natgillin/translations-raw huggingface dataset:
• itching in the hand 
• srbenje roke;
Powder and solvent for solution for injection. 
PIP sklepov po enkratni injekciji na prizadeti sklep.
The company withdrew the application on 29 October 2019. 
Družba je vlogo umaknila 29. oktobra 2019.
In addition, more data were needed to show that the quality of the medicine is consistent. 
Poleg tega je potrebnih več podatkov, ki bodo pokazali doslednost pri kakovosti zdravila.
As a result, bacteria cannot multiply and they die. 
Bakterije se tako ne morejo razmnoževati in posledično umrejo.
The Agency considered that the two studies presented did not show convincingly that the medicine was effective. 
Agencija je menila, da predstavljeni študiji nista dovolj prepričljivo pokazali, da je zdravilo učinkovito.
What did the Agency recommend at that time? 
Kakšno je bilo takrat priporočilo agencije?
This was intended to slow down the medicine's release into the lungs, allowing it to act for longer. 
Tako naj bi se upočasnilo sproščanje zdravila v pljuča, kar bi omogočilo daljše delovanje.
How does Linhaliq work? 
Kako zdravilo Linhaliq deluje?
The company presented the results of two studies in a total of 582 patients with non-cystic fibrosis bronchiectasis. 
Družba je predstavila rezultate dveh študij pri skupno 582 bolnikih z bronhiektazijami brez cistične fibroze.
What is Linhaliq and what was it intended to be used for? 
Kaj je zdravilo Linhaliq in za kaj naj bi se uporabljalo?
Does this withdrawal affect patients in clinical trials or compassionate use programmes? 
Kakšne so posledice umika vloge za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila?
Fluoroquinolones work by preventing bacteria from making copies of their DNA (genetic material). 
Fluorokinoloni delujejo, tako da bakterijam preprečujejo kopiranje njihove lastne DNK (genetskega materiala).
The application was withdrawn after that the European Medicines Agency had evaluated the information from the company and prepared questions for the company. 
Vlogo so umaknili po tem, ko je Evropska agencija za zdravila že ocenila informacije, ki jih je predložila družba, in oblikovala seznam vprašanj.
The company informed the Agency that there are no ongoing clinical trials or compassionate use programmes with Linhaliq. 
Družba je agencijo obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe z zdravilom Linhaliq.
Withdrawal of application for the marketing authorisation of Linhaliq (ciprofloxacin) EMA/610519/2019 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Linhaliq (ciprofloksacin) EMA/610519/2019
The main measure of effectiveness was the time it took until patients had a flare-up of bronchiectasis. 
Glavno merilo učinkovitosti je bil čas do izbruha bronhiektazij pri bolniku.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it decided to withdraw its application because the data provided do not allow EMA's committee for human medicines to conclude on a positive benefit-risk balance for the medicine. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da se je odločila umakniti vlogo, saj predloženi podatki odboru CHMP pri agenciji EMA ne omogočajo pozitivne ocene razmerja med tveganji in koristmi zdravila.
The active substance in Linhaliq, ciprofloxacin, is an antibiotic belonging to a group called fluoroquinolones. 
Učinkovina v zdravilu Linhaliq, ciprofloksacin, je antibiotik, ki spada v skupino, imenovano fluorokinoloni.
The company had responded to the last round of questions, and the Agency was completing its assessment of the responses at the time of the withdrawal. 
Družba je odgovorila na zadnja zastavljena vprašanja in agencija je ob umiku vloge ocenjevala odgovore družbe na zastavljena vprašanja.
Linhaliq was developed for patients with ‘non-cystic fibrosis bronchiectasis', which means it was not intended for patients with bronchiectasis due to cystic fibrosis. 
Zdravilo Linhaliq so razvili za bolnike z „bronhoektazijami brez cistične fibroze“, kar pomeni, da ni bilo namenjeno bolnikom z bronhiektazijami, ki so posledica cistične fibroze.
Therefore, at the time of the withdrawal, the Agency's opinion was that the benefits of Linhaliq did not outweigh its risks. 
Zato je agencija ob umiku vloge menila, da koristi zdravila Linhaliq ne odtehtajo z njim povezanih tveganj.
