natgillin/translations-raw huggingface dataset:
Irbesartan/Hydrochlorothia zid Heumann 300 mg/12.5 mg Filmtabletten mg/12,5 mg 
Irbesartan/Hydrochlorot hiazid Heumann 300 mg/12.5 mg Filmtabletten
BOSENTAN SANDOZ 125 mg Film - coated tablet 
BOSENTAN SANDOZ 125 mg Filmom obložena tableta Kroz usta
150 mg Prolongedreleased capsule, hard 
150 mg Kapsula, tvrda
Capsule, hard Oral use 
Kapsula, tvrda
Clonazepam Clonazepam Sandoz 2 mg, tabletten 
Veluwezoom 22 1327 AH Almere The Netherlands klonazepam Clonazepam Sandoz 2 mg, tabletten
Alterfast 
TRAMADOL
Prolongedrelease capsule 
Kapsula s produljenim oslobadjanjem
Alendronic acid Alendronic Acid Accord 70 mg 
Alendronic Acid Accord 70 mg
Escitalopram ESCITALOPRAM COMBIX 15 mg COMPRIMIDOS 
Spain escitalopram ESCITALOPRAM COMBIX 15 mg
Metformin 
Mylcande
Trimetazidina Pharmakern 35 mg 
Trimetazidina Mylan 35 mg
Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow HA1 4HF Middlesex 
North Harrow HA1 4HF Middlesex
Metoclopramide hydrochloride 
S Denmark metoklopramid hidroklorid
Escitalopram ESCITALOPRAM BROWN 5 mg, comprimé pelliculé sécable 
TW4 5DQ Middlesex United Kingdom escitalopram ESCITALOPRAM BROWN 5 mg, comprimé pelliculé sécable
Desloratadine/Genepharm 2,5 mg δισκία διασπειρόμενα στο στόμα 
18 Km Marathon Avenue, 15351 Pallini Greece desloratadin Desloratadine/Genephar m 2,5 mg δισκία διασπειρόμενα στο στόμα
Irbesartan/Hydrochlorothia zide 300mg/12.5mg filmcoated tablets mg/12,5 mg 
Irbesartan/Hydrochlorot hiazide 300mg/12.5mg film-coated tablets
Sinalerg 5 mg filmom obložene tablete 
PharmaS 10 mg filmom obložene tablete
Rizatriptan Mylan 5 mg 5 mg 
Donepezilo Mylan 5 mg
Levetiracetam Letiramyl 1000 mg potahované tablety 
Hertfordshire, EN6 1TL United Kingdom levetiracetam Letiramyl 1000 mg potahované tablety
Wólczyńska 232 
Darwinweg 20
Levetiracetam LEVETIRACETAM MYLAN PHARMA 1000mg, comprimé pelliculé 
MYLAN PHARMA 1000mg, comprimé pelliculé
Fexofenadine HCL 180 A, filmomhulde tabletten 120 mg 
3771 ME Barneveld The Netherlands feksofenadin Fexofenadine HCL 180 A, filmomhulde tabletten 120 mg
Desloratadine Labormed 5 mg 
Spain desloratadin DESLORATADINA COMBIX 5 mg
Desmopressin DESMOPRESSINE MYLAN 60 µg, orodispersible tablet 
MYLAN 60 µg, orodispersible tablet
150 mg Modified - release capsule, hard 
150 mg Kapsula s prilagođenim oslobađanjem, tvrda
VENLAFAXIN ORION 37,5 mg Prolongedreleased capsule, hard 
VENLAFAXIN ORION 37,5 mg Kapsula s produljenim oslobađanjem, tvrda
Escitalopram ESCITALOPRAM BROWN 10 mg, comprimé pelliculé sécable 
TW4 5DQ Middlesex United Kingdom escitalopram ESCITALOPRAM BROWN 10 mg, comprimé pelliculé sécable
Irbesartan HCT Fair-Med 300 mg/25 mg 
Irbesartan Fair-Med 75 mg
Trimetazidina Brown 
Czech Republic trimetazidin
VENLAFAXINE ORION 37,5 mg Prolongedreleased capsule, hard 
VENLAFAXINE ORION 37,5 mg Kapsula s produljenim oslobađanjem, tvrda
VENLAFAXIN ORION 150 mg Prolongedreleased capsule, hard 
VENLAFAXIN ORION 150 mg Kapsula s produljenim oslobađanjem, tvrda
Fexofenadine HCL Mylan 120 mg, filmomhulde tabletten 
3752 LB Bunschoten The Netherlands feksofenadin Fexofenadine HCL Mylan 120 mg, filmomhulde tabletten
