natgillin/translations-raw huggingface dataset:
The MAH's grounds for re-examination of the CVMP opinion of 11 December 2013 focused on the factors to be taken into account to establish a “well-established veterinary medicinal use of constituents of veterinary medicinal products”, largely following the headings contained under Title III of Annex I to Directive 2001/82/EC (Directive 2009/9/EC). 
Razlogi imetnika dovoljenja za promet z zdravilom za zahtevo za ponoven pregled mnenja odbora CVMP z dne 11. decembra 2013 so bili osredotočeni na dejavnike, ki se upoštevajo pri ugotavljanju „dobro uveljavljene veterinarske uporabe sestavin zdravila za uporabo v veterinarski medicini“, pri čemer so v glavnem sledili razdelkom pod Naslovom III Priloge I k Direktivi 2001/82/ES (Direktiva 2009/9/ES).
The major point put forward by the MAH was that insecticidal activity is high in both dogs and cats, irrespective of the formulation; products are effective for up to 8 weeks in dogs and up to 5 weeks in cats. 
Glavni argument, ki ga je izpostavil imetnik dovoljenja za promet z zdravilom, je bil, da je insekticidno delovanje zelo dobro pri psih in mačkah, ne glede na formulacijo; zdravila učinkujejo do 8 tednov pri psih in do 5 tednov pri mačkah.
List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States 
Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe zdravila in imetnikov dovoljenj za promet z zdravilom v državah članicah
During the procedure, there was disagreement between the reference Member State and a concerned Member State, Ireland, on the adequacy of the data presented by the marketing authorisation holder (MAH) in support of efficacy and target animal safety. 
Med postopkom je prišlo do nesoglasja med referenčno državo članico in zadevno državo članico Irsko glede zadostnosti podatkov, ki jih je imetnik dovoljenja za promet z zdravilom predložil v podporo učinkovitosti in varnosti zdravila pri ciljnih živalskih vrstah.
Austria1 
Avstrija1
The pharmacovigilance data submitted by the MAH did not meet the standard of published, peerreviewed post-marketing data, i.e. controlled studies or epidemiological studies, as required by the legislation, and therefore could not be considered in the frame of this assessment. 
Farmakovigilančni podatki, ki jih je predložil imetnik dovoljenja za promet z zdravilom, niso izpolnjevali standardov za objavljene, strokovno pregledane podatke iz obdobja trženja, tj. nadzorovane študije ali epidemiološke študije, kot jih zahteva zakonodaja, zato jih ni bilo mogoče upoštevati v okviru tega ocenjevanja.
The duration of efficacy for currently authorised fipronil-containing spot-on products varies from 4-8 weeks for fleas and 1-4 weeks for different tick species. 
Trenutno odobrena zdravila za kožni nanos, ki vsebujejo fipronil, učinkujejo od 4 do 8 tednov proti bolham in od 1 do 4 tedne proti različnih vrstam klopov.
Bibliographic data has been provided in order to cover all aspects of the safety and/or efficacy assessment of the product for the proposed indication in the target species using the proposed route of administration and dosage regimen. 
Predloženi so bili bibliografski podatki za obravnavo vseh vidikov ocene varnosti in/ali učinkovitosti zdravila za predlagano indikacijo pri ciljnih živalskih vrstah pri dajanju po predlagani poti uporabe in režimu odmerjanja.
In addition, the available published literature did not allow for such a conclusion as Fiprex is qualitatively and quantitatively different from other authorised fipronilcontaining products. 
Poleg tega tudi razpoložljiva objavljena literatura ni omogočala zaključkov o tem, saj se zdravilo Fiprex kvalitativno in kvantitativno razlikuje od drugih odobrenih zdravil, ki vsebujejo fipronil.
The legal basis of the application was Article 13a of Directive 2001/82/EC i.e. citing well-established use. 
Pravna podlaga za vlogo je bil člen 13a Direktive 2001/82/ES, kar pomeni, da so se sklicevali na dobro uveljavljeno uporabo.
