The submitted data for the indication“symptomatic gastroesophageal reflux disease” support this the indication.
Predloženi podatki za indikacijo» simptomatska gastroezofagealna refluksna bolezen« podpirajo to indikacijo.
As regards the use of spirodiclofen on strawberries, the submitted data are not sufficient to set a new MRL.
Predloženi podatki o uporabi spirodiklofena na jagodah ne zadostujejo za določitev nove MRL.
Germany considered that the submitted data was insufficient for granting a marketing authorisation for the proposed indications.
Nemčija je menila, da predloženi podatki niso bili zadostni za odobritev dovoljenja za promet z zdravilom za predlagane indikacije.
As regards the use of bixafen on oilseed rape, linseed,poppy seed and mustard seed, the submitted data are not sufficient to set a new MRL.
Predloženi podatki o uporabi biksafena na oljni ogrščici, lanenem semenu, makovem semenu in gorčičnem semenu ne zadostujejo za določitev nove MRL.
In 2012 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1 Ovis to convert to normal.
Leta 2012 je CVMP menil, da predloženi podatki zadostujejo, da se dovoljenje za promet z zdravilom Zulvac 1 Ovis spremeni v običajno.
The Authority concluded in its reasoned opinions that,as regards the use of ametoctradin on spring onions, the submitted data are not sufficient to set a new MRL.
Agencija je v obrazloženih mnenjih ugotovila, da predloženi podatki o uporabi ametoktradina na spomladanski čebuli ne zadostujejo za določitev nove MRL.
In 2013 the CVMP considered that the submitted data were adequate for the authorisation of BTVPUR AlSap 1 to convert to a normal status.
Leta 2013 je CVMP menil, da predloženi podatki zadostujejo, da dovoljenje za promet s cepivom BTVPUR AlSap 1 dobi običajen status.
The approved calendar for the whole year is already ready,and the inhabitants of Russia have the opportunity to now dispose of the submitted data and plan work and rest.
Odobreni koledar za celo leto je že pripravljenin prebivalci Rusije imajo možnost, da zdaj razpolagajo s predloženimi podatki in načrtujejo delo in počitek.
The administrator shall assume responsibility for the submitted data only when they are sent in an appropriate manner.
Skrbnik prevzame odgovornost za posredovane podatke zgolj takrat, ko so posredovani na ustrezen način.
Based on the submitted data, there appears to be an effect for veralipride in the treatment of vasomotor symptoms associated with the menopause.
Na podlagi predloženih podatkov je videti, da ima veraliprid določen učinek pri zdravljenju vazomotoričnih simptomov, povezanih z menopavzo.
If the data controller concludes an employment contract with an applicant, the submitted data will be stored for the purpose of processingthe employment relationship in compliance with legal requirements.
Če upravljavec s prosilcem sklene pogodbo o zaposlitvi, bodo posredovani podatki shranjeni za namene delovnega razmerja v skladu z zakonom.
The submitted data on the use of maintenance antisecretory therapy to prevent duodenal ulcer recurrence predates the use of such eradication therapy.
Predloženi podatki v zvezi z vzdrževalnim antisekretornim zdravljenjem z namenom preprečevanja ponovitev razjed dvanajstnika pogojujejo uporabo takega eradikacijskega zdravljenja.
If the data controller concludes an employment contract with an applicant, the submitted data will be stored for the purpose of processingthe employment relationship in compliance with legal requirements.
Če odgovorni za obdelavo podatkov s kandidatom sklene pogodbo o zaposlitvi, bodo posredovani podatki v skladu z zakonodajo shranjeni za namene sklenitve delovnega razmerja.
The submitted data needs to be viewed in the context of current clinical practice, which would mandate H. pylori screening and eradication therapy in the treatment of duodenal ulcers.
Predložene podatke je potrebno obravnavati v luči trenutne klinične prakse, ki bi naj predvidevala presejanje in eradikacijsko zdravljenje H. pylori pri zdravljenju razjed dvanajstnika.