Venlafaxina Bluepharma 150 mg Prolongedreleased capsule, hard 
Venlafaxina Bluepharma 150 mg Kapsula s produljenim oslobađanjem, tvrda
Fexofenadine HCL Mylan 180 mg, filmomhulde tabletten 
3752 LB Bunschoten The Netherlands feksofenadin Fexofenadine HCL Mylan 180 mg, filmomhulde tabletten
Alvotadin 2.5 mg szájban diszpergálódó tabletta 
L-1736 Senningerberg Luxembourg desloratadin Alvotadin 2.5 mg szájban diszpergálódó tabletta
Venlafaxina Bluepharma 37,5 mg Prolongedreleased capsule, hard 
Venlafaxina Bluepharma 37,5 mg Kapsula s produljenim oslobađanjem, tvrda
37,5 mg Prolongedreleased capsule, hard 
37,5 mg Kapsula s produljenim oslobađanjem, tvrda
Irbesartan/Hydrochlorothia zide Fairmed 
Germany irbesartan/hidroklo rotijazid
FEXOFENADINE BIOGARAN 180 mg, comprimé pelliculé 
MYLAN PHARMA 250mg, comprimé pelliculé
VENLAFAXINE ORION 150 mg Prolongedreleased capsule, hard 
Venlafaxine Orion 150 mg Kapsula s produljenim oslobađanjem, tvrda
Donepezil Odis Mylan 
Donepezil Odis Mylan 5 mg
Fexofenadine HCl 120 PCH, filmomhulde tabletten 120 mg 
2031 GA Haarlem The Netherlands feksofenadin Fexofenadine HCl 120 PCH, filmomhulde tabletten 120 mg
Levetiracetam Letiramyl 750 mg potahované tablety 
Hertfordshire, EN6 1TL United Kingdom levetiracetam Letiramyl 750 mg potahované tablety
Venlafaxine Bluefish XL 150 mg Prolongedreleased capsule, hard 
Venlafaxine Bluefish XL 150 mg Kapsula s produljenim oslobađanjem, tvrda
Telmisartan 
PELICULA
DESLORATADINA APOTEX 5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG 
WELDING 150 MG/12.5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Venlafaxine Bluefish 150 mg Prolongedreleased capsule, hard 
Venlafaxine Bluefish 150 mg Kapsula s produljenim oslobađanjem, tvrda
Venlafaxina Bluefish XR 150 mg Prolongedreleased capsule, hard 
Venlafaxina Bluefish XR 150 mg Kapsula s produljenim oslobađanjem, tvrda
G.L. 
Alfred E.
Fexofenadine HCl 180 PCH, filmomhulde tabletten 120 mg 
2031 GA Haarlem The Netherlands feksofenadin Fexofenadine HCl 180 PCH, filmomhulde tabletten 120 mg
Venlafaxine Bluefish 37,5 mg Prolongedreleased capsule, hard 
Venlafaxine Bluefish 37,5 mg Kapsula s produljenim oslobađanjem, tvrda
Venlafaxine Bluefish 150 mg Prolongedrelease capsule 
Venlafaxine Bluefish 150 mg Kapsula s produljenim oslobadjanjem
DE-22765 Hamburg Germany 
D-22767 Hamburg Germany levocetirizin
DONEPEZILO FLAS MYLAN PHARMACEUTICALS 10 mg COMPRIMIDOS BUCODISPERSABLES EFG 
PHARMACEUTICALS 10 mg COMPRIMIDOS BUCODISPERSABLES EFG
ACCORD HEALTHCARE France SAS 
Accord Healthcare Limited
160 mg/25 mg 
CODRAMOL 160/25 MG
Desloratadine/Genepharm 5 mg δισκία διασπειρόμενα στο στόμα 
18 Km Marathon Avenue, 15351 Pallini Greece desloratadin Desloratadine/Genephar m 5 mg δισκία διασπειρόμενα στο στόμα
Trakt Lubelski 135 
Pelplińska 19
Potactasol topotecan 
Potactasol topotekan
The full EPAR for Potactasol can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Cjeloviti EPAR za lijek Potactasol nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It is also used together with cisplatin (another cancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (the cancer has spread beyond the cervix). 
