natgillin/translations-raw huggingface dataset:
• The Committee considered the notification under Article 20 of Regulation (EC) No 726/2004 for
• odbor je upošteval obvestilo v skladu s členom 20 Uredbe (ES) št. 726/2004 za zdravilo MACI in osnutek mnenja odbora CHMP, ki ga pripravil odbor CAT;
• The Committee concluded that in view of the absence of an authorised manufacturing site for the active substance, finished product and batch release, the requirements laid down in Article 41 of
• odbor CHMP je zaključil, da zaradi neobstoja odobrenega mesta za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje serij niso več izpolnjene zahteve, opredeljene v členu 41 Direktive 2001/83/ES.
For the suspension of the marketing authorisation to be lifted, the MAH shall register a site for manufacture of the active substance, finished product and batch release.
Za preklic začasnega umika dovoljenja za promet z zdravilom mora imetnik dovoljenja za promet z zdravilom registrirati mesto za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje serij.
For the suspension to be lifted, the MAH shall register a manufacturing site for the active substance, finished product and batch release (see Annex II).
Za preklic začasnega umika mora imetnik dovoljenja za promet z zdravilom registrirati mesto za proizvodnjo zdravilne učinkovine in končnega izdelka ter sproščanje serij (glejte Prilogo II).
ATC vet code: QI07AB01.
Oznaka ATC vet: QI07AB01.
Pharmacotherapeutic group: Immunologicals for canidae, inactivated bacterial vaccines.
Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae) - inaktivirana bakterijska cepiva.
* Antibody micro agglutination-lytic reaction.
* reakcija mikroaglutinacije-lize protiteles.
Duration of immunity: At least one year following the primary vaccination course for all components of Versican Plus L4.
Trajanje imunosti: Vsaj eno leto po osnovnem cepljenju proti vsem komponentam cepiva Versican Plus L4.
No data are available on the safety of an overdose.
Ni podatkov o varnosti ob prevelikem odmerjanju.
50 x 1 dose
50 x 1 odmerek
Type I glass vial containing 1 ml closed with a chlorobutyl rubber stopper and aluminium cap.
Viala iz stekla tipa I, ki vsebuje 1 ml cepiva, zaprta z zamaškom iz klorobutilne gume in aluminijasto zaporko.
Vaccination against distemper, adeno, parvo and parainfluenza virus (DHPPi):
Cepljenje proti virusu pasje kuge, adenovirusu, parvovirusu in virusu parainfluence (DHPPi):
10 DATE OF REVISION OF THE TEXT Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
PACKAGE SIZE 25 x 1 dose
VELIKOST PAKIRANJA 25 x 1 odmerek
Plastic box containing 50 vials (1 ml).
Plastična škatla s 50 vialami (po 1 ml).
Plastic box containing 25 vials (1 ml).
Plastična škatla s 25 vialami (po 1 ml).
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products except those mentioned in section 4.8.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini, razen s tistimi navedenimi v poglavju 4.8.
Appearance: whitish liquid with fine sediment.
Videz: belkasta tekočina s finim sedimentom.
Once mixed, the contents of the vial should appear a whitish to yellowish colour with a slight opalescence.
Po zmešanju mora vsebina viale izgledati belkasto do rumenkasto z rahlo opalescenco.
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Cepivo je namenjeno aktivni imunizaciji zdravih pasjih mladičev in odraslih psov proti boleznim, ki jih povzročajo Leptospira interrogans serološka skupina Australis serovar Bratislava, Leptospira interrogans serološka skupina Canicola serovar Canicola, Leptospira kirschneri serološka skupina Grippotyphosa serovar Grippotyphosa in Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae.
Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Water for injections
Suspenzija: natrijev klorid kalijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat voda za injekcije
Name and address of the manufacturer of the biological active substances
Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin)
Primary vaccination scheme: Two doses of Versican Plus L4 3-4 weeks apart from 6 weeks of age.
Dva odmerka cepiva Versican Plus L4 v razmaku 3-4 tednov od starosti 6 tednov naprej.
ADVICE ON CORRECT ADMINISTRATION Shake well and administer immediately the entire contents (1 ml) of the product.
Pred uporabo dobro pretresite in takoj aplicirajte celotno vsebino (1 ml).
