FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreases in neutrophil counts below 1 x 109/L occurred in 6.4% and 3.6% of patients in the 200 mg and 150 mg Kevzara + DMARDs group, respectively, compared to no patients in the placebo + DMARDs group.
Croatian: Pad broja neutrofila ispod 1 x 109/l zabilježen je u 6,4% i 3,6% bolesnika koji su primali lijek Kevzara u dozi od 200 mg odnosno 150 mg + DMARD-ove, dok u bolesnika koji su primali placebo +
English: Let the pen warm up to room temperature for at least 60 minutes before using.
Croatian: Pričekajte najmanje 60 minuta da se brizgalica ugrije na sobnu temperaturu prije nego primijenite lijek.
English: The interval between live vaccinations and initiation of Kevzara therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents (see section 4.5).
Croatian: Kevzara treba biti u skladu s važećim smjernicama za cijepljenje kod primjene imunosupresivnih lijekova (vidjeti dio 4.5).
English: Blood and Lymphatic System Disorders
Croatian: Poremećaji krvi i limfnog sustava vrlo često neutropenija često trombocitopenija
English: Do not remove the cap until you are ready to inject.
Croatian: Nemojte skinuti zatvarač dok ne budete spremni injicirati lijek.
English: Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating treatment with Kevzara.
Croatian: Prije početka liječenja lijekom Kevzara potrebno je provesti procjenu faktora rizika za tuberkulozu i testirati bolesnike na latentnu infekciju.
English: Keep the syringe out of the sight and reach of children.
Croatian: Štrcaljku čuvajte izvan pogleda i dohvata djece.
English: KEVZARA 150 mg q2w* + cDMARDs (N = 181)
Croatian: KEVZARA 150 mg svaka 2 tjedna + kDMARD (N = 181)
English: Kevzara 200 mg q2w (N=184)
Croatian: Kevzara 200 mg svaka 2 tjedna (N=184)
English: Do not use the pen if the date has passed.
Croatian: Nemojte upotrijebiti brizgalicu ako joj je istekao rok valjanosti.
English: Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including Kevzara for RA.
Croatian: U bolesnika koji su primali imunosupresivne lijekove za RA, uključujući lijek Kevzara, prijavljene su ozbiljne infekcije, ponekad sa smrtnim ishodom, uzrokovane bakterijskim, mikobakterijskim,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NAPUNJENA BRIZGALICA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON without Blue Box - 2 PRE-FILLED SYRINGES (MULTIPACK PRESENTATION)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJE PAKIRANJE BEZ PLAVOG OKVIRA - 2 NAPUNJENE ŠTRCALJKE (VIŠESTRUKO PAKIRANJE)
English: In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the rates of malignancies were consistent with the rate observed in the placebo-controlled population (see section 4.4).
Croatian: DMARD-ove i onoj koja je primala monoterapiju lijekom Kevzara bile su u skladu sa stopama opaženima u placebom kontroliranoj populaciji (vidjeti dio 4.4).
English: Neutropenia
Croatian: Cijepljenje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON without Blue Box - 2 PRE-FILLED PENS (MULTIPACK PRESENTATION)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJE PAKIRANJE BEZ PLAVOG OKVIRA - 2 NAPUNJENE BRIZGALICE (VIŠESTRUKO PAKIRANJE)
English: Laboratory parameters Neutrophil count Treatment with Kevzara was associated with a higher incidence of decrease in ANC.
Croatian: Liječenje lijekom Kevzara bilo je povezano s višom incidencijom pada ABN-a.
English: NA§
Croatian: I DOHVATA
English: In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations on neutrophil counts were consistent with those seen in the placebo-controlled population (see section 4.4).
Croatian: DMARD i onoj koja je primala monoterapiju lijekom Kevzara bili su u skladu s onima opaženima u placebom kontroliranoj populaciji (vidjeti dio 4.4).
English: KEVZARA 200 mg q2w* + cDMARDs (N = 184)
Croatian: KEVZARA 200 mg svaka 2 tjedna + kDMARD (N = 184)
English: Sarilumab exposure was not affected when coadministered with MTX based on the population pharmacokinetic analyses and across study comparisons.
