FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 92/22 micrograms
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED MITMIKPAKENDI VÄLISETIKETT (BLUE BOX'IGA - AINULT MITMIKPAKEND) 92/22 mikrogrammi
English: What Relvar Ellipta contains - The active substances are fluticasone furoate and vilanterol.
Estonian: Toimeained on flutikasoonfuroaat ja vilanterool.
English: Teл.
Estonian: I LISA
English: Arthralgia Back pain Fractures** Muscle spasms
Estonian: Liigesvalu Seljavalu Luumurrud** Lihaskrambid
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol
Estonian: Relvar Ellipta 92 mikrogrammi/22 mikrogrammi annustatud inhalatsioonipulber flutikasoonfuroaat/vilanterool
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate /vilanterol
Estonian: Relvar Ellipta 184 mikrogrammi/22 mikrogrammi annustatud inhalatsioonipulber flutikasoonfuroaat/vilanterool
English: Common
Estonian: KOK
English: • irregular heartbeat
Estonian: • ebakorrapärane südametegevus
English: NAME OF THE MARKETING AUTHORISATION HOLDER GSK Logo
Estonian: MÜÜGILOA HOIDJA NIMI
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 92 micrograms/22 micrograms inhalation powder, pre-dispensed
Estonian: Relvar Ellipta 92 mikrogrammi/22 mikrogrammi annustatud inhalatsioonipulber
English: Posology
Estonian: Häälekähedus
English: NAME OF THE MEDICINAL PRODUCT Relvar Ellipta 184 micrograms/22 micrograms inhalation powder, pre-dispensed
Estonian: Relvar Ellipta 184 mikrogrammi/22 mikrogrammi annustatud inhalatsioonipulber
English: If you are breast-feeding, check with your doctor before you use Relvar Ellipta.
Estonian: Kui te imetate, pidage enne Relvar Ellipta kasutamist nõu oma arstiga.
English: Uncommon Rare
Estonian: • ähmane nägemine
English: FF/VI 92/22 Once Daily vs placebo Once Daily Change from Baseline in Trough FEV1 Last Observation Carried Forward (LOCF) Treatment difference P value (95% CI)
Estonian: Minimaalse FEV1 viimase edasikantud väärtuse (LOCF) muutus ravieelsest väärtusest Ravierinevus p-väärtus (95% CI)
English: Dysphonia
Estonian: Neerukahjustus
English: EU/1/02/238/001 Zavesca
Estonian: EU/1/02/238/001
English: Blister (alu/Aclar)
Estonian: Blisterpakend (alu/Aclar) 84 kapslit
English: Oral use
Estonian: Peroraalne
English: These member states were not able to reach an agreement.
Estonian: Nimetatud liikmesriigid ei jõudnud selles küsimuses kokkuleppele.
English: Ref. EMEA/CHMP/194784/2009 EMEA/H/A-29/990
Estonian: viide EMEA/CHMP/194615/2009 EMEA/H/A-29/990
English: The European Commission issued a decision on 12 March 2009.
Estonian: Euroopa Komisjon võttis oma otsuse vastu 12. märtsil 2009.
English: London, 17 March 2009 Doc.
Estonian: London, 17. märts 2009 Dok.
English: Dr Gonzalo Calvo Rojas (Spain)
Estonian: Dr Gonzalo Calvo Rojas (Hispaania)
English: Prof Michal Pirożynski (Poland)
Estonian: Prof Michal Pirożynski (Poola)
English: The review was carried out under an ‘Article 29' referral1.
Estonian: Läbivaatamine toimus vastavalt artikli 29 kohasele esildismenetlusele1.
English: What is Sabumalin?
Estonian: Mis on Sabumalin?
English: 19 March 2008
Estonian: 19. märts 2008
English: This is a procedure when one Member State (the ‘reference Member State', in this instance Sweden) assesses a medicine with a view of 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 Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom).
