FrancophonIA/ELRC3.0 huggingface dataset:
English: - The Committee considered that robust data is available showing the efficacy of Octegra in the indication “Treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” , however due to emerging resistance of N. gonorrhoeae, moxifloxacin should not be used in empirical monotherapy, unless moxifloxacinresistant N. gonorrhoeae can be excluded.
Maltese: - Il-Kumitat ikkunsidra li hemm dejta robusta li turi l-effikaċja ta' Octegra fl-indikazzjoni “Trattament ta' mard infjammatorju tal-pelvis (PID) ħafif jew moderat, jiġifieri infezzjonijiet tal-passaġġ ġenitali ta' fuq, inklużi s-salpinġite u l-endometrite”, madankollu minħabba r-reżistenza li qed tiżviluppa minn N. gonorrhoeae, moxifloxacin m'għandux jintuża fil-monoterapija empirika, sakemm ma tkunx tista' tiġi eskluża razza ta' N. gonorrhoeae reżistenti għal moxifloxacin.
English: Resistant
Maltese: IPPREŻENTATI
English: - The Committee, in view of the presented data on efficacy and safety, considered that the Benefit / Risk balance for Octegra and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable; - The CHMP, as a consequence, recommended the amendment of the Summary of Product Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Octegra and associated names (see Annex I).
Maltese: - Minħabba f'hekk, is-CHMP irrakkomanda l-emenda ta' sezzjonijiet 4.1, 4.2, 4.3, 4.4, 5.1 u 5.2 tasSommarju tal-Karatteristiċi tal-Prodott u s-sezzjonijiet relevanti tal-Fuljett ta' Tagħrif stabbiliti flAnness
English: Zoetis France 23-25 Avenue du Dr Lannelongue 75014 Paris France
Maltese: Zoetis France 23-25 Avenue du Dr Lannelongue 75014
English: Powder and solvent
Maltese: Trab u solvent
English: France
Maltese: Paris France
English: Cattle, cats, dogs
Maltese: Frat, qtates, klieb
English: Germany1 CP-Pharma Handelsgesellschaft mbH Ostlandring 13
Maltese: Handelsgesellschaft mbH Ostlandring 13
English: • After administration of 400 µg/kg bw for 5 consecutive days, residues in injection site muscle ranged from below LOQ (10 µg/kg) to 8393 µg/kg at day 7 after injection and at day 14 from below LOQ to 90 µg/kg.
Maltese: • Wara l-għoti ta' 400 µg/kg bw għal 5 ijiem konsekuttivi, ir-residwi fil-muskolu tas-sit tal-injezzjoni varjaw minn inqas mil-LOQ (10 µg/kg) għal 8393 µg/kg f'jum 7 wara l-injezzjoni u f'jum 14 minn inqas mil-LOQ għal 90 µg/kg.
English: In addition, the pharmacological ADI was exceeded up to 262 fold at day 7 and up to 2.8 fold at day 14.
Maltese: Barra minn hekk, l-ADI aċċettabbli nqabżet b'sa 262 darba f'jum 7 u b'sa 2.8 darbiet f'jum 14.
English: No residue depletion data are available for veterinary medicinal products containing methylprednisolone hydrogen succinate.
Maltese: M'hemm l-ebda data disponibbli għall-prodotti mediċinali veterinarji li fihom methylprednisolone hydrogen succinate.
English: 2 CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01-FINAL)http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2009/11/WC500015081.pdf alcohol) and two antibiotic substances (neomycin and benzylpenicillin).
Maltese: http://www.ema.europa.eu/docs/en_GB/document_library/Maximum_Residue_Limits__Report/2009/11/WC500015081.pdf
English: Following a marketing authorisation application to the Federal Office of Consumer Protection and Food Safety of Germany, under Article 13(1) of Directive 2001/82/EC, i.e., a generic application, for the veterinary medicinal product Solupred 125 mg (applicant: CP-Pharma), it appeared that no productspecific residue data are available in support of the cattle meat and offal withdrawal periods of 6 days for the reference products Solu-Medrol 120 mg and Solu-Medrol 500 mg which are authorised in France for use in dogs, cats and cattle (marketing authorisation holder: Zoetis).
