FrancophonIA/ELRC3.0 huggingface dataset:
English: Each nasal spray contains 1.8 mg of naloxone (as hydrochloride dihydrate).
Danish: Hver næsespray indeholder 1,8 mg naloxon (i form af hydrochloriddihydrat).
English: E-Mail: office@mundipharma.cz
Danish: e-mail: mundipharma@mundipharma.bg
English: Each nasal spray container delivers 1.8 mg of naloxone (as hydrochloride dihydrate)
Danish: Hver næsespraybeholder afgiver 1,8 mg naloxon (i form af hydrochloriddihydrat)
English: Uncommon Arrhythmia, Bradycardia Very rare
Danish: Arytmi, bradykardi
English: • Difficulty in sleeping.
Danish: • udtalt søvnighed
English: Dizziness, Headache Uncommon Tremor Cardiac disorders Common
Danish: Almindelig Svimmelhed, hovedpine Ikke almindelig
English: Receiving Nyxoid close to giving birth Tell your midwife or doctor if you have received Nyxoid close to or during labour.
Danish: Fortæl din jordemoder eller læge, hvis du er blevet behandlet med Nyxoid lige før, eller mens du har veer.
English: Tlf: + 47 67 51 89 00
Danish: Mundipharma AS Tlf: + 47 67 51 89 00 post@mundipharma.no
English: Nasal use.
Danish: Til anvendelse i næsen.
English: Tel: +43 (0)1 523 25 05-0
Danish: Tel: +43 (0)1 523 25 05-0 info@mundipharma.at
English: Nyxoid 1.8 mg nasal spray, solution in a single-dose container
Danish: Nyxoid 1,8 mg næsespray, opløsning i enkeltdosisbeholder.
English: • severe sleepiness
Danish: Abstinenssyndrom
English: • Access to a video on how to use Nyxoid The HCP Guidance Document should include:
Danish: • Adgang til en instruktionsvideo i brug af Nyxoid
English: Pulmonary oedema Gastrointestinal disorders Very common Nausea Common
Danish: Mave-tarm-kanalen Meget almindelig Kvalme Almindelig Opkastning Ikke almindelig
English: • Rapid breathing
Danish: • Hurtig vejrtrækning
English: General disorders and administration site conditions Uncommon Drug withdrawal syndrome (in patients dependent on opioids)
Danish: Abstinenssyndrom (hos opioidafhængige patienter)
English: What Nyxoid looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Breast-feeding
Danish: Hyperhidrose
English: • Dry mouth
Danish: • Mundtørhed
English: Skin and subcutaneous tissue disorders Uncommon Hyperhidrosis Very rare
Danish: Hud og subkutane væv
English: Tel: +386 158969 00
Danish: Tel: +386 158969 00 info@medis.si
English: Tel: + 385 (0) 1 230 34 46
Danish: Tel: + 385 (0) 1 230 34 46 info@medisadria.hr
English: Immune system disorders Very rare:
Danish: Meget sjælden:
English: Tel: + 46 (0)31 773 75 30
Danish: Mundipharma AB Tel: + 46 (0)31 773 75 30 info@mundipharma.se
English: Naloxone
Danish: Amning
English: icepharma@icepharma.is
Danish: Sími: + 354 540 8000 icepharma@icepharma.is
English: Vomiting Uncommon Diarrhoea, Dry mouth
Danish: Diarré, mundtørhed
English: • Sweating
Danish: • Svedtendens
English: Nasal spray, solution in a single-dose container (nasal spray) Clear, colourless to pale yellow solution
Danish: Næsespray, opløsning i enkeltdosisbeholder (næsespray).
English: SIA Inovatīvo biomedicīnas tehnoloģiju institūts Tel: + 37167800810
Danish: Tel: + 37167800810 anita@ibti.lv
English: The review of fenspiride was initiated on 14 February 2019 at the request of France, under Article 107i of Directive 2001/83/EC.
Danish: Gennemgangen af fenspirid blev indledt den 14. februar 2019 på anmodning af Frankrig i medfør af artikel 107i i direktiv 2001/83/EF.
English: 29 May 2019 EMA/285298/2019
Danish: 29. maj 2019 EMA/285298/2019
English: The PRAC recommendation was adopted by the CMDh1 by consensus and will be implemented directly at national level.
