FrancophonIA/ELRC3.0 huggingface dataset:
English: 60, 90 and 120 mg Aluminum/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets.
Danish: Aluminum/aluminiumblister i pakninger indeholdende 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 eller 100 tabletter.
English: The effects of etoricoxib 120 mg on the exposure (AUC0-24hr) to these estrogenic components of PREMARIN were less than half of those observed when PREMARIN was administered alone and the dose was increased from 0.625 to 1.25 mg.
Danish: Effekten af etoricoxib 120 mg (AUC0-24t) sammen med Premarins østrogene komponenter var mindre end halvdelen af den observerede effekt, når Premarin blev givet alene og dosis blev øget fra 0,625 mg til 1,25 mg.
English: Quinta da Fonte - Edifício Vasco da Gama,
Danish: Quinta da Fonte, Edifício Vasco da Gama n.º 19, Porto Salvo
English: Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a risk of thrombotic events (especially myocardial infarction (MI) and stroke), relative to placebo and some NSAIDs.
Danish: Kliniske undersøgelser tyder på, at gruppen af selektive COX-2 hæmmere kan være forbundet med en risiko for thrombotiske hændelser (specielt myokardieinfarkt og apopleksi), i forhold til placebo og nogle NSAID.
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Danish: Hos nogle patienter med kompromitteret nyrefunktion (f.eks. dehydrerede eller ældre patienter med kompromitteret nyrefunktion), kan samtidig administration af ACE-hæmmere eller angiotensin-II-receptorantagonister og stoffer der hæmmer cyclooxygenasen medføre yderligere forværring af nyrefunktionen, inklusiv mulig akut nyresvigt.
English: The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and selective COX-2 inhibitors may be of clinical significance in patients at risk of thrombo-embolic events.
Danish: Forskellen i antitrombocytaktivitet mellem COX-1 hæmmende NSAID og COX-2 selektive hæmmere kan være af klinisk betydning for patienter med risiko for udvikling af thromboemboliske hændelser.
English: Concomitant administration of etoricoxib with doses of acetylsalicylic acid above those for cardiovascular prophylaxis or with other NSAIDs is not recommended (see sections 5.1 and 4.4.
Danish: Samtidig administration af etoricoxib og doser af acetylsalicylsyre, der er højere end de, der anvendes til kardiovaskulær profylakse eller andre NSAID bør undgås (se afsnit 5.1 og 4.4).
English: Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Danish: Kendt hypersensitivitet over for den aktive substans eller et af hjælpestofferne i produktet (se afsnit
English: Via Benedetto Croce, 37 56125 Pisa
Danish: Via Mazzini, 112 I-56125 Pisa Italien
English: The 30-, 60- and 120-mg tablets also contain indigo carmine lake (E132) and yellow ferric oxide (E172).
Danish: 60 mg og 120 mg tabletten indeholder endvidere gul jernoxid (E172) og indigo carmine lake (E132).
English: Hertfordshire EN11 9B4 United Kingdom
Danish: Hertfordshire EN11 9BU Storbritannien
English: Tablet coating: carnauba wax, lactose monohydrate, hypromellose, titanium dioxide (E171), triacetin.
Danish: Tabletovertræk: Carnaubavoks, hypromellose, lactosemonohydrat, titandioxid (E171), glyceroltriacetat.
English: National competent authorities (NCA) shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Danish: Registreringsindehaverens opfølgende foranstaltninger På CHMP's anmodning indvilgede indehaveren af markedsføringstilladelsen i at træffe følgende opfølgende foranstaltninger:
English: Oral contraceptives: Etoricoxib 60 mg given concomitantly with an oral contraceptive containing 35 micrograms ethinyl estradiol (EE) and 0.5 to 1 mg norethindrone for 21 days increased the steady state AUC0-24hr of EE by 37%.
Danish: Oral antikonception: Ved samtidig indtagelse af etoricoxib 60 mg og et oralt antikonceptionsmiddel, som indeholder 35 µg ethinyløstradiol (EØ) og 0,5-1 mg norethindron, i 21 dage øgedes steady-state AUC0-24t af EØ med 37 %.
English: For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.
