FrancophonIA/ELRC3.0 huggingface dataset:
English: Seroquel XR contains lactose
Slovenian: Zdravilo Seroquel SR vsebuje laktozo
English: If you are not sure, talk to your doctor or pharmacist before taking Seroquel.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
English: Seroquel XR 50 mg prolonged-release tablets quetiapine
Slovenian: IME ZDRAVILA Seroquel SR 50 mg tablete s podaljšanim sproščanjem kvetiapin
English: • Feeling like your heart is pounding, racing or has skipped beats.
Slovenian: • občutek razbijanja, hitrega bitja ali preskakovanja bitja srca (ali izpuščenih utripov srca),
English: Seroquel XR 50 mg prolonged-release tablets Seroquel XR 150 mg prolonged-release tablets Seroquel XR 200 mg prolonged-release tablets Seroquel XR 300 mg prolonged-release tablets Seroquel XR 400 mg prolonged-release tablets
Slovenian: Seroquel SR 50 mg tablete s podaljšanim sproščanjem Seroquel SR 150 mg tablete s podaljšanim sproščanjem Seroquel SR 200 mg tablete s podaljšanim sproščanjem Seroquel SR 300 mg tablete s podaljšanim sproščanjem Seroquel SR 400 mg tablete s podaljšanim sproščanjem
English: Carton (pack) contents Blisters
Slovenian: Vsebina škatle (pakiranja) Pretisni omoti
English: 10 blisters of 10 tablets
Slovenian: 10 pretisnih omotov po 10 tablet
English: Psychiatric disorders
Slovenian: Ekstrapiramidni simptomi
English: Hepatic Impairment
Slovenian: Bolezni prebavil bruhanje
English: Children and Adolescents Seroquel is not for use in children and adolescents below 18 years of age.
Slovenian: Zdravilo Seroquel ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: Dysphagia (See section 4.8 ) has been reported with quetiapine.
Slovenian: Disfagija Med uporabo kvetiapina je bila zabeležena disfagija (glejte poglavje 4.8).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg quetiapine (as fumarate) Each tablet contains 100 mg quetiapine (as fumarate) Each tablet contains 200 mg quetiapine (as fumarate)
Slovenian: Pomožna snov: 71 mg laktoze (brezvodne) na tableto Zdravilo Seroquel SR 200 mg vsebuje 200 mg kvetiapina (v obliki kvetiapinijevega fumarata).
English: Seroquel 300 mg contains 300 mg quetiapine (as quetiapine fumarate) Excipient : 59 mg lactose (anhydrous) per tablet
Slovenian: Pomožna snov: 50 mg laktoze (brezvodne) na tableto Zdravilo Seroquel SR 300 mg vsebuje 300 mg kvetiapina (v obliki kvetiapinijevega fumarata).
English: In the schizophrenia study, the difference in LS mean change from baseline in PANSS total score (active minus placebo) was -8.16 for Seroquel 400 mg/day and -9.29 for Seroquel 800 mg/day.
Slovenian: V študiji shizofrenije je bila razlika v povprečni spremembi po metodi najmanjših kvadratov celotnega seštevka PANSS v primerjavi z izhodiščem (učinkovina minus placebo) - 8,16 za Seroquel
English: Neuroleptic malignant syndrome 1, hypothermia
Slovenian: blaga astenija, periferni edemi, razdražljivost, zvišana telesna temperatura maligni nevroleptični sindrom 1, hipotermija
English: Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.
Slovenian: Med zdravljenjem, še posebej po uvedbi zdravljenja in pri vsaki spremembi odmerka, je treba bolnike skrbno nadzirati.
English: Individual dosage adjustments may be necessary.
Slovenian: Potrebno je lahko takojšnje zdravniško ukrepanje,
English: decreased neutrophil count, eosinophils increased
Slovenian: povečanje števila eozinofilcev trombocitope nija, anemija, zmanjšano število trombocitov13
English: Seroquel XR is indicated for: • treatment of Schizophrenia
Slovenian: 4.1 Terapevtske indikacije Zdravilo Seroquel SR je indicirano za:
English: Children and Adolescents Seroquel XR is not for use in children and adolescents below 18 years of age.
Slovenian: Zdravilo Seroquel SR ni namenjeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
English: Seroquel XR tablets contain lactose.
Slovenian: Tablete s podaljšanim sproščanjem zdravila Seroquel SR vsebujejo laktozo.
