natgillin/translations-raw huggingface dataset:
Crookes Healthcare Limited, Regulatory Department Wellcroft House, Wellcroft Road, Slough, Berkshire SL1 4AQ United Kingdom
Reckitt Benckiser Healthcare (UK) Ltd Regulatory Department Wellcroft House Wellcroft Road Slough, SL1 4AQ United Kingdom
IBUPROFENO ZENTIVA 400 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO ZENTIVA 400 mg comprimidos recubiertos con película EFG
NUROFEN® 200 mg IBUPROFEN
IBUPROFEEN NUROFEN® 200 mg 200 mg Kõvakapsel
Buplex 200mg filmcoated tablets
Ibuprofeen Buplex 200mg filmcoated tablets
Brufen 600mg filmcoated tablets
Ibuprofeen Brufen 600mg filmcoated tablets
BRUFEN TABLETS 400MG
TABLETS 400MG
IBUPROFENO MABO 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO MABO 600 mg comprimidos recubiertos con película EFG
R. da Indústria, 2 - Quinta Grande
Osa Mayor, 4Area B
Ibu KD 400 mg akut Ibuprofen
Ibuprofeen Ibu KD 400 mg akut 400 mg Kaetud tablett
Nurofen-Ibuprofen 200 mg
Ibuprofeen Dismenol Ibuprofen 200 mg
IBUPROFENO PENSA 400 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO PENSA 400 mg comprimidos recubiertos con película EFG
Sweden ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Rootsi ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
IBUPROFENE TEVA 400 mg, comprimé pelliculé
Ibuprofeen IBUPROFENE TEVA 400 mg, comprimé pelliculé
Pfizer Consumer Healthcare Walton Oaks
Pfizer Consumer Healthcare Walton Oaks Dorking Road Tadworth, Surrey KT20 7NS United Kingdom
Ibustar 400 mg filmcoated tablets
Ibuprofeen Ibustar 400 mg filmcoated tablets
Lannacher Heilmittel GmbH Schlossplatz 1
Lannacher Heilmittel GmbH
Dolgit Schmerzdragees
Ibuprofeen Dolgit Schmerzdragees
IBUPROFENO TEVA 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO TEVA 600 mg comprimidos recubiertos con película EFG
Nurofen Express 400 mg meke kapsule
Ibuprofeen Nurofen Rapid Forte 400 mg meke kapsule
Reckitt Benckiser Healthcare International Limited Bath Road 103-105
Rumeenia Reckitt Benckiser Healthcare International Limited
Dolgit 400 mgDragees
Ibuprofeen Dolgit 400 mgDragees
Ibuprofen 400 mg filmom obložene tablete
Ibuprofeen Ibuprofen 400 mg filmom obložene tablete
IBUPROFENO ACOST 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO ACOST 600 mg comprimidos recubiertos con película EFG
Novartis Consumer Health S.P.A.,
Novartis Consumer Health S.P.A., Largo Umberto Boccioni
Ibudolor 400 mg Filmtabletten
Ibuprofeen Ibudolor 400 mg Filmtabletten
Sandoz Pharmaceuticals GmbH Raiffeisenstr.
