natgillin/translations-raw huggingface dataset:
EU/1/11/719/011 14x1 tablet EU/1/11/719/012 28x1 tablet EU/1/11/719/013 30x1 tablet EU/1/11/719/014 40x1 tablet EU/1/11/719/015 56x1 tablet EU/1/11/719/016 60x1 tablet EU/1/11/719/017 84x1 tablet EU/1/11/719/018 90x1 tablet EU/1/11/719/019 98x1 tablet EU/1/11/719/020 100x1 tablet EU/1/11/719/063 28 tabletter 
EU/1/11/719/011 14x1 tablets EU/1/11/719/012 28x1 tablets EU/1/11/719/013 30x1 tablets EU/1/11/719/014 40x1 tablets EU/1/11/719/015 56x1 tablets EU/1/11/719/016 60x1 tablets EU/1/11/719/017 84x1 tablets EU/1/11/719/018 90x1 tablets EU/1/11/719/019 98x1 tablets EU/1/11/719/020 100x1 tablets EU/1/11/719/063 28 tablets
I den første periode af behandlingen skal blodtrykket kontrolleres regelmæssigt. 
At the beginning of the preventive therapy with Telmisartan Teva 80 mg, blood pressure should be frequently monitored.
Provokeret opkastning og/eller maveudskylning er mulige behandlinger. 
Suggested measures include induction of emesis and / or gastric lavage.
Tel: (351) 214 235 910 
Teva Pharma - Produtos Farmacêuticos Lda Tel: (351) 214 235 910
Medlemsland (EU/EEA) 
Member State (EU/EEA)
Ved den gensidige anerkendelsesprocedure var Ungarn referencemedlemsstat, og Østrig, Belgien, Bulgarien, Kroatien, Cypern, Tjekkiet, Estland, Finland, Tyskland, Grækenland, Island, Irland, Italien, Letland, Litauen, Nederlandene, Polen, Portugal, Rumænien, Slovakiet, Slovenien, Sverige og Det Forenede Kongerige var berørte medlemsstater. 
For the mutual recognition procedure (MRP), Hungary acted as a reference Member State and Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Italy, Latvia, Lithuania, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden and the United Kingdom were concerned Member States.
Produktnavn Styrke 
Product name Strength
Nærmere bestemt er p-værdien under 0,0001, dvs. at sandsynligheden for en falsk positiv korrelation er under 0,01 %. 
Specifically, the p-value is below 0.0001 which means that the probability of a false positive correlation is under 0.01%.
Desuden blev det bekræftet, at de variable var standardiseret. 
Furthermore, it was confirmed that standardisation of variables was applied.
Immunitetens varighed 
Duration of immunity
monografi 1360. 
Monograph 1360.
Vaccinens virkning under praktiske anvendelsesforhold 
Efficacy of the vaccine under practical conditions of use
Det totale antal er 20 x 109 inaktiverede bakterier pr. dosis. 
The total quantity is 20 x 109 inactivated germs per dose.
Desuden blev der rejst tvivl om formuleringen af det færdige produkt, enten hvad angår antigenindhold eller andre indholdsstoffer. 
Furthermore, the formulation of the finished product, either in terms of antigen content or of additional components, was questioned.
Efter gennemgang af alle de forelagte oplysninger konkluderede CVMP følgende: 
Having considered all data submitted the CVMP concluded that:
831 53 Bratislava Slovakiet 
831 53 Bratislava Slovakia
Grækenland Ceva Hellas LLC 15, Agiou Nikolaou str. 
Ceva Hellas LLC 15, Agiou Nikolaou str.
Alle stammer udtrykker også ApxII. 
All the strains express also ApxII.
Disse batcher var testet efter de krav, der var gældende ved første godkendelse af produktet i Ungarn. 
These batches had been tested according to the requirements when the product was first authorised in Hungary.
40472 Düsseldorf Tyskland 
40472 Düsseldorf Germany
monografi 04/2013:1360. 
