FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol
Slovenian: Relvar Ellipta 184 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol
English: Extrasystoles Palpitations Tachycardia
Slovenian: Srčne bolezni ekstrasistole palpitacije tahikardija občasni redki redki
English: Very common Rare
Slovenian: izpuščajem in urtikarijo redki
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol
Slovenian: Relvar Ellipta 92 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni flutikazonfuroat/vilanterol
English: Tell your doctor as soon as possible if you develop any of these symptoms.
Slovenian: Če se vam pojavi kateri od teh simptomov, morate to čim prej povedati svojemu zdravniku.
English: There was no evidence for gender, weight or BMI to influence the pharmacokinetics of vilanterol based on a population pharmacokinetic analysis in 856 subjects with asthma (500 females).
Slovenian: preiskovancev s KOPB (340 žensk) ni pokazala, da bi spol, telesna masa ali ITM vplivali na farmakokinetiko vilanterola.
English: 287% higher and AUC(0-24) comparable for those subjects from an Asian heritage compared with subjects from other racial groups.
Slovenian: AUC(0-24)) v primerjavi z zdravimi preiskovanci.
English: The inhaler consists of a light grey body, a yellow mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
Slovenian: Inhalator sestavljajo svetlo sivo ohišje, rumen pokrovček ustnika in števec odmerkov.
English: Headache Tremor
Slovenian: • glavobol,
English: if you have thyroid gland problems.
Slovenian: če imate težave s ščitnico;
English: Do not shake the inhaler.
Slovenian: Inhalatorja ne smete stresati.
English: Dysphonia
Slovenian: Odmerjanje
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/886/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/886/006
English: Marketing Authorisation Holder:
Slovenian: Kaj vsebuje navodilo:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/886/004
English: Upper respiratory tract infection Bronchitis
Slovenian: okužba zgornjih dihal bronhitis gripa kandidoza ust in žrela pogosti
English: - For the 92/22mcg dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Slovenian: - Za odmerek 92/22 mcg: ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 92
English: - For the 184/22 dose: each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 184 micrograms of fluticasone furoate and 22 micrograms of vilanterol (as trifenatate).
Slovenian: - Za odmerek 184/22 mcg: ena inhalacija zagotavlja oddani odmerek (odmerek, ki zapusti ustnik) 184
English: At Day 169 fluticasone furoate/vilanterol 92/22 micrograms and vilanterol increased adjusted mean trough FEV1 by 129 mL (95% CI: 91, 167 mL, p<0.001) and 83 mL (95% CI: 46, 121mL, p<0.001) respectively compared to placebo.
Slovenian: 92/22 mikrogramov povečal korigirani povprečni najnižji FEV1 169. dan za 129 ml (95 % IZ: 91, 167 ml, p
English: The increase in fluticasone furoate systemic exposure in subjects with moderate hepatic impairment (Child-Pugh B; fluticasone furoate/vilanterol 184/22 micrograms) was associated with an average 34% reduction in serum cortisol compared with healthy subjects.
Slovenian: 184/22 mikrogramov) povezano s povprečno 34 % znižanjem kortizola v serumu v primerjavi z zdravimi preiskovanci.
English: Cough
Slovenian: KOPB.
English: The recommended dose to treat COPD is one inhalation (92 micrograms of fluticasone furoate and 22 micrograms of vilanterol) once daily at the same time each day.
Slovenian: KOPB Priporočeni odmerek za zdravljenje KOPB je ena inhalacija (92 mikrogramov flutikazonfuroata in
English: Change from Baseline in AM Peak Expiratory Flow Treatment difference
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija pogosti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/886/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/886/003
English: • stomach pain
Slovenian: • tesnoba.
English: Blister (alu/Aclar)
Slovenian: Pretisni omot (alu/Aclar) 84 kapsul
English: Oral use
Slovenian: Za peroralno uporabo
English: Capsule, hard
Slovenian: 100 mg Kapsula, trda
English: Pharmaceutical Form
Slovenian: Jakost Farmacevtska oblika Pot uporabe Stična ovojnina
English: These member states were not able to reach an agreement.
Slovenian: Te države članice niso mogle doseči soglasja.
English: The European Commission issued a decision on 12 March 2009.
Slovenian: Evropska komisija je odločbo izdala dne 12. marca 2009.