PACKAGE LEAFLET: Versican Plus L4 suspension for injection for dogs
Versican Plus L4 suspenzija za injiciranje za pse
EXPIRY DATE EXP {month/year} Once broached, use immediately.
EXP {mesec/leto} Načeto zdravilo uporabite takoj.
Suspension (inactivated):
Učinkovina(e): Sus pe nzija (inaktivirana):
ALR* titre ≥ 1:40
titer ALR* ≥ 1:40
Active substances:
Pomožna(pomožne) snovi:
VIAL (1 ML SUSPENSION)
VIALA (1 ML SUSPENZIJE) IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
Onset of immunity: 4 weeks after completion of the primary course.
4 tedne po zaključku osnovnega cepljenja.
Re-vaccination scheme: A single dose of Versican Plus L4 to be given annually.
Enkratni odmerek cepiva Versican Plus L4 letno.
Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versican Plus DHPPi and Versican Plus Pi. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen s cepivoma Versican Plus DHHPi in Versican Plus Pi.
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus L4 suspension for injection for dogs
NAVODILO ZA UPORABO Versican Plus L4 suspenzija za injiciranje za pse
Once broached, use immediately.
Načeto zdravilo uporabite takoj.
ALR* titre ≥ 1:51
titer ALR* ≥ 1:51
If protection against DHPPi or Pi is required, dogs can be vaccinated with two doses of Versican Plus DHPPi or Versican Plus Pi mixed with Versican Plus L4 3-4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus DHPPi or Versican Plus Pi should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent).
Vsebino viale cepiva Versican Plus DHPPi ali Versican Plus Pi je treba rekonstituirati z vsebino viale cepiva Versican Plus L4 (namesto vehikla).
L. kirschneri serovar Grippotyphosa
L. kirschneri, serološka skupina Grippotyphosa, serovar Grippotyphosa.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products other than those mentioned in section 8.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili za uporabo v veterinarski medicini.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versican Plus DHPPi and Versican Plus Pi. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini razen s cepivoma Versican Plus DHHPi in Versican Plus Pi.
L. interrogans serovar Icterohaemorrhagiae
L. interrogans serovar Icterohaemorrhagiae titer ALR ≥ 1:51
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
− to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae and
L. interrogans, serološka skupina Canicola,serovar Canicola ter L. interrogans, serološka skupina Icterohaemorrhagiae, serovar Icterohaemorrhagiae in
Suspension:
Nastop imunosti:
Overdose (symptoms, emergency procedures, antidotes): No data are available on the safety of an overdose.
Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi):
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
PHARMACEUTICAL FORM Suspension for injection
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
4.2 Indications for use, specifying the target species
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Aktivna imunizacija psov, starejših od 6 tednov:
10 July 2015
10. julij 2015
This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
To pomeni, da je kljub pomanjkljivim dokazom iz kliničnih preskušanj učinkovitost teh zdravil rastlinskega izvora verjetna in da obstajajo dokazi, da so se na ta način varno uporabljala že vsaj 30 let (najmanj 15 let tudi v EU).
At the time of the HMPC assessment, no side effects had been reported with these medicines.
V času ocene odbora HMPC v zvezi s temi zdravili niso poročali o nobenih neželenih učinkih.
For further information, see the HMPC assessment report.
Za podrobnejše informacije glejte poročilo o oceni zdravila odbora HMPC.
Mouse-ear hawkweed EMA/HMPC/331455/2015
zel in korenina dolgodlakave škržolice EMA/HMPC/331455/2015
Mouse-ear hawkweed medicines must not be used in patients with conditions in which a reduced fluid intake is recommended (such as severe heart or kidney disease).
Zdravila z zeljo in korenino dolgodlakave škržolice se ne smejo uporabljati pri bolnikih s stanji, pri katerih je priporočeno zmanjšano uživanje tekočine (kot je huda srčna ali ledvična bolezen).
The HMPC noted the lack of clinical studies with mouse-ear hawkweed, but took into account the well documented use of this herbal medicine for the above uses.
Odbor HMPC je izpostavil pomanjkanje kliničnih študij z zeljo in korenino dolgodlakave škržolice, vendar je upošteval dobro dokumentirano uporabo tega zdravila rastlinskega izvora pri zgoraj navedenih načinih uporabe.
