FrancophonIA/ELRC3.0 huggingface dataset:
English: This resolved spontaneously within 24 hours without treatment.
Danish: Dette forsvandt spontant inden for 24 timer uden behandling.
English: Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting, diarrhea or depression.
Danish: Der kan forekomme umiddelbare, lette overfølsomhedslignende reaktioner efter vaccinationen, som medfører forbigående kliniske tegn såsom opkastning, diarré eller depression.
English: Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpation, are very common and may last for up to 2 days (based on laboratory safety studies).
Danish: Lokale vævsreaktioner i form af hævelse på injektionsstedet, der kan være forbundet med lokal varme, rødme og smerte ved berøring, er meget almindelige og kan vare op til to dage (baseret på laboratorieundersøgelser af sikkerheden).
English: Major incompatibilities: Do not mix with any other vaccine or immunological product.
Danish: Uforligeligheder: Må ikke blandes med andre vacciner eller immunologiske lægemidler.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelige (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter)
English: CONTENTS BY WEIGHT, VOLUME OR BY NUMBER OF DOSES 25 doses
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 25 doser
English: 0.2 mg *Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
Danish: 0,2 mg *Relativ styrke påvist vha. ELISA antigentest (in vitro styrketest) ved sammenligning med referencevaccine.
English: PACKAGE SIZE 125 doses
Danish: PAKNINGSSTØRRELSE 125 doser
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009, når det anvendes som i dette veterinære lægemiddel.
English: Marketing authorization holder and manufacturer responsible for batch release: Zoetis Belgium SA
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse: Zoetis Belgium SA
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Danish: FREMSTILLERENS BATCHNUMMER Lot {nummer}
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (2 ml) contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosis (2 ml) indeholder:
English: Upon shaking, the black deposit disappears and the emulsion becomes homogenous again.
Danish: Når beholderen rystes, forsvinder den sorte aflejring, og emulsionen bliver homogen igen.
English: WITHDRAWAL PERIOD(S) Withdrawal period: Zero days
Danish: TILBAGEHOLDELSESTID(er) Tilbageholdelsestid: 0 dage
English: EXPIRY DATE EXP {month/year} Once broached use immediately.
Danish: UDLØBSDATO EXP (Måned/år) Anvendes straks efter anbrud.
English: It is intended to stimulate active immunity against PCV2 in pigs.
Danish: Den er beregnet til at stimulere aktiv immunitet mod PCV2 hos svin.
English: Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral vaccines for pigs.
Danish: Farmakoterapeutisk gruppe: immunologiske lægemidler til svin, inaktiverede virale vacciner til svin.
English: Squalane Poloxamer 401 Polysorbate 80
Danish: Squalan Poloxamer 401 Polysorbat 80
English: Special warnings for use in animals: Vaccinate only healthy animals.
Danish: Særlige forholdsregler til brug hos dyr: Kun raske dyr må vaccineres.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Intramuscular use.
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJE Intramuskulær anvendelse.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikker har virket efter anbefalingern.
English: The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Danish: Veterinærlægemidlets sikkerhed under drægtighed eller laktation er ikke fastlagt.
English: Do not use during pregnancy and lactation.
Danish: Må ikke anvendes under drægtighed og laktation.
English: In a laboratory study, a postmortem examination of the injection site, performed 4 weeks after the administration of a single dose of the vaccine, revealed a mild inflammatory response, as evidenced by the absence of tissue necrosis and little fibrosis.
Danish: I et laboratoriestudie viste en undersøgelse af injektionsstedet (under en obduktion) 4 uger efter administration af en enkeltdosis af vaccinen en let inflammatorisk reaktion, hvilket kunne ses ved manglende vævsnekrose og kun let fibrose.
English: A transient increase in body temperature (on average 1°C) is very common during the first 24 hours after vaccination.
Danish: En forbigående stigning i kropstemperaturen (i gennemsnit 1 °C) er meget almindeligt i løbet af de første 24 timer efter vaccination.