English: Iron oxide, yellow (E172) (50, 200 and 300 mg tablets) Iron oxide, red (E172) (50 mg tablets) 6.2 Incompatibilities
Slovenian: Obloga hipromeloza 2910 makrogol 400 titanov dioksid (E171) rumen železov oksid (E172) (50-, 200- in 300-mg tablete)
English: Seroquel 150 mg contains 150 mg quetiapine (as quetiapine fumarate) Excipient : 29 mg lactose (anhydrous) per tablet
Slovenian: Zdravilo Seroquel 150 mg vsebuje 150 mg kvetiapina (v obliki kvetiapinijevega fumarata).
English: SOC
Slovenian: mg.
English: Constipation, dyspepsia, vomiting
Slovenian: Bolezni prebavil suha usta zaprtost, dispepsija, bruhanje25
English: Macrogol 400
Slovenian: P450.
English: Dysphagia
Slovenian: podaljšanje
English: Seroquel 200 mg contains 200 mg quetiapine (as quetiapine fumarate) Excipient : 39 mg lactose (anhydrous) per tablet
Slovenian: Zdravilo Seroquel 200 mg vsebuje 200 mg kvetiapina (v obliki kvetiapinijevega fumarata).
English: (cannot be estimated from the available data).
Slovenian: Kljub temu dokončnega sklepa, na podlagi vseh podatkov, ki so na voljo, ni mogoče narediti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 4-Day starter pack
Slovenian: Seroquel 3-dnevno začetno pakiranje (kombinirano pakiranje) Seroquel 4-dnevno začetno pakiranje
English: The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4).
Slovenian: Za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji Za zdravljenje maničnih epizod, povezanih z bipolarno motnjo je treba zdravilo Seroquel jemati dvakrat na dan. Celokupni dnevni odmerki za prve štiri dni zdravljenja so: 100 mg (1. dan), 200 mg (2. dan), 300 mg (3. dan) in 400 mg (4. dan).
English: Vomiting
Slovenian: Obloga
English: The safety and efficacy of doses greater than 800 mg/day have not been evaluated.
Slovenian: Varnost in učinkovitost odmerkov, večjih od
English: Hepatic Impairment:
Slovenian: Zapoznela diskinezija:
English: 400 mg of quetiapine (as quetiapine fumarate).
Slovenian: 200 mg, 300 mg ali 400 mg kvetiapina (v obliki kvetiapinijevega fumarata).
English: Suicide/suicidal thoughts or clinical worsening:
Slovenian: Samomor/samomorilne misli ali klinično poslabšanje Depresija pri bipolarni motnji je povezana z večjim tveganjem za pojav samomorilnih misli,
English: Agranulocytosis
Slovenian: agranulocitoza nevtropeni ja
English: Seizures:
Slovenian: Konvulzije:
English: Jaundice Hepatitis
Slovenian: • zdravljene shizofrenije
English: Very Common side effects (may affect more than 1 in 10 people):
Slovenian: Pogosti neželeni učinki: pojavijo se lahko pri največ 1 od 10 bolnikov
English: Seroquel 25 mg film-coated tablets are peach coloured, round biconvex and engraved with SEROQUEL 25 on one side
Slovenian: Izgled zdravila Seroquel in vsebina pakiranja Seroquel 25 mg filmsko obložene tablete so breskove barve, okrogle, bikonveksne in z vtisnjeno oznako SEROQUEL 25 na eni strani.
English: Hyponatraemia 19, Diabetes Mellitus
Slovenian: Srčne bolezni tahikardija 4, palpitacije podaljšanje QT bradikardija32
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 3-Day starter pack
Slovenian: FOLIJA PRETISNEGA OMOTA (3-dnevno začetno pakiranje)
English: How to store Seroquel XR
Slovenian: Shranjevanje zdravila Seroquel SR
English: Information from a sixth study that was submitted during the procedure was also considered.
Slovenian: Upoštevane so bile tudi informacije iz šeste študije, predložene med postopkom.
English: In addition, Trulicity has the advantage of being given once a week.
Slovenian: Poleg tega je prednost zdravila Trulicity to, da se daje enkrat na teden.
English: Trulicity dulaglutide
Slovenian: Trulicity dulaglutid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Trulicity on 21 November 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Trulicity, veljavno po vsej Evropski uniji, izdala 21. novembra 2014.
English: This is a summary of the European public assessment report (EPAR) for Trulicity.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Trulicity.
