natgillin/translations-raw huggingface dataset:
CHMP anerkender, at der ikke blev konstateret kritiske mangler ved en række revisioner foretaget af GVK's kunder eller ved inspektioner foretaget af de kompetente myndigheder hos GVK Bio i Hyderabad gennem en lang periode.
The CHMP acknowledges that a number of audits by GVK's clients and inspections by competent authorities were carried out at GVK Bio-Hyderabad over a large period without identifying critical findings.
Indehaveren af markedsføringstilladelsen skal derfor stadig fastslå bioækvivalens med EUreferencelægemidlet for at der kan drages konklusioner om det positive benefit/risk-forhold for lægemidlet.
Therefore the MAH still needs to establish bioequivalence with the EU reference medicinal product in order to conclude on the positive benefit-risk balance of the medicinal product.
Efter modtagelse af besvarelserne fra indehaverne af markedsføringstilladelse blev de forelagte argumenter og data inddelt i tre kategorier under behørigt hensyn til besvarelserne fra de enkelte indehavere af markedsføringstilladelse.
Following submission of MAHs' responses, and whilst due consideration was given to every MAHs' replies, the arguments and data provided were classified into three categories.
CHMP finder derfor, at undersøgelserne ikke kan ligge til grund for at fastslå bioækvivalens med EU-referencelægemidlet.
Therefore the CHMP is of the opinion that the studies cannot be relied upon to establish bioequivalence vis-àvis the EU reference medicinal product.
Det er CVMP's opfattelse, at dette argument ikke kan træde i stedet for nødvendigheden af at fastslå bioækvivalens med et EU-referencelægemiddel med henblik på en konklusion om et positivt benefit/risk-forhold for de omfattede lægemidler.
The CHMP is of the view that this argument does not substitute the need to establish bioequivalence with an EU reference medicinal product in order to conclude on the positive benefitrisk balance of the concerned medicinal products.
• Udvalget konkluderede, at benefit/risk-forholdet er positivt til de godkendte indikationer for lægemidlerne i bilag IA indeholdende bendroflumethiazid, bosentan, fexofenadin, lansoprazol, levetiracetam, levocetirizin, metoclopramid, nebivolol og venlafaxin.
• The Committee concluded for marketing authorisations of medicinal products of Annex IA containing Bendroflumetiazid, Bosentan, Fexofenadine, Lansoprazole, Levetiracetam, Levocetirizine, Metoclopramide, Nebivolol and Venlafaxine that the benefit risk balance is positive in the approved indications.
CHMP konkluderede, at der ikke var påvist bioækvivalens med EU-referencelægemidlet, hvorfor virkningen og sikkerheden ikke var fastlagt for det pågældende lægemiddel i kategori 1, og at benefit/risk-forholdet derfor ikke kunne anses for positivt.
In conclusion, in the absence of demonstration of the bioequivalence vis-à-vis the EU reference medicinal product, the CHMP concluded that the efficacy and safety of the concerned category 1 medicinal product can not be established, and hence the benefit-risk balance cannot be considered positive.
Efterfølgende blev der til den australske generiske ansøgning udført en bioækvivalensundersøgelse med Alembics irbesartan/hydrochlorthiazid, filmovertrukne tabletter, 300 mg/25 mg, sammenlignet med det australske referencelægemiddel AVAPRO HCT, filmovertrukne tabletter, 300 mg, hidrørende fra det australske marked.
Subsequently, for AU generic dossier submission, a bioequivalence study was performed using Alembic's Irbesartan Hydrochlorothiazide Film-coated Tablets 300mg/25 mg against the AU reference product AVAPRO HCT 300mg Film-coated Tablets sourced from Australian market.
CHMP konkluderer, at de af indehaveren af markedsføringstilladelsen forelagte data ikke underbygger et positivt benefit/risk-forhold for lægemidlet.
In conclusion, the CHMP is of the view that the data submitted by the MAHs are not suitable to support the positive benefit-risk balance of the medicinal product.
For lægemidler, der anses for kritisk nødvendige, kan suspenderingen af markedsføringstilladelsen i de pågældende medlemsstater udsættes i en periode af højst 24 måneder efter Kommissionens beslutning.
For marketing authorisation(s) of a medicinal product considered critical, the suspension may be deferred in the relevant Member State(s) for a period which shall not exceed twenty-four months from the Commission Decision.
Nedenfor følger CHMP's konklusioner til besvarelse af de punkter, der er rejst i begrundelsen fra indehaveren af markedsføringstilladelsen.
