natgillin/translations-raw huggingface dataset:
40.1-60.0 1 pipette of Evicto 360 mg for dogs 40.1-60.0 kg 
40,1-60,0 1 merilna kapalka zdravila Evicto 360 mg za pse 40,1-60,0 kg > 60 Ustrezna kombinacija merilnih kapalk
1 pipette 4 pipettes 24 pipettes x 0.25 ml 
1 merilna kapalka 4 merilne kapalke 24 merilnih kapalk x 0,25 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sachets 15mg, 30mg, 45mg, 60mg, 120mg, 240mg, 360mg, 
Vrečka 15mg, 30mg, 45mg, 60mg, 120mg, 240mg, 360mg
2.6-5.0 1 pipette of Evicto 30 mg for dogs 2.6-5.0 kg 5.1-10.0 1 pipette of Evicto 60 mg for dogs 5.1-10.0 kg 10.1-20.0 1 pipette of Evicto 120 mg for dogs 10.1-20.0 kg 
2,6-5,0 1 merilna kapalka zdravila Evicto 30 mg za pse 2,6-5,0 kg 5,1-10,0 1 merilna kapalka zdravila Evicto 60 mg za pse 5,1-10,0 kg 10,1-20,0 1 merilna kapalka zdravila Evicto 120 mg za pse 10,1-20,0 kg
Remove the cap prior to treatment application. 
Pred nanašanjem pokrovček odstranite.
PHARMACOLOGICAL PROPERTIES 
FARMAKOLOŠKELASTNOSTI
EVICTO 240 mg for dogs 
EVICTO 240 mg za pse
Treatment of biting lice (cats and dogs) 
Zdravljenje infestacij z ušmi, ki grizejo (mačke in psi)
Excipient: 
Učinkovina:
EVICTO 120 mg for dogs 
Evicto 120 mg za pse
Prevention of heartworm disease (cats and dogs) 
Preprečevanje obolenja, ki ga povzroča srčna glista (mačke in psi)
Mg of selamectin dispensed 
Selamektin (selamectin)
Evicto 60 mg for cats 
Evicto 60 mg za mačke
Pregnancy and lactation: Can be used in pregnant and lactating cats and dogs. 
Lahko se uporablja pri brejih in doječih mačkah in psicah.
This product is a skin and eye irritant.Wash hands after use and wash off any product in contact with the skin immediately with soap and water. 
Po uporabi si umijte roke in takoj sperite, tiste dele kože, ki so prišli v stik z zdravilom z vodo in milom.
EVICTO 360 mg for dogs 
EVICTO 360 mg za pse
Evicto 30 mg for dogs 
EVICTO 30 mg za pse
EVICTO 30 mg for dogs 
Evicto 30 mg za pse
7.6-10.0 1 pipette of Evicto 60 mg for cats 7.6-10.0kg 
7,6-10,0 1 merilna kapalka zdravila Evicto 60 mg za mačke 7,610,0kg > 10 Ustrezna kombinacija merilnih kapalk
Treatment of ear mites (cats) 
Zdravljenje ušesnih garij (mačke)
≤ 2.5 1 pipette of Evicto 15 mg for cats and dogs ≤2.5 kg 2.6-7.5 1 pipette of Evicto 45 mg for cats 2.6-7.5 kg 
2.6-7,5 1 merilna kapalka zdravila Evicto 45 mg za mačke 2,6-7,5 kg
AUTHORISATION 
Selamectin
Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will aid prevention of flea infestation in the litter up to seven weeks of age. 
Mesečno zdravljenje brejih in doječih živali zmanjša populacijo bolh in pomaga preprečiti infestacijo legla do sedmega tedna starosti.
