natgillin/translations-raw huggingface dataset:
What Oprymea looks like and contents of the pack Oprymea 0.088 mg tablets are white, round, with bevelled edges and imprint "P6" on one side of the tablet. 
Oprymea 0,088 mg tablete so bele, okrogle, s posnetimi robovi in oznako P6 na eni strani tablete.
EU/1/08/469/034 [10 prolonged-release tablets] EU/1/08/469/035 [30 prolonged-release tablets] EU/1/08/469/036 [90 prolonged-release tablets] EU/1/08/469/037 [100 prolonged-release tablets] 
EU/1/08/469/034 [10 tablet s podaljšanim sproščanjem] EU/1/08/469/035 [30 tablet s podaljšanim sproščanjem] EU/1/08/469/036 [90 tablet s podaljšanim sproščanjem] EU/1/08/469/037 [100 tablet s podaljšanim sproščanjem]
Dose reduction/tapered discontinuation should be considered if such symptoms develop. 
Če se razvijejo simptomi teh motenj, je treba presoditi o zmanjšanju odmerka ali postopni ukinitvi zdravila.
Oprymea 1.57 mg prolonged-release tablets are white or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P12 on one side, with bevelled edges and possible spots. 
Oprymea 1,57 mg tablete s podaljšanim sproščanjem so bele ali skoraj bele, okrogle (premera 10 mm), rahlo izbočene, s prirezanimi robovi in z morebitnimi pikami ter z vtisnjeno oznako P12 na eni strani.
EU/1/08/469/046 [10 prolonged-release tablets] EU/1/08/469/047 [30 prolonged-release tablets] EU/1/08/469/048 [90 prolonged-release tablets] EU/1/08/469/049 [100 prolonged-release tablets] 
EU/1/08/469/046 [10 tablet s podaljšanim sproščanjem] EU/1/08/469/047 [30 tablet s podaljšanim sproščanjem] EU/1/08/469/048 [90 tablet s podaljšanim sproščanjem] EU/1/08/469/049 [100 tablet s podaljšanim sproščanjem]
EU/1/08/469/030 [10 prolonged-release tablets] EU/1/08/469/031[30 prolonged-release tablets] EU/1/08/469/032[90 prolonged-release tablets] EU/1/08/469/033[100 prolonged-release tablets] 
EU/1/08/469/030 [10 tablet s podaljšanim sproščanjem] EU/1/08/469/031 [30 tablet s podaljšanim sproščanjem] EU/1/08/469/032 [90 tablet s podaljšanim sproščanjem] EU/1/08/469/033 [100 tablet s podaljšanim sproščanjem]
Oprymea has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease. 
Nenaden nepremagljiv spanec in zaspanost Pramipeksol povezujejo z zaspanostjo in nenadnimi epizodami spanja, zlasti pri bolnikih s
EU/1/08/469/038 [10 prolonged-release tablets] EU/1/08/469/039 [30 prolonged-release tablets] EU/1/08/469/040 [90 prolonged-release tablets] EU/1/08/469/041 [100 prolonged-release tablets] 
EU/1/08/469/038 [10 tablet s podaljšanim sproščanjem] EU/1/08/469/039 [30 tablet s podaljšanim sproščanjem] EU/1/08/469/040 [90 tablet s podaljšanim sproščanjem] EU/1/08/469/041 [100 tablet s podaljšanim sproščanjem]
Oprymea 2.1 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/042 30 prolonged-release tablets: EU/1/08/469/043 90 prolonged-release tablets: EU/1/08/469/044 100 prolonged-release tablets: EU/1/08/469/045 
10 tablet s podaljšanim sproščanjem: EU/1/08/469/042 30 tablet s podaljšanim sproščanjem: EU/1/08/469/043 90 tablet s podaljšanim sproščanjem: EU/1/08/469/044 100 tablet s podaljšanim sproščanjem: EU/1/08/469/045
Oprymea 0.088 mg tablets Each tablet contains 0.088 mg pramipexole (as 0.125 mg pramipexole dihydrochloride monohydrate). 
Ena tableta vsebuje 0,088 mg pramipeksola v obliki 0,125 mg pramipeksolijevega dihidroklorida monohidrata.
Oprymea 1.57 mg prolonged-release tablets Pramipexole 
Oprymea 1,57 mg tablete s podaljšanim sproščanjem pramipeksol
Oprymea 2.1 mg prolonged-release tablets Pramipexole 
Oprymea 2,1 mg tablete s podaljšanim sproščanjem pramipeksol
Superiority of pramipexole prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (CGI-I and PGI-I responder rates) efficacy endpoints in a double-blind placebo-controlled trial including a total of 539 patients with early Parkinson's disease. 
