FrancophonIA/ELRC3.0 huggingface dataset:
English: Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal
Romanian: Parque Industrial Manuel Lourenço Ferreira, Lote 15
English: ADVIL TABLETS 200MG
Romanian: ADVIL TABLETS 200MG 200 mg
English: Ibuprofen 400mg film-coated tablets
Romanian: Ibuprofen 400mg filmcoated tablets
English: HEALTHCARE IBUPROFEN TABLETS BP 400 MG
Romanian: ACCORD HEALTHCARE IBUPROFEN TABLETS BP 400 MG
English: HEALTHCARE IBUPROFEN TABLETS BP 200MG
Romanian: ACCORD HEALTHCARE IBUPROFEN TABLETS BP 200MG
English: Athlone Laboratories Limited, Ballymurray,
Romanian: Ballymurray,
English: Nurofen cold & flu Ibuprofen
Romanian: Nurofen cold & flu
English: HEALTHCARE IBUPROFEN TABLETS BP 600 MG
Romanian: ACCORD HEALTHCARE IBUPROFEN TABLETS BP 600 MG
English: Vitabiotics Limited, 1 Apsley Way London NW2 7HF United Kingdom
Romanian: Regatul Unit Vitabiotics Limited, 1 Apsley Way
English: Avenida Professor Doutor Cavaco Silva, 10E - Taguspark 2740-255 Porto Salvo Portugal
Romanian: Avenida Professor Doutor Cavaco Silva, 10E
English: Berkshire SL6 6PT United Kingdom
Romanian: Slough, Berkshire SL1 4AQ United Kingdom
English: Via Cesarea 11/10
Romanian: Boots Pharmaceuticals S.R.L. Via Cesarea 11/10
English: Germany axcount Generika GmbH Max-Planck-Str. 36b 61381 Friedrichsdorf Germany
Romanian: 36d 61381 Friedrichsdorf Germany
English: Ibugesic 600 mg film-coated tablets
Romanian: Ibugesic 600 mg filmcoated tablets
English: Linkstr.
Romanian: Benzstr.
English: Ibumyl Rapid 200 mg Ibuprofen
Romanian: Ibumyl Rapid 200 mg 200 mg
English: HEALTHCARE IBUPROFEN TABLETS 600MG
Romanian: CHELONIA HEALTHCARE IBUPROFEN TABLETS 600MG
English: IBUPROFENO (ARGININA) SANDOZ 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) SANDOZ 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: Ibu-ratiopharm 400 mg akut
Romanian: Ibu-ratiopharm 400 mg akut Schmerztabletten
English: Ibuprofen PB 600 mg Ibuprofen
Romanian: Ibuprofen PB 600 mg 600 mg
English: ALGIDRIN 600
Romanian: NORVECTAN 600
English: Seractil forte 400 mg - Filmtabletten
Romanian: Seractil forte 400 mgFilmtabletten
English: Belgium Boehringer Ingelheim International GmbH Binger Straße 173
Romanian: Portugalia Boehringer Ingelheim International GmbH Binger Straße 173
English: FARMAKOPEA S.P.A.
Romanian: US Pharmacia Sp.
English: IBUPROFEN TABLETS BP 600MG
Romanian: WAYMADE IBUPROFEN TABLETS BP 600MG
English: IBUPROFEN ACTAVIS Ibuprofen
Romanian: Ibuprofen Actavis
English: Ibuprofen codeine phosphate hemihydrate
Romanian: Ibuprofen Fosfat de codeină hemihidrat
English: PharmaSwiss d.o.o.
