natgillin/translations-raw huggingface dataset:
Meda Pharma - Produtos Farmacêuticos, S.A. 
Meda Pharma - Produtos Farmacźuticos, S.A.
Trancopal Dolo capsule 
Trancopal Dolo kapsel
164,5 mg / 3 ml solution for injection intramuscular use 
164,5 mg / 3 ml süstelahus intramuskulaarne
61352 Bad Homburg v. d. H. Germany 
61352 Bad Homburg v. d. H. Saksamaa
Dr. Kade Pharmazeutische Fabrik GmbH 
Kade Pharmazeutische Fabrik GmbH
Dolokadin einmal täglich prolonged release tablet 
Dolokadin einmal täglich toimeainet prolongeeritult vabastav tablett
Trancopal Dolo Suppositorien 150 mg suppository rectal use 
Trancopal Dolo Suppositorien 150 mg rektaalsuposiit rektaalne
Slovak Republic TEVA Pharmaceuticals Slovakia, s.r.o. 
TEVA Pharmaceuticals Slovakia, s.r.o.
Flupirtinmaleat Winthrop 400 mg Retardtabletten prolonged release tablet 
Flupirtinmaleat Winthrop 400 mg Retardtabletten toimeainet prolongeeritult vabastav tablett
Katadolon Kinderzäpfchen suppository rectal use 
Katadolon Kinderzäpfchen rektaalsuposiit rektaalne
Hormosan Pharma GmbH Wilhelmshöher Str. 106 60389 Frankfurt Germany 
Hormosan Pharma GmbH Wilhelmshöher Str. 106 60389 Frankfurt Saksamaa
Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany 
Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Saksamaa
130 U kabelovn Prague 10237 
130 U kabelovn Prague 10237 Tšehhi
Kabelovny 130 102 37 Praha 10 Czech Republic 
U Kabelovny 130 102 37 Praha 10 Tšehhi
U Kabelovny 130, Dolní Měcholupy 
U Kabelovny 130, Dolnķ Mģcholupy
AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Saksamaa
Flupirtinmaleat Midas 100 mg Hartkapseln ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Flupirtinmaleat Midas 100 mg Hartkapseln ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Saksamaa
Flupirtinmaleat-ratiopharm 100 mg Hartkapsel ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Flupirtinmaleat-ratiopharm 100 mg Hartkapsel ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Saksamaa
102 37, Praga 10, Czech Republic 
102 37, Praga 10, Tehhi
Trancolong prolonged release tablet 
Trancolong toimeainet prolongeeritult vabastav tablett
FLUPIZEN 100 mg capsule 
FLUPIZEN 100 mg kapsel
Katadolon Zäpfchen suppository rectal use 
Katadolon Zäpfchen rektaalsuposiit rektaalne
Katadolon S long prolonged release tablet 
Katadolon S long toimeainet prolongeeritult vabastav tablett
MEDA Pharma GmbH & Co. KG Benzstr. 
MEDA Pharma GmbH & Co.
Katadolon retard prolonged release tablet 
Katadolon retard toimeainet prolongeeritult vabastav tablett
Midas Pharma GmbH Rheinstrasse, 49 55218 Ingelheim Germany 
Midas Pharma GmbH Rheinstrasse, 49
U 
Dr.
Further information can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Lisateave on aadressil ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The inflammation may cause discomfort, pain, blurring of vision, and may lead to partial or complete blindness. 
See põletik võib põhjustada ebamugavustunnet, valu ja nägemise ähmastumist ning edaspidi osalist või täielikku nägemiskaotust.
The data from the clinical study was not sufficient to demonstrate the benefit of Opsiria, particularly in European patients. 
Kliiniliste uuringute andmed ei võimaldanud piisavalt tõendada Opsiria kasulikkust, eelkõige Euroopa patsientidele.
The main measure of effectiveness was the number of patients in whom inflammation resolved after 5 months of treatment. 
Efektiivsuse põhinäitaja oli nende patsientide arv, kellel oli põletik pärast 5-kuulist ravi paranenud.
In this study, Opsiria was not compared with any other treatment. 
Uuringus ei võrreldud Opsiriat ühegi muu ravimeetodiga.
Withdrawal of the marketing authorisation application for Opsiria (sirolimus) EMA/358774/2016 
Müügiloa taotluse tagasivõtmise teave: Opsiria (siroliimus) EMA/358774/2016
Withdrawal of the marketing authorisation application for Opsiria (sirolimus) 
Müügiloa taotluse tagasivõtmise teave: Opsiria (siroliimus)
What is Opsiria? 
