natgillin/translations-raw huggingface dataset:
The pharmacokinetics of dolutegravir in 10 antiretroviral treatment-experienced HIV-1 infected adolescents (12 to <18 years of age) showed that Tivicay 50 mg once daily oral dosage resulted in dolutegravir exposure comparable to that observed in adults who received Tivicay 50 mg orally once daily. 
Farmakokinetika dolutegravira u 10 adolescenata (12 do < 18 godina) s HIV-1 infekcijom koji su prethodno liječeni antiretroviroticima pokazala je da peroralna primjena lijeka Tivicay u dozi od
The two-drug regimen of dolutegravir 50 mg once daily and lamivudine 300 mg once daily was explored in two large randomized and blinded studies, GEMINI 1 and GEMINI 2 (see section 5.1). 
Dvojni režim liječenja dolutegravirom u dozi od 50 mg jedanput na dan i lamivudinom u dozi od 300 mg jedanput na dan ispitivao se u dvama velikim randomiziranim i slijepim ispitivanjima,
Dolutegravir has a less than or equal to 10 FC against 94% of the 705 clinical isolates. 
94% od 705 kliničkih izolata.
≤200 c/ mm3 
stanice/mm3
Patients with prior treatment failure, but not exposed to the integrase class In the international multicentre, double-blind SAILING study (ING111762), 719 HIV-1 infected, antiretroviral therapy (ART)-experienced adults were randomized and received either dolutegravir 50 mg once daily or raltegravir 400 mg twice daily with investigator selected background regimen consisting of up to 2 agents (including at least one fully active agent). 
719 odraslih osoba s HIV-1 infekcijom koje su prethodno primale antiretrovirusnu terapiju (ART) randomizirano je u skupinu koja je primala ili dolutegravir u dozi od 50 mg jedanput na dan ili raltegravir u dozi od 400 mg dvaput na dan s osnovnim režimom liječenja po izboru ispitivača, koji se sastojao od najviše 2 lijeka (uključujući najmanje jedan potpuno aktivan lijek).
In Phase III studies patients with hepatitis B and/or C co-infection were permitted to enrol provided that baseline liver chemistry tests did not exceed 5 times the upper limit of normal (ULN). 
pod uvjetom da im nalazi pretraga biokemijskih parametara jetre na početku ispitivanja nisu bili više od 5 puta iznad gornje granice normale (GGN).
• stomach (abdominal) discomfort 
• nelagoda u trbuhu (abdomenu)
Dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76% (induction of UGT1A1 and CYP3A enzymes) 
dolutegravir ↓ AUC ↓ 59% Cmax ↓ 47% Cτ ↓ 76% (indukcija enzima UGT1A1 i CYP3A)
At baseline, median patient age was 36 years, 14% were female, 15% non-white, 11% had hepatitis B and/or C co-infection and 2% were CDC Class C, these characteristics were similar between treatment groups. 
Na početku ispitivanja medijan dobi bolesnika iznosio je 36 godina, 14% bolesnika bile su žene, 15% bolesnika nisu bili bijelci, 11% bolesnika imalo je istodobnu infekciju hepatitisom B i/ili C, a 2% bolesnika imalo je
Dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (induction of UGT1A1 and CYP3A enzymes) 
rifabutin dolutegravir ↔ AUC ↓ 5% Cmax ↑ 16% Cτ ↓ 30% (indukcija enzima UGT1A1 i CYP3A)
Adults 
Djeca
Laboratorios ViiV Healthcare, S.L. 
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Multivitamin 
NRTI-jem
Integrase class resistance of particular concern 
Osobito važna rezistencija na skupinu inhibitora integraze
>100,000 cps/mL By CD4+ 
≤ 100 000 kopija/ml > 100 000 kopija/ml Prema broju CD4+ stanica ≤ 200 stanica/mm3 > 200 stanica/mm3
Nervous system disorders 
Oštećenje bubrežne funkcije
Tivicay 10 mg film-coated tablets are white, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘10' on the other side. 
Tivicay 10 mg filmom obložene tablete su okrugle, bikonveksne tablete bijele boje s oznakom „SV 572“ s jedne strane i „10“ s druge strane.
No dosage adjustment is considered necessary for patients with renal impairment. 
