natgillin/translations-raw huggingface dataset:
- The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl hydroxybenzoate (E 216), xanthan gum, purified water (see also section 2 “Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol”).
- Pomožne snovi so izostearinska kislina, benzilalkohol, cetilalkohol, stearilalkohol, beli vazelin, polisorbat 60, sorbitan stearat, glicerol, metilparahidroksibenzoat (E 218), propilparahidroksibenzoat (E 216), ksantanski gumi, prečiščena voda (glejte tudi poglavje 2 ''Krema Aldara vsebuje metilparahidroksibenzoat, propilparahidroksibenzoat, cetilalkohol, stearilalkohol in benzilalkohol'').
Target tumours were histologically confirmed single primary superficial basal cell carcinomas with a minimum size of 0.5 cm and a maximum diameter of 2 cm. Tumours located within 1 cm of the eyes, nose, mouth, ears or hairline were excluded.
Ciljni tumorji so bili histološko potrjeni posamezni primarni površinski karcinomi bazalnih celic, ki so obsegali najmanj 0,5 cm2, njihov premer pa ni presegal 2 cm.
Rare cases of remote site dermatologic drug reactions, including erythema multiforme, have been reported from clinical trials.
Pri kliničnih preskušanjih so poročali o redkih blagih primerih kožnih reakcij, vključno z multiformnim eritemom.
Five -year data from a long-term open-label uncontrolled study indicate that an estimated 77.9% [95% CI (71.9%, 83.8%)] of all the subjects who initially received treatment became clinically clear and remained clear at 60 months.
Ocenjujejo, da so pri 77,9 % [(95 % interval zaupanja (IZ) 71,9; 83,8 %)] bolnikov, ki so prejeli zdravilo na začetku, klinični znaki bolezni izginili in se 60 mesecev niso ponovno pojavili.
LE11 5SF, United Kingdom
Loughborough Leicestershire LE11 5SF, Velika Britanija
Do not cover the treated area with bandages or other dressings after you have applied Aldara cream.
Ne pokrivajte področja zdravljenja s povoji ali obvezami po nanosu kreme Aldara.
● If you are being treated for basal cell carcinoma:
● Če se zdravite zaradi karcinoma bazalnih celic:
Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been observed in clinical trials.
V kliničnih preskušanjih so opazili znižanje vrednosti hemoglobina, levkocitov, absolutnih nevtrofilcev in trombocitov.
Do not apply the cream on Saturday and Sunday.
Nanašajte kremo npr. od ponedeljka do petka, v soboto in nedeljo pa kreme ne nanašajte.
Excipients: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl hydroxybenzoate (E 216), xanthan gum, purified water.
Pomožne snovi: izostearinska kislina, benzilalkohol, cetilalkohol, stearilalkohol, beli vazelin, polisorbat 60, sorbitan stearat, glicerol, metilparahidroksibenzoat (E 218), propilparahidroksibenzoat (E 216), ksantanski gumi, prečiščena voda.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity and teratogenicity.
Neklinični podatki na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
What Aldara cream contains
Kaj vsebuje krema Aldara
• Do not apply the cream internally.
• Krema je namenjena samo za zunanjo uporabo.
Patient reported adverse reactions from 252 patients treated with imiquimod cream in vehicle controlled phase III clinical studies for actinic keratosis are presented below.
V preglednici so navedeni neželeni učinki, ki so se pojavili pri zdravljenju 252 bolnikov z imikvimod kremo v nadzorovanih kliničnih študijah faze III z vehiklom.
Continue treatment for four weeks.
Kremo uporabljajte štiri tedne.
Imiquimod cream is indicated for the topical treatment of:
Kremo z imikvimodom uporabljamo za topikalno zdravljenje:
Aldara 5% cream Imiquimod
Aldara 5 % krema imikvimod
Topical administration of imiquimod cream resulted in no tumour enhancement at any dose, in comparison with the vehicle cream group.
Topikalno nanašanje kreme z imikvimodom v primerjavi s skupino, ki so ji nanašali le vehikel, pri nobenem odmerku ni povzročilo rasti tumorjev.
