FrancophonIA/ELRC3.0 huggingface dataset:
English: Cinryze is also used for routine prevention in adults, adolescents and children from 6 years of age who have severe and frequent angioedema attacks for which prevention with oral medicines is not adequate or in patients whose attacks are not adequately treated.
Danish: Cinryze anvendes også til rutineforebyggelse hos voksne og unge og hos børn fra 6 år og opefter, som har alvorlige og hyppige anfald af angioødem, der ikke kan forebygges i tilstrækkelig grad med orale lægemidler, eller hos patienter, hvis anfald ikke behandles i tilstrækkelig grad.
English: The second study, involving 24 patients from the first study, looked at the number of attacks over 12week periods when patients were given Cinryze or placebo as prevention.
Danish: I den anden undersøgelse, som omfattede 24 patienter fra den første undersøgelse, så man på antallet af anfald over en række 12-ugers perioder, hvor patienterne fik Cinryze eller placebo som forebyggende behandling.
English: For the full list of all side effects and restrictions with Cinryze, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Cinryze fremgår af indlægssedlen.
English: What are the risks associated with Cinryze?
Danish: Hvilke risici er der forbundet med Cinryze?
English: Over 50% of patients receiving Cinryze had started having improvements 2 hours into treatment, compared with 33% of patients given placebo.
Danish: Over 50 % af de patienter, der fik Cinryze, begyndte at mærke en forbedring to timer inde i behandlingen sammenlignet med 33 % af de patienter, der fik placebo.
English: The dose is reduced to 500 Units in children aged 2 to 11 years weighing 10 to 25 kg.
Danish: Dosen reduceres til 500 enheder hos børn mellem 2 og 11 år, der vejer mellem 10 og 25 kg.
English: For treatment of angioedema attacks in adults, adolescents and children over 2 years and weighing more than 25 kg, the patient is given 1,000 Units at the first sign of an angioedema attack.
Danish: Ved behandling for anfald af angioødem hos voksne og unge og hos børn over 2 år, der vejer over 25 kg, modtager patienten 1 000 enheder ved første tegn på et anfald af angioødem.
English: In the first study, Cinryze or placebo (a dummy treatment) were used to treat angioedema attacks in 71 patients.
Danish: I den første undersøgelse blev Cinryze og placebo (en virkningsløs behandling) anvendt til at behandle anfald af angioødem hos 71 patienter.
English: Cinryze is a medicine used to treat angioedema (swelling) attacks in adults, adolescents and children over 2 years with hereditary angioedema.
Danish: Cinryze er et lægemiddel til behandling af anfald af angioødem (hævelse) hos voksne og unge og hos børn over 2 år med hereditært angioødem.
English: The dose is reduced to 500 Units in children aged 2 to 11 years weighing 10 to 25 kg. For routine prevention in adults and adolescents, Cinryze is given as 1,000 Units every 3 or 4 days.
Danish: Dosen reduceres til 500 enheder hos børn mellem 2 og 11 år, der vejer mellem 10 og 25 kg. Ved rutineforebyggelse hos voksne og unge gives der 1 000 enheder Cinryze hver tredje eller fjerde dag.
English: For prevention before a medical, dental or surgical procedure in adults, adolescents and children over 2 years and weighing more than 25 kg, Cinryze is given as 1,000 Units within the 24 hours before the procedure.
Danish: Som forebyggelse forud for et medicinsk, dentalt eller kirurgisk indgreb hos voksne og unge og hos børn over 2 år, der vejer over 25 kg, gives der 1 000 enheder Cinryze inden for 24 timer før indgrebet.
English: Cinryze is available as a powder and solvent that are made up into a solution for injection into a vein.
Danish: Cinryze leveres som pulver og solvens til injektionsvæske, opløsning, til indgivelse i en vene.
English: The average number of attacks during 12 weeks of treatment with Cinryze was reduced compared with the period before Cinryze and the attacks were less severe, did not last as long and required less treatment.
Danish: Cinryze varede, blev reduceret i sammenligning med perioden før Cinryze, og anfaldene var mindre svære, varede ikke så længe og var mindre behandlingskrævende.
English: How is Cinryze used?
Danish: Hvordan anvendes Cinryze?
English: In the second study, Cinryze was given as prevention to 6 children with hereditary angioedema.
