FrancophonIA/ELRC3.0 huggingface dataset:
English: The volume of distribution at steady-state (VSS) determined after intravenous administration was 11 l/kg.
Estonian: Jaotumustugevus stabiilses seisundis (VSS) määratuna pärast intravenoosset manustamist oli 11 l/kg.
English: Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep Tulathromycin
Estonian: Draxxin 100 mg/ml süstelahus veistele, sigadele ja lammastele tulatromütsiin
English: Draxxin 25 mg/ml solution for injection for pigs
Estonian: Draxxin 25 mg/ml süstelahus sigadele
English: The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 l/kg.
Estonian: Jaotumustugevus stabiilses seisundis (VSS) määratuna pärast intravenoosset manustamist oli 13,2 l/kg.
English: Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumonia, Haemophilus parasuis and Bordetella bronchiseptica the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively.
Estonian: Tulatromütsiinil on in vitro toime Mannheimia haemolytica, Pasteurella multocida, Histophilus somni ja Mycoplasma bovis'e vastu, samuti Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis'i ja Bordetella bronchiseptica vastu, mis on kõige sagedamini vastavalt veiste ja sigade respiratoorhaigustega seostatavad patogeenid.
English: Following intravenous dosing the volume of distribution at steady-state (Vss) was 31.7 l/kg.
Estonian: Jaotumustugevus stabiilses seisundis (VSS) pärast intravenoosset manustamist oli 31,7 l/kg.
English: Treatment and metaphylaxis of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin.
Estonian: Tulatromütsiini suhtes tundlike Mannheimia haemolytica, Pasteurella multocida, Histophilus somni ja Mycoplasma bovis'ega seotud veiste respiratoorhaiguse (BRD) ravi ja metafülaktika.
English: 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
Estonian: 2,5 mg tulatromütsiini kg kehamassi kohta (1 ml / 40 kg kehamassi kohta).
English: Monothioglycerol Propylene glycol Citric acid Hydrochloric acid Sodium hydroxide Water for injections
Estonian: Monotioglütserool PropüleenglükoolSidrunhape Soolhape
English: Do not use in lactating animals producing milk for human consumption.
Estonian: Mitte kasutada lakteerivatel loomadel, kelle piima tarvitatakse inimtoiduks.
English: Mild myocardial degeneration has been observed in cattle receiving 5 to 6 times the recommended dose.
Estonian: Viie- kuni kuuekordse soovitatava annuse saanud veistel ilmnes kergekujuline südamelihase degeneratsioon.
English: A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
Estonian: Ühekordne subkutaanne manustamine 2,5 mg tulatromütsiini kg kehamassi kohta (1 ml / 40 kg kehamassi kohta).
English: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin.
Estonian: Tulatromütsiini suhtes tundlike Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis'i ja Bordetella bronchiseptica'ga seotud sigade respiratoorhaiguse (SRD) ravi ja metafülaktika.
English: The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 L/kg.
Estonian: Jaotumisruumala püsikontsentratsiooni staadiumis (VSS) määratuna pärast intravenoosset manustamist oli 13,2 l/kg.
English: A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight) in the neck.
Estonian: Ühekordne intramuskulaarne manustamine kaela 2,5 mg tulatromütsiini kg kehamassi kohta (1 ml / 40 kg kehamassi kohta).
English: A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/10 kg bodyweight) in the neck.
Estonian: Ühekordne intramuskulaarne süste kaela annuses 2,5 mg tulatromütsiini/kg kehamassi kohta (1 ml 10 kg kehamassi kohta).
English: Not authorised for use in lactating cattle producing milk for human consumption.
Estonian: Ei ole lubatud kasutamiseks lakteerivatel veistel, kelle piima tarvitatakse inimtoiduks.
English: The volume of distribution at steady-state (Vss) determined after intravenous administration was 11 l/kg.
Estonian: Jaotumustugevus stabiilses seisundis (VSS) määratuna pärast intravenoosset manustamist oli 1 l/kg.