Application site papules
Papule na mestu aplikacije pogosti
Common effects include: pins and needles, small swollen areas in the skin, pain, burning, irritation, bleeding, redness or rash.
Pogosti neželeni učinki so: mravljinčenje, majhne otekline v koži, bolečina, pekoč občutek, draženje, krvavitev, rdečica in izpuščaj.
Uncommonly some patients experience changes at the application site (discharge, inflammation, swelling, scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flulike symptoms and tiredness.
Občasno so se pri nekaterih bolnikih pojavile spremembe na mestu nanosa (izcedek, vnetje, oteklina, razvoj krast, razpokanje kože, mehurčki, dermatitis) ali draženje, občutek slabosti, izsušena usta, gripi podobni simptomi in utrujenost.
Open a new sachet each time you use the cream.
Vsakič, ko uporabljate kremo Aldara, odprite novo vrečko.
Some systemic adverse reactions, including back pain (1.1%) and influenza-like symptoms (0.5%) were reported by imiquimod cream patients.
Bolniki, ki so prejemali imikvimod kremo, so poročali o nekaterih sistemskih neželenih reakcijah, med drugim o bolečini v križu (1,1 %) in simptomih podobnih gripi (0,5 %).
Apply the cream to the affected area.
Nanesite tanek sloj kreme Aldara na prizadeto področje.
The risk for recurrence of AK lesions in the treated field (as defined above) was 39.7% (50 of 126 patients) until month 12 for patients treated with imiquimod compared with 50.0% (42 of 84 patients) for patients treated with topical diclofenac, a difference of -10.3% (95% CI: -23.6% to
Tveganje za ponovitev AK lezij na zdravljenem predelu (kot je opredeljeno zgoraj) je bilo 39,7 % (50 od 126 bolnikov) do 12. meseca za bolnike, zdravljene z imikvimodom v primerjavi s 50,0 % (42 od 84 bolnikov) za bolnike, zdravljene s topičnim diklofenakom, razlika -10,3 % (95 % IZ: -23,6 % do 3,3 %); ter 66,7 % (84 od 126 bolnikov) za zdravljenje z imikvimodom in 73,8 % (62 od 84 bolnikov) za topični diklofenak do 36 meseca, razlika -7,1 % (95 % IZ: -19,0 % do 5,7 %).
The induction of alpha interferon and other cytokines following imiquimod cream application to genital wart tissue has also been demonstrated in clinical studies.
V kliničnih študijah je bilo po nanosu imikvimod kreme dokazano spodbujanje interferona alfa in drugih citokinov v tkivu z genitalnimi bradavicami.
Irritability
Razdraženost
One sachet contains enough cream to cover an area of 25 cm
Količina kreme v eni vrečki zadostuje za prekritje 25 cm2.
Application site skin breakdown
Razpokanje kože na mestu aplikacije
Malaise
Neugodje
Postmarketing reports of suspected alopecia occurring during the treatment of sBCC and EGW have been received.
O sumu pojava alopecije v času zdravljenja sBCC in zunanjih genitalnih bradavic so poročali v času trženja zdravila.
Apply a thin layer of Aldara cream onto clean, dry wart area and rub gently into the skin until cream vanishes.
Nanesite tanek sloj kreme Aldara na umito in suho področje z bradavicami.
Talk to your doctor or pharmacist before using Aldara cream
Pred začetkom uporabe kreme Aldara se posvetujte z zdravnikom ali farmacevtom
Application site reactions occurred more frequently after imiquimod than after vehicle, however, incidence and intensity of these reactions were not different from that seen in the licensed indications in adults.
Vendar pogostost in intenzivnost teh reakcij ni odstopala od tistih, ki so jih opazovali pri registriranih indikacijah in odraslih osebah.
A different therapy is recommended if the treated lesion(s) shows insufficient response to Aldara.
V kolikor odziv zdravljenih lezij na zdravilo Aldara ni zadosten, se priporoča drugačno zdravljenje.