Danish: Symptomlindring i behandling af osteoarthrose (OA), rheumatoid arthritis (RA) samt ved smerter og tegn på inflammation i forbindelse med akut arthritis urica.
English: As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention, oedema and hypertension have been observed in patients taking etoricoxib.
Danish: Som med andre lægemidler der vides at hæmme prostaglandinsyntesen, er der set væskeretention, ødem og hypertension hos patienter i behandling med etoricoxib.
English: Elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials treated for up to one year with etoricoxib 30, 60 and 90 mg daily.
Danish: Der er rapporteret stigninger i ALAT og/eller ASAT (ca. 3 gange eller mere end den øvre normalgrænse) hos ca. 1% af patienterne i kliniske undersøgelser, behandlet i op til 1 år med etoricoxib 60 eller 90 mg daglig.
English: Some selective COX2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of any drug allergy.
Danish: NSAID og nogle selektive COX-2 hæmmere er blevet sat i forbindelse med en øget risiko for hudreaktioner hos patienter med enhver form for lægemiddelallergi i anamnesen.
English: Box 581
Danish: Post Bus 581
English: Tatoiou Street, Nea Erythrea 14671 Greece
Danish: National Road 14671Nea Erythrea, Athens Grækenland
English: Uncommon: abdominal distention, acid reflux, bowel movement pattern change, constipation, dry mouth, gastroduodenal ulcer, irritable bowel syndrome, oesophagitis, oral ulcer, vomiting, gastritis.
Danish: Ikke-almindelig: Abdominal udspilning, syrerefluks, ændringer i tarmmotilitetsmønstret, obstipation, tør mund, gastroduodenal ulcera, colon irritabile, esophagitis, orale ulcera, opkastning.
English: In clinical trials, etoricoxib was evaluated for safety in 7152 individuals, including 4614 patients with OA, RA, chronic low back pain or ankylosing spondylitis (approximately 600 patients with OA or RA were treated for one year or longer).
Danish: Etoricoxib er i kliniske undersøgelser vurderet med hensyn til sikkerhed hos ca. 4800 patienter, inklusiv ca. 3400 patienter med OA, RA eller kroniske lændesmerter (ca. 600 patienter med OA eller RA blev behandlet i 1 år eller mere).
English: Regardless of indication, in patients with mild hepatic dysfunction (Child-Pugh score 5-6) a dose of 60 mg once daily should not be exceeded.
Danish: Hos patienter med mild leverdysfunktion (Child-Pugh score 5-6) bør dosis på 60 mg én gang daglig ikke overskrides.
English: <Etoricoxib> is administered orally and may be taken with or without food.
Danish: 4.2 Dosering og indgivelsesmåde <SÆRNAVN> administreres oralt og kan tages med eller uden mad.
English: NL-2003 PC Haarlem The Netherlands
Danish: 2003 PC Haarlem Holland
English: Very rare: hypersensitivity reactions, including angioedema, anaphylactic/anaphylactoid reactions including shock.
Danish: Meget sjælden: Overfølsomhedsreaktioner omfattende angioødem, anafylaktiske/anafylaktoide reaktioner.
English: In rats and rabbits, there was a dose dependent increase in post implantation loss at exposures greater than or equal to 1.5 times the human exposure (see sections 4.3 and 4.6).
Danish: Der var imidlertid et fald i embryo/føtal overlevelse ved doser højere eller svarende til 1,5 gange den daglige humandosis (se afsnit 4.3 og 4.6).
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids, coxibs, ATC Code: M01 AH05
Danish: Farmakoterapeutisk gruppe: Antiinflammatoriske og antirheumatiske lægemidler, non-steriod, coxiber.
English: Addenda Pharma S.r.l Viale Shakespeare, 47 00144 Roma Italy
Danish: Viale Shakespeare, 47 00100 Roma Italien
English: Eye disorders: Uncommon: blurred vision, conjunctivitis.
Danish: Lidelser i øjne: Ikke-almindelig: Sløret syn.
English: Each film coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 60, 90 eller 120 mg etoricoxib.
English: For a full list of excipients, see section 6.1.
Danish: Hjælpestoffer er anført under afsnit 6.1.