Croatian: Populacijske farmakokinetičke analize i usporedbe različitih ispitivanja pokazale su da istodobna primjena s MTX-om nije utjecala na izloženost sarilumabu.
English: MARKETING AUTHORISATION NUMBERS
Croatian: PUŠTANJE SERIJE LIJEKA U PROMET
English: Use the syringe within 14 days after taking it out of the refrigerator or insulated bag.
Croatian: Štrcaljka se mora upotrijebiti unutar 14 dana nakon vađenja iz hladnjaka ili prijenosnog hladnjaka.
English: Do not try to put the cap back on a pen.
Croatian: Nemojte pokušavati vratiti zatvarač na brizgalicu.
English: Patients receiving Kevzara 200 mg or 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline in physical function compared to placebo at Week 16 and Week 12 in MOBILITY and TARGET, respectively.
Croatian: U bolesnika koji su primali lijek Kevzara u dozi od 200 mg ili 150 mg + DMARD-ove svaka 2 tjedna zabilježeno je veće poboljšanje fizičke funkcije od početka ispitivanja do 16. tjedna (MOBILITY) odnosno
English: Do
Croatian: Da
English: kevzara 200 mg syringe
Croatian: kevzara 200 mg štrcaljka
English: • Keep the syringe in the original carton in order to protect it from light.
Croatian: • Štrcaljku čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
English: In the placebo-controlled population, injection site reactions were reported in 9.5%, 8%, and 1.4% of patients receiving Kevzara 200 mg, 150 mg, and placebo respectively.
Croatian: Reakcije na mjestu injiciranja u placebom kontroliranoj populaciji prijavljene su u 9,5% bolesnika koji su primali lijek Kevzara u dozi od 200 mg, 8% bolesnika koji su primali lijek Kevzara u dozi od
English: • Use the syringe within 14 days after taking it out of the refrigerator or the insulated bag.
Croatian: • Štrcaljka se mora upotrijebiti unutar 14 dana nakon vađenja iz hladnjaka ili prijenosnog hladnjaka.
English: Week 24
Croatian: Srednja vrijednost promjene u 24. tjednu
English: Kevzara 150 mg solution for injection in pre-filled syringe Kevzara 200 mg solution for injection in pre-filled syringe
Croatian: Kevzara 150 mg otopina za injekciju u napunjenoj brizgalici Kevzara 200 mg otopina za injekciju u napunjenoj brizgalici sarilumab
English: • Do not freeze or heat the syringe.
Croatian: • Štrcaljka se ne smije zamrzavati niti zagrijavati.
English: Platelet count Treatment with Kevzara was associated with a reduction in platelet counts in clinical studies.
Croatian: U kliničkim je ispitivanjima liječenje lijekom Kevzara bilo povezano s padom broja trombocita.
English: Pull off the needle cap.
Croatian: Povucite zatvarač igle i skinite ga.
English: DAS28-CRP remission (< 2.6) ACR20‡ ACR50
Croatian: 12. tjedan Remisija prema DAS28-CRP rezultatu (< 2,6) ACR20 ACR50 ACR70 24. tjedan Remisija prema DAS28-CRP rezultatu (< 2,6) 10,1% 27,8% ACR20‡
English: kevzara 150 mg syringe
Croatian: kevzara 150 mg štrcaljka
English: How to use Kevzara
Croatian: Kako primjenjivati lijek Kevzara
English: In the placebo-controlled population, 0.2% of the patients treated with Kevzara 200 mg q2w + DMARD reported serious adverse events of hypersensitivity reactions, and none from Kevzara 150 mg q2w + DMARD group.
Croatian: 0,2% bolesnika liječenih lijekom Kevzara u dozi od 200 mg svaka 2 tjedna + DMARD-om, ali ni u jednog bolesnika liječenog lijekom Kevzara u dozi od 150 mg svaka 2 tjedna + DMARD-om.
English: Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.
Croatian: Neupotrijebljene štrcaljke držite u originalnom pakiranju i čuvajte u hladnjaku na temperaturi od
English: The rates of serious infections were 4.3, 3.0, and 3.1 events per 100 patient-years, in the 200 mg, 150 mg Kevzara + DMARDs, and placebo + DMARDs groups, respectively.