Application Instructions - (Mon, Tues, Wed, Thurs and Fri) 1.
Navodila za nanos (ponedeljek, torek, sreda, četrtek in petek) 1.
Thereof 4 of 242 patients (1.7%) of the imiquimod and 7 of 237 patients (3.0%) of the diclofenac group were found to have a histological progression to invasive SCC within the 3-year period.
Histološko napredovanje v invazivni SCC v obdobju 3 let so potrdili pri 4 od 242 bolnikov (1,7 %) v skupini z imikvimodom in 7 od 237 bolnikov (3,0 %) v skupini z diklofenakom.
• If the treated site becomes too uncomfortable, wash the cream off with mild soap and water.
• Če se na področju nanosa kreme pojavi neprijeten ali pekoč občutek, kremo sperite z blagim milom in vodo.
If required by the patient's discomfort or the severity of the local skin reaction, a rest period of several days may be taken.
Zdravljenje se lahko za nekaj dni prekine zaradi nelagodja bolnika ali resnosti lokalne reakcije na koži.
No quantifiable levels (>5 ng/ml) of drug were detected in serum after single or multiple topical doses.
Po enkratnem in večkratnem topičnem odmerku v serumu ni bilo zaznavnih koncentracij imikvimoda (>5 ng/ml).
Aldara 5% cream Imiquimod Cutaneous use
Aldara 5 % krema imikvimod dermalna uporaba
Application site reaction
Reakcija na mestu aplikacije pogosti
Skin infections during treatment with imiquimod have been observed.
Med zdravljenjem z imikvimod kremo so opazili kožne infekcije.
Lethargy
Urtikarija
Nervous system disorders: Headache
Bolezni živčevja: Glavobol pogosti pogosti
Vulval disorder
Spremembe vulve
Following accidental ingestion, nausea, emesis, headache, myalgia and fever could occur after a single dose of 200 mg imiquimod which corresponds to the content of approximately 16 sachets.
Pri slučajnem zaužitju enkratnega odmerka 200 mg imikvimoda, kar ustreza vsebini približno 16 vrečk, se lahko pojavijo slabost, bruhanje, glavobol, bolečine v mišicah in vročina.
Application site hyperaesthesia
Hiperstezija na mestu aplikacije
The use of an occlusive dressing is not recommended with imiquimod cream therapy.
Nošenje tesnih obvez med zdravljenjem z imikvimod kremo ni priporočljivo.
Imiquimod cream should be used with caution in organ transplant patients (refer to section 4.5).
Pri bolnikih po presaditvi organov imikvimod kremo uporabljamo previdno (glejte poglavje 4.5).
Superficial basal cell carcinoma:
Površinski karcinom bazalnih celic:
Sweating increased
Povečano potenje
Fungal infection
Okužba z glivami
Increases in systemic levels of alpha interferon and other cytokines following topical application of imiquimod were demonstrated in a pharmacokinetic study.
V farmakokinetični raziskavi so po topični aplikaciji imikvimoda dokazali povečanje sistemskih vrednosti interferona alfa in drugih citokinov.
Very common Very common Very common
Pruritus na mestu aplikacije zelo pogosti zelo pogosti zelo pogosti
A total of 126 of 242 patients treated with imiquimod (52.1%) and 84 of 237 patients treated with topical diclofenac (35.4%) showed complete clinical clearance of the treated AK field at week 20 (i.e. about 8 weeks after the end of the initial treatment cycle); a difference of 16.6% (95% CI: 7.7% to 25.1%).
Pri skupno 126 od 242 bolnikov, zdravljenih z imikvimodom (52,1 %) in 84 od 237 bolnikov, zdravljenih s topičnim diklofenakom (35,4 %), se je pokazala popolna klinična ozdravitev lezij na zdravljenem AK predelu v 20. tednu (t.j.
Some systemic adverse reactions, including myalgia (2%) were reported by imiquimod treated patients.
Pri bolnikih, zdravljenih z imikvimodom, so poročali tudi o nekaterih sistemskih neželenih učinkih, vključno z mialgijo (2 %).