Fleas are obligate parasites commonly brought into homes by pet cats and dogs. 
Bolhe so obligatni paraziti, ki jih pogosto v domove prinašajo mačke in psi.
The CVMP had no data available to conclude upon the appropriate duration of efficacy for Fiprex. 
Odbor CVMP ni imel na voljo nobenih podatkov, da bi lahko podal zaključke glede ustreznega trajanja učinkovitosti za zdravilo Fiprex.
The objecting concerned Member States considered that the authorisation of Fiprex may present a potential serious risk to animal health since the target animal safety and efficacy of the product had not been sufficiently demonstrated. 
Zadevna država članica, ki je izrazila pomisleke, je menila, da bi izdaja dovoljenja za promet z zdravilom Fiprex lahko pomenila morebitno resno tveganje za zdravje živali, saj varnost in učinkovitost zdravila pri ciljnih živalskih vrstah nista bili zadovoljivo dokazani.
This study included basic tests to evaluate characteristics such as drying time and surface spreading of the different products in vitro. 
Študija je vključevala osnovne preskuse za oceno lastnosti, kot sta čas sušenja različnih zdravil in njihova razporeditev po površini in vitro.
Fiprex is a spot-on formulation containing fipronil as the active substance (pharmacotherapeutic group: ectoparasiticides for topical use). 
Zdravilo Fiprex je formulacija za kožni nanos, ki vsebuje zdravilno učinkovino fipronil (farmakoterapevtska skupina: ektoparazitiki za lokalno uporabo).
In the case of ticks, the MAH asserted that the data for Rhipicephalus spp. 
Kar zadeva klope, je imetnik dovoljenja za promet z zdravilom zatrdil, da je na podlagi podatkov za Rhipicephalus spp.
The benefit-risk balance for Fiprex remains inconclusive in the absence of adequate data to justify the proposed indications. 
Razmerja med tveganji in koristmi zdravila Fiprex še naprej ni mogoče določiti, saj ni na voljo zadostnih podatkov, s katerimi bi utemeljili predlagane indikacije.
The application was submitted for a mutual recognition procedure, using the legal basis of well-established use (Article 13a of Directive 2001/82/EC). 
Za zdravilo je bila predložena vloga za postopek z medsebojnim priznavanjem, za katero je bila pravna podlaga dobro uveljavljena uporaba (člen 13a Direktive 2001/82/ES).
The CVMP was asked to give its opinion on the concerns raised by the objecting concerned Member State and to conclude on the benefit-risk balance for Fiprex. 
Odbor CVMP so zaprosili, naj poda mnenje o pomislekih, ki jih je izrazila omenjena zadevna država članica, in ugotovi, kakšno je razmerje med tveganji in koristmi zdravila Fiprex.
According to the MAH, the submitted published reports provided sufficient comfort relating to the safety and efficacy of different fipronil spot-on products, such that any quantitative differences in active ingredient content or quantitative/qualitative differences in excipient content between products would not result in different safety or efficacy outcomes. 
Po mnenju imetnika dovoljenja za promet z zdravilom so predložena objavljena poročila podala zadostna zagotovila glede varnosti in učinkovitosti različnih zdravil za kožni nanos, ki vsebujejo fipronil, tako da kakršne koli kvantitativne razlike v vsebnosti zdravilne učinkovine ali kvantitativne/kvalitativne razlike v vsebnosti pomožnih snovi med zdravili ne bi vodile do drugačnih zaključkov glede varnosti ali učinkovitosti.
Scientific conclusions and grounds for the refusal of the marketing authorisation and for suspension of the existing marketing authorisations 
Znanstveni zaključki in podlaga za zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom in začasen umik obstoječih dovoljenj
• The CVMP considered that the data submitted is insufficient to conclude on the efficacy of Fiprex, particularly in terms of duration of efficacy; 
• odbor CVMP je menil, da predloženi podatki ne zadoščajo za sprejetje sklepa o učinkovitosti zdravila Fiprex, zlasti glede trajanja učinkovitosti;
• The CVMP considered that the data submitted in support of this application are adequate to support the safety of the Fiprex spot-on formulations in the target species; 
• odbor CVMP je menil, da so podatki, ki so bili predloženi v podporo tej vlogi, zadostni za potrditev varnosti formulacij zdravila Fiprex za kožni nanos pri ciljnih živalskih vrstah;
It was not possible to consider the post-authorisation safety data presented by the MAH (related to periodic safety update reports and sales volume data) since these data included reference to products that were not included in the scope of this referral procedure. 