English: Across clinical pharmacology studies, <Etoricoxib> produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily.
Danish: I alle kliniske, farmakologiske undersøgelser forårsagede <SÆRNAVN>, i doser op til 150 mg daglig, dosisafhængig hæmning af COX-2 uden hæmning af COX-1.
English: In clinical studies excluding the MEDAL Program Studies, approximately 3100 patients were treated with etoricoxib ≥60 mg daily for 12 weeks or longer.
Danish: Ca. 3100 patienter blev behandlet med etoricoxib ≥ 60 mg daglig i 12 uger eller længere.
English: Blisters: Store in the original package in order to protect from moisture.
Danish: Blisterpakning: Opbevares i den originale emballage.
English: Ear and labyrinth disorders: Uncommon: tinnitus, vertigo.
Danish: Lidelser i ører: Ikke-almindelig: Tinnitus.
English: The following undesirable effects were reported at an incidence greater than placebo in clinical trials in patients with OA, RA, chronic low back pain or ankylosing spondylitis treated with etoricoxib 30 mg, 60 mg or 90 mg for up to 12 weeks, or in the MEDAL Program studies, or in post-marketing experience:
Danish: Følgende lægemiddelrelaterede bivirkninger er i kliniske undersøgelser eller efter markedsføring rapporteret med højere incidens end for placebo hos patienter med OA, RA eller kroniske lændesmerter i behandling med etoricoxib 60 mg eller 90 mg i op til 12 uger.
English: Merck Sharp & Dohme S.p.A.
Danish: Merck Sharp & Dohme Italia S.p.A.
English: The dose for OA should not exceed 60 mg daily
Danish: Ved osteoarthrose bør dosis ikke overstige 60 mg dagligt.
English: White, round, HDPE bottles with a white, polypropylene closure containing 30 tablets and two1-gram desiccant containers or 90 tablets and one1-gram desiccant container.
Danish: Hvid, rund, HDPE-beholder med hvid polypropylenlukning, indeholdende 30 eller 90 tabletter.
English: Strength Pharmaceutical form Route of administration
Danish: Lœgemiddel-form Indgivelses-vej
English: LABELLING
Danish: Beskrivelse
English: Merck Sharp & Dohme, Lda.
Danish: Merck Sharp & Dohme, (Portugal) Lda.
English: Merck Sharp & Dohme BV.
Danish: Merck Sharp & Dohme B.V.
English: Immune system disorder:
Danish: Lidelser i immunsystemet
English: A significant difference in GI safety between selective COX-2 inhibitors + acetylsalicylic acid vs.
Danish: I langtidsundersøgelser er der ikke vist en signifikant forskel på GI-sikkerheden mellem selektive COX-2 hæmmere + acetylsalicylsyre versus NSAID + acetylsalicylsyre (se afsnit 5.1).
English: Patients with moderate hepatic dysfunction (Child-Pugh score 7-9) administered etoricoxib 60 mg every other day had similar mean AUC to the healthy subjects given etoricoxib 60 mg once daily; etoricoxib 30 mg once daily has not been studied in this population.
Danish: Patienter med moderat leverdysfunktion (Child-Pugh score 7-9), der fik etoricoxib 60 mg hver anden dag havde samme middel-AUC som raske frivillige, der fik etoricoxib 60 mg én gang daglig.
English: PHARMACEUTICAL FORM Film-coated tablet (tablet).
Danish: Filmovertrukken tablet
English: Merck Sharp & Dohme B.V. Waarderweg 39, NL 2031 BN, Haarlem, Postbox 581
Danish: Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581 NL-2003 PC Haarlem Holland
English: The recommended dose is 30 mg once daily.
Danish: Anbefalet dosis er 60 mg, én gang daglig.
English: In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), regardless of indication, the dose of 60 mg every other day should not be exceeded; administration of 30 mg once daily can also be considered.
Danish: Hos patienter med moderat leverdysfunktion (Child-Pugh score 7-9) anbefales at dosis på 60 mg hver anden dag ikke overskrides.
