FrancophonIA/ELRC3.0 huggingface dataset:
English: Augmentin and associated names (see Annex I) 500 mg/100 mg powder for solution injection/infusion} {Augmentin and associated names (see Annex I) 1000 mg/100 mg powder for solution for injection/infusion} {Augmentin and associated names (see Annex I) 1000 mg/200 mg powder for solution for injection/infusion} {Augmentin and associated names (see Annex I) 2000 mg/200 mg powder for solution for infusion}
Danish: LÆGEMIDLETS NAVN { Augmentin og tilhørende navne (se bilag I)500 mg/100 mg pulver til injektions- og infusionsvæske, opløsning} { Augmentin og tilhørende navne (se bilag I) 1000 mg/200 mg pulver til injektions- og infusionsvæske, opløsning} [Se Bilag I - skal udfyldes nationalt]
English: 250 mg/25 mg powder for solution for injection or infusion Powder for solution for injection or infusion.
Danish: 250 mg/25 mg pulver til injektions- og infusionsvæske, opløsning pulver til injektions- og infusionsvæske, opløsning [Udfyldes nationalt]
English: • fever, joint pain, sw
Danish: • Hududslæt, kløe
English: If r child is taking probenecid (used for gout), your doctor may decide to adjust the dose of entin.
Danish: Hvis Deres barn tager probenecid (mod gigt), kan Deres læge beslutte at ændre Deres barns dosis af Augmentin.
English: • Lower dose - 1 sachets two times a day
Danish: • Lav dosering - 1 brev 2 gange daglig
English: • Children aged 3 months and over: 25 mg/5 mg per kg every 8 hours
Danish: og der over: 25 mg/5 mg per kg hver 8. time
English: 500 mg/125 mg film-coated tablets
Danish: 500 mg/125 filvovertrukne tabletter
English: Alternatively fill the bottle with water to just below the mark on bottle label, invert and shake well, Then top up with water exactly to the mark, invert and again shake well.
Danish: Alternativt kan man fylde beholderen med vand lige under markeringsstregen.
English: {Augmentin and associated names (see Annex I) 500 mg/62.5 mg film-coated tablets} {Augmentin and associated names (see Annex I) 1000 mg/125 mg powder for oral suspension in sachets} {Augmentin and associated names (see Annex I) 250 mg/31.25 mg powder for oral suspension in sachets} {Augmentin and associated names (see Annex I) 500 mg/62.5 mg powder for oral suspension in sachets} {Augmentin and associated names (see Annex I) 100 mg/12.5 mg/ml powder for oral suspension}
Danish: LÆGEMIDLETS NAVN { Augmentin og tilhørende navne (se bilag I) 500 mg/62,5 mg filmovertukne tabletter} { Augmentin og tilhørende navne (se bilag I)1000 mg/125 mg pulver til oral suspension i breve} { Augmentin og tilhørende navne (se bilag I)250 mg/31,25 mg pulver til oral suspension i breve} { Augmentin og tilhørende navne (se bilag I)500 mg/62,5 mg pulver til oral suspension i breve} { Augmentin og tilhørende navne (se bilag I) 100 mg/12,5 mg/ml pulver til oral suspension} [Se bilag I - skal udfyldes nationalt]
English: Augmentin powder for oral suspension contains maltodextrin (glucose).
Danish: Augmentin pulver til oral suspension indeholder maltodextrin (glucose) Og bør ikke anvendes til patienter med glucose/galactosemalabsorption.