English: Disodium phosphate anhydrous Sodium phosphate dibasic heptahydrate Disodium tetraborate decahydrate EDTA tetrasodium
Danish: Dinatriumphosphat, vandfri Dibasisk natriumphosphat heptahydrat Dinatriumtetraborat decahydrat Tetranatrium EDTA Vand til injektionsvæsker
English: In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2 °C.
Danish: Hos enkelte svin kan det være almindeligt, at temperaturen stiger mere end 2 °C i forhold til temperaturen før behandlingen.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals: Not applicable.
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Ikke relevant.
English: Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 3 weeks of age.
Danish: En enkelt injektion af én dosis (2 ml) i nakkemusklen, bag øret, til svin fra 3-ugers alderen.
English: During storage, a slight black deposit may appear and the emulsion may separate into two distinct phases.
Danish: Der kan forekomme en lille, sort aflejring under opbevaring, og emulsionen kan skilles i to adskilte faser.
English: 8 µl (0.4% v/v) 4 µl (0.2% v/v) 0.64 µl (0.032% v/v)
Danish: 0,64 µl (0,032 % v/v)
English: TARGET SPECIES Pigs (for fattening).
Danish: DYREARTER Svin (til opfedning)
English: STATEMENT OF ACTIVE SUBSTANCES One dose (2 ml) contains:
Danish: ANGIVELSE AF AKTIVE STOFFER Én dosis (2 ml) indeholder:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS HDPE vials (25 or 50 doses)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER HDPE-hætteglas (25 eller 50 doser)
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Danish: TEKSTEN “ KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: Duration of immunity: 23 weeks after vaccination
Danish: Varighed af immunitet: 23 uger efter vaccination
English: Excipients: Thiomersal
Danish: Hjælpestoffer: Thiomersal
English: Fertility No information is available on the safety of this vaccine in breeding boars.
Danish: Der foreligger ingen oplysninger om sikkerheden af denne vaccine hos avlsorner.
English: A slight black deposit may appear and the emulsion may separate into two distinct phases during storage.
Danish: Der kan forekomme en lille sort aflejring under opbevaring, og emulsionen kan skilles i to adskilte faser.
English: High density polyethylene vials of 50 ml, of 100 ml and of 250 ml (25, 50 and 125 doses), with a chlorobutyl elastomer closure and sealed with an aluminium cap.
Danish: Hætteglas af HDPE med 50 ml, 100 ml og 250 ml (med hhv. 25, 50 og 125 doser) med et låg af chlorbutylelastomer og forseglet med en aluminiumshætte.
English: Onset of immunity: from 3 weeks after vaccination.
Danish: Indtræden af immunitet: fra 3 uger efter vaccination.
English: PACKAGE LEAFLET: Suvaxyn Circo emulsion for injection for pigs
Danish: INDLÆGSSEDDEL: Suvaxyn Circo injektionsvæske, emulsion til svin
English: For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
Danish: Aktiv immunisering af svin i alderen 3 uger og opefter mod porcint circovirus type 2 (PCV2) til reduktion af virusmængden i blod og lymfevæv og spredning via afføring forårsaget af infektion med PCV2.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Suvaxyn Circo emulsion for injection for pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN Suvaxyn Circo injektionsvæske, emulsion til svin
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose (2 ml) contains:
Danish: ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER Én dosis (2 ml) indeholder:
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE HDPE vials (125 doses)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE HDPE-hætteglas (125 doser)
English: Monobasic potassium phosphate anhydrous Sodium chloride
Danish: Monobasisk kaliumphosphat, vandfri Natriumchlorid
English: 25 doses (50 ml) 50 doses (100 ml) 125 doses (250 ml)
Danish: 25 doser (50 ml) 50 doser (100 ml) 125 doser (250 ml)
English: A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2fold overdose.
Danish: Der blev observeret en forbigående stigning i kropstemperatur (i gennemsnit 0,8 °C) 4 timer efter administration af en overdosering på 2 gange den tilladte dosis.
English: 4.2 Indications for use, specifying the target species For active immunisation of pigs from 3 weeks of age against porcine circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Aktiv immunisering af svin i alderen 3 uger og opefter mod porcint circovirus type 2 (PCV2) til reduktion af virusmængden i blod og lymfevæv og spredning via fæces forårsaget af infektion med PCV2.
