FrancophonIA/ELRC3.0 huggingface dataset:
English: Further information on Tyverb can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Tyverb so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: All of the tablets must be taken together at the same time every day, at least 1 hour before or 1 hour after food.
Slovenian: Vse tablete je treba vzeti sočasno vsak dan ob istem času, najmanj eno uro pred obrokom ali eno uro po njem.
English: This means that there was more evidence to come about the effectiveness of the medicine.
Slovenian: To pomeni, da se je pričakovalo še več dokazov o učinkovitosti zdravila.
English: This was switched to a full marketing authorisation on 17 February 2015.
Slovenian: To je bilo 17. februarja 2015 spremenjeno v običajno dovoljenje za promet.
English: Tyverb is used in the following ways:
Slovenian: Zdravilo Tyverb se uporablja na naslednje načine:
English: What measures are being taken to ensure the safe and effective use of Tyverb?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Tyverb?
English: The European Medicines Agency decided that Tyverb's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Tyverb večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: In all the studies, the main measure of effectiveness was how long the patients lived without their disease getting worse, which was assessed in scans.
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti čas, kako dolgo so bolnice živele, ne da bi se bolezen poslabšala, kar se je ocenjevalo s slikanjem.
English: Tyverb received a conditional marketing authorisation valid throughout the EU on 10 June 2008.
Slovenian: Za zdravilo Tyverb je bilo 10. junija 2008 izdano pogojno dovoljenje za promet, veljavno po vsej EU.
English: This combination is used in women who do not currently need to receive standard chemotherapy to treat their cancer.
Slovenian: Ta kombinacija se uporablja pri ženskah, ki za zdravljenje raka trenutno ne potrebujejo standardne kemoterapije.
English: The studies also looked at how long the patients survived.
Slovenian: V študijah so prav tako proučevali čas preživetja bolnic.
English: The doctor may decide to interrupt or stop treatment in patients experiencing certain side effects, especially those affecting the heart, lungs or liver.
Slovenian: Zdravnik se lahko odloči za začasno prekinitev ali prenehanje zdravljenja pri bolnicah, ki imajo določene neželene učinke, zlasti tiste, ki prizadenejo srce, pljuča ali jetra.
English: As for all medicines, data on the use of Tyverb are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Tyverb stalno spremljajo.
English: Other information about Tyverb
Slovenian: Druge informacije o zdravilu Tyverb
English: What benefits of Tyverb have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Tyverb izkazalo v študijah?
English: Why is Tyverb authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Tyverb odobreno v EU?
English: What is Tyverb and what is it used for?
Slovenian: Kaj je zdravilo Tyverb in za kaj se uporablja?
English: Tyverb was originally given ‘conditional approval'.
Slovenian: Zdravilo Tyverb je prvotno pridobilo „pogojno dovoljenje za promet“.
English: What are the risks associated with Tyverb?
Slovenian: Kakšna tveganja so povezana z zdravilom Tyverb?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tyverb have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Tyverb upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: ‘Advanced' means that the cancer has started to spread and ‘metastatic' means that the cancer has already spread to other parts of the body;
Slovenian: „Napredovali“ pomeni, da se je rak začel širiti, „metastatski“ pa, da se je že razširil na druge dele telesa;
English: Tyverb is available as tablets (250 mg) and the recommended dose is 4 tablets a day when used with trastuzumab, 5 tablets a day when it is used with capecitabine, and 6 tablets a day when taken with an aromatase inhibitor.
Slovenian: Zdravilo Tyverb je na voljo v obliki tablet (250 mg), pri čemer je priporočeni odmerek štiri tablete na dan, če se uporablja v kombinaciji s trastuzumabom, pet tablet na dan, če se uporablja v kombinaciji s kapecitabinom, in šest tablet na dan, če se uporablja v kombinaciji z zaviralci aromataze.
English: Patients who stop taking Tyverb after developing severe liver problems should not start to take the medicine again.
Slovenian: Bolnice, ki prenehajo jemati zdravilo Tyverb po tem, ko so se pri njih pojavile hude težave z jetri, zdravila ne smejo začeti ponovno jemati.
English: If patients start to take Tyverb again, they may need to use a lower dose.
Slovenian: Če se zdravljenje z zdravilom Tyverb uvaja ponovno, bo morda potreben manjši odmerek.
English: An overview of Tyverb and why it is authorised in the EU
Slovenian: Pregled zdravila Tyverb in zakaj je odobreno v EU
English: For more information about using Tyverb, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Tyverb glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Tyverb in combination with another cancer medicine was shown to be more effective than the comparator treatment in three main studies involving women with breast cancer.
