natgillin/translations-raw huggingface dataset:
Jakavi 20 mg tablets are white to almost white elongated tablets with “NVR” debossed on one side and “L20” debossed on the other side. 
Jakavi 20 mg tabletid on valged või peaaegu valged pikergused tabletid, mille ühel küljel on pimetrükk „NVR“ ja teisel küljel on „L20“.
Haematocrit control without phlebotomy 
≥35% põrna mahu vähenemine Hematokriti kontroll ilma flebotoomiata
The recommended starting dose of ruxolitinib in PV is 10 mg given orally twice daily. 
PV korral on ruksolitiniibi soovitatav algannus 10 mg suukaudselt kaks korda ööpäevas.
- Each 5 mg Jakavi tablet contains 5 mg of ruxolitinib. 
- Üks 5 mg Jakavi tablett sisaldab 5 mg ruksolitiniibi.
More frequent monitoring (e.g. twice a week) of haematology parameters and of clinical signs and symptoms of ruxolitinib-related adverse drug reactions is recommended while on strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes. 
Ravi ajal tugevatoimelise CYP3A4 või CYP2C9 ja CYP3A4 ensüümide ühiste inhibiitoritega on soovitatav sagedamini jälgida (nt kaks korda nädalas) hematoloogilisi parameetreid ning ruksolitiniibiga seotud kõrvaltoimete nähtusid ja sümptomeid.
Round curved white to almost white tablets of approximately 9.3 mm in diameter with “NVR” debossed on one side and “L10” debossed on the other side. 
Valged või peaaegu valged ümmargused kumera servaga ligikaudu 9,3 mm diameetriga tabletid, mille ühel küljel on pimetrükk „NVR“ ja teisel küljel on pimetrükk „L10“.
Dose proportionality was demonstrated in the single and multiple dose studies. 
Nii ühekordse kui ka mitmekordse annustamisega uuringutes on näidatud plasmakontsentratsiooni proportsionaalset suurenemist manustatud annusega.
- The recommended starting dose in myelofibrosis is 15 mg twice daily or 20 mg twice daily, 
- Müelofibroosi korral on soovitatav algannus 15 mg kaks korda ööpäevas või 20 mg kaks korda ööpäevas, sõltuvalt teie vererakkude arvust.
Most of the patients with bleeding events during the treatment reported bruising 
Enamikul patsientidest, kellel ravi ajal täheldati verejookse, esinesid verevalumid (65,3%).
No dose adjustment is recommended when ruxolitinib is co-administered with mild or moderate CYP3A4 inhibitors (e.g. erythromycin). 
Ruksolitiniibi samaaegsel manustamisel koos nõrga või mõõduka tugevusega CYP3A4 inhibiitoritega (näiteks erütromütsiin) ei ole annuse kohandamine vajalik.
Some are very common (may affect more than 1 in 10 people), some are common (may affect up to 1 in 10 people): - any sign of bleeding in the brain, such as sudden altered level of consciousness, persistent headache, numbness, tingling, weakness or paralysis (common) - any sign of bleeding in the stomach or intestine, such as passing black or bloodstained stools, or vomiting blood (common) - unexpected bruising and/or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections (possible symptoms of blood disorders) (very common) - painful skin rash with blisters (possible symptoms of shingles (herpes zoster)) (common) - fever, chills or other symptoms of infections (very common) - low level of red blood cells (anaemia), low level of white blood cells (neutropenia) or low level of platelets (thrombocytopenia) (very common) 
Rääkige oma arsti või apteekriga ravi ajal Jakavi'ga - kui teil tekivad ootamatult verevalumid ja/või verejooks, ebatavaline väsimus, õhupuudustunne füüsilise koormuse korral või rahuolekus, ebatavaliselt kahvatu nahk või sagedased infektsioonid (need on verehäirete sümptomid); - kui teil tekivad palavik, külmavärinad või teised infektsiooni sümptomid; - kui teil esineb krooniline köha, veresegune röga, palavik, öine higistamine ja kaalulangus (need võivad olla tuberkuloosi tunnused); - kui teil tekivad või kui keegi teie lähedane märkab teil mis tahes järgmisi sümptomeid: segasusseisund või raskused mõtlemisel, tasakaaluhäired või raskused kõndimisel, kohmakus, raskused rääkimisel, jõu vähenemine või nõrkus ühel kehapoolel, ähmane nägemine ja/või nägemiskadu.