English: Prof Michal Pirożynski (Poland)
Slovenian: prof. Michal Pirożynski (Poljska)
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Slovenian: Člen 29 Direktive 2001/83/ES, kakor je bila spremenjena, o napotitvi na podlagi možnega resnega tveganja za javno zdravje.
English: Ref. EMEA/CHMP/194784/2009 EMEA/H/A-29/990
Slovenian: EMEA/CHMP/194677/2009 EMEA/H/A-29/991
English: London, 17 March 2009 Doc.
Slovenian: London, 17. marca 2009 Sklic dok.
English: It can also be used to prevent asthma symptoms caused by exercise or other triggering factors, such as house dust, pollen, cats, dogs and cigarette smoke.
Slovenian: Uporablja se lahko tudi za preprečevanje simptomov astme, ki jih povzročajo telovadba ali drugi sprožilni dejavniki, kot so hišni prah, cvetni prah, mačke, psi in cigaretni dim.
English: On 4 March 2008, the Swedish medicines regulatory agency referred the matter to the CHMP.
Slovenian: Švedska regulatorna agencija za zdravila je 4. marca 2008 zadevo napotila na CHMP.
English: This makes the airways widen, allowing the air to flow more freely.
Slovenian: Zaradi tega se dihalne poti razširijo, pretok zraka pa je tako bolj prost.
English: This means that Sabumalin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sultanol inhaler.
Slovenian: To pomeni, da je zdravilo Sanohex podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Sultanol inhalator.
English: The review was carried out under an ‘Article 29' referral1.
Slovenian: Pregled se je opravil v okviru napotitvenega postopka v skladu s členom 291.
English: Questions and answers on the referral for Sabumalin salbutamol, metered dose aerosol inhaler, 100 μg/dose
Slovenian: Vprašanja in odgovori v zvezi z napotitvijo za zdravilo Sanohex salbutamol, inhalator za merjeni odmerek aerosola, 100 μg/odmerek
English: Why was Sabumalin reviewed?
Slovenian: Zakaj je bilo zdravilo Sanohex pregledano?
English: The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sabumalin.
Slovenian: Evropska agencija za zdravila (EMEA) je končala napotitveni postopek, do katerega je prišlo po nesoglasju med državami članicami Evropske unije glede odobritve zdravila Sanohex.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sabumalin outweigh its risks, and that therefore the marketing authorisation for Sabumalin should be granted in all concerned member states.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CHMP je ta zaključil, da koristi zdravila Sanohex odtehtajo z njim povezana tveganja ter da je zato treba dovoljenje za promet z zdravilom Sanohex odobriti v vseh zadevnih državah članicah.
English: Concerns were also raised regarding how to store the inhaler and the effect of the orientation of the inhaler on the delivery of the medicine.
Slovenian: Zadržki so bili izraženi tudi glede načina shranjevanja inhalatorja in učinka usmerjenosti inhalatorja na vnos zdravila.
English: Sabumalin is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD).
Slovenian: Zdravilo Sanohex se uporablja za zdravljenje težav pri dihanju, ki jih povzroča astma, in kronične obstruktivne pljučne bolezni (KOPB).
English: Company responses provided on: 30 May 2008, 20 October 2008 Opinion date:
Slovenian: dr. Gonzalo Calvo Rojas (Španija) Datum začetka postopka napotitve: 19. marec 2008 Datum prejema odgovorov družbe: 30. maj 2008, 20. oktober 2008 Datum izdaje mnenja:
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘concerned Member States', in this instance Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom).
Slovenian: To je postopek, v katerem ena od držav članic („referenčna država članica“, v tem primeru Švedska) ovrednoti zdravilo za odobritev dovoljenja za promet z zdravilom v tej državi in tudi drugih državah članicah („zadevne države članice“, v tem primeru Avstrija, Nemčija, Irska in Španija).
English: The grounds for the referral were concerns regarding that there was not enough data showing that Sabumalin is equivalent to the reference medicine.
Slovenian: Razlogi za napotitveni postopek so bili zadržki glede nezadostnih podatkov, ki bi dokazovali, da je zdravilo Sanohex enakovredno referenčnemu zdravilu.
English: Hexal AG submitted Sabumalin to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
Slovenian: Družba Hexal AG je dne 5. decembra 2006 švedski regulatorni agenciji za zdravila predložila vlogo za začetek decentraliziranega postopka za zdravilo Sanohex.
