FrancophonIA/ELRC3.0 huggingface dataset:
English: Fatigue Pyrexia Chills Pain Chest pain Malaise Asthenia Injection site reaction Note: Valganciclovir is a pro-drug of ganciclovir, and adverse reactions associated with valganciclovir can be expected to occur with ganciclovir.
Danish: NB: Valganciclovir er et prodrug til ganciclovir, og bivirkninger set med valganciclovir kan forventes at forekomme med ganciclovir.
English: - Prophylaxis:
Danish: Profylaktisk behandling:
English: <10 mL/min 1.25 mg/kg 3x/wk after haemodialysis
Danish: 1,25 mg/kg 3 gange om ugen efter hæmodialyse
English: Abdominal pain Abdominal pain upper Constipation Flatulence
Danish: Abdominalsmerter Smerter i øvre abdomen Obstipation
English: Ear and labyrinth disorders: Common (≥ 1/100, < 1/10):
Danish: Øre og labyrint: Almindelig (≥ 1/100 til < 1/10):
English: Convulsions
Danish: Konfusion
English: 50-69 mL/min 2.5 mg/kg q12h
Danish: 50-69 ml/min
English: It will be given through a tube into your vein.
Danish: Cymevene gives gennem en slange i en blodåre.
English: Tabulated list of adverse reactions Infections and infestations:
Danish: Almene symptomer og reaktioner fra administrationsstedet:
English: • changes to the way things taste
Danish: • ændret smagssans
English: >70 mL/min 5.0 mg/kg q12h
Danish: >70 ml/min
English: Depression Anxiety
Danish: Depression
English: 10-24 mL/min 1.25mg/kg/day
Danish: 10-24 ml/min
English: 2.5 mg/kg/day
Danish: 2,5 mg/kg/dag
English: • low red blood cell counts - signs include feeling short of breath or tired, palpitations or pale skin.
Danish: • lavt antal røde blodlegemer - tegn på dette kan være åndenød, træthed, hjertebanken eller bleghed.
English: • low red blood cell counts - signs include feeling short of breath or tired, palpitations or pale skin
Danish: • lavt antal røde blodlegemer - tegn på dette kan være åndenød, træthed, hjertebanken eller bleghed
English: Induction dose
Danish: Initial dosis
English: prevention of CMV disease in patients with drug-induced immunosuppression (for example following organ transplantation or cancer chemotherapy).
Danish: Cymevene er indiceret til voksne og unge over 12 år til - behandling af cytomegalovirus- (CMV-) infektion hos immunkompromitterede patienter, - forebyggelse af CMV-infektion hos patienter med lægemiddelinduceret immunsuppression (fx efter organtransplantation eller kemoterapi).
English: Do not administer by intramuscular or subcutaneous injection because this may result in severe tissue irritation due to the high pH (~11) of ganciclovir solutions (see section 4.8).
Danish: Ganciclovir må ikke administreres ved intramuskulær eller subkutan injektion, da den høje pH (~11) i ganciclovir-infusionsvæsken kan medføre svær vævsirritation (se pkt.
English: days after discontinuation of the drug or dose reduction (see section 4.4).
Danish: Celletallet normaliseres sædvanligvis inden for 2-5 dage efter seponering af lægemidlet eller dosisreduktion (se pkt.
English: 5.0 mg/kg/day
Danish: 5,0 mg/kg/dag
English: What Cymevene contains
Danish: Cymevene indeholder:
English: Musculo-skeletal and connective tissue disorders: Common (≥ 1/100, < 1/10):
Danish: Knogler, led, muskler og bindevæv: Almindelig (≥ 1/100 til < 1/10):
English: Severe leucopenia, neutropenia, anaemia, thrombocytopenia and pancytopenia See section 4.4 before initiation of treatment.
Danish: Svær leukopeni, neutropeni, anæmi, trombocytopeni og pancytopeni
English: • loss of appetite, anorexia or weight loss
Danish: • appetitløshed, madlede eller vægttab
English: Uncommon (≥ 1/1000, <1/100):
Danish: Ikke almindelig (≥ 1/1.000 til < 1/100):
English: Uncommon (≥ 1/1000, < 1/100):
Danish: Ikke almindelig (≥ 1/1.000 til <1/100):
English: Nausea
Danish: Kvamle
English: • fits
Danish: • mundsår
English: Dizziness
Danish: Døvhed
English: Estimated creatinine clearance can be calculated from serum creatinine using the following formulae: For males: (140 - age [years]) x (body weight [kg])
Danish: Estimeret creatininclearance kan beregnes ud fra serum-creatinin ved hjælp af følgende formler:
English: • deafness
Danish: • kramper
English: Eye disorders: Common (≥ 1/100, < 1/10):
Danish: Øjne: Almindelig (≥ 1/100 til < 1/10):
English: Excipients
Danish: Flatulens
English: [See Annex I - To be completed nationally] ganciclovir
Danish: [Se bilag I - udfyldes nationelt]
English: Your doctor will work out how much you need.
