natgillin/translations-raw huggingface dataset:
Oral explanations were presented on 10 October 2007 by the Marketing Authorisation Holder to the Committee.
Imetnik dovoljenja za promet z zdravilom je Odboru predstavil ustna pojasnila 10. oktobra 2007.
During its 6-8 November 2007 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion that since the product is intended for use in a minor species (horses) that is reared and treated similarly to a major species, the conclusions on the Environmental Risk Assessment of the major species apply, and therefore the product should be exempt from providing a Phase II assessment and no risk mitigation measures should be included in the SPC of the product.
CVMP je na svojem zasedanju od 6. do 8. novembra 2007 ob upoštevanju vseh predloženih podatkov in znanstvene razprave v okviru Odbora soglasno sprejel mnenje, da, glede na dejstvo, da je zdravilo namenjeno za uporabo pri manj pomembni vrsti (konjih), ki se vzreja in goji podobno kot pomembnejša vrsta, veljajo za to vrsto zaključki Presoje vplivov na okolje za pomembnejše vrste ter da je izdelek posledično mogoče oprostiti priprave ocene v skladu s fazo II kakor tudi da v Povzetek glavnih značilnosti zdravila za ta izdelek ni treba vključiti ukrepov za zmanjševanje tveganj.
The scientific conclusions are provided in Annex II.
Znanstveni zaključki so navedeni v Dodatku II.
The final opinion was converted into a Decision by the European Commission on 17 January 2008.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 17. januarja 2008.
EMEA/ 48261/ 2008
EMEA/ 48261/ 2008
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/ APPLICANT(S)
IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, POTI UPORABE IN IMETNIK/ PREDLAGATELJ( I) DOVOLJENJA ZA PROMET Z ZDRAVILOM
EMEA/ CVMP/ 495339/ 2007-EN
EMEA/ CVMP/ 495339/ 2007- SL
Marketing Authorisation Holder/ Applicant
Imetnik/ predlagatelj dovoljenja za promet z zdravilom
Frequency and route Recommended dose of administration
Pogostost in pot uporabe zdravila
78 Coombe Road New Malden Surrey KT3 4QS United Kingdom
78 Coombe Road New Malden Surrey KT3 4QS Združeno kraljestvo
Ecomectin 18.7 mg/ g Oral Paste for Horses
Ecomectin 18, 7 mg/ g peroralna pasta za konje
Ivermax 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Ivermax Kot zgoraj Kot zgoraj Kot zgoraj Kot zgoraj 18, 7 mg/ g peroralna pasta za konje
Tizoval 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Tizoval Kot zgoraj Kot zgoraj Kot zgoraj Kot zgoraj 18, 7 mg/ g peroralna pasta za konje
Vetimec 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Vetimec Kot zgoraj Kot zgoraj Kot zgoraj Kot zgoraj 18, 7 mg/ g peroralna pasta za konje
Finland
Danska
Ecomectin As above As above As above As above 18.7 mg/ g Oral Paste for Horses
Ecomectin Kot zgoraj Kot zgoraj Kot zgoraj Kot zgoraj 18, 7 mg/ g peroralna pasta za konje
Divamectin As above As above As above As above 18.7 mg/ g Oral Paste for Horses
Ecomectin 18, 7 mg/ g peroralna pasta za konje
Germany
Kot zgoraj
Tizoval 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Kot zgoraj
Tizoval 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Divamectin Kot zgoraj Kot zgoraj Kot zgoraj Kot zgoraj 18, 7 mg/ g peroralna pasta za konje
Hungary
Nemčija
Ecomectin As above As above As above As above 18.7 mg/ g Oral Paste for Horses
Tizoval Kot zgoraj Kot zgoraj Kot zgoraj Kot zgoraj 18, 7 mg/ g peroralna pasta za konje
The Netherlands
Madžarska
Ivermax 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Ecomectin Kot zgoraj Kot zgoraj Kot zgoraj Kot zgoraj 18, 7 mg/ g peroralna pasta za konje
Norway
Italija
Frequency and route Recommended dose of administration
Ivermax 18, 7 mg/ g peroralna pasta za konje
Portugal
Kot zgoraj
Animec 18.7 As above As above As above As above mg/ g Oral Paste for Horses
Animec Kot zgoraj Kot zgoraj Kot zgoraj Kot zgoraj 18, 7 mg/ g peroralna pasta za konje
EMEA/ CVMP/ 495339/ 2007-EN SCIENTIFIC CONCLUSIONS
EMEA/ CVMP/ 495339/ 2007- SL ZNANSTVENI ZAKLJUČKI
Ireland notified the EMEA on 4 July 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding Ecomectin 18.7 mg/ g Oral Paste for Horses.
