FrancophonIA/ELRC3.0 huggingface dataset:
English: Each dose contains 75 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution.
Estonian: Üks annus sisaldab pärast manustamiskõlblikuks muutmist 75 mikrogrammi parathormooni 71,4 mikroliitris lahuses.
English: Each dose contains 75 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Estonian: Üks annus sisaldab pärast manustamiskõlblikuks muutmist 75 mikrogrammi parathormooni (rDNA) 71,4 mikroliitris lahuses .
English: Each dose contains 25 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution.
Estonian: Üks annus sisaldab pärast manustamiskõlblikuks muutmist 25 mikrogrammi parathormooni 71,4 mikroliitris lahuses.
English: Talk to your doctor or pharmacist before using Natpar if you suffer from kidney stones.
Estonian: Kui teil on neerukivid, pidage enne Natpar'i kasutamist nõu oma arsti või apteekriga.
English: Renal and urinary disorders hypercalciuria pollakiuria
Estonian: Neerude ja kuseteede häired hüperkaltsiuuria*, pollakisuuria
English: Dose
Estonian: TÄITMISEKS
English: Each dose contains 25 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Estonian: Üks annus sisaldab pärast manustamiskõlblikuks muutmist 25 mikrogrammi parathormooni (rDNA) 71,4 mikroliitris lahuses.
English: Each dose contains 50 micrograms parathyroid hormone in 71.4 microlitre solution following reconstitution.
Estonian: Üks annus sisaldab pärast manustamiskõlblikuks muutmist 50 mikrogrammi parathormooni 71,4 mikroliitris lahuses .
English: Each dose contains 50 micrograms parathyroid hormone (rDNA) in 71.4 microlitre solution following reconstitution.
Estonian: Üks annus sisaldab pärast manustamiskõlblikuks muutmist 50 mikrogrammi parathormooni (rDNA) 71,4 mikroliitris lahuses .
English: • stomach pain*
Estonian: kõhu ülaosa valu*
English: • need to pass urine often
Estonian: • sage urineerimisvajadus
English: • muscle spasms
Estonian: • lihasevalu
English: The Member States competent authorities will continue to keep the product under regular review.
Estonian: Liikmesriikide pädevad asutused teostavad selle toote üle jätkuvalt regulaarset järelevalvet.
English: London, 29 May 2006 EMEA/262776/2005
Estonian: London, 29. mai 2006 EMEA/262776/2006
English: It was subsequently authorised by Mutual Recognition Procedure in all EU Member States except Ireland.
Estonian: Hiljem anti vastastikuse tunnustamise menetlusega müügiluba kõikides Euroopa Liidu liikmesriikides peale Iirimaa.
English: Written explanations were provided by the Marketing Authorisation Holder by 30 June 2005, 15 July 2005, 19 July 2005, 20 December 2005 and 7 March 2006.
Estonian: Müügiloa hoidja esitas kirjalikud selgitused 30. juunil 2005, 15. juulil 2005, 19. juulil 2005, 20. detsembril 2005 ja 7. märtsil 2006.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
Estonian: INIMTERVISHOIUS KASUTATAVATE RAVIMITE KOMITEE (CHMP)
English: Oral explanations were given on 22 March 2006.
Estonian: Suulised selgitused anti 22. märtsil 2006.
English: The Rapporteur and Co-Rapporteur appointed were Dr. Julia Dunne and Dr. Ingemar Persson, respectively.
Estonian: Määratud ettekandja ja kaasettekandja olid vastavalt dr Julia Dunne ja dr Ingemar Persson.
English: SUMMARY INFORMATION ON REFERRAL OPINION PURSUANT TO ARTICLE 31 OF COUNCIL DIRECTIVE 2001/83/EC, AS AMENDED, FOR
Estonian: TEABEKOKKUVÕTE ARVAMUSEST NÕUKOGU MUUDETUD DIREKTIIVI 2001/83/EÜ ARTIKLI 31 ALUSEL
English: It is also approved in Norway and Iceland.
Estonian: Ravimil on müügiluba ka Norras ja Islandil.
English: The referral procedure started on 21 April 2005.