English: Special precautions for use in animals None
Danish: Særlige forsigtighedsregler vedrørende brug til dyr
English: Once broached use immediately.
Danish: Anvendes straks efter anbrud.
English: Local tissue reaction in the form of swelling (below 2 cm in diameter) at the injection site was commonly observed and resolved within 2 days.
Danish: Der blev observeret en lokal vævsreaktion i form af hævelse (under 2 cm i diameter) på injektionsstedet.
English: 10 vial pack: 10 x 25 doses (50 ml) 10 vial pack: 10 x 50 doses (100 ml) 4 vial pack: 4 x 125 doses (250 ml)
Danish: Papæske med 10 hætteglas: 10 x 25 doser (50 ml) Papæske med 10 hætteglas: 10 x 50 doser (100 ml) Papæske med 4 hætteglas: 4 x 125 doser (250 ml)
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr Ikke relevant.
English: Cardboard box of 10 vials of 50 ml (25 doses ) or 100ml (50 doses).
Danish: Papæske med 10 hætteglas med 50 ml (25 doser) eller 100 ml (50 doser).
English: QUANTITY OF THE ACTIVE SUBSTANCES Inactivated recombinant chimeric PCV type 1 containing the PCV type 2 ORF2 protein
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Inaktiveret, rekombinant kimært PCV type 1 med PCV type 2 ORF2-protein
English: WITHDRAWAL PERIOD(S) Zero days
Danish: 10. TILBAGEHOLDELSESTID 0 dage
English: Inactivated recombinant chimeric PCV type 1 containing the PCV type 2 ORF2 protein
Danish: Inaktiveret, rekombinant kimært PCV type 1 med PCV type 2 ORF2-protein
English: Cardboard box of 1 vial of 50 ml (25 doses), 100ml (50 doses) or 250 ml (125 doses).
Danish: Papæske med 1 hætteglas med 50 ml (25 doser), 100 ml (50 doser) eller 250 ml (125 doser).
English: The vaccine contains an inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein.
Danish: Vaccinen indeholder et inaktiveret, rekombinant kimært porcint circovirus type 1 med porcint circovirus type 2 ORF2-protein.
English: STATEMENT OF ACTIVE SUBSTANCES Each dose (2 ml) contains: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Danish: ANGIVELSE AF AKTIVE STOFFER Hver dosis (2 ml) indeholder: Inaktiveret, rekombinant kimært porcint circovirus type 1 med porcint circovirus type 2 ORF2-protein 2,3-12,4 RP
English: Cardboard box of 4 vials of 250 ml (125 doses)
Danish: Papæske med 4 hætteglas med 250 ml (125 doser).
English: Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
Danish: Inaktiveret, rekombinant kimært porcint circovirus type 1 med porcint circovirus type 2 ORF2-protein
English: During the procedure, the applicant further substantiated the justification.
Danish: Under proceduren underbyggede ansøgeren begrundelsen yderligere.
English: Both medications were similarly effective
Danish: De to lægemidler var lige effektive
English: Similar results were shown in the published study M3
Danish: Der blev observeret lignende resultater i den publicerede undersøgelse M3
English: • the safety profile of pantoprazole is well established and acceptable.
Danish: • pantoprazols sikkerhedsprofil er veletableret og acceptabel.
English: Treatment Duration N (ITT)
Danish: Behandling Varighed N (ITT)
English: - to support clinical efficacy and safety, the application is based on the results of 17 clinical studies.
Danish: - Til støtte for den kliniske virkning og sikkerhed er ansøgningen baseret på resultaterne af 17 kliniske undersøgelser.
English: The results showed that all of the above doses are effective and comparable in the treatment of GORD.
Danish: Resultaterne viste, at alle ovenstående doser er effektive og sammenlignelige ved behandling af GORD.
