FrancophonIA/ELRC3.0 huggingface dataset:
English: IBUPROFENE TEVA 400 mg, comprimé pelliculé
Latvian: Ibuprofēns IBUPROFENE TEVA 400 mg, comprimé pelliculé
English: Ibuprofen 400 mg filmom obložene tablete
Latvian: Ibuprofēns Ibuprofen 400 mg filmom obložene tablete
English: Nurofen Express 200 mg meke kapsule
Latvian: Ibuprofēns Nurofen Rapid 200 mg meke kapsule
English: GELOFENO 200 mg comprimidos
Latvian: Ibuprofēns GELOFENO 200 mg comprimidos
English: NEOBRUFEN 600 mg comprimidos recubiertos con película EFG
Latvian: JUVENTUS 600 mg comprimidos recubiertos con película EFG
English: Rockspring Healthcare Limited 38/40 Chamberlayne Road London NW10 3JE United Kingdom
Latvian: Galpharm Healthcare Limited Hugh House Upper Cliffe Road Barnsley, South Yorkshire
English: IBUPROFENO ZENTIVA 400 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO ZENTIVA 400 mg comprimidos recubiertos con película EFG
English: IBUPROFENO PENSA 400 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO PENSA 400 mg comprimidos recubiertos con película EFG
English: IBUPROFENO FARMALTER 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO FARMALTER 600 mg comprimidos recubiertos con película EFG
English: Íbúfen
Latvian: Hoofddorp
English: Nurofen 200 mg obložene tablete
Latvian: Ibuprofēns Nurofen 200 mg obložene tablete
English: SPEDIFEN 400 mg, comprimé pelliculé
Latvian: 400 mg, comprimé pelliculé
English: Brufen 20 mg/ml oral suspension
Latvian: Ibuprofēns Brufen 20 mg/ml oral suspension
English: Ibuprofen Pfleger 400 mg Filmtabletten
Latvian: Ibuprofēns SPIDIFEN 400 mg Filmtabletten
English: IbuPhar 600 mg filmom obložene tablete
Latvian: Ibuprofēns IbuPhar 600 mg filmom obložene tablete
English: Abbott Laboratories Ellas ABEE Agiou Dimitriou 63
Latvian: Laboratories Ellas ABEE
English: Ibuprofen 200mg Effervescent Granules
Latvian: Ibuprofēns Brufen 200mg Effervescent
English: Nurofen 400 tablet, omhulde tabletten 400 mg
Latvian: Ibuprofēns Nurofen 400 tablet, omhulde tabletten 400 mg
English: Ibuprofen EG 400 mg Ibuprofen
Latvian: Ibuprofēns Ibuprofen EG 400 mg
English: Etos Ibuprofen Liquid caps 400 mg, capsules, zacht
Latvian: Ibuprofēns Etos Ibuprofen Liquid caps 400 mg, capsules, zacht
English: IBUPROFENO TEVA 400 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO TEVA 400 mg comprimidos recubiertos con película EFG
English: Smelttabletten 200 mg
Latvian: Ibuprofēns Nurofen Smelttabletten 200 mg
English: Wrafton, Braunton Devon EX33 2DL United Kingdom
Latvian: Exeter Road Wrafton Braunton Devon
English: IBUPROFENO CINFA 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO CINFA 600 mg comprimidos recubiertos con película EFG
English: Ibuprofeno Farmoz Ibuprofen
Latvian: Ibuprofēns PHARMAVIT IBUPROFEN
English: APOTEX ESPAÑA, S.L.
Latvian: Aurovitas Spain, S.A.U.
English: Healthypharm B.V. Nieuwe Donk 3
Latvian: Nīderlande Healthypharm B.V.
English: ADVIL RAPID
Latvian: Ibuprofēns ADVIL RAPID
English: Advil Rapid
Latvian: Ibuprofēns Advil Rapid
English: IBUPROFENO ALMUS 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO ALMUS 600 mg comprimidos recubiertos con película EFG
English: Ibubel 400 mg filmsko obložene tablete
Latvian: Ibuprofēns Ibubel 400 mg filmsko obložene tablete
English: Zweigniederlassung Wick Pharma
Latvian: Lielbritānija Horizon Pharma Gmbh
English: Ibumax Forte 600 mg Ibuprofen
Latvian: Ibuprofēns Ibumax Forte 600 mg
English: BRUFEN TABLETS 400MG
Latvian: TABLETS 400MG
English: MIG
Latvian: Leur
English: IBUPROFENO LIDERFARM 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO LIDERFARM 600 mg comprimidos recubiertos con película EFG
English: Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany
Latvian: 96052 Bamberg Germany
English: Ibuprofen-Actavis 400 mg Filmtabletten
Latvian: Ibuprofēns ibuprofen-ct 400 mg Filmtablette
English: Ibuprofeno Generis 400 mg Comprimidos
Latvian: Ibuprofēns Spidifen 400 mg Comprimidos
English: ANTARENE 200 mg, comprimé pelliculé
Latvian: Ibuprofēns ANTARENE 200 mg, comprimé pelliculé
English: IBUMAX
Latvian: Ibuprofēns IBUMAX
English: Nurofen-Ibuprofen 200 mg
Latvian: Ibuprofēns Dismenol Ibuprofen 200 mg
English: IBUPROFENO ACTAVIS 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO ACTAVIS 600 mg comprimidos recubiertos con película EFG
English: Idyl Ibuprofen Liquid Caps 400 mg, capsules, zacht
Latvian: Ibuprofēns Idyl Ibuprofen Liquid Caps 400 mg, capsules, zacht
English: IBUTABS 400 mg, comprimé pelliculé
Latvian: Ibuprofēns IBUTABS 400 mg, comprimé pelliculé
English: Buprophar
Latvian: Bucureşti
English: LACER, S.A.
Latvian: Laboratories, S.A.
English: NEOBRUFEN 400 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns NEOBRUFEN 400 mg comprimidos recubiertos con película EFG
English: G. M. Dimitrov Blvd Sofia, 1172
Latvian: 1 G. M. Dimitrov Blvd
English: Butifen 400 mg filmcoated tablets
Latvian: Ibuprofēns Butifen 400 mg filmcoated tablets
English: Flarin
Latvian: Angelini
English: Brufen 600mg filmcoated tablets
Latvian: Ibuprofēns Brufen 600mg filmcoated tablets
English: Nurofen 200 mg Coated Tablets
Latvian: Ibuprofēns Nurofen 200 mg Coated Tablets
English: Ibudolor 400 mg Filmtabletten
Latvian: Ibuprofēns Ibudolor 400 mg Filmtabletten
English: Buskofem
Latvian: EFFERVESCENT
English: ANTARENE 400 mg, comprimé pelliculé
Latvian: Ibuprofēns ANTARENE 400 mg, comprimé pelliculé
English: IBUPROFENO MABO 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO MABO 600 mg comprimidos recubiertos con película EFG
English: Dolofort 400 mgFilmtabletten
Latvian: Ibuprofēns Dolofort 400 mgFilmtabletten
English: IBUPROFENO PENSA 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO PENSA 600 mg comprimidos recubiertos con película EFG
English: Ibumax 400 mg filmcoated tablets
Latvian: Ibuprofēns Ibumax 400 mg film-coated tablets
English: Ibustar 400 mg filmom obložene tablete
Latvian: Ibuprofēns Ibustar 400 mg filmom obložene tablete