Monograph 04/2013:1360.
Farmaceuticsk form 
Pharmaceutical form
Vaccinationsplanen omfatter 2 doser, der gives til dyr fra 7-ugers alderen med et interval på 3 uger mellem doserne. 
The vaccination schedule is 2 doses administered to animals from 7 weeks of age with an interval of 3 weeks between doses.
Viale Colleoni 15, 20864 Agrate Brianza (MB) Italien 
Viale Colleoni 15, 20864 Agrate Brianza (MB)
Tiendweg 8 c, 2670 AB Naaldwijk Holland 
Tiendweg 8 c, 2670 AB Naaldwijk The Netherlands
Sundere vaccinerede svin forventes at have bedre tilvækst, hvilket dog ikke blev påvist under feltbetingelser. 
Healthier vaccinated pigs are expected to give better growth rates, although this was not demonstrated under field conditions.
Der blev forelagt statistiske detaljer for hver serotype til støtte for størrelsen af den positive korrelation mellem de to pågældende parametre. 
Details of statistics were provided for each serotype in order to support the magnitude of the positive relationship between the two concerned measures.
Hovedforskellen er, at den anvendte vaccinebatch i disse undersøgelser havde højere antigenindhold end det ansøgte minimum til EU markedet. 
The main difference was that the vaccine batch used in these studies had a higher antigen content than the minimum one proposed for the EU market.
Liste med navne, farmaceutisk form, styrke af veterinærlægemidlet, dyrearter, administrationsvej(e), indehaver af Markedsføringstilladelser i medlemslandene 
List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States
Da de af Italien rejste spørgsmål forblev uafklarede, var de berørte medlemsstater ikke i stand til at nå til enighed om virkningen af Coglapix, hvorfor sagen blev indbragt for CVMP den 24. oktober 2014 i henhold til artikel 33, stk. 4, i direktiv 2001/82/EF. 
Since the issues raised by Italy remained unresolved, the Member States concerned failed to reach agreement regarding the efficacy of Coglapix and consequently the matter was referred to the CVMP on 24 October 2014 under Article 33(4) of Directive 2001/82/EC.
Indikationen blev desuden fundet acceptabel i betragtning af den påtænkte anvendelse af vaccinen og de eksisterende data fra laboratorieundersøgelserne. 
It is also considered that the indication is acceptable taking account of the intended use of the vaccine and the existing data from the laboratory studies.
Heller ikke oplysningerne fra de periodiske opdaterede sikkerhedsindberetninger kunne betragtes som andet end støttende eller lægges til grund for påstandene. 
Furthermore, the information gathered from Periodic Safety Update Reports was similarly considered to be only supportive and did not substantiate the claims.
Disse spørgsmål forblev uafklarede, hvorfor der blev foretaget en indbringelse i medfør af artikel 33, stk. 1, i direktiv 2001/82/EF, for CMD(v) (koordinationsgruppen vedrørende gensidig anerkendelse og decentrale procedurer - veterinær). 
These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Det gyldige Produktresumé, etikettering og indlægsseddel er de endelige versioner modtaget under proceduren i Coordination Group med følgende ændringer: 
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Indehaveren af markedsføringstilladelsen, Ceva-Phylaxia Veterinary Biologicals Co. Ltd., indgav en ansøgning om gensidig anerkendelse af den markedsføringstilladelse, der er udstedt af Ungarn i overensstemmelse med artikel 32 i direktiv 2001/82/EF. 
The marketing authorisation holder (MAH), Ceva-Phylaxia Veterinary Biologicals Co. Ltd., submitted an application for mutual recognition of the marketing authorisation granted by Hungary in accordance with Article 32 of Directive 2001/82/EC.
Rumænien Ceva Santé Animale Romania 
Romania Ceva Santé Animale Romania
Bulgarien Ceva Animal Health Bulgaria ul. 
Bulgaria Ceva Animal Health Bulgaria ul.
monografi 04/2013:1360, vacciner mod porcin actinobacillose (inaktiverede)). 