Estonian: Esildise menetlemine algas 21. aprillil 2005.
English: The final opinion was converted into a Decision by the European Commission on 29 May 2006.
Estonian: See lõpparvamus kinnitati Euroopa Komisjoni otsusena 29. mail 2006.
English: International Non-Proprietary Name (INN): pimecrolimus
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): pimekroliimus
English: Pimecrolimus is a calcineurin inhibitor approved as cream formulation at a 1% concentration.
Estonian: Pimekroliimus on kaltsineuriini inhibiitor, mis on heaks kiidetud 1% kontsentratsiooniga kreemina.
English: * Note: The information given in this document and Annexes reflect only the CHMP Opinion dated 23 March 2006.
Estonian: * Märkus: Käesolevas dokumendis ja selle lisades esitatud teave kajastab üksnes inimtervishoius kasutatavate ravimite komitee 23. märtsi 2006. aasta arvamust.
English: Pimecrolimus was first authorised in the EU in Denmark on 15 March 2002.
Estonian: Pimekroliimusele anti Euroopa Liidus esmalt müügiluba 15. märtsil 2002.
English: Elidel and associated names (See Annex 1)
Estonian: ravimi Elidel ja seotud nimetuste kohta (vt I lisa) SAADETUD ESILDISE KOHTA
English: On 21 April 2005, Denmark presented a referral to the EMEA under Article 31 of Directive 2001/83, as amended.
Estonian: 21. aprillil 2005 esitas Taani Euroopa Ravimiametile muudetud direktiivi nr 2001/83 järgse esildise.
English: The reasons for referral concerned a review of the benefit/risk profile of medicinal products containing pimecrolimus considering efficacy and safety concerns with regards to the potential risk of cancer.
Estonian: Esildise põhjus oli soov saada hinnang pimekroliimust sisaldavate ravimite kasulikkuse/riski profiilile, arvestades tõhususe ja ohutuse küsimusi seoses võimaliku vähiriskiga.
English: Pimecrolimus was initially approved for the use in patients with mild to moderate atopic dermatitis aged 2 years and over for short-term treatment of signs and symptoms and intermittent long-term treatment for prevention of progression to flares.
Estonian: Pimekroliimus kiideti esmalt heaks kasutamiseks vähemalt 2-aastastel patsientidel, kes põevad kerget kuni mõõdukat atoopilist dermatiiti, tunnuste ja sümptomite lühiajaliseks raviks ning vahelduvaks pikaajaliseks punetavate alade progressiooni vältivaks raviks.
English: The CHMP recommended the restriction of use to these patients where treatment with topical corticosteroids is either inadvisable or not possible.
Estonian: Inimtervishoius kasutatavate ravimite komitee soovitas kehtestada kasutuspiirangu patsientide suhtes, kellel ravi paikse toimega kortikosteroididega ei ole kas soovitatav või võimalik.
English: Based on evaluation of the available data and the Rapporteurs' assessment reports, the CHMP considered that the benefit/risk profile of pimecrolimus containing medicinal products remains favourable, and therefore adopted an opinion on 23 March 2006 recommending the maintenance of the Marketing Authorisations with amendments to the Summary of Product Characteristics, Labelling and Package Leaflet for pimecrolimus containing medicinal products.
Estonian: Kättesaadavate andmete ja ettekandjate hindamisaruannete põhjal leidis inimtervishoius kasutavate ravimite komitee, et pimekroliimust sisaldavate ravimite kasulikkuse ja riski suhe on jätkuvalt soodne ning võttis seepärast 23. märtsil 2003 vastu arvamuse pimekroliimust sisaldavate ravimite kohta, kus soovitab säilitada müügiloa, muutes ravimi omaduste kokkuvõtet ning pakendi infolehte
English: The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics, Labelling and Package Leaflet in the Annex III and the conditions of the marketing authorisations in the Annex IV.
Estonian: Teaduslikud järeldused on II lisas, toote omaduste muudetud kokkuvõte ja ravimi infoleht III lisas ning müügiloa tingimused IV lisas.
