natgillin/translations-raw huggingface dataset:
Therefore, the Agency will continue providing technical support to the EC with respect to discussion in Parliament and Council on their proposal for revision of the veterinary legislation, including on amendments to the framework for authorisation of innovative veterinary medicines, simplification of post-authorisation maintenance of veterinary products, pharmacovigilance and other aspects.
Agencija bo zato Evropski komisiji še naprej zagotavljala tehnično podporo v zvezi z razpravo v Evropskem parlamentu in Svetu glede predloga za revizijo veterinarske zakonodaje, med drugim o predlaganih spremembah okvira za odobritev inovativnih zdravil za uporabo v veterinarski medicini, poenostavitvi ohranjanja proizvodov za uporabo v veterinarski medicini po pridobitvi dovoljenja za promet, farmakovigilanci in drugih vidikih.
Growing interdependencies between committees and scientific disciplines in the decision-making further emphasise the need to continuously simplify and align processes, improve quality assurance and quality control, increase robustness of the processes and reach higher efficiency of the evaluation procedures.
Vse večja medsebojna odvisnost odborov in znanstvenih disciplin pri odločanju dodatno poudarja potrebo po nenehnem poenostavljanju in usklajevanju postopkov, izboljševanju zagotavljanja in nadzora kakovosti, povečevanju zanesljivosti procesov in doseganju večje učinkovitosti postopkov vrednotenja.
The move towards developing more targeted and individualised medicines, continuous development and use of state-of-the-art knowledge and technologies in drug development, and integration of development and use of medicines and medical devices all contribute to the increasing complexity of the scientific advice and other Agency's activities.
Premik v smeri razvoja bolj ciljno usmerjenih in individualiziranih zdravil, nenehen razvoj in uporaba najsodobnejših znanj in tehnologij pri razvoju zdravil ter povezovanje razvoja in uporabe zdravil in medicinskih pripomočkov skupaj prispevajo k vse večji zapletenosti znanstvenega svetovanja in drugih dejavnosti agencije.
The growing need for industry and academia to approach the regulators early in their endeavours increases the role of the Agency in facilitating such contact and ensuring early knowledge sharing.
Zaradi vse večje potrebe po tem, da industrija in akademski krogi do regulativnih organov pristopijo že na začetku svojih prizadevanj, ima agencija vse večjo vlogo pri olajševanju tovrstnega stika in zagotavljanju zgodnje izmenjave znanja.
EMA priorities and key influences
Prednostne naloge Evropske agencije za zdravila (EMA) in ključni dejavniki, ki vplivajo nanje
Pharmacovigilance and clinical trials legislation
Zakonodaja o farmakovigilanci in kliničnem preskušanju
The ever-increasing expectations of patients and healthcare professionals to have medicines available to treat various conditions, in combination with the continuous need for flexible and fast reaction to arising public health threats, highlights the importance of ensuring faster patient access to medicines on the market, while maintaining the quality of scientific assessment.
Vse večja pričakovanja bolnikov in zdravstvenih delavcev glede razpoložljivosti zdravil za zdravljenje različnih bolezenskih stanj ter stalna potreba po prožnem in hitrem odzivanju na pojavljajoče se nevarnosti za javno zdravje izpostavljajo pomen zagotavljanja hitrejšega dostopa bolnikov do zdravil na trgu, pri čemer pa je treba ohraniti kakovost znanstvene ocene.
The increasing complexity and globalisation of medicines supply chains will also require improved information exchange and closer, more streamlined cooperation among authorities, to ensure product and data integrity, and continuity of the medicines supply chain.
Zaradi vse večje kompleksnosti in globalizacije dobavnih verig zdravil bosta potrebna tudi boljša izmenjava informacij ter tesnejše in racionalnejše sodelovanje med organi, da se zagotovita neoporečnost proizvodov in podatkov ter neprekinjenost dobavne verige zdravil.
This translates into an increasing need for managing and sharing reliable data, in particular to support evidence-based regulatory decision-making grounded on science, improve the use of medicines and satisfy the demands for greater transparency and openness.
Zato bo potreba po upravljanju in izmenjavi zanesljivih podatkov vse večja, zlasti z namenom, da se podpre na znanosti temelječe regulativno odločanje na podlagi dokazov, izboljša uporaba zdravil in zadovoljijo potrebe po večji preglednosti in odprtosti.
As the EMA enhances its efforts to share knowledge and information with the NCAs, patients, healthcare professionals, the media and other stakeholders, the demand for data is expected to increase, and the central coordination role of the Agency, combined with improvements in data integration, becomes more important.
