FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Armisarte is a hybrid medicine that is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Armisarte on hübriidravim, mida manustatakse infusioonina, ja sisaldab sama toimeainet kui võrdlusravim, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: For practical information about using Armisarte, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Armisarte kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Armisarte is a cancer medicine used to treat two types of lung cancer:
Estonian: Armisarte on vähiravim, mida kasutatakse kaht tüüpi kopsuvähi raviks:
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Armisarte.
Estonian: Kõrvalnähtude vähendamiseks tuleb patsiendil võtta kortikosteroide (põletikuvastane ravim) ja foolhapet (teatud vitamiin) ning talle tuleb ravimiga Armisarte toimuva ravi ajal süstida vitamiini B12.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Estonian: Pemetrekseed muundub organismis aine aktiivseks vormiks, mis blokeerib nukleotiidide (rakkude geenimaterjali DNA ja RNA komponendid) tekkes osalevate ensüümide toimet.
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Estonian: • kaugelearenenud mitteväikerakk-kopsuvähi muu kui lamerakuline vorm, kusjuures ravimit kasutatakse varem ravimata patsientidel koos tsisplatiiniga, või ainsa ravimina patsientidel, kes on varem saanud vähiravi.
English: How has Armisarte been studied?
Estonian: Kuidas Armisartet uuriti?
English: Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu Alimta puhul, ületab ka Armisarte kasulikkus sellega kaasnevad riskid.
English: What are the benefits and risks of Armisarte?
Estonian: Milles seisneb Armisarte kasulikkus ja mis riskid ravimiga kaasnevad?
English: For more information about treatment with Armisarte, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Armisartega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: How is Armisarte used?
Estonian: Kuidas Armisartet kasutatakse?
English: When Armisarte is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Estonian: Kui Armisartet kasutatakse koos tsisplatiiniga, tuleb enne või pärast tsisplatiini annuse manustamist anda patsiendile antiemeetikumi (oksendamise ennetamiseks) ja vedelikke (dehüdratsiooni ennetamiseks).
English: For more information, see the summary of product characteristics (also part of the EPAR).
Estonian: Üksikasjalik teave on ravimi omaduste kokkuvõttes (mis on samuti Euroopa avaliku hindamisaruande osa).
English: The active substance in Armisarte, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Estonian: Armisarte toimeaine pemetrekseed on antimetaboliitide rühma kuuluv tsütotoksiline ravim (ravim, mis hävitab poolduvaid rakke, näiteks vähirakke).
English: How does Armisarte work?
Estonian: Kuidas Armisarte toimib?
English: While Alimta is available as a powder to be made up into a solution for infusion (drip) into a vein, Armisarte is available as a concentrated liquid to be made up into a solution for infusion.
Estonian: Kui Alimtat turustatakse pulbrina, millest valmistatakse infusioonilahus (veeni tilgutatav lahus), siis Armisartet turustatakse kontsentreeritud vedelikuna, millest valmistatakse infusioonilahus.
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
Estonian: Kui patsiendi vereanalüüsis on kõrvalekaldeid või esinevad teatud muud kõrvalnähud, tuleb ravi edasi lükata või katkestada või annust vähendada.
English: Armisarte pemetrexed
Estonian: Armisarte pemetrekseed
English: Armisarte is available as a concentrate for solution for infusion into a vein.
Estonian: Armisartet turustatakse veeni manustatava infusioonilahuse kontsentraadina.
English: Armisarte contains the active substance pemetrexed.
Estonian: Armisarte sisaldab toimeainena pemetrekseedi.
English: Vipidia alogliptin
Estonian: Vipidia alogliptiin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vipidia on 19 September 2013.
Estonian: Euroopa Komisjon andis Vipidia müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 19. septembril
English: A risk management plan has been developed to ensure that Vipidia is used as safely as possible.
Estonian: Töötati välja riskijuhtimisstrateegia, et tagada Vipidia võimalikult ohutu kasutamine.
English: The full EPAR for Vipidia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Vipidia kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Vipidia?
Estonian: Mis meetmeid võetakse, et tagada Vipidia kasutamise efektiivsus ja ohutus?
English: Other information about Vipidia
Estonian: Muu teave Vipidia kohta
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Vipidia's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee järeldas, et Vipidia kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Vipidia has been studied in seven main studies involving 5,675 adults with type 2 diabetes.