Mis on Opsiria?
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. 
Santen Oy teatas 20. mail 2016 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Opsiria müügiloa taotlus.
Opsiria was investigated in one main study in 347 patients with non-infectious uveitis. 
Opsiriat uuriti ühes põhiuuringus (347 patsienti, kellel oli mittenakkuslik uveiit).
Opsiria is a medicine that contains the active substance sirolimus. 
Opsiria on ravim, mis sisaldab toimeainena siroliimust.
In addition, the Committee questioned the proposed method of sterilisation of the medicine. 
Komitee ei olnud ka veendunud ravimi kavandatud steriliseerimisviisi efektiivsuses.
The application was withdrawn after that the CHMP had evaluated the documentation provided by the company and formulated lists of questions. 
Taotlus võeti tagasi pärast seda, kui inimravimite komitee oli hinnanud ettevõtte esialgselt esitatud dokumente ja koostanud ettevõttele vastamiseks küsimused.
Sirolimus has been used for several years to prevent organ rejection following a transplant. 
Siroliimust on aastaid kasutatud siiratud elundi äratõukereaktsiooni ennetamiseks.
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. 
Ettevõtte tunnistas kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, vajadust esitada praegu toimuvast uuringust täiendavaid andmeid Opsiria kasulikkuse kohta.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016 EMA/358774/2016 EMEA/H/C/003978 
EMA/358774/2016 EMEA/H/C/003978
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. 
Et mTOR osaleb T-lümfotsüütide (põletiku tekkimises osalevad vere valgelibled) aktiveerimisel ja proliferatsioonis, vähendab siroliimus eeldatavalt põletikku kroonilise mittenakkusliku uveiidi korral.
How is Opsiria expected to work? 
Milline on Opsiria eeldatav toime?
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. 
Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi komitee taotluse tagasivõtmise ajal põhjust ettevaatlikkuseks ja oli esialgsel seisukohal, et ravimi Opsiria kasutamist mittenakkusliku uveiidi raviks ei ole võimalik heaks kiita.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Opsiria did not outweigh its risks. 
Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et ravimi Opsiria kasulikkus ei ole suurem kui sellega kaasnevad riskid.
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. 
Opsiriat kavatseti kasutada mittenakkusliku uveiidi (uuvea ehk silmamunaseina kesmise kesta põletik) raviks täiskasvanutel.
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. 
Opsiria nimetati 30. augustil 2011 kroonilise mittenakkusliku uveiidi harvikravimiks (ravim, mida kasutatakse harvaesinevate haiguste korral).
What was Opsiria expected to be used for? 
Milleks kavatseti Opsiriat kasutada?
The active substance in Opsiria, sirolimus, is expected to work by blocking an enzyme called ‘mammalian target of rapamycin' (mTOR). 
Opsirias toimeainena sisalduva siroliimuse eeldatav toime seisneb ensüümi mTORi (imetajate rapamütsiinisihtvalk) blokeerimises.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Opsiria. 
Taotluse tagasivõtmine ei mõjuta praegu Opsiria kliinilistes uuringutes osalevaid patsiente.
It was to be available as a solution to be injected into the eye. 
Ravimit kavatseti turustada silma süstitava lahusena.
London, 25 October 2007 EMEA/CHMP/350251/2007 
London, 25. oktoober 2007 EMEA/CHMP/350251/2007
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. 
Viiteliikmesriik oli Saksamaa ning asjaomased liikmesriigid olid Austria, Taani, Hispaania, Soome, Prantsusmaa, Itaalia, Luksemburg, Norra, Poola, Portugal, Rootsi ja Ühendkuningriik.
The Mutual Recognition Procedure started on 24 October 2006. 
Vastastikuse tunnustamise menetlus algas 24. oktoobril 2006.
A positive opinion was adopted by majority on 19 July 2007. 
19. juulil 2007 võeti häälteenamusega vastu positiivne arvamus.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. 
Need liikmesriigid ei suutnud jõuda viiteliikmesriigi antud müügiloa vastastikuse tunnustamise osas kokkuleppele.
The Marketing Authorisation Holder provided written explanations on 25 May 2007. 
Müügiloa hoidja esitas kirjalikud selgitused 25. mail 2007.
