FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin and subcutaneous tissue disorders Uncommon Hyperhidrosis Very rare
Estonian: Aeg-ajalt kõhulahtisus, suukuivus Naha ja nahaaluskoe kahjustused Aeg-ajalt hüperhidroos
English: Tlf: + 47 67 51 89 00
Estonian: Mundipharma AS Tlf: + 47 67 51 89 00 post@mundipharma.no
English: Tel: +43 (0)1 523 25 05-0
Estonian: Tel: +43 (0)1 523 25 05-0 info@mundipharma.at
English: • Dry mouth
Estonian: • suukuivus;
English: Posology
Estonian: Nasaalne
English: Tlf: + 354 540 8000
Estonian: Tlf: + 354 540 8000 icepharma@icepharma.is
English: Hypersensitivity, Anaphylactic shock
Estonian: ülitundlikkus, anafülaktiline šokk Närvisüsteemi häired Sage pearinglus, peavalu
English: • Access to a video on how to use Nyxoid The HCP Guidance Document should include:
Estonian: • Ligipääsu videole Nyxoidi kasutamise kohta
English: • Tremor
Estonian: • tugev unisus
English: Naloxone
Estonian: ABIAINED
English: Very common: may affect more than 1 in 10 people
Estonian: Väga sage: võib esineda rohkem kui 1-l inimesel 10-st): • Iiveldus.
English: The recommended dose is 1.8 mg administered into one nostril (one nasal spray).
Estonian: Täiskasvanud ning noorukid vanuses 14 aastat ja vanemad Soovitatav annus on 1,8 mg manustatuna ühte ninasõõrmesse (üks pihustus ninna).
English: Tel: +386 158969 00
Estonian: Tel: +386 158969 00 info@medis.si
English: Tel: + 385 (0) 1 230 34 46
Estonian: Tel: + 385 (0) 1 230 34 46 info@medisadria.hr
English: - Keep this leaflet.
Estonian: Hoidke ninaspreid käepärast.
English: • Sweating
Estonian: • oksendamine.
English: Uncommon Arrhythmia, Bradycardia Very rare
Estonian: Seedetrakti häired Väga sage iiveldus
English: Tel: + 46 (0)31 773 75 30
Estonian: Mundipharma AB Tel: + 46 (0)31 773 75 30 info@mundipharma.se
English: LIST OF EXCIPIENTS
Estonian: Opioidi võõrutussündroom
English: Mundipharma AB
Estonian: Mundipharma Comm.
English: Mundipharma Oy
Estonian: Mundipharma A/S Tlf.
English: • Fast heart rate
Estonian: • kiirenenud südame löögisagedus;
English: Nervous system disorders Common
Estonian: Immuunsüsteemi häired
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Estonian: C. MÜÜGILOA MUUD TINGIMUSED JA NÕUDED • Perioodilised ohutusaruanded
English: SIA Inovatīvo biomedicīnas tehnoloģiju institūts Tel: + 37167800810
Estonian: Tel: + 37167800810 anita@ibti.lv
English: 29 May 2019 EMA/285298/2019
Estonian: 29. mai 2019 EMA/285298/2019
English: The review of fenspiride was initiated on 14 February 2019 at the request of France, under Article 107i of Directive 2001/83/EC.
Estonian: Fenspiriidi sisaldavate ravimite läbivaatamine algatati 14. veebruaril 2019 Prantsusmaa taotlusel direktiivi 2001/83/EÜ artikli 107i alusel.
English: In the EU, fenspiride medicines have been authorised via national procedures in Bulgaria, France, Latvia, Lithuania, Poland, Portugal and Romania and are available under various brand names (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал and Сиресп).
Estonian: ELis on fenspiriidi sisaldavad ravimid saanud müügiloa riiklike menetluste kaudu Bulgaarias, Leedus, Lätis, Poolas, Portugalis, Prantsusmaal ja Rumeenias ning neid turustatakse mitme erineva kaubandusliku nimetuse all (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал ja Сиресп).
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures.
Estonian: Komisjon vastutab riiklike menetluste kaudu müügiloa saanud ravimite ühtlustatud ohutusstandardite tagamise eest.
English: • If you have any concerns about your medicine, discuss them with your doctor or pharmacist.
Estonian: • Kui teil on küsimusi oma ravimi kohta, pöörduge oma arsti või apteekri poole.
English: • You should stop taking these medicines and contact your doctor or pharmacist for advice on alternative treatments, if needed.
Estonian: • Te peate lõpetama nimetatud ravimite kasutamise ja võtma vajaduse korral ühendust oma arsti või apteekriga, et saada nõu alternatiivsete ravivõimaluste kohta.
English: Withdrawal of marketing authorisations for fenspiride medicines EMA/285298/2019
Estonian: Fenspiriidi sisaldavate ravimite müügilubade tühistamine EMA/285298/2019
English: The PRAC recommendation will now be implemented by EU Member States, Iceland, Lichtenstein and Norway.
Estonian: Ravimiohutuse riskihindamise komitee soovitust hakkavad nüüd rakendama ELi liikmesriigid, Island, Liechtenstein ja Norra.
English: • Return unused medicines to your pharmacy for appropriate disposal.
Estonian: • Tagastage kasutamata ravimid nõuetekohaseks hävitamiseks apteeki.
English: • Given the authorised uses of fenspiride for symptomatic treatment only and the seriousness of the safety concern, the benefit-risk balance of these medicines is negative for the currently authorised uses.
Estonian: • Võttes arvesse asjaolu, et fenspiriid on heaks kiidetud üksnes sümptomaatiliseks raviks, ja ohutusprobleemi tõsidust, on nende ravimite kasulikkuse ja riski suhe praegu heakskiidetud kasutusnäidustustel negatiivne.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Estonian: Läbivaatamise viis esmalt läbi inimravimite ohutusprobleemide hindamise eest vastutav ravimiohutuse riskihindamise komitee, kes võttis vastu terve rea soovitusi.
English: • Cough medicines containing fenspiride will no longer be marketed in the EU because of data showing a risk of sudden, serious heart rhythm problems.
Estonian: • Fenspiriidi sisaldavaid köharavimeid ei turustata enam ELis andmete tõttu, mis näitavad äkiliste ja tõsiste südamerütmiprobleemide ohtu.
English: Therefore, the PRAC considered that these medicines should no longer be marketed.
Estonian: Seetõttu oli ravimiohutuse riskihindamise komitee arvamusel, et neid ravimeid ei tohi enam turustada.
English: On 16 May 2019, EMA's safety committee (PRAC) recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU.
Estonian: 16. mail 2019 soovitas Euroopa Ravimiameti ravimiohutuse riskihindamise komitee tühistada fenspiriidi sisaldavate ravimite müügiload, et neid ravimeid ei saaks ELis enam turustada.
English: Heart rhythm problems can be serious and occur suddenly, and it is not feasible to identify in advance the patients who may be at risk of these problems with fenspiride.
Estonian: Südamerütmiprobleemid võivad olla rasked ja tekkida äkki ning enne ravi alustamist ei ole võimalik kindlaks teha patsiente, keda need probleemid võivad fenspiriidi kasutamise ajal ohustada.
English: You can check the ingredients of your medicine in the package leaflet accompanying the medicine.
Estonian: Teil on võimalik kontrollida ravimi koostisaineid ravimiga kaasasolevast pakendi infolehest.
English: This included cases of QT prolongation and torsades de pointes (abnormalities of the heart's electrical activity that may lead to heart rhythm disturbances) in patients using these medicines, results of laboratory studies, data from published literature and stakeholder input.
Estonian: Need hõlmasid QT intervalli pikenemise ja torsades de pointes'i (südame elektrilise aktiivsuse häired, mis võivad põhjustada südame rütmihäireid) juhte neid ravimeid kasutanud patsientidel, laboriuuringute tulemusi, kirjanduses avaldatud andmeid ning sidusrühmadelt saadud teavet.
English: • Patients are only at risk of heart rhythm problems with fenspiride while they are taking these medicines.
Estonian: • Patsiente ohustavad fenspiriidist tingitud südamerütmiprobleemid üksnes nimetatud ravimite võtmise ajal.
English: Withdrawal of marketing authorisations for fenspiride medicines
Estonian: Fenspiriidi sisaldavate ravimite müügilubade tühistamine
English: This follows a review that confirmed that these cough medicines could cause heart rhythm problems.
Estonian: See otsus järgnes andmete läbivaatamisele, mis kinnitas, et need köharavimid võivad põhjustada südamerütmiprobleeme.
English: At that time, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended that supply of fenspiride medicines be suspended as a precautionary measure while the review was ongoing.
Estonian: Sel ajal soovitas ravimiohutuse riskihindamise komitee, et fenspiriidi sisaldavate ravimite tarned peatataks ettevaatusabinõuna seni, kuni läbivaatamine on pooleli.
English: • Healthcare professionals should no longer prescribe fenspiride medicines and should advise their patients to stop taking fenspiride medicines.
Estonian: • Tervishoiutöötajad ei tohi fenspiriidi sisaldavaid ravimeid enam välja kirjutada ja nad peavad soovitama, et patsiendid lõpetaksid fenspiriidi sisaldavate ravimite võtmise.
English: Fenspiride medicines are available as syrup or tablets and used in adults and children from the age of 2 years to relieve cough resulting from lung diseases.
Estonian: Fenspiriidi sisaldavaid ravimeid turustatakse siirupina või tablettidena ning neid määratakse täiskasvanutele ja vähemalt 2-aastastele lastele kopsuhaigustest põhjustatud köha leevendamiseks.
English: The PRAC recommendation was sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted it by consensus on 29 May 2019.
Estonian: Ravimiohutuse riskihindamise komitee soovitused edastati inimravimite vastastikuse tunnustamise menetluse ja detsentraliseeritud menetluste koordineerimisrühmale, kes kiitis need üksmeelselt heaks 29. mail 2019.
English: • The withdrawal of the marketing authorisations of fenspiride medicines is based on case reports and nonclinical studies (including hERG channel binding) that showed that fenspiride can cause QT prolongation and has proarrhythmia potential (could cause triggering or worsening of arrhythmia) with the associated risk of torsades de pointes.
Estonian: • Fenspiriidi sisaldavate ravimite müügilubade tühistamine põhineb teatatud juhtudel ja mittekliiniliste uuringute andmetel (sh hERG kanalitega seondumine), mis näitasid, et fenspiriid võib põhjustada QT intervalli pikenemist ja et sel on proarütmiline potentsiaal (võib vallandada arütmia või seda süvendada) koos seonduva torsades de pointes'i ohuga.
English: 1 Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human
Estonian: 1 Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühm
English: The PRAC considered all the available evidence in its review.
Estonian: Ravimiohutuse riskihindamise komitee arutas läbivaatamise käigus kõiki kättesaadavaid tõendeid.
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühm on üksus, mis esindab nii ELi liikmesriike kui ka Islandit, Liechtensteini ja Norrat.
English: In contrast, fenspiride medicines are used to treat non-serious cough.
Estonian: Fenspiriidi sisaldavaid ravimeid kasutatakse samas kergemat sorti köha raviks.
English: The PRAC recommendation was adopted by the CMDh1 by consensus and will be implemented directly at national level.
Estonian: Ravimiohutuse riskihindamise komitee soovituse kiitis üksmeelselt heaks inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühm1 ning see rakendatakse riiklikul tasandil.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Estonian: I lisa Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, müügiloa hoidjate loetelu liikmesriikides
English: 00-113 Warsaw Poland
Estonian: 00-113 Warsaw Poola
English: Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal
Estonian: Empreendimento Lagoas Park, Edifķcio 7 - 3ŗ Piso 2740-244 Porto Salvo Portugal
English: Sanofi-Aventis - Produtos Farmacêuticos, Lda.
Estonian: Sanofi-Aventis - Produtos Farmacźuticos, Lda.
English: 55218 Ingelheim Germany
Estonian: 55218 Ingelheim Saksamaa
English: 821 02 Bratislava
Estonian: 821 02 Bratislava Slovakkia
English: MEDA PHARMA S.p.A., Viale Brenta 18, 20139 Milano Italy
Estonian: MEDA PHARMA S.p.A., Viale Brenta 18, 20139 Milano Itaalia
English: Meda Pharma - Produtos Farmacêuticos, S.A.
Estonian: Meda Pharma - Produtos Farmacźuticos, S.A.
English: Trancopal Dolo capsule
Estonian: Trancopal Dolo kapsel
English: 164,5 mg / 3 ml solution for injection intramuscular use
Estonian: 164,5 mg / 3 ml süstelahus intramuskulaarne
English: 61352 Bad Homburg v. d. H. Germany
Estonian: 61352 Bad Homburg v. d. H. Saksamaa
English: Dr. Kade Pharmazeutische Fabrik GmbH
Estonian: Kade Pharmazeutische Fabrik GmbH
English: Dolokadin einmal täglich prolonged release tablet
Estonian: Dolokadin einmal täglich toimeainet prolongeeritult vabastav tablett
English: Trancopal Dolo Suppositorien 150 mg suppository rectal use
Estonian: Trancopal Dolo Suppositorien 150 mg rektaalsuposiit rektaalne
English: Slovak Republic TEVA Pharmaceuticals Slovakia, s.r.o.
Estonian: TEVA Pharmaceuticals Slovakia, s.r.o.