EVICTO 60 mg for dogs 
Evicto 60 mg za pse
Evicto 60 mg for dogs 
EVICTO 60 mg za pse
5.1-10.0 1 pipette of Evicto 60 mg for dogs 5.1-10.0 kg 10.1-20.0 1 pipette of Evicto 120 mg for dogs 10.1-20.0 kg 20.1-40.0 1 pipette of Evicto 240 mg for dogs 20.1-40.0 kg 40.1-60.0 1 pipette of Evicto 360 mg for dogs 40.1-60.0 kg Appropriate combination of pipettes 
Evicto 60 mg kožni nanos, raztopina za pse 5,1 - 10 kg Evicto 120 mg kožni nanos, raztopina za pse 10,1 - 20,0 kg Evicto 240 mg kožni nanos, raztopina za pse 20,1 - 40,0 kg Evicto 360 mg kožni nanos, raztopina za pse 40,1 - 60,0 kg
Evicto 30 mg spot-on solution for dogs 2.6-5.0 kg Evicto 60 mg spot-on solution for dogs 5.1-10.0 kg 
Evicto v30 mg kožni nanos, raztopina za pse 2,6 - 5,0 kg
Evicto 45 mg spot-on solution for cats 2.6-7.5 kg Evicto 60 mg spot-on solution for cats 7.6-10.0 kg selamectin 
EVICTO 45 mg kožni nanos, raztopina za mačke 2,6 - 7,5 kg EVICTO 60 mg kožni nanos, raztopina za mačke 7,6 - 10 kg
Evicto 15 mg spot-on solution for cats and dogs ≤2.5 kg selamectin 
EVICTO 15 mg kožni nanos, raztopina za mačke in pse ≤ 2,5 kg
Spot-on use. 
UPORABE, ČE JE SMISELNO
Evicto 120 mg spot-on solution for dogs 10.1-20.0 kg Evicto 240 mg spot-on solution for dogs 20.1-40.0 kg Evicto 360 mg spot-on solution for dogs 40.1-60.0 kg selamectin 
EVICTO 60 mg kožni nanos, raztopina za pse 5,1 - 10 kg EVICTO 120 mg kožni nanos, raztopina za pse 10,1 - 20,0 kg EVICTO 240 mg kožni nanos, raztopina za pse 20,1 - 40,0 kg EVICTO 360 mg kožni nanos, raztopina za pse 40,1 - 60,0 kg
Why was Syner-Kinase reviewed? 
Zakaj je bilo zdravilo Syner-Kinase pregledano?
The review of Syner-Kinase was initiated on 26 July 2018 at the request of the United Kingdom, under Article 29(4) of Directive 2001/83/EC. 
Pregled zdravila Syner-Kinase se je začel 26. julija 2018 na zahtevo Združenega kraljestva v skladu s členom 29(4) Direktive 2001/83/ES.
What is Syner-Kinase? 
Kaj je zdravilo Syner-Kinase?
A European Commission decision valid throughout the EU was issued on 16/05/2019. 
Sklep Evropske komisije, ki velja po vsej EU, je bil izdan 16. maja 2019.
The Agency also considered that the data provided by the company show that the purification process is suitable for the removal of possible viral and prion impurities. 
Agencija je menila tudi, da podatki, ki jih je predložilo podjetje, dokazujejo, da je postopek čiščenja primeren za odstranjevanje morebitnih virusnih in prionskih nečistot.
Syner-Kinase is a medicine used to dissolve blood clots in the lungs, in deep veins, in arteries in the arms, hands, legs and feet, or in catheters or cannulae (surgical tubes) placed in a vein. 
Syner-Kinase je zdravilo, ki se uporablja za raztapljanje krvnih strdkov v pljučih, globokih venah, arterijah v rokah, dlaneh, nogah in stopalih ali v katetrih ali kanilah (kirurških cevkah), nameščenih v veni.
The marketing authorisation holder, Syner-Medica Ltd, requested that the marketing authorisation for Syner-Kinase granted in the UK on 29 September 2006 be recognised in France, Germany, the Netherlands and Spain (the ‘concerned Member States'). 
Imetnik dovoljenja za promet z zdravilom, podjetje Syner-Medica Ltd, je zaprosil, da se dovoljenje za promet z zdravilom za zdravilo Syner-Kinase, izdano v Združenem kraljestvu dne 29. septembra 2006, prizna tudi v Franciji, Nemčiji, na Nizozemskem in v Španiji („zadevnih državah članicah“).
Syner-Kinase contains the active substance urokinase, a natural enzyme that helps to dissolve blood clots in the body. 
Zdravilo Syner-Kinase vsebuje učinkovino urokinazo, naravni encim, ki pomaga raztapljati krvne strdke v telesu.