Koristi se također zajedno sa cisplatinom (drugim protutumorskim lijekom) za liječenje žena s metastatskim karcinomom vrata maternice nakon što se karcinom ponovno pojavio nakon radioterapije, ili ako se bolest nalazi u uznapredovaloj fazi (rak se proširio izvan vrata maternice).
For both ovarian and lung cancer, Potactasol is given every day for five days with a three-week interval between the start of each course. 
U slučaju raka jajnika i pluća, Potactasol se primjenjuje svaki dan tijekom razdoblja od pet dana s intervalom od tri tjedna između početka svakog ciklusa.
What are the benefits and risks of Potactasol? 
Koje su koristi i rizici VMP-a Potactasol?
This is a summary of the European public assessment report (EPAR) for Potactasol. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Potactasol.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Potactasol. 
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Potactasol.
The European Commission granted a marketing authorisation valid throughout the European Union for Potactasol to on 06 January 2011. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Potactasol na snazi u Europskoj uniji od 6. siječnja 2011.
Other information about Potactasol 
Ostale informacije o lijeku Potactasol
For more information about treatment with Potactasol, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Više informacija o terapiji lijekom Potactasol pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
The company has provided data from the published literature on topotecan. 
Farmaceutska tvrtka je dostavila podatke o topotekan iz objavljenje literature.
This means that Potactasol is similar to a ‘reference medicine' already authorised in the European Union (EU) called Hycamtin. 
To znači da je Potactasol sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Hycamtin.
The CHMP concluded that, in accordance with EU requirements, Potactasol has been shown to be comparable to Hycamtin. 
CHMP zaključio je kako je, u skladu sa zahtjevima EU, potvrđeno kako Potactasol posjeduje usporedivu kakvoću te je usporediv s lijekom Hycamtin.
No additional studies were needed as Potactasol is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin. 
Nisu bila potrebna dodatna ispitivanja jer je Potactasol generički lijek koji se daje infuzijom i sadrži istu djelatnu tvar kao i referentni lijek Hycamtin.
Potactasol also affects non-cancer cells, which causes side effects. 
Potactasol djeluje također na netumorske stanice, što uzrokuje nuspojave.
Treatment with Potactasol should only be given under the supervision of a doctor experienced in the use of chemotherapy. 
Terapija lijekom Potactasol smije se primjenjivati samo pod nadzorom liječnika s iskustvom u primjeni kemoterapije.
Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk. 
Stoga je stav CHMP-a da, kao u slučaju lijeka Hycamtin, koristi nadmašuju utvrđeni rizik.
The Committee recommended that Potactasol be given marketing authorisation. 
Odbor je preporučio izdavanje odobrenja za stavljanje lijeka Potactasol u promet.
When used with cisplatin in cervical cancer, Potactasol is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1). 
U slučaju primjene sa cisplatinom za liječenje raka vrata maternice, Potactasol primjenjuje se 1., 2. i 3. dana (pri čemu se cisplatin primjenjuje 1. dan).
The dose of Potactasol to be used depends on the type of cancer that it is being used to treat and the patient's weight and height. 
Doza lijeka Potactasol, koju treba primijeniti, ovisi o tipu raka koji se liječi te tjelesnoj težini i visini bolesnika.
Why has Potactasol been approved? 
Zašto je lijek Potactasol odobren?
It is available as a powder to be made up into a solution for infusion (drip) into a vein. 
Postoji kao koncentrat za otopinu za infuziju (drip) u venu.
The active substance in Potactasol, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'. 
