FrancophonIA/ELRC3.0 huggingface dataset:
English: Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538).
Croatian: Tadalafil nije pokazao djelotvornost u usporavanju opadanja pokretljivosti, što se mjerilo primarnom mjerom ishoda - udaljenošću prijeđenom za 6 minuta hodanja (6MWD): srednja promjena 6MWD rezultata u 48. tjednu izračunata metodom najmanjih kvadrata iznosila je -51,0 metar (m) u skupini koja je primala placebo, u usporedbi s -64,7 m u skupini liječenoj tadalafilom u dozi od 0,3 mg/kg (p = 0,307) odnosno -59,1 m u skupini liječenoj tadalafilom u dozi od 0,6 mg/kg (p = 0,538).
English: These events have either been assigned a frequency of “Not known,” as the frequency in PAH patients cannot be estimated from the available data or assigned a frequency based on the clinical study data from the pivotal placebo-controlled study of tadalafil.
Croatian: Tim je događajima ili dodijeljena kategorija učestalosti "nepoznato", jer se učestalost u bolesnika s PAH-om ne može procijeniti iz dostupnih podataka, ili im je dodijeljena kategorija učestalosti na temelju podataka iz pivotalnog, placebom kontroliranog ispitivanja tadalafila.
English: Protein binding is not affected by impaired renal function.
Croatian: Oštećenje funkcije bubrega ne utječe na vezivanje za proteine.
English: Talmanco contains lactose
Croatian: Talmanco sadrži laktozu
English: Bosentan (125 mg twice daily), a substrate of CYP2C9 and CYP3A4 and a moderate inducer of CYP3A4, CYP2C9 and possibly CYP2C19, reduced tadalafil (40 mg once per day) systemic exposure by 42% and Cmax by 27% following multiple dose co-administration.
Croatian: Antagonisti receptora endotelina-1 (npr. bosentan) Bosentan (125 mg dvaput na dan), supstrat CYP2C9 i CYP3A4 i umjeren induktor CYP3A4, CYP2C9, a možda i CYP2C19, je nakon istodobne primjene višestrukih doza smanjio sistemsku izloženost tadalafilu (40 mg jedanput na dan) za 42%, a Cmax za 27%.
English: How to take Talmanco
Croatian: Kako uzimati Talmanco
English: Talmanco is supplied as a 20 mg tablet.
Croatian: Talmanco je dostupan u obliku tablete od 20 mg.
English: At steady-state, tadalafil (40 mg once per day) increased ethinylestradiol exposure (AUC) by 26% and Cmax by 70% relative to oral contraceptive administered with placebo.
Croatian: U stanju dinamičke ravnoteže tadalafil (40 mg jedanput na dan) je povećao izloženost etinilestradiolu (AUC) za 26%, a Cmax za 70% u odnosu na primjenu oralnog kontraceptiva s placebom.
English: 5 The adverse reactions have been included in the table as a result of postmarketing or clinical study data from the use of tadalafil in the treatment of erectile dysfunction; and in addition, the frequency estimates are based on only 1 or 2 patients experiencing the adverse reaction in the pivotal placebocontrolled study of tadalafil.
Croatian: Ove su nuspojave uključene u tablicu na temelju podataka prikupljenih nakon stavljanja lijeka u promet, odnosno u kliničkim ispitivanjima primjene tadalafila u liječenju erektilne disfunkcije, a dodatno se procjena učestalosti temelji na samo jednom ili dva bolesnika koji su dobili tu nuspojavu u pivotalnom placebom kontroliranom ispitivanju tadalafila.
English: Musculoskeletal and connective tissue disorders Myalgia, Back pain, Pain in extremity (including limb discomfort)
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mialgija, bol u leđima, bolovi u udovima (uključujući nelagodu u udovima)
English: PVC/PE/PVdC-Alu perforated unit dose blisters in carton containing 28 x 1 and 56 x 1 film-coated tablets.
Croatian: PVC/PE/PVdC-Al perforirani blisteri djeljivi na pojedinačne doze u kutijama koje sadrže 28 x 1 i 56 x 1 filmom obloženu tabletu.