Danish: Lægen beregner din dosis på baggrund af
English: PACKAGE LEAFLET
Danish: Nethindeløsning
English: Cardiac disorders: Uncommon (≥ 1/1000, < 1/100):
Danish: Hjerte: Ikke almindelig (≥ 1/1.000 til < 1/100):
English: Vascular disorders: Uncommon (≥ 1/1000, < 1/100):
Danish: Vaskulære sygdomme: Ikke almindelig ≥ 1/1.000 til < 1/100):
English: - Induction treatment: 5 mg/kg given as an intravenous infusion over one hour, every 12 hours for 1421 days.
Danish: Behandling af CMV-infektion hos voksne og unge over 12 år med normal nyrefunktion Initialbehandling: 5 mg/kg som intravenøs infusion over 1 time hver 12. time i 14-21 dage.
English: The vial should be gently rotated/ swirled for some minutes to obtain a clear reconstituted solution.
Danish: Vend/rotér forsigtigt hætteglasset i nogle minutter, indtil alt pulveret er opløst, og væsken fremstår klar.
English: Retinal detachment
Danish: Almen utilpashed Asteni
English: Tremor
Danish: Træthed
English: Dyspnoea
Danish: Dysfagi
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Danish: Styrke Lægemiddelform Administration Emballage
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Danish: Resultatet af en procedure i henhold til artikel 30 i Direktiv 2001/83/EF
English: A decision on this opinion was issued by the European Commission on 20/08/2015.
Danish: En beslutning angående denne udtalelse blev truffet af Europa-Kommissionen 20/08/2015.
English: Amoxil is marketed in the following EU Member States: Belgium, Cyprus, France, Greece, Ireland, Latvia, Lithuania, Luxembourg, Malta, Portugal, Spain and the United Kingdom.
Danish: Amoxil markedsføres i følgende EU-medlemsstater: Belgien, Cypern, Frankrig, Grækenland, Irland, Letland, Litauen, Luxembourg, Malta, Portugal, Spanien og Storbritannien.
English: Doses range from 250 mg to 2 g two or three times a day for adults and children weighing more than 40 kilograms, and from 20 to 200 mg per kilogram per day for children weighing less than 40 kilograms.
Danish: Doser varierer fra 250 mg til 2 g to til tre gange dagligt til voksne og børn, der vejer mere end 40 kg, og fra 20 til 200 mg pr. kg dagligt til børn, der vejer mindre end 40 kg.
English: Amoxil has been authorised in the EU via national procedures.
Danish: Amoxil blev godkendt i EU via nationale procedurer.
English: What is Amoxil?
Danish: Hvad er Amoxil?
English: Why was Amoxil reviewed?
Danish: Hvorfor blev Amoxil vurderet igen?
English: This is either because antibiotics are no longer used to treat these conditions, or because other antibiotics have been shown to be more effective than amoxicillin.
Danish: Dette er, enten fordi antibiotika ikke længere anvendes til behandling af disse sygdomme, eller fordi det er påvist, at andre antibiotika er mere effektive end amoxicillin.
English: On 25 June 2015, the European Medicines Agency completed a review of Amoxil.
Danish: Den 25. juni 2015 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Amoxil.
English: The recommended dose of Amoxil varies depending on the infection it is used to treat, the way it is given, and the age and weight of the patient.
Danish: Den anbefalede dosis af Amoxil varierer, afhængigt af den infektion, det anvendes til behandling af, måden, det gives på, og patientens alder og vægt.
English: Questions and answers on Amoxil and associated names (amoxicillin)
Danish: Spørgsmål og svar vedrørende Amoxil og relaterede navne (amoxicillin)
English: In some countries it is available under the trade names Amoxicilline Biogaran and Clamoxyl.
Danish: I nogle lande fås det under handelsnavnene Amoxicilline Biogaran og Clamoxyl.
