natgillin/translations-raw huggingface dataset:
The CHMP requested that specifically for the special populations of hepatic and renal impaired patients the warnings related to paracetamol use are all in line with the warnings existing in the mono-component's product information, for completeness of the safety information. 
Odbor CHMP je zaradi zagotavljanja celovitosti informacij o varnosti zahteval, da morajo biti opozorila za posebne populacije bolnikov z jetrno ali ledvično okvaro glede uporabe paracetamola v skladu z obstoječimi opozorili v informacijah o zdravilu z eno samo komponento.
The important safety risk associated with prolonged use of paracetamol and ibuprofen are well known and are hepatotoxicity, peptic ulceration and gastrointestinal bleeding, nephrotoxicity, cardiac, cardiovascular and cerebrovascular effects .The applicant has provided a comprehensive review of the safety data both from the submitted studies and from overall pooled study data including the exposure of the combination in elderly patients. 
Pomembna varnostna tveganja, povezana z dolgotrajno uporabo paracetamola in ibuprofena, so dobro znana in vključujejo hepatotoksičnost, peptične ulkuse in krvavitev iz prebavil, nefrotoksičnost ter srčne, kardiovaskularne in cerebrovaskularne učinke.
• The Committee is of the opinion that the available data is supportive of the efficacy of Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination in short-term symptomatic treatment of mild to moderate pain. 
• odbor je mnenja, da razpoložljivi podatki podpirajo učinkovitost zdravila s fiksno kombinacijo odmerkov Paracetamol/ibuprofen 500 mg/150 mg filmsko obložene tablete in povezanih imen pri kratkotrajnem simptomatskem zdravljenju blage do zmerne bolečine;
The short term use (max for 3 days) of this fixed dose combination has been recommended by the CHMP and accepted by the applicant. 
Odbor CHMP je priporočil kratkotrajno uporabo (največ 3 dni) te fiksne kombinacije odmerkov, kar je predlagatelj sprejel.
Study AFT-MX-3 was a dose response study and a double-blind, placebo-controlled, randomised, parallel group comparison of the effects of different paracetamol and ibuprofen combination doses and placebo in participants with pain from removal of 2-4 third molars. 
Študija AFT-MX-3 je bila študija odzivnosti na odmerke in dvojno slepa, s placebom nadzorovana, randomizirana študija z vzporednimi skupinami, v kateri so primerjali učinke različnih odmerkov kombinacije paracetamola in ibuprofena ter placeba pri udeležencih z bolečino zaradi izdrtja 24 tretjih kočnikov.
In conclusion, the safety outcomes examined were consistent in the concomitant use of ibuprofen and paracetamol compared with paracetamol or ibuprofen alone. 
Preučeni varnostni izidi pri sočasni uporabi ibuprofena in paracetamola v primerjavi s samostojno uporabo paracetamola ali ibuprofena so bili torej skladni.
Therefore the risk for prolonged use of the fixed dose combination and Paracetamol or Ibuprofen alone should have a similar risk/benefit profile. 
Zato bi moralo biti razmerje med koristmi in tveganji fiksne kombinacije odmerkov in samega paracetamola ali ibuprofena podobno.
Study AFT-MX-6E was a phase III trial in another acute pain model (arthroscopy). 
Študija AFT-MX-6E je bilo preskušanje II.
Study AFT-MX-4 was a phase II exploratory study with a double-blind, randomized, parallel group comparison of the effects of Paracetamol and Ibuprofen Combined with Paracetamol, Low and High Dose Ibuprofen on Patients with Pain from Osteoarthritis of the Knee, and a 12 month open label extension. 
faze, ki je vključevala randomizirano, dvojno slepo študijo z vzporednimi skupinami, v kateri so primerjali učinke kombinacije paracetamola in ibuprofena z učinki paracetamola ter majhnimi in velikimi odmerki ibuprofena pri bolnikih z bolečino zaradi osteoartritisa kolena, in 12-mesečno odprto podaljšanje.
Paracetamol and ibuprofen are two analgesic compounds with long histories of clinical use and both have been shown to be safe and well tolerated at maximum recommended daily doses. 
Paracetamol in ibuprofen sta analgetični spojini z dolgoletno klinično uporabo.
Annex II Scientific conclusions 
Ta raziskovalna študija II.
The applicant was requested to provide the following information: 1. 
Odbor je od predlagatelja zahteval naslednje informacije: 1.
CVMP started the procedure on 6 November 2007. 