Prilagođavanje doze u bolesnika s oštećenjem bubrežne funkcije ne smatra se potrebnim.
Q148+≥2 secondary mutationsb *Of 98 on RAL/EVG as part of current failing regimen, 88 had detectable primary INI mutations at Baseline and a Day 8 Plasma HIV-1 RNA outcome for evaluation a Included primary IN resistance mutations N155H, Y143C/H/R, T66A, E92Q b Secondary mutations from G140A/C/S, E138A/K/T, L74I. 
88 imalo je mjerljive primarne INI mutacije na početku liječenja te ishod za HIV-1 RNK u plazmi 8. dana dostupan za procjenu a Uključujući primarne mutacije uzrokovane rezistencijom integraze: N155H, Y143C/H/R,
No dosage adjustment is considered necessary for patients with mild to moderate hepatic impairment. 
Prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije ne smatra se potrebnom.
Dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49% (induction of UGT1A1 and CYP3A enzymes) 
dolutegravir ↓ AUC ↓ 35% Cmax ↓ 24% Cτ ↓ 49% (indukcija enzima UGT1A1 i CYP3A)
EU/1/13/892/002 
EU/1/13/892/001 EU/1/13/892/002
At baseline, median patient age was 43 years, 32% were female, 50% non-white, 16% had hepatitis B and/or C co-infection, and 46% were CDC Class C. All patients had at least two class ART resistance, and 49% of subjects had at least 3-class ART resistance at baseline. 
Na početku ispitivanja medijan dobi bolesnika iznosio je 43 godine, 32% bolesnika bile su žene, 50% bolesnika nisu bili bijelci, 16% bolesnika imalo je istodobnu infekciju hepatitisom B i/ili C, a 46% imalo je HIV infekciju kategorije C prema CDC klasifikaciji.
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 viiv.fi.pt@viivhealthcare.com 
Laboratorios ViiV Healthcare, S.L. Tel: + 34 902 051 260 es-ci@viivhealthcare.com
If you are breast-feeding, or thinking about breast-feeding: → Talk to your doctor immediately. 
Ako dojite ili razmišljate o dojenju:
In the SAILING study, virologic suppression (HIV-1 RNA <50 copies/mL) in the Tivicay arm (71%) was statistically superior to the raltegravir arm (64%), at Week 48 (p=0.03). 
Tivicay (71%) nakon 48 tjedana bila statistički superiorna u odnosu na skupinu koja je primala raltegravir (64%) (p=0,03).
Yellow, round, biconvex tablets approximately 9 mm in diameter debossed with ‘SV 572' on one side and ‘50' on the other side. 
Žute, okrugle, bikonveksne tablete, promjera približno 9 mm, s utisnutom oznakom „SV 572“ s jedne i „50“ s druge strane.
>200 c/ mm3 By HIV-1 subtype B 
Prema podvrsti virusa HIV-1 B
Tivicay 25 mg film-coated tablets are pale yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘25' on the other side. 
Tivicay 25 mg filmom obložene tablete su okrugle, bikonveksne tablete blijedo žute boje s oznakom „SV 572“ s jedne strane i „25“ s druge strane.
Very common Headache Common Dizziness 
Vrlo česte nuspojave
White, round, biconvex tablets approximately 6 mm in diameter debossed with ‘SV 572' on one side and ‘10' on the other side. 
Bijele, okrugle, bikonveksne tablete, promjera približno 6 mm, s utisnutom oznakom „SV 572“ s jedne i „10“ s druge strane.
Tivicay 10 mg film-coated tablets 
Tivicay 10 mg filmom obložene tablete
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 25 mg film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOCE 25 mg filmom obložene tablete
Median baseline CD4+ was 160 cells/mm3, median duration of prior ART was 13 years, and 63% were CDC Class C. Subjects showed multiple class ART resistance at baseline: 80% had ≥2 NRTI, 73% ≥1 NNRTI, and 67% ≥2 PI major mutations; 83% had non-R5 virus. 
Početni medijan CD+4 bio je 160 stanica/mm3, medijan trajanja prethodne antiretrovirusne terapije (ART) bio je 13 godina, i 63% ispitanika imalo je HIV infekciju kategorije C prema CDC klasifikaciji.