Romanian: PharmaSwiss d.o.o. Miramarska 23
English: Ibu-Lysin Ratiopharm Ibuprofen lysine 342 mg Coated tablet
Romanian: Ibu-Lysin Ratiopharm 342 mg
English: Brufen 400 mg šumivé granule
Romanian: Brufedol 400 mg šumivé granule
English: Nurofen 400 mg obložene tablete
Romanian: Nurofen Forte 400 mg obložene tablete
English: 174 56 Alimos
Romanian: 3465-051 Campo de Besteiros
English: Ibu-Lysin Ratiopharm Ibuprofen lysine 684 mg Coated tablet
Romanian: Ibu-Lysin Ratiopharm 684 mg
English: IBUPROFENO FARLINE 400 mg comprimidos bucodispersables
Romanian: IBUPROFENO ASTREL 400 mg comprimidos bucodispersables
English: Avenida Professor Doutor Cavaco Silva, 10 E, Taguspark 2740-255 Porto Salvo Portugal
Romanian: Avenida Professor Doutor Cavaco Silva, 10 E,
English: Ibugesic 400 mg film-coated tablets
Romanian: Ibugesic 400 mg filmcoated tablets
English: Ibuprofen 200mg film-coated tablets
Romanian: Ibuprofen 200mg filmcoated tablets
English: Ibuprofeno Farmoz Ibuprofen
Romanian: Ibuprofeno Farmoz
English: GRANULADO EFERVESCENTE EFG
Romanian: Comprimat efervescent
English: Ibuprofen "Alternova" Ibuprofen
Romanian: Ibuprofen "Alternova" 600 mg
English: SSL International plc Wellcroft House Wellcroft Road Slough, Berkshire SL1 4AQ United Kingdom
Romanian: Regatul Unit SSL International plc Wellcroft House
English: Zafen 400 Tablet, filmomhulde tabletten 400 mg
Romanian: Ibuprofen arginină Zafen 400 Tablet, filmomhulde tabletten 400 mg
English: IBUPROFENO (ARGININA) NORMON 400 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) NORMON 400 mg GRANULADO PARA SOLUCION ORAL EFG
English: Ibumetin 200 mg film-coated tablets
Romanian: Ibumetin 200 mg filmcoated tablets
English: Ibuprofeno Zentiva Ibuprofen
Romanian: Ibuprofeno Zentiva
English: Togal-Werk AG Kardinal-Faulhaber-Str. 5 80333 München Germany
Romanian: Luxemburg Hexal AG Industriestrasse 25 83607 Holzkirchen Germany
English: IBUPROFEN TABLETS BP 400MG
Romanian: WAYMADE IBUPROFEN TABLETS BP 400MG
English: Ibumetin 400 mg film-coated tablets
Romanian: Ibumetin 400 mg filmcoated tablets
English: IBUPROFENO ABEX 600 MG GRANULADO EFERVESCENTE EFG
Romanian: IBUKERN 600 MG GRANULADO EFERVESCENTE EFG
English: IBUPROFENO (ARGININA) NORMON 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) NORMON 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: DUEXIS TABLETS Ibuprofen
Romanian: DUEXIS TABLETS
English: Ibuprofen pseudoephedrine hydrochloride
Romanian: Ibuprofen Clorhidrat de pseudoefedrină
English: Ctavis Spain, S.A. Avda.
Romanian: Aurovitas Spain, S.A.U. Avda.
English: Temmler Werke GmbH Weihenstephaner Str. 28 81673 München Germany
Romanian: Germania Temmler Werke GmbH Weihenstephaner Str. 28
English: IBUPROFENRATIOPHARM 200 MG
Romanian: Ibuprofen ratiopharm 200 mg
English: IBUPROFEN ARGININE
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA)
English: Ibuprofen EG 800 mg Ibuprofen
Romanian: Ibuprofen EG 800 mg 800 mg
English: Ibuprofen phenylephrine
Romanian: Ibuprofen fenilefrină
English: IBUPROFENO (ARGININA) CODRAMOL 400 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) CODRAMOL 400 mg GRANULADO PARA SOLUCION ORAL EFG
English: Heumann Pharma GmbH & Co. Generika KG
Romanian: Germania Heumann Pharma GmbH & Co.