English: Lot
Estonian: LISAINFO
English: Name and address of the manufacturers responsible for batch release
Estonian: MÜÜGILOA HOIDJA NING, KUI NEED EI KATTU, RAVIMIPARTII VABASTAMISE EEST VASTUTAVA TOOTMISLOA HOIDJA NIMI JA AADRESS
English: (Invented) name Strength Pharmaceutical Form
Estonian: Ravimi (väljamõeldud) nimetus
English: Pack size
Estonian: Manustam istee
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Estonian: Ravimiteavet võivad hiljem uuendada liikmesriigi pädevad asutused koostöös viiteliikmesriigiga, kui see on asjakohane, järgides direktiivi 2001/83/EÜ III köite 4. peatükis kirjeldatud menetlusi.
English: Talk to your doctor or pharmacist before taking this medicine if you have any of the following conditions.
Estonian: Enne selle ravimi võtmist pidage nõu oma arsti või apteekriga, kui teil on ükskõik milline järgmistest seisunditest.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Estonian: Olemasolevat ravimiteavet tuleb parandada (vajaduse järgi sisestades, asendades või kustutades teksti), et see kajastaks allpool kirjeldatud kokkulepitud sõnastust.
English: What you need to know before you are given <invented name> Do not use <invented name and strength(s)>:
Estonian: Mida on vaja teada enne <väljamõeldud nimetus> kasutamist Ärge kasutage <väljamõeldud nimetus ja kontsentratsioon(id)>:
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Estonian: Need parandused ravimi omaduste kokkuvõtte ja pakendi infolehe asjakohastes lõikudes on tehtud esildismenetluse tulemusena.
English: [A warning should be included as follows]
Estonian: [Lisada tuleb järgmine hoiatus]
English: Annex III Amendments to relevant sections of the Product Information
Estonian: III lisa Ravimiteabe asjakohaste lõikude parandused
English: Administration of <invented name and strength(s)> should be stopped, and the patient's condition should be treated accordingly.
Estonian: <Väljamõeldud nimetus ja kontsentratsioon(id)> manustamine tuleb lõpetada ja patsienti ravida vastavalt tema seisundile.
English: 4.3 Contraindications [The following contraindication should be included]
Estonian: 4.3 Vastunäidustused [Lisada tuleb järgmine vastunäidustus]
English: 4.4 Special warnings and precautions for use [The following warning should be included] Immune System Effects
Estonian: 4.4 Erihoiatused ja ettevaatusabinõud kasutamisel [Lisada tuleb järgmine hoiatus] Toimed immuunsüsteemile
English: Serious allergic reactions have occurred in patients allergic to cow's milk.
Estonian: Lehmapiima suhtes allergilistel patsientidel on esinenud raskeid allergilisi reaktsioone.
English: OTHER [A warning should be included as follows] Do not use in cow's milk allergy patients.
Estonian: MUU [Lisada tuleb järgmine hoiatus] Mitte kasutada lehmapiimaallergiaga patsientidel.
English: If you are allergic or suspected to be allergic to cow's milk.
Estonian: kui olete lehmapiima suhtes allergiline või kui seda kahtlustatakse.
English: Cow's milk allergy [The following clarification in brackets should be included in case of combined SmPC with strength(s) not included in Annex I] (the following paragraphs only apply to <invented name and strength(s)>)
Estonian: Lehmapiimaallergia [kui on ühine ravimi omaduste kokkuvõte, tuleb järgmine sulgudes toodud selgitus lisada tugevusele (tugevustele), mida ei ole I lisas nimetatud] (järgmised lõigud rakenduvad ainult <väljamõeldud nimetus ja kontsentratsioon(id)>)
English: <invented name and strength(s)> contains cow's milk proteins If you are allergic or suspected to be allergic to cow's milk, you must not be given this medicine as it may contain trace amounts of cow's milk proteins.
Estonian: <väljamõeldud nimetus ja kontsentratsioon(id)> sisaldab lehmapiimavalke Kui olete lehmapiima suhtes allergiline või kui seda kahtlustatakse, ei tohi teile seda ravimit anda, sest see võib sisaldada lehmapiimavalkude jääke.