Estonian: Vipidia kasutamist uuriti seitsmes põhiuuringus, milles osales 5675 II tüüpi diabeediga patsienti.
English: What is Vipidia and what is it used for?
Estonian: Mis on Vipidia ja milleks seda kasutatakse
English: When used alone or in combination with other anti-diabetes medicines, Vipidia reduced HbA1c levels by 0.48-0.61% more than placebo.
Estonian: Kasutamisel ainsa ravimina või koos teiste diabeediravimitega vähendas Vipidia HbA1c-sisaldust 0,480,61% võrra rohkem kui platseebo.
English: Together, these processes reduce blood glucose levels and help to control type-2 diabetes.
Estonian: Need protsessid koos vähendavad vere glükoosisisaldust ja aitavad II tüüpi diabeeti reguleerida.
English: Why is Vipidia approved?
Estonian: Miks Vipidia heaks kiideti?
English: What are the risks associated with Vipidia?
Estonian: Mis riskid Vipidiaga kaasnevad?
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Estonian: II tüüpi diabeet on haigus, mille korral kõhunäärmes ei teki vere glükoosisisalduse reguleerimiseks piisavalt insuliini või organism ei suuda insuliini efektiivselt kasutada.
English: It is not intended to provide practical advice on how to use Vipidia.
Estonian: Hindamisaruandes ei anta Vipidia kasutamise praktilisi nõuandeid.
English: The recommended dose is 25 mg taken by mouth once daily, in combination with other diabetes medicines as prescribed by a doctor.
Estonian: Vipidia soovitatav annus on 25 mg suu kaudu üks kord ööpäevas koos teiste arsti määratud diabeediravimitega.
English: Vipidia must not be used in patients who are hypersensitive (allergic) to the active substances or any of the ingredients or who have had serious allergic reactions to any DPP 4 inhibitor.
Estonian: Vipidiat ei tohi kasutada patsiendid, kes on toimeainete või ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised) või kel on esinenud dipeptidüülpeptidaas-4 (DPP-4) inhibiitorite suhtes raskeid allergilisi reaktsioone.
English: In two other studies, Vipidia was compared with the diabetes medicines glipizide and pioglitazone in patients who were already taking metformin.
Estonian: Kahes ülejäänud uuringus võrreldi Vipidiat diabeediravimite glipisiidi ja pioglitasooniga patsientidel, kes juba võtsid metformiini.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vipidia, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Strateegiast lähtudes lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Vipidia ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: In patients with reduced kidney function, the daily dose of Vipidia should be reduced.
Estonian: Neerupuudulikkusega patsientidel tuleb Vipidia ööpäevast annust vähendada.
English: These hormones are released after a meal and stimulate the pancreas to produce insulin.
Estonian: Need hormoonid vabanevad pärast sööki ja stimuleerivad insuliini teket kõhunäärmes.
English: Vipidia is available as tablets (6.25, 12.5 and 25 mg) and can only be obtained with a prescription.
Estonian: Vipidia on retseptiravim ja seda turustatakse 6,25 mg, 12,5 mg ja 25 mg tablettidena.
English: The most common side effect with Vipidia (which may affect up to 1 in 10 people) is pruritus (itching).
Estonian: Vipidia kõige sagedam kõrvalnäht (võib esineda kuni 1 patsiendil 10st) on kihelus.
English: Vipidia is a diabetes medicine that contains the active substance alogliptin.
Estonian: Vipidia on diabeediravim, mille toimeaine on alogliptiin.
English: How does Vipidia work?
Estonian: Kuidas Vipidia toimib?
English: When Vipidia is added to a sulphonylurea (a type of diabetes medicine) or insulin, the doctor may need to lower the dose of these medicines to reduce the risk of hypoglycaemia (low blood sugar level).
Estonian: Kui Vipidiat võetakse koos sulfonüüluurearavimiga (samuti diabeediravim) või insuliiniga, peab arst vajaduse korral vähendama nende ravimite annuseid, et vähendada hüpoglükeemia riski (normaalsest väiksem glükoosisisaldus veres).
English: For practical information about using Vipidia, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Vipidia kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: HbA1c levels were measured after 26 weeks when Vipidia was used alone or added to other diabetes medicines, and after 52 weeks when Vipidia was compared with glipizide or pioglitazone.