The CHMP conclusions on the points raised in the MAH's grounds are given below.
Denne kategori omfatter lægemidler, for hvilke der ikke er anmodet om dispensation for bioækvivalensundersøgelse i forhold til EU-referencelægemidlet og ikke er forelagt en sådan undersøgelse udført på et andet center end Biosciences Pvt. Ltd.'s center i Hyderabad, Indien.
The category encompasses products for which MAHs have not provided any biowaiver request or bioequivalence study vis-à-vis the EU reference medicinal product generated elsewhere than at GVK Biosciences Pvt. Ltd. facility in Hyderabad, India, or where MAHs have not responded.
Indehaverne af markedsføringstilladelse begrundede anmodningen om fornyet overvejelse med, at benefit/risk-forholdet er positivt for de lægemidler, for hvilke markedsføringstilladelsen suspenderes.
In support of their request for re-examination, MAHs submitted grounds to argue that the benefit risk balance of their products subject to a suspension of MA is positive.
Et lægemiddel, der er opført i bilag IB, kan anses for kritisk nødvendigt af en medlemsstat på grundlag af en vurdering af det potentielle uopfyldte medicinske behov.
A medicinal product listed in Annex IB may be considered critical by the Member State(s) based on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective Member State(s) and, as appropriate, the nature of the disease to be treated.
• CHMP finder bioækvivalensen fastlagrt for lægemidler i bilag IA (dvs. lægemidler indeholdende bendroflumethiazid, bosentan, fexofenadin, lansoprazol, levetiracetam, levocetirizin, metoclopramid, nebivolol og venlafaxin), for hvilke CHMP har modtaget, vurderet og godkendt enten andre bioækvivalensundersøgelser end den, der er udført på GVK Biosciences center i Hyderabad, eller påberåbelse af, at lægemidlerne opfylder kriterierne for dispensation for bioækvivalensundersøgelse baseret på biofarmaceutisk klassificering (BCS) som beskrevet i Appendix III til vejledningen om undersøgelser af bioækvivalens (CPMP/EWP/QWP/1401/98).
• For medicinal products (Annex IA) for which other bioequivalence studies than the one(s) performed at GVK Biosciences Hyderabad site or claims that the medicinal products fulfil the criteria for a Biopharmaceutics Classification System (BCS)-based biowaiver as described in Appendix III of the Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98) were submitted, assessed and considered positive by the CHMP (i.e. medicinal products containing Bendroflumetiazid, Bosentan, Fexofenadine, Lansoprazole, Levetiracetam, Levocetirizine, Metoclopramide, Nebivolol and Venlafaxine), the CHMP is of the opinion that the bioequivalence has been established.
Bioækvivalens for irbesartan påvist i forhold til et ikke-EU-sammenligningslægemiddel: Som dokumentation til EU-markedsføringstilladelse for irbesartan, tabletter, 75 mg, 150 mg og 300 mg, er der udført følgende bioækvivalensundersøgelse: Bioækvivalensundersøgelse for irbesartan, filmovertrukne tabletter, 300 mg, sammenlignet med EU-referencelægemidlet APROVEL, filmovertrukne tabletter, 300 mg. Til en generisk ansøgning i Australien blev der efterfølgende udført en bioækvivalensundersøgelse med irbesartan, filmovertrukne tabletter, 300 mg, over for det australske referencelægemiddel AVAPRO, filmovertrukne tabletter, 300 mg, indhentet fra det australske marked.
BE established versus non-EU RMP for Irbesartan: For the EU MA dossier for Irbesartan 75, 150 and 300 mg tablets, the following bioequivalence study has been performed: bioequivalence study for Irbesartan Film-coated Tablets using 300mg strength against EU reference product APROVEL 300 mg Film-coated Tablets.
CVMP finder, at ovenstående argument fra markedsføringstilladelsesindehaverne må afvises, da det ikke kan træde i stedet for fastlæggelse af bioækvivalens med et EU-referencelægemiddel med henblik på en konklusion om et positivt benefit/risk-forhold for de omfattede lægemidler.
The CHMP is of the view that the argument presented by the MAHs above does not substitute the need to establish bioequivalence with an EU reference medicinal product in order to conclude on the positive benefit-risk balance of the concerned medicinal products and therefore should be rejected.
I henhold til artikel 10 i direktiv 2001/83/EF skal der være fastlagt bioækvivalens med et EU-referencelægemiddel.