Jakavi 15 mg tablets Each tablet contains 15 mg ruxolitinib (as phosphate). 
Jakavi 15 mg tabletid Üks tablett sisaldab 15 mg ruksolitiniibi (Ruxolitinibum) (fosfaadina).
- Each 15 mg Jakavi tablet contains 15 mg of ruxolitinib. 
- Üks 15 mg Jakavi tablett sisaldab 15 mg ruksolitiniibi.
Excipients 
Ajapunktid
was 0-2 mmHg on ruxolitinib versus a decrease of 2-5 mmHg in the placebo arm. 
COMFORT-I (MF'i patsiendid) uuringus oli keskmine süstoolse vererõhu tõus võrreldes algtasemega 0…2 mmHg ruksolitiniibi puhul vs 2…5 mmHg langus platseebo puhul.
Jakavi 15 mg tablets are white to almost white oval tablets with “NVR” debossed on one side and “L15” debossed on the other side. 
Jakavi 15 mg tabletid on valged või peaaegu valged ovaalsed tabletid, mille ühel küljel on pimetrükk „NVR“ ja teisel küljel on „L15“.
Round curved white to almost white tablets of approximately 7.5 mm in diameter with “NVR” debossed on one side and “L5” debossed on the other side. 
Valged või peaaegu valged ümmargused kumera servaga ligikaudu 7,5 mm diameetriga tabletid, mille ühel küljel on pimetrükk „NVR“ ja teisel küljel on pimetrükk „L5“.
- Each 10 mg Jakavi tablet contains 10 mg of ruxolitinib. 
- Üks 10 mg Jakavi tablett sisaldab 10 mg ruksolitiniibi.
Jakavi 20 mg tablets ruxolitinib 
Jakavi 20 mg tabletid Ruxolitinibum
The primary efficacy endpoint was proportion of subjects achieving ≥35% reduction from baseline in spleen volume at week 24 as measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT). 
Uuringu esmane tulemusnäitaja oli patsientide osakaal, kellel saavutati magnetresonantstomograafia (MRT) või kompuutertomograafia (KT) alusel hinnates 24. nädalal põrna mahu ≥ 35% vähenemine võrreldes lähtetasemega.
Jakavi contains the active substance ruxolitinib. 
Jakavi sisaldab toimeainena ruksolitiniibi.
Ovaloid curved white to almost white tablets of approximately 15.0 x 7.0 mm with “NVR” debossed on one side and “L15” debossed on the other side. 
Valged või peaaegu valged ovaalsed kumera servaga ligikaudu 15,0 x 7,0 mm tabletid, mille ühel küljel on pimetrükk „NVR“ ja teisel küljel on pimetrükk „L15“.
These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up. 
Need võivad olla tõsise ajuinfektsiooni nähud ja teie arst võib teile määrata täiendavad uuringud ja jälgimisperioodi; - kui teil tekib valulik nahalööve koos villidega (need on vöötohatise sümptomid); - kui te märkate nahamuutusi.
Jakavi 5 mg tablets ruxolitinib 
Jakavi 5 mg tabletid Ruxolitinibum
Your doctor will carefully check if you have any signs or symptoms of infection before starting and during your treatment with Jakavi. 
Enne ravi alustamist ja ravi ajal Jakavi'ga kontrollib teie arst hoolikalt, kas teil on infektsioonile viitavaid nähte või sümptome.
Jakavi 10 mg tablets are white to almost white round tablets with “NVR” debossed on one side and “L10” debossed on the other side. 
Jakavi 10 mg tabletid on valged või peaaegu valged ümmargused tabletid, mille ühel küljel on pimetrükk „NVR“ ja teisel küljel on „L10“.
After recovery of blood counts above these levels, dosing may be re-started at 5 mg twice daily and gradually increased based on careful monitoring of complete blood cell count, including a white blood cell count differential. 
Pärast näitajate taastumist verepildis üle nimetatud taseme võib ravi taasalustada annusega 5 mg kaks korda ööpäevas ning annust järkjärgult suurendada.
