natgillin/translations-raw huggingface dataset:
Being aware of a referral ongoing at the time under Article 35 of Directive 2001/ 82/ EC, as amended, for reference product Tribrissen Oral Paste, CVMP recommended that the outcome of that referral procedure (EMEA/ V/ 023) should apply to the marketing authorisation of Equibactin vet.
Ob upoštevanju, da trenutno poteka napotitveni postopek v skladu s členom 35 Direktive 2001/ 82/ ES, kakor je bila spremenjena, za referenčno zdravilo Tribrissen peroralna pasta, je CVMP priporočil, da se rezultat tega napotitvenega postopka (EMEA/ V/ 023) upošteva tudi pri dovoljenju za promet z zdravilom Equibactin vet.
The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 3 March 2008.
Mnenje Odbora za zdravila za uporabo v veterinarski medicini (CVMP) je bilo sprejeto dne 12. decembra 2007, s tem povezana odločba Komisije pa 3. marca 2008.
EMEA/ 455818/ 2008-EN
EMEA/ 455818/ 2008- SL
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKA VRSTA, NAČIN UPORABE ZDRAVILA IN IMETNIK DOVOLJENJA ZA PROMET
1/ 7 Applicant or Marketing Authorisation Holder
1/ 7 Predlagatelj ali imetnik dovoljenja za promet z zdravilom
Willeskop 212 3421 GW Oudewater The Netherlands
Willeskop 212 3421 GW Oudewater Nizozemska
(333 mg/ g + 67 mg/ g) Oral Paste for Horses.
(333 mg/ g + 67 mg/ g) peroralna pasta za konje.
333.3 mg/ g sulfadiazine and 66.7 mg/ g trimethoprim.
333, 3 mg/ g sulfadiazina konj in 66, 7 mg/ g trimetoprima.
horse
peroralno
The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 24 September 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement for Equibactin vet.
Nizozemska, referenčna država članica, je v decentraliziranem postopku dne 24. septembra 2007 obvestila agencijo EMEA, da Koordinacijska skupina za medsebojno prepoznavanje in decentralizirane postopke – veterina (CMD( v) ni dosegla sporazuma o zdravilu Equibactin vet.
CVMP noted that Equibactin vet.
Odbor CVMP je ugotovil, da je zdravilo Equibactin vet.
(333 mg/ g + 67 mg/ g) Oral Paste for Horses is a generic of Tribrissen oral paste (authorised in the Netherlands) and that the concerns raised by France can only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy.
(333 mg/ g + 67 mg/ g) peroralna pasta za konje generično zdravilo, ki izhaja iz zdravila Tribrissen peroralna pasta (odobreno na Nizozemskem), in da je mogoče na zadržke, ki jih je imela Francija, odgovoriti le v okviru tega postopka, če bi kakršna koli razlika med obema zdraviloma utemeljila različne zaključke o varnosti ali učinkovitosti.
The applicant was requested to provide the following information:
Odbor je od predlagatelja zahteval naslednje informacije:
A copy of the dossier of Equibactin vet.
Kopijo dosjeja zdravila Equibactin vet.
(333 mg/ g + 67 mg/ g) Oral Paste for Horses and any supplementary data added to it, up to day 60 of the referral procedure in CM(v).
(333 mg/ g + 67 mg/ g) peroralna pasta za konje in vse dodatne podatke, do 60. dne napotitvenega postopka v CM( v).
In view of the concerns raised by France, to indicate and to substantiate where necessary any differences between Equibactin vet.
Glede na zadržke, ki jih je imela Francija, prikaz in po potrebi utemeljitev morebitnih razlik med zdravilom Equibactin vet.
(333 mg/ g + 67 mg/ g) Oral Paste for Horses and the reference product Tribrissen Oral Paste (authorised in the Netherlands) that could justify different conclusions on the safety or efficacy for the two products.
(333 mg/ g + 67 mg/ g) peroralna pasta za konje in referenčnim zdravilom Tribrissen peroralna pasta (odobreno na Nizozemskem), s katerimi bi lahko utemeljili različne zaključke glede varnosti ali učinkovitosti obeh zdravil.
