FrancophonIA/ELRC3.0 huggingface dataset:
English: IBUPROFENO PENSA 600 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUPROFENO PENSA 600 mg comprimidos recubiertos con película EFG
English: FENBID
Danish: BLANDAS
English: Pfizer Consumer Healthcare Walton Oaks
Danish: Pfizer Consumer Healthcare Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS United Kingdom
English: Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Danish: Norge ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Ibuprofen Actavis 400 mg Filmtabletten
Danish: Ibuprofen Ibuprofen Actavis 400 mg Filmtabletten
English: IBUFEN 200 mg, comprimé enrobé
Danish: Ibuprofen ALGIFENE 200 mg, comprimé enrobé
English: Buscofem
Danish: Winthrop
English: SERACTIL
Danish: Aspar
English: WRAFTON LABS IBUPROFEN PERRIGO TABLETS 400 MG
Danish: Ibuprofenlysin Ibuprofen Perrigo 400 mg
English: BRUFEN RETARD TABLETS 800MG
Danish: TABLETS 800MG
English: Ibuprofen 400mg film-coated tablets
Danish: Ibuprofen Melfen 400mg Film-coated tablets
English: Ifenin 400mg
Danish: Ingelheim 400 mg
English: Schmerztabletten
Danish: TABLETS
English: LIDERFEME 400 mg comprimidos
Danish: Ibuprofen LIDERFEME 400 mg comprimidos
English: Ibunex 200 mg potahované tablety
Danish: Ibuprofen Ibunex 200 mg potahované tablety
English: IBUTABS 400 mg, comprimé pelliculé
Danish: Ibuprofen IBUTABS 400 mg, comprimé pelliculé
English: Dolocyl
Danish: CHEWABLE
English: Ibuprofeno Generis Ibuprofen
Danish: Ibuprofen Ibuprofeno Generis
English: IBUPROFEN MEPHA 400MG
Danish: Ibuprofen Ibu-Hemopharm 400mg
English: Ibuprofen Hasco
Danish: Ibuprofen Fenpic
English: Ibuprom Sinus
Danish: IBUPROFENLY SINAT
English: MELFEN 200 mg bevont tabletta
Danish: Ibuprofen MELFEN 200 mg bevont tabletta
English: Willy-Brandt-Allee 2
Danish: Lil-Dagover-Ring 7
English: Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal
Danish: Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal
English: Ibuprofen ratiopharm 4 % Sirup für Kinder
Danish: Ibuprofen Ibuprofen ratiopharm 4 %
English: Advil 200mg Tablets Ibuprofen
Danish: Ibuprofen Advil 200mg Tablets
English: IBUPROFENO ACOST 600 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUPROFENO ACOST 600 mg comprimidos recubiertos con película EFG
English: IBUPROFEN LYSINATE
Danish: Ibuprofenlysin Ibuzin
English: Ibuprofeno Generis 600 mg Comprimidos Revestidos
Danish: Ibuprofen Ibuprofeno Generis 600 mg Comprimidos
English: Ibuprofen - Grindeks 200 mg film-coated tablets
Danish: Ibuprofen IbuprofenGrindeks 200 mg film-coated tablets
English: Healthypharm B.V. Nieuwe Donk 3
Danish: Nederlandene Healthypharm B.V.
English: RELONCHEM IBUPROFEN TABLETS 400MG
Danish: Ibuprofen CUPROFEN TABLETS 400MG
English: Fenopine 400 mg Film-coated Tablets.
Danish: Ibuprofen Fenopine 400 mg Film-coated Tablets.
English: Ibuprofen Rockspring 200 mg šumeča zrnca
Danish: Ibuprofen Brufen Gran 200 mg šumeča zrnca
English: IBUMAX 400 mg filmtabletta
Danish: Ibuprofen IBUMAX 400 mg filmtabletta
English: Ibalgin NEO 400 mg filmsko obložene tablete
Danish: Ibuprofen Ibalgin NEO 400 mg filmsko obložene tablete
English: IBUPROFENO ONEDOSE 600 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUPROFENO ONEDOSE 600 mg comprimidos recubiertos con película EFG
English: Fenopine 200 mg Film-coated Tablets.