English: These formulations can be used to treat adults and children with the following bacterial infections:
Danish: Disse formuleringer kan anvendes til behandling af voksne og børn med følgende bakterieinfektioner:
English: The Committee also harmonised other sections of the SmPC including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), and 4.8 (side effects).
Danish: Udvalget harmoniserede derudover andre afsnit i produktresuméet, herunder 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen), 4.6 (graviditet og amning) og 4.8 (bivirkninger).
English: Amoxil is an antibiotic used to treat a wide range of bacterial infections.
Danish: Amoxil er et antibiotikum og anvendes til behandling af en lang række bakterieinfektioner.
English: It contains the active substance amoxicillin which belongs to the ‘beta-lactam' family (the family that includes penicillins).
Danish: Det indeholder det aktive stof amoxicillin, der tilhører "beta-lactam"-gruppen (den gruppe, der omfatter penicillin).
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Danish: Dette har medført afvigelser i lægemidlets anvendelsesmåde i medlemsstaterne, hvilket fremgår af forskellene i produktresuméerne (SmPC'er), etiketteringen og indlægssedlerne i de lande, hvor lægemidlet markedsføres.
English: The injectable formulations can also be used for the treatment and prevention of endocarditis.
Danish: Injektionsformuleringerne kan også anvendes til behandling og forebyggelse af endokarditis.
English: The CHMP also agreed that Amoxil should no longer be used to treat female genital infections, because not enough clinical data are available to support this indication.
Danish: CHMP besluttede også, at Amoxil ikke længere må anvendes til behandling af infektioner i kvinders kønsorganer, idet der ikke foreligger tilstrækkelige, kliniske data til at underbygge denne indikation.
English: The CHMP agreed that the oral (to be taken by mouth) formulations of Amoxil (such as capsules, tablets and suspensions) can be used in adults and children for the treatment of the following bacterial infections:
Danish: CHMP vedtog, at de orale (tages gennem munden) formuleringer af Amoxil (såsom kapsler, tabletter og suspensioner) kan anvendes til voksne og børn til behandling af følgende bakterieinfektioner:
English: Additionally, Amoxil should no longer be used in several other indications (treatment of bronchitis, acute lung disease, urethritis (inflammation of the urethra, the tube that carries urine from the bladder out of the body), gonococcal infections, male genital infections, gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae), enteritis (inflammation of the small intestine) with bacteraemia and intra-abdominal infections such as peritonitis, cholecystitis and acute cholangitis, and serious infections caused by Haemophilus influenzae).
Danish: Endvidere må Amoxil ikke længere anvendes ved adskillige andre indikationer (behandling af bronkitis, akutte lungesygdomme, urethritis (betændelse i urinlederen, røret, der fører urinen fra blæren ud af kroppen), gonokokinfektioner, infektioner i de mandlige kønsorganer, gonorré (en seksuelt overført infektion af bakterier, der kaldes Neisseria gonorrhoeae), enteritis (betændelse i tyndtarmen) med bakteriæmi og intra-abdominale infektioner, f.eks. peritonitis, cholecystitis og akut cholangitis og svære infektioner, forårsaget af Haemophilus influenzae).
English: • Bacteraemia (bacteria detected in the blood) that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Danish: • Bakteriæmi (bakterier påvist i blodet), der optræder sammen med eller formodes at være forbundet med en af de infektioner, som er anført ovenfor.
English: On 22 July 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Amoxil in the EU.
Danish: Den 22. juli 2013 indbragte Europa-Kommissionen sagen for CHMP med henblik på at harmonisere markedsføringstilladelserne for Amoxil i EU.
English: Oral Amoxil can also be used for the prevention of endocarditis (infection of the inner lining of the heart).
Danish: Oral Amoxil kan også anvendes til forebyggelse af endokarditis (infektion i hjertets indervægge).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there was a need to harmonise the prescribing information for Amoxil in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der var behov for at harmonisere ordineringsoplysningerne for Amoxil i Den Europæiske Union (EU).
English: • Typhoid and paratyphoid fever;
Danish: • Tyfoid og paratyfoid feber
English: Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Amoxil.
Danish: Foruden indikationerne harmoniserede CHMP også anbefalingerne for brug af Amoxil.
English: • Asymptomatic bacteriuria (bacteria detected in the urine) in pregnancy;
Danish: • Asymptomatisk bakteriuri (bakterier påvist i urinen) under graviditet
English: • Helicobacter pylori eradication;
Danish: • Helicobacter pylori-udryddelse
English: Additionally, Amoxil must not be used in patients who have had severe allergic reactions to another type of beta-lactam antibiotic (e.g. a cephalosporin, carbapenem or monobactam).