According to article 10 of Directive 2001/83/EC, the bioequivalence vis-à-vis an EU reference medicinal product needs to be established and therefore the abovementioned studies can not be considered fulfilling the criteria of article 10.
Ovenstående blev drøftet på CHMP's plenarmøde i december 2014, hvor CHMP godkendte denne inddeling.
• Category 3: New bioequivalence vis-à-vis the EU reference medicinal product study submitted Discussions on the above took place during the December 2014 CHMP plenary meeting during which the CHMP endorsed the above mentioned classification.
• For de lægemidler (bilag IB), for hvilke der enten ikke er forelagt bioækvivalensdata, eller hvor CHMP ikke har fundet disse tilstrækkelige til at dokumentere et positiv benefit/risk-forhold for de pågældende lægemidler, finder CHMP, at der ikke er fastlagt bioækvivalens med et godkendt EU-referencelægemiddel.
• With regards to medicinal products (Annex IB) for which bioequivalence data was not submitted or considered insufficient by the CHMP to support a positive benefit risk balance of the concerned medicinal products, the CHMP is of the opinion that the bioequivalence with an EU authorised reference medicinal product has not been established and therefore concluded that the particulars supporting the marketing authorisation are incorrect and that the benefit-risk balance of the concerned medicinal products is not positive as pursuant to Article 116 of Directive 2001/83/EC.
Uanset ovennævnte krav gennemgik CHMP indehaveren af markedsføringstilladelsens argumentation og fandt, at det fra et videnskabeligt perspektiv med de forelagte data ikke er påvist, at det australske lægemiddel og EU-sammenligningslægemidlet er identiske (således er fremstillingsstederne ukendt, og den kvantitative sammensætning er ukendt).
AU and EU reference medicinal products are identical (e.g., the manufacturing sites are unknown, the quantitative compositions are unknown).
Der tages herunder hensyn til rådigheden over egnede alternative lægemidler i de pågældende medlemsstater og, i givet fald, arten af den behandlede sygdom.
Some of these medicinal products may be considered critical by the individual Member States on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective Member State(s) and, as appropriate, the nature of the disease to be treated.
Den 23. maj 2014 EMA/299385/2014 EMEA/H/C/002817
23 May 2014 EMA/299385/2014 EMEA/H/C/002817
Virkningerne af Reasanz blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Reasanz were first tested in experimental models before being studied in humans.
Hvad er Reasanz?
What is Reasanz?
Desuden havde udvalget betænkelighed ved den måde, lægemidlets effektivitet var blevet analyseret på i undersøgelsen.
Furthermore, the Committee had concerns about the way the effectiveness of the medicine in the study had been analysed.
Afslag på ansøgningen om markedsføringstilladelse for Reasanz (serelaxin) EMA/299385/2014
Refusal of the marketing authorisation for Reasanz (serelaxin) EMA/299385/2014
Reasanz er et lægemiddel, der indeholder det aktive stof serelaxin.
Reasanz is a medicine that contains the active substance serelaxin.
Afslag på ansøgningen om markedsføringstilladelse for Reasanz (serelaxin)
Refusal of the marketing authorisation for Reasanz (serelaxin)
Hvis du deltager i en klinisk undersøgelse med Reasanz og har behov for mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Ansøgningen byggede hovedsagelig på resultaterne af en enkelt hovedundersøgelse med 1 161 patienter, der fik en episode med akut hjertesvigt.
The application was mainly based on the results of one main study involving 1,161 patients with an episode of acute heart failure.
Hvordan forventes Reasanz at virke?
How is Reasanz expected to work?
Reasanz forventedes anvendt til behandling af symptomerne på akut hjertesvigt (en episode med svære eller forværrede symptomer hos patienter, hos hvem hjertet ikke kan pumpe tilstrækkeligt med blod rundt i kroppen).
Reasanz was expected to be used to treat the symptoms of acute heart failure (an episode of severe or worsening symptoms in patients in whom the heart cannot pump sufficient blood around the body).
Lægemidlet var beregnet til brug som tillægsbehandling til anden behandling.
The medicine was to be used as an addition to other treatment.
Rekombinant betyder, at det fremstilles ved dyrkning af bakterier, der har fået indsat et gen (DNA), som gør dem i stand til at producere hormonet.
Recombinant means that it is produced by bacteria into which a gene (DNA) has been introduced that makes the bacteria able to produce the hormone.