Danish: Ibuprofen Fenopine 200 mg Film-coated Tablets.
English: Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Danish: Tyskland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Ibuprofen lysine 684 mg Coated tablet
Danish: Ibuprofenlysin Ibu-Lysin CT 684 mg Overtrukket tablet Oral anvendelse
English: 400 mg Powder for oral solution
Danish: 400 mg Pulver til oral opløsning
English: IBUPROFENO ACTAVIS 600 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUPROFENO ACTAVIS 600 mg comprimidos recubiertos con película EFG
English: BUSCAFEM 400 MG CAPSULAS BLANDAS EFG
Danish: Ibuprofen BUSCAFEM 400 MG CAPSULAS
English: Brufen 800 mg prolonged-release tablets
Danish: Ibuprofen Brufen 800 mg prolongedrelease tablets
English: Lagoas Park, 2740-298 Porto Salvo
Danish: Lagoas Park, 2740
English: Ibuprofeno Cinfa
Danish: Ibuprofen Kifen
English: IBUPROFENO STADA 600 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUPROFENO STADA 600 mg comprimidos recubiertos con película EFG
English: Ibuprofen arginine 600 mg Granules for oral solution
Danish: IBUPROFEN FASPIC 600 600 mg Granulat til oral opløsning
English: SERACTIL TABLETS 400MG
Danish: TABLETS 400MG
English: Ibu-Lysin-CT 342 mg Filmtabletten
Danish: Ibuprofen Ibu-Lysin-CT 342 mg
English: Ibuprofen codeine phosphate
Danish: Ibuprofen codeinphosph at
English: Estonia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Danish: Estland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Ibumed 200 mg
Danish: IBUPROFEN NUROFEN® 200 mg
English: Ibuprofen - Grindeks 400 mg film-coated tablets
Danish: Ibuprofen IbuprofenGrindeks 400 mg film-coated tablets
English: Ibumax 200 mg filmcoated tablets
Danish: Ibuprofen Ibumax 200 mg film-coated tablets
English: DK-2800 Kongens Lyndby Denmark
Danish: Lyndby Denmark
English: Chaul End Lane 30
Danish: Finchley Road 108
English: IBUPROFENO OSODENT 600 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUPROFENO OSODENT 600 mg comprimidos recubiertos con película EFG
English: Ibuprofen Manston 400 mg, filmomhulde tabletten
Danish: Ibuprofen Sarixell 400 mg, filmomhulde tabletten
English: Lithuania ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Danish: Litauen ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: 800 mg Film-coated prolongedrelease tablet
Danish: 800 mg Filmovertrukket depottablet
English: Ibuprofen Actavis 400mg Film-Coated Tablets
Danish: Ibuprofen Brufen 400mg film-coated tablets
English: Hungary ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Danish: Ungarn ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Alcobendas (Madrid), 28108 Spain
Danish: Alcobendas (Madrid),
English: Oral drops, solution Oral use
Danish: Oral suspension Oral anvendelse
English: CUPROFEN TABLETS BP 200MG
Danish: TABLETS BP 200MG
English: Ibuprofen EG 400 mg Ibuprofen
Danish: Ibuprofen Ibuprofen EG 400 mg
