FrancophonIA/ELRC3.0 huggingface dataset:
English: The referral started on 12 March 2014.
Slovenian: Napotitveni postopek se je začel 12. marca 2014.
English: International non-proprietary name (INN): gentamicin
Slovenian: Mednarodno nelastniško ime (INN): gentamicin
English: The Committee appointed K. Baptiste as rapporteur and C. Muñoz Madero as co-rapporteur.
Slovenian: Odbor je imenoval Keitha Baptista za poročevalca in Cristino Muñoz Madero za soporočevalko.
English: Written explanations were provided by the applicants and marketing authorisation holders on 16 May 2014 and 4 September 2014.
Slovenian: Predlagatelji in imetniki dovoljenja za promet so predložili pisna pojasnila 16. maja 2014 in 4. septembra 2014.
English: It is currently included in the list of essential medicines for human use of the World Health Organisation (WHO).
Slovenian: Trenutno je vključen na seznam nujnih zdravil za uporabo v humani medicini Svetovne zdravstvene organizacije (SZO).
English: It is normally used as the sulphate salt.
Slovenian: Običajno se uporablja v obliki sulfata.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Prilogi I. Znanstveni zaključki so podani v Prilogi II, Priloga III pa vsebuje spremembe povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov je CVMP menil, da splošno razmerje med koristmi in tveganji za ta zdravila ostaja pozitivno, če se upoštevajo spremembe v informacijah o zdravilu.
English: It is also used in human medicine, usually as a solution for injection for intramuscular administration.
Slovenian: Prav tako se uporablja v humani medicini, običajno v obliki raztopine za injiciranje za intramuskularno uporabo.
English: In veterinary medicine gentamicin is used mainly as a solution for injection for pigs, cattle and horses and as an oral solution for poultry.
Slovenian: V veterinarski medicini se gentamicin uporablja predvsem v obliki raztopine za injiciranje za prašiče, govedo in konje ter v obliki peroralne raztopine za perutnino.
English: On 14 February 2014, Denmark presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Slovenian: Danska je dne 14. februarja 2014 agenciji predložila obvestilo o napotitvi v skladu s členom 35 Direktive št. 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so na voljo v obliki raztopin za injiciranje za konje.
English: Therefore, on 6 November 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Slovenian: Zato je 6. novembra 2014 soglasno sprejel pozitivno mnenje, v katerem je priporočil spremembo pogojev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so na voljo v obliki raztopin za injiciranje za konje.
English: The CVMP was requested to harmonise the indications and dosing regimens of the concerned products, taking into account the available data and in particular with regard to the target animal safety.
Slovenian: Odbor CVMP so zaprosili, naj ob upoštevanju razpoložljivih podatkov, zlasti tistih, povezanih z varnostjo za ciljne živalske vrste, uskladi indikacije in režime odmerjanja za zadevna zdravila.
English: Opinion following an Article 351 referral for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 350F za zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so na voljo v obliki raztopin za injiciranje za konje stran 2/2
English: Version 10.1, 06/2019
Slovenian: Različica 10.1, 06/2019
English: At the request of the European Medicines Agency;
Slovenian: na zahtevo Evropske agencije za zdravila;
English: Risk management plan (RMP)
Slovenian: Načrt za obvladovanje tveganj (RMP)
English: <This product contains cells of <human> <animal> origin.>
Slovenian: <Zdravilo vsebuje celice <humanega> <živalskega> izvora.>
English: <The following information is intended for healthcare professionals only:>
Slovenian: <Naslednje informacije so namenjene samo zdravstvenemu osebju:>
English: Pharmacotherapeutic group: {group}, ATC code: <{code}> <not yet assigned>
Slovenian: Farmakoterapevtska skupina: {skupina}, oznaka ATC: <{oznaka}> <še ni bila dodeljena>
English: <Other sources of information>
Slovenian: <Drugi viri informacij>
English: <In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.>
Slovenian: <V primeru pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.>
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.>
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.>
English: NN {number} [national reimbursement number or other national number identifying the medicinal product]>
Slovenian: NN {številka} [nacionalna številka povračila stroškov za zdravilo ali druga nacionalna številka za identifikacijo zdravila]>
English: <Currently available data are described in section <4.8> <5.1> <5.2> but no recommendation on a posology can be made.>
Slovenian: <Podatkov ni na voljo.> <Trenutno razpoložljivi podatki so opisani v poglavju <4.8> <5.1> <5.2>, vendar priporočil o odmerjanju ni mogoče dati.>
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: <This medicinal product must not be mixed with other medicinal products except those mentioned in section <6.6> <and> <12>.>
Slovenian: <Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju <6.6> <in> <12>.>
English: You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V.* S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: <X contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Slovenian: <Zdravilo X vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že pridobilo dovoljenje za promet v EU.
