FrancophonIA/ELRC3.0 huggingface dataset:
English: - the CVMP assessed the information provided by the Marketing Authorisation Holder in response to the list of questions agreed by the CVMP, the argumentation provided by the Marketing Authorisation Holder in support of the request for the re-examination of the opinion and new residue data made available by the Marketing Authorisation Holder during the re-consideration of the opinion requested by the European Commission;
Slovenian: - CVMP je ocenil podatke, ki jih je posredoval imetnik dovoljenja za promet v odgovor na seznam vprašanj, ki so zanimala CVMP, argumente, ki jih je imetnik dovoljenja za promet predložil v podporo svoji prošnji za ponovno preučitev mnenja, ter nove podatke o ostankih, ki jih je imetnik dovoljenja za promet dal na voljo med ponovno preučitvijo mnenja, izvedeno na zahtevo Evropske komisije;
English: Several cases of allergic reactions in humans following the ingestion of food containing penicillin residues were reviewed.
Slovenian: Preučili so več primerov alergijske reakcije pri ljudeh po zaužitju hrane, vsebujoče ostanke penicilina.
English: Target tissue
Slovenian: MRL Ciljno tkivo
English: Whereas: - the CVMP considered the referral made under Article 35 of Directive 2001/82/EC in the interest of the Community regarding consumer safety for national marketing authorisations for Suramox 15% LA or variations of that name as referred to in Annex I;
Slovenian: Ob upoštevanju naslednjega: - Odbor je obravnaval napotitev, sproženo v skladu s členom 35 Direktive 2001/82/ES v interesu Skupnosti glede varnosti potrošnika, v zvezi z nacionalnimi dovoljenji za promet z zdravilom Suramox 15 % LA ali različic tega imena, kot so navedene v Dodatku I;
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ZAČASNI PREKLIC DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Marker residue
Slovenian: Označevalec ostanka
English: Being aware of cases of allergic reactions at very low doses, JECFA recommended that the daily intake of benzylpenicillin from food be kept as low as practicable, and in any case below 30 µg parent drug per person.
Slovenian: Zaradi primerov alergijskih reakcij pri zelo nizkih odmerkih je JEFCA priporočil, naj bo dnevni vnos benzilpenicilina s hrano tako nizek, kakor je to praktično mogoče, in na vsak način manjši od 30 µg sorodnega zdravila na osebo.
English: - the CVMP, having considered the data provided concluded that the currently established withdrawal periods for cattle and pigs are inadequate to ensure that foodstuffs obtained from the treated animals do not contain residues which might constitute a health hazard to the consumer;
Slovenian: - CVMP je ob upoštevanju predloženih podatkov zaključil, da trenutno določene karence za goveje in prašičje meso niso dovolj ustrezne, da bi zagotovili, da živila, proizvedena iz zdravljenih živali, ne vsebujejo ostankov zdravila, ki bi utegnil predstavljati nevarnost za zdravje potrošnika;
English: The data generated from these studies however, did not allow, at that stage, to establish withdrawal periods for cattle or pigs with the desired level of reliability.
Slovenian: Vendar izsledki teh raziskav na tej stopnji ne omogočajo določitve karence za govedo ali prašiče z želeno stopnjo zanesljivosti.
English: The CVMP set MRLs such that consumer intake from all foods would not exceed this 30 µg threshold.
Slovenian: CVMP je določil take MRL, da vnos z vso hrano pri potrošniku ne preseže te meje 30 µg.
English: the CVMP recommends the suspension of the marketing authorisations for Suramox 15% LA or variations of that name as referred in Annex I, presented as injectable suspension for pigs and cattle.
Slovenian: CVMP priporoča umik dovoljenj za promet z zdravilom Suramox 15 % LA in različic tega imena kot so navedene v Dodatku I, ki so na voljo kot suspenzija za injiciranje za prašiče in govedo.
English: The MAH initially provided residue data in cattle and pigs using the product under consideration at the recommended dose treatment.
Slovenian: MAH je prvotno priskrbel podatke o ostankih pri govedu in prašičih, ki so bili zdravljeni s priporočenim odmerkom obravnavanega izdelka.
