natgillin/translations-raw huggingface dataset:
The reason for this alternative was the fact that the combination of 200 mg mifepristone with oral misoprostol was associated with a potentially higher risk of continuing pregnancy, whereas 1mg gemeprost vaginally had been demonstrated in many studies to provide a strong prostaglandin action also in combination with a lower dose of mifepristone. 
Razlog za to alternativo je dejstvo, da je kombinacija 200 mg zdravila mifepristone s peroralnim misoprostolom povezana z možnim višjim tveganjem za nadaljevanje nosečnosti, pri vaginalni uporabi 1 mg gemeprosta pa so številne študije pokazale močno delovanje prostaglandina tudi v kombinaciji z nižjim odmerkom zdravila mifepristone.
- The organisation Gynuity Health Projects performed a GCP-compliant study in Mexico in 1000 women (open-label, non-comparative, prospective multi-site study of mifepristone 200 mg followed 24-48 hours later by buccal misoprostol 800 mcg for termination of pregnancy through 63 days). 
- Organizacija Gynuity Health Projects je v Mehiki izvedla študijo v skladu z dobro klinično prakso, v kateri je sodelovalo 1000 žensk (odprta, neprimerjalna, prospektivna študija v več centrih z zdravilom mifepristone 200 mg, ki mu je po 24-48 urah sledila bukalna uporaba misoprostola 800 µg za prekinitev nosečnosti do vključno s 63. dnem).
Based on the above, in view of the slightly increased Cmax, the CHMP is of the opinion that a higher dose than 200mg of Mifepristone Linepharma should not be administered and that this should be clearly indicated in the Product Information and a prospective observational study aiming to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination should be performed. 
Na podlagi zgoraj navedenega in ob upoštevanju nekoliko povišanega Cmax je CHMP mnenja, da se ne sme uporabiti odmerka zdravila Mifepristone Linepharma, višjega kot 200 mg, kar je treba jasno navesti v informacijah o zdravilu, opraviti pa je treba tudi prospektivno opazovalno študijo z namenom oceniti priporočila za predpisovanje zdravila Mifepristone Linepharma za zgodnjo prekinitev nosečnosti.
Compared to Mifegyne, which could be administered either at a high dose of 600 mg or a lower dose of 200 mg, only the lower dose of 200 mg is approved for Mifepristone Linepharma. 
V primerjavi z zdravilom Mifegyne, ki se lahko uporabi v visokem odmerku 600 mg ali nižjem odmerku 200 mg, je za zdravilo Mifepristone Linepharma odobren le nižji odmerek 200 mg.
The posology of Mifepristone Linepharma is not the same as for the reference product Mifegyne. 
Zdravilo Mifepristone Linepharma se ne odmerja enako kot referenčno zdravilo Mifegyne.
The marketing authorisation holder was in agreement with the amendments of the section 4.2 of the SmPC and section 3 of the Package Leaflet as proposed by the CHMP. 
Imetnik dovoljenja za promet z zdravilom se je strinjal s spremembami poglavja 4.2 povzetka glavnih značilnosti zdravila in poglavja 3 navodila za uporabo, ki jih je predlagal CHMP.
Taking into consideration that Mifepristone Linepharma is only given once and as a single dose of 200mg, the CHMP is of the opinion that the provided clinical data supports that the slightly higher Cmax would not affect efficacy and safety of Mifepristone Linepharma. 
Ob upoštevanju, da se zdravilo Mifepristone Linepharma uporabi le enkrat kot enkratni odmerek 200 mg, je CHMP mnenja, da predloženi klinični podatki podpirajo, da nekoliko višji Cmax ne vpliva na varnost in učinkovitost zdravila Mifepristone Linepharma.
Based on the above, the CHMP considers that the overall efficacy and safety profile of the Mifepristone Linepharma has been sufficiently proven by the studies presented and therefore concluded that the benefit-risk balance for Mifepristone Linepharma in the applied indication “Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of amenorrhea” is favourable. 
Na podlagi zgoraj navedenega CHMP meni, da je splošni profil učinkovitosti in varnosti za zdravilo Mifepristone Linepharma v zadostni meri dokazan v predloženih študijah, in je zato sklenil, da je razmerje med koristmi in tveganji za zdravilo Mifepristone Linepharma za navedeno indikacijo „umetna prekinitev poteka intrauterine nosečnosti v okviru zaporedne uporabe v kombinaciji z analogom prostaglandina (gemeprostom ali mizoprostolom) do 63. dneva amenoreje” pozitivno.