English: Periodic safety update reports (PSURs)
Slovenian: Redno posodobljena poročila o varnosti zdravila (PSUR)
English: <The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.>
Slovenian: <Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.>
English: < PC {number} [product code]
Slovenian: < PC {številka} [koda zdravila]
English: <2.2 Qualitative and quantitative composition> [For advanced therapy products only]
Slovenian: <2.2 Kakovostna in količinska sestava> [Samo za zdravila za napredno zdravljenje]
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.>
Slovenian: V skladu s členom 114 Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.>
English: 6.5 Nature and contents of container <and special equipment for use, administration or implantation>
Slovenian: Vrsta ovojnine in vsebina <ter posebna oprema za uporabo, dajanje ali implantacijo>
English: - <if you are allergic to {active substance(s)} or any of the other ingredients of this medicine (listed in section 6).>
Slovenian: - <če ste alergični na {učinkovino(-i/-e)} ali katero koli sestavino tega zdravila (navedeno v poglavju 6).>
English: <Precautions to be taken before handling or administering the medicinal product>
Slovenian: <Previdnostni ukrepi, potrebni pred ravnanjem z zdravilom ali dajanjem zdravila>
English: <The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.>
Slovenian: <V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov proizvajalca, odgovornega za sprostitev zadevne serije.>
English: <Non-interventional post-authorisation safety study (PASS):>>
Slovenian: <Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS):>>
English: <Environmental risk assessment (ERA)>
Slovenian: <Ocena tveganja za okolje>
English: <{(Invented) name} is a biosimilar medicinal product.
Slovenian: <Zdravilo {(izmišljeno) ime} je podobno biološko zdravilo.
English: Do not use this medicine after the expiry date which is stated on the <label> <carton> <bottle> <…> <after {abbreviation used for expiry date}.> <The expiry date refers to the last day of that month.>
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na <nalepki> <škatli> <steklenici> <...> <poleg oznake {okrajšava za rok uporabnosti}.> <Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.>
English: <An updated RMP shall be submitted by {CHMP agreed deadline}.>
Slovenian: <Posodobljen RMP je treba predložiti do{skrajni rok, ki ga določi CHMP}>.