English: Ibu 600 - 1 A Pharma Ibuprofen
Romanian: Ibu 600 - 1 A Pharma 600 mg
English: Ibuprofen AL 800 retard
Romanian: Ibuprofen AL 800 retard 800 mg
English: IBUPROFENO (ARGININA) CINFAMED 400 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) CINFAMED 400 mg GRANULADO PARA SOLUCION ORAL EFG
English: Aharnon str, Limassol Industrial Estate, Limassol
Romanian: Limassol Industrial Estate Limassol 3508
English: Ibumetin forte 400 mg - Filmtabletten
Romanian: Ibumetin forte 400 mgFilmtabletten
English: IBUPROFENO (ARGININA) PENSA 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) PENSA 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: Ibuprofen Lannacher Ibuprofen
Romanian: Ibuprofen Lannacher
English: 200 mg Dragee
Romanian: 200 mg/30mg Drajeu
English: Dr.-Robert-Pfleger-Str. 12 96052 Bamberg Germany
Romanian: 96052 Bamberg
English: IBUPROFENO (ARGININA) TARBIS 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) TARBIS 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: IBUPROFENO (ARGININA) CINFA 400 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) CINFA 400 mg GRANULADO PARA SOLUCION ORAL EFG
English: Nurofen-Ibuprofen 200 mg
Romanian: IBUPROFEN-GRINDEKS 200 mg
English: Pharmaceutical Works Polfa in Pabianice Joint-Stock Co. Marszałka J. Piłsudskiego St. 5 95-200 Pabianice Poland
Romanian: Pharmaceutical Works Polfa in Pabianice Joint-Stock Co.
English: IBUPROFENO (ARGININA) CINFAMED 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) CINFAMED 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: IBUPROFENO (ARGININA) TECNIGEN 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) TECNIGEN 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: Via delle Ande, 15
Romanian: Bruno Farmaceutici S.p.A. Via delle Ande, 15
English: Sandoz Pharmaceuticals GmbH Raiffeisenstr.
Romanian: Germania Sandoz Pharmaceuticals GmbH
English: LABORATORI ALTER S.R.L.
Romanian: LABORATORI ALTER S.R.L. Via Egadi 7
English: IBUPROFENO (ARGININA) STADA 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) STADA 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: IBUPROFENO (ARGININA) MYLAN 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) MYLAN 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: 200 mg/5 mg
Romanian: 100 mg/5 ml
English: Ibuberl 400 mg
Romanian: IBUFLUX 400 MG
English: Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal
Romanian: Portugalia Generis Farmacêutica, S.A. Rua João de Deus, 19
English: Ibuprofen phenylephrine hydrochloride
Romanian: Ibuprofen Clorhidrat de fenilefrină
English: EUDORLIN Migräne Ibuprofen
Romanian: EUDORLIN Migräne
English: IBUPROFENO STADA GENERICOS 400 mg comprimidos recubiertos EFG
Romanian: IBUPROFENO STADAGEN 400 mg comprimidos recubiertos EFG
English: IBUPROFENO (ARGININA) CODRAMOL 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) CODRAMOL 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: IBUPROFENO ASTREL 400 mg comprimidos recubiertos
Romanian: Ibuprofen arginină ESPIDIFEN 400 mg comprimidos recubiertos
English: Ibu-Lysin Abz Migraene
Romanian: Ibu-Lysin Abz Migraene 684 mg
English: ANADIN LIQUIFAST 200 MG
Romanian: SPIDIDOL ANALGESICO 200 mg
English: IBUPROFENO (ARGININA) COMBIX 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) COMBIX 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: Nurofen Stopgrip Ibuprofen pseudoephedrine hydrochloride
Romanian: Ibuprofen/Clorhidrat de pseudoefedrină
English: Ibuprofen Aflofarm Ibuprofen
Romanian: Ibuprofen Aflofarm 200 mg
English: 81479 München Germany ib-u-ron 75 mg Zäpfchen
Romanian: Germany ib-u-ron 75 mg Zäpfchen
English: Bronzactiv Pharma GmbH Carl-von-Linde-Str. 30 85716 Unterschleißheim Germany
Romanian: 85716 Unterschleißheim Germany
English: Nurofen Express 200 mg meke kapsule
Romanian: Nurofen Rapid 200 mg meke kapsule
English: Zanza Laboratories (Holdings) Limited
Romanian: Pinewood Laboratories Limited
English: Ibuprofeno OM Pharma
Romanian: Ibuprofeno OM Pharma 200 mg
English: IBUPROFENO (ARGININA) CINFA 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) CINFA 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: Ibuprofeno Generis Ibuprofen
Romanian: Ibuprofeno Generis
English: Wrafton, Braunton Devon EX33 2DL United Kingdom
Romanian: Germania Wrafton Laboratories Limited EX33 2DL Wrafton
English: IBUPROFENO (ARGININA) CUVE 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) CUVE 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: Ibuprofen 600mg Effervescent Granules
Romanian: Brufen 600mg Effervescent Granules
English: Ibuprofen PB 400 mg Ibuprofen
Romanian: Ibuprofen PB 400 mg 400 mg
English: Ibuprofen EG 200 mg Ibuprofen
Romanian: Ibuprofen EG 200 mg 200 mg
English: IBUPROFENO STADA GENERICOS 600 mg comprimidos recubiertos EFG
Romanian: IBUPROFENO STADA GENÉRICOS 600 mg comprimidos recubiertos con película EFG
English: Nurofen Express 400 mg meke kapsule
Romanian: Nurofen Rapid Forte 400 mg meke kapsule
English: Teva Nederland B.V. Swensweg 5 2031 GA Haarlem The Netherlands
Romanian: Teva Nederland B.V. Swensweg 5
English: Remedica Ltd.
