FrancophonIA/ELRC3.0 huggingface dataset:
English: An additional increase in peak exposure of lapatinib can be expected when lapatinib is taken repeatedly with food (see sections 4.2 and 5.2) or concomitantly with strong CYP3A4 inhibitors.
Danish: En yderligere stigning i maksimal eksponering for lapatinib kan forventes, når lapatinib tages gentagne gange sammen med mad (se pkt.
English: The recommended dose of capecitabine is 2000 mg/m2/day taken in 2 doses 12 hours apart on days 1-14 in a 21 day cycle (see section 5.1).
Danish: Den anbefalede dosis af capecitabin er 2000 mg/m2/dag fordelt på to doser med 12 timers mellemrum.
English: Tyverb / aromatase inhibitor combination posology Each pack of Tyverb contains 84 film-coated tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 12 tablets each.
Danish: Tabletterne er pakket i blisterpakninger (polyamid/aluminium/polyvinylchlorid/aluminium) med 12 stk.
English: Serious cutaneous reactions have been reported with Tyverb.
Danish: Alvorlige hudlidelser er set ved anvendelse af Tyverb.
English: Tyverb is prescribed in combination with trastuzumab, for patients who have hormone receptornegative metastatic breast cancer and have had other treatment for advanced or metastatic breast cancer before.
Danish: Patienter, der har hormonreceptornegativ brystkræft, og som tidligere har fået behandling mod avanceret eller metastatisk brystkræft, skal tage Tyverb i kombination med trastuzumab.
English: Trastuzumab (loading dose of 8mg/kg followed by 6mg/kg q3 weekly infusions)
Danish: Trastuzumab (infusion med startdosis på 8 mg/kg efterfulgt af infusion af 6 mg/kg hver 3. uge) + capecitabin (2500 mg/m2/dag, dag 1-14 hver 21. dag)
English: • joint or back pain
Danish: • led- eller rygsmerter
English: • treatment-induced lung inflammation, which may cause shortness of breath or cough Tell your doctor immediately if you get either of these symptoms.
Danish: • lungebetændelse, som er forårsaget af behandlingen, og som kan medføre åndenød og hoste.
English: • nail disorders - such as a tender infection and swelling of the cuticles Tell your doctor if you get any of these symptoms.
Danish: • neglelidelser - såsom ømhed på grund af infektion og hævede neglebånd.
English: Interstitial lung disease/pneumonitis.
Danish: interstitiel lungesygdom og pneumonitis (se pkt.
English: Gastrointestinal disorders Very common Diarrhoea, which may lead to dehydration (see section 4.2 - dose delay and dose reduction - other toxicities and section 4.4), nausea, vomiting, dyspepsia*, stomatitis*, constipation*, abdominal pain*.
Danish: 4.4), kvalme, opkastning, dyspepsi*, stomatitis*, obstipation*, abdominalsmerter*
English: • being sick (vomiting)
Danish: • udslæt (herunder kløende, ujævnt udslæt)
English: Check with your doctor or pharmacist if you're not sure.
Danish: • Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide.
English: • Use a reliable method of contraception to avoid becoming pregnant while you're taking
Danish: • Brug sikker prævention for at undgå at blive gravid, mens du er i behandling med Tyverb og i mindst 5 dage efter den sidste dosis.
English: Tyverb / capecitabine combination posology
Danish: Dosering ved kombination af Tyverb og capecitabin
English: Cardiac disorders Common
Danish: Meget almindelig Anoreksi Psykiske forstyrrelser
English: Tyverb / aromatase inhibitor combination posology
Danish: Dosering ved kombination af Tyverb og en aromatasehæmmer
English: - if your dogs is less than 6 weeks of age
Danish: - hvis din hund er yngre end 6 uger
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14.11.2007
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 14.11.2007
English: Not all pack sizes may be marketed.
Danish: Muligvis er alle pakkestørrelser ikke markedsført.
English: Date of last renewal:
Danish: Dato for seneste fornyelse:
English: A clinical response is normally seen within 3 - 4 days.