Croatian: Stopa ozbiljnih infekcija iznosila je 4,3 događaja na 100 bolesnik-godina u skupini koja je primala lijek Kevzara u dozi od 200 mg + DMARD-ove, 3,0 događaja na 100 bolesnik-godina u skupini koja je primala lijek Kevzara u dozi od 150 mg + DMARD-ove te 3,1 događaj na 100 bolesnik-godina u skupini koja je primala placebo + DMARD-ove.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 1 PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - PAKIRANJE OD 1 NAPUNJENE BRIZGALICE
English: s*
Croatian: U
English: solution for injection 2 pre-filled syringes
Croatian: otopina za injekciju 2 napunjene brizgalice
English: Tell your doctor, pharmacist, or nurse if you notice any of the following side effects: Very Common (may affect more than 1 in 10 people):
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava:
English: Solution for injection 2 pre-filled syringes.
Croatian: otopina za injekciju 2 napunjene štrcaljke.
English: In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations on platelet counts were consistent with those seen in the placebo-controlled population.
Croatian: + DMARD i onoj koja je primala monoterapiju lijekom Kevzara bili su u skladu s onima opaženima u placebom kontroliranoj populaciji.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 2 PRE-FILLED PENS
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - PAKIRANJE OD 2 NAPUNJENE BRIZGALICE
English: EU/1/17/1196/004 6 pre-filled syringes (3 packs of 2)
Croatian: EU/1/17/1196/004 6 napunjenih štrcaljki (3 pakiranja od 2)
English: Use the pen within 14 days after taking it out of the refrigerator or insulated bag.
Croatian: Brizgalica se mora upotrijebiti unutar 14 dana nakon vađenja iz hladnjaka ili prijenosnog hladnjaka.
English: Kevzara 200 mg q2w* + MTX (N = 399)
Croatian: Kevzara 200 mg svaka 2 tjedna + MTX (N = 399)
English: KEVZARA 200 mg q2w* + MTX (N = 399)
Croatian: KEVZARA 200 mg svaka 2 tjedna + MTX (N = 399)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PACK OF 2 PRE-FILLED SYRINGES
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - PAKIRANJE OD 2 NAPUNJENE ŠTRCALJKE
English: DAS28-CRP remission (< 2.6) ACR20
Croatian: ACR50 ACR70 52. tjedan Remisija prema DAS28-CRP rezultatu (< 2,6)
English: Keep the pen out of the sight and reach of children.
Croatian: Brizgalicu čuvajte izvan pogleda i dohvata djece.
English: In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations in lipid parameters were consistent with those seen in the placebo-controlled population.
Croatian: Opažene vrijednosti lipidnih parametara u populaciji za ocjenu dugoročne sigurnosti koja je primala lijek Kevzara + DMARD-ove i onoj koja je primala monoterapiju lijekom Kevzara bile su u skladu s onima opaženima u placebom kontroliranoj populaciji.
English: EU/1/17/1196/008 6 pre-filled pens (3 packs of 2)
Croatian: EU/1/17/1196/008 6 napunjenih brizgalica (3 pakiranja od 2)
English: Name and address of the manufacturer(s) responsible for batch release Sanofi Winthrop Industrie
Croatian: Sjedinjene Američke Države Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet
English: Injection site rash, rash, and urticaria were the most frequent hypersensitivity reactions.
Croatian: Najčešće reakcije preosjetljivosti bile su osip na mjestu injiciranja, osip i urtikarija.
English: EU/1/17/1196/002 6 pre-filled syringes (3 packs of 2)
Croatian: EU/1/17/1196/002 6 napunjenih štrcaljki (3 pakiranja od 2)
English: • Use the pen within 14 days after taking it out of the refrigerator or the insulated bag.
Croatian: • Brizgalica se mora upotrijebiti unutar 14 dana nakon vađenja iz hladnjaka ili prijenosnog hladnjaka.
