FrancophonIA/ELRC3.0 huggingface dataset:
English: Type I colourless glass vials with 0.5 ml (1 dose), 5 ml (10 doses) and 20 ml (40 doses).
Croatian: I s 0,5 ml (1 dozom), 5 ml (10 doza) i 20 ml (40 doza).
English: For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2).
Croatian: Za aktivnu imunizaciju kunića u dobi od 30 dana i starijih za smanjenje smrtnosti prouzročene virusom hemoragijske bolesti kunića tipa 2 (RHDV2).
English: Nodules or swelling (< 2 cm) can be very commonly observed in the injection site, which may last 24 hours.
Croatian: Na mjestu ubrizgavanja vrlo se često može uočiti kvržica ili oteklina, što može potrajati 24 sata.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVAR I PROIZVOĐAČ ODGOVORAN ZA
English: The frequency of adverse reactions is defined using the following convention: -very common (more than 1 in 10 animals treated displaying adverse reaction (s) -common (more than 1 but less than 10 animals in 100 animals treated) -uncommon (more than 1 but less than 10 animals in 1,000 animals treated) -rare (more than 1 but less than 10 animals in 10,000 animals treated) -very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Croatian: - rijetke (više od 1 ali manje od 10 životinja na 10.000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10.000 tretiranih životinja, uključujući izolirane slučajeve).
English: Rabbits
Croatian: Kunići
English: (*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Croatian: (*) ≥70 % cijepljenih kunića u testu cELISA imaju titar protutijela 40 ili viši.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Croatian: SASTAV DJELATNIH TVARI I DRUGIH TVARI
English: 1 x 10 doses (5 ml).
Croatian: 1 x 10 doza (5 ml).
English: CARTON NAME OF THE VETERINARY MEDICINAL PRODUCT
Croatian: KUTIJA NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA
English: Cardboard box of 1 glass vial of 40 doses (20 ml).
Croatian: Kartonska kutija s 1 staklenom bočicom od 40 doza (20 ml).
English: 10 x 1 dose (0.5 ml).
Croatian: 10 x 1 dozom (0,5 ml).
English: Inactivated RHDV2, strain V-1037: ………….≥70% cELISA40
Croatian: Inaktivirani RHDV2, soj V-1037: ≥70% cELISA40*
English: Store and transport refrigerated.
Croatian: 11. POSEBNI UVJETI ČUVANJA Čuvati i prevoziti na hladnom
English: For the full list of excipients, see section 6.1.
Croatian: Tiomersal……………………0,05 mg Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
English: ERAVAC emulsion for injection for rabbits
Croatian: ERAVAC Emulzija za injekciju za kuniće
English: ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Croatian: (*) ≥70 % cijepljenih kunića u testu cELISA imaju titar protutijela 40 ili viši
English: Cardboard box of 10 glass vials of 1 dose (0.5 ml).
Croatian: Kartonska kutija s 10 staklenih bočica od 1 dozom (0,5 ml).
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 …..≥70% cELISA40* (*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Croatian: Inaktivirani virus hemoragijske bolesti kunića tipa 2 (RHDV2) sojV-1037: ……≥70% cELISA40* (*) ≥70 % cijepljenih kunića u testu cELISA imaju titar protutijela 40 ili viši
English: la Selva, 135 17170 Amer (Girona) SPAIN
Croatian: Laboratorios Hipra S.A. Avda. la Selva, 135 17170 Amer (Girona) SPAIN
English: Cardboard box of 1 glass vial of 10 doses (5 ml).
Croatian: Kartonska kutija s 1 staklenom bočicom od 10 doza (5 ml).
English: Pregnancy:
Croatian: Liječniku:
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-1037……≥70% cELISA40*
Croatian: Inaktivirani virus hemoragijske bolesti kunića tipa 2 (RHDV2), sojV-1037…………≥70% cELISA40*
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ……≥70% cELISA40*
Croatian: Inaktivirani virus hemoragijske bolesti kunića tipa 2 (RHDV2), soj V-1037 ≥70% cELISA40*
English: To the physician:
Croatian: UPUTA O VMP:
English: ERAVAC emulsion for injection for rabbits.