English: B-1180 Brussels
Danish: Chaussée de Waterloo 1135 B-1180 Bruxelles BELGIEN
English: CONDITIONS OF THE MARKETING AUTHORISATION
Danish: BEGRUNDELSER FOR ÆNDRINGEN AF MARKEDSFØRINGSTILLADELSEN
English: Uncommon: atrial fibrillation, congestive heart failure, non-specific ECG changes, myocardial infarction
Danish: Lidelser i myo-, endo- eller perikardium og klapper: Ikke-almindelig: Venstresidig hjerteinsufficiens, uspecifikke EKG-forandringer, myokardieinfarkt
English: Very rare: hypertensive crisis.
Danish: Ikke-almindelig: Rødmen, cerebrovaskulære tilfælde Meget sjælden: Hypertensiv krise.
English: Hormone Replacement Therapy (HRT): Administration of etoricoxib 120 mg with hormone replacement therapy consisting of conjugated estrogens (0.625 mg PREMARINTM ) for 28 days, increased the mean steady state AUC0-24hr of unconjugated estrone (41%), equilin (76%), and 17-β-estradiol (22%).
Danish: ), i 28 dage, øgede den gennemsnitlige steady-state AUC0-24t af ukonjugeret estron (41 %), equilin (76 %) og 17-ß-østradiol (22 %).
English: Safety and effectiveness of etoricoxib in paediatric patients have not been established (see section
Danish: Sikkerhed og effekt af etoricoxib hos børn er ikke undersøgt (se afsnit 4.2, Børn).
English: Therefore, hypertension should be controlled before treatment with etoricoxib (see section 4.3) and special attention should be paid to blood pressure monitoring during treatment with etoricoxib.
Danish: Derfor bør der udvises særlig opmærksomhed på monitorering af blodtrykket under behandling med etoricoxib.
English: PRT
Danish: th
English: <Etoricoxib containing medicinal products (see Annex I)> 30 mg film-coated tablets <Etoricoxib containing medicinal products (see Annex I)> 60 mg film-coated tablets <Etoricoxib containing medicinal products (see Annex I)> 90 mg film-coated tablets <Etoricoxib containing medicinal products (see Annex I)> 120 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN <SÆRNAVN> (se Bilag I) 60 mg filmovertrukne tabletter/tabletter <SÆRNAVN> (se Bilag I) 90 mg filmovertrukne tabletter/tabletter <SÆRNAVN> (se Bilag I) 120 mg filmovertrukne tabletter/tabletter
English: Merck Sharp & Dohme de España, S.A., Josefa Valcárcel, 38 28027 Madrid Spain
Danish: Merck Sharp & Dohme de Espana, S.A. c/ Josefa Valcarcel 38
English: There was no significant difference between etoricoxib and diclofenac in the rate of complicated events.
Danish: Der var ingen statistisk signifikante forskelle mellem etoricoxib og placebo.
English: 6.6 Special precautions for disposal No special requirements.
Danish: 6.6 Eventuelle instruktioner vedrørende anvendelse og håndtering Ikke relevant.
English: Etoricoxib was associated with a statistically significantly lower rate of discontinuations due to hepaticrelated adverse experiences than diclofenac.
Danish: Hepatiske hændelser: Etoricoxib var forbundet med en statistisk signifikant lavere forekomst af behandlingsophør på grund af store stigninger i leverfunktionstests end diclofenac (0,3% versus 5,2%).
English: Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled.
Danish: Patienter med hypertension, hvor blodtrykket ikke er tilfredsstillende kontrolleret
English: The rates per hundred patient-years of confirmed complicated and uncomplicated upper GI clinical events (perforations, ulcers and bleeds (PUBs)) were 0.67 (95% CI 0.57, 0.77) with etoricoxib and 0.97 (95% CI 0.85, 1.10) with diclofenac, yielding a relative risk of 0.69 (95% CI 0.57, 0.83).
Danish: Kardiovaskulære data: Forekomsten af alvorlige thrombotiske hændelser var for etoricoxib 1,25 hændelse pr. 100 patientår versus 1,15 hændelse pr. 100 patientår for diclofenac (relativ risiko 1,07; 95% konfidensinterval: 0,65%, 1,74%).
