FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP was requested in particular to provide its opinion under Article 31 of Directive 2001/83/EC as to whether marketing authorisations of these products should be maintained, varied, suspended, or revoked and whether marketing authorisations applications should be authorised.
Danish: CHMP blev navnlig anmodet om at afgive en udtalelse i henhold til artikel 31 i direktiv 2001/83/EF om, hvorvidt markedsføringstilladelserne for disse produkter bør fastholdes, ændres, suspenderes eller tilbagekaldes, og om, hvorvidt ansøgninger om markedsføringstilladelse bør godkendes.
English: Furthermore, the Committee recommends that the concerned marketing authorisations should be suspended unless the medicinal product is considered critical by the relevant national competent authorities.
Danish: Desuden anbefaler udvalget, at de pågældende markedsføringstilladelser suspenderes, medmindre lægemidlet anses for kritisk nødvendigt af de pågældende kompetente nationale myndigheder.
English: In addition, a study performed at the Micro Therapeutic Research Labs Pvt. Ltd site in Coimbatore was inspected.
Danish: Desuden er der foretaget inspektion af en undersøgelse udført af Micro Therapeutic Research Labs Pvt. Ltd's center i Coimbatore.
English: Data from bioequivalence studies submitted to the Competent Authorities to demonstrate bioequivalence of medicinal products with their originator is considered unreliable.
Danish: Data fra bioækvivalens-undersøgelser, der er indsendt til de kompetente myndigheder som dokumentation for lægemidlers bioækvivalens med originalproduktet, anses for at være upålidelige.
English: The findings of the Austrian and Dutch inspections raise serious concerns relating to the suitability of the quality management system in place at Micro Therapeutics Research LTd, India.
Danish: De østrigske og nederlandske myndigheders fund giver anledning til alvorlige betænkeligheder ved egnetheden af kvalitetssikringssystemet i Micro Therapeutics Research LTd, Indien.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for marketing authorisations and marketing authorisation applications for medicinal products for which the clinical and/or bioanalytical parts of the bioequivalence studies were performed at Micro Therapeutic Research Labs Limited during the period between June 2012 and June 2016;
Danish: • Udvalget har behandlet sagen i henhold til artikel 31 i direktiv 2001/83/EF, for så vidt angår markedsføringstilladelser og ansøgninger om markedsføringstilladelse for lægemidler, hvor de kliniske og/eller bioanalytiske dele af bioækvivalensundersøgelserne er udført af Micro Therapeutic Research Labs Limited mellem juni 2012 og juni 2016.
English: d. Bioequivalence vis-à-vis a valid EU reference medicinal product has been established for marketing authorisation applications listed in Annex Ia of the CHMP Opinion.
Danish: d. Bioækvivalensen med et godkendt EU-referencelægemiddel er fastlagt for de ansøgninger om markedsføringstilladelse, der er anført i bilag IA til CHMP's udtalelse.
English: Grounds for CHMP opinion Whereas,
Danish: Begrundelse for CHMP's udtalelse CHMP's udtalelse er baseret på følgende betragtninger:
English: In view of the critical inspection findings and the necessity to protect public health in the EU, several Member States considered that it is in the interest of the Union to refer the matter to the CHMP and request that it assesses the impact of the findings mentioned above on the benefit-risk balance of the medicinal products which have been authorised by the Member States on the basis of relevant trials performed at these sites between June 2012 and June 2016 and also that of pending marketing authorisation applications (MAA) that include such studies.
Danish: I lyset af de kritisable forhold og behovet for at beskytte den offentlige sundhed i EU har en lang række medlemsstater vurderet, at det er i EU's interesse at indbringe sagen for CHMP, idet de anmoder om, at udvalget vurderer betydningen af fundene for benefit/risk-forholdet for de lægemidler, der er godkendt af medlemsstaterne på basis af undersøgelser, som er udført af disse centre mellem juni 2012 og juni 2016, samt for de verserende ansøgninger om markedsføringstilladelse, der benytter disse undersøgelser.
English: The CHMP therefore recommended the suspension of the marketing authorisations for all remaining medicinal products concerned by this referral procedure, as bioequivalence vis-à-vis the EU reference medicinal products has not been demonstrated.