Croatian: ERAVAC, emulzija za injekciju, za kuniće.
English: Tel: +48 22 642 33 06
Croatian: HIPRA POLSKA Sp.z.o.o. Tel: +48 22 642 33 06
English: This means that cancer cells cannot divide and they eventually die.
Croatian: To znači da se stanice raka ne mogu dijeliti i naposljetku umiru.
English: The recommendation was confirmed after re-examination.
Croatian: Preporuka je potvrđena nakon preispitivanja.
English: Doxorubicin has been available since the 1960s.
Croatian: Doksorubicin je dostupan od šezdesetih godina 20. stoljeća.
English: Refusal of the marketing authorisation for Doxolipad (doxorubicin) EMA/295022/2019
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Doxolipad (doksorubicin) EMA/295022/2019
English: After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 29 May 2019.
Croatian: Nakon razmatranja razloga za ovaj zahtjev CHMP je preispitao prvotno mišljenje i potvrdio odbijanje izdavanja odobrenja za stavljanje lijeka u promet 29. svibnja 2019.
English: The liposomes reduce the rate at which the active substance is broken down, allowing it to circulate in the blood for longer.
Croatian: Liposomi smanjuju brzinu razgradnje djelatne tvari, zbog čega ona dulje cirkulira krvotokom.
English: What is Doxolipad?
Croatian: Što je Doxolipad?
English: For more information on hybrid medicines, see the question-and-answer document here.
Croatian: Više informacija o hibridnim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje.
English: The company that applied for authorisation is TLC Biopharmaceuticals B.V.
Croatian: Zahtjev za izdavanje odobrenja podnijela je tvrtka TLC Biopharmaceuticals B.V.
English: Doxolipad was developed as a ‘hybrid medicine'.
Croatian: Doxolipad je razvijen kao „hibridni lijek”.
English: They also reduce the medicine's effects on non-cancer cells, so it is less likely to cause some side effects.
Croatian: Oni također umanjuju djelovanje lijeka na stanice koje nisu stanice raka te je manje vjerojatno da će lijek uzrokovati nuspojave.
English: Doxolipad was expected to be used to treat metastatic breast cancer in patients at risk of heart problems (‘metastatic' means the cancer has spread to other parts of the body), and cancer of the ovary in women whose previous treatment including a platinum-based cancer medicine has stopped working.
Croatian: Doxolipad se trebao primjenjivati za liječenje metastatskog raka dojke u bolesnika izloženih riziku od problema sa srcem („metastatski” znači da se rak proširio u druge dijelove tijela) te raka jajnika u žena u kojih je prethodno liječenje lijekom protiv raka na bazi platine prestalo djelovati.
English: The company informed the CHMP that there are no ongoing clinical trials with Doxolipad in the EU.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja lijeka Doxolipad koja su u tijeku u EU-u.
English: This means that Doxolipad was intended to be similar to a ‘reference medicine' already authorised in the European Union called Adriamycin.
Croatian: To znači da je Doxolipad trebao biti sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Adriamycin.
English: What was Doxolipad expected to be used for?
Croatian: Za što se Doxolipad trebao koristiti?
English: Because Doxolipad was developed as a hybrid medicine, the company also presented the results of a study carried out to investigate whether it is ‘bioequivalent' to Caelyx.
Croatian: Budući da je Doxolipad razvijen kao hibridni lijek, tvrtka je također predstavila rezultate ispitivanja provedenog kako bi se istražilo je li „bioekvivalentan” lijeku Caelyx.
English: Refusal of the marketing authorisation for Doxolipad (doxorubicin)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Doxolipad (doksorubicin)
English: The applicant presented data from the scientific literature, and data from studies conducted in experimental models, including comparisons with another authorised doxorubicin medicine, Caelyx, which contains doxorubicin in pegylated liposomal form.
Croatian: Podnositelj zahtjeva dostavio je podatke iz znanstvene literature i podatke iz ispitivanja u eksperimentalnim modelima, uključujući usporedbe s lijekom Caelyx, drugim odobrenim lijekom koji sadrži doksorubicin u pegiliranom liposomalnom obliku.