Jakavi 10 mg tablets ruxolitinib 
Jakavi 10 mg tabletid Ruxolitinibum
Jakavi 15 mg tablets ruxolitinib 
Jakavi 15 mg tabletid Ruxolitinibum
Keep this medicine out of the sight and reach of children. 
Kuidas Jakavi't säilitada Hoidke seda ravimit laste eest varjatud ja kättesaamatus kohas.
Each tablet contains 20 mg ruxolitinib (as phosphate). 
Üks tablett sisaldab 20 mg ruksolitiniibi (fosfaadina).
Each tablet contains 5 mg ruxolitinib (as phosphate). 
Üks tablett sisaldab 5 mg ruksolitiniibi (fosfaadina).
There was no clinically relevant change in the pharmacokinetics of ruxolitinib upon administration with a high-fat meal. 
Ruksolitiniibi manustamisel koos suure rasvasisaldusega toiduga ei täheldatud kliiniliselt olulisi muutusi ruksolitiniibi farmakokineetikas.
There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm and <100,000/mm 3. 
Andmed soovitatava algannuse kohta patsientidel, kellel trombotsüütide arv on vahemikus 50 000/mm
Each tablet contains 15 mg ruxolitinib (as phosphate). 
Üks tablett sisaldab 15 mg ruksolitiniibi (fosfaadina).
The starting dose of Jakavi should be reduced in patients with severe renal impairment. 
Raske neerukahjustusega patsientidel tuleb Jakavi algannust vähendada.
Baseline demographics and disease characteristics were comparable between the two treatments arms. 
Uuringu alguses olid rühmad demograafiliselt ja haiguse omaduste poolest võrreldavad.
Each tablet contains 10 mg ruxolitinib (as phosphate). 
Üks tablett sisaldab 10 mg ruksolitiniibi (fosfaadina).
Hepatic impairment 
Seedetrakti verejooks
Gastrointestinal disorders Flatulence a 
Seedetrakti häired Kõhupuhitus a
MF patients did not become refractory to the pharmacodynamic effects of ruxolitinib treatment over time. 
Ravi vältel ei tekkinud MF'iga patsientidel resistentsust ruksolitiniibi suhtes.
No effects were noted in an evaluation of the neuropharmacological effects of ruxolitinib. 
Ruksolitiniibi neurofarmakoloogiliste toimete hindamisel ei ole vastavaid toimeid täheldatud.
A single dose of 20 mg or two doses of 10 mg given 12 hours apart is recommended for MF patients with platelet count of >200,000/mm Subsequent doses (single administration or two doses of 10 mg given 12 hours apart) should be administered only on haemodialysis days following each dialysis session. 
Üksikannus 20 mg või kaks 10 mg annust 12-tunnise vahega on soovitatav MF'i patsientidele, kelle trombotsüütide arv on > 200 000/mm
Nevertheless, studies have shown that the medicine benefits patients and has no significant side effects. 
Uuringutes on siiski tõendatud, et ravim on patsientidele kasulik ja olulised kõrvalnähud puuduvad.
This means that it is similar to a ‘reference medicine' containing the same active substance. 
See tähendab, et ta on sarnane võrdlusravimiga, mis sisaldab sama toimeainet.
However, due to the rarity of the disease, there are still limited data available on the use of the medicine. 
Et haigus esineb harva, on andmed ravimi kasutamise kohta endiselt piiratud.
Most patients also had improvements in symptoms of the disease: all reported an improvement in diarrhoea, 89% of patients showed an improvement in their mental ability, 60% of patients showed improvement in mobility, and 85% and 77% of patients showed psychiatric improvement based on two different scores. 
Enamikul patsientidest paranesid ka haiguse sümptomid: kõik teatasid kõhulahtisuse vähenemisest, 89%-l paranes vaimne võimekus, 60%-l paranes liikuvus ning kahe eri skoori järgi hinnates oli patsiente, kelle psühhiaatriline seisund paranes, vastavalt 85% ja 77%.
This helps to reduce the production of abnormal substances and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the disease. 
See aitab vähendada ebanormaalsete ainete teket ja soodustab sapi normaalset toimimist seedesüsteemis, leevendades sellega haiguse sümptomeid.
They were mild or moderate in severity and did not last. 