Saksamaa Sandoz Pharmaceuticals GmbH
IBUPROFENO ACTAVIS 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO ACTAVIS 600 mg comprimidos recubiertos con película EFG
Aspire Pharma Limited 102 High Street GB-GU7 1DS GODALMING, SURREY
Saksamaa Aspire Pharma Limited 102 High Street
Ibacut 200 mg filmsko obložene tablete
Ibuprofeen Ibacut 200 mg filmsko obložene tablete
Ibuprofeno Alter 600 mg Comprimidos Revestidos
Ibuprofeen Ibuprofeno Alter 600 mg Comprimidos
IBUPROFENO PENSA 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO PENSA 600 mg comprimidos recubiertos con película EFG
Ibumetin 400 mg film-coated tablets
Ibuprofeen Ibumetin 400 mg film-coated tablets
400 mg Capsule, soft
CAPSULES, SOFT 400 MG
Buplex 400mg filmcoated tablets
Ibuprofeen Buplex 400mg filmcoated tablets
RUPAN 200 mg
IBUPROFEEN RUPAN 200 mg
Ibudolor 40 mg/ml Suspension zum Einnehmen
Ibuprofeen Brufen 40 mg/ml Suspension zum
Buscofem
Winthrop
Dolgit 600 mgDragees
Ibuprofeen Dolgit 600 mgDragees
IBUPROFENO ONEDOSE 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO ONEDOSE 600 mg comprimidos recubiertos con película EFG
Norway ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Norra ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Genericos Juventus Limited Julian Camarillo, 37 28037 Madrid Spain
Julián Camarillo, 37
Ibuprofeno Odipe
Ibuprofeen SPIDIDOL
IBUPROFENO STADA GENERICOS 400 mg comprimidos recubiertos EFG
Ibuprofeen IBUPROFENO STADAGEN 400 mg comprimidos recubiertos EFG
Ibuprofeno Generis 400 mg Comprimidos
Ibuprofeen Spidifen 400 mg Comprimidos
NUROFEN FORTE 400 mg bevont tabletta
Ibuprofeen NUROFEN FORTE 400 mg bevont tabletta
NUROFEN FORTE EXPRESS
Ibuprofeen Nurofen Forte Express
Nurofen Forte Express
Ibuprofeen NUROFEN FORTE EXPRESS
Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany
96052 Bamberg Germany
Ibuhexal
Ibuprofeen Ibuhexal
Ibumax 400 mg filmcoated tablets
Ibuprofeen Ibumax 400 mg film-coated tablets
Brufen Forte
Ibuprofeen Brufen forte
Brufen forte
Ibuprofeen Brufen Forte
IBUPROFEN ACTAVIS Ibuprofen
Ibuprofeen IBUPROFEN ACTAVIS
DALSY 400 mg comprimidos recubiertos con película
Ibuprofeen DALSY 400 mg comprimidos recubiertos con película
Ibuprofeno Farmoz Ibuprofen
Ibuprofeen PHARMAVIT IBUPROFEN
800 mg Slow-release filmcoated tablet
800 mg Toimeainet aeglaselt vabastav õhukese polümeerikattega tablett
GELOFENO 400 mg comprimidos
400 mg Kihisev tablett
Aktren 400 mgKapseln
Ibuprofeen Aktren 400 mgKapseln
Ibuprofen Rockspring 200 mg effervescent granules
Ibuprofeen Brufen 200 mg effervescent granules
IBUPROFENO ZENTIVA 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO ZENTIVA 600 mg comprimidos recubiertos con película EFG
IBUPROFEN BOEHRINGER INGELHEIM 400 mg lágy kapszula
Ibuprofeen RAPIDOPHEN 400 mg lágy kapszula
Str. Calea Rahovei nr. 266-268 Corp 60, Etaj 2, Sector 5 Bucuresti
corp 63, anexele B-C, stâlpii 3-4, etaj 3, cam.
Guglgasse 17
Heinzelova 70
Ibuprofeno Sandoz Ibuprofen
Ibuprofeen DENTOGEN IBUPROFEN
Ibubel 400 mg filmsko obložene tablete
Ibuprofeen Ibacut 400 mg filmsko obložene tablete
IBUPROFENO CINFA 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO CINFA 600 mg comprimidos recubiertos con película EFG
Nurofen 200 mg Coated Tablets
Ibuprofeen Nurofen 200 mg Coated Tablets
EUDORLIN Migräne Ibuprofen
Ibuprofeen EUDORLIN Extra Ibuprofen
Carretera M-300, Km.
Hispaania MABO FARMA, S.A. Carretera M-300, Km.
