FrancophonIA/ELRC3.0 huggingface dataset:
English: When administered to opioid dependent subjects, naloxone can cause acute withdrawal symptoms in some individuals.
Slovenian: Nalokson lahko pri nekaterih osebah, odvisnih od opioidov, povzroči akutne odtegnitvene simptome.
English: Training will be provided on how to use Nyxoid before it is supplied to you.
Slovenian: Preden boste prejeli zdravilo Nyxoid, se boste izobrazili, kako ga uporabljati.
English: Lay down.
Slovenian: Osebo položite.
English: Each nasal spray contains 1.8 mg of naloxone (as hydrochloride dihydrate).
Slovenian: En vsebnik za pršilo za nos vsebuje 1,8 mg naloksona (v obliki hidroklorida dihidrata).
English: Tlf: + 47 67 51 89 00
Slovenian: Mundipharma AS Tlf: + 47 67 51 89 00 post@mundipharma.no
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INTRANASAL SPRAY/DEVICE LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Tel: +43 (0)1 523 25 05-0
Slovenian: Tel: +43 (0)1 523 25 05-0 info@mundipharma.at
English: Package leaflet: Information for the user Nyxoid 1.8 mg nasal spray, solution in a single-dose container
Slovenian: Navodilo za uporabo Nyxoid 1,8 mg pršilo za nos, raztopina v enoodmernem vsebniku nalokson
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Tlf: + 354 540 8000
Slovenian: Tlf: + 354 540 8000 icepharma@icepharma.is
English: • Fast heart rate
Slovenian: • pospešen srčni utrip
English: • Diarrhoea
Slovenian: Žilne bolezni
English: Single-dose nasal spray for overdose of opioids (such as heroin) Do not test before use
Slovenian: Pršilo za nos v enoodmernem vsebniku za prekomerne odmerke opioidov (npr. heroina).
English: • Access to a video on how to use Nyxoid The HCP Guidance Document should include:
Slovenian: • Dostop do videoposnetka o uporabi zdravila Nyxoid
English: Nyxoid 1.8 mg nasal spray, solution in a single-dose container naloxone
Slovenian: Nyxoid 1,8 mg pršilo za nos, raztopina v enoodmernem vsebniku nalokson
English: • severe sleepiness
Slovenian: • suha usta
English: Common: may affect up to 1 in 10 people
Slovenian: Pogosti: pojavijo se lahko pri največ 1 od 10 oseb
English: Tell your doctor if you experience any of these symptoms.
Slovenian: Če se pri vas pojavijo kateri koli od zgornjih simptomov, se posvetujte z zdravnikom.
English: B. PACKAGE LEAFLET
Slovenian: Ιρλανδία
English: Tel: +386 158969 00
Slovenian: Tel: +386 158969 00 info@medis.si
English: Nyxoid 1.8 mg nasal spray, solution in a single-dose container
Slovenian: Nyxoid 1,8 mg pršilo za nos, raztopina v enoodmernem vsebniku.
English: Tabulated list of adverse reactions
Slovenian: Povzetek neželenih učinkov v preglednici
English: Ireland .
Slovenian: Irska
English: Tel: + 385 (0) 1 230 34 46
Slovenian: Tel: + 385 (0) 1 230 34 46 info@medisadria.hr
English: Uncommon: may affect up to 1 in 100 people
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 oseb • tremor
English: Tel: + 46 (0)31 773 75 30
Slovenian: Mundipharma AB Tel: + 46 (0)31 773 75 30 info@mundipharma.se
English: Can you hear breathing sounds?
Slovenian: da oseba diha?
English: Vascular disorders Common
Slovenian: Občasni hiperventilacija
English: Instructions for giving Nyxoid nasal spray: Check for symptoms and response.
Slovenian: Navodila za dajanje pršila za nos zdravila Nyxoid:
English: Place the nasal spray within easy reach.
Slovenian: Pršilo za nos odložite v bližini na lahko dostopnem mestu.
English: - The active substance is naloxone.
Slovenian: Zgornja noga je pokrčena.
English: SIA Inovatīvo biomedicīnas tehnoloģiju institūts Tel: + 37167800810
Slovenian: Tel: + 37167800810 anita@ibti.lv
English: Mundipharma Oy
Slovenian: Mundipharma A/S Tlf.
English: Naloxone
Slovenian: ZDRAVILA
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures.
Slovenian: Odgovorna je za zagotovitev usklajenih varnostnih standardov za zdravila, ki so odobrena po nacionalnih postopkih.