S krepitvijo prizadevanj agencije za izmenjavo znanja in informacij s pristojnimi nacionalnimi organi, bolniki, zdravstvenimi delavci, mediji in drugimi deležniki se bo predvidoma povečalo povpraševanje po podatkih, zaradi česar bo postala osrednja usklajevalna vloga agencije, vključno z izboljšavami pri povezovanju podatkov, še pomembnejša.
The growing trend for patients and healthcare professionals to use the internet, mobile communications and social media when searching for medicines-related information raises the importance of using these communication channels more widely, to ensure easy, consistent and timely access to authoritative, reliable and understandable information on medicines.
Zaradi vse bolj poudarjenega trenda, da bolniki in zdravstveni delavci pri iskanju informacij o zdravilih uporabljajo internet, mobilne komunikacije in družbene medije, je treba razširiti uporabo teh komunikacijskih kanalov, da se zagotovi preprost, dosleden in pravočasen dostop do verodostojnih, zanesljivih in razumljivih informacij o zdravilih.
Factors such as advances in and growing complexity of medicines development, globalisation, the increasing role of social media as an information source, growing expectation for transparency, key legislation changes and continuous striving for increased efficiency, all impact the Agency's work.
Na njeno delo vplivajo številni dejavniki, kot so nova dognanja v razvoju zdravil in njegova vse večja kompleksnost, globalizacija, vse večja vloga družbenih medijev kot vira informacij, vse večja pričakovanja glede preglednosti, bistvene zakonodajne spremembe in nenehno prizadevanje za večjo učinkovitost.
Veterinary medicines legislation
Zakonodaja o zdravilih za uporabo v veterinarski medicini
Along with SMEs, academia and public-private partnerships are also becoming an increasingly important source of innovation in medicines.
Vse pomembnejši vir inovacij na področju zdravil so poleg MSP tudi akademski krogi in javno-zasebna partnerstva.
Organization (WHO), thus highlighting AMR as a global health crisis of similar importance to pandemics of an infectious disease.
Resnost težave priznava tudi Svetovna zdravstvena organizacija (SZO), ki z razvojem svetovnega akcijskega načrta za boj proti protimikrobni odpornosti poudarja, da je protimikrobna odpornost svetovna zdravstvena kriza, ki je po pomembnosti na podobni ravni kot pandemija nalezljive bolezni.
substance management service
Namestnik izvršnega direktorja
Subtotal AST Total AST SC 6
Namestnik izvršnega direktorja Andreas Pott
International non-proprietary name (INN): deltamethrin
Mednarodno nelastniško ime (INN): deltametrin
The opinion was converted into a Decision by the European Commission on 24 September 2013.
Mnenje je bilo 24. septembra 2013 spremenjeno v sklep Evropske komisije.
The Committee appointed Dr C. Ibrahim as rapporteur and Ms H. Jukes as co-rapporteur.
Odbor je za poročevalca imenoval dr. C Ibrahima, za soporočevalko pa H. Jukes.
For the pour-on product 24 concerned Member States are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Za zdravilo v polivu je zadevnih 24 držav članic, in sicer Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Francija, Grčija, Irska, Islandija, Italija, Latvija, Litva, Luksemburg, Madžarska, Nemčija, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija in Španija.
The reference Member State is the United Kingdom for both products.
Referenčna država članica za obe zdravili je Združeno kraljestvo.
Written explanations were provided by the applicant on 22 May
Predlagatelj je 22. maja 2013 podal pisna pojasnila.
The decentralised procedure started on 19 December 2011.
Decentralizirani postopek se je začel 19. decembra 2011.
The referral procedure started on 6 March 2013.
Napotitveni postopek se je začel 6. marca 2013.
Potential serious risks were identified during the decentralised procedure by Germany and the Netherlands regarding the environmental safety of the product.
Med decentraliziranim postopkom sta Nemčija in Nizozemska ugotovili možnost resnega tveganja v zvezi z varnostjo zdravila za okolje.
On 26 February 2013, the reference Member State, the United Kingdom, notified the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Referenčna država članica, Združeno kraljestvo, je 26. februarja 2013 obvestila Evropsko agencijo za zdravila, da skupina CMD(v) ni dosegla soglasja v zvezi z zdravilom, in zadevo napotila na CVMP skladno s členom 33(4) Direktive 2001/82/ES.
These are ‘hybrid' applications according to Art. 13(3) Directive 2001/82/EC, as amended, referring to the reference products Pfizer Pour On Insecticide 1% w/v Cutaneous Solution and Pfizer Spot On Insecticide 1% w/v Cutaneous Solution multidose registered in the United Kingdom.