Irfen 200 mg Filmtabletten
Ibuprofeen Irfen 200 mg Filmtabletten
NUREFLEX 200 mg, comprimé enrobé
Ibuprofeen NUREFLEX 200 mg, comprimé enrobé
Brufen 400mg filmcoated tablets
Ibuprofeen Brufen 400mg filmcoated tablets
Ibustar 400 mg filmom obložene tablete
Ibuprofeen Ibustar 400 mg filmom obložene tablete
IBUPROFENO OSODENT 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO OSODENT 600 mg comprimidos recubiertos con película EFG
NUROFEN FORTE IBUPROFEN
Ibuprofeen EXTRA STRENGTH IBUPROFEN
Ibuprofen Boehringer Ingelheim 400 mg
Ibuprofeen Ibuprofen Galpharm 400 mg
400 mg Dispersible tablet
400 mg Lahustuv tablett Suukaudne
Smelttabletten 200 mg
Ibuprofeen Nurofen Smelttabletten 200 mg
IBUPROFENO COMBIX 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO COMBIX 600 mg comprimidos recubiertos con película EFG
Butifen 400 mg filmcoated tablets
Ibuprofeen Butifen 400 mg filmcoated tablets
Tabalon 400mg
CAPLETS 400MG
IBUPROFENO CODRAMOL 400 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUKERN 400 mg comprimidos recubiertos con película EFG
Ibuberl 400 mg
Ibuprofeen ibuTAD 400mg
200 mg Dispersible tablet
200 mg Suukaudse suspensiooni pulber
Brufen 400 mg filmsko obložene tablete
Ibuprofeen Brufen 400 mg filmsko obložene tablete
Ibuprofen Perrigo 400 mg Filmtabletten
Ibuprofeen Ibusan 400 mg Filmtabletten
Ibuprofen 200mg Effervescent Granules
Ibuprofeen Brufen 200mg Effervescent
Brufen 400 mg filmcoated tablets
Ibuprofeen Brufen 400 mg filmcoated tablets
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE TABLETS 200 MG/5 MG
HYDROCHLORIDE TABLETS 200 MG/5
IBUTABS 400 mg, comprimé pelliculé
Ibuprofeen BRUFEN 400 mg, comprimé pelliculé
Ibuprofen Actavis 400 mg Filmtabletten
Ibuprofeen SPEDIFEN 400 mg filmtabletta
Ibuprofen lysine 342 mg Effervescent tablet
Ibuprofeen Ibu 342 Lysinat JJ 342 mg Õhukese polümeerikattega tablett
NUROFEN RECOVERY Ibuprofen
Ibuprofeen NUROFEN RECOVERY
IBUFEN 200 mg, comprimé enrobé
Ibuprofeen ALGIFENE 200 mg, comprimé enrobé
Nurofen 200 mg obložene tablete
Ibuprofeen Nurofen 200 mg obložene tablete
IBUPROFEN TABLETS BP 600MG
TABLETS BP 600MG
Nurofen Ultra Express 200 mg capsules, soft
Ibuprofeen Nurofen Express Capsules, Soft
Ibuprofen-Actavis 400 mg Filmtabletten
Ibuprofeen ibuprofen-ct 400 mg Filmtablette
NUROFEN 200MG LIQUICAPS PHARMACY ONLY
Ibuprofeen NUROFEN 200MG LIQUICAPS
Brufen 600 mg filmsko obložene tablete
Ibuprofeen Brufen 600 mg filmsko obložene tablete
WAYMADE
CHEWABLE
DALSY 400 MG GRANULADO EFERVESCENTE
Ibuprofeen DALSY 400 MG GRANULADO
Brufen 40 mg/ml Suspension zum Einnehmen
Erdbeer 40 mg/ml Suspension zum
Horizon Pharma Gmbh Joseph Meyer Strasse 13-15 68167 Mannheim Germany
Horizon Pharma Gmbh Joseph Meyer Strasse
Ibumed 200 mg
GRANULES 200 MG
Bronzactiv Pharma GmbH Carl-von-Linde-Str. 30 85716 Unterschleißheim Germany
85716 Unterschleißheim Germany
Ibuprofen Boehringer Ingelheim 400 mg Weichkapsel
Ibuprofeen Ibuprom Max Sprint 400 mg Pehmekapsel
IBUPROFENO GOIBELA 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUPROFENO GOIBELA 600 mg comprimidos recubiertos con película EFG
EBUFAC TABLETS 400 MG
Ibuprofeen EBUFAC TABLETS 400 MG
NUROFEN 400 mg, comprimé enrobé
Ibuprofeen NUROFEN 400 mg, comprimé enrobé
Dolgit 200 mgDragees
200 mg Kõvakapsel
ToLife - Produtos Farmacêuticos, S.A.