Kõrvalnähud olid kerged või mõõdukad ega olnud püsivad.
Among 23 patients for whom data on blood levels of bile acids were available, all had reductions in their levels (average reduction of 56-69 µmol/l). 
23 patsiendist, kelle vere sapphapete sisalduse kohta olid andmed olemas, vähenes kõigil sapphapete sisaldus (keskmine vähenemine 56-69 µmol/l).
Chenodeoxycholic acid Leadiant is available as capsules (250 mg) which are taken 3 times a day at approximately the same time every day. 
Ravimit Chenodeoxycholic acid Leadiant turustatakse kapslitena (250 mg), mida võetakse 3 korda ööpäevas iga päev ligikaudu samal kellaajal.
For small children and children who cannot swallow capsules, the contents of the capsules can be mixed with sodium bicarbonate solution 8.4% to make a liquid. 
Väikelastel ja lastel, kes ei suuda kapsleid neelata, tohib kapslisisu segada naatriumbikarbonaadi 8,4% lahusega vedelikuks.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Chenodeoxycholic acid Leadiant's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Inimravimite komitee otsustas, et ravimi Chenodeoxycholic acid Leadiant kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
The daily dose is chosen and adjusted during treatment for each patient depending on the patient's age, liver function and levels of bile acids in their blood and urine. 
Igale patsiendile sobiva ööpäevase annuse valimisel ja raviaegsel kohandamisel lähtutakse patsiendi vanusest, maksafunktsioonist ning sapphapete sisaldusest veres ja uriinis.
For the list of restrictions, see the package leaflet. 
Piirangute täielik loetelu on pakendi infolehel.
Since Chenodeoxycholic acid Leadiant has been approved under exceptional circumstances, the company that markets this medicine will set up a registry to monitor the benefits and safety of the medicine. 
Et Chenodeoxycholic acid Leadiant on saanud müügiloa erandlikel asjaoludel, hakkab ravimi turustaja pidama ravimi kasulikkuse ja ohutuse hindamiseks registrit.
When primary bile acids are lacking, the body produces abnormal bile acids and other substances instead which accumulate throughout the body, causing damage. 
Primaarsete sapphapete vaeguse korral tekib organismis ebanormaalseid sapphappeid ja muid aineid, mis kogunevad organismi ja kahjustavad seda.
The European Commission granted a marketing authorisation valid throughout the European Union for Chenodeoxycholic acid sigma-tau on 10 April 2017. 
Euroopa Komisjon andis ravimi Chenodeoxycholic acid sigma-tau müügiloa, mis kehtib kogu Euroopa Liidus, 10. aprillil 2017.
The side effects seen with Chenodeoxycholic acid Leadiant are constipation and abnormal liver test values; however their frequency could not be reliably estimated from the available limited data. 
Ravimi Chenodeoxycholic acid Leadiant kõige sagedamad kõrvalnähud on kõhukinnisus ja maksaanalüüside ebanormaalsed väärtused, kuid nende esinemissagedust ei ole olemasolevate andmete põhjal võimalik usaldusväärselt hinnata.
The summary of the opinion of the Committee for Orphan Medicinal Products for Chenodeoxycholic acid Leadiant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation. 
Harvikravimite komitee arvamuse kokkuvõte ravimi Chenodeoxycholic acid Leadiant kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Among 14 patients for whom data on urine levels of bile acids were available, 79% (11 out of 14) had reduced levels at their most recent test. 
14 patsiendist, kelle kohta olid olemas andmed sapphapete sisalduse kohta uriinis, vähenes see sisaldus viimaseks analüüsiks 79%-l (11 patsienti 14st).
The full EPAR for Chenodeoxycholic acid Leadiant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Euroopa avaliku hindamisaruande täistekst ravimi Chenodeoxycholic acid Leadiant kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Chenodeoxycholic acid Leadiant have been included in the summary of product characteristics and the package leaflet. 
Ravimi Chenodeoxycholic acid Leadiant ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
Chenodeoxycholic acid Leadiant has been investigated in a study which looked at the records of 35 patients with cerebrotendinous xanthomatosis who received chenodeoxycholic acid for around 9 years. 