Estonian: Tegemist on menetlusega, mille käigus üks liikmesriik (viiteliikmesriik, käesoleval juhul Rootsi) hindab ravimit eesmärgiga anda sellele müügiluba, mis kehtib nii selles riigis kui ka teistes liikmesriikides (asjaomastes liikmesriikides, käesoleval juhul Belgias, Eestis, Hispaanias, Itaalias, Kreekas, Leedus, Lätis, Madalmaades, Norras, Poolas, Portugalis, Saksamaal, Sloveenias, Soomes, Taanis, Ungaris ja Ühendkuningriigis).
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sabumalin outweigh its risks, and that therefore the marketing authorisation for Sabumalin should be granted in all concerned member states.
Estonian: Praeguseks kättesaadavate andmete hindamise ning komitees toimunud teadusliku arutelu põhjal jõudis inimravimite komitee järeldusele, et Sabumalinist saadav kasu kaalub üles sellega kaasnevad riskid ning seetõttu tuleb kõikides asjaomastes liikmesriikides anda ravimile müügiluba.
English: It can also be used to prevent asthma symptoms caused by exercise or other triggering factors, such as house dust, pollen, cats, dogs and cigarette smoke.
Estonian: Seda võib kasutada ka füüsilise koormuse või muude vallandavate tegurite, näiteks kodutolmu, õietolmu, kasside, koerte või sigaretisuitsu mõjul ilmnevate astmasümptomite ennetamiseks.
English: The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sabumalin.
Estonian: Euroopa Ravimiamet (EMEA) on pärast Euroopa Liidu liikmesriikide vahelise lahkarvamuse ilmnemist lõpetanud esildise menetlemise, milles käsitletakse ravimile Sabumalin müügiloa andmist.
English: Hexal AG submitted Sabumalin to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
Estonian: Hexal AG esitas Rootsi ravimiametile 5. detsembril 2006 taotluse Sabumalini käsitleva detsentraliseeritud menetluse rakendamiseks.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Sabumalin outweigh its risks, and that the marketing authorisation can be granted in Sweden as well as in the following Member States of the European Union: Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom.
Estonian: Ameti inimravimite komitee on jõudnud otsusele, et Sabumalinist saadav kasu kaalub üles sellega kaasnevad riskid ning ravimile võib anda müügiloa Rootsis ja ka järgmistes Euroopa Liidu liikmesriikides: Belgias, Eestis, Hispaanias, Itaalias, Kreekas, Leedus, Lätis, Madalmaades, Norras, Poolas, Portugalis, Saksamaal, Sloveenias, Soomes, Taanis, Ungaris ja Ühendkuningriigis.
English: This makes the airways widen, allowing the air to flow more freely.
Estonian: See laiendab hingamisteid ja soodustab õhu vaba liikumist.
English: Sabumalin is used to relieve symptoms, and its use should not delay the use of inhaled steroids.
Estonian: Sabumalini kasutatakse sümptomite leevendamiseks ning selle kasutamisel ei tohiks inhaleeritavate steroidide manustamisega viivitada.
English: Sabumalin is a ‘generic medicine'.
Estonian: Sabumalin on geneeriline ravim.
English: Concerns were also raised regarding how to store the inhaler and the effect of the orientation of the inhaler on the delivery of the medicine.
Estonian: Kahtlused puudutasid ka seda, kuidas inhalaatorit säilitada ja kuidas inhalaatori asend mõjutab ravimi manustamist.
English: This means that Sabumalin is similar to a ‘reference medicine' already authorised in the European Union (EU) called Sultanol inhaler.
Estonian: See tähendab, et Sabumalin sarnaneb Euroopa Liidus juba müügiloa saanud inhaleeritava võrdlusravimiga Sultanol.
English: On 4 March 2008, the Swedish medicines regulatory agency referred the matter to the CHMP.
Estonian: Rootsi ravimiamet tegi 4. märtsil 2008 inimravimite komiteele asjakohase esildise.
English: The grounds for the referral were concerns regarding that there was not enough data showing that Sabumalin is equivalent to the reference medicine.
Estonian: Esildise aluseks olid kahtlused seoses sellega, et Sabumalini võrdväärsuse kohta võrdlusravimiga puuduvad piisavad andmed.
English: Why was Sabumalin reviewed?
Estonian: Mis oli Sabumalini läbivaatamise põhjus?
English: Salbutamol is a beta2-adrenergic receptor agonist.
Estonian: Salbutamool on β2-adrenergiliste retseptorite agonist.
English: Sabumalin is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD).
Estonian: Sabumalini kasutatakse astmast ja kroonilisest obstruktiivsest kopsuhaigusest tingitud hingamisraskuste raviks.
English: Sabumalin is a medicine in a pressurised inhaler that contains salbutamol as active substance.
Estonian: Sabumalin on survestatud inhalaatoris turustatav ravim, mis sisaldab toimeainena salbutamooli.
English: When given by inhalation as in Sabumalin, salbutamol directly activates the beta2-receptors in the respiratory system.
Estonian: Kui salbutamooli manustatakse inhaleerimise teel, nagu Sabumalini puhul, aktiveerib see vahetult hingamiselundkonna β2-retseptorid.
English: This means that salbutamol activates the beta2receptors in the body.
Estonian: See tähendab, et salbutamool aktiveerib organismis β2-retseptorid.
English: Questions and answers on the referral for Sabumalin salbutamol, metered dose aerosol inhaler, 100 μg/dose
Estonian: Teave järgmise ravimi esildise kohta: Sabumalin, mis sisaldab annuse kohta 100 μg salbutamooli ja mida manustatakse aerosoolina dosaatorinhalaatori abil
English: Company responses provided on: 30 May 2008, 20 October 2008 Opinion date:
Estonian: 30. mai 2008, 20. oktoober 2008
English: (Invented) name
Estonian: (Väljamõeldud ) nimetus
English: EMA Number
Estonian: EMA protseduuri number
English: Content (concentration)
Estonian: Pakendi sisu (kontsentratsio on)
English: 4 pre-filled syringes
Estonian: 4 süstlit
English: Strength Pharmaceutical Form Route of Administration
Estonian: Tugevus Ravimvorm Manustamisviis Sisepakendi iseloomustus
English: MA (EU) number (Invented) Name
Estonian: Müügiloa (EU) number
English: Content (concent ration)
Estonian: Pakendi sisu (kontsentratsioon)
English: EMA completes review following disagreement among EU Member States
Estonian: EMA vaatas ravimiteabe läbi pärast ELi liikmesriikide erimeelsust
English: The Agency also considered that, although the effectiveness of diclofenac and other NSAIDs applied to the skin is somewhat modest, these medicines have been authorised and used for decades and their safety is not in question.
Estonian: Samuti oli EMA arvamusel, et kuigi diklofenaki ja muude nahale kantavate NSAID-ravimite efektiivsus on üsna tagasihoidlik, on need ravimid heaks kiidetud ja kasutusel olnud aastakümneid ning nende ohutusprobleeme ei ole.
English: The Agency concluded that the benefits of the medicine outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Estonian: EMA järeldas, et ravimi kasulikkus on suurem kui sellega kaasnevad riskid ja et Ühendkuningriigis antud müügiluba saab tunnustada teistes Euroopa Liidu liikmesriikides, kus ettevõte on taotlenud müügiluba.
English: The spray gel is applied on the skin of affected areas to relieve pain and swelling due to trauma in small and medium joints and surrounding tissues.
Estonian: Geelsprei kantakse haaratud nahapiirkondadele traumast põhjustatud valu ja turse leevendamiseks väikestes ja keskmise suurusega liigestes ning liigeseid ümbritsevates kudedes.
English: The grounds for the referral were concerns raised by Germany and Spain that the data provided by the company were not sufficient to show that the product was effective at treating joint pain and swelling.
Estonian: Esildise aluseks olid Hispaania ja Saksamaa väljendatud ettevaatlikkus, et ettevõtte esitatud andmed ei olnud piisavad tõendamaks ravimi efektiivsust liigesevalu ja -turse raviks.
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 4 April 2018.
Estonian: Liikmesriigid ei jõudnud üksmeelele ja Ühendkuningriigi ravimiamet tegi 4. aprillil 2018 EMA-le vahekohtumenetluse alustamise esildise.