Danish: Endvidere må Amoxil ikke anvendes til patienter, der har haft svære allergiske reaktioner over for en anden type betalactam-antibiotikum (f.eks. cefalosporin, carbapenem eller monobactam).
English: Amoxil is also available as a solution for injection or infusion (drip) into a vein, and as a solution for injection into a muscle.
Danish: Amoxil fås også som en opløsning til injektion eller infusion (drop) i en vene samt som en opløsning til injektion i en muskel.
English: The CHMP agreed that Amoxil must not be used in patients who are hypersensitive (allergic) to amoxicillin or any other ingredients of Amoxil, and to any of the penicillins.
Danish: CHMP vedtog, at Amoxil ikke må anvendes til patienter, der er overfølsomme (allergiske) over for amoxicillin eller et andet indholdsstof i Amoxil og over for et af penicillinerne.
English: • Community acquired pneumonia (infection of the lungs acquired outside the hospital);
Danish: • Samfundserhvervet lungebetændelse (infektion i lungerne, som er erhvervet uden for hospitalet)
English: • Bacterial meningitis (infection of the membranes around the brain and spine);
Danish: • Bakteriel meningitis (infektion af membranerne omkring hjernen og rygmarven)
English: • Acute pyelonephritis;
Danish: • Akut pyelonefritis
English: • Acute exacerbations of chronic bronchitis;
Danish: • Akutte eksacerbationer af kronisk bronkitis
English: • Acute cystitis;
Danish: • Akut cystitis
English: • Severe dental abscess with spreading cellulitis;
Danish: • Svær tandbyld med spredende cellulitis
English: • Dental abscess with spreading cellulitis (inflammation of the deep skin tissue);
Danish: • Tandbyld med spredende cellulitis (betændelse i det dybe hudvæv)
English: • Acute otitis media (infection of the middle ear);
Danish: • Akut otitis media (mellemørebetændelse)
English: • Community acquired pneumonia;
Danish: • Samfundserhvervet lungebetændelse
English: • Acute exacerbations (flare-ups) of chronic bronchitis (inflammation of the airways in the lungs);
Danish: • Akut eksacerbation (opblussen) af kronisk bronkitis (betændelse i luftvejene i lungerne)
English: • Acute pyelonephritis (kidney infection);
Danish: • Akut pyelonefritis (nyreinfektion)
English: • Acute streptococcal tonsillitis and pharyngitis (infections of the tonsils and throat);
Danish: • Akut tonsillitis og faryngitis forårsaget af streptokokker (infektioner i mandlerne og halsen)
English: • Acute cystitis (infection of the bladder);
Danish: • Akut cystitis (blærebetændelse)
English: Amoxil was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker(CMDh) fandt det nødvendigt at harmonisere Amoxil.
English: • Acute bacterial sinusitis (infection of the sinuses);
Danish: • Akut bakteriel sinusitis (bihulebetændelse)
English: epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms);
Danish: • Svære øre-næse-hals-infektioner (f.eks. mastoiditis, peritonsillære infektioner, epiglottitis og sinuitis, når de er ledsaget af svære systemiske tegn og symptomer)
English: The competent authorities of the Member States will continue to keep the product under regular review.
Danish: Medlemsstaternes kompetente myndigheder vil fortsat føre regelmæssigt tilsyn med produktet.
English: These review procedures were started in November 2004.
Danish: Vurderingsprocedurerne blev indledt i november 2004.
English: International Non-Proprietary Name (INN): LUMIRACOXIB
Danish: Internationalt fællesnavn ( INN): LUMIRACOXIB
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL
Danish: UDTALELSE FRA UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 31
English: Public7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.eu.int http://www.emea.eu.int
Danish: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea.eu.int http://www.emea.eu.int
English: * Notes: The information given in this document and Annexes reflect only the CHMP Opinion dated 23 June 2005.
Danish: * Bemærkninger: Oplysningerne i dette dokument og bilagene afspejler udelukkende CHMP's udtalelse af 23. juni 2005.
English: On 18 November 2004, the CHMP requested comprehensive cardiovascular safety information for these products.
Danish: Den 18. november 2004 anmodede CHMP om omfattende oplysninger vedrørende den kardiovaskulære sikkerhed ved disse lægemidler.
English: The Marketing Authorisation Holder of lumiracoxib provided written explanations by 10 January and 10 May 2005.