English: KEVZARA 150 mg q2w* + MTX (N = 400)
Croatian: Kevzara 150 mg svaka 2 tjedna + MTX (N = 400)
English: Hepatic impairment:
Croatian: Posebne populacije Oštećenje funkcije bubrega:
English: solution for injection 2 pre-filled pens.
Croatian: otopina za injekciju 2 napunjene brizgalice.
English: Keep unused pens in the original carton and store in the refrigerator between 2ºC and 8ºC.
Croatian: Neupotrijebljene brizgalice držite u originalnom pakiranju i čuvajte u hladnjaku na temperaturi od
English: Malignancies
Croatian: Imunogenost
English: EU/1/17/1196/006 6 pre-filled pens (3 packs of 2)
Croatian: EU/1/17/1196/006 6 napunjenih brizgalica (3 pakiranja od 2)
English: Kevzara 150 mg solution for injection in a pre-filled syringe sarilumab
Croatian: KEVZARA 150 mg otopina za injekciju u napunjenoj štrcaljki sarilumab
English: Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Croatian: Jedna napunjena brizgalica sadrži 200 mg sarilumaba u 1,14 ml otopine (175 mg/ml).
English: Each pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Croatian: Jedna napunjena štrcaljka sadrži 150 mg sarilumaba u 1,14 ml otopine (131,6 mg/ml).
English: Kevzara 200 mg solution for injection in a pre-filled syringe sarilumab
Croatian: KEVZARA 200 mg otopina za injekciju u napunjenoj štrcaljki sarilumab
English: In patients who develop elevated ALT greater than 5 x ULN, treatment with Kevzara should be discontinued (see section 4.2).
Croatian: potrebno je prekinuti liječenje lijekom Kevzara (vidjeti dio 4.2).
English: KEVZARA 150 mg solution for injection in pre-filled syringe sarilumab
Croatian: KEVZARA 150 mg otopina za injekciju u napunjenoj brizgalici sarilumab
English: DAS28-CRP remission (< 2.6)
Croatian: Disease Activity Score 28-C-Reactive Protein, DAS28-CRP) < 2,6.
English: solution for injection 1 pre-filled syringe
Croatian: otopina za injekciju 1 napunjena brizgalica.
English: KEVZARA 200 mg solution for injection in pre-filled syringe sarilumab
Croatian: Kevzara 200 mg otopina za injekciju u napunjenoj brizgalici sarilumab
English: Decreases in neutrophil counts below 0.5 x 109/L occurred in 0.8% and 0.6% of patients in the 200 mg and 150 mg Kevzara+ DMARDs groups, respectively.
Croatian: 0,8% odnosno 0,6% bolesnika koji su primali lijek Kevzara u dozi od 200 mg odnosno 150 mg + DMARD-ove.
English: At steady state, exposure over the dosing interval measured by AUC increased approximately 2fold with a 1.33-fold increase in dose from 150 to 200 mg every two weeks.
Croatian: 150 na 200 mg svaka dva tjedna (doza povećana 1,33 puta) izloženost lijeku tijekom intervala doziranja, mjerena na temelju AUC-a, se udvostručila.
English: Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Croatian: Jedna napunjena brizgalica sadrži 150 mg sarilumaba u 1,14 ml otopine (131,6 mg/ml).
English: Each single-dose pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Croatian: Jedna jednodozna napunjena štrcaljka sadrži 200 mg sarilumaba u 1,14 ml otopine (175 mg/ml).
English: The syringe components are pre-assembled into a single-use pre-filled pen with a yellow needle cover and dark-orange cap.
Croatian: Napunjena brizgalica od 200 mg: Sastavnice štrcaljke uložene su u napunjenu brizgalicu za jednokratnu uporabu sa žutim pokrovom igle i tamnonarančastim zatvaračem.
English: Each single-dose pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Croatian: Jedna jednodozna napunjena štrcaljka sadrži 150 mg sarilumaba u 1,14 ml otopine (131,6 mg/ml).
English: No formal study of the effect of hepatic impairment on the pharmacokinetics of sarilumab was conducted (see section 4.2).