English: <Additional risk minimisation measures>
Slovenian: • <Dodatni ukrepi za zmanjševanje tveganj>
English: <2.1 General description> [For advanced therapy products only]
Slovenian: <2.1 Splošen opis> [Samo za zdravila za napredno zdravljenje]
English: <{(Invented) name} has <no or negligible influence> <minor influence> <moderate influence> <major influence> on the ability to drive and use machines.>
Slovenian: <Zdravilo {izmišljeno ime} <nima vpliva ali ima zanemarljiv vpliv> <ima blag vpliv> <ima zmeren vpliv> <ima pomemben vpliv> na sposobnost vožnje in upravljanja strojev.>
English: X with <food> <and> <,> <drink> <and> <alcohol>
Slovenian: Zdravilo X skupaj 
<z> <hrano> <in> <,> <pijačo> <in> <alkoholom>
English: <The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.>
Slovenian: <Imetnik dovoljenja za promet z zdravilom mora prvo PSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.>
English: <This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:>
Slovenian: <Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v določenem časovnem okviru izvesti naslednje ukrepe:>
English: <Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:>
Slovenian: <Neželeni učinki, ki jih v kliničnih študijah niso opazili, opazili pa so jih v študijah na živalih pri stopnjah izpostavljenosti, ki so bile podobne stopnjam klinične izpostavljenosti in so morda pomembni za klinično uporabo, so naslednji:>
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.*
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.*
English: <For storage conditions after <reconstitution> <dilution> <first opening> of the medicinal product, see section 6.3.>
Slovenian: <Za pogoje shranjevanja po <rekonstituciji> <redčenju> <prvem odprtju> zdravila glejte poglavje 6.3.>
English: <If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your <doctor> <or> <pharmacist> for advice before taking this medicine.>
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z <zdravnikom> <ali> <farmacevtom>, preden vzamete to zdravilo.>
English: <Traceability
Slovenian: <Sledljivost
English: D. conditions or restrictions with regard to the safe and effective use of the medicinal product
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: <For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: <Postauthorisation efficacy study (PAES):>
Slovenian: <Študija učinkovitosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PAES):>
English: Description Due date
Slovenian: Opis Do datuma
English: A. <MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND> MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. <PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN> PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: <Obligation to conduct post-authorisation measures
Slovenian: • <Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
English: <{X} is indicated in <adults> <neonates> <infants> <children> <adolescents> <aged {x to y}> <years> <months>.>
Slovenian: <Zdravilo {X} je indicirano pri <odraslih> <novorojenčkih> <dojenčkih> <otrocih> <mladostnikih>, <starih {x do y}> <let> <mesecev>.>
English: The European Medicines Agency will review any new information on the reference medicine every year and any updates for the reference medicine will also be included as appropriate in the information for X, such as this leaflet.>
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke za referenčno zdravilo, ki bodo na voljo, in kakršne koli posodobitve informacij o referenčnem zdravilu bodo vključene tudi v informacije o zdravilu X, npr. v to navodilo za uporabo.>
English: <The tablet can be divided into equal doses.>
Slovenian: <Tableta se lahko deli na <enaka odmerka> <enake odmerke>.>
English: <Name and address of the manufacturer(s) of the biological active substance(s)
Slovenian: <Ime in naslov proizvajalca (proizvajalcev) biološke učinkovine (učinkovin)
English: Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu.>
Slovenian: Podrobne informacije so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu>
English: <This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:>
Slovenian: <Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14-a(4) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe:>
English: <For instructions on <reconstitution> <dilution> of the medicinal product before administration, see section <6.6> <and> <12>.>
Slovenian: <Za navodila glede <rekonstitucije> <redčenja> zdravila pred dajanjem glejte poglavje <6.6> <in> <12>.>
English: <Official batch release
Slovenian: <Uradna sprostitev serije:
English: <Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 <or {name of the residue(s)}>.>
Slovenian: <Preobčutljivost na <učinkovino> <učinkovini> <učinkovine> ali katero koli pomožno snov, navedeno v poglavju 6.1 <ali {imena ostankov topil}>.>
English: <This medicine is subject to additional monitoring.
Slovenian: <Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: <The European Medicines Agency has waived the obligation to submit the results of studies with <{(Invented) name}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in all subsets of the paediatric population in {condition as per paediatric investigation plan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Slovenian: <Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom {(izmišljeno) ime}> [ali za generična zdravila: <referenčno zdravilo, ki vsebuje {ime učinkovine(učinkovin)}>] za vse podskupine pediatrične populacije {pod pogoji, ki so za odobreno indikacijo zdravila navedeni v izvedbenem načrtu za pediatrično populacijo (PIP)} (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).>
English: <The European Medicines Agency has deferred the obligation to submit the results of studies with <{(Invented) name}> [or for generics: <the reference medicinal product containing {name of the active substance(s)}>] in one or more subsets of the paediatric population in {condition, as per paediatric investigation plan (PIP) decision, for the granted indication} (see section 4.2 for information on paediatric use).>
Slovenian: <Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom {(izmišljeno) ime}> [ali za generična zdravila: <referenčno zdravilo, ki vsebuje {ime učinkovine(učinkovin)}>] za eno ali več podskupin pediatrične populacije {pod pogoji, ki so za odobreno indikacijo zdravila navedeni v izvedbenem načrtu za pediatrično populacijo (PIP)} (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).>
English: The reference medicine for X has been authorised under ‘exceptional circumstances'.
