natgillin/translations-raw huggingface dataset:
In NEOSPHERE, two patients in the Perjeta and docetaxel-treated group experienced anaphylaxis. 
V preskušanju NEOSPHERE je pri dveh bolnicah iz skupine, ki je prejemala zdravilo Perjeta in docetaksel, prišlo do pojava anafilaksije.
and all patients were female. 
Vsi vključeni bolniki so bili ženskega spola, demografska struktura je bila dobro uravnotežena
Perjeta 420 mg concentrate for solution for infusion pertuzumab 
Perjeta 420 mg koncentrat za raztopino za infundiranje pertuzumab
Each vial contains a total of 420 mg pertuzumab at a concentration of 30 mg/ml 
Ena 14 ml viala vsebuje 420 mg pertuzumaba s koncentracijo 30 mg/ml.
Shortness of breath 
• težko dihanje
• 3 cycles of FEC alone followed by 3 cycles of docetaxel, with trastuzumab and Perjeta given concurrently 
• 3 cikli samostojne sheme FEC, ki so ji sledili 3 cikli zdravljenja z docetakselom, sočasno s trastuzumabom in zdravilom Perjeta,
It should not be administered as an intravenous push or bolus. 
Zdravila se ne sme dajati v obliki bolusa.
Most events were Grade 1 or 2 in severity, occurred in the first two cycles, and responded to standard therapies, such as topical or oral treatment for acne. 
Večina dogodkov je bila po resnosti opredeljena kot 1. ali 2. stopnje in se je pojavila v prvih dveh ciklih.
21.0, 23.6) in the Perjeta arm versus +9.2 (95% CI 8.2, 10.2) in the placebo arm. 
Ocena simptomov driske se je v skupini z zdravilom Perjeta povečala na +22,3 (95-% IZ 21,0; 23,6) in v skupini s placebom na +9,2 (95-% IZ 8,2; 10,2).
Baseline albumin and lean body weight were the most significant covariates influencing CL. CL decreased in patients with higher baseline albumin concentrations and increased in patients with greater lean body weight. 
Ta je bil manjši pri večji izhodiščni koncentraciji albumina in večji pusti telesni masi.
Do not freeze 
Ne zamrzujte
In the TRYPHAENA trial, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was 85.3% in patients treated with neoadjuvant Perjeta + TCH and 77.0% in patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC, including 66.7% and 59.5% Grade 4 neutropenia, 
V preskušanju TRYPHAENA je bila incidenca nevtropenije stopnje 3-4 po merilih NCI-CTCAE (različica 3) 85,3 % pri bolnicah, ki so se neoadjuvantno zdravile z zdravilom Perjeta in shemo TCH, ter 77,0 % pri bolnicah, ki so se neoadjuvantno zdravile s kombinacijo zdravila Perjeta, trastuzumaba in docetaksela po shemi FEC, pri čemer se je nevtropenija stopnje 4 pojavila pri 66,7 % bolnic, ki so se neoadjuvantno zdravile z zdravilom Perjeta in shemo TCH in 59,5 % bolnic, ki so se neoadjuvantno zdravile s kombinacijo zdravila Perjeta, trastuzumaba in docetaksela po shemi FEC.
In the neoadjuvant trial TRYPHAENA, the incidence of LVD (during the overall treatment period) 
V neoadjuvantnem obdobju preskušanja BERENICE je bila incidenca simptomatske LVD NYHA
In the NEOSPHERE trial, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was 74.5% in patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel compared with 84.5% in patients treated with trastuzumab and docetaxel, including 50.9% and 60.2% Grade 4 neutropenia, respectively. 
V preskušanju NEOSPHERE je bila incidenca nevtropenije stopnje 3-4 po merilih NCI-CTCAE (različica 3) 74,5 % pri bolnicah, ki so se neoadjuvantno zdravile z zdravilom Perjeta, trastuzumabom in docetakselom, v primerjavi s 84,5 % pri bolnicah, ki so se zdravile s trastuzumabom in docetakselom, pri čemer se je nevtropenija stopnje 4 pojavila pri 50,9 % bolnic, ki so se neoadjuvantno zdravile z zdravilom Perjeta, trastuzumabom in docetakselom, in 60,2 % bolnic, ki so se zdravile s trastuzumabom in docetakselom.
The bag should be gently inverted to mix the solution in order to avoid foaming. 