Maltese: Wara applikazzjoni tal-awtorizzazzjoni għat-tqegħid fis-suq lill-Uffiċċju Federali tal-Ġermanja għallProtezzjoni tal-Konsumatur u s-Sikurezza Alimentari, skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE, jiġifieri, applikazzjoni ġenerika, għall-prodott mediċinali veterinarju Solupred 125 mg (applikant:
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, applicant/marketing authorisation holder in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali veterinarji, speċi ta' annimali, rotta ta' amministrazzjoni, l-applikant/id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq fl-Istati Membri
English: Residues in muscle, liver, kidney and fat were already below LOQ (10 µg/kg) at the earliest slaughter time (day 7).
Maltese: Ir-residwi fil-muskoli, fil-fwied, fil-kliewi u fixxaħam kienu diġà inqas mil-LOQ (10 µg/kg) fl-aktar żmien kmieni tal-qatla (jum 7).
English: The only residue depletion study for methylprednisolone after intramuscular injection in cattle is cited in the CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01-FINAL).
Maltese: L-uniku studju dwar it-tnaqqis ta' residwu għal methylprednisolone wara injezzjoni ġol-muskoli fil-frat huwa ċċitat fl-EPMAR tas-CVMP għal methylprednisolone (EMEA/MRL/798/01-FINAL).
English: No information has been found in open databases (e.g. PubMed, Scopus, VetMed Resource, Web of Science) regarding pharmacokinetic and residue data of methylprednisolone hydrogen succinate in edible tissues and at the injection site of cattle.
Maltese: Ma nstabet l-ebda informazzjoni fil-bażijiet ta' data miftuħin (eż. PubMed, Scopus, VetMed Resource, Web of Science) rigward data farmakokinetika u dwar ir-residwu ta' methylprednisolone hydrogen succinate f'tessuti li jittieklu u fis-sit tal-injezzjoni tal-frat.
English: SOLU-MEDROL 120 MG Methylprednisolone hydrogen succinate
Maltese: MG Methylprednisolone hydrogen succinate
English: Therefore, on 2 May 2016, Germany initiated a procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing methylprednisolone hydrogen succinate presented as solutions for injection for intramuscular use in cattle.
Maltese: Għalhekk, fit-2 ta' Mejju 2016, il-Ġermanja bdiet proċedura skont l-Artikolu 35 tadDirettiva 2001/82/KE, għall-prodotti mediċinali veterinarji li fihom methylprednisolone hydrogen succinate li huma ppreżentati bħala soluzzjonijiet għall-injezzjoni għall-użu ġol-muskoli fil-frat.
English: Methylprednisolone, a 6α-methyl derivative of prednisolone, is a synthetic corticosteroid, which is used in veterinary medicine as a free alcohol, and as various esters.
Maltese: Methylprednisolone hydrogen succinate huwa ester tal-methylprednisolone glukokortikojde sintetiku. Methylprednisolone, derivattiv 6α-methyl ta' prednisolone, huwa kortikosterojde sintetiku, li jintuża filmediċina veterinarja bħala alkoħol liberu, u bħala diversi esteri.
English: Using the data available in the CVMP EPMAR for methylprednisolone (EMEA/MRL/798/01-FINAL)2, Germany considered that residues of methylprednisolone at injection sites may lead to intake of amounts of methylprednisolone significantly above the Acceptable Daily Intake (ADI).
Maltese: Waqt li użat id-data disponibbli fl-EPMAR tas-CVMP għal methylprednisolone (EMEA/MRL/798/01FINAL)2, il-Ġermanja kkunsidrat li r-residwi ta' methylprednisolone fis-siti tal-injezzjoni jistgħu jwasslu għal teħid ta' ammonti ta' methylprednisolone ferm akbar mid-Doża Aċċettabbli Ta' Kuljum (ADI, Acceptable Daily Intake).