Monograph 04/2013:1360, Porcine Actinobacillosis Vaccines (inactivated)).
Denne indbringelsesprocedure omfatter ikke kvalitet eller sikkerhed, da referencemedlemsstaten ikke anmeldte betænkeligheder herved. 
Quality and safety were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Korrelation mellem reduktion af lungeforandringer og reduktion af kliniske tegn 
Correlation between the reduction of lung lesions and the reduction of clinical signs
Stamme NT3 tilhører serotype 1, der udtrykker ApxI medens stamme SzII, PO, U3 og B4 tilhører serotype 2, der udtrykker ApxIII. 
Strain NT3 belongs to the serotype 1, expressing ApxI whereas strains SzII, PO, U3 and B4 belong to the serotype 2, expressing ApxIII.
17455 ALIMOS 
17455 ALIMOS Greece
Til påvisning af vaccinens immunogenicitet blev der udført seks laboratorieundersøgelse af virkning i henhold til en acceptabel standard og udformning til fastlæggelse af immunitetens indsætten og varighed og til opfyldelse af kriterierne i Ph. Eur. 
To demonstrate the immunogenicity of the vaccine, six laboratory efficacy studies were conducted to an acceptable standard and design to establish the onset and duration of immunity and meet the criteria of the Ph. Eur.
CVMP blev anmodet om at vurdere de foreliggende data til støtte for virkningen af Coglapix og konkludere, om veterinærlægemidlet kan udgøre en potentiel alvorlig risiko for dyrs sundhed. 
The CVMP was asked to consider the available data supporting the efficacy of Coglapix and conclude whether the veterinary medicinal product may present a potential serious risk to the animal health.
040185 Bucharest 
040185 Bucharest Romania
Virkning blev demonstreret under laboratorieforhold men ikke under feltbetingelser. 
Efficacy was demonstrated under laboratory but not under field conditions.
Under den gensidige anerkendelsesprocedure fandt Italien som berørt medlemsstat, at Coglapix kan udgøre en potentiel alvorlig risiko for dyrs helbred. 
During the MRP Italy, as a concerned Member State, considered that Coglapix may present a potential serious risk to animal health.
Farmakoterapeutisk gruppe: Actinobacillus/Haemophilus vaccine. 
Pharmacotherapeutic group: Actinobacillus/Haemophilus vaccine.
CVMP konkluderede, at de af Italien udtrykte betænkeligheder ikke bør forhindre udstedelse af markedsføringstilladelserne for Coglapix, og anbefalede ændringer i de relevante afsnit af produktresuméet og indlægssedlen (se bilag III). 
The CVMP concluded that the concerns expressed by Italy should not prevent the granting of marketing authorisations for Coglapix and recommended amendments in the relevant sections of the Summary of Product Characteristics and package leaflet (see Annex III).
Vaccinen leveres i flerdosisbeholdere som en injektionsvæske, suspension, med et adjuvans baseret på aluminiumhydroxid. 
The vaccine is supplied in multidose containers as a suspension for injection containing an aluminium hydroxide-based adjuvant.
Markedsføringstilladelsesindehaverens oplysninger om salgstal for de sidste 15 år fandtes ikke at være tilstrækkeligt grundlag for påstandene. 
The market sales over the past 15 years provided by the MAH were not considered sufficient to support the claims.
Italien fandt således, at (i) korrelationen mellem reduktion af lungeforandringer og reduktion af kliniske tegn ikke var tilfredsstillende godtgjort, at (ii) fordelene ved vaccinen ikke var påvist under praktiske anvendelsesbetingelser (dvs. at reduktion af lungeforandringer og kliniske tegn nedsatte vægttabet hos de vaccinerede dyr), og (iii) at undersøgelserne af immunitetens varighed ikke gav samstemmende resultater. 