Tivicay 50 mg film-coated tablets are yellow, round, biconvex tablets marked with the code ‘SV 572' on one side and ‘50' on the other side. 
Tivicay 50 mg filmom obložene tablete su okrugle, bikonveksne tablete žute boje s oznakom „SV 572“ s jedne strane i „50“ s druge strane.
EU/1/13/892/004 
EU/1/13/892/003 EU/1/13/892/004
At baseline, median patient age was 35 years, 16% were female, 32% nonwhite, 7% had hepatitis C co-infection and 4% were CDC Class C, these characteristics were similar between treatment groups. 
Na početku ispitivanja medijan dobi bolesnika iznosio je 35 godina, 16% bolesnika bile su žene, 32% bolesnika nisu bili bijelci, 7% bolesnika imalo je istodobnu infekciju hepatitisom C, a 4% bolesnika imalo je
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
Table 6 Response in SAILING at 48 Weeks (Snapshot algorithm, <50 copies/mL) Dolutegravir 50 mg Once Daily + BR N=354§ 
Tablica 6 Odgovori u ispitivanju SAILING nakon 48 tjedana (algoritam za globalnu snimku distribuiranog sustava, < 50 kopija/ml)
Alternative combinations that do not include St. John's wort should be used where possible in INI-resistant patients. 
Kad je to moguće potrebno je primijeniti zamjenske kombinacije koje ne uključuju gospinu travu u bolesnika rezistentnih na inhibitore integraze.
Elderly 
Antacidi
• For the treatment of HIV that is resistant to other medicines similar to Tivicay, the usual dose of 
• Za liječenje HIV infekcije otporne na druge lijekove slične lijeku Tivicay, uobičajena doza lijeka Tivicay je jedna tableta od 50 mg dvaput na dan.
Pale yellow, round, biconvex tablets approximately 7 mm in diameter debossed with ‘SV 572' on one side and ‘25' on the other side. 
Blijedo žute, okrugle, bikonveksne tablete, promjera približno 7 mm, s utisnutom oznakom „SV 572“ s jedne i „25“ s druge strane.
Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir. 
Jedna filmom obložena tableta sadrži 10 mg dolutegravira u obliku dolutegravirnatrija.
ANNEX II 
Tablicu 2).
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with tipranavir/ritonavir. 
Preporučena doza dolutegravira u odraslih pri istodobnoj primjeni s tipranavirom/ritonavirom iznosi 50 mg dvaput na dan.
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with efavirenz. 
Preporučena doza dolutegravira u odraslih je 50 mg dvaput na dan kad se istodobno primjenjuje s karbamazepinom.
Tivicay 25 mg film-coated tablets 
Tivicay 25 mg filmom obložene tablete
Etravirine ↔ 
SPRING-2
Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg dolutegravir. 
Jedna filmom obložena tableta sadrži 25 mg dolutegravira u obliku dolutegravirnatrija.
Tivicay 50 mg film-coated tablets 
Tivicay 50 mg filmom obložene tablete
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 10 mg film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOCE 10 mg filmom obložene tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 25mg film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 25 mg filmom obložene tablete
Dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (induction of UGT1A1 and CYP3A enzymes) 
darunavir/ritonavir dolutegravir ↓ AUC ↓ 22% Cmax ↓ 11% C24 ↓ 38% (indukcija enzima UGT1A1 i CYP3A)
Oral administration of dolutegravir to pregnant rats at doses up to 1000 mg/kg daily from days 6 to 17 of gestation did not elicit maternal toxicity, developmental toxicity or teratogenicity (27 times the 50 mg twice daily human clinical exposure based on AUC). 
