natgillin/translations-raw huggingface dataset:
In addition, the genome carries an exact duplicate of the modified immune-relevant Gprotein (glycoprotein) gene, which results in the significant higher expression of the G protein gene.
Genom je prav tako nosilec natančnega duplikata modificiranega gena imunorelevantnega G-proteina (glikoproteina), kar povzroči močno povečano izraženost gena G-proteina.
Plastic foil sleeves or bags in cardboard boxes of:
Plastične cevaste folije ali vreče v kartonastih škatlah po:
Aerial distribution of the baits by any suitable flight devices (such as airplane, helicopter, drones or similar) is recommended for open or sparsely populated areas, and manual distribution in areas with a high human population.
Polaganje vab iz zraka s primernim zrakoplovom (na primer letalom, helikopterjem, brezpilotnimi letali ali podobno) se priporoča za odprta, redko poseljena območja, na območjih z gosto obljudenostjo pa se priporoča ročno polaganje.
Name and address of the manufacturer responsible for batch release IDT Biologika GmbH
Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij IDT Biologika GmbH
In case of contact of the vaccine fluid, immediately remove it by thoroughly rinsing with water and soap.
V primeru stika s tekočino cepiva jih takoj odstranite in začnite temeljito spiranje z milnico.
The active ingredient is a quadruple highly attenuated genetically modified rabies virus construct, derived from the SAD B19 vaccine strain.
Učinkovina je štirikratno močno oslabljen, gensko modificiran konstrukt virusa stekline, izpeljan iz seva cepiva SAD B19.
Rabitec is used for the induction of the protective immunity in foxes and raccoon dogs by the oral route characterised by the induction of rabies virus specific (neutralising) antibodies induced primarily by the G-protein (glycoprotein).
Zdravilo Rabitec se uporablja za indukcijo zaščitne imunitete pri lisicah in rakunastih psih po peroralni poti, za katero je značilna indukcija za virus stekline specifičnih (nevtralizirajočih) protiteles, ki jih primarno inducira G-protein (glikoprotein).
For the active immunization of foxes and raccoon dogs against rabies to prevent infection and mortality.
Za aktivno imunizacijo lisic in rakunastih psov, da se prepreči okužba z virusom stekline in smrtnost.
Dispose of waste material in accordance with local requirements.
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Odpadne snovi odstranite v skladu z lokalnimi zahtevami.
Baits are packed in plastic foil sleeves or bags in cardboard boxes of:
Vabe so pakirane v plastične cevaste folije ali vreče v kartonastih škatlah po:
Foxes, raccoon dogs
Lisice, rakunasti psi
Since this vaccine has been prepared with live, attenuated microorganisms, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process.
Ker je bilo cepivo izdelano iz živih oslabljenih mikroorganizmov, so potrebni ustrezni ukrepi, da bi preprečili okužbo osebe, ki pride v stik s cepivom ter drugih oseb, ki sodelujejo pri cepljenju.
Vaccine baits are not intended for vaccination of domestic animals.
Posebni previdnostni ukrepi za uporabo pri živalih: Vabe s cepivom niso namenjene cepljenju domačih živali.
Liquid vaccine contained in a polymer/aluminium blisters which are embedded in a bait matrix attractive for the target species.
Tekoče cepivo v pretisnih omotih iz polimera/aluminija, ki so vdelani v matriko z vabo, privlačno za ciljne vrste.
The vaccine suspension is filled in polymer/aluminium blisters which are embedded in a bait matrix attractive for the target species.
Suspenzija cepiva je napolnjena v pretisne omote iz polimera/aluminija, ki so vdelani v matriko z vabo, privlačno za ciljne vrste.
Pharmacotherapeutic group: Immunologicals for canidae, live viral vaccines.
Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae), živa virusna cepiva Oznaka ATC vet:
SPECIAL STORAGE CONDITIONS Store and transport frozen.
Shranjujte in prevažajte zamrznjeno.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/Aluminium blister
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU Pretisni omot PVC/aluminija
The baits are rectangular, brown coloured and have an intensive smell.
Vaba je pravokotne oblike, rjavkaste barve in intenzivnega vonja.
The thawed vaccine may be stored for up to 7 days at 2 °C - 8 °C before use; however baits for which the cooling chain was disrupted, because they were not stored in a refrigerator, should be destroyed.
Odmrznjene vabe s cepivom lahko shranjujete do 7 dni pri temperaturi od 2 °C - 8 °C pred uporabo, vendar pa je treba vabe, pri katerih je bila hladilna veriga prekinjena, uničiti, saj niso bile shranjene v hladilniku.