To sta vlogi za „hibridna zdravila“ v skladu s členom 13(3) Direktive 2001/82/ES, kakor je bila spremenjena, v zvezi z referenčnima zdraviloma Pfizer insekticid v polivu 1 % w/v dermalna raztopina in insekticid za kožni nanos 1 % w/v večodmerna dermalna raztopina, odobrenima v Združenem kraljestvu.
Day 60 of the CMD(v) procedure was on 14 February 2013, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Na šestdeseti dan postopka CMD(v), 14. februarja 2013, zadevne države članice niso dosegle soglasja o zdravilu, zato je bil postopek napoten na odbor CVMP.
For the spot-on product Belgium, France, Germany and the Netherlands are involved as concerned Member States.
Za zdravilo za kožni nanos pa so zadevne države članice Belgija, Francija, Nemčija in Nizozemska.
Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle contain deltamethrin as active ingredient and is intended for use in cattle and sheep as a topical application for the treatment and prevention of infestations by lice and flies on cattle; ticks, lice, keds and established blowfly strike on sheep and lice and ticks on lambs.
Deltanil 10 mg/ml, raztopina za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopina za kožni nanos za govedo, vsebujeta zdravilno učinkovino deltametrin in sta namenjeni lokalni uporabi pri govedu in ovcah za zdravljenje in preprečevanje napadov uši in muh na govedu, ugrizov klopov, uši, muhe melophagus ovinus in mesarskih muh na ovcah ter klopov in uši pri jagnjetih.
Therefore, the Committee adopted by majority a positive opinion on 17 July 2013 recommending the granting of the marketing authorisations for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Odbor je zato 17. julija 2013 z večino sprejel pozitivno mnenje, da priporoča izdajo dovoljenj za promet z zdravili Deltanil 10 mg/ml, raztopina za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopina za kožni nanos za govedo.
On day 210, these issues remained unsolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures
Ker ti pomisleki na 210. dan postopka še vedno niso bili rešeni, je bila zadeva 17. decembra 2012 v skladu s členom 33(1) Direktive 2001/82/ES napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirani postopek − zdravila za uporabo v veterinarski medicini (CMD(v)).
The applicant, Virbac, submitted an application for a decentralised procedure for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle.
Predlagatelj, družba Virbac, je predložil vlogo za decentralizirani postopek za zdravili Deltanil 10 mg/ml, raztopina za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopina za kožni nanos za govedo.
Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle is positive.
Na podlagi ocene trenutno razpoložljivih podatkov je CVMP menil, da je razmerje med tveganji in koristmi za zdravili Deltanil 10 mg/ml, raztopina za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopina za kožni nanos za govedo, ugodno.
Opinion following an Article 33(4)1 referral for Deltanil 10 mg/ml Pour-on Solution for cattle and sheep and Deltanil 100 mg Spot-on Solution for cattle
Mnenje v zvezi z napotitvijo v skladu s členom 33(4)1 za zdravili Deltanil 10 mg/ml, raztopino za kožni poliv za govedo in ovce, in Deltanil 100 mg, raztopino za kožni nanos za govedo
The procedure started on 5 May 2011.
Postopek se je začel 5. maja 2011.
The final opinion was converted into a Decision by the European Commission on 3 November 2011.
Končno mnenje se je 3. novembra 2011 spremenilo v odločbo Evropske komisije.
1 Article 78 of Directive 2001/82/EC
1 Člen 78 Direktive 2001/82/ES.
Opinion following an Article 78
Mnenje v zvezi s postopkom iz člena 78
The rapporteur and co-rapporteur appointed were Dr JeanClaude Rouby and Dr David Murphy, respectively.
Za poročevalca je bil imenovan dr. Jean-Claude Rouby, za soporočevalca pa dr. David Murphy.
A written explanation was provided by the representative of the marketing authorisation holder on 23 May 2011.
Predstavnik imetnika dovoljenja za promet z zdravilom je 23. maja 2011 predložil pisno obrazložitev.
HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names
HIPRABOVIS PNEUMOS emulzija za injiciranje za govedo in povezana imena
Due to concerns regarding reports of anaphylactic-type events following use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle, France suspended the marketing authorisation for the product on 6 April 2011 triggering a procedure under Article 78 of Directive 2001/82/EC.
Zaradi poročil o dogodkih anafilaktičnega tipa po uporabi zdravila HIPRABOVIS PNEUMOS emulzija za injiciranje za govedo je Francija 6. aprila 2011 začasno umaknila dovoljenje za promet z zdravilom in sprožila postopek v skladu s členom 78 Direktive 2001/82/ES.