Danish: Indehaveren af markedsføringstilladelsen for lumiracoxib fremsendte skriftlige redegørelser den 10. januar og den 10. maj 2005.
English: On 7 April 2005, the FDA (Food and Drug Administration) and the EMEA requested Pfizer to voluntarily withdraw Bextra (valdecoxib) from the market.
Danish: Den 7. april 2005 anmodede FDA (Food and Drug Administration) og EMEA Pfizer om frivilligt at trække Bextra (valdecoxib) tilbage fra markedet.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og det ændrede produktresumé i bilag III.
English: Pfizer agreed to suspend sale and marketing of Bextra worldwide pending further discussions on the unfavorable risk versus benefit due to data on serious skin reactions.
Danish: Pfizer indvilligede i at indstille salget og markedsføringen af Bextra på verdensplan, mens man afventede de videre drøftelser af det ugunstige risk/benefit-forhold på grundlag af oplysningerne om alvorlige hudreaktioner.
English: COX-2 inhibitors have been introduced in medical practice for treatment of patients with chronic inflammatory degenerative diseases such as rheumatoid arthritis and osteoarthritis.
Danish: COX-2-hæmmere er blevet indført i klinisk praksis til behandling af patienter med kroniske inflammatoriske degenerative sygdomme som reumatoid arthritis og osteoartrose.
English: FOR ALL MEDICINAL PRODUCTS CONTAINING CELECOXIB, ETORICOXIB, LUMIRACOXIB, PARECOXIB, AND VALDECOXIB
Danish: FOR SAMTLIGE LÆGEMIDLER INDEHOLDENDE CELECOXIB, ETORICOXIB, LUMIRACOXIB, PARECOXIB OG VALDECOXIB
English: In September 2004, the Marketing Authorisation Holder of rofecoxib informed the EMEA that new clinical trial (APPROVe) data for rofecoxib have revealed a risk of thrombotic cardiovascular events.
Danish: I september 2004 underrettede indehaveren af markedsføringstilladelsen for rofecoxib EMEA om, at oplysninger fra en ny klinisk undersøgelse (APPROVe) af rofecoxib havde vist risiko for thrombotiske kardiovaskulære hændelser.
English: Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events should be the subject of Community referrals under Article 31 of Directive 2001/83/EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/Rayzon) and valdecoxib (Bextra/Valdyn).
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).
English: The COX-2 inhibitors celecoxib, etoricoxib, lumiracoxib, parecoxib, rofecoxib and valdecoxib comprise a relatively new group of substances whose common pharmacological action is the selective inhibition of cyclooxygenase-2.
Danish: COX-2 hæmmerne celecoxib, etoricoxib, lumiracoxib, parecoxib, rofecoxib og valdecoxib udgør en forholdsvis ny gruppe stoffer, hvis fælles farmakologiske virkning er selektiv hæmning af cyclooxygenase-2.
English: On the basis of the CHMP Opinion, the European Commission issued a Decision on 28 November
Danish: Europa-Kommissionen traf en afgørelse den 28. november 2005 på grundlag af CHMP's udtalelse.
English: These data resulted in the worldwide withdrawal of rofecoxib (Vioxx) from the market on 30 September 2004 by the Marketing Authorisation Holder and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.
Danish: Disse oplysninger førte til, at indehaveren af markedsføringstilladelsen den 30. september 2004 trak rofecoxib (Vioxx) tilbage fra verdensmarkedet, og satte spørgsmålstegn ved den kardiovaskulære sikkerhed ved andre Cox-2-hæmmere.
English: Therefore, on 20 April 2005 further to a request from the EC, the CHMP broadened the scope of the procedure under Article 31 of Directive 2001/83/EC, as amended and the review procedure under Article 18 of Council Regulation (EEC) No 2309/93, to include the assessment of serious skin reactions in the ongoing class review in addition to the cardiovascular safety aspects.
Danish: CHMP udvidede derfor, den 20. april 2005 efter anmodning fra Europa-Kommissionen og i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, og gennemgangen af CHMP i henhold til artikel 18 i Rådets forordning (EF) nr. 2309/93, formålet med proceduren til ud over de kardiovaskulære sikkerhedsaspekter også at omfatte vurderingen af oplysninger om alvorlige hudreaktioner.
English: Oral explanation was given by the Marketing Authorisation Holder on 18 January
Danish: Indehaverne af markedsføringstilladelserne afgav mundtlige redegørelser den 18. januar 2005.