Da bi preprečili penjenje raztopine, je treba vrečko previdno obračati, da se tekočina premeša.
Perjeta+ Trastuzuma b N=107 
trastuzumab docetaksel n = 107
No differences in pertuzumab PK were observed in patients with early breast cancer compared to patients with metastatic breast cancer. 
Pri bolnikih z zgodnjim rakom dojk in bolnikih z metastatskim rakom dojk ni bilo razlik v farmakokinetiki pertuzumaba.
(vs. Trastuzumab +Docetaxel) 
trastuzumab + docetaksel)
6.5 Nature and contents of container 
FARMACEVTSKA OBLIKA IN VSEBINA
In the neoadjuvant period of the BERENICE trial, the incidence of NYHA Class III/IV symptomatic LVD (congestive heart failure according to NCI-CTCAE v.4) was 1.5% in the group treated with dose dense doxorubicin and cyclophosphamide (AC) followed by Perjeta plus trastuzumab and paclitaxel and none of the patients (0%) experienced symptomatic LVD in the group treated with FEC followed by Perjeta in combination with trastuzumab and docetaxel. 
razreda III/IV (kongestivnega srčnega popuščanja po merilih NCI-CTCAE v.4) v skupini, zdravljeni s pogostimi odmerki (angl. dose dense) doksorubicina in ciklofosfamida, čemur je sledilo zdravilo Perjeta v kombinaciji s trastuzumabom in paklitakselom, 1,5 %.
In addition, ADRs reported in the post-marketing setting are included in Table 2. 
V preglednici 2 so vključeni tudi neželeni učinki, o katerih so poročali v obdobju trženja zdravila.
Leucopenia 
trastuzumab
You should use effective contraception during treatment with Perjeta and for 6 months after stopping treatment. 
6 mesecev po koncu zdravljenja morate uporabljati učinkovito kontracepcijsko zaščito.
decline of at least 10% points from baseline and to <50% was <1% (0.6% of Perjeta-treated patients vs 0.3% of placebo-treated patients). 
Pojavnost simptomatskega srčnega popuščanja (razred III ali IV po NYHA) z zmanjšanjem LVEF za vsaj 10 odstotnih točk od izhodiščne vrednosti in na < 50 % je bila v študiji APHINITY < 1 % (0,6 %
pCR rate in the breast and lymph node (ypT0/is N0) 
Dodatni eksplorativni deleži pCR vključujejo status bezgavk (ypT0/isN0 in ypT0N0).
See section 4 “Serious side effects” for more details about infusion reactions to look out for during the infusion and thereafter. 
Za podrobnosti o infuzijskih reakcijah, na katere morate biti pozorni med infuzijo zdravila in po njej, glejte poglavje 4, “Resni neželeni učinki”.
Glacial acetic acid, L-histidine, sucrose and polysorbate 20. 
koncentrirana ocetna kislina, L-histidin, saharoza, polisorbat 20, voda za injekcije
Asymptomatic or mildly symptomatic (NYHA class II) 
incidenca LVD razreda III/IV po NYHA ali upad
TRYPHAENA is a multicentre, randomised phase II clinical trial conducted in 225 adult female patients with HER2-positive locally advanced, operable, or inflammatory breast cancer (T2-4d; primary tumour > 2cm in diameter) who had not received prior trastuzumab, chemotherapy or radiotherapy. 
TRYPHAENA je multicentrično, randomizirano, klinično preskušanje faze II pri 225 odraslih bolnicah s HER2-pozitivnim lokalno napredovalim, operabilnim ali vnetnim rakom dojk (T2-4d;
(71.2%) compared to the placebo arm (45.2%). 
V preskušanju APHINITY so poročali o večji pojavnosti driske v skupini z zdravilom Perjeta (71,2 %) kot v skupini s placebom (45,2 %).
When administered with Perjeta, docetaxel can be started at 75 mg/m2, and subsequently escalated to 100 mg/m2 depending on the chosen regimen and tolerability of the initial dose. 
Začetni odmerek docetaksela ob zdravilu Perjeta je lahko 75 mg/m2, nato pa se ga poveča na
Fatigue 
Driska
Interstitial lung disease Pleural effusion 
Žilne bolezni oblivi vročine
In the pivotal trial CLEOPATRA in metastatic breast cancer, rash occurred in 51.7% of Perjeta-treated patients, compared with 38.9% of placebo-treated patients. 