Distrifarma - Companhia de Distribuição Farmacêutica, S.A.
Faspic 600
IBUPROFEEN FASPIC 600
CUPROFEN TABLETS 400MG
Ibuprofeen CUPROFEN TABLETS 400MG
Brufen 200 mg filmcoated tablets
Ibuprofeen Brufen 200 mg filmcoated tablets
FENBID
Granules
Ibuprofeno Abbott
Ibuprofeen Ibufen
GELOFENO 200 mg comprimidos
200 mg Kihisev tablett
Dolgit 400 mgKapseln
400 mg Kõvakapsel
Latvia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Eesti ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
IBUPROFENO STADA GENERICOS 600 mg comprimidos recubiertos EFG
Ibuprofeen IBUPROFENO STADA GENÉRICOS 600 mg comprimidos recubiertos con película EFG
Ibruprofenum 200 mg
Ibuprofeen Extrapan Ibruprofenum 200 mg
Ibuprofen Boehringer Ingelheim
Ibuprofeen Ibuprofen Boehringer
Ibuaktiv 200 mg Ibuprofen lysine 342 mg Effervescent tablet
Ibuaktiv 200 mg 342 mg Kihisev tablett
Epsilon
EFFERVESCENT
Ibuprofen PB 400 mg Ibuprofen
Ibuprofeen Ibuprofen PB 400 mg
Ibuprofen Actavis 600 mg Filmtabletten
Ibuprofeen Esprenit 600mg Filmtabletten
MIG-400
Ibuprofeen MIG-400
Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Island ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Procedure Management and Business Support
Przedsiębiorstwo Produkcji
300 mg Granules for oral suspension
300 mg Suukaudse suspensiooni graanulid
Ibumetin Retard Ibuprofen
Ibuprofeen REMEDICA IBUPROFEN
BRUFEN TABLETS 200MG
TABLETS BP 200MG
Luxembourg Pfizer bv Rivium Westlaan 142
Luksemburg Pfizer bv Rivium Westlaan 142 2909 LD, Capelle a/d Ijssel
NUROFEN 200 mg bevont tabletta
Ibuprofeen NUROFEN 200 mg bevont tabletta
100 mg Capsule, soft
100 mg Pehmekapsel
Johnson and Johnson, S.A. Pº de las 12 Estrellas, 5-7 Campo de las Naciones 28042 Madrid Spain
Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium
Ibuprofen Genericon 400 mg Filmtabletten
Ibuprofeen Irfen 400 mg Filmtabletten
Ibuprofen Rockspring 200 mg šumivé granule
Ibuprofeen Brufedol 200 mg šumivé granule
Ibuprofeno Zentiva Ibuprofen
Ibuprofeen VITABIOTICS IBUPROFEN
Hexal AG
Hugh House
Brufen Forte sirup bez cukru 200 mg/5 ml perorálna suspenzia
Ibuprofeen Brufen Sem Açúcar 40 mg/ml
IBUPROFEN 200 MG FILM-COATED TABLETS
Ibuprofeen Nurofen 200 mg film-coated tablets
Nurofen 200 fastsodium200 mg Coated tablet
Ibuprofeen Nurofen 200 fastsodium200 mg Kaetud tablett
IBUPROFENO ABEX 600 mg comprimidos recubiertos con película EFG
Ibuprofeen IBUKERN 600 mg comprimidos recubiertos con película EFG
RXT
KG
Ibuprom200 mg Coated tablet
Ibuprofeen Ibuprom200 mg Kaetud tablett
Ibumax 400 mg
Ibumyl Rapid 400 mg
ANTARENE 200 mg, comprimé pelliculé
Ibuprofeen ANTARENE 200 mg, comprimé pelliculé
ADVIL 400 mg, comprimé enrobé