English: It was to be available as a concentrate to be made into a solution for infusion (drip) into a vein.
Croatian: Lijek je trebao biti dostupan kao koncentrat od kojeg se priprema otopina za intravensku infuziju (ukapavanje).
English: Although the reference medicine for Doxolipad is Adriamycin, this could not be used in the bioequivalence study because it contains doxorubicin in a different form (not enclosed in pegylated liposomes).
Croatian: Iako je lijek Adriamycin referentni lijek za Doxolipad, nije se mogao koristiti u ispitivanju bioekvivalentnosti jer sadrži doksorubicin u drugačijem obliku (ne nalazi se u pegiliranim liposomima).
English: On 31 January 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Doxolipad, intended for the treatment of breast and ovarian cancer.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje odobrenja za stavljanje u promet lijeka Doxolipad, koji je namijenjen liječenju raka dojke i jajnika.
English: How does Doxolipad work?
Croatian: Kako djeluje Doxolipad?
English: Doxolipad is a cancer medicine that contains the active substance doxorubicin.
Croatian: Doxolipad je lijek protiv raka koji sadrži djelatnu tvar doksorubicin.
English: It works by interfering with the DNA within cells, preventing them from making more copies of DNA and making proteins.
Croatian: Ta tvar ometa funkciju DNK-a u stanicama i time sprječava stvaranje novih kopija DNKa i proizvodnju bjelančevina.
English: The results of the bioequivalence study showed that Doxolipad is comparable to Caelyx in terms of ‘liposome-encapsulated doxorubicin', but failed to show that the amount of ‘free doxorubicin' is the same for the two medicines.
Croatian: Rezultati ispitivanja bioekvivalentnosti pokazali su da je lijek Doxolipad usporediv s lijekom Caelyx u smislu doksorubicina smještenog u liposomima, no nije dokazano da je razina „slobodnog doksorubicina” ista kod oba lijeka.
English: On that basis, the CHMP recommended that Doxolipad be refused marketing authorisation.
Croatian: Na temelju toga CHMP je preporučio da se odbije izdavanje odobrenja za stavljanje lijeka Doxolipad u promet.
English: Therefore, the CHMP was of the opinion that there was insufficient evidence to show that Doxolipad was bioequivalent to Caelyx, and it was not possible to establish that the benefits of Doxolipad outweigh its risks.
Croatian: Stoga je CHMP smatrao da ne postoje dostatni dokazi koji bi pokazali da je lijek Doxolipad bioekvivalentan lijeku Caelyx te da nije moguće utvrditi da koristi od lijeka Doxolipad nadmašuju s njim povezane rizike.
English: In Doxolipad, it is enclosed in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol).
Croatian: U lijeku Doxolipad smješten je u „pegiliranim liposomima” (sitne kuglice masti obložene kemijskom tvari koja se zove polietilenglikol).
English: Therefore, Caelyx was used instead.
Croatian: Stoga je provedeno ispitivanje lijeka Caelyx.
English: The difference between the products is that in Doxolipad the active substance doxorubicin is enclosed in tiny fatty spheres called liposomes (see below for more details).
Croatian: Razlika između tih dvaju lijekova je u tome da je djelatna tvar lijeka Doxolipad, doksorubicin, smještena unutar sitnih kuglica masti koje se zovu liposomi (više pojedinosti dostupno je u nastavku).
English: The active substance in Doxolipad, doxorubicin, is a cytotoxic medicine that belongs to the group ‘anthracyclines'.
Croatian: Djelatna tvar u lijeku Doxolipad, doksorubicin, citotoksičan je lijek koji se ubraja u skupinu „antraciklina”.
English: The recommended dose is one 150 microgram capsule, once a day at the same time each day.
Croatian: Preporučena doza je jedna kapsula od 150 mikrograma jedanput dnevno u isto vrijeme svakog dana.
English: The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks.
Croatian: Glavno mjerilo djelotvornosti temeljilo se na promjenama forsiranog izdisajnog volumena u bolesnika (FEV1, maksimalan volumen zraka koji osoba može izdahnuti u jednoj sekundi) nakon 12 tjedana liječenja.