Izpuščaj V ključnem preskušanju CLEOPATRA pri metastatskem raku dojk se je izpuščaj pojavil pri 51,7 %
In the hormone receptor-positive subgroup estimates of IDFS rates were 94.8% versus 94.4% at 3 years and 93.0% versus 91.6% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively. 
Po 4 letih je bil ta delež pri bolnikih v podskupini s pozitivnimi hormonskimi receptorji, ki so prejemali zdravilo Perjeta, 93,0 %, pri bolnikih, ki so prejemali placebo, pa 91,6 %.
Name and address of the manufacturer of the biological active substance(s) Genentech, Inc. 
Ime in naslov izdelovalca biološke učinkovine
Ask your doctor or nurse to give you information about these other medicines. 
Z zdravnikom ali medicinsko sestro se posvetujte, preden dobite zdravilo Perjeta:
FEC Perjeta+ Trastuzumab 
FEC Perjeta +
In both the TRYPHAENA and APHINITY trials, the overall frequency of hypersensitivity/anaphylaxis was highest in the Perjeta and TCH treated group (13.2% and 7.6%, respectively), of which 2.6% and 1.3% of events, respectively, were NCI-CTCAE Grade 3-4. 
V obeh preskušanjih TRYPHAENA in APHINITY je bila v skupini, zdravljeni z zdravilom Perjeta in shemo TCH, skupna pogostnost preobčutljivosti/anafilaksije največja (13,2 % v preskušanju
The 840 mg loading dose of pertuzumab should be re-administered as a 60 minute infusion, followed by a maintenance dose of 420 mg IV administered every 3 weeks thereafter. 
Ponovno je treba dati uvajalni 840-mg odmerek pertuzumaba v 60minutni intravenski infuziji, ki mu sledi vzdrževalni odmerek
In the lymph node- negative subgroup, estimates of IDFS rates were 97.5% versus 98.4% at 3 years and 
V podskupini z negativnimi bezgavkami je bil ocenjeni delež IDFS po 3 letih pri bolnikih, ki so prejemali zdravilo Perjeta, 97,5 %, pri bolnikih, ki so prejemali placebo, pa 98,4 %.
during FEC treatment prior to receiving Perjeta plus trastuzumab and docetaxel) and also 1.3% in the group treated with Perjeta in combination with TCH. 
1,3 % v skupini bolnic, ki so po zdravljenju s FEC prejele zdravilo Perjeta, trastuzumab in docetaksel (izključena je bolnica, pri kateri se je simptomatska LVD pojavila med zdravljenjem s FEC pred prejemom zdravila Perjeta, trastuzumaba in docetaksela) ter tudi 1,3 % v skupini, zdravljeni z zdravilom Perjeta v kombinaciji s shemo TCH.
NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion 
Perjeta 420 mg koncentrat za raztopino za infundiranje
Hair loss 
Razredčena raztopina
There was no evidence of any PK interaction between pertuzumab and any of these agents. 
Med pertuzumabom in navedenimi zdravili niso ugotovili nobenih farmakokinetičnih medsebojnih delovanj.
NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion pertuzumab 
Navodilo za uporabo Perjeta 420 mg koncentrat za raztopino za infundiranje pertuzumab
Trastuzum ab +Docetaxel N=107 
Parameter trastuzumab + docetaksel n = 107
p-value (Log-Rank test, stratified1) 3 year event-free rate2 [95% CI] 
HR [95-% IZ] Vrednost p (log-rang test, stratificirani1)
18.1% of patients in the Perjeta arm vs. 9.2% of patients in the placebo arm in the post-chemotherapy targeted therapy period. 
Po zaključku kemoterapije je bila pojavnost driske precej manjša; med obdobjem ciljnega zdravljenja po kemoterapiji je prizadela 18,1 % bolnikov v skupini z zdravilom Perjeta in 9,2 % bolnikov v skupini s placebom.
In the TRYPHAENA trial, rash occurred in 36.8% of patients treated with neoadjuvant Perjeta + TCH and 20.0% of patients treated with neoadjuvant Perjeta, trastuzumab and docetaxel following FEC. 
bolnikc, ki so se neoadjuvantno zdravile z zdravilom Perjeta in shemo TCH, in pri 20,0 % bolnic, ki so se neoadjuvantno zdravile s kombinacijo zdravila Perjeta, trastuzumaba in docetaksela po shemi FEC.