English: Cytochrome P450 Inhibitors
Croatian: Inhibitori citokroma P450
English: What Talmanco looks like and contents of the pack This medicine is a white, film-coated, round, biconvex, bevelled edge tablet marked with ‘M' on one side of the tablet and ‘TA20' on the other side.
Croatian: Ovaj lijek je bijela, filmom obložena bikonveksna okrugla tableta s ukošenim rubom s oznakom „M” na jednoj strani tablete i „TA20” na drugoj strani tablete.
English: Unstable angina pectoris, Ventricular arrhythmia, Myocardial Infarction2
Croatian: iznenadna srčana smrt2, 5, tahikardija nestabilna angina pektoris, ventrikularna aritmija, infarkt miokarda
English: Method of administration Talmanco is for oral use.
Croatian: Način primjene Talmanco je namijenjen za peroralnu primjenu.
English: The proportion of patients with improvement in WHO functional class by week 16 was similar in the tadalafil 40 mg and placebo groups (23% vs. 21%).
Croatian: Udio bolesnika kojima se do 16. tjedna poboljšao funkcionalni stupanj prema SZO-u bio je podjednak u skupini koja je primala tadalafil u dozi od 40 mg i skupini koja je primala placebo (23% u odnosu na 21%).
English: Ritonavir (500 mg or 600 mg twice daily) increased tadalafil (20 mg) single-dose exposure (AUC) by 32% and decreased Cmax by 30%.
Croatian: Ritonavir (500 mg ili 600 mg dvaput na dan) je povećao izloženost tadalafilu (AUC) nakon primjene jedne doze za 32%, a smanjio Cmax za 30%.
English: Physicians should carefully consider whether their patients with certain underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by such vasodilatory effects.
Croatian: Liječnici moraju pažljivo razmotriti hoće li ti vazodilatacijski učinci nepovoljno djelovati na bolesnike s određenim komorbiditetima, kao što su teška opstrukcija istisnog dijela lijeve klijetke, dehidracija, autonomna hipotenzija ili hipotenzija u mirovanju.
English: Tadalafil exposure (AUC) in patients with diabetes was approximately 19% lower than the AUC value for healthy subjects after a 10 mg dose.
Croatian: U bolesnika sa šećernom bolešću je izloženost tadalafilu (AUC) nakon doze od 10 mg bila oko 19% manja nego u zdravih ispitanika.
English: Tadalafil 40 mg increased cardiac output (0.6 L/min) and reduced pulmonary artery pressures (-4.3 mm Hg) and pulmonary vascular resistance (-209 dyn.s/cm5) compared to baseline (p < 0.05).
Croatian: Tadalafil u dozi od 40 mg je povećao minutni volumen srca (0,6 l/min) te snizio plućni arterijski tlak (-4,3 mmHg) i plućni krvožilni otpor (-209 dyn.s/cm
English: Antimicrobial medicinal products (e.g. rifampicin) A CYP3A4 inducer, rifampicin (600 mg daily), reduced tadalafil AUC by 88% and Cmax by 46%, relative to the AUC and Cmax values for tadalafil alone (10 mg).
Croatian: Induktor izoenzima CYP3A4 rifampicin (600 mg na dan) smanjio je AUC tadalafila za 88%, a Cmax za 46% u odnosu na vrijednosti AUC-a i Cmax kod primjene samog tadalafila (10 mg).
English: year is 96.4%.
Croatian: Za bolesnike za koje postoje podaci, preživljenje nakon godinu dana iznosi 96,4%.
English: 3 Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower,
Croatian: 3 Obuhvaća MedDRA termine: nelagoda u abdomenu, bol u abdomenu, bol u donjem dijelu abdomena, bol u gornjem dijelu abdomena i nelagoda u želucu.
English: Seizures Transient amnesia5
Croatian: napadaji5, prolazna amnezija5
English: General disorders and administration site conditions Facial oedema, Chest pain 1 Events not reported in registration studies and cannot be estimated from the available data.