English: Amoxicillin was previously evaluated by the CVMP together with other penicillins, in order to establish maximum residue limits (MRLs).
Slovenian: Predhodno je CVMP ocenil amoksicilin skupaj z ostalimi penicilini, da bi določil najvišje mejne vrednosti ostankov zdravila (MRL).
English: Neither the statistical (large extrapolation) nor the alternative approach (values above the MRL at the last time point) could be applied to the data provided, and therefore a withdrawal period could not be set according to the “Note for guidance: Approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95-FINAL).
Slovenian: Ker ni bil za priskrbljene podatke primeren niti statističen (velika ekstrapolacija) niti alternativen pristop (vrednosti nad MRL ob zadnji časovni točki), karenca v skladu z »Navodila: Pristop k usklajevanju karenc« (EMEA/CVMP/036/95-FINAL) ni bila določena.
English: In the detailed grounds for the re-examination of the opinion the MAH argued that the three out of eight kidney samples with amoxicillin concentrations higher than the MRL at 21 and 27 days after the last administration should be considered artefacts because of the abnormal kinetic depletion residue profile.
Slovenian: V podrobnostih o podlagi za svojo prošnjo za ponovno preučitev mnenja MAH trdi, da je treba tri izmed osmih vzorcev ledvic s koncentracijami amoksicilina višjimi od MRL na 21. in 27. dan po zadnjem dajanju, imeti za artefakte zaradi nenormalnega kinetičnega profila izločanja ostankov.
English: Strength Animal species Frequency and route of administration
Slovenian: Živalska vrsta Pogostost in način uporabe zdravila
English: Furthermore, the method provided was validated over a range using fortified samples.
Slovenian: Poleg tega je bila uporabljena metoda potrjena z uporabo ojačanih vzorcev v določenem obsegu.
English: In order to ensure a harmonised conclusion on the establishment of the withdrawal periods, it is highly recommended that any new residue depletion studies intended for the lifting of the suspensions of the marketing authorisations are submitted to the CVMP for assessment.
Slovenian: Da bi zagotovili usklajen sklep o določitvi karenc, je močno priporočljivo, da se morebitne nove raziskave izločanja ostankov, namenjene za odpravo začasnega preklica dovoljenja za promet, predložijo v oceno CVMP.
English: The MAH finally argued that the fluorimetric method used was capable of detecting residues of amoxicillin degradation products, and thus, the concentrations reported may have been overestimated.
Slovenian: Nazadnje je MAH trdil, da je bilo z uporabljeno fluorimetrično metodo možno zaznati ostanke produktov, ki nastanejo ob razgradnji amoksicilina, in so torej sporočene koncentracije lahko previsoko ocenjene.
English: Assuming the MAH has a valid scientific point, and thus the method should have included an additional clean-up step to improve recovery, the weakness of this argument was that all sample results could therefore be understated.
Slovenian: Ob predpostavki, da MAH ponuja veljavno znanstveno razlago in bi torej metoda za izboljšanje obnovljivosti morala vključevati dodaten očiščevalni korak, pa je bil ta argument pomanjkljiv, saj bi to pomenilo, da bi lahko bili vsi rezultati iz vzorcev nezadostni.
English: 15 mg amoxicillin/kg bw (equivalent to 1ml/10 kg)
Slovenian: 15 mg amoksicilina/kg tt (enakovredno 1ml/10 kg)
English: As a validated method was used with appropriate controls, the CVMP did not consider it appropriate to invalidate the method whilst arguing for its validity for all other results.
Slovenian: Ker je bila potrjena metoda uporabljena z ustreznimi kontrolami, je CVMP menil, da je ni primerno razveljaviti, in hkrati trditi, da je veljavna za vse druge rezultate.
English: In a complementary study, eight pigs were slaughtered at 30 and 36 days after treatment with Suramox.
Slovenian: V dopolnilni raziskavi je bilo zaklanih osem prašičev 30 in 36 dni po zdravljenju z zdravilom Suramox.
English: The data available did not allow establishing a reliable withdrawal period based on residues in kidney by either the statistical or the alternative method.
