FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP considered that Gardasil 9 offers a broader protection against cancer than its precursor Gardasil, since it protects against additional 5 new types of HPV (31, 33, 45, 52 and 58), which although less common than types 16 and 18, are also considered high-risk HPV types.
Estonian: Inimravimite komitee oli seisukohal, et Gardasil 9 pakub laialdasemat kaitset vähi eest kui selle varasem variant Gardasil, sest Gardasil 9 kaitseb veel 5 uue HPV tüübi (31, 33, 45, 52 ja 58) eest, mida peetakse samuti suure riskiga HPV tüüpideks, kuigi need esinevad harvem kui tüübid 16 ja 18.
English: The second study in 3066 subjects compared the effect of Gardasil 9 in girls and boys aged nine to 15 years with the effect of Gardasil 9 in young women aged 16 to 26 years.
Estonian: Teises uuringus (3066 osalejat) võrreldi Gardasil 9 toimet 9-15-aastastele tüdrukutele ja poistele vaktsiini Gardasil 9 toimega 16-26-aastastele noortele naistele.
English: The study looked at the development of antibodies one month after the third dose, and it showed that girls vaccinated with Gardasil 9 have similar levels of protection against types 6, 11, 16 and 18 as girls vaccinated with Gardasil.
Estonian: Uuringus vaadeldi antikehade teket ühe kuu jooksul pärast kolmanda annuse manustamist ning tõendati, et vaktsiinidega Gardasil 9 ja Gardasil vaktsineeritud tüdrukute kaitse tüüpide 6, 11, 16 ja 18 vastu on sarnasel tasemel.
English: Gardasil 9 is normally given according to a either a two-dose schedule or a three-dose schedule for males and females from 9 to 14 years old and a three-dose schedule for males and females 15 years old and over.
Estonian: Vaktsiini Gardasil 9 manustatakse tavaliselt kas kahe või kolme annusena 9-14-aastastele ja kolme annusena vähemalt 15-aastastele mees- ja naispatsientidele.
English: How does Gardasil 9 work?
Estonian: Kuidas Gardasil 9 toimib?
English: What benefits of Gardasil 9 have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Gardasil 9 kasulikkus?
English: The third study compared the effect of Gardasil 9 with the effect of Gardasil in 600 girls aged 9 to 15 years.
Estonian: Kolmandas uuringus võrreldi Gardasil 9 toimet Gardasili toimega 600 tüdrukule vanuses 915 eluaastat.
English: It contains purified proteins from the nine types of HPV listed above.
Estonian: Vaktsiin sisaldab HPV eespool loetletud 9 tüübi puhastatud valke.
English: This study looked at the development of antibodies one month after the last dose, and it showed that boys and girls given two doses of Gardasil 9 have similar levels of protection against all nine virus types to girls and women given three doses of Gardasil 9.
Estonian: Uuringus vaadeldi antikehade teket ühe kuu jooksul pärast viimase annuse manustamist ning tõendati, et vaktsiini Gardasil 9 kahe annusega vaktsineeritud tüdrukute ja poiste kaitse viiruse kõigi 9 tüübi vastu on sarnasel tasemel võrreldes sama vaktsiini kolm annust saanud tüdrukute ja naiste kaitsega.
English: This study showed that 1 out of 6,016 women vaccinated with 3 doses of Gardasil 9 developed disease related to HPV types 31, 33, 45, 52 and 58, compared with 30 out of 6,017 women vaccinated with 3 doses of Gardasil.
Estonian: Uuringus tõendati, et HPV tüüpidega 31, 33, 45, 52 ja 58 seotud haigus tekkis Gardasil 9 kolme annusega vaktsineeritud 6016 naisest 1 naisel ja Gardasili kolme annusega vaktsineeritud 6017 naisest 30 naisel.
English: Gardasil 9 can provide protection against all nine types of HPV infection, as seen in five main studies.
Estonian: Viies põhiuuringus selgus, et Gardasil 9 kaitseb kõigi üheksa HPV-infektsiooni tüübi eest.
English: It is recommended that individuals who receive the first dose of Gardasil 9 should complete the dosing regimen using this medicine.
Estonian: Esimese annusena vaktsiini Gardasil 9 saanutel on soovitatav teha kogu vaktsineerimiskuur sama vaktsiiniga.
English: How is Gardasil 9 used?
Estonian: Kuidas vaktsiini Gardasil 9 kasutatakse?
English: The study should be conducted in more than one Member State.