Danish: En klinisk reaktion ses normalt inden for 3 - 4 dage.
English: Dispose of waste material in accordance with local requirements.
Danish: Bortskaf affaldsmateriale i overensstemmelse med lokale krav.
English: Approximately 97 % of meloxicam is bound to plasma proteins.
Danish: Ca. 97% af meloxicam er bundet til plasmaproteiner.
English: White to yellowish opaque suspension.
Danish: Hvid til gullig uigennemsigtig suspension.
English: Do not use in pregnant or lactating dogs.
Danish: Må ikke anvendes til gravide eller diende hunde.
English: Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 6.1 hours.
Danish: Meloxicam absorberes fuldstændigt efter peroral administration, og den maksimale plasmakoncentration opnås efter ca. 6,1 time.
English: Meloxivet must not be administered in conjunction with other NSAIDs or glucocorticosteroids.
Danish: Meloxivet må ikke gives samtidig med andre NSAID-præparater eller glucocortikosteroider.
English: SPECIAL WARNING(S), IF NECESSARY Do not use in pregnant or lactating dogs
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Må ikke anvendes til gravide eller diende hunde.
English: The volume of distribution is 0.3 1/kg.
Danish: Fordelingsvolumenet er 0,3 1/kg.
English: Thus for the first day, twice the maintenance volume will be required.
Danish: Den første dag gives der således en dobbelt så stor dosis som vedligeholdelsesdosis.
English: Once opened, use within 6 months.
Danish: Efter åbning skal produktet anvendes inden for 6 måneder.
English: To be administered with food.
Danish: Skal administreres sammen med foder.
English: Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity.
Danish: Undgå anvendelse til dehydrerede, hypovole eller hypotensive hunde, da der er en potentiel risiko for øget renal toksisitet.
English: Approximately 75 % of the administered dose of meloxicam is eliminated via faeces and the remainder via urine.
Danish: Ca. 75 % af den indgivne meloxicamdosis elimineres via fæces og den resterende del med urinen.
English: For longer term treatment once clinical response has been observed (after 4 or more days), the dose of Meloxivet can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.
Danish: Ved længerevarende behandling, når der er observeret klinisk reaktion (efter ≥ 4 dage), kan dosis af Meloxivet tilpasses til den laveste, effektive, individuelle dosis, idet der tages hensyn til, at graden af smerte og inflammation, som er forbundet med kroniske lidelser i bevægeapparatet, kan variere over tid.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary In case of overdose symptomatic treatment should be initiated.
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt I tilfælde af overdosering bør symptomatisk behandling initieres.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ml indeholder:
English: The suspension of the 10 ml pack size could be administered using the smallest syringe for dogs less than 8 kg body weight (one graduation corresponding to 0.5 kg of body weight) or the largest syringe for dogs over than 8 kg body weight (one graduation corresponding to 2.0 kg of body weight).
Danish: Doseringssprøjten i pakken på 10 ml kan indgives med den mindste doseringssprøjte til hunde med en kropsvægt på under 8 kg (én gradering svarer til en kropsvægt på 0,5 kg) eller den største doseringssprøjte til hunde med en kropsvægt på over 8 kg (én gradering svarer til en kropsvægt på 2,0 kg).
English: Pull the plunger out until the black on the plunger corresponds to your dog's bodyweight in kilograms.
Danish: Træk stemplet tilbage til den sorte streg, som svarer til hundens legemsvægt i kilogram.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each ml contains:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Hver ml indeholder:
English: 1 mg For a full list of excipients, see section 6.1.
Danish: 1 mg Se afsnit 6.1 for en fuldstændig liste over hjælpestoffer.
English: Pre- treatment with anti-inflammatory substances may result in additional or increased adverse reactions and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment.
Danish: Forudgående behandling med antiinflammatoriske substanser kan resultere i yderligere eller forstærkede bivirkninger, og derfor bør der indlægges en periode uden behandling med sådanne veterinære lægemidler på mindst 24 timer, inden behandlingen påbegyndes.