English: OTHER SPECIAL WARNING(S), IF NECESSARY [A warning should be included as follows] Do not use in cow's milk allergy patients.
Estonian: TEISED ERIHOIATUSED (VAJADUSEL) [Lisada tuleb järgmine hoiatus] Mitte kasutada lehmapiimaallergiaga patsientidel.
English: <Invented name and strength(s)> contains lactose <monohydrate> produced from bovine origin as an excipient and may therefore contain trace amounts of cow's milk proteins (the allergens of cow's milk).
Estonian: <Väljamõeldud nimetus ja kontsentratsioon(id)> sisaldab abiainena veistelt pärinevat laktoos<monohüdraat>i ja võib seega sisaldada lehmapiimavalkude (lehmapiima allergeenid) jääke.
English: In case of combined package leaflet with strength(s) not included in Annex I, the strength(s) of products in Annex I should be specified in the subheading above]
Estonian: [Lisada tuleb järgmine hoiatus.Kui ravimi tugevust (tugevusi) ei ole I lisas nimetatud, tuleb kombineeritud pakendi infolehtede korral I lisas nimetatud ravimite tugevust (tugevusi) täpsustada ülaltoodud alapealkirjas]
English: <Invented name and strength(s)> is contraindicated in patients with a known or suspected allergy to cow's milk (see section 4.4).
Estonian: <Väljamõeldud nimetus ja kontsentratsioon(id)> on vastunäidustatud patsientidele, kellel on teadaolev allergia lehmapiimale või kellel seda kahtlustatakse (vt lõik 4.4).
English: Patients with known or suspected allergy to cow's milk must not be administered <invented name and strength(s)> (see section 4.3).
Estonian: Patsientidele, kellel on teadaolev allergia lehmapiimale või kellel seda kahtlustatakse, ei tohi <väljamõeldud nimetus ja kontsentratsioon(id)> manustada (vt lõik 4.3).
English: Serious allergic reactions, including bronchospasm and anaphylaxis, were reported in patients allergic to cow's milk proteins who were treated for acute allergic conditions.
Estonian: Lehmapiimavalkudele allergilistel patsientidel, kellel raviti allergilist seisundit, teatati raskete allergiliste reaktsioonide, sealhulgas bronhospasmi ja anafülaksia tekkest.
English: Allergic reactions to cow's milk proteins should be considered in patients receiving <invented name and strength(s)> for the treatment of acute allergic conditions in whom symptoms worsen or who are presenting new allergic symptoms (see section 4.3).
Estonian: Patsientidel, kes saavad ägeda allergia raviks <väljamõeldud nimetus ja kontsentratsioon(id)> ja kelle sümptomid süvenevad või kellel tekivad uued allergia sümptomid (vt lõik 4.3), tuleb kahtlustada allergilist reaktsiooni lehmapiimavalkudele.
English: Immediate Packaging Pack size
Estonian: Sildenafil Teva 100 mg Õhukese polümeerikattega tablett
English: MA (EU) number
Estonian: Müügiloa number Euroop Liidus
English: Severe neutropenia lasted on average for 1.4 days.
Estonian: Raske neutropeenia kestis keskmiselt 1,4 ööpäeva.
English: Accofil filgrastim
Estonian: Accofil filgrastiim
English: This is comparable with 1.6 days and 1.8 days reported in other studies found in the literature using filgrastim.
Estonian: See on võrreldav 1,6 ja 1,8 ööpäevaga, mis esines muudes kirjanduses avaldatud filgrastiimi kasutamise uuringutes.
English: The main measure of effectiveness was the duration of severe neutropenia.
Estonian: Efektiivsuse põhinäitaja oli raske neutropeenia kestus.
English: A risk management plan has been developed to ensure that Accofil is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Accofili võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Accofil on 18 September 2014.
Estonian: Euroopa Komisjon andis Accofili müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 18. septembril
English: The full EPAR and risk management plan summary for Accofil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Accofili 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 Accofil?
Estonian: Mis meetmed võetakse, et tagada Accofili ohutu ja efektiivne kasutamine?