Estonian: Uuring tuleb läbi viia enam kui ühes liikmesriigis.
English: The protocol shall be submitted in accordance with Article 107n (1) of Directive 2001/83/EC:
Estonian: Protokoll esitatakse kooskõlas direktiivi 2001/83/EÜ artikli 107n lõikega 1:
English: Within 6 months of the Coordination group agreement.
Estonian: 6 kuu möödumisel kooskõlastusrühma kokkuleppest.
English: National competent authorities of Member State(s) or reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Estonian: Liikmesriikide või viiteliikmesriikide (kui asjakohane) pädevad asutused peavad tagama, et müügiloa hoidjad täidavad järgmisi tingimusi:
English: Further interim reports should be submitted to the PRAC 6-monthly thereafter for the first 2 years.
Estonian: Seejärel tuleb järgmised vahearuanded esitada ravimiohutuse järelevalve riskihindamiskomiteele esimese 2 aasta jooksul iga 6 kuu järel.
English: The study design should aim to evaluate and quantify the effectiveness of the risk minimisation measures, and should include a pre- and postimplementation analysis and assessment.
Estonian: Uuringu eesmärk peaks olema riskivähendusmeetmete efektiivsuse hindamine ja mõõtmine ning uuring peaks hõlmama rakendamiseelset ja -järgset analüüsi ja hindamist.
English: The Marketing Authorisation Holders of valproate and related substances shall develop and submit educational materials according to agreed core elements.
Estonian: Valproaadi ja sarnaste ainete müügiloa hoidjad töötavad välja ja esitavad teabematerjali vastavalt kokkulepitud põhipunktidele.
English: These should be submitted to the National Competent Authorities: By 12 January 2015
Estonian: 12. jaanuariks 2015.
English: These materials should ensure that prescriber are informed and the patients understand and acknowledge the risks associated with valproate in utero exposure.
Estonian: Sellega tagatakse, et ravimi määrajad teavad ning patsiendid mõistavad ja teadvustavad valproaadiga üsasisesest kokkupuutest tulenevaid riske.
English: The Marketing Authorisation Holders of valproate and related substances shall perform a drug utilisation study to assess the effectiveness of the risk minimisation measures and to further characterise the prescribing patterns for valproate.
Estonian: Valproaadi ja sarnaste ainete müügilubade hoidjad korraldavad ravimite kasutamise uuringu, et hinnata riskivähendusmeetmete efektiivsust ja kirjeldada täpsemini valproaadi määramise praktikat.
English: The first interim report shall be submitted to the PRAC :
Estonian: Esimene vahearuanne esitatakse ravimiohutuse järelevalve riskihindamiskomiteele:
English: The final study report shall be submitted to the PRAC:
Estonian: Viimane vahearuanne esitatakse ravimiohutuse järelevalve riskihindamiskomiteele:
English: 10 (1 x 10) vial (multipack)
Estonian: 10 (1 × 10) viaali (multipakend)
English: Concentrate for solution for intraocular irrigation
Estonian: Intraokulaarse loputuslahuse kontsentraat
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Estonian: Ravimvorm Manustamisviis Sisepakendi iseloomustus
English: 28 March 2014
Estonian: 28. märts 2014
English: EMA/197955/2014 Veterinary Medicines
Estonian: EMA/197955/2014 Veterinaarravimid
English: The revised opinion was converted into a Decision by the European Commission on 28 March 2014.
Estonian: Uus arvamus vormistati Euroopa Komisjoni otsusena 28. märtsil 2014.
English: The re-examination procedure started on 11 June 2013.
Estonian: Taasläbivaatamise menetlus algas 11. juunil 2013.
English: International non-proprietary name (INN): barium selenate
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): baariumselenaat
English: Written explanations were provided by the applicants and marketing authorisation holders on 14 November 2011 and on 30 November 2012.
Estonian: Taotlejad ja müügiloa hoidjad esitasid kirjalikud selgitused 14. novembril 2011 ja 30. novembril 2012.
English: The Committee appointed C. Ibrahim as rapporteur and H. Jukes as co-rapporteur.
Estonian: Komitee määras hindajaks C. Ibrahimi ja kaashindajaks H. Jukesi.
English: On 23 August 2013, the European Commission requested the CVMP to review its opinion, mainly to clarify some aspects related to consumer risk assessment.
