natgillin/translations-raw huggingface dataset:
68165 Mannheim Germany 
Theodor Heuss Anlage 68165 Mannheim Germany
Ibuprofen Nurofen Expres 400 mg 
Nurofen Expres 400 mg
Ibuprofen Nurofen 400 orange bruisgranulaat, bruisgranulaat 
Nurofen 400 orange bruisgranulaat, bruisgranulaat 400 mg per sachet
Ibuprofen IBUPROFENO PENSA 400 mg comprimidos recubiertos con película EFG 
IBUPROFENO PENSA 400 mg comprimidos recubiertos con película EFG
Ibuprofen Ibumax 600 mg film-coated tablets 
Ibumax 600 mg filmcoated tablets
IBUPROFEN PADUDEN FORTE 400 mg 
PADUDEN FORTE 400 mg
Ibuprofen Etos Ibuprofen Liquid caps 400 mg, capsules, zacht 
Etos Ibuprofen Liquid caps 400 mg, capsules, zacht
Angelini 
Flarin
Ibuprofen IBUPROFENO TEVA 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO TEVA 600 mg comprimidos recubiertos con película EFG
Ibuprofen Ibuprofen Zentiva 400 mg film-coated tablets 
Ibuprofen Zentiva 400 mg film-coated tablets
Ibuprofen IBUPROFENE TEVA 400 mg, comprimé pelliculé 
IBUPROFENE TEVA 400 mg, comprimé pelliculé
OM Pharma, S.A. R. da Indústria, 2Quinta Grande 2610 - 088 Amadora - Lisboa 
Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal
D90 West First 17 Thane Road Nottingham NG90 
The Boots Company PLC Nottingham Support Office D90 West First 17
Ibuprofen Nurofen Forte 400 mg coated tablets 
Nurofen Forte 400 mg coated tablets
Ibuprofen IBUPROFENO ZENTIVA 400 mg comprimidos recubiertos con película EFG 
IBUPROFENO ZENTIVA 400 mg comprimidos recubiertos con película EFG
Swensweg 5 
Ulica Danica 5
Ibuprofen IBUPROFENO COMBIX 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO PHARMA COMBIX 600 mg comprimidos recubiertos con película EFG
Ibuprofen IbuprofenActavis 400 mg Filmtabletten 
Ibuprofen-Actavis 400 mg Filmtabletten
Ibuprofenlysin Nurofen 400 tablet Female, filmomhulde tabletten 400mg 
Nurofen 400 tablet Female, filmomhulde tabletten 400mg
Ibuprofen Ibacut 200 mg filmsko obložene tablete 
Ibacut 200 mg filmsko obložene tablete
Ibuprofen IBUPROFENO STADAGEN 400 mg comprimidos recubiertos EFG 
IBUPROFENO STADA GENERICOS 400 mg comprimidos recubiertos EFG
Ibuprofen Ibugesic 400 mg film-coated tablets 
Ibugesic 400 mg film-coated tablets
Ibuprofen IBULAR TABLETS 200MG 
HEDEX IBUPROFEN TABLETS 200MG
Den 
MIG
Ibuprofen Nurofen 400 tablet, omhulde tabletten 400 mg 
Nurofen 400 tablet, omhulde tabletten 400 mg
31620 Huarte 
33011 Oviedo
Ibuprofen Ibu-ratiopharm 600 mg 
IBUPROFENRATIOPHARM 200 MG
Luxembourg Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel 
Luxembourg Pfizer bv Rivium Westlaan 142
IBUPROFENO (ARGININA) KERN PHARMA 600 mg 
IBUPROFENO KERN PHARMA 600 mg comprimidos EFG