In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and any supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
V odgovor na 1. vprašanje je predlagatelj priskrbel kopijo originalnega dosjeja, predloženega v podporo uporabi decentraliziranega postopka, in vse dodatne podatke, ki so bili predloženi med decentraliziranim postopkom v odgovor na I. in II. fazo ocenjevanja in napotitvenega postopka v CMD( v) za tem.
Oral Paste for Horses proved to be bioequivalent to the reference products Tribrissen (REG NL 5055 in the Netherlands) and Tribissen (Vm 0201/ 4064 in the UK).
V študiji GLP biološke enakovrednosti enkratnega odmerka pri konjih, ki je bila izvedena skladno z ustreznimi smernicami, so dokazali, da je zdravilo Equibactin vet. peroralna pasta za konje biološko enakovredna referenčnemu zdravilu Tribrissen (REG NL 5055 na Nizozemskem) in zdravilu Tribissen (Vm 0201/ 4064 v Združenem kraljestvu).
The original reference product "Tribrissen Oral Paste" was authorised in the Netherlands in 1992.
Originalno referenčno zdravilo “ Tribrissen peroralna pasta ” je bilo na Nizozemskem odobreno leta 1992.
Moreover, there are only
Še več, obstajajo le podobnosti, ki dokazujejo
Oral Paste for Horses with the reference product Tribrissen Oral Paste (authorised in the Netherlands under REG NL 5055).
4/ 7 enako varnost in učinkovitost zdravila Equibactin vet. peroralna pasta za konje in referenčnega zdravila Tribrissen peroralna pasta (odobreno na Nizozemskem pod REG NL 5055).
Oral Paste and Tribrissen oral paste for trimethoprim as well as for sulfadiazine, the products are regarded to be essentially similar.
Glede na enako sestavo, kar zadeva zdravilni učinkovini trimetoprim in sulfadiazin, enako farmacevtsko obliko in dokazano biološko enakovrednost med zdravilom Equibactin vet. peroralna pasta in zdravilom Tribrissen peroralna pasta za učinkovini trimetoprim in sulfadiazin, se zdravili obravnavata za bistveno podobni.
Oral Paste.
Posledično je mogoče zaključke o učinkovitosti in varnosti referenčnega zdravila Tribrissen oralna pasta razširiti na generično zdravilo Equibactin vet. peroralna pasta.
Oral Paste, in accordance with the outcome of referral procedure EMEA/ V/ 023 under Article 35 of Directive 2001/ 82/ EC as amended, for the reference medicinal product Tribrissen Oral Paste authorised in The Netherlands.
Predlagatelj se je strinjal s predložitvijo zahteve za odobritev zdravila Equibactin vet. peroralna pasta, v skladu z rezultatom napotitvenega postopka EMEA/ V/ 023 iz člena 35 Direktive 2001/ 82/ ES, kakor je bila spremenjena, kot različice referenčnega zdravila Tribrissen peroralna pasta, odobrenega na Nizozemskem.
Oral Paste.
Zadržki, ki jih je imela Francija, ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom Equibactin vet. peroralna pasta.
Oral Paste in accordance with the outcome of referral procedure EMEA/ V/ 023 under Article 35 of Directive 2001/ 82/ EC as amended, for the reference medicinal product Tribrissen Oral Paste authorised in The Netherlands.
Priporoča se uporaba zdravila Equibactin vet. peroralna pasta, v skladu z rezultatom napotitvenega postopka EMEA/ V/ 023 iz člena 35 Direktive 2001/ 82/ ES, kakor je bila spremenjena, kot različice referenčnega zdravila Tribrissen peroralna pasta, odobrenega na Nizozemskem.
6/ 7 The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except France) at day 210 of the decentralised procedure.
6/ 7 Veljavni povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so različice, s katerimi se so referenčna država članica in zadevne države članice (z izjemo Francije) strinjale na 210. dan decentraliziranega postopka.
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, NAČINI UPORABE IN IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Država članica
Frequency and route of administration
Živalska Pogostost in način uporabe vrsta
Netherlands, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Poland, Portugal and Spain.
