natgillin/translations-raw huggingface dataset:
Holoclar har fået en »betinget godkendelse«.
Holoclar has therefore been given ‘conditional approval'.
Andre oplysninger om Holoclar
Other information about Holoclar
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Holoclar.
This is a summary of the European public assessment report (EPAR) for Holoclar.
Holoclar er beregnet til en enkelt behandling, men behandlingen kan gentages, hvis lægen anser det for nødvendigt.
Holoclar is intended for a single treatment, although treatment can be repeated if the doctor considers it necessary.
Der er udarbejdet en risikostyringsplan for at sikre, at Holoclar anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Holoclar is used as safely as possible.
Der var desuden bedring i patienternes symptomer såsom smerter og inflammation, og deres syn var blevet bedre.
There were also reductions in patients' symptoms, such as pain and inflammation, and improvements in vision.
I det første trin af behandlingen udtages der fra patienten på hospitalet et lille stykke sundt limbalt væv (1−2 mm2), som samme dag sendes til fremstilleren.
In the first stage of treatment, a small part of healthy limbal tissue (1−2 mm2 in size) is taken from the patient in hospital and sent to the manufacturer on the same day.
Der skal derudover udleveres oplysningsmateriale til de patienter, der modtager behandlingen.
Educational material will also be provided to patients undergoing treatment.
Hvorfor blev Holoclar godkendt?
Why is Holoclar approved?
Virksomheden skal fremlægge data om fordelene og risiciene ved Holoclar fra en prospektiv klinisk undersøgelse.
The company is to provide data on the benefits and risks of Holoclar from a prospective clinical study.
Da Holoclar har fået en betinget godkendelse, skal virksomheden, der markedsfører Holoclar, fremlægge yderligere data om Holoclar.
Since Holoclar has been granted a conditional approval, the company that markets Holoclar will provide further data on Holoclar.
Hvad er Holoclar, og hvad anvendes det til?
What is Holoclar and what is it used for?
Da antallet af patienter med mangel på limbale stamceller er lavt, betragtes sygdommen som »sjælden«, og Holoclar blev udpeget som »lægemiddel til sjældne sygdomme« den 7. november 2008.
Because the number of patients with limbal stem-cell deficiency due to burns to the eyes is low, the disease is considered ‘rare', and Holoclar was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Da bivirkningerne ved behandling med Holoclar sædvanligvis kan behandles, konkluderede CHMP, at fordelene ved Holoclar opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
As the side effects of Holoclar treatment are generally manageable, the CHMP concluded that Holoclar's benefits outweigh its risks and recommended that it be approved for use in the EU.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Holoclar?
What measures are being taken to ensure the safe and effective use of Holoclar?
Efter operationen skal patienten have antibiotika og passende antiinflammatorisk medicin.
Following the surgery, the patient should receive antibiotics and an appropriate antiinflammatory medicine.
Derefter dyrkes cellerne i vævet i laboratoriet og nedfryses, indtil operationsdagen er fastlagt.
Next, the cells in the tissue are grown in a laboratory and frozen until the date of surgery is confirmed.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Holoclar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Holoclar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det er ikke en praktisk vejledning i, hvordan Holoclar bør anvendes.
It is not intended to provide practical advice on how to use Holoclar.
Holoclar er et lægemiddel til avanceret terapi, som kaldes et »produkt fremstillet ved vævsteknik«.
Holoclar is a type of advanced therapy product called a ‘tissue engineered product'.
Den hyppigste bivirkning ved Holoclar (som optræder hos mere end 1 ud af 10 patienter) er inflammation af øjenlåget (blefaritis).
The most common side effect with Holoclar (seen in more than 1 patient in 10) is blepharitis (inflammation of the eye lid).
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Holoclar findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Holoclar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Hvilke oplysninger afventes der stadig for Holoclar?
What information is still awaited for Holoclar?
Udvalget bemærkede, at moderat til svær mangel på limbale stamceller er en alvorlig tilstand, som uden behandling kan medføre svær synsnedsættelse eller fuldstændigt tab af synet.
The Committee noted that that moderate to severe forms of limbal stem-cell deficiency are serious conditions which, if untreated, can lead to severe reduction or complete loss of vision.
Hvilke risici er der forbundet med Holoclar?