English: More about the procedure
Slovenian: Več informacij o postopku
English: 29 May 2019 EMA/285298/2019
Slovenian: 29. maj 2019 EMA/285298/2019
English: The PRAC considered all the available evidence in its review.
Slovenian: Odbor PRAC je pri svojem pregledu upošteval vse razpoložljive dokaze.
English: The review of fenspiride was initiated on 14 February 2019 at the request of France, under Article 107i of Directive 2001/83/EC.
Slovenian: Pregled zdravil, ki vsebujejo fenspirid, se je začel 14. februarja 2019 na zahtevo Francije v skladu s členom 107i Direktive 2001/83/ES.
English: The PRAC recommendation was adopted by the CMDh1 by consensus and will be implemented directly at national level.
Slovenian: Priporočilo odbora PRAC je soglasno sprejela skupina CMDh1, uveljavljeno pa bo neposredno na nacionalni ravni.
English: 1 Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human
Slovenian: 1 Usklajevalna skupina za postopek vzajemnega priznavanja in decentralizirani postopek - v humani medicini.
English: In the EU, fenspiride medicines have been authorised via national procedures in Bulgaria, France, Latvia, Lithuania, Poland, Portugal and Romania and are available under various brand names (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал and Сиресп).
Slovenian: V Evropski uniji je bilo dovoljenje za promet z zdravili, ki vsebujejo fenspirid, izdano po nacionalnem postopku v Bolgariji, Franciji, Latviji, Litvi, na Poljskem, na Portugalskem in v Romuniji, ta zdravila pa so na voljo pod več različnimi tržnimi imeni (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал in Сиресп).
English: • If you have any concerns about your medicine, discuss them with your doctor or pharmacist.
Slovenian: • Če imate kakršne koli pomisleke glede svojega zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: Therefore, the PRAC considered that these medicines should no longer be marketed.
Slovenian: Zato je odbor PRAC presodil, da ta zdravila ne smejo več biti na tržišču.
English: • Return unused medicines to your pharmacy for appropriate disposal.
Slovenian: • Neuporabljena zdravila vrnite v lekarno, da jih bodo ustrezno odstranili.
English: The PRAC recommendation will now be implemented by EU Member States, Iceland, Lichtenstein and Norway.
Slovenian: Priporočilo odbora PRAC bodo zdaj uveljavile države članice EU, Islandija, Lihtenštajn in Norveška.
English: Withdrawal of marketing authorisations for fenspiride medicines EMA/285298/2019
Slovenian: Umik dovoljenja za promet z zdravilom za zdravila, ki vsebujejo fenspirid EMA/285298/2019
English: This follows a review that confirmed that these cough medicines could cause heart rhythm problems.
Slovenian: To je posledica pregleda, pri katerem je bilo potrjeno, da lahko ta zdravila proti kašlju povzročijo težave s srčnim ritmom.
English: • Given the authorised uses of fenspiride for symptomatic treatment only and the seriousness of the safety concern, the benefit-risk balance of these medicines is negative for the currently authorised uses.
Slovenian: • Na podlagi dovoljene uporabe fenspirida samo za simptomatsko zdravljenje in resnosti varnostnih pomislekov je razmerje med tveganji in koristmi za trenutno dovoljeno uporabo pri teh zdravilih negativno.
English: The PRAC recommendation was sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted it by consensus on 29 May 2019.
Slovenian: Priporočilo odbora PRAC je bilo poslano Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (skupini CMDh), ki je stališče soglasno sprejela 29. maja 2019.
English: Heart rhythm problems can be serious and occur suddenly, and it is not feasible to identify in advance the patients who may be at risk of these problems with fenspiride.
Slovenian: Težave s srčnim ritmom so lahko resne in se pojavijo nenadoma, nemogoče pa je vnaprej napovedati, pri katerih bolnikih se lahko pojavi tveganje za težave, povezane s fenspiridom.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Slovenian: Pregled je najprej opravil Odbor za oceno tveganja na področju farmakovigilance (odbor PRAC), ki je odgovoren za presojo varnostnih vprašanj v zvezi z zdravili za uporabo v humani medicini, in podal več priporočil.
English: You can check the ingredients of your medicine in the package leaflet accompanying the medicine.
Slovenian: Sestavine zdravila lahko preverite v navodilu za uporabo, priloženem zdravilu.
English: In contrast, fenspiride medicines are used to treat non-serious cough.
Slovenian: V nasprotju s tem se zdravila, ki vsebujejo fenspirid, uporabljajo za zdravljenje kašlja, ki ni resen.