Irska je dne 4. julija 2007 obvestila EMEA, da usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirani postopek za zdravila v veterinarski medicini (CMD( v)) ni uspela doseči soglasja glede peroralne paste za konje Ecomectin 18, 7 mg/ g.
The Marketing Authorisation Holder should provide complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment; 2.
Imetnik dovoljenja za promet mora predložiti celovite informacije, ki jih je predložil referenčni državi članici in usklajevalni skupini CMD( v) v zvezi z oceno tveganja za okolje; 2.
The Marketing Authorisation Holder should provide an updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II; 3.
Imetnik dovoljenja za promet mora predložiti posodobljeno oceno tveganja za okolje v skladu s smernicami CVMP v zvezi s to tematiko, vključno z morebitno utemeljitvijo za izvzetje faze II; 3.
The Marketing Authorisation Holder provided the following information: • An updated Environmental Risk Assessment • The complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment.
Imetnik dovoljenja za promet z zdravilom je predložil naslednje informacije: • posodobljeno oceno tveganja za okolje • celovite informacije, ki jih je predložil referenčni državi članici in usklajevalni skupini CMD( v) v zvezi z oceno tveganja za okolje.
2.1 Updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II
2. 1 Posodobljena ocena tveganja za okolje v skladu s smernicami CVMP v zvezi s to tematiko, vključno z morebitno utemeljitvijo za izvzetje faze II
Ecomectin 18.7 mg/ g Oral Paste for Horses is a generic product and as such an environmental risk assessment is now required under Directive 2001/ 82, as amended.
Ecomectin 18, 7 mg/ g peroralna pasta za konje spada med generična zdravila, za katera pa se zdaj v skladu z Direktivo 2001/ 82, kakor je bila spremenjena, zahteva priprava ocene tveganja za okolje.
The Marketing Authorisation Holder considers it inconceivable that the risks posed to the environment associated with the use of Ecomectin 18.7 mg/ g Oral Paste for Horses in particular are any greater than those posed by other ivermectin-based products, particularly as the concentration of the active ingredient and the proposed usage regime is identical to that of the reference and other similar products.
Imetniku dovoljenja za promet z zdravilom se zdi nepredstavljivo, da bi lahko bila tveganja za okolje, povezana z uporabo peroralne paste za konje Ecomectin 18, 7 mg/ g, kakor koli večja od tveganj, ki jih predstavljajo druga zdravila na osnovi ivermektina, še zlasti zato, ker sta koncentracija zdravilne učinkovine in predlagan režim uporabe enaka kot pri referenčnem zdravilu in drugih podobnih zdravilih.
Based on this, the applicant argued that the horse should be classed as “ minor use/ minor species” and that no Phase II risk assessment is required.
Na podlagi tega je predlagatelj mnenja, da bi konji morali soditi v skupino » manjše uporabe/ manj pomembne vrste « ter da faza II ocenjevanja tveganja ni potrebna.
The PEC in soil were calculated for intensively reared animals and pasture animals, according to the CVMP Guideline on Environmental Impact Assessment for Veterinary medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/ CVMP/ ERA/ 418282/ 2005-corr).