Concerns were also raised regarding the manufacturing and purification processes for the active substance urokinase, which is extracted from human urine. 
Pojavili so se tudi pomisleki o postopku proizvodnje in čiščenja učinkovine urokinaze, ki se ekstrahira iz človeškega urina.
demonstrated that the production of the semi-purified urokinase (an intermediate step in the production of the active substance) is adequately controlled, and that this intermediate is manufactured at a site that complies with the principles and guidelines of Good Manufacturing Practice (GMP). 
Končno je podjetje dokazalo tudi, da je proizvodnja delno očiščene urokinaze (vmesna faza pri proizvodnji učinkovine) primerno nadzorovana in da je intermediat izdelan na lokaciji, ki deluje v skladu z načeli in smernicami dobre proizvodne prakse (GMP).
The grounds for the referral were concerns that the data provided by the company, which included published data on other urokinase-containing medicines, were not sufficient to demonstrate that the benefits of Syner-Kinase outweigh its risks. 
Razlogi za napotitev so bili pomisleki, da podatki, ki jih je predložilo podjetje in so vključevali objavljene podatke o drugih zdravilih, ki vsebujejo urokinazo, niso zadoščali za dokaz, da koristi zdravila Syner-Kinase odtehtajo z njim povezana tveganja.
On 28 February 2019, the European Medicines Agency completed a review of Syner-Kinase and associated names following a disagreement among EU Member States regarding its authorisation. 
Evropska agencija za zdravila je 28. februarja 2019 zaključila pregled v zvezi z izdajo dovoljenja za promet z zdravilom Syner-Kinase in povezanimi imeni po nesoglasju med državami članicami EU.
However, the Member States were not able to reach an agreement and the UK medicines agency referred the matter to EMA for arbitration on 5 July 
Ker pa države članice niso dosegle soglasja, je britanska agencija za zdravila 5. julija 2018 zadevo napotila na Evropsko agencijo za zdravila v arbitražo.
The Agency concluded that the benefits of Syner-Kinase outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation. 
Agencija je zaključila, da koristi zdravila Syner-Kinase odtehtajo z njim povezana tveganja in da se dovoljenje za promet z njim, izdano v Združenem kraljestvu, lahko prizna tudi v drugih državah članicah EU, v katerih je podjetje zanj zaprosilo.
EMA recommends authorisation of Syner-Kinase (urokinase) in the EU 
Evropska agencija za zdravila priporoča izdajo dovoljenja za promet z zdravilom Syner-Kinase (urokinaza) v EU
Having reviewed the available data, EMA considered that Syner-Kinase is comparable to the urokinase products mentioned in the published literature, and that the data are adequate to support its proposed use. 
Po pregledu razpoložljivih podatkov je agencija EMA ocenila, da je zdravilo Syner-Kinase primerljivo z zdravili, ki vsebujejo urokinazo, iz objavljene literature, in da razpoložljivi podatki ustrezno podpirajo
EMA recommends authorisation of Syner-Kinase (urokinase) in the EU EMA/299749/2019 
Kinase (urokinaza) v EU EMA/446079/2019
Therefore, based on the evaluation of the available data, the Agency concluded that the benefits of Syner-Kinase outweigh its risks, and that the marketing authorisation for Syner-Kinase should be granted in all concerned Member States. 
Zato je agencija na podlagi vrednotenja razpoložljivih podatkov zaključila, da koristi zdravila SynerKinase odtehtajo z njim povezana tveganja in da se dovoljenje za promet s tem zdravilom izda v vseh zadevnih državah članicah.
For publication with complete documentation after commission decision: The European Commission issued a decision on 16 February 2009. 
Za objavo s celotno dokumentacijo po odločitvi Komisije: Evropska komisija je odločbo izdala dne 16. februarja 2009.
Ref. EMEA/CHMP/137577/2009 EMEA/H/A-30/998 
EMEA/150579/2009 EMEA/H/A-30/998
Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States 
Člen 30 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev na podlagi različnih odločitev, ki so jih sprejele države članice.
London, 18 February 2009 Doc. 
London, 18. februarja 2009 Sklic dok.
Dr Alar Irs (Estonia) 
dr Alar Irs (Estonija)
The company that markets it is Novartis. 