What are the risks associated with Holoclar?
Holoclar - som består af cellerne og membranen - sendes derefter retur til hospitalet, hvor det straks implanteres i patientens øje ved operation.
Holoclar, comprising the cells and the membrane, is then sent back to the hospital, where it is immediately surgically implanted in the patient's eye.
Det består af celler, der tages fra patientens hornhinderand (limbus) og derefter dyrkes i laboratoriet, så de kan anvendes til at reparere den beskadigede overflade af hornhinden.
It consists of cells taken from the patient's limbus (at the edge of the cornea) and then grown in a laboratory so that they can be used to repair the damaged corneal surface.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Holoclar, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Holoclar, including the appropriate precautions to be followed by healthcare professionals and patients.
Desuden skal virksomheden, der fremstiller Holoclar, udlevere oplysningsmateriale til sundhedspersoner om sikker brug af lægemidlet, herunder udvælgelse og opfølgning af patienterne og indberetning af bivirkninger.
In addition, the company that makes Holoclar will provide healthcare professionals with educational material on the safe use of this treatment, including on the selection and follow-up of patients and on reporting side effects.
Hvis du ønsker yderligere oplysninger om behandling med Holoclar, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Holoclar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Før Holoclar anvendes, fjernes det beskadigede område af hornhindeoverfladen i det pågældende øje.
Before Holoclar is used, the damaged corneal surface tissue of the affected eye is removed.
Det aktive stof i Holoclar er patientens egne limbale celler, dvs. celler fra hornhindeoverfladen og limbale stamceller dyrket i laboratoriet.
The active substance in Holoclar is the patient's own limbal cells, which include cells from the surface of the cornea and limbal stem cells grown in a laboratory.
Disse patienter har ikke tilstrækkeligt med limbale stamceller, der normalt virker som et gendannelsessystem og erstatter de yderste celler i hornhinden, når de bliver beskadiget eller ældet.
Patients with this condition do not have enough limbal stem cells which normally act as a regeneration system, replenishing the outer corneal cells when they get damaged and when they age.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at behandling med Holoclar var effektivt til at gendanne en sund hornhindeoverflade hos patienter med moderat til svær mangel på limbale stamceller efter forbrændinger, og at det gav bedring i deres symptomer og syn.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Holoclar treatment was effective in restoring healthy corneal surfaces in patients with moderate or severe limbal stem-cell deficiency caused by burns as well as in improving their symptoms and vision.
Holoclar autologe ex vivo-ekspanderede humane corneaepitelceller indeholdende stamceller
Holoclar ex vivo expanded autologous human corneal epithelial cells containing stem cells
Det betyder, at der er flere videnskabelige beviser på vej om lægemidlet.
This means that there is more evidence to come about the medicine, which the company is required to provide.
Den fuldstændige liste over bivirkninger og begrænsninger ved Holoclar fremgår af indlægssedlen.
For the full list of all side effects and restrictions, see the package leaflet.
Hvis du ønsker praktisk vejledning om anvendelsen af Holoclar, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Holoclar, patients should read the package leaflet or contact their doctor or pharmacist.
Holoclar fremstilles ved dyrkning af optøede celler på en membran fremstillet af proteinet fibrin.
Thawed cells are used to make Holoclar by growing them on a membrane made of a protein called fibrin.
Når hornhindecellerne i Holoclar er implanteret i øjet, gendanner de hornhindeoverfladen, mens de limbale stamceller virker som et reservoir, der til stadighed fornyer hornhinden.
Once implanted in the eye, the corneal cells of Holoclar help to replace the corneal surface, while the limbal stem cells serve as a reservoir of new cells that continuously replenish the cornea.
Holoclar er et lægemiddel, der indeholder stamceller og anvendes til at erstatte beskadigede celler på overfladen (epitelet) af øjets hornhinde, det gennemsigtige lag, der dækker øjets forside og regnbuehinden.
Holoclar is a stem-cell treatment used in the eye to replace damaged cells on surface (epithelium) of the cornea, the transparent layer in front of the eye covering the iris (the coloured part).
Hvordan anvendes Holoclar?
How is Holoclar used?
Det anvendes hos voksne patienter med moderat til svær mangel på limbale stamceller efter forbrænding eller ætsning af øjnene.