To je pokazalo dvojno slepo, s placebom nadzorovano preskušanje, ki je skupno zajela 539 bolnikov z zgodnjo Parkinsonovo boleznijo, ko so po 18 tednih jemanja z dvema lestvicama ocenili primarne (lestvica UPDRS, ocena II.
Inform your doctor if you find tablet pieces in your faeces. 
Če v blatu opazite dele tablete, to povejte zdravniku.
Oprymea 0.26 mg Oprymea 0.52 mg Oprymea 1.05 mg prolonged-release tablets Pramipexole 
Oprymea 0,26 mg tablete s podaljšanim sproščanjem Oprymea 0,52 mg tablete s podaljšanim sproščanjem Oprymea 1,05 mg tablete s podaljšanim sproščanjem pramipeksol
Pramipexole should be tapered off at a rate of 0.54 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.54 mg of base (0.75 mg of salt). 
dokler dnevnega odmerka ne zmanjšamo na 0,54 mg pramipeksola (0,75 mg soli).
Pramipexole 
Distonija
Pregelatinised maize starch Povidone K25 
6.1 Seznam pomožnih snovi manitol koruzni škrob predgelirani koruzni škrob povidon K25 brezvodni koloidni silicijev dioksid magnezijev stearat
Antipsychotic medicinal products 
Antipsihotiki
Further information on Viread can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/viread. 
Nadaljnje informacije o zdravilu Viread so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/viread.
What measures are being taken to ensure the safe and effective use of Viread? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Viread?
The European Medicines Agency decided that Viread's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Viread večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Viread received a marketing authorisation valid throughout the EU on 5 February 2002. 
Za zdravilo Viread je bilo 5. februarja 2002 izdano dovoljenje za promet, veljavno po vsej EU.
As for all medicines, data on the use of Viread are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Viread stalno spremljajo.
Why is Viread authorised in the EU? 
Zakaj je zdravilo Viread odobreno v EU?
Viread, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. 
Zdravilo Viread v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
An overview of Viread and why it is authorised in the EU 
Pregled zdravila Viread in zakaj je odobreno v EU
Viread (tenofovir disoproxil) 
Viread (dizoproksiltenofovirat)
In children and adolescents it is only used in patients who cannot be treated with other first-line nucleotide reverse transcriptase inhibitors (NRTI). 
Pri otrocih in mladostnikih se uporablja samo pri bolnikih, ki jih ni mogoče zdraviti z drugimi nukleotidnimi zaviralci reverzne transkriptaze (NRTI) prve izbire.
What are the risks associated with Viread? 
Kakšna tveganja so povezana z zdravilom Viread?
The company that makes Viread will ensure that all doctors who are expected to prescribe or use Viread in children are provided with educational materials containing important safety information, particularly on the risks and precautions relating to kidney function and the bones. 
Podjetje, ki izdeluje zdravilo Viread, bo zagotovilo, da bodo vsi zdravniki, ki naj bi predpisovali ali uporabljali to zdravilo pri otrocih, prejeli izobraževalno gradivo, ki bo vsebovalo pomembne varnostne informacije, zlasti o tveganjih in previdnostnih ukrepih, ki se nanašajo na delovanje ledvic in kosti.
Side effects reported with Viread are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Viread, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What benefits of Viread have been shown in studies? 
Kakšne koristi je zdravilo Viread izkazalo v študijah?
Moreover, Viread may cause a reduction in bone density. 
Poleg tega lahko zdravilo Viread povzroči zmanjšanje kostne gostote.
For more information about using Viread, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Viread glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Viread is used in combination with other HIV medicines. 
Zdravilo Viread se uporablja v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV.
Viread does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS. 
Zdravilo Viread ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Viread have also 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 Viread upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Viread once they have looked at the antiviral medicines the patient has taken before or the likelihood that the virus will respond to antiviral medicines. 
Bolnikom, ki so predhodno že jemali zdravila za zdravljenje okužbe z virusom HIV, smejo zdravniki zdravilo Viread predpisati šele, ko se seznanijo s protivirusnimi zdravili, ki jih je bolnik jemal pred tem, oziroma ko ocenijo, kakšna je verjetnost, da se bo virus odzval na protivirusna zdravila.
The most common side effects with Viread (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, dizziness, hypophosphataemia (low levels of phosphate in the blood), rash and asthenia (weakness). 
