natgillin/translations-raw huggingface dataset:
PACKAGE LEAFLET: Innovax-ND-IBD suspension and solvent for suspension for injection for chickens
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Innovax-ND-IBD suspenzija in vehikel za suspenzijo za injiciranje za piščance
STORAGE CONDITIONS
NAVODILA ZA SHRANJEVANJE
Suspension: off-red to red suspension.
Suspenzija: rdečkasta do rdeča suspenzija Vehikel: bistra, rdeča raztopina
The vaccine is a cell-associated live recombinant turkey herpesvirus (HVT) expressing the F protein of Newcastle disease virus and the VP2 protein of Infectious bursal disease virus.
Cepivo je na celico vezan živ rekombinantni puranji virus herpesa (HVT), ki izraža F protein virusa atipične kokošje kuge in VP2 protein virusa Gumborske bolezni.
Bag of 400 ml solvent or bag of 800 ml solvent.
Vrečka s 400 ml vehikla ali vrečka z 800 ml vehikla.
Before withdrawing the ampoules from the liquid nitrogen container, protect hands with gloves, wear long sleeves and use a facemask or goggles.
Preden vzamete ampule iz posode s tekočim dušikom, zaščitite roke z rokavicami, nosite dolge rokave in si nadenite obrazno masko ali zaščitna očala.
The solvent must be clear, red coloured, without sediment and at room temperature (15-25 °C) at the time of mixing.
Ob mešanju mora biti vehikel bister, rdeče obarvan, brez sedimenta in pri sobni temperature
In order to protect the cells, it is important that the suspension is mixed, immediately after thawing, with the solvent.
Pomembno je, da supenzijo takoj, ko se otopi, zmešate v vehikel, da zaščitite celice.
Zero days.
MD: 9 dni.
1 ampoule, containing 2,000 or 4,000 doses.
Velikosti pakiranj: 1 ampula, ki vsebuje 2.000 ali 4.000 odmerkov.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENA NA MANJŠIH NA STIČNIH OVOJNINAH
Name and address of the manufacturer responsible for batch release
ZDRUŽENE DRŽAVE AMERIKE Ime in naslov proizvajalca(proizvajalcev) zdravila, odgovornega(odgovornih) za sproščanje serij
EXP
AMPULA
(gloved) hand holding the ampoule away from the body and face.
Ko jemljete ampulo iz posode, jo držite v dlani orokavičene roke proč od telesa in obraza.
Bag of 400 ml solvent
Vrečka po 400 ml vehikel
Bag of 800 ml solvent
Vrečka po 800 ml vehikel
4 ampoules containing 4000 doses
4 ampule, ki vsebujejo 4000 odmerkov
8 ampoules containing 2000 doses
8 ampul ki vsebuje 2000 odmerkov
2 ampoules containing 4000 doses
2 ampuli ki vsebujeta 4000 odmerkov
1 ampoule containing 2000 doses
1 ampula ki vsebuje 2000 odmerkov
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE SOLVENT BAG
PODATKI NA STIČNI OVOJNINI VREČKA Z VEHIKLOM
4 ampoules containing 2000 doses
4 ampule, ki vsebujejo 2000 odmerkov
Excipients:
PREVIDNOST:
2 ampoules containing 2000 doses
2 ampuli, ki vsebujeta 2000 odmerkov
Active substance:
Nastop imunosti:
Content (concentration) Package size
Vsebina Velikost pakiranja
EU-number
Vsebnik
Blister (PA/Al/PVC//Al) 336 (3x112) tablets
336 (3x112) tablet
In such case, treatment must be stopped immediately.
V takih primerih je treba z zdravljenjem takoj prenehati.
The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Informacije o zdravilu bodo pristojni organi držav članic v sodelovanju z referenčno državo članico kasneje posodobili za zdravilo(a) odobrena v skladu s poglavjem 4 naslova III Direktive 2001/83/ES.