Mouse-ear hawkweed is the common name for the above-ground parts (which may include flowers) and parts of the root of the plant Hieracium pilosella L. The plant is cultivated or gathered to obtain the plant parts for medicinal use.
Zel in korenina dolgodlakave škržolice je splošno ime za nadzemne dele (ki lahko vključujejo cvetove) in dele korenine rastline Hieracium pilosella L. Rastlina se goji in nabira za pridobivanje delov za medicinsko uporabo.
Further information on the risks associated with mouse-ear hawkweed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo zel in korenino dolgodlakave škržolice, vključno z ustreznimi previdnostmi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
The HMPC conclusions on the use of mouse-ear hawkweed medicines for the relief of minor urinary problems are based on their ‘traditional use'.
Zaključki odbora HMPC glede uporabe zdravil z zeljo in korenino dolgodlakave škržolice za lajšanje manjših težav s sečili temeljijo na njihovi „tradicionalni uporabi“.
This summary is not intended to provide practical advice on how to use medicines containing mouseear hawkweed.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo zel in korenino dolgodlakave škržolice.
The HMPC concluded that, on the basis of its long-standing use, mouse-ear hawkweed can be used as a mild diuretic (a medicine to increase production of urine) for the relief of minor problems of the urinary tract (the structures that carry urine).
Odbor HMPC je sklenil, da se lahko na podlagi njune dolgotrajne uporabe zel in korenina dolgodlakave škržolice uporabljata kot blag diuretik (zdravilo, ki poveča tvorbo urina) za lajšanje manjših težav s sečili (organov, po katerih se pretaka urin).
Mouse-ear hawkweed should only be used in adults.
Zel in korenina dolgodlakave škržolice se smeta uporabljati samo pri odraslih.
Herbal medicines containing mouse-ear hawkweed are usually available as a herbal tea to be drunk and in solid forms to be taken by mouth.
Zdravila rastlinskega izvora, ki vsebujejo zel in korenino dolgodlakave škržolice, so običajno na voljo kot zdravilni čaj za pitje in v trdnih oblikah, ki se zaužijejo skozi usta.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of mouse-ear hawkweed.
To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo zeli in korenine dolgodlakave škržolice.
Information on the use and licensing of mouse-ear hawkweed medicines in EU Member States should be obtained from the relevant national authorities.
Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo zel in korenino dolgodlakave škržolice, v državah članicah EU se obrnite na pristojni nacionalni organ.
Any applications for the licensing of medicines containing mouse-ear hawkweed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo zel in korenino dolgodlakave škržolice, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
Detailed instructions on how to take mouse-ear hawkweed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Podrobna navodila o tem, kako jemati zdravila z zeljo in korenino dolgodlakave škržolice ter kdo jih sme uporabljati, so v navodilu za uporabo, ki je priloženo zdravilu.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing mouse-ear hawkweed.
Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo zel in korenino dolgodlakave škržolice.
Further information on the HMPC assessment of mouse-ear hawkweed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Dodatne informacije o oceni zdravil, ki vsebujejo zel in korenino dolgodlakave škržolice, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“«: ema.europa.eu/Find medicine/Herbal medicines for human use.
How are mouse-ear hawkweed medicines approved in the EU?
Kako so zdravila, ki vsebujejo zel in korenino dolgodlakave škržolice, odobrena v EU?
Herbal medicine: summary for the public
Zdravilo rastlinskega izvora: povzetek za javnost zel in korenina dolgodlakave škržolice
Mouse-ear hawkweed preparations are obtained by comminuting (reducing into tiny pieces) or powdering the dried plant parts.
Pripravki zeli in korenine dolgodlakave škržolice se pridobivajo z drobljenjem (zmanjševanjem na majhne delce) posušenih rastlinskih delov ali njihovim mletjem v prah.
For more information about treatment with mouse-ear hawkweed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravili, ki vsebujejo zel in korenino dolgodlakave škržolice, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
What evidence supports the use of mouse-ear hawkweed medicines?
Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo zel in korenino dolgodlakave škržolice?
For practical information about using mouse-ear hawkweed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
What is mouse-ear hawkweed?
Kaj je zel in korenina dolgodlakave škržolice?
What are the risks associated with mouse-ear hawkweed medicines?
Kakšna tveganja so povezana z zdravili, ki vsebujejo zel in korenino dolgodlakave škržolice?