It is used in adult patients with moderate to severe limbal stem-cell deficiency caused by burns, including chemical burns, to the eyes.
Hvilke fordele viser undersøgelserne, at der er ved Holoclar?
What benefits of Holoclar have been shown in studies?
Konklusionen om benefit/risk-forholdet for Holoclar er baseret på resultaterne af to undersøgelser af allerede eksisterende patientjournaler (retrospektive undersøgelser).
The conclusion on the benefit-risk balance of Holoclar is based on results of two retrospective studies (using past medical records), and the company is to provide further data from a prospective study (that records outcomes during the course of the study).
Et år efter implantationen af Holoclar blev 75 af de 104 undersøgte patienter (72 %) bedømt til at have fået et vellykket implantat.
One year after Holoclar implantation, 75 out of 104 patients studied (72%) were judged to have had successful implants based on the presence of stable corneal surface with no surface defects and little or no ingrown blood vessels (a common feature of limbal stem-cell deficiency).
Hvordan virker Holoclar?
How does Holoclar work?
Holoclar må kun anvendes af en tilstrækkeligt oplært og kvalificeret øjenkirurg på et hospital.
Holoclar must only be used by an appropriately trained and qualified eye surgeon in a hospital, and must only be given to the patient whose limbal cells were used to manufacture the medicine.
Det fremgik, at Holoclar var effektivt til at gendanne en stabil hornhindeoverflade hos patienter med moderat til svær mangel på limbale stamceller efter forbrændinger.
Holoclar was shown to be effective in restoring a stable corneal surface in patients with moderate or severe limbal stem-cell deficiency caused by burns in a retrospective study using patients' past medical records.
Efter at have fået udtaget limbalt væv skal patienten have antibiotika for at forebygge øjeninfektion.
Antibiotics to prevent eye infection should be given to patients after limbal tissue has been taken from them.
Außerdem hatte der Ausschuss Bedenken bezüglich der Art und Weise, wie die Daten analysiert wurden.
They had concerns with the way the data were analysed.
In den Studien wurde gemessen, wie lange es dauerte, bis die Krankheit fortschritt.
The studies measured how long it would take before the disease would progress.
FRAGEN UND ANTWORTEN ZUR RÜCKNAHME EINES ANTRAGS AUF ÄNDERUNG DER GENEHMIGUNG FÜR DAS INVERKEHRBRINGEN von DEPOCYTE
QUESTIONS AND ANSWERS ON WITHDRAWAL OF APPLICATION FOR A VARIATION OF MARKETING AUTHORISATION for DEPOCYTE
Die Beuteilung war abgeschlossen, und der CHMP hätte ein negatives Gutachten abgegeben.
The evaluation was finished and the CHMP would have given a negative opinion.
Internationaler Freiname (INN): Cytarabin
International Non-proprietary Name (INN): cytarabine
Cytarabin wird seit den 1970er Jahren als Krebsmedikament eingesetzt.
Cytarabine has been used as an anti-cancer medicine since the 1970s.
Was ist DepoCyte?
What is DepoCyte?
Es ergeben sich keine Konsequenzen für die Anwendung von DepoCyte in den Indikationen, für die es bereits zugelassen ist und bei denen das bekannte Nutzen-/Risikoprofil unverändert bleibt.
There are no consequences for DepoCyte's use in the indications for which it is already authorised, where the known benefit and risk remain unchanged.
DepoCyte hilft, die Symptome der Krankheit zu bekämpfen.
DepoCyte helps control the symptoms of the disease.
Das Schreiben, mit dem das Unternehmen die EMEA von der Rücknahme des Antrags für DepoCyte in Kenntnis setzt, finden Sie hier.
The letter from the Company notifying the EMEA of the withdrawal of DepoCyte is available here.
Was waren die wesentlichen Bedenken des CHMP?
What were the main concerns of the CHMP?
Gutachten des CHMP dauert es in der Regel 6 Wochen, bis die Europäische Kommission die Zulassung aktualisiert.
Following CHMP opinion, it usually takes around 6 weeks for the European Commission to update the licence.
Sollten Sie an einer klinischen Studie oder an einem derartigen “Compassionate-Use”-Programm teilnehmen und weitere Informationen zu Ihrer Behandlung benötigen, wenden Sie sich an Ihren behandelnden Arzt.
