qanastek/EMEA-V3 huggingface dataset:
Further, the study should include prostate cancer subgroups to include those on bicalutamide, and those treated with LHRH analogues, orchidectomy, and other hormonal therapies.
Barra minn hekk, l- istudju għandu jinkludi l- gruppi bil- kanċer tal- prostata biex ikunu inklużi dawk ittrattati bl- analogi ta ’ LHRH, bit- tneħħija tat- testikoli, u b’ terapiji ormonali oħra.
The results should be reported to the RMS and the NCAs where bicalutamide 150 mg is authorised.
Ir- riżultati għandhom jiġu rrappurtati lill- RMS u lill- NCAs fejn bicalutamide 150 mg hu awtorizzat.
- The outcome of the 4th analysis of the EPC data should be provided to the RMS and the NCAs where
- Ir- riżultat tar- raba ’ analiżi tat- tagħrif ta ’ l- EPC għandha tingħata lill- RMS u lill- NCAs fejn
bicalutamide 150 mg is authorised.
bicalutamide 150 mg hu awtorizzat
- For all MAHs, in addition to routine pharmacovigilance activities, identified and potential risks
- Għad- Deteneturi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq, minbarra l- attivitajiet ta ’ viġilanza
highlighted for increased monitoring and follow-up should include:
farmakoloġika ta ’ rutina, għandu jkun hemm żieda fis- sorveljanza u ta ’ riskji identifikati jew potenzjali, fosthom:
Heart failure Hepatic failure Interstitial lung disease Breast cancer Reports concerning pregnancy in partners of patients taking bicalutamide
Il- kollass tal- qalb Il- falliment tal- fwied Il- mard fil- borża ta ’ madwar il- pulmun Il- kanċer tas- sider Rapporti dwar it- tqala fis- sħab ta ’ pazjenti li jkunu qed jieħdu bicalutamide
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
LISTA TAL- ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWA TAL- PRODOTT MEDIĊINALI, MNEJN JINGĦATA, APPLIKANTI FL- ISTATI MEMBRI
1 Member State EU/ EEA
1 Stat Membru UE/ ŻEE
Marketing Authorisation Holder
Detentur tal - Awtorizzazzjon i għat- tqegħid fis- Suq
Applicant
Applikant
(Invented) Name
Isem (Inventat)
Content (concentrati on)
Kontenut (konċentraz zjoni)
Bleomycin „ Pharmachemie“ 15000 I. E. - Pulver zur Herstellung einer Injektionslösung
Bleomycin „ Pharmachemie “ 15000
15 U (USP)/ vial
15 U (USP) / kunjett
powder for solution for injection
trab għal soluzzjoni
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local injection
Injezzjoni ġol- muskolu Injezzjoni taħt il- ġilda
15 U (USP)/ vial
15 U (USP) / kunjet
Box 552 2003 RN Haarlem, The Netherlands
Box 552 2003 RN Haarlem, L- Olanda
powder for solution for injection
trab għal soluzzjoni għall- injezzjoni
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/ Intratumoral injections
Injezzjoni ġol- muskolu Injezzjoni taħt il- ġilda Għoti ġol- vina Għoti ġol- arterja Injezzjoni ġol- plewra Għoti ġol- peritew Injezzjonijiet lokali/ ġot- tumur
15 U (USP)/ vial
15 U (USP) / kunjet t
Bulgaria
Il- Bulgarja
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/ Intratumoral injections
Injezzjoni ġol- muskolu Injezzjoni taħt il- ġilda Għoti ġol- vina Għoti ġol- arterja Injezzjoni ġol- plewra Għoti ġol- peritonew Injezzjonijiet lokali/ ġot- tumur Injezzjoni ġol- muskolu
Czech Republic
Ir- Repubblika
Bleomycin-Teva 15U, práš ek pro př ípravu injekč ního roztoku
Bleomycin- Teva 15U,
powder for solution for injection
trab għal
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/ Intratumoral injections
Injezzjoni taħt il- ġilda
Denmark
Ċeka
2
2 Stat Membru UE/ ŻEE
Member State EU/ EEA
Detentur tal - Awtorizzazzjon i għat- tqegħid fis- Suq
Marketing Authorisation Holder
Applikant 2003 RN Haarlem, L- Olanda
Applicant
Isem (Inventat)
(Invented) Name
Qawwa
Strength
Għamla Farmaċewtika
Pharmaceutical Route of administration Form
Mnejn jingħata Għoti ġol- arterja Injezzjoni ġol- plewra Għoti ġol- peritonew Injezzjonijiet lokali/ ġot- tumur
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/ Intratumoral injections
Injezzjoni ġol- muskolu Injezzjoni taħt il- ġilda Għoti ġol- vina Għoti ġol- arterja Injezzjoni ġol- plewra Għoti ġol- peritonew Injezzjonijiet lokali/ ġot- tumur
Intramuscular injection Intravenous administration Intra-pleural injection
Injezzjoni ġol- muskolu Għoti ġol- vina Injezzjoni ġol- plewra
Bleomicina TEVA, 15 U 15 U (USP)/ vial polvere per soluzione iniettabile
Bleomicina TEVA, 15 U 15 U polvere per soluzione (USP) / kunjett iniettabile
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/ Intratumoral injections
Injezzjoni ġol- muskolu Injezzjoni taħt il- ġilda Għoti ġol- vina Għoti ġol- arterja Injezzjoni ġol- plewra Għoti ġol- peritonew
3
3 Stat Membru UE/ ŻEE
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration
Injezzjoni taħt il- ġilda
Member State EU/ EEA
Swensweg 5 P. O.