Romanian: Pharmaceutical plants Milve Ltd.
English: Rue Heienhaff, 5
Romanian: Rua Henrique Paiva
English: Perrdophen 400mg Ibuprofen lysine 684 mg Coated tablet
Romanian: Perrdophen 400mg 684 mg
English: Nurofen 400 fastsodium
Romanian: Nurofen 400 fastsodium 400 mg
English: Great West Road 980
Romanian: West End Road
English: IBUPROFENO (ARGININA) ZENTIVA 600 mg GRANULADO PARA SOLUCION ORAL EFG
Romanian: Ibuprofen arginină IBUPROFENO (ARGININA) ZENTIVA 600 mg GRANULADO PARA SOLUCION ORAL EFG
English: Ibuklaph 800 mg Ibuprofen
Romanian: Ibuklaph 800 mg
English: Industriestr.
Romanian: Prinzregentenstr.
English: NUROFEN APPELSIINI
Romanian: Pulbere orală
English: Relonchem Limited Cheshire House Gorsey Lane Widnes WA8 0RP United Kingdom
Romanian: Regatul Unit Relonchem Limited Cheshire House
English: Ibuprofen EG 600 mg Ibuprofen
Romanian: Ibuprofen EG 600 mg 600 mg
English: Ibuprofen lysine 342 mg Effervescent tablet
Romanian: ANADIN LIQUIFAST 200 MG EFFERVESCENT TABLETS
English: Luxembourg Dolorgiet GmbH & Co. KG Otto-von-Guericke-Str. 1
Romanian: KG Otto-von-Guericke-Str.
English: Fibraflex 600 mg Ibuprofen
Romanian: Fibraflex 600 mg
English: 821 11 Bratislava Slovakia
Romanian: BGP Products s.r.o. Karadžičova 10 821 08 Bratislava Slovakia
English: Ibumyl Rapid 400 mg Ibuprofen
Romanian: Ibumyl Rapid 400 mg 400 mg
English: Belgium Johnson & Johnson Consumer SA/NV
Romanian: Johnson & Johnson Consumer SA/NV Antwerpseweg 15-17 2340 Beerse Belgium
English: IBUPROFEN TABLETS 400MG
Romanian: WAYMADE IBUPROFEN TABLETS 400MG
English: Therefore, the Committee recommends the suspension of the marketing authorisations, subject to the conditions outlined in Annex III of the Opinion.
Romanian: Prin urmare, Comitetul recomandă suspendarea autorizaţiilor de punere pe piaţă sub rezerva condiţiilor prevăzute în Anexa III la aviz.
English: Furthermore, the MAH has adapted the study design.
Romanian: De asemenea, DAPP a adaptat structura studiului.
English: The new study design has been submitted to the German Competent Authority (BfArM) for advice and is currently under review.
Romanian: Noua structură a studiului a fost prezentată autorităţii competente din Germania (BfArM) în vederea unui aviz şi este în prezent în curs de evaluare.
English: Overall summary of the scientific evaluation of Novimp 3,6 mg Implantat and associated names (see Annex I)
Romanian: Rezumat general al evaluării ştiinţifice pentru Novimp 3,6 mg Implantat şi denumirile asociate (vezi Anexa I)
English: It is an LHRH agonist (analogue of the natural luteinizing hormone-releasing hormone) and suppresses the serum testosterone to castration level to inhibit the growth of hormonedepending prostate carcinoma.
Romanian: Acesta este un agonist al LHRH (analog al hormonului natural de eliberare a hormonului luteinizant) şi produce supresia testosteronului seric până la nivelul de castrare pentru a inhiba creşterea carcinomului prostatic dependent de hormoni.