English: Marketing authorisation holder: Eli Lilly and Company Limited Elanco Animal Health Lilly House, Priestley Road Basingstoke
Danish: Indehaver af markedsføringstilladelsen: Eli Lilly and Company Limited Elanco Animal Health Lilly House, Priestley Road Basingstoke
English: The treatment-free period, however, should take into account the pharmacological properties of veterinary medicinal products used previously.
Danish: Længden af den behandlingsfri periode bør dog fastlægges under hensyntagen til de farmakologiske egenskaber af tidligere anvendte veterinære præparater.
English: The syringe should be stored in the carton box in between uses.
Danish: Sprøjten skal opbevares i kartonemballagen når den ikke bruges.
English: ADVICE ON CORRECT ADMINISTRATION Particular care should be taken with regard to the accuracy of dosing.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Der bør udvises særlig forsigtighed i forbindelse med doseringsnøjagtigheden.
English: Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound.
Danish: Meloxicam findes hovedsagelig i plasma, og stoffet udskilles i høj grad via galden, hvorimod urinen kun indeholder spor af uomdannet substans.
English: Manufacturer for the batch release:
Danish: Fremstiller af batchfrigivelse:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Danish: Særlige forsigtighedsregler for personer, som indgiver det veterinære medicinske produkt til dyr
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN ”KUN TIL DYR” Kun til dyr.
English: Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment.
Danish: Forudgående behandling med antiinflammatoriske substanser kan resultere i yderligere eller forstærkede bivirkninger, og derfor bør der indlægges en behandlingsfri periode på mindst 24 timer, inden behandling påbegyndes.
English: After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly.
Danish: Efter hver doses skal sprøjtens spids aftørres og flaskehættes påskrues tæt.
English: When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.
Danish: Når præparatet anvendes i overensstemmelse med den anbefalede daglige dosering, nås steady-state plasmakoncentrationer af meloxicam 2 dage efter behandlingens påbegyndelse.
English: Two measuring syringes are provided.
Danish: To doseringssprøjter medfølger.
English: By pushing the plunger in empty the contents of the syringe onto the food.
Danish: Ved at trykke stemplet i bund tømmes sprøjtens indhold i foderet.
English: There is a linear relationship between the dose of meloxicam administered and plasma concentration observed in the therapeutic dose range.
Danish: Der er et lineært forhold mellem den indgivne meloxicam-dosis og den observerede plasmakoncentration i det terapeutiske dosisinterval.
English: People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
Danish: Personer med kendt hypersensivitet overfor non-steroide anti-inflammatoriske medikamenter (NSAIDs) skal undgå kontakt med dette veterinære medicinske produkt.
English: Treatment is to be continued once daily by oral administration (24 hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
Danish: Behandlingen fortsættes én gang dagligt med peroral administration (24 timers interval) af en vedligeholdelsesdosis på 0,1 mg meloxicam/kg legemsvægt.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One ml contains:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER En ml indeholder:
English: Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Danish: Må ikke anvendes til hunde, der lider af mave- og tarmsygdomme som f.eks. irritation og blødning, nedsat lever-, hjerte eller nyrefunktion eller blødningsforstyrrelser.
English: 4.2 Indications for use, specifying the target species Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Lindring af betændelse og smerter ved såvel akutte som kroniske lidelser i bevægeapparatet hos hunde.
English: The suspension has to be given with the measuring syringes provided in the package of the 30 ml and 150 ml pack size or with one of the two measuring syringes provided in the package of the 10 ml pack size.
Danish: Suspensionen skal indgives med de doseringssprøjter, der følger med pakken på 30 ml og 150 ml, eller med en af de to doseringssprøjter, der følger med pakken på 10 ml.
English: INDICATION(S) Acute and chronic musculo-skeletal disorders.
Danish: INDIKATION(ER) Akutte og kroniske lidelser i bevægeapparatet.
English: Do not use after the expiry date stated on the label and carton after EXP.