Marketing Authorisation Holder
Box 552 2003 RN Haarlem, L- Olanda
(Invented) Name
(USP) / kunjett
Pharmaceutical Form
soluzzjoni għall- injezzjoni
Route of administration Local/ Intratumoral injections
Għoti ġol- vina Għoti ġol- arterja Injezzjoni ġol- plewraGħoti ġol - peritonew Injezzjonijiet lokali/ ġot- tumur
Content (concentrati on)
(USP) / kunjet t
Luxembourg
Il- Lussemburgu
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local/ Intratumoral injections
Injezzjoni ġol- muskolu
Bleomycine 15 U (USP), 15 U (USP)/ vial poeder voor oplossing voor injectie
15U poudre pour solution (USP) / kunjett injectable
powder for solution for injection
soluzzjoni għall- injezzjoni
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/ Intratumoral injections
Injezzjoni taħt il- ġilda Għoti ġol- vina Għoti ġol- arterja Injezzjoni ġol- plewra Injezzjonijiet lokali/ ġot- tumur Injezzjoni ġol- muskolu
15 U (USP)/ vial
(USP) / kunjet t
Norway
L- Olanda
Bleomycin Teva, Pulver 15 U (USP)/ vial og væske til injeksjonsvæske, oppløsning
Bleomycine 15 U (USP), 15 U
Bleomycin Teva 15 U (USP)/ vial
Bleomycin Teva, Pulver 15 U
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection
Injezzjoni ġol- muskolu
4
4 Stat Membru UE/ ŻEE
Member State EU/ EEA
Għamla Farmaċewtika
Marketing Authorisation Holder
Kontenut (konċentraz zjoni)
Applicant
Swensweg 5
Strength
soluzzjoni
Pharmaceutical Form
għall- injezzjoni
Route of administration Intraperitoneal administration Local/ Intratumoral injections
Għoti ġol- vina Għoti ġol- arterja Injezzjoni ġol- plewra Għoti ġol- peritonew Injezzjonijiet lokali/ ġot- tumur
Content (concentrati on)
t
Portugal
Il- Polonja
Slovak Republic
Il- Portugall
Slovenia
Ir- Repubblika Slovakka
Spain
Is- Slovenja
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/ Intratumoral injections
Għoti ġol- arterja Injezzjoni ġol- plewra Għoti ġol- peritonew Injezzjonijiet lokali/ ġot- tumur
SCIENTIFIC CONCLUSIONS
soluzzjoni għall- injezzjoni
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BLEOMYCIN PHARMACHEMIE AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU ĠENERALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ BLEOMYCIN PHARMACHEMIE U ISMIJIET ASSOĊJATI (ARA ANNESS I)
Bleomycin belongs to the cytostatic antibiotics: it is a mixture of structurally related, alkaline, water soluble, glycopeptide antibiotics with a cytostatic effect.
Il- bloemiċina (bleomycin) tappartieni għall- antibijotiċi ċitostatiċi: hija taħlita ta ’ antibijotiċi glikopeptidi strutturalment relatati, alkalini, li jdubu fl- ilma b’ effett ċitostatiku.
The effect of bleomycin rests on intercalation with single and double strands of DNA, resulting in single and double strand ruptures, which inhibit cell division, growth and DNA synthesis.
L- effett tal- bleomiċina jibbaża fuq interkalazzjoni ma ’ ħjut singoli u doppji ta ’ DNA, li jirriżulta fi xpakkar ta ’ ħjut singoli u doppji, li jimpedixxi d- diviżjoni, l- iżvilupp u s- sinteżi tad- DNA taċ- ċellola.
In a lower degree bleomycin also affects the RNA and protein synthesis.
Fi grad iktar baxx, il- bleomiċina taffettwa wkoll l- RNA u s- sinteżi tal- proteini.
The administration of bleomycin almost always takes place in combination with other cytostatic drugs and/ or radiation therapy.
L- għoti tal- bleomiċina kważi dejjem isir f’ kombinazzjoni ma ’ mediċini ċitostatiċi oħrajn u/ jew ma ’ terapija ta ’ radjazzjoni.