HIPRABOVIS PNEUMOS Emulsion for injection for cattle is an inactivated vaccine for reduction of the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age.
HIPRABOVIS PNEUMOS emulzija za injiciranje za govedo je inaktivirano cepivo za zmanjšanje kliničnih znakov in pljučnih lezij, ki jih povzročata Mannheimia haemolytica, serotip A1, in Histophilus somni pri teletih, starejših od dveh mesecev.
Based on the rapporteurs' assessment of the data available from pharmacovigilance reports and a laboratory study, the CVMP concluded that the underlying cause of the adverse events observed has yet to be determined; the data evaluated indicated an association between vaccination of cattle with HIPRABOVIS PNEUMOS Emulsion for injection for cattle and the occurrence of anaphylactic-type events; no corrective measures could be recommended; and the benefit-risk balance for the product was unfavourable.
Na podlagi poročevalčeve ocene podatkov, na voljo v poročilih o farmakovigilanci in laboratorijski študiji, je odbor CVMP sklenil, da je treba osnovni vzrok za neželene dogodke šele ugotoviti; ocenjeni podatki kažejo na povezavo med cepljenjem govedi z zdravilom HIPRABOVIS PNEUMOS emulzija za injiciranje za govedo in pojavnostjo dogodkov anafilaktičnega tipa; priporočiti ni mogoče nobenih popravnih ukrepov, razmerje med tveganji in koristmi pri tem zdravilu pa je bilo neugodno.
The Committee, adopted on 14 July 2011, an opinion recommending the suspension of the marketing authorisations for HIPRABOVIS PNEUMOS Emulsion for injection for cattle and associated names until the marketing authorisation holder proposes appropriate measures to mitigate the risk of occurrence of such adverse events and demonstrates a favourable benefit-risk balance for the product when used according to the recommendations of the summary of product characteristics The list of product names concerned is given in Annex I. The scientific conclusions and grounds for suspension of the marketing authorisations are provided in Annex II.
Komisija je 14. julija 2011 sprejela sklep, ki priporoča začasni umik dovoljenja za promet z zdravilom HIPRABOVIS PNEUMOS emulzija za injiciranje za govedo in povezana imena, dokler imetnik dovoljenja za promet z zdravilom ne priporoči ustreznih ukrepov za ublažitev tveganja pojava takih neželenih dogodkov ter dokaže ugodno razmerje med tveganji in koristmi pri zdravilu, če se uporablja skladno s priporočili v povzetku glavnih značilnosti zdravila.
procedure for
za zdravilo
Children and adolescents under 16 years of age.
Otroci in mladostniki, mlajši od 16 let.
The absolute bioavailability is approximately 100%.
Absolutna biološka uporabnost je približno 100 %.
Therefore, the dose for each indication is the maximum recommended dose:
Zato odmerek za posamezno indikacijo predstavlja maksimalni priporočeni odmerek:
This increase is not generally important for most patients.
To povečanje pri večini bolnikov večinoma ni pomembno.
The potential for human risk in pregnancy is unknown.
Možnost za tveganje pri človeku v nosečnosti ni znana.
11415 Tallinn Estonia
11415 Tallinn Estonija
Bottles: Keep the container tightly closed.
Plastenke: Vsebnik shranjujte tesno zaprt.
This should be considered when rapid symptomatic relief is needed.
To moramo upoštevati, kadar je potrebno hitro lajšanje simptomov.
Patients were treated for a median duration of 11 months.
Bolniki so se zdravili povprečno 11 mesecev.
[Very Common (>1/10) Common (>1/100, <1/10) Uncommon (>1/1000, <1/100) Rare (>1/10,000, <1/1,000) Very rare (<1/10,000) including isolated cases]
[Zelo pogosti (>1/10), pogosti (> 1/100, < 1/10), občasni (> 1/1000, < 1/100), redki (> 1/10.000, < 1/1.000), zelo redki (< 1/10.000 vključno s posameznimi primeri)]
<INVENTED NAME> tablets contain lactose.
Tablete < IZMIŠLJENO IME > vsebujejo laktozo.
However, current estimates are based on limited data and the extent of under-reporting is unquantifiable.
Vendarle pa sedanje ocene temeljijo na omejenih podatkih in pomanjkanja podatkov ni mogoče količinsko oceniti.
The onset of drug effect may be faster when <INVENTED NAME> is administered without food.
Učinek lahko nastopi hitreje, če < IZMIŠLJENO IME > vzamemo brez hrane.
There was an increase in digoxin Cmax (approximately 33%).
Prišlo je do povečanja Cmax digoksina (približno 33 %).
Less than 2% was recovered as unchanged drug.