Podatkov o varnosti iz obdobja trženja (povezanih z redno posodobljenimi poročili o varnosti zdravila in podatki o obsegu prodaje), ki jih je predložil imetnik dovoljenja za promet z zdravilom, ni bilo mogoče upoštevati, saj so se ti podatki nanašali tudi na zdravila, ki niso bila zajeta v tem napotitvenem postopku.
Spot-on products containing fipronil provide a user-friendly means of targeting flea and tick infestations in the aforementioned companion animal species, as well as the consequential complications that these parasites can cause to both their hosts and pet owners. 
Zdravila za kožni nanos, ki vsebujejo fipronil, so uporabniku prijazna sredstva za obvladovanje infestacij z bolhami in klopi pri navedenih hišnih živalskih vrstah ter kasnejših zapletov, ki jih ti paraziti lahko povzročijo pri gostiteljih in tudi lastnikih hišnih ljubljenčkov.
As significant deficiencies were noted in the proprietary clinical studies conducted with Fiprex, these data were not considered reliable. 
Pri lastniških kliničnih študijah, opravljenih z zdravilom Fiprex, so odkrili velike pomanjkljivosti, zato so bili ti podatki ocenjeni kot nezanesljivi.
The MAH stated that all necessary criteria were fulfilled under Art. 13a of Directive 2001/82/EC (wellestablished use). 
Imetnik dovoljenja za promet z zdravilom je navedel, da so izpolnjena vsa potrebna merila iz člena 13a Direktive 2001/82/ES (dobro uveljavljena uporaba).
Fipronil is an ectoparasiticide that, depending on the approved product, can be used to prevent and treat flea infestations in dogs and cats, to control flea allergic dermatitis as part of a treatment strategy and also to control infestations of biting lice. 
Fipronil je ektoparazitik, ki se v različnih odobrenih zdravilih lahko uporablja za preprečevanje in zdravljenje infestacij z bolhami pri psih in mačkih, kot del strategije zdravljenja za nadzor alergijskega dermatitisa, ki ga povzročajo bolhe, in za nadzor infestacij s tekuti (Mallophaga).
The Committee also confirmed that the active substance fipronil has a low order of toxicity and no specific safety concerns exist in terms of the Fiprex spot-on formulations. 
Odbor je tudi potrdil, da je toksičnost zdravilne učinkovine fipronila majhna in da v zvezi z varnostjo formulacij zdravila Fiprex za kožni nanos ni nobenih posebnih zadržkov.
To this effect, the MAH provided a comparison of the differences in formulation between various fipronil-containing products and outlined the similarities in their indications. 
Zato je imetnik dovoljenja za promet z zdravilom predložil primerjavo razlik v formulaciji med različnimi zdravili, ki vsebujejo fipronil, in izpostavil podobnosti v njihovih indikacijah.
The MAH further outlined studies submitted on behalf of various generic products, which showed that each product had acceptable efficacy compared to the originator product on the EU market, despite differences in excipient content. 
Imetnik dovoljenja za promet z zdravilom je izpostavil tudi študije, predložene za različna generična zdravila, ki kažejo, da je vsako od zdravil kljub razlikam v vsebnosti pomožnih snovi imelo sprejemljivo učinkovitost v primerjavi z originatorskim zdravilom na trgu EU.
Consequently, the CVMP cannot conclude that the findings of the MAH's in vitro investigations can be applied to the in vivo situation or to the expected efficacy of the products. 
Odbor CVMP zato ni mogel zaključiti, da je ugotovitve raziskav in vitro imetnika dovoljenja za promet z zdravilom mogoče upoštevati tudi pri pogojih in vivo ali pri pričakovani učinkovitosti zdravil.