Danish: I den anden undersøgelse blev Cinryze givet som forebyggende behandling til seks børn med hereditært angioødem.
English: What benefits of Cinryze have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cinryze?
English: How does Cinryze work?
Danish: Hvordan virker Cinryze?
English: In the first study, Cinryze was used to treat angioedema attacks in 9 children with hereditary angioedema.
Danish: I den første undersøgelse blev Cinryze brugt som behandling for anfald af angioødem hos 9 børn med hereditært angioødem.
English: The company provided data on the use of Cinryze in 91 adults and children with hereditary angioedema to prevent attacks when undergoing a medical, surgical or dental procedure.
Danish: Virksomheden fremlagde data om brugen af Cinryze som forebyggende behandling ved et medicinsk, dentalt eller kirurgisk indgreb hos 91 voksne og børn med hereditært angioødem.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinryze have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Cinryze.
English: Cinryze was more effective than placebo in treating and preventing attacks of angioedema in two main studies involving patients with hereditary angioedema, most of whom were adults.
Danish: Af to hovedundersøgelser hos mestendels voksne patienter med hereditært angioødem, fremgik det, at Cinryze var mere effektivt end placebo til at behandle og forebygge anfald af angioødem.
English: Therefore, this wording may not necessarily represent the current text.
Danish: Denne tekst repræsenterer derfor ikke nødvendigvis den gældende tekst.
English: Following the review of the data available to the national competent authorities, the European Commission triggered an article 31 of Directive 2001/83/EC, as amended, on 17 December 2004.
Danish: Efter undersøgelsen af de data, der er tilgængelige for de kompetente nationale myndigheder, indbragte Europa-Kommissionen den 17. december 2004 en sag i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer.
English: The EC requested the CHMP to give its opinion on whether the marketing authorisation for medicinal products containing the above mentioned active substances should be maintained, varied, suspended or withdrawn.
Danish: Europa-Kommissionen anmodede CHMP om af afgive udtalelse om, hvorvidt markedsføringstilladelsen for lægemidler indeholdende ovennævnte aktive stoffer skulle opretholdes, ændres, suspenderes eller inddrages.
English: The Committee also concluded that a different warning was more appropriate for atomoxetine, which is only indicated in the treatment of ADHD.
Danish: Udvalget konkluderede ligeledes, at en anden advarsel var mere hensigtsmæssig for atomoxetin, som kun er indiceret til behandling af ADHD.
English: If your doctor has prescribed [Invented Name] for a patient under 18 and you want to discuss this, please go back to your doctor.
Danish: Hvis din læge har ordineret [særnavn] til en patient under 18 år, og du ønsker at drøfte dette, skal du henvende dig til din læge.
English: This signal was present in all products for which studies were available, and from the available evidence it could not be excluded that this signal would be class related.
Danish: Disse tegn sås for samtlige lægemidler, for hvilke der forelå undersøgelser, og på baggrund af de tilgængelige oplysninger kunne det ikke udelukkes, at symptomerne var relateret til klassen af lægemidler.
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Danish: Derudover mangler der langtidsdata om sikkerhed hos børn og unge med hensyn til vækst, modning og kognitiv og adfærdsmæssig udvikling.
English: SSRIs are described as 'selective' because they affect only the reuptake pumps responsible for serotonin.
Danish: SSRI beskrives som 'selektive', fordi de kun påvirker genoptagelsespumperne, som er ansvarlige for serotonin.
English: These products are not authorised Europe-wide for the treatment of depression and anxiety disorders in children or adolescents.
Danish: Disse lægemidler er ikke godkendt i Europa til behandling af depression og angstforstyrrelser hos børn og unge.
English: Despite this, your doctor may prescribe [Invented Name] for patients under 18 because he/she decides that this is in their best interests.
Danish: Trods dette kan din læge ordinere [særnavn] til patienter under 18 år, hvis han/hun beslutter, at det er i deres bedste interesse.
English: Patients beginning treatment for ADHD should be carefully monitored for the appearance or worsening of hostility and emotional lability.
Danish: Patienter, der behandles for ADHD, bør nøje overvåges for forekomst af eller øget fjendtlighed og emotionel labilitet.
English: Examination of suicide-related behaviours indicated that no completed suicide was reported in any of the reviewed studies.