Odbor CVMP je s postopkom začel dne 6. novembra 2007.
3421 GW Oudewater The Netherlands 
3421 GW Oudewater Nizozemska
In response to question 2, the applicant pointed out that there are no differences at all that would justify different conclusions on the safety and efficacy for the two products. 
V odgovor na 2. vprašanje je predlagatelj poudaril, da ni nikakršnih razlik, ki bi utemeljile različne zaključke o varnosti in učinkovitosti obeh zdravil.
France considers that the dosing regime of the product is not correct. 
Francija meni, da urnik odmerjanja zdravila ni pravilen.
A list of questions was adopted on 8 November 2007 and sent to the marketing authorisations holders (MAH), by which the procedure clock was stopped. 
Seznam vprašanj je bil sprejet dne 8. novembra 2007 in poslan imetnikom dovoljenja za promet (MAH), s čimer se je merjenje časa za postopek ustavilo.
The aim of the assessment is to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral. 
Cilj ocenjevanja je ugotoviti, ali naj se dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki so vključena v napotitveni postopek, obdržijo, kakršna so, zadržijo, spremenijo ali prekličejo glede na razloge za napotitev.
This may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned. 
To lahko privede do pomanjkljive učinkovitosti in nadaljnjega razvoja odpornosti ciljnih patogenih organizmov, kar bi lahko v primeru zoonoznih bakterij povzročilo tudi tveganje za človeško zdravje.
horse oral 
konj peroralno
5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days. 
5 mg trimetoprima in 25 mg sulfadiazina na kg telesne mase na dan do največ pet dni
The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except France) at day 210 of the decentralised procedure. 
Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so različice, s katerimi se so referenčna država članica in zadevne države članice (z izjemo Francije) strinjale na 210. dan decentraliziranega postopka.
The original reference product "Tribrissen Oral Paste" was authorised in the Netherlands in 1992. 
Originalno referenčno zdravilo “Tribrissen peroralna pasta” je bilo na Nizozemskem odobreno leta 1992.
333.3 mg/g sulfadiazine and 66.7 mg/g trimethoprim. 
333,3 mg/g sulfadiazina in 66,7 mg/g trimetoprima.
In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and any supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter. 
V odgovor na 1. vprašanje je predlagatelj priskrbel kopijo originalnega dosjeja, predloženega v podporo uporabi decentraliziranega postopka, in vse dodatne podatke, ki so bili predloženi med decentraliziranim postopkom v odgovor na I. in II.
The objections raised by France should not prevent the granting of a marketing authorisation for Equibactin vet. 
Zadržki, ki jih je imela Francija, ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom Equibactin vet. peroralna pasta.
Under these conditions the applicant is exempted from submitting further preclinical or clinical data on efficacy of the proposed product, and can claim the same indications for use and the same precautionary warnings to ensure safe use for the product as for the reference product Tribrissen Oral Paste. 
Pod temi pogoji predlagatelju ni potrebno predložiti nadaljnjih predkliničnih ali kliničnih podatkov o učinkovitosti predlaganega zdravila in lahko uveljavlja iste indikacije za uporabo in ista previdnostna opozorila za zagotovitev varne uporabe zdravila kot za referenčno zdravilo Tribrissen oralna pasta.
The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 24 September 2007 that the Co-ordination Group for Mutual Recognition and Decentralised ProceduresVeterinary (CMD(v)) failed to reach an agreement for Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses. 
Nizozemska, referenčna država članica, je v decentraliziranem postopku dne 24. septembra 2007 obvestila agencijo EMEA, da Koordinacijska skupina za medsebojno prepoznavanje in decentralizirane postopke - veterina (CMD(v) ni dosegla sporazuma o zdravilu Equibactin vet. (333 mg/g + 67 mg/g) peroralna pasta za konje.
Frequency and route of administration 
Pogostost in način uporabe zdravila
On 16 November 2007 responses to the questions were received from MAH and the clock restarted. 
Dne 16. novembra 2007 je Odbor od imetnikov dovoljenja za promet prejel odgovore na vprašanja, zato so z merjenjem časa nadaljevali.
ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER 
DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKA VRSTA, NAČIN UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET
Consequently, the conclusions on efficacy and safety for the reference product, Tribrissen oral paste, can be extended to the generic product, Equibactin vet. 
Posledično je mogoče zaključke o učinkovitosti in varnosti referenčnega zdravila Tribrissen oralna pasta razširiti na generično zdravilo Equibactin vet. peroralna pasta.