DODATEK II
Williskop 212 3421 GW Oudewater The Netherlands
Nizozemska
Oral gel
Peroralni gel
Oral use.
Konji Peroralna uporaba.
A single administration of 0.2 A single administration mg ivermectin per kg of odyweight. of 0.2 mg ivermectin Retreatment should be done according to per kg of bodyweight. the epidemiological situation, but not at less than 30 days interval
Ponovno zdravljenje se naj izvaja v skladu z epidemiološko situacijo, vendar ne v intervalu, ki je krajši od 30 dni.
EMEA/ CVMP/ 73765/ 2007 SCIENTIFIC CONCLUSIONS
En odmerek 0, 2 mg ivermektina na kg telesne mase.
The current application cannot be considered satisfactory as there is no scientific basis on which to grant an authorisation with the proposed SPC.
ZNANSTVENI ZAKLJUČKI ZNANSTVENI ZAKLJUČKI Sedanje vloge ni mogoče oceniti kot zadovoljive, saj ni znanstvene osnove, na podlagi katere bi bilo mogoče odobriti dovoljenje s predlaganim Povzetkom glavnih značilnosti zdravila (SPC).
The wording of the proposal for Section 4.2 of the SPC is not supported.
Predlagano besedilo poglavja 4. 2 SPC ni utemeljeno.
The statement ‘ The treatment of gastrointestinal endoparasite infections in horses ’ implies that all gastrointestinal endoparasite infections in horses are treated with this product; ‘ particularly’ implies that the product has a specific action against those species listed.
Iz navedbe „ Zdravljenje gastrointestinalnih endoparazitskih okužb pri konjih “ sledi, da se s tem zdravilom zdravijo vse gastrointestinalne endoparazitske okužbe pri konjih; „ še zlasti “ izraža, da ima izdelek poseben učinek proti navedenim vrstam.
The effect against e. g. the large strongyles that are important parasites in the horse is not supported by the presented data and moreover, as the effect on the L4 stage of the small strongyles is not substantiated, the period between necessary prophylactic deworming will be significantly shortened.
Predloženi podatki ne potrjujejo učinka proti npr. velikim strongilidom, ki so pomembni zajedavci pri konju, poleg tega pa se bo interval med potrebnimi profilaktičnimi zatiranji notranjih zajedavcev bistveno skrajšal, saj učinek proti razvojni stopnji L4 malih strongilidov ni dokazan.
Ivermectin containing pastes/ oral gels for horses are well established on the market and the prescriber/ animal owner would expect Equimectin to be interchangeable with other available products of the avermectin class.
Paste/ peroralni geli z ivermektinom za konje so dobro uveljavljeni na trgu, zato bi predpisovalec zdravila/ lastnik živali pričakoval, da je zdravilo Equimectin medsebojno zamenljivo z drugimi razpoložljivimi izdelki iz razreda avermektinov.
During the referral procedure, it has been established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance EMEA/ CVMP/ 016/ 00-corr- FINAL), however from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.
Med postopkom napotitve je bilo ugotovljeno, da predložena bioekvivalenčna raziskava ni ustrezna, da bi lahko dokazala bioekvivalenco (kot jo določa veljavna smernica EMEA/ CVMP/ 016/ 00- corr - FINAL), vendar pa je glede na primerjalne farmakokinetične podatke mogoče, da je testni izdelek sistemsko biološko manj uporaben od referenčnega izdelka.
- The principle criteria used for a comparison of effect is egg count reduction/ larval identification or
- Načelni kriterij, uporabljen za primerjavo učinka, je zmanjšanje števila jajčec/ identifikacija ličink ali
parasite counts in dose confirmation studies.
število zajedavcev v raziskavah za določitev odmerka.
The test procedure did not follow the methods for a controlled or critical test.
Za raziskave za določitev odmerka velja, da » sta priporočljivi vsaj dve kontrolirani ali, kjer ustreza, kritični raziskavi za določitev odmerka «.
This does not comply with the recommendations of the current guidance document (CVMP/ VICH/ 832/ 99), ‘ where pharmacokinetic parameters cannot demonstrate a relationship with effectiveness, two dose confirmation studies using the dose limiting parasite for therapeutic claims ….. will be needed .’ For dose confirmation studies, ‘ at least two controlled or, where appropriate, critical dose confirmation studies ….. are recommended. ’ Efficacy could be claimed if effectiveness against each parasite declared on the labelling was at 90% or above based on calculation of geometric means and there was a statistically significant difference in parasite numbers between control and treated horses.
Učinkovitost bi bilo mogoče uveljavljati, če bi bila učinkovitost proti posameznemu zajedavcu, označenemu na ovojnini, 90% ali več, izračunana na podlagi geometričnih povprečij, ter če bi bila razlika med številom zajedavcev pri konjih v kontrolni skupini in pri zdravljenih konjih statistično značilna.
- The tables included in the response dossier do not indicate which parasites are referred to, and there
- Iz tabel, ki so vključene v dokumentaciji odgovora, ni razvidno, za katere zajedavce veljajo, prav
is no break down of species of parasite.
tako ni razdelitve po vrstah zajedavcev.
It is known that there is a potential
Znano je, da obstaja
resistance build up to ivermectin in Parascaris equorum, however the highest number of P. equorum may be found in grazing horses 3-18 months old.
možnost razvoja odpornosti pri vrsti Parascaris equorum na ivermektin, vendar pa je največje število P. equorum mogoče najti pri konjih, starih med 3 in 18 meseci, ki se pasejo.
- Based on the type of study conducted, the background exposure of the ponies included in the trial
- V odvisnosti od vrste izvedene raziskave ni bila podana obremenitev v okolju, kateri so bili
was not stated therefore the adequacy of the infections cannot be documented.
izpostavljeni poniji, ki so bili vključeni v raziskavo, zato ustreznosti okužb ni mogoče dokumentirati.
The WAAVP guidelines
Smernice združenja
state that, for a field trial, data from at least 100 horses should be obtained in each of 3 different areas.
WAAVP navajajo, da je treba pri terenskih raziskavah zbrati podatke za najmanj 100 konj za vsako od 3 različnih področij.
- The mean dose of test product administered was consistently and significantly more (40%,
- Povprečen odmerek testnega izdelka je bil stalno in značilno večji (40%, 0, 278 mg/ kg) od
0.278mg/ kg) than the recommended treatment dose.
priporočenega odmerka za zdravljenje.
The dose of Eqvalan was found to be 10% higher in the field trial than indicated.
Odmerek zdravila Eqvalan pri terenski raziskavi je bil 10% večji od navedenega.
- The test product demonstrated lower bioavailability compared to Eqvalan, the cited reference
- Testni izdelek je med bioekvivalenčno raziskavo izkazal manjšo biološko uporabnost od zdravila
product, during the bioequivalence study, and the test product was administered at greater than the recommended treatment dose in the field study.
Eqvalan, ki je naveden kot referenčni izdelek, poleg tega pa je bil uporabljeni odmerek testnega izdelka pri terenski raziskavi večji od priporočenega odmerka za zdravljenje.
- Although non-inferiority was demonstrated to Eqvalan, this is not a recognised measure of efficacy
- Čeprav je bila dokazana enakovrednost zdravilu Eqvalan, to ni priznano merilo učinkovitosti novega
of a new product.
izdelka.
Relative reductions for the number of eggs per gram of faeces for the test product were calculated as 88.2% against Strongylus type eggs on day 3, and 88.2% at day 8.
Relativno zmanjšanje števila jajčec rodu Strongylus v gramu iztrebkov za testni izdelek je bilo 3. dan 88, 2% in 8. dan 88, 2%.
For Parascaris type eggs, the results were 50% by day 3 and 65.2% by day 8.
Za jajčeca rodu Parascaris je bilo 3. dne zmanjšanje 50%, 8. dan pa 65, 2%.
The results for efficacy of Eqvalan measured this way were also below 90%.
Tudi rezultati učinkovitosti zdravila Eqvalan, ki so bili izmerjeni na ta način, so bili pod 90%.
These results were below the accepted 90% or higher and, as there was no control group to compare the differences in parasite counts statistically, which should be significant at p < 0.05, it is not possible to determine the efficacy of Equimectin from this study.