Izračunana je bila PEC (predvidena koncentracija v okolju) v prsti za živali v intenzivni reji in pašne živali, v skladu s smernico CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/ CVMP/ ERA/ 418282/ 2005- popr.).
PECSOIL- Intensively reared animals = 1.036 µg. kg-1 PECSOIL- Pasture animals = 0.48 µg. kg-1 For two soil exposure scenarios the PECSOIL values did not exceed the 100 µg/ kg threshold value as stated in the VICH Guideline for Phase I assessments of veterinary medicines.
PECTLA - živali v intenzivni reji = 1, 036 µg. kg- 1 PECTLA - pašne živali = 0, 48 µg. kg- 1 Pri teh dveh scenarijih izpostavljenosti vrednosti PECTLA nista presegli mejne vrednosti 100 µg/ kg, kot je navedeno v smernici VICH za fazo I ocenjevanja za zdravila za uporabo v veterinarski medicini.
Despite this, Step 16 of the Phase I decision tree would indicate that a Phase II assessment is required for a product of this nature i. e. ecto/ endoparasiticide for major species.
Ne glede na to bi iz koraka 16 odločitvenega drevesa za fazo I sledilo, da je faza II ocenjevanja za tovrstno zdravilo, tj. ekto - / endoparaziticid za pomembnejše vrste, potrebna.
Question 4 - Is the VMP intended for use in a minor species that is reared and treated similarly to a major species for which an EIA (Environmental Impact Assessment) already exists?
Vprašanje 4 – Ali je zdravilo za uporabo v veterinarski medicini namenjeno za uporabo pri manj pomembni vrsti, ki se vzreja in goji podobno kot pomembnejša vrsta, za katero presoja vplivov na okolje (EIA, Environmental Impact Assessment) že obstaja?
The use of Ecomectin 18.7 Oral Paste for Horses does not result in an increase of the exposure to the environment compared to products for major species and therefore the conclusions of their environmental impact assessment is applicable for this product for horses.
Uporaba peroralne paste za konje Ecomectin 18, 7 mg/ g, v primerjavi z zdravili za pomembnejše vrste, ne povečuje izpostavljenosti okolja, zato so zaključki presoje njihovih vplivov na okolje prenosljivi na to zdravilo za konje.
EMEA/ CVMP/ 495339/ 2007-EN 3 Conclusions and recommendations
EMEA/ CVMP/ 495339/ 2007- SL Nikakršni ukrepi za zmanjšanje tveganja niso
November 2007
November 2007 ocenjeni kot primerni.
London, June 2008 EMEA/ 532222/ 2007 – Rev.1
London, junij 2008 EMEA/ 532222/ 2007 – Rev. 1
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR ENURACE 50
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33( 4) ZA ZDRAVILO ENURACE 50
Enurace 50 is a tablet formulation containing ephedrine as active ingredient and is indicated for treatment of urinary incontinence caused by urethral sphincter mechanism incompetence in ovario- hysterectomised dogs.
Zdravilo Enurace 50 je pripravek v obliki tablet, ki vsebuje zdravilno učinkovino efedrin in je indicirano za zdravljenje urinarne inkontinence, ki je posledica nepravilnega delovanja sfinkterskega mehanizma uretre pri psicah po ovariohisterektomiji.
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the Committee for Medicinal Products for Veterinary Use.
Zadeva je bila napotena na Usklajevalno skupino za postopek z medsebojnim priznavanjem in decentralizirane postopke za zdravila za uporabo v veterinarski medicini (CMD( v)) in nato na Odbor za zdravila za uporabo v veterinarski medicini.
France considered the benefit/ risk analysis unfavourable for the animal when the adverse effects were weighed against the potential benefits of effective treatment of incontinence.
Francija je menila, da je analiza koristi in tveganj, če neželene učinke primerjamo z možnimi koristmi učinkovitega zdravljenja inkontinence, za žival neugodna.
The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC as amended for Enurace 50.
CVMP je med svojim zasedanjem decembra 2006 pričel napotitveni postopkom v skladu s členom 33( 4) Direktive 2001/ 82/ ES, kakor je bila spremenjena, za zdravilo Enurace 50.