Applicant or Marketing 
Predlagatelj ali imetnik dovoljenja za promet z zdravilom
Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter was referred to the CVMP. 
Zadeva je bila skladno s členom 33(4) Direktive Sveta 2001/82/ES, kakor je bila spremenjena, napotena na Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses. 
Equibactin vet. (333 mg/g + 67 mg/g) peroralna pasta za konje.
CVMP noted that Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses is a generic of Tribrissen oral paste (authorised in the Netherlands) and that the concerns raised by France can only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy. 
Odbor CVMP je ugotovil, da je zdravilo Equibactin vet. (333 mg/g + 67 mg/g) peroralna pasta za konje generično zdravilo, ki izhaja iz zdravila Tribrissen peroralna pasta (odobreno na Nizozemskem), in da je mogoče na zadržke, ki jih je imela Francija, odgovoriti le v okviru tega postopka, če bi kakršna koli razlika med obema zdraviloma utemeljila različne zaključke o varnosti ali učinkovitosti.
In view of the concerns raised by France, to indicate and to substantiate where necessary any differences between Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses and the reference product Tribrissen Oral Paste (authorised in the Netherlands) that could justify different conclusions on the safety or efficacy for the two products. 
Glede na zadržke, ki jih je imela Francija, prikaz in po potrebi utemeljitev morebitnih razlik med zdravilom Equibactin vet. (333 mg/g + 67 mg/g) peroralna pasta za konje in referenčnim zdravilom Tribrissen peroralna pasta (odobreno na Nizozemskem), s katerimi bi lahko utemeljili različne zaključke glede varnosti ali učinkovitosti obeh zdravil.
A copy of the dossier of Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses and any supplementary data added to it, up to day 60 of the referral procedure in CM(v). 
Kopijo dosjeja zdravila Equibactin vet. (333 mg/g + 67 mg/g) peroralna pasta za konje in vse dodatne podatke, do 60. dne napotitvenega postopka v CM(v).
Equibactin vet Oral Paste proved to be essentially similar to the reference product, Tribrissen Oral Paste. 
Zdravilo Equibactin vet. peroralna pasta se je izkazalo za bistveno podobno referenčnemu zdravilu Tribrissen peroralna pasta.
Oral Paste for Horses proved to be bioequivalent to the reference products Tribrissen (REG NL 5055 in the Netherlands) and Tribissen (Vm 0201/4064 in the UK). 
V študiji GLP biološke enakovrednosti enkratnega odmerka pri konjih, ki je bila izvedena skladno z ustreznimi smernicami, so dokazali, da je zdravilo Equibactin vet. peroralna pasta za konje biološko enakovredna referenčnemu zdravilu Tribrissen (REG NL 5055 na Nizozemskem) in zdravilu Tribissen (Vm 0201/4064 v Združenem kraljestvu).
Oral Paste in accordance with the outcome of referral procedure EMEA/V/023 under Article 35 of Directive 2001/82/EC as amended, for the reference medicinal product Tribrissen Oral Paste authorised in The Netherlands. 
Priporoča se uporaba zdravila Equibactin vet. peroralna pasta, v skladu z rezultatom napotitvenega postopka EMEA/V/023 iz člena 35 Direktive 2001/82/ES, kakor je bila spremenjena, kot različice referenčnega zdravila Tribrissen peroralna pasta, odobrenega na Nizozemskem.
Product invented name 
Izmišljeno ime zdravila Farmacevtska oblika
Oral Paste for Horses with the reference product Tribrissen Oral Paste (authorised in the Netherlands under REG NL 5055). 
Še več, obstajajo le podobnosti, ki dokazujejo enako varnost in učinkovitost zdravila Equibactin vet. peroralna pasta za konje in referenčnega zdravila Tribrissen peroralna pasta (odobreno na Nizozemskem pod REG NL 5055).
Based on the identical composition with respect to active ingredients, Trimethoprim and Sulfadiazine, the same pharmaceutical form, and proven bioequivalence between Equibactin vet. 
Glede na enako sestavo, kar zadeva zdravilni učinkovini trimetoprim in sulfadiazin, enako farmacevtsko obliko in dokazano biološko enakovrednost med zdravilom Equibactin vet. peroralna pasta in zdravilom Tribrissen peroralna pasta za učinkovini trimetoprim in sulfadiazin, se zdravili obravnavata za bistveno podobni.
Treatment should always be started during the first week of the menstrual period. 