English: Flupirtinmaleat Winthrop 400 mg Retardtabletten prolonged release tablet
Estonian: Flupirtinmaleat Winthrop 400 mg Retardtabletten toimeainet prolongeeritult vabastav tablett
English: Katadolon Kinderzäpfchen suppository rectal use
Estonian: Katadolon Kinderzäpfchen rektaalsuposiit rektaalne
English: Hormosan Pharma GmbH Wilhelmshöher Str. 106 60389 Frankfurt Germany
Estonian: Hormosan Pharma GmbH Wilhelmshöher Str. 106 60389 Frankfurt Saksamaa
English: Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany
Estonian: Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Saksamaa
English: 130 U kabelovn Prague 10237
Estonian: 130 U kabelovn Prague 10237 Tšehhi
English: Kabelovny 130 102 37 Praha 10 Czech Republic
Estonian: U Kabelovny 130 102 37 Praha 10 Tšehhi
English: U Kabelovny 130, Dolní Měcholupy
Estonian: U Kabelovny 130, Dolnķ Mģcholupy
English: AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Estonian: AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Saksamaa
English: Flupirtinmaleat Midas 100 mg Hartkapseln ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Estonian: Flupirtinmaleat Midas 100 mg Hartkapseln ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Saksamaa
English: Flupirtinmaleat-ratiopharm 100 mg Hartkapsel ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Estonian: Flupirtinmaleat-ratiopharm 100 mg Hartkapsel ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Saksamaa
English: 102 37, Praga 10, Czech Republic
Estonian: 102 37, Praga 10, Tehhi
English: Trancolong prolonged release tablet
Estonian: Trancolong toimeainet prolongeeritult vabastav tablett
English: FLUPIZEN 100 mg capsule
Estonian: FLUPIZEN 100 mg kapsel
English: Katadolon Zäpfchen suppository rectal use
Estonian: Katadolon Zäpfchen rektaalsuposiit rektaalne
English: Katadolon S long prolonged release tablet
Estonian: Katadolon S long toimeainet prolongeeritult vabastav tablett
English: MEDA Pharma GmbH & Co. KG Benzstr.
Estonian: MEDA Pharma GmbH & Co.
English: Katadolon retard prolonged release tablet
Estonian: Katadolon retard toimeainet prolongeeritult vabastav tablett
English: Midas Pharma GmbH Rheinstrasse, 49 55218 Ingelheim Germany
Estonian: Midas Pharma GmbH Rheinstrasse, 49
English: U
Estonian: Dr.
English: Further information can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Lisateave on aadressil ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The inflammation may cause discomfort, pain, blurring of vision, and may lead to partial or complete blindness.
Estonian: See põletik võib põhjustada ebamugavustunnet, valu ja nägemise ähmastumist ning edaspidi osalist või täielikku nägemiskaotust.
English: The data from the clinical study was not sufficient to demonstrate the benefit of Opsiria, particularly in European patients.
Estonian: Kliiniliste uuringute andmed ei võimaldanud piisavalt tõendada Opsiria kasulikkust, eelkõige Euroopa patsientidele.
English: The main measure of effectiveness was the number of patients in whom inflammation resolved after 5 months of treatment.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel oli põletik pärast 5-kuulist ravi paranenud.
English: In this study, Opsiria was not compared with any other treatment.
Estonian: Uuringus ei võrreldud Opsiriat ühegi muu ravimeetodiga.
English: Withdrawal of the marketing authorisation application for Opsiria (sirolimus) EMA/358774/2016
Estonian: Müügiloa taotluse tagasivõtmise teave: Opsiria (siroliimus) EMA/358774/2016
English: Withdrawal of the marketing authorisation application for Opsiria (sirolimus)
Estonian: Müügiloa taotluse tagasivõtmise teave: Opsiria (siroliimus)
English: What is Opsiria?
Estonian: Mis on Opsiria?
English: 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.
Estonian: Santen Oy teatas 20. mail 2016 ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Opsiria müügiloa taotlus.
English: Opsiria was investigated in one main study in 347 patients with non-infectious uveitis.
Estonian: Opsiriat uuriti ühes põhiuuringus (347 patsienti, kellel oli mittenakkuslik uveiit).
English: Opsiria is a medicine that contains the active substance sirolimus.
Estonian: Opsiria on ravim, mis sisaldab toimeainena siroliimust.
English: In addition, the Committee questioned the proposed method of sterilisation of the medicine.
Estonian: Komitee ei olnud ka veendunud ravimi kavandatud steriliseerimisviisi efektiivsuses.