Danish: CHMP anbefaler derfor suspendering af markedsføringstilladelsen for alle øvrige lægemidler, der er omfattet af denne procedure, da der ikke er påvist bioækvivalens med EU-referencelægemidlerne.
English: • The Committee concluded that the particulars supporting the marketing authorisations and marketing authorisation applications are incorrect and that the benefit-risk balance is considered not favourable for:
Danish: • Udvalget konkluderer, at oplysningerne til understøttelse af markedsføringstilladelserne og ansøgningerne om markedsføringstilladelse ikke er korrekte, og at benefit/risk-forholdet ikke kan betragtes som positivt, hvad angår:
English: For all other marketing authorisation applications subject to this referral the CHMP considers that the applicants did not submit information which allows establishing bioequivalence to the EU reference medicinal product, and therefore the marketing authorisation applications do not currently fulfil the criteria for authorisation.
Danish: For så vidt angår alle andre ansøgninger om markedsføringstilladelse, der er omfattet af denne procedure, finder CHMP, at ansøgerne ikke har fremsendt oplysninger, der gør det muligt at fastslå bioækvivalens med EU-referencelægemidlet, og ansøgningerne om markedsføringstilladelse opfylder derfor ikke aktuelt kriterierne for godkendelse.
English: Therefore, for those products bioequivalence is not established.
Danish: De pågældende lægemidlers bioækvivalens er således ikke påvist.
English: Micro Therapeutic Research Labs Ltd is a contract research organisation (CRO) which conducts the analytical and clinical parts of bioequivalence studies, some of which have been used to support marketing authorisation applications of medicines in the EU.
Danish: Micro Therapeutic Research Labs Ltd er en kontraktforskningsorganisation, der står for den analytiske og kliniske del af bioækvivalensundersøgelser.
English: − Authorised medicinal products for which alternative data or a justification was submitted but considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product;
Danish: − godkendte lægemidler, for hvilke der er fremlagt alternative data eller begrundelser, men hvor CHMP ikke finder disse fyldestgørende til at godtgøre bioækvivalens med EUreferencelægemidlet.
English: For the Hydrokortison Alternova (Orifarm) and Hydrokortison BBS marketing authorisation applications, the CHMP concluded that the Member State(s) will have to consider whether the bridging between the proposed product and the medicinal products described in the literature as par Annex I of Directive 2001/83/EC is sufficiently established as the applications relate to Article 10a of Directive 2001/83/EC (‘Well-established use').
Danish: Hvad angår ansøgningerne om markedsføringstilladelse for Hydrokortison Alternova (Orifarm) og Hydrokortison BBS, har CHMP konkluderet, at de pågældende medlemsstater skal vurdere, hvorvidt forbindelsen mellem det lægemiddel, der søges markedsføringstilladelse for, og de lægemidler, der er beskrevet i litteraturen, jf. bilag I til direktiv 2001/83/EF, er tilstrækkeligt dokumenteret, jf. artikel 10a i direktiv 2001/83/EF ("almindelig anerkendt anvendelse").
English: c. Marketing authorisations for medicinal products for which the bioequivalence vis-à-vis the EU reference medicinal product has been established should be maintained, as the benefit risk balance of these marketing authorisation is considered favourable.
Danish: c. Markedsføringstilladelser for lægemidler, hvis bioækvivalens med EU-referencelægemidlet er påvist, bør fastholdes, da benefit/risk-forholdet for disse lægemidler anses for at være positivt.
English: For these medicinal products considered critical by EU Member State(s), the marketing authorisations holders shall submit a bioequivalence study conducted vis-à-vis the EU Reference Medicinal Product within 12 months from the Commission Decision.
Danish: For lægemidler, der anses for at være kritisk nødvendige af medlemsstaten, skal indehaverne af markedsføringstilladelse fremlægge en undersøgelse af lægemidlets bioækvivalens med EU-referencelægemidlet senest 12 måneder efter Kommissionens beslutning.
English: Where on the basis of these criteria the relevant national competent authorities of the EU Member States consider that a medicinal product is critical, the suspension of the concerned marketing authorisation(s) may be deferred by the period for which the medicinal product is considered critical.
Danish: Når medlemsstatens nationale kompetente myndigheder efter disse kriterier anser et lægemiddel for at være kritisk nødvendigt, kan suspenderingen af de pågældende markedsføringstilladelser udskydes, så længe som lægemidlet anses for at være kritisk nødvendigt.