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.
Romanian: Prin urmare, nici structura studiului comparativ, nici rezultatele invocate ale studiului nu pot compensa încălcarea cerinţelor legale de a prezenta studii conforme cu BPC în sprijinul unei CAPP.
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.
Romanian: • Comitetul a analizat procedura de sesizare declanşată în temeiul articolului 36 din Directiva 2001/83/CE pentru Novimp 3,6 mg Implantat şi denumirile asociate, enumerate în Anexa I.
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.
Romanian: În pofida faptului că siguranţa pacientului şi eficacitatea produsului au fost în permanenţă asigurate, DAPP a decis să efectueze o nouă investigaţie clinică a actualului produs pe bază de goserelin cu acţiune de 1 lună.
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.
Romanian: S-au constatat încălcări grave ale standardelor ICH GCP fundamentale şi ale standardelor de laborator acceptate la nivel internaţional în timpul testelor bioanalitice ale probelor de sânge atât din studiul GOS/001 (formulă cu acţiune prelungită de 1 lună), cât şi din studiul GOS/002 (formulă cu acţiune prelungită de 1 şi 3 luni).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14/06/2018
Romanian: DATA PRIMEI AUTORIZĂRI/REÎNNOIRII AUTORIZAȚIEI <Data primei autorizări:> <14/06/2018>
English: The outside temperature during treatment with Dany's BienenWohl should be at least 3 °C.
Romanian: Temperatura exterioară în timpul tratamentului cu Dany's BienenWohl trebuie să fie de cel puțin 3 °C.
English: The use of Dany's BienenWohl with the above dosing scheme only applies to hives with vertical frames that can be accessed from the top, as the treatment of bees in other types of hives has not been investigated.
Romanian: Utilizarea Dany's BienenWohl cu schema de dozare de mai sus se aplică doar pentru stupii cu rame verticale la care accesul se poate face de deasupra, întrucât tratamentul albinelor în alte tipuri de stupi nu a fost investigat.
English: Mix with Dany's BienenWohl solution before use.
Romanian: A se amesteca cu soluția Dany's BienenWohl înainte de utilizare.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 colonies treated displaying adverse reaction(s)) - common (more than 1 but less than 10 colonies in 100 colonies treated) - uncommon (more than 1 but less than 10 colonies in 1,000 colonies treated) - rare (more than 1 but less than 10 colonies in 10,000 colonies treated) - very rare (less than 1 colony in 10,000 colonies treated, including isolated reports.
Romanian: Frecvența reacțiilor adverse este definită utilizând următoarea convenție: - foarte frecvente (mai mult de 1 din 10 colonii tratate care prezintă reacții adverse) - frecvente (mai mult de 1 dar mai puțin de 10 colonii din 100 de colonii tratate) - mai puțin frecvente (mai mult de 1 dar mai puțin de 10 colonii din 1 000 de colonii tratate)
English: Mix with Dany's BienenWohl powder as instructed, before use.
Romanian: A se amesteca cu pulberea Dany's BienenWohl conform instrucțiunilor, înainte de utilizare.
English: Dany's BienenWohl has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Romanian: Dany's BienenWohl are proprietăți corozive asupra componentelor sensibile la corosiune ale echipamentelor apicole.
English: PSUR submissions shall be synchronised and submitted at the same frequency as for the reference product.
Romanian: ALTE CONDIȚII ȘI CERINȚE ALE AUTORIZAȚIEI DE PUNERE PE PIAȚĂ Rapoartele periodice actualizate privind siguranța trebuie sincronizate și trimise cu aceeași frecvență ca pentru produsul de referință.
English: Dany's BienenWohl should not be used when honey supers are present.
Romanian: Dany's BienenWohl nu trebuie utilizat atunci când există miere in magazie.
English: Dany's BienenWohl must only be applied only once in brood-free colonies.
Romanian: Dany's BienenWohl trebuie aplicat doar o singură dată, în colonii fără puiet.
English: Dany's BienenWohl should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Romanian: Dany's BienenWohl nu trebuie să fie deversat în cursuri de apă, datorită pericolului pentru pești și alte organisme acvatice.