Družba, ki zdravilo trži, je Novartis.
The review was carried out under an ‘Article 30' referral1. 
Pregled je bil izveden v skladu z napotitvenim postopkom1 po členu 30.
Dr Liv Mathison (Norway) 
dr Liv Mathison (Norveška)
• how to manage dose increases, 
• kako voditi večanje odmerkov,
Why was Diovan reviewed? 
Zakaj je bilo zdravilo Diovan pregledano?
However the Committee agreed that such a combination should still not be recommended until there is more evidence to support its positive benefit-risk balance. 
Vendar pa se je Odbor strinjal, da se tovrstna kombinacija ne sme priporočati, dokler ni več dokazov, ki podpirajo njegovo pozitivno ravnotežje med koristmi in tveganji.
The 320 mg strength was not available in all markets. 
Jakost v odmerku 320 mg ni bila na voljo na vseh trgih.
Consideration should be given to reducing the dose of concomitant diuretics. 
Razmisliti je treba o zmanjšanju odmerka sočasnih diuretikov.
As a result, blood vessels relax and blood pressure is lowered. 
Posledično se sprostijo krvne žile, krvni tlak pa zniža.
Questions and answers on the referral for Diovan film coated tablets and hard capsules containing valsartan 40, 80, 160 or 320 mg 
Vprašanja in odgovori v zvezi z napotitvenim postopkom za zdravilo Diovan filmsko obložene tablete in trde kapsule, ki vsebujejo valsartan 40, 80, 160 ali 320 mg
The CHMP discussed three areas where there was a divergence: 
CHMP je razpravljal o treh področjih, na katerih je bilo neskladje:
Diovan can also be available in the EU and the EEA under other trade names: Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg, and Varexan. 
Zdravilo Diovan je v EU in EGP lahko na voljo tudi pod drugimi imeni: Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg in Varexan.
Diovan is authorised in the European Union (EU) via national procedures. 
Zdravilo Diovan je v Evropski uniji (EU) odobreno z nacionalnimi postopki.
What is Diovan? 
Kaj je zdravilo Diovan?
All strengths can be used in these diseases, except the lowest (40 mg) strength, which cannot be used to treat hypertension. 
Za te bolezni se lahko uporabijo vse jakosti, razen najmanjše jakosti (40 mg), ki je ne moremo uporabiti za zdravljenje hipertenzije.
The CHMP also updated other parts of the products information to put it in line with the new data available. 
CHMP je prav tako posodobil druge dele informacij o zdravilu, da bodo v skladu z novo dostopnimi podatki.
• concomitant use of other medicinal products containing, or raising the level of, potassium. 
• sočasna uporaba drugih zdravil, ki vsebujejo kalij ali zvišajo njegovo raven.
The European Medicines Agency (EMEA) has completed a review of Diovan (and associated names). 
Evropska agencija za zdravila (EMEA) je zaključila pregled zdravila Diovan (in z njim povezanih imen).
The maximum daily dose administered in clinical trials is 320 mg in divided doses. 
Največji dnevni odmerek v kliničnih preskušanjih je 320 mg v razdeljenih odmerkih.
Evaluation of patients with heart failure should always include assessment of renal function.” 
V ocenjevanje bolnikov s srčnim popuščanjem mora biti vedno vključevana ocena ledvične funkcije.“
The Committee also concluded that the 320 mg dose provides a modest, but statistically significant additional reduction in blood pressure compared to 160 mg and a similarly modest increase in the rate of blood pressure control. 
Odbor je prav tako zaključil, da 320-miligramski odmerek v primerjavi s 160-miligramskim zagotavlja zmerno, a statistično pomembno dodatno znižanje krvnega tlaka in podobno zmerno povečan obseg nadzora krvnega tlaka.
Having assessed the data available, the CHMP agreed that valsartan 80 mg can be used as a starting dose in patients with reduced kidney function. 
Po oceni razpoložljivih podatkov se je CHMP strinjal, da se valsartan v odmerku 80 mg lahko uporablja kot začetni odmerek pri bolnikih z zmanjšano ledvično funkcijo.
However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1). 