Danish: Må ikke anvendes efter den udløbsdato, der er nævnt på mærkaten og kartonen efter ordet EXP. Opbevaringstid efter første åbning af beholderen: 6 måneder.
English: PACKAGE SIZE 150 ml
Danish: PAKNINGSSTØRRELSE 150 ml
English: The suspension has to be given with the measuring syringe provided in the package of the 30 and 150 ml pack size or with one of the two measuring syringes provided in the package of the 10 ml pack size.
Danish: Suspensionen skal indgives med de doseringssprøjter, der følger med pakningen på 30 og 150 ml, eller med en af de to doseringssprøjter, der følger med pakningen på 10 ml.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 1.5 mg/ml
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Meloxicam 1,5 mg/ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for bottle 10, 30 and 150 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonboks til flaske 10, 30 og 150 ml
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 0.5 mg/ml
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Meloxicam 0,5 mg/ml
English: The suspension has to be given with the measuring syringe provided in the package.
Danish: Suspensionen kan indgives med de doseringssprøjter, der følger med pakningen.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Label bottle 150 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Mærke på flaske 150 ml
English: Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams), ATCvet code: QM01AC06
Danish: Farmakoterapeutisk gruppe: Antiinflammatoriske og antireumatiske lægemidler, non-steroider (oxicam).
English: Do not administer Meloxivet: - if your dog is pregnant or during lactation - if your dog is suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders - if your dog is hypersensitive (allergic) to the active substance or to any of the other ingredients.
Danish: Giv ikke Meloxivet: - hvis din hund er gravid eller dier - hvis din hund lider af mave-tarmsygdomme som f.eks. irritation eller blødninger, nedsat lever-,
English: Attach the dosing syringe to the bottle by gently pushing the end onto the top the bottle
Danish: Sæt doseringssprøjten på flasken ved forsigtigt at trykke sprøjtespidsen ned over flaskens åbning.
English: Microcrystalline cellulose Xxanthan gum Carboxymethylcellulose Sodium benzoate Sodium saccharinate
Danish: 6.1 Fortegnelse over hjælpestoffer mikrokrystallisk cellulose xanthan-gummi karbolmethylcellulose natriumbenzoat natriumsaccharinat glycerol sorbitol citronsyre-monohydrat natriumhydroxid renset vand
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label bottle 10 and 30 ml
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Mærke på flaske 10 og 30 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for bottle 10 and 30 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonboks til flaske 10 og 30 ml
English: People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Danish: Ved overfølsomhed over for NSAID-præparater bør kontakt med lægemidlet undgås.
English: Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle.
Danish: Vend flasken om igen og vrid forsigtigt doseringssprøjten af flasken.
English: ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Oral indgivelse.
English: INDICATION(S) Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
Danish: Lindring af betændelse og smerter ved såvel akutte som kroniske lidelser i bevægeapparatet hos hunde.
English: Sodium benzoate
Danish: Hjælpestof: Natriumbenzoat
English: MARKETING AUTHORISATION NUMBER(S) EU/2/07/077/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/07/077/001
English: In very rare cases haemorrhagic diarrhoea, haematemisis, gastrointestinal ulceration and elevated liver enzymes have been reported.
Danish: I meget sjældne tilfælde er der set hæmoragisk diarré, opkastning af blod, mavesår og forhøjede leverenzymer..
English: Push down and unscrew bottle top.
Danish: Tryk ned og drej skruelåget af.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/07/077/003
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/07/077/003
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvindgift ved hændeligt uheld skal der straks søges lægehjælp og indlægssedlen eller etiketten vises til lægen.
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects.
Danish: Det virker ved hæmning af prostaglandinsyntesen, hvorved det har antiinflammatorisk, analgetisk, antiexudativ og antipyretisk effekt.
English: A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: 30 ml and 150 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe.