Virkningen blev hovedsagelig bedømt på, hvor meget behandlingen mindskede kortåndethed, målt på kort sigt (efter 6, 12 og 24 timer) og i løbet af 5 dage.
The main measure of effectiveness was the extent to which dyspnoea was relieved, measured short-term (after 6, 12 and 24 hours) and over 5 days.
Hvad forventedes Reasanz anvendt til?
What was Reasanz expected to be used for?
Infusion af Reasanz blev sammenlignet med placebo (virkningsløs behandling) som tillægsbehandling til patienternes øvrige behandling.
Reasanz infusion was compared with placebo (a dummy treatment) as an addition to their other treatment.
Den 23. januar 2014 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Reasanz til behandling af akut hjertesvigt.
On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Reasanz, intended for the treatment of acute heart failure.
Det aktive stof i Reasanz, serelaxin, er en rekombinant form af kroppens naturlige hormon relaxin-2.
The active substance in Reasanz, serelaxin, is a recombinant form of relaxin-2, a hormone naturally found in the body.
Selv om sikkerheden af Reasanz så ud til at være acceptabel, konkluderede CHMP derfor, at fordelene ved Reasanz ikke var større end risiciene, og udvalget fastholdt sin tidligere anbefaling om afslag på ansøgningen om markedsføringstilladelse.
Therefore, although the safety of Reasanz seemed acceptable, the CHMP concluded that the benefits of Reasanz did not outweigh its risks and maintained its previous recommendation that the medicine be refused marketing authorisation.
Når serelaxin bindes til receptorer for relaxin, får det karrene til at afslappes, så de udvider sig.
When serelaxin attaches to receptors for relaxin in the blood vessels, it causes these vessels to relax and widen.
Resultaterne indeholdt tildelte værdier for en række patienter, som var døde eller havde fået ekstra behandling på grund af forværrede symptomer.
The results included assigned values for a number of patients who had died or had required additional treatment for worsening symptoms and whose actual data were not used.
Den virksomhed, der har indgivet ansøgningen, er Novartis Europharm Ltd. Ansøgeren anmodede om fornyet overvejelse af udtalelsen.
The company that applied for authorisation is Novartis Europharm Ltd.
Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for Reasanz.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Reasanz.
Da ansøgningen kun omfattede én hovedundersøgelse, konkluderede CHMP, at der skulle flere undersøgelser til for at fastslå effektiviteten af Reasanz til behandling af akut hjertesvigt.
Since only one main study was included in the application, the CHMP concluded that further studies would be needed to confirm the effectiveness of Reasanz in the treatment of acute heart failure.
Under den fornyede overvejelse gennemgik CHMP igen dataene fra ansøgningens eneste hovedundersøgelse og fastholdt, at effektiviteten af Reasanz ikke var tilfredsstillende påvist.
During the re-examination, the CHMP reviewed again the data from the only main study submitted and confirmed its opinion that the effectiveness of Reasanz had not been sufficiently demonstrated.
Desuden mente CHMP, at resultaterne kan være blevet påvirket af den baggrundsbehandling, der blev givet til patienterne i de to grupper i forsøget.
In addition, the CHMP questioned whether the type of the background treatment given to patients in the two study groups might have influenced the results.
Det var meningen, at det skulle leveres som en væske til indgivelse i en vene gennem et drop (et koncentrat til infusionsvæske, opløsning).
It was to be available as a concentrate to be diluted and given by infusion (drip) into a vein.
Dette sænker trykket i blodkarrene, så det bliver lettere for hjertet at pumpe blodet rundt i kroppen.
pressure in the blood vessels and makes it easier for the heart to pump blood around the body, which helps to relieve the symptoms of acute heart failure.
På tidspunktet for den indledende vurdering konstaterede CHMP, at undersøgelsen ikke viste gavnlig virkning i form af mindskelse af kortåndethed på kort sigt indtil 24 timer.
At the time of the initial evaluation, the CHMP noted that the study results did not demonstrate a benefit for short-term relief of dyspnoea over up to 24 hours, and although some benefit was shown over 5 days it was not clear how this was of clinical relevance.
Det medfører væskeophobning (kongestion) og kortåndethed (dyspnø).
These symptoms include high blood pressure in the vessels leaving the lungs, leading to congestion (fluid build-up) and dyspnoea (shortness of breath).
Samlet resumé af den videnskabelige vurdering af Tibolona Aristo og relaterede navne (se bilag I)
Overall summary of the scientific evaluation of Tibolona Aristo and associated names (see Annex I)
Produktresuméet, etiketteringen og indlægssedlen hertil forbliver uændrede og svarer til endelige version, der er fastlagt ved behandlingen i koordinationsgruppen, som anført i bilag III for Tibolona Aristo og relaterede navne (se bilag I).