Estonian: 23. augustil 2013 palus Euroopa Komisjon veterinaarravimite komiteel arvamus läbi vaadata eeskätt tarbijaohutuse hindamisega seotud aspektide selgitamiseks.
English: The referral started on 15 September 2011.
Estonian: Esildise menetlemine algas 15. septembril 2011.
English: An oral explanation was given by the applicant/marketing authorisation holders on 6 March 2013.
Estonian: Taotleja / müügiloa hoidjad andsid suulised selgitused 6. märtsil 2013.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisations in Annex III.
Estonian: Asjakohased raviminimetused on I lisas, teaduslikud järeldused on II lisas ja müügilubade peatamise lõpetamise tingimus III lisas.
English: On 14 September 2011, Germany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all long-acting formulations for injection containing barium selenate for all food producing species.
Estonian: 14. septembril 2011 esitas Saksamaa Euroopa Ravimiametile direktiivi 2001/82/EÜ artikli 35 kohase esildise seoses kõigil toiduloomadel kasutatavate baariumselenaati sisaldavate pikatoimeliste süstitavate ravimvormidega.
English: On 26 April 2013, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) notified the Agency of their intention to request a reexamination of the CVMP opinion of 10 April 2013.
Estonian: 26. aprillil 2013 teavitasid Cross Vetpharm Group Limited ja Tairigi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products, BVP) ametit, et nad taotlevad veterinaarravimite komitee 10. aprilli 2013. aasta arvamuse taasläbivaatamist.
English: The Committee therefore adopted by majority a negative opinion on 10 April 2013, recommending suspension of the marketing authorisations for all concerned products.
Estonian: Sellepärast võttis komitee 10. aprillil 2013 häälteenamusega vastu negatiivse arvamuse, soovitades peatada kõigi kõnealuste ravimite müügiload.
English: During its meeting of 14-16 May 2013 the CVMP appointed K. Törneke as rapporteur and K. Baptiste as co-rapporteur for the re-examination procedure.
Estonian: 14.-16. mail 2013 toimunud kohtumisel määras veterinaarravimite komitee taasläbivaatamise hindajaks K. Törneke ja kaashindajaks K. Baptiste'i.
English: Based on the evaluation of the available data, the CVMP considered that the benefit-risk balance for the concerned veterinary medicinal products was negative as, following treatment at recommended doses, barium selenate remains at injection sites for long time periods after treatment and, consequently, consumption of injection-site residues could pose a significant risk to human health.
Estonian: Pärast saadaolevate andmete hindamist leidis veterinaarravimite komitee, et kõnealuste veterinaarravimite kasulikkuse ja riski suhe on negatiivne, sest pärast ravi soovitatavate annustega püsib manustatud baariumselenaat süstekohas kaua ja seega võib süstekohajääkide tarbimine inimtervist raskelt ohustada.
English: On 6 November 2013, the CVMP adopted by majority a revised opinion confirming the recommendation included in its opinion of 17 July 2013, that the benefit-risk balance for the concerned veterinary medicinal products was negative and therefore the CVMP recommended the refusal of the granting of the marketing authorisation and suspension of the existing marketing authorisations for the products concerned.
Estonian: 6. novembril 2013 võttis veterinaarravimite komitee häälteenamusega vastu uue arvamuse, milles kinnitati 17. juuli 2013. aasta arvamuses esitatud soovitust, et kõnealuste veterinaarravimite kasulikkuse ja riski suhe on negatiivne, ning seega soovitab veterinaarravimite komitee keelduda müügiloa andmisest ja peatada kõnealuste ravimite olemasolevad müügiload.
English: The consolidated detailed grounds for the re-examination were submitted by Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) on 10 June 2013.
Estonian: Cross Vetpharm Group Limited ja Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products, BVP) esitasid taasläbivaatamise konsolideeritud ja üksikasjalikud põhjendused 10. juunil 2013.
English: Germany referred the matter to the CVMP due to serious human health concerns related to exposure to injection site residues from the use of long-acting barium selenatecontaining injectable veterinary medicinal products.
Estonian: Saksamaa esitas küsimuse arutamiseks veterinaarravimite komiteele raske ohu tõttu inimtervisele, mida põhjustab kokkupuude ravimjääkidega, mis võivad jääda süstekohta pärast pikatoimeliste baariumselenaati sisaldavate veterinaarravimite süstimist.
English: On 17 July 2013, the CVMP adopted by majority an opinion confirming the recommendation for suspension of the marketing authorisations for the concerned veterinary medicinal products.
