qanastek/EMEA-V3 huggingface dataset:
Furthermore, it could not be accepted that no data on the use of Menitorix or on antibody persistence beyond the second year of life was provided.
Barra minn dan, ma setax jiġi aċċettat li l- ebda dejta ma ġiet provduta dwar l- użu ta 'Menitorix jew dwar il- persistenza ta' antikorpi wara t- tieni sena ta 'ħajja.
These objections were considered to be of serious public health concern.
Dawn l- objezzjonijiet tqiesu bħala tħassib serju għas- saħħa pubblika.
The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Il- proċedura ta 'arbitraġġ bdiet fis- 26 ta ’ April 2007 permezz ta' l- adozzjoni ta 'lista ta' mistoqsijiet.
The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Michał Piroż ynski.
Ir - Rapporteur kien id- Dr Ian Hudson l- ko- Rapporteur kien id- Dr Michał Pirożynski.
The Marketing Authorisation Holder provided written explanations on 19 July 2007 and on 17 October 2007.
Id- Detentur ta 'l - Awtorizzazzjoni għat- Tqegħid fis- Suq ta spjegazzjonijiet bil- miktub fid- 19 ta' Lulju 2007 u fis- 17 ta 'Ottubru 2007.
During their November 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Menitorix, that the objections raised by Greece, Poland and Spain should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Waqt il- laqgħa tiegħu f' Novembru 2007, is- CHMP, fid- dawl tat- tagħrif globali ppreżentat u fid- dawl tad - diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- fehma li l- bilanċ bejn il- benefiċċji u r- riskji kien favorevoli għal Menitorix, li l- objezzjonijiet imqajma mill- Greċja, il- Polonja u Spanja ma għandhomx jimpedixxu l - għoti ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u li s- Sommarju tal- Karatteristiċi tal- Prodott, it- tikketta u l - fuljett ta' tagħrif ta 'l- Istat Membru ta' Referenza għandhom jiġu emendati.
A positive opinion was adopted by consensus on 15 November 2007.
Ġiet adottata opinjoni pożittiva permezz ta 'kunsens fil- 15 ta' Novembru 2007.
The list of the product names concerned is given in Annex I.
Il- lista ta 'ismijiet tal- prodotti hija mogħtija fl- Anness I.
The final opinion was converted into a Decision by the European Commission on 01 April 2008.
L- opinjoni finali hija konvertita f' Deċiżjoni mill- Kummissjoni Ewropea fl- 01 ta 'April 2008.
LIST OF THE PRODUCT NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND ICELAND
LISTA TA` L- ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID- DETENTURI TA` L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FL- ISTATI MEMBRI U TA ’ L- ISLANDA
1 Member State MAH name and address
1 Stat Membru
Product Name
Isem tal- prodott
Austria Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Il- Ġermanja
Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Il- Ġermanja
Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria
Bayer Austria GmbH Herbststraße 6- 10 1160 Wien L- Awstrija
Bayer AG 51368 Leverkusen Germany
Bayer AG 51368 Leverkusen Il- Ġermanja
Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgium
Avenue Louise 143 Louizalaan B- 1050 Bruxelles Il- Belġju
Rue Egide Van Ophem 108 1180 Bruxelles Belgium
Rue Egide Van Ophem 108 1180 Bruxelles Il- Belġju
Sorou 18-20 151 25 Marousi - Athens Greece
Sorou 18- 20 151 25 Marousi - Athens Il- Greċja
2 Member State MAH name and address
2 Stat Membru
Germany Bayer Vital GmbH 51368 Leverkusen Germany
Bayer Vital GmbH 51368 Leverkusen Il- Ġermanja
Germany Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Il- Ġermanja
Denmark Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Il- Ġermanja
Denmark Teva Denmark A/ S, Parallelvej 10, 2800 Kongens Lyngby Denmark
Teva Denmark A/ S, Parallelvej 10, 2800 Kongens Lyngby Id- Danimarka
Denmark Teva UK Limited Brampton Road BN22 9AG East Sussex United Kingdom
Teva UK Limited Brampton Road BN22 9AG East Sussex Ir- Renju Unit
Estonia Bayer Health Care AG 51368 Leverkusen Germany
Bayer Health Care AG 51368 Leverkusen Il- Ġermanja
3 Member State MAH name and address
3 Stat Membru
Greece Bayer Hellas Abee Sorou 18-20 15125 Maroussi - Athens Greece
Bayer Hellas Abee Sorou 18- 20 15125 Maroussi - Athens Il- Greċja
Greece Bayer plc, Pharmaceutical Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom
Bayer plc, Pharmaceutical Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Ir- Renju Unit
Baix Llobregat, 3 y 5 hydrochloride 08970 Sant Joan Despi Barcelona Spain
Baix Llobregat, 3 y 5 hydrochloride 08970 Sant Joan Despi Barcelona Spanja
Procter and Gamble Pharmaceuticals Iberia, SL Moxifloxacin WTC Almeda park, Edif 1, 2º planta hydrochloride 08940 Cornellá de Llobregat Barcelona Spain
Procter and Gamble Pharmaceuticals Iberia, SL Moxifloxacin WTC Almeda park, Edif 1, 2º planta hydrochloride 08940 Cornellá de Llobregat Barcelona Spanja
RECORDATI ESPAÑA, SL Moxifloxacin Carretera De Zeneta, 149 hydrochloride 30588 Beniel (Murcia) Spain
RECORDATI ESPAÑA, SL Moxifloxacin Carretera De Zeneta, 149 hydrochloride 30588 Beniel (Murcia) Spanja