English: Withdrawal of marketing authorisations for fenspiride medicines
Slovenian: Umik dovoljenja za promet z zdravilom za zdravila, ki vsebujejo fenspirid
English: • The withdrawal of the marketing authorisations of fenspiride medicines is based on case reports and nonclinical studies (including hERG channel binding) that showed that fenspiride can cause QT prolongation and has proarrhythmia potential (could cause triggering or worsening of arrhythmia) with the associated risk of torsades de pointes.
Slovenian: • Umik dovoljenja za promet z zdravili, ki vsebujejo fenspirid, temelji na poročilih o primerih in nekliničnih študijah (vključno z vezanjem na kanalček hERG), s katerimi so dokazali, da lahko ta učinkovina povzroči podaljšanje intervala QT in ima proaritmični potencial (aritmijo lahko sproži ali poslabša), s tem tveganjem pa je povezano tudi tveganje za polimorfno ventrikularno tahikardijo („torsades de pointes“).
English: More about the medicines
Slovenian: Več informacij o zdravilih
English: • Patients are only at risk of heart rhythm problems with fenspiride while they are taking these medicines.
Slovenian: • Tveganje za težave s srčnim ritmom se pri bolnikih pojavi le, dokler jemljejo ta zdravila.
English: Fenspiride medicines are available as syrup or tablets and used in adults and children from the age of 2 years to relieve cough resulting from lung diseases.
Slovenian: Zdravila, ki vsebujejo fenspirid, so na voljo v obliki sirupa ali tablet in se uporabljajo za lajšanje kašlja, ki ga povzročajo pljučne bolezni, pri odraslih in otrocih, starejših od dveh let.
English: This included cases of QT prolongation and torsades de pointes (abnormalities of the heart's electrical activity that may lead to heart rhythm disturbances) in patients using these medicines, results of laboratory studies, data from published literature and stakeholder input.
Slovenian: Med temi dokazi so bili primeri podaljšanja intervala QT in polimorfna ventrikularna tahikardija („torsades de pointes“, nenormalna električna dejavnost srca, ki lahko povzroči motnje srčnega ritma) pri bolnikih, ki so uporabljali ta zdravila, rezultati laboratorijskih študij, podatki iz objavljene literature ter poročila zainteresiranih skupin.
English: On 16 May 2019, EMA's safety committee (PRAC) recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU.
Slovenian: Odbor za ocenjevanje tveganja na področju farmakovigilance (odbor PRAC) Evropske agencije za zdravila je 16. maja 2019 priporočil ukinitev dovoljenja za promet za zdravila, ki vsebujejo fenspirid, tako da promet s temi zdravili v Evropski uniji ni več mogoč.
English: • Healthcare professionals should no longer prescribe fenspiride medicines and should advise their patients to stop taking fenspiride medicines.
Slovenian: • Zdravstveni delavci ne smejo več predpisovati zdravil, ki vsebujejo fenspirid, bolnikom, ki ta zdravila jemljejo, pa morajo jemanje odsvetovati.
English: At that time, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended that supply of fenspiride medicines be suspended as a precautionary measure while the review was ongoing.
Slovenian: Takrat je Odbor za ocenjevanje tveganja na področju farmakovigilance (odbor PRAC) kot previdnostni ukrep priporočil, da se zdravila, ki vsebujejo fenspirid, med pregledom začasno umaknejo.
English: • You should stop taking these medicines and contact your doctor or pharmacist for advice on alternative treatments, if needed.
Slovenian: • Ta zdravila morate prenehati jemati in se o drugačnem zdravljenju po potrebi posvetovati s svojim zdravnikom ali farmacevtom.
English: • Cough medicines containing fenspiride will no longer be marketed in the EU because of data showing a risk of sudden, serious heart rhythm problems.
Slovenian: • Zaradi podatkov, na podlagi katerih je dokazano tveganje za nenadne in resne težave s srčnim ritmom, promet z zdravili proti kašlju, ki vsebujejo fenspirid, v Evropski uniji ne bo več dovoljen.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Sanofi-Aventis - Produtos Farmacêuticos, Lda.
Slovenian: Portugalska Sanofi-Aventis - Produtos Farmacêuticos, Lda.
English: 164,5 mg / 3 ml solution for injection intramuscular use
Slovenian: 164,5 mg / ml raztopina za injiciranje intramuskularna uporaba
English: 821 02 Bratislava
Slovenian: 821 02 Bratislava Slovak Republic
English: Dolokadin einmal täglich prolonged release tablet
Slovenian: Dolokadin einmal täglich 400 mg tableta s podaljšanim sproščanjem
English: Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Slovenian: Empreendimento Lagoas Park, Edifício 7 - 3º Piso
English: Slovak Republic TEVA Pharmaceuticals Slovakia, s.r.o.