6. do 17. dana gestacije nije uzrokovala toksičnost za majku, razvojnu toksičnost niti teratogenost (izloženost 27 puta veća od kliničke izloženosti pri primjeni doze od 50 mg dvaput na dan u ljudi, što je utvrđeno na temelju AUC-a).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10mg film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 10 mg filmom obložene tablete
2.5% (95% CI: -2.2%, 7.1%) 
Razlika između liječenja* 2,5% (95% CI: -2,2%; 7,1%) 7,4% (95% CI: 2,5%; 12,3%)
EU/1/13/892/006 
EU/1/13/892/005 EU/1/13/892/006
Dolutegravir ↓ (Not studied, decrease expected due to induction of UGT1A1 and CYP3A enzymes, a similar reduction in exposure as observed with carbamazepine is expected) 
okskarbazepin fenitoin fenobarbital dolutegravir ↓ (interakcija nije ispitivana; očekuje se smanjenje koncentracije zbog indukcije enzima UGT1A1 i CYP3A,
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL 50 mg film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA BOCE 50 mg filmom obložene tablete
Dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (induction of UGT1A1 and CYP3A enzymes) 
Antimikobakterici rifampicin dolutegravir ↓ AUC ↓ 54% Cmax ↓ 43% Cτ ↓72% (indukcija enzima UGT1A1 i CYP3A)
Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Tivicay. 
Ne smijete uzeti nadomjestak kalcija, nadomjestak željeza niti multivitaminski pripravak unutar 6 sati prije primjene lijeka Tivicay i još najmanje 2 sata nakon njegove primjene (pogledajte i dio 3.) • etravirin, efavirenz, fosamprenavir/ritonavir, nevirapin ili tipranavir/ritonavir, koji se koriste za liječenje HIV infekcije
Nelfinavir 
OBLIK
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50mg film-coated tablets 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 50 mg filmom obložene tablete
Factors that decrease dolutegravir exposure should be avoided in the presence of integrase class resistance. 
Interakcije s drugim lijekovima U slučaju rezistencije na skupinu inhibitora integraze potrebno je izbjegavati čimbenike koji smanjuju izloženost dolutegraviru.
NAME OF THE MEDICINAL PRODUCT Tivicay 25 mg tablets dolutegravir 
Tivicay 25 mg tablete dolutegravir
NAME OF THE MEDICINAL PRODUCT Tivicay 10 mg tablets dolutegravir 
Tivicay 10 mg tablete dolutegravir
Virologic suppression (HIV-1 RNA <50 copies/mL) in the dolutegravir plus lamivudine group was non-inferior to the dolutegravir plus TDF/FTC group at 48 weeks, as shown in Table 5. 
U 48. tjednu virološka supresija (HIV-1 RNK < 50 kopija/ml) u skupini koja je primala dolutegravir plus lamivudin bila je neinferiorna onoj u skupini koja je primala dolutegravir plus TDF/FTC, kao što je prikazano u Tablici 5. Rezultati analize objedinjenih podataka odgovarali su onima iz pojedinačnih ispitivanja, kod kojih je postignuta primarna mjera ishoda (razlika u udjelu bolesnika kojima je u 48. tjednu vrijednost HIV-1 RNK u plazmi iznosila < 50 kopija/ml na temelju algoritma za globalnu snimku distribuiranog sustava).
NAME OF THE MEDICINAL PRODUCT Tivicay 25 mg film-coated tablets dolutegravir 
Tivicay 25 mg filmom obložene tablete dolutegravir
NAME OF THE MEDICINAL PRODUCT Tivicay 10 mg film-coated tablets dolutegravir 
Tivicay 10 mg filmom obložene tablete dolutegravir
Median Percent Change from Baseline 
Medijan promjene od početne vrijednosti,
NAME OF THE MEDICINAL PRODUCT Tivicay 50 mg film-coated tablets dolutegravir 
Tivicay 50 mg filmom obložene tablete dolutegravir
Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir. 
Jedna filmom obložena tableta sadrži 50 mg dolutegravira u obliku dolutegravirnatrija.
NAME OF THE MEDICINAL PRODUCT Tivicay 50 mg tablets dolutegravir 
Tivicay 50 mg tablete dolutegravir
Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age. 
adolescenata i djece starije od 6 godina zaraženih virusom humane imunodeficijencije (HIV) .
Tablet coating 
Česte nuspojave
AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73% 
Antikonvulzivi karbamazepin dolutegravir ↓ AUC ↓ 49% Cmax ↓ 33% Cτ ↓ 73%
Subjects were enrolled with a screening plasma HIV-1 RNA of 1000 
Bilo je predviđeno da će se udio bolesnika koji reagiraju na liječenje (HIV-1 RNK
The apparent volume of distribution is 17 L to 20 L in HIV-infected patients, based on a population pharmacokinetic analysis. 