English: With reference to the above 6 studies, the CHMP made the following observations (see also comments included in the above table):
Danish: Under henvisning til ovenstående 6 undersøgelser havde CHMP følgende bemærkninger (se også bemærkningerne i ovenstående tabel:
English: Symptomatic relief was comparable between the products though no statistically significant differences could be found between the groups at the end of week 1.
Danish: Symptomlindringen var sammenlignelig mellem produkterne, selv om der ikke kunne findes nogen statistisk signifikante forskelle mellem grupperne ved udgangen af uge 1.
English: • the applicant's justification to extrapolate the results of these studies to the proposed non prescription setting is acceptable
Danish: • ansøgerens begrundelse for ekstrapolering af resultaterne af disse undersøgelser til den foreslåede ikke-receptpligtige sammenhæng er acceptabel
English: The study contained a treatment phase C; days 29-56, but again, this is not relevant to a non-prescription indication of no more than 28 days.
Danish: Undersøgelsen indeholdt en behandlingsfase C, dag 29-56, men igen er dette ikke relevant for en ikke-receptpligtig indikation på maksimalt 28 dage.
English: Overall this study provides no relevant data analogous to the initial non-prescription medication period of up to 14 days.
Danish: Generelt set frembringer denne undersøgelse ikke relevante data, som er analoge med den indledende ikke-receptpligtige medicineringsperiode på op til 14 dage.
English: Such exclusivity requires that the change of classification “has been authorised on the basis of significant preclinical tests or clinical trials”.
Danish: En sådan databeskyttelse kræver, at ændringen af klassificeringen "er godkendt på grundlag af signifikante prækliniske eller kliniske undersøgelser".
English: It was stated that these 6 studies support the proposed new indication and treatment duration by providing at least one symptom recording point of reflux-related symptoms during the first 14 days of treatment with pantoprazole and therefore are considered significant for the application.
Danish: Det blev fremført, at disse 6 undersøgelser støtter den nye foreslåede indikation og behandlingsvarighed ved at give mindst et registreringspunkt for refluksrelaterede symptomer i løbet af de første 14 dages behandling med pantoprazol, og derfor anses for væsentlige for ansøgningen.
English: Therefore, the 6 above-mentioned studies do not provide clinical data which has genuine impact on the assessment of the application.
Danish: De 6 ovennævnte undersøgelser frembringer således ikke kliniske data, som har en reel indvirkning på vurderingen af ansøgningen,
English: Secondary Objective
Danish: Sekundært mål
English: None of the 6 above-mentioned studies provide data to support the proposed indication and treatment duration that could not be derived from the other 11 studies provided in the application.
Danish: Ingen af de 6 ovennævnte undersøgelser frembringer data, som støtter den foreslåede indikation og behandlingsvarighed, og som ikke kunne være udledt af de øvrige 11 undersøgelser, der er anført i ansøgningen.
English: CSR = Clinical Study Report, N = Number of Patients, Eso = Esomeprazole, Lan = Lansoprazole, Niz = Nizatidine, Ome = Omeprazole, Pan = Pantoprazole, Pla = Placebo, Ran = Ranitidine, bid =twice daily
Danish: CSR = Klinisk undersøgelsesrapport, N = Antal patienter, Eso = Esomeprazol, Lan = Lansoprazol, Niz = Nizatidin, Ome = Omeprazol, Pan = Pantoprazol, Pla = Placebo, Ran = Ranitidin, bid = to gange dagligt
English: Based on the above results the CHMP considered the following:
Danish: Under henvisning til ovenstående resultater havde CHMP følgende bemærkninger:
English: 322 There was no statistically significant difference between the treatment groups
Danish: 4/8 uger 322 Der var ikke nogen statistisk signifikant forskel mellem behandlingsgrupperne
English: The justification of the applicant was based on 6 ‘non-published' studies, 5 full and one published by abstract only, which have been provided in support of the application (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309).
Danish: Ansøgerens begrundelse var baseret på 6 "ikke-publicerede" undersøgelser, 5 i deres helhed og 1, som kun var publiceret i form af et sammendrag, der var indsendt til støtte for ansøgningen (BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 og BY1023/VMG309).