Slovenian: Zdravilo Tyverb se je v kombinaciji z drugimi zdravili za zdravljenje raka izkazalo za učinkovitejše od primerjalnega zdravljenja v treh glavnih študijah, v katere so bile vključene ženske z rakom dojke.
English: Side effects reported with Tyverb are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Tyverb, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnic.
English: 219 of the women had cancer that was producing large quantities of HER2.
Slovenian: 219 žensk je imelo raka, ki je izražal velike količine HER-2.
English: The active substance in Tyverb, lapatinib, belongs to a group of medicines called protein kinase inhibitors.
Slovenian: Učinkovina v zdravilu Tyverb, lapatinib, spada v skupino zdravil, imenovanih zaviralci proteinske kinaze.
English: The women had not received trastuzumab or an aromatase inhibitor before entering this study.
Slovenian: Bolnice pred začetkom študije še niso prejemale trastuzumaba ali zaviralcev aromataze.
English: These medicines work by blocking enzymes known as protein kinases, which can be found in some receptors (targets) on the surface of cancer cells including HER2.
Slovenian: Ta zdravila delujejo tako, da zavirajo vrste encimov, znane kot proteinske kinaze, ki jih najdemo v nekaterih receptorjih (prijemališčih) na površini rakavih celic, med drugim tudi pri beljakovini HER-2.
English: It involved 1,286 women who had been through the menopause with metastatic breast cancer that was sensitive to hormones.
Slovenian: Vanjo je bilo vključenih 1 286 žensk po menopavzi, ki so imele metastatski rak dojke, občutljiv za hormone.
English: Tyverb can only be obtained with a prescription and should only be started by a doctor who has experience in giving cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Tyverb je le na recept, zdravljenje z njim pa sme uvesti samo zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: It involved 296 women with metastatic disease that was producing large quantities of HER2 and got worse despite treatment with trastuzumab and other cancer medicines (including anthracyclines and taxanes).
Slovenian: Vanjo je bilo vključenih 296 žensk z metastatskim rakom, ki je izražal velike količine HER-2, njihovo stanje pa se je poslabšalo kljub zdravljenju s trastuzumabom in drugimi zdravili za zdravljenje raka (vključno z antraciklini in taksani).
English: The company that markets Tyverb will evaluate ways to predict resistance (the medicine becoming less effective) in breast cancer patients taking Tyverb with other cancer medicines.
Slovenian: Podjetje, ki trži zdravilo Tyverb, bo ocenilo načine napovedovanja odpornosti (ko zdravilo postane manj učinkovito) pri bolnicah z rakom dojke, ki zdravilo Tyverb jemljejo v kombinaciji z drugimi zdravili za zdravljenje raka.
English: The most common side effects with Tyverb (which may affect more than 1 in 4 patients) are rash and side effects affecting the stomach and gut (such as diarrhoea, nausea (feeling sick) and vomiting).
Slovenian: Najpogostejši neželeni učinki zdravila Tyverb (opaženi pri več kot četrtini bolnic) so izpuščaji in neželeni učinki, ki prizadenejo želodec in črevesje (kot so driska, slabost in bruhanje).
English: • in combination with an aromatase inhibitor (another type of cancer medicine) in women who have been through the menopause, when the cancer is metastatic and responds to hormones.
Slovenian: • v kombinaciji z zaviralcem aromataze (drugo vrsto zdravila za zdravljenje raka) pri ženskah po menopavzi, kadar je rak metastatski in se odziva na hormone.
English: About a quarter of breast cancers produce HER2.
Slovenian: Za približno četrtino primerov raka dojke je značilna izražena beljakovina HER-2.
English: In addition, women taking the combination survived for 14.0 months on average, compared with 9.5 months in those taking Tyverb alone.
Slovenian: Poleg tega je bil pri ženskah, ki so prejemale kombinacijo zdravil, povprečni čas preživetja 14,0 meseca v primerjavi z 9,5 meseca pri ženskah, ki so prejemale le zdravilo Tyverb.
English: Tyverb contains the active substance lapatinib.
Slovenian: Zdravilo Tyverb vsebuje učinkovino lapatinib.
English: • in combination with trastuzumab for metastatic cancer that does not respond to hormones (hormone receptor-negative disease), and which got worse when previously treated with a combination of trastuzumab and other cancer medicines (chemotherapy);
Slovenian: • v kombinaciji s trastuzumabom za zdravljenje metastatskega raka, ki se ne odziva na hormone (bolezen, ki je negativna na hormonske receptorje) ter se je med predhodnimi zdravljenji s kombinacijo trastuzumaba in drugih zdravil za zdravljenje raka (kemoterapijo) poslabšal;
English: HER2 is a receptor for a substance called epidermal growth factor which stimulates the cancer cells to grow uncontrollably.