Section 4.1 “Therapeutic indications”
Poglavje 4.1 - »Terapevtske indikacije«
Section 4.4 “Special Warnings and Precautions for Use”
Poglavje 4.4 - »Posebna opozorila in previdnostni ukrepi«
There is limited experience on the safety and efficacy of the use of <name of product>in patients over 65 years of age.
Podatkov o varnosti in učinkovitosti zdravila <ime zdravila> pri bolnikih, starih več kot 65 let, je malo.
Tell your doctor if you have high blood pressure or if you are treated for high blood pressure, as testosterone may cause a rise in blood pressure.
Obvestite zdravnika, če imate visok krvni tlak ali se zdravite zaradi visokega krvnega tlaka, saj lahko testosteron zviša krvni tlak.
[the wording below should be inserted in the relevant sections]
[besedilo, kot je navedeno spodaj je treba vstaviti v ustrezna poglavja] Povzetek glavnih značilnosti zdravila
However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.
Kljub temu je treba upoštevati, da se fiziološke vrednosti testosterona v serumu s starostjo manjšajo.
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile.
Pri bolnikih na dolgotrajnem androgenskem zdravljenju, je treba redno spremljati tudi naslednje laboratorijske parametre: hemoglobin in hematokrit, jetrne teste in lipidni profil.
What <name of product> is and what it is used for <name of product> is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism).
Kaj je zdravilo <ime zdravila> in za kaj ga uporabljamo Zdravilo <ime zdravila> se pri odraslih moških uporablja za nadomeščanje testosterona in za zdravljenje težav, ki jih povzroči pomanjkanje testosterona (hipogonadizem pri moških).
Testosterone may cause a rise in blood pressure and <name of product> should be used with caution in men with hypertension.
Testosteron lahko povzroči zvišanje krvnega tlaka, zato je treba zdravilo <ime zdravila> pri moških s hipertenzijo uporabljati previdno.
Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Nadomestno zdravljenje s testosteronom pri moških s hipogonadizmom, kadar je bilo pomanjkanje testosterona potrjeno s kliničnimi znaki in biokemijskimi preiskavami.
Frequency common: Increase in red blood cell count, haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests.
Pogostnost - pogosti: povečano število rdečih krvnih celic, zvišane vrednosti hematokrita (odstotek rdečih krvnih celic v krvi) in povečane vrednosti hemoglobina (sestavina rdečih krvnih celic, ki prenaša kisik), kar se ugotavlja s krvnimi preiskavami v rednih časovnih intervalih.
In patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.
Pri bolnikih s hudim srčnim popuščanjem, jetrno ali ledvično okvaro ali ishemično boleznijo srca lahko zdravljenje s testosteronom povzroči hude zaplete, za katere je značilen edem z ali brez kongestivne srčne odpovedi.
Testosterone level should be monitored at baseline and at regular intervals during treatment.
Vrednosti testosterona je treba spremljati na začetku zdravljenja, nato pa v rednih presledkih med zdravljenjem.
Currently, there is no consensus about age specific testosterone reference values.
Soglasja glede referenčnih vrednosti testosterona, specifičnih za starost, ni.
The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.
Pred in med zdravljenjem mora zdravnik opraviti naslednje krvne preiskave: določiti vrednost testosterona v krvi, narediti celotno krvno sliko.
Package Leaflet
Priloga III
Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.
Zdravniki morajo odmerke prilagoditi posameznikom, da zagotovijo vzdrževanje ravni testosterona v okviru normalnih vrednosti.
If you are suffering from severe heart, liver or kidney disease, treatment with <name of product> may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure.
Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila> Če imate hudo bolezen srca, jeter ali ledvic, lahko zdravljenje z <ime zdravila> povzroči hude zaplete kot so zastajanje vode v telesu, ki ga včasih spremlja (kongestivna) srčna odpoved.
These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo so bila dogovorjena v postopku napotitve.
Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Dopolnitev ustreznih poglavij v povzetku glavnih značilnosti zdravila in navodila za uporabo
Haematocrit increased, Red blood cell count increased, Haemoglobin increased Frequency common.