English: Sabumalin is used to relieve symptoms, and its use should not delay the use of inhaled steroids.
Slovenian: Zdravilo Sanohex se uporablja za lajšanje simptomov, zaradi uporabe tega zdravila pa se ne sme preložiti uporabe inhalacijskih steroidov.
English: Sabumalin is a ‘generic medicine'.
Slovenian: Zdravilo Sanohex je „generično zdravilo“.
English: This means that salbutamol activates the beta2receptors in the body.
Slovenian: To pomeni, da salbutamol aktivira receptorje beta-2 v telesu.
English: Salbutamol is a beta2-adrenergic receptor agonist.
Slovenian: Salbutamol je agonist adrenergičnih receptorjev beta-2.
English: Sabumalin is a medicine in a pressurised inhaler that contains salbutamol as active substance.
Slovenian: Sanohex je zdravilo v inhalatorju pod tlakom, ki vsebuje zdravilno učinkovino salbutamol.
English: When given by inhalation as in Sabumalin, salbutamol directly activates the beta2-receptors in the respiratory system.
Slovenian: Pri jemanju zdravila z inhaliranjem, kot velja za zdravilo Sanohex, salbutamol neposredno aktivira receptorje beta-2 v dihalih.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Sabumalin outweigh its risks, and that the marketing authorisation can be granted in Sweden as well as in the following Member States of the European Union: Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP), ki je del agencije EMEA, je zaključil, da koristi zdravila Sanohex odtehtajo z njim povezana tveganja in da se lahko dovoljenje za promet z zdravilom odobri na Švedskem ter tudi v naslednjih državah članicah Evropske unije: Avstrija, Nemčija, Irska in Španija.
English: What is Sabumalin?
Slovenian: Kaj je zdravilo Sanohex?
English: (Invented) name
Slovenian: (izmišljeno)
English: EMA Number
Slovenian: Številka postopka
English: Pack size
Slovenian: EMA
English: MA (EU) number (Invented) Name
Slovenian: (Izmišljeno) ime
English: Content (concent ration)
Slovenian: Vsebina (koncentracija)
English: MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK (the ‘reference Member State') in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain (the ‘concerned Member States').
Slovenian: Podjetje MIKA Pharma GmbH je zahtevalo, da se dovoljenje za promet z zdravilom Diclofenac Sodium Spray Gel 4%, ki ga je leta 2001 izdalo Združeno kraljestvo (referenčna država članica), pozneje pa tudi Avstrija, Estonija, Madžarska, Irska, Latvija, Litva in Slovenija, prizna tudi v Nemčiji, Italiji in Španiji (zadevne države članice).
English: The review of Diclofenac Sodium Spray Gel 4% was initiated at the request of the United Kingdom under Article 29(4) of Directive 2001/83/EC.
Slovenian: Pregled zdravila Diclofenac Sodium Spray Gel 4% se je začel na zahtevo Združenega kraljestva v skladu s členom 29(4) Direktive 2001/83/ES.
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 4 April 2018.
Slovenian: Ker pa države članice niso dosegle soglasja, je britanska regulativna agencija za zdravila 4. aprila 2018 zadevo napotila na Evropsko agencijo za zdravila v arbitražo.
English: The spray gel is applied on the skin of affected areas to relieve pain and swelling due to trauma in small and medium joints and surrounding tissues.
Slovenian: Gel v obliki pršila se nanese na kožo na prizadete dele, kjer lajša bolečino in otekanje zaradi poškodbe majhnih in srednje velikih sklepov in obdajajočih tkiv.
English: The grounds for the referral were concerns raised by Germany and Spain that the data provided by the company were not sufficient to show that the product was effective at treating joint pain and swelling.
Slovenian: Podlaga za napotitev so bili pomisleki, ki sta jih izrazili Nemčija in Španija, da podatki, ki jih je predložilo podjetje, ne zadoščajo za dokaz, da je zdravilo učinkovito pri zdravljenju bolečine v sklepih in otekanja sklepov.
English: The Agency also considered that, although the effectiveness of diclofenac and other NSAIDs applied to the skin is somewhat modest, these medicines have been authorised and used for decades and their safety is not in question.