Ibuprofen IBUPROFENO PENSA 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO PENSA 600 mg comprimidos recubiertos con película EFG
BLANDAS 
FENBID
Pfizer Consumer Healthcare Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS United Kingdom 
Pfizer Consumer Healthcare Walton Oaks
Norge ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Ibuprofen Ibuprofen Actavis 400 mg Filmtabletten 
Ibuprofen Actavis 400 mg Filmtabletten
Ibuprofen ALGIFENE 200 mg, comprimé enrobé 
IBUFEN 200 mg, comprimé enrobé
Winthrop 
Buscofem
Aspar 
SERACTIL
Ibuprofenlysin Ibuprofen Perrigo 400 mg 
WRAFTON LABS IBUPROFEN PERRIGO TABLETS 400 MG
TABLETS 800MG 
BRUFEN RETARD TABLETS 800MG
Ibuprofen Melfen 400mg Film-coated tablets 
Ibuprofen 400mg film-coated tablets
Ingelheim 400 mg 
Ifenin 400mg
TABLETS 
Schmerztabletten
Ibuprofen LIDERFEME 400 mg comprimidos 
LIDERFEME 400 mg comprimidos
Ibuprofen Ibunex 200 mg potahované tablety 
Ibunex 200 mg potahované tablety
Ibuprofen IBUTABS 400 mg, comprimé pelliculé 
IBUTABS 400 mg, comprimé pelliculé
CHEWABLE 
Dolocyl
Ibuprofen Ibuprofeno Generis 
Ibuprofeno Generis Ibuprofen
Ibuprofen Ibu-Hemopharm 400mg 
IBUPROFEN MEPHA 400MG
Ibuprofen Fenpic 
Ibuprofen Hasco
IBUPROFENLY SINAT 
Ibuprom Sinus
Ibuprofen MELFEN 200 mg bevont tabletta 
MELFEN 200 mg bevont tabletta
Lil-Dagover-Ring 7 
Willy-Brandt-Allee 2
Rua D. Cristovão da Gama, 1 - 1º C/D 1400-113 Lisboa Portugal 
Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal
Ibuprofen Ibuprofen ratiopharm 4 % 
Ibuprofen ratiopharm 4 % Sirup für Kinder
Ibuprofen Advil 200mg Tablets 
Advil 200mg Tablets Ibuprofen
Ibuprofen IBUPROFENO ACOST 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO ACOST 600 mg comprimidos recubiertos con película EFG
Ibuprofenlysin Ibuzin 
IBUPROFEN LYSINATE
Ibuprofen Ibuprofeno Generis 600 mg Comprimidos 
Ibuprofeno Generis 600 mg Comprimidos Revestidos
Ibuprofen IbuprofenGrindeks 200 mg film-coated tablets 
Ibuprofen - Grindeks 200 mg film-coated tablets
Nederlandene Healthypharm B.V. 
Healthypharm B.V. Nieuwe Donk 3
Ibuprofen CUPROFEN TABLETS 400MG 
RELONCHEM IBUPROFEN TABLETS 400MG
Ibuprofen Fenopine 400 mg Film-coated Tablets. 
Fenopine 400 mg Film-coated Tablets.
Ibuprofen Brufen Gran 200 mg šumeča zrnca 
Ibuprofen Rockspring 200 mg šumeča zrnca
Ibuprofen IBUMAX 400 mg filmtabletta 
IBUMAX 400 mg filmtabletta
Ibuprofen Ibalgin NEO 400 mg filmsko obložene tablete 
Ibalgin NEO 400 mg filmsko obložene tablete
Ibuprofen IBUPROFENO ONEDOSE 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO ONEDOSE 600 mg comprimidos recubiertos con película EFG
Ibuprofen Fenopine 200 mg Film-coated Tablets. 
Fenopine 200 mg Film-coated Tablets.