Poglavje 4.8 - »Neželeni učinki« zvišane vrednosti hematokrita, povečano število rdečih krvnih celic, povečane vrednosti hemoglobina Pogostnost: pogosti
This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as: impotence infertility low sex drive tiredness depressive moods bone loss caused by low hormone levels
impotenca neplodnost pomanjkanje želje po spolnosti utrujenost depresivno razpoloženje izguba kostne mase zaradi nizkih vrednosti hormona
The reference authority for the worksharing procedure is Sweden.
Referenčni organ za postopek za delitev dela je Švedska.
A potential serious risk to public health was raised by the Netherlands.
Nizozemska je izpostavila morebitno resno tveganje za javno zdravje.
The relevant authorities of the concerned marketing authorisations are: AT, BE, DE, DK, ES, FI, FR, IE, IT, LU, NL, NO, PT.
Ustrezni organi za zadevna dovoljenja za promet z zdravilom so: AT, BE, DE, DK, ES, FI, FR, IE, IT, LU, NL, NO, PT.
• The Committee considered the referral under Article 13 of Regulation (EC) No 1234/2008;
• odbor je obravnaval napotitev v skladu s členom 13 Uredbe (ES) št. 1234/2008;
The worksharing procedure SE/H/xxxx/WS/190 started on 20 January 2018.
Postopek za delitev dela SE/H/xxxx/WS/190 se je začel 20. januarja 2018.
The CHMP noted that according to the ICH Quality Guidelines, none of the Member States of the EU is considered a Zone IV region.
Odbor CHMP je ugotovil, da v skladu s smernicami o kakovosti ICH nobena od držav članic EU ni država območja IV.
The clinical relevance of the test results therefore could not be determined;
Kliničnega pomena rezultatov preskusa torej ni bilo mogoče določiti;
As per the Note for Guidance on the clinical requirements for locally applied, locally acting products containing known constituents (EMA CPMP/EWP/239/95), clinical data are in principle necessary to establish therapeutic equivalence between two products.
V skladu z Navodili o kliničnih zahtevah za lokalno uporabljana in lokalno delujoča zdravila, ki vsebujejo znane sestavine (EMA CPMP/EWP/239/95), so za ugotavljanje terapevtske enakovrednosti dveh zdravil načeloma potrebni klinični podatki.
Day 60 of the CMDh procedure was on 25 October 2018 and as no agreement amongst member states could be reached, Sweden notified the European Medicines Agency on 26 October 2018 of a referral under Article 13 of Regulation EC No 1234/2008.
60. dan postopka skupine CMDh je bil 25. oktobra 2018, in ker ni bilo mogoče doseči dogovora, je Švedska 26. oktobra 2018 obvestila Evropsko agencijo za zdravila o napotitvi v skladu s členom 13 Uredbe ES št. 1234/2008.
The clinical significance of the observed differences cannot be determined, since the criteria for the selected non-inferiority margins have not been adequately justified, and therefore these results cannot support the efficacy and safety of the new formulation.
Kliničnega pomena opaženih razlik ni mogoče določiti, ker merila za izbor meje neinferiornosti niso ustrezno utemeljena, zato ti rezultati ne morejo podpirati učinkovitosti in varnosti nove formulacije.
Moreover the Committee noted that the in-vitro tests used were not validated for the therapeutic situation and that they had several methodological limitations.
Poleg tega je odbor ugotovil, da uporabljeni preskusi in vitro niso bili validirani za terapevtske pogoje in da so imeli več metodoloških omejitev.
Furthermore, the CHMP considered that the submitted in-vitro studies had several methodological limitations including the absence of a positive control, the duration, and the high heterogeneity among the donors.
Odbor CHMP je ocenil tudi, da imata predloženi študiji in vitro več metodoloških omejitev, vključno z odsotnostjo pozitivne kontrole, trajanjem in veliko raznolikostjo darovalcev.