In each study Linhaliq was compared with placebo (a dummy treatment). 
V obeh študijah so zdravilo Linhaliq primerjali s placebom (zdravilom brez učinkovine).
Withdrawal of application for the marketing authorisation of Linhaliq (ciprofloxacin) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Linhaliq (ciprofloksacin)
Linhaliq contains the active substance ciprofloxacin and was to be available for inhalation using an inhaler device. 
Zdravilo Linhaliq vsebuje učinkovino ciprofloksacin in naj bi bilo na voljo za inhaliranje z uporabo inhalacijskega pripomočka.
In Linhaliq, some of the active substance is enclosed in tiny fat particles called liposomes. 
V zdravilu Linhaliq nekaj učinkovine vsebujejo majhni maščobni delci, imenovani liposomi.
Bronchiectasis is a long-term condition in which the airways have widened and become flabby and scarred, with a build-up of mucus. 
Bronhiektazije so dolgotrajna bolezen, pri kateri se kopiči sluz in se razširijo dihalne poti, ki postanejo mlahave in brazgotinaste.
Based on the review of the data, at the time of the withdrawal, the Agency had several concerns and its provisional opinion was that Linhaliq could not have been authorised for treating or preventing flare-ups in adults with non-cystic fibrosis bronchiectasis who have long-term lung infection with Pseudomonas aeruginosa. 
Agencija je na podlagi pregleda podatkov ob umiku vloge izrazila več zadržkov in je začasno menila, da zdravila Linhaliq ni mogoče odobriti za zdravljenje ali preprečevanje izbruhov bronhiektazij brez cistične fibroze pri odraslih, ki imajo dolgotrajno pljučno okužbo z bakterijo Pseudomonas aeruginosa.
Linhaliq was developed as a medicine for preventing and reducing exacerbations (flare-ups) of bronchiectasis in adults who have long-term lung infection with Pseudomonas aeruginosa bacteria. 
Zdravilo Linhaliq so razvili za preprečevanje in zmanjševanje poslabšanj (izbruhov) bronhiektazij pri odraslih z dolgotrajno pljučno okužbo z bakterijo Pseudomonas aeruginosa.
Aradigm Pharmaceuticals Limited withdrew its application for a marketing authorisation of Linhaliq for treating and preventing flare-ups of bronchiectasis in patients with long-term lung infection caused by Pseudomonas aeruginosa bacteria. 
Družba Aradigm Pharmaceuticals Limited je umaknila vlogo za pridobitev dovoljenja za promet z zdravilom Linhaliq, namenjenim zdravljenju in preprečevanju izbruhov bronhiektazije pri bolnikih z dolgotrajno pljučno okužbo z bakterijo Pseudomonas aeruginosa.
The most common side effect with Bovilis Blue-8 (which may affect up to 1 in 10 animals) is an increase in body temperature between 0.5 and 1.0˚C that lasts no longer than one to two days. 
Najpogostejši neželeni učinek zdravila Bovilis Blue-8 (ki lahko prizadene največ 1 žival od 10) je povišanje telesne temperature od 0,5 do 1,0 ˚C, ki ne traja dlje kot dan do dva.
The effectiveness of the vaccine was investigated in a number of laboratory trials in sheep and cattle of the minimum recommended age. 
Učinkovitost zdravila so proučevali v vrsti laboratorijskih preskušanj pri ovcah in govedu najmanjše priporočene starosti.
For booster vaccination a single injection is given every year. 
Za poživitveno cepljenje se vsako leto injicira en odmerek.
The full EPAR for Bovilis Blue-8 can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila Bovilis Blue-8 je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovilis Blue-8's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Bovilis Blue-8 večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This is a summary of the European public assessment report (EPAR) for Bovilis Blue-8. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bovilis Blue-8.
This medicine is the same as Bluevac BTV8, which is already authorised in the EU. 
To zdravilo je enako zdravilu Bluevac BTV8, ki je že odobreno v Evropski uniji (EU).
In the future, if the animals are exposed to the same type of bluetongue virus, the immune system will be able to produce antibodies more quickly. 
Ob ponovni izpostavitvi istemu tipu virusa modrega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
The European Commission granted a marketing authorisation valid throughout the EU for Bovilis Blue-8 on 21 November 2017. 