English: EXPANFEN 200 mg, comprimé enrobé
Latvian: Ibuprofēns EXPANFEN 200 mg, comprimé enrobé
English: Ibuprofen Lannacher Ibuprofen
Latvian: Ibuprofēns RELONCHEM IBUPROFEN
English: IBUPROFENO STADA GENERICOS 400 mg comprimidos recubiertos EFG
Latvian: Ibuprofēns IBUPROFENO STADAGEN 400 mg comprimidos recubiertos EFG
English: Ibuprofeno Abbott
Latvian: Ibuprofēns Butifen
English: Ibu 600 - 1 A Pharma Ibuprofen
Latvian: Ibuprofēns Ibu 600 - 1 A Pharma
English: IBUPROFENO ACOST 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO ACOST 600 mg comprimidos recubiertos con película EFG
English: Ibuprofeno Sandoz Ibuprofen
Latvian: Ibuprofēns DENTOGEN IBUPROFEN
English: Kruidvat Ibuprofen Liquid Caps 400 mg, capsules, zacht
Latvian: Ibuprofēns Kruidvat Ibuprofen Liquid Caps 400 mg, capsules, zacht
English: IBUPROFENO ZENTIVA 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO ZENTIVA 600 mg comprimidos recubiertos con película EFG
English: Ibuprofen phenylephrine hydrochloride
Latvian: Ibuprofēns pseidoefedrī na hidrohlorīds
English: 2132 WT Hoofddorp The Netherlands
Latvian: 2132 WT
English: Ibalgin 400 mg filmom obložene tablete
Latvian: Ibuprofēns Ibalgin 400 mg filmom obložene tablete
English: Brufen 400 mg filmsko obložene tablete
Latvian: Ibuprofēns Brufen 400 mg filmsko obložene tablete
English: 81479 München Germany
Latvian: Herterichstr. 1 - 3 81479 München Germany
English: IBUPROFEN TABLETS BP 600MG
Latvian: TABLETS BP 600MG
English: Nurofen fasttabs
Latvian: Ibuprofēns Nurofen fasttabs
English: Sulzbacher Str. 40
Latvian: Binger Str. 148
English: Archimedesweg 2 2333 CN Leiden The Netherlands
Latvian: Darwinweb, 20 2333-CR Leiden Netherlands
English: CUPROFEN TABLETS 400MG
Latvian: Ibuprofēns CUPROFEN TABLETS 400MG
English: NG2 3AA
Latvian: KT10 9NW
English: IBUPROFENO TEVA 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO TEVA 600 mg comprimidos recubiertos con película EFG
English: Roscommon,
Latvian: Keyworth,
English: NUROFEN 200MG LIQUICAPS PHARMACY ONLY
Latvian: Ibuprofēns NUROFEN 200MG LIQUICAPS
English: IBUPROFENO STADA 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO STADA 600 mg comprimidos recubiertos con película EFG
English: Brufen 400
Latvian: Ibuprofēns Brufen 400
English: IBUPROFENO COMBIX 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO COMBIX 600 mg comprimidos recubiertos con película EFG
English: IBUPROFEN TABLETS 200MG
Latvian: Ibuprofēns NUROFEN TABLETS 200MG
English: Brausegranulat
Latvian: Granulat
English: Boehringer Ingelheim International GmbH Binger Str. 148 - 173 55216 Ingelheim Germany
Latvian: Binger Straße 173 55216 Ingelheim am Rhein Germany
English: NUROFEN
Latvian: Hennig
English: IBUPROFENO ONEDOSE 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO ONEDOSE 600 mg comprimidos recubiertos con película EFG
English: Ibuprofeno Odipe
Latvian: Ibuprofēns SPIDIDOL
English: DADOSEL 20 mg/ml SUSPENSIÓN ORAL
Latvian: Ibuprofēns DADOSEL 20 mg/ml SUSPENSIÓN ORAL
English: Nolofene
Latvian: Abrunheira
English: Ibu KD 400 mg akut Ibuprofen
