel benene, ledsaget af ubehagelige følelser)
English: Tasigna is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib.
Danish: Tasigna er indiceret til behandling af: - voksne og pædiatriske patienter med nydiagnosticeret Philadelphiakromosom-positiv kronisk myeloid leukæmi (CML) i kronisk fase.
English: Exfoliative rash, drug eruption, skin pain, ecchymosis, swelling face
Danish: Eksfoliativt udslæt, medikamentelt udsæt, smerte i huden, ekkymose, hævet ansigt
English: Renal impairment
Danish: Febril neutropeni
English: PVC/PVDC/Alu [in carton] 28 hard capsules
Danish: PVC/PVDC/Alu [i karton] 28 hårde kapsler
English: Eye haemorrhage, periorbital oedema, eye pruritus, conjunctivitis, dry eye (including xerophthalmia)
Danish: Øjenblødning, periorbitalt ødem, øjenkløe, konjunktivitis, tørre øjne (inklusive xeroftalmi)
English: Chronic phase n=321
Danish: Kronisk CML n=321
English: No subject had a QTcF >450 msec. Additionally, no clinically relevant arrhythmias were observed during the conduct of the trial.
Danish: Ingen forsøgspersoner havde et QTcF >450 msek.
English: Breast induration, menorrhagia, nipple swelling General disorders and administration site conditions Common:
Danish: Brystspændinger, menorrhagi, hævede brystvorter Almene symptomer og reaktioner på administrationsstedet Almindelig:
English: Multipack: 112 (4 wallets of 28) hard capsules.
Danish: Multipakning: 112 (4 foldere med 28) hårde kapsler.
English: Pulmonary hypertension, wheezing, oropharyngeal pain Gastrointestinal disorders
Danish: Pulmonal hypertension, pibende vejrtrækning, orofaryngeal smerte
English: If the prior dose was 400 mg once daily in adult patients or 230 mg/m once daily in paediatric patients, treatment should be discontinued.
Danish: Hvis den tidligere dosis var 400 mg 1 gang dagligt hos voksne patienter, eller 230 mg/m
English: Tasigna should be used with caution in patients who have or who are at significant risk of developing prolongation of QTc, such as those: - with congenital long QT prolongation - with uncontrolled or significant cardiac disease including recent myocardial infarction,
Danish: Tasigna bør anvendes med forsigtighed til patienter, som har QT-forlængelse eller har signifikant risiko for at udvikle det.
English: Periorbital oedema, blepharitis, eye pain, chorioretinopathy, conjunctivitis allergic, ocular surface disease, vision blurred Ear and labyrinth disorders Common:
Danish: Periorbitalt ødem, blefaritis, smerter i øjnene, korioretinopati, allergisk konjunktivitis, okulær overfladesygdom, sløret syn
English: If you have questions about how long to take Tasigna, talk to your doctor.
Danish: Tal med din læge, hvis du har spørgsmål til, hvor længe du skal tage Tasigna.
English: PVC/PVDC/Alu [in wallet] 28 hard capsules
Danish: PVC/PVDC/Alu [i folder] 28 hårde kapsler
English: If you take more Tasigna than you should
Danish: Hvis du har taget for meget Tasigna
English: 88.6-96.4%) in the nilotinib 300 mg twice daily group, 92.2% (95% CI: 88.5-95.9%) in the nilotinib 400 mg twice daily group and 88.0% (95% CI: 83.0-93.1%) in the imatinib 400 mg once daily group.
Danish: Baseret på Kaplan-Meier-estimater af varigheden af første MMR var andelen af patienter, der opretholdt responset i 72 måneder, blandt patienter, der opnåede MMR, 92,5 % (95 % CI: 88,6-96,4 %) i gruppen, der fik nilotinib 300 mg 2 gange dagligt, 92,2 % (95 % CI: 88,5-95,9 %) i gruppen, der fik nilotinib 400 mg 2 gange dagligt, og 88,0 % (95 % CI: 83,0-93,1 %) i gruppen, der fik imatinib 400 mg 1 gang dagligt.
English: Each hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).
Danish: Hver hård kapsel indeholder 200 mg nilotinib (som hydrochloridmonohydrat).
English: One hard capsule contains 200 mg nilotinib (as hydrochloride monohydrate).
Danish: En hård kapsel indeholder 200 mg nilotinib (som hydrochloridmonohydrat).
English: Shellac (E904) Dehydrated alcohol Isopropyl alcohol Butyl alcohol Propylene glycol Strong ammonia solution Potassium hydroxide Red iron oxide (E172)
Danish: Shellac (E 904) Vandfri alkohol Isopropylalkohol Butylalkohol
English: Bone pain, back pain, muscular weakness
Danish: Knoglesmerter, rygsmerter, muskelsvaghed
English: Hepatic function abnormal
Danish: Unormal leverfunktion.