Slovenian: Razpoložljivi podatki niso omogočali zanesljive določitve karence glede na ostanke v ledvicah niti po statistični niti po alternativni metodi.
English: As the validation data fell within accepted specifications, the CVMP could not agree that it was appropriate to simply dismiss the findings above the MRL as artefacts.
Slovenian: Ker so potrjeni podatki znotraj sprejetih specifikacij, se CVMP ne more strinjati, da je primerno izsledke, ki presegajo MRL, enostavno prezreti kot artefakte.
English: These samples were chilled, homogenized and stored at -80°C until analysis 4 to 6 months later; the storage stability was confirmed.
Slovenian: Vzorce so ohladili, homogenizirali in do analize, 4 do 6 mesecev kasneje, hranili pri -80 °C; obstojnost skladiščenja je bila potrjena.
English: For the referral procedure, the MAH presented one residue study in cattle and one in pigs.
Slovenian: Za napotitveni postopek obravnave je MAH predstavil eno raziskavo ostankov pri govedu in eno pri prašičih.
English: - the CVMP considered that based on the residue depletion data provided concerning the depletion of residues of amoxicillin when administered by injection it was not possible to establish a withdrawal period for cattle and pigs as:
Slovenian: - CVMP je menil, da na podlagi predloženih podatkov o izločanju ostankov v zvezi z izločanjem ostankov amoksicilina, kadar je ta injiciran, ni bilo mogoče določiti karence za govedo in prašiče, ker:
English: Liver Kidney Milk
Slovenian: Mišica Maščoba Jetra Ledvica Mleko
English: When providing oral explanations to the Committee concerning the new data submitted the MAH agreed however that withdrawal periods for cattle could not be set on the basis of the data available.
Slovenian: Vendar pa se je pri podajanju ustne razlage v zvezi z novo predloženimi podatki Odboru imetnik dovoljenja za promet strinjal, da na podlagi razpoložljivih podatkov ni mogoče določiti karenc za govedo.
English: Considering that the study was GLP-compliant, the CVMP cannot lightly dismiss the results in question, especially as there were a total of three ‘positive' samples found.
Slovenian: Ob upoštevanju, da je bila raziskava v skladu z dobro laboratorijsko prakso, CVMP ne more kar tako prezreti teh rezultatov, zlasti ker so bili v celoti najdeni trije "pozitivni" rezultati.
English: Benzylpenicillin was considered by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) at its 36th meeting in 1990.
Slovenian: Na 36. seji Skupnega strokovnega odbora FAO/WHO za aditive za živila (JECFA) leta 1990 je bil obravnavan benzilpenicilin.
English: Establishment of the withdrawal period following consideration of all residue studies for pigs and cattle available
Slovenian: Določitev karence na podlagi upoštevanja vseh razpoložljivih raziskav ostankov pri prašičih in govedi
English: From the original residue depletion study in pigs, the CVMP concluded that the kidney was the limiting tissue for the establishment of a withdrawal period.
Slovenian: Na podlagi prvotne študije o izločanju ostankov pri prašičih je CVMP zaključil, da so bila ledvice omejevalno tkivo za določitev karence.
English: However, the residue depletion profile in kidney indicated a non-regular profile.
Slovenian: Vendar je profil izločanja ostankov v ledvicah pokazal neredno izločanje.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SURAMOX 15% LA3
Slovenian: ZNANSTVENI ZAKLJUČKI SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SURAMOX 15 %
English: Pharmacologically active substance
Slovenian: Farmakološka učinkovina
English: The injection sites contained the highest residue concentrations followed by kidney.
Slovenian: Mesta injiciranja so vsebovala najvišje koncentracije ostankov, na drugem mestu so sledile ledvice.
English: With the submission of the new residue study for cattle the MAH proposed a withdrawal period of 96 days based on the statistical method.
Slovenian: Ob predložitvi novih raziskav ostankov za govedo je imetnik dovoljenja za promet predlagal karenco 96 dni, temelječo na statistični metodi.
English: In order to consider lifting the suspension of the marketing authorisations residue depletion data on later time points allowing to establish withdrawal periods for both cattle and pigs meat and offal would be necessary.
Slovenian: Za odpravo umika dovoljenja za promet z zdravilom bi bili potrebni podatki o izločanju ostankov za kasnejše časovne točke, ki bi omogočali določitev karenc za meso in drobovino govedi in prašičev.
English: Sixteen cattle were slaughtered at 7, 14, 46 and 57 days after treatment with Suramox.
Slovenian: Šestnajst glav govedi je bilo zaklanih 7, 14, 46 in 57 dni po zdravljenju z zdravilom Suramox.
English: Residues in kidney ranged from below the limit of quantification to 150 µg/kg at 7 days and were below the limit of quantification at later time points.
Slovenian: Ostanki v ledvicah so bili po 7 dneh v razponu od vrednosti pod mejo kvantifikacije do 150 µg/kg, ob drugih časovnih točkah pa pod mejo kvantifikacije.
English: However, taking into account also the two new residue depletion studies in pigs, the CVMP concludes that the totality of the data indicates that the residue depletion at the injection site will determine the withdrawal period.
Slovenian: Vendar pa CVMP, upoštevaje tudi dve novi raziskavi izločanja ostankov pri prašičih, ugotavlja, da celokupni podatki nakazujejo, da je za določitev karence odločilno izločanje ostankov.
English: These samples were chilled, homogenised and stored at -80°C until analysis 4 to 6 months later (storage stability confirmed).
Slovenian: Vzorce so ohladili, homogenizirali in do analize, 4 do 6 mesecev kasneje, hranili pri -80 °C (obstojnost skladiščenja potrjena).
English: For pigs of 40-50 kg, it was possible to derive a withdrawal period of 35 days based on injection site residues.
Slovenian: Pri prašičih, težkih 40-50 kg, je bila na podlagi ostankov na mestih injiciranja določena karenca 35 dni.
English: Sixteen pigs were slaughtered at 7, 14, 21 and 27 days after treatment with Suramox.
Slovenian: Šestnajst prašičev je bilo zaklanih 7, 14, 21 in 27 dni po zdravljenju z zdravilom Suramox.
English: All samples were analysed for amoxicillin concentrations using an HPLC-UV method (HPLC-fluorescence for liver) with a claimed limit of quantification of 25 µg/kg for all tissues.
Slovenian: Pri vseh vzorcih so analizirali koncentracije amoksicilina z metodo HPLC-UV (HPLC-fluorescenca za jetra) z zahtevano mejo kvantifikacije 25 µg/kg za vsa tkiva.
English: The results reported indicated residue values below the muscle MRL at all time points except for 1 animal at the last time point, which had a concentration of 6 times above the muscle MRL. For one animal the result at 30 days was not reported.
Slovenian: Rezultati, o katerih so poročali, so nakazovali vrednosti ostankov pod MRL za mišično maso ob vseh časovnih točkah, razen pri eni živali ob zadnji časovni točki, pri kateri je bila koncentracija šestkrat večja od MRL za mišično maso.
English: With the submission of the new residue studies for pigs the MAH proposed a withdrawal period of 38 days based on the two studies provided.
Slovenian: Ob predložitvi novih študij o ostankih zdravila za prašiče je imetnik dovoljenja za promet predlagal karenco 38 dni, temelječo na dveh predloženih študijah.
English: All samples were analysed for amoxicillin concentrations using an HPLC-UV method with a claimed limit of quantification of 25 µg/kg for all tissues.
Slovenian: Pri vseh vzorcih so analizirali koncentracije amoksicilina z metodo HPLC-UV z zahtevano mejo kvantifikacije 25 µg/kg za vsa tkiva.
English: Suramox 15% LA contains amoxicillin which is a beta lactam antibiotic belonging to the group of penicillins.
Slovenian: beta-laktamski antibiotik iz skupine penicilinov.
English: In addition, samples were taken from muscle (mixed sample of hindquarter/forequarter muscle), fat (mixed sample of perirenal/omental fat), the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth).
Slovenian: Poleg tega so vzeli vzorce mišic (mešani vzorec zadnje in sprednje četrti), maščobe (mešani vzorec perirenalne maščobe/maščobe pečice), cela jetra, obe ledvici in desno (zadnje) mesto injiciranja (približne dimenzije 10 cm premera in 6 cm globine).