English: Other information about Accofil
Estonian: Muu teave Accofili kohta
English: Patients were given the chemotherapy on day 1 of a three-week cycle, and then received one dose of Accofil the next day and daily for up to 14 days.
Estonian: Patsiendid said keemiaravi kolmenädalase ravitsükli 1. päeval ja alates järgmisest päevast manustati neile 14 päeva vältel iga päev üks annus Accofili.
English: Data from published studies indicate that the benefits and safety of filgrastim are similar in both adults and children receiving chemotherapy.
Estonian: Avaldatud uuringuandmete põhjal on filgrastiimi kasulikkus ja ohutus keemiaravi saavatel täiskasvanutel ja lastel sarnased.
English: What is Accofil and what is it used for?
Estonian: Mis on Accofil ja milleks seda kasutatakse?
English: Why is Accofil approved?
Estonian: Miks Accofil heaks kiideti?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Accofil has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Estonian: Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele bioloogiliselt sarnaste ravimite kohta on tõendatud Accofili võrreldav kvaliteedi-, ohutus- ja efektiivsusprofiil ravimi Neupogen profiiliga.
English: This means that Accofil is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Estonian: See tähendab, et Accofil sarnaneb bioloogilise ravimiga (võrdlusravimiga), millel juba on Euroopa Liidus müügiluba.
English: This is a summary of the European public assessment report (EPAR) for Accofil.
Estonian: See on ravimi Accofil Euroopa avaliku hindamisaruande kokkuvõte.
English: Accofil was studied in one main study involving 120 female adult patients with breast cancer treated with chemotherapy known to cause neutropenia.
Estonian: Accofili uuriti ühes põhiuuringus, milles osales 120 rinnanäärmevähiga naispatsienti, kes said keemiaravi, mis teadaolevalt põhjustab neutropeeniat.
English: For the full list of all side effects and restrictions reported with Accofil, see the package leaflet.
Estonian: Accofili kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Therefore, the CHMP's view was that, as for Neupogen, the benefit outweighs the identified risks and recommended that it be approved for use in the EU.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Neupogeni korral, ületab ravimi Accofil kasulikkus sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: The way Accofil is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Estonian: Accofili manustamisviis, annus ja ravi kestus sõltuvad näidustusest ning patsiendi kehakaalust ja ravivastusest.
English: It is not intended to provide practical advice on how to use Accofil.
Estonian: Hindamisaruandes ei anta Accofili kasutamise praktilisi nõuandeid.
English: The most common side effect with Accofil (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Estonian: Accofili kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) on luu-lihaskonna valu.
English: The active substance in Accofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Estonian: Accofili toimeaine filgrastiim on väga sarnane inimvalguga, mida nimetatakse granulotsüütide kolooniat stimuleerivaks faktoriks (G-CSF).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Accofil, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Accofili omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: What are the risks associated with Accofil?
Estonian: Mis riskid Accofiliga kaasnevad?
English: • to help release cells from the bone marrow in patients who are about to donate blood stem cells for transplant;
Estonian: • luuüdist rakkude vabanemise soodustamiseks patsientidel, kellelt hakatakse siirdamiseks võtma vere tüvirakke;
English: Accofil, which contains the active substance filgrastim, is a ‘biosimilar medicine'.
Estonian: Accofil, mis sisaldab toimeainena filgrastiimi, on bioloogiliselt sarnane ravim.
English: Studies were carried out to show that Accofil produces similar levels of the active substance in the body to Neupogen and increases the numbers of neutrophils in a comparable way.
Estonian: Korraldati uuringud, mille eesmärk oli tõestada, et Accofili manustamisel on toimeaine sisaldus organismis samasugune kui Neupogeni manustamisel ja Accofil suurendab neutrofiilide sisaldust sama palju.
English: For practical information about using Accofil, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Accofili kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The filgrastim in Accofil is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce filgrastim.
Estonian: Accofilis sisalduvat filgrastiimi valmistatakse rekombinantDNA-tehnika abil: seda toodavad bakterid, millele on lisatud filgrastiimi teket võimaldav geen (DNA).
English: • to treat persistent neutropenia in patients with advanced Human-Immunodeficiency-Virus (HIV) infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Estonian: • püsiva neutropeenia raviks kaugelearenenud HIV-infektsiooniga täiskasvanutel bakteriaalsete infektsioonide riski vähendamiseks, kui muu ravi ei sobi.
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
Estonian: • neutropeenia kestuse vähendamiseks patsientidel, kes saavad ravi, millega hävitatakse luuüdi rakud enne luuüdi siirdamist (näiteks mõnel leukeemiaga patsiendil), kui on pikaajalise raske neutropeenia risk;
English: For more information about treatment with Accofil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Accofiliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Accofil is a medicine that is used to stimulate the production of white blood cells in the following situations:
Estonian: Accofili kasutatakse leukotsüütide (vere valgeliblede) tekke stimuleerimiseks järgmistel näidustustel:
English: How is Accofil used?
Estonian: Kuidas Accofili kasutatakse?
English: What benefits of Accofil have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Accofili kasulikkus?
English: How does Accofil work?
Estonian: Kuidas Accofil toimib?
English: Filgrastim acts in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Estonian: Filgrastiim toimib samal viisil kui looduslikult tekkiv G-CSF, soodustades leukotsüütide teket luuüdis.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving cytotoxic chemotherapy (medicines to treat cancer by killing cells);
Estonian: • neutropeenia (neutrofiilide ehk teatud valgeliblede sisalduse vähenemine) kestuse ja febriilse neutropeenia (palavikuga neutropeenia) esinemissageduse vähendamiseks tsütotoksilist keemiaravi (rakke hävitavad vähiravimid) saavatel patsientidel;
English: It can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.
Estonian: Accofil on retseptiravim ja seda tohib kasutada üksnes vähiravikeskuse juhiste kohaselt.
English: It is given by injection under the skin or infusion into a vein.
Estonian: Ravimit manustatakse nahaaluse süstina või veeniinfusioonina.
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Accofil is being used for.
Estonian: Olenevalt Accofili kasutamise näidustusest võivad ka muud kõrvalnähud esineda enam kui 1 patsiendil 10st.
English: The reference medicine for Accofil is Neupogen.
Estonian: Accofili võrdlusravim on Neupogen.
English: Accofil is available as a solution for injection or infusion (drip) in pre-filled syringes.
Estonian: Accofili turustatakse süste- või infusioonilahusena eeltäidetud süstaldes.
English: More information can be found in 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: 10 (2 x 5) pre-filled pens (multipack)
Estonian: 10 (2 x 5) pensüstlit (hulgipakend)
English: 5 pre-filled pens
Estonian: 5 pensüstlit
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Estonian: di d nimetus Tugevus Ravimvorm Manustamistee Pakendi Müügiloa nr Euroopa Liidu Ravimpreparaa iseloomustus
English: The medicine is used when initial treatment has not worked or the cancer has come back.
Estonian: Ravimit kasutatakse siis, kui esmaravi ei ole toiminud või vähk on taastunud.
English: Carmustine Obvius (carmustine) EMA/273425/2018
Estonian: Carmustine Obvius (karmustiin) EMA/273425/2018
English: Carmustine Obvius (carmustine)
Estonian: Carmustine Obvius (karmustiin)
English: By damaging the DNA of cancer cells, carmustine can help kill them and prevent the cancer from growing and spreading.
Estonian: Vähirakkude DNA-d kahjustades võib karmustiin aidata vähirakke hävitada ning ennetada vähi kasvu ja levikut.
English: What measures are being taken to ensure the safe and effective use of Carmustine Obvius?
Estonian: Mis meetmed võetakse, et tagada ravimi Carmustine Obvius ohutu ja efektiivne kasutamine?
English: Further information on Carmustine Obvius can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave ravimi Carmustine Obvius kohta on ameti veebilehel ema.europa.eu/Find medicine/Human medicines/European public assessment reports Teave võrdlusravimi kohta on samuti Euroopa Ravimiameti veebilehel.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Carmustine Obvius has been shown to be comparable to Carmubris.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele on tõendatud ravimi Carmustine Obvius võrreldavus ravimiga Carmubris.