Tyskland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Ibuprofenlysin Ibu-Lysin CT 684 mg Overtrukket tablet Oral anvendelse 
Ibuprofen lysine 684 mg Coated tablet
400 mg Pulver til oral opløsning 
400 mg Powder for oral solution
Ibuprofen IBUPROFENO ACTAVIS 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO ACTAVIS 600 mg comprimidos recubiertos con película EFG
Ibuprofen BUSCAFEM 400 MG CAPSULAS 
BUSCAFEM 400 MG CAPSULAS BLANDAS EFG
Ibuprofen Brufen 800 mg prolongedrelease tablets 
Brufen 800 mg prolonged-release tablets
Lagoas Park, 2740 
Lagoas Park, 2740-298 Porto Salvo
Ibuprofen Kifen 
Ibuprofeno Cinfa
Ibuprofen IBUPROFENO STADA 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO STADA 600 mg comprimidos recubiertos con película EFG
IBUPROFEN FASPIC 600 600 mg Granulat til oral opløsning 
Ibuprofen arginine 600 mg Granules for oral solution
TABLETS 400MG 
SERACTIL TABLETS 400MG
Ibuprofen Ibu-Lysin-CT 342 mg 
Ibu-Lysin-CT 342 mg Filmtabletten
Ibuprofen codeinphosph at 
Ibuprofen codeine phosphate
Estland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Estonia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
IBUPROFEN NUROFEN® 200 mg 
Ibumed 200 mg
Ibuprofen IbuprofenGrindeks 400 mg film-coated tablets 
Ibuprofen - Grindeks 400 mg film-coated tablets
Ibuprofen Ibumax 200 mg film-coated tablets 
Ibumax 200 mg filmcoated tablets
Lyndby Denmark 
DK-2800 Kongens Lyndby Denmark
Finchley Road 108 
Chaul End Lane 30
Ibuprofen IBUPROFENO OSODENT 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO OSODENT 600 mg comprimidos recubiertos con película EFG
Ibuprofen Sarixell 400 mg, filmomhulde tabletten 
Ibuprofen Manston 400 mg, filmomhulde tabletten
Litauen ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Lithuania ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
800 mg Filmovertrukket depottablet 
800 mg Film-coated prolongedrelease tablet
Ibuprofen Brufen 400mg film-coated tablets 
Ibuprofen Actavis 400mg Film-Coated Tablets
Ungarn ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Hungary ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Oral suspension Oral anvendelse 
Oral drops, solution Oral use
TABLETS BP 200MG 
CUPROFEN TABLETS BP 200MG
Ibuprofen Ibuprofen EG 400 mg 
Ibuprofen EG 400 mg Ibuprofen
Ibuprofen IBUPROFENO ZENTIVA 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO ZENTIVA 600 mg comprimidos recubiertos con película EFG
683,34 mg Oralt pulver 
Ibuprofen lysine 683,34 mg Oral powder
Revestidos 
Strovolos
2 Park Street Woburn, 
2 Victoria Road Harpenden
Ibuprofen Brufen 400 mg pezsgőgranulátu m 
IBUPROFEN ROCKSPRING 600 mg pezsgőgranulátum
Ibuprofen Abfen 
Ibuprofeno Abbott
Ibuprofen IBUPROFENO CINFA 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO CINFA 600 mg comprimidos recubiertos con película EFG
Ibuprofen NUROFEN 200 mg, comprimé orodispersible 
NUROFENTABS 200 mg, comprimé orodispersible
Italien ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Italy ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Ibuprofen Ibudolor 200 mg Filmtabletten 
Ibudolor 200 mg Filmtabletten
27472 Cuxhaven Germany 
40476 Düsseldorf Germany
Ibuprofen Ibum Forte 
Ibum Forte
Ibuprofen Ibulain 200 mg film-coated tablets 