In particular, Italy considered that (i) the correlation between the reduction of lung lesions and the reduction of clinical signs has not been adequately demonstrated; (ii) the benefit of the vaccine under practical conditions of use (i.e. reduction of lung lesions and clinical signs resulting in reduced weight losses in vaccinated animals) has not been demonstrated and (iii) inconsistent results were obtained from duration of immunity studies.
På grundlag af vurderingen af den overordnede virkning af Coglapix vaccine blev varigheden af immuniteten for begge serotyper (1 og 2) op til 16 uger efter vaccination bestemt ved relevante belastningsundersøgelser, der blev udført efter 16 og 24 uger. 
Based on the assessment of the overall efficacy of Coglapix vaccine, duration of immunity was established for both serotypes (1 and 2) up to 16 weeks after vaccination according to the results of relevant challenge studies carried out at 16 and 24 weeks.
Påvisning af immunitet: 21 dage efter anden vaccination Varighed af immunitet: 16 uger efter anden vaccination 
Onset of immunity: 21 days following second vaccination Duration of immunity: 16 weeks following second vaccination
Skønt der må forventes positiv korrelation mellem reduktion af lungeforandringer og reduktion af kliniske tegn som følge af vaccinationen, kunne størrelsen af en sådan korrelation ikke bestemmes. 
Although a positive correlation between the reduction of lung lesions and the reduction of clinical signs as a consequence of the vaccination is predictable, it was not possible to evaluate the magnitude of such a correlation.
Immunitetens varighed er 16 uger efter den anden vaccination. 
Duration of immunity is 16 weeks following second vaccination.
Feltundersøgelserne har ikke bekræftet resultaterne fra laboratorieundersøgelserne, og der var betænkelighed vedrørende fordelen ved vaccinen under praktiske anvendelsesforhold. 
Field trials have not corroborated the results obtained under laboratory conditions and there were concerns regarding the benefit of the vaccine under practical conditions of use.
Coglapix, injektionsvæske, suspension, til svin (herefter benævnt "Coglapix") er en inaktiveret bakteriel vaccine mod porcin actinobacillose. 
Coglapix suspension for injection for pigs (hereafter called ‘Coglapix') is an inactivated bacterial vaccine against porcine actinobacillosis.
Samlet resumé af den videnskabelige vurdering af Coglapix, injektionsvæske, suspension, til svin (se bilag I) 
Overall summary of the scientific evaluation of Coglapix suspension for injection for pigs (see Annex I)
Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne Frankrig 
Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne France
Desuden blev indehaveren af markedsføringstilladelsen anmodet om at kommentere, hvorvidt den påviste signifikans (for både serotype 1 og 2) af resultaterne (for indvirkning på tilvækst) i to laboratorieundersøgelser er tilstrækkelig til at opveje den manglende signifikans af resultaterne i tre "ikke-signifikante" laboratorieundersøgelser. 
Furthermore, the MAH was requested to comment on whether the significance (for both serotypes 1 and 2) of the results (concerning the impact on weight gain) shown in two laboratory studies is sufficient to erase the nonsignificance of the results in three ‘non-significant' laboratory studies.
Indehaveren af markedsføringstilladelsen fremlagde desuden en præcisering vedrørende uoverensstemmende data fra en sammenlignende analyse af batchprotokollerne for de to vacciner. 
The MAH also provided clarification in relation to some discrepant data emerging from a comparative analysis of the batch protocols of the two vaccines.
• Denne indbringelse blev indledt på grund af betænkeligheder vedrørende vaccinens overordnede virkning. 
• This referral was raised due to concerns regarding the overall efficacy of the vaccine.
Indehaver af Markedsføringstilladelsen 
Marketing authorisation holder
Indehaveren af markedsføringstilladelsen blev derfor anmodet om yderligere at underbygge konklusionen om, at vaccinens virkning under praktiske anvendelsesforhold er tilstrækkeligt godtgjort. 
The MAH was therefore requested to further support the conclusion that the efficacy of the vaccine under practical conditions of use has been adequately demonstrated.
De pågældende afsnit af produktresuméet og indlægssedlen bør derfor rettes, så denne konklusion klart fremgår. 
Therefore the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to clearly reflect this conclusion.
Indehaveren af markedsføringstilladelsen forelagde data fra 12 laboratorieundersøgelser og 3 feltundersøgelser til støtte for den påberåbte virkning. 
The MAH submitted data from 12 laboratory studies and 3 field studies to support the efficacy claim.
Indehaveren af markedsføringstilladelsen blev anmodet om skriftligt at bekræfte, at den statistiske analyse var udformet på grundlag af resultaterne af relevante undersøgelser, at skaffe sikkerhed for, at den anvendte analysemetode var velegnet, og om muligt at forelægge en metaanalyse af resultaterne fra de forskellige undersøgelser. 
The MAH was requested to confirm, in writing, that the statistical analysis was performed using the results of relevant studies and to provide assurance the data-analysis method used was adequate and submit, if possible, a meta-analysis of all the results obtained from the different studies.
Stammerne er af serotype 1 og serotype 2. 
The strains belong to the serotype 1 or serotype 2 groups.
Under den gensidige anerkendelsesprocedure indskrænkede markedsføringstilladelsesindehaveren den oprindelige indikation fra fire kliniske parametre (kliniske tegn, tab, lungeforandringer og infektion forbundet med sygdommen) til kun to, dvs. reduktion af kliniske tegn og lungeforandringer (som begge indgår i Den Europæiske Farmakopé (Ph. 
During the MRP the MAH reduced the initial indication from four clinical parameters (clinical signs, losses, lung lesions and infection associated with the disease) to only two i.e. reduction of clinical signs and lung lesions (both of which are included in the European Pharmacopoeia (Ph.
Begrænsningen af indikationen til to kliniske parametre krævede yderligere påvisning af signifikant forskel mellem vaccinerede dyr og kontroldyr i disse to øvrige virkningsparametre. 
The reduction of the indication to two clinical parameters required a further demonstration of significance for these two remaining efficacy parameters between vaccinates and controls.
Derudover blev der redegjort for væsentlige problemer forbundet med den komplekse karakter af infektioner med A. pleuropneumaniae og overholdelsen af kravene i Ph.Eur. 
Major issues concerning the complex nature of A. pleuropneumaniae infections, and compliance with the requirements of European Pharmacopoeia was also addressed.
Indehaveren af markedsføringstilladelsen fastslog, at den statistiske analyse til påvisning af korrelation med reduktion af lungeforandringer og kliniske tegn var udført på grundlag af resultaterne fra relevante undersøgelser (dvs. 12 belastningsundersøgelser, 6 for hver serotype). 
The MAH confirmed that the statistical analyses aiming to establish the correlation between reduction of lung lesions and reduction of clinical signs were performed using the results of all relevant studies (i.e., 12 challenge studies, 6 for each serotype).
Okrzei 1A, 03-715 Warszawa Polen 
03-715 Warszawa Poland
I tilslutning til dette svar blev der fremlagt protokoller for frigivelse af to batcher, som udviste ensartet formulering baseret på kimtal. 
To complement the answer, the batch release protocols for two batches were provided revealing consistent germ-count-based target formulation.
Da korrelationskoefficienten var højsignifikant i hvert tilfælde, konkluderede indehaveren af markedsføringstilladelsen, at det er meget usandsynligt, at den iagttagne sammenhæng mellem klinisk score og score for lungeforandringer skyldes en tilfældighed. 
As the correlation coefficient was highly significant in each case, the MAH concluded that it is very unlikely that the observed relationship between clinical and lung lesion scores is only due to chance.
Indehaveren af markedsføringstilladelsen fastslog, at batcherne var fremstillet med en ensartet fremstillingsproces i henhold til EU's standarder for god fremstillingspraksis (GMP) og var af tilstrækkelig kvalitet til anvendelse i undersøgelser af virkning. 