The suspension has a yellow colour in a frozen state and a reddish colour in the liquid state.
Zamrznjena suspenzija je rumene barve, tekoča suspenzija pa rdečkaste barve.
The thawed vaccine bait may be stored for 7 days between 2 °C- 8 °C before use; however baits for which the cooling chain was disrupted, because they were not stored in a refrigerator, should be destroyed.
Odmrznjene vabe s cepivom lahko shranjujete 7 dni pri temperaturi od 2 °C - 8 °C pred uporabo, vendar pa je treba vabe, pri katerih je bila hladilna veriga prekinjena, uničiti, saj niso bile shranjene v hladilniku.
Oxytetracycline hydrochloride (may be added as biomarker if requested by authorities)
Vaba: ribja moka palmova mast kokosova mast parafin oksitetraciklinijev klorid (lahko se doda kot biooznačevalec, če organ tako zahteva)
Rabitec is a live modified rabies vaccine for oral administration to foxes and raccoon dogs.
Zdravilo Rabitec je živo modificirano cepivo proti steklini za peroralno dajanje lisicam in rakunastim psom.
Gastrointestinal signs (potentially due to the indigestible blister material) have been reported in dogs following accidental ingestion of the bait.
Pri psih, ki so nenamerno zaužili vabo, so poročali o prebavnih znakih (morebiti zaradi neprebavljivega materiala pretisnega omota).
SPECIAL WARNING(S), IF NECESSARY
POSEBNO(A) OPOZORILO(A), ČE JE/SO POTREBNO(A) Z vabami ravnajte previdno.
Attenuated live rabies vaccine virus, strain SPBN GASGAS 106.8 FFU*/dose - 108.1 FFU*/dose (* Focus Forming Units)
NAVEDBA UČINKOVIN(E) Učinkovina: Oslabljen živ virus cepiva proti steklini, sev SPBN GASGAS FFU*/odmerek - 10
NAME OF THE MARKETING AUTHORISATION HOLDER IDT Biologika, Germany
IDT Biologika, Nemčija
It is recommended to wear disposable rubber gloves when handling and distributing baits.
Med ravnanjem z vabo in polaganjem se priporoča uporaba gumijastih rokavic za enkratno uporabo.
MINIMUM PARTICULARS TO APPEAR ON BAITS
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI VABI
PACKAGE LEAFLET Rabitec oral suspension, for foxes and raccoon dogs
Rabitec peroralna suspenzija za lisice in rakunaste pse
Attenuated live rabies vaccine virus, strain SPBN GASGAS: 106.8 FFU* - 108.1 FFU* (* Focus Forming Units)
Oslabljen živ virus cepiva proti steklini, sev SPBN GASGAS: 10
NAME OF THE VETERINARY MEDICINAL PRODUCT Rabitec oral suspension for foxes and raccoon dogs
NAVODILO ZA UPORABO Rabitec peroralna suspenzija za lisice in rakunste pse
Vaccine:
ZDRAVILA
Baits should be distributed immediately after thawing.
Odmrznjene vabe položite takoj.
Oral use blister (PCTFE/PVC/alu) 28 capsules
Thalidomide Celgene 50 mg Trda kapsula Peroralna uporaba Pretisni omot (PCTFE/PVC/aluminij)
MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/08/443/001 Thalidomide Celgene 50 mg Capsule, hard
(Izmišljeno) ime Jakost Farmacevtska oblika
The standard dose of Clopidogrel Sandoz is one 75 mg tablet once a day, taken with or without food.
Običajni odmerek zdravila Clopidogrel Sandoz je ena 75-miligramska tableta enkrat na dan, vzeta s hrano ali brez nje.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Sandoz to Acino Pharma GmbH on 21 september 2009.
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel Sandoz, veljavno po vsej Evropski uniji, odobrila družbi Acino Pharma GmbH dne 21. septembra 2009.
This means that Clopidogrel Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
To pomeni, da je zdravilo Clopidogrel Sandoz podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
Clopidogrel Sandoz is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Zdravilo Clopidogrel Sandoz se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
Clopidogrel Sandoz can be given to the following groups of patients:
Zdravilo Clopidogrel Sandoz se lahko daje naslednjim skupinam bolnikov:
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Sandoz has been shown to have comparable quality and to be bioequivalent to Plavix.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel Sandoz primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
Because Clopidogrel Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Ker je zdravilo Clopidogrel Sandoz generično zdravilo in je biološko enakovredno referenčnemu zdravilu, velja, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Other information about Clopidogrel Sandoz:
Druge informacije o zdravilu Clopidogrel Sandoz:
Clopidogrel Sandoz can be started between a few days and 35 days after the attack;
Zdravilo Clopidogrel Sandoz se lahko začne jemati od nekaj dni po napadu do 35 dni po njem;
Clopidogrel Sandoz clopidogrel EPAR summary for the public
Clopidogrel Sandoz klopidogrel Povzetek EPAR za javnost
Clopidogrel Sandoz is a ‘generic medicine'.