The Marketing Authorisation Holder was requested to provide all supporting data to justify a positive benefit/ risk ratio for the treated animal.
Od imetnika dovoljenja za promet z zdravilom je bilo zahtevano, da predloži vse podporne podatke, da bi upravičil pozitivno razmerje med koristmi in tveganji za zdravljeno žival.
With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “ the dog’ s cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”.
Glede srčno- žilnih bolezni je treba poglavje 4. 5 povzetka glavnih značilnosti zdravila dopolniti s stavkom „ Pred začetkom zdravljenja z zdravilom Enurace 60 je treba natančno ugotoviti deloavnje srca in ožilja ter to med zdravljenjem redno spremljati “.
These results were convincing when compared to the 20% placebo treated animals that became continent in study ACE129801.
Ti rezultati so bili prepričljivi pri primerjavi z 20% živali iz študije ACE129801, ki so bile zdravljene s placebom in postale kontinentne.
The CVMP, therefore, concluded that the benefit/ risk for this product was favourable.
CVMP je zato zaključil, da je razmerje med koristmi in tveganji za to zdravilo ugodno.
EMEA/ 532222/ 2007 – Rev.1
EMEA/ 532222/ 2007 – Rev. 1- SL
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel:
1/ 7 Država članica
Frequency and route of administration
Živalsk Pogostost in pot a vrsta uporabe zdravila
ACE Pharmaceuticals BV Schepenveld 41 3891 ZK Zeewolde The Netherlands + 31 36 522 7201 + 31 36 522 9096 fs@ace-pharm. nl
ACE Pharmaceuticals BV Schepenveld 41 3891 ZK Zeewolde Nizozemska + 31 36 522 7201 + 31 36 522 9096 fs@ ace- pharm. nl
For oral administration only, to be administered with food
Psice Samo za peroralno uporabo skupaj s hrano
The application was made in accordance with Article 12.3 of Directive 2001/ 82/ EC as a stand alone application.
Vloga je bila predložena v skladu s členom 12( 3) Direktive 2001/ 82/ ES kot samostojna vloga.
The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) for a 60 day procedure in accordance with Article 33(1) of Directive 2001/ 82/ EC, as amended.
Zadeva je bila skladno s členom 33( 1) Direktive 2001/ 82/ ES, kakor je bila spremenjena, napotena na Koordinacijsko skupino za medsebojno priznavanje in decentralizirane postopke CMD( v).
CMD(v) could not reach an agreement by day 60 of this procedure, as France and Italy maintained their concerns.
V CMD( v) do 60. dne tega postopka ni bilo doseženo soglasje, saj sta Francija in Italija vztrajala pri svojih zadržkih.
France considers the risk/ benefit analysis unfavourable for the animal when the adverse effects (in very rare cases atrium fibrillation and tachycardia) are weighed against the potential benefits of effective treatment of incontinence.
Francija meni, da je razmerje med tveganji in koristmi neugodno za živali, če tehtamo neželene učinke (atrijska fibrilacija in tahikardija v zelo redkih primerih) in potencialne koristne učinke učinkovitega zdravljenja inkontinence.
Italy could accept the application with revised wording in the SPC.
Italija bi lahko sprejela vlogo s popravljenim besedilom Povzetka glavnih značilnosti zdravila.
The CVMP during its meeting of December 2006 started a referral procedure under Article 33(4) of Directive 2001/ 82/ EC as amended for Enurace 50.
CVMP je na seji decembra 2006 za zdravilo Enurace 50 začel napotitveni postopek po členu 33( 4) Direktive 2001/ 82/ ES, kakor je bila spremenjena.
The Marketing Authorisation Holder should provide all supporting data (preclinical and clinical documentation, including the expert reports, efficacy and tolerance studies conducted), to justify a positive benefit-risk ratio for the treated animal.