English: An alternative method could not be used because at the last time point residue concentrations at the injection site were up to 5 times the MRL for muscle.
Slovenian: Alternativne metode ni bilo mogoče uporabiti, ker so bile koncentracije ostankov na mestu injiciranja v zadnji časovni točki do petkrat višje od MRL za mišično maso.
English: In pigs ten male and ten female (bw 42 ± 7 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/kg bw (1 ml per 10 kg).
Slovenian: Pri prašičih je deset samcev in deset samic (tt 42 ± 7 kg) prejelo dve intramuskularni injekciji zdravila Suramox 15 % LA z odmerkom 15 mg/kg tt (1 ml na 10 kg).
English: In cattle ten male and ten female (body weight: 184 ± 24 kg) were given two intramuscular injections with Suramox 15% LA at a dose of 15 mg/kg bw (1 ml per 10 kg).
Slovenian: Pri govedu je deset samcev in deset samic (telesna teža: 184 ± 24 kg) prejelo dve intramuskularni injekciji zdravila Suramox 15 % LA z odmerkom 15 mg/kg tt (1 ml na 10 kg).
English: GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS
Slovenian: PODLAGA ZA UMIK DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: In addition, samples were taken from muscle (mixed sample of hindquarter/forequarter muscle), skin+fat in natural proportions, the entire liver, both kidneys, and the right (final) injection site (approximate dimensions of 10 cm diameter and 6 cm depth).
Slovenian: Poleg tega so vzeli vzorce mišic (mešan vzorec zadnje in sprednje četrti), kože in maščobe v naravnem razmerju, cela jetra, obe ledvici, in desno (zadnje) mesto injiciranja (približne dimenzije 10 cm premera in 6 cm globine).
English: The CVMP noted that the MAH excluded two observations as being outliers when calculating the withdrawal period.
Slovenian: CVMP je ugotovil, da je MAH pri izračunavanju karence izključil dva dobljena rezultata kot posamični napaki.
English: o in cattle, residue concentration at the injection site were still above the MRL at the last slaughter time point; o in pigs, residue concentrations in kidneys were still above the MRL at the last slaughter time point;
Slovenian: o so bile pri govedu koncentracije ostankov na mestu injiciranja v zadnji časovni točki, to je ob zakolu, še vedno višje od MRL; o so bile pri prašičih koncentracije ostankov v ledvicah še v zadnji časovni točki, to je ob zakolu, še vedno višje od MRL;
English: In the injection sites, the amoxicillin concentrations were 14209 to 109535 µg/kg at day 1, 358 to 5429 µg/kg at day 7, 182 to 2816 µg/kg at day 14, below the limit of quantification to 211 µg/kg at day 21 and below the limit of quantification to 38 µg/kg at day 27.
Slovenian: Na mestih injiciranja so bile koncentracije amoksicilina 14209 do 109535 µg/kg na 1. dan, 358 to 5429 µg/kg na 7. dan, 182 to 2816 µg/kg na 14. dan, pod mejo kvantifikacije do 211 µg/kg na 21. dan in pod mejo kvantifikacije do 38 µg/kg na 27. dan.
English: Therefore kidney was considered the tissue determining the withdrawal period.
Slovenian: Zato so bile ledvice upoštevane kot tkivo za določitev karence.
English: 2.1 Calculation of withdrawal periods for Suramox 15% LA
Slovenian: 2.1 Izračun karence za zdravilo Suramox 15 % LA
English: In kidney, amoxicillin concentrations were 5446 to 9896 µg/kg at day 1, 45 to 811 µg/kg at day 7, below the limit of quantification at day 14, below the limit of quantification to 180 µg/kg at day 21 and below the limit of quantification to 62 µg/kg at day 27.
Slovenian: V ledvicah so bile koncentracije amoksicilina 5446 do 9896 µg/kg 1. dan, 45 do 811 µg/kg na 7. dan, pod mejo kvantifikacije na 14. dan, pod mejo kvantifikacije do 180 µg/kg na 21. dan in pod mejo kvantifikacije do 62 µg/kg na 27. dan.