Mare de Déu de Montserrat, 221 hydrochloride 08041 Barcelona Spain
Mare de Déu de Montserrat, 221 hydrochloride 08041 Barcelona Spanja
4 Member State MAH name and address
4 Stat Membru
Finland Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Il- Ġermanja
Moxifloxacin hydrochloride
Moxifloxacin
France BAYER HEALTHCARE AG 51368 Leverkusen Germany
BAYER HEALTHCARE AG 51368 Leverkusen Il- Ġermanja
Hungary Bayer Hungária Kft Alkotás ut.50 1123 Budapest Hungary
Bayer Hungária Kft Alkotás ut. 50 1123 Budapest L- Ungerija
Iceland Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Il- Ġermanja
Viale Certosa, 130 20156 Milano Italy
Viale Certosa, 130 20156 Milano I- Italja
Italy Bayer AG 51368 Leverkusen Germany
Bayer AG 51368 Leverkusen Il- Ġermanja
Civitali, 1 20148 Milano Italy
Civitali, 1 20148 Milano I- Italja
MAH name and address
Isem u indirizz tad- Detentur ta ’ l - Awtorizzazzjoni għat- tqegħid fis- suq
Italy
S. p. A.
Viale Shakespeare, 47 00144 Roma Italy
Viale Shakespeare, 47 00144 Roma I- Italja
Moxifloxacin hydrochloride
hydrochloride
Ireland
I- Irlanda
Bayer Limited The Atrium Blackthorn Road, Dublin 18 Ireland
Bayer Limited The Atrium Blackthorn Road, Dublin 18 I- Irlanda
Bayer Healthcare AG 51368 Leverkusen Germany
Bayer Healthcare AG 51368 Leverkusen Il- Ġermanja
Avenue Louise 143 Louizalaan 1050 Bruxelles Belgium
Avenue Louise 143 Louizalaan 1050 Bruxelles Il- Belġju
Therabel Pharma 110 Rue Egide Van Ochem 1180 Bruxelles Belgium
Therabel Pharma 110 Rue Egide Van Ochem 1180 Bruxelles Il- Belġju
Bayer Vital GmbH 51368 Leverkusen Germany
Bayer Vital GmbH 51368 Leverkusen Il- Ġermanja
6 Member State MAH name and address
6 Stat Membru
Netherlands Bayer BV Energieweg 1 3641 RT Mijdrecht Nederland
Bayer BV Energieweg 1 3641 RT Mijdrecht L- Olanda
Netherlands Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Il- Ġermanja
Poland Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Il- Ġermanja
Portugal Bayer AG 51368 Leverkusen Germany
Bayer AG 51368 Leverkusen Il- Ġermanja
Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Rua Quinta do Pinheiro, 5 2794- 003 Carnaxide Il- Portugall
Mamede do Coronado Portugal
Mamede do Coronado Il- Portugall
Romania Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Il- Ġermanja
Sweden Bayer HealthCare AG 51368 Leverkusen Germany
Bayer HealthCare AG 51368 Leverkusen Il- Ġermanja
7 Member State MAH name and address
7 Stat Membru
Bravnič arjeva 13 1000 Ljubljana Slovenia
Bravničarjeva 13 1000 Ljubljana Is- Slovenja
Bayer plc, Pharmaceutical Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom
Bayer plc, Pharmaceutical Bayer House Strawberry Hill Newbury Berkshire RG14 1JA Ir- Renju Unit
THE SCIENTIFIC CONCLUSIONS AND THE GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦAL EMENDI TAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT U L- FULJETT TA 'TAGĦRIF
1 SCIENTIFIC CONCLUSIONS
1 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ORAL FORMULATIONS OF MOXIFLOXACIN CONTAINING MEDICINAL PRODUCTS (see Annex I)
FORMULAZZJONIJIET ORALI TA 'PRODOTTI MEDIĊINALI LI MOXIFLOXACIN (ara l- Anness I)
Moxifloxacin is a fluoroquinolone antibiotic with a broad spectrum of activity and bactericidal action.
Moxifloxacin huwa antibijotiku tal- kategorija tal- fluworokinoloni (fluoroquinolones) bi spettru
In the European Union (EU), Moxifloxacin film coated tablet are indicated for the treatment of acute bacterial sinusitis (ABS), acute exacerbation of chronic bronchitis (AECB) and community acquired pneumonia (CAP) except severe cases, at the dose of 400 mg daily for 7 days for ABS, 5-10 days for AECB and for 10 days for CAP.
Fl- Unjoni Ewropea (UE), il- pilloli ta 'moxifloxacin miksijin b' rita huma indikati għat- trattament tas- sinużite akuta ta' oriġini batterika (acute bacterial sinusitis, ABS), tat - taħrix akut tal- bronkite kronika (AECB) u pulmonite akkwiżita f' komunità (CAP) għajr għal każijiet gravi, f' doża ta '400 mg kuljum għal 7 ijiem għal ABS, 5- 10 ijiem għal AECB u għal 10 ijiem għal CAP.
In the EU, moxifloxacin is authorised in all Member States, via the Mutual Recognition or National Procedure.
Fl- UE, moxifloxacin huwa awtorizzat fl- Istati Membri kollha, permezz tar- Rikonoxximent Reċiproku jew Proċedura Nazzjonali.
Severe hepatotoxicity, cardiac toxicity including QTc interval prolongation, severe skin reactions, Clostridium difficile associated colitis, tendon and muscular toxicity (including rhabdomyolysis) are important identified risks of the treatment with moxifloxacin which are already described in the product information (PI) and under close monitoring.
Epatotossiċità serja, tossiċità kardijaka inkluż prolungament tal- intervall QTc, reazzjonijiet gravi tal - ġilda, kolite assoċjata ma 'Clostridium difficile, tossiċità fit- tendini u muskolari (inkluż rabdomjoliżi) jikkostitwixxu riskji identifikati importanti tat- trattament b' moxifloxacin li huma diġà deskritti fit - tagħrif dwar il- prodott (PI) u taħt monitoraġġ mill- qrib.
In October 2007, the assessment of the 15th and 16th PSUR for moxifloxacin identified major safety concerns including life threatening hepatotoxicity cases.
F' Ottubru 2007, il- valutazzjoni tal- 15 u s- 16- il PSUR għal moxifloxacin identifikat tħassib maġġuri għas- sigurtà, fosthom każijiet ta 'epatotossiċità potenzjalment fatali.
A cumulative review up to 30 September 2007 of all hepatic reactions (serious and non-serious) and an overall assessment of the benefit/ risk ratio of moxifloxacin treatment was performed.
