FrancophonIA/ELRC3.0 huggingface dataset:
English: It is supplied in units of 3 pipettes per cardboard card and one or two cards per cardboard box.
Danish: Det fås i pakninger med blisterkort med 3 pipetter og med 1 eller 2 blisterkort pr. æske.
English: In sick or debilitated animals, use only according to the benefit/risk assessment by the responsible veterinarian.
Danish: I tilfælde af syge eller svækkede dyr må præparatet kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af risk-benefit-forholdet.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 160 mg
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box for 1 blister card -Carton box for 2 blister cards
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Papæske med 1 blisterkort - Papæske med 2 blisterkort
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS , IF ANY
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE, OM NØDVENDIGT
English: For optimal control of flea infestation, the veterinary medicinal product can be administered at 4 to 6 week intervals throughout the flea season or the treatment schedule can be based on the local epidemiological situation.
Danish: For at opnå optimal kontrol af loppeangreb skal lægemidlet administreres med 4 til 6 ugers mellemrum gennem hele loppesæsonen.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 320 mg Spot-on for large cats {> 4 kg}
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris 320 mg Spot-on, opløsning til store katte {> 4 kg}
English: If the veterinary medicinal product accidentally gets into eyes, they should be thoroughly flushed with water.
Danish: Hvis præparatet ved et uheld kommer i øjnene, skylles de grundigt med vand.
English: MINIMUM PARTICULARS TO APPEAR ON PIPETTES for small cats
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ PIPETTE til små katte
English: Each unit dose (pipette) of ProMeris delivers:
Danish: Én enkeltdosis (pipette) ProMeris indeholder: Volumen (ml)
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Lægemiddelovervågningssystem
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 160 mg Spot-on for small cats ProMeris 320 mg Spot-on for large cats
Danish: VETERINÆRLÆGEMIDLETS NAVN ProMeris 160 mg Spot-on, opløsning til små katte ProMeris 320 mg Spot-on, opløsning til store katte
English: If the veterinary medicinal product accidentally gets into eyes, flush the eyes thoroughly with water.
Danish: Hvis præparatet ved et uheld kommer i øjnene, skylles grundigt med vand.
English: MINIMUM PARTICULARS TO APPEAR ON PIPETTES for large cats
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ PIPETTE til store katte
English: Manufacturer for the batch release Wyeth Lederle Italia S.p.A. 18, Via Franco Gorgone 95121 Catania
Danish: 18, Via Franco Gorgone 95121 Catania
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 1.60 ml for large cats
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Foliepakning 1.60 ml
English: In sick or debilitated animals use only according to the benefit/risk assessment.
Danish: Må kun anvendes til syge eller svækkede dyr i overensstemmelse med en vurdering af risiko og fordele.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS FOIL 0.80ml for small cats
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Foliepakning 0,80 ml
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Correct application will minimise licking of the application site.
Danish: Ved at påføre præparatet korrekt kan man minimere risikoen for, at dyret slikker sig.
English: In sick or debilitated animals, use only according to the benefit/risk assessment.
Danish: I tilfælde af syge eller svækkede dyr må præparatet kun anvendes efter en vurdering af risk-benefitforholdet.
English: Box of 1 or 2 blister card of 3 x 0.80 ml pipettes Box of 1 or 2 blister card of 3 x 1.60 ml pipettes
Danish: Æske med 1 eller 2 blisterkort á 3 x 0,80 ml pipetter Æske med 1 eller 2 blisterkort á 3 x 1,60 ml pipetter
English: PACKAGE LEAFLET ProMeris Spot-on for cats
Danish: INDLÆGSSEDDEL ProMeris Spot-on, opløsning til katte
English: Box of 1 blister card of 3 x 0.80 ml pipettes Box of 2 blister cards of 3 x 0.80 ml pipettes
Danish: Æske med 1 blisterkort med 3 x 0,80 ml pipetter Æske med 2 blisterkort med 3 x 0,80 ml pipetter
English: Box of 1 blister card of 3 x 1.60 ml pipettes Box of 2 blister cards of 3 x 1.60 ml pipettes
Danish: Æske med 1 blisterkort med 3 x 1,60 ml pipetter Æske med 2 blisterkort med 3 x 1,60 ml pipetter
English: SPECIAL STORAGE PRECAUTIONS Keep out of the reach and sight of children.