English: There have been reports of acute overdosage with etoricoxib, although adverse experiences were not reported in the majority of cases.
Danish: Der har ikke været rapporter vedrørende overdosering med etoricoxib i kliniske undersøgelser.
English: 120 mg pale-green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 120' on one side and ‘204' on the other.
Danish: 120 mg tablet: Lysegrøn, æbleformet, bikonveks tablet med ”541” præget på den ene side og ”MSD” på den anden side.
English: Merck, Sharp & Dohme Ltd Hertfordshire Road Hoddesdon
Danish: Merck Sharp & Dohme Limited Hertfordshire Road Hoddesdon
English: <Etoricoxib> Tablets should not be taken by children or adolescents under 16 years of age.
Danish: Børn <SÆRNAVN> er kontraindiceret til børn og unge under 16 år.
English: Uncommon: facial oedema, pruritus, rash.
Danish: Ikke-almindelig: Ekkymoser, ansigtsødem, pruritus, udslæt.
English: The rate per hundred patient-years was 0.22 on etoricoxib and 1.84 for diclofenac (p-value was <0.001 for etoricoxib vs. diclofenac).
Danish: Forekomsten af iskæmisk apopleksi var 0,14 versus 0,23 pr. 100 patientår henholdsvis for etoricoxib og diclofenac.
English: UAB, Merck Sharp & Dohme“, Lenktoji str. 27/ Kestucio str. 59 LT-08124 Vilnius Lithuania
Danish: Merck Sharp & Dohme UAB, Lithuania Gelezinio Vilko 18A 01112 Vilnius
English: 90 mg white, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 90' on one side and ‘202' on the other.
Danish: 90 mg tablet: Hvid, æbleformet, bikonveks tablet med ”454” præget på den ene side og ”MSD” på den anden side.
English: The CHMP reviewed the data submitted by the marketing authorisation holders from clinical trials, drug utilisation studies and spontaneous reporting of adverse drug reactions.
Danish: Indehaveren af markedsføringstilladelsen forelægger CHMP en deskriptiv undersøgelsesprotokol.
English: OTHER
Danish: Styrker
English: - In view of the available data, the CHMP considered that the benefit/risk balance for etoricoxib 90mg dose in the RA and AS indications is positive; however, revisions to the contraindications and warnings sections have been added to the summary of product characteristics and package leaflet in relation to cardiorenal safety.
Danish: CHMP - er af den opfattelse, at benefit/risk-forholdet for lægemidler indeholdende etoricoxib til de godkendte indikationer fortsat er gunstigt, og at markedsføringstilladelserne bør opretholdes i overensstemmelse med de reviderede produktresuméer (vedlagt i bilag III til CHMP's udtalelse), - konkluderede, at den kardiovaskulære sikkerhed og de alvorlige hudreaktioner løbende skal overvåges nøje og vurderes, - anbefaler opfølgningsforanstaltninger til videre undersøgelse af sikkerheden af etoricoxib.
English: Hertsfordshire EN11 9BU
Danish: Hertford Road, Hoddesdon, Hertfordshire EN11 9BU
English: Arcoxia 30 mg, 60 mg, 90 mg un 120 mg apvalkotās tablets
Danish: <SÆRNAVN> indeholder laktose (4 mg, 6 mg og 8 mg i henholdsvis 60 mg, 90 mg og 120 mg tabletten).
English: B - 1180 Bruxelles
Danish: Chaussée de Waterloo, 1135 B- 1180 Bruxelles Belgien
English: In March 2006, the marketing authorisation holders (MAH) for etoricoxib submitted an application to extend the licensed indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Danish: I september 2004 underrettede indehaveren af markedsføringstilladelsen for rofecoxib (en selektiv Cox-2-hæmmer) EMEA om, at oplysninger fra en ny klinisk undersøgelse (APPROVe) af rofecoxib havde vist risiko for thrombotiske kardiovaskulære hændelser.
English: 60 mg dark green, apple-shaped, biconvex film coated tablets marked ‘ARCOXIA 60' on one side and ‘200' on the other.
Danish: 60 mg tablet: Grøn, æbleformet, bikonveks tablet med ”447” præget på den ene side og ”MSD” på den anden side.