Slovenian: Beljakovina HER-2 je receptor za snov, imenovano epidermalni rastni faktor, ki spodbuja nenadzorovano širjenje rakavih celic.
English: How does Tyverb work?
Slovenian: Kako zdravilo Tyverb deluje?
English: This means that the cancer produces a specific protein called HER2 (also known as ErbB2) in large quantities on the surface of the cancer cells.
Slovenian: To pomeni, da na površini rakavih celic v velikih količinah nastaja določena beljakovina, imenovana HER-2 (znana tudi pod imenom ErbB2).
English: How is Tyverb used?
Slovenian: Kako se zdravilo Tyverb uporablja?
English: The third study compared Tyverb with placebo (a dummy treatment), both of which were taken together with letrozole (an aromatase inhibitor).
Slovenian: V tretji študiji so zdravilo Tyverb primerjali s placebom (zdravilom brez učinkovine), pri čemer so bolnice oboje prejemale v kombinaciji z letrozolom (zaviralcem aromataze).
English: The women whose cancer was producing large quantities of HER2 taking Tyverb in combination with letrozole survived for an average of 35.4 weeks without their disease getting worse.
Slovenian: Pri ženskah, katerih rak je izražal velike količine HER-2 in ki so zdravilo Tyverb prejemale v kombinaciji z letrozolom, je bil povprečni čas preživetja brez poslabšanja bolezni 35,4 tedna.
English: For the full list of side effects and restrictions with Tyverb, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Tyverb glejte navodilo za uporabo.
English: The second study compared Tyverb alone with a combination of Tyverb plus trastuzumab.
Slovenian: V drugi študiji so uporabo zgolj zdravila Tyverb primerjali s kombinacijo zdravila Tyverb in trastuzumaba.
English: By blocking HER2 receptors, Tyverb helps to control growth of the cancer.
Slovenian: Zdravilo Tyverb z zaviranjem receptorjev HER-2 prispeva k nadzoru nad širjenjem raka.
English: Tyverb in combination with other cancer medicines has been shown to improve survival of patients with breast cancer that produces large quantities of HER2, and its side effects are considered acceptable.
Slovenian: Za zdravilo Tyverb je bilo dokazano, da njegovo prejemanje v kombinaciji s prejemanjem drugih zdravil za zdravljenje raka izboljša preživetje bolnic z rakom dojke, ki izraža velike količine HER-2, njegovi neželeni učinki pa se štejejo za sprejemljive.
English: Women taking Tyverb with capecitabine survived for an average of 75 weeks, and those taking capecitabine alone survived for an average of 64.7 weeks.
Slovenian: Pri ženskah, ki so prejemale zdravilo Tyverb v kombinaciji s kapecitabinom, je bil povprečni čas preživetja 75 tednov, pri tistih, ki so prejemale le kapecitabin, pa 64,7 tedna.
English: • in combination with capecitabine (another cancer medicine) when the cancer is advanced or metastatic and got worse following previous treatment including an anthracycline and a taxane (other types of cancer medicine), and following treatment of the patient's metastatic disease with trastuzumab (another cancer medicine).
Slovenian: • v kombinaciji s kapecitabinom (drugim zdravilom za zdravljenje raka), če gre za napredovali ali metastatski rak, ki se je po predhodnem zdravljenju z antraciklini in taksani (drugima vrstama zdravil za zdravljenje raka) poslabšal, ter po zdravljenju metastaz s trastuzumabom (drugim zdravilom za zdravljenje raka).
English: Tyverb is a cancer medicine used to treat patients with breast cancer that has been shown to be ‘expressing' large amounts of HER2.
Slovenian: Zdravilo Tyverb je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje bolnic z rakom dojke s prekomerno izraženim HER-2.
English: Women taking Tyverb with trastuzumab lived without their disease getting worse for 12.0 weeks on average, compared with 8.1 weeks in those taking Tyverb alone.
Slovenian: Bolnice, ki so prejemale zdravilo Tyverb v kombinaciji s trastuzumabom, so v povprečju živele 12,0 tedna brez poslabšanja bolezni, medtem ko je to obdobje pri tistih, ki so prejemale le zdravilo Tyverb, znašalo 8,1 tedna.
English: The first study compared Tyverb in combination with capecitabine, with capecitabine taken alone.
Slovenian: V prvi študiji so zdravilo Tyverb v kombinaciji s kapecitabinom primerjali s kapecitabinom kot samostojnim zdravilom.
