natgillin/translations-raw huggingface dataset:
28010 Madrid 
28050 Madrid Spain
Nurofen Meltlets Mint 200 mg 
Ibuprofen Nurofen Meltlets Mint 200 mg
800 mg Coated tablet 
800 mg Obložena tableta
Actavis EAD Atanas Dukov str. 29 1407 Sofia Bulgaria 
Bolgarija Actavis EAD Atanas Dukov str.
HEDEX IBUPROFEN TABLETS 200MG 
Ibuprofen HEDEX IBUPROFEN TABLETS 200MG
NUROFEN RECOVERY Ibuprofen 
Ibuprofen NUROFEN RECOVERY
NUROFEN EXPRESS 200 mg 
IBUPROFEN NUROFEN EXPRESS 200 mg
200 mg Capsule, hard 
200 mg kapsula, trda
Novartis Consumer Health S.P.A., 
Portugalska Novartis Consumer Health - Produtos Farmacêuticos e
Ibu 600 - 1 A Pharma Ibuprofen 
Ibuprofen Ibu 600 - 1 A Pharma
Ibufen Coated Tablets 400mg 
Ibuprofen Ibufen Coated Tablets 400mg
Nurofen Della 
Ibuprofen Nurofen Della
Rapidol S 400 mg kapsula, meka 
Ibuprofen Rapidol S 400 mg kapsula, meka
200 mg Modified-release capsule, hard 
200 mg Kapsula s prirejenim sproščanjem, trda
800 mg Film-coated prolongedrelease tablet 
800 mg Filmsko obložena tableta s podaljšanim sproščanjem
RXT 
ARROW
C/ Aragoneses, 15 
C/ Grassot, 16
Ibuprofen FAIR-MED Healthcare 200 mg Filmtabletten 
Ibuprofen Ibuprofen FAIR-MED Healthcare 200 mg Filmtabletten
Ibu KD 600 mg 
Ibuprofen Ibu KD 600 mg
Reckitt Benckiser Healthcare S.A. 
Reckitt Benckiser Healthcare S.A. Mataró, 28.
90449 Nürnberg Germany 
Generika KG Südwestpark 50 90449 Nürnberg Germany
400 mg Modified-release capsule 
400 mg Kapsula s prirejenim sproščanjem
Nurofen 
Poalnd
Ibufen Coated Tablets 200mg 
Ibuprofen Ibufen Coated Tablets 200mg
Ibuprofen Farmalider Ibuprofen 
Ibuprofen IBUPROFEN FARMALIDER
Ibuprofeno Azevedos 600 mg Comprimidos 
Ibuprofen Ibuprofeno Azevedos 600 mg Comprimidos
DOLGIT MAX 800 mg filmtabletta 
Ibuprofen DOLGIT MAX 800 mg filmtabletta
Perrdophen 400mg Ibuprofen lysine 684 mg Coated tablet 
Perrdophen 400mg 684 mg Obložena tableta
Tradil 
MERCK
LABORATORIOS JUVENTUS, S.A. 
LABORATORIOS ALTER, S.A.
Ibuprofen FAIR-MED Healthcare 400 mg Filmtabletten 
Ibuprofen Ibuprofen FAIR-MED Healthcare 400 mg Filmtabletten
IBUMAX 800 mg filmtabletta 
Ibuprofen IBUMAX 800 mg filmtabletta
EFFERVESCENT GRANULES 400 MG 
Ibuprofen BRUFEN EFFERVESCENT GRANULES 400 MG
Ibuprofen FAIR-MED Healthcare 600 mg Filmtabletten 
Ibuprofen Ibuprofen FAIR-MED Healthcare 600 mg Filmtabletten
MYLAN PHARMACEUTICALS, S.L. 
PHARMACEUTICAL S, S.L.
200 mg Powder for oral suspension 
200 mg Prašek za peroralno suspenzijo
Sameko Farma B.V. Archimedesweg 2 
Nizozemska Focus Farma B.V Lagedijk 1-3
Ibu 800 - 1 A Pharma Ibuprofen 
Ibuprofen Ibu 800 - 1 A Pharma
Polígono Arroyo de la Vega, Alcobendas (Madrid), 28108 
Farmalider S.A. C/ Aragoneses, 15 Alcobendas (Madrid), 28108 Spain
Ibuprofeno Azevedos 400 mg Comprimidos 
Ibuprofen Ibuprofeno Azevedos 400 mg Comprimidos
Ibu 400 - 1 A Pharma Ibuprofen 
Ibuprofen Ibu 400 - 1 A Pharma
600 mg Oral suspension 
600 mg Peroralna suspenzija Peroralna uporaba
IBUPROFENE ZF 400 mg, comprimé pelliculé 
Ibuprofen IBUPROFENE ZF 400 mg, comprimé pelliculé
Butifen 
Boots
KENDO 
Croydon
PANNONPHARMA Gyógyszergyártó Kft. 7720 Pécsvárad Pannonpharma út 1. 