Clopidogrel Sandoz je „generično zdravilo“.
The Committee recommended that Clopidogrel Sandoz be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Clopidogrel Sandoz odobri dovoljenje za promet.
Because Clopidogrel Sandoz is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Ker je zdravilo Clopidogrel Sandoz generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
What are the benefit and risk of Clopidogrel Sandoz?
Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel Sandoz?
Clopidogrel Sandoz can be started between seven days and six months after the
Zdravilo Clopidogrel Sandoz se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
Clopidogrel Sandoz is a medicine that contains the active substance clopidogrel.
Clopidogrel Sandoz je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The active substance in Clopidogrel Sandoz, clopidogrel, is an inhibitor of platelet aggregation.
Zdravilna učinkovina v zdravilu Clopidogrel Sandoz, klopidogrel, je zaviralec agregacije trombocitov.
The full EPAR for Clopidogrel Sandoz can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel Sandoz je na voljo tukaj.
Why has Clopidogrel Sandoz been approved?
Zakaj je bilo zdravilo Clopidogrel Sandoz odobreno?
How has Clopidogrel Sandoz been studied?
Kako je bilo zdravilo Clopidogrel Sandoz raziskano?
What is Clopidogrel Sandoz used for?
Za kaj se zdravilo Clopidogrel Sandoz uporablja?
What is Clopidogrel Sandoz?
Kaj je zdravilo Clopidogrel Sandoz?
How does Clopidogrel Sandoz work?
Kako zdravilo Clopidogrel Sandoz deluje?
How is Clopidogrel Sandoz used?
Kako se zdravilo Clopidogrel Sandoz uporablja?
5 were from Canada and 5 from the USA, with no reports coming from Europe.
Pet jih je bilo iz Kanade in pet iz ZDA, medtem ko iz Evrope ni bilo nobenega poročila.
The dissolution testing data submitted was not considered complete as it was performed with a surfactant and only done in water and was therefore considered to be only of limited value.
Predloženi podatki o testiranju raztapljanja niso bili popolni, saj je bilo opravljeno s surfaktantom in samo v vodi, zato se šteje, da ima samo omejeno vrednost.
All three facilities became part of Cetero Research.
Vsi trije centri so postali del ustanove Cetero Research.
The studies had a cross-over design with 2 weeks wash-out in between the study periods.
Študije so imele navzkrižni načrt z 2-tedenskim izplavljanjem med študijami.
In all 4 studies, the 90% confidence intervals for AUC0-72 and Cmax were within the 80% to 125% limits.
V vseh 4 študijah so bili 90-odstotni intervali zaupanja za AUC0-72 in Cmax znotraj 80- do 125-odstotnih omejitev.
Overall summary of the scientific evaluation of Leflunomide Apotex (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Leflunomide Apotex (glejte Prilogo I)
However, according to the new bioequivalence guideline, such studies should be performed without the addition of surfactants and in media pH 1.2, 4.5, 6.8 and with the quality control method.
Skladno z novo smernico za biološke enakovrednosti je treba take študije opraviti brez dodajanja surfaktantov, v mediju s pH 1,2, 4,5, 6,8 in z metodo kontrole kakovosti.
It is used in the treatment of adults with active moderate to severe rheumatoid arthritis and psoriatic arthritis.
Uporablja se za zdravljenje odraslih z aktivnim zmernim do hudim revmatoidnim artritisom in psoriaznim artritisom.
The CHMP noted that such dissolution results were not provided.
Odbor CHMP je ugotovil, da taki rezultati za raztapljanje niso bili predloženi.
• The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Leflunomide Apotex and associated names.
• Odbor je obravnaval postopek v skladu s členom 31 Direktive 2001/83/ES za zdravilo Leflunomide Apotex in povezana imena.
The CHMP agreed that the generic formulation is qualitative and quantitatively the same for the markets referred to and that the products are manufactured in the same manufacturing site, via the same manufacturing process.
Odbor CHMP se je strinjal, da je generična formulacija kakovostno in količinsko enaka na navedenih trgih ter da se izdelki izdelujejo v istem proizvodnem obratu po istem proizvodnem postopku.
The clinical phase of the study was performed in January and February 2006 at Gateway Medical Research Inc. in St. Charles (USA) while the analytical phase was performed at BA Research International LP in Houston (USA) and the statistical phase was performed at BA Research International LP in Austin (USA) in February and March 2006.