English: IBUPROFENO ZENTIVA 600 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUPROFENO ZENTIVA 600 mg comprimidos recubiertos con película EFG
English: Ibuprofen lysine 683,34 mg Oral powder
Danish: 683,34 mg Oralt pulver
English: Strovolos
Danish: Revestidos
English: 2 Victoria Road Harpenden
Danish: 2 Park Street Woburn,
English: IBUPROFEN ROCKSPRING 600 mg pezsgőgranulátum
Danish: Ibuprofen Brufen 400 mg pezsgőgranulátu m
English: Ibuprofeno Abbott
Danish: Ibuprofen Abfen
English: Lannacher Heilmittel GmbH Schlossplatz 1
Danish: Lannacher Heilmittel GmbH
English: Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany
Danish: 96052 Bamberg Germany
English: IBUPROFENO CINFA 600 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUPROFENO CINFA 600 mg comprimidos recubiertos con película EFG
English: NUROFENTABS 200 mg, comprimé orodispersible
Danish: Ibuprofen NUROFEN 200 mg, comprimé orodispersible
English: Italy ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Danish: Italien ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: Zweigniederlassung Wick Pharma
Danish: Bronzactiv Pharma GmbH
English: Ibudolor 200 mg Filmtabletten
Danish: Ibuprofen Ibudolor 200 mg Filmtabletten
English: 40476 Düsseldorf Germany
Danish: 27472 Cuxhaven Germany
English: Ibum Forte
Danish: Ibuprofen Ibum Forte
English: IBUPROFEN 200 MG FILM-COATED TABLETS
Danish: Ibuprofen Ibulain 200 mg film-coated tablets
English: IBUSTAR 400 mg filmtabletta
Danish: Ibuprofen IBUSTAR 400 mg filmtabletta
English: Ibumax 400 mg filmcoated tablets
Danish: Ibuprofen Ibumax 400 mg film-coated tablets
English: Ibuprofen Mepha
Danish: Ibuprofen Ibupama
English: NUROFEN FORTE IBUPROFEN
Danish: IBUPROFEN NUROFEN FORTE
English: NUROFEN FORTE Ibuprofen
Danish: Ibuprofen NUROFEN FORTE
English: Fenpic
Danish: ALMUS
English: Ibuprofen Actavis 800mg Film-Coated Tablets
Danish: Ibuprofen Ibuprofen Actavis 800mg Film-Coated
English: Northamptonshire NN11 8PB United Kingdom
Danish: 7 Sopwith Way, Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom
English: Drayton Fields Industrial Estate, Daventry
Danish: Sefton Business Park Bootle, Liverpool
English: Nurofen Expres 200 mg
Danish: Ibuprofen Nurofen Expres 200 mg
English: Seractil forte 400 mg - Filmtabletten
Danish: Dexibuprofen Seractil 300 mg - Filmtabletten
English: IBUPROFENO ABEX 400 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUKERN 400 mg comprimidos recubiertos con película EFG
English: McNeil GmbH & Co.oHG Johnson & Johnson Platz 2 41470 Neuss
Danish: Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium
English: Ibuprofen AL 600 Ibuprofen
Danish: IBUPROFEN IBUPROFEN CIPLA 600
English: Ibuprofen 200mg Effervescent Granules
Danish: Ibuprofen Nurofen 200mg Effervescent
English: Ibuprofen lysine 342 mg Coated tablet