The Committee, as a consequence, recommends the refusal of the variation to the terms of the marketing authorisation application for the medicinal products referred to in Annex I of the CHMP opinion.
je zato odbor priporočil zavrnitev spremembe pogojev dovoljenja za promet z zdravilom za zdravila,navedena v Prilogi I k mnenju odbora CHMP.
However, since the tests have not been validated for the therapeutic situation, the clinical relevance of the test results is unclear.
Ker pa preskusi niso bili validirani za terapevtske pogoje, je klinični pomen rezultatov preskusa nejasen.
In absence of clinical data, non-clinical validated models can be accepted.
V odsotnosti kliničnih podatkov so lahko sprejemljivi neklinični validirani modeli.
The MAH conducted two in-vitro studies which showed that there were differences in the absorbed dose (35% lower absorbed dose) and less significant differences in the penetrated doses.
Imetnik dovoljenja za promet z zdravilom je opravil dve študiji in vitro, ki sta dokazali, da obstajajo razlike v absorbiranem odmerku (za 35 % manjši absorbirani odmerek) in manj pomembne razlike v odmerkih, ki so prodrli v telo.
The reformulation was focused on the gelling agent to improve physical stability in order to extend the shelf-life of the products in Zone IV countries where viscosity value tends to decrease due to higher temperature.
Pri reformulaciji so se osredotočili na želirno sredstvo, da bi izboljšali fizikalno stabilnost in tako podaljšali rok uporabnosti v državah območja IV, v katerih se vrednost viskoznosti zaradi višjih temperatur povečuje.
As documented in the scientific literature1 changes in the qualitative composition of semi-solid topical formulation can have an impact on drug release and efficacy of the topical products.
Kot je dokumentirano v znanstveni literaturi1, lahko spremembe v kakovostni sestavi poltrdne topične formulacije vplivajo na sproščanje učinkovine in učinkovitost topičnih zdravil.
However, in support of this application neither clinical data nor validated non-clinical data have been submitted.
Vendar pa v podporo tej vlogi niso bili predloženi niti klinični podatki niti validirani neklinični podatki.
The rationale for the change in the formulation was to extend the shelf-life of the products in Zone IV countries.
Namen spremembe formulacije je bil podaljšanje roka uporabnosti zdravila v državah območja IV.
Safety data of the new gelling agent Simulgel 600 PHA has been evaluated in 2008 for Epiduo 0.1%, which contains adapalene 0.1% and benzoyl peroxide 2.5%, in a vehicle containing Simulgel 600 PHA.
Podatke o varnosti novega želirnega sredstva Simulgel 600 PHA so ovrednotili leta 2008 za zdravilo Epiduo 0,1 %, ki vsebuje 0,1 % adapalena in 2,5 % benzoil peroksida v vehiklu, ki vsebuje Simulgel 600 PHA.
Therefore the benefit/risk balance of the reformulated medicinal product isconsidered unfavourable.
Razmerje med tveganji in koristmi reformuliranega zdravila torej velja za neugodno,
In the clinical studies performed in support of the Epiduo gel, approximately 2500 subjects above 9 years of age were exposed to Simulgel 600 PHA.
V kliničnih študijah, opravljenih v podporo zdravilu Epiduo gel, je bilo sredstvu Simulgel 600 PHA izpostavljenih približno 2 500 preiskovancev, starejših od devet let.
This variation relates to a change of formulation for Basiron in order to replace the gelling agent Carbomer 940 with Simulgel 600 PHA (acrylamide - sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate and water).
Ta sprememba se nanaša na spremembo formulacije zdravila Basiron, pri čemer bi se želirno sredstvo Carbomer 940 nadomestilo z želirnim sredstvom Simulgel 600 PHA (kopolimer akrilamida - natrijevega akrilodimetiltavrata, izoheksadekan, polisorbat 80, sorbitan oleat in voda).
• Having assessed the totality of the data, the Committee was of the view that the available data were not sufficient to demonstrate therapeutic equivalence of the new and the currently marketed formulation.