HIV infekcijom kreće se u rasponu od 17 l do 20 l.
Other agents Antiarrhythmics Dofetilide 
Drugi lijekovi i Tivicay
Don't take Tivicay with the following medicine: • dofetilide, used to treat heart conditions 
• dofetilidom, koji se koristi za liječenje srčanih bolesti
The recommended adult dose of dolutegravir is 50 mg twice daily when co-administered with nevirapine. 
Preporučena doza dolutegravira u odraslih je 50 mg dvaput na dan kad se istodobno primjenjuje s gospinom travom.
Clade C 
PRILOG III.
When co-administered with dolutegravir 50mg once daily: 
Antidijabetici metformin metformin ↑ Kad se istodobno primjenjuje s dolutegravirom 50 mg jedanput na dan: metformin
Uncommon Suicidal ideation*, suicide attempt* 
Psihijatrijski poremećaji često nesanica često neuobičajeni snovi često depresija često anksioznost manje često suicidalne ideje*, pokušaj suicida*
• muscle or joint aches. 
• bolove u mišićima ili zglobovima
Alternatives to carbamazepine should be used where possible for INI resistant patients. 
Kad je to moguće, bolesnicima rezistentnima na inhibitore integraze umjesto karbamazepina potrebno je primijeniti zamjenski lijek.
Rifabutin 
• tjeskoba
Therefore, the 50 mg once daily dose should not be given as five 10 mg tablets (see section 5.2). 
Potrebno je slijediti posebne preporuke za doziranje tablete od 10 mg, kako je navedeno u Tablici 1. Stoga, doza od 50 mg jedanput na dan se ne smije primijeniti kao pet tableta od 10 mg (vidjeti dio
All factors that decrease dolutegravir exposure should be avoided in the presence of integrase class resistance. 
U slučaju rezistencije na skupinu inhibitora integraze, potrebno je izbjegavati sve čimbenike koji smanjuju izloženost dolutegraviru.
Clade B 
Dob (godine)
Efavirenz 
• omaglica
Derived IN Mutation Group 
Učinak mutacija
Dolutegravir ↓ AUC ↓ 71% Cmax ↓ 52% Cτ ↓ 88% 
Nenukleozidni inhibitori reverzne transkriptaze etravirin bez pojačanih inhibitora proteaze dolutegravir ↓ AUC ↓ 71% Cmax ↓ 52% Cτ ↓ 88%
In adolescents (12 to less than 18 years of age and weighing at least 40 kg) infected with HIV-1 without resistance to the integrase class, the recommended dose of dolutegravir is 50 mg once daily. 
U adolescenata (12 do manje od 18 godina i tjelesne težine od najmanje 40 kg) zaraženih virusom
Polyvinyl alcohol-partially hydrolyzed Titanium dioxide (E171) 
Jezgra tablete manitol (E421)
In addition, population PK modelling and simulation analyses showed dosing of 
Na temelju populacijske farmakokinetičke analize, prividni volumen distribucije u bolesnika s
blister (PVC/PVDC/alu) 50 x 1 tablets (unit dose) 
PKroz usta
Whereas 
Slijedom toga
In the meantime, the applicant withdrew the application in the Netherlands. 
Podnositelj zahtjeva u međuvremenu je povukao zahtjev u Nizozemskoj.
The decentralised procedure PT/H/1256/001/DC started on 04 June 2014. 
Decentralizirani postupak PT/H/1256/001/DC započeo je 4. lipnja 2014.
The application was submitted to the reference Member State (RMS): Portugal and the concerned Member States (CMS): Germany, Netherlands and United Kingdom. 
Zahtjev je dostavljen referentnoj državi članici: Portugalu te predmetnim državama članicama: Njemačkoj, Nizozemskoj i Ujedinjenoj Kraljevini.
• The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health. 
• Odbor je razmotrio cjelokupne podatke koje je podnositelj zahtjeva dostavio u vezi s iznesenim primjedbama o potencijalnom ozbiljnom riziku za javno zdravlje;
• The Committee considered the referral under Article 29(4) of Directive 2001/83/EC. 
• Odbor je razmotrio postupak upućivanja u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ;
The CMDh 60 day procedure was initiated on 29 January 2018. 