• the CHMP considered that the available data confirms that the results of the bioequivalence study are reliable and demonstrate the bioequivalence of the proposed products and the reference product the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Tibolona Aristo and associated names (see Annex I).
• tredje trimester af en graviditet
• third trimester of pregnancy
Spædbørn og børn
Infants and children
• Punkt 3: Sådan skal du bruge X
• Section 3: How to use X
Lægen vil fortælle dig, hvordan du skal tage <særnavn>.
Your doctor will tell you how to take <invented name>.
• Punkt 4.3 Kontraindikationer
• Section 4.3 Contraindications
Den eksisterende ordlyd bør om nødvendigt ændres.
Existing wording should be amended as necessary.
Der foreligger ikke nogen erfaring med langvarig brug.
There is no experience available with long-term use.
Den eksisterende produktinformation skal ændres (ved indsættelse, erstatning eller sletning af tekst), så den gengiver den godkendte ordlyd, som er angivet nedenfor.
The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Punkt 2: Det skal du vide, før du begynder at bruge X Nedenstående ordlyd bør gengives i dette punkt.
Section 2: What you need to know before you use X This following wording should be reflected in this section.
Metamizol passerer placentabarrieren.
Metamizole crosses the placental barrier.
300 mg suppositorie
300 mg suppository
For at minimere risikoen for en hypotensiv reaktion skal den intravenøse injektion indgives meget langsomt.
In order to minimize the risk of a hypotensive reaction, the intravenous injection must be administered very slowly.
For alle formuleringer, herunder lægemidler i fast kombination:
For all formulations including fixed combination medicinal products:
Du vil få <særnavn> administreret som en injektion i en blodåre eller muskel.
<Invented name> will be given to you as injection into your vein or into muscle.
Der foreligger kun begrænsede data fra anvendelse af metamozil hos gravide kvinder.
There are only limited data available on the use of metamizole in pregnant women.
11 måneder kun intramuskulært
3-11 months intramuscular only
Metamizols nedbrydningsprodukter passerer over i modermælk i betydelige mængder, og en risiko for det diende spædbarn kan ikke udelukkes.
The breakdown products of metamizole pass into breast-milk in considerable amounts and a risk to the breastfed infant cannot be excluded.
• Punkt 4.2 Dosering og administration
• Section 4.2 Posology and method of administration
I de sidste tre måneder af graviditeten må du ikke tage <særnavn>, da der er en øget risiko for komplikationer for moderen og barnet (blødning, for tidlig lukning af en vigtig blodåre hos det ufødte barn (ductus Botalli), der naturligt lukker efter fødslen).
During the last three months of pregnancy you must not take <invented name> because of an increased risk of complications for the mother and child (haemorrhaging, premature closure of an important vessel, the so-called Ductus Botalli, of the unborn, which naturally closes only after birth).
Alle formuleringer, herunder lægemidler i fast kombination o Brug ikke X: - hvis du er i de sidste tre måneder af en graviditet - hvis du ammer
All formulations including fixed combination medicinal products o Do not use X: - if you are in the last three months of pregnancy - if you are breast-feeding
På grundlag af publicerede data fra gravide kvinder, der var blevet eksponeret for metamizol i løbet af det første trimester (n = 568), blev der ikke fundet evidens for teratogene eller embryotoksiske virkninger.
Based on published data from pregnant women exposed to metamizole during the first trimester (n=568) no evidence for teratogenic or embryotoxic effects was identified.
250 mg tabletter
250 mg tablets
Der er til dato ikke tilstrækkelig erfaring med langvarig brug af metamizol hos patienter med svært nedsat lever- og nyrefunktion.
To date, there has been insufficient experience with long-term use of metamizole in patients with severe hepatic and renal impairment.
Voksne og unge fra 15 år eller derover
Adults and adolescents 15 years of age or older
Barnets alder (legemsvægt)
Children age range (body weight)
Bilag III Ændringer af relevante punkter i produktinformationen
Annex III Amendments to relevant sections of the Product Information
De tilgængelige data om brug af metamizol i de første tre måneder af graviditeten er begrænsede, men indikerer ikke, at det er skadeligt for fostret.
Available data on the use of metamizole during the first three months of pregnancy is limited but do not indicate harmful effects to the embryo.