English: With respect to safety, effects of longer term use and safety in vulnerable groups such as the very elderly would need to be monitored, but there were no specific areas of major concern and the risks were considered similar to those of other medicines in its class.
Slovenian: Kar zadeva varnost, bi bilo treba spremljati učinke dolgoročne uporabe in varnost pri ranljivih skupinah, kot so zelo stari bolniki, vendar ni bilo posebnih področij, pri katerih bi se pojavili večji pomisleki, tveganja pa so bila označena za podobna tveganjem pri drugih zdravilih iz iste skupine.
English: The benefits of Trulicity have been studied in 5 main studies involving over 4,500 patients with type 2 diabetes.
Slovenian: Koristi zdravila Trulicity so raziskali v petih glavnih študijah, v katere je bilo vključenih več kot 4 500 bolnikov s sladkorno boleznijo tipa 2.
English: This was considered to be clinically meaningful and there was evidence that the benefits were maintained during long-term treatment.
Slovenian: To so ocenili za klinično pomembno in dokazano je bilo, da so se koristi pri dolgotrajnem zdravljenju ohranile.
English: What measures are being taken to ensure the safe and effective use of Trulicity?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Trulicity?
English: The full EPAR and risk management plan summary for Trulicity can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Trulicity sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Trulicity's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Trulicity večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Other information about Trulicity
Slovenian: Druge informacije o zdravilu Trulicity
English: A risk management plan has been developed to ensure that Trulicity is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Trulicity je bil pripravljen načrt obvladovanja tveganj.
English: Patients inject the medicine themselves (after suitable training) under the skin in the abdomen or thigh.
Slovenian: Bolniki si zdravilo sami injicirajo (po ustreznem usposabljanju) v podkožje trebuha ali stegna.
English: The medicine was more effective at weekly doses of 1.5 mg than 0.75 mg.
Slovenian: Zdravilo je bilo učinkovitejše pri tedenskih odmerkih v višini 1,5 mg kot 0,75 mg.
English: The most common side effects with Trulicity (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting and diarrhoea.
Slovenian: Najpogostejši neželeni učinki zdravila Trulicity (ki lahko prizadenejo več kot 1 osebo od 10) so navzeja (slabost), bruhanje in driska.
English: It works by attaching to receptors for a substance called glucagon-like peptide 1 (GLP-1), which are found on the surface of the cells in the pancreas and stimulate them to release insulin.
Slovenian: Deluje tako, da se veže na receptorje glukagonu podobnega peptida 1 (GLP-1), ki se nahajajo na površini celic v trebušni slinavki, in jih spodbudi k izločanju insulina.
English: The Committee noted that the medicine produces a significant and clinically relevant effect in controlling blood glucose when used with other medicines.
Slovenian: Odbor je ugotovil, da ima zdravilo znaten in klinično pomemben učinek pri uravnavanju glukoze v krvi, kadar se uporablja v kombinaciji z drugimi zdravili.
English: What benefits of Trulicity have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Trulicity izkazalo v študijah?
English: For the full list of all side effects and restrictions with Trulicity, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri zdravilu Trulicity glejte navodilo za uporabo.
English: However, when used alone in patients who cannot take metformin, or when used in very elderly patients (aged over 75), the ratio of benefit to risk was greatest at the lower dose.
Slovenian: Vendar je bilo pri samostojni uporabi pri bolnikih, ki ne morejo jemati metformina, in pri zelo starih bolnikih (starih več kot 75 let) razmerje med koristmi in tveganji največje pri manjšem odmerku.
English: What is Trulicity and what is it used for?
Slovenian: Kaj je zdravilo Trulicity in za kaj se uporablja?
English: It is not intended to provide practical advice on how to use Trulicity.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: The main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Slovenian: Glavno merilo učinkovitosti je bila sprememba ravni glikoziliranega hemoglobina (HbA1c) v krvi, kar je odstotek hemoglobina v krvi, na katerega je vezana glukoza.
English: What are the risks associated with Trulicity?
Slovenian: Kakšna tveganja so povezana z zdravilom Trulicity?
English: The recommended dose is 0.75 mg injected once a week when used on its own, and 1.5 mg once a week in combination with other diabetes medicines (although doctors may begin with the lower dose in patients at potentially greater risk such as those aged over 75).