Estonian: HbA1c sisaldust mõõdeti uuringutes, milles vaadeldi Vipidia kasutamist ainsa ravimina või lisamist teistele diabeediravimitele, 26 nädala järel ning Vipidiat glipisiidi ja pioglitasooniga võrdlevates uuringutes 52 nädala järel.
English: In all studies Vipidia led to a decrease in HbA1c indicating that blood glucose levels had been reduced.
Estonian: Kõikides uuringutes vähendas Vipidia HbA1c sisaldust, mis näitab vere glükoosisisalduse vähenemist.
English: Alogliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Estonian: Alogliptiin vähendab ka maksas tekkiva glükoosi kogust, suurendades insuliini ja vähendades glükagooni (teatud hormoon) sisaldust.
English: For more information about treatment with Vipidia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Vipidiaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: How is Vipidia used?
Estonian: Kuidas Vipidiat kasutatakse?
English: For the full list of all side effects reported with Vipidia, see the package leaflet.
Estonian: Vipidia kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: HbA1c levels give an indication of how well the blood glucose is controlled.
Estonian: HbA1c näitab vere glükoosisisalduse reguleeritavust.
English: Five of the studies compared Vipidia with placebo (a dummy treatment), when used alone or added to other diabetes medicines, in patients in whom previous treatment had failed.
Estonian: Viies uuringus võrreldi Vipidia kasutamist ainsa ravimina või koos teiste diabeediravimitega platseeboga (näiv ravim) patsientidel, kelle varasem ravi oli ebaõnnestunud.
English: What benefits of Vipidia have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Vipidia kasulikkus?
English: Regarding its safety, Vipidia's safety profile was consistent with that seen with other DPP-4 inhibitors.
Estonian: Ohutuse osas sarnanes Vipidia ohutusprofiil teiste dipeptidüülpeptidaas-4 (DPP-4) inhibiitorite omaga.
English: This is a summary of the European public assessment report (EPAR) for Vipidia.
Estonian: See on ravimi Vipidia Euroopa avaliku hindamisaruande kokkuvõte.
English: The CHMP considered that the effects of Vipidia on HbA1c levels were similar to those of other DPP-4 inhibitors and were modest but clinically relevant.
Estonian: Komitee järeldas, et Vipidia vähendab HbA1c sisaldust samamoodi kui teised dipeptidüülpeptidaas-4 (DPP-4) inhibiitorid ning et ravimil on tagasihoidlik, kuid kliiniliselt oluline toime.
English: It is used, together with diet and exercise, as an addition to other diabetes medicines in adults with type 2 diabetes, to control their blood glucose (sugar) level.
Estonian: Vipidiat kasutatakse koos dieedi ja füüsilise koormusega ning teiste diabeediravimitega II tüüpi diabeediga täiskasvanute raviks, et parandada vere glükoosisisalduse reguleeritavust organismis.
English: In all of the studies, the main measure of effectiveness was the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Estonian: Kõikides uuringutes oli efektiivsuse põhinäitaja glükoseerunud hemoglobiini (HbA1c; hemoglobiin, millele on kinnitunud glükoos) sisalduse muutus.
English: By blocking the breakdown of incretin hormones in the blood, alogliptin prolongs their action in stimulating the pancreas to produce more insulin when blood glucose levels are high.
Estonian: Kui vere glükoosisisaldus on suur, blokeerib alogliptiin inkretiinhormoonide lagunemise, pikendades nende toimet kõhunäärmele ja stimuleerides seda tekitama rohkem insuliini.
English: Alogliptin does not work when the blood glucose is low.
Estonian: Kui vere glükoosisisaldus on väike, alogliptiin ei toimi.
English: Vipidia was as least as affective as pioglitazone in lowering HbA1c when added to metformin, but the study comparing Vipidia with glipizide was not conclusive.
Estonian: Vipidia vähendas metformiinile lisamisel HbA1c sisaldust vähemalt sama efektiivselt kui pioglitasoon.
English: The active substance in Vipidia, alogliptin, is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Estonian: Vipidia toimeaine alogliptiin on ensüümi dipeptidüülpeptidaas-4 (DPP-4) inhibiitor, mis blokeerib organismis inkretiinhormoonide lagunemise.
English: 8 January 2010
Estonian: 8. jaanuar 2010
English: Opinion following an Article 33(4)
Estonian: Arvamus pärast artikli 33 lõike 4
English: The Decentralised Procedure NL/V/0127/001/DC started on 23 March 2007.