If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Wie lautete die Empfehlung des CHMP zu diesem Zeitpunkt?
What was the recommendation of the CHMP at that time?
Was geschieht mit DepoCyte zur Behandlung der lymphomatösen Meningitis?
What is happening for DepoCyte for the treatment of lymphomatous meningitis?
Der CHMP äußerte Bedenken dahingehend, die vom Unternehmen vorgelegten Studien hätten nicht ausreichend belegt, dass Depocyte genauso wirksam oder wirksamer als intrathekal verabreichtes Methotrexat sei.
The CHMP had concerns that the studies presented by the Company had not sufficiently shown that Depocyte was as effective as, or more effective than intrathecal methotrexate.
Am 28. Juni 2006 teilte SkyePharma PLC dem Ausschuss für Humanarzneimittel (CHMP) offiziell mit, dass das Unternehmen seinen Antrag für eine neue Indikation für DepoCyte 50 mg Injektionssuspension zur intrathekalen Behandlung der durch solide Tumoren verursachten neoplastischen Meningitis zurückzieht.
On 28 June 2006, SkyePharma PLC officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for DepoCyte 50 mg suspension for injection, in the intrathecal treatment of solid tumour neoplastic meningitis.
DepoCyte wurde mit Methotrexat (einem anderen Krebsmedikament) verglichen, und beide Medikamente wurden intrathekal verabreicht.
DepoCyte was compared with methotrexate (another anti-cancer medicine), both medicines being administered intrathecally.
Das Unternehmen legte die Ergebnisse von zwei Studien an 164 Patienten mit neoplastischer Meningitis infolge von soliden Tumoren vor.
The company presented the results of two studies, involving 164 patients with solid tumour neoplastic meningitis.
Welche Unterlagen hat das Unternehmen dem CHMP zur Stützung des Antrags vorgelegt?
What documentation has been presented by the Company to support the application to the CHMP?
DepoCyte sollte intrathekal injiziert werden.
DepoCyte was to be injected intrathecally.
In welchem Stadium der Beurteilung befand sich der Antrag zum Zeitpunkt der Rücknahme?
How far into the evaluation was the application when it was withdrawn?
Aus welchen Gründen hat das Unternehmen den Antrag zurückgezogen?
What were the reasons given by the Company to withdraw the application?
DepoCyte ist eine Injektionssuspension, die 50 mg des arzneilich wirksamen Bestandteils Cytarabin enthält.
DepoCyte is a suspension for injection that contains 50 mg of the active substance cytarabine.
DepoCyte enthält Cytarabin in einer besonderen Darreichungsform: der arzneilich wirksame Bestandteil ist in Liposomen (kleinen Fettpartikeln) enthalten, aus denen er langsam freigesetzt wird.
DepoCyte contains cytarabine in a special formulation: the active substance is contained in liposomes (small fatty particles) from which it is slowly released.
Der arzneilich wirksame Bestandteil in DepoCyte, Cytarabin, ist ein Mittel gegen Krebs.
The active substance in DepoCyte, cytarabine, is an anti-cancer agent.
Wofür sollte DepoCyte angewendet werden?
What was DepoCyte expected to be used for?
DepoCyte wird direkt in das Nervensystem, d. h. in den Raum zwischen den Hirn- und Rückenmarkshäuten, gespritzt (intrathekale Injektion).
DepoCyte is injected directly into the nervous system, in the space between the lining of the spinal cord and brain (intrathecal injection).
Als der Antrag vom Unternehmen zurückgezogen wurde, war im Antragsverfahren Tag 90 erreicht.
The application was at Day 90 when the Company withdrew.
Es ist ein Zytostatikum (ein Medikament, das Zellen abtötet, die sich teilen, wie z. B. Krebszellen) aus der Gruppe der Antimetabolite.
It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells) that belongs to the group of anti-metabolites.
Wie soll DepoCyte wirken?
How is DepoCyte expected to work?
Aus diesem Grund vertrat der CHMP zum Zeitpunkt der Rücknahme des Antrags die Ansicht, es sei nicht belegt worden, dass der Nutzen von DepoCyte bei der Behandlung der durch solide Tumoren verursachten neoplastischen Meningitis gegenüber den Risiken überwiegt.