English: Thus, the MRLs established by the CVMP for benzylpenicillin were 50 µg/kg for edible tissues.
Slovenian: Tako je CVMP določil, da je najvišja mejna vrednost ostankov benzilpenicilina v užitnem tkivu 50 µg/kg..
English: Residues in muscle, fat, liver and kidney were below the MRL at all time points.
Slovenian: Ob vseh časovnih točkah so bili ostanki v mišični masi, maščevju, jetrih in ledvicah manjši od MRL.
English: 150 mg/ml
Slovenian: 150 mg/ml govedo, prašiči
English: Residues in the injection sites were high and still up to 5 times above the muscle MRL at the latest time point.
Slovenian: Ostanki na mestih injiciranja so bili visoki in ob zadnji časovni točki še vedno petkrat višji od MRL za mišično maso.
English: For cattle the injection site was the withdrawal time determining tissue and the residue concentrations of amoxicillin in the injection sites were still above the MRL at the last slaughter time point.
Slovenian: Pri govedu je bilo tkivo za določitev karence mesto injiciranja, vendar so bile koncentracije amoksicilina na mestih injiciranja še pri zadnji časovni točki (ob zakolu) višje od MRL.
English: One new GLP-study in cattle and two complementary GLP-residue studies in pigs were submitted during the procedure for the reconsideration of the opinion.
Slovenian: Med postopkom ponovne preučitve mnenja je bila predložena ena nova raziskava, skladna z dobro laboratorijsko prakso, pri govedu in dve dopolnilni raziskavi ostankov, skladni z dobro laboratorijsko prakso, pri prašičih.
English: Groups of 4 animals (2 male and 2 female) were slaughtered at 1, 7, 14, 21, and 36 days after the final injection.
Slovenian: Razpon vbrizgane količine je segal od 15,0 do 25,9 ml. Skupine po 4 živali (2 samca in 2 samici) so bile zaklane 1, 7, 14, 21 in 36 dni po zadnjem injiciranju.
English: Residues in muscle, fat and liver were below the MRL at all time points.
Slovenian: Ob vseh časovnih točkah so bili ostanki v mišični masi, maščevju in jetrih manjši od MRL.
English: However, the residues in kidney showed an irregular depletion profile and concentrations above the MRL were still observed at the last slaughter time point.
Slovenian: Vendar je profil izločanja ostankov v ledvicah nereden, koncentracije pa so bile še pri zadnji časovni točki (ob zakolu) višje od MRL.
English: Groups of 4 animals (2 male, 2 female) were slaughtered at 1, 7, 14, 21, and 27 days after the final injection.
Slovenian: Razpon vbrizgane količine je segal od 2,88 do 5,52 ml. Skupine po 4 živali (2 samca in 2 samici) so bile zaklane 1, 7, 14, 21 in 27 dni po zadnjem injiciranju.
English: In the injection sites, the amoxicillin concentrations were 5822 to 149831 µg/kg at day 1, below the limit of quantification to 21724 µg/kg at day 7, below the limit of quantification to 1651 µg/kg at day 14, below the limit of quantification to 472 µg/kg at day 21 and below the limit of quantification to 162 µg/kg at day 36.
Slovenian: kvantifikacije do 21724 µg/kg na 7. dan, pod mejo kvantifikacije do 1651 µg/kg na 14. dan, pod mejo kvantifikacije do 472 µg/kg na 21. dan in pod mejo kvantifikacije do 162 µg/kg na 36. dan.
English: France2
Slovenian: LA3
English: The statistical nor the alternative method could be used as at the last time point residues at the injection site were up to 6 times the MRL for muscle.
Slovenian: Ker so bile koncentracije ostankov na mestu injiciranja v zadnji časovni točki do šestkrat višje od MRL za mišično maso, ni bilo mogoče uporabiti ne statistične ne alternativne metode.
English: This summary was last updated on 14/01/2010.
Slovenian: Povzetek je bil nazadnje posodobljen dne 14/01/2010.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for RESPIPORC FLU3 to IDT Biologika GmbH on 14/01/2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom RESPIPORC FLU3, veljavno po vsej Evropski uniji, odobrila družbi IDT Biologika GmbH dne 14/01/2010.