Estonian: Detsentraliseeritud menetlus NL/V/0127/001/DC algas 23. märtsil 2007.
English: The final opinion was converted into a Decision by the European Commission on 8 January 2010.
Estonian: Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 8. jaanuaril 2010.
English: The referral procedure started on 14 May 2008.
Estonian: Esildise menetlemine algas 14. mail 2008.
English: Committee for medicinal products for veterinary use (CVMP)
Estonian: Veterinaarravimite komitee
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, as amended, where the reference member state was the Netherlands and the concerned member states (CMSs) were Austria, Belgium, Bulgaria, Czech Republic, Germany, Denmark, Spain, Hungary, Ireland, Italy, Poland, Portugal, Romania and United Kingdom.
Estonian: Taotlus esitati muudetud direktiivi 2001/82/EÜ artikli 32 kohaselt; viiteliikmesriik oli Madalmaad ja asjaomased liikmesriigid Austria, Belgia, Bulgaaria, Hispaania, Iirimaa, Itaalia, Poola, Portugal, Rumeenia, Saksamaa, Taani, Tšehhi Vabariik, Ungari ja Ühendkuningriik.
English: Written explanations were provided by the applicant on 18 August 2008.
Estonian: Taotleja esitas kirjalikud selgitused 18. augustil 2008.
English: The rapporteur and co-rapporteur appointed were: Dr Cristina Muñoz Madero (Spain) and Dr Boris Kolar (Slovenia), respectively.
Estonian: Hindajaks ja kaashindajaks määrati vastavalt dr Cristina Muñoz Madero (Hispaania) ja dr Boris Kolar (Sloveenia).
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Estonian: Asjaomaste raviminimetuste loetelu on esitatud I lisas ja teaduslikud järeldused II lisas.
English: The re-examination procedure started on 6 February 2009 and oral explanations were given by Huvepharma NV on 10 March 2009.
Estonian: Taasläbivaatamise menetlus algas 6. veebruaril 2009 ja Huvepharma NV esitas suulised selgitused 10. märtsil 2009.
English: 1 Article 33(4) of Directive 2001/82/EC, as amended.
Estonian: Taotluse üksikasjalik põhjendus esitati 1 Muudetud direktiivi 2001/82/EÜ artikli 33 lõige 4.
English: On 24 December 2008, Huvepharma NV, notified the Agency of his intention to request the reexamination of the CVMP opinion.
Estonian: 24. detsembril 2008 teatas Huvepharma NV Euroopa Ravimiametile oma kavatsusest taotleda veterinaarravimite komitee arvamuse taasläbivaatamist.
English: Background information
Estonian: Taustteave
English: Tylosin is a macrolide antibiotic.
Estonian: Tülosiin on makroliidantibiootikum.
English: No consideration was given nor conclusion drawn regarding the applicability of the conclusions to other licensed products containing the same active ingredients.
Estonian: Kaalutlemisel ja järelduste tegemisel ei võetud arvesse võimalust kasutada sama toimeainet sisaldavate müügiloaga ravimite kohta tehtud järeldusi.
English: Furthermore, the CVMP recommended the revocation of the marketing authorisations for the above-mentioned product already granted in Austria, Ireland, the Netherlands and the United Kingdom.
Estonian: Veterinaarravimite komitee soovitas ka tühistada eespool nimetatud ravimile Austrias, Iirimaal, Madalmaades ja Ühendkuningriigis juba antud müügiload.
English: The rapporteur and co-rapporteur appointed for the re-examination were: Dr Ruth Kearsley as the rapporteur and Dr Michael Holzhauser-Alberti as the co-rapporteur respectively.
Estonian: Taasläbivaatamise hindajaks määrati dr Ruth Kearsley ja kaashindajaks dr Michael Holzhauser-Alberti.
English: It exerts its antimicrobial effect by inhibiting protein synthesis of susceptible micro-organisms.
Estonian: Ravimi antimikroobne toime põhineb ravimitundlike mikroorganismide valgusünteesi inhibeerimisel.
English: During its 9-11 December 2008 meeting, the CVMP in light of the overall data submitted and the scientific discussion within the Committee, considered by consensus that the application did not satisfy the criteria for authorisation in respect of environmental risk.