Ibuprofeen ADVIL 400 mg, comprimé enrobé
Ibuprofen Polfarmex Ibuprofen
Ibuprofeen MERCURY PHARMS IBUPROFEN
Ibumax
Ibuprofeen IBUMAX
Brufen 400 mg filmom obložene tablete
Ibuprofeen Brufen 400 mg filmom obložene tablete
Berkshire SL6 3UG United Kingdom
Wrexham, LL13 9UF United Kingdom
Ibuprofeno Ciclum Ibuprofen
Ibuprofeen Ibuprom
Estonia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Itaalia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
ABBOTT LABS IBUPROFEN GRANULES 200 MG
Ibuprofeen Ibuprofen Perrigo 200 mg
DALSY 200 mg GRANULADO EFERVESCENTE
Ibuprofeen DALSY 200 mg GRANULADO
Ibuprofen Sandoz Ibuprofen
Ibuprofeen AYRTON SAUNDERS IBUPROFEN
TOMIBU
Taani
Nurofen fasttabs
Ibuprofeen Nurofen fasttabs
Derendorfer Allee 6
Ronda de Valdecarrizo, 6
Togal-Werk AG Kardinal-Faulhaber-Str. 5 80333 München Germany
Luksemburg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany
Ibuprofen sodium 256 mg Tablet
Ibuprofeen NUROFEN EXPRESS 256 MG TABLETS
Dorking Road
Darkes Lane
Eudorlin Ibuprofen 20 mg/ml Suspension zum Einnehmen
Ibuprofeen RATIODOL 20 mg/ ml SUSPENSION
The new study design has been submitted to the German Competent Authority (BfArM) for advice and is currently under review.
Uus uuringuplaan on nõuannete saamiseks esitatud Saksamaa pädevale asutusele (BfArM) ja seda vaadatakse praegu läbi.
Since testosterone levels measured were either below or close to limit of quantitation (0.1 ng/ml) and clearly below the castration level of 0.5 ng/ml clinical efficacy is ensured even if the analytical method is not sufficiently precise.
Kuna mõõdetud testosteroonisisaldus oli kas alla määramispiiri (0,1 ng/ml) või selle lähedal ja selgelt alla kastratsiooni puhul saavutatava sisalduse (0,5 ng/ml), on kliiniline efektiivsus tagatud isegi siis, kui analüütiline meetod ei ole piisavalt täpne.
These included insufficient validation of the bioanalytical methods, deletion of raw data by re-injection of samples, inconsistent manual reintegration of chromatograms, lack of crucial acceptance criteria for analyses and an insufficient quality management by the sponsor.
Nende rikkumiste hulka kuulusid bioanalüütiliste meetodite ebapiisav valideeritus, algandmete kustutamine proovide uuestisüstimise teel, kromatogrammide ebaühtlane manuaalne reintegreerimine, analüüside nõuetekohasuse oluliste näitajate puudumine ja sponsori puudulik kvaliteedijuhtimine.
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.
Vaatamata sellele, et patsientide ohutus ja ravimi efektiivsus olid kogu aeg tagatud, otsustas müügiloa hoidja praegust gosereliini ühekuulist ravimit uuesti kliiniliselt uurida.
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.