Vendar pa trojna kombinacija zaviralca angiotenzinske konvertaze, zaviralca beta receptorjev in valsartana ni priporočljiva (glejte poglavji 4.4 in 5.1).
The CHMP considered the need to harmonise a number of precautions for use: 
CHMP je razpravljal o potrebi uskladitve številnih previdnostnih ukrepov:
This has led to divergences across member states on the way the medicine can be used, as seen in the differences observed in the Summaries of Product Characteristics (SPCs), labelling and package leaflets in the countries where the product is marketed. 
To je v državah članicah vodilo v razhajanja glede uporabe zdravila, kot je razvidno iz povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo v državah, v katerih je zdravilo na trgu.
Angiotensin II is a substance in the body that causes vessels to tighten, thus causing blood pressure to increase. 
Angiotenzin II je snov v telesu, ki povzroči zoženje žil in s tem poviša krvni tlak.
The CHMP endorsed the following text: “If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised”. 
CHMP je podprl naslednje besedilo: „Če se meni, da je zdravilo, ki vpliva na raven kalija, potrebno v kombinaciji z valsartanom, se priporoča spremljanje ravni kalija v plazmi.“;
The CHMP endorsed the use of Diovan in the “treatment of essential hypertension”. 
CHMP je odobril uporabo zdravila Diovan za „zdravljenje esencialne hipertenzije“.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diovan in the European Union (EU) and the European Economic Area (EEA). 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) in v Evropskem gospodarskem prostoru (EGP) uskladiti podatke o predpisovanju zdravila Diovan.
However, the dose of valsartan should not exceed 80 mg in patients with cholestasis and should be used with caution. 
Vendar pa odmerek valsartana pri bolnikih s holestazo ne sme presegati 80 mg in ga je treba uporabljati previdno.
The CHMP also aligned the contraindication for the use of Diovan during pregnancy or lactation with recent the recommendations of the Pharmacovigilance experts, and therefore recommended that the contraindication in pregnancy be removed and the recommendation for the use during breast feeding be: “Because no information is available regarding the use of valsartan during breastfeeding, Diovan (Valsartan) is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant”. 
CHMP je prav tako uskladil kontraindikacije za uporabo zdravila Diovan med nosečnostjo ali dojenjem z nedavnimi priporočili strokovnjakov za farmakovigilanco in je tako priporočil, da se kontraindikacija za nosečnost odstrani in da se priporočilo o uporabi med dojenjem glasi: „Ker ni podatkov o uporabi valsartana med dojenjem, zdravilo Diovan (Valsartan) ni priporočljivo; zaželeno je alternativno zdravljenje z bolj uveljavljenimi varnostnimi profili med dojenjem, še posebno med dojenjem novorojenca ali nedonošenca“.
Diovan works by blocking the effect of angiotensin II. 
Zdravilo Diovan deluje z zaviranjem učinka angiotenzina II.
Valsartan may be administered with other heart failure therapies. 
Valsartan se lahko uporablja z drugimi zdravili za srčno popuščanje.
The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SPCs, labelling and package leaflets should be harmonised across the EU. 
CHMP je ob upoštevanju predloženih podatkov in znanstvenih razprav v okviru Odbora menil, da je treba povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo uskladiti v celotni EU.
Diovan belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. 
Zdravilo Diovan spada v razred zdravil, imenovanih antagonisti receptorjev angiotenzina II, ki pomagajo pri nadzorovanju visokega krvnega tlaka.
Diovan can be used to treat patients with hypertension (high blood pressure), patients who just have had a heart attack (between 12 hours and 10 days earlier), or patients with heart failure when they show signs that their heart not working fully, such as shortness of breath, and swelling of the feet and legs due to fluid build-up. 
Zdravilo Diovan se lahko uporablja za zdravljenje bolnikov s hipertenzijo (visokim krvnim tlakom), bolnikov, ki so pravkar prestali srčni infarkt (pred 12 urami do 10 dnevi), ali bolnikov s srčnim popuščanjem, ko imajo znake, kot so zasoplost ter zatekanje stopal in nog zaradi zastoja tekočine, ki kažejo na to, da jim srce ne deluje v celoti.
Looking at the results of studies where triple combination treatment was used (such as a study called VALIANT), the CHMP noted that as there was no increased mortality in patients receiving all three medicines, and therefore there should be no concerns regarding the triple combination. 