IBUPROFEN 200 MG FILM-COATED TABLETS
Ibuprofen IBUSTAR 400 mg filmtabletta 
IBUSTAR 400 mg filmtabletta
Ibuprofen Ibumax 400 mg film-coated tablets 
Ibumax 400 mg filmcoated tablets
Ibuprofen Ibupama 
Ibuprofen Mepha
IBUPROFEN NUROFEN FORTE 
NUROFEN FORTE IBUPROFEN
Ibuprofen NUROFEN FORTE 
NUROFEN FORTE Ibuprofen
ALMUS 
Fenpic
Ibuprofen Ibuprofen Actavis 800mg Film-Coated 
Ibuprofen Actavis 800mg Film-Coated Tablets
Sefton Business Park Bootle, Liverpool 
Drayton Fields Industrial Estate, Daventry
Ibuprofen Nurofen Expres 200 mg 
Nurofen Expres 200 mg
Dexibuprofen Seractil 300 mg - Filmtabletten 
Seractil forte 400 mg - Filmtabletten
Ibuprofen IBUKERN 400 mg comprimidos recubiertos con película EFG 
IBUPROFENO ABEX 400 mg comprimidos recubiertos con película EFG
IBUPROFEN IBUPROFEN CIPLA 600 
Ibuprofen AL 600 Ibuprofen
Ibuprofen Nurofen 200mg Effervescent 
Ibuprofen 200mg Effervescent Granules
Ibuprofenlysin Ibu-Lysin CT 342 mg Overtrukket tablet Oral anvendelse 
Ibuprofen lysine 342 mg Coated tablet
Ibuprofen NUROFEN CAPLETS 200MG 
ASPAR IBUPROFEN CAPLETS 200MG
Ibuprofen Anco 600mg Filmtabletten 
Ibuprofen AbZ 600 mg Filmtablette
Zakłady 
Suppository
Ibuprofen Brufen 600 mgFilmtabletten 
Ibuprofen Stada 600 mg Filmtabletten
Ibuprofen RELONCHEM IBUPROFEN 
Ibuprofen Lannacher Ibuprofen
Ibuprofen IBUPROFENO GOIBELA 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO GOIBELA 600 mg comprimidos recubiertos con película EFG
Ibuprofen Ibubel 200 mg filmsko obložene tablete 
Ibubel 200 mg filmsko obložene tablete
MG TABLETS 
Schmelztabletten
Brufen Plus 
Brufen forte
Ibuprofen IBUPROFENO CINFA 100 mg/ 5 ml 
JUNIOR IBUPROFEN SUSPENSION 100MG/5ML
Ibuprofen Ibumetin 400 mg film-coated tablets 
Ibuprofen Mepha 400 mg film-coated tablets
400 mg Brusegranulat 
Brufen 400 mg šumivé granule
Ibuprofen Buplex 200mg film-coated tablets 
Ibuprofen Galpharm 200mg Film-coated Tablets
Ibuprofen Brufen Retard 800 mg 
Brufen Retard 800 mg
Ibuprofen LIBROFEM TABLETS 200MG 
IBULAR TABLETS 200MG
Ibuprofen Ibuprofen PB 400 mg 
Ibuprofen PB 400 mg Ibuprofen
Denk Pharma GmbH & Co. 
Denk Pharma GmbH & Co. KG Prinzregentenstr.
Ibuprofen NORVECTAN 
Ibuprofen LGO
LabialfarmaLaboratório de Produtos Farmacêuticos e 
Labialfarma - Laboratório de Produtos Farmacêuticos e Nutracêuticos, S.A.
Luxembourg CT Arzneimittel GmbH 
Luxembourg CT Arzneimittel GmbH Graf-Arco-Str. 3
Ibuprofen Ibunin 400 mg Filmtabletten 
Ibuprofen Genericon 400 mg Filmtabletten
Polígono 
Ibunin
Ibuprofen Spidifen Limão 400 mg Granulat til oral opløsning 
Ibuprofen lysinate 400 mg Powder for oral suspension
Ibuprofen Ibumetin 200 mg film-coated tablets 
Ibumetin 200 mg film-coated tablets
Ibuprofen Ibuflam 4% 200 mg Oral suspension Oral anvendelse 
IBUFARMALID 200 mg SUSPENSION ORAL
Avenue Einstein 12 1300 Wavre Belgium 
Floridsdorfer Hauptstraße 1 1210 Wien
Ibuprofen TODALGIL 400 mg comprimidos recubiertos con película 
TODALGIL 400 mg comprimidos recubiertos con película
Ibuprofen ibuprofen-ct 400 mg Filmtablette 
Ibuprofen-CT 200 mg Filmtabletten
Ibuprofen Pfeil ZahnschmerzTabletten forte 400mg 
Pfeil ZahnschmerzTabletten forte 400mg Filmtabletten
TAD Pharma GmbH Heinz-Lohmann-Str. 