Croatian: Nije provedeno formalno ispitivanje učinka oštećenja funkcije jetre na farmakokinetiku sarilumaba
English: Lipid abnormalities
Croatian: Prijavljivanje nuspojava
English: Each single-dose pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Croatian: Jedna jednodozna napunjena brizgalica sadrži 150 mg sarilumaba u 1,14 ml otopine (131,6 mg/ml).
English: Week 52
Croatian: Srednja vrijednost promjene u 52. tjednu
English: Each single-dose pre-filled pen contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Croatian: Jedna jednodozna napunjena brizgalica sadrži 200 mg sarilumaba u 1,14 ml otopine (175 mg/ml).
English: 14 July 2014
Croatian: 14. srpnja 2014.
English: The opinion was converted into a Decision by the European Commission on 14 July 2014.
Croatian: Europska komisija to je mišljenje 14. srpnja 2014. pretvorila u odluku.
English: Potential serious risks to animal health were identified during the mutual recognition procedure by Ireland regarding the efficacy and target animal safety of the products.
Croatian: Potencijalni ozbiljni rizici za zdravlje životinja identificirani su tijekom postupka međusobnog priznavanja od strane Irske u vezi djelotvornosti i sigurnosti proizvoda za ciljne životinjske vrste.
English: International non-proprietary name (INN): fipronil
Croatian: Međunarodni nezaštićeni naziv (INN): fipronil
English: were involved ( Austria, Belgium, Denmark, Greece, Ireland, Italy, the Netherlands, Spain, the Slovak Republic and the United Kingdom).
Croatian: Referentna država članica za postupak međunarodnog priznavanja bila je Češka Republika te je bilo uključeno 10 država članica (Austrija, Belgija, Danska, Grčka, Irska, Italija, Nizozemska, Španjolska, Slovačka Republika i Ujedinjena Kraljevina).
English: The presentations for dogs have been nationally authorised in the Czech Republic since December 2011, and the presentation for cats has also been nationally authorised in the Czech Republic since May 2012.
Croatian: Formulacije za pse odobrene su nacionalnim postupcima u Češkoj Republici od prosinca 2011. godine, a formulacije za mačke također su odobrene na nacionalnoj razini u Češkoj Republici od svibnja 2012.
English: Fiprex is available in five different presentations, one for cats and four for different sizes of dogs.
Croatian: Fiprex je dostupan u pet različitih pakiranja, jedno za mačke i četiri za pse različitih veličina.
English: Based on the evaluation of the available data, the CVMP concluded that Fiprex does not pose a risk in terms of target animal safety.
Croatian: Na temelju procjene dostupnih podataka, CVMP je zaključio da Fiprex ne predstavlja rizik u smislu sigurnosti ciljnih životinja.
English: Day 60 of the CMDv referral procedure was on 18 April 2013.
Croatian: Dan 60 postupka arbitraže CMDv bio je 18. travnja 2013.
English: The re-examination procedure started on 11 February 2014.
Croatian: Postupak ponovne procjene započeo je 11. veljače 2014.
English: The mutual recognition procedures, CZ/V/0116/001/MR concerning the presentation for cats and CZ/V/0116/002-005/MR concerning the four presentations for dogs, started on 25 October 2012.
Croatian: Postupci međusobnog priznavanja CZ/V/0116/001/MR koji se odnose na formulaciju za mačke i CZ/V/0116/002-005/MR koji se odnose na četiri formulacije za pse, započeli su 25. listopada 2012. godine.
English: Regarding efficacy, the CVMP concluded that the data provided for Fiprex could not adequately justify the proposed duration of efficacy and consequently it is not possible to establish a positive benefit-risk balance for the product.
Croatian: Što se tiče djelotvornosti, CVMP je zaključio da podaci dani za Fiprex ne mogu opravdati na odgovarajući način predloženo trajanje djelotvornosti te posljedično tome nije moguće utvrditi pozitivan omjer koristi i rizika za proizvod.
English: On 29 April 2013, the reference Member State, the Czech Republic, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Croatian: Dana 29. travnja 2013., referentna država članica, Češka Republika obavijestila je Europsku agenciju za lijekove da CMD(h) nije postigao dogovor u svezi lijeka te je proslijedila predmet CVMP-u u skladu s člankom 33. stavkom 4. Direktive 2001/82/EZ.