English: → if affected take Augmentin before foo
Danish:  Hvis de får kvalme, skal De tage Augmentin før et måltid
English: {Augmentin and associated names (see Annex I) 125 mg/31.25 mg powder for oral suspension in sachet} {Augmentin and associated names (see Annex I) 250 mg/62.5 mg powder for oral suspension in sachet} {Augmentin and associated names (see Annex I) 500 mg/125 mg powder for oral suspension in sachet}
Danish: { Augmentin og tilhørende navne (se bilag I) 125 mg/31,25 mg pulver til oral suspension i breve} { Augmentin og tilhørende navne (se bilag I) 250 mg/62,5 mg pulver til oral suspension i breve} { Augmentin og tilhørende navne (se bilag I) 500 mg/125 mg pulver til oral suspension i breve}
English: NAME OF THE MEDICINAL PRODUCT {Augmentin and associated names (see Annex I) 1000 mg/62.5 mg prolonged release tablets} [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN { Augmentin og tilhørende navne (se bilag I) 1000 mg/62,5 mg depot tabletter} [Se bilag I - skal udfyldes nationalt]
English: Lactation
Danish: Uforligeligheder
English: You must look out fo certain symptoms while you are taking Augmentin, to reduce the risk of any problems.
Danish: De skal være særligt opmærksom på visse symptomer, mens Deres barn tager Augmentin for at nedsætte risikoen for problemer.
English: 2000 mg/200 mg powder for infusion
Danish: 2000 mg/200 mg pulver til infusionsvæske, opløsning.
English: your blood tests: increase in some substances (enzymes) produced by the liver.
Danish: Ikke almindelige bivirkninger, der kan vise sig i blodprøver: • Forhøjede værdier af stoffer (enzymer), produceret i leveren.
English: Augmentin and associated names (see Annex I) 500 mg/62.5 mg powder for oral suspension [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 500 mg/62,5 mg pulver til oral suspension [Se Bilag I - skal udfyldes nationalt]
English: Augmentin and associated names (see Annex I) 125 mg/62.5 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 125 mg/62,5 mg/5 ml pulver til oral suspension [Se Bilag I - skal udfyldes nationalt]
English: NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 500 mg/62.5 mg film-coated tablets [See Annex I - To be completed nationally] Amoxicillin/clavulanic acid
Danish: Augmentin og tilhørende navne (se Bilag I) 500 mg/62,5 mg filmovertrukne tabletter [Se Bilag I - skal udfyldes nationalt]
English: epatitis) s in the blood of bilirubin (a substance produced in the liver) which w t king high doses of Augmentin or who have kidney problems).
Danish: • Gulsot, forårsaget af hævet indhold af bilirubin i blodet (et stof der produceres i leveren).
English: What Augmentin is and what it is used for Before you take Augmentin
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE AUGMENTIN
English: ay show up in blood or urine tests:
Danish: Bivirkninger kan vise sig i blodprøver eller urinprøver
English: • Usual dose - 1 sachet three times a day
Danish: • Normal dosering - 1 brev 3 gange daglig
English: pharmacist if any of the side effects become severe or troublesome, or if de effects not listed in this leaflet.
Danish: Hvis De får bivirkninger  Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: lood of bilirubin (a substance produced in the liver) which
Danish: • Gulsot forårsaget af øget indhold af bilirubin i blodet (et stof der produceres i leveren).
English: Augmentin and associated names (see Annex I) 2000 mg/200 mg powder for solution for infusion [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 2000 mg/200 mg pulver til infusions- og injektionsvæske, opløsning [Se Bilag I - skal udfyldes nationalt]
English: You should not give your s before giving the next dose.
Danish: De skal mindst vente 4 timer, før De giver den næste dosis.
English: 250 mg/62.5 mg powder for oral suspension in sachets Spain l
Danish: 250 mg/62,5 mg pulver til oral suspension i breve Spanien - Clavumox
English: Augmentin and associated names (see Annex I) 125 mg/62.5 mg/ml powder for oral suspension [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 125 mg/62,5 mg/ml pulver til oral suspension [Se Bilag I - skal udfyldes nationalt]
English: NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 1000/62.5 mg prolonged-release tablets [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 1000 mg/62,5 mg depot tabletter [Se Bilag I - skal udfyldes nationalt]
English: Important information about some of the ingredi ingredients of Augmentin (listed in section
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Augmentin Vigtig information om nogle af de øvrige indholdsstoffer i Augmentin Augmentin indeholder aspartam (E 951) som er en kilde til fenylalanin.
English: Dose with caution and monitor hepatic function at regular intervals (see sections 4.3 and 4.4).