Where such reactions have occurred at the urethral meatus, some women have experienced difficulty in urinating, sometimes requiring emergency catheterisation and treatment of the affected area.
V nekaterih primerih je bila potrebna nujna uvedba katetra in zdravljenje prizadetega področja.
- If any get any side effects talk to your doctor or pharmacist.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
Vaginal pain
Atrofični vaginitis
Skin and subcutaneous tissue disorders:
Bolezni kože in podkožja: Pruritus
Imiquimod cream should be used with caution in patients with autoimmune conditions (refer to section 4.5).
Imikvimod kremo pri bolnikih z avtoimunskimi boleznimi uporabljamo previdno (glejte poglavje 4.5).
Application site inflammation
Brazgotina na mestu aplikacije
Common effects include pain, burning, irritation or redness.
Pogosti neželeni učinki so: bolečina, pekoč občutek, draženje ali rdečica.
Pustules
Otrplost
56% of the patients have been free of hypopigmentation; hyperpigmentation has not been reported.
O hiperpigmentaciji ni bilo poročil.
Application site paraesthesia
Parestezija na mestu aplikacije pogosti
How to store Aldara cream
Shranjevanje kreme Aldara
Very common Common
Pustule pogosti
Pain in extremity
Bolečine v okončinah
Eye disorders Conjunctival irritation
Očesne bolezni Draženje veznice
In the pivotal trials with 3 times per week dosing for up to 2 courses each of 4 weeks, 56% of imiquimod patients reported at least one adverse event.
V treh preskušanjih z odmerjanjem trikrat tedensko so bili bolniki zdravljeni v do 2 stopnjah, ki so trajale po 4 tedne.
Application site irritation
Razjeda na mestu aplikacije
Folliculitis
Vulvitis
This leaflet was last revised in (MM/YYYY).
Navodilo je bilo nazadnje revidirano dne
Use in the paediatric patient population is not recommended.
Uporaba pri otrocih se ne priporoča.
Skin ulcer
Kožna razjeda
There is limited experience in the use of imiquimod cream in the treatment of men with foreskinassociated warts.
Izkušnje z zdravljenjem bradavic na kožici penisa z imikvimod kremo so omejene.
One sachet contains enough cream to cover a wart area of 20 cm2 (approx. 3 square inches).
Količina kreme v eni vrečki zadostuje za prekritje 20 cm področja z bradavicami.
Application Instructions - (Mon, Wed and Fri)
Navodila za nanos (ponedeljek, sreda in petek)
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aldara cream.
Če se ne počutite dobro med uporabo kreme Aldara, čim prej obvestite svojega zdravnika ali farmacevta.
Application site erythema
Eritmatozen izpuščaj
Upper respiratory tract infection Uncommon Vulvitis
Okužba zgornjih dihal
Uterovaginal prolapse
ZUNANJA OVOJNINA
Application site bleeding
Krvavitev na mestu aplikacije pogosti
The equivalence limits were set at 80 - 125 %.
Omejitve enakovrednosti so bile postavljene pri 80-125 %.
The Applicant should justify:
Predlagatelj mora obrazložiti naslednje:
(Invented) Name Strength
Izmišljeno ime Ime
Conclusion of the assessment of the Applicant response to the List of Outstanding Issues
Zaključki vrednotenja odgovorov predlagatelja na seznam nerešenih vprašanj
The Applicant is required to present this discussion.
Predlagatelj mora predstaviti to razlago.
Critical Evaluation
Kritično ovrednotenje
c) Pooling of stages is justified based on safety and efficacy, taking into account the particularities of salbutamol and its site of action.
c) Združevanje stopenj je utemeljeno na podlagi varnosti in učinkovitosti, ob upoštevanju posebnosti salbutamola in njegovega mesta delovanja.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SABUMALIN AND ASSOCIATED NAMES (SEE ANNEX I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SABUMALIN IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
For stages with a small deposition of particles and a relatively high standard deviation it is particularly critical to reach a confidence interval within the defined limits.