Hence the CHMP is of the opinion that a revised protocol should be submitted to the national competent authorities, for final agreement prior the start of the clinical trial, as a condition to the marketing authorisation. 
Zato je CHMP mnenja, da je treba pred začetkom kliničnega preskušanja pristojnim nacionalnim organom predložiti revidiran protokol za dokončno potrditev, kar je pogoj za pridobitev dovoljenja za promet z zdravilom.
The fact that buccal misoprostol and not vaginal gemeprost (as proposed in the current application) was used as follow up treatment would, if anything, lower the success rates and therefore is reassuring to the CHMP. 
Stopnjo uspeha bi zmanjšalo le dejstvo, da je bila za nadaljevanje zdravljenja uporabljena bukalna oblika misoprostola in ne vaginalna oblika gemeprosta (kot predlaga trenutna vloga), zato so bili rezultati za CHMP pomirjujoči.
Women were entitled to be treated with 200 mg of Mifepristone Linepharma orally followed by 800 μg of misoprostol if their pregnancy age was 63 days of amenorrhea or less. 
Ženske so izpolnjevale kriterije za peroralno zdravljenje z 200 mg zdravila Mifepristone Linepharma, ki mu je sledilo 800 μg misoprostola, če je nosečnost trajala 63 dni amenoreje ali manj.
A preliminary publication in 1343 women has been provided by the MAH. 
Imetnik dovoljenja za promet z zdravilom je predložil predhodno objavo za 1 343 žensk.
The approved indication for Mifepristone Linepharma through the initial Mutual Recognition Procedure is “Medical termination of a developing intra-uterine pregnancy in sequential combination with a prostaglandin analogue up to 63 days of amenorrhea”. 
Indikacija za zdravilo Mifepristone Linepharma, odobrena v okviru prvotnega postopka z medsebojnim priznavanjem, je „umetne prekinitve poteka intrauterine nosečnosti v okviru zaporedne uporabe v kombinaciji z analogom prostaglandina (gemeprostom ali mizoprostolom) do 63. dneva amenoreje”.
Grounds for positive opinion subject to condition to the marketing authorisation and amendment of the summary of product characteristics and package leaflet 
Podlaga za pozitivno mnenje v skladu s pogoji za dovoljenje za promet z zdravilom in spremembo povzetka glavnih značilnosti zdravila in navodila za uporabo
The CHMP is of the opinion that the marketing authorisation holder should submit a revised protocol to the national competent authorities, for final agreement prior the start of the clinical trial. 
CHMP je mnenja, da mora imetnik dovoljenja za promet z zdravilom pred začetkom kliničnega preskušanja pristojnim nacionalnim organom predložiti revidiran protokol za dokončno potrditev.
• Therefore the Committee concluded that the benefit-risk balance for Mifepristone Linepharma in the applied indications is favourable, the CHMP has recommended the granting of the marketing authorisation subject to a recommended condition with regard to the safe and effective use of the medicinal product as set out in Annex IV and for which the amended sections of the summary of product characteristics and package leaflet are set out in Annex III for Mifepristone Linepharma and associated names (see Annex I). 
je CHMP priporočil, da se odobri dovoljenje za promet z zdravilom pod pogojem upoštevanja priporočila za varno in učinkovito uporabo zdravila, navedenega v Prilogi IV, pri čemer so spremenjena poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo navedena v Prilogi III zdravila Mifepristone Linepharma in povezana imena (glejte Prilogo I).
Mifepristone Linepharma is submitted as a hybrid application. 
Za zdravilo Mifepristone Linepharma je bila vložena hibridna vloga.
Compared to Mifegyne, which can be administered either at a high dose of 600 mg or a lower dose of 200 mg, only the lower dose of 200 mg was approved for Mifepristone Linepharma through the first wave of the Mutual Recognition Procedure and was also being proposed in the current MRP repeated procedure. 
V primerjavi z zdravilom Mifegyne, ki se lahko uporabi kot visok odmerek 600 mg ali nizek odmerek 200 mg, je bil za zdravilo Mifepristone Linepharma v okviru prvega vala postopka z medsebojnim priznavanjem odobren le nižji odmerek 200 mg, ki je predlagan tudi za ponovno uporabo postopka z medsebojnim priznavanjem.
As proposed by the MAH at the time of the CMDh referral procedure, the protocol for the prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination was reviewed by the CHMP during the referral procedure. 
Kot je predlagal imetnik dovoljenja za promet z zdravilom v času napotitvenega postopka CMDh, je protokol prospektivne opazovalne študije za ocenitev priporočil za predpisovanje zdravila Mifepristone Linepharma za zgodnjo prekinitev nosečnosti v okviru napotitvenega postopka pregledal CHMP.