Danish: Leverfunktionen monitoreres regelmæssigt (se pkt.
English: AMX/CA 875 mg/125 mg
Danish: 400 mg/57 mg, 875 mg/125 mg breve
English: Augmentin and associated names (see Annex I) 125 mg/31.25 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 125 mg/31,25 mg/5 ml pulver til oral suspension [Se Bilag I - skal udfyldes nationalt]
English: • 1 sachet three times a day
Danish: • 1 brev 3 gange daglig
English: NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 500 mg/125 mg film-coated tablets [See Annex I - To be completed nationally] Amoxicillin/clavulanic acid
Danish: Augmentin og tilhørende navne (se Bilag I) 500 mg/125 mg filmovertrukne tabletter [Se Bilag I - skal udfyldes nationalt]
English: 500 mg/125 mg dispersible tablets Dispersible tablet.
Danish: 500 mg/125 mg opløselige tabletter Opløselig tablet [Udfyldes nationalt]
English: • Augmentin 1000 mg/100 mg contains approximately 62.9 mg (2.7 mmol) of sodium.
Danish: 1000 mg/100 mg/pulver til injektions- og infusionsvæske Augmentin 1000 mg/100 mg indeholder cirka 62,9 mg (2,7 mmol) natrium.
English: 500 mg/100 mg powder for injection or infusion
Danish: 500 mg/500 mg pulver til injektions- og infusionsvæske, opløsning.
English: 500 mg/50 mg powder for solution for injection or infusion This medicinal product contains 31.5 mg (1.4 mmol) of sodium per vial or bottle.
Danish: 500 mg/50 mg/pulver til injektions- og infusionsvæske Augmentin 500 mg/50 mg indeholder cirka 31,5 mg (1,4 mmol) natrium.
English: Moreover, adjustments in the dose of oral anticoagulants may be necessary (see section 4.4 and 4.8).
Danish: Derudover kan det blive nødvendigt at regulere dosis af antikoagulans (se pkt.
English: 1000 mg/200 mg powder for solution for injection or infusion Powder for solution for injection or infusion.
Danish: 1000 mg/200 mg pulver til injektions- og infusionsvæske, opløsning pulver til injektions- og infusionsvæske, opløsning [Udfyldes nationalt]
English: This can include a skin rash or swelling of the face or neck if you have ever had liver problems or jaundice (yellow g in of the skin) when taking an antibiotic.
Danish: - Barnet tidligere har fået dårlig lever eller gulsot (huden bliver gul) under behandling med antibiotika.
English: • middle ear infections
Danish: • Mellemørebetændelse
English: If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Augmentin is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see sections 4.4 and
Danish: Hvis en højere dosis amixicillin er påkrævet, anbefales det at vælge en andenformulering af Augmention for at undgå administration af unødvendigt høje dagsdoser af clavulansyre (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 500 mg/125 mg powder for oral suspension [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 500 mg/125 mg pulver til oral suspension [Se Bilag I - skal udfyldes nationalt]
English: {Augmentin and associated names (see Annex I) 400 mg/57 mg powder for oral suspension in sachets} {Augmentin and associated names (see Annex I) 200 mg/28.5 mg/5 ml powder for oral suspension} {Augmentin and associated names (see Annex I) 400 mg/57 mg/5 ml powder for oral suspension (strawberry flavour)} {Augmentin and associated names (see Annex I) 400 mg/57 mg/5 ml powder for oral suspension (mixed fruit flavour)}
Danish: { Augmentin og tilhørende navne (se bilag I) 875 mg/125 mg filmovertukne tabletter} { Augmentin og tilhørende navne (se bilag I) 875 mg/125 mg pulver til oral suspension i breve} { Augmentin og tilhørende navne (se bilag I) 400 mg/57 mg pulver til oral suspension i breve} { Augmentin og tilhørende navne (se bilag I) 200 mg/28,5 mg/5 ml pulver til oral suspension} { Augmentin og tilhørende navne (se bilag I) 400 mg/57 mg/5 ml pulver til oral suspension (jordbær smag)} { Augmentin og tilhørende navne (se bilag I) 400 mg/57 mg/5 ml pulver til oral suspension (frugtmix smag)}