English: For marketing authorisations of a medicinal product considered critical, the suspension may be deferred in the relevant EU Member States for a period which shall not exceed twenty-four (24) months from the Commission Decision.
Danish: For lægemidler, der anses for kritisk nødvendige, kan suspenderingen af markedsføringstilladelsen i de pågældende medlemsstater udsættes i en periode på højst 24 måneder efter Kommissionens beslutning.
English: For the suspension of the marketing authorisations to be lifted the MAH shall demonstrate bioequivalence data vis-à-vis a valid EU reference medicinal product based on relevant data, in accordance with the requirements of Article 10 of Directive 2001/83/EC (e.g. a bioequivalence study conducted vis-à-vis the EU reference medicinal product).
Danish: For at suspenderingen af en markedsføringstilladelse skal kunne ophæves, skal markedsføringstilladelsesindehaveren kunne påvise bioækvivalens med et godkendt EUreferencelægemiddel baseret på relevante data, jf. bestemmelserne i artikel 10 i direktiv 2001/83/EF (f.eks. en undersøgelse af bioækvivalensen med det pågældende EUreferencelægemiddel).
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP concludes that: a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 116 of Directive 2001/83/EC.
Danish: I overensstemmelse med artikel 31 og 32 i direktiv 2001/83/EF konkluderer CHMP derfor følgende: a. Markedsføringstilladelser for lægemidler, for hvilke der ikke er fremlagt bioækvivalensdata eller begrundelser, eller hvis bioækvivalensdata eller begrundelser af CHMP ikke vurderes at være fyldestgørende til at godtgøre bioækvivalens med EU-referencelægemidlet, bør suspenderes, da oplysningerne til støtte for markedsføringstilladelserne ikke er korrekte, og da benefit/riskforholdet for disse lægemidler derfor ikke kan anses for at være positivt, jf. artikel 116 i direktiv 2001/83/EF.
English: In the absence of the demonstration of bioequivalence vis-à-vis the EU reference medicinal product, the requirements of Article 10 of Directive 2001/83/EC cannot be considered fulfilled, the efficacy and safety of the concerned medicinal products cannot be established, hence the benefit-risk balance cannot be considered positive.
Danish: Som følge af manglende påvisning af bioækvivalens med EU-referencelægemidlet kan kravene i artikel 10 i direktiv 2001/83/EF ikke anses for at være opfyldt, og de pågældende lægemidlers virkning og sikkerhed kan ikke klarlægges.
English: b. Marketing authorisation applications for which data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product do not satisfy the criteria for authorisation, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 26 of Directive 2001/83/EC.
Danish: b. Ansøgninger om markedsføringstilladelse, for hvilke der ikke er fremlagt data eller begrundelser, eller hvis data eller begrundelser af CHMP ikke vurderes at være fyldestgørende til at godtgøre bioækvivalens med EU-referencelægemidlet, opfylder ikke kriterierne for godkendelse, da oplysningerne til støtte for markedsføringstilladelserne ikke er korrekte, og da benefit/risk-forholdet for disse lægemidler derfor ikke kan anses for at være positivt, jf. artikel 26 i direktiv 2001/83/EF.
English: An authorised medicinal product may be considered critical by the EU Member States based on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member States and, as appropriate, the nature of the disease to be treated.
Danish: En medlemsstat kan anse et godkendt lægemiddel for at være kritisk nødvendigt, hvis den vurderer, at der foreligger et uopfyldt medicinsk behov, idet den skal tage højde for tilgængeligheden af andre egnede lægemidler i landet samt, hvis det er relevant, arten af den sygdom, der skal behandles.
English: Critical findings were identified following inspections to check compliance with Good clinical practice (GCP) by the Austrian Federal Office for Safety in Healthcare (BASG) and the Health Care Inspectorate of the Netherlands (IGZ) in February 2016 at Micro Therapeutic Research Labs Pvt. Ltd, Chennai, India.
Danish: På Micro Therapeutic Research Labs Pvt. Ltd, Chennai, Indien, fandt de østrigske sundhedsmyndigheder (BASG) og de nederlandske sundhedsmyndigheder (IGZ) i februar 2016 kritisable forhold under en inspektion vedrørende god klinisk praksis.