In addition, a prospective observational study aiming to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination should be performed; 
Dodatno je treba izvesti prospektivno opazovalno študijo z namenom oceniti priporočila za predpisovanje zdravila Mifepristone Linepharma za zgodnjo prekinitev nosečnosti.
The CHMP considers however that a higher dose than 200mg of Mifepristone Linepharma should not be administered and that this should be clearly indicated in the Product Information. 
Vendar pa CHMP meni, da višjega odmerka zdravila Mifepristone Linepharma kot 200 mg ni dovoljeno uporabiti, kar je treba v informacijah o zdravilu jasno navesti.
The current SmPC for the reference product mifepristone recommends mifepristone at the dose of 600 mg followed 36 to 48 hours later by 400 µg misoprostol orally or gemeprost 1 mg per vaginam for pregnancy termination up to 49 days of amenorrhea. 
Trenutni povzetek glavnih značilnosti zdravila za referenčno zdravilo mifepristone priporoča 600 mg mifepristona, nato pa po 36 do 48 urah 400 µg misoprostola peroralno ali 1 mg gemeprosta vaginalno za prekinitev nosečnosti do 49. dneva amenoreje.
• The CHMP is of the opinion that a dose higher than 200 mg should not be administered and that this should be clearly indicated in the Product Information. 
• CHMP meni, da višjega odmerka kot 200 mg zdravila Mifepristone Linepharma ni dovoljeno uporabiti, kar je treba v informacijah o zdravilu jasno navesti.
The approved posology is 200 mg of mifepristone in a single oral dose, followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam. 
Odobreno odmerjanje je 200 mg zdravila mifepristone v enem peroralnem odmerku, ki mu po 36 do 48 urah sledi vaginalna uporaba 1 mg gemeprosta, analoga prostaglandina.
An alternative of 200 mg of mifepristone was also approved to be used as a single dose, provided that this dose is followed 36 to 48 hours later by the administration of the prostaglandin analogue gemeprost 1 mg per vaginam. 
Alternativno je odobreno tudi odmerjanje 200 mg zdravila mifepristone v enkratnem odmerku, če mu po 36 do 48 urah sledi vaginalna uporaba 1 mg gemeprosta, analoga prostaglandina.
The MAH provided the synopsis and abstract of this study. 
Imetnik dovoljenja za promet z zdravilom je predložil pregled in povzetek teh študij.
The active substance in Pioglitazone ratiopharm GmbH, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. 
Zdravilna učinkovina zdravila Pioglitazone ratiopharm GmbH, pioglitazon, poveča občutljivost celic (maščevja, mišic in jeter) za insulin, kar pomeni, da telo bolje izrablja insulin, ki ga proizvaja.
The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratiopharm GmbH had been shown to have comparable quality and to be bioequivalent to Actos. 
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Pioglitazone ratiopharm GmbH primerljivo raven kakovosti kot zdravilo Actos ter da mu je biološko enakovredno.
On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratiopharm GmbH, for the treatment of type 2 diabetes. 
Družba ratiopharm GmbH je dne 3. februarja 2012 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Pioglitazone ratiopharm GmbH, namenjenim zdravljenju sladkorne bolezni tipa 2.
Because Pioglitazone ratiopharm GmbH is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos. 
Ker je zdravilo Pioglitazone ratiopharm GmbH generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Actos.
Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratiopharm GmbH for the treatment of type 2 diabetes. 
Odbor je zato v času umika vloge izrazil pozitivno mnenje in priporočil odobritev vloge za pridobitev dovoljenja za promet z zdravilom Pioglitazone ratiopharm GmbH za zdravljenje sladkorne bolezni tipa 2.
This means that Pioglitazone ratiopharm GmbH is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Actos.
Pioglitazone ratiopharm GmbH was to be used to treat type 2 diabetes in adults, particularly those who are overweight. 
Zdravilo Pioglitazone ratiopharm GmbH naj bi se uporabljalo za zdravljenje sladkorne bolezni tipa 2 pri odraslih, zlasti tistih s prekomerno telesno maso.
Pioglitazone ratiopharm GmbH was developed as a ‘generic medicine'. 
Zdravilo Pioglitazone ratiopharm GmbH je bilo razvito kot „generično zdravilo“.
Pioglitazone ratiopharm GmbH is a medicine that contains the active substance pioglitazone. 
Pioglitazone ratiopharm GmbH je zdravilo, ki vsebuje zdravilno učinkovino pioglitazon.
Pioglitazone ratiopharm GmbH was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone. 