Slovenian: TEVA Pharmaceuticals Slovakia, s.r.o.
English: Slovak Republic Zentiva k.s.
Slovenian: Madžarska ZENTIVA k.s.
English: Trancopal Dolo capsule
Slovenian: Trancopal Dolo
English: Flupirtinmaleat Winthrop 400 mg Retardtabletten prolonged release tablet
Slovenian: Flupirtinmaleat Winthrop mg Retardtabletten
English: Flupirtinmaleat AbZ 100 mg Kapseln
Slovenian: Flupirtinmaleat AbZ 100 mg
English: Kabelovny 130 102 37 Praha 10 Czech Republic
Slovenian: 102 37 Praha 10 Czech Republic
English: Flupizen 100 mg tvrdé kapsuly 100 mg
Slovenian: Flupizen 100 mg tvrdé kapsuly
English: Katadolon S long prolonged release tablet
Slovenian: Katadolon S long
English: MEDA Pharma GmbH & Co. KG Benzstr.
Slovenian: MEDA Pharma GmbH & Co.
English: FLUPIZEN 100 mg capsule
Slovenian: 100 mg kapsula
English: Trancopal Dolo Suppositorien 150 mg suppository rectal use
Slovenian: Trancopal Dolo Suppositorien
English: Flupimal 100 mg Hertkapseln 100 mg
Slovenian: Flupimal 100 mg Hertkapseln
English: Katadolon Kinderzäpfchen suppository rectal use
Slovenian: Katadolon Kinderzäpfchen 75 mg svečka rektalna uporaba
English: Midas Pharma GmbH Rheinstrasse, 49 55218 Ingelheim Germany
Slovenian: Portugalska Midas Pharma GmbH Rheinstrasse, 49
English: Flupsadim 100 mg Hartkapseln 100 mg
Slovenian: Flupsadim 100 mg Hartkapseln
English: Miflumal 100 mg Hartkapseln 100 mg
Slovenian: Miflumal 100 mg Hartkapseln
English: Fluporol 100 mg Hartkapseln 100 mg
Slovenian: Fluporol 100 mg Hartkapseln
English: U
Slovenian: KG
English: Flupivil 100 mg Hartkapseln 100 mg
Slovenian: Flupivil 100 mg Hartkapseln
English: Flupigil 100 mg Hartkapseln 100 mg
Slovenian: Flupigil 100 mg Hartkapseln
English: Flupin 100 mg Hartkapseln 100 mg
Slovenian: Flupin 100 mg Hartkapseln 100 mg kapsula, trda
English: Further information can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Dodatne informacije so na voljo tukaj: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In addition, the Committee questioned the proposed method of sterilisation of the medicine.
Slovenian: Poleg tega je podvomil o predlagani metodi sterilizacije zdravila.
English: Sirolimus has been used for several years to prevent organ rejection following a transplant.
Slovenian: Sirolimus se je več let uporabljal za preprečevanje zavračanja organov po presaditvi.
English: The inflammation may cause discomfort, pain, blurring of vision, and may lead to partial or complete blindness.
Slovenian: Vnetje lahko povzroči neprijeten občutek, bolečino in zamegljen vid ter lahko povzroči delno ali popolno slepoto.
English: The main measure of effectiveness was the number of patients in whom inflammation resolved after 5 months of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih je bilo vnetje ozdravljeno po petih mesecih zdravljenja.
English: The data from the clinical study was not sufficient to demonstrate the benefit of Opsiria, particularly in European patients.
Slovenian: Podatki iz klinične študije niso zadoščali za dokaz koristi zdravila Opsiria, zlasti pri evropskih bolnikih.
English: Withdrawal of the marketing authorisation application for Opsiria (sirolimus)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Opsiria (sirolimus)
English: Withdrawal of the marketing authorisation application for Opsiria (sirolimus) EMA/358774/2016
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Opsiria (sirolimus) EMA/358774/2016
English: Opsiria was investigated in one main study in 347 patients with non-infectious uveitis.
Slovenian: Zdravilo Opsiria so proučevali v eni glavni študiji pri 347 bolnikih z neinfektivnim uveitisom.
English: In this study, Opsiria was not compared with any other treatment.
Slovenian: V tej študiji zdravila Opsiria niso primerjali z nobenim drugim zdravilom.
English: Opsiria is a medicine that contains the active substance sirolimus.
Slovenian: Opsiria je zdravilo, ki vsebuje zdravilno učinkovino sirolimus.
English: The application was withdrawn after that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Slovenian: Vlogo so umaknili po tem, ko je odbor CHMP ocenil dokumentacijo, ki jo je predložila družba, in oblikoval sezname vprašanj.