Tegemist on LHRH agonistiga (loodusliku luteiniseerivat hormooni vabastava hormooni analoog), mis langetab seerumi testosteroonisisalduse kastratsiooni korral saavutatavale tasemele, pärssides sel viisil hormoonsõltuva eesnäärmekartsinoomi kasvu.
Important aspects such as the difficulty of endogeneous testosterone levels in female blank plasma were only considered in the retrospective validation report with additional testing on either pre-treated or pre-selected matrix.
Olulisi aspekte, näiteks probleemid endogeense testosteroonitaseme määramisel naiste plasma tühiproovis, kajastati ainult retrospektiivses valideerimisaruandes, kus esitati eeltöödeldud või eelvalitud maatriksi lisatestide tulemused.
Overall summary of the scientific evaluation of Novimp 3,6 mg Implantat and associated names (see Annex I)
Ravimi Novimp 3,6 mg Implantat ja sarnaste nimetuste (vt I lisa) teadusliku hindamise üldkokkuvõte
• 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.
• inimravimite komitee arutas direktiivi 2001/83/EÜ artikli 36 alusel tehtud esildist ravimi Novimp 3,6 mg Implantat ja sarnaste nimetuste (vt I lisa) kohta;
Analytical inadequacies would affect comparator and MAH's product in the same way: Since the clinical efficacy was based on a comparison between two products analytical errors would be expected to affect both products in the same way.
Analüütilised puudused mõjutaks võrdlusravimi ja müügiloa hoidja ravimi kasutamisel saadud tulemusi samal moel − kuna kliiniline efektiivsus põhines kahe ravimi võrdlusel, mõjutavad analüütilised vead mõlema ravimi kasutamisel saadud tulemusi eeldatavalt samal moel.
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.
Seetõttu ei kompenseeri ei võrdlev uuringuplaan ega osutatud uuringutulemused õigusnõuete, mille kohaselt tuleb müügiloa taotluse toetuseks esitada hea kliinilise tava põhimõtteid järgivate uuringute tulemused, rikkumist.
Furthermore, the MAH has adapted the study design.
Samuti kohandas müügiloa hoidja uuringuplaani.
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.
Nii GOS/001 (ühekuuline depooravim) kui ka GOS/002 (ühe- ja kolmekuuline depooravim) uuringu vereproovide bioanalüütiliste analüüside teostamisel tehti kindlaks rahvusvahelise ühtlustamiskonverentsi hea kliinilise tava põhinormide ja rahvusvaheliselt tunnustatud laboristandardite olulisi rikkumisi.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018
ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV <Esmase müügiloa väljastamise kuupäev:> <14/06/2018>
The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C.
Välistemperatuur peab Dany's BienenWohliga ravi ajal olema vähemalt 3 °C.
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:
Dany's BienenWohli toimeaine on komisjoni määruse (EL) nr 37/2010 lisa tabelis 1 kirjeldatud lubatud aine.
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.
Dany's BienenWohli eespool toodud annustamisskeem kehtib ainult ülalt ligipääsetavate vertikaalsete kärgedega tarude kohta, sest mesilaste ravi muud tüüpi tarudes ei ole uuritud.
PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
Perioodiliste ohutusaruannete esitamine peab toimuma sünkroonis ja sama sagedusega kui võrdlusravimi korral.
Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Dany's BienenWohl ei tohi sattuda veekogudesse, sest võib olla ohtlik kaladele ja teistele veeorganismidele.
Citric acid monohydrate Glycerol (85%) Water, purified
Sidrunhappe monohüdraat Glütserool (85%) Puhastatud vesi
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001-002
MÜÜGILOA NUMBER (NUMBRID) EU/2/18/225/001-002
EU/2/18/225/002 (750 g solution)
EU/2/18/225/002 (750 g lahus)
Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Dany's BienenWohlil on söövitav toime mesilaste pidamise varustuse korrosioonitundlikele osadele.