Danish: Ibuprofenlysin Ibu-Lysin CT 342 mg Overtrukket tablet Oral anvendelse
English: ASPAR IBUPROFEN CAPLETS 200MG
Danish: Ibuprofen NUROFEN CAPLETS 200MG
English: Lifepharma (Z.A.M) Ltd Agiou Nicolaou Street 8 1523 Lefkosia Cyprus
Danish: Lifepharma (Z.A.M) Ltd
English: Ibuprofen AbZ 600 mg Filmtablette
Danish: Ibuprofen Anco 600mg Filmtabletten
English: Suppository
Danish: Zakłady
English: Ibuprofen Stada 600 mg Filmtabletten
Danish: Ibuprofen Brufen 600 mgFilmtabletten
English: Ibuprofen Lannacher Ibuprofen
Danish: Ibuprofen RELONCHEM IBUPROFEN
English: IBUPROFENO GOIBELA 600 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUPROFENO GOIBELA 600 mg comprimidos recubiertos con película EFG
English: Ibubel 200 mg filmsko obložene tablete
Danish: Ibuprofen Ibubel 200 mg filmsko obložene tablete
English: Schmelztabletten
Danish: MG TABLETS
English: Brufen forte
Danish: Brufen Plus
English: JUNIOR IBUPROFEN SUSPENSION 100MG/5ML
Danish: Ibuprofen IBUPROFENO CINFA 100 mg/ 5 ml
English: Ibuprofen Mepha 400 mg film-coated tablets
Danish: Ibuprofen Ibumetin 400 mg film-coated tablets
English: Brufen 400 mg šumivé granule
Danish: 400 mg Brusegranulat
English: Ibuprofen Galpharm 200mg Film-coated Tablets
Danish: Ibuprofen Buplex 200mg film-coated tablets
English: Brufen Retard 800 mg
Danish: Ibuprofen Brufen Retard 800 mg
English: IBULAR TABLETS 200MG
Danish: Ibuprofen LIBROFEM TABLETS 200MG
English: Ibuprofen PB 400 mg Ibuprofen
Danish: Ibuprofen Ibuprofen PB 400 mg
English: Denk Pharma GmbH & Co. KG Prinzregentenstr.
Danish: Denk Pharma GmbH & Co.
English: Ibuprofen LGO
Danish: Ibuprofen NORVECTAN
English: Labialfarma - Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.
Danish: LabialfarmaLaboratório de Produtos Farmacêuticos e
English: Luxembourg CT Arzneimittel GmbH Graf-Arco-Str. 3
Danish: Luxembourg CT Arzneimittel GmbH
English: Ibuprofen Genericon 400 mg Filmtabletten
Danish: Ibuprofen Ibunin 400 mg Filmtabletten
English: Ibunin
Danish: Polígono
English: Ibuprofen lysinate 400 mg Powder for oral suspension
Danish: Ibuprofen Spidifen Limão 400 mg Granulat til oral opløsning
English: Ibumetin 200 mg film-coated tablets
Danish: Ibuprofen Ibumetin 200 mg film-coated tablets
English: IBUFARMALID 200 mg SUSPENSION ORAL
Danish: Ibuprofen Ibuflam 4% 200 mg Oral suspension Oral anvendelse
English: Floridsdorfer Hauptstraße 1 1210 Wien
Danish: Avenue Einstein 12 1300 Wavre Belgium
English: TODALGIL 400 mg comprimidos recubiertos con película
Danish: Ibuprofen TODALGIL 400 mg comprimidos recubiertos con película
English: Ibuprofen-CT 200 mg Filmtabletten
Danish: Ibuprofen ibuprofen-ct 400 mg Filmtablette
English: Pfeil ZahnschmerzTabletten forte 400mg Filmtabletten
Danish: Ibuprofen Pfeil ZahnschmerzTabletten forte 400mg
English: Dexcel Pharma GmbH Carl-Zeiss-Str. 2
Danish: TAD Pharma GmbH Heinz-Lohmann-Str.