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING Opbevares utilgængeligt for børn.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/001 - 1 blister card of 3 pipettes of 0.80 ml EU/2/06/064/002 - 2 blister cards of 3 pipettes of 0.80 ml
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/064/001 - 1 blisterkort af 3 x 0,80 ml pipetter
English: MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/003 - 1 blister card of 3 pipettes of 1.60 ml EU/2/06/064/004 - 2 blister cards of 3 pipettes of 1.60 ml
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/06/064/003 - 1 blisterkort af 3 x 1,60 ml pipetter
English: Apply the content of the pipette to a single spot on the skin of the cat's neck at the base of the skull.
Danish: Del pelsen på kattens nakke, og påfør indholdet på samme sted på huden.
English: Avoid contact with the eyes of the cat and avoid oral ingestion by the animal.
Danish: Undgå at præparatet kommer i kontakt med kattens øjne, eller at katten indtager præparatet.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT ProMeris 160 mg Spot-on for small cats {< 4 kg}
Danish: ProMeris 160 mg Spot-on, opløsning til små katte {≤ 4 kg}
English: 4.9 Amounts to be administered and administration route Dosage:
Danish: 4.9 Dosering og indgivelsesvej
English: Pharmacovigilance system
Danish: VETERINÆRLÆGEMIDLETS NAVN
English: SPECIAL WARNING(S), IF NECESSARY
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
English: Luxembourg Pfizer Animal Health s.a.,
Danish: Pfizer Animal Health s.a., Tél/Tel.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: This veterinary medicinal product is for spot-on application only.
Danish: Må kun udleveres efter veterinærrecept.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary No adverse effects were observed in cats aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Må ikke administreres til killinger under 8 uger.
English: PHARMACEUTICAL FORM Spot-on solution A clear, yellow to amber solution
Danish: Klar gullig til brunlig opløsning.
English: ProMeris for Small Cats (≤ 4 kg)*
Danish: (≤ 4 kg)*
English: Each ml contains 200 mg metaflumizone.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Aktivt stof: Én ml indeholder 200 mg metaflumizon.
English: In view of the elements described above, BfArM considered that there was a need to take action at EU level.
Danish: I lyset af de ovenfor beskrevne elementer fandt BfArM, at der var et behov for at rejse denne sag på EU-niveau.
English: This was neither avoided nor detected by the quality management system, which was in place at the site during this time period.
Danish: Dette blev hverken undgået eller påvist af kvalitetskontrolsystemet, hvilket var på plads på stedet under denne tidsperiode.
English: Three bioequivalence trials, two performed in 2013 and one performed in 2014, were inspected.
Danish: Tre bioækvivalensforsøg, to udført i 2013 og ét udført i 2014, blev inspiceret.
English: It has been highlighted that all the CAPAs agreed after the BfArM/IGZ inspection have been either implemented (for critical observations) or committed to (for other observations).
Danish: Det er blevet fremhævet, at alle CAPA'er var i overensstemmelse, efter BfArM/IGZ-inspektionen enten er blevet implementeret (for kritiske observationer) eller indledt (for andre observationer).
English: Riluzole
Danish: Riluzol
English: A later MHRA inspection (March 2016) has also resulted in one critical and 2 major observations, for which CAPAs have already been agreed with the inspectors.
Danish: En senere MHRA-inspektion (marts 2016) resulterede også i én kritisk og to større observationer, for hvilke der allerede er opnået enighed om CAPA'er med inspektørerne.
English: Cefuroxime
Danish: Cefuroxim
English: There was one general quality management system implemented at the site which included a quality assurance unit which was responsible for the clinical and the bioanalytical parts of the trial and which reported to the CEO of the facility.
Danish: Der var et enkelt generelt kvalitetskontrolsystem på stedet, som inkluderede en kvalitetssikringsenhed, der var ansvarlig for de kliniske og de bioanalytiske dele af forsøget, og som rapporterede til den administrerende direktør for faciliteten.
English: Intentional misrepresentation of data happened at the site in two different trials performed in 2013 and 2014.
Danish: Der forekom tilsigtet datamanipulation på stedet i to forskellige forsøg, der blev udført i 2013 og 2014.
English: The CHMP considered these data, however a conclusion on bioequivalence cannot be drawn from a simple comparison of dissolution profiles.
Danish: CHMP overvejede disse data, men en konklusion om bioækvivalens kan dog ikke drages på grundlag af en enkel sammenligning af opløsningsprofiler.