Danish: PRAC's anbefaling blev enstemmigt vedtaget af CMDh1 og vil blive gennemført direkte på nationalt plan.
English: The PRAC considered all the available evidence in its review.
Danish: PRAC havde medtaget al tilgængelig evidens i sin gennemgang.
English: In the EU, fenspiride medicines have been authorised via national procedures in Bulgaria, France, Latvia, Lithuania, Poland, Portugal and Romania and are available under various brand names (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал and Сиресп).
Danish: Fenspirid-lægemidler har i EU været godkendt via nationale procedurer i Bulgarien, Frankrig, Letland, Litauen, Polen, Portugal og Rumænien og fås under forskellige handelsnavne (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал og Сиресп).
English: Withdrawal of marketing authorisations for fenspiride medicines
Danish: Tilbagetrækning af markedsføringstilladelserne for fenspirid-holdige lægemidler
English: You can check the ingredients of your medicine in the package leaflet accompanying the medicine.
Danish: Du kan tjekke indholdsstofferne i dit lægemiddel i indlægssedlen, der følger med lægemidlet.
English: 1 Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human
Danish: 1 Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker
English: On 16 May 2019, EMA's safety committee (PRAC) recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU.
Danish: Den 16. maj 2019 anbefalede EMA's sikkerhedskomité (PRAC), at markedsføringstilladelserne for fenspirid-holdige lægemidler tilbagekaldes, så lægemidlerne ikke længere kan markedsføres i EU.
English: The PRAC recommendation will now be implemented by EU Member States, Iceland, Lichtenstein and Norway.
Danish: PRAC's anbefaling vil nu blive gennemført af EU's medlemsstater, Island, Lichtenstein og Norge.
English: The PRAC recommendation was sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted it by consensus on 29 May 2019.
Danish: PRAC's anbefalinger blev overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh), som enstemmigt vedtog et standpunkt den 29. maj 2019.
English: Fenspiride medicines are available as syrup or tablets and used in adults and children from the age of 2 years to relieve cough resulting from lung diseases.
Danish: Fenspirid-holdige lægemidler fås som syrup eller tabletter og anvendes hos voksne og børn fra 2 år til lindring af hoste, der er forårsaget af lungesygdomme.
English: • Return unused medicines to your pharmacy for appropriate disposal.
Danish: • Levér ubrugt medicin tilbage til apoteket med henblik på korrekt bortskaffelse.
English: Withdrawal of marketing authorisations for fenspiride medicines EMA/285298/2019
Danish: Tilbagetrækning af markedsføringstilladelserne for fenspirid-holdige lægemidler EMA/285298/2019
English: • Given the authorised uses of fenspiride for symptomatic treatment only and the seriousness of the safety concern, the benefit-risk balance of these medicines is negative for the currently authorised uses.
Danish: • I betragtning af de godkendte anvendelser af fenspirid kun til symptomatisk behandling og alvoren af den sikkerhedsmæssige betænkelighed er benefit/risk-forholdet for disse lægemidler ikke gunstigt for de aktuelt godkendte anvendelser.
English: Heart rhythm problems can be serious and occur suddenly, and it is not feasible to identify in advance the patients who may be at risk of these problems with fenspiride.
Danish: Hjerterytmeproblemer kan være alvorlige og opstå pludseligt, og det er ikke muligt på forhånd at identificere de patienter, der kan have risiko for disse problemer med fenspirid.
English: • Healthcare professionals should no longer prescribe fenspiride medicines and should advise their patients to stop taking fenspiride medicines.
Danish: • Sundhedspersoner bør ikke længere ordinere fenspirid-holdige lægemidler og bør råde deres patienter til at stoppe med at bruge disse lægemidler.
English: This included cases of QT prolongation and torsades de pointes (abnormalities of the heart's electrical activity that may lead to heart rhythm disturbances) in patients using these medicines, results of laboratory studies, data from published literature and stakeholder input.
Danish: Dette omfattede tilfælde af QTforlængelse og torsades de pointes (unormale forhold i hjertets elektriske aktivitet, der kan medføre forstyrrelser i hjerterytmen) hos patienter, der bruger disse lægemidler, resultater af laboratorieundersøgelser, data fra den offentliggjorte litteratur og oplysninger fra interessenterne.