Danish: Undersøgelser af selvmordsrelateret adfærd viste, at der ikke var indberettet tilfælde af selvmord i de gennemgåede undersøgelser.
English: As with other psychotropic medication, the possibility of rare, serious psychiatric adverse effects cannot be excluded.
Danish: Ligesom ved anvendelse af andre psykotrope lægemidler kan forekomsten af sjældne, alvorlige psykiatriske bivirkninger ikke udelukkes.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEER OG INDLÆGSSEDLER FREMLAGT AF EMEA
English: You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Danish: Du bør underrette din læge, hvis nogle af ovennævnte symptomer opstår eller forværres efter påbegyndt behandling.
English: With the preliminary review of the data available to the national competent authorities the CHMP concluded that there were grounds for concerns about increased suicide-related behaviours in paediatric populations.
Danish: Efter den indledende gennemgang af de data, der er tilgængelige for de kompetente nationale myndigheder, konkluderede CHMP, at der var grund til bekymring for øget selvmordsrelateret adfærd i pædiatriske patientgrupper.
English: Following a request from the European Commission, the CHMP reviewed the data from clinical trials available to the national competent authorities for the following SSRI
Danish: Efter anmodning fra Europa-Kommissionen gennemgik CHMP dataene fra de kliniske undersøgelser, der var tilgængelige for de nationale kompetente myndigheder for følgende lægemidler af typen SSRI
English: The data reviewed included short-term placebo controlled randomised clinical trials submitted to the competent authorities, randomised clinical trials published in the medical literature, observational studies and ecological studies.
Danish: De gennemgåede data omfattede kortvarige, placebokontrollerede, randomiserede kliniske undersøgelser, som var forelagt for de kompetente myndigheder, randomiserede kliniske undersøgelser offentliggjort i den medicinske litteratur, observationsundersøgelser og økologiske undersøgelser.
English: However, there was a clear suicide-related behaviours signal from the depression studies and a less strong signal from the anxiety studies.
Danish: Der var dog tydelige signaler på selvmordsrelateret adfærd i undersøgelserne af depression og mindre stærke signaler i undersøgelserne af angst.
English: [Invented Name] is not indicated for the treatment of major depressive episodes and/or anxiety as the results of clinical trials that were conducted in adults did not show any effect compare to placebo, and therefore were negative.
Danish: [Særnavn] er ikke indiceret til behandling af svære depressive episoder og/eller angst, da resultaterne af de kliniske undersøgelser, der er udført på voksne, ikke viste nogen virkning i forhold til placebo og derfor var negative.
English: 6XA, United Kingdom
Danish: 6XA, Great Britain
English: KSK-Pharma Vertriebs AG Finkenstr.
Danish: Tyskland KSK-Pharma Vertriebs AG Finkenstr.
English: Lithuania Latvian JSC Grindeks, Krustpils ul.
Danish: Latvian JSC Grindeks, Krustpils ul.
English: N.V. Organon Molenstraat 110.
Danish: Organon Molenstraat 110.
English: In addition there were some trials with patients suffering from Attention Deficit/Hyperactivity Disorder (ADHD).
Danish: Derudover var der nogle undersøgelser med patienter, der led af ADHD - Attention Deficit/Hyperactivity Disorderopmærksomhedsforstyrrelse og hyperaktivitet.
English: Note: This section of the Package Leaflet is the one that was Annexed to the Commission Decision on this Article 31 referral .
Danish: Bemærk: Dette afsnit af SPCet, er det afsnit, der var bilag til Europa-Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag.
English: The CHMP considered that there wasn't any signal of increased risk of suicide related behaviour in the atomoxetine studies, however, there was a signal of an increased risk of behavioural abnormalities with more aggression and hostility effects.
Danish: CHMP var af den opfattelse, at der ikke var noget signal om øget risiko for selvmordsrelateret adfærd i atomoxetin-undersøgelserne, men der var dog et signal om øget risiko for adfærdsafvigelser med større aggression og fjendtlighed til følge.
English: The majority of trials included patients with major depressive disorders (MDD) while a few included patients with various anxiety disorders (Obsessive Compulsive Disorder (OCD), Generalised Anxiety Disorder (GAD), and Social Anxiety Disorder (SAD)).