English: The findings of the above mentioned inspection cast doubts on the reliability of the data of bioequivalence studies conducted between 2013 and 2014 at the site inspected.
Danish: Resultaterne af ovenstående inspektion rejser tvivl om pålideligheden af bioækvivalensundersøgelserne, der blev udført mellem 2013 og 2014 på det inspicerede sted.
English: • The Committee reviewed all available data and information provided by the MAHs/applicants, as well as information provided by Alkem Laboratories;
Danish: • Udvalget gennemgik alle foreliggende data og oplysninger fra indehaverne af markedsføringstilladelsen/ansøgerne samt oplysninger fra Alkem Laboratories.
English: However, the CHMP is of the opinion that the absence of the identification of any pharmacovigilance signals does not provide sufficient reassurance because it is not established that the pharmacovigilance activities may be designed to detect such a signal.
Danish: Det er imidlertid CHMP's opfattelse, at manglende konstatering af lægemiddelovervågningssignaler ikke giver tilstrækkelig sikkerhed, da lægemiddelovervågningen ikke er påvist at være tilrettelagt, således at et sådant signal detekteres.
English: The conditions imposed to lift the suspension of the marketing authorisation are set out in section 4 of this report.
Danish: Betingelserne for ophævelse af suspenderingen af markedsføringstilladelsen fremgår af afsnit 4 i denne rapport.
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 Alkem Laboratories Limited during the period between March 2013 and March 2015;
Danish: • Udvalget fulgte proceduren i henhold til artikel 31 i direktiv 2001/83/EF for markedsføringstilladelser og ansøgninger om markedsføringstilladelser for lægemidler, for hvilke de kliniske og/eller bioanalytiske dele af bioækvivalensundersøgelserne blev udført på Alkem Laboratories Limited i løbet af perioden mellem marts 2013 og marts 2015.
English: The CHMP therefore recommends the suspension of the marketing authorisation for Riluzole Alkem.
Danish: CHMP anbefaler derfor, at markedsføringstilladelsen for Riluzol Alkem suspenderes.
English: Therefore BfArM considered that this affects the trustworthiness of the data generated by the site (clinical and bioanalytical) in the time period from the beginning of the first study in March 2013 until the date when the inspection took place in March 2015, as it must be assumed that critical deficiencies could not be detected by the quality management system at the site in the meantime, because corrective actions and preventive actions (CAPAs) were only implemented after the inspection.
Danish: BfArM fandt derfor, at dette påvirker pålideligheden af dataene genereret af det inspicerede sted (kliniske og bioanalytiske) i tidsperioden fra begyndelsen af den første undersøgelse i marts 2013 og indtil datoen, hvor inspektionen fandt sted i marts 2015, da det kan antages, at kritiske mangler ikke blev påvist af kvalitetskontrolsystemet på stedet i løbet af denne tidsperiode, fordi korrigerende og forbyggende handlinger (CAPA'er) først blev implementeret efter inspektionen.
English: Although Alkem agreed to the CAPAs and committed to implement them following the joint GCP inspection in March 2015, the fact that a second inspection in March 2016 by the MHRA identified critical/major findings during the period of concern further demonstrates that the quality management system in place during the period concerned by the procedure was suboptimal.
Danish: Selvom Alkem indvilgede i CAPA'erne og forpligtede sig til at implementere dem efter den fælles GCP-inspektion i marts 2015, viser den kendsgerning, at endnu en inspektion i marts 2016 foretaget af MHRA identificerede kritiske/større fund i løbet af problemperioden, at det eksisterende kvalitetskontrolsystem i løbet af perioden, der var berørt af proceduren, var suboptimal.
English: On 8 March 2016 the BfArM initiated a referral under Article 31 of Directive 2001/83/EC, and asked the CHMP to assess the potential impact of the above findings on the benefit-risk balance of marketing authorisation applications and medicinal products authorised on the basis of relevant trials performed at the inspected site between March 2013-March 2015, and issue a recommendation on whether the marketing authorisations should be maintained, varied, suspended or revoked.