English: The legal basis of the applications was also Article 13a of Directive 2001/82/EC.
Croatian: Pravni temelj aplikacija bio je također članak 13.a Direktive 2001/82/EZ.
English: The CVMP therefore adopted by majority a negative opinion recommending the refusal of the granting of the marketing authorisations and the suspension of the existing marketing authorisations for the aforementioned veterinary medicinal products.
Croatian: CVMP je stoga većinski usvojio negativno mišljenje koje preporučuje odbijanje davanja odobrenja i suspenziju postojećih odobrenja za stavljanje proizvoda u promet za prethodno spomenute veterinarsko-medicinske proizvode.
English: Written explanations were provided by the marketing authorisation holder on 10 September 2013 and 21 October 2013.
Croatian: Nositelji odobrenja podnijeli su napismena objašnjenja 10. rujna 2013. godine i 21. listopada 2013. godine.
English: On day 90 of the mutual recognition procedure these issues remained unsolved and therefore a referral procedure under Article 33(1) of Directive 2001/82/EC to the veterinary coordination group for the mutual recognition and decentralised procedures (CMDv) was started on 18 February 2013.
Croatian: Na 90. dan postupka međusobnog priznavanja ta pitanja ostaju neriješena i stoga je pokrenuta arbitraža u skladu s člankom 33. stavkom 1. Direktive 2001/82/EZ prema Koordinacijskoj skupini za međusobno priznavanje i decentralizirane postupke (za veterinarske lijekove) (CMD(v) na dan 18. veljače 2013.
English: During its meeting of 14-16 January 2014 the CVMP appointed R. Breathnach as rapporteur and B. Zemann as the co-rapporteur for the re-examination procedure.
Croatian: Tijekom sastanka od 14. do 16. siječnja 2014 CVMP je dodijelio R. Breathnacha kao ocjenitelja i B.
English: The Committee appointed D. Murphy as rapporteur and J. Bureš as co-rapporteur.
Croatian: Murphyja kao procjenitelja i J. Bureša kao pomoćnog procjenitelja.
English: Fiprex is a veterinary medicinal product presented as a spot-on formulation containing fipronil as an active substance (pharmacotherapeutic group: ectoparasiticides for topical use).
Croatian: Fiprex je veterinarsko-medicinski proizvod koji se isporučuje kao formulacija za nakapavanje koja sadrži fipronil kao djelatnu tvar (farmakoterapijska skupina: ektoparazitici za topikalnu primjenu).
English: The referral procedure started on 15 May 2013.
Croatian: Postupak procjene započeo je 15. svibnja 2013.
English: Article 33(4) of Directive 2001/82/EC, as amended
Croatian: Članak 33. stavak 4. Direktive 2001/83/EZ, kako je izmijenjena.
English: The legal basis of the marketing authorisations granted by the Czech Republic was Article 13a of Directive 2001/82/EC i.e. citing well-established use.
Croatian: Pravna osnova za odobrenja koje je dala Češka Republika bila je članak 13.a Direktive 2001/82/EZ primjerice, pozivanje na dobro utvrđenu primjenu.
English: On 9 April 2014, the CVMP adopted by majority a final opinion confirming the recommendation included in its opinion of 11 December 2013, that the granting of the marketing authorisations should be refused and the existing marketing authorisations should be suspended 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 spot-on solution for dogs.
Croatian: Dana 9. travanja CVMP je usvojio većinski konačno mišljenje o preporuci koja je uključena u mišljenje Odbora od 11. prosinca 2013. da izdavanje odobrenja za stavljanje veterinarsko-medicinskog proizvoda u promet treba odbiti i da postojeća odobrenja treba suspendirati za Fiprex CAT 52,5 mg otopinu za nakapavanje za mačke, Fiprex S 75 mg otopinu za nakapavanje za pse, Fiprex M 150 mg otopinu za nakapavanje za pse, Fiprex L 300 mg otopinu za nakapavanje za pse i Fiprex XL 412,5 mg otopinu za nakapavanje za pse.