English: On the grounds of safety and efficacy, the CHMP was of the opinion that pimecrolimus should be limited to second line use.
Estonian: Ohutuse ja efektiivsuse andmete põhjal järeldas inimtervishoius kasutatavate ravimite komitee, et pimekroliimuse kasutamine peab piirnema teisese valiku preparaatidega.
English: It should be used after careful evaluation of alternative treatment options;
Estonian: Seda peab kasutama pärast alternatiivsete ravivõimaluste hoolikat kaalutlemist.
English: Further information on Pexion can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Lisateave Pexioni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: These side effects are mild and generally short-lived.
Estonian: Need kõrvalnähud on kerged ja enamasti lühiajalised.
English: Pexion (imepitoin)
Estonian: Pexion (imepitoiin)
English: The European Medicine Agency decided that Pexion's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Pexioni kasulikkus on suurem kui sellega kaasnevad riskid, ja et ravimi kasutamise saab Euroopa Liidus heaks kiita.
English: Pexion received a marketing authorisation valid throughout the EU on 25 February 2013.
Estonian: Pexioni müügiluba, mis kehtib kogu Euroopa Liidus, anti 25. veebruaril 2013.
English: This may also help in controlling seizures.
Estonian: Samuti võib see aidata krambihoogude teket kontrolli all hoida.
English: Other information about Pexion
Estonian: Muu teave Pexioni kohta
English: Epilepsy is caused by excessive electrical activity in the brain.
Estonian: Epilepsiat põhjustab aju liigne elektriline aktiivsus.
English: What is Pexion and what is it used for?
Estonian: Mis on Pexion ja milleks seda kasutatakse?
English: • reduce anxiety and fear associated with noise phobia.
Estonian: • Mürakartusega seotud ärevuse ja hirmu vähendamine.
English: The dose is calculated according to the dog's weight.
Estonian: Annus arvutatakse koera kehamassi alusel.
English: In case of accidental ingestion, especially by a child, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Estonian: Ravimi juhuslikul allaneelamisel (eriti kui ravimit on neelanud laps) tuleb viivitamatult pöörduda arsti poole ja näidata pakendi infolehte või pakendi etiketti.
English: To prevent accidental ingestion, the bottle cap should be replaced immediately after withdrawing the required number of tablets for one dose.
Estonian: Tablettide juhusliku allaneelamise vältimiseks tuleb pärast üheks manustamiskorraks vajaliku arvu tablettide pudelist väljavõtmist sellele kork kohe peale tagasi keerata.
English: What are the risks associated with Pexion?
Estonian: Mis riskid Pexioniga kaasnevad?
English: This overview was last updated in May 2018.
Estonian: Kokkuvõtte viimane uuendus: 05-2018.
English: 25% of dogs did not respond to Pexion treatment and had the same or an increased number of seizures.
Estonian: 25%-l koertest ei tekkinud Pexionile ravivastust ja nende krambihoogude arv kas jäi samaks või suurenes.
English: Pexion is a veterinary medicine used in dogs to:
Estonian: Pexion on veterinaarravim, mida kasutatakse koertel järgmistel näidustustel.
English: • reduce the frequency of generalised seizures (fits affecting most or all of the brain) due to epilepsy of unknown causes (idiopathic).
Estonian: • Teadmata põhjusega (idiopaatilise) epilepsia põhjustatud generaliseerunud (kogu aju või sellest enamiku haaratusest tingitud) krambihoogude esinemissageduse vähendamine.
English: If seizures are not adequately controlled after one week, the veterinary surgeon may increase the dose by 50 - 100% at a time, to a maximum of 30 mg per kg bodyweight twice a day.
Estonian: Kui pärast üht nädalat ei ole krambihood piisava kontrolli all, võib veterinaararst suurendada annust korraga 50-100% võrra, maksimaalse annuseni 30 mg/kg kaks korda ööpäevas.
English: Ingestion of this medicine may cause dizziness, lethargy and nausea.
Estonian: Selle ravimi allaneelamine võib põhjustada peapööritust, loidust ja iiveldust.
English: Pexion contains the active substance imepitoin.
Estonian: Pexion sisaldab toimeainena imepitoiini.