Najpogostejši neželeni učinki zdravila Viread (opaženi pri več kot 1 od 10 bolnikov) so navzeja (siljenje na bruhanje), bruhanje, driska, omotica, hipofosfatemija (nizke ravni fosfatov v krvi), izpuščaji in astenija (šibkost).
Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI). 
Tenofovir je nukleotidni zaviralec reverzne transkriptaze (NRTI).
A study carried out in 87 adolescents (12 to 18 years of age) investigated the effects of adding Viread to existing treatment. 
S študijo, ki je bila opravljena pri 87 mladostnikih (starih od 12 do 18 let), so poučevali učinke dodajanja zdravila Viread obstoječemu zdravljenju.
What is Viread and what is it used for? 
Kaj je zdravilo Viread in za kaj se uporablja?
Viread stops the virus making DNA and prevents it from multiplying and spreading. 
Zdravilo Viread ustavi tvorbo DNK v virusu in tako prepreči njegovo razmnoževanje in širjenje.
Although it showed no benefit of adding Viread to existing treatment compared with adding placebo, Viread produced similar levels of the active substance in the body compared to adults, and it was judged that the results were influenced by the type of patients included in the Viread group. 
Čeprav dodajanje zdravila Viread obstoječemu zdravljenju ni pokazalo koristi v primerjavi z dodajanjem placeba, je zdravilo Viread doseglo podobne ravni učinkovine v telesu kot pri odraslih, zato so ocenili, da je na rezultate vplivala vrsta bolnikov, vključenih v skupino, ki je prejemala zdravilo Viread.
For the treatment of HIV, Viread was more effective than placebo (a dummy treatment) when added to existing treatment. 
Pri zdravljenju virusa HIV je bilo zdravilo Viread učinkovitejše od placeba (zdravila brez zdravilne učinkovine), ko je bilo dodano obstoječemu zdravljenju.
Tenofovir also interferes with the action of an enzyme produced by the hepatitis B virus called DNA polymerase, which is involved in the formation of viral DNA. 
Tenofovir prav tako ovira delovanje encima, ki ga proizvaja virus hepatitisa B, imenovan „DNK-polimeraza“, ki je vključen v proces nastajanja virusne DNK.
Viread is a medicine used to treat patients aged 2 years and above infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS). 
Viread je zdravilo, ki se uporablja za zdravljenje bolnikov, starejših od dveh let, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV 1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
In adults, it can also be used for those patients with liver damage whose liver is not working properly (decompensated liver disease) and those patients who do not respond to treatment with lamivudine (another medicine for hepatitis B infection). 
Pri odraslih se lahko uporablja tudi pri tistih bolnikih z okvaro jeter, pri katerih ta ne delujejo pravilno (dekompenzirana jetrna bolezen), in tistih, ki se ne odzivajo na zdravljenje z lamivudinom (drugim zdravilom za zdravljenje okužbe z virusom hepatitisa B).
Viread can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection or chronic hepatitis B. Viread, available as tablets and as granules, is taken once a day with food. 
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV ali kroničnega hepatitisa B. Na voljo je v obliki tablet in zrnc in se jemlje enkrat na dan skupaj s hrano.
One of these studies involved patients with ‘HBeAg-negative' hepatitis B, a type that is more difficult to treat, while the other involved the more common ‘HBeAgpositive' hepatitis B. After 48 weeks, 71% of the HBeAg-negative and 67% of HBeAg-positive patients taking Viread had a complete response to treatment, compared with 49% and 12%, respectively, of the patients taking adefovir dipivoxil. 
V eno od teh študij so bili vključeni bolniki s „HBeAg negativnim“ hepatitisom B, vrsto, ki jo je težje zdraviti, medtem ko so bili v drugo vključeni bolniki z običajnejšim „HBeAg pozitivnim“ hepatitisom B. Po 48 tednih se je 71 % bolnikov, ki so bili „HBeAg negativni“, in 67 % tistih, ki so bili „HBeAg pozitivni“, popolnoma odzvalo na zdravljenje z zdravilom Viread v primerjavi z 49 % oziroma 12 % bolnikov, ki so jemali dipivoksiladefovirat.
In a third study Viread was as effective as another medicine stavudine, when added to lamivudine and efavirenz. 
V tretji študiji je bilo zdravilo Viread enako učinkovito kot drugo zdravilo stavudin, ko je bilo dodano lamivudinu in efavirenzu.
The figure for the combination treatment of Viread and emtricitabine was 88%. 
Pri bolnikih, ki so jemali kombinacijo zdravila Viread in emtricitabina, pa je bilo takih bolnikov 88 %.