The Rapporteur was Dr Karl Broich and Co-Rapporteur(s) was Dr Pierre Demolis. 
Ettekandja oli dr Karl Broich ja kaasettekandja dr Pierre Demolis.
The final opinion was converted into a Decision by the European Commission on 24 October 2007. 
Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 24. oktoobril 2007.
Germany referred the reasons for disagreement to the EMEA on 29 March 2007. 
Saksamaa esitas lahkarvamuse põhjused EMEAle 29. märtsil 2007.
The arbitration procedure started on 26 April 2007 with the adoption of a list of questions. 
Vahekohtumenetlus algas 26. aprillil 2007 küsimuste loetelu kinnitamisega.
The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III. 
Seotud toodete nimetuste loetelu on esitatud I lisas, teaduslikud järeldused II lisas ning ravimi omaduste kokkuvõte III lisas.
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A 
INIMTERVISHOIUS KASUTATAVATE RAVIMITE KOMITEE ARVAMUS PÄRAST ARTIKLI 29 LÕIKE 41 KOHAST ESILDIST, MIS KÄSITLES RAVIMIT Xeomin Rahvusvaheline mittekaubanduslik nimetus (INN): bakteri Clostridium botulinum A-tüüpi neurotoksiin
During their 16-19 July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Xeomin, that the objections raised by Finland, France and Italy, should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. 
16.-19. juuli 2007 koosolekul leidis inimtervishoius kasutatavate ravimite komitee, tuginedes kõigile esitatud andmetele ja komiteesisesele teaduslikule arutelule, et Xeomini kasulikkuse ja riski suhe on soodne, et Soome, Prantsusmaa ja Itaalia tõstatatud küsimused ei saa olla müügiloa andmisel takistuseks ning et viiteliikmesriigi esitatud ravimi omaduste kokkuvõtet, märgistust ja pakendi infolehte tuleb muuta.
On the basis of the questions raised by the Member States, the points to be considered by the CHMP concerned the posology, the repeated administration and safety profile in two Phase III studies. 
Tuginedes liikmesriikide tõstatatud küsimustele, arutas inimtervishoius kasutatavate ravimite komitee ravimi annustamist, korduvat manustamist ja kahes III faasi uuringutes tekkinud ohutusküsimusi.
Merz Pharmaceuticals GmbH submitted applications for mutual recognition of Xeomin, 100 LD50 units powder for solution for injection, on the basis of the marketing authorisation granted by Germany on 31 May 2005. 
Merz Pharmaceuticals GmbH esitas taotlused Xeomini süstelahuse pulbri (100 LD50 ühikut) vastastikuseks tunnustamiseks Saksamaa poolt 31. mail 2005 antud müügiloa alusel.
Xeomin, 100 LD50 units powder for solution for injection, is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults. 
Xeomin, süstelahuse pulber (100 LD50 ühikut), on näidustatud laukrambi ja kaelalihaste toonusehäire valdavalt rotatsioonilise vormi (krambitaolise lihaskontraktsiooni tekitatud kõverkaelsus, torticollis spastica) sümptomaatiliseks raviks täiskasvanutel.
The tablets should be taken with food. 
Tablette tuleb võtta koos toiduga.
The recommended dose is 4 tablets once a day for the first 2 weeks and then 2 tablets taken 3 times a week for the next 22 weeks. 
Soovitatav annus on 4 tabletti üks kord ööpäevas esimese 2 nädala jooksul ja seejärel 2 tabletti kolm korda nädalas järgmise 22 nädala jooksul.
The medicine is available as 100 mg tablets. 
Ravimit turustatakse 100 mg tablettidena.
A risk management plan has been developed to ensure that Sirturo is used as safely as possible. 
Töötati välja riskijuhtimiskava, et tagada Sirturo võimalikult ohutu kasutamine.
The company will also provide longer term safety data on the medicine. 
Ettevõte esitab ka ravimi pikaajalise kasutuse ohutusandmed.
What measures are being taken to ensure the safe and effective use of Sirturo? 
Mis meetmed võetakse, et tagada Sirturo ohutu ja efektiivne kasutamine?
Sirturo bedaquiline 
Sirturo bedakviliin
Without the ability to generate energy, the bacteria die and the patient's condition can start to improve. 
Energiaallikata bakterid hävivad ja patsiendi seisund saab hakata paranema.
In addition, it is recommended that patients are directly observed by a healthcare professional as they take the medicine. 