The CVMP considers that differences in formulation between spot-on products may impact on efficacy, particularly in terms of duration of efficacy. 
Odbor CVMP je menil, da razlike v formulaciji med zdravili za kožni nanos lahko vplivajo na učinkovitost, še zlasti na trajanje učinkovitosti.
The raw data were made available as separate documentation. 
Dokumentacijo z neobdelanimi podatki je predložil ločeno.
Depending on the approved product, Fipronil can also be used to treat and prevent tick infestations in dogs. 
Nekatera odobrena zdravila, ki vsebujejo fipronil, se lahko uporabljajo tudi za zdravljenje in preprečevanje infestacij s klopi pri psih.
Ticks are obligate parasites that are vectors for diseases to animals and humans e.g. Lyme disease. 
Klopi so obligatni paraziti, ki na živali in ljudi prenašajo bolezni, kot je limska borelioza.
Having reviewed the documentation submitted by the MAH, the CVMP concluded that there were not sufficient scientific grounds to revise its conclusions of 11 December 2013, and that the overall benefitrisk balance for the range of Fiprex spot-on formulations is negative. 
Po pregledu dokumentacije, ki jo je predložil imetnik dovoljenja za promet z zdravilom, je odbor CVMP zaključil, da zahteva za ponoven pregled zaključkov z dne 11. decembra 2013 ni bila zadovoljivo znanstveno utemeljena in da je splošno razmerje med tveganji in koristmi za različne formulacije zdravila Fiprex za kožni nanos negativno.
The MAH felt that CVMP erred when refusing to assess the submitted pharmacovigilance data relating to other authorised fipronil-containing products manufactured by the same company that manufactures Fiprex (i.e. Vet-Agro). 
Imetnik dovoljenja za promet z zdravilom je menil, da se je odbor CVMP napačno odločil, ko ni želel oceniti predloženih farmakovigilančnih podatkov, povezanih z drugimi odobrenimi zdravili, ki vsebujejo fipronil in jih izdeluje ista farmacevtska družba, ki izdeluje tudi zdravilo Fiprex (tj. Vet-Agro).
Whilst the CVMP accepted that Fiprex does not pose a risk in terms of target animal safety, based on the overall data presented, the CVMP concluded that the data provided for Fiprex could not adequately justify the proposed indications and that the benefit-risk balance is currently not favourable. 
Odbor CVMP je na podlagi vseh predloženih podatkov potrdil, da zdravilo Fiprex ne pomeni tveganja z vidika varnosti za ciljne živalske vrste, vendar je zaključil, da s podatki, ki so bili predloženi za zdravilo Fiprex, ni mogoče zadovoljivo utemeljiti predlaganih indikacij in da razmerje med tveganji in koristmi trenutno ni ugodno.
The MAH disagreed with the previous CVMP conclusion that differences in the formulation between Fiprex and other fipronil-containing products would impact on the absorption, the rate and extent of distribution, and persistence of the active substance on the target species. 
Imetnik dovoljenja za promet z zdravilom se ni strinjal s predhodnim zaključkom odbora CVMP, da bi razlike v formulaciji med zdravilom Fiprex in drugimi zdravili, ki vsebujejo fipronil, vplivale na absorpcijo, hitrost in obseg porazdelitve ter obstojnost zdravilne učinkovine pri ciljnih živalskih vrstah.
Condition for lifting the suspension of the marketing authorisations 
Pogoj za preklic začasnega umika dovoljenj za promet z zdravilom
The CVMP considers that differences in formulation between spot-on products may impact on efficacy and this is reflected in the range of customised claims regarding immediate and persistent efficacy for other approved spot-on products. 
Odbor CVMP je menil, da razlike v formulaciji med zdravili za kožni nanos lahko vplivajo na učinkovitost, kar dokazuje vrsta nekoliko različnih trditev glede takojšnje in dolgotrajne učinkovitosti drugih odobrenih zdravil za kožni nanos.