Danish: BfArM indledte den 8. marts 2016 en indbringelsesprocedure i henhold til artikel 31 i direktiv 2001/83/EF, og anmodede CHMP om at vurdere de mulige konsekvenser af ovenstående inspektionsresultater for benefit/risk-forholdet for ansøgninger om markedsføringstilladelse og lægemidler, der er godkendt på grundlag af relevante forsøg, der blev udført på det inspicerede sted mellem marts 2013 og marts 2015, samt udstede en anbefaling om opretholdelse, ændring, suspendering eller ophævelse af disse markedsføringstilladelser.
English: • The Committee concluded that the particulars supporting the marketing authorisation/marketing authorisation application are incorrect and that the benefit-risk balance is considered not favourable for:
Danish: • Udvalget konkluderede, at oplysningerne til dokumentation af markedsføringstilladelsen/ansøgningen om markedsføringstilladelsen er urigtige, og at benefit/riskforholdet ikke er positivt for:
English: In view of the inspection findings and the conclusion that there was a failure of the overall quality management system in place at the site, even of the ECG data for this particular study has no abnormalities, severe failures in other parts of the trial could not be excluded and all the data generated by the site during the period from March 2013 to March 2015 cannot be relied upon.
Danish: I lyset af inspektionsresultaterne og konklusionen, at der var en mangel i det generelle kvalitetskontrolsystem på det inspicerede sted, også selv om der ikke var uregelmæssigheder i EKG-dataene for denne specifikke undersøgelse, kunne alvorlige mangler i andre dele af forsøget ikke udelukkes, og alle data genereret af det inspicerede sted i løbet af perioden fra marts 2013 til marts 2015 er ikke troværdige.
English: − Marketing authorisation applications for which no alternative bioequivalence data or a justification was submitted (annex IB).
Danish: − Ansøgninger om markedsføringstilladelser for hvilke ingen alternative bioækvivalensdata eller begrundelse blev forelagt (bilag IB).
English: • The Committee concluded that, for both marketing authorisations and marketing authorisation applications referred to in annex IA, there was alternative data to establish bioequivalence vis-àvis the EU reference medicinal product.
Danish: • Udvalget konkluderede, at for både markedsføringstilladelser og ansøgninger om markedsføringstilladelser i bilag IA var der alternative data til godtgørelse af bioækvivalens med EU-referencelægemidlet.
English: d. Bioequivalence vis-à-vis the EU reference medicinal product has been established for marketing authorisation applications listed in annex IA.
Danish: d. Bioækvivalensen med EU-referencelægemidlet er fastlagt for ansøgninger om markedsføringstilladelser i bilag IA.
English: The MAH also submitted an expert report with a reassessment of the original bioequivalence study performed by Alkem, concluding that no abnormalities were observed with the ECG data.
Danish: Indehaveren af markedsføringstilladelsen indsendte også en ekspertrapport med en ny vurdering af den oprindelige bioækvivalensundersøgelse udført af Alkem, som konkluderede, at der ikke blev observeret nogen uregelmæssigheder med EKG-dataene.
English: Where the bioequivalence is not established, safety and efficacy cannot be extrapolated from the EU reference medicinal product to the generic medicinal product as the bioavailability of the active substance between the two medicinal products may differ.
Danish: På grund af manglende påvisning af bioækvivalens kan sikkerheden og virkningen således ikke ekstrapoleres fra EU-referencelægemidlet til det generiske lægemiddel, da der kan være forskel på biotilgængeligheden af det aktive stof mellem de to lægemidler.
English: For cefuroxime-containing products affected by this review (Cefuroxime Alkem, Cefuroxime Krka and Cefuroxime Ingen Pharma), bioequivalence to the EU reference medicinal product was established based on an alternative bioequivalence study conducted at a different facility (study 0258-16, Lambda therapeutic Research Inc.).
Danish: For cefuroxim-indeholdende lægemidler berørt af denne gennemgang (Cefuroxim Alkem, Cefuroxim Krka og Cefuroxim Ingen Pharma) blev bioækvivalensen med EU-referencelægemidlet fastlagt på grundlag af en alternativ bioækvivalensundersøgelse foretaget på en anden facilitet (undersøgelse 0258-16, Lambda therapeutic Research Inc.).
English: Having assessed the alternative study, the CHMP considered that it supports bioequivalence of these medicinal products to the reference medicinal product Zinnat.
Danish: Efter vurdering af den alternative undersøgelse fandt CHMP, at den understøtter bioækvivalensen for disse lægemidler med lægemidlet Zinnat.