For the full list of side effects and restrictions with Viread, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Viread glejte navodilo za uporabo.
Viread is also used to treat chronic (long-term) hepatitis B virus infection in adults and children aged 2 years and above with liver damage whose liver is still working properly (compensated liver disease). 
Zdravilo Viread se uporablja tudi za zdravljenje kronične (dolgotrajne) okužbe z virusom hepatitisa B pri odraslih in otrocih, starejših od dveh let, z okvaro jeter, ki še delujejo pravilno (kompenzirano jetrno boleznijo).
Other information about Viread: 
Druge informacije o zdravilu Viread
How is Viread used? 
Kako se zdravilo Viread uporablja?
For the treatment of hepatitis B, two studies involving 641 adult patients compared Viread with another medicine, adefovir dipivoxil. 
Za zdravljenje hepatitisa B so v dveh študijah, v katerih je sodelovalo 641 odraslih bolnikov, zdravilo Viread primerjali z drugim zdravilom, imenovanim dipivoksiladefovirat.
In HIV infection, it blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. 
Pri okužbi z virusom HIV zavira delovanje reverzne transkriptaze, tj. encima, ki ga tvori virus HIV, da lahko okuži celice v telesu ter tvori nove viruse.
The active substance in Viread, tenofovir disoproxil, is a ‘prodrug' that is converted into tenofovir in the body. 
Učinkovina zdravila Viread, dizoproksiltenofovirat, je „predzdravilo“, ki se v telesu pretvori v tenofovir.
Rare cases of severe kidney problems have also been seen in patients treated with Viread. 
Pri bolnikih, zdravljenih z zdravilom Viread, so bili opaženi tudi redki primeri hudih težav z ledvicami.
A study in 97 children (aged 2 to 12 years) treated with stavudine or zidovudine, compared the effects of switching their treatment to Viread with continuing previous treatment. 
V študiji pri 97 otrocih (starih od dve do 12 let), ki so bili zdravljeni s stavudinom ali zidovudinom, so primerjali učinke prehoda na zdravljenje z zdravilom Viread z nadaljevanjem predhodnega zdravljenja.
It showed that the majority of those who switched treatment from stavudine or zidovudine maintained their low HIV blood levels on Viread (83% of children in the Viread group and 92% of those on stavudine or zidovudine had viral loads below 400 copies/ml after 48 weeks). 
Študija je pokazala, da je večina tistih, ki so se zdravili s stavudinom ali zidovudinom, ohranila nizko raven virusa HIV pri zdravljenju z zdravilom Viread (83 % otrok v skupini, ki je prejemala zdravilo Viread in 92 % tistih, ki so prejemali stavudin ali zidovudin, je imelo po 48 tednih virusno breme pod 400 kopij/ml).
Two studies involving 741 HIV-infected adults showed that Viread resulted in a fall in the levels of HIV in the blood (viral load) of around 75% after 4 and after 24 weeks, compared with a small rise or fall in viral load of around 5% in the patients taking placebo. 
Dve študiji, v katerih je sodelovalo 741 odraslih, okuženih z virusom HIV, sta pokazali, da je zdravilo Viread po štirih in 24 tednih povzročilo padec ravni virusa HIV v krvi (virusno breme) za približno 75 % v primerjavi z majhnim povečanjem oziroma padcem virusnega bremena za približno 5 % pri bolnikih, ki so jemali placebo.
Overall, 70% of patients taking Viread or entecavir had a viral load below 400 copies/ml. 
Pri 70 % bolnikov, ki so jemali zdravilo Viread ali entekavir, je bilo virusno breme pod 400 kopij/ml.
A fourth study, involving 280 adults who had not responded to treatment with lamivudine, compared Viread alone with a combination treatment of Viread and emtricitabine. 
V četrti študiji, v katero je bilo vključenih 280 odraslih, ki se niso odzvali na zdravljenje z lamivudinom, so zdravilo Viread kot samostojno zdravilo primerjali s kombiniranim zdravljenjem z zdravilom Viread in emtricitabinom.
89% of patients taking Viread had a viral load below 400 copies/ml after 96 weeks of treatment, compared with 86% of patients taking the combination treatment of Viread and emtricitabine. 
Pri 89 % bolnikov, ki so jemali zdravilo Viread, je bilo virusno breme po 96 tednih zdravljenja pod 400 kopijami/ml v primerjavi s 86 % bolnikov, ki so jemali kombinacijo zdravila Viread in emtricitabina.
In a third study involving 112 adults whose liver had stopped working properly (decompensated liver disease) Viread was compared with entecavir and a combination treatment of Viread and emtricitabine. 