English: Staphylococcus aureus (methicillin-susceptible) Streptococcus agalactiae
Danish: Staphylococcus aureus (methicillinfølsomme) Streptococcus agalactiae Streptococcus pneumoniae1
English: 500 mg/125 dispersible tablets
Danish: 500 mg/125 mg opløselige tabletter
English: Augmentin and associated names (see Annex I) 125 mg/31.25 mg powder for oral suspension [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 125 mg/31,25 mg pulver til oral suspension [Se Bilag I - skal udfyldes nationalt]
English: Augmentin and associated names (see Annex I) 250 mg/62.5 mg/5 ml powder for oral suspension [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 250 mg/62,5 mg/5 ml pulver til oral suspension [Se Bilag I - skal udfyldes nationalt]
English: NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 250 mg/125 mg dispersible tablets [See Annex I - To be completed nationally] Amoxicillin/clavulanic acid
Danish: Augmentin og tilhørende navne (se Bilag I) 250 mg/125 mg opløselige tabletter [Se Bilag I - skal udfyldes nationalt]
English: Augmentin and associated names (see Annex I) 125 mg/31.25 mg/ml powder for oral suspension [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 125 mg/31,25 mg/ml pulver til oral suspension [Se Bilag I - skal udfyldes nationalt]
English: liver problems you may have m
Danish: Andre arter for hvilke resistens kan være et problem
English: Staphylococcus aureus (methicillin-susceptible)£ Streptococcus agalactiae
Danish: Staphylococcus aureus (methicillinfølsomme)£ Streptococcus agalactiae Streptococcus pneumoniae1
English: £ All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic acid.
Danish: £ Alle methicillinresistente stafylokokker er resistente overfor amoxicillin/clavulansyre § Alle stammer med amoxicillinresistens, som er følsom overfor betalaktamaser er resistente mod amoxicillin/clavulansyre.
English: You should not take the next dose too l better.
Danish: De må ikke give Deres barn en dosis for hurtigt.
English: • If you have liver problems you may have more frequent blood tests to c working.
Danish: • Hvis De har problemer med Deres lever, kan det være nødvendigt at få foretaget flere blodprøver for at kontrollere leverens funktion.
English: Blood or urine tests If y ll status tests or liver function tests) or urine tests, let the doctor or nurse know that they are taking Augmentin.
Danish: Hvis De får taget blodprøver for at kontrollere Deres leverfunktion (leverfunktionsprøver) eller urinprøver (for glucose), skal De fortælle lægen eller sygeplejersken, at De tager Augmentin.
English: Make up to mark
Danish: Tilsæt vand til stregen
English: Adults and children  40 kg CrCl: 10-30 ml/min 500 mg/125 mg twice daily CrCl < 10 ml /min
Danish: CrCl: 10-30 ml/min 500 mg/125 mg, to gange daglig CrCl < 10 ml /min
English: Augmentin and associated names (see Annex I) 250 mg/62.5 mg/ml powder for oral suspension [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 250 mg/62,5 mg/ml pulver til oral suspension [Se Bilag I - skal udfyldes nationalt]
English: Augmentin and associated names (see Annex I) 250 mg/62.5 mg powder for oral suspension [See Annex I - To be completed nationally]
Danish: Augmentin og tilhørende navne (se Bilag I) 250 mg/62,5 mg pulver til oral suspension [Se Bilag I - skal udfyldes nationalt]
English: Wh [To be com
Danish: T ½ (timer)
English: BEFORE YOU GIVE AUGMENTIN
Danish: Hvis De glemt at give Augmentin
English: • Give at the start of a meal or slight enly during the day
Danish: • Giv miksturen til Deres barn i starten af et måltid eller lige før måltidet.