English: • Patients are only at risk of heart rhythm problems with fenspiride while they are taking these medicines.
Danish: • Patienterne har kun risiko for hjerterytmeproblemer med fenspirid, så længe de tager disse lægemidler.
English: • You should stop taking these medicines and contact your doctor or pharmacist for advice on alternative treatments, if needed.
Danish: • Du bør holde op med at tage disse lægemidler og om nødvendigt kontakte din læge eller dit apotek for at få råd om alternative behandlingsmuligheder.
English: At that time, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended that supply of fenspiride medicines be suspended as a precautionary measure while the review was ongoing.
Danish: På det tidspunkt anbefalede Det Rådgivende Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC) suspendering af leveringen af fenspiridholdige lægemidler som en sikkerhedsmæssig foranstaltning, mens gennemgangen blev foretaget.
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures.
Danish: CMDh er ansvarlig for at sikre ensartede sikkerhedsstandarder for lægemidler, der godkendes via nationale procedurer.
English: • If you have any concerns about your medicine, discuss them with your doctor or pharmacist.
Danish: • Hvis du har betænkeligheder ved dit lægemiddel, kan du kontakte din læge eller apotekspersonalet.
English: This follows a review that confirmed that these cough medicines could cause heart rhythm problems.
Danish: Anbefalingen blev fremsat efter en gennemgang, der bekræftede, at disse hostestillende midler kan forårsage problemer med hjerterytmen.
English: • Cough medicines containing fenspiride will no longer be marketed in the EU because of data showing a risk of sudden, serious heart rhythm problems.
Danish: • Hostestillende midler, der indeholder fenspirid, vil ikke længere blive markedsført i EU, da data har vist, at de er forbundet med en risiko for pludselige og alvorlige hjerterytmeproblemer.
English: • The withdrawal of the marketing authorisations of fenspiride medicines is based on case reports and nonclinical studies (including hERG channel binding) that showed that fenspiride can cause QT prolongation and has proarrhythmia potential (could cause triggering or worsening of arrhythmia) with the associated risk of torsades de pointes.
Danish: • Tilbagetrækningen af markedsføringstilladelserne for fenspirid-holdige lægemidler er baseret på indberettede tilfælde og ikke-kliniske studier (herunder hERG-kanalbinding), der har vist, at fenspirid kan medføre QT-forlængelse og har et pro-arytmisk potentiale (kan udløse eller forværre arytmier) med en forbundet risiko for torsades de pointes.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev først foretaget af PRAC, som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger.
English: Therefore, the PRAC considered that these medicines should no longer be marketed.
Danish: Fenspirid anvendes imidlertid til behandling af ikke-alvorlig hoste, og PRAC finder derfor, at lægemidlerne ikke længere bør markedsføres.
English: Dolokadin einmal täglich prolonged release tablet
Danish: Dolokadin einmal täglich
English: 821 02 Bratislava
Danish: 821 02 Bratislava Slovak Republic
English: Slovak Republic TEVA Pharmaceuticals Slovakia, s.r.o.
Danish: TEVA Pharmaceuticals Slovakia, s.r.o.
English: Trancopal Dolo Suppositorien 150 mg suppository rectal use
Danish: Trancopal Dolo Suppositorien 150 mg
English: Katadolon Kinderzäpfchen suppository rectal use
Danish: Katadolon Zäpfchen suppositorier
English: 164,5 mg / 3 ml solution for injection intramuscular use
Danish: 164,5 mg / 3 ml
English: Trancopal Dolo capsule
Danish: Trancopal Dolo
English: Flupirtinmaleat Winthrop 400 mg Retardtabletten prolonged release tablet
Danish: Flupirtinmaleat Winthrop 400 mg Retardtabletten
English: Katadolon S long prolonged release tablet
Danish: Katadolon S long
English: Kabelovny 130 102 37 Praha 10 Czech Republic
Danish: 102 37 Praha 10 Czech Republic
English: MEDA Pharma GmbH & Co. KG Benzstr.
Danish: MEDA Pharma GmbH & Co.