If the data controller concludes an employment contract with an applicant, the submitted data will be stored for the purpose of processingthe employment relationship in compliance with legal requirements.
Če oseba upravljavca sklene s prijaviteljem na delovno mesto pogodbo o zaposlitvi, potem bodo posredovani podatki shranjeni za namene izvedbe zaposlitvenega razmerja z upoštevanjem zakonodaje.
Withdrawn Indications Overall, the CHMP considered that the therapeutic indication“ acute sinusitis” could not be accepted, as the most commonly involved pathogen in this infection, Streptococcus pneumoniae, is only intermediately susceptible to ciprofloxacin andits efficacy in this indication is poorly substantiated by the submitted data.
Izbrisane indikacije CHMP je menil, da indikacija„ akutni sinuzitis“ ne more biti sprejemljiva, saj je najbolj pogost patogen pri tej okužbi Streptococcus pneumoniae, ki pa je le začasno dovzeten na ciprofloksacin,tako da učinkovitost pri tej indikaciji s predloženimi podatki ni ustrezno utemeljena.
In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 8 Ovis to convert to a normal status.
Leta 2012 je CVMP menil, da predloženi podatki zadostujejo, da se dovoljenje za promet z zdravilom Zulvac 1 Ovis spremeni v običajno.
Because the benefit/ risk assessment for these indications was negative for the originator product and because the indications were consequently deleted from the authorised indications for all bleomycin-containing products in Germany, the indications were regarded as new indications,and the objecting member state considered that the submitted data was insufficient for granting a marketing authorisation for the proposed new indications.
Ker je bilo ocena koristi in tveganj teh indikacij za originatorsko zdravilo negativno in ker so v Nemčiji te indikacije posledično izbrisali iz odobrenih indikacij vseh zdravil, ki vsebujejo bleomicin, so indikacije upoštevali kot nove indikacije,ugovarjajoča država članica pa je menila, da predloženi podatki ne zadostujejo za odobritev dovoljenja za promet z zdravilom za predlagane nove indikacije.
In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 1+8 Ovis to convert to a normal status.
Leta 2013 je CVMP menil, da predloženi podatki zadostujejo, da dovoljenje za promet s cepivom ZULVAC 1+8 Ovis dobi običajen status.
The CHMP assessed the MAH responses and the submitted data, noting that Risperdal Consta was developed for the maintenance treatment of schizophrenia and adopting a harmonised wording that conveys the concept of a therapy to be administered after a disease has been brought under control.
CHMP je ocenil odgovore in predložene podatke ter izjavil, da je bilo zdravilo Risperdal Consta razvito za vzdrževalno zdravljenje shizofrenije in sprejel usklajeno besedilo, ki odraža terapevtski koncept namenjen uporabi po tem, ko je bolezen ustrezno nadzorovana.
In 2014 the CVMP considered that the submitted data were adequate for the authorisation of Coxevac to convert to a normal status.
Leta 2014 je odbor CVMP menil, da predloženi podatki zadostujejo, da se dovoljenje za promet s cepivom Coxevac spremeni v običajno dovoljenje.
The Commission may share the submitted data so far as necessary in specific cases with competent authorities of the Parties concerned and may do either of the following:.
Komisija lahko v določenih primerih izmenjuje predložene podatke, kolikor je to potrebno, s pristojnimi organi zadevnih pogodbenic in lahko sprejme enega od naslednjih ukrepov:.
Note: The Data Connection Wizard will not enable the submit data connection in a browser-compatible form template.
Opomba: Čarovnik za povezavo podatkov ne bo omogočite Pošlji podatkovne povezave v predlogi obrazca, združljiva z brskalnikom.
If InfoPath disables the submit data connection, the main data connection for your form template will contain only a query data connection.
Če InfoPath onemogoči Pošlji podatkovne povezave, glavno podatkovno povezavo za predlogo obrazca, bo vsebovala le poizvedbe podatkovne povezave.
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