English: Ibuprofen AFL
Danish: Ibuprofen Íbúfen
English: 06796 Brehna Germany
Danish: 69007 Lyon France
English: Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78
Danish: Bulgarien Actavis Group PTC ehf
English: Ibubeta 400
Danish: Ibuprofen Dolgit 400
English: IBUPROFENO STADA GENERICOS 600 mg comprimidos recubiertos EFG
Danish: Ibuprofen IBUPROFENO STADAGEN 600 mg comprimidos recubiertos EFG
English: Ibuprofeno Ratiopharm 400 mg Comprimidos Revestidos
Danish: Ibuprofen Ibu-Ratiopharm 400 mg Overtrukket tablet Oral anvendelse
English: Luton, Bedfordshire LU4 8EZ United Kingdom
Danish: Fourrts (UK) Pharmacare Limited Chaul End Lane 30 Luton, Bedfordshire LU4 8EZ
English: Brufen 400 mg šumivý granulát
Danish: Ibuprofen Brufedol 400 mg šumivý granulát
English: Tabalon 400mg
Danish: CAPLETS 400MG
English: Guglgasse 17
Danish: Verovškova 57
English: France ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Danish: Frankrig ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
English: ETHYPHARM
Danish: INTERPHARMAC EUTIQUE
English: Ibuprofen Heumann 200mg Filmtabletten
Danish: Ibuprofen Irfen 200 mg Filmtabletten
English: NUROFEN FORTE 400 mg bevont tabletta
Danish: Ibuprofen NUROFEN FORTE 400 mg bevont tabletta
English: Ibuprofen Boehringer Ingelheim 400 mg
Danish: Ibuprofen Ibuprofen Galpharm 400 mg
English: Ibumetin 400 mg film-coated tablets
Danish: Ibuprofen Butifen 400 mg film-coated tablets
English: Neofen 200 mg filmom obložene tablete
Danish: Ibuprofen Neofen 200 mg filmom obložene tablete
English: SPEDIFEN 200 mg, comprimé
Danish: Ibuprofen SPEDIFEN 200 mg, comprimé
English: ADVIL 400 mg, comprimé enrobé
Danish: Ibuprofen ADVIL 400 mg, comprimé enrobé
English: 512 mg Coated tablet
Danish: 512 mg Overtrukket tablet Oral anvendelse
English: Ibustar 400 mg filmcoated tablets
Danish: Ibuprofen Ibustar 400 mg film-coated tablets
English: Ibuprofen dura 600mg Filmtabletten
Danish: Ibuprofen Esprenit 600mg Filmtabletten
English: Nottingham NG90 5EF United Kingdom
Danish: London NW3 5JJ United Kingdom
English: IBUPROFENE E PSEUDOEFEDRINA BOEHRINGER INGELHEIM
Danish: IBUPROFENE E PSEUDOEFEDRI NA
English: IBUPROFENO CODRAMOL 400 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen UNODOL 400 mg comprimidos recubiertos con película EFG
English: Ibustar 400 mg filmom obložene tablete
Danish: Ibuprofen Ibustar 400 mg filmom obložene tablete
English: Buskofem200 mg Capsule, soft
Danish: Ibuprofen Buskofem 200 mg Kapsel, blød
English: ALGOFLEX 200 mg filmtabletta
Danish: Ibuprofen ALGOFLEX 200 mg filmtabletta
English: IBUPROFENO ABEX 600 mg comprimidos recubiertos con película EFG
Danish: Ibuprofen IBUKERN 600 mg comprimidos recubiertos con película EFG
English: Ibuprofen-mp 600 Ibuprofen
Danish: Ibuprofen Ibuprofen-mp
English: Ibuprofen dura 400 mg Filmtabletten
Danish: Ibuprofen Irfen 400 mg Filmtabletten
English: ALGOFLEX 400 mg filmtabletta
Danish: Ibuprofen ALGOFLEX 400 mg filmtabletta
English: ANTARENE 200 mg, comprimé pelliculé
Danish: Ibuprofen ANTARENE 200 mg, comprimé pelliculé
English: Buskofem
Danish: EFERVESCENTE
English: Zanza Laboratories (Holdings) Limited
Danish: Nederlandene Wrafton Laboratories Limited
English: Ibuprofen Liderfarm Ibuprofen
Danish: Ibuprofen WAYMADE IBUPROFEN
English: Pharmachemie B.V. Swensweg 5 - Haarlem PO Box 552
Danish: Swensweg 5Haarlem
English: Ibu-Ratiopharm Ibuprofen
Danish: Ibuprofen IBUPROFENRATIOPHARM
English: Brufen Forte 600 Ibuprofen
Danish: Ibuprofen Brufen 600
English: IBUPROFENE FARMALIDER 400 mg, comprimé pelliculé
Danish: Ibuprofen BRUFEN 400 mg, comprimé pelliculé
English: Dismenol Ibuprofen 200 mg Filmtabletten
Danish: Ibuprofen Ibunin 200 mg Filmtabletten
English: Ibacut 400 mg filmsko obložene tablete
Danish: Ibuprofen Ibacut 400 mg filmsko obložene tablete
English: 256 mg Coated tablet
Danish: 256 mg Overtrukket tablet Oral anvendelse
English: MIG 40 mg/ ml
Danish: 40 MG/ML
English: The new study design has been submitted to the German Competent Authority (BfArM) for advice and is currently under review.