Madžarska PANNONPHARMA Gyógyszergyártó Kft.
HEMA Ibuprofen 200 mg, omhulde tabletten 
Ibuprofen HEMA Ibuprofen 200 mg, omhulde tabletten
Movone 300 mgFilmtabletten 
Deksibuprofen Movone 300 mgFilmtabletten
IBUPROFEN TABLETS 200MG 
Ibuprofen BRUFEN TABLETS 200MG
300 mg Powder for oral suspension 
300 mg Prašek za peroralno suspenzijo
Researchdreef 20 
Babeş Nr. 50
Gyno-Neuralgin 
Cluj-Napoca Romania
400 mg Orodispersible tablet Oral use 
400 mg Disperzibilna tableta Peroralna uporaba
Movone 200 mgFilmtabletten 
Deksibuprofen Movone 200 mgFilmtabletten
Ibu KD 400 mg 
Ibuprofen Ibu KD 400 mg
Gran Via Carlos III, 94, Barcelona, 08028 Spain 
Pedro IV, 499 Barcelona 08020 Spain
Ibum200 mg Capsule, soft 
Ibuprofen Ibum200 mg Kapsula, mehka
Dolocyl 
Dalkeith
Wegalaan 9 
Sellhopsweg 1
IBUPROFENRATIOPHARM 400 MG 
Ibuprofen IBUPROFENRATIOPHARM 400
DERMOGEN FARMA, S.A. San Rafael, 3 
ZAMBON, S.A. Maresme, 5
NUROFEN CAPSULE 400 MG 
CAPSULES 300MG
Miramarska 23 
Veluwezoom 22
Nurofen 400 mg obložene tablete 
400 mg Obložena tableta
600 MG Coated tablet 
600 mg Obložena tableta
300 mg Granules for oral suspension 
300 mg Zrnca za peroralno suspenzijo
600 mg Powder for oral suspension 
600 mg Prašek za peroralno suspenzijo
Deltaran 400 mg Filmtabletten 
Deksibuprofen Deltaran 400 mg Filmtabletten
Ibuprofen Sandoz 400 mg 
Ibuprofen Ibuprofen Sandoz 400 mg
200 mg Oral suspension 
200 mg Peroralna suspenzija Peroralna uporaba
100 mg Oral suspension 
100 mg peroralna suspenzija peroralna uporaba
Ibuprofeno Generis 400 mg Comprimidos 
Ibuprofen GELOFENO 400 mg comprimidos
G. M. Dimitrov Blvd Sofia, 1172 
1 G. M. Dimitrov Blvd
200 mg Orodispersible tablet Oral use 
200 mg Disperzibilna tableta Peroralna uporaba
BRUFEN 400 mg, comprimé pelliculé 
400 mg, comprimé pelliculé
Nurofen 400 
Landstr 100
Belgium Abbott S.A-N.V. Avenue Einstein 14 
Nizozemska Abbott B.V Wegalaan 9
Solution for injection Parenteral use 
Peroralna raztopina Peroralna uporaba
Luxembourg Hexal AG Industriestrasse 25 
Luksemburg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany
200 mg Granules 
200 mg Zrnca
Seractil 400 mg filmtabletta 
Deksibuprofen Seractil 400 mg filmtabletta
BRUFEN RETARD 800 mg 
Ibuprofen Brufen Retard 800 mg
ETHYPHARM 
Amersfoort
Avenida de Pádua, 11 1800-294 Lisboa Portugal 
1800-294 Lisboa Portugal
Ibuprofen lysine 342 mg Film-coated tablet 
Ibuprofen Ibu 342 Lysinat JJ 342 mg Filmsko obložena tableta
Íbúfen 
Hoofddorp
Ibuprofen Sandoz 600 mg Filmtabletten 
Ibuprofen Ibuprofeno Sandoz 600 mg Filmsko obložena tableta
MIG 
Leur
Ibuprofen phenylephrine hydrochloride 
Ibuprofen fenilefrinijev klorid
Zanza Laboratories (Holdings) Limited 
Nizozemska Wrafton Laboratories Limited
Mercury Pharmaceuticals Ltd Capital House 
Pharmaceuticals Ltd
Nurofen Forte 400 mg coated tablets 
Ibuprofen Nurofen Forte 400 mg coated tablets
Sandoz Pharmaceuticals GmbH Raiffeisenstr. 