Slovenian: Priporočeni odmerek je 0,75 mg enkrat na teden, kadar se zdravilo uporablja samostojno, oziroma 1,5 mg enkrat na teden, kadar se uporablja v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni (vendar pa lahko zdravnik pri morebitno ranljivih bolnikih, kot so bolniki, starejši od 75 let, na začetku predpiše manjši odmerek).
English: The active substance in Trulicity, dulaglutide, is a ‘GLP-1 receptor agonist'.
Slovenian: Zdravilna učinkovina v zdravilu Trulicity, dulaglutid, je agonist receptorjev GLP-1.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Trulicity, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Trulicity in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Trulicity is available as prefilled pens (0.75 mg and 1.5 mg) containing a solution to be injected under the skin.
Slovenian: Zdravilo Trulicity je na voljo v obliki napolnjenih injekcijskih peresnikov (0,75 mg in 1,5 mg), ki vsebujejo raztopino za injiciranje pod kožo.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Slovenian: HbA1c kaže, kako dobro je uravnana raven glukoze v krvi.
English: The patients' average HbA1c at baseline ranged from 7.6 to 8.5% and patients were treated for at least 52 weeks.
Slovenian: Ob začetku zdravljenja so povprečne ravni HbA1c pri bolnikih znašale med 7,6 in 8,5 %, bolniki pa so se zdravili vsaj 52 tednov.
English: This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes.
Slovenian: To povzroči sproščanje insulina ter prispeva k znižanju ravni glukoze v krvi in uravnavanju sladkorne bolezni tipa 2.
English: When Trulicity is injected, dulaglutide reaches the receptors in the pancreas and activates them.
Slovenian: Ko se zdravilo Trulicity injicira, dulaglutid doseže receptorje v trebušni slinavki in jih aktivira.
English: Why is Trulicity approved?
Slovenian: Zakaj je bilo zdravilo Trulicity odobreno?
English: Trulicity can be used on its own in patients whose blood glucose levels are not satisfactorily controlled on diet and exercise alone and who cannot take metformin (another diabetes medicine).
Slovenian: Zdravilo Trulicity se lahko uporablja samostojno pri bolnikih, pri katerih ravni glukoze v krvi ni mogoče zadovoljivo uravnavati samo z dieto in telesno vadbo in ki ne morejo jemati metformina (drugega zdravila za zdravljenje sladkorne bolezni).
English: For more information about treatment with Trulicity, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Trulicity preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Trulicity, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Trulicity naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: After 26 weeks of treatment, Trulicity reduced HbA1c by between 0.71 and 1.59 percentage points at the lower dose, and by between 0.78 and 1.64 percentage points at the higher dose.
Slovenian: Po 26 tednih zdravljenja je zdravilo Trulicity v manjšem odmerku znižalo HbA1c za od 0,71 do 1,59 odstotne točke, v večjem pa za od 0,78 do 1,64 odstotne točke.
English: It can also be used as an ‘add-on' to other diabetes medicines, including insulin, when these medicines together with exercise and diet are not providing adequate control of blood glucose.
Slovenian: Uporablja se lahko tudi kot dodatno zdravilo skupaj z drugimi zdravili za zdravljenje sladkorne bolezni, vključno z insulinom, kadar ta zdravila skupaj z dieto in telesno vadbo ne omogočajo zadostnega uravnavanja ravni glukoze v krvi.
English: About 51% of those given the lower dose and 60% of patients given the higher dose of Trulicity achieved a target HbA1c below 7.0% and this was generally more than the proportion achieving this target with alternative treatments.
Slovenian: Približno 51 % bolnikov, ki so prejemali manjši odmerek, in 60 % bolnikov, ki so prejemali večji odmerek zdravila Trulicity, je doseglo ciljno raven HbA1c pod 7,0 %, kar je v splošnem višji delež, kot je bil ugotovljen pri bolnikih, ki so navedeno ciljno raven skušali doseči z drugimi zdravili.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Slovenian: Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne proizvaja zadostne količine insulina za uravnavanje ravni sladkorja (glukoze) v krvi ali pri kateri telo insulina ne more učinkovito izrabljati.
English: In these studies Trulicity was compared with placebo (a dummy treatment) or with other diabetes medicines when used alone or as an add-on to various combination treatments.
Slovenian: V teh študijah so zdravilo Trulicity primerjali s placebom (zdravilom brez zdravilne učinkovine) ali drugimi zdravili za zdravljenje sladkorne bolezni, in sicer pri samostojni uporabi in kot dodatno zdravljenje v kombinaciji z različnimi drugimi zdravili.