The MAH did not adequately justify why the outcome of this study was of particular relevance in defining the pharmacological properties, and thereby clinical efficacy, of Fiprex in relation to other fipronil spot ons. 
Imetnik dovoljenja za promet z zdravilom ni zadovoljivo utemeljil, zakaj naj bi bil rezultat te študije posebej pomemben za opredelitev farmakoloških lastnosti in s tem tudi klinične učinkovitosti zdravila Fiprex v primerjavi z drugimi zdravili za kožni nanos, ki vsebujejo fipronil.
The MAH presented proprietary clinical studies investigating the efficacy of Fiprex spot-on (the product concerned) and Fiprex spray (not concerned by this procedure) against fleas and ticks in dogs and cats. 
Imetnik dovoljenja za promet z zdravilom je predložil lastniške klinične študije, v katerih so proučevali učinkovitost zdravila Fiprex za kožni nanos (zadevnega zdravila) ter zdravila Fiprex v obliki pršila (ki ni predmet tega postopka) proti bolham in klopom pri psih in mačkah.
Following a review of these data, the CVMP concluded that the conduct of the studies was not sufficiently robust and the results not sufficiently reliable to take the MAH's proprietary data in account as regards the clinical efficacy of Fiprex spot-on. 
Po pregledu teh podatkov je zaključil, da izvedba študij ni bila dovolj zanesljiva in da rezultati niso dovolj prepričljivi, da bi lahko lastniške podatke imetnika dovoljenja za promet z zdravilom upoštevali pri oceni klinične učinkovitosti zdravila Fiprex za kožni nanos.
Based on the accepted well-established use substantiated by the MAH through public literature within their application, the Committee was able to conclude that the target animal safety was adequately supported despite the difference in formulations between the candidate product and products referenced in the published literature. 
Odbor je na podlagi splošno priznane dobro uveljavljene uporabe, ki jo je imetnik dovoljenja za promet z zdravilom v vlogi podprl z dokazi iz javno dostopne literature, zaključil, da je bila varnost zdravila pri ciljnih živalskih vrstah kljub razlikam v formulaciji med zdravilom, za katerega je bila predložena vloga, in zdravili iz objavljene literature, zadovoljivo dokazana.
The MAH additionally presented a study to compare the physicochemical properties of a number of different fipronil-containing spot-on products, including Fiprex and the pioneer product. 
Imetnik dovoljenja za promet z zdravilom je predložil tudi študijo za primerjavo fizikalno-kemijskih lastnosti več različnih zdravil za kožni nanos, ki vsebujejo fipronil, vključno z zdravilom Fiprex in izvornim zdravilom.
Despite differences in formulation and dose between Fiprex and other fipronil-containing spot-on products cited in the published literature, it is accepted that such products are generally well tolerated and have a wide margin of safety. 
Čeprav so med zdravilom Fiprex in drugimi zdravili za kožni nanos z vsebnostjo fipronila, navedenimi v objavljeni literaturi, obstajale razlike v formulaciji in odmerkih, za ta zdravila velja, da jih živali običajno dobro prenašajo in imajo širok terapevtski indeks.
Based on the accepted well-established use substantiated by the MAH through public literature within their application, the Committee was able to conclude that the target animal safety was adequately supported. 
Odbor je na podlagi splošno priznane dobro uveljavljene uporabe, ki jo je imetnik dovoljenja za promet v vlogi podprl z dokazi iz javno dostopne literature, zaključil, da je varnost zdravila pri ciljnih živalskih vrstah zadovoljivo dokazana.
It has therefore not been possible to establish the efficacy profile of the formulation for Fiprex spot-on. 
Profila učinkovitosti formulacije zdravila Fiprex za kožni nanos zato ni bilo mogoče opredeliti.
The literature cited by the MAH relates to products that are quantitatively different in terms of the active substance and both qualitatively and quantitatively different in terms of the excipients. 