Estimates of IDFS rates in the lymph node- positive subgroup were 92.0% versus 90.2% at 3 years and 89.9% vs. 86.7% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively. 
Ocenjeni delež IDFS je bil v podskupini s pozitivnimi bezgavkami po 3 letih pri bolnikih, ki so prejemali zdravilo Perjeta, 92,0 %, pri bolnikih, ki so prejemali placebo, pa 90,2 %.
Dose modification 
• spremembe nohtov
96.2% versus 96.7% at 4 years in Perjeta-treated patients versus placebo-treated patients, respectively. 
Po 4 letih je bil ta delež pri bolnikih v podskupini z negativnimi bezgavkami, ki so prejemali zdravilo Perjeta, 96,2 %, pri bolnikih, ki so prejemali placebo, pa 96,7 %.
An observation period of 30 - 60 minutes is recommended after completion of each infusion. 
Po koncu vsakega infundiranja je bolnike priporočljivo opazovati 30 do 60 minut.
Stomatitis 
Izdelovalec
Neutropenia 
• nespečnost
Diarrhoeal events responded well to proactive management with anti-diarrhoeal agents. 
Driska se je umirila in bila obvladljiva po uvedbi zdravil proti driski.
(ejection fraction decrease according to NCI-CTCAE v.4) was 7% in the group treated with dose dense AC followed by Perjeta plus trastuzumab and paclitaxel and 3.5% in the group treated with FEC 
Incidenca asimptomatske LVD (zmanjšanja iztisnega deleža levega prekata po merilih NCI-CTCAE v.4) je bila 7 % v skupini, zdravljeni s pogostimi odmerki doksorubicina in ciklofosfamida, čemur je sledilo zdravilo Perjeta v kombinaciji s trastuzumabom in paklitakselom, in
Weak, numb, tingling or prickling sensations mainly affecting the feet and legs Nose bleeds 
• šibkost, odrevenelost, mravljinčenje, zbadanje, zlasti v stopalih in nogah
Inflammation of the nail bed where the nail and skin meet Condition in which the left ventricle of the heart is functionally impaired with or without symptoms 
• funkcijska okvara levega prekata srca, ki je lahko simptomatska ali prikrita (ne daje simptomov)
The infusion rate may be slowed or interrupted if the patient develops an infusion reaction (see section 4.8). 
Če se razvije infuzijska reakcija, se hitrost infuzije upočasni ali infundiranje prekine (glejte poglavje
NA 
ali
Five studies evaluated the effects of pertuzumab on the PK of co-administered cytotoxic agents, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin and erlotinib. 
FEC: 5-fluorouracil, epirubicin, ciklofosfamid; TCH: docetaksel, karboplatin and trastuzumab, CMH: CochranMantel-Haenszel, IZ: interval zaupanja
Tell your doctor straight away, if you get pregnant during treatment with Perjeta or during the 6 months after stopping treatment. 
• Če med zdravljenjem z zdravilom Perjeta ali v 6 mesecih po koncu zdravljenja zanosite, morate o tem takoj obvestiti zdravnika.
Grounds for the variation to the terms of the marketing authorisation(s) 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Drug hypersensitivity°, 
preobčutljivost na zdravilo°, *
• Trastuzumab plus docetaxel 
tras tuzumab + docetaksel)
The primary endpoint of the study was progression-free survival (PFS) as assessed by an independent review facility (IRF) and defined as the time from the date of randomisation to the date of disease progression or death (from any cause) if the death occurred within 18 weeks of the last tumour assessment. 
Opredeljen je bil kot čas od datuma randomizacije do datuma napredovanja bolezni ali do smrti (zaradi kakršnega koli vzroka),
Patients were randomised to receive one of the following neoadjuvant regimens for 4 cycles prior to surgery: 
Bolnice so pred operacijo randomizirali v enega od naslednjih neoadjuvantnih shem (prejele so 4
The incidence of asymptomatic LVD 
Incidenca simptomatske LVD (kongestivnega srčnega popuščanja) je bila
Key to abbreviations (Table 5): HR: Hazard Ratio; CI: Confidence Interval 
3-letni delež brez dogodkov2 [95-% IZ] Legenda okrajšav (preglednica 5): HR = razmerje ogroženosti, IZ = interval zaupanja.