Slovenian: Agencija je tudi upoštevala, da se, čeprav je učinkovitost diklofenaka in drugih nesteroidnih protivnetnih zdravil, ki se nanesejo na kožo, precej skromna, dovoljenja za promet s temi zdravili izdajajo že desetletja, toliko časa pa se ta zdravila tudi uporabljajo, tako da njihova varnost ni vprašljiva.
English: The Agency concluded that the benefits of the medicine outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Slovenian: Agencija je zaključila, da koristi zdravila odtehtajo z njim povezana tveganja in da se dovoljenje za promet z njim, izdano v Združenem kraljestvu, lahko prizna tudi v drugih državah članicah EU, v katerih je podjetje zanj zaprosilo.
English: On 15 November 2018, the European Medicines Agency completed a review of Diclofenac Sodium Spray Gel 4% following a disagreement among EU Member States regarding its authorisation.
Slovenian: Evropska agencija za zdravila je 15. novembra 2018 zaključila pregled zdravila Diclofenac Sodium Spray Gel 4% po nesoglasju med državami članicami EU v zvezi z izdajo dovoljenja za promet z njim.
English: What is Diclofenac Sodium Spray Gel 4%?
Slovenian: Kaj je zdravilo Diclofenac Sodium Spray Gel 4%?
English: In addition, the use of data from the published literature obtained with other diclofenac medicines to demonstrate the benefits of Diclofenac Sodium Spray Gel 4% needed to be further justified.
Slovenian: Poleg tega je bilo treba uporabo podatkov iz objavljene literature, ki so jih pridobili z drugimi zdravili z diklofenakom, za prikaz koristi zdravila Diclofenac Sodium Spray Gel 4% dodatno utemeljiti.
English: Since Diclofenac Sodium Spray Gel 4% is absorbed in a similar way to other diclofenac medicines applied to the skin and the supporting study demonstrated an effect similar to that of other diclofenac medicines in the published literature, the Agency considered that it was acceptable to use published data on the effectiveness and safety of other diclofenac medicines to support the use of Diclofenac Sodium Spray Gel 4%.
Slovenian: Ker se zdravilo Diclofenac Sodium Spray Gel 4% absorbira podobno kot druga zdravila, ki vsebujejo diklofenak in se nanesejo na kožo, in ker so v podporni študiji dokazali, da ima zdravilo podoben učinek kot druga zdravila z diklofenakom v objavljeni literaturi, je agencija zaključila, da je sprejemljivo uporabiti objavljene podatke o učinkovitosti in varnosti drugih zdravil, ki vsebujejo diklofenak, tudi v podporo uporabi zdravila Diclofenac Sodium Spray Gel 4%.
English: Diclofenac Sodium Spray Gel 4% contains the active substance diclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Zdravilo Diclofenac Sodium Spray Gel 4% vsebuje učinkovino diklofenak, ki spada v skupino nesteroidnih protivnetnih zdravil.
English: The company also provided the results of a study indicating that Diclofenac Sodium Spray Gel 4% is effective at reducing joint swelling and relieving pain.
Slovenian: Podjetje je predložilo tudi rezultate študije, ki kažejo, da je zdravilo Diclofenac Sodium Spray Gel 4% učinkovito pri zmanjševanju otekanja sklepov in lajšanju bolečine.
English: The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Diclofenac Sodium Spray Gel 4% on 18/01/2019.
Slovenian: Evropska komisija je 18. januarja 2019 izdala končni pravno zavezujoči sklep, ki velja po vsej EU, o izdaji dovoljenja za promet z zdravilom Diclofenac Sodium Spray Gel 4%.
English: Overall, the totality of the data provided by the company was considered sufficient to demonstrate that Diclofenac Sodium Spray Gel 4% is effective at treating joint swelling and pain due to trauma.
Slovenian: V splošnem je bilo mogoče sklepati, da so vsi podatki, ki jih je predložilo podjetje, zadostni za dokaz, da je zdravilo Diclofenac Sodium Spray Gel 4% učinkovito pri zdravljenju otekanja sklepov in lajšanju bolečin zaradi poškodbe.
English: The Agency considered that the data provided by the company show that, when applied to the skin, Diclofenac Sodium Spray Gel 4% produces similar levels of diclofenac in the body to another diclofenac
Slovenian: Agencija je zaključila, da podatki, ki jih je predložilo podjetje, dokazujejo, da je količina diklofenaka v telesu pri nanosu zdravila Diclofenac Sodium Spray Gel 4% na kožo podobna kot pri drugem gelu, ki vsebuje diklofenak, ki je že odobren za enako uporabo.