English: In addition, the Committee questioned the proposed method of sterilisation of the medicine.
Danish: Derudover satte udvalget spørgsmålstegn ved den foreslåede metode til sterilisering af lægemidlet.
English: Further information can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Yderligere oplysninger findes her: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What is Opsiria?
Danish: Hvad er Opsiria?
English: Sirolimus has been used for several years to prevent organ rejection following a transplant.
Danish: Sirolimus er blevet anvendt i mange år til forebyggelse af organafstødning efter en transplantation.
English: Withdrawal of the marketing authorisation application for Opsiria (sirolimus)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Opsiria (sirolimus)
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: In this study, Opsiria was not compared with any other treatment.
Danish: I undersøgelsen blev Opsiria ikke sammenlignet med nogen anden behandling.
English: The inflammation may cause discomfort, pain, blurring of vision, and may lead to partial or complete blindness.
Danish: Betændelsen kan medføre ubehag, smerter, synsforstyrrelser og helt eller delvist synstab.
English: Opsiria is a medicine that contains the active substance sirolimus.
Danish: Opsiria er et lægemiddel, der indeholder det aktive stof sirolimus.
English: The data from the clinical study was not sufficient to demonstrate the benefit of Opsiria, particularly in European patients.
Danish: Dataene fra den kliniske undersøgelse var ikke tilstrækkelige til at påvise fordelen ved Opsiria, især hos europæiske patienter.
English: Withdrawal of the marketing authorisation application for Opsiria (sirolimus) EMA/358774/2016
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Opsiria (sirolimus) EMA/358774/2016
English: Opsiria was investigated in one main study in 347 patients with non-infectious uveitis.
Danish: Opsiria er undersøgt i én hovedundersøgelse med 347 patienter med ikke-smitsom uveitis.
English: The main measure of effectiveness was the number of patients in whom inflammation resolved after 5 months of treatment.
Danish: Det primære mål for virkningen var antallet af patienter, hos hvem betændelsen forsvandt efter 5 måneders behandling.
English: The active substance in Opsiria, sirolimus, is expected to work by blocking an enzyme called ‘mammalian target of rapamycin' (mTOR).
Danish: Det aktive stof i Opsiria, sirolimus, forventes at virke ved at blokere et enzym, der hedder "mammalt mål for rapamycin" (mTOR).
English: On 20 May 2016, Santen Oy officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opsiria, for the treatment of non-infectious uveitis.
Danish: Den 20. maj 2016 meddelte Santen Oy officielt til Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Opsiria til behandling af ikke-smitsom uveitis.
English: What was Opsiria expected to be used for?
Danish: Hvad forventedes Opsiria anvendt til?
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Opsiria did not outweigh its risks.
Danish: På tidspunktet for tilbagetrækningen var CHMP derfor af den opfattelse, at fordelene ved Opsiria ikke var større end risiciene.
English: The application was withdrawn after that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Danish: Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, virksomheden havde indsendt, og stillet en række spørgsmål.
English: In its letter notifying the Agency of the withdrawal of application, the company acknowledged the need to submit additional data on the benefits of Opsiria from an ongoing clinical study.
Danish: I det brev, hvori virksomheden orienterer udvalget om, at den trækker ansøgningen tilbage, erkender virksomheden, at der er behov for at indsende yderligere data om fordelene ved Opsiria fra en igangværende klinisk undersøgelse.
English: Since mTOR is involved in the activation and proliferation of T lymphocytes (white blood cells that play a role in inflammation), sirolimus is expected to reduce the inflammation in chronic non-infectious uveitis.
Danish: Da mTOR er involveret i aktiveringen og udbredelsen af T-lymfocytter (hvide blodlegemer, der spiller en rolle i betændelse), forventes sirolimus at mindske betændelsen ved kronisk ikke-smitsom uveitis.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Opsiria.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Opsiria.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Opsiria?
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Opsiria could not have been approved for the treatment of non-infectious uveitis.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's lister med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Opsiria ikke kunne være blevet godkendt til behandling af ikkesmitsom uveitis.
English: How is Opsiria expected to work?
Danish: Hvordan forventes Opsiria at virke?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016 EMA/358774/2016 EMEA/H/C/003978
Danish: EMA/358774/2016 EMEA/H/C/003978
English: Opsiria was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 30 August 2011 for the treatment of chronic non-infectious uveitis.