Other information about mouse-ear hawkweed medicines
Druge informacije o zdravilih, ki vsebujejo zel in korenino dolgodlakave škržolice
Mouse-ear hawkweed medicines are generally well tolerated.
Zdravila, ki vsebujejo zel in korenino dolgodlakave škržolice, bolniki običajno dobro prenašajo.
The recommended dose is 300 mg twice a day on the first day followed by 300 mg once a day thereafter; the duration of treatment depends on the severity of the disease and the patient's response.
Priporočeni odmerek je 300 mg dvakrat na dan na prvi dan zdravljenja, temu pa sledi jemanje 300-miligramskega odmerka enkrat na dan, pri čemer je trajanje zdravljenja odvisno od resnosti bolezni in bolnikovega odziva.
It works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Deluje tako, da preprečuje tvorbo ergosterola, ki je pomembna sestavina celičnih sten glivic.
Further information on Posaconazole Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/posaconazole-accord.
Nadaljnje informacije o zdravilu Posaconazole Accord so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/posaconazole-accord.
The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Izvedlo je tudi študije, ki so pokazale, da je zdravilo „bioekvivalentno“ referenčnemu zdravilu.
Gastro-resistant means that the tablets pass through the stomach without being broken down until they reach the intestine.
„Gastrorezistentne“ pomeni, da tableta potuje skozi želodec, razgrajevati pa se začne šele, ko prispe v črevesje.
The European Medicines Agency concluded that, in accordance with EU requirements, Posaconazole Accord has been shown to have comparable quality and to be bioequivalent to Noxafil.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Posaconazole Accord primerljivo raven kakovosti in je bioekvivalentno zdravilu Noxafil.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Noxafil, and do not need to be repeated for Posaconazole Accord.
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Noxafil, zato jih ni treba ponoviti za zdravilo Posaconazole Accord.
Because Posaconazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Posaconazole Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Posaconazole Accord is also used to prevent invasive fungal infections in patients whose immune system is weakened because of treatments they are receiving for blood or bone marrow cancers or medicines used in haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is replaced by stem cells from a donor to form new bone marrow).
Zdravilo Posaconazole Accord se uporablja tudi za preprečevanje invazivnih glivičnih okužb pri bolnikih, katerih imunski sistem je oslabljen zaradi zdravil, ki jih prejemajo za zdravljenje krvnega ali kostnega raka, ali zdravil, ki se uporabljajo pri presaditvi hematopoetskih matičnih celic (postopku, pri katerem se bolnikov kostni mozeg nadomesti z darovanimi matičnimi celicami, kar omogoča tvorbo novega kostnega mozga).
Posaconazole Accord is an antifungal medicine used to treat adults with the following fungal diseases, when treatments with other antifungal medicines (amphotericin B, itraconazole or fluconazole) cannot be tolerated or have failed:
Posaconazole Accord je protiglivično zdravilo, ki se uporablja za zdravljenje odraslih z naslednjimi glivičnimi obolenji, kadar so bila druga protiglivična zdravila (amfotericin B, itrakonazol ali flukonazol) neuspešna ali jih bolnik ni mogel prenašati:
For more information about using Posaconazole Accord, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Posaconazole Accord glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Posaconazole Accord are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Posaconazole Accord, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
As for every medicine, the company provided studies on the quality of Posaconazole Accord.
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Posaconazole Accord.
What measures are being taken to ensure the safe and effective use of Posaconazole Accord?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Posaconazole Accord?
An overview of Posaconazole Accord and why it is authorised in the EU
Pregled zdravila Posaconazole Accord in zakaj je odobreno v EU
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Posaconazole Accord have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Posaconazole Accord upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Posaconazole Accord is available as gastro-resistant tablets (100 mg).
Zdravilo Posaconazole Accord je na voljo v obliki gastrorezistentnih tablet (100 mg).
• chromoblastomycosis and mycetoma (long-term fungal infections of the skin or the tissue just below the skin, usually caused by fungal spores infecting wounds due to thorns or splinters),
• kromoblastomikoze in micetoma (dolgotrajnih glivičnih okužb kože in podkožnega tkiva, ki ju navadno povzročajo glivične spore, ki okužijo rane, nastale zaradi trnov ali trsk),
This means that Posaconazole Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Noxafil.
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Noxafil.