Therefore, at the time of the withdrawal, the CHMP's view was that it had not been shown that the benefits of DepoCyte in the treatment of solid tumour neoplastic meningitis were greater that its risks.
DepoCyte wird zur Behandlung der lymphomatösen Meningitis angewendet, einer Erkrankung, bei der die Zellen eines Lymphknotentumors in die Membranen eingedrungen sind, die das Nervensystem umgeben (Meninges - Hirn- und Rückenmarkshäute).
DepoCyte is used to treat lymphomatous meningitis: this is a condition where lymphoma tumour cells have spread to the membranes that surround the nervous system (meninges).
Wenn der CHMP einen Antrag auf eine Änderung der Genehmigung für das Inverkehrbringen erhält, braucht der Ausschuss in der Regel bis zu 90 Tage, um ein Gutachten abzugeben.
The CHMP normally takes up to 90 days to adopt an opinion after it has received an application for a change to a marketing authorisation.
London, 29. Juni 2006 Dok.-Ref. EMEA/349175/2006
London, 29 June 2006 Doc.Ref.
„Compassionate-Use“-Programmen mit DepoCyte?
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with DepoCyte?
Das Unternehmen hat den CHMP darüber informiert, dass die Entscheidung keine Konsequenzen für Patienten hat, die an klinischen Studien oder „Compassionate-Use“-Programmen (Programmen, bei denen Ärzte ein Arzneimittel zur Behandlung einer bestimmten Erkrankung für einen ihrer Patienten beantragen können, bevor dieses Mittel vollständig genehmigt wurde) teilnehmen.
The company has informed the CHMP that the decision has no consequences for patients enrolled in clinical trials or compassionate use programmes.
Dies ist eine Erkrankung, bei der sich Krebszellen aus einem soliden (festen) Tumor (wie z. B. Lungen- oder Brustkrebs) auf die Membranen des Nervensystems ausbreiten.
DepoCyte was to be used in the treatment of solid tumour neoplastic meningitis: this is a disease where cancer cells, originally from a solid tumour (such as lung or breast cancer), spread to the membranes of the nervous system.
Der Ausschuss war der vorläufigen Ansicht, dass DepoCyte nicht zur intrathekalen Behandlung der durch solide Tumoren verursachten neoplastischen Meningitis zugelassen werden könne.
Based on the review of the data at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that DepoCyte could not be approved for the intrathecal treatment of solid tumour neoplastic meningitis.
Den 6. august 2014
06 August 2014
Europa-Kommissionen traf en beslutning den 6. august 2014.
The European Commission issued a decision on 06 August 2014.
Hvad er Dexamed?
What is Dexamed?
Hvorfor blev Dexamed vurderet igen?
Why was Dexamed reviewed?
Den 22. maj 2014 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i Den Europæiske Union (EU) om godkendelsen af lægemidlet Dexamed (dexamfetaminsulfat).
On 22 May 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Dexamed (dexamfetamine sulphate).
Disse konklusioner blev støttet af en gruppe af eksperter i adfærdsproblemer hos børn og unge, som CHMP rådførte sig med om sagen.
These conclusions were supported by a group of experts in childhood and adolescent behavioural problems consulted by the CHMP.
Ved denne procedure vurderer én medlemsstat (“referencemedlemsstaten”, her Det Forenede Kongerige) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de “berørte medlemsstater”, her Danmark, Finland, Irland, Luxembourg, Nederlandene, Norge, Spanien og Sverige).
This is a procedure where one European country (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other European countries (the ‘concerned Member States', in this instance Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain, and Sweden).
Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og Det Forenede Kongeriges lægemiddelstyrelse indbragte den 10. juni 2013 sagen for CHMP med henblik på voldgift.
However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 10 June 2013.
Dexamed er et lægemiddel, der indeholder det aktive stof dexamfetaminsulfat.
Dexamed is a medicine that contains the active substance dexamfetamine sulphate.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Dexamed opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Det Forenede Kongerige og i følgende lande: Danmark, Finland, Irland, Luxembourg, Nederlandene, Norge, Spanien og Sverige.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Dexamed outweigh its risks, and the marketing authorisation can be granted in the United Kingdom and in the following countries: Denmark, Finland, Ireland, Luxembourg, the Netherlands, Norway, Spain and Sweden.