English: The shortcomings of this study are the same as described above for study BF010: lack of day 14 makes this study of limited value in the non-prescription context where the patient would be self-referring to their physician if no symptomatic relief was obtained by day 14.
Danish: Manglerne i denne undersøgelse er de samme som beskrevet ovenfor for undersøgelse BF010: Manglen på data på dag 14 gør, at denne undersøgelse er af begrænset værdi i den ikke-receptpligtige sammenhæng, hvor patienten selv skulle søge læge, hvis symptomerne ikke var afhjulpet på dag 14.
English: Disorientation (and all aggravations)
Danish: Desorientering (og forværring af allerede eksisterende symptomer)
English: No day 14 data was available in the study report.
Danish: Der forelå ingen data for dag 14 i undersøgelsesrapporten.
English: Overall the applicant considered that the new data from the aforementioned studies added significant support to the classification as non-prescription product as they provided both effect and relevance to the assessment.
Danish: Alt i alt anså ansøgeren de nye data fra ovennævnte undersøgelser som væsentlige i forbindelse med klassificeringen som ikke-receptpligtigt lægemiddel, da de tilførte vurderingen både betydning og relevans.
English: 14 day data was not provided by this study.
Danish: Der blev ikke fremlagt data for dag 14 i denne undersøgelse.
English: The applicant, in addition to study BGI022 (CSR 257/2004), referred to study MEX020 (CSR 200/2004).
Danish: Ansøgeren henviste ud over undersøgelse BGI022 (CSR 257/2004) til undersøgelse MEX020 (CSR 200/2004).
English: 4 weeks
Danish: 4 uger
English: The applicant also referred to studies BF010 (CSR 298E/99) and VMG309 (CSR 323/2004) which were considered to provide data for early onset of relief of reflux symptoms.
Danish: Ansøgeren henviste også til undersøgelse BF010 (CSR 298E/99) og VMG309 (CSR 323/2004), som mentes at dokumentere, at reflukssymptomerne begynder at lindres tidligt.
English: The study concluded that pantoprazole 20 mg has a trend to have a faster relief of symptoms during the first 7 days of treatment compared with omeprazole 10 mg, but no statistically significant differences were found after 7 days, 4 weeks or 8 weeks treatment between the groups.
Danish: Af undersøgelsen blev det konkluderet, at pantoprazol 20 mg har tendens til hurtigere lindring af symptomer i løbet af de første 7 dages behandling i forhold til omeprazol 10 mg, men der blev ikke fundet nogen statistisk signifikante forskelle mellem grupperne efter 7 dages, 4 ugers eller 8 ugers behandling.
English: Out of the 17 studies provided by the applicant, the following 6 studies formed the basis of the applicant's request for data exclusivity:
Danish: Af de 17 undersøgelser fremsendt af ansøgeren udgjorde følgende 6 undersøgelser en del af grundlaget for ansøgerens anmodning om databeskyttelse:
English: • pantoprazole 20mg is effective in the short-term treatment of GORD symptoms
Danish: • pantoprazol 20 mg er virkningsfuldt til kortvarig behandling af GORD-symptomer
English: very rare
Danish: Ikke almindelig Sjælden
English: the CHMP concluded that the studies BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY1023/MEX020, BY1023/FK3037 and BY1023/VMG309 submitted by the applicant for which the claim of one year data exclusivity is sought, were not relevant and necessary to the classification of CONTROLOC Control 20 mg gastro-resistant tablets as ‘medicinal product not subject to medical prescription'.
Danish: konkluderede CHMP, at undersøgelse BY1023/BGI022, BY1023/BF010, BY1023/ESP009, BY 1023/MEX020, BY1023/FK3037 og BY1023/VMG309, for hvilke resultaterne er indsendt af ansøgeren, og for hvilke der er fremsat anmodning om en etårig databeskyttelsesperiode, ikke var relevante og nødvendige for klassificeringen af CONTROLOC Control 20 mg enterotabletter som et "ikke-receptpligtigt lægemiddel".
English: Nycomed GmbH, D-78467 Konstanz
Danish: Nycomed GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Tyskland