English: Even if formulation differences and differences between the chemical forms of the active substances (methylprednisolone as free alcohol versus methylprednisolone hydrogen succinate) are taken into account, these data strongly indicate that a withdrawal period of 6 days for cattle (meat and offal) treated with methylprednisolone hydrogen succinate-containing products is insufficient to ensure consumer safety.
Maltese: Anki jekk jitqiesu d-differenzi fil-formulazzjoni u d-differenzi bejn il-forom kimiċi tas-sustanzi attivi (methylprednisolone bħala mingħajr alkoħol kontra methylprednisolone hydrogen succinate), il-Ġermanja kkunsidrat li din id-data tindika b'mod qawwi li perjodu ta' twaqqif ta' 6 ijiem għal frat (laħam u ġewwieni tal-annimal) ikkurati bi prodotti li fihom methylprednisolone hydrogen succinate jista' ma jkunx biżżejjed biex jiżgura s-sikurezza tal-konsumatur.
English: Applicant/Marketing authorisation holder
Maltese: L-Applikant/Id-Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq
English: At the injection site, the MRL for muscle was exceeded more than 800 fold at day 7 and still 9 fold at day 14.
Maltese: Fit-sit tal-injezzjoni, l-MRL għall-muskolu nqabeż b'aktar minn 800 darba f'jum 7 u xorta b'9 darbiet f'jum 14.
English: ADI, indicating a serious risk for consumer safety;
Maltese: farmakoloġika, li jindika riskju serju għas-sikurezza tal-konsumatur;
English: The residue depletion data do not allow a statistically based determination of a withdrawal period.
Maltese: Id-data dwar it-tnaqqis ta' residwu ma tippermettix determinazzjoni ta' perjodu ta' distakk ibbażata fuq l-istatistika.
English: • the CVMP considered that a withdrawal period for meat and offal derived from treated cattle cannot be set; the CVMP has recommended the refusal of the granting of the marketing authorisation for the target species cattle and the variation of the existing marketing authorisations in order to remove any reference to the target species cattle for veterinary medicinal products containing methylprednisolone hydrogen succinate as referred in Annex I.
Maltese: • is-CVMP ikkunsidra li ma jistax jiġi stabbilit perjodu ta' twaqqif għal-laħam u l-ġewwieni tal-annimali derivati minn frat ikkurati; is-CVMP irrakkomanda r-rifjut tal-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq għall-frat speċi fil-mira u l-varjazzjoni għall-awtorizzazzjonijiet għat-tqegħid fis-suq eżistenti sabiex titneħħa kwalunkwe referenza għall-frat speċi fil-mira għal prodotti mediċinali veterinarji li fihom methylprednisolone hydrogen succinate kif imsemmija f'Anness I.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing methylprednisolone hydrogen succinate for use in target species cattle (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċinali veterinarji li fihom methylprednisolone hydrogen succinate għall-użu fi frat speċi fil-mira (ara Anness I)
English: Strength
Maltese: Anness
English: Taking all the information together, it cannot be confirmed from the available data that the withdrawal period of 6 days for cattle (meat and offal) for the reference product Solu-Medrol is safe for the consumer.
Maltese: Meta tittieħed din l-informazzjoni kollha f'daqqa, ma jistax jiġi kkonfermat mid-data disponibbli li lperjodu ta' distakk ta' 6 ijiem għall-frat (laħam u ġewwieni tal-annimali) għall-prodott ta' referenza Solu-Medrol huwa sigur għall-konsumatur.
English: Furthermore, the data from the MRL file on methylprednisolone support the assumption that the potential consumer exposure from injection site residue will be above the pharmacological ADI, indicating a serious risk for consumer safety.
Maltese: Barra minn hekk, id-data mill-fajl tal-MRL dwar methylprednisolone tappoġġja s-suppożizzjoni li l-esponiment potenzjali talkonsumatur mir-residwu fis-sit tal-injezzjoni se jkun ‘il fuq mill-ADI farmakoloġika, li jindika riskju serju għas-sikurezza tal-konsumatur.