English: An overview of Pexion and why it is authorised in the EU
Estonian: Pexioni ülevaade ja Euroopa Liidus heakskiitmise põhjused
English: Imepitoin also has a weak blocking effect on calcium channels.
Estonian: Imepitoiinil on ka nõrk kaltsiumikanaleid blokeeriv toime.
English: Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other.
Estonian: Neurotransmitterid (nt GABA) on keemilised ained, mis vahendavad närvirakkudevahelisi signaale.
English: Imepitoin's effect on GABA receptors also reduces fear and anxiety.
Estonian: Imepitoiini toime GABA-retseptoritele vähendab ka hirmu ja ärevust.
English: Pexion must not be used in dogs with severely impaired liver, kidney or heart function.
Estonian: Pexioni ei tohi kasutada maksa-, neeru- või südametalitluse raske häirega koertel.
English: By activating its receptors, imepitoin increases GABA's effects and helps to prevent seizures.
Estonian: GABA retseptorite aktiveerimisega suurendab imepitoiin GABA toimet ja aitab ennetada krambihooge.
English: For epilepsy, the most common side effects with Pexion (which may affect more than 1 in 10 dogs) are ataxia (inability to coordinate muscle movements), vomiting, polyphagia (excessive eating), and somnolence (sleepiness).
Estonian: Epilepsia ravi korral on Pexioni kõige sagedamad kõrvalnähud (mis võivad esineda enam kui 1 koeral 10st) ataksia (tahtlike liigutuste koordineerimatus), oksendamine, polüfaagia (liigsöömine) ja somnolentsus (unisus).
English: The effectiveness of Pexion to treat dogs with status epilepticus and cluster seizures has not been studied.
Estonian: Pexioni efektiivsust epileptilise staatusega ja seeriaepilepsiahoogudega koertel ei ole uuritud.
English: Out of 104 Pexion-treated dogs, 64% showed a good or excellent effect compared to 25% of 122 dogs receiving dummy treatment (placebo) as reported by owners.
Estonian: Omanike teatel oli toime hea või suurepärane 64%-l 104st Pexioniga ravitud koerast, võrreldes 25%-ga 122st näivat ravimit (platseebot) saanud koerast.
English: How does Pexion work?
Estonian: Kuidas Pexion toimib?
English: Imepitoin partially activates the receptors for the neurotransmitter GABA, a substance that reduces electrical activity in the brain.
Estonian: Imepitoiin aktiveerib osaliselt neurotransmitteri gamma-aminovõihappe (GABA; aine, mis vähendab aju elektrilist aktiivsust) retseptorid ajus.
English: How is Pexion used?
Estonian: Kuidas Pexioni kasutatakse?
English: For the full list of side effects and restrictions of Pexion, see the package leaflet.
Estonian: Pexioni kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Pexion is available as tablets and can only be obtained with a prescription.
Estonian: Pexioni turustatakse tablettidena ja see on retseptiravim.
English: The active substance in Pexion, imepitoin, is an anti-epileptic and anti-anxiety medicine.
Estonian: Pexioni toimeaine imepitoiin on epilepsia- ja ärevusevastane ravim.
English: Therefore, Pexion should not be used as a primary treatment for dogs with cluster seizures (group of seizures occurring close together) and status epilepticus (continual seizures).
Estonian: Seetõttu ei tohi Pexioni kasutada esmavaliku ravimina seeriaepilepsiahoogude (krambihood, mis korduvad lühikeste ajavahemike tagant) ja epileptilise staatusega (kestvad krambihood) koertel.
English: As side-effects were less frequent than with phenobarbital, Pexion is a suitable treatment option for some dogs, considering in particular its safety profile.
Estonian: Et kõrvalnähte esines Pexioni kasutamisel harvem kui fenobarbitaali korral, siis on Pexion mõnedel koertel ravimi ohutusprofiili arvesse võttes sobiv ravivõimalus.
English: These are pores which let calcium move into the nerve cells allowing electrical impulses to be transmitted between nerve cells.
Estonian: Kaltsiumikanalite kaudu pääsevad kaltsiumiioonid närvirakku, võimaldades elektriimpulssidel levida ühest närvirakust teise.
English: Pexion-treated dogs also had reduced anxiety scores compared to the placebo group.
Estonian: Pexioniga ravitud koertel esines ka vähem ärevust kui platseeborühmas.
English: For noise phobia, the most common side effects with Pexion (which may affect more than 1 in 10 dogs) are short-lived ataxia, increased appetite, and lethargy (lack of energy).
Estonian: Mürakartuse ravi korral on Pexioni kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 koeral 10st) lühiajaline ataksia, suurenenud söögiisu ja loidus (energiapuudus).
English: Even though the proportion of seizure-free dogs was lower with Pexion than with phenobarbital, some dogs were well-controlled with Pexion.
Estonian: Kuigi krambihoogudeta koerte osakaal oli Pexioni rühmas väiksem kui fenobarbitaali rühmas, toimis Pexion osal koertest hästi.
English: During the evaluation phase of 12 weeks, 47% (30 out of 64) of Pexion-treated dogs were free from generalised seizures, whilst 58% (51 out of 88) of phenobarbital-treated dogs had no seizures.
Estonian: Koeri, kellel ei esinenud 12-nädalase hindamisetapi vältel generaliseerunud krambihooge, oli Pexioniga ravitutest 47% (30 koera 64st) ning fenobarbitaaliga ravitutest 58% (51 koera 88st).
English: In an EU field study looking at effects on epilepsy, Pexion at a dose of 10 to 30 mg/kg bodyweight twice daily reduced the average number of generalised seizures from 2.3 to 1.1 per month after 20 weeks of treatment.
Estonian: ELi väliuuringus, milles uuriti toimet epilepsiale, vähendas Pexion 20 ravinädala järel annuses 1030 mg/kg kaks korda ööpäevas generaliseerunud krambihoogude keskmist arvu kuus 2,3 krambihoolt 1,1 krambihoole.
English: What benefits of Pexion have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Pexioni kasulikkus?
English: In an EU field study looking at effects on noise phobia, the effectiveness of 3 days' treatment with Pexion, at a dose of 30 mg/kg bodyweight twice daily, was investigated during New Year's Eve fireworks in dogs diagnosed with noise phobia.
Estonian: ELi väliuuringus, milles uuriti toimet mürakartusele, uuriti mürakartuse diagnoosiga koertel uue aasta ilutulestiku ajal 3-päevase Pexion-ravi efektiivsust annuses 30 mg/kg kaks korda ööpäevas.
English: In a second US field study looking at effects on epilepsy and involving 151 dogs, Pexion treatment for 12 weeks at a fixed dose of 30 mg/kg bodyweight twice daily resulted in 21% of dogs (21 out of 99) being free of generalised seizures compared to 8% of dogs (4 out of 52) given a dummy treatment.
Estonian: Teises, USAs tehtud väliuuringus (151 koera), milles uuriti toimet epilepsiale, ei esinenud generaliseerunud krambihooge 21%-l koertest (21 koeral 99st), keda raviti 12 nädala vältel Pexioniga fikseeritud annuses 30 mg/kg kaks korda ööpäevas, samas kui näivat ravimit saanud koerte rühmas oli see näitaja 8% (4 koera 52st).
English: For epilepsy, treatment with Pexion should be started at a dose of 10 mg per kg bodyweight twice a day.
Estonian: Epilepsiaravi Pexioniga alustatakse annuses 10 mg kehamassi kg kohta (mg/kg) kaks korda ööpäevas.
English: This compared with a reduction of 2.4 seizures to 1.1 per month with phenobarbital (another anti-epileptic medicine).
Estonian: Fenobarbitaal (samuti epilepsiaravim) vähendas krambihoogude keskmist arvu kuus 2,4-lt 1,1-le.
English: Why is Pexion authorised in the EU?
Estonian: Pexioni Euroopa Liidus heakskiitmise põhjused
English: For noise phobia, treatment with Pexion is given at a dose of 30 mg per kg bodyweight twice a day, starting 2 days before an expected noise event and continuing through it.
Estonian: Mürakartuse raviks manustatakse Pexioni annuses 30 mg/kg kaks korda ööpäevas.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 January 2017
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: It encourages the bone marrow to produce more neutrophils and improves the patient's ability to fight off infections.
Estonian: See ergutab luuüdi tootma rohkem neutrofiile ja parandab patsiendi võimet võidelda infektsioonidega.
English: Withdrawal of the marketing authorisation application for Zioxtenzo (pegfilgrastim) EMA/47326/2017
Estonian: Müügiloa taotluse tagasivõtmise teave: Zioxtenzo (pegfilgrastiim) EMA/47326/2017
English: What is Zioxtenzo?
Estonian: Mis on Zioxtenzo?
English: An inspection of the site will therefore be needed before the medicine can be approved.
Estonian: Enne ravimi heakskiitmist on seega vaja kontrollkäiku tootmiskohta.
English: This means that it was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union.
Estonian: See tähendab, et Zioxtenzo pidi olema sarnane bioloogilise ravimiga (võrdlusravimiga), millel juba on Euroopa Liidus müügiluba.
English: The other concern was the lack of a certificate of Good Manufacturing Practice (GMP) for the medicine's manufacturing site.
Estonian: Teiseks puudus ravimi tootmiskohal hea tootmistava sertifikaat.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would not be able to provide the additional data required by the CHMP within the timeframe allowed for the procedure.
Estonian: Ettevõtte kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, märkis ettevõte põhjuseks, et tal ei ole võimalik taotluse menetlemise tähtajaks esitada inimravimite komitee nõutud lisaandmeid.
English: Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments and can lead to development of serious infections.
Estonian: Neutropeenia on teatud tsütotoksiliste (rakke hävitavate) vähiravimite kõrvalnäht ning võib põhjustada raskeid infektsioone.
English: On 18 January 2017, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zioxtenzo, intended for treating neutropenia in patients taking cancer treatments.
Estonian: Sandoz GmbH teatas 18. jaanuaril 2017 inimravimite komiteele oma soovist võtta tagasi ravimi Zioxtenzo müügiloa taotlus.
English: Withdrawal of the marketing authorisation application for Zioxtenzo (pegfilgrastim)
Estonian: Müügiloa taotluse tagasivõtmise teave: Zioxtenzo (pegfilgrastiim)
English: Because filgrastim is pegylated, its removal from the body is slowed down, allowing the medicine to be given less often.
Estonian: Et filgrastiim on pegüleeritud, püsib see organismis kauem ja ravimit võib manustada harvem.
English: In addition, two studies in patients receiving cancer medicines compared the safety and effectiveness of Zioxtenzo and Neulasta.
Estonian: Peale selle võrreldi kahes uuringus vähiravimeid saanud patsientidel Zioxtenzo ja Neulasta ohutust ja efektiivsust.
English: How does Zioxtenzo work?
Estonian: Kuidas Zioxtenzo toimib?
English: Zioxtenzo is a medicine that contains the active substance pegfilgrastim.
Estonian: Zioxtenzo on ravim, mis sisaldab toimeainena pegfilgrastiimi.
English: The reference medicine for Zioxtenzo is Neulasta.
Estonian: Zioxtenzo võrdlusravim on Neulasta.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Estonian: Bioloogiliselt sarnaste ravimite lisateave on teabedokumendis siin.
English: The company presented results of studies designed to show that Zioxtenzo is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Estonian: Ettevõte esitas tulemused uuringutest, mille eesmärk oli tõendada, et Zioxtenzo sarnaneb keemilise struktuuri, puhtuse, toimemehhanismi ja organismis metaboliseerumise poolest võrdlusravimiga Neulasta.
English: The company informed the CHMP that there is no impact of the withdrawal of Zioxtenzo on ongoing clinical trials and there are no compassionate use programmes for Zioxtenzo.
Estonian: Ettevõte teatas inimravimite komiteele, et Zioxtenzo taotluse tagasivõtmine ei mõjuta praegu toimuvaid kliinilisi uuringuid ning Zioxtenzo eriloaga kasutamise programmid puuduvad.