Zdravilo Pioglitazone ratiopharm GmbH naj bi se uporabljalo tudi v kombinaciji z metforminom pri bolnikih, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega nadzora.
What is Pioglitazone ratiopharm GmbH? 
Kaj je zdravilo Pioglitazone ratiopharm GmbH?
How is Pioglitazone ratiopharm GmbH expected to work? 
Kako naj bi zdravilo Pioglitazone ratiopharm GmbH delovalo?
Pioglitazone ratiopharm GmbH was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable. 
Prav tako naj bi se uporabljalo samostojno pri bolnikih, za katere metformin (drugo zdravilo proti sladkorni bolezni) ni primeren.
What was Pioglitazone ratiopharm GmbH expected to be used for? 
Za kaj naj bi se zdravilo Pioglitazone ratiopharm GmbH uporabljalo?
Pioglitazone ratiopharm GmbH was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin. 
Uporabljalo naj bi se tudi skupaj z insulinom pri bolnikih, pri katerih bolezen ni zadostno nadzorovana z insulinom samim in za katere metformin ni primeren.
The safety and effectiveness of the product has not changed. 
Varnost in učinkovitost zdravila se nista spremenili.
Consequently, the licence of the manufacturing site was withdrawn. 
Posledično je bila licenca za proizvodno mesto preklicana.
Since 2013 MACI has been marketed in Denmark, Greece and the UK. 
Od leta 2013 je zdravilo MACI na voljo na Danskem, v Grčiji in Združenem kraljestvu.
The final opinion was sent to the European Commission, which issued a legally binding decision on 19 November 2014. 
Končno mnenje je bilo posredovano Evropski komisiji, ki je 19. novembra 2014 izdala pravno
MACI was on the market since 1998 in individual EU countries according to national procedures. 
Zdravilo MACI je v posameznih državah EU v skladu z nacionalnimi postopki na voljo od leta 1998.
Article 118 of Directive 2001/83/EC, which specifies that a marketing authorisation must be suspended in case any one of the requirements laid down in Article 41 (such as the need for a manufacturing site) is no longer met. 
Člen 118 Direktive 2001/83/ES, ki določa, da je treba dovoljenje za promet umakniti, če katera od zahtev iz člena 41 (npr., da morajo biti na voljo proizvodni prostori) ni več izpolnjena.
This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate 
To je vrsta zdravila, ki vsebuje celice ali tkiva, ki so bila spremenjena tako, da lahko pomagajo pri popravljanju, obnavljanju ali nadomeščanju tkiva.
Because MACI is an advanced therapy medicine, the review was carried out by the Committee on Advanced Therapies (CAT), and was subsequently endorsed by the Committee for Medicinal Products for Human Use (CHMP), which is responsible for questions concerning medicines for human use. 
Ker je zdravilo MACI namenjeno naprednemu zdravljenju, je pregled opravil Odbor za napredno zdravljenje (CAT), nato pa ga je potrdil Odbor za zdravila za uporabo v humani medicini (CHMP), ki je odgovoren za vprašanja, povezana z zdravili za uporabo v humani medicini.
The European Medicines Agency has been working with the marketing authorisation holder since June 2014 to ensure that patients who had already started the treatment procedure were able to complete their treatment. 
Evropska agencija za zdravila od junija 2014 sodeluje z imetnikom dovoljenja za promet z zdravilom, ki bo zagotovil, da bodo bolniki, ki so že začeli s postopkom zdravljenja, lahko zaključili zdravljenje.
Following the closure of the manufacturing site and because EU legislation1 requires authorised medicines to have a registered manufacturing site, a review was initiated at the request of the European Commission on 10 September 2014 (under Article 20 of Regulation (EC) No 726/2004) to determine whether the marketing authorisation for MACI should be suspended or revoked. 
Po zaprtju proizvodnega mesta in na podlagi zakonodaje EU,1 ki zahteva, da imajo odobrena zdravila registrirano proizvodno mesto, je Evropska komisija 10. septembra 2014 uvedla pregled (v skladu s členom 20 Uredbe (ES) št. 726/2004), da bi ugotovila, ali je treba dovoljenje za promet z zdravilom MACI začasno umakniti ali preklicati.
MACI is an advanced therapy medicinal product called a ‘tissue engineered product'. 
MACI je zdravilo za napredno zdravljenje, ki ga imenujemo „izdelek tkivnega inženirstva“.
MACI is an implant used to repair cartilage defects at the ends of the bones of the knee joint. 
Zdravilo MACI je implantat, ki se uporablja za odpravljanje hrustančnih okvar na koncih kosti kolenskega sklepa.