Croatian: Opći poremećaji i reakcije na mjestu primjene edem lica, bol u prsnom košu 1 Događaji koji nisu prijavljeni u ispitivanjima u svrhu registracije lijeka i učestalost im se ne može se procijeniti iz dostupnih podataka.
English: Talmanco 20 mg film-coated tablets tadalafil
Croatian: Talmanco 20 mg filmom obložene tablete tadalafil
English: Ketoconazole (200 mg daily), increased tadalafil (10 mg) single dose exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone.
Croatian: Ketokonazol (u dozi od 200 mg na dan) je povećao izloženost tadalafilu (AUC) nakon jedne doze od 10 mg dvostruko, a Cmax za 15%, u odnosu na vrijednosti AUC-a i Cmax kod primjene samog tadalafila.
English: Priapism5, Penile haemorrhage, Haematospermia
Croatian: prijapizam5, krvarenje iz penisa, hematospermija dugotrajna erekcija
English: How to take Talmanco 4.
Croatian: Kako uzimati Talmanco 4. Moguće nuspojave
English: NAME OF THE MEDICINAL PRODUCT Talmanco 20 mg film-coated tablets
Croatian: NAZIV LIJEKA Talmanco 20 mg filmom obložene tablete
English: How to store Talmanco
Croatian: Kako čuvati Talmanco
English: if you are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain.
Croatian: ako ste alergični na tadalafil ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.) ako uzimate bilo koji oblik nitrata, npr. amilnitrit, koji se koristi za ublažavanje boli u prsnom košu.
English: Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect
Croatian: Poremećaji oka zamagljen vid nearterijska prednja ishemijska optička neuropatija, okluzija krvnih žila mrežnice, poremećaj vidnog polja
English: Ketoconazole (400 mg daily) increased tadalafil (20 mg) single dose exposure (AUC) 4-fold and Cmax by 22%.
Croatian: Ketokonazol (u dozi od 400 mg na dan) je povećao izloženost (AUC) tadalafilu nakon jedne doze od 20 mg četverostruko, a Cmax za 22%.
English: Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.
Croatian: Dok ste trudni ili dojite, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Croatian: 5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
English: NAME OF THE MEDICINAL PRODUCT Talmanco 20 mg film-coated tablets tadalafil
Croatian: NAZIV LIJEKA Talmanco 20 mg filmom obložene tablete tadalafil
English: swelling of the face.
Croatian: Za primjenu kroz usta.
English: For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the use of tadalafil is not recommended (see section 4.5).
Croatian: Primjena tadalafila se ne preporučuje u bolesnika koji istodobno uzimaju snažne inhibitore CYP3A4, poput ketokonazola ili ritonavira, (vidjeti dio 4.5).
English: LIST OF EXCIPIENTS Contains lactose.
Croatian: 3. POPIS POMOĆNIH TVARI Sadrži laktozu.
English: Common (may affect up to 1 in 10 people) allergic reactions including skin rashes.
Croatian: Često (mogu se javiti u do 1 na 10 osoba) alergijske reakcije, uključujući kožne osipe bol u prsnom košu - nemojte uzimati nitrate nego odmah zatražite liječničku pomoć
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg tadalafil.
Croatian: 2. NAVOĐENJE DJELATNE TVARI Jedna filmom obložena tableta sadrži 20 mg tadalafila
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: bolovi u mišićima, bol u leđima i bol u udovima (uključujući i nelagodu u udovima)
English: Skin and subcutaneous tissue disorders Rash
Croatian: Poremećaji kože i potkožnog tkiva osip urtikarija hiperhidroza (znojenje)5
English: For patients chronically taking potent inducers of CYP3A4, such as rifampicin, the use of tadalafil is not recommended (see section 4.5).
Croatian: Primjena tadalafila se ne preporučuje u bolesnika na kroničnoj terapiji snažnim induktorima izoenzima CYP3A4, poput rifampicina, (vidjeti dio 4.5).
English: What Talmanco is and what it is used for Talmanco contains the active substance tadalafil.
Croatian: Talmanco sadrži djelatnu tvar tadalafil.
English: migraine.