Danish: Det nye undersøgelsesdesign er indsendt til den kompetente tyske myndighed (BfArM) med henblik på vejledning og gennemgås i øjeblikket.
English: • testosterone levels below castration for both products.
Danish: • testosteronniveauer under kastrationsniveau for begge lægemidler
English: Overall summary of the scientific evaluation of Novimp 3,6 mg Implantat and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Novimp 3,6 mg implantat og relaterede navne (se bilag I)
English: It is an LHRH agonist (analogue of the natural luteinizing hormone-releasing hormone) and suppresses the serum testosterone to castration level to inhibit the growth of hormonedepending prostate carcinoma.
Danish: Det er en LHRH-agonist (analog af det naturlige luteiniserende hormonfrigivende hormon) og supprimerer serumtestosteron til kastrationsniveau for at hæmme væksten af hormonafhængigt prostatakarcinom.
English: Considering the above, the CHMP is of the opinion that the particulars submitted in support of the application do not comply with article 10 of Directive 2001/83/EC as amended.
Danish: På baggrund af ovennævnte er CHMP af den opfattelse, at de oplysninger, der blev fremsendt til støtte for ansøgningen, ikke var i overensstemmelse med artikel 10 i direktiv 2001/83/EF med senere ændringer.
English: • The Committee considered the referral triggered under Article 36 of Directive 2001/83/EC for Novimp 3,6 mg Implantat and associated names as listed in Annex I.
Danish: • Udvalget behandlede indbringelsen i henhold til artikel 36 i direktiv 2001/83/EF for Novimp 3,6 mg implantat og relaterede navne som anført i bilag 1.
English: Therefore, neither the comparative study design nor the cited results of the study can compensate for the breach of the legal requirements to provide GCP-compliant studies in support of a MAA.
Danish: Derfor kan hverken det komparative undersøgelsesdesign eller de anførte resultater kompensere for overtrædelsen af de juridiske krav til at levere undersøgelser, som overholder GCP, til støtte for en ansøgning om markedsføringstilladelse.
English: Critical violations of fundamental standards of ICH GCP and internationally accepted laboratory standards during the bioanalytical analyses of the blood samples from both GOS/001 (1month depot formulation) and GOS/002 (1 and 3-month depot formulation) were uncovered.
Danish: Der blev fundet kritiske overtrædelser af grundlæggende ICH GCP-standarder og internationalt anerkendte laboratoriestandarder under de bioanalytiske analyser af blodprøverne fra både GOS/001 (1-måneds depotformulering) og GOS/002 (1- og 3-måneders depotformulering).
English: Furthermore, the MAH has adapted the study design.
Danish: Desuden har indehaveren af markedsføringstilladelsen tilpasset undersøgelsens udformning.
English: In spite of the fact that patient safety and product efficacy was always ensured, the MAH decided to clinically reinvestigate the current goserelin 1-month product.
Danish: Til trods for at patientsikkerheden og lægemiddelvirkningen hele tiden var sikker, besluttede indehaveren af markedsføringstilladelsen at foretage en klinisk undersøgelse af den aktuelle 1månedsformulering af goserelin.
English: Based on the totality of data submitted, the CHMP considered that therapeutic equivalence with Zoladex had not been demonstrated and as such the benefit risk ratio for this generic product was considered negative until the MAH can demonstrate therapeutic equivalence with the reference product.