How you are given Perjeta 
Kako boste prejeli zdravilo Perjeta Prejemanje tega zdravila
In the APHINITY trial, a higher incidence of diarrhoea was reported in the Perjeta-treated arm 
Po oceni raziskovalca se je anafilaksija skupno pojavila pri 2 bolnikih v skupini, ki je prejemala placebo,
The primary endpoint of cardiac safety, i.e. the incidence of NYHA Class III/IV LVD and LVEF declines, was consistent with previous data in the neoadjuvant setting (see section 4.4. and 4.8). 
LVEF, je bila skladna z že znanimi podatki pri neoadjuvantnem zdravljenju (glejte poglavji 4.4 in
Fever associated with dangerously low levels of a type of white blood cell (neutrophils) Pain in the body, arms, legs, and belly 
• zvišana telesna temperatura, povezana z nevarno majhnim številom vrste belih krvih celic
Difference in ORR: 
Razlika v deležu objektivnega odgovora:
How to store Perjeta 
Shranjevanje zdravila Perjeta
No pharmacokinetic (PK) interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel in a sub-study of 37 patients in the randomised, pivotal trial CLEOPATRA in metastatic breast cancer. 
CLEOPATRA pri metastatskem raku dojk, niso opazili medsebojnega farmakokinetičnega delovanja med pertuzumabom in trastuzumabom in tudi ne med pertuzumabom in docetakselom.
Fertility 
BERENICE.
Table 1 Recommendations regarding delayed or missed doses Time between two sequential infusions 
Priporočila glede zamujenih ali izpuščenih odmerkov
Decreas ed appetite 
v dojki in bezgavki
Keep this medicine out of the sight and reach of children. 
• Zdravilo shranjujte nedosegljivo otrokom!
• Perjeta plus docetaxel. 
• zdravilo Perjeta in docetaksel.
Therefore, care must be taken to ensure the sterility of the prepared solution for infusion and should be prepared by a healthcare professional. 
Zdravilo Perjeta ne vsebuje protimikrobnih konzervansov, zato ga mora pripraviti zdravstveni delavec; pri tem je treba uporabiti aseptične postopke za zagotovitev sterilnosti pripravljene raztopine.
In the neoadjuvant trial NEOSPHERE, in which patients received 4 cycles of Perjeta as neoadjuvant treatment, the incidence of LVD (during the overall treatment period) was higher in the Perjeta, 
V preskušanju neoadjuvantnega zdravljenja NEOSPHERE, v katerem so bolnice za neoadjuvantno zdravljenje prejele 4 cikle zdravila Perjeta, je bila incidenca LVD (tekom celotnega obdobja zdravljenja) večja v skupini, zdravljeni z zdravilom Perjeta, trastuzumabom in docetakselom (7,5 %), v primerjavi s skupino, zdravljeno s trastuzumabom in docetakselom (1,9 %).
• the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1) 
• neoadjuvantno zdravljenje odraslih bolnikov s HER2-pozitivnim, lokalno napredovalim,
Overall, 2 patients in the placebo-treated group and 4 patients in the Perjeta-treated group experienced events described as anaphylaxis by the investigator (see section 
in pri 4 bolnikih v skupini, ki je prejemala zdravilo Perjeta (glejte poglavje 4.4).
trastuzumab and docetaxel-treated group (7.5%) compared to the trastuzumab and docetaxel-treated group (1.9%). 
TRYPHAENA; 7,6 % v preskušanju APHINITY), od tega je bilo 2,6 % (TRYPHAENA) in 1,3 % (APHINITY) dogodkov stopnje 3-4 po merilih NCI-CTCAE.
In the pivotal trial CLEOPATRA in metastatic breast cancer, the incidence of NCI-CTCAE v.3 Grade 3-4 neutropenia was balanced in the two treatment groups (86.3% of Perjeta-treated patients and 86.6% of placebo-treated patients, including 60.7% and 64.8% Grade 4 neutropenia, respectively). 
(86,3 % v skupini, ki je prejemala zdravilo Perjeta, in 86,6 % v skupini, ki je prejemala placebo; vključno z nevtropenijo stopnje 4 pri 60,7 % v skupini, ki je prejemala zdravilo Perjeta, in 64,8 % v skupini, ki je prejemala placebo).