English: Some of these authorised medicinal products may be considered critical by the individual EU Member States on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member State(s) and, as appropriate, the nature of the disease to be treated.
Danish: De enkelte medlemsstater kan anse visse af disse lægemidler for at være kritisk nødvendige, hvis de vurderer, at der foreligger et uopfyldt medicinsk behov, idet de skal tage højde for tilgængeligheden af andre egnede lægemidler i landet samt, hvis det er relevant, arten af den sygdom, der skal behandles.
English: Should during this period the EU Member State(s) consider a medicinal product not critical anymore, the suspension of the concerned marketing authorisation shall apply.
Danish: Hvis medlemsstaten i løbet af denne periode ikke længere anser lægemidlet for at være kritisk nødvendigt, træder suspenderingen af den pågældende markedsføringstilladelse i kraft.
English: • The Committee concluded that, for both marketing authorisations and marketing authorisation applications where there was alternative data to establish bioequivalence vis-à-vis the EU reference medicinal product the benefit-risk balance is considered favourable.
Danish: • Med hensyn til markedsføringstilladelser og ansøgninger om markedsføringstilladelse, for hvilke der er fremlagt alternative data, der påviser bioækvivalens med EU-referencelægemidlet, har udvalget konkluderet, at benefit/risk-forholdet kan anses for at være positivt.
English: Bioequivalence (BE) is required for the conclusion that efficacy and safety are similar to those of the reference medicinal product for a medicinal product with a marketing authorisation or marketing authorisation application under Article 10(1) of Directive 2001/83/EC.
Danish: For at kunne konkludere, at et givet lægemiddel, for hvilket der er udstedt markedsføringstilladelse eller indgivet en ansøgning om markedsføringstilladelse, har samme virkning og sikkerhed som referencelægemidlet, skal bioækvivalens med referencelægemidlet kunne påvises, jf. artikel 10, stk. 1, i direktiv 2001/83/EF.
English: Package size
Danish: Indhold Paknings-størrelser
English: Not known (frequency cannot be estimated from the available data):
Danish: Ikke kendte (hyppighed kan ikke estimeres ud fra forhåndenværende data):
English: Ergates Industrial Area, 2643 Nicosia Cyprus
Danish: Ergates Industrial Area, 2643 Nicosia Cypren
English: Once daily.
Danish: En gang dagligt.
English: The tablets should be swallowed with a little water.
Danish: Tabletterne bør synkes sammen med lidt vand.
English: Date of latest renewal: 3rd August 2018
Danish: Dato for seneste fornyelse: 3. august 2018
English: Memantine Accord with food and drink
Danish: Brug af Memantin Accordsammen med mad og drikke
English: The film-coated tablets can be taken with or without food.
Danish: De filmovertrukne tabletter kan tages med eller uden mad.
English: Memantine is eliminated in a monoexponential manner with a terminal t½ of 60-100hours.
Danish: Memantin har en monoeksponentiel elimination med en terminal t½ på 60-100 timer.
English: 1 Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Danish: 1Hallucinationer er hovedsageligt observeret hos patienter med svær Alzheimers sygdom.
English: These compounds act at the same receptor system as memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be more frequent or more pronounced (see also section 4.5).
Danish: Disse forbindelser påvirker det samme receptorsystem som memantin, og derfor kan bivirkninger (hovedsageligt relaterede til centralnervesystemet (CNS)) indtræffe hyppigere og være mere udtalte (se også under punkt 4.5).
English: The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7-9 (see section 4.4).
Danish: Den renale eliminationsrate for memantin kan, under alkaliske urinforhold, reduceres med en faktor på 7-9 (se under punkt 4.4).
English: Some factors that may raise urine pH (see section 5.2 'Elimination') may necessitate careful monitoring of the patient.
Danish: Visse faktorer, der kan forhøje urin-pH (se under punkt 5.2), kan nødvendiggøre omhyggelig monitorering af patienten.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactosemalabsorption should not take this medicinal product.
Danish: Patienter med sjældne arvelige problemer med galactoseintolerans, Lapp lactasemangel eller glucose-galactosemalabsorption bør ikke tage dette lægemiddel.
English: Date of first authorisation: 04 December 2013
Danish: Dato for første markedsføringstilladelse: 04-12-2013
English: If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product.