The MAH confirmed that the batches were produced according to a consistent manufacturing process under EU Good Manufacturing Practice (GMP) standards and of adequate quality for use in the efficacy trials.
Immunitet opnås 21 dage efter den anden vaccination. 
Onset of immunity is 21 days following second vaccination.
Som konklusion fandt CVMP, at indehaveren af markedsføringstilladelsen havde forelagt tilfredsstillende dokumentation for, at Coglapix fremstilles og testes efter en acceptabel kvalitetsstandard for batchernes styrke, og at forekomsten af kliniske tegn dermed er korreleret med tilstedeværelsen af lungeforandringer. 
In conclusion, the CVMP agreed that the MAH has provided satisfactory evidence that Coglapix is manufactured and tested to an acceptable quality standard regarding the batch potency test and consequently the appearance of clinical signs are correlated with the presence of lung lesions.
Indehaveren af markedsføringstilladelsen bekræftede, at fremtidige produktionsbatcher til EU-markedet vil blevet fremstillet på grundlag af faste målværdier og kontrolleret i henhold til de specifikationer for det færdige produkt, der er vedtaget ved den gensidige anerkendelsesprocedure. 
The MAH confirmed that future commercial batches for the EU market will be produced based on fixed formulation targets and will be controlled in line with the finished product specifications agreed during the MRP.
Uanset markedsføringstilladelsesindehaverens begrundelse vedrørende emnets kompleksitet og de tekniske vanskeligheder gav sagen anledning til det vigtige spørgsmål, om påvisning af signifikans af en parameter i én relevant undersøgelse kan begrunde, at der ses bort fra manglende signifikans af samme parameter i en "ikke-signifikant" undersøgelse. 
Although acknowledging the justifications provided by the MAH concerning the complexity of the topic and the technical difficulties encountered, a major question arose as to whether a parameter shown to be significant in one relevant study is sufficient to erase the non-significance of the same parameters in a “non-significant” study.
Ved vurderingen af resultaterne fra undersøgelserne af virkning blev der yderligere rejst et problem vedrørende overensstemmelsen mellem de anvendte vaccinebatcher i disse undersøgelser. 
When assessing the results of efficacy studies an additional point for concern was raised in relation to the consistency of the vaccine batches used for these trials.
De pågældende afsnit af produktresuméet og indlægssedlen bør rettes, så de afspejler dette (se bilag III). 
Therefore, the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to reflect this (see Annex III).
CVMP anbefalede derfor udstedelse af markedsføringstilladelse for de i bilag I angivne veterinærlægemidler, idet referencemedlemsstatens produktresumé og indlægsseddel ændres. 
Therefore the CVMP recommended the granting of the marketing authorisations for the veterinary medicinal products referred to in Annex I with amendments to the Summary of Product Characteristics and package leaflet of the reference Member State.
På baggrund af disse overvejelser blev indehaveren af markedsføringstilladelsen anmodet om at påvise, at den signifikans, der i nogle laboratorieundersøgelser af virkning var påvist for de kliniske tegn, er tilstrækkelig til at opveje den manglende signifikans af samme parameter i "ikke-signifikante" laboratorieundersøgelser af virkning. 
Based on these considerations, the MAH was requested to demonstrate that the significance shown for clinical signs in some laboratory efficacy studies is sufficient to overcome the non-significance of the same parameter in ‘non-significant' laboratory efficacy studies.
De er imidlertid udført med henblik på markedsføringstilladelsen for Coglapix i et land uden for EU, og visse elementer opfylder ikke kriterierne i Ph. Eur. 
Six additional laboratory studies were also provided, but these studies were carried out for the marketing authorisation of Coglapix in a country outside the EU and in some elements did not meet the criteria of Ph. Eur.
Tilføjelser i de relevante afsnit i Produktresuméet og indlægssedlen 
Amendments in the relevant sections of the Summary of Product Characteristics and package leaflet