Evropska komisija je dovoljenje za promet z zdravilom Bovilis Blue-8, veljavno po vsej Evropski uniji, izdala 21/11/2017.
The withdrawal period for meat and milk from cattle and sheep treated with Bovilis Blue-8 is ‘zero' days, which means there is no mandatory waiting time. 
Karenca za meso in mleko goveda in ovac, zdravljenih z zdravilom Bovilis Blue-8, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
The main measures of the effectiveness of the vaccine were viraemia (levels of BTV8 in the blood) and clinical signs of bluetongue virus infection. 
Glavna merila učinkovitosti cepiva so bila viremija (količina virusa BTV8 v krvi) in klinični znaki okužbe z virusom modrega jezika.
The studies showed that the vaccine prevents viraemia in sheep and cattle and reduces clinical signs in sheep when infected with bluetongue virus serotype 8. 
Študije so pokazale, da cepivo preprečuje viremijo pri ovcah in govedu ter zmanjšuje klinične znake pri ovcah, okuženih s serotipom 8 virusa modrega jezika.
For the full list of restrictions and all side effects reported with Bovilis Blue-8, see the package leaflet. 
Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Bovilis Blue-8, glejte navodilo za uporabo.
bluetongue virus vaccine, serotype 8 (inactivated) 
cepivo z virusom modrega jezika, serotip 8 (inaktivirano)
This authorisation was based on the authorisation granted to Bluevac BTV8 in 2011 (‘informed consent'). 
Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Bluevac BTV8, ki je bilo izdano leta 2011 („uporaba dokumentacije s soglasjem“).
Bovilis Blue-8 is a vaccine. 
Zdravilo Bovilis Blue-8 je cepivo.
Bovilis Blue-8 contains bluetongue viruses of one type (‘serotype 8'). 
Zdravilo Bovilis Blue-8 vsebuje en tip virusov modrega jezika („serotip 8“).
The company that makes Bluevac BTV8 has agreed that its scientific data can be used for Bovilis Blue-8 (‘informed consent'). 
Družba, ki proizvaja zdravilo Bluevac BTV8, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Bovilis Blue-8 („uporaba dokumentacije s soglasjem“).
The vaccine is used to prevent viraemia (the presence of viruses in the blood) and to reduce clinical signs caused by bluetongue virus in sheep and to prevent viraemia in cattle. 
Cepivo se uporablja pri ovcah za preprečevanje viremije (prisotnosti virusov v krvi) in zmanjšanje kliničnih znakov, ki jih povzroča virus modrega jezika, ter pri govedu za preprečevanje viremije.
Bovilis Blue-8 is a vaccine used in cattle and sheep to protect them against bluetongue disease, an infection caused by the bluetongue virus, which is transmitted by midges. 
Zdravilo Bovilis Blue-8 je cepivo, ki se uporablja pri govedu in ovcah za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo prenašajo trzače, povzroča pa jo virus modrega jezika.
Other information about Bovilis Blue-8: 
Druge informacije o zdravilu Bovilis Blue-8:
For practical information about using Bovilis Blue-8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za praktične informacije o uporabi zdravila Bovilis Blue-8 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
For more information about treatment with Bovilis Blue-8, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist. 
Za več informacij o zdravljenju z zdravilom Bovilis Blue-8 naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
The vaccine contains inactivated (killed) bluetongue virus, serotype 8. 
Cepivo vsebuje inaktivirane (uničene) viruse modrega jezika, serotip 8.
What are the risks associated with Bovilis Blue-8? 
Kakšna tveganja so povezana z zdravilom Bovilis Blue-8?
Bovilis Blue-8 contains a bluetongue virus that has been inactivated so that it cannot cause the disease. 
Cepivo Bovilis Blue-8 vsebuje inaktivirani virus modrega jezika, ki ne povzroča bolezni.
What benefits of Bovilis Blue-8 have been shown in studies? 
Kakšne koristi je zdravilo Bovilis Blue-8 izkazalo v študijah?
What is Bovilis Blue-8 and what is it used for? 
Kaj je zdravilo Bovilis Blue-8 in za kaj se uporablja?
Why is Bovilis Blue-8 approved? 