English: On 20 May 2016, Santen Oy officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opsiria, for the treatment of non-infectious uveitis.
Slovenian: Družba Santen Oy je 20. maja 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Opsiria, namenjenim zdravljenju neinfektivnega uveitisa.
English: Since mTOR is involved in the activation and proliferation of T lymphocytes (white blood cells that play a role in inflammation), sirolimus is expected to reduce the inflammation in chronic non-infectious uveitis.
Slovenian: Ker mTOR sodeluje pri aktivaciji in proliferaciji limfocitov T (belih krvnih celic, ki imajo pomembno vlogo pri vnetju), naj bi sirolimus zmanjšal vnetje pri kroničnem neinfektivnem uveitisu.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Slovenian: Potem ko je ocenil odgovore družbe na zadnja vprašanja, so nekatera vprašanja še vedno ostala nerešena.
English: In its letter notifying the Agency of the withdrawal of application, the company acknowledged the need to submit additional data on the benefits of Opsiria from an ongoing clinical study.
Slovenian: V dopisu, v katerem družba agencijo obvešča o umiku vloge, družba priznava nujnost predložitve dodatnih podatkov o koristih zdravila Opsiria iz klinične študije, ki še poteka.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Opsiria could not have been approved for the treatment of non-infectious uveitis.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil odbor CHMP, je ta v času umika izrazil določene zadržke in je začasno menil, da zdravila Opsiria ni mogoče odobriti za zdravljenje neinfektivnega uveitisa.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Opsiria.
Slovenian: Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Opsiria.
English: Opsiria was expected to be used for the treatment of non-infectious uveitis (inflammation of the uvea, the middle layer of the eye) in adults.
Slovenian: Zdravilo Opsiria naj bi se uporabljalo za zdravljenje infektivnega uveitisa (vnetja uvee, srednjega sloja očesa) pri odraslih.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016 EMA/358774/2016 EMEA/H/C/003978
Slovenian: EMA/358774/2016 EMEA/H/C/003978
English: What is Opsiria?
Slovenian: Kaj je zdravilo Opsiria?
English: Opsiria was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 30 August 2011 for the treatment of chronic non-infectious uveitis.
Slovenian: Zdravilo Opsiria je bilo 30. avgusta 2011 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za zdravljenje kroničnega neinfektivnega uveitisa.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Opsiria did not outweigh its risks.
Slovenian: Zato je v času umika menil, da koristi zdravila Opsiria ne odtehtajo z njim povezanih tveganj.
English: What was Opsiria expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Opsiria uporabljalo?
English: The active substance in Opsiria, sirolimus, is expected to work by blocking an enzyme called ‘mammalian target of rapamycin' (mTOR).
Slovenian: Zdravilna učinkovina v zdravilu Opsiria, sirolimus, naj bi delovala z zaviranjem encima, imenovanega „tarča rapamicina pri sesalcih“ (mTOR).
English: It was to be available as a solution to be injected into the eye.
Slovenian: Na voljo naj bi bilo v obliki raztopine za injiciranje v oko.
English: How is Opsiria expected to work?
Slovenian: Kako naj bi zdravilo Opsiria delovalo?
English: London, 25 October 2007 EMEA/CHMP/350251/2007
Slovenian: London, 25. oktober 2007 EMEA/CHMP/350251/2007
English: The Reference Member State was Germany and the Concerned Member States were Austria, Denmark, Spain, Finland, France, Italy, Luxembourg, Norway, Poland, Portugal, Sweden and United Kingdom.
Slovenian: Referenčna država članica je bila Nemčija, zadevne države članice pa Avstrija, Danska, Španija, Finska, Francija, Italija, Luksemburg, Norveška, Poljska, Portugalska, Švedska in Združeno kraljestvo.
English: The Mutual Recognition Procedure started on 24 October 2006.
Slovenian: Postopek medsebojnega priznavanja se je pričel 24. oktobra 2006.
English: The Rapporteur was Dr Karl Broich and Co-Rapporteur(s) was Dr Pierre Demolis.
Slovenian: Poročevalec je bil dr. Karl Broich, soporočevalec pa dr. Pierre Demolis.
English: A positive opinion was adopted by majority on 19 July 2007.
Slovenian: Pozitivno mnenje je bilo sprejeto z večino glasov dne 19. julija 2007.
English: The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Slovenian: Arbitražni postopek se je začel 26. aprila 2007 s sprejetjem seznama vprašanj.
English: The final opinion was converted into a Decision by the European Commission on 24 October 2007.
Slovenian: Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 24. oktobra 2007.