Sar eżami kumulattiv mill- ġdid tar- reazzjonijiet epatiċi kollha (gravi u mhux gravi) sad- data tat- 30 ta 'Settembru 2007 u valutazzjoni ġenerali tar- relazzjoni benefiċċju/ riskju tat- trattament b' moxifloxacin.
Of a total of 48 identified cases of possibly moxifloxacin-related liver disorders with a fatal outcome of any cause, 8 were suspected cases of moxifloxacin-induced fatal hepatotoxicity.
Minn total ta '48 każ identifikat ta' disturbi epatiċi possibbilment relatati ma 'moxifloxacin b' eżitu fatali ta' kwalunkwe kawża, 8 kienu każijiet suspettati ta 'epatotossiċità fatali indotta minn moxifloxacin.
In 3 of these, moxifloxacin was used for treating less severe indications (sinusitis, pharyngitis and acute bronchitis).
Fi 3 minn dawn, moxifloxacin intuża għat- trattament ta 'indikazzjonijiet inqas severi (sinużite, farinġite u bronkite akuta).
These findings and additional available data (observational study and clinical trials) suggested that serious liver injuries occurred more frequently with moxifloxacin then with the comparators.
Dan ir- riżultati flimkien ma 'tagħrif disponibbli addizzjonali (studju ta' osservazzjoni u provi kliniċi) jissuġġerixxu li leżjonijiet epatiċi gravi seħħew b' mod aktar frekwenti b' moxifloxacin milli bil - mediċini tat- tqabbil (comparators).
Based on the above, on 2 June 2008, the UK issued a Rapid Alert informing Members States, the European Medicines Agency (EMEA) and the European Commission (EC) in accordance with Article 107 of Directive 2001/ 83/ EC, as amended of its intention to vary the marketing authorisation of all oral formulations of moxifloxacin containing medicinal products to remove the indications in ABS and AECB and to restrict the indication in CAP.
Abbażi ta 'dan ta' hawn fuq, fit- 2 ta 'Ġunju 2008, ir- Renju Unit ħareġ Twissija Rapida li fiha informa lill- Istati Membri, lill- Aġenzija Ewropea għall- Mediċini (EMEA) u lill- Kummissjoni Ewropea (KE) skont l- Artikolu 107 tad- Direttiva 2001/ 83/ KE, kif emendata, bl- intenzjoni tiegħu li jbiddel l - awtorizzazzjoni għat- tqegħid fis- suq għall- formulazzjonijiet orali kollha ta' prodotti mediċinali li fihom moxifloxacin sabiex jitneħħew l- indikazzjonijiet fl- ABS u AECB u sabiex tiġi ristretta l - indikazzjoni għall- CAP.
The CHMP reviewed all of the information made available by marketing authorisation holders (MAH) on the balance of benefits and risks of oral moxifloxacin in the above indications.
Is- CHMP studja t- tagħrif kollu għad- dispożizzjoni tad- detenturi tal- awtorizzazzjoni għat- tqegħid fis - suq (MAH) dwar ir- relazzjoni bejn il- benefiċċji u r- riskji ta 'moxifloxacin orali fl- indikazzjonijiet ta' hawn fuq.
Moxifloxacin has shown efficacy in all of the approved indications.
Moxifloxacin wera effikaċja fl- indikazzjonijiet approvati kollha.
Notwithstanding this fact, the safety profile of the product is of concern.
Minkejja dan il- fatt, il- profil tas - sigurtà tal- prodott iqajjem tħassib.
The CHMP noted:
Is- CHMP innota:
ABS ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
ABS Normalment, ABS hija infezzjoni mhux severa assoċjata ma 'rati għoljin ta' kura spontanja (90%).
A substantial proportion of prescriptions for sinusitis in clinical practice may be empirical and without confirmation of bacterial origin.
Fil - prattika klinika, huwa possibbli li proporzjon sostanzjali tal- preskrizzjonijiet għal sinużite jsiru fuq bażi empirika u mingħajr konferma tal- oriġini batterika.
Although moxifloxacin has shown to be effective, the available data is limited as studies have been mainly performed against comparators and the only placebo controlled study failed to demonstrate statistical superiority over placebo.
Għalkemm moxifloxacin wera li huwa effikaċi, it- tagħrif disponibbli huwa limitat minħabba li l- istudji prinċipalment saru fil- konfront tal - comparators u l- uniku studju kkontrollat kontra plaċebo naqas milli juri s- superjorità statistika meta mqabbel mal- plaċebo.
Considering the higher incidence of serious and even life-threatening risks in the treatment of an infection which has a high spontaneous resolution rate without antibiotics was considered of concern.
L- inċidenza ogħla ta 'riskji serji u potenzjalment fatali fit- trattament ta' infezzjoni b' rata ta 'riżoluzzjoni spontanja għolja ħafna mingħajr antibijotiċi tat lok għal tħassib.
However, the benefit risk of moxifloxacin may be favourable if other antibiotherapy has failed or cannot be used.
2 Madankollu, ir- relazzjoni bejn ir- riskju u l- benefiċċju ta 'moxifloxacin tista' tkun favorevoli fil - każijiet li fihom terapija antibijotiċi oħra ma jkunux ħadmu jew ma jkunux jistgħu jintużaw.
However, it was noted that until recently antibiotic comparative trials in AECB designed to
AECB Il- benefiċċju tat- trattament antibijotiku tal- AECB ġie appoġġjat minn bosta pubblikazzjonijiet inkluż minn metanaliżi u minn reviżjoni sistematika reċenti mwettqa minn Cochrane Centre li tissuġġerixxi benefiċċju meta mqabbla ma 'plaċebo, f' termini ta' mortalità, bl- użu ta 'antibijotiċi f' din l- indikazzjoni u effett pożittiv fuq il- funzjoni tal- pulmun.
2 show equivalence between medicinal products did not demonstrate clinical superiority of any class of antibiotics over another.
Madankollu, ġie nnotat li sa ftit taż- żmien ilu, provi komparattivi antibijotiċi għal AECB imfassla sabiex juru l- ekwivalenza bejn il- prodotti mediċinali ma wrewx superjorità klinika fuq klassijiet ta 'antibijotiċi oħrajn.