Latvian: Ibuprofēns Ibu KD 400 mg akut 400 mg
English: 20139 Milano
Latvian: Via Lorenzini, 8 20139 Milano Italy
English: Ibuprofen Rockspring 200 mg effervescent granules
Latvian: Ibuprofēns Brufen 200 mg effervescent granules
English: Ibacut 400 mg filmsko obložene tablete
Latvian: Ibuprofēns Ibacut 400 mg filmsko obložene tablete
English: CUFEN-EF
Latvian: Fair-Med
English: Ibruprofenum 200 mg
Latvian: Ibuprofēns Extrapan Ibruprofenum 200 mg
English: Nurofen Ultra Express 200 mg capsules, soft
Latvian: Ibuprofēns Nurofen Express Capsules, Soft
English: Ibuprofen Boehringer Ingelheim 400 mg Weichkapsel
Latvian: Ingelheim 400 mg Weichkapsel
English: Abbott B.V
Latvian: APOTEX EUROPE B.V
English: MCNeil Products Limited Johnson & Johnson Ltd UK Regulatory Department Foundation Park Roxborough
Latvian: Foundation Park Roxborough
English: INTRALGIS 200 mg, comprimé pelliculé
Latvian: Ibuprofēns INTRALGIS 200 mg, comprimé pelliculé
English: Spidifen
Latvian: Poligono
English: IBUPROFENO GOIBELA 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO GOIBELA 600 mg comprimidos recubiertos con película EFG
English: Ibuprofen Actavis 400 mg Filmtabletten
Latvian: Ibuprofēns SPEDIFEN 400 mg filmtabletta
English: ABBOTT LABS IBUPROFEN GRANULES 600 MG
Latvian: Ibuprofēns Ibuprofen Genericon 600 mg
English: IBUPROFEN ROCKSPRING 600 mg
Latvian: Ibuprofēns Ibuprofen Lannacher 600 mg
English: Aktren forte
Latvian: Ibuprofēns Aktren forte
English: Brufen forte
Latvian: Ibuprofēns Brufen Forte
English: Brufen Forte
Latvian: Ibuprofēns Brufen forte
English: Ibuprofen "Orifarm" Ibuprofen
Latvian: Ibuprofēns Ibuprofen "Orifarm" 600 mg
English: Ibu 800 - 1 A Pharma Ibuprofen
Latvian: Ibuprofēns Ibu 800 - 1 A Pharma
English: Gyno-Neuralgin
Latvian: Cluj-Napoca Romania
English: Ibudolor 40 mg/ml Suspension zum Einnehmen
Latvian: Ibuprofēns Ibudolor 40 mg/ml Suspension zum
English: San Pablo, 27 Coslada (Madrid), 28823 Spain
Latvian: C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain
English: Spalt Kopfschmerz Ibuprofen
Latvian: Ibuprofēns SOLPADEINE MIGRAINE
English: EUDORLIN Migräne Ibuprofen
Latvian: Ibuprofēns CHELONIA HEALTHCARE IBUPROFEN
English: Slovak Republic
Latvian: Slovākija Dr.
English: CRIFENE 400 mg, comprimé pelliculé
Latvian: Ibuprofēns CRIFENE 400 mg, comprimé pelliculé
English: FENBID
Latvian: Granules
English: Alindrin
Latvian: Danderyd
English: Dolocyl
Latvian: CHEWABLE
English: 1033 SB Amsterdam The Netherlands
Latvian: 1033 SB
English: Brufen 600 mg filmom obložene tablete
Latvian: Ibuprofēns Brufen 600 mg filmom obložene tablete
English: ADVILMED 400 mg, comprimé enrobé
Latvian: Ibuprofēns ADVILMED 400 mg, comprimé enrobé
English: Brufen 200 mg filmcoated tablets
Latvian: Ibuprofēns Brufen 200 mg filmcoated tablets
English: Dolgit
Latvian: Mureş
English: Brufen Forte sirup bez cukru 200 mg/5 ml perorálna suspenzia
Latvian: Ibuprofēns Brufen Sem Açúcar 40 mg/ml
English: Julián Camarillo, 37 Madrid, 28037
Latvian: Mateo Inurria, 30 28036 Madrid Spain
English: Fenpic