Estonian: 17. juulil 2013 võttis veterinaarravimite komitee häälteenamusega vastu arvamuse, milles kinnitati kõnealuste veterinaarravimite müügilubade peatamise soovitust.
English: Opinion following an Article 351 referral for long-acting formulations for injection containing barium selenate for all food producing species
Estonian: Arvamus pärast artikli 350F kohast esildist Kõigil toiduloomadel kasutatavad pikatoimelised baariumselenaati sisaldavad süstitavad ravimvormid
English: Selenium is an essential micronutrient for both animals and man. Barium selenate has been used in slow-release injectable veterinary medicinal products for therapeutic and prophylactic use against selenium deficiencies in cattle and sheep.
Estonian: Baariumselenaati on aeglaselt vabaneva süstitava veterinaarravimina kasutatud seleenivaeguse ennetamiseks ja raviks veistel ja lammastel.
English: 29 January 2016
Estonian: 04. aprill 2016
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom ainuõigus.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Lithuania) 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 Bulgaria, Estonia, Hungary, Latvia, Poland and Romania).
Estonian: See on menetlus, kus üks liikmesriik (viiteliikmesriik, praegusel juhul Leedu) hindab ravimit, et otsustada, kas anda müügiluba, mis kehtib selles riigis ja teistes liikmesriikides (asjaomased liikmesriigid, praegusel juhul Bulgaaria, Eesti, Läti, Poola, Rumeenia ja Ungari).
English: EMEA/H/A-29/1428
Estonian: EMA/55653/2016 rev.1 EMEA/H/A-29/1428
English: What is Tobramycin VVB?
Estonian: Mis on Tobramycin VVB?
English: However, the Member States were not able to reach an agreement and the Lithuanian medicines regulatory agency referred the matter to the CHMP for arbitration on 14 October 2015.
Estonian: Liikmesriigid ei jõudnud selles küsimuses üksmeelele ja Leedu ravimiamet tegi 14. oktoobril 2015 inimravimite komiteele vahekohtumenetluse alustamise esildise.
English: On 28 January 2015, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Tobramycin VVB.
Estonian: Euroopa Ravimiamet (EMA) lõpetas 28. jaanuaril 2015 vahekohtumenetluse, mis algatati pärast seda, kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele ravimi Tobramycin VVB heakskiitmises.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Tobramycin VVB can be granted marketing authorisation in Lithuania and in the following Member States of the EU: Bulgaria, Estonia, Hungary, Latvia, Poland and Romania.
Estonian: Euroopa Ravimiameti inimravimite komitee (CHMP) võttis vastu otsuse anda Tobramycin VVB-le müügiluba Leedus ja järgmistes EL-i liikmesriikides: Bulgaaria, Eesti, Ungari, Läti, Poola ja Rumeenia.
English: Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily and cause infections.
Estonian: Tsüstiline fibroos on pärilik haigus, mille korral koguneb kopsu paks lima, mis soodustab bakterite kasvu, põhjustades infektsioone.
English: Demonstration of clinical superiority is required because Tobi Podhaler is an orphan medicine and was granted market exclusivity in the EU at the time of its market authorisation in July 2011.
Estonian: Nõutav on kliinilise paremuse tõendamine, sest Tobi Podhaler on harvikravim, millele anti müügiloa väljastamisel juulis 2011 Euroopa Liidus turustamise
English: A European Commission decision on this opinion will be issued in due course.
Estonian: Euroopa Komisjon tegi sellel arvamusel põhineva otsuse 04. aprillil 2016.
English: It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria which eventually kills them.
Estonian: Ravim takistab P. aeruginosa rakuseinte ehitamiseks vajalike valkude tootmist, kahjustades sellega baktereid, mis lõpuks hävivad.
English: Why was Tobramycin VVB reviewed?
Estonian: Miks Tobramycin VVB kohta esitatud taotlus läbi vaadati?
English: The reason for the referral was a disagreement over whether Tobramycin VVB is clinically superior to Tobi Podhaler, another medicine containing tobramycin.
Estonian: Esildise põhjuseks oli lahkarvamus selle üle, kas Tobramycin VVB on kliiniliselt parem kui teine tobramütsiini sisaldav ravim Tobi Podhaler.
English: UAB VVB submitted Tobramycin VVB to the Lithuanian medicines regulatory agency for a decentralised procedure.
Estonian: UAB VVB esitas Leedu ravimiametile Tobramycin VVB detsentraliseeritud menetlusega heakskiitmise taotluse.