Omega Pharma Deutschland GmbH Benzstr.
200 mg Coated Tablet 
200 mg Obložena tableta
Buskofem200 mg Capsule, soft 
Ibuprofen Buskofem200 mg Kapsula, mehka
IbuTAD 800mg 
Ibuprofen IbuTAD 800mg
Abbott Laboratories Ellas ABEE Agiou Dimitriou 63 
Laboratories Ellas ABEE
Flarin 
Angelini
Ibuprofen lysinate 400 mg Powder for oral suspension 
Ibuprofen NORVECTAN 400 400 mg Prašek za peroralno suspenzijo
Ibuprom Max Sprint Ibuprofen 
Ibuprofen MAX REMEDIES IBUPROFEN
Granules for oral suspension 
Zrnca za peroralno suspenzijo
Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1 53757 Sankt Augustin Germany 
Procter & Gamble Service GmbH Zweigniederlassun g Wick Pharma Sulzbacher Str. 40 65824 Schwalbach / Taunus
400 mg Powder for oral suspension 
400 mg Prašek za peroralno suspenzijo
Sweden ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Švedska ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Dolomate 200 
Ibuprofen Dolomate 200
IBALGIN FAST 
Ibuprofen IBALGIN FAST
France ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Francija ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Ibuprofen lysinate 600 mg Powder for oral suspension 
Ibuprofen NORVECTAN 600 600 mg Prašek za peroralno suspenzijo
Estonia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Estonija ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Ulica Danica 5 
Piłsudskiego St. 5
Italy ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Italija ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
150 mg Suppository 
150 mg Svečka
400 mg Granules 
400 mg Zrnca
Nurofen 200 mg filmcoated tablets 
NUROFEN STOPGRIP 200 mg Filmsko obložena tableta
600 mg Granules 
600 mg Zrnca
Sulzbacher Str. 40 
Binger Str. 148
Archimedesweg 2 2333 CN Leiden The Netherlands 
Darwinweb, 20 2333-CR Leiden Netherlands
Perdofemina 400mg Ibuprofen lysine 684 mg Film-coated tablet 
Perdofemina 400mg 684 mg Filmsko obložena tableta
SERACTIL 
Aspar
NG2 3AA 
M & A
NUROFEN 
Hennig
40476 Düsseldorf Germany 
27472 Cuxhaven Germany
IBULAR TABLETS 200MG 
Ibuprofen IBULAR TABLETS 200MG
Maidenhead 
CHEWABLE
Brufen 200 mg filmsko obložene tablete 
NUROFENIMMEDIA 200 mg Filmsko obložena tableta
Mataró, 28. 
Weihenstephaner Str. 28
Trifene 200 
Ibuprofen Trifene 200
Ibuprofeno Abbott 
Ibuprofen ABFEN
Nurofen Rapid 200 mg Capsules 
Ibuprofen Nurofen Rapid 200 mg Capsules
Nurofen Rapid 200 mg capsules 
Ibuprofen Nurofen Rapid 200 mg capsules
400 mg Oral suspension 
400 mg Peroralna suspenzija Peroralna uporaba
Latvia ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Latvija ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Estrada Marco do GriloZemouto 
Peterborough Road Harrow
Denk Pharma GmbH & Co. KG Prinzregentenstr. 
Denk Pharma GmbH & Co.