Zdravljenje je treba vedno začeti v prvem tednu menstruacijskega ciklusa.
Further information on Esmya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Nadaljnje informacije za zdravilo Esmya so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
1 See outcome of safety review carried out in 2018 here. 
Izid varnostnega pregleda, opravljenega v letu 2018, si lahko ogledate tukaj.
Esmya (ulipristal acetate) 
Esmya (ulipristalacetat)
The recommended dose is one tablet a day for up to three months (one treatment course). 
Priporočeni odmerek je ena tableta na dan največ tri mesece (en ciklus zdravljenja).
Esmya received a marketing authorisation valid throughout the European Union on 23 February 2012. 
Za zdravilo Esmya je bilo 23. februarja 2012 izdano dovoljenje za promet, veljavno po vsej EU.
It is available as tablets (5 mg) to be taken by mouth. 
Na voljo je v obliki tablet (5 mg), ki se jemljejo peroralno.
What measures are being taken to ensure the safe and effective use of Esmya? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Esmya?
A reduction in fibroid size was also observed. 
Opaziti je bilo mogoče tudi zmanjšanje velikosti leiomiomov.
The European Medicines Agency decided that the benefits of Esmya outweigh its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da koristi zdravila Esmya odtehtajo njegova tveganja in da se lahko odobri za uporabo v EU.
An overview of Esmya and why it is authorised in the EU 
Pregled zdravila Esmya in zakaj je odobreno v EU
As for all medicines, data on the use of Esmya are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Esmya stalno spremljajo.
Esmya can be given: 
Zdravilo Esmya se lahko daje:
The three-month treatment course can be repeated in women in whom surgery is not suitable. 
Trimesečni ciklus zdravljenja se lahko pri ženskah, za katere kirurški poseg ni primeren, ponovi.
What benefits of Esmya have been shown in studies? 
Kakšne koristi zdravila Esmya so se pokazale v študijah?
Other information about Esmya 
Druge informacije o zdravilu Esmya
The company that markets Esmya will ensure that doctors who are expected to prescribe this medicine receive educational material with information about the safety of Esmya, including recommendations for monitoring liver function and endometrial changes during treatment. 
Podjetje, ki trži zdravilo Esmya, bo zagotovilo, da bodo zdravniki, ki naj bi predpisovali to zdravilo, prejeli izobraževalno gradivo z informacijami o njegovi varnosti, vključno s priporočili za spremljanje delovanja jeter in sprememb endometrija med zdravljenjem.
Side effects reported with Esmya are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Esmya, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The size of the fibroids was also smaller in women treated with Esmya than in those who received placebo. 
Prav tako je bila velikost leiomiomov manjša pri ženskah, ki so se zdravile z zdravilom Esmya, kot pri tistih, ki so prejemale placebo.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Esmya have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Esmya upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Long-term treatment with Esmya has been investigated in a main study involving 451 women who were given 4 three-month courses of 5 or 10 mg of Esmya. 
Dolgotrajno zdravljenje z zdravilom Esmya so proučevali v eni glavni študiji, v katero je bilo vključenih 451 žensk, ki so prejele štiri trimesečne cikluse zdravljenja s 5- ali 10-miligramskim odmerkom zdravila Esmya.
What is Esmya and what is it used for? 
Kaj je zdravilo Esmya in za kaj se uporablja?
Esmya must not be used in women who are pregnant or breastfeeding, have bleeding from the genital region of unknown cause or for reasons other than uterine fibroids, have cancer of the womb, cervix (the neck of the womb), ovary or breast, or have liver problems. 
Zdravila Esmya ne smejo uporabljati ženske, ki so noseče ali dojijo, krvavijo iz spolovil iz neznanega razloga ali razloga, ki ni povezan z materničnimi leiomiomi, oziroma imajo raka maternice, cerviksa (materničnega vratu), jajčnikov ali dojke, ali imajo težave z jetri.
The most common side effects with Esmya (which may affect more than 1 in 10 patients) are amenorrhea (absence of menstrual period) and endometrial thickening (thickening of the lining of the womb). 
Najpogostejša neželena učinka zdravila Esmya (ki se lahko pojavita pri več kot 1 od 10 bolnic) sta amenoreja (izostanek menstruacije) in odebelitev endometrija (odebelitev maternične sluznice).
In some women, progesterone may promote the growth of fibroids, which can cause symptoms such as heavy uterine bleeding (bleeding from the womb during or outside the menstrual period), anaemia (low red blood cell counts, due to bleeding) and abdominal pain (such as period pain). 