Ravimit Chenodeoxycholic acid Leadiant uuriti ühes uuringus, milles analüüsiti 35 tserebrotendinoosse ksantomatoosiga patsiendi andmeid, kes kasutasid kenodeoksükoolhapet ligikaudu 9 aastat.
What measures are being taken to ensure the safe and effective use of Chenodeoxycholic acid Leadiant? 
Mis meetmed võetakse, et tagada ravimi Chenodeoxycholic acid Leadiant ohutu ja efektiivne kasutamine?
Because the number of patients with this condition is low, the disease is considered ‘rare', and Chenodeoxycholic acid Leadiant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 December 2014. 
Et selle seisundiga patsiente on vähe ja see haigus esineb harva, nimetati Chenodeoxycholic acid Leadiant 16. detsembril 2014 harvikravimiks.
However, Xenbilox differs from Chenodeoxycholic acid Leadiant in that it is authorised for a different use (to dissolve cholesterol gallstones). 
erineb ravimist Chenodeoxycholic acid Leadiant selle poolest, et on heaks kiidetud kasutamiseks muul näidustusel (kolesterool-sapikivide lagundamine).
Chenodeoxycholic acid has been used to treat cerebrotendinous xanthomatosis for about 40 years, although it was not licensed for this use. 
Kenodeoksükoolhapet on tserebrotendinoosse ksantomatoosi raviks kasutatud ligikaudu 40 aastat, kuigi ravimi kasutamine sellel näidustusel ei ole heaks kiidetud.
The name of the product was changed to Chenodeoxycholic acid Leadiant on 12 May 2017. 
Ravimi nimetus muudeti 12. mail 2017 nimetuseks Chenodeoxycholic acid Leadiant.
Previously known as Chenodeoxycholic acid sigma-tau. 
Varasem nimetus Chenodeoxycholic acid sigma-tau.
For practical information about using Chenodeoxycholic acid Leadiant, patients should read the package leaflet or contact their doctor or pharmacist. 
Kui vajate ravimi Chenodeoxycholic acid Leadiant kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
Chenodeoxycholic acid Leadiant has been authorised under ‘exceptional circumstances'. 
Chenodeoxycholic acid Leadiant on saanud müügiloa erandlikel asjaoludel.
What is Chenodeoxycholic acid Leadiant and what is it used for? 
Mis on Chenodeoxycholic acid Leadiant ja milleks seda kasutatakse?
For more information about treatment with Chenodeoxycholic acid Leadiant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Kui vajate ravimiga Chenodeoxycholic acid Leadiant toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
This is because it has not been possible to obtain complete information about Chenodeoxycholic acid Leadiant due to the rarity of the disease. 
See tähendab, et harvaesineva haiguse tõttu ei olnud võimalik saada ravimi Chenodeoxycholic acid Leadiant kohta täielikku teavet.
The chenodeoxycholic acid contained in this medicine replaces the patient's missing chenodeoxycholic acid. 
Ravimis sisalduv kenodeoksükoolhape asendab patsiendi puuduvat kenodeoksükoolhapet.
This is a ‘primary bile acid', which is a main component of bile (a fluid produced by the liver that helps to digest fats). 
Kenodeoksükoolhape on primaarne sapphape, mis on sapi (maksa eritatav vedelik, mis aitab rasvu seedida) põhikomponent.
These patients cannot produce enough of the primary bile acid chenodeoxycholic acid due to genetic abnormalities that result in a lack of the liver enzyme sterol 27 hydroxylase. 
Geenihäirete tõttu ei teki nende patsientide organismis piisavalt primaarset sapphapet kenodeoksükoolhapet, sest puudub maksaensüüm 27hüdroksülaas.
It is not intended to provide practical advice on how to use Chenodeoxycholic acid Leadiant. 
Hindamisaruandes ei anta ravimi Chenodeoxycholic acid Leadiant kasutamise praktilisi nõuandeid.
Why is Chenodeoxycholic acid Leadiant approved? 
Miks Chenodeoxycholic acid Leadiant heaks kiideti?
Chenodeoxycholic acid Leadiant is used to treat adults and children from one month of age with cerebrotendinous xanthomatosis. 
Ravimit Chenodeoxycholic acid Leadiant kasutatakse tserebrotendinoosse ksantomatoosiga täiskasvanute ja vähemalt 1-kuuste laste raviks.