Ibubel 200 mg filmsko obložene tablete 
Ibuprofen Ibacut 200 mg filmsko obložene tablete
IBUPROFEN ACTAVIS Ibuprofen 
Ibuprofen IBUPROFEN ACTAVIS
Germany ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Nemčija ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
400 mg Prolonged-release tablet 
400 mg Tableta s podaljšanim sproščanjem
Nurofen Rapid 400 mg capsules 
Ibuprofen NUROFEN Rapid 400 mg Capsules
Ibuprofen Banner 400 mg 
Ibuprofen Ifenin 400mg
BRUFEN 20 mg/ml 
IBUPROFEN BRUFEN 20 mg/ml
1033 SB Amsterdam The Netherlands 
1033 SB
RATIODOL 400 mg comprimidos bucodispersables 
400 mg Orodisperzibilna tableta
Nurofen-Ibuprofen 200 mg 
Ibuprofen Dismenol Ibuprofen 200 mg
DUEXIS TABLETS Ibuprofen 
Natrijev ibuprofenat
Fenpic 
ALMUS
Julián Camarillo, 37 Madrid, 28037 
Mateo Inurria, 30 28036 Madrid Spain
Ibuprofen Polfarmex Ibuprofen 
Ibuprofen MERCURY PHARMS IBUPROFEN
EFFERVESCENT TABLETS 
CODEINE TABLETS
Finland ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany 
Finska ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany
Ibuprofen Mepha 
Ibuprofen Ibupama
Theodor Heuss Anlage 68165 Mannheim Germany 
68165 Mannheim Germany
Guglgasse 17 
Verovškova 57
Ibuprofen-Actavis 800 mg Filmtabletten 
Ibuprofen Ibuprofeno Actavis 800 mg Filmsko obložena tableta
Ibuaktiv 200 mg Ibuprofen lysine 342 mg Effervescent tablet 
Ibuaktiv 200 mg 342 mg Šumeča tableta
Belgium Actavis Group PTC ehf Reykjavíkurvegi 76-78 
Nizozemska Actavis Group PTC ehf
NUROFEN FORTE Ibuprofen 
Ibuprofen Nurofen Forte
Dexcel Pharma GmbH Carl-Zeiss-Str. 2 
Reckitt Benckiser Deutschland GmbH Theodor-HeussAnlage 12
Ibuprofen Liderfarm Ibuprofen 
Ibuprofen WAYMADE IBUPROFEN
Lannacher Heilmittel GmbH Schlossplatz 1 
Lannacher Heilmittel GmbH Schlossplatz 1 A-8502 Lannach Austria
Dolofort 400 mgFilmtabletten 
Deksibuprofen Movone 400 mgFilmtabletten
Abbott B.V 
APOTEX EUROPE B.V
Laboratorio de Aplicaciones Farmacodinamicas, S.A. C/ Grassot, 16 
Portugalska Farmalider S.A. C/ Aragoneses, 15
400 mg Granules for oral suspension 
400 mg Zrnca za peroralno suspenzijo
Strovolos 
Revestidos
06796 Brehna Germany 
69007 Lyon France
Teva Denmark A/S Parallelvej 10-12 
Teva Denmark A/S Parallelvej 10-12 DK-2800 Kongens Lyndby
ALGOFLEX 400 mg filmtabletta 
Ibuprofen ALGOFLEX 400 mg filmtabletta
Nurofen Expres 200 mg 
Nurofen STOPCOLD 200 mg 30 mg
Dexibuprofen Gebro 300 mg Pulver zur Herstellung einer Suspension zum Einnehmen 
Ibuprofen Dexibuprofen Gebro 300 mg Pulver zur
DOLOFAST 
Taguspark
Wrafton, Braunton Devon EX33 2DL United Kingdom 
Exeter Road Wrafton Braunton Devon
20139 Milano 
Via Lorenzini, 8 20139 Milano Italy
20128 Milano 
Viale Monza 270 20128 Milano Italy
Ibuprofeno Farmoz Ibuprofen 
Ibuprofen PHARMVIT IBUPROFEN
ABBOTT LABS IBUPROFEN GRANULES 200 MG 
Ibuprofen Ibuprofen Galpharm 200 mg
PFIZER HOLDING FRANCE 23-25, avenue du Docteur Lannelongue 
23-25, avenue du Docteur
Ibux 
Bexal
Nurofen 200 mg obložene tablete 
200 mg Šumeča tableta
Advil 200 
Ibuprofen Advil 200
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. 
Je agonist LHRH (analog naravnega luteinizirajočega hormona za sproščanje hormonov) in zmanjša raven testosterona v serumu na raven kastracije, s čimer zavira rast hormonsko odvisnega raka prostate.
Overall summary of the scientific evaluation of Novimp 3,6 mg Implantat and associated names (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravila Novimp 3,6 mg Implantat in z njim povezanih imen (glejte Dodatek I)
The new study design has been submitted to the German Competent Authority (BfArM) for advice and is currently under review. 
Nova zasnova študije je bila predložena nemškemu pristojnemu organu (BfArM), da bi ta podal svoje mnenje, vendar njen pregled trenutno še poteka.
The Committee further considers that it is not possible, on the basis of the data submitted in support of this application, to establish a positive benefit-risk balance for this product and that, in these circumstances, the marketing of the product constitutes a risk to public health. 