English: Grounds for CHMP opinion
Danish: Begrundelse for CHMP's udtalelse Ud fra følgende betragtninger:
English: Marketing authorisation holders (MAHs) have argued that pharmacovigilance data collected on their medicinal products have not indicated any problems which could be attributed to non-bioequivalence, such as reduced efficacy or worsened safety and tolerability.
Danish: En række indehavere af markedsføringstilladelse har desuden gjort gældende, at lægemiddelovervågningsdata for deres lægemidler ikke har tydet på problemer, der kan tilskrives manglende bioækvivalens, såsom nedsat virkning eller forringet sikkerhed og tolerabilitet.
English: As regards the marketing authorisation application for Ibuprofen Orion, the CHMP considers that the applicant did not establish bioequivalence to the EU reference medicinal product and therefore the marketing authorisation application does not currently fulfil the criteria for authorisation.
Danish: Med hensyn til ansøgningen om markedsføringstilladelse for Ibuprofen Orion finder CHMP, at ansøgeren ikke fastlagde bioækvivalens med EU-referencelægemidlet, og ansøgningen om markedsføringstilladelse opfylder derfor ikke aktuelt kriterierne for godkendelse.
English: The applicant for the ibuprofen-containing medicinal product affected by the review (Ibuprofen Orion) did not submit alternative data to establish bioequivalence vis-à-vis an EU reference medicinal product.
Danish: Ansøgeren for lægemidlet indeholdende ibuprofen, der er berørt af denne gennemgang (Ibuprofen Orion), fremlagde ikke alternative data til fastlæggelse af bioækvivalens med et EUreferencelægemiddel.
English: The Federal Institute of Drugs and Medical Devices (BfArM), Germany, and the Health Care Inspectorate (IGZ), Ministry of Health of the Netherlands performed a joint GCP inspection from 9 - 12 March 2015 at Alkem Laboratories Limited, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410 208, India (Inspection references: BfArM: 2015 03 D / 2015_05_D, NL: VGR-1005124).
Danish: - 12. marts 2015 på Alkem Laboratories Limited, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410 208, Indien (Inspektionsreferencer: BfArM: 2015 03 D / 2015_05_D, NL: VGR1005124).
English: Alternative data were submitted to demonstrate the bioequivalence of Cefuroxime Alkem, Cefuroxime Krka and Cefuroxime Ingen Pharma to an EU reference medicinal product.
Danish: Alternative data blev indsendt til påvisning af bioækvivalensen for Cefuroxim Alkem, Cefuroxim Krka og Cefuroxim Ingen Pharma med et EU-referencelægemiddel.
English: Therefore CHMP concluded that bioequivalence to the EU reference medicinal product is not established for Riluzole Alkem.
Danish: CHMP konkluderede derfor, at bioækvivalens med EU-referencelægemidlet ikke er fastlagt for Riluzol Alkem.
English: The condition for the lifting of the suspension of the Marketing Authorisations, as applicable, is set out in Annex III.
Danish: Betingelsen for ophævelse af suspenderingen af de pågældende markedsføringstilladelser fremgår af bilag III.
English: The arguments of the MAH were considered, including the results of the studies with the US and Australian originator medicines, the data submitted do not address the requirement to demonstrate bioequivalence vis-à-vis an EU reference medicinal product as required by Article 10 of Directive 2001/83/EC.
Danish: Argumenterne fra indehaveren af markedsføringstilladelsen blev overvejet, herunder resultaterne af undersøgelsen med de oprindelige lægemidler fra USA og Australien, men de indsendte data forholder sig ikke til kravet om påvisning af bioækvivalens med et EU-referencelægemiddel i henhold til bestemmelserne i artikel 10 i direktiv 2001/83/EF.
English: If the bioavailability of the generic product is lower than the bioavailability of the reference medicinal product, this may result in a lower than intended exposure to the active substance, leading potentially to a decrease in efficacy, a delay or even a lack of therapeutic effect.
Danish: Hvis lægemidlet havde lavere biotilgængelighed end referencelægemidlet, ville det medføre lavere eksponering af patienterne for det aktive stof end tilsigtet, hvilket potentielt kunne føre til ringere virkning og forsinket eller endog manglende terapeutisk virkning.
English: The data generated at the site can therefore not be relied upon to establish bioequivalence of products to the EU reference medicinal product.
Danish: De genererede data på stedet kan derfor ikke med pålidelighed fastlægge bioækvivalens for lægemidler med EU-referencelægemidlet.