Ti rezultati so bili pod sprejetimi 90% ali več, ker pa ni bilo kontrolne skupine za statistično primerjavo razlik v številu zajedavcev, ki bi naj bile statistično značilne s p < 0, 05, iz te raziskave ni mogoče določiti učinkovitosti zdravila Equimectin.
The Marketing Authorisation Holder re- examined the data from this study and stated that on day 6 after treatment no small nor large strongyle larvae were detected in a minimum amount of 25 gram faeces indicating 100% efficacy for all animals, and the recalculated effectiveness against Strongylides is > > 90% on 2 and 7 days after treatment.
Imetnik dovoljenja za promet je znova preučil podatke iz te raziskave in izjavil, da 6. dan po zdravljenju v minimalni količini blata 25 gramov ni bilo več ličink ne malih ne velikih strongilidov, kar kaže na 100% učinkovitost za vse živali, preračunana učinkovitost proti strongilidom za 2. in 7. dan po zdravljenju pa je > > 90%.
Based on the critical test performed, the efficacy against Parascaris was 100%.
Na podlagi opravljene kritične raziskave je bila učinkovitost proti rodu Parascaris 100%.
The efficacy of the product for the treatment of endo- and ectoparasitic infections has not been demonstrated.
Učinkovitost izdelka za zdravljenje endo - in ektoparazitskih okužb ni bila dokazana.
EMEA/ CVMP/ 73765/ 2007 ANNEX III
DODATEK III
CONDITION FOR THE LIFTING OF THE SUSPENSION
POGOJ ZA PREKLIC UMIKA POGOJ ZA PREKLICA UMIKA
London, June 2008 EMEA/ 532271/ 2007 – Rev.1
London, junij 2008 EMEA/ 532271/ 2007 – Rev. 1
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR EQUIMECTIN 12MG/ G ORAL GEL FOR HORSES
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33( 4) ZA ZDRAVILO EQUIMECTIN 12 MG/ G PERORALNI GEL ZA KONJE
Equimectin 12mg/ g oral gel for horses contains ivermectin.
Zdravilo Equimectin 12 mg/ g peroralni gel za konje vsebuje ivermektin.
The product is indicated for the treatment of endo- and ectoparasitic infections in horses, particularly gastrointestinal nematodes, dermal nematodes, lung nematodes and bots.
Zdravilo je indicirano za zdravljenje endo - in ektoparazitskih okužb pri konjih, zlasti gastrointestinalnih nematodov, dermalnih nematodov, pljučnih nematodov in zoljev.
A Mutual Recognition Procedure (MRP) was started based on the Marketing Authorisation granted by the Netherlands with fourteen Concerned Member States.
Postopek medsebojnega priznavanja se je pričel na podlagi dovoljenja za promet, odobrenega na Nizozemskem, in je vključeval štirinajst zadevnih držav članic.
The Member States who raised concerns regarding the potential risk to animal health were Belgium, Denmark, France, Germany, Ireland, Italy, Portugal and Spain.
Države članice, ki so izrazile pomisleke glede morebitnega tveganja za zdravje živali, so bile Belgija, Danska, Francija, Nemčija, Irska, Italija, Portugalska in Španija.
The ground for the referral was the substantiation of the bioavailability/ bioequivalence of Equimectin in comparison to Eqvalan.
Razlog za napotitev je bila utemeljitev biološke uporabnosti/ bioekvivalence zdravila Equimectin v primerjavi z zdravilom Eqvalan.
The CVMP during its meeting of May 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC as amended.
Odbor za zdravila za uporabo v veterinarski medicini je med svojim zasedanjem maja 2006 pričel s postopkom napotitve v skladu s členom 33( 4) Direktive 2001/ 83/ ES, kot je bila spremenjena.
The Marketing Authorisation Holder was requested to substantiate the bioavailability/ bioequivalence of the product, justifying the efficacy of the product.
Odbor je imetnika dovoljenja za promet pozval, da utemelji biološko uporabnost/ bioekvivalenco zdravila ter tako potrdi učinkovitost zdravila.