V tretji študiji so pri 112 odraslih, pri katerih jetra ne delujejo pravilno (dekompenzirana bolezen jeter), zdravilo Viread primerjali z entekavirjem in kombinacijo zdravljenja z zdravilom Viread in emtricitabinom.
The dose may need to be reduced or the medicine given less often in patients who have moderately or severely reduced kidney function. 
Pri bolnikih z zmerno ali hudo okvaro delovanja ledvic bo morda treba odmerek zdravila zmanjšati ali ga dajati manj pogosto.
In a study in 89 children aged between 2 and 12 years the results were similar: 77% of patients on Viread had a viral load reduced to below 400 copies/ml after 48 weeks compared with 7% of patients on placebo. 
Rezultati so bili podobni v študiji pri 89 otrocih, starih od dve do 12 let: pri 77 % bolnikov, ki so prejemali zdravilo Viread se je virusno breme po 48 tednih zmanjšalo pod 400 kopij/ml v primerjavi s 7 % bolnikov, ki so jemali placebo.
Viread contains the active substance tenofovir disoproxil. 
Vsebuje učinkovino dizoproksiltenofovirat.
Similar numbers of patients in the Viread and stavudine groups had viral loads below 400 copies/ml after 48 weeks. 
Po 48 tednih je imelo podobno število bolnikov iz skupin, ki sta prejemali zdravilo Viread in stavudin, virusno breme pod 400 kopij/ml.
A study in 106 adolescents with either HBeAg-negative or HBeAg-positive hepatitis B compared Viread with placebo and found that in 88% of patients taking Viread the viral load reduced to below 400 copies/ml after 72 weeks compared with 0% of those taking placebo. 
Ugotovljeno je bilo, da se je pri 88 % bolnikov, ki so jemali zdravilo Viread, po 72 tednih raven virusnega bremena zmanjšala pod 400 kopij/ml v primerjavi z 0 % bolnikov, ki so jemali placebo.
How does Viread work? 
Kako zdravilo Viread deluje?
--1 Recombinant verotoxin 2e of E. coli……………..RP* ≥ 1.50 * RP - relative potency (ELISA) 
--1 rekombinantni verotoksin 2e iz E. coli ............................................................ RP* ≥ 1,50 *RP = relativna potenca (ELISA)
EU (MA) number Invented name 
EU (MA) številka Izmišljeno ime Jakost
Packaging Content Package size 
Velikost pakiranja
10 vials 
Karenca vialami
A procedure under Article 29(4) was therefore triggered in February 2012. 
Zato je bil februarja 2012 sprožen postopek skladno s členom 29(4).
Scientific conclusions and grounds for positive opinion 
Znanstveni zaključki in podlaga za pozitivno mnenje
• the CHMP assessed the entirety of the data submitted by the Applicant, 
• CHMP je ocenil vse razpoložljive podatke, ki jih je predložil predlagatelj;
Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active. 
Mometazonfuroat je topični glukokortikosteroid z lokalnim protivnetnim učinkom pri odmerkih, ki niso sistemsko aktivni.
Overall summary of the scientific evaluation of Mometasone Furoate Sandoz and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Mometasone Furoate Sandoz in povezanih imen (glejte Prilogo I)
1 Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents (CPMP/EWP/4151/00 Rev. 1, January 2009) 
Smernica o zahtevah za klinično dokumentacijo za peroralno inhalirana zdravila (OIP), vključno z zahtevami za dokaz terapevtske enakovrednosti dveh inhaliranih zdravil, ki se uporabljata za zdravljenje astme in kronične obstrukcijske pljučne bolezni (KOPB) pri odraslih in za zdravljenje astme pri otrocih in mladostnikih (CPMP/EWP/4151/00 Rev. 1, januar 2009)
However, in this specific case, the CHMP considered the adequacy of the applied statistical methods to be of secondary importance compared to the evaluation of the available in vitro data, as supported by the available in vivo data, which was considered sufficient to reach a conclusion. 
Vendar je CHMP v tem posebnem primeru menil, da je ustreznost uporabljenih statističnih metod drugotnega pomena v primerjavi z ocenjevanjem razpoložljivih podatkov in vitro, ki jih podpirajo razpoložljivi podatki in vivo, kar se je štelo zadostno za sprejem zaključka.
The CHMP also discussed the objections raised regarding the statistical methodology used for the in vitro comparison. 
CHMP je razpravljal tudi o zadržkih, ki so bili izpostavljeni pri statistični metodologiji, uporabljeni v primerjavi in vitro.