• po oceni vseh podatkov je odbor menil, da razpoložljivi podatki ne zadoščajo za dokaz terapevtske enakovrednosti nove formulacije in formulacije, ki je trenutno na trgu.
The CHMP concluded that the submitted data are not sufficient to demonstrate therapeutic equivalence of the new and the currently marketed formulation.
Odbor CHMP je zaključil, da predloženi podatki ne zadostujejo za dokazovanje terapevtske enakovrednosti nove formulacije in formulacije, ki je trenutno na trgu.
Therefore, the safety and the efficacy of the reformulated product cannot be considered established.
Zato ni mogoče sklepati, da sta varnost in učinkovitost reformuliranega zdravila dokazani.
The change in composition due to the replacement of the gelling agent cannot be considered minor per se, and the available data from in-vitro tests are not considered suitable to fully elucidate the clinical impact of this reformulation.
Sprememba v sestavi zaradi zamenjave želirnega sredstva sama po sebi ne more veljati za majhno, razpoložljivi podatki iz preskusov in vitro pa niso primerni za popolno razjasnitev kliničnega vpliva te formulacije.
On 1 December 2017, a Quality type II variation application was submitted by Galderma Nordic AB in line with Article 10(1) of Commission Regulation (EC) No 1234/2008 under the worksharing procedure in accordance with Article 20 of Commission Regulation (EC) No 1234/2008 (SE/H/xxxx/WS/190) for the marketing authorisations for Basiron AC 5% w/w gel and 10% w/w gel to change the formulation by replacing the gelling agent excipient Carbomer 940 with Simulgel 600 PHA (acrylamide sodium acrylodimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate and water).
Družba Galderma Nordic AB je v skladu s členom 10(1) Uredbe Komisije (ES) št. 1234/2008 v postopku za delitev dela v skladu s členom 20 Uredbe Komisije (ES) št. 1234/2008 (SE/H/xxxx/WS/190) za dovoljenja za promet z zdravilom za zdravilo Basiron AC 5 % m/m gel in 10 % m/m gel 1. decembra 2017 predložila spremembo tipa II v zvezi s kakovostjo, in sicer za spremembo formulacije z zamenjavo pomožne snovi - želirnega sredstva Carbomer 940 z želirnim sredstvom Simulgel 600 PHA (kopolimer akrilamida - natrijevega akrilodimetiltavrata, izoheksadekan, polisorbat 80, sorbitan oleat in voda).
• The Committee considered the supportive clinical data of another medicinal product containing benzoyl peroxide 2.5% in combination with adapalene 0.1%, in a vehicle containing Simulgel 600 PHA, and concluded that data of the reformulated Basiron AC gels 5% w/w and 10% w/w could not be extrapolated from the dossier of another product in view of qualitative and quantitative differences between Basiron AC gels 5% w/w and 10% w/w and the other medicinal product;
• odbor je ocenil podporne klinične podatke za drugo zdravilo, ki vsebuje 2,5 % benzoil peroksida v kombinaciji z 0,1 % adapalena v vehiklu, ki vsebuje Simulgel 600 PHA, in zaključil, da ob upoštevanju kakovostnih in količinskih razlik med zdravilom Basiron AC gel 5 % m/m in 10 % m/m ter drugim zdravilom podatkov za reformulirano zdravilo Basiron AC gel 5 % m/m in 10 % m/m ni mogoče ekstrapolirati iz dokumentacije drugega zdravila;
Taking into consideration the qualitative and quantitative differences between Epiduo gel and the re-formulated Basiron, it cannot be concluded based on the data provided that the data from Epiduo gel can be extrapolated to the new formulation of Basiron AC
Z upoštevanjem kakovostnih in količinskih razlik med zdravilom Epiduo gel in reformuliranim zdravilom Basiron na podlagi predloženih podatkov ni mogoče sklepati, da bi podatke o zdravilu Epiduo gel lahko ekstrapolirali na novo formulacijo zdravila Basiron AC.