Pri nekaterih ženskah lahko progesteron spodbuja rast leiomiomov, kar lahko povzroči simptome, kot so močne krvavitve iz maternice (krvavitve iz maternice med menstruacijskim ciklusom ali zunaj njega), anemija (nizko število rdečih krvnih celic zaradi krvavitev) in bolečine v trebuhu (kot so bolečine med menstruacijo).
For more information about using Esmya, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Esmya glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What are the risks associated with Esmya? 
Kakšna tveganja so povezana z zdravilom Esmya?
49% of women receiving 5 mg Esmya (95 out of the 195 women who were assessed) had no more than one day of spotting (minimal uterine bleeding) within a 35-day interval after each treatment course, and 70% had no more than one day of spotting within a 35-day interval at the end of the fourth treatment course. 
Pri 49 % žensk, ki so prejemale 5-miligramski odmerek zdravila Esmya (95 od ocenjenih 195 žensk), se je v 35 dneh po vsakem ciklusu zdravljenja krvavitev (minimalna krvavitev iz maternice) pojavila v največ enem dnevu, na koncu četrtega ciklusa pa se pri 70 % žensk v 35 dneh krvavitev ni pojavila.
Why is Esmya authorised? 
Zakaj je bilo zdravilo Esmya odobreno?
• as intermittent treatment for women in whom surgery is not suitable. 
• v okviru zdravljenja s prekinitvami pri ženskah, za katere kirurški poseg ni primeren.
The active substance in Esmya, ulipristal acetate, blocks the activity of progesterone, a hormone in the body involved in controlling the growth of the lining of the womb. 
Učinkovina v zdravilu Esmya, ulipristalacetat, zavira delovanje progesterona, hormona, ki v telesu sodeluje pri nadzorovanju rasti maternične sluznice.
Esmya is a medicine used to treat moderate to severe symptoms of uterine fibroids in adult women who have not yet reached the menopause. 
Zdravilo Esmya se uporablja za zdravljenje zmernih do hudih simptomov materničnih leiomiomov pri odraslih ženskah, ki še niso v menopavzi.
Esmya improved the symptoms of uterine fibroids in two main studies involving 549 women who were to have surgery to remove the fibroids. 
Zdravilo Esmya je izboljšalo simptome materničnih leiomiomov v dveh glavnih študijah, v kateri je bilo vključenih 549 žensk, pri katerih naj bi opravili kirurški poseg za odstranitev leiomiomov.
In the first study, uterine bleeding was reduced in 92% of women taking Esmya for three months (one treatment course) compared with 19% of women taking placebo (a dummy treatment). 
V prvi študiji so se krvavitve iz maternice zmanjšale pri 92 % žensk, ki so zdravilo Esmya jemale tri mesece (en ciklus zdravljenja), in pri 19 % žensk, ki so jemale placebo (zdravilo brez učinkovine).
In the second study, Esmya taken for three months was as effective as leuprorelin (another medicine for fibroids) in reducing heavy uterine bleeding, with bleeding reduced in 90% of women treated with Esmya compared with 89% of women treated with leuprorelin. 
V drugi študiji je bil trimesečni ciklus zdravljenja z zdravilom Esmya enako učinkovit kot levprorelin (drugo zdravilo za leiomiome) pri zmanjševanju močnih krvavitev iz maternice, saj so se krvavitve zmanjšale pri 90 % žensk, ki so se zdravile z zdravilom Esmya, in pri 89 % tistih, ki so prejemale levprorelin.
• as a single treatment course in women before they have surgery for their fibroids; 
• v okviru enega ciklusa zdravljenja pri ženskah pred kirurškim posegom zaradi leiomiomov;
Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus). 
Maternični leiomiomi so nerakavi (benigni) tumorji maternice (uterusa).
Esmya has been shown to be effective in reducing symptoms as well as the size of the fibroids in women who were to have surgery for their fibroids and when used intermittently for longer periods (up to 4 treatment courses). 
Pokazalo se je, da zdravilo Esmya učinkovito zmanjšuje simptome in velikost leiomiomov pri ženskah, pri katerih naj bi opravili kirurški poseg zaradi leiomiomov, in je učinkovito pri dolgotrajni uporabi s prekinitvami (v največ štirih ciklusih zdravljenja).
Esmya can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the diagnosis and treatment of uterine fibroids. 
Predpisovanje in izdaja zdravila Esmya je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem materničnih leiomiomov.