In the Netherlands bleomycin is currently approved for the following indications:
Fl- Olanda, il- bleomiċina bħalissa hija approvata għall - indikazzjonijiet li ġejjin:
- Squamous cell carcinoma of Head and neck (SCCHN)
- Karċinoma b’ ċelloli squamous tar- ras u tal- għonq (SCCHN);
- Squamous cell carcinoma of external genitalia: penile carcinoma, cervix carcinoma.
- Karċinoma b’ ċelloli squamous tal- ġenitali esterni: karċinoma tal- pene, karċinoma tal- għonq tal -
- (Non-)Hodgkin´s lymphoma and other malignant lymphomas
- Linfoma mhux ta ’ Hodgkin u linfomi malinji oħrajn;
- Testis carcinoma
- Karċinoma tat- testikolu;
- Intrapleural therapy of malignant pleural effusion.
- Terapija intraplewrika ta ’ effużjoni plewrika malinja.
The Application for Bleomycin Pharmachemie was submitted as a generic application based on the marketing authorisation granted for the reference product in the Netherlands on 18 November 1997.
L- Applikazzjoni għal Bleomycin Pharmachemie ġiet sottomessa bħala applikazzjoni ġenerika bbażata fuq l - awtorizzazzjoni għat- tqegħid fis- suq mogħtija għall- prodott ta ’ referenza fl- Olanda fit- 18 ta ’ Novembru 1997.
Concerns were raised on the proposed indications by an objecting member state, Germany.
Tqajjem tħassib dwar l- indikazzjonijiet proposti minn Stat Membru li oġġezzjona, il- Ġermanja.
Because the benefit/ risk assessment for these indications was negative for the originator product and because the indications were consequently deleted from the authorised indications for all bleomycin-containing products in Germany, the indications were regarded as new indications, and the objecting member state considered that the submitted data was insufficient for granting a marketing authorisation for the proposed new indications.
Minħabba li l- valutazzjoni ta ’ benefiċċju/ riskju għal dawn l- indikazzjonijiet kienet waħda negattiva għall- prodott oriġinatur u minħabba li l- indikazzjonijiet ġew konsegwentament imħassrin mill - indikazzjonijiet awtorizzati għall- prodotti kollha li fihom il- bleomiċina fil- Ġermanja, l- indikazzjonijiet tqiesu bħala indikazzjonijiet ġodda, u l- Istat Membru li oġġezzjona kkunsidra li d- dejta sottomessa ma kinitx biżżejjed biex tingħata awtorizzazzjoni għat- tqegħid fis- suq għall- indikazzjonijiet ġodda proposti.
Although the applicant was willing to remove the indications objected to by the objecting CMS, the RMS and the other positive CMSs were in favour of retaining these indications.
Għalkemm l- applikant kien lest li jneħħi l- indikazzjonijiet għal liema kien hemm oġġezzjoni mis- CMS li oġġezzjona, l- RMS u s- CMSs pożittivi l- oħrajn kienu favur li jżommu dawn l- indikazzjonijiet.
Because consensus could not be reached, the CMD(h) referred the procedure to the CHMP.
Minħabba li ma setax jintlaħaq qbil, is- CMD( h) irrefera l- proċedura lis- CHMP.
The CHMP assessed the available data in order to establish whether the two indications can be supported.
Is- CHMP ivvaluta d- dejta disponibbli sabiex jistabbilixxi jekk iż- żewġ indikazzjonijiet jistgħux jiġu appoġġjati.
The CHMP noted that bleomycin is in clinical use since the 1960ies, thereby explaining the lack of a clinical development programme.
Is- CHMP innota li l- bleomiċina ilha f’ użu kliniku mis- snin sittin, b’ hekk jispjega n- nuqqas ta ’ programm ta ’ żvilupp kliniku.
Most of the presented data describe bleomycin as component of multi- drug chemotherapy including cisplatin and therefore the individual contribution of bleomycin cannot be unequivocally determined, however a number of studies and publications clearly indicate that bleomycin demonstrates efficacy.
Il- maġġoranza tad- dejta ppreżentata tiddeskrivi l- bleomiċina bħala komponent ta ’ kemjoterapija b’ iktar minn mediċina waħda inkluż ċisplatinu (cisplatin) u għaldaqstant il- kontribut individwali tal- bleomiċina ma jistax jiġi stabbilit b’ mod inekwivokabbli, madankollu numru ta ’ studji u pubblikazzjonijiet jindikaw b’ mod ċar li l- bleomiċina turi effikaċja.
Regarding the indication in Head and Neck cancer, the CHMP is of the opinion that although bleomycin has obvious disadvantages related to its toxicity (pulmonitis, pulmonary fibrosis, stomatitis and skin changes), there is still a role for bleomycin in (neoadjuvant) treatment of the disease.
Rigward l- indikazzjoni ta ’ kanċer tar- ras u tal- għonq, is- CHMP huwa tal- opinjoni li għalkemm l- bleomiċina għandha żvantaġġi evidenti relatati mat- tossiċità tagħha (pulmonite, fibrