FrancophonIA/ELRC3.0 huggingface dataset:
English: Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Croatian: Preporučene modifikacije liječenja za YERVOY u kombinaciji s nivolumabom ili primjena u drugoj fazi liječenja (nivolumab u monoterapiji) nakon kombiniranog liječenja Stevens-Johnsonov sindrom (SJS) ili toksična epidermalna nekroliza (TEN)
English: Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.35 (0.22, 0.55) Nivolumab vs. Ipilimumab - hazard ratio: 0.41 (0.27, 0.62) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.87 (0.54, 1.41)
Croatian: Nivolumab+ipilimumab naspram ipilimumaba - omjer hazarda 0,35 (0,22, 0,55) Nivolumab naspram ipilimumaba - omjer hazarda: 0,41 (0,27, 0,62)
English: The following side effects have been reported in patients receiving 3 mg/kg ipilimumab alone:
Croatian: U bolesnika koji su primali samo ipilimumab 3 mg/kg zabilježene sljedeće nuspojave
English: ipilimumab Median OS (95% CI)
Croatian: ipilimumab Medijan OS-a (95% CI)
English: Uncommon pleural effusion Gastrointestinal disorders Very common colitisa, diarrhoea, vomiting, nausea,
Croatian: Manje često pleuralni izljev Poremećaji probavnog sustava Vrlo često kolitisa, proljev, povraćanje, mučnina, bol u abdomenu proljev, povraćanje, mučnina
English: NR (32.72, NR)
Croatian: N.D. (26.45, N.D.)
English: Hepatitis
Croatian: Dojenje
English: If no side effects are experienced during the initial treatment, the injections can be repeated after at least 3 months.
Croatian: Ako tijekom početnog liječenja ne dođe do nikakvih nuspojava, injekcije se mogu ponoviti nakon najmanje tri mjeseca.
English: Further information on Nuceiva can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nuceiva.
Croatian: Više informacija o lijeku Nuceiva dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/nuceiva.
English: Further data on the long-term safety of the medicine will be collected post-marketing.
Croatian: Dodatni podatci o dugoročnoj sigurnosti lijeka prikupit će se nakon stavljanja lijeka u promet.
English: The medicine is injected in 5 different places above and between the eyebrows.
Croatian: Lijek se injektira u pet različitih mjesta iznad i između obrva.
English: What is Nuceiva and what is it used for?
Croatian: Što je Nuceiva i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Nuceiva?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nuceiva?
English: Nuceiva (botulinum toxin type A) EMA/249428/2019
Croatian: Nuceiva (botulinski toksin tipa A) EMA/249428/2019
English: Other information about Nuceiva
Croatian: Ostale informacije o lijeku Nuceiva
English: Serious side effects include drooping eyelids, immune responses (when the body's defence system produces antibodies against the botulinum toxin which stop the medicine from working), spread of the toxin to other parts of the body (which may lead to muscle weakness, difficulty breathing or swallowing, and constipation), development or worsening of disorders affecting the muscles and nerves, and hypersensitivity (allergic) reactions.
Croatian: Ozbiljne nuspojave uključuju spuštanje očnog kapka, imunosne odgovore (kada obrambeni mehanizam tijela proizvodi antitijela protiv botulinskog toksina koja blokiraju djelovanje lijeka), širenje toksina u druge dijelove tijela (što može dovesti do slabosti mišića, poteškoća pri disanju ili gutanju i konstipacije), razvoj ili pogoršanje poremećaja koji zahvaćaju mišiće i živce te reakcije (alergijske) preosjetljivosti.
English: Side effects reported with Nuceiva are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Nuceiva pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The European Medicines Agency decided that Nuceiva's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Nuceiva nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The toxin reduces the release of acetylcholine, a chemical messenger that causes muscle contraction.
Croatian: Toksin smanjuje oslobađanje acetilkolina, kemijskog glasnika koji uzrokuje kontrakcije mišića.
English: Thirty days after treatment, 87% (205 out of 235) of adults who received Nuceiva had either mild or no vertical lines between the eyebrows, compared with 83% (202 out of 244) of patients who received another medicine containing botulinum toxin type A and 4% (2 out of 48) of patients who were given placebo.
Croatian: Trideset dana nakon liječenja, 87 % (205 od 235) odraslih osoba koje su primale lijek Nuceiva imale su blage vertikalne bore između obrva ili su one potpuno nestale, u usporedbi s 83 % (202 od 244) bolesnika koji su primali drugi lijek koji sadrži botulinski toksin tipa
English: It is used in adults less than 65 years of age who have moderate to severe facial lines and in whom those lines are having a significant psychological impact.
Croatian: Koristi se u odraslih osoba mlađih od 65 godina koje imaju umjereno do jako izražene bore na licu i kod kojih te bore imaju značajan psihološki učinak.
English: The effectiveness of treatment was measured using a standard 4-point scale, called glabellar line scale (GLS), where 0 = no lines, 1 = mild, 2 =moderate and 3 = severe.
Croatian: Učinkovitost liječenja mjerena je standardnom ljestvicom od četiri vrijednosti, koja se naziva ljestvica glabelarnih bora (GLS), prema kojoj su vrijednosti: 0=nema bora, 1=blage, 2=umjerene, 3=jako izražene.
English: The most common side effects with Nuceiva (which may affect up to 1 in 10 people) include headache and drooping eyelids.
Croatian: Najčešće nuspojave lijeka Nuceiva (koje se mogu javiti u najviše 1 na 10 osoba) uključuju glavobolju i spuštanje očnog kapka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nuceiva have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Nuceiva nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Nuceiva must not be used in people with diseases affecting the muscles, such as myasthenia gravis or Eaton-Lambert syndrome, and those who have an infection or inflammation at the planned site of injection.
Croatian: Lijek Nuceiva ne smije se primjenjivati u osoba oboljelih od bolesti koje zahvaćaju mišiće, kao što su miastenija gravis ili Eaton-Lambertov sindrom, i u onih koji imaju infekciju ili upalu na planiranom mjestu primjene injekcije.
English: For more information about using Nuceiva, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Nuceiva pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: The side effects seen with Nuceiva are as expected from this type of medicine and do not raise any major concerns.
Croatian: Nuspojave zabilježene prilikom primjene lijeka Nuceive očekivane su za ovu vrstu lijeka i ne izazivaju ozbiljne razloge za zabrinutost.
English: As for all medicines, data on the use of Nuceiva are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Nuceiva kontinuirano se prate.
English: An overview of Nuceiva and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Nuceiva i zašto je odobren u EU-u
English: The medicine can only be obtained with a prescription and must be given by a doctor with expertise in the treatment of vertical lines between the eyebrows and the use of the required equipment.
Croatian: Lijek se izdaje samo na recept i mora ga davati liječnik s iskustvom u liječenju vertikalnih bora između obrva i iskustvom u rukovanju odgovarajućom opremom.
English: Why is Nuceiva authorised in the EU?
Croatian: Zašto je lijek Nuceiva odobren u EU-u?
English: What are the risks associated with Nuceiva?
Croatian: Koji su rizici povezani s lijekom Nuceiva?
English: Nuceiva has been shown to make the vertical lines between the eyebrows less noticeable in a main study involving 540 adults with moderate or severe vertical lines that affected their mood or caused symptoms of anxiety or depression.
Croatian: Pokazalo se da lijek Nuceiva vertikalne bore između obrva čini manje uočljivima u glavnom ispitivanju na 540 odraslih osoba s umjerenim ili jako izraženim vertikalnim borama koje su utjecale na njihovo raspoloženje ili su uzrokovale nastanak simptoma anksioznosti ili depresije.
English: The active substance in Nuceiva, botulinum toxin type A, is produced by the bacterium Clostridium botulinum.
Croatian: Djelatnu tvar u lijeku Nuceiva, botulinski toksin tipa A, proizvodi bakterija Clostridium botulinum.
English: When Nuceiva is injected directly into the muscles above and between the eyebrows, it causes the muscles to relax, helping to make the vertical lines less noticeable.
Croatian: Kada se Nuceiva injicira izravno u mišiće iznad ili između obrva, time se postiže relaksacija mišića, što vertikalne bore čini manje uočljivima.
English: Nuceiva is a medicine used to temporarily improve the appearance of vertical frown lines between the eyebrows.
Croatian: Nuceiva je lijek koji se koristi za privremeno poboljšanje izgleda vertikalnih bora između obrva vidljivih pri mrštenju.
English: How does Nuceiva work?
Croatian: Kako djeluje Nuceiva?
English: Nuceiva is given by injection into the muscles in the forehead whose contractions cause the vertical lines between the eyebrows.
Croatian: Nuceiva se primjenjuje injektiranjem u mišiće čela čija kontrakcija uzrokuje stvaranje vertikalnih bora između obrva.
English: What benefits of Nuceiva have been shown in studies?
Croatian: Koje su koristi od lijeka Nuceiva utvrđene u ispitivanjima?
English: Nuceiva (botulinum toxin type A)
Croatian: Nuceiva (botulinski toksin tipa
English: Nuceiva contains the active substance botulinum toxin type A.
Croatian: Nuceiva sadrži djelatnu tvar botulinski toksin tipa A.
English: How is Nuceiva used?
Croatian: Kako se Nuceiva primjenjuje?
English: For the full list of side effects of Nuceiva, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Nuceiva potražite u uputi o lijeku.
English: Nuceiva is at least as effective as another medicine containing botulinum toxin type A and more effective than placebo in adults with moderate to severe vertical lines between the eyebrows.
Croatian: Nuceiva je barem jednako učinkovit kao drugi lijek koji sadrži botulinski toksin tip
English: In the study, Nuceiva was compared with another medicine containing botulinum toxin type A and placebo (a dummy treatment).
Croatian: U tom je ispitivanju lijek Nuceiva uspoređen s drugim lijekom koji je sadržavao botulinski toksin tipa
English: Invented name Strength Pharmaceutical form Route of administration Immediate Packaging
Croatian: Put primjene Unutarnje pakovanje Veličina pakovanja
English: MA (EU) number
Croatian: Broj (EU) odobrenja (Zaštićeno) ime Doza Farmaceutski oblik
English: EMA/CHMP/472738/2013 EMEA/H/C/002679
Croatian: EMA/472738/2013 EMEA/H/C/002679
English: This summary was last updated in 09/2013.
Croatian: Sažetak je posljednji put ažuriran 09-2013.
English: However, the CHMP considered that its effects on reducing the rate of exacerbations were too small to recommend the use for reducing exacerbations.
Croatian: Međutim, CHMP je smatrao da su njegovi učinci na smanjivanje stope pogoršavanja bili premaleni kako bi se preporučila njegova upotreba za smanjivanje pogoršavanja.
English: The full EPAR for Ultibro 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 ocjeni dokumentacije o lijeku (EPAR) za Ultibro Breezhaler može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Ultibro Breezhaler is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Ultibro Breezhaler koristi što je sigurnije moguće.
English: It is taken at the same time each day using the Ultibro Breezhaler device.
Croatian: Uzima se svaki dan u isto vrijeme upotrebom uređaja Ultibro Breezhaler.
English: Ultibro Breezhaler has been studied in two main studies involving a total of 2,667 patients with COPD.
Croatian: Ultibro Breezhaler ispitan je u dva glavna ispitivanja koja uključuju 2 667 bolesnika s KOBP.
English: It is not intended to provide practical advice on how to use Ultibro Breezhaler.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja Ultibro Breezhaler.
English: Ultibro Breezhaler is a medicine that contains two active substances, indacaterol (85 micrograms) and glycopyrronium (43 micrograms).
Croatian: Ultibro Breezhaler je lijek koji sadrži dvije djelatne tvari, indakaterol (85 mikrograma) o glikopironij (43 mikrograma).
English: In both studies, the main measure of effectiveness was how Ultibro Breezhaler improved patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 26 weeks of treatment.
Croatian: U oba ispitivanja, glavna mjera djelotvornosti bila je način na koji je Ultibro Breezhaler poboljšao bolesnikove forsirane izdisajne volumene (FEV1, maksimalni volumen zraka koji osoba može izdahnuti u jednoj sekundi) nakon 26 tjedana liječenja.
English: This is a summary of the European public assessment report (EPAR) for Ultibro Breezhaler.