Imetnik dovoljenja za promet z zdravilom (MAH) mora predložiti vse podporne podatke (predklinično in klinično dokumentacijo, vključno s strokovnimi poročili, opravljenimi raziskavami učinkovitosti in tolerance) za utemeljitev pozitivnega razmerja med koristmi/ tveganji za zdravljeno žival.
Proposed dose of 1 – 3 mg Ephedrine HCl / kg/ day, divided in two oral doses is effective and safe, but some animals may need a higher dose, which is associated with individual variation in the response to ephedrine.
Predlagani odmerek 1 – 3 mg efedrina HCl/ kg/ dan, ki ga razdelimo v dva peroralna odmerka, je učinkovit in varen, vendar nekatere živali potrebujejo višji odmerek, ki je povezan z individualno variacijo odziva na efedrin.
Taking the benefit of the treatment into account and the relatively low level of adverse effects, as it appears from PMS studies, the risk/ benefit balance is considered favourable.
Če upoštevamo koristne učinke zdravljenja in relativno nizko pojavnost neželenih učinkov, ki je razvidna iz postmarketinških raziskav, se lahko šteje, da je razmerje med tveganji in koristmi ugodno.
4/ 7 Considering safety, the product seems not to create a considerable risk to young and healthy animals.
4/ 7 Kar se tiče varnosti, ni videti, da bi zdravilo povzročilo pomembno tveganje za mlade in zdrave živali.
Taking into account that urinary incontinence may occur even several years after the operation it can be suspected that Enurace would be used mostly in older animals, more frequently suffering form cardiovascular, liver, renal and other diseases.
Ob upoštevanju, da se urinska inkontinenca lahko pojavi celo več let po operaciji, lahko sklepamo, da bi se zdravilo Enurace uporabljalo večinoma pri starejših živalih, ki imajo pogosteje srčno- žilne, jetrne, ledvične in druge bolezni.
Although toxicity data for the target animal may be scarce, the adverse effects connected to ephedrine treatment are well known from human use, and the applicant has provided some post-marketing information regarding the use in dogs.
Poleg tega je vlagatelj predložil nekaj podatkov o uporabi pri psih iz postmarketinškega obdobja.
With regard to the related to cardiovascular diseases, the SPC is to be modified under section 4.5 to include the sentence “ the dog’ s cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment”.
Glede srčno- žilnih bolezni je treba poglavje 4. 5 Povzetka glavnih značilnosti zdravila dopolniti s stavkom „ pred začetkom zdravljenja z zdravilom Enurace 60 je treba natančno določiti funkcionalnost srca in ožilja ter to funkcionalnost redno spremljati v času zdravljenja “.
The raw outcome shows good effect in both test and control groups (87% vs 85.5%), an effect that might be somewhat higher in treatment naïve animals (93.7% vs 88.9%).
Neobdelani podatki o rezultatih kažejo dober učinek v testni in kontrolni skupini (87% proti 85, 5%), ki pa je še boljši pri zdravljenju prej nezdravljenih živali (93, 7% napram 88, 9%).
These figures seem highly convincing when compared to the 20% placebo treated animals that became continent in study ACE129801.
Te številke so zelo prepričljive v primerjavi z 20% živalih, ki so dobivale placebo in postale kontinenčne v raziskavi ACE129801.
The CVMP has concluded that the risk/ benefit for this product is favourable.
CVMP meni, da je razmerje med tveganji koristmi za to zdravilo ugodno.
Section 4.5 of the SPC and Section 12 of the Package Leaflet:
poglavje 4. 5 v Povzetku glavnih značilnosti zdravila in poglavje 12 Navodila za uporabo:
Special precautions for use
6/ 7 4. 5 Posebni previdnostni ukrepi
The dog’ s cardiovascular functionality should be carefully assessed before the start of the treatment with Enurace 50 and it should be periodically monitored during the treatment.
Pred zdravljenjem z Enurace 50 je treba pozorno preveriti delovanje kardiovaskularnega sistema psa in ga med zdravljenjem periodično nadzorovati.