Additionally, most of the phase III studies designed for non-inferiority for moxifloxacin did not use the recommended agent of choice.
Barra minn hekk, bosta mill- istudji tal - fażi III mfassla għal nuqqas ta 'inferjorità għal moxifloxacin ma użawx is- sustanza rakkomandata tal - għażla.
Therefore, since the impact of the choice of an antibiotic therapy for AECB on the outcome of the patients remains unclear, the safety profile of the different antibiotherapy options must be considered.
Għaldaqstant, minħabba li l- impatt tal- għażla ta 'terapija antibijotika għall- AECB fuq ir - riżultat tal- pazjenti jibqa' mhux ċar, għandu jiġi kkunsidrat il- profil tas- sigurtà tal- alternattivi differenti ta 'antibijoterapija.
In line with the safety profile, and considering that AECB can be a less severe infection, with high spontaneous resolution rate for which bacteria can be found in only 50% of all exacerbations, the benefit risk can only be considered favourable if moxifloxacin is not used as the first line treatment option.
B' konformità mal- profil tas- sigurtà, u filwaqt li jiġi kkunsidrat li AECB tista 'tikkostitwixxi infezzjoni inqas severa, b' rata ta' riżoluzzjoni spontanja għolja bi preżenza batterika tal- 50% biss tat- taħrixiet kollha, ir- relazzjoni bejn ir- riskju u l- benefiċċju jista 'jitqies favorevoli biss jekk moxifloxacin ma jintużax bħala l- għażla ta' trattament tal- ewwel linja.
CAP Clinical trial and published data indicate that moxifloxacin generally has benefits in the indication CAP.
CAP Prova klinika u tagħrif ippubblikat jindikaw li b' mod ġenerali, moxifloxacin għandu benefiċċji fl - indikazzjoni CAP.
Furthermore, when taking into account other antiobiotherapy available and resistance, some times advantages over other therapies are observed in the treatment of CAP of mild to moderate severity.
Barra minn hekk, meta tiġi kkunsidrata d- disponibbiltà ta 'terapiji antiobijotiċi oħra u r- reżistenza, xi kultant jiġu osservati vantaġġi meta mqabbla ma' terapiji oħrajn fit- trattament tal - CAP ta 'serjetà ħafifa għal moderata.
However, considering the safety profile with observed increased incidence of risks, moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.
Madankollu, meta jiġi kkunsidrat il- profil tas- sigurtà b' inċidenza miżjuda tar- riskji osservati, moxifloxacin għandu jintuża biss meta l- użu ta 'aġenti antibatteriċi li huma rrakkomandati b' mod komuni għat- trattament inizjali ta' din l- infezzjoni jkun ikkunsidrat mhux xieraq.
In view of the above, the CHMP recommended the restriction to 2nd line treatment in the indications for moxifloxacin containing medicinal products (oral formulation) and further amendments to the PI, to include fatal hepatotoxicity cases, risk factors for QTc interval prolongation, and strengthen the warnings on Clostridium difficille-associated colitis and bullous skin reactions.
Minħabba dan li għandu kif intqal hawn fuq, is- CHMP irrakkomanda r- restrizzjoni għat- trattament tat- tieni linja fl- indikazzjonijiet għal prodotti mediċinali li fihom moxifloxacin (formulazzjoni orali) u emendi oħra għall- PI, sabiex jinkludi każijiet ta 'epatotossiċità fatali u fatturi ta' riskju għall - prolungament tal- intervall QTc, u li jsiru iktar inċiżivi t- twissijiet dwar kolite assoċjata ma 'Clostridium difficile u reazzjonijiet tal- ġilda bl- infafet (bullous).
GROUNDS
RAĠUNIJIET GĦAL EMENDA TAS- SOMMARJI PRODOTT U FULJETTI TA 'TAGĦRIF
OF THE SUMMARIES OF
TAL- KARATTERISTIĊI
PRODUCT
TAL -
Whereas,
Billi,
The Committee considered the procedure under Article 107 of Directive 2001/ 83/ EC, as amended, for medicinal products containing moxifloxacin in oral formulations.
Il- Kumitat ikkunsidra l- proċedura skont l- Artikolu 107 tad- Direttiva 2001/ 83/ KE, kif emendata, għal prodotti mediċinali li fihom moxifloxacin f' formulazzjonijiet orali.
In view of the available data the Committee concluded that the benefit risk balance of moxifloxacin containing medicinal products in oral formulations in the approved indications under review is favourable as second line indications.
Minħabba t- tagħrif disponibbli, il- Kumitat ikkonkluda li l- bilanċ bejn il- benefiċċju u r- riskju ta 'prodotti mediċinali li fihom moxifloxacin f' formulazzjonjiet orali fl- indikazzjonijiet approvati studjati huwa wieħed favorevoli daqs dak ta' indikazzjonijiet tat- tieni linja.
In ABS and AECB, moxifloxacin should only be used when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed to resolve the infection.
Fl- ABS u AECB, moxifloxacin għandu jintuża biss fil- każijiet li fihom jitqies mhux xieraq l- użu ta 'sustanzi antibatteriċi li huma rakkomandati b' mod komuni għat- trattament inizjali ta' dawn l- infezzjonijiet jew meta dawn ikunu naqsu milli jirrisolvu l- infezzjoni.
In CAP, it is to be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection.
Fil- CAP, għandu jintuża biss fil- każijiet li fihom jitqies mhux xieraq l- użu ta 'sustanzi antibatteriċi li huma rakkomandati b' mod komuni għat- trattament inizjali ta' dawn l- infezzjonijiet.
In view of the safety available data the Committee concluded that cases of fatal hepatotoxicity, risk factors for QTc interval prolongation should be reflected in the product information, and that the warnings on Clostridium difficille-associated colitis and bullous skin reactions should be strengthen.