English: The veterinary medicinal product that has been used in the residue depletion study for the establishment of maximum residue limits (MRLs) for methylprednisolone is a combination product containing methylprednisolone (as free
Maltese: Il-prodott mediċinali veterinarju li ntuża fl-istudju dwar it-tnaqqis ta' residwu għall-istabbiliment ta' limiti massimi ta' residwi (MRLs) għal methylprednisolone huwa prodott ikkombinat li fih methylprednisolone (bħala mingħajr alkoħol) u żewġ sustanzi antibijotiċi (neomycin u benzylpenicillin).
English: Benefit/risk
Maltese: Relazzjoni benefiċċju/riskju
English: Av. Tomás Ribeiro, 43 - Bloco 2, 3º FEdifício Neopark
Maltese: Tomás Ribeiro, 43 - Bloco 2, 3º FEdifício Neopark
English: House, 97/107 Uxbridge Road, Ealing
Maltese: C.P. House, 97/107 Uxbridge Road, Ealing
English: Magyarország Kereskedelmi Kft 1036 Budapest,
Maltese: Kft 1036 Budapest,
English: Via A. Fleming 2 - 37135 Verona Italy
Maltese: Fleming 2 - 37135 Verona Italy
English: Pabianickie Zakłady Farmaceutyczne Polfa S.A., ul.Marszałka J. Piłsudskiego 5
Maltese: Pabianickie Zakłady Farmaceutyczne Polfa S.A., ul.Marszałka J.
English: Ratiopharm Oy, Vitikka 1 F, P.O Box 67, 02630 Espoo, Finland
Maltese: Ratiopharm Oy, Vitikka 1 F, P.O Box 67, 02630
English: Via G. Fabbroni, 6 - 00191 Roma Italy
Maltese: Fabbroni, 6 - 00191 Roma Italy
English: S.C Terapia S.A Str. Fabricii nr. 124, Zip code : 400640 Cluj Napoca, România
Maltese: Fabricii nr. 124, Zip code : 400640 Cluj Napoca, România
English: Francia Farmaceutici Industria Farmaco Biologica Srl Via dei Pestagalli 7
Maltese: Industria Farmaco Biologica Srl Via dei Pestagalli 7
English: S.C AC Helcor S.R.L Str. Victor Babes nr.50, Baia Mare, Jud Maramures, zip code; 430092
Maltese: Victor Babes nr.50, Baia Mare, Jud Maramures, zip code; 430092
English: Sanofi Aventis France 1/13, Bd Romain Rolland 75014 Paris
Maltese: France 1/13, Bd Romain Rolland 75014
English: Xrispa Alpha Farmaceuticals S.A
Maltese: Xrispa Alpha Farmaceuticals
English: Francia Farmaceutici Industria Farmaco Biologica SrlVia dei Pestagalli 7
Maltese: Industria Farmaco Biologica SrlVia dei Pestagalli 7
English: Ratiopharm Hungária Kft. 1145 Budapest Uzsoki u. 36/a Hungary
Maltese: Ratiopharm Hungária Kft. 1145 Budapest Uzsoki u.
English: I-27010 Valle Salimbene (PV) Italy
Maltese: Valle Salimbene (PV) Italy
English: Ratiopharm Nederland BV, Ronde Tocht 11, 1507 CC Zaandam, The Netherlands
Maltese: Ratiopharm Nederland BV, Ronde Tocht 11, 1507 CC
English: Eurogenerics Heizel Esplanade B22 1020 Brussel Belgium
Maltese: Eurogenerics Heizel Esplanade B22 1020
English: Ranbaxy (UK) Ltd. C.P.
Maltese: Ranbaxy (UK) Ltd.