Odbor tudi meni, da na podlagi podatkov, predloženih v podporo tej vlogi, ni mogoče vzpostaviti pozitivnega razmerja med tveganji in koristmi za to zdravilo in da v teh okoliščinah trženje zdravila pomeni tveganje za javno zdravje.
• 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. 
• Odbor je upošteval napotitveni postopek, sprožen v skladu s členom 36 Direktive 2001/83/ES, za zdravilo Novimp 3,6 mg Implantat in povezana imena, kot določa Priloga I.
• The Committee agreed that the bioanalytical studies submitted by the MAHs were not conducted in accordance with GCP as required by Annex I of Directive 2001/83/EC as amended and the nature of the findings is such that the conduct of the studies and their results cannot be relied on to maintain the marketing authorisation. 
• Odbor se je strinjal, da bioanalitične študije, ki so jih predložili imetniki dovoljenja za promet z zdravilom, niso bile izvedene v skladu z dobro klinično prakso, kot določa Priloga I Direktive 2001/83/ES, kakor je bila spremenjena, ugotovitve pa so takšne narave, da se glede ohranitve dovoljenja za promet z zdravili ni mogoče zanesti na izvedbo študij in na njihove rezultate.
Furthermore, the MAH has adapted the study design. 
Poleg tega je imetnik dovoljenja za promet z zdravilom spremenil zasnovo študije.
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. 
Čeprav sta bili varnost bolnika in učinkovitost zdravila vedno zagotovljeni, se je imetnik dovoljenja za promet z zdravilom odločil, da bo ponovno klinično preučil trenutni enomesečni depo goserelina.
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. 
Zato niti primerjalna študija niti navedeni rezultati študije ne morejo odtehtati kršitev pravnih zahtev, da bi bilo na ta način mogoče zagotoviti študije v skladu z dobro klinično prakso v podporo vlogi za pridobitev dovoljenja za promet z zdravilom.
The MAH agreed with the authorities that GCP violations have happened at the bioanalytical testing facility of the contract laboratory and has taken extensive measures to correct these facts for future clinical trials. 
Imetnik dovoljenja za promet z zdravilom se je strinjal z organi, da je bila v pogodbenem laboratoriju za izvajanje bioanalitičnega preskušanja kršena dobra klinična praksa, in je sprejel obsežne ukrepe za odpravo tovrstnih kršitev v prihodnjih kliničnih preskušanjih.
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. 
V obeh študijah GOS/001 (enomesečna depo formulacija) in GOS/002 (eno- in trimesečna depo formulacija) so bile med izvajanjem bioanalitičnih analiz vzorcev krvi ugotovljene kritične kršitve temeljnih standardov dobre klinične prakse ICH in mednarodno sprejetih laboratorijskih standardov.
Interaction with other medicinal products and other forms of interaction: 
Medsebojno delovanje z drugimi zdravili ter druge oblike interakcij:
The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C. 
Zunanja temperatura med zdravljenjem z zdravilom Dany's BienenWohl mora biti vsaj 3 °C.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET <Datum pridobitve:> <14/06/2018>
PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product. 
Poročila PSUR se časovno uskladijo in predložijo v enakih časovnih presledkih kot za referenčno zdravilo.
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. 
Uporaba zdravila Dany's BienenWohl po zgornji shemi odmerjanja velja le za panje s pokončnimi satniki, do katerih lahko dostopate z vrha, saj zdravljenja čebel v drugih vrstah panjev niso proučevali.
Do not exceed the recommended dose and do not administer this veterinary medicinal product more than once. 
Ne presezite priporočenega odmerka in tega zdravila za uporabo v veterinarski medicini ne uporabite več kot enkrat.
Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms. 
Zdravilo Dany's BienenWohl ne sme priti v vodotoke, ker je lahko nevarno za ribe in druge vodne organizme.
EU/2/18/225/002 (750 g solution) 
EU/2/18/225/002 (raztopina s 750 g)
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001-002 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/18/225/001-002
Dany's BienenWohl must only be applied only once in brood-free colonies. 
Zdravilo Dany's BienenWohl se sme uporabiti samo enkrat, in sicer pri kolonijah brez zalege.
Dany's BienenWohl should not be used when honey supers are present. 
Zdravilo Dany's BienenWohl se ne sme uporabljati v prisotnosti mediščnih naklad.
MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001 (375 g solution) 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/18/225/001 (raztopina s 375 g)
Mix with Dany's BienenWohl solution before use. 