Minħabba d- dejta disponibbli dwar is- sigurtà, il- Kumitat ikkonkluda fit- tagħrif dwar il- prodott għandhom jissemmgħu l- każijiet ta 'epatotossiċità fatali u l- fatturi ta' riskju għall- prolungament tal - intervall QTc għandhom ikunu riflessi, u li t- twissijiet dwar kolite assoċjata ma 'Clostridium difficille u reazzjonijiet tal- ġilda bl- infafet (bullous) isiru iktar inċiżivi.
The CHMP, as a consequence recommended amendments to the relevant sections of the summary of product characteristics and package leaflet for the medicinal products containing moxifloxacin (see Annex III).
3 Bħala konsegwenza, is- CHMP irrakkomanda emendi għas- sezzjonijiet rilevanti fis- sommarju tal - karatteristiċi tal- prodott u fuljett ta 'tagħrif għall- prodotti mediċinali li fihom moxifloxacin (ara l - Anness III).
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA ’ L- ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, U D- DETENTURI TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FL- ISTATI MEMBRI Stat Membru
Film-coated tablet
Pillola miskija b’ rita
Belgium
Qawwa
Coated tablets
Pilloli miskijin
Pharmaceutical Form
Ir- Repubblika Ċeka
Coated tablet
Pillola miskija
Oral
Jittieħed mill - ħalq
Germany Germany
Il- Ġermanja
coated tablet
Pillola miskija
12 Member State
L- Italja
Marketing Authorisation Holder
Francia Farmaceutici Industria Farmaco Biologica Srl –
Invented name
Diperflox
Strength
540mg ta ’
Pharmaceutical Form
Pillola
Route of administration
Jittieħed mill -
Francia Farmaceutici Industria Farmaco Biologica Srl - Via dei Pestagalli 7 Milano Italy
Via dei Pestagalli 7 Milano Italy
540mg of Norfloxacin pivaloil-oxy- methyl-ester as 400mg of Norfloxacin
Norfloxacin pivaloil- oxy - methyl- ester bħala 400mg ta ’
Tablet
ħalq
Italy
Norfloxacin L- Italja
100ml contains 5,4g of Norfloxacin pivaloil-oxy- methyl-ester as 4,0g of Norfloxacin
Sospensjoni orali
Oral suspension
Jittieħed mill - ħalq
Oral use
Norfloxacin pivaloil- oxy - methyl- ester
Italy
bħala 4. 0g ta ’ Norfloxacin L- Italja
Pliva Pharma S. p. A via Tranquillo Cremona, 10 – 20092 Cinisello Balsamo (MI) Italy
Pliva Pharma S. p. A
540mg of Norfloxacin pivaloil-oxy- methyl-ester as 400mg of Norfloxacin
540mg ta ’
Pliva Pharma S. p. A. via Tranquillo Cremona, 10 – 20092 Cinisello Balsamo (MI) Italy
Pliva Pharma S. p. A. via Tranquillo Cremona,
Strength
Il- Latvja
14 Member State
Il- Lussemburgu
Utinor 400mg tablets
Utinor
400mg
400mg tablets 400mg
Film-coated tablets
Pilloli miskijin b’ rita
Utinor Tablets 400mg
Utinor Tablets
Oral Use
Jittieħed mill - ħalq
Norfloxacin 400mg Tablets
Norfloxacin Tablets
Oral Use
400mg
20 Member State
Pillola miskija
Route of administration
Jittieħed mill - ħalq
Ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
Ratiopharm GmbH, Graf- Arco- Strasse 3, D- 89079 Ulm, Germany ANNESS II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE REMOVAL OF THE THERAPEUTIC INDICATION “ ACUTE AND CHRONIC COMPLICATED PYELONEPHRITIS” PRESENTED BY THE EMEA SCIENTIFIC CONCLUSIONS
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET IPPREŻENTATA MILL- EMEA GĦAT- TNEĦĦIJA TAL- INDIKAZZJONI TERAPEWTIKA "PJELONEFRITE AKUTA U KRONIKA KUMPLIKATA" KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NORFLOXACIN CONTAINING MEDICINAL PRODUCTS (see Annex I)
SOMMARJU GLOBALI TAL- EVALWAZZJONI XJENTIFIKA TA 'PRODOTTI MEDIĊINALI LI FIHOM NORFLOXACIN (ara l- Anness I)
Norfloxacin is a broad-spectrum, quinolone bactericidal agent indicated for the treatment of acute or chronic complicated or uncomplicated pyelonephritis due to susceptible organisms.
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.
It is currently authorised in the EU under the different names referred in Annex I.
Bħalissa huwa awtorizzat fl- UE taħt l- ismijiet differenti li jissemmew fl- Anness I.
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 re- assessment of norfloxacin benefit/ risk balance.
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.
This request was based on the following reasons:
Din it- talba kienet ibbażata fuq dawn ir- raġunijiet:
- Pyelonephritis is often associated with bacteraemia.
- Il- pjelonefrite ħafna drabi tkun assoċjata ma 'batterjemija.
Norfloxacin containing medicinal products,
Il- prodotti mediċinali abbażi ta '
which are only available as an oral formulation, do not provide adequate serum levels for the treatment of concomitant bacteraemia.
norfloxacin, disponibbli biss bħala formulazzjoni orali, ma jipprovdux livelli fis- serum adegwat għat- trattament ta 'batterjemija konkomitanti.
- There are other alternative treatments available for the above-mentioned indication.
- Jeżistu trattamenti alternattivi oħra għall- indikazzjoni msemmija hawn fuq.
Second
Il- fluworokinoloni tat -
generation fluoroquinolones such as ciprofloxacin, ofloxacin and levofloxacin show higher serum concentrations and a much better tissue distribution than norfloxacin.
tieni ġenerazzjoni bħal ciprofloxacin, ofloxacin u levofloxacin urew konċentrazzjonijiet fis- serum ogħla u distribuzzjoni fit- tessuti ħafna aħjar minn norfloxacin.
- Complicated pyelonephritis can be treated orally or intravenously (according to local treatment
- Il- pjelonefrite kumplikata tista 'tiġi ttrattata b' formulazzjonijiet orali jew intravenużi (skont ir -
policy and diagnostic criteria used for defining complicated infection).
regoli lokali dwar it- trattamenti u l- kriterji dijanjostiċi użati għad- definizzjoni ta 'infezzjoni kumplikata).