Klinična faza študije je bila opravljena januarja in februarja 2006 v centru Gateway Medical Research Inc. v St. Charlesu (ZDA), medtem ko je bila analitična faza opravljena v centru BA Research International LP v Houstonu (ZDA), statistična faza pa v centru BA Research International LP v Austinu (ZDA) februarja in marca 2006.
The studies with the US and Canadian products were performed by Apotex Research Inc., Toronto, Canada.
Študije z zdravili iz ZDA in Kanade je opravila ustanova Apotex Research Inc., Toronto, Kanada.
The AUC, Cmax and Tmax of the US and Canadian fasting studies were comparable to the values obtained in the European study, which was also performed in fasting state.
Vrednosti AUC, Cmax in Tmax v študijah na tešče v ZDA in Kanadi so bile primerljive z vrednostmi, ki so jih pridobili v evropski študiji, ki je bila prav tako opravljena na tešče.
In addition, all Leflunomide Apotex products for these markets are manufactured at the same manufacturing site, Apotex Inc., Toronto (Canada), according to the same manufacturing process.
Poleg tega so vsa zdravila Leflunomide Apotex za te trge izdelana v istem proizvodnem obratu, Apotex Inc., Toronto (Kanada), po istem proizvodnem postopku.
For ten of these cases, the potential involvement of Leflunomide Apotex was ruled out.
Pri desetih od teh primerov je bila izključena morebitna vpletenost zdravila Leflunomide Apotex.
The CHMP also noted that due to the lack of availability of samples, it was not possible to reanalyse the samples from the clinical study in order to check the validity of the original findings.
Odbor CHMP je prav tako ugotovil, da zaradi pomanjkljive razpoložljivosti vzorcev ni bilo mogoče ponovno analizirati vzorcev iz klinične študije, da bi se tako preverila veljavnost izvirnih ugotovitev.
Based on the available safety data, the CHMP was therefore of the view that no signal of lack of efficacy was identified.
Na podlagi razpoložljivih varnostnih podatkov je odbor CHMP menil, da ni bila ugotovljena nobena težava z odsotnostjo učinkovitosti.
The CHMP also noted the safety assessment carried out by the MAH but carried out a separate search of EudraVigilance, identifying 14 cases of lack of efficacy specifically for generic products.
Odbor CHMP je prav tako upošteval varnostno oceno, ki jo je opravil imetnik dovoljenja za promet z zdravilom, vendar je izvedel ločeno iskanje v zbirki EudraVigilance, pri čemer je odkril 14 primerov z odsotnostjo učinkovitosti, predvsem pri generičnih zdravilih.
According to the bioequivalence guideline, dissolution studies to compare the proposed product with the reference product can be submitted as supportive of the results of bioequivalence studies, to evaluate whether there may still be differences between the formulations that might be relevant for efficacy and safety.
Skladno s smernico za biološko enakovrednost se lahko študije raztapljanja, v katerih se primerja predlagano zdravilo z referenčnim zdravilom, predložijo kot podpora rezultatom študij biološke enakovrednosti, da se oceni, ali še vedno obstajajo razlike med formulacijami, ki so lahko pomembne za učinkovitost in varnost.
Of the four remaining cases potentially attributable to Leflunomide Apotex, two involved arthralgia and swollen joints not related to rheumatoid arthritis (RA) while one was confounded by the concomitant use of other drugs while the last suggested concomitant use of TNF-alpha inhibitors.
Od preostalih štirih primerov, ki so morebitno povezani z zdravilom Leflunomide Apotex, sta dva vključevala artralgijo in otekle sklepe, ki niso bili povezani z revmatoidnim artritisom (RA), enega je povzročila sočasna uporaba drugih zdravil, zadnji primer pa kaže povezavo s sočasno uporabo zaviralcev TNF-alfa.
The Committee, as a consequence, recommended the suspension of the marketing authorisations for Leflunomide Apotex and associated names, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
je odbor priporočil začasen umik dovoljenj za promet z zdravilom Leflunomide Apotex in povezanimi imeni v skladu s členom 116 Direktive 2001/83/ES, ker a. razmerje med tveganji in koristmi ni pozitivno ter b. podatki, ki naj bi podprli vlogo v skladu s členom 10 Direktive 2001/83/ES, niso pravilni.
The CHMP also noted the PSUR data, which did not indicate any safety concerns; however this is insufficient to confirm the bioequivalence of the product.
Odbor CHMP je pregledal tudi podatke v poročilu PSUR, ki niso kazali na nobene varnostne težave, vendar to ni bilo zadostno za potrditev biološke enakovrednosti zdravila.