English: The full EPAR for Oslif Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o procjeni lijeka (EPAR) Oslif Breezhaler nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax.
Croatian: Djeluje vezivanjem na beta2 receptore koji se nalaze u mišićnim stanicama brojnih organa i prouzročuju opuštanje mišića.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing.
Croatian: KOPB je dugotrajna bolest kod koje su dišni putovi i zračne vrećice u plućima oštećeni ili začepljeni, što dovodi do teškoća pri disanju.
English: This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Croatian: To prouzročuje opuštanja mišića dišnih putova, što pomaže pri održavanju dišnih putova otvorenima i omogućuje bolesniku lakše disanje.
English: Overall, the effects of the 150 and 300 microgram doses of Oslif Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease.
Croatian: Ukupno gledano, učinci doza lijeka Oslif Breezhaler od 150 i 300 mikrograma bili su slični, ali su rezultati pokazali da se dozom od 300 mikrograma može postići veći učinak u bolesnika s ozbiljnijom bolešću.
English: The increase in FEV1 was 130 ml with tiotropium, and 80 ml with formoterol.
Croatian: Povećanje FEV1-a iznosilo je 130 ml pri primjeni tiotropija i 80 ml pri primjeni formoterola.
English: On average, the increase in FEV1 in patients who received Oslif Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml.
Croatian: U prosjeku, povećanje FEV1-a u bolesnika koji su primili lijek Oslif Breezhaler iznosilo je od 150 do 190 ml, dok je u bolesnika koji su primili placebo promjena FEV1-a bila u rasponu od smanjenja od 10 ml do povećanja od 20 ml.
English: To receive a dose, the patient places a capsule into the inhaler and breathes the powder in through the mouth.
Croatian: Kako bi primili potrebnu dozu, bolesnici trebaju staviti kapsulu u inhalator i kroz usta udahnuti prašak.
English: Other common side effects include chest pain, cough and muscle cramps.
Croatian: Ostale česte nuspojave uključuju bol u prsima, kašalj i grčeve mišića.
English: European Commission granted a marketing authorisation valid throughout the European Union for Oslif Breezhaler on 30 November 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Oslif Breezhaler u promet koje vrijedi na prostoru Europske unije od 30. studenoga 2009.
English: In three main studies involving over 4,000 patients with COPD, Oslif Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD).
Croatian: U trima glavnim ispitivanjima kojima je obuhvaćeno više od 4 000 bolesnika s KOPB-om lijek Oslif Breezhaler uspoređen je s placebom (prividnim liječenjem), tiotropijem ili formoterolom (drugi inhalacijski lijekovi za liječenje KOPB-a).
English: The most common side effects with Oslif Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat).
Croatian: Najčešće nuspojave lijeka Oslif Breezhaler (koje se mogu javiti u više od 1 na 10 osoba) jesu nazofaringitis (upala nosa i grla) i infekcije gornjeg dišnog sustava (infekcije nosa i grla).
English: Oslif Breezhaler capsules, which contain a powder for inhalation, are only used with a Oslif Breezhaler inhaler and must not be swallowed.
Croatian: Kapsule lijeka Oslif Breezhaler, koje sadržavaju prašak inhalata, primjenjuju se samo s inhalatorom za Oslif Breezhaler i ne smiju se progutati.
English: This is a summary of the European public assessment report (EPAR) for Oslif Breezhaler.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni lijeka (EPAR) Oslif Breezhaler.
English: Therefore, the Agency decided that Oslif Breezhaler's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Agencija je stoga odlučila da koristi lijeka Oslif Breezhaler nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oslif Breezhaler have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Oslif Breezhaler nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Oslif Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD).
Croatian: Oslif Breezhaler je lijek koji se primjenjuje za održavanje otvorenih dišnih putova u odraslih osoba oboljelih od kronične opstruktivne plućne bolesti (KOPB).
English: The active substance in Oslif Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist.
Croatian: Djelatna tvar lijeka Oslif Breezhaler, indakaterol, jest agonist beta2-adrenergičkih receptora.
English: What measures are being taken to ensure the safe and effective use of Oslif Breezhaler?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Oslif Breezhaler?