London, August 2008 EMEA/ 455918/ 2008
London, avgust 2008 EMEA/ 455918/ 2008
OPINION FOLLOWING AN ARTICLE 33 (4) REFERRAL FOR EQUIBACTIN VET.
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 33( 4) ZA ZDRAVILO EQUIBACTIN VET.
Equibactin vet. is a generic product.
Zdravilo Equibactin vet. je pasta za peroralno uporabo, ki kot zdravilni učinkovini vsebuje trimetoprim in sulfadiazin ter je indicirano za zdravljenje okužb pri konjih, ki jih povzročajo bakterije, občutljive na kombinacijo trimetoprima in sulfadiazina, še posebej: • okužb dihal, povezanih z bakterijama Streptococcus spp. in Staphylococcus aureus; • okužb prebavil, povezanih z E. coli; • okužb urogenitalnega trakta, povezanih z beta- hemolitičnimi streptokoki; • okužb ran in odprtih ali drenažnih abscesov, povezanih s Streptococcus spp. in Staphylococcus aureus; Zdravilo Equibactin vet. je generično zdravilo.
In August 2006 a decentralised procedure started with The Netherlands as Reference Member State and 17 Concerned Member States.
Nizozemska kot referenčna država članica je skupaj s 17 zadevnimi državami članicami avgusta 2006 sprožila decentralizirani postopek.
France could not agree to the granting of a marketing authorisation as it considered there were potential serious risks to animal health.
Francija se ni strinjala z odobritvijo dovoljenja za promet z zdravilom, saj je menila, da obstaja možnost resnega tveganja za zdravje živali.
It considered this may lead to lack of efficacy and furthering resistance development in target pathogens, which could possibly lead to risks to human health where zoonotic bacteria are concerned.
Prepričana je bila, da lahko tak način odmerjanja povzroči zmanjšanje učinkovitosti in razvoj nadaljnje odpornosti pri ciljnih patogenih, kar bi posledično lahko vodilo k tveganju za človeško zdravje, kadar gre za bakterije zoonoze.
The CVMP started the referral procedure during its meeting of 6-8 November 2007.
CVMP je napotitveni postopek sprožil med svojim zasedanjem od 6. do 8. novembra 2007.
The Marketing Authorisation Holder was requested to provide a copy of the dossier and, in view of the concerns raised by France, to indicate and to substantiate where necessary, any differences between Equibactin vet. and the reference product Tribrissen Oral Paste that could justify different conclusions on the safety or efficacy.
Imetnik dovoljenja za promet z zdravilom je bil naprošen, da predloži kopijo dokumentacije, zaradi izraženih zadržkov Francije pa tudi, da navede in po potrebi obrazloži kakršne koli razlike med zdravilom Equibactin vet. in referenčnim zdravilom Tribrissen peroralna pasta, ki bi lahko utemeljile različne zaključke glede varnosti ali učinkovitosti obeh zdravil.
In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of compositions and pharmacokinetic data, that there are no differences between Equibactin vet. and the reference product that would justify different conclusions on the safety and efficacy for the two products.
V odgovor na vprašanja je predlagatelj predložil dokumentacijo in na podlagi primerjave sestave in farmakokinetičnih podatkov trdil, da ne obstajajo nobene razlike med zdravilom Equibactin vet. in referenčnim zdravilom, ki bi lahko utemeljile različne zaključke o varnosti in učinkovitosti obeh zdravil.
CVMP agreed that Equibactin vet. proved to be essentially similar to reference product Tribrissen Oral Paste.
CVMP se je strinjal, da je zdravilo Equibactin vet. bistveno podobno referenčnemu zdravilu Tribrissen peroralna pasta.
Therefore the same conclusions on efficacy and safety apply equally to both products and the objections raised by France should not prevent the granting of a marketing authorisation.
Tako za obe zdravili veljajo enaki zaključki o učinkovitosti in varnosti zdravila, zadržki Francije pa ne bi smeli preprečiti odobritve dovoljenja za promet z zdravilom.