In case of oral treatment, second generation fluoroquinolones are superior to norfloxacin because they present higher serum and tissue levels.
Fil- każ ta 'trattament orali, il- fluworokinoloni tat- tieni ġenerazzjoni huma superjuri għal norfloxacin minħabba li jippreżentaw livelli ogħla fis- serum u fit- tessuti.
The same objections are obviously valid for the oral treatment of uncomplicated pyelonephritis.
L- istess oġġezzjonijet huma ovvjament validi għat- trattament orali ta 'pjelonefrite mhux kumplikata.
The referral procedure was then started on 20 September 2007.
Il- proċedura ta 'referenza nbdiet fl- 20 ta' Settembru 2007.
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.
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 il - proċedura.
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.
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.
As a response to CHMP, most of the MAHs proposed to withdraw the indication in question, while some MAHs chose to submit bibliographic data, because no unpublished data from clinical trials were available to them.
Bi tweġiba lis- CHMP, ħafna mill- MAHs ipproponew it- tneħħija tal- indikazzjoni inkwistjoni, waqt li xi MAHs għażlu li jippreżentaw dejta bibljografika, għax ma kellhom l- ebda dejta minn provi kliniċi li ma kinitx diġa ppubblikata.
The data submitted did not demonstrate that serum levels after oral treatment with norfloxacin are adequate for eradicating pathogens involved in bacteraemia associated with complicated pyelonephritis.
Id- dejta ppreżentata ma wrietx li, wara trattament orali b' norfloxacin, il- livelli tas- serum huma adegwati għall- eradikazzjoni tal- aġenti patoġeni involuti fil- batterjemija assoċjata mal- pjelonefrite kumplikata.
Additionally, the relationship between the Pharmacokinetic and the Pharmacodynamic of orally administered norfloxacin in the treatment of complicated pyelonephritis was been established.
Barra minn hekk, ġiet stabbilita r- rabta bejn il- farmakokinetika u l- farmakodinamika ta 'norfloxacin amministrat oralment fit- trattament ta' pjelonefrite kumplikata.
The MAHs did not provide any relevant information showing comparison of tissue concentrations after oral treatment with norfloxacin, ciprofloxacin, ofloxacin and levofloxacin.
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.
It is though known that the second generation fluoroquinolones (ciprofloxacin, ofloxacin and levofloxacin) show higher serum concentrations and a more favourable tissue distribution than norfloxacin.
Madankollu huwa magħruf li l- fluworokinoloni tat- tieni ġenerazzjoni (ciprofloxacin, ofloxacin u levofloxacin) juru konċentrazzjoni tas- serum ogħla u distribuzzjoni fit- tessuti aktar favorevoli minn norfloxacin.
Further to the discussion held in May 2008, the CHMP agreed that the second generation of fluoroquinolones result in higher serum concentrations than norfloxacin.
Wara d- diskussjoni li saret f' Mejju 2008, is- CHMP qabel li l- fluworokinoloni tat- tieni ġenerazzjoni jirriżultaw f' konċentrazzjonijiet tas- serum ogħla minn norfloxacin.
However the CHMP requested a more detailed review of all relevant data specifically on resistance to common urinary pathogens and the possible consequences on the section 5.1 of the SPC before the final conclusion could be made, which lead to the adoption of a List of Outstanding Issues.
Madankollu, is- CHMP talab, bil - għan li jkun jista 'jasal għal konklużjoni finali, analiżi iktar dettaljata tad- dejta rilevanti kollha speċifikament fuq ir- reżistenza għal patoġeni komuni tal- apparat urinarju u l- konsegwenzi possibbli li hemm fis- sezzjoni 5. 1 tal- SPC, u dan wassal għall- adozzjoni ta' Lista ta 'Kwistjonijiet Pendenti.
Only 3 MAHs answered to this List of outstanding issues adopted in May 2008.
Tliet MAHs biss wieġbu għal din il- Lista ta 'kwistjonijiet pendenti adottata f' Mejju 2008.
Overall, the responses provided included bibliographical data and a proposal to update the section 5.1 of the SPC.
Globalment, it- tweġibiet ipprovduti inkludew dejta bibljografika u proposta għall- aġġornament tas- sezzjoni 5. 1 tal - SPC.
None of the answer submitted in June 2008 could demonstrate the efficacy of the oral formulation of medicinal products containing norfloxacine in the treatment of acute and chronic complicated pyelonephritis.
L- ebda mit- tweġibiet ippreżentati f' Ġunju 2008 ma setgħu juru l- effikaċja tal- formulazzjonijiet orali ta 'prodotti mediċinali li fihom norfloxacine fit- trattament ta' pjelonefrite akuta jew kronika kumplikata.
Therefore the CHMP remained of the opinion that this indication should be withdrawn.
Għalhekk is- CHMP baqa 'tal- fehma li din l- indikazzjoni għandha tiġi rtirata.
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.
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.
This could indeed be done through a type II variation at national level.
Dan jista 'fil- fatt isir permezz ta' varjazzjoni tat- tip II fuq livell nazzjonali.
Benefit/ risk
Relazzjoni benefiċċju/ riskju
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.
Wara li kkunsidra d- dejta globali pprovduta fi Frar u f' Ġunju 2008, is- CHMP ikkonkluda li l - awtorizzazzjonijiet 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.
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.
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.
Therefore, the CHMP recommended the removal of the therapeutic indication “ acute and chronic complicated pyelonephritis” for products containing norfloxacin throughout Europe.
Għalhekk, is- CHMP irrakkomanda t- tneħħija tal- indikazzjoni terapewtika "pjelonefrite akuta jew kronika kumplikata" għall- prodotti li fihom norfloxacin fl- Ewropa kollha.