English: • respiratory tract infections
Danish: • Infektioner i luftvejene
English: NAME OF THE MEDICINAL PRODUCT Augmentin and associated names (see Annex I) 500 mg/125 mg dispersible tablets [See Annex I - To be completed nationally] Amoxicillin/clavulanic acid
Danish: Augmentin og tilhørende navne (se Bilag I) 500 mg/125 mg opløselige tabletter [Se Bilag I - skal udfyldes nationalt]
English: • Usual dose - 1 sachet two times a day
Danish: • Normal dosering - 1 brev 2 gange daglig
English: dispose of medicines no longer required.
Danish: Dosisjustering er ikke nødvendig.
English: United Kingdom - Augmentin Duo 400 m g/57 mg/5 ml powder for oral suspension (m ixed fruit flavour)
Danish: 400 mg/57 mg/5 ml pulver til oral suspension (frugtmix smag)
English: Lithuania - Augmentin
Danish: Litanun - Augmentin
English: If your child is taking allopurinol (used for gout) with Augmentin, it may be more likely that they will you Augm If medicines to help stop blood clots (such as warfarin) are taken with Augmentin then extra blood sts may be needed.
Danish: Hvis Deres barn tager medicin for at forebygge blodpropper (såsom warfarin) samtidig med at barnet tager Augmentin, kan der være behov for at få taget ekstra blodprøver.
English: • Higher dose - 1 sachet three times a day
Danish: • Høj dosering - 1 brev 3 gange daglig
English: This leaflet was last approved i To be completed nationally]
Danish: Denne indlægsseddel blev senest godkendt {MM/ÅÅÅÅ} [se Bilag I - udfyldes nationalt]
English: 50 mg/12.5 mg/ml, 125 mg/31.25 mg/5 ml, 250 mg/62.5 mg/5 ml powder for oral suspension Shake to loosen powder, add water as directed, invert and shake.
Danish: 50 mg/12,5 mg/ml, 125 mg/31,25 mg/5 ml, 250 mg/62,5 mg/5 ml pulver til oral suspension.
English: • If your child has liver problems they may have more frequent blood tes is working.
Danish: • Hvis Deres barn har problemer med sin lever kan det være nødvendigt at få taget flere blodprøver for at kontrollere leverens funktion.
English: Aerobic Gram-positive micro-organisms Staphylococcus aureus (methicillin-susceptible)$ Streptococcus pneumoniae1
Danish: Staphylococcus aureus (methicillinfølsomme)$ Streptococcus pneumoniae1
English: • are not passing water regularly.
Danish: • Flasken skal omrystes grundigt hver gang før brug.
English: Co on side effects These may affect up to 1 in 10 people a yeast infection of the vagina, mou
Danish: Ikke almindelige bivirkninger De forekommer hos mellem 1 og 10 ud af 1.000 patienter
English: Belgium - Augmentin Bulgaria - Augmentin SR Czech Republic - Augmentin France - Duamentin Greece - Augmentin SR
Danish: Finland - Augmentin, Clavurion Grækenland - Augmentin Ungarn - Augmentin Duo Island - Augmentin
English: • Augmentin 500 mg/100 mg contains approximately 31.4 mg (1.4 mmol) of sodium.
Danish: 500 mg/100 mg/pulver til injektions- og infusionsvæske Augmentin 500 mg/100 mg indeholder cirka 31,4 mg (1,4 mmol) natrium.
English: This is so they can be swallowed more easily.
Danish: Det er næppe sandsynligt, at de får for meget Augment.
English: 500 mg/100 mg powder for solution for injection or infusion Water for Injection Ph.Eur.
Danish: 500 mg/100 mg pulver til injektions- og infusionsvæske, opløsning pulver til injektions- og infusionsvæske, opløsning [Udfyldes nationalt]
English: Renal impairment
Danish: Chlamydia trachomatis
English: Lithuania - Augmentin ES Poland - Augmentin ES
Danish: Malta Augmentin, Noprilam DT Polen - Augmentin
English: Depending on the results, your child may be given a different strength of Augm m ine.
Danish: Afhængigt af resultatet kan det medføre, at Deres barn får en anden styrke af Augmentin eller et andet lægemiddel.
English: 6 July 2012
Danish: Den 6. juli 2012
English: Outcome of a procedure under Article 6(12) of Regulation (EC) 1084/2003 as amended
Danish: Resultatet af en procedure i henhold til artikel 6, stk. 12, i forordning (EF) nr. 1084/2003, som ændret
English: The Committee reviewed the two main studies presented by the company to support the new indication.
Danish: Udvalget gennemgik de to hovedundersøgelser, som virksomheden havde forelagt til støtte for den nye indikation.
English: concerned Member States.
Danish: Nederlandene og alle andre berørte medlemsstater.
English: 1 Yaz is authorised in all EU Member States except Hungary, and Ethinylestradiol-Drospirenone 24+4 is authorised in the following Member States: Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Malta, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
Danish: 1 Yaz er godkendt i alle EU medlemsstater bortset fra Ungarn, og Ethinylestradiol-Drospirenone 24+4 er godkendt i følgende medlemsstater: Østrig, Bulgarien, Cypern, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Grækenland, Italien, Malta, Polen, Portugal, Slovakiet, Slovenien, Spanien, Sverige og Det Forenede Kongerige.
English: The Committee concluded that the change to the marketing authorisations cannot be granted.
Danish: Udvalget konkluderede, at ændringen af markedsføringstilladelserne ikke kan godkendes.
English: The grounds for the referral were concerns over whether the medicines' benefits in the combined indication outweighed their risks, particularly the risk of venous thromboembolism (VTE, formation of blood clots in the veins).
Danish: Begrundelsen for henvisningen var bekymring for, at fordelene ved lægemidlerne i forhold til den kombinerede indikation overstiger risiciene, navnlig risikoen for venøs tromboembolisme (VTE, dannelse af blodpropper i venerne).
English: Because the Member States were not able to reach an agreement on this new indication, on 28 and 29 June 2011 the Italian and Swedish medicines regulatory agencies referred the matter to the CHMP for arbitration.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed om den nye indikation, og de italienske og svenske lægemiddelstyrelser henviste derfor sagen til CHMP med henblik på voldgift den 28. og 29. juni 2011.
English: They contain two active substances, ethinylestradiol and drospirenone, which are derived from natural hormones produced in the ovaries: ethinylestradiol is derived from oestrogen and drospirenone is derived from progesterone.
Danish: De indeholder to aktive stoffer, ethinylestradiol og drospirenon, der er afledt af naturlige hormoner, der produceres i æggestokkene: Ethinylestradiol er afledt af østrogen, og drospirenon er afledt af progesteron.
English: Yaz 24+4 and Ethinylestradiol-Drospirenone 24+4 are authorised in several Member States of the European Union (EU)1 under a mutual recognition procedure on the basis of an initial authorisation granted by the Netherlands.
Danish: Yaz 24+4 og Ethinylestradiol-Drospirenone 24+4 er godkendt i flere medlemsstater i Den Europæiske Union (EU)1 efter en gensidig anerkendelsesprocedure på grundlag af en indledende godkendelse, der er udstedt af Nederlandene.
English: The Committee concluded that the variation to the marketing authorisations for these medicines cannot be approved.
Danish: Udvalget konkluderede, at ændringen af markedsføringstilladelserne for disse lægemidler ikke kan godkendes.
English: The company applied for a change to the marketing authorisations of these medicines to extend their use to include the ‘treatment of moderate acne vulgaris only in women seeking oral contraception'.
Danish: Virksomheden ansøgte om en ændring af markedsføringsgodkendelsen for disse lægemidler med henblik på, at deres anvendelse blev udvidet med “behandling af moderat acne vulgaris udelukkende hos kvinder med behov for oral antikonception”.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to consider a proposed change to the marketing authorisations for these medicines to include a new indication for the treatment of moderate acne in women seeking oral contraception.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) var blevet anmodet om at behandle en ansøgning om ændring af markedsføringstilladelsen for disse lægemidler med henblik på tilføjelse af en ny indikation: behandling af moderat acne hos kvinder med behov for oral svangerskabsforebyggelse.