The documentation submitted with this application consisted of literature referring to the use of the originator product Eqvalan, a comparative pharmacokinetic study using Equimectin and Eqvalan, and a supplementary clinical field study.
Dokumentacija, ki je bila predložena s to vlogo, je obsegala literaturo v zvezi z uporabo originatorskega zdravila Eqvalan, primerjalno farmakokinetično študijo zdravil Equimectin in Eqvalan ter dodatno klinično terensko študijo.
During the referral procedure, it was established that the submitted bioequivalence study was inadequate to demonstrate bioequivalence (as defined in current guidance EMEA/ CVMP/ 016/ 00-corr- FINAL); however, from the comparative pharmacokinetic data it is possible that the test product is systemically less bioavailable than the reference product.
Med postopkom napotitve je bilo ugotovljeno, da predložena študija bioekvivalence ni ustrezna, da bi lahko dokazala bioekvivalenco (kot jo določa veljavna smernica EMEA/ CVMP/ 016/ 00- corr- FINAL), vendar pa je glede na primerjalne farmakokinetične podatke mogoče, da je testno zdravilo sistemsko biološko manj uporabno od referenčnega zdravila.
Therefore, the relevance of the bibliographical data regarding Eqvalan to the test product cannot be confirmed.
Iz tega razloga ni mogoče potrditi, da so bibliografski podatki o zdravilu Eqvalan relevantni za testno zdravilo.
The residue data provided was inadequate and the withdrawal period is therefore inadequately supported.
Predloženi podatki o ostankih so bili neustrezni, zato čas karence ni ustrezno utemeljen.
The Committee, having considered the matter, concluded that on the basis of the available data for Equimectin, bioequivalence with the reference product had not been shown.
Odbor je po presoji zadeve zaključil, da na osnovi razpoložljivih podatkov o zdravilu Equimectin njegova bioekvivalenca z referenčnim zdravilom ni bila dokazana.
The amended indication for the treatment of gastrointestinal endoparasitic infections in horses had not been demonstrated by the data provided.
Predloženi podatki ne utemeljujejo spremenjene indikacije za zdravljenje gastrointestinalnih endoparazitskih okužb pri konjih.
The CVMP recommended the refusal of the granting of the Marketing Authorisation and the suspension of the Marketing Authorisation for Equimectin where appropriate.
Odbor za zdravila za uporabo v veterinarski medicini je priporočil zavrnitev odobritve dovoljenja za promet in umik dovoljenja za promet za zdravilo Equimectin, kjer je to ustrezno.
The CVMP Opinion was adopted on 17 January 2007 and the subsequent Commission Decision on 2 April 2007.
Mnenje CVMP je bilo sprejeto 17. januarja 2007, odločba Komisije pa 2. aprila 2007.
EMEA/ 532271/ 2007 – Rev.1
EMEA/ 532271/ 2007 – Rev. 1- SL
London, August 2008 EMEA/ 458933/ 2008
London, avgust 2008 EMEA/ 458933/ 2008
OPINION FOLLOWING AN ARTICLE 34 REFERRAL FOR METHOXASOL-T
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 34 ZA ZDRAVILO METHOXASOL- T
On 8 September 2006, Germany presented to the EMEA a referral under Article 34 of Directive 2001/ 82/ EC, as amended, concerning Methoxasol-T (including associated names), containing trimethoprim and sulfamethoxazole as active ingredient.
Nemčija je dne 8. septembra 2006 Evropski agencija za zdravila predložila napotitev v skladu s členom 34 Direktive 2001/ 82/ ES, kakor je bila spremenjena, za zdravilo Methoxasol- T (in z njim povezana imena), ki vsebuje zdravilni učinkovini trimetoprim in sulfametoksazol.
Methoxasol-T was authorised through a national procedure in The Netherlands in 1999, but a marketing authorisation was refused in Germany in 2001.
Zdravilo Methoxasol- T je dovoljenje za promet pridobilo leta 1999 z nacionalnim postopkom na Nizozemskem, vendar so v Nemčiji vlogo za dovoljenje za promet z zdravilom v letu 2001 zavrnili.