Danish: 30 ml og 150 ml præsentation: præsentation: ravgul glasflaske (type III) med børnesikret lukning af polypropylen, polyethylen-indlæg og klar polypropylen-doseringssprøjte.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: Anvendelsesmåde og indgivelsesvej(e)
English: Excipient:
Danish: (EXP)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxivet 0.5 mg/ml oral suspension for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Meloxivet 0,5 mg/ml oral suspension til hunde
English: Turn the bottle syringe upside down.
Danish: Vend flasken med sprøjten på hovedet.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxivet 1.5 mg/ml oral suspension for dogs
Danish: VETERINÆRLÆGEMIDLETS NAVN Meloxivet 1,5 mg/ml oral suspension til hunde
English: Shake bottle well.
Danish: Flasken rystes kraftigt.
English: MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: 10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe.
Danish: 10 ml præsentation: ravgul glasflaske (type III) med børnesikret lukning af polyethylen, polyethylenindlæg og klar polypropylen-doseringssprøjte.
English: Route and method of administration
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Shake well before use.
Danish: Ryst flasken grundigt før brug.
English: 4.11 Withdrawal period(s) Not applicable.
Danish: 10. TILBAGEHOLDELSESTID Ikke relevant.
English: PACKAGE LEAFLET FOR: Meloxivet 1.5 mg/ml oral suspension for dogs
Danish: INDLÆGSSEDDEL Meloxivet 1,5 mg/ml oral suspension til hunde
English: PACKAGE LEAFLET FOR: Meloxivet 0.5 mg/ml oral suspension for dogs
Danish: INDLÆGSSEDDEL Meloxivet 0,5 mg/ml oral suspension til hunde
English: 30 ml: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and amber polypropylene dosing syringe.
Danish: 30 ml: ravgul glasflaske (type III) med børnesikret lukning af polypropylen, polyethylen-indlæg og ravgul polypropylen-doseringssprøjte.
English: 10 ml: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and amber polypropylene dosing syringe.
Danish: 10 ml: ravgul glasflaske (type III) med børnesikret lukning af polyethylen, polyethylen-indlæg og ravgul polypropylen-doseringssprøjte.
English: Significant differences have been identified with regard to the benefit/risk ratio of the product.
Danish: Der er identificeret væsentlige forskelle med hensyn til benefit/risk-forholdet for produktet.
English: London, 22 November 2007 EMEA/433691/2007
Danish: London, den 22. november 2007 EMEA/433691/2007
English: The Reference Member State was Czech Republic and the Concerned Member States were Austria, Denmark, Germany, Estonia, Greece, France, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovak Republic and the United Kingdom.
Danish: Referencemedlemsstaten var Den Tjekkiske Republik, og de berørte medlemsstater var Østrig, Danmark, Tyskland, Estland, Grækenland, Frankrig, Ungarn, Italien, Letland, Litauen, Nederlandene, Norge, Polen, Portugal, Sverige, Slovenien, Den Slovakiske Republik og Det Forenede Kongerige.
English: The Rapporteur was Dr Ondrej Slanar and Co-Rapporteur was Dr Matthew Thatcher.
Danish: Ordføreren var dr. Ondrej Slanar, og medrapportøren var dr. Matthew Thatcher.
English: These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Danish: Disse medlemsstater kunne ikke nå til enighed om en gensidig anerkendelse af den af referencemedlemsstaten udstedte markedsføringstilladelse.
English: The Mutual Recognition Procedure started on 21 September 2006.
Danish: Den gensidige anerkendelsesprocedure indledtes den 21. september 2006.
English: Czech Republic referred the reasons for disagreement to the EMEA on 30 March 2007.
Danish: Den Tjekkiske Republik fremsendte begrundelserne for uenighederne til EMEA den 30. marts 2007.
English: The final opinion was converted into a Decision by the European Commission on 22 November 2007.
Danish: Den endelige udtalelse blev omdannet til en afgørelse truffet af Europa-Kommissionen den 22. november
English: A positive opinion was adopted by consensus on 20 September
Danish: Der blev vedtaget en positiv udtalelse ved konsensus den 20. september 2007.
English: The Marketing Authorisation Holder provided written explanations on 20 July 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 20. juli 2007.