Croatian: Oštećenje bubrega
English: OTHER
Croatian: Vid
English: Microcrsytalline cellulose (PH 101) Croscarmellose sodium
Croatian: Jezgra tablete: povidon (K-25) natrijev laurilsulfat poloksamer 188 bezvodna laktoza mikrokristalična celuloza (PH101) umrežena karmelozanatrij koloidni bezvodni silicijev dioksid magnezijev stearat
English: acid reflux.
Croatian: Oštećenje jetre
English: Stroke
Croatian: OBLIK
English: Warnings and precautions
Croatian: Djeca i adolescenti
English: Invented Name
Croatian: Izmišljeno ime
English: EU/2/11/126/001 MS-H Vaccine
Croatian: EU/2/11/126/001 MS-H Cjepivo 10 5.7 to Jedinice mijenjanja boje/doza
English: Chickens
Croatian: Karencija
English: Ocular use LDPE bottle 30ml
Croatian: Očna primjena LDPE boca 30 ml
English: 1 bottle N/A
Croatian: 1 boca
English: Target species Route of administration
Croatian: Ciljne vrste životinja
English: Eye drop, suspension
Croatian: Otopina kapi za oči Pilići
English: 1 spot-on applicator
Croatian: 1 aplikator za nakapavanje
English: The product should not be re-applied (within 7 weeks) to cattle.
Croatian: Proizvod se ne smije ponovno primjenjivati (unutar 7 tjedana) u goveda.
English: Add, to all products (if not already present):
Croatian: Dodati svim proizvodima (ako već nije prisutno):
English: However, there is no evidence to date to support this hypothesis.
Croatian: No, do danas nema dokaza koji bi potkrijepili ovu hipotezu.
English: Higher incidence values were reported in Sweden (0.011%) and France (0.007%).
Croatian: Vrijednosti veće incidencije prijavljene su u Švedskoj (0,011 %) i Francuskoj (0,007 %).
English: This should be done before their implementation and for any future changes to the measures deemed necessary.
Croatian: To je potrebno izvršiti prije njihove implementacije i za sve buduće izmjene u mjerama koje se smatraju neophodnima.
English: − intensified data collection relating to pharmacovigilance reports; and
Croatian: − intenzivnije prikupljanje podataka povezanih s farmakovigilancijskim izvješćima; te
English: The average number of affected animals per adverse event report in the EU was 3.9.
Croatian: Prosječan broj zaraženih životinja po nuspojavi prijavljen u EU-u bio je 3,9.
English: − education, training and guidance for end-users.
Croatian: − obrazovanje, osposobljavanje i usmjeravanje krajnjih korisnika.
English: Sales volumes should also be reported separately for specific products for each Member State.
Croatian: Treba zasebno podnositi izvještaje prodajnih volumena za određene proizvode za svaku državu članicu.
English: The overall EU incidence of adverse events, in relation to sales volumes was classified as ‘very rare' (0.003%) and considered within acceptable limits.
Croatian: Cjelokupna incidencija nuspojava na razini EU-a, vezana uz prodajne volumene klasificirana je kao "vrlo rijetka" (0,003 %) i smatra se unutar prihvatljivih ograničenja.
English: • implementation of a risk management plan addressing the following risk mitigation and surveillance measures:
Croatian: • provedba plana upravljanja rizikom uz navođenje sljedećih mjera za ublažavanje rizika i nadzor:
English: • Closivet Solución Pour-On (Spain); and
Croatian: • Closivet Solución Pour-On (Španjolska); i
English: A single risk management plan should be presented covering all products included within the scope of this procedure.
Croatian: Treba predstaviti jedinstven plan upravljanja rizikom kojim bi bili obuhvaćeni svi proizvodi uključeni u ovaj postupak.
English: It was noted that these events often involved more than one animal within affected herds.
Croatian: Zaključeno je kako ovi događaji često zahvaćaju više od jedne životinje unutar zaraženog krda.
English: It was also recommended to ensure data collection on a representative sample of unaffected treated animals within the same herd.
Croatian: Također je preporučeno da se osigura prikupljanje podataka o reprezentativnom uzorku nezaraženih liječenih životinja unutar istog krda.
English: Other treatment options have limited activity against immature fluke.
Croatian: Druge opcije za liječenje imaju ograničeno djelovanje protiv nezrelog metilja.
English: • UK/V/0368/001 - Closiver 5mg/ml & 200 mg/ml Pour-On (UK); Closamectin 5mg/ml & 200 mg/ml Pour-On (Austria, Belgium, Czech Republic, Denmark, Germany, Greece, Italy, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden);
Croatian: • UK/V/0368/001 - otopina za polijevanje po koži Closiver 5mg/ml i 200 mg/ml (UK); Otopina za polijevanje po koži Closamectin 5mg/ml i 200 mg/ml (Austrija, Belgija, Češka Republika, Danska, Njemačka, Grčka, Italija, Poljska, Portugal, Rumunjska, Slovačka, Slovenija, Španjolska i Švedska);
English: CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS is a veterinary medicinal product which has been authorised in France since 25 May 2011 following a decentralised procedure (DCP) (UK/V/0369/001) with the United Kingdom (UK) as reference Member State.
Croatian: Otopina za polijevanje po koži CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS veterinarski je proizvod koji je odobren u Francuskoj od 25. svibnja 2011. godine nakon decentraliziranog postupka (DCP-a) (UK/V/0369/001) s Ujedinjenom Kraljevinom (UK) kao referentnom državom članicom.
English: Closivet Solución Pour- On Ivermectin Closantel
Croatian: Closivet Solución Pour- On klozantel i ivermektin
English: • UK/V/0325/001 - Closamectin Pour-On (UK, Ireland);
Croatian: • UK/V/0325/001 - Otopina za polijevanje po koži Closamectin (UK, Irska);
English: On 19 June 2015, ANMV circulated a rapid alert notifying Member States, the European Commission and the European Medicines Agency of the intention to suspend the marketing authorisation for CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS in France, following the evaluation of pharmacovigilance data.
Croatian: Dana 19. srpnja 2015. ANMV izdao je brzo upozorenje kojim obavještava države članice, Europsku komisiju i Europsku agenciju za lijekove o namjeri da suspendira odobrenje za izdavanje lijeka u promet za OTOPINU ZA POLIJEVANJE PO KOŽI ZA GOVEDA CLOSAMECTIN u Francuskoj, nakon evaluacije farmakovigilancijskih podataka.
English: Member State (EU/EEA)
Croatian: (EU/EGP)
English: The ANMV received a total of 123 adverse event reports involving CLOSAMECTIN POUR-ON POUR BOVINS between 25 May 2011 and 31 May 2015 in which 401 animals were affected and 121 died.
Croatian: ANMV je zaprimio ukupno 123 prijava nuspojava koje su bile povezane s OTOPINOM ZA POLIJEVANJE PO KOŽI ZA GOVEDA CLOSAMECTIN između 25. svibnja 2011. i 31. svibnja 2015. pri čemu je 401 životinja zahvaćeno, a 121 je preminulo.
English: The detailed results of these analyses should be reported at regular intervals with every PSUR submission and immediately in case of any significant finding or upon request.
Croatian: Detaljni rezultati ovih analiza trebaju se prijaviti u redovitim intervalima sa svakim dostavljanjem PSUR-a i neodloživo u slučaju bilo kakvog značajnog nalaza ili na zahtjev.
English: Other veterinary medicinal products with the same qualitative and quantitative composition which belong to the same marketing authorisation holder (MAH), Norbrook Laboratories Ltd, are also authorised under two other DCP and three national procedures, as follows:
Croatian: Drugi veterinarsko-medicinski proizvodi s istim kvalitativnim i kvantitativnim sastavom koji pripadaju istim nositeljima odobrenja za stavljanje VMP-a u promet (nositeljima odobrenja), Norbrook Laboratories Ltd, također su odobreni u sklopu dva DCP-a i tri nacionalna postupka, kako slijedi:
English: Annex IV Conditions of the marketing authorisations
Croatian: Dodatak IV Uvjeti odobrenja za stavljanje lijeka u promet
English: It was however, suggested that licking/grooming, possibly associated with the predominantly beef cattle breeding systems in France could explain, in part, the comparatively higher number of events reported there.