Literatura, na katero se je skliceval imetnik dovoljenja za promet z zdravilom, se nanaša na zdravila, ki se kvantitativno razlikujejo glede zdravilne učinkovine ter kvalitativno in kvantitativno glede pomožnih snovi.
The CVMP is of the opinion that the MAH has inadequately bridged the difference between the formulations of the products cited in the published literature and the formulation of Fiprex. 
Menil je tudi, da imetnik dovoljenja za promet z zdravilom ni uspel dovolj dobro premostiti razlik med formulacijami zdravil, navedenih v objavljeni literaturi, in formulacijo zdravila Fiprex.
The study reports were significantly re-worked by the MAH for review during this referral procedure. 
Imetnik dovoljenja za promet z zdravilom je poročila o študijah za namene pregleda v okviru tega napotitvenega postopka precej priredil.
Fiprex spot-on solutions for dogs and cats contain fipronil. 
Zdravilo Fiprex v obliki raztopin za kožni nanos za pse in mačke vsebuje fipronil.
In accordance with the legal basis of the application, i.e. well established use, the MAH has cited published literature to support the efficacy of the product. 
Ob upoštevanju pravne podlage za vlogo, ki je bila dobro uveljavljena uporaba, se je imetnik dovoljenja za promet z zdravilom pri dokazovanju učinkovitosti zdravila skliceval na objavljeno literaturo.
Whilst the efficacy of fipronil is well-documented, the MAH has not been able to refine the claims for efficacy of their formulation due to quantitative and qualitative differences compared to those products cited in the product literature. 
Čeprav je učinkovitost fipronila izčrpno dokumentirana, imetnik dovoljenja za promet z zdravilom zaradi kvantitativnih in kvalitativnih razlik v primerjavi z zdravili, navedenimi v literaturi, ni uspel podrobneje utemeljiti trditev o učinkovitosti svoje formulacije.
Grounds for the refusal of the granting of marketing authorisations and for suspension of the existing marketing authorisations 
Podlaga za zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom in začasen umik obstoječih dovoljenj
There are five presentations, one for cats (52.5 mg) and four for different sizes of dogs (S, M, L, XL) corresponding to 75, 150, 300 and 412.5 mg, respectively. 
Na voljo je pet različic zdravila, od tega ena za mačke (52,5 mg) ter štiri za pse različnih velikosti (majhne, srednje velike, velike in zelo velike) z jakostjo 75, 150, 300 oziroma 412,5 mg. Koncentracija zdravilne učinkovine, fipronila, je v vseh primerih 75 mg/ml, prostornina enoodmerne pipete pa je različna.
• Appropriate efficacy data, in accordance with legislative requirements and with regard to the relevant CVMP guidelines, should be provided in support of the claimed indications for Fiprex CAT 52.5 mg spot-on solution for cats, Fiprex S 75 mg spot-on solution for dogs, Fiprex M 150 mg spot-on solution for dogs, Fiprex L 300 mg spot-on solution for dogs and Fiprex XL 412.5 mg spoton solution for dogs. 
• predložiti je treba ustrezne podatke o učinkovitosti, skladne z zakonskimi zahtevami in zadevnimi smernicami odbora CVMP, ki podpirajo predlagane indikacije za zdravila Fiprex CAT 52,5 mg kožni nanos, raztopina za mačke, Fiprex S 75 mg kožni nanos, raztopina za pse, Fiprex M 150 mg kožni nanos, raztopina za pse, Fiprex L 300 mg kožni nanos, raztopina za pse, in Fiprex XL 412,5 mg kožni nanos, raztopina za pse.
Therefore the CVMP concludes that it is not possible to establish the efficacy profile of Fiprex through extrapolation of data from the published literature. 
Zato je zaključil, da z ekstrapolacijo podatkov iz objavljene literature ni mogoče ugotoviti, kakšen je profil učinkovitosti zdravila Fiprex.
Fiprex CAT 52,5 mg Διάλυμα για επίχυση σε σημείο (spot-on) για γάτες 
Fiprex CAT 52,5 mg Διάλυμα για επίχυση σε σημείο (spot-on) για γάτες nanos na kožo mačke