Zakaj je bilo zdravilo Bovilis Blue-8 odobreno?
How does Bovilis Blue-8 work? 
Kako zdravilo Bovilis Blue-8 deluje?
How is Bovilis Blue-8 used? 
Kako se zdravilo Bovilis Blue-8 uporablja?
The recommended dose is one tablet taken once a day. 
Priporočeni odmerek zdravila je ena tableta enkrat dnevno.
The tablets must always be taken after the patient has fasted overnight for at least six hours and at least 30 minutes before the first food or drink of the day. 
Tableto mora bolnik vedno vzeti zjutraj na tešče, ko ni jedel vsaj šest ur, in vsaj 30 minut pred prvim obrokom ali pijačo.
This leads to less bone loss. 
Zaradi tega je izgubljanje kostne mase manjše.
The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases. 
Zmanjšano izgubljanje kostnine pripomore k manjši verjetnosti zloma, kar je koristno za preprečevanje zlomov pri bolnikih z rakom in metastazami v kosteh.
The patient must also not lie down for one hour after taking the tablets. 
Eno uro po tem bolnik ne sme ležati.
The full EPAR for Ibandronic Acid Sandoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ibandronic Acid Sandoz je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It stops the action of osteoclasts, the cells in the body that are involved in breaking down the bone tissue. 
Ta zavira delovanje osteoklastov, tj. celic v telesu, ki sodelujejo pri razgradnji kostnega tkiva.
Ibandronic Acid Sandoz is used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone). 
Zdravilo Ibandronic Acid Sandoz se uporablja za preprečevanje z okostjem povezanih dogodkov (zlomov kosti ali z okostjem povezanih zapletov, ki zahtevajo zdravljenje) pri bolnikih z rakom dojke in metastazami v kosteh (ko se je rak razširil v kosti).
This means that Ibandronic Acid Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU). 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU).
For more information about treatment with Ibandronic Acid Sandoz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Ibandronic Acid Sandoz preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
This document is a summary of the European public assessment report (EPAR) for Ibandronic Acid Sandoz. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ibandronic Acid Sandoz.
Ibandronic Acid Sandoz must be taken with a full glass of plain water (but not mineral water) while standing or sitting up, and the tablets should not be chewed, sucked or crushed. 
Zdravilo Ibandronic Acid Sandoz je treba vzeti v stoječem ali sedečem položaju in popiti poln kozarec navadne (ne mineralne) vode; tableta se ne sme žvečiti, lizati ali zdrobiti.
Because Ibandronic Acid Sandoz 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. 
Ker je zdravilo Ibandronic Acid Sandoz generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
The European Commission granted a marketing authorisation valid throughout the EU for Ibandronic Acid Sandoz on 26 July 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Ibandronic Acid Sandoz, veljavno po vsej Evropski uniji, izdala 26. julija 2011.
Because Ibandronic Acid Sandoz is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine. 
Ker je zdravilo Ibandronic Acid Sandoz generično zdravilo, so bile študije na ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu.
The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Sandoz has been shown to have comparable quality and to be bioequivalent to Bondronat. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ibandronic Acid Sandoz primerljivo raven kakovosti kot zdravilo Bondronat in da mu je biološko enakovredno.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ibandronic Acid Sandoz, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
What measures are being taken to ensure the safe and effective use of Ibandronic Acid Sandoz? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ibandronic Acid Sandoz ?
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 Ibandronic Acid Sandoz. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Ibandronic Acid Sandoz, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Ibandronic Acid Sandoz ibandronic acid 
Ibandronic Acid Sandoz ibandronska kislina
Other information about Ibandronic Acid Sandoz: 
Druge informacije o zdravilu Ibandronic Acid Sandoz:
The Committee recommended that Ibandronic Acid Sandoz be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Ibandronic Acid Sandoz izda dovoljenje za promet.
Ibandronic Acid Sandoz is a ‘generic medicine'. 
Ibandronic Acid Sandoz je „generično zdravilo“.
What are the benefits and risks of Ibandronic Acid Sandoz? 
Kakšne so koristi in tveganja, povezani z zdravilom Ibandronic Acid Sandoz?