Latvian: ALMUS
English: Ibumed 200 mg
Latvian: Ibuprofēns Ibumed 200 mg 200 mg
English: IBUPROFENO CODRAMOL 400 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUKERN 400 mg comprimidos recubiertos con película EFG
English: IBUPROFENO OSODENT 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO OSODENT 600 mg comprimidos recubiertos con película EFG
English: Brufen 400mg filmcoated tablets
Latvian: Ibuprofēns Brufen 400mg filmcoated tablets
English: BRUFEN TABLETS 200MG
Latvian: TABLETS BP 200MG
English: Ibuberl 400 mg
Latvian: Ibuprofēns Ibudolor 400 mg 400 mg
English: IBUPROFEN TABLETS 400MG
Latvian: Ibuprofēns BRUFEN TABLETS 400MG
English: Esprenit 600mg Filmtabletten
Latvian: Ibuprofēns Esprenit 600mg Filmtabletten
English: Eudorlin Ibuprofen 20 mg/ml Suspension zum Einnehmen
Latvian: Ibuprofēns RATIODOL 20 mg/ ml SUSPENSION
English: Ibuprofen PB 400 mg Ibuprofen
Latvian: Ibuprofēns Ibuprofen PB 400 mg
English: Ibuprofen Sandoz Ibuprofen
Latvian: Ibuprofēns AYRTON SAUNDERS IBUPROFEN
English: Nurofen STOPCOLD Ibuprofen pseudoephedrine
Latvian: Ibuprofēns Ibuprofen Heumann Schmerztabletten
English: MIGRAFEN TABLETS 200MG
Latvian: Ibuprofēns MIGRAFEN TABLETS 200MG
English: Brufen 400 mg šumivé granule
Latvian: Ibuprofēns Brufedol 400 mg umivé granule
English: Brufen 400 mg filmcoated tablets
Latvian: Ibuprofēns Brufen 400 mg filmcoated tablets
English: Buscofem
Latvian: Winthrop
English: PIREXIN 20 mg/ml SUSPENSION ORAL
Latvian: Ibuprofēns PIREXIN 40 mg/ml SUSPENSION ORAL
English: Ibuprofen Boehringer Ingelheim 400 mg
Latvian: Ibuprofēns Ibuprofen Lannacher 400 mg
English: Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78
Latvian: Bulgārija Actavis Group PTC ehf
English: Ibuprofen pseudoephedrine hydrochloride
Latvian: Ibuprofēns, pseidoefedrī na hidrohlorīds
English: Ibumetin Retard Ibuprofen
Latvian: Ibuprofēns REMEDICA IBUPROFEN
English: Strovolos
Latvian: Revestidos
English: Brufen 600
Latvian: Ibuprofēns Brufen 600
English: Teva Denmark A/S Parallelvej 10-12
Latvian: Teva Denmark A/S Parallelvej 10-12 DK-2800 Kongens Lyndby
English: WICK DayMed Duo 200 mg/30 mg Filmtabletten
Latvian: Ibuprofēns WICK DayMed Duo 200 mg/30 mg
English: Relonchem Limited Cheshire House Gorsey Lane Widnes WA8 0RP United Kingdom
Latvian: Lielbritānija Relonchem Limited Cheshire House
English: DOLOFAST
Latvian: Taguspark
English: Tabalon 400mg
Latvian: CAPLETS 400MG
English: ABBOTT LABS IBUPROFEN GRANULES 200 MG
Latvian: Ibuprofēns Ibuprofen Aflofarm 200 mg
English: Brufen 400 mg filmom obložene tablete
Latvian: Ibuprofēns Brufen 400 mg filmom obložene tablete
English: Ibuprofen Rockspring 600 mg šumeča zrnca
Latvian: Ibuprofēns Brufen 600 mg šumeča zrnca
English: IBUPROFENO STADA GENERICOS 600 mg comprimidos recubiertos EFG
Latvian: Ibuprofēns IBUPROFENO STADAGEN 600 mg comprimidos recubiertos EFG
English: Irfen 200 mg Filmtabletten
Latvian: Ibuprofēns Irfen 200 mg Filmtabletten
English: Luxembourg CT Arzneimittel GmbH Graf-Arco-Str. 3
Latvian: AbZ-Pharma GmbH Graf-Arco-Str.