English: Korinthou 12, N. Psychiko, 15451 Greece
Maltese: Psychiko, 15451 Greece
English: Farmaceutici Caber S.p.A. Viale Città d'Europa 681 - 00144 Roma Italy
Maltese: Viale Città d'Europa 681 - 00144
English: Avgis & Gallinis 15, N. Kifissia Greece
Maltese: Avgis & Gallinis 15, N.
English: Merck Sharp - Dohme Chibret 3 avenue Hoche 75114 Paris Cedex 08
Maltese: Merck Sharp - Dohme Chibret 3 avenue Hoche 75114
English: Vilco S.A Pefkon Street 121 N. Irakleion 14122 Greece
Maltese: Vilco S.A Pefkon Street 121 N.
English: Overall, the responses provided included bibliographical data and a proposal to update the section 5.1 of the SPC.
Maltese: Globalment, it-tweġibiet ipprovduti inkludew dejta bibljografika u proposta għall-aġġornament tas-sezzjoni 5.1 talSPC.
English: S.C Labormed-Pharma S.A Splaiul Independentei nr. 319E, sector 6, Bucharest, zip code: 060044
Maltese: 319E, sector 6, Bucharest, zip code: 060044
English: Largo Umberto Boccioni, 1 21040 - Origgio (VA) Italy
Maltese: Largo Umberto Boccioni, 1 21040
English: Gyrablock 400 mg 400 mg
Maltese: Gyrablock 400 mg
English: Krka, d.d., Novo mesto Šmarješka cesta 6
Maltese: Ir-Repubblika Ċeka Krka, d.d., Novo mesto Šmarješka cesta 6
English: de Burgos, 91 28050 Madrid Spain
Maltese: Abbott Laboratories, S.A Avda. de Burgos, 91 28050 Madrid Spain
English: • The Committee considered the referral made under article 31 of Directive 2001/83/EC, as amended, for medicinal products containing norfloxacin;
Maltese: • Il-Kumitat ikkunsidra r-referenza magħmula skont l-Artiklu 31 tad-Direttiva 2001/83/KE, kif emendata, għall-prodotti mediċinali li fihom norfloxacin;
English: 100ml contains 5,4g of Norfloxacin pivaloil-oxymethyl-ester as 4,0g of Norfloxacin
Maltese: 100ml fih 5.4g ta' Norfloxacin pivaloil-oxymethyl-ester bħala 4.0g ta' Norfloxacin
English: Norflox-1A Pharma 400 mg
Maltese: Norflox-1A Pharma
English: United Kingdom Ratiopharm GmbH, Graf-Arco-Strasse 3,
Maltese: Ir-Repubblika Ċeka Ratiopharm GmbH Graf-Arco-Strasse 3
English: Ruhrpharm AG Heidsieker Heide 114 D-33739 Bielefeld Germany
Maltese: Ruhrpharm AG Heidsieker Heide 114
English: However the CHMP welcomed the idea to update the MIC breakpoints in section 5.1 of the SPC to include the clinical MIC breakpoints as defined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) in section 5.1 of the SPC as these breakpoints are not only related to the pathogens found in complicated pyelonephritis, but to common urinary pathogens found in other urinary indications.
Maltese: Madankollu s-CHMP laqa' l-idea li jiġu aġġornati l-breakpoints tal-MIC fis-sezzjoni 5.1 tal-SPC biex jinkludu l-breakpoints tal-MIC kif definiti mill-Kumitat Ewropew għall-Ittestjar tas-Suxxettibilità Antimikrobika (EUCAST) fis-sezzjoni 5.1 tal-SPC għax dawn il-breakpoints mhumiex relatati biss mal-patoġeni preżenti fil-pjelonefrite kumplikata, iżda wkoll ma' patoġeni komuni tal-apparat urinarju preżenti f'indikazzjonijiet urinarji oħra.