English: The following other side effects have been reported with frequency not known (cannot be estimated from the available data): - allergy (hypersensitivity to Tasigna) - memory loss, disturbed mood - skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin discolouration, fungal infection of the feet - thickened patches of red/silver skin (signs of psoriasis) - bleeding, tender or enlarged gums - oral warts - reddening and/or swelling and possibly peeling on the palms and soles (so called hand-foot syndrome) - increased sensitivity of the skin to light - difficulty hearing, ear pain, noises (ringing) in the ears - joint inflammation - urinary incontinence - enterocolitis (inflammation of the bowel) - haemorrhoids, anal abscess - feeling of hardening in the breasts, heavy periods, nipple swelling - symptoms of restless legs syndrome (an irresistable urge to move a part of the body, usually the leg, accompanied by uncomfortable sensations)
Danish: svampeinfektion på fødderne - fortykkede hudpletter med rød/sølvfarvet hud (tegn på psoriasis) - blødning, ømme eller hævede gummer - vorter i munden - rødme og/eller hævelse af håndflader og fodsåler med risiko for afskalning af huden (også kaldet hand-foot-syndrom) - øget lysfølsomhed i huden over for lys -- hørebesvær, smerter i ørerne, støj (ringen) for ørene - betændelse i ledene - ufrivillig vandladning - betændelse i tarmene (enterocolitis) - hæmorroider, bylder i endetarmen - følelse af spændte bryster, kraftige menstruationer, hævelse af brystvorterne - symptomer på restless legs syndrom (en uimodståelig trang til at bevæge en del af kroppen, som regel benene, ledsaget af ubehagelige følelser)
English: Each hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate).
Danish: Hver hård kapsel indeholder 50 mg nilotinib (som hydrochloridmonohydrat).
English: One hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).
Danish: En hård kapsel indeholder 150 mg nilotinib (som hydrochloridmonohydrat).
English: Each hard capsule contains 150 mg nilotinib (as hydrochloride monohydrate).
Danish: Hver hård kapsel indeholder 150 mg nilotinib (som hydrochloridmonohydrat).
English: Disorientation, confusional state, amnesia, dysphoria Nervous system disorders Common:
Danish: Desorientering, konfusion, amnesi, dysfori
English: One hard capsule contains 50 mg nilotinib (as hydrochloride monohydrate).
Danish: En hård kapsel indeholder 50 mg nilotinib (som hydrochloridmonohydrat).
English: Very common:
Danish: Ikke almindelig:
English: Muscle spasms
Danish: Amnesi, dysfori
English: Fluid retention and oedema
Danish: Væskeretention og ødem
English: Dyspnoea exertional, pleurisy, epistaxis, oropharyngeal pain Gastrointestinal disorders
Danish: Funktionsdyspnø, pleuritis, epistaxis, orofaryngeal smerte
English: Metabolism and nutrition disorders Very common:
Danish: Metabolisme og ernæring
English: Printing ink
Danish: Muskelspasme r
English: Use in adults - The recommended dose is 600 mg per day.
Danish: Den sædvanlige dosis er 600 mg dagligt.
English: 2 Very common
Danish: 12 0 Meget almindelig
English: Capsule shell
Danish: Kapsel
English: Gastrointestinal disorders Nausea
Danish: Mave-tarm-kanalen Kvalme
English: Gynaecomastia, breast induration, menorrhagia, nipple swelling General disorders and administration site conditions Common:
Danish: Gynækomasti, brystspændinger, menorrhagi, hævede brystvorter Almene symptomer og reaktioner på administrationsstedet Almindelig:
English: This means that it is similar to a ‘reference medicine' containing the same active substance.
Danish: Det betyder, at det er identisk med et "referencelægemiddel", der indeholder det samme aktive stof.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use.
Danish: Gennemgangen blev foretaget af EMA's Udvalg for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker.
English: The review of Flurbiprofen Geiser was initiated on 27 June 2019 at the request of Spain, under Article 29(4) of Directive 2001/83/EC.
Danish: Gennemgangen af Flurbiprofen Geiser blev på foranledning af Spanien indledt den 27. juni 2019 i medfør af artikel 29, stk. 4, i direktiv 2001/83/EF.
English: Because there is a small difference in concentration between the two medicines, it was considered that data from a clinical trial in healthy volunteers would be needed to determine whether they have the same effect.
Danish: Da der er en lille forskel i koncentration mellem de to lægemidler, blev det vurderet, at data fra et klinisk studie hos raske forsøgspersoner ville være påkrævet for at afgøre, om de har samme virkning.
English: However, the Member States were not able to reach an agreement and the Spanish medicines agency referred the matter to EMA for arbitration on 10 June 2019.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den spanske lægemiddelstyrelse indbragte den 10. juni 2019 sagen for EMA med henblik på voldgift.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Spain) 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 Czech Republic, the Netherlands, Portugal and Slovakia) where the company has applied for a marketing authorisation.
Danish: Ved denne procedure vurderer én medlemsstat ("referencemedlemsstaten", her Spanien) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de "berørte medlemsstater", her Tjekkiet, Holland, Portugal og Slovakiet), hvor virksomheden har søgt om markedsføringstilladelse.
English: On 17 October 2019, the European Medicines Agency completed a review of Flurbiprofen Geiser following a disagreement among EU Member States regarding its authorisation.
Danish: Den 17. oktober 2019 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Flurbiprofen Geiser efter en uoverensstemmelse blandt medlemsstaterne om dets godkendelse.
English: Flurbiprofen Geiser was developed as a ‘hybrid medicine'.
Danish: Flurbiprofen Geiser blev udviklet som et "hybridlægemiddel".
English: The Agency concluded that the benefits of Flurbiprofen Geiser outweigh its risks, and the marketing authorisation can be granted in Spain and in other Member States of the EU where the company has applied for a marketing authorisation: Czech Republic, the Netherlands, Portugal and Slovakia.
Danish: Agenturet konkluderede, at fordelene ved Flurbiprofen Geiser opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Spanien, kan anerkendes i andre EU-medlemsstater, hvor virksomheden har ansøgt om en markedsføringstilladelse: Tjekkiet, Holland, Portugal og Slovakiet.
English: Flurbiprofen Geiser contains the active substance flurbiprofen, a 'non-steroidal anti-inflammatory drug' (NSAID) which reduces the body's production of substances called prostaglandins.
Danish: Flurbiprofen Geiser indeholder det aktive stof flurbiprofen, der er et non-steroidt antiinflammatorisk lægemiddel (NSAID), som reducerer kroppens dannelse af såkaldte prostaglandiner.
English: Why was Flurbiprofen Geiser reviewed?
Danish: Hvorfor blev Flurbiprofen Geiser undersøgt?
English: The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Flurbiprofen Geiser on 16/12/2019.
Danish: Europa-Kommissionen traf en juridisk bindende afgørelse for hele EU om markedsføringstilladelsen for Flurbiprofen Geiser den 16. december 2019.
English: This is supported by data showing that even flurbiprofen medicines taken by mouth in very different forms, such as lozenges, granules and spray, behave the same way in the body.
Danish: Dette understøttes af data, der viser, at selv meget forskellige former af flurbiprofen-holdige lægemidler, der tages gennem munden (som f.eks. sugetabletter, granulat og spray), opfører sig ens i kroppen.
English: The grounds for the referral were concerns that the laboratory data submitted were not enough to show that Flurbiprofen Geiser is equally as effective as Strefen Direct.
Danish: Begrundelsen for indbringelsen var betænkeligheder ved, at de indsendte laboratoriedata ikke var tilstrækkelige til at påvise, at Flurbiprofen Geiser er lige så effektivt som Strefen Direct.
English: However, the reference medicine, Strefen Direct, has a different concentration to Flurbiprofen Geiser.
Danish: Referencelægemidlet (Strefen Direct) har imidlertid en anden koncentration end Flurbiprofen Geiser.
English: EMA recommends authorisation of Flurbiprofen Geiser (flurbiprofen, 8.75 mg, oromucosal spray) in the EU
Danish: EMA anbefaler godkendelse af Flurbiprogen Geiser (flurbiprofen, 8,75 mg; mundhulespray) i EU
English: What is Flurbiprofen Geiser?
Danish: Hvad er Flurbiprofen Geiser?
English: Since some prostaglandins are involved in causing pain and inflammation in the body, reducing prostaglandin production reduces pain and inflammation.
Danish: Prostaglandiner medvirker til smerter og inflammation i kroppen, og ved at nedsætte dannelsen af prostaglandiner kan man derfor dæmpe smerter og inflammation.
English: Published data show that differences of this size in concentration of the active substance, flavour and amount of cyclodextrins do not affect how the medicine works.
Danish: Offentliggjorte data viser, at forskelle af denne størrelsesorden i koncentrationen af aktivt stof, smagen og mængden af cyclodextriner ikke påvirker virkningen af lægemidlet.
English: submitted Flurbiprofen Geiser to the Spanish medicines agency for a decentralised procedure.
Danish: søgte om at få Flurbiprofen Geiser godkendt hos den spanske lægemiddelstyrelse gennem en decentraliseret procedure.
English: Having reviewed the available data, EMA considered that differences between Flurbiprofen Geiser and Strefen Direct are minor and do not affect the amount of active substance that is released in the mouth and into the bloodstream.
Danish: Efter gennemgang af de tilgængelige data vurderede EMA, at forskellene mellem Flurbiprofen Geiser og Strefen Direct er små og ikke påvirker mængden af aktivt stof, der frigives i munden og til blodbanen.
English: EMA recommends authorisation of Flurbiprofen Geiser (flurbiprofen, 8.75 mg, oromucosal spray) in the EU EMA/631051/2019
Danish: EMA anbefaler godkendelse af Flurbiprogen Geiser (flurbiprofen, 8,75 mg; mundhulespray) i EU EMA/631051/2019
English: Based on evaluation of the currently available data, the Agency concluded that the benefits of Flurbiprofen Geiser outweigh its risks, and therefore the marketing authorisation for Flurbiprofen Geiser should be granted in all concerned Member States.
Danish: På grundlag af gennemgangen af de aktuelt tilgængelige data vurderede agenturet, at fordelene ved Flurbiprofen Geiser opvejer risiciene, og anbefalede derfor udstedelse af markedsføringstilladelse for Flurbiprofen Geiser i alle de berørte medlemsstater.