Croatian: No, nagađa se da lizanje/trebljenje, koje se može povezati s predominatnim sustavima uzgoja goveda u Francuskoj, može, djelomično, pojasniti usporedivo veći broj događaja koji su tamo prijavljeni.
English: From the literature review reported it appeared that variability existed between animals in terms of their clinical response to a same level of overdose.
Croatian: U pregledu literature koji je isto prijavio čini se da postoji varijabilnost između životinja u smislu njihovog kliničkog odgovora na istu razinu predoziranja.
English: It was proposed that third parties involved in pharmacovigilance activities related to these products (e.g distributors) be made aware of the risk management measures proposed.
Croatian: Predloženo je da se treće strane uključene u farmakovigilancijske aktivnosti povezane s ovim proizvodima (primjerice distributeri) upoznaju s predloženim mjerama za upravljanje rizikom.
English: In line with the requirements, all communication tools relating to pharmacovigilance should be submitted to the concerned NCAs, for information, before dissemination.
Croatian: U skladu sa zahtjevima, svi komunikacijski alati povezani s farmakovigilancijom trebaju se dostaviti nadležnim NCA-ovima, za potrebe informiranja prije distribucije.
English: This follow-up should also continue to investigate other potential risk factors which may also play a role in the adverse events observed, including, for example, aspects related to animal husbandry.
Croatian: Ova kontrola treba također nastaviti istraživanje drugih potencijalnih faktora rizika koji mogu također imati ulogu u uočenim nuspojavama, uključujući, primjerice, aspekte povezane s životinjskim parenjem.
English: The national competent authorities of Member State(s) or the reference Member State, as applicable, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Croatian: Nadležna nacionalna tijela države(a) članice(a) ili referentne države članice, prema potrebi, osiguravaju da nositelji odobrenja za stavljanje lijeka u promet ispunjavaju sljedeće uvjete:
English: The aforementioned products have the same qualitative and quantitative composition and consequently it was considered that the animal health issues described were applicable to these products as well.
Croatian: Prethodno navedeni proizvodi imali su isti kvalitativni i kvantativni sastav i posljedično je zaključeno da su opisani zdravstveni problemi u životinja primjenjivi i na ove proizvode.
English: SPC section 4.5 Special precautions for use: Special precautions for use in animals:
Croatian: Odjeljak SPC-a 4.5 Posebne mjere opreza za uporabu: Posebne mjere opreza za primjenu u životinja:
English: The data reviewed did not indicate age, sex, breed or geographical distribution as potential risk factors for the adverse events observed.
Croatian: Pregledani podaci nisu navodili dob, spol, vrstu ili geografičku distribuciju potencijalnih faktora rizika u slučaju uočenih nuspojava.
English: Information should also be collected on the affected herd and husbandry system in general, including herd health status.
Croatian: Potrebno je prikupiti informacije o zaraženom krdu i sustavu razmnožavanja općenito, uključujući zdravstveni status krda.
English: Although the overall incidence of adverse events was considered to be within acceptable limits (0.006% in the last annual periodic safety update report (PSUR)) the continued occurrence of serious adverse events and the severity of subsequent losses on farms in France were considered significant, which led to the suspension of the marketing authorisation in France on 6 July 2015.
Croatian: Iako je zaključeno kako je ukupna incidencija nuspojava unutar prihvatljivih ograničenja (0,006% u posljednjem godišnjem izvještaju o neškodljivosti (PSUR-u)),zaključeno je kako je nastavljeno pojavljivanje ozbiljnih nuspojava i ozbiljnost naknadnog gubitka na farmama u Francuskoj značajno, što je rezultiralo suspenzijom odobrenja za stavljanje VMP-a u promet u Francuskoj na dan 6. srpnja 2015.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holder in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, životinjskih vrsta, putova primjene, nositelja odobrenja za stavljanje veterinarsko-medicinskog proizvoda u promet u državama članicama