CMDh-ov postupak od 60 dana započeo je 29. siječnja 2018.
The reference medicinal product (Taxol) has a complex formulation for which it is known that the micellar formulation affects the pharmacokinetic profile of paclitaxel after intravenous administration. 
Referentni lijek (Taxol) ima složenu formulaciju za koju je poznato da micelarna formulacija utječe na farmakokinetički profil paklitaksela nakon intravenske primjene.
The CHMP considered that it is essential in order to waive the bioequivalence study requirement to establish that the generic medicinal product and the reference medicinal product have the same behaviour in plasma and ultimately in vivo, i.e. a direct comparison of the free fraction between the two medicinal products should be considered in line with the “Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems” (EMA/CHMP/QWP/799402/2011 
CHMP je smatrao da je za zahtjev za izuzeće od ispitivanja bioekvivalencije ključno utvrditi da se generički i referentni lijek jednako ponašaju u plazmi i slijedom toga, in vivo, tj. treba razmotriti izravnu usporedbu slobodnih frakcija dvaju lijekova treba razmotriti u skladu s dokumentom „Reflection paper on the pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems” (EMA/CHMP/QWP/799402/2011)
Day 60 of the CMDh procedure was on 29 March 2018 and as no agreement could be reached the procedure was referred to the CHMP. 
60. dan CMDh-ova postupka bio je 29. ožujka 2018., a budući da nije postignut dogovor, postupak je upućen Odboru za lijekove za humanu uporabu (CHMP).
On 29 March 2018 Portugal therefore triggered a referral under Article 29(4) of Directive 2001/83/EC. 
Portugal je stoga 29. ožujka 2018. pokrenuo postupak upućivanja u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
An application was submitted under the decentralised procedure for Paclitaxel Hetero, 6 mg/mL, concentrate for solution for infusion on 15 May 2014. 
Zahtjev je podnesen 15. svibnja 2014. u okviru decentraliziranog postupka za lijek Paclitaxel Hetero, 6 mg/ml, koncentrat za otopinu za infuziju.
The applicant submitted a study report with results of the direct comparison of micelles' characteristics of Paclitaxel Hetero and Taxol and another publication containing data on the free drug fraction of Taxol in human plasma. 
Podnositelj zahtjeva predao je izvješće o ispitivanju s rezultatima izravne usporedbe svojstava micela u lijekovima Paclitaxel Hetero i Taxol i dodatnu publikaciju s podatcima o slobodnim frakcijama za lijek Taxol u ljudskoj plazmi.
However, the additional data provided were not robust enough to establish equivalence between Paclitaxel Hetero and the EU reference medicinal product. 
Međutim, dodatni dostavljeni podatci nisu bili dovoljno pouzdani za uspostavljanje ekvivalencije između lijeka Paclitaxel Hetero i referentnog lijeka odobrenog u EU-u.
The Netherlands raised objections on the fact that the indirect comparison data on which the applicant based its claim for equivalence was not considered robust nor was convincing enough to support a biowaiver, and this was regarded to be a potential serious risk to public health. 
Nizozemska je iznijela prigovore u vezi s činjenicom da se podatci o neizravnoj usporedbi na kojima je podnositelj zahtjeva temeljio svoje tvrdnje ne smatraju pouzdanima ni dovoljno uvjerljivima da bi išli u prilog izuzeću od ispitivanja bioekvivalencije, što je smatrano potencijalnim ozbiljnim rizikom za javno zdravlje.
While there may be occasions where an indirect comparison may be acceptable to support a biowaiver, having assessed the literature provided, the CHMP concluded that the data was not sufficiently robust nor convincing enough to replace the need for a head-to-head comparison using identical methods and performed at the same time for test and reference product, and therefore should be understood as supportive only. 
Premda mogu postojati slučajevi u kojima neizravna usporedba može biti prihvatljiva za podupiranje izuzeća od ispitivanja bioekvivalencije, CHMP je nakon procjene dostavljene literature zaključio da podatci nisu dovoljno pouzdani ni uvjerljivi da bi se njima nadomjestila potreba za izravnom usporedbom identičnim metodama koja se provodi istovremeno za ispitivani i referentni lijek, te se stoga podatci trebaju uzeti samo kao dodatni.