• Surgeons and hospitals that have been using MACI were informed in June 2014 of the planned closure of the EU manufacturing site for MACI. 
• Junija 2014 so bili kirurgi in bolnišnice, ki so uporabljali zdravilo MACI, obveščeni o načrtovanem zaprtju proizvodnega mesta za zdravilo MACI v EU.
In addition, surgeons were asked not to start new patients on MACI. 
Poleg tega so kirurge prosili, naj zdravila MACI ne uvajajo pri novih bolnikih.
Closure of EU manufacturing site for MACI 
Zaprtje proizvodnega mesta v EU za zdravilo MACI
• The closure was due to commercial reasons and is not related to any change in the safety and 
• Razlogi za zaprtje so bili poslovni in niso povezani z nobeno spremembo varnosti ter učinkovitosti zdravila MACI.
It was subsequently evaluated through the European Medicines Agency to comply with the EU regulation on advanced therapies, which requires all advanced therapies in EU Member States to undergo an evaluation by the Agency in order to obtain an EU-wide marketing authorisation; this was obtained in 2013. 
Pozneje so ga ocenjevale evropske agencije za zdravila, ki so preverjale skladnost z uredbo EU o naprednih oblikah zdravljenja, ki zahteva, da agencija oceni vse napredne oblike zdravljenja v državah članicah EU, preden pridobijo dovoljenje za promet z zdravilom po celotni EU; to je bilo pridobljeno leta 2003.
Arrangements in place for existing patients to complete their treatment 
Uvedeni postopki, ki bodo obstoječim bolnikom omogočili zaključek
A letter was sent to healthcare professionals informing them of the site closure and requesting that they notify the marketing authorisation holder of those patients who wish to complete their treatment. 
Zdravstveni delavci so prejeli dopis z obvestilom glede zaprtja proizvodnega mesta, v katerem so jih prosili, naj imetnika dovoljenja za promet z zdravilom obvestijo o bolnikih, ki želijo dokončati zdravljenje.
Based on the draft opinion adopted by the CAT, the CHMP adopted a final opinion on 25 September 2014, recommending the suspension of the marketing authorisation for MACI until a new manufacturing site is registered in the EU. 
Na podlagi osnutka mnenja odbora CAT je odbor CHMP 25. septembra 2014 sprejel končno mnenje, s katerim je priporočil umik dovoljenja za promet z zdravilom MACI, dokler ne bo v EU registrirano novo proizvodno mesto.
• New patients should be treated with a suitable alternative and surgeons should not order new 
• Nove bolnike je treba zdraviti z ustrezno alternativo, kirurgi pa ne smejo naročati novih biopsijskih kompletov za zdravilo MACI.
On 5 September 2014, the marketing authorisation holder for the advanced therapy medicine MACI (matrix applied characterised autologous cultured chondrocytes) closed the EU manufacturing site for the medicine, which is located in Denmark. 
Imetnik dovoljenja za promet z zdravilom MACI (na matriks naneseni karakterizirani avtologni gojeni hondrociti) za napredno zdravljenje je 5. septembra 2014 zaprl proizvodno mesto za zdravilo v EU, ki je bilo na Danskem.
Following the closure of the site, the marketing authorisation holder has been requested to store any remaining biopsies that have not yet been used to allow for potential later treatment with MACI, unless patients and their treating surgeons have explicitly indicated that they do not wish to complete 
Po zaprtju proizvodnega mesta so imetnika dovoljenja za promet z zdravilom prosili, naj shrani morebitne preostale biopsije, ki še niso bile uporabljene, za morebitno poznejše zdravljenje z zdravilom MACI, razen če sta bolnik in njegov lečeči kirurg izrecno navedla, da ne želita dokončati
• Patients who have already started treatment (i.e. those who have had their biopsies taken) should have been informed about the closure and should have discussed arrangements for completion of treatment with their treating surgeon. 
• Bolnike, ki so že začeli zdravljenje (tj. pri katerih so že opravili biopsije), je treba obvestiti o zaprtju.
• The company has made arrangements to store any existing biopsies so that treatment can be completed unless patients and their treating surgeons explicitly indicated that they no longer wish 
• Družba je uvedla postopke za shranjevanje vseh obstoječih biopsij, tako da lahko bolnik dokonča zdravljenje, razen če bolnik in njegov lečeči kirurg izrecno navedeta, da ne želita dokončati
The closure was due to commercial reasons and the safety and effectiveness of 
Razlogi za zaprtje so bili poslovni; varnost ter učinkovitost zdravila MACI se nista spremenili.