CHMP je po pregledu rezultatov študij, pri katerih so uporabili trojno kombinacijsko zdravljenje (kot v študiji, imenovani VALIANT), ugotovil, da ne vidi razloga za zadržke glede trojne kombinacije zdravil, saj se umrljivost pri bolnikih, ki so prejemali vsa tri zdravila, ni povečala.
In heart failure, Diovan is used when other types of medicines used in heart failure such as Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers, cannot be used. 
Pri srčnem popuščanju se zdravilo Diovan uporablja, ko drugih vrst zdravil, uporabljenih pri srčnem popuščanju, kot so zaviralci angiotenzinske konvertaze (ACE) ali zaviralci beta receptorjev, ne moremo uporabiti.
The CHMP noted that there was a divergence on whether the use of Diovan should be contraindicated in patients with kidney failure. 
CHMP je opazil neskladje glede tega, ali naj bo uporaba zdravila Diovan pri bolnikih z ledvično odpovedjo kontraindicirana.
The CHMP also discussed the indications in the treatment of heart failure and after a recent myocardial infarction (MI). 
CHMP je prav tako razpravljal o indikacijah pri zdravljenju srčnega popuščanja in posledic nedavnega miokardnega infarkta.
• dosage recommendations in patients with renal and hepatic impairment. 
• priporočeni odmerki pri bolnikih z okvaro ledvic in jeter.
But considering that valsartan given on its own is at least as effective as captopril (an ACE inhibitor) given on its own in the reduction of total mortality after an acute MI, the CHMP endorsed the harmonised indication: Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours - 10 days) myocardial infarction. 
CHMP je ob upoštevanju, da je pri zmanjševanju skupne umrljivosti po akutnem miokardnem infarktu valsartan, dajan samostojno, vsaj tako učinkovit kot kaptopril (zaviralec angiotenzinske konvertaze) samostojno, odobril usklajeno indikacijo: Zdravljenje klinično stabilnih bolnikov s simptomatskim srčnim popuščanjem ali asimptomatsko sistolično disfunkcijo levega prekata po nedavnem (pred 12 urami-10 dnevi) miokardnem infarktu.
It can be used on its own and in combination with ACE inhibitors. 
Uporabljamo ga lahko samega in v kombinaciji z zaviralci angiotenzinske konvertaze.
However, because Diovan is eliminated via the biliary route, the CHMP agreed that it should be contraindicated in patients with severe liver diseases and “should not be administered in patients with severe hepatic impairment, cirrhosis or biliary obstruction”. 
Vendar pa se je CHMP strinjal, da mora biti zdravilo Diovan, ker se izloča z žolčem, kontraindicirano pri bolnikih s hudim obolenjem jeter in da „se ne sme dajati bolnikom s hudo okvaro jeter, cirozo ali obstrukcijo žolčevoda“.
The Committee noted that there has been no study of valsartan in patients with severe kidney failure, but they did not identify any possible safety issue has he primary route of elimination of valsartan is via the digestive (biliary), not renal route The CHMP therefore recommended that the contraindication be removed. 
Odbor je ugotovil, da ni nobene študije o valsartanu pri bolnikih s hudo ledvično odpovedjo, vendar pa ni ugotovil nobenih vprašanj glede njegove varnosti, saj je primarna pot izločanja valsartana prek prebavne (žolčne) in ne ledvične poti.
On 30 May 2008 the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Diovan in the EU and the EEA. 
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Diovan v EU in EGP, je dne 30. maja 2008 zadevo napotila na Odbor za zdravila za uporabo v humani medicini (CHMP).
The Committee noted that some Member States (MSs) had a limitation of the use of Diovan after MI to patients intolerant to ACE inhibitors. 
Odbor je opozoril, da so imele nekatere države članice omejitev uporabe zdravila Diovan po miokardnem infarktu pri bolnikih, ki zaviralcev angiotenzinske konvertaze niso prenašali.
The CHMP endorsed following text: No dosage adjustment is required for patients with a creatinine clearance >10ml/min. 
Pri bolnikih z očistkom kreatinina > 10 ml/min prilagoditev odmerka ni potrebna.