English: Tobramycin VVB is an antibiotic for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older who have cystic fibrosis.
Estonian: Tobramycin VVB on antibiootikum, mida kasutatakse bakteri Pseudomonas aeruginosa põhjustatud kroonilise kopsuinfektsiooni raviks 6-aastastel ja vanematel tsüstilise fibroosiga patsientidel.
English: Tobramycin VVB is to be available as a nebuliser solution (300 mg/5 ml) to be inhaled.
Estonian: Tobramycin VVB on saadaval inhaleeritava nebuliseeritava lahusena (300 mg / 5 ml).
English: The active substance in Tobramycin VVB, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides'.
Estonian: Tobramycin VVB toimeaine tobramütsiin kuulub aminoglükosiid-antibiootikumide rühma.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Tobramycin VVB is clinically superior to Tobi Podhaler because a substantial proportion of patients are intolerant to Tobi Podhaler but can be treated with Tobramycin VVB.
Estonian: Praegu teadaolevate andmete ja komiteesiseste teadusliku arutelu põhjal tegi inimravimite komitee järelduse, et Tobramycin VVB on kliiniliselt parem kui Tobi Podhaler, sest suurt osa patsiente, kes Tobi Podhalerit ei talu, saab ravida Tobramycin VVB-ga. Inimravimite komitee soovitas seetõttu anda Tobramycin VVB müügiluba Leedus ja teistes asjaomastes liikmesriikides.
English: Tobramycin VVB is a ‘hybrid medicine' that has been developed to be comparable to a ‘reference medicine' containing tobramycin called Tobi (300 mg/5 ml nebuliser solution).
Estonian: Tobramycin VVB on hübriidravim, mis on loodud võrreldavana tobramütsiini sisaldava viiteravimiga Tobi (300 mg / 5 ml nebuliseeritav lahus).
English: This means that during the period of market exclusivity similar products, such as Tobramycin VVB, cannot be placed on the market; there are, however, exceptions such as where clinically superiority over Tobi Podhaler can be shown.
Estonian: See tähendab, et turustamise ainuõiguse omamise perioodil on keelatud turustada sarnaseid ravimeid, sh Tobramycin VVB-d.
English: budesonide / formoterol
Estonian: budesoniid/formoterool
English: The full EPAR and risk management plan summary for Budesonide/Formoterol Teva Pharma B.V. can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Budesonide/Formoterol Teva Pharma B.V. 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Estonian: tugevuste 160/4,5 μg ja 320/9 μg võrreldav kvaliteet ja bioekvivalentsus ravimi Symbicort Turbohaleri vastavate tugevustega.
English: The two active substances in Budesonide/Formoterol Teva Pharma B.V. are well known and are present in several medicines used to treat asthma, either alone or in combination with other medicines.
Estonian: mõlemad toimeained on hästi tuntud ja neid kasutatakse paljudes astmaravimites nii ainsa toimeainena kui ka kombinatsioonis teiste toimeainetega.
English: For more information about treatment with Budesonide/Formoterol Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: A risk management plan has been developed to ensure that Budesonide/Formoterol Teva Pharma B.V. is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada ravimi Budesonide/Formoterol Teva Pharma B.V.
English: For practical information about using Budesonide/Formoterol Teva Pharma B.V., patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Budesonide/Formoterol Teva Pharma B.V., including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: What measures are being taken to ensure the safe and effective use of Budesonide/Formoterol Teva Pharma B.V.?
Estonian: Mis meetmed võetakse, et tagada ravimi Budesonide/Formoterol Teva Pharma B.V.
English: This is a summary of the European public assessment report (EPAR) for Budesonide/Formoterol Teva Pharma B.V.
Estonian: Euroopa avaliku hindamisaruande täistekst ravimi Budesonide/Formoterol Teva Pharma B.V.
English: Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Symbicort Turbohaleri korral, ületab ravimi Budesonide/Formoterol Teva Pharma B.V.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Budesonide/Formoterol Teva Pharma B.V. on 19 November 2014.
Estonian: müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. novembril 2014.
English: Other information about Budesonide/Formoterol Teva Pharma B.V.
Estonian: Muu teave ravimi Budesonide/Formoterol Teva Pharma B.V.
English: The reference medicine for Budesonide/Formoterol Teva Pharma B.V. is Symbicort Turbohaler.
Estonian: võrdlusravim on Symbicort Turbohaler.