Danish: På baggrund af de samlede indsendte data var CHMP af den opfattelse, at den terapeutiske ækvivalens med Zoladex ikke er påvist, og at benefit/risk-forholdet for dette generiske lægemiddel er negativt, indtil indehaveren af markedsføringstilladelsen kan påvise terapeutisk ækvivalens med referencelægemidlet.
English: The active substance in Dany's BienenWohl is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Danish: Det aktive stof i Dany's BienenWohl er et tilladt stof, der er beskrevet i tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010:
English: The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C.
Danish: Den udendørs temperatur skal ved behandlingen med Dany's BienenWohl være mindst 3 °C.
English: The use of Dany's BienenWohl with the above dosing scheme only applies to hives with vertical frames that can be accessed from the top, as the treatment of bees in other types of hives has not been investigated.
Danish: Anvendelsen af Dany's BienenWohl efter ovennævnte doseringsskema gælder kun for stader med lodrette rammer, som er tilgængelige ovenfra, da behandling af bier i andre typer stader ikke er undersøgt.
English: PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
Danish: D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN PSUR'er skal synkroniseres og indsendes med samme hyppighed som for referenceproduktet.
English: Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Danish: Dany's BienenWohl virker tærende på korrosionsfølsomme dele af biavlsudstyr.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018
Danish: <Dato for første markedsføringstilladelse> <14/06/2018>
English: Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Danish: Dany's BienenWohl må ikke tilføres vandløb, da det kan være farligt for fisk og andre vandlevende organismer.
English: Dany's BienenWohl should not be used when honey supers are present.
Danish: Dany's BienenWohl må ikke anvendes ved tilstedeværelse af honningmagasiner.
English: Mix with Dany's BienenWohl powder as instructed, before use.
Danish: Opblandes med Dany's BienenWohl pulver som anvist, inden brug.
English: Mix with Dany's BienenWohl solution before use.
Danish: Opblandes med Dany's BienenWohl opløsning inden brug.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001-002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/2/18/225/001-002
English: Dany's BienenWohl must only be applied only once in brood-free colonies.
Danish: Dany's BienenWohl må kun anvendes én gang i kolonier uden yngel.
English: EU/2/18/225/002 (750 g solution)
Danish: EU/2/18/225/002 (750 g opløsning)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g solution)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/2/18/225/001 (375 g opløsning)
English: Dany's BienenWohl must only be applied once in brood-free colonies.
Danish: Dany's BienenWohl må kun anvendes i kolonier uden yngel.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl solution for bee-hive dispersion oxalic acid dihydrate
Danish: VETERINÆRLÆGEMIDLETS NAVN Dany's BienenWohl, opløsning til bistadedispersion oxalsyredihydrat
English: ADVICE ON CORRECT ADMINISTRATION The product should be administered using a suitable measuring device with appropriate graduations (e.g. automatic pipette, disposable syringe) onto the bees sitting in seams.
Danish: Produktet påføres ved hjælp en egnet doseringsanordning med passende inddeling (fx en automatisk pipette eller en engangssprøjte) på bierne, der sidder i tavlerne.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose
Danish: VETERINÆRLÆGEMIDLETS NAVN Dany's BienenWohl, pulver til bistadedispersion saccharose
English: Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Danish: Dany's BienenWohl, pulver og opløsning til bistadedispersion, 39,4 mg/ml, til honningbier
English: AUTHORISATION
Danish: ANVENDELSE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
Danish: VETERINÆRLÆGEMIDLETS NAVN Dany's BienenWohl, pulver og opløsning til bistadedispersion, 39,4 mg/ml oxalsyredihydrat
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Danish: VETERINÆRLÆGEMIDLETS NAVN Dany's BienenWohl, pulver og opløsning til bistadedispersion, 39,4 mg/ml, til honningbier