Danish: I størsteparten af undersøgelserne indgik patienter med svære depressive forstyrrelser (MDD), mens enkelte undersøgelser omfattede patienter med forskellige angstforstyrrelser (obsessivkompulsiv tilstand (OCD), generaliseret angst (GAD) og social angst (SAD)).
English: [Invented Name] should normally not be used for children and adolescents under 18 years < except for patients with [approved indication]>.
Danish: [Særnavn] bør normalt ikke anvendes til børn og unge under 18 år < undtagen til patienter med [godkendt indikation]>.
English: Moreover there was a signal concerning related adverse events like hostility, self-harm and emotional lability in almost all products and indications.
Danish: Desuden var der signaler om relaterede bivirkninger, f.eks. fjendtlighed, selvbeskadigelse og emotionel labilitet i næsten alle lægemidler og indikationer.
English: You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking [Invented Name].
Danish: Du bør underrette din læge, hvis nogle af de ovennævnte symptomer opstår eller forværres, når patienter under 18 år indtager [særnavn].
English: [Invented Name] should not be used in the treatment of children and adolescents under the age of 18 years <, except for patients with [approved indication]>.
Danish: [Særnavn] bør ikke anvendes til behandling af børn og unge under 18 år < undtagen til patienter med [godkendt indikation]>.
English: Only some of these products are authorised for the treatment of children and adolescents with obsessive-compulsive disorder and only one of them for the treatment of Attention Deficit/Hyperactivity Disorder.
Danish: Kun nogle af disse lægemidler er godkendt til behandling af børn og unge med obsessivkompulsiv tilstand, heraf en til behandling af opmærksomhedsforstyrrelse og hyperaktivitet.
English: Patients under 18 have an increased risk of side-effects such as hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability.
Danish: Patienter under 18 år har øget risiko for bivirkninger som f.eks. fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) og emotionel labilitet.
English: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D. De Luxembourg
Danish: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D.
English: 1 SSRI stands for ‘Serotonin-Selective Reuptake Inhibitor'.
Danish: 1 SSRI står for ‘Serotonin-Selective Reuptake Inhibitor' (selektiv serotonin-genoptagelseshæmmer).
English: LABORATORIOS CINFA, S.A., Olaz-Chipi, 10.
Danish: LABORATORIOS CINFA, S.A., Olaz-Chipi, 10. Polig.
English: Belgium LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
Danish: LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
English: Organon GmbH Mittenheimer Str. 62
Danish: Tyskland Organon GmbH Mittenheimer Str. 62
English: The CHMP reviewed the data submitted by the MAHs in relation to the signal of suicidal behaviour in children and adolescents.
Danish: CHMP har gennemgået de data, der er fremlagt af indehaverne af markedsføringstilladelse vedrørende signalet om selvmordsadfærd hos børn og unge.
English: Pfizer Luxembourg SARL, 283, route d' Arlon, L-8011 Strassen, Luxembourg
Danish: Slovenien Pfizer Luxembourg SARL, 283, route d' Arlon, L-8011 Strassen,
English: Netherlands Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Danish: Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
English: Belgium 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
Danish: 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
English: STADA Arzneimittel AG Stadastr.
Danish: Tyskland STADA Arzneimittel AG Stadastr.
English: Denmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Danish: Danmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
English: Molteni Farmaceutici S.p.A. Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
Danish: Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
English: Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of [Invented Name] in this age group have not yet been demonstrated.
Danish: Derudover foreligger der ikke langtidsdata om sikkerhed for[særnavn] med hensyn til vækst, modning og kognitiv og adfærdsmæssig udvikling i denne aldersgruppe.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEERNE
English: Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
Danish: Storbritannien Pliva Pharma Ltd; Vision House; Bedford Road; Petersfield, Hampshire GU32 3QB; UK
English: Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Danish: Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
English: Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
Danish: Storbritannien Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG 1 LISTE OVER LÆGEMIDLERNES SÆRNAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Denmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
Danish: Danmark Nycomed Danmark ApS, Langebjerg 1, DK-4000 Roskilde, Denmark
English: KLEVA, 189 Parnithos, 13671 Aharne Attikis, Greece
Danish: Grœkenland KLEVA, 189 Parnithos, 13671 Aharne Attikis, Greece
English: SNRIs work on the norepinephrine and serotonin neurotransmitters
Danish: SNRI påvirker noradrenalin- og serotonin-neurotransmittere
English: Box 7071
Danish: Postbus 7071
English: Netherlands Merck Generics BV Dieselweg 25
Danish: Merck Generics BV Dieselweg 25
English: Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
Danish: Storbritannien Wessex Fine Chemicals Limited, Thornhill Works, Coolham, West Sussex RH13 8QN; UK
English: Lithuania Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
Danish: Nycomed SEFA AS, Jaama 55B, 63308 Polva, Estonia
English: Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
Danish: Storbritannien Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR; UK
English: The CHMP agreed that there was a potential signal of an increase in suicidal behaviour, including suicide attempts and suicidal ideation and/or related behaviour like self-harm, hostility and mood lability in children and adolescents treated with SSRIs and SNRIs.