Danish: Opsiria blev udpeget som lægemiddel til sjældne sygdomme den 30. august 2011 til behandling af kronisk ikke-smitsom uveitis.
English: Opsiria was expected to be used for the treatment of non-infectious uveitis (inflammation of the uvea, the middle layer of the eye) in adults.
Danish: Opsiria forventedes at blive anvendt til behandling af ikke-smitsom uveitis (betændelse i det mellemste lag i øjnene, tunica vasculosa bulbi).
English: It was to be available as a solution to be injected into the eye.
Danish: Det var meningen, at det skulle leveres som en injektionsvæske, der skulle injiceres i øjet.
English: London, 25 October 2007 EMEA/CHMP/350251/2007
Danish: London, den 25. oktober 2007 EMEA/CHMP/350251/2007
English: A positive opinion was adopted by majority on 19 July 2007.
Danish: Der blev vedtaget en positiv udtalelse med flertal den 19. juli 2007.
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Danish: 1 Artikel 29, stk. 4, i direktiv 2001/83/EF, med senere ændringer.
English: The Mutual Recognition Procedure started on 24 October 2006.
Danish: Den gensidige anerkendelsesprocedure indledtes den 24. oktober 2006.
English: The Reference Member State was Germany and the Concerned Member States were Austria, Denmark, Spain, Finland, France, Italy, Luxembourg, Norway, Poland, Portugal, Sweden and United Kingdom.
Danish: Referencemedlemsstaten var Tyskland, og de berørte medlemsstater var Østrig, Danmark, Spanien, Finland, Frankrig, Italien, Luxembourg, Norge, Polen, Portugal, Sverige og Det Forenede Kongerige.
English: The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Danish: Voldgiftsproceduren indledtes den 26. april 2007 med vedtagelsen af en liste med spørgsmål.
English: The final opinion was converted into a Decision by the European Commission on 24 October 2007.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 24. oktober
English: Germany referred the reasons for disagreement to the EMEA on 29 March 2007.
Danish: Tyskland fremsendte begrundelserne for uenigheden til EMEA den 29. marts 2007.
English: The Marketing Authorisation Holder provided written explanations on 25 May 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 25. maj 2007.
English: The Rapporteur was Dr Karl Broich and Co-Rapporteur(s) was Dr Pierre Demolis.
Danish: Rapportøren og medrapportør var hhv. dr. Karl Broich og dr. Pierre Demolis.
English: On the basis of the questions raised by the Member States, the points to be considered by the CHMP concerned the posology, the repeated administration and safety profile in two Phase III studies.
Danish: På grundlag af de spørgsmål, der er rejst af medlemsstaterne, blev følgende punkter taget i betragtning af CHMP, nemlig dosering, gentagen anvendelse og sikkerhedsprofil i to fase III-undersøgelser.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 41, OM Xeomin Internationalt fællesnavn (INN): Clostridium botulinum neurotoxin type A
English: During their 16-19 July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Xeomin, that the objections raised by Finland, France and Italy, should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: I lyset af de samlede data, der var blevet fremlagt, og den faglige drøftelse i udvalget var CHMP på sit møde den 16.-19. juli 2007 af den opfattelse, at benefit-risk forholdet er gunstigt for Xeomin, at de rejste indvendinger af Finland, Frankrig og Italien ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: Merz Pharmaceuticals GmbH submitted applications for mutual recognition of Xeomin, 100 LD50 units powder for solution for injection, on the basis of the marketing authorisation granted by Germany on 31 May 2005.
Danish: Merz Pharmaceuticals GmbH indgav ansøgninger om gensidig anerkendelse af Xeomin, 100 LD50 -enheder pulver til injektionsvæske, opløsning, på grundlag af den markedsføringstilladelse, Tyskland udstedte den 31. maj 2005.
English: Xeomin, 100 LD50 units powder for solution for injection, is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.
Danish: Xeomin, 100 LD50 -enheder pulver til injektionsvæske, opløsning, er indiceret til symptombehandling af blefarospame og cervikal dystoni, specielt rotationsdystoni (spastisk torticollis) hos voksne.