Danish: Hvis du har fået at vide af lægen, at du ikke tåler visse sukkerarter, skal du kontakte din læge, før du tager dette lægemiddel.
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opdelt efter organklassesystem med følgende betegnelser: Meget almindelig ( 1/10), almindelig ( 1/100 til < 1/10), ikke almindelig ( 1/1.000 til < 1/100), sjælden ( 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Not known Psychotic reactions2
Danish: Psykotiske reaktioner2
English: If you go into hospital, let your doctor know that you are taking Memantine Accord.
Danish: Hvis du kommer på hospitalet, skal du sige til lægen, at du får Memantin Accord.
English: The Memantine Accord treatment initiation pack is only to be used for the beginning of the treatment with Memantine Accord.
Danish: Denne pakke er til den indledende behandling med Memantin Accordog må kun anvendes i begyndelsen af behandlingen med Memantin Accord.
English: Memantine Accord is not recommended for children and adolescents under the age of 18 years.
Danish: Memantin Accord anbefales ikke til børn og unge under 18 år.
English: In general, taking too much Memantine Accord should not result in any harm to you.
Danish: Generelt bør indtagelse af for meget Memantin Accord ikke være skadeligt for dig.
English: The most frequently occurring adverse reactions with a higher incidence in the memantine group than in the placebo group were dizziness (6.3 % vs 5.6 %, respectively), headache (5.2 % vs 3.9 %), constipation (4.6 % vs 2.6 %), somnolence (3.4 % vs 2.2 %) and hypertension (4.1 % vs 2.8 %).
Danish: De bivirkninger, der forekom oftest og med en højere incidens i memantin -gruppen end i placebogruppen, var svimmelhed (hhv. 6,3 % vs. 5,6 %), hovedpine (5,2 % vs. 3,9 %), forstoppelse (4,6 % vs. 2,6 %), sløvhed (søvntrang) (3,4 % vs. 2,2 %) og hypertension (4,1 % vs. 2,8 %).
English: PVC/PE/PVDC-aluminium blister
Danish: PVC/PE/PVDC-aluminiumsblister
English: If you take a large overdose of Memantine Accord, contact your doctor or get medical advice, as you may need medical attention.
Danish: Hvis du tager en stor overdosis af Memantin Accord, skal du søge læge, da du kan have behov for medicinsk behandling.
English: Memantine Accord should be administered once a day and should be taken at the same time every day.
Danish: Memantin Accord bør gives en gang om dagen og bør tages på samme tidspunkt hver dag.
English: Iron oxide yellow and red (E 172)
Danish: Gul og rød jernoxid (E 172)
English: Memantine Accord is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Danish: Memantin Accord bør ikke anvendes til børn under 18 år pga. manglende dokumentation for sikkerhed og virkning.
English: CARTON FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE
Danish: PAKNING TIL 28 TABLETTER - BEHANDLINGSINDLEDENDE PAKNING - 4 UGERS BEHANDLINGSSKEMA
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated 7 patients as memantine-treated patients showed worsening in all three domains (21 % vs. 11 %, p < 0.0001).
Danish: Når patienterne havde fået konstateret en samtidig forværring i alle tre domæner, viste resultaterne en statistisk signifikant effekt af memantin hvad angår forebyggelse af forværring, eftersom dobbelt så mange placebobehandlede 7 patienter som memantinbehandlede patienter frembød forværring i alle tre domæner (21 % vs. 11 %, p< 0,0001).
English: In particular, Memantine Accord may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Danish: I særdeleshed kan Memantin Accord ændre virkningen af følgende medicin, og lægen kan derfor være nødt til at ændre doseringen:
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10-40 mg.
Danish: Studier hos frivillige forsøgspersoner har vist en lineær farmakokinetik i dosisinterval på 10-40 mg.
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine Accord assessed by your doctor on a regular basis.
Danish: I disse situationer bør behandlingen overvåges nøje, og den kliniske gavn af Memantin Accordskal regelmæssigt vurderes af din læge.
English: Very Rare (may affect up to 1 in 10,000 people):
Danish: Meget sjældne (kan påvirke op til 1 ud af 10.000 personer):
English: Additional for 15 mg and 20 mg film-coated tablets Iron oxide yellow and red (E 172)
Danish: Yderligere for 15 og 20 mg filmovertrukne tabletter Gul og rød jernoxid (E 172)