Djelatna tvar lijeka Potactasol, topotekan, je protutumorski lijek koji se ubraja u grupu „inhibitora topoisomeraze".
It is used on its own to treat patients with: 
Koristi se kao monoterapija za liječenje bolesnika s:
This summary was last updated in 10-2015. 
Sažetak je posljednji put ažuriran u 10.
When Potactasol is used on its own for ovarian cancer, it is given by infusion over 30 minutes. 
U slučaju kada se Potactasol primjenjuje kao monoterapija za liječenje karcinoma jajnika, primjenjuje se infuzijom tijekom 30 minuta.
What is Potactasol? 
Što je Potactasol?
Doses of Potactasol may need to be adjusted or treatment delayed, depending on side effects. 
Ovisno o nuspojavama može biti potrebna prilagodba doza lijeka Potactasol ili se terapija treba odgoditi.
Potactasol is a medicine that contains the active substance topotecan. 
Potactasol je lijek koji sadrži djelatnu tvar topotekan.
Potactasol is a cancer medicine. 
Potactasol je lijek protiv raka.
Because Potactasol is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Budući da je Potactasol generički VMP te je bioekvivalent referentnom VMP-u, smatra se da su njegove koristi i rizici isti kao i oni referentnog VMP-a.
Potactasol is a ‘generic medicine'. 
Potactasol je „generički lijek”.
What is Potactasol used for? 
Za što se Potactasol koristi?
How does Potactasol work? 
Kako djeluje Potactasol?
For full details, see the summary of product characteristics, also part of the EPAR. 
Za više informacija vidjeti sažetak opisa svojstava lijeka (također dio EPAR-a).
How has Potactasol been studied? 
Kako je Potactasol ispitivan?
How is Potactasol used? 
Kako se Potactasol koristi?
Strength Pharmaceutical Form 
Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja
60 sachets + 2 syringes (1 ml) + 2 syringes (3 ml) + 2 syringes (10 ml) + 2 mixing cups 
60 vrećica + 2 štrcaljke (1 ml) + 2 štrcaljke (3 ml) + 2 štrcaljke (10 ml) + 2 čaše za miješanje
Granules for oral suspension sachet (PET/Alu/LLDPE) 
(PET/Alu/LLDPE)
For more information, see here. 
Za više informacije pogledajte ovdje.
What is Masican? 
Što je Masican?
21 March 2014 EMA/167920/2014 EMEA/H/C/002670 
EMA/167920/2014 EMEA/H/C/002670
The applicant requested a re-examination of the opinion. 
Podnositelj zahtjeva zahtijevao je ponovni pregled mišljenja.
The main measure of effectiveness was progression-free survival (how long the patients lived without the disease getting worse). 
Glavna mjera djelotvornosti bilo je preživljenje bez napredovanja bolesti (koliko su dugo bolesnici živjeli bez pogoršavanja bolesti).
What were the CHMP's main concerns that led to the refusal? 
Koja je bila glavna bojazan CHMP-a koja je uzrokovala odbijanje?
What consequences does this refusal have for patients in clinical trials or compassionate use programmes? 
Koje posljedice ima ovo povlačenje za bolesnike u kliničkim ispitivanjima ili programima milosrdnog davanja lijeka?
In addition, there were still outstanding problems related to quality control during its manufacture. 
Pored toga, još uvijek postoje neriješeni problemi povezani s kontrolom kvalitete lijeka tijekom njegove proizvodnje.
The study was a ‘phase II study', an exploratory study designed to see if a medicine is worth investigating further. 
Ispitivanje je bilo „ispitivanje faze II”, eksplorativno ispitivanje osmišljeno kako bi se vidjelo je li lijek vrijedan daljnjeg ispitivanja.
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. 
Ako sudjelujete u kliničkom ispitivanju ili u programu milosrdnog davanja lijeka te Vam je potrebno više informacija o terapiji, obratite se liječniku koji Vas liječi.
Refusal of the marketing authorisation for Masican (masitinib) EMA/167920/2014 
Odbijanje zahtjeva za odobrenjem lijeka Masican (masitinib) EMA/167920/2014
Finally, there were concerns about the quality control of the medicine during manufacture, which led to uncertainties about the impurities that patients would be exposed to. 
Naposljetku, postojale su bojazni o kontroli kvalitete lijeka tijekom proizvodnje koje su uzrokovale nesigurnosti oko nečistoća kojima bi bolesnici bili izloženi.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 March 2014. 
Nakon razmatranja temelja za ovaj zahtjev, CHMP je ponovno pregledao početno mišljenje i potvrdio odbijanje odobrenja za stavljanje lijeka u promet 20. ožujka 2014.
During the re-examination, although the medicine's safety was of less concern, the Committee still had major concerns about the medicine's benefits. 
Tijekom ponovnog pregleda, iako je sigurnost lijeka predstavljala manju bojazan, Povjerenstvo je još uvijek imalo velike bojazni oko koristi lijeka.
At the time of the initial evaluation, the CHMP was concerned that the study was not designed to compare Masican with sunitinib and that it was difficult to interpret the results. 
U vrijeme inicijalne procjene, CHMP je bio zabrinut da ispitivanje nije bilo dizajnirano kako bi se usporedio Masican sa sunitinibom te da je teško protumačiti rezultate.
By blocking these receptors, Masican might help in controlling cell division and thereby slow down the growth of the cancer. 
Blokadom ovih receptora Masican može pomoći u kontroli diobe stanica i tako usporiti rast karcinoma.
On 21 November 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masican, intended for the treatment of malignant gastrointestinal stromal tumour (GIST). 
Dana 21. studenog 2013. godine, Povjerenstvo za humane lijekove (CHMP) usvojilo je negativno mišljenje i preporučilo odbijanje odobrenja za stavljanje u promet lijeka Masican koji je namijenjen za liječenje malignog gastrointestinalnog stromalnog tumora (GIST).
The study included a group of patients treated with Masican and one group treated with sunitinib, another medicine of the same class. 
Ispitivanje je uključivalo skupinu bolesnika liječenih lijekom Masican i jednu skupinu liječenih sunitinibom, drugim lijekom iste klase.
The CHMP was also concerned that safety data were only available for a few patients treated with Masican at the proposed dose and this did not allow a proper evaluation of the medicine's side effects. 
CHMP je također bio zabrinut da su sigurnosni podaci bili dostupni samo za nekoliko bolesnika liječenih lijekom Masican pri predloženoj dozi i to nije omogućilo ispravnu procjenu nuspojava lijeka.
Masican was expected to be used to treat gastrointestinal stromal tumour (GIST), a cancer of the stomach and bowel, in adults whose cancer cannot be removed surgically or has spread and is getting worse despite treatment with imatinib, another medicine used to treat this cancer. 
Očekivalo se da će se Masican koristiti za liječenje gastrointestinalnog stromalnog tumora (GIST), karcinoma trbuha i crijeva u odraslih čiji se karcinom ne može ukloniti kirurški ili se proširio te se pogoršava unatoč liječenju imatinibom, drugim lijekom za liječenje ovog karcinoma.
Therefore, the Committee concluded that there were insufficient data to establish the benefits of Masican. 
Stoga je Povjerenstvo zaključilo da nema dovoljno podataka kako bi se utvrdile koristi lijeka Masican.
Refusal of the marketing authorisation for Masican (masitinib) 
Odbijanje zahtjeva za odobrenjem lijeka Masican (masitinib)
Although the group of patients treated with Masican appeared to live longer than those treated with sunitinib, the possibility that this was a chance finding could not be ruled out because of the exploratory nature of the study and because other supportive evidence was lacking. 
Iako se čini da je skupina bolesnika liječenih lijekom Masican živjela dulje od onih bolesnika liječenih lijekom sunitinib, mogućnost da se radilo o slučajnom nalazu ne može se isključiti zbog eksplorativne prirode ispitivanja i zato jer nema drugog suportivnog dokaza.
Therefore the CHMP concluded that the benefits of Masican did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation. 
Stoga je CHMP zaključio da koristi lijeka Masican nisu nadmašile njegove rizike te je zadržao prethodnu preporuku o odbijanju odobrenja za stavljanje lijeka u promet.