• The Committee noted that the in-vitro tests indicated differences between the marketed formulation and the new proposed formulation containing the new gelling agent Simulgel 600 PHA.
• odbor je ugotovil, da preskusi in vitro kažejo na razlike med formulacijo, ki je na trgu, in novo predlagano formulacijo, ki vsebuje novo želirno sredstvo Simulgel 600 PHA.
• The Committee considered the totality of the data submitted by the MAH in support of the type II quality variation for Basiron AC gels 5% w/w and 10% w/w;
• odbor je proučil vse podatke, ki jih je imetnik dovoljenja za promet z zdravilom predložil v podporo spremembi tipa II v zvezi s kakovostjo za zdravili Basiron AC gel 5 % m/m in 10 % m/m;
There may be differences in absorption and stability of the active substance between the Epiduo and the new Basiron formulation, which cannot be determined in the absence of relevant data for Basiron.
Med zdravilom Epiduo in novo formulacijo zdravila Basiron lahko obstajajo razlike v absorpciji in stabilnosti učinkovine, ki jih v odsotnosti ustreznih podatkov za zdravilo Basiron ni mogoče določiti.
• The Committee noted the absence of clinical data generated with the reformulated product containing the gelling agent excipient Simulgel 600 PHA for Basiron and associated names;
• odbor je poudaril odsotnost kliničnih podatkov, pridobljenih z reformuliranim zdravilom, ki vsebuje pomožno snov - želirno sredstvo Simulgel 600 PHA, za zdravilo Basiron in povezana imena;
• The Committee reviewed the available data submitted in support of the new formulation of Basiron containing the new gelling agent excipient Simulgel 600 PHA;
• odbor je pregledal razpoložljive podatke, predložene v podporo novi formulaciji zdravila Basiron, ki vsebuje novo pomožno snov - želirno sredstvo Simulgel 600 PHA;
The procedure was referred to the Coordination Group for Mutual Recognition and Decentralised Procedures Human (CMDh), under Article 13(1), paragraph 1 of Regulation EC No 1234/2008 by Sweden on 21 August 2018.
Švedska je 21. avgusta 2018 v skladu s prvim odstavkom člena 13(1) Uredbe (ES) št. 1234/2008 postopek napotila na Skupino za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh).
Cashel Road, Dublin 12, Ireland.
Cashel Road, Dublin 12, Irska.
Very rare Not known (cannot be estimated from the available data)
Zelo redki Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Date opened: ____________________
Datum odpiranja: ____________________
It may harm them, even if their symptoms are the same as yours.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni podobne vašim.
It was therefore not possible to add additional wording to the statement in section 4.4.
Zato ni bilo mogoče dodati dopolnjenega besedila izjavi v poglavju 4.4.
Effects on endocrine system
Vpliv na endokrini sistem
Vodopivceva 9 SI-4000 Kranj Slovenia
Vodopivceva 9 SI-4000 Kranj Slovenija
The potential risk for humans is uncertain.
Morebitna tveganja pri ljudeh so nejasna.
However, in a number of member states alternative text has been included following the outcome of National Procedures.
Vendar pa je bilo v več državah članicah v skladu z izidi nacionalnih postopkov vključeno tudi alternativno besedilo.
The statement “children and adolescents below the age of 18 years” has been simplified to “children below the age of 18 years”.
Izjava „otroci in mladostniki, mlajši od 18 let“ je bila poenostavljena v „otroci, mlajši od 18 let“.
% of patients with controlled disease
% bolnikov z nadzorovano boleznijo
The CHMP endorsed these changes as they improve the definition of the target population and reflect the data offered in support of the indications.
CHMP je potrdil te spremembe, saj izboljšujejo definicijo ciljne populacije in odražajo podatke, ki so jih predložili za potrditev indikacij.
Mean percentage reduction in PASI (SD)
Povprečno zmanjšanje deleža PASI (SD)