English: Sede legale: ABC Farmaceutici S.p.A. Corso Vittorio Emanuele II, 72 Torino
Maltese: Corso Vittorio Emanuele II, 72 Torino
English: via Felice Casati, 16 - 20124 Milano Italy
Maltese: Tad Pharma Italia S.r.l. via Felice Casati, 16 - 20124
English: GROUNDS FOR THE REMOVAL OF THE THERAPEUTIC INDICATION “ACUTE AND CHRONIC COMPLICATED PYELONEPHRITIS”
Maltese: GĦAT-TNEĦĦIJA TAL-INDIKAZZJONI TERAPEWTIKA "PJELONEFRITE AKUTA U KRONIKA KUMPLIKATA"
English: So. Se. Pharm S.r.l.
Maltese: Pharm S.r.l.
English: Merck, Sharp & Dohme GmbH Donau - City - Straße 6 A-1220 Wien
Maltese: Merck, Sharp & Dohme GmbH Donau - City - Straße 6
English: United Kingdom Merck Sharpe & Dohme Limted, Hertford Road, Hoddesdon,
Maltese: Merck Sharpe & Dohme Limted, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU.
English: 540mg of Norfloxacin pivaloil-oxymethyl-ester as 400mg of Norfloxacin
Maltese: 540mg ta' Norfloxacin pivaloil-oxymethyl-ester bħala 400mg ta' Norfloxacin
English: Eurogenerics Esplanade Heysel, B.22 B-1020 Bruxelles Belgium
Maltese: Il-Lussemburgu Eurogenerics Esplanade Heysel, B.22
English: Floxolone 400mg 400 mg
Maltese: Floxolone 400mg
English: Medochemie Ltd, Limassol Constantinoupoleos St. 1-10, P.O.Box 51409, CY-3505 Limassol Cyprus
Maltese: St. 1-10, P.O.Box 51409, CY-3505 Limassol Cyprus
English: The referral procedure was then started on 20 September 2007.
Maltese: Il-proċedura ta' referenza nbdiet fl-20 ta' Settembru 2007.
English: The MAHs did not provide any relevant information showing comparison of tissue concentrations after oral treatment with norfloxacin, ciprofloxacin, ofloxacin and levofloxacin.
Maltese: Il-MAHs ma pprovdew l-ebda tagħrif rilevanti li juri l-paragun tal-konċentrazzjonijiet fit-tessuti wara t-trattament orali b'norfloxacin, ciprofloxacin, ofloxacin u levofloxacin.
English: The MAHs that answered to the questions were unable to provide unpublished scientific data, and some proposed to withdraw this indication, at the exception of 2 MAHs.
Maltese: Il-MAHs li wieġbu għall-mistoqsijiet ma kinux kapaċi jipprovdu dejta xjentifika li ma kinitx diġa ppubblikata, u wħud ipproponew l-irtirar ta' din l-indikazzjoni, bl-eċċezzjoni ta' 2 MAHs.
English: Bialfar - Produtos Farmacêuticos, S.A., Av. da Siderurgia Nacional, P.O.
Maltese: Bialfar - Produtos Farmacêuticos, S.A., Av. da Siderurgia Nacional, P.O. Box 56 4745-457 S.
English: Aliud Pharma GmbH & Co.KG Gottlieb-Daimler-Str. 19
Maltese: Aliud Pharma GmbH & Co.KG Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
English: Sandoz Farmaceutica, S.A Avenida de Osa Mayor 4.
Maltese: Sandoz Farmaceutica, S.A Avenida de Osa Mayor 4. 28023 Aravaca Madrid
English: The CHMP has recommended the removal of the therapeutic indication “acute and chronic complicated pyelonephritis” for the medicinal products containing norfloxacin taken orally (referred to medicinal products listed in Annex I).
Maltese: Is-CHMP irrakkomanda t-tneħħija tal-indikazzjoni terapewtika "pjelonefrite akuta jew kronika kumplikata" għall-prodotti mediċinali li fihom norfloxacin meħudin oralment (b'referenza għallprodotti mediċinali elenkati fl-Anness I).