Danish: CHMP var enige om, at der forelå potentielle tegn på øget selvmordsadfærd, herunder selvmordsforsøg og selvmordstanker og/eller relateret adfærd som f.eks. selvbeskadigelse, fjendtlighed og humørlabilitet hos børn og unge, der behandles med SSRI og SNRI.
English: Netherlands Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
Danish: Stichting Registratiebeheer, Bosstraat 69, NL-3766 AC Soest
English: Merz Pharmaceuticals GmbH Eckenheimer Landstr.
Danish: Tyskland Merz Pharmaceuticals GmbH Eckenheimer Landstr.
English: Netherlands Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
Danish: Pharmacin Products B.V., Molenvliet 103, NL-3335 LH Zwijndrecht
English: 1 A Pharma GmbH Keltenring 1 + 3
Danish: Tyskland 1 A Pharma GmbH Keltenring 1 + 3
English: Belgium OLYMPO PHARMA B.V.B.A.
Danish: OLYMPO PHARMA B.V.B.A.
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Danish: Desuden gøres opmærksom på, at patienter under 18 år har øget risiko for bivirkninger som f.eks. selvmordsforsøg, selvmordstanker og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede), når de behandles med denne klasse af lægemidler.
English: FAMAR ABE, P.Marinopopulou 7, P.O Box 3327 17456 Kalamaki, Greece
Danish: Grœkenland FAMAR ABE, P.Marinopopulou 7, P.O Box 3327 17456 Kalamaki, Greece
English: 2 SNRI stands for ‘Serotonin-Norepinephrine Reuptake Inhibitor'.
Danish: 2 SNRI står for ‘Serotonin-Norepinephrine Reuptake Inhibitor' (serotonin-noradrenalin-genoptagelseshæmmer).
English: Denmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
Danish: Danmark Wyeth Laboratories, New Lane, P092NG Havant, Hants, GB
English: Netherlands Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
Danish: Pfizer B.V., Postbus 37, NL-2900 AA Capelle a/d IJssel
English: Lange Munteplein 7b 4, 8500
Danish: Lange Munteplein 7b 4, 8500 Kortrijk, Belgium
English: SIEMENS & CO Postfach 1262
Danish: Tyskland SIEMENS & CO Postfach 1262
English: Netherlands Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
Danish: Kromme Rijn Apotheek B.V., Postbus 141, 3980 CC Bunnik, the Netherlands
English: FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
Danish: Grœkenland FARMEDIA AE, 2 B Aigaiou Pelagous, 15343 Agia Paraskevi, Greece
English: AAI Deutschland GmbH & Co.KG Wegenerstr.
Danish: Tyskland AAI Deutschland GmbH & Co.KG Wegenerstr.
English: PharmaSelect GmbH Am Saegewerk 13
Danish: Tyskland PharmaSelect GmbH Am Saegewerk 13
English: Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, SI1000 Ljubljana, Slovenia
Danish: Slovenien Merck, Proizvodnja in prodaja farmacevtskih in kemijskih proizvodov, d.o.o., Dunajska 156, SI1000 Ljubljana, Slovenia
English: HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
Danish: Grœkenland HELP, 4 Valaoritou, 14452 Metamorfosi Attikis, Greece
English: IV.2 AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE PL FOR ATOMOXETINE
Danish: IV.2 ÆNDRINGER I DE RELEVANTE DELE AF INDLÆGSSEDLEN FOR ATOMOXETIN