The active substance in Masican, masitinib, is a tyrosine-kinase inhibitor. 
Djelatna tvar u lijeku Masican, masitinib je inhibitor tirozin kinaze.
Masican is an anticancer medicine that contains the active substance masitinib. 
Masican je lijek protiv karcinoma koji sadrži djelatnu tvar masitinib.
Masican was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 21 December 2004 for the treatment of malignant GIST. 
Masicanu je dodijeljen status „lijeka siročeta” (lijeka za liječenje rijetkih bolesti) 21. prosinca 2004. godine za liječenje malignog GIST-a.
The applicant presented results of a main study in 44 patients with GIST that could not be removed surgically or that had spread and was resistant to imatinib treatment. 
Podnositelj zahtjeva predložio je rezultate glavnog ispitivanja na 44 bolesnika s GIST-om koji se nije mogao ukloniti kirurški ili koji se proširio te je bio rezistentan na imatinib.
These enzymes can be found in some receptors on the 
Ovaj je enzim nađen u nekim receptorima na površini kanceroznih stanica
surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably. 
uključujući i receptore koji su uključeni u stimulaciju nekontrolirane diobe stanice.
What was Masican expected to be used for? 
Koja je bila očekivana namjena lijeka Masican?
How is Masican expected to work? 
Koje je bilo očekivano djelovanje lijeka Masican?
It is given to newborn calves once a day for one week. 
Daje se novorođenoj teladi jedanput dnevno tijekom jednog tjedna.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dolazi do izlučivanja u izmet.
For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of diarrhoea. 
Za prevenciju proljeva s liječenjem treba započeti unutar 24 do 48 sati od rođenja; za smanjenje proljeva s liječenjem treba započeti unutar 24 sata od početka proljeva.
Halagon halofuginone 
Halagon halofuginon
The infection is known as cryptosporidiosis. 
Ta infekcija poznata je pod nazivom kriptosporidioza.
The full EPAR for Halagon can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Cjeloviti EPAR za VMP Halagon nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
It explains how the Agency assessed this veterinary medicine to recommend its authorisation in the European Union (EU) and its conditions of use. 
Objašnjava kako je Agencija ocijenila ovaj veterinarsko-medicinski proizvod (VMP), kako bi preporučila njegovo odobrenje u Europskoj uniji (EU) i uvjete za njegovu primjenu.
Halagon should be given after feeding. 
VMP Halagon treba davati nakon hranjenja.
Halagon can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth). 
Halagon se izdaje samo na recept i dostupan je kao oralna otopina (tekućina koja se daje u usta).
The withdrawal period for meat from newborn calves treated with Halagon is 13 days. 
Razdoblje karencije za meso novorođene teladi liječene VMP-om Halagon iznosi 13 dana.
The company provided data on the quality and manufacture of Halagon. 
Proizvođač je dostavio podatke o kvaliteti i proizvodnji VMP-a Halagon.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that, in accordance with EU requirements, Halagon has been shown to have comparable quality to Halocur. 
Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Halagon posjeduje usporedivu kvalitetu s VMP-om Halocur.
The European Commission granted a marketing authorisation valid throughout the EU for Halagon on 13 December 2016. 
Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Halagon na snazi u Europskoj uniji od 13/12/2016.
What is Halagon and what is it used for? 
Što je Halagon i za što se koristi?
Halagon is a ‘generic medicine'. 
Halagon je „generički VMP”.
It is not intended to provide practical advice on how to use Halagon. 
Svrha sažetka nije davati praktične savjete o korištenju VMP-a Halagon.
What are the benefits and risks of Halagon? 
Koje su koristi i rizici VMP-a Halagon?
No additional studies were needed as Halagon is a water based oral solution containing the same active substance and other ingredients as the reference medicine, in the same concentrations. 
Nisu bila potrebna dodatna ispitivanja jer je VMP Halagon oralna otopina na bazi vode koja sadrži istu djelatnu tvar i druge sastojke u istim koncentracijama kao i referentni VMP.
Why is Halagon approved? 
Zašto je Halagon odobren?