Samuti on soovitatav, et tervishoiutöötaja jälgib patsiente vahetult ravimi võtmise ajal.
Tuberculosis is an infection caused by the bacterium Mycobacterium tuberculosis. 
Tuberkuloos on infektsioon (nakkus), mida põhjustab bakter Mycobacterium tuberculosis.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Sirturo's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Inimravimite komitee otsustas, et Sirturo kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
The summary of the opinion of the Committee for Orphan Medicinal Products for Sirturo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Harvikravimite komitee arvamuse kokkuvõte Sirturo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The full EPAR and risk management plan summary for Sirturo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Sirturo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Committee highlighted the need for new medicines to treat multi-drug resistant tuberculosis and noted that Sirturo was the first of a new class of medicines for which cross-resistance with other medicines had not yet been seen. 
Komitee rõhutas multiresistentse tuberkuloosi uute ravimite vajadust ja märkis, et Sirturo on esimene uue ravimiklassi ravim, mille korral ei ole veel esinenud ristresistentsust teiste ravimitega.
What is Sirturo and what is it used for? 
Mis on Sirturo ja milleks seda kasutatakse?
Other information about Sirturo 
Muu teave Sirturo kohta
The most common side effects with Sirturo (which may affect more than 1 in 10 people) are headache, dizziness, nausea (feeling sick), vomiting, and arthralgia (joint pain). 
Sirturo kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on peavalu, peapööritus, iiveldus, oksendamine ja liigesevalu.
This is a summary of the European public assessment report (EPAR) for Sirturo. 
See on ravimi Sirturo Euroopa avaliku hindamisaruande kokkuvõte.
Because the number of patients with tuberculosis is low in the EU, the disease is considered ‘rare', and Sirturo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 26 August 2005. 
Et tuberkuloosiga patsientide arv Euroopa Liidus on väike ja see haigus esineb harva, nimetati Sirturo 26. augustil 2005 harvikravimiks.
Why is Sirturo approved? 
Miks Sirturo heaks kiideti?
Although an analysis of these deaths did not support the conclusion that they were caused by Sirturo, the CHMP has required the company to provide more information from a long-term follow-up study to allay any concerns. 
Kuigi surmajuhtumite analüüs ei kinnitanud, et põhjuseks oli Sirturo, küsis inimravimite komitee ettevõttelt probleemi selgitamiseks lisateavet pikaajalisest järeluuringust.
Sirturo is a tuberculosis medicine that contains the active substance bedaquiline. 
Sirturo on tuberkuloosiravim, mis sisaldab toimeainena bedakviliini.
Since Sirturo has been granted a conditional approval, the company that markets Sirturo will provide additional data on the medicine's benefits and safety when used with different combinations of medicines. 
Et Sirturo kiideti heaks tingimuslikult, esitab Sirturot turustav ettevõte veel andmeid ravimi kasulikkuse ja ohutuse kohta kasutamisel koos teiste ravimitega.
Cross-resistance is when bacteria develop resistance to a medicine after being exposed to another one, which is often the case with multi-drug resistant tuberculosis. 
Ristresistentsus tähendab bakteri resistentsust ravimi suhtes pärast kokkupuudet muu ravimiga, mida sageli juhtub multiresistentse tuberkuloosi korral.
It is not intended to provide practical advice on how to use Sirturo. 
Hindamisaruandes ei anta Sirturo kasutamise praktilisi nõuandeid.
With regard to safety, the side effects reported in the Sirturo group in the main study were not markedly different from those in the placebo group, though there were higher levels of liver enzymes and some reports of alterations in the heart's electrical activity (known as prolonged QT interval). 
Ohutuse suhtes ei erinenud põhiuuringus Sirturo rühma patsientide kõrvalnähud oluliselt platseeborühma omadest, kuigi maksaensüümide aktiivsus suurenes ja mõnel juhul teatati südame elektrilise talitluse muutustest (pikenenud QT-intervall).
Sirturo is used in combination with other tuberculosis medicines in adults with tuberculosis that is affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, two standard tuberculosis medicines). 
Sirturot kasutatakse koos teiste tuberkuloosiravimitega täiskasvanutel, kellel on multiresistentne kopsutuberkuloos (resistentne vähemalt isoniasiidi ja rifampitsiini suhtes; mõlemad on tavalised tuberkuloosiravimid).