English: The review of Diclofenac Sodium Spray Gel 4% was initiated at the request of the United Kingdom under Article 29(4) of Directive 2001/83/EC.
Estonian: Ravimi Diclofenac Sodium Spray Gel 4% ravimiteabe läbivaatamine algas Ühendkuningriigi taotlusel vastavalt direktiivi 2001/83/EÜ artikli 29 lõikele 4.
English: MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK (the ‘reference Member State') in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain (the ‘concerned Member States').
Estonian: MIKA Pharma GmbH taotles Ühendkuningriigis (viiteliikmesriik) 2001. aastal ning hiljem Austrias, Eestis, Iirimaal, Leedus, Lätis, Sloveenias ja Ungaris ravimile Diclofenac Sodium Spray Gel 4% (naatriumdiklofenaki 4% spreigeel) antud müügiloa tunnustamist ka Hispaanias, Itaalias ja Saksamaal (asjaomased liikmesriigid).
English: The Agency therefore concluded that the benefits of the medicine outweigh its risks, and therefore the marketing authorisation should be granted in the concerned Member States.
Estonian: Seetõttu järeldas EMA, et ravimi kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda müügiloa asjaomastes liikmesriikides.
English: What is Diclofenac Sodium Spray Gel 4%?
Estonian: Mis on Diclofenac Sodium Spray Gel 4%?
English: On 15 November 2018, the European Medicines Agency completed a review of Diclofenac Sodium Spray Gel 4% following a disagreement among EU Member States regarding its authorisation.
Estonian: 15. novembril 2018 lõpetas Euroopa Ravimiamet (EMA) ravimi Diclofenac Sodium Spray Gel 4% ravimiteabe läbivaatamise, mille oli põhjustanud Euroopa Liidu liikmesriikide erimeelsus seoses müügiloa andmisega.
English: Diclofenac Sodium Spray Gel 4% contains the active substance diclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Estonian: Diclofenac Sodium Spray Gel 4% sisaldab toimeainena diklofenakki, mis kuulub mittesteroidsete põletikuvastaste ravimite (NSAID) rühma.
English: Since Diclofenac Sodium Spray Gel 4% is absorbed in a similar way to other diclofenac medicines applied to the skin and the supporting study demonstrated an effect similar to that of other diclofenac medicines in the published literature, the Agency considered that it was acceptable to use published data on the effectiveness and safety of other diclofenac medicines to support the use of Diclofenac Sodium Spray Gel 4%.
Estonian: Et Diclofenac Sodium Spray Gel 4% imendub muude nahale kantavate diklofenakravimitega sarnaselt ja toetavas uuringus tõendati, et ravimil on sarnane toime nagu avaldatud kirjandusandmetes kirjeldatud muudel diklofenakravimitel, oli EMA arvamusel, et muude diklofenakravimite kohta avaldatud efektiivsus- ja ohutusandmete kasutamine ravimi Diclofenac Sodium Spray Gel 4% kasutamise toetuseks on vastuvõetav.
English: Overall, the totality of the data provided by the company was considered sufficient to demonstrate that Diclofenac Sodium Spray Gel 4% is effective at treating joint swelling and pain due to trauma.
Estonian: Üldkokkuvõttes peeti ettevõtte esitatud andmekogumit piisavaks, et tõendada ravimi Diclofenac Sodium Spray Gel 4% efektiivsus traumast põhjustatud liigeseturse ja -valu raviks.
English: The company also provided the results of a study indicating that Diclofenac Sodium Spray Gel 4% is effective at reducing joint swelling and relieving pain.
Estonian: Samuti esitas ettevõte uuringutulemused, mille kohaselt on Diclofenac Sodium Spray Gel 4% liigeseturse ja -valu vähendamisel efektiivne.
English: The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Diclofenac Sodium Spray Gel 4% on 18/01/2019.
Estonian: Euroopa Komisjon tegi ravimi Diclofenac Sodium Spray Gel 4% müügiloa kohta 18. jaanuaril 2019 õiguslikult siduva otsuse, mis kehtib kogu Euroopa Liidus.