Pri stopnjah z majhno mero odlaganja delcev in relativno visoko standardno deviacijo je še posebej pomembno doseči interval zaupanja znotraj opredeljenih omejitev.
In the opinion of the CHMP, this small difference is not expected to be clinically significant and a pharmacodynamic study does not seem to be required.
Po mnenju odbora CHMP se ne pričakuje, da bo ta majhna razlika klinično pomembna, farmakodinamična študija pa se ne zdi potrebna.
Therefore, the different cloud size/shape or the humid environment that exists in the respiratory tree may be relevant.
Zaradi tega so morda pomembne različne velikosti/oblike oblaka ali vlažno okolje, ki obstaja v dihalnih poteh.
The fine particle dose ratio was 1.01 and the corresponding confidence interval was 0.97 - 1.04 and the data therefore clearly demonstrate that the expected spacer effect is identical for test and reference product.
Razmerje odmerka drobnih delcev je bilo 1,01, ustrezajoč interval zaupanja pa je bil 0,97-1,04, tako da podatki jasno kažejo, da je pričakovani učinek podaljška enak za testno in referenčno zdravilo.
a) The Applicant quoted the EMEA draft guideline on orally inhaled products (OIP) which offers the possibility to pool different stages of the Andersen Cascade Impactor.
a) Predlagatelj je navedel osnutek smernice agencije EMEA za peroralno inhalirana zdravila (OIP), ki daje možnost združevanja različnih stopenj Andersenovega kaskadnega impaktorja.
On the basis of these data the two formulations are considered to exhibit an equivalent therapeutic ratio and to be clinically interchangeable”.
Na teh podatkih temelji mnenje, da obe formulaciji izkazujeta enakovredno terapevtsko razmerje in sta klinično medsebojno zamenljivi“.
In absolute terms, the values outside the +/20% limit represent a negligible mean difference which is clinically irrelevant in the context of any overall potential increase in systemic exposure.
V absolutnem smislu predstavljajo vrednosti zunaj ±20-odstotne omejitve zanemarljivo povprečno razliko, ki nima kliničnega pomena glede kakršnega koli morebitnega povečanja sistemske izpostavitve.
c. The Applicant should discuss why the ranges of particles that are deposited in the large conducting intrathoracic airways are pooled instead of investigating them with the highest accuracy and precision in the large possible number of categories (stages).
c. Predlagatelj mora odgovoriti, zakaj je združil razpone delcev, ki se odlagajo v velikih prevodnih intratorakalnih dihalnih poteh, namesto da bi jih preiskal z največjo mero natančnosti in točnosti v velikemu številu možnih kategorij (stopenj)?
Question 3 - The Applicant´s justification to widen the acceptance range taken from the draft guideline is not acceptable.
Tretje vprašanje - Predlagateljeva utemeljitev za razširitev razpona sprejemljivosti, dobljena iz osnutka smernice, ni sprejemljiva.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
In addition, the Applicant provided a consolidated final protocol consisting of all single protocols retrospectively combined and a retrospectively combined report from all the corresponding study reports including the raw data and study results.
Predlagatelj je poleg tega priskrbel združeni končni protokol, sestavljen iz vseh posameznih, retrospektivno kombiniranih protokolov, ter retrospektivno kombinirano poročilo iz vseh ustreznih poročil o študiji, vključno z neobdelanimi podatki in rezultati študij.
Furthermore, the CHMP did not agree that particles larger then 6 µm are not relevant for the demonstration of efficacy, as even such large particles may penetrate to the peripheral airways.
Poleg tega se odbor CHMP ni strinjal z navedbo, da delci, večji od 6 µm, niso pomembni za dokazovanje učinkovitosti, saj tudi tako veliki delci lahko prodrejo do perifernih dihalnih poti.
The Applicant provided raw data obtained under humid condition clearly demonstrating that the aerodynamic characteristic of salbutamol sulphate particles do not change under humid conditions.
Predlagatelj je predložil neobdelane podatke, pridobljene v vlažnih pogojih, ki jasno dokazujejo, da se aerodinamične lastnosti delcev salbutamol sulfata ne spremenijo v vlažnih pogojih.