GROUNDS FOR THE REMOVAL OF THE THERAPEUTIC INDICATION “ ACUTE AND CHRONIC COMPLICATED PYELONEPHRITIS”
RAĠUNIJIET GĦAT- TNEĦĦIJA TAL- INDIKAZZJONI TERAPEWTIKA "PJELONEFRITE AKUTA U KRONIKA KUMPLIKATA"
Whereas • The Committee considered the referral made under article 31 of Directive 2001/ 83/ EC, as amended, for medicinal products containing norfloxacin;
Billi • Il- Kumitat ikkunsidra r- referenza magħmula skont l- Artiklu 31 tad- Direttiva 2001/ 83/ KE, kif emendata, għall- prodotti mediċinali li fihom norfloxacin;
• The Committee considered that Marketing Authorisation Holders did not present data demonstrating that norfloxacin taken orally presents efficacy in the treatment of acute or chronic complicated pyelonephritis due to susceptible organisms;
• Il- Kumitat ikkunsidra li d- Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ma ppreżentawx dejta li turi li norfloxacin meħud oralment huwa effikaċi fit- trattament ta 'pjelonefrite akuta jew kronika kumplikata minħabba organiżmi suxxettibbli;
• The Committee concluded that the oral use of norfloxacin containing medicinal products in the treatment of acute or chronic complicated pyelonephritis due to susceptible organisms could no longer be supported; • The Committee, as a consequence, concluded that the benefit/ risk balance of oral norfloxacin containing medicinal products is negative in the above indication.
• Il- Kumitat ikkonkluda li ma setax jibqa 'jiġi appoġġjat l- użu orali ta' prodotti mediċinali li fihom norfloxacin fit- trattament ta 'pjelonefrite akuta jew kronika kumplikata minħabba organiżmi suxxettibbli; • Il- Kumitat, għaldaqstant, ikkonkluda li r- relazzjoni bejn il- benefiċċju u r- riskju ta' prodotti mediċinali orali li fihom norfloxacin huwa negattiv fl- indikazzjoni msemmija hawn fuq.
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).
Is- CHMP irrakkomanda t- tneħħija tal- indikazzjoni terapewtika "pjelonefrite akuta jew kronika kumplikata" għall- prodotti mediċinali li fihom norfloxacin meħudin oralment (b' referenza għall - prodotti mediċinali elenkati fl- Anness I).
13 January 2009 EMEA/ 660192/ 2008
13 ta ’ Jannar 2009 EMEA/ CHMP/ 89926/ 2009
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL
KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦALL- UŻU MILL- BNIEDEM (CHMP) OPINJONI WARA REFERENZA SKONT L- ARTIKOLU 31
Norfloxacin containing medicinal products
Norfloxacin fi prodotti mediċinali
International non-proprietary name (INN): norfloxacin
Denominazzjoni Komuni Internazzjonali (DKI): norfloxacin
Norfloxacin is a broad-spectrum, quinolone bactericidal agent indicated for the treatment of acute or chronic complicated or uncomplicated pyelonephritis due to susceptible organisms.
Norfloxacin huwa aġent broad- spectrum batteriċida kwinolon indikat għal trattament ta ’ pjelonefrite akuta jew kronika jew pjelonefrite mhux ikkumplikata dovuta għal organiżmi suxxettibbli.
On 14 September 2007, Belgium referred the matter to the EMEA under Article 31 of Directive 2001/ 83/ EC and asked the CHMP to give its opinion on whether the marketing authorisations for oral formulations of medicinal 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 re-assessment of norfloxacin benefit/ risk balance.
Fl- 14 ta ’ Settembru 2007, il- Belġju rrefera l- kwistjoni lill- EMEA skont l- Artikolu 31 tad- Direttiva 2001/ 83/ KE u talab lis- CHMP sabiex jagħti l- opinjoni tiegħu dwar jekk l- awtorizzazzjonijiet għat - tqegħid fis- suq għal formulazzjonijiet orali ta ’ prodotti mediċinali li fihom norfloxacin fit- trattament ta ’ pjelonefrite akuta jew kronika kumplikata jew mhux kumplikata għandha tinżamm, tiġi varjata, sospiża jew imneħħija mill- Unjoni Ewropea kollha wara valutazzjoni mill- ġdid tal- bilanċ tal - benefiċċju/ riskju tan- norfloxacin.
This request was based on the following reasons:
Din it- talba hija bbażata fuq ir- raġunijiet li ġejjin:
- Pyelonephritis is often associated with bacteraemia.
- Il- pjelonefrite hija sikwit assoċjata mal- batterjemija.
Norfloxacin containing medicinal products,
Norfloxacin fi prodotti mediċinali, li huma
which are only available as an oral formulation, do not provide adequate serum levels for the treatment of concomitant bacteraemia.
disponibbli biss bħala formulazzjoni orali, ma jipprovdux livelli xierqa ta ’ serum għat- trattament ta ’ batterjemija konkomitanti.
- There are other alternative treatments available for the above-mentioned indication.
- Hemm trattamenti alternattivi oħrajn disponibbli għall- indikazzjoni msemmija hawn fuq.
Second
Il -
generation fluoroquinolones such as ciprofloxacin, ofloxacin and levofloxacin show higher serum concentrations and a much better tissue distribution than norfloxacin.
fluworokwinoloni tat- tieni ġenerazzjoni bħalma huma ciprofloxacin, ofloxacin u levofloxacin juru konċentrazzjonijiet b’ aktar serum u b’ distribuzzjoni tat- tessuti ħafna aħjar minn dik ta ’ norfloxacin.
- Complicated pyelonephritis can be treated orally or intravenously (according to local treatment
- Il- pjelonefrite kkumplikata tista ’ tiġi ttrattata oralment jew fil- vina (skont politika ta ’ trattament
policy and diagnostic criteria used for defining complicated infection).
lokali u kriterji dijanjostiċi użati għad- definizzjoni ta ’ infezzjoni kkumplikata).
In case of oral treatment, second generation fluoroquinolones are superior to norfloxacin because they present higher serum and tissue levels.
F’ każ ta ’ trattament orali, fluworokwinoloni tat- tieni ġenerazzjoni huma superjuri għal norfloxacin minħabba li jippreżentaw livelli għola ta ’ serum u ta ’ tessut.
The same objections are obviously valid for the oral treatment of uncomplicated pyelonephritis.
L- istess objezzjonijiet huma ovvjament validi għat- trattament orali ta ’ pjelonefrite mhux ikkumplikata.