Manj kot 2 % sta se izločila v obliki nespremenjene učinkovine.
Av. Da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugal
Av. Da Siderurgia Nacional 4745-457 S. Mamede do Coronado Portugalska
Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied.
Odmerki, večji od priporočenih za posamezno indikacijo, niso pokazali dodatne učinkovitosti ali pa njihove uporabe niso raziskali.
Therefore, the combination should be administered with caution, especially in the elderly.
Zato je treba kombinacijo uporabljati previdno, še posebej pri starejših bolnikih.
The relationship to treatment is not established.
Povezava z zdravljenjem ni bila dokazana.
To undertaking its risk management plan as communicated to the CHMP during May 2005 CHMP meeting and outlined in the assessment report response on 10 May 2005.
Da bo izvedel svoj načrt o obvladovanju tveganj, kot ga je sporočil CHMP-ju na sestanku maja 2005 in kot je opisan v odgovoru na poročilo o oceni z dne 10. maja 2005.
Studies in animals have shown reproductive toxicity (see section 5.3).
Raziskave pri živalih so pokazale toksičnost za reprodukcijo (glejte 5.3).
Edificio Vasco da Gama, nº19, Porto Salvo 2770-192 Paço d´Arcos Portugal
Edificio Vasco da Gama, nº19, Porto Salvo 2770-192 Paço d´Arcos Portugalska
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND NORWAY AND ICELAND
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK TER JAKOSTI ZDRAVILA, POT UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH TER NORVEŠKA IN ISLANDIJA
Puławska 303 02-785 Warszawa Poland
Puławska 303 02-785 Warszawa Poljska
The following additional safety results were observed in the study:
V raziskavi so prišli še do naslednjih ugotovitev v zvezi z varnostjo:
This USR was initiated on 16 February 2005 and finalised on 17 February 2005.
Nujen varnostni ukrep se je začel 16. februarja 2005 in zaključil 17. februarja 2005.
Very rare: confusion, hallucinations.
Zelo redke: zmedenost, halucinacije
Aluminum/aluminium blisters in packs containing 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 or 100 tablets.
Aluminij/aluminij pretisni omoti v škatlah, ki vsebujejo 2, 5, 7, 10, 14, 20, 28, 30, 50, 84, 98 ali 100 tablet.
Pain relief was observed as early as four hours after initiation of treatment.
Olajšanje bolečine so opazili že 4 ure po začetku zdravljenja.
The absolute risk increase for such events is unlikely to exceed 1% per year based on existing data (uncommon).
Glede na obstoječe podatke je malo verjetno, da absolutno povečanje tveganja teh dogodkov preseže 1 % na leto (občasni).
Hertfordshire EN11 9BU United Kingdom
Hertfordshire EN11 9BU Velika Britanija
Further to the assessment of:
po vrednotenju:
Congestive heart failure (NYHA II-IV).
Kongestivno srčno popuščanje (NYHA II-IV).
These beneficial effects were observed as early as the second day of therapy and maintained for up to 52 weeks.
Ti koristni učinki so se pojavili že drugi dan zdravljenja in so vztrajali do 52 tednov.
- Addition of a more detailed description of the first signs of skin reactions leading to discontinuation of the treatment.
- Dodan je podrobnejši opis začetnih znakov kožnih reakcij, zaradi katerih se zdravljenje prekine.
Patients with hypertension whose blood pressure has not been adequately controlled.
Bolniki z visokim krvnim tlakom, ki ni zadostno nadzorovan.
These data are not considered clinically significant.
Ti podatki ne veljajo za klinično pomembne.
The CHMP confirmed changes to the Product Information already introduced through a type II variation adopted in May 2005 further to the February USR and requested further changes.
CHMP je potrdil spremembe informacij o zdravilu, že vnešene z variacijo tipa II, sprejeto aprila 2005 po februarskem nujnem varnostnem ukrepu in zahteval še nadaljnje spremembe.
After the Commission Decision, the Member State competent authorities will update the product information as required.
Pristojne oblasti držav članic bodo podatke o izdelku posodobile v skladu z zahtevami, ko bo podana odločba Komisije.
Via Benedetto Croce, 37 I-56125 Pisa Italy
Via Benedetto Croce, 37 I-56125 Pisa Italija
The rate of absorption was affected, resulting in a 36% decrease in Cmax and an increase in Tmax by 2 hours.
Vplivalo je na hitrost absorpcije in povzročilo 36 % zmanjšanje Cmax in podaljšanje tmax za 2 uri.
To submit a descriptive study protocol to CHMP.
Da bo CHMP-ju predložil opisni protokol študije.