This is a summary of the European public assessment report (EPAR) for Chenodeoxycholic acid Leadiant. 
See on ravimi Chenodeoxycholic acid Leadiant Euroopa avaliku hindamisaruande kokkuvõte.
Chenodeoxycholic acid Leadiant is a medicine that contains the active substance chenodeoxycholic acid. 
Chenodeoxycholic acid Leadiant on ravim, mis sisaldab toimeainena kenodeoksükoolhapet.
What information is still awaited for Chenodeoxycholic acid Leadiant? 
Mis teavet ravimi Chenodeoxycholic acid Leadiant kohta veel oodatakse?
Chenodeoxycholic acid is one of the main primary bile acids produced by the liver. 
Kenodeoksükoolhape on üks peamisi maksas tekkivaid primaarseid sapphappeid.
Chenodeoxycholic acid Leadiant can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cerebrotendinous xanthomatosis or other diseases of primary bile acid production. 
Ravi tohib määrata ning seda peab jälgima tserebrotendinoosse ksantomatoosi või primaarsete sapphapete tekkega seotud muude haiguste ravis kogenud arst.
Other information about Chenodeoxycholic acid Leadiant 
Muu teave ravimi Chenodeoxycholic acid Leadiant kohta
The reference medicine for Chenodeoxycholic acid Leadiant is Xenbilox. 
Ravimi Chenodeoxycholic acid Leadiant võrdlusravim on Xenbilox.
What are the risks associated with Chenodeoxycholic acid Leadiant? 
Mis riskid ravimiga Chenodeoxycholic acid Leadiant kaasnevad?
Chenodeoxycholic acid Leadiant is a ‘hybrid medicine'. 
Chenodeoxycholic acid Leadiant on hübriidravim.
How does Chenodeoxycholic acid Leadiant work? 
Kuidas Chenodeoxycholic acid Leadiant toimib?
chenodeoxycholic acid 
Chenodeoxycholic acid Leadiant kenodeoksükoolhape
How is Chenodeoxycholic acid Leadiant used? 
Kuidas ravimit Chenodeoxycholic acid Leadiant kasutatakse?
What benefits of Chenodeoxycholic acid Leadiant have been shown in studies? 
Milles seisneb uuringute põhjal ravimi Chenodeoxycholic acid Leadiant kasulikkus?
21 February 2011 
21. veebruar 2011
What is Galantamine Stada? 
Mis on Galantamine Stada?
The European Commission issued a decision on this referral on 21 February 2011. 
Euroopa Komisjon tegi otsuse vahekohtumenetluse kohta 21. veebruaril 2011.
This is a procedure where one Member State (the ‘reference Member State', in this instance Austria) assesses a medicine with a view to 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 the Czech Republic, Denmark, Estonia, Finland, Ireland, Portugal, Slovakia and Spain). 
Selle menetluse korral hindab üks liikmesriik (viiteliikmesriik, praegusel juhul Austria) ravimit eesmärgiga anda müügiluba, mis kehtib nii selles kui ka teistes riikides (asjaomased liikmesriigid, praegusel juhul Eesti, Hispaania, Iirimaa, Portugal, Slovakkia, Soome, Taani ja Tšehhi Vabariik).
Alfred E. Tiefenbacher GmbH & Co KG submitted Galantamine Stada to the Austrian medicines regulatory agency for a decentralised procedure. 
Ettevõte Alfred E. Tiefenbacher GmbH & Co KG esitas Galantamine Stada müügiloa taotluse Austria ravimiametile detsentraliseeritud menetluse kaudu.
Why was Galantamine Stada reviewed? 
Miks Galantamine Stada üle vaadati?
However, the Member States were not able to reach an agreement and the Czech Republic referred the matter to the CHMP for arbitration on 26 March 2010. 
Liikmesriigid ei jõudnud aga kokkuleppele ja Tšehhi Vabariik tegi 26. märtsil 2010 inimravimite komiteele esildise vahekohtumenetluse alustamiseks.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicinal product has not been shown. 
Tuginedes olemasolevate andmete hindamisele ja komiteesisesele teaduslikule arutelule, järeldas inimravimite komitee, et Galantamine Stada bioekvivalentsus võrdlusravimiga ei ole tõendatud.