English: The Agency considered that the data provided by the company show that, when applied to the skin, Diclofenac Sodium Spray Gel 4% produces similar levels of diclofenac in the body to another diclofenac
Estonian: EMA järeldas, et ettevõtte esitatud andmed tõendavad, et pärast ravimi Diclofenac Sodium Spray Gel 4% nahale kandmist on diklofenaki sisaldus organismis sarnane muu sama näidustuse jaoks juba
English: In addition, the use of data from the published literature obtained with other diclofenac medicines to demonstrate the benefits of Diclofenac Sodium Spray Gel 4% needed to be further justified.
Estonian: Samuti peeti vajalikuks lisapõhjendusi, miks ravimi Diclofenac Sodium Spray Gel 4% kasulikkuse tõendamiseks kasutati muude diklofenakravimite kohta avaldatud kirjandusandmeid.
English: Classification as an exceptional case
Estonian: Klassifitseerimine eriliseks juhuks
English: Plaça de la Pau s/n 08940 Cornellà de Llobregat (Barcelona) Spain
Estonian: Plaça de la Pau s/n 08940 Cornellà de Llobregat (Barcelona) Hispaania
English: • the data submitted in the initial authorisation application product file was considered to sufficiently support the marketing authorisation application,
Estonian: • esialgses müügiloa taotluses esitatud andmeid peeti piisavaks, et toetada müügiloa andmise taotlust,
English: Public health benefit and improved compliance
Estonian: Kasu rahvatervisele ja paranenud ravijärgimus
English: Data submitted by the Applicant
Estonian: Taotleja esitatud andmed
English: In conclusion, the CHMP considered the Applicant to have submitted all relevant and necessary data to support a full dossier application under Article 8(3).
Estonian: Kokkuvõttes oli inimravimite komitee seisukohal, et taotleja on esitanud kõik asjassepuutuvad ja vajalikud andmed, et toetada kogu toimikut, mis kaasneb artikli 8 lõike 3 alusel esitatud taotlusega.
English: The CHMP considered this to be a clear public health benefit.
Estonian: Inimravimite komitee luges seda ilmseks kasuks rahvatervisele.
English: Bisphosphonates maintain their activity for extended periods and as a result, do not need continuous dosing.
Estonian: Bisfosfonaadid säilitavad oma aktiivsuse pikkade ajavahemike jooksul, seetõttu ei ole vaja neid pidevalt annustada.
English: Overall summary of the scientific evaluation of Fortipan Combi D and associated names (see Annex I)
Estonian: Fortipan Combi D ja sarnase nimetusega ravimite (vt I lisa) teadusliku hindamise üldkokkuvõte
English: The CHMP noted the data submitted in the initial application.
Estonian: Inimravimite komitee võttis arvesse esialgses taotluses esitatud andmeid.
English: The CHMP was of the opinion that the application is approvable.
Estonian: Inimravimite komitee oli seisukohal, et taotlusele võib anda heakskiidu.
English: In conclusion, the CHMP considered all the objections raised by the objecting concerned member to be adequately addressed and that they should not prevent the authorisation of the product.
Estonian: Kokkuvõttes leidis inimravimite komitee, et kõik asjaomase liikme tõstatatud vastuväited on saanud küllaldase vastuse ja need ei tohiks takistada ravimile müügiloa andmist.
English: A concerned member state (CMS) raised Potential Serious Risks to Public Health pertaining to the lack of evidence of efficacy; in particular regarding the claims of improved benefit compared to the individual products and improved compliance compared to standard treatment.
Estonian: Asjaomane liikmesriik tõstatas küsimuse võimalikust tõsisest ohust rahvatervisele seoses efektiivsuse kohta käivate andmete puudumisega, eriti väidete kohta, mis puudutavad suurenenud kasu võrreldes üksikpreparaatidega ja paranenud ravijärgimust võrreldes tavapärase raviga.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Estonian: Kehtivad ravimi omaduste kokkuvõte, märgistus ja pakendi infoleht on koordineerimisrühma menetluse tulemusena saavutatud lõplikud versioonid.