English: Palmar-plantar erythrodysaesthesia (rash and numbness on the palms and soles) is also very common when Tyverb is taken with capecitabine.
Slovenian: Kadar se zdravilo Tyverb jemlje v kombinaciji s kapecitabinom, se zelo pogosto pojavi tudi palmarno-plantarna eritrodisestezija (izpuščaji in otrplost v dlaneh in podplatih).
English: This compared with 13.0 weeks in those taking placebo in combination with letrozole.
Slovenian: Pri bolnicah, ki so prejemale placebo v kombinaciji z letrozolom, pa je to obdobje znašalo 13,0 tedna.
English: The women taking Tyverb in combination with capecitabine lived for an average of 23.9 weeks without their disease getting worse, as assessed by their doctors, compared with 18.3 weeks in the women taking capecitabine alone.
Slovenian: Po ocenah zdravnikov, ki so spremljali bolnice, se pri ženskah, ki so prejemale zdravilo Tyverb v kombinaciji s kapecitabinom, bolezen ni poslabšala v povprečju 23,9 tedna, medtem ko se pri ženskah, ki so prejemale le kapecitabin, bolezen ni poslabšala v povprečju 18,3 tedna.
English: It involved 408 women with advanced or metastatic disease that was producing large quantities of HER2 who had already been treated with anthracyclines, taxanes and trastuzumab but whose disease had got worse or come back.
Slovenian: Te ženske so že bile zdravljene z antraciklini, taksani in trastuzumabom, vendar se je njihova bolezen poslabšala oziroma ponovila.
English: Castilla 2, Edificio Berlín 2ª planta Parque Empresarial San Fernando
Slovenian: Edificio Berlín 2 a planta Parque Empresarial San Fernando
English: Unit 34/35, Block A Dunboyne Business Park Dunboyne
Slovenian: Unit 34/35, Block A Dunboyne Business Park Dunboyne Co. Meath Ireland
English: Meda AS, Askerveien 61, Postboks 194, 1371 Asker
Slovenian: Meda AS Askerveien 61 Postboks 194 1371 Asker Norway
English: Germany betapharm Arzneimittel GmbH
Slovenian: Betapharm Arzneimittel GmbH
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for bromocriptine-containing medicinal products indicated in the “prevention or suppression of physiological lactation in the immediate post-partum period and in the late post-partum period”
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Belgium Meda Pharma s.a. Chaussée de la Hulpe 166 1170 Brussels
Slovenian: Meda Pharma, s. a. Chaussée de la Hulpe 166 1170 Brussels Belgium
English: The Netherlands Meda Pharma B.V. Krijgsman 20
Slovenian: Meda Pharma, B. V. Krijgsman 20
English: United Kingdom Meda Pharmaceuticals Limited,
Slovenian: Meda Pharmaceuticals Limited
English: MEDA PHARMACEUTICALS S.A., GREECE 3 Evrytanias Str., Halandri, 15231, Attiki, Greece
Slovenian: 3 Evrytanias Str., Halandri 15231, Attiki
English: 170 09 Solana Box 906
Slovenian: 170 09 Solna Box 906
English: United Kingdom Teva UK Limited, Brampton Road,
Slovenian: Teva UK Limited Brampton Road, Hampden Park Eastbourne, East Sussex
English: S.C. BIOFARM S.A. Str. Logofăt Tăutu nr. 99, sector 3,
Slovenian: Str. Logofăt Tăutu nr. 99 sector 3, Bucureşti
English: MEDA PHARMA 25, boulevard de l'Amiral Bruix,
Slovenian: MEDA PHARMA 25, boulevard de l'Amiral Bruix 75016 Paris France
English: Skyway House,
Slovenian: Skyway House Parsonage Road
English: Verovškova 57, 1000 Ljubljana, Slovenia
Slovenian: 1526 Ljubljana Slovenia
English: Parlodel 10 mg 10 mg
Slovenian: Parlodel 10 mg
English: Portugal capsule
Slovenian: Kapsula
English: Meda AS, Solvang 8, DK-3450 Allerød, Denmark
Slovenian: DK-3450 Allerød Denmark
English: MEDA PHARMA, S.A.U.
Slovenian: MEDA PHARMA, S. A. U. Avda.
English: Gedeon Richter Plc Gyömrői út 19-21.