A risk management plan has been developed to ensure that Ibandronic Acid Sandoz is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Ibandronic Acid Sandoz je bil pripravljen načrt obvladovanja tveganj.
Ibandronic Acid Sandoz is a medicine that contains the active substance ibandronic acid. 
Ibandronic Acid Sandoz je zdravilo, ki vsebuje zdravilno učinkovino ibandronska kislina.
The reference medicine for Ibandronic Acid Sandoz is Bondronat. 
Referenčno zdravilo za Ibandronic Acid Sandoz je zdravilo Bondronat.
Why has Ibandronic Acid Sandoz been approved? 
Zakaj je bilo zdravilo Ibandronic Acid Sandoz odobreno?
The active substance in Ibandronic Acid Sandoz, ibandronic acid, is a bisphosphonate. 
Zdravilna učinkovina v zdravilu Ibandronic Acid Sandoz, ibandronska kislina, je difosfonat.
What is Ibandronic Acid Sandoz? 
Kaj je zdravilo Ibandronic Acid Sandoz?
How has Ibandronic Acid Sandoz been studied? 
Kako je bilo zdravilo Ibandronic Acid Sandoz raziskano?
How does Ibandronic Acid Sandoz work? 
Kako zdravilo Ibandronic Acid Sandoz deluje?
What is Ibandronic Acid Sandoz used for? 
Za kaj se zdravilo Ibandronic Acid Sandoz uporablja?
How is Ibandronic Acid Sandoz used? 
Kako se zdravilo Ibandronic Acid Sandoz uporablja?
17 December 2009 EMA/830685/2009 EMEA/H/C/1020 
17. december 2009 EMEA/830685/2009 EMEA/H/C/1020
Idiopathic means that the disease has no obvious cause. 
Idiopatsko pomeni, da bolezen nima nikakršnega očitnega vzroka.
The 210 patients who completed the first 12 weeks were also offered the opportunity to continue treatment in an extension study. 
Prav tako so 210 bolnikom, ki so zaključili prvih 12 tednov zdravljenja, ponudili možnost nadaljevanja zdravljenja v podaljšku študije.
The company had also provided results on studies involving patients with Parkinson's disease. 
Družba je prav tako priložila rezultate študij, ki so vključevale bolnike s Parkinsonovo boleznijo.
The effects of Nenad were first tested in experimental models before being studied in humans. 
Učinki zdravila Nenad so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
There were also problems with the patches not sticking well enough to the skin. 
Prav tako so se pojavljale težave, ker se obliž ni dovolj dobro prilepil na kožo.
What is Nenad? 
Kaj je zdravilo Nenad?
Restless legs syndrome is a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night. 
Sindrom nemirnih nog je motnja, pri kateri ima bolnik nenadzorovano potrebo po premikanju okončin, da prepreči neprijetne, boleče ali nenavadne občutke v telesu, najpogosteje ponoči.
The company presented results of one main study of 309 patients with moderate-to-severe restless legs syndrome. 
Družba je predložila rezultate ene glavne študije, ki je vključevala 309 bolnikov z zmernim do hudim sindromom nemirnih nog.
On 30 November 2009, Axxonis Pharma AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Nenad, for the treatment of the signs and symptoms of moderate-to-severe idiopathic restless legs syndrome in adults. 
Družba Axxonis Pharma AG je dne 30. novembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Nenad, namenjenim zdravljenju znakov in simptomov zmernega do hudega idiopatskega sindroma nemirnih nog pri odraslih.
The Committee was also concerned that a large proportion of patients in the study stopped treatment with Nenad because of skin irritation, making the patch unsuitable for long-term use. 
Odbor je prav tako izrazil zaskrbljenost nad tem, da je velik delež bolnikov v študiji prekinil zdravljenje z zdravilom Nenad zaradi draženja kože, zaradi česar je obliž neprimeren za dolgotrajno uporabo.
What documentation did the company present to support its application to the Agency? 
Katero dokumentacijo je družba predložila Evropski agenciji za zdravila v podporo svoji vlogi?
Since restless legs syndrome is often a lifelong disease, long-term data were considered essential. 
Ker je sindrom nemirnih nog pogosto doživljenjska bolezen, so podatki o dolgotrajnih učinkih bistveni.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Nenad? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Nenad?