Slovenian: Referenčno zdravilo zdravila X je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu<, and on the website of {name of Member State Agency (link)}>.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/<in na spletni strani {ime agencije v državi članici (povezava)}>.
English: Do not <take> <use> X
Slovenian: Ne <jemljite> <uporabljajte> zdravila X
English: <This medicinal product has been authorised under a so-called ‘conditional approval' scheme.
Slovenian: <Zdravilo je pridobilo tako imenovano „pogojno dovoljenje za promet”.
English: The active substance(s) is (are)…
Slovenian: Učinkovina(-i/-e) je(sta/so) …
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR <THE CONDITIONAL MARKETING AUTHORISATION> <THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES>
Slovenian: SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI <POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM> <DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH>>
English: <Medicinal product not subject to medical prescription.>
Slovenian: <Izdaja zdravila je brez recepta.>
English: <No data are available.>
Slovenian: <Podatek ni potreben.>
English: <Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).>
Slovenian: <Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).>
English: <The reference medicinal product containing {active substance} has been authorised under ‘exceptional circumstances'.
Slovenian: <Referenčno zdravilo, ki vsebuje {učinkovina}, je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: The other <ingredient(s)> <(excipient(s))> is (are)...
Slovenian: Druga(-i/-e) <sestavina(-i/-e) zdravila> <(pomožna(-i/-e) snov(-i))> je(sta/so)...
English: <You must talk to a doctor if you do not feel better or if you feel worse <after {number of} days>.>
Slovenian: <Če se znaki vaše bolezni poslabšajo ali ne izboljšajo <v {število} dneh>, se morate posvetovati z zdravnikom.>
English: <This medicine has been authorised under ‘exceptional circumstances'.
Slovenian: <Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: <This medicine has been given ‘conditional approval'.
Slovenian: <Zdravilo je pridobilo tako imenovano „pogojno dovoljenje za promet“.
English: <There is no relevant use of {X} <in the paediatric population> <in children aged {x to y} <years> <months> [or any other relevant subsets, e.g. weight, pubertal age, gender] <for the indication of...>.>
Slovenian: <Zdravilo {X} ni namenjeno za uporabo <pri pediatrični populaciji> <pri otrocih, starih {x do y} <let> <mesecev>, [ali drugi primerni skupini, npr. glede na telesno maso, dobo pubertete, spol] <za indikacijo...>.>
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU {VRSTA/TIP}
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH {VRSTA/TIP}
English: You must talk to a doctor if you do not feel better or if you feel worse <after {number of} days>.>
Slovenian: Če se znaki vaše bolezni poslabšajo ali ne izboljšajo <v {število} dneh>, se morate posvetovati z zdravnikom.>
English: <The <safety> <and> <efficacy> of {X} in children aged {x to y} <months> <years> [or any other relevant subsets, e.g. weight, pubertal age, gender] <has> <have> not <yet> been established.>
Slovenian: <<Varnost> <in> <učinkovitost> zdravila {X} pri otrocih, starih {x do y} <mesecev> <let>, [ali drugi primerni skupini, npr. glede na telesno maso, dobo pubertete, spol] <še> <ni> <nista> <bila> <bili> <dokazana><dokazani>.>
English: <If you have any further questions on the use of this medicine, ask your <doctor> <,> <or> <pharmacist> <or nurse>.>
Slovenian: <Če imate dodatna vprašanja o uporabi zdravila, se posvetujte <z>
 <zdravnikom><,> <ali> <farmacevtom> <ali medicinsko sestro>.>
English: <Medicinal product subject to special medical prescription.>
Slovenian: <Predpisovanje in izdaja zdravila je le na posebni recept.>
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu<, and on the website of {name of MS Agency (link)}>.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu< in na spletni strani {ime agencije v državi članici (povezava)}><, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju>.
English: <- This medicine has been prescribed for you only.
Slovenian: <Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.