The CHMP did not agree that this amount of drug is too small to be relevant and could furthermore not support the Applicant claim that stage 1 is related only to safety.
Odbor CHMP se ni strinjal s tem, da je količina zdravila premajhna, da bi veljala kot pomembna, poleg tega pa ni mogel podpreti trditve predlagatelja, da je 1. stopnja povezana samo z varnostjo.
The undesirable reflow from suspension formulation into the canister does not occur if the cans are stored in an inverted or lying position but may occur if the inhaler is stored in an upright position.
Do neželenega ponovnega pretoka iz formulacije suspenzije v vsebnik ne pride, če so pločevinke shranjene v obrnjenem ali ležečem položaju, vendar do njega lahko pride, če je inhalator shranjen v pokončnem položaju.
The indication sought is “Symptomatic treatment of bronchoconstriction due to bronchial asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD) and emphysema.
Indikacija, za katero je bila predložena vloga, je „simptomatsko zdravljenje bronhospazma zaradi bronhitične astme, kroničnega bronhitisa, kronične obstruktivne pljučne bolezni (COPD) in emfizema.
The functionality of the applicator is not affected and therefore the aerosol cloud and the aerodynamic particle size distribution remain the same.
Vpliva na funkcionalnost aplikatorja ni, zato ostaneta oblak aerosola in velikost aerodinamičnih delcev enaka.
During drug product development, the Applicant optimised the applicator, modifying the shape of the device to make it possible to store the applicator in the two identified required storage orientations.
Med razvojem zdravila je predlagatelj optimiziral aplikator s spremembo oblike pripomočka, da bi ga bilo možno hraniti v dveh ugotovljenih zahtevanih položajih za shranjevanje.
Question 2 - The Applicant´s justification of the selected pooling of stages is not acceptable.
Drugo vprašanje - Predlagateljeva utemeljitev izbranega združevanja stopenj ni sprejemljiva.
However, for some substances, clinical efficacy and safety is not represented by a specific stage but a range of stages and therefore, comparison of individual stages cannot detect differences between formulations that may have clinical relevance.
Vendar pri nekaterih snoveh klinična učinkovitost in varnost nista predstavljeni s točno določeno stopnjo temveč z več stopnjami, zato s primerjavo posameznih stopenj ni mogoče odkriti razlik med formulacijami, ki imajo morda klinični pomen.
Therefore, the CHMP concluded that the products should be considered as interchangeable.
Zaradi tega je odbor CHMP zaključil, da je treba zdravili upoštevati kot medsebojno zamenljivi.
In addition, because two clinical studies are submitted for demonstration of in vivo equivalence and for confirming the in vitro data, the in vitro results obtained under humid condition become less important.
Ker sta bili poleg tega predloženi tudi dve klinični študiji za dokazovanje in vivo enakovrednosti in za potrditev in vitro podatkov, postanejo in vitro rezultati, pridobljeni v vlažnih pogojih, manj pomembni.
This difference is not expected to be of clinical relevance and the two products are therefore considered to exhibit an equivalent bronchodilator response.
Ker se pričakuje, da ta razlika nima kliničnega pomena, se upošteva, da imata obe zdravili enakovreden bronhodilatacijski odziv.
The Applicant responded to the outstanding issues during an Oral Explanation held during the November CHMP meeting.
Predlagatelj je med ustnim pojasnilom, ki je potekalo med novembrskim zasedanjem odbora CHMP, odgovoril na nerešena vprašanja.
Major objections were raised and because the main issues on quality (in vitro equivalence to the reference product) and the insufficiency of the clinical studies could not be resolved, the procedure was referred to CHMP by a number of objecting concerned member states.
Ugotovljeni so bili večji zadržki in ker glavnih vprašanj glede kakovosti (in vitro enakovrednost z referenčnim zdravilom) in nezadostnosti kliničnih študij ni bilo mogoče rešiti, je več ugovarjajočih zadevnih držav članic zadevo napotilo na CHMP.