English: The application was withdrawn after that the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Estonian: Taotlus võeti tagasi pärast seda, kui inimravimite komitee oli hinnanud ettevõtte esialgselt esitatud dokumente ja koostanud ettevõttele vastamiseks küsimused.
English: Sirolimus has been used for several years to prevent organ rejection following a transplant.
Estonian: Siroliimust on aastaid kasutatud siiratud elundi äratõukereaktsiooni ennetamiseks.
English: 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.
Estonian: Ettevõtte tunnistas kirjas, milles ta teatab Euroopa Ravimiametile oma taotluse tagasivõtmisest, vajadust esitada praegu toimuvast uuringust täiendavaid andmeid Opsiria kasulikkuse kohta.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016 EMA/358774/2016 EMEA/H/C/003978
Estonian: EMA/358774/2016 EMEA/H/C/003978
English: 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.
Estonian: Et mTOR osaleb T-lümfotsüütide (põletiku tekkimises osalevad vere valgelibled) aktiveerimisel ja proliferatsioonis, vähendab siroliimus eeldatavalt põletikku kroonilise mittenakkusliku uveiidi korral.
English: How is Opsiria expected to work?
Estonian: Milline on Opsiria eeldatav toime?
English: 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.
Estonian: 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.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Opsiria did not outweigh its risks.
Estonian: Seetõttu oli inimravimite komitee müügiloa taotluse tagasivõtmise ajal arvamusel, et ravimi Opsiria kasulikkus ei ole suurem kui sellega kaasnevad riskid.
English: 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.
Estonian: Opsiriat kavatseti kasutada mittenakkusliku uveiidi (uuvea ehk silmamunaseina kesmise kesta põletik) raviks täiskasvanutel.
English: 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.
Estonian: Opsiria nimetati 30. augustil 2011 kroonilise mittenakkusliku uveiidi harvikravimiks (ravim, mida kasutatakse harvaesinevate haiguste korral).
English: What was Opsiria expected to be used for?
Estonian: Milleks kavatseti Opsiriat kasutada?
English: The active substance in Opsiria, sirolimus, is expected to work by blocking an enzyme called ‘mammalian target of rapamycin' (mTOR).
Estonian: Opsirias toimeainena sisalduva siroliimuse eeldatav toime seisneb ensüümi mTORi (imetajate rapamütsiinisihtvalk) blokeerimises.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Opsiria.
Estonian: Taotluse tagasivõtmine ei mõjuta praegu Opsiria kliinilistes uuringutes osalevaid patsiente.
English: It was to be available as a solution to be injected into the eye.
Estonian: Ravimit kavatseti turustada silma süstitava lahusena.
English: London, 25 October 2007 EMEA/CHMP/350251/2007
Estonian: London, 25. oktoober 2007 EMEA/CHMP/350251/2007
English: 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.
Estonian: Viiteliikmesriik oli Saksamaa ning asjaomased liikmesriigid olid Austria, Taani, Hispaania, Soome, Prantsusmaa, Itaalia, Luksemburg, Norra, Poola, Portugal, Rootsi ja Ühendkuningriik.
English: The Mutual Recognition Procedure started on 24 October 2006.
Estonian: Vastastikuse tunnustamise menetlus algas 24. oktoobril 2006.
English: A positive opinion was adopted by majority on 19 July 2007.
Estonian: 19. juulil 2007 võeti häälteenamusega vastu positiivne arvamus.
English: 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.
Estonian: Need liikmesriigid ei suutnud jõuda viiteliikmesriigi antud müügiloa vastastikuse tunnustamise osas kokkuleppele.
English: The Marketing Authorisation Holder provided written explanations on 25 May 2007.
Estonian: Müügiloa hoidja esitas kirjalikud selgitused 25. mail 2007.
English: The Rapporteur was Dr Karl Broich and Co-Rapporteur(s) was Dr Pierre Demolis.
Estonian: Ettekandja oli dr Karl Broich ja kaasettekandja dr Pierre Demolis.
English: The final opinion was converted into a Decision by the European Commission on 24 October 2007.
Estonian: Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 24. oktoobril 2007.
English: Germany referred the reasons for disagreement to the EMEA on 29 March 2007.
Estonian: Saksamaa esitas lahkarvamuse põhjused EMEAle 29. märtsil 2007.
English: The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Estonian: Vahekohtumenetlus algas 26. aprillil 2007 küsimuste loetelu kinnitamisega.
English: 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.
Estonian: Seotud toodete nimetuste loetelu on esitatud I lisas, teaduslikud järeldused II lisas ning ravimi omaduste kokkuvõte III lisas.