English: The Agency therefore concluded that the benefits of the medicine outweigh its risks, and therefore the marketing authorisation should be granted in the concerned Member States.
Slovenian: Agencija je zaključila, da koristi zdravila Diclofenac Sodium Spray Gel 4% odtehtajo njegova tveganja, in priporočila, da se dovoljenje za promet z zdravilom izda v zadevnih državah članicah.
English: EMA/631720/2018 Rev. 1
Slovenian: 18. januar 2019
English: Classification as an exceptional case
Slovenian: Razvrstitev kot izjemni primer
English: (Invented) Name Strength
Slovenian: (Izmišljeno) ime Jakost
English: Twenty-eight adequate non-clinical literature references were also submitted.
Slovenian: Predloženih je bilo tudi osemindvajset primernih nekliničnih virov.
English: Overall summary of the scientific evaluation of Fortipan Combi D and associated names (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravila Fortipan Combi D in z njim povezanih imen (glejte Prilogo I)
English: Plaça de la Pau s/n 08940 Cornellà de Llobregat (Barcelona) Spain
Slovenian: Plaça de la Pau s/n 08940 Cornellà de Llobregat (Barcelona) Španija
English: Bisphosphonates maintain their activity for extended periods and as a result, do not need continuous dosing.
Slovenian: Bisfosfonati ohranijo svojo aktivnost dolga časovna obdobja in posledično ne potrebujejo stalnega odmerjanja.
English: The CHMP noted the data submitted in the initial application.
Slovenian: CHMP je upošteval podatke, predložene v prvotni vlogi.
English: Data submitted by the Applicant
Slovenian: Podatki, ki jih je predložil predlagatelj
English: • the data submitted in the initial authorisation application product file was considered to sufficiently support the marketing authorisation application,
Slovenian: • Podatki, predloženi v prvotni vlogi za odobritev dovoljenja za promet, so se šteli za zadostno podporo v vlogi za odobritev dovoljenja za promet.
English: In conclusion, the CHMP considered the Applicant to have submitted all relevant and necessary data to support a full dossier application under Article 8(3).
Slovenian: CHMP je torej menil, da je predlagatelj preložil vse ustrezne in potrebne podatke v podporo vloge s popolno dokumentacijo v skladu s členom 8(3).
English: The CHMP considered this to be a clear public health benefit.
Slovenian: Upošteval je, da je to jasna korist za javno zdravje.
English: Therefore, the proposed dosage is one risedronate tablet on day 1 followed by one sachet of calcium/colecalciferol daily for day 2 through to day 7, repeating this 7-day sequence each week.
Slovenian: Zato je predlagano odmerjanje ena tableta risedronata 1. dan, čemur sledi ena vrečka kalcija/holekalciferola dnevno od 2. do 7. dne, nato pa se to 7-dnevno zaporedje vsak teden ponavlja.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, applicant and marketing authorisation holders in the Member States
Slovenian: SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: Public health benefit and improved compliance
Slovenian: Korist za javno zdravje in izboljšanje bolnikovega upoštevanja navodil
English: The CHMP was of the opinion that the application is approvable.
Slovenian: CHMP je menil, da je vlogo mogoče odobriti.
English: According to the CHMP Guideline on combination products, “combination packs would only be acceptable in exception al cases, when there would be clear public health benefits of the treatment regimen and/or compliance, taking into account the required justifications set-out in section 5 of this guideline”.
Slovenian: V skladu s Smernico CHMP za kombinirana zdravila so „kombinirana pakiranja sprejemljiva le v izjemnih primerih, ko obstajajo jasne koristi za javno zdravje zaradi režima zdravljenja in/ali upoštevanja navodil, če upoštevamo zahtevane utemeljitve v 5. poglavju omenjene smernice“.
English: The procedure started in November 2009 and the indications applied for are the “treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures” and the “treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures”.
Slovenian: Postopek se je začel novembra leta 2009, predlagani indikaciji pa sta bili „zdravljenje osteoporoze pri ženskah po menopavzi, za zmanjšanje nevarnosti zlomov vretenc“ in „zdravljenje razvite osteoporoze pri ženskah po menopavzi, za zmanjšanje nevarnosti zlomov kolka“.