English: PFIZER HOLDING FRANCE 23-25, avenue du Docteur Lannelongue
Latvian: 23-25, avenue du Docteur
English: Ibruprofenum 400 mg
Latvian: IBUPROFĒNS REUPROFEN 400 mg 400 mg
English: Ibuprofen Polfarmex Ibuprofen
Latvian: Ibuprofēns MERCURY PHARMS IBUPROFEN
English: Ibu 400 - 1 A Pharma Ibuprofen
Latvian: Ibuprofēns Ibu 400 - 1 A Pharma
English: IBUPROFENO GENÉRICOS JUVENTUS 600 mg comprimidos recubiertos con película EFG
Latvian: Ibuprofēns IBUPROFENO STADA GENÉRICOS 600 mg comprimidos recubiertos con película EFG
English: MERCK MEDICATION FAMILIALE 37, rue Saint-Romain 69379 Lyon Cedex 08
Latvian: 69379 Lyon Cedex
English: Derendorfer Allee 6
Latvian: Hertfordshire HP4
English: Ethypharm Ibuprofen Sparklets 200mg
Latvian: Ibuprofēns Ibuprofen Perrigo 200 mg
English: Ibusan 400 mg Filmtabletten
Latvian: Ibuprofēns Ibusan 400 mg Filmtabletten
English: IBUPROFEN TABLETS 200 MG
Latvian: Ibuprofēns Advil 200mg Tablets 200 mg
English: Laboratorio de Aplicaciones Farmacodinamicas, S.A. C/ Grassot, 16
Latvian: C/ Grassot, 16
English: S.C. Sandoz S.R.L.
Latvian: Sandoz S.R.L. Str. Livezeni, Nr.
English: 2132 JD HOOFDDORP The Netherlands
Latvian: 2132 JD
English: Denk Pharma GmbH & Co. KG Prinzregentenstr.
Latvian: Denk Pharma GmbH & Co.
English: Wrafton Laboratories Limited Trading as Perrigo New Lane
Latvian: Nīderlande Wrafton Laboratories Limited
English: 400 mg Tablet
Latvian: TABLETS 400 MG
English: LABORATORI ALTER S.R.L.
Latvian: LABORATORIOS ALTER, S.A.
English: Furthermore, the MAH has adapted the study design.
Latvian: Turklāt reģistrācijas apliecības īpašnieks pielāgoja pētījuma plānojumu.
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.
Latvian: Tas ir LHRH agonists (dabīgā luteinizējošā hormona atbrīvotājhormona analogs) un pazemina testosterona līmeni serumā līdz kastrācijas līmenim, lai nomāktu hormonatkarīgas prostatas karcinomas augšanu.
English: The new study design has been submitted to the German Competent Authority (BfArM) for advice and is currently under review.
Latvian: Jauno pētījuma plānojumu iesniedza Vācijas Zāļu aģentūrai (BfArM), lai tā varētu sniegt konsultāciju, un tas pašlaik tiek pārskatīts.
English: Overall summary of the scientific evaluation of Novimp 3,6 mg Implantat and associated names (see Annex I)
Latvian: Novimp 3,6 mg implanta un sinonīmisko nosaukumu zāļu (skatīt pielikumu I) zinātniskā novērtējuma vispārējs kopsavilkums
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.
Latvian: Tādēļ ne salīdzinošā pētījuma plānojums, ne pētījuma citētie rezultāti nevar kompensēt likumdošanas prasību pārkāpumus, lai iesniegtu LKP atbilstošus klīniskos pētījumus reģistrācijas pieteikuma atbalstam.
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.
Latvian: • Komiteja ņēma vērā pārvērtēšanas procedūru, kas ierosināta saskaņā ar Direktīvas 2001/83/EK 36. pantu Novimp 3,6 mg implanta un sinonīmisku nosaukumu zālēm, kas uzskaitītas I pielikumā.
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.
Latvian: Neraugoties uz faktu, ka pacienta drošums un preparāta efektivitāte vienmēr tika nodrošināta, reģistrācijas apliecības īpašnieks nolēma klīniski vēlreiz izpētīt pašlaik pieejamo goserelīna preparātu ar vienu mēnesi ilgu iedarbību.
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.
Latvian: Ņemot vērā iesniegto datu pilnīgumu, CHMP uzskatīja, ka terapeitiskā līdzvērtība ar Zoladex nav pierādīta, un līdz ar to šī ģenēriskā preparāta ieguvuma un riska attiecība uzskatāma par negatīvu, līdz reģistrācijas apliecības īpašnieks var pierādīt terapeitisko līdzvērtību ar atsauces zālēm.