Estonian: 9.-11. detsembri 2008 koosolekul jõudis veterinaarravimite komitee kõigi esitatud andmete põhjal ja komiteesisese teadusliku arutelu tulemusel konsensusele, et keskkonnariskiga seoses ei vasta taotlus müügiloa andmise kriteeriumidele.
English: 100% W/W Water Soluble Granules and associated names
Estonian: Pharmasin 100% W/W Water Soluble Granules ja sarnased nimetused
English: Furthermore, the CVMP recommended that the existing marketing authorisations for the abovementioned product should be revoked.
Estonian: Veterinaarravimite komitee soovitas ka tühistada eespool nimetatud ravimi juba antud müügiload.
English: On 29 April 2008 the Netherlands referred the matter to the European Medicines Agency (the Agency) under Article 33 (4) of Directive 2001/82/EC, due to concerns, raised by Germany, that tylosin may present a potential serious risk to the environment (risk to algae and to terrestrial plants).
Estonian: 29. aprillil 2008 tegid Madalmaad Saksamaa tõstatatud probleemi tõttu, et tülosiini kasutamisega võib kaasneda suur keskkonnarisk (seoses riskiga vetikatele ja maismaataimedele), Euroopa Ravimiametile direktiivi 2001/82/EÜ artikli 33 lõike 4 kohase esildise.
English: On 16 September 2008 the CVMP agreed a list of outstanding issues and the written explanations were provided by the applicant on 12 November 2008.
Estonian: 16. septembril 2008 koostas veterinaarravimite komitee lahendamata küsimuste loetelu, millele müügiloa taotleja esitas kirjalikud selgitused 12. novembril 2008.
English: During its 10-12 March 2009 meeting, the Committee, having considered the grounds for appeal and the oral explanations provided by Huvepharma NV, concluded by consensus that its opinion of 10 December 2008 should not be revised and that the marketing authorisations for Pharmasin 100% W/W Water Soluble Granules and associated names should be refused by the member states.
Estonian: 10.-12. märtsi 2009 koosolekul jõudis veterinaarravimite komitee taotluse põhjenduste ja Huvepharma NV esitatud suulisi selgituste alusel konsensuseni, et 10. detsembril 2008 esitatud arvamust ei ole vaja muuta ning et liikmesriigid peaksid ravimi Pharmasin 100% W/W Water Soluble Granules ja sarnaste nimetuste müügiloa andmisest keelduma.
English: The applicant, Huvepharma NV, submitted an application for a decentralised procedure for Pharmasin 100% W/W Water Soluble Granules and associated names indicated for oral use in pigs, chickens (broilers, pullets), turkeys and calves.
Estonian: Müügiloa taotleja Huvepharma NV esitas ravimi Pharmasin 100% W/W Water Soluble Granules ja sarnased nimetused, mis on näidustatud suukaudseks kasutamiseks sigadel, kanadel (broileritel, noorkanadel), kalkunitel ja vasikatel, detsentraliseeritud menetluse taotluse.
English: Therefore the CVMP recommended the refusal of the granting of the marketing authorisations for Pharmasin 100% W/W Water Soluble Granules and associated names.
Estonian: Sel põhjusel soovitas veterinaarravimite komitee ravimile Pharmasin 100% W/W Water Soluble Granules ja sarnastele nimetustele müügiloa andmisest keelduda.
English: Opinion following an Article 33(4)F F referral for Pharmasin 100% W/W Water Soluble Granules and associated names
Estonian: Arvamus pärast artikli 33 lõike 4F F kohast esildist Pharmasin 100% W/W Water Soluble Granules ja sarnased nimetused EMA/303267/2010
English: The detailed grounds for the request were submitted to the Agency on 5 February 2009.
Estonian: Euroopa Ravimiametile 5. veebruaril 2009.
English: In line with the restrictions in legislation with respect to data on environmental risk, the Committee limited its considerations to the data presented by Huvepharma NV in the dossier for Pharmasin 100% W/W Water Soluble Granules and associated names.
Estonian: Komitee piiras oma seisukoha andmetega, mida taotleja Huvepharma NV esitas ravimi Pharmasin 100% W/W Water Soluble Granules ja sarnaste nimetuste dokumentatsioonis ja mis olid kooskõlas keskkonnaohu andmeid sätestavate õigusaktide piirangutega.
English: This summary was last updated in 10-2016.
Estonian: Kokkuvõtte viimane uuendus: 10-2016.