The referral procedure started on 20 September 2007.
Il- proċedura ta ’ referenza bdiet fl- 20 ta ’ Settembru 2007.
Dr.
Ir- Rapporteur u l- Ko- Rapporteur maħtura kienu: id- dott.
Ondř ej Slanař and Dr.
Ondřej Slanař u d- dott.
Pieter Neels, respectively.
Pieter Neels, rispettivament.
Written explanations were provided by the Marketing Authorisation Holder by 25 February and 20 June 2008.
Spjegazzjonijiet bil- miktub ġew ipprovduti mid- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq sal- 25 ta ’ Frar u l- 20 ta ’ Ġunju 2008.
Based on evaluation of the currently available data and the Rapporteurs’ assessment reports, the CHMP concluded that for oral formulations of norfloxacin containing medicinal products the benefit does not outweigh the risk in acute or chronic complicated pyelonephritis, and therefore adopted an opinion on 24 July 2008 recommending the variation of the Marketing Authorisations by removing the therapeutic indication “ acute and chronic complicated pyelonephritis” from the Product Information for the norfloxacin containing medicinal products taken orally.
Ibbażat fuq l- evalwazzjoni tad- dejta disponibbli attwalment u r- rapporti ta ’ valutazzjoni tar - Rapporteurs, is- CHMP ikkonkluda illi għal formulazzjonijiet orali ta ’ prodotti mediċiniali li fihom norfloxacin il- benefiċċju mhumiex ikbar mir- riskju fi pjelonefrite akuta jew kronika kkumplikata, u għalhekk adotta opinjoni fl- 24 ta ’ Lulju 2008 fejn irrakkommanda l- varjazzjoni tal - Awtorizzazzjonijiet għat- Tqegħid fis- Suq billi titneħħa l- indikazzjoni terapewtika “ pjelonefrite akuta jew kronika kkumplikata ” mill- Informazzjoni tal- Prodott għal prodotti mediċinali li fihom norfloxacin li jiġu meħuda b’ mod orali.
The list of product names concerned is given in the Annex I.
Il- lista ta ’ ismijiet tal- prodott konċernat hija mogħtija fl- Anness I.
The scientific conclusions are provided in the Annex II.
Il- konklużjonijiet xjentifiċi huma pprovduti fl- Anness II.
The Member States competent authorities will continue to keep the product under regular review.
L- opinjoni finali hija konvertita f’ Deċiżjoni mill- Kummissjoni Ewropea fid- 19 ta ’ Novembru 2008.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. * Noti:
London, 14 August 2008 EMEA/ CHMP/ 524284/ 2008
Londra, 14 ta ’ Awwissu 2008 EMEA/ CHMP/ 524293/ 2008
Octegra and associated names
Octegra u ismijiet assoċjati
Octegra film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Octegra pilloli miksijin b’ rita fihom 400 mg moxifloxacin bħala hydrochloride.
Octegra was initially approved in June 1999.
Octegra ġie approvat inizjalment f’ Ġunju 1999.
LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTT MEDIĊINALI, MNEJN JINGĦATA, L- APPLIKANT( I) FL- ISTATI MEMBRI
Marketing Authorisation Holder
Id- Detentur ta ’ l - L- Applikant Awtorizzazzjoni għat- tqegħid fis -
Pharmaceutical Form
Mnjen jingħata
Route of administration
Kapsula li terħi l- mediċina b' mod Orali
FGK Representative Service GmbH Heimeranstrasse 35 80339 München, Germany
FGK Representative Service GmbH Heimeranstrasse 35 80339 München, Il- Ġermanja
Modified-release capsule, hard
modifikat, iebsa
Prolonged-release capsule, hard
Kapsula li terħi l- mediċina bil- mod, Orali iebsa
Modified-release capsule, hard
Kapsula li terħi l- mediċina b' mod Orali modifikat, iebsa
Luxembourg
Il - Lussemburgu
Oral
1 L- approvazzjoni ta ’ l- isem għadha pendenti 2 L- approvazzjoni ta ’ l- isem għadha pendenti
United Kingdom
2 Ir- Renju Unit
3 SCIENTIFIC CONCLUSIONS
3 ANNESS II
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF ORACEA
SOMMARJU TOTALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ ORACEA
Rosacea is a well-recognized chronic cutaneous disorder, often characterized by remissions and exacerbations, that primarily affects the face causing significant psychological problems in addition to the physical discomfort.
Rosacea hija disturb kroniku tal- ġilda magħruf sewwa, ħafna drabi kkaratterizzat minn remissjonijiet u taħrixijiet, li jaffettwa primarjament il- wiċċ billi jikkaġuna problemi psikoloġiċi sinifikattivi flimkien ma ’ skonfort fiżiku.
Treatment of rosacea is mainly aimed at reducing the papulopustular lesions while the erythema and telangiectasia components are difficult to alleviate.
Il- kura ta ’ rosacea hija primarjament immirata għat- tnaqqis ta ’ leżjonijiet papulopustulari waqt li l- komponenti eritima u telangiektasja huma diffiċli biex jittaffew.
The only treatments currently widely authorized in the EU are topical therapies containing metronidazole or azelaic acid, which require twice daily administration and may give rise to local adverse events such as skin irritation or worsening of rosacea.
L- uniċi kuri awtorizzati b’ mod mifrux fl- UE fil- preżent huma terapiji topiċi li fihom metronidazole jew azelaic acid, li jeħtieġu għoti darbtejn kuljum u jistgħu jikkaġunaw episodji avversi lokali bħalma huma irritazzjoni tal- ġilda jew aggravar ta ’ rosacea.
Doxycycline, generally in the dose of 100-200 mg daily, has been widely used in clinical practice for the treatment of various infectious diseases for more than 25 years, with a well documented safety profile.
Doxycycline, ġeneralment f’ doża ta ’ 100- 200 mg kuljum, ilu jintuża fil- prattika klinika għall- kura ta ’ diversi mard infettiv għal iktar minn 25 sena, bi profil ta ’ sigurtà ddokumentat sewwa.