Leflunomide Apotex contains leflunomide, a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous.
Zdravilo Leflunomide Apotex vsebuje leflunomid, zaviralec sinteze pirimidina, ki spada v skupino imunomodulirajočih protirevmatičnih zdravil (DMARD), ki je kemijsko in farmakološko zelo heterogena.
The fact that the qualitative compositions of the EU and non-EU Leflunomide Apotex products are fully identical and that the products are manufactured at the same manufacturing facility via the same manufacturing process can only be considered as supportive evidence.
Dejstvo, da je kakovostna sestava zdravil Leflunomide Apotex popolnoma enaka znotraj EU in zunaj nje ter da se zdravila izdelujejo v istem proizvodnem obratu po istem proizvodnem postopku, se lahko obravnava samo kot podporni dokaz.
The CHMP noted the data from the bioequivalence studies performed with the US and Canadian product and identified some minor protocol violations.
Odbor CHMP je upošteval podatke iz študij biološke enakovrednosti, opravljenih z zdravilom iz ZDA in Kanade, ter odkril nekaj manjših kršitev protokola.
It is therefore plausible that the same quality active substance and excipients are used, although these bioequivalence studies were conducted using different sources of the reference product and no evidence was presented to confirm whether the reference product is indeed the same in all the studies.
Zato je mogoče, da se uporabljajo zdravilne učinkovine in pomožne snovi enake kakovosti, čeprav so se te študije biološke enakovrednosti opravile z različnimi viri referenčnega zdravila in niso bili predstavljeni nobeni dokazi, ki bi potrdili, da je referenčno zdravilo dejansko enako v vseh študijah.
The MAH stated that plasma samples are no longer available and that there is therefore no possibility to reanalyse the data.
Imetnik dovoljenja za promet z zdravilom je navedel, da vzorci plazme niso več na voljo in da zaradi tega ni bilo mogoče ponovno analizirati podatkov.
Leflunomide Apotex is available as 10 mg and 20 mg tablets.
Zdravilo Leflunomide Apotex je na voljo v obliki 10- in 20-miligramskih tablet.
Regarding the safety profile of Leflunomide Apotex, the MAH performed a search for lack of effect / drug ineffectiveness in all case reports for leflunomide in the MAH's global pharmacovigilance database, from the date of first authorization of Leflunomide Apotex (08 September 2004) to 08
Glede varnostnega profila zdravila Leflunomide Apotex je imetnik dovoljenja za promet z zdravilom opravil iskanje odsotnosti učinka/neučinkovitosti zdravila v vseh poročilih o primeru za leflunomid v globalni farmakovigilančni zbirki podatkov imetnika dovoljenja za promet z zdravilom, od datuma prve odobritve zdravila Leflunomide Apotex (8. septembra 2004) do 8. avgusta 2012.
Although the company did not discuss any other potential safety signals, the CHMP acknowledged that there are no signals of increased adverse events when compared to the reference product, based on the data in the last PSUR (reporting period 28-10-2010 until 27-10-2011).
Čeprav družba ni omenila nobenih drugih morebitnih varnostnih težav, je odbor CHMP na podlagi zadnjega poročila PSUR (obdobje poročanja od 28. 10. 2010 do 27. 10. 2011) potrdil, da ni znakov povečanja neželenih dogodkov v primerjavi z referenčnim zdravilom.
The annual PSUR (data lock point 27 October 2011) submitted to the European authorities did not identify any lack of efficacy cases reported globally and the MAH therefore concluded that there was no change to the benefit risk ratio of Leflunomide Apotex.
V letnem poročilu PSUR (zaključek vnosa podatkov 27. oktobra 2011), ki je bilo predloženo evropskim organom, ni bilo ugotovljenih nobenih globalnih primerov odsotnosti učinkovitosti, zato je imetnik dovoljenja za promet z zdravilom sklenil, da pri zdravilu Leflunomide Apotex v razmerju med tveganji in koristmi ni bilo spremembe.
As the results from the bioequivalence study for the European product are in line with the results for US and Canadian products, in particular with regard to the blood plasma level results, the MAH considered the US and Canadian bio-equivalence data to support the data from the questioned EU bio-equivalence study.
Ker so rezultati študije biološke enakovrednosti za evropsko zdravilo skladni z rezultati za zdravila iz ZDA in Kanade, zlasti glede na rezultate ravni v krvni plazmi, je imetnik dovoljenja za promet z zdravilom sklepal, da podatki o biološki enakovrednosti za ZDA in Kanado podpirajo podatke iz zadevne študije biološke enakovrednosti v EU.