Pred uporabo zmešajte z Dany's BienenWohl raztopino.
Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment. 
Zdravilo Dany's BienenWohl na delih čebelarske opreme, občutljivih za korozijo, deluje jedko.
Powder and solution for bee-hive dispersion. 
Prašek in raztopina za disperzijo za čebeljo družino.
Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees 
Dany's BienenWohl prašek in raztopina za 39,4 mg/ml disperzijo za čebeljo družino za medonosne čebele
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Dany's BienenWohl prašek in raztopina za 39,4 mg/ml disperzijo za čebeljo družino oksalna kislina dihidrat
Name and address of the manufacturer responsible for batch release 
A. PROIZVAJALEC ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca zdravila odgovornega za sproščanje serij
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl solution for bee-hive dispersion oxalic acid dihydrate 
Dany's BienenWohl raztopina za disperzijo za čebeljo družino oksalna kislina dihidrat
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT 
PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ, ČE STA RAZLIČNA
Mix with Dany's BienenWohl powder as instructed, before use. 
Pred uporabo po navodilih zmešajte z Dany's BienenWohl praškom.
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: 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina v zdravilu Dany's BienenWohl je dovoljena učinkovina, kot je navedena v tabeli 1
NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose 
Dany's BienenWohl prašek za disperzijo za čebeljo družino saharoza
The standard dose of Clopidogrel DURA is one 75 mg tablet once a day, taken with or without food. 
Običajni odmerek zdravila Clopidogrel DURA je ena 75-miligramska tableta enkrat na dan, ki se vzame s hrano ali brez nje.
The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel DURA to Mylan dura GmbH on 21 September 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Clopidogrel DURA, veljavno po vsej Evropski uniji, odobrila družbi Mylan dura GmbH dne 21. septembra 2009.
This means that Clopidogrel DURA is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix. 
To pomeni, da je zdravilo Clopidogrel DURA podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Plavix.
Clopidogrel DURA can be given to the following groups of patients: 
Zdravilo Clopidogrel DURA se lahko daje naslednjim skupinam bolnikov:
Clopidogrel DURA is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries). 
Zdravilo Clopidogrel DURA se uporablja pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost krvnih žil).
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. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Clopidogrel DURA primerljivo raven kakovosti kot zdravilo Plavix ter da mu je biološko enakovredno.
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. 
Ker je zdravilo Clopidogrel DURA generično zdravilo in je biološko enakovredno referenčnemu zdravilu, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Clopidogrel DURA can be started between a few days and 35 days after the attack; 
Zdravilo Clopidogrel DURA se lahko začne jemati nekaj dni po napadu do 35 dni po njem;
The Committee recommended that Clopidogrel DURA be given marketing authorisation. 
Odbor je zato priporočil, da se za zdravilo Clopidogrel DURA odobri dovoljenje za promet.
What are the benefit and risk of Clopidogrel DURA? 
Kakšne so koristi in tveganja, povezana z zdravilom Clopidogrel DURA?
Other information about Clopidogrel DURA: 
Druge informacije o zdravilu Clopidogrel DURA:
Clopidogrel DURA can be started between seven days and six months after the 
Zdravilo Clopidogrel DURA se lahko začne jemati od sedem dni po napadu do šest mesecev po njem;
Because Clopidogrel DURA is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix. 
Ker je zdravilo Clopidogrel DURA generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Plavix.
Clopidogrel DURA is a ‘generic medicine'. 
Zdravilo Clopidogrel DURA je „generično zdravilo“.
Clopidogrel DURA is a medicine that contains the active substance clopidogrel. 
Clopidogrel DURA je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
The active substance in Clopidogrel DURA, clopidogrel, is an inhibitor of platelet aggregation. 
Zdravilna učinkovina v zdravilu Clopidogrel DURA, klopidogrel, je zaviralec agregacije trombocitov.
Why has Clopidogrel DURA been approved? 
Zakaj je bilo zdravilo Clopidogrel DURA odobreno?
The full EPAR for Clopidogrel DURA can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Clopidogrel DURA je na voljo tukaj.
How has Clopidogrel DURA been studied? 
Kako je bilo zdravilo Clopidogrel DURA raziskano?
What is Clopidogrel DURA used for? 
Za kaj se zdravilo Clopidogrel DURA uporablja?
How is Clopidogrel DURA used? 
Kako se zdravilo Clopidogrel DURA uporablja?
What is Clopidogrel DURA? 
Kaj je zdravilo Clopidogrel DURA?