Perjeta contains the active substance pertuzumab and is used to treat adult patients with breast cancer when: 
Pet študij je ocenjevalo vpliv pertuzumaba na farmakokinetiko sočasno danih citotoksičnih zdravil:
80.6% of placebo-treated patients had recovered at the data cutoff. 
bolnikov, ki so prejemali zdravilo Perjeta, v primerjavi s 38,9 % bolnikov, ki so prejemali placebo.
This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions. 
To pomeni, da je CHMP takrat ocenjeval začetno dokumentacijo, ki jo je predložila družba, in pripravil seznam vprašanj.
The company had not yet responded to the questions at the time of the withdrawal. 
Družba se ob umiku vloge še ni odzvala na vprašanja.
It was to be used on its own or with other anticancer medicines. 
Uporabljalo naj bi se samostojno ali v kombinaciji z drugimi zdravili proti raku.
The application was withdrawn at ‘day 120'. 
Družba je vlogo umaknila na 120. dan postopka.
On 8 March 2010, Mylan S.A.S. 
Družba Mylan S.A.S.
With the skeleton still in place, the cells cannot divide and they eventually die. 
Če je skelet še vedno zdrav, se celice ne morejo deliti in sčasoma odmrejo.
The company provided data on docetaxel from the published literature. 
Družba je predstavila podatke o docetakselu iz objavljene literature.
Other substances are added to docetaxel to help it form small spherical structures called ‘micelles' that are suitable for injection. 
Docetakselu se dodajajo druge snovi, s pomočjo katerih se tvorijo majhne okrogle strukture, imenovane „micele“, ki so primerne za injiciranje.
Docetaxel blocks the ability of cells to destroy the internal ‘skeleton' that allows them to divide and multiply. 
Docetaksel zavira sposobnost celic, da uničijo notranji „skelet“, ki celicam omogoča deljenje in razmnoževanje.
However, the substances added in Docetaxel Mylan and Taxotere to form the micelles are not the same. 
Vendar snovi, ki se dodajajo zdraviloma Docetaxel Mylan in Taxotere za tvorbo micel, niso enake.
This means that Docetaxel Mylan was intended to be similar to a ‘reference medicine' already authorised in the European Union called Taxotere. 
To pomeni, da je zdravilo Docetaxel Mylan podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
Because of this and the complex nature of micelles themselves, the Committee had concluded that additional studies on Docetaxel Mylan were necessary, including studies on how the medicine would be treated by the body and its safety. 
Zaradi omenjenega in zapletene narave micel je odbor zaključil, da bi bile za zdravilo Docetaxel Mylan potrebne dodatne študije, vključno s študijami o varnosti zdravila in o tem, kako bi se telo odzvalo na zdravilo.
Because Docetaxel Mylan contains the same active substance as Taxotere and was to be given directly into a vein, the company did not consider additional studies on the Docetaxel Mylan to be necessary according to EU rules. 
Ker zdravilo Docetaxel Mylan vsebuje enako zdravilno učinkovino kot zdravilo Taxotere in naj bi se dajalo neposredno v veno, je družba menila, da v skladu s pravili EU dodatne študije za zdravilo Docetaxel Mylan niso potrebne.
Docetaxel Mylan was developed as a ‘generic medicine'. 
Zdravilo Docetaxel Mylan je bilo razvito kot „generično zdravilo“.
It was to be available as a powder and solvent to be made up into a solution for infusion (drip into a vein). 
Na voljo naj bi bilo v obliki praška in vehikla za pripravo raztopine za infundiranje (kapalne infuzije v veno).
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Docetaxel Mylan. 
Zato je CHMP v času umika vloge menil, da družba ni predložila dovolj podatkov v podporo vlogi za zdravilo Docetaxel Mylan.
Docetaxel Mylan was expected to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma (a type of stomach cancer) and head and neck cancer. 
Zdravilo Docetaxel Mylan naj bi se uporabljalo za zdravljenje bolnikov z rakom dojke, nedrobnoceličnim pljučnim rakom, rakom prostate, adenokarcinomom želodca (vrsto želodčnega raka) in rakom glave in vratu.
officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Mylan intended to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. 
je 8. marca 2010 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Docetaxel Mylan, namenjenim zdravljenju bolnikov z rakom dojke, nedrobnoceličnim pljučnim rakom, rakom prostate, adenokarcinomom želodca ter rakom glave in vratu.