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Romanian: B. CONDIȚII SAU RESTRICȚII ALE AUTORIZAȚIEI DE COMERCIALIZARE
English: EU/2/18/225/002 (750 g solution)
Romanian: EU/2/18/225/001 (375 g de soluție) EU/2/18/225/002 (750 g de soluție)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (for powder and solution for bee-hive dispersion)
Romanian: Cutie din carton (pentru pulbere și soluție pentru dispersie pentru stupi)
English: In clinical trials, increased bee mortality was very commonly observed.
Romanian: REACȚII ADVERSE În studiile clinice s-a observat foarte frecvent creșterea mortalității albinelor.
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:
Romanian: C. DECLARAȚIE REFERITOARE LA LIMITELE MAXIME DE REZIDUURI Substanța activă din Dany's BienenWohl este o substanță permisă așa cum este descrisă în tabelul 1
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder for bee-hive dispersion sucrose
Romanian: DENUMIREA PRODUSULUI MEDICINAL VETERINAR Dany's BienenWohl pulbere pentru dispersie pentru stupi zaharoză
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/225/001-002
Romanian: EU/2/18/225/001-002
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
Romanian: DENUMIREA PRODUSULUI MEDICINAL VETERINAR Dany's BienenWohl pulbere și soluție pentru 39,4 mg/ml dispersie pentru stupi acid oxalic dihidrat
English: 4.6 Adverse reactions (frequency and seriousness)
Romanian: 4.6 Reacții adverse (frecvență și gravitate) În studiile clinice s-a observat foarte frecvent creșterea mortalității albinelor.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl solution for bee-hive dispersion oxalic acid dihydrate
Romanian: Dany's BienenWohl soluție pentru dispersie pentru stupi acid oxalic dihidrat
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle
Romanian: INFORMAȚII CARE TREBUIE ÎNSCRISE PE AMBALAJUL PRIMAR Flacon
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Romanian: DENUMIREA PRODUSULUI MEDICINAL VETERINAR Dany's BienenWohl pulbere și soluție pentru 39,4 mg/ml dispersie pentru stupi de albine melifere
English: Dany's BienenWohl powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Romanian: PROSPECT: Dany's BienenWohl pulbere și soluție pentru 39,4 mg/ml dispersie pentru stupi de albine melifere
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Sachet
Romanian: INFORMAȚII CARE TREBUIE ÎNSCRISE PE AMBALAJUL SECUNDAR
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product not subject to prescription.
Romanian: Produs medicinal veterinar care nu este supus eliberării cu rețetă veterinară.
English: The standard dose of Clopidogrel DURA is one 75 mg tablet once a day, taken with or without food.
Romanian: Doza standard de Clopidogrel DURA este de un comprimat de 75 mg o dată pe zi, luat cu sau fără alimente.
English: This means that Clopidogrel DURA is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Romanian: Aceasta înseamnă că Clopidogrel DURA este similar cu „medicamentul de referinţă” deja autorizat în Uniunea Europeană (UE), denumit Plavix.
English: Clopidogrel DURA can be given to the following groups of patients:
Romanian: Clopidogrel DURA poate fi administrat următoarelor grupe de pacienţi:
English: Other information about Clopidogrel DURA:
Romanian: Alte informaţii despre Clopidogrel DURA:
English: 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.
Romanian: Comitetul pentru produse medicamentoase de uz uman (CHMP) a concluzionat că, în conformitate cu cerinţele UE, s-a demonstrat că Clopidogrel DURA are o calitate comparabilă şi că este bioechivalent cu Plavix.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel DURA to Mylan dura GmbH on 21 September 2009.
Romanian: Comisia Europeană a acordat Mylan dura GmbH o autorizaţie de introducere pe piaţă pentru Clopidogrel DURA, valabilă pe întreg teritoriul UE, la 21 septembrie 2009.
English: Clopidogrel DURA is a ‘generic medicine'.
Romanian: Clopidogrel DURA este un „medicament generic”.
English: What are the benefit and risk of Clopidogrel DURA?
Romanian: Care sunt beneficiile şi riscurile asociate cu Clopidogrel DURA?
English: Clopidogrel DURA is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Romanian: Clopidogrel DURA se utilizează la adulţi pentru prevenirea evenimentelor aterotrombotice (probleme cauzate de cheaguri de sânge şi de rigidizarea arterelor).