English: The Agency also noted that there were no major safety concerns with Oslif Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines.
Croatian: Agencija je također zaključila da nisu ustanovljeni razlozi za ozbiljnu zabrinutost u pogledu sigurnosti lijeka Oslif Breezhaler te da se nuspojave mogu kontrolirati i da su slične nuspojavama drugih lijekova agonista beta2-adrenergičkih receptora.
English: Oslif Breezhaler indacaterol
Croatian: Oslif Breezhaler indakaterol
English: What is Oslif Breezhaler and what is it used for?
Croatian: Što je Oslif Breezhaler i za što se koristi?
English: For more information about treatment with Oslif Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Oslif Breezhaler pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svojem liječniku ili ljekarniku.
English: The European Medicines Agency concluded that Oslif Breezhaler was shown to be effective at improving the lung function in COPD.
Croatian: Europska agencija za lijekove zaključila je da se lijek Oslif Breezhaler pokazao djelotvornim u poboljšanju funkcije pluća u bolesnika s KOPB-om.
English: Oslif Breezhaler is used for maintenance (regular) treatment.
Croatian: Lijek Oslif Breezhaler primjenjuje se kao (redovita) terapija održavanja.
English: For practical information about using Oslif Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Oslif Breezhaler bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: When Oslif Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them.
Croatian: Pri inhalaciji lijeka Oslif Breezhaler indakaterol dolazi do receptora u dišnim putovima i aktivira ih.
English: It is not intended to provide practical advice on how to use Oslif Breezhaler.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Oslif Breezhaler.
English: Oslif Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD.
Croatian: Lijek Oslif Breezhaler bio je djelotvorniji od placeba u poboljšavanju rada pluća u bolesnika s KOPB-om.
English: The doctor may increase the dose to one 300 microgram capsule once a day in cases of severe COPD.
Croatian: U bolesnika s teškim KOPB-om liječnik može povećati dozu na jednu kapsulu od 300 mikrograma jedanput dnevno.
English: Other information about Oslif Breezhaler
Croatian: Ostale informacije o lijeku Oslif Breezhaler
English: For the full list of all side effects and restrictions with Oslif Breezhaler, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja pri primjeni lijeka Oslif Breezhaler potražite u uputi o lijeku.
English: What are the risks associated with Oslif Breezhaler?
Croatian: Koji su rizici povezani s lijekom Oslif Breezhaler?
English: Why is Oslif Breezhaler approved?
Croatian: Zašto je lijek Oslif Breezhaler odobren?
English: How is Oslif Breezhaler used?
Croatian: Kako se Oslif Breezhaler koristi?
English: How does Oslif Breezhaler work?
Croatian: Kako djeluje Oslif Breezhaler?
English: What benefits of Oslif Breezhaler have been shown in studies?
Croatian: Koje su koristi lijeka Oslif Breezhaler utvrđene u ispitivanjima?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 November 2014
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The full European Public Assessment Report for Ceprotin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelokupan sažetak europskoga javnog izvješća o ocjeni dokumentacije za lijek Ceprotin dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: There are no consequences on the use of Ceprotin in its authorised indication.
Croatian: Nema posljedica za korištenje Ceprotin u odobrenoj indikaciji.
English: What is Ceprotin?
Croatian: Što je Ceprotin?
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju ili programu milosrdnog davanja lijekova, te vam je potrebno više informacija o svom liječenju, obratite se liječniku koji vas liječi.
English: As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Croatian: Budući da je CHMP ocjenjivao inicijalnu dokumentaciju koju je dostavila tvrtka, još uvijek nije donio nikakve preporuke.
English: Detailed information on the approved use of Ceprotin in the European Union (EU) can be found here.
Croatian: Detaljne informacije o odobrenoj primjeni za lijek Ceprotin na razini Europske unije (EU) dostupne su ovdje.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Croatian: Koje posljedice ima ovo povlačenje za bolesnike u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
English: The application was withdrawn while CHMP was still evaluating the initial documentation provided by the company.
Croatian: Zahtjev je povučen dok je CHMP još uvijek ocjenjivao početnu dokumentaciju koju je dostavila tvrtka.