Croatian: Ovo je sažetak Europskog javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Ultibro Breezhaler.
English: The effects of Ultibro Breezhaler when used to relieve symptoms of COPD were clinically meaningful.
Croatian: Učinci lijeka Ultibro Breezhaler, kad se koristi za olakšavanje simptoma KOBP, bili su klinički značajni.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ultibro Breezhaler on 19 September 2013.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za Ultibro Breezhaler vrijedi na prostoru Europske unije od 19/09/2013.
English: Ultibro Breezhaler also increased FEV1 by 70 ml more than indacaterol alone and 90 ml more than glycopyrronium alone.
Croatian: Ultibro Breezhaler također je povećao FEV1 za 70 ml više od samo indakaterola i za 90 ml više od samog glikopirija.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ultibro Breezhaler's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Ultibro Breezhaler nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: The most common side effects with Ultibro Breezhaler (which may affect more than 1 in 10 people) are upper respiratory tract infections (colds).
Croatian: Najčešće su nuspojave lijeka Ultibro Breezhaler (koje se mogu javiti u više od 1 na 10 osoba) infekcije gornjeg respiratornog trakta (prehlade).
English: Ultibro Breezhaler is available as capsules containing a powder for inhalation and can only be obtained with a prescription.
Croatian: Ultibro Breezhaler dostupan je u obliku koje sadrže prašak za inhalaciju o može se dobiti samo na recept.
English: The reduction in the rate of exacerbations was 10 to 12% higher with Ultibro Breezhaler than with tiotropium and glycopyrronium.
Croatian: Smanjenje stope pogoršanja bila je 10 do 12 % viša s lijekom Ultibro Breezhaler nego s tiotropijem i glikopironijem.
English: The first study showed that treatment with Ultibro Breezhaler was more effective than placebo and increased FEV1 by an average of 200 ml more.
Croatian: Prvo je ispitivanje pokazalo da je liječenje lijekom Ultibro Breezhaler bilo djelotvornije od placeba i da je povećalo FEV1 u prosjeku za 200 ml više.
English: The active substances in Ultibro Breezhaler, indacaterol and glycopyrronium, work in different ways to widen the airways and improve breathing in COPD.
Croatian: Djelatne tvari u Ultibro Breezhaler, indakaterol i glikopironij, djeluju na različite načine kako bi proširili dišne putove i poboljšali disanje u KOBP.
English: For more information about treatment with Ultibro Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju s Ultibro Breezhaler pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: In patients with severely reduced kidney function Ultibro Breezhaler should only be used after a careful benefit-risk assessment.
Croatian: U bolesnika s teško oštećenom funkcijom bubrega Ultibro Breezhaler treba koristiti samo nakon pomne procjene omjera koristi i rizika.
English: Regarding its safety, Ultibro Breezhaler is comparable to indacaterol and glycopyrronium used as separate medicines.
Croatian: Vezano uz njegovu sigurnosti, Ultibro Breezhaler može se uspoređivati s indakaterolom i glikopironijem koji se koriste kao zasebni lijekovi.
English: What measures are being taken to ensure the safe and effective use of Ultibro Breezhaler?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ultibro Breezhaler?
English: While one study compared the effects of Ultibro Breezhaler with those of placebo (a dummy inhalation), or indacaterol or glycopyrronium alone, the other study compared Ultibro Breezhaler with fluticasone plus salmeterol, a standard treatment for COPD.
Croatian: Dok je jedno ispitivanje uspoređivalo učinke lijeka Ultibro Breezhaler s onima od placeba (slijepa inhalacija) ili samog indakaterola ili glikopirija, drugo je ispitivanje uspoređivalo Ultibro Breezhaler s flutikazonom i salmeterolom, standardnim liječenjem za KOBP.
English: For practical information about using Ultibro Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju Ultibro Breezhaler bolesnici trebaju pročitati u uputi o lijeku ili se obratiti svom liječniku ili ljekarniku.
English: A third study studied the effects of Ultibro Breezhaler on the rate of exacerbations (flare-ups) patients experienced during 64 weeks of treatment when compared with treatment with glycopyrronium or tiotropium (other treatments for COPD).