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.
Latvian: Kritiskus ICH LKP pamatstandartu un starptautiski pieņemto laboratorijas standartu pārkāpumus GOS/001 (ar viena mēneša depo preparātu) un GOS/002 (ar viena un trīs mēnešu depo preparātiem veiktos) pētījumos asins paraugu bioanalītisko analīžu laikā nekonstatēja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018
Latvian: REĢISTRĀCIJAS/PĀRREĢISTRĀCIJAS DATUMS <Pirmās reģistrācijas datums:> <14/06/2018>
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:
Latvian: MAKSIMĀLI PIEĻAUJAMO ATLIEKU DAUDZUMS (MRL) Veterināro zāļu Dany's BienenWohl aktīvā viela ir iekļauta atļauto vielu sarakstā, kas noteikts Komisijas Regulas (EK) Nr. 37/2010 pielikuma 1. tabulā:
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.
Latvian: Dany's BienenWohl lietošana ar iepriekš minēto dozēšanas shēmu ir attiecināma uz stropiem ar vertikāliem rāmjiem, kuriem var piekļūt no augšpuses, jo nav pētīta bišu ārstēšana citu veidu stropos.
English: The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C.
Latvian: Lietojot Dany's BienenWohl, āra temperatūrai ir jābūt vismaz 3 °C.
English: Dany's BienenWohl should not be used when honey supers are present.
Latvian: Dany's BienenWohl nedrīkst lietot, ja ir ievietotas medus kāres.
English: Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Latvian: Dany's BienenWohl nedrīkst nonākt ūdens tilpēs, jo tas var apdraudēt zivis un citus ūdenī dzīvojošus organismus.
English: PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
Latvian: D. CITI REĢISTRĀCIJAS NOSACĪJUMI UN PRASĪBAS Periodiskie atjaunināmie drošuma ziņojumi (PSUR) ir jāsinhronizē un jāiesniedz tikpat bieži kā par atsauces zālēm.
English: The final bee-hive dispersion should be a colourless, clear to slightly turbid dispersion.
Latvian: Gatavās bišu stropa dispersijai ir jābūt bezkrāsainai, dzidrai līdz nedaudz duļķainai dispersijai.
English: Mix with Dany's BienenWohl solution before use.
Latvian: Pirms lietošanas samaisiet ar Dany's BienenWohl.
English: Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Latvian: Dany's BienenWohl ir kodīgs pret kodīgumu jutīgām biškopības aprīkojuma daļām.
English: Dany's BienenWohl must only be applied only once in brood-free colonies.
Latvian: Dany's BienenWohl drīkst lietot tikai kolonijām bez periem tikai vienu reizi.
English: EU/2/18/225/002 (750 g solution)
Latvian: EU/2/18/225/001-002
English: Mix with Dany's BienenWohl powder as instructed, before use.
Latvian: Pirms lietošanas samaisiet ar Dany's BienenWohl pulveri, kā norādīts.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g solution)
Latvian: EU/2/18/225/001 (375 g šķīduma) EU/2/18/225/002 (750 g šķīduma)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose
Latvian: Dany's BienenWohl pulveris bišu stropa dispersijai saharoze
English: Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Latvian: Dany's BienenWohl pulveris un šķīdums 39,4 mg/ml bišu stropa dispersijai medus bitēm
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Latvian: VETERINĀRO ZĀĻU NOSAUKUMS Dany's BienenWohl pulveris un šķīdums 39,4 mg/ml dispersijai lietošanai bišu stropā medus bitēm
English: No MRL required
Latvian: MRL nav nepieci ešams
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel DURA to Mylan dura GmbH on 21 September 2009.
Latvian: Eiropas Komisija 2009. gada 21. septembrī izsniedza Clopidogrel DURA reģistrācijas apliecību, kas derīga visā Eiropas Savienībā, uzņēmumam Mylan dura GmbH.
English: This means that Clopidogrel DURA is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Latvian: Tas nozīmē, ka Clopidogrel DURA ir līdzīgas „atsauces zālēm”, kas jau ir reģistrētas Eiropas Savienībā ar nosaukumu Plavix.