English: Concomitant administration of calcium significantly impairs the absorption of risedronate and must therefore be avoided.
Estonian: Samaaegne kaltsiumi manustamine pärsib suurel määral risedronaadi imendumist ja seetõttu tuleb sellest hoiduda.
English: Old Belfast Road, Millbrook, Larne, County Antrim, BT40 2SH United Kingdom
Estonian: Old Belfast Road, Millbrook, Larne, County Antrim, BT40 2SH Ühendkuningriik
English: Module 2 contained the Quality Overall Summary together with the Clinical and Non Clinical overview and summary documents.
Estonian: 2. moodul sisaldas kvaliteedi üldkokkuvõtet ning kliinilist ja mittekliinilist ülevaadet ning kokkuvõtvaid dokumente.
English: The objecting CMS considered the benefit-risk balance of Fortipan Combi D to be unfavourable and presented specific points for objection to the application.
Estonian: Vaidlustuse esitanud asjaomane liikmesriik leidis, et Fortipan Combi D kasulikkuse ja riski suhe on ebasoodne ning tõi välja kindlad punktid, mille põhjal taotlus tagasi lükata.
English: Marketing authorisation holder
Estonian: Müügiloa hoidja Taotleja
English: Pharmaceutical form
Estonian: Ravimvorm Manustamisviis
English: Summary of product characteristics, labelling and package leaflet
Estonian: RAVIMI OMADUSTE KOKKUVÕTE, PAKENDI MÄRGISTUS JA INFOLEHT
English: Twenty-eight adequate non-clinical literature references were also submitted.
Estonian: Esitati ka 28 adekvaatset viidet mittekliinilistele publikatsioonidele.
English: PROCTER AND GAMBLE PHARMACEUTICALS IBERIA, S.L.
Estonian: PHARMACEUTICALS IBERIA, S.L.
English: Module 4 contained three preclinical risedronate studies.
Estonian: 4. moodul sisaldas kolme prekliinilist uuringut risedronaadi kohta.
English: The CHMP agreed that the pharmacology and toxicology of calcium and colecalciferol are well-established, that combinations of these two products have been used globally in clinical practice for many years, and that the human experience supersedes non-clinical data.
Estonian: Inimravimite komitee leidis, et kaltsiumi ja kolekaltsiferooli farmakoloogia ning toksikoloogia on põhjalikult läbi uuritud, et nende kahe preparaadi kombinatsioone on kliinilises praktikas kasutatud paljude aastate jooksul kogu maailmas ja et inimestel kasutamise kogemus on tähtsam kui mittekliinilised andmed.
English: • the CHMP was convinced of the clear public health benefits and improved compliance resulting from the this product, the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Fortipan Combi D and associated names (see Annex I).
Estonian: • inimravimite komitee oli veendunud, et ravim toob ilmset kasu rahvatervisele ja parandab ravijärgimust, soovitab inimravimite komitee anda müügiload, milles ravimi omaduste kokkuvõte, pakendi märgistus ja pakendi infoleht jäävad sellisteks nagu viimases versioonis, milleni jõuti koordineerimisrühma menetluses, nagu on sätestatud III lisas Fortipan Combi D ja sarnaste nimedega ravimite jaoks (vt I lisa).
English: According to the CHMP Guideline on combination products, “combination packs would only be acceptable in exception al cases, when there would be clear public health benefits of the treatment regimen and/or compliance, taking into account the required justifications set-out in section 5 of this guideline”.
Estonian: Inimravimite komitee kombineeritud preparaatide juhend näeb ette, et „kombineeritud pakendit võib lubada ainult erilistel juhtudel, kui ravirežiimist ja/või ravijärgimusest on ilmne kasu rahvatervisele, arvestades käesoleva eeskirja lõigus 5 välja toodud nõutavaid põhjendusi”.
English: film-coated tablets + effervescent granules
Estonian: Õhukese polümeerikattega tabletid + kihisevad graanulid