English: Trulicity was more effective than metformin at reducing HbA1c levels when used alone, and was more effective than the diabetes medicines exenatide (given twice daily) or sitagliptin, and at least as good as insulin glargine, when used as add-on to other treatments.
Slovenian: Pri samostojni uporabi je bilo zdravilo Trulicity pri zniževanju ravni HbA1c učinkovitejše od metformina, pri dodatnem zdravljenju v kombinaciji z drugimi zdravili pa je bilo učinkovitejše od zdravil za zdravljenje sladkorne bolezni, ki vsebujejo eksenatid (ki se daje dvakrat na dan) in sitagliptin, ter vsaj tako učinkovito kot insulin glargin.
English: How does Trulicity work?
Slovenian: Kako zdravilo Trulicity deluje?
English: Trulicity contains the active substance dulaglutide.
Slovenian: Zdravilo Trulicity vsebuje zdravilno učinkovino dulaglutid.
English: Trulicity is a diabetes medicine used in adults with type 2 diabetes to control their blood glucose (sugar) level.
Slovenian: Zdravilo Trulicity se uporablja za zdravljenje sladkorne bolezni pri odraslih s sladkorno boleznijo tipa 2, in sicer za uravnavanje ravni glukoze (sladkorja) v krvi.
English: How is Trulicity used?
Slovenian: Kako se zdravilo Trulicity uporablja?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom with a type of diabetes medicine called a sulphonylurea or with insulin, the dose of the sulphonylurea or insulin may need to be lowered to avoid hypoglycaemia (low blood sugar levels).
Slovenian: Če se zdravilo uporablja v kombinaciji z vrsto zdravila za sladkorno bolezen, ki se imenuje sulfonilsečnina, ali insulinom, bo morda treba odmerek sulfonilsečnine ali insulina zmanjšati, da se izognemo hipoglikemiji (nizki ravni sladkorja v krvi).
English: 340 ml (0.5 mg/ml) 1 bottle + 2 syringes + 1 bottle adapter
Slovenian: 1 plastenka + 2 brizgi + 1 nastavek za plastenko
English: 0.5 mg/ml
Slovenian: 0,5 mg/ml peroralna suspenzija peroralna uporaba plastenka (PET) 340 ml (0,5 mg/ml)
English: Outcome of re-examination of procedure under Article 29(4) of Directive 2001/83/EC
Slovenian: Izid ponovne proučitve postopka v skladu s členom 29(4) Direktive 2001/83/ES
English: The company requested a re-examination of the initial opinion.
Slovenian: Družba je zahtevala ponovno proučitev prvotnega mnenja.
English: Risk minimisation measures were proposed for the known risks.
Slovenian: Za znana tveganja so bili predlagani ukrepi za zmanjševanje tveganja.
English: Alcover syrup is available in Austria and Italy.
Slovenian: Zdravilo Alcover v obliki sirupa je na voljo v Avstriji in Italiji.
English: (the ‘concerned Member States', in this instance Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom).
Slovenian: drugih državah članicah („zadevnih državah članicah“, v tem primeru na Danskem, Finskem, v Franciji, na Irskem, Nizozemskem, Poljskem, Portugalskem, v Španiji, na Švedskem in v Združenemu kraljestvu).
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid nationally as well as in other Member States
Slovenian: To je postopek, pri katerem ena od držav članic („referenčna država članica“, v tem primeru Avstrija) oceni zdravilo glede tega, ali se zanj lahko izda dovoljenje za promet, ki bo veljalo v tej državi in
English: Why were Alcover granules reviewed?
Slovenian: Zakaj je bilo zdravilo Alcover v obliki zrnc pregledano?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Alcover granules did not outweigh their risks, and the marketing authorisation could not be granted in Austria or in the following Member States of the EU: Denmark, Finland, France, Ireland, the Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Alcover v obliki zrnc niso večje od z njim povezanih tveganj ter da se dovoljenje za promet ne more izdati v Avstriji in v naslednjih državah članicah EU: na Danskem, Finskem, v Franciji, na Irskem, Nizozemskem, Poljskem, Portugalskem, v Španiji, na Švedskem in v Združenem kraljestvu.
English: On 22 June 2017, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Alcover granules.
Slovenian: Evropska agencija za zdravila je 22. junija 2017 končala postopek arbitraže, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Alcover v obliki zrnc.