What information is still awaited for Sirturo? 
Mis teavet Sirturo kohta veel oodatakse?
The active substance in Sirturo, bedaquiline, works by specifically blocking an enzyme inside the M. tuberculosis bacteria called ATP synthase, which the bacteria need to generate energy. 
Sirturo toimeaine bedakviliin blokeerib bakteri M. tuberculosis ensüümi ATP süntaasi, mida bakter vajab energia tootmiseks.
It is given when combinations without Sirturo cannot be used, either because the disease is resistant to them or because of their side effects. 
Sirturot kasutatakse, kui Sirturota ravimikombinatsioone ei saa kasutada haiguse resistentsuse või ravimite kõrvalnähtude tõttu.
What are the risks associated with Sirturo? 
Mis riskid Sirturoga kaasnevad?
The study showed that after 24 weeks, 79% of the patients given Sirturo (52 out of 66 patients) tested negative for the bacteria in the sputum (phlegm) compared with 58% of patients given placebo (38 out of 66 patients). 
Patsiente, kellel oli 24 nädala pärast bakterid rögas puudusid, oli Sirturo rühmas 79% (52 patsienti 66st) ja platseeborühmas 58% (38 patsienti 66st).
Sirturo increased the number of patients who tested negative for the tuberculosis bacteria and shortened the average time it took to clear the bacteria from the sputum. 
Sirturo kasutamisel suurenes tuberkuloosibakterite suhtes negatiivse analüüsiga patsientide arv ja vähenes bakteri rögast kadumise keskmine aeg.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sirturo, including the appropriate precautions to be followed by healthcare professionals and patients. 
Selle alusel lisati Sirturo omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on tervishoiuspetsialistide ja patsientide võetavad meetmed.
For practical information about using Sirturo, patients should read the package leaflet or contact their doctor or pharmacist. 
Kui vajate Sirturo kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
How does Sirturo work? 
Kuidas Sirturo toimib?
For more information about treatment with Sirturo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Kui vajate Sirturoga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
The European Commission granted a marketing authorisation valid throughout the European Union for Sirturo on 05/03/2014. 
Euroopa Komisjon andis Sirturo müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, <müügiloa andmise kuupäev>.
In a main study in adults with multi-drug resistant tuberculosis affecting the lung, Sirturo was compared with placebo (a dummy treatment) when added to combination treatment with other standard tuberculosis medicines. 
Põhiuuringus, kus osalesid multiresistentse kopsutuberkuloosiga täiskasvanud, võrreldi Sirturot platseeboga (näiva ravimiga) kasutamisel kombineeritud ravis tavaliste tuberkuloosiravimitega.
For the full list of all side effects and restrictions, see the package leaflet. 
Sirturo kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
The average time it took to clear the bacteria from the sputum was also shorter for patients in the Sirturo group than for those in the placebo group (83 days versus 125 days). 
Bakterid kadusid rögast Sirturo rühma patsientidel keskmiselt kiiremini (83 päevaga) kui platseeborühmas (125 päevaga).
How is Sirturo used? 
Kuidas Sirturot kasutatakse?
There was also a higher number of reported deaths in the Sirturo group. 
Sirturo rühmas oli suremus suurem.
What benefits of Sirturo have been shown in studies? 
Milles seisneb uuringute põhjal Sirturo kasulikkus?
Treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis. 
Ravi peab alustama multiresistentse tuberkuloosi ravis kogenud arst ja see peab toimuma tema järelevalve all.
Sirturo can only be obtained with a prescription. 
Sirturo on retseptiravim.
Sirturo has been given ‘conditional approval'. 
Situro müügiluba anti tingimuslikult.
List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants /marketing authorisation holders in the Member States 
Loetelu ravimpreparaadi nimetustest, ravimvormidest, kontsentratsioonidest, manustamisteedest ja müügiloa taotlejatest/hoidjatest liikmesriikides
Member State EU/EEA 
EL/EEA liikmesriik
Pharmaceutical form 
Ravimvorm Manustamistee
Mifepristone Linepharma 200 mg tablet 
Mifepristone 200 mg tablet
Annex I 
Kontsentratsio on
Elocta received a marketing authorisation valid throughout the EU on 19 November 2015. 
Elocta on saanud müügiloa, mis kehtib kogu ELis, 19. novembril 2015.
Further information on Elocta can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Elocta. 
Lisateave Elocta kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Elocta.