Dexcel Pharma GmbH Carl-Zeiss-Str. 2
Ibuprofen Íbúfen 
Ibuprofen AFL
Bulgarien Actavis Group PTC ehf 
Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78
Ibuprofen Dolgit 400 
Ibubeta 400
Ibuprofen IBUPROFENO STADAGEN 600 mg comprimidos recubiertos EFG 
IBUPROFENO STADA GENERICOS 600 mg comprimidos recubiertos EFG
Ibuprofen Ibu-Ratiopharm 400 mg Overtrukket tablet Oral anvendelse 
Ibuprofeno Ratiopharm 400 mg Comprimidos Revestidos
Fourrts (UK) Pharmacare Limited Chaul End Lane 30 Luton, Bedfordshire LU4 8EZ 
Luton, Bedfordshire LU4 8EZ United Kingdom
Ibuprofen Brufedol 400 mg šumivý granulát 
Brufen 400 mg šumivý granulát
CAPLETS 400MG 
Tabalon 400mg
Verovškova 57 
Guglgasse 17
Frankrig ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
France ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
INTERPHARMAC EUTIQUE 
ETHYPHARM
Ibuprofen Irfen 200 mg Filmtabletten 
Ibuprofen Heumann 200mg Filmtabletten
Ibuprofen NUROFEN FORTE 400 mg bevont tabletta 
NUROFEN FORTE 400 mg bevont tabletta
Ibuprofen Ibuprofen Galpharm 400 mg 
Ibuprofen Boehringer Ingelheim 400 mg
Ibuprofen Butifen 400 mg film-coated tablets 
Ibumetin 400 mg film-coated tablets
Ibuprofen Neofen 200 mg filmom obložene tablete 
Neofen 200 mg filmom obložene tablete
Ibuprofen SPEDIFEN 200 mg, comprimé 
SPEDIFEN 200 mg, comprimé
Ibuprofen ADVIL 400 mg, comprimé enrobé 
ADVIL 400 mg, comprimé enrobé
512 mg Overtrukket tablet Oral anvendelse 
512 mg Coated tablet
Ibuprofen Ibustar 400 mg film-coated tablets 
Ibustar 400 mg filmcoated tablets
Ibuprofen Esprenit 600mg Filmtabletten 
Ibuprofen dura 600mg Filmtabletten
London NW3 5JJ United Kingdom 
Nottingham NG90 5EF United Kingdom
IBUPROFENE E PSEUDOEFEDRI NA 
IBUPROFENE E PSEUDOEFEDRINA BOEHRINGER INGELHEIM
Ibuprofen UNODOL 400 mg comprimidos recubiertos con película EFG 
IBUPROFENO CODRAMOL 400 mg comprimidos recubiertos con película EFG
Ibuprofen Ibustar 400 mg filmom obložene tablete 
Ibustar 400 mg filmom obložene tablete
Ibuprofen Buskofem 200 mg Kapsel, blød 
Buskofem200 mg Capsule, soft
Ibuprofen ALGOFLEX 200 mg filmtabletta 
ALGOFLEX 200 mg filmtabletta
Ibuprofen IBUKERN 600 mg comprimidos recubiertos con película EFG 
IBUPROFENO ABEX 600 mg comprimidos recubiertos con película EFG
Ibuprofen Ibuprofen-mp 
Ibuprofen-mp 600 Ibuprofen
Ibuprofen Irfen 400 mg Filmtabletten 
Ibuprofen dura 400 mg Filmtabletten
Ibuprofen ALGOFLEX 400 mg filmtabletta 
ALGOFLEX 400 mg filmtabletta
Ibuprofen ANTARENE 200 mg, comprimé pelliculé 
ANTARENE 200 mg, comprimé pelliculé
EFERVESCENTE 
Buskofem
Nederlandene Wrafton Laboratories Limited 
Zanza Laboratories (Holdings) Limited
Ibuprofen WAYMADE IBUPROFEN 
Ibuprofen Liderfarm Ibuprofen
Swensweg 5Haarlem 
Pharmachemie B.V. Swensweg 5 - Haarlem PO Box 552
Ibuprofen IBUPROFENRATIOPHARM 
Ibu-Ratiopharm Ibuprofen
Ibuprofen Brufen 600 
Brufen Forte 600 Ibuprofen
Ibuprofen BRUFEN 400 mg, comprimé pelliculé 
IBUPROFENE FARMALIDER 400 mg, comprimé pelliculé
Ibuprofen Ibunin 200 mg Filmtabletten 
Dismenol Ibuprofen 200 mg Filmtabletten
Ibuprofen Ibacut 400 mg filmsko obložene tablete 
Ibacut 400 mg filmsko obložene tablete
256 mg Overtrukket tablet Oral anvendelse 
256 mg Coated tablet
40 MG/ML 
MIG 40 mg/ ml
Det nye undersøgelsesdesign er indsendt til den kompetente tyske myndighed (BfArM) med henblik på vejledning og gennemgås i øjeblikket. 
The new study design has been submitted to the German Competent Authority (BfArM) for advice and is currently under review.