English: Microcrystalline cellulose
Danish: Km Athens-Lamia
English: Rheumatoid arthritis The recommended dose is 90 mg once daily.
Danish: Ved rheumatoid arthritis bør dosis ikke overstige 90 mg dagligt.
English: Waarderweg 39, NL - 2031 BN Haarlem, The Netherlands
Danish: Waarderweg 39, Post Bus 581 2003 PC Haarleem Holland
English: BATCH NUMBER
Danish: BILAG I
English: Allergic reactions (which may be serious enough to require immediate medical attention) including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing, bronchospasm (wheezing or shortness of breath), severe skin reactions, inflammation of the stomach lining or stomach ulcers that can become serious and may lead to bleeding, liver problems, serious kidney problems, severe increase in blood pressure, confusion, seeing, feeling or hearing things that are not there (hallucinations).
Danish: Ændringerne i produktinformationen vedrørende de kardiovaskulære risici kan sammenfattes således: - tilføjelse af, at beslutningen om ordinering af en selektiv COX-2-hæmmer bør baseres på en vurdering af den enkelte patients samlede risici, - tilføjelse af, at ordinerende læger bør ordinere den laveste virksomme dosis i så kort tid som muligt, og at behovet for smertelindring ofte bør tages op til fornyet vurdering, - tilføjelse af kontraindikationerne: Konstateret iskæmisk hjertesygdom og/eller cerebrovaskulær sygdom samt perifer arteriel sygdom, - tilføjelse af en advarsel om, at kliniske undersøgelser tyder på, at selektive Cox-2-hæmmere kan være forbundet med risiko for thrombotiske hændelser (navnlig myokardieinfarkt og slagtilfælde) i forhold til placebo og nogle NSAIDs, - tilføjelse af en advarsel til patienter med risikofaktorer for hjertesygdom som f.eks. hypertension, hyperlipidæmi (højt kolesterolniveau), diabetes og rygning, - tilføjelse af en advarsel til ordinerende læger om at overveje afbrydelse af behandlingen, hvis patienten under behandlingen oplever en forværring af en hvilken som helst af de beskrevne organsystemfunktioner - tilføjelse af en advarsel til ordinerende læger om hypertension og overvågning af blodtryk under behandling med etoricoxib.
English: - The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing 90 mg etoricoxib.
Danish: Bemærk: Dette er det SPC, der var bilag til Europa-Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag vedrørende lægemidler indeholdende etoricoxib.
English: As a consequence, the CHMP has recommended to maintain the Marketing Authorisation for all medicinal products containing 90 mg of etoricoxib referred to in Annex I of the Opinion and to amend the relevant sections of the summary of product characteristics and package leaflet, as set out in Annex III of the Opinion in accordance with Article 31 (2) of Directive 2001/83/EC, as amended.
Danish: I fortsættelse af drøftelserne på CHMP's plenarmøde i oktober 2004 henstillede EuropaKommissionen til, at dette folkesundhedsspørgsmål, der vedrører alle aspekter af den kardiovaskulære sikkerhed, herunder thrombotiske hændelser og kardiorenale hændelser, indbringes for CHMP for at få det behandlet efter artikel 31 (”Referrals”) i direktiv 2001/83/EF, med senere ændringer, når det gælder decentralt godkendte produkter indeholdende celecoxib, etoricoxib og lumiracoxib, og underkastes en gennemgang af CHMP i henhold til artikel 18 i Rådets forordning (EF) nr. 2309/93, med senere ændringer, når det gælder de centralt godkendte produkter indeholdende celecoxib (Onsenal), parecoxib (Dynastat/Rayzon) og valdecoxib (Bextra/Valdyn), hvilket blev påbegyndt i november 2004.
English: 1123 Budapest Hungary
Danish: MSD Hungary Ltd. Alkotás utca 50 H-1123 Budapest Ungarn
English: Laboratórios Bial - Portela & Cª, S.A. PRT
Danish: Laboratórios BIAL-Portela S.A. Av.
English: Bottles: Keep the container tightly closed in order to protect from moisture.
Danish: Beholder: Opbevares i original emballage tæt tillukket.