Croatian: Treće je ispitivanje proučavalo učinke lijeka Ultibro Breezhaler na stupanj egzarcebacija (pogoršanja) kod bolesnika koji su prošli 64 tjedna liječenja u usporedbi s liječenjem glikopironijem ili tiotropijem (druga liječenja za KOBP).
English: In the second study the average increase in FEV1 was 140 ml more with Ultibro Breezhaler treatment than with treatment with fluticasone and salmeterol.
Croatian: U drugom ispitivanju prosječan porast u FEV1 bio je 140 ml viši s Ultibro Breezhaler nego s flutikazonom i salmeterolom.
English: Other information about Ultibro Breezhaler
Croatian: Druge informacije o Ultibro Breezhaler
English: What is Ultibro Breezhaler and what is it used for?
Croatian: Što je Ultibro Breezhaler i za što se koristi?
English: What are the risks associated with Ultibro Breezhaler?
Croatian: Koji su rizici povezani s lijekom Ultibro Breezhaler?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ultibro Breezhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Breezhaler uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: For the full list of all side effects reported with Ultibro Breezhaler, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s Ultibro Breezhaler potražite u uputi o lijeku.
English: Why is Ultibro Breezhaler approved?
Croatian: Za što je Ultibro Breezhaler odobren?
English: How does Ultibro Breezhaler work?
Croatian: Kako Ultibro Breezhaler djeluje?
English: What benefits of Ultibro Breezhaler have been shown in studies?
Croatian: Koje su koristi lijeka Ultibro Breezhaler dokazane u ispitivanjima?
English: How is Ultibro Breezhaler used?
Croatian: Kako se Ultibro Breezhaler koristi?
English: The studies lasted 12 weeks.
Croatian: Ispitivanja su trajala 12 tjedana.
English: Other information about Levitra:
Croatian: Ostale informacije o lijeku Levitra:
English: The full EPAR for Levitra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Levitra nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 01-2016.
Croatian: Sažetak je posljednji put ažuriran u 01.2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levitra on 6 March 2003.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Levitra na snazi u Europskoj uniji od 6. ožujka 2003.
English: What measures are being taken to ensure the safe and effective use of Levitra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Levitra?
English: The recommended dose of Levitra is 10 mg, taken about 25 to 60 minutes before sexual activity.
Croatian: Preporučena doza lijeka Levitra iznosi 10 mg, koja se uzima otprilike 25 do 60 minuta prije seksualne aktivnosti.
English: Because Levitra has not been studied in the following group patients, they must not use the medicine:
Croatian: S obzirom na to da lijek Levitra nije ispitivan u sljedećim skupinama bolesnika, lijek ne smiju koristiti:
English: What is Levitra?
Croatian: Što je Levitra?
English: What is the risk associated with Levitra?
Croatian: Koji su rizici povezani s lijekom Levitra?
English: In all of the studies, the main measure of effectiveness was the ability to get and maintain an erection.
Croatian: Glavno mjerilo djelotvornosti bila je mogućnost postizanja i održavanja erekcije.
English: Two additional main studies compared orodispersible tablets with placebo in 701 men aged 21 to 84 years
Croatian: Dva dodatna glavna ispitivanja usporedila su raspadljive tablete za usta s placebom kod 701 muškarca u dobi od 21 do 84 godine.
English: The most common side effect with Levitra (seen in more than 1 patient in 10) is headache.
Croatian: Najčešća nuspojava lijeka Levitra (može se javiti u više od 1 na 10 osoba) jest glavobolja.
English: If Levitra film-coated tablets are taken with a high fat meal, the onset of activity may be delayed.
Croatian: Ako se filmom obložene tablete Levitra uzimaju s obrokom koji sadrži puno masnoće, nastup djelovanja može biti odgođen.
English: The active ingredient of Levitra, vardenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Croatian: Djelatni sastojak lijeka Levitra, vardenafil, pripada skupini lijekova zvanih inhibitori fosfodiesteraze tipa 5 (PDE5).
English: This document is a summary of the European public assessment report (EPAR) for Levitra.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Levitra.
English: 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 Levitra.
Croatian: 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 svoje preporuke o uvjetima za primjenu lijeka Levitra.