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g solution)
MÜÜGILOA NUMBER (NUMBRID) EU/2/18/225/001 (375 g lahus)
Advice on correct administration:
SOOVITUSED ÕIGE MANUSTAMISE OSAS
Dany's BienenWohl should not be used when honey supers are present.
Dany's BienenWohli ei tohi kasutada, kui tarus on meekärjed.
1 ml of mixed bee-hive dispersion contains:
1 ml segatud mesitaru dispersiooni sisaldab Toimeaine
Dany's BienenWohl must only be applied only once in brood-free colonies.
Dany's BienenWohli tohib haudeta peredes kasutada ainult üks kord.
Mix with Dany's BienenWohl solution before use.
Enne kasutamist segage Dany's BienenWohli lahusega.
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl solution for bee-hive dispersion oxalic acid dihydrate
VETERINAARRAVIMI NIMETUS Dany's BienenWohl lahus mesitaru dispersiooni valmistamiseks Oksaalhappe dihüdraat
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose
VETERINAARRAVIMI NIMETUS Dany's BienenWohl pulber mesitaru dispersiooni valmistamiseks sahharoos
AUTHORISATION
Lahus
Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Dany's BienenWohl 39,4 mg/ml mesitaru dispersiooni pulber ja lahus meemesilastele
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
VETERINAARRAVIMI NIMETUS Dany's BienenWohl 39,4 mg/ml mesitaru dispersiooni pulber ja lahus meemesilastele
Sucrose Anise oil Eucalyptus oil
Sahharoos Aniisiõli Eukalüptiõli
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel DURA to Mylan dura GmbH on 21 September 2009.
Euroopa Komisjon andis Clopidogrel DURA müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Mylan dura GmbH 21. septembril 2009.
The standard dose of Clopidogrel DURA is one 75 mg tablet once a day, taken with or without food.
Clopidogrel DURA tavaannus on üks 75 mg tablett üks kord ööpäevas koos toiduga või ilma.
Clopidogrel DURA can be given to the following groups of patients:
Clopidogrel DURAt võib kasutada järgmiste patsiendirühmade korral:
Clopidogrel DURA can be started between seven days and six months after the
Clopidogrel DURA manustamist võib alustada seitsme päeva kuni kuue kuu jooksul pärast insulti;
The Committee recommended that Clopidogrel DURA be given marketing authorisation.
Komitee soovitas anda Clopidogrel DURAle müügiloa.
The full EPAR for Clopidogrel DURA can be found here.
Euroopa avaliku hindamisaruande täisteksti Clopidogrel DURA kohta leiate siit.
Clopidogrel DURA can be started between a few days and 35 days after the attack;
Clopidogrel DURA manustamist võib alustada mõne kuni 35 päeva jooksul pärast infarkti;
Because Clopidogrel DURA is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Et Clopidogrel DURA on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
This means that Clopidogrel DURA is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
See tähendab, et Clopidogrel DURA on sarnane võrdlusravimiga Plavix, millel juba on Euroopa Liidus müügiluba.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel DURA has been shown to have comparable quality and to be bioequivalent to Plavix.
Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud Clopidogrel DURA võrdväärne kvaliteet ja bioekvivalentsus ravimiga Plavix.
Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Seetõttu arvas inimravimite komitee, et nagu ka Plavixi korral, ületab Clopidogrel DURA kasulikkus sellega kaasnevad riskid.
Clopidogrel DURA is a ‘generic medicine'.
Clopidogrel DURA on geneeriline ravim.
Clopidogrel DURA is a medicine that contains the active substance clopidogrel.
Clopidogrel DURA on ravim, mis sisaldab toimeainena klopidogreeli.
Why has Clopidogrel DURA been approved?
Miks Clopidogrel DURA heaks kiideti?
Clopidogrel DURA is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Clopidogrel DURAt kasutatakse aterotrombootiliste nähtude (trombide ehk soonesiseste verehüüvete moodustumisest ja arterite lubjastumisest põhjustatud probleemide) ennetamiseks täiskasvanutel.