English: Belgium triggered a referral procedure on 14 September 2007 and requested the CHMP to give its opinion on whether the marketing authorisations for oral formulations of products containing norfloxacin in the treatment of acute or chronic complicated or uncomplicated pyelonephritis should be maintained, varied, suspended or withdrawn across the European Union following the reassessment of norfloxacin benefit/risk balance.
Maltese: Il-Belġju beda proċedura ta' referenza fl-14 ta' Settembru 2007 u talab lis-CHMP biex jagħti l-opinjoni tiegħu dwar jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq għal formulazzjonijiet orali ta' prodotti li fihom norfloxacin fit-trattament ta' pjelonefrite akuta jew kronika b'kumplikazzjonijiet jew mingħajrhom għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew jitneħħew fl-Unjoni Ewropea kollha wara l-valutazzjoni ġdida tal-bilanċ bejn il-benefiċċju u r-riskju ta' norfloxacin.
English: Sede legale: Laboratori Alter s.r.l.
Maltese: Laboratori Alter s.r.l. Via Egadi,
English: Norfloxacin containing medicinal products, which are only available as an oral formulation, do not provide adequate serum levels for the treatment of concomitant bacteraemia.
Maltese: Il-prodotti mediċinali abbażi ta' norfloxacin, disponibbli biss bħala formulazzjoni orali, ma jipprovdux livelli fis-serum adegwat għat-trattament ta' batterjemija konkomitanti.
English: Utinor 400mg tablets 400mg
Maltese: Utinor 400mg tablets
English: United Kingdom TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, Cuxhaven, D-27472
Maltese: TAD Pharma GmbH, Heinz-Lohmann-Strasse 5, Cuxhaven, D-27472 Germany
English: Utinor Tablets 400mg 400mg
Maltese: Utinor Tablets 400mg 400mg Pillola miskija
English: Having considered the overall data provided in February and June 2008, the CHMP concluded that the marketing authorisations for the oral formulations of medicinal products containing norfloxacin, when used in the treatment of acute or chronic complicated pyelonephritis, should be withdrawn because the efficacy can no longer be demonstrated in this indication.
Maltese: Wara li kkunsidra d-dejta globali pprovduta fi Frar u f'Ġunju 2008, is-CHMP ikkonkluda li lawtorizzazzjonijiet għat-tqegħid fis-suq għall-formulazzjonijiet orali tal-prodotti mediċinali li fihom norfloxacin, meta jintużaw fit-trattament ta' pjelonefrite akuta jew kronika kumplikata, għandhom jitneħħew billi mhuwiex possibbli li tintwera l-effikaċja f'din l-indikazzjoni.
English: Norfloxacin is a broad-spectrum, quinolone bactericidal agent indicated for the treatment of acute or chronic complicated or uncomplicated pyelonephritis due to susceptible organisms.
Maltese: Norfloxacin huwa aġent batteriċida bi spettru wiesa' tal-kategorija tal-kinoloni (quinolones) indikat għat-trattament tal-pjelonefrite akuta jew kronika kumplikata kkawżata minn organiżmi suxxettibbli.
English: Coated tablets
Maltese: Nalion comprimidos
English: Most of the Marketing Authorisation Holders (MAHs) involved in the referral did not provide any answer to the list of questions adopted by the CHMP in September 2007, when the procedure was initiated.
Maltese: Ħafna mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAHs) involuti fil-proċedura ta' referenza ma wiġbux għall-lista ta' mistoqsijiet adottata mis-CHMP f'Settembru 2007, meta nbdiet ilproċedura.
English: Norflohexal 400mg 400 mg
Maltese: Norflohexal 400mg
English: This request was based on the following reasons:
Maltese: Sede legale:
English: The CHMP therefore concluded on 24 July 2008 that for oral norfloxacin containing medicinal products the benefit does not outweigh the risk in complicated pyelonephritis.
Maltese: Għalhekk, fl-24 ta' Lulu 2008, is-CHMP ikkonkluda li għal prodotti mediċinali orali li fihom norfloxacin, il-benefiċċju mhuwiex ogħla mir-riskji fit-trattament tal-pjelonefrite kumplikata.