• testosteronniveauer under kastrationsniveau for begge lægemidler 
• testosterone levels below castration for both products.
Samlet resumé af den videnskabelige vurdering af Novimp 3,6 mg implantat og relaterede navne (se bilag I) 
Overall summary of the scientific evaluation of Novimp 3,6 mg Implantat and associated names (see Annex I)
Det er en LHRH-agonist (analog af det naturlige luteiniserende hormonfrigivende hormon) og supprimerer serumtestosteron til kastrationsniveau for at hæmme væksten af hormonafhængigt prostatakarcinom. 
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.
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. 
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.
• 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. 
• 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.
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. 
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.
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). 
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.
Desuden har indehaveren af markedsføringstilladelsen tilpasset undersøgelsens udformning. 
Furthermore, the MAH has adapted the study design.
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. 
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.
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. 
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.
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: 
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:
Den udendørs temperatur skal ved behandlingen med Dany's BienenWohl være mindst 3 °C. 
The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C.
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. 
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.
D. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN PSUR'er skal synkroniseres og indsendes med samme hyppighed som for referenceproduktet. 
PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
Dany's BienenWohl virker tærende på korrosionsfølsomme dele af biavlsudstyr. 
Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
<Dato for første markedsføringstilladelse> <14/06/2018> 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018
Dany's BienenWohl må ikke tilføres vandløb, da det kan være farligt for fisk og andre vandlevende organismer. 
Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Dany's BienenWohl må ikke anvendes ved tilstedeværelse af honningmagasiner. 
Dany's BienenWohl should not be used when honey supers are present.
Opblandes med Dany's BienenWohl pulver som anvist, inden brug. 
Mix with Dany's BienenWohl powder as instructed, before use.
Opblandes med Dany's BienenWohl opløsning inden brug. 
Mix with Dany's BienenWohl solution before use.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/2/18/225/001-002 
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001-002
Dany's BienenWohl må kun anvendes én gang i kolonier uden yngel. 
Dany's BienenWohl must only be applied only once in brood-free colonies.
EU/2/18/225/002 (750 g opløsning) 
EU/2/18/225/002 (750 g solution)
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/2/18/225/001 (375 g opløsning) 
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g solution)
Dany's BienenWohl må kun anvendes i kolonier uden yngel. 
Dany's BienenWohl must only be applied once in brood-free colonies.
VETERINÆRLÆGEMIDLETS NAVN Dany's BienenWohl, opløsning til bistadedispersion oxalsyredihydrat 
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl solution for bee-hive dispersion oxalic acid dihydrate
Produktet påføres ved hjælp en egnet doseringsanordning med passende inddeling (fx en automatisk pipette eller en engangssprøjte) på bierne, der sidder i tavlerne. 
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.
VETERINÆRLÆGEMIDLETS NAVN Dany's BienenWohl, pulver til bistadedispersion saccharose 
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose
Dany's BienenWohl, pulver og opløsning til bistadedispersion, 39,4 mg/ml, til honningbier 
Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
ANVENDELSE 
AUTHORISATION
VETERINÆRLÆGEMIDLETS NAVN Dany's BienenWohl, pulver og opløsning til bistadedispersion, 39,4 mg/ml oxalsyredihydrat 
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
VETERINÆRLÆGEMIDLETS NAVN Dany's BienenWohl, pulver og opløsning til bistadedispersion, 39,4 mg/ml, til honningbier 
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel DURA til Mylan dura GmbH den 21. september 2009. 
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel DURA to Mylan dura GmbH on 21 September 2009.
Standarddosis af Clopidogrel DURA er en 75 mg tablet en gang dagligt med eller uden et måltid. 
The standard dose of Clopidogrel DURA is one 75 mg tablet once a day, taken with or without food.
Hvilken fordel og risiko er der forbundet med Clopidogrel DURA? 
What are the benefit and risk of Clopidogrel DURA?
Den fuldstændige EPAR for Clopidogrel DURA findes her. 
The full EPAR for Clopidogrel DURA can be found here.
Det betyder, at Clopidogrel DURA er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union, og som hedder Plavix. 
This means that Clopidogrel DURA is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Clopidogrel DURA anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning). 
Clopidogrel DURA is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel DURA. 
The Committee recommended that Clopidogrel DURA be given marketing authorisation.