Slovenian: Gedeon Richter Plc Gyömrői út 19-21 H-1103 Budapest Hungary
English: Parlodel 2,5 mg 2.5 mg
Slovenian: Parlodel 2,5 mg
English: Kodaňská 1441/46
Slovenian: MEDA Pharma, s. r. o. Kodaňská 1441/46
English: Maksimirska 120/V, Zagreb
Slovenian: Sandoz, d. o. o. Maksimirska 120 V Zagreb 10 000 Croatia
English: Bishops Stortford
Slovenian: Skyway House Parsonage Road Takeley Bishops Stortford
English: 89079 Ulm germany bromocriptin-ct 2,5mg Tabletten
Slovenian: AbZ-Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany bromocriptin-ct 2,5 mg
English: PARLODEL 2,5 mg inhibition de la lactation
Slovenian: 2,5 mg lnhibition de la lactation
English: Czech Republic Medochemie Ltd. Konstantinoupoleos Str. 1_10 3011 Limassol - Tsiflikoudia Cyprus
Slovenian: 3011 Limassol - Tsiflikoudia Cyprus
English: Sandoz d.o.o.
Slovenian: Medochemie Ltd.
English: Parlodel 10mg Tablets capsule
Slovenian: Parlodel 10 mg Tablets
English: Slovak Republic MEDA Pharma s.r.o.
Slovenian: Meda Pharma s.a.
English: Slovak Republic Medochemie Ltd. 1-10 Constantinoupoleos St. 3011 Limassol,
Slovenian: 1-10 Constantinoupoleos St. 3011 Limassol Cyprus
English: Parlodel 5mg Tablets capsule
Slovenian: Parlodel 5 mg Tablets
English: Parlodel 2,5 mgTabletten
Slovenian: Parlodel 2,5 mg Tabletten
English: Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim) EMA/822769/2016
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Cavoley (pegfilgrastim) EMA/822769/2016
English: Filgrastim is very similar to a human protein called
Slovenian: Filgrastim je zelo podoben človeški
English: On 16 November 2016, Gedeon Richter Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cavoley, for reducing neutropenia.
Slovenian: Družba Gedeon Richter Plc je 16. novembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Cavoley, namenjenim zmanjševanju nevtropenije.
English: A further study in patients receiving cancer medicines compared the safety and effectiveness of Cavoley and Neulasta.
Slovenian: V drugi študiji pri bolnikih, ki so prejemali zdravila za zdravljenje raka, so primerjali varnost in učinkovitost zdravil Cavoley in Neulasta.
English: This means that Cavoley was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Neulasta.
Slovenian: To pomeni, da naj bi bilo zelo podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v Evropski uniji, in sicer zdravilu Neulasta.
English: granulocyte-colony-stimulating factor (G-CSF).
Slovenian: beljakovini, imenovani granulocitne kolonije stimulirajoči faktor (G-CSF).
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Cavoley.
Slovenian: Družba je odbor CHMP obvestila, da trenutno ne potekajo klinična preskušanja ali programi sočutne uporabe zdravila Cavoley.
English: Withdrawal of the marketing authorisation application for Cavoley (pegfilgrastim)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Cavoley (pegfilgrastim)
English: Cavoley was developed as a ‘biosimilar' medicine.
Slovenian: Zdravilo Cavoley je bilo razvito kot „podobno biološko zdravilo“.
English: How does Cavoley work?
Slovenian: Kako zdravilo Cavoley deluje?
English: Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments because the treatments also kill white blood cells.
Slovenian: Nevtropenija je neželeni učinek določenih citotoksičnih zdravil za zdravljenje raka (zdravil, ki uničujejo celice), saj ta zdravila uničujejo tudi bele krvne celice.
English: The company presented results of studies in healthy people designed to show that Cavoley is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Slovenian: Družba je predstavila rezultate študij pri zdravih ljudeh, ki naj bi pokazale, da je zdravilo Cavoley po kemijski strukturi, čistosti, načinu delovanja in tem, kako ga telo presnavlja, zelo podobno referenčnemu zdravilu Neulasta.
English: What was Cavoley expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Cavoley uporabljalo?
English: What is Cavoley?
Slovenian: Kaj je zdravilo Cavoley?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that having considered the CHMP's conclusion, it has decided to withdraw the application but to continue developing the product and follow the CHMP's advice to eliminate the remaining uncertainty.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da se je po razmisleku o sklepu odbora CHMP odločila, da bo vlogo umaknila, vendar bo zdravilo razvijala še naprej in upoštevala nasvet odbora, naj razreši obstoječi zadržek.
English: The active substance in Cavoley, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Slovenian: Zdravilna učinkovina v zdravilu Cavoley, pegfilgrastim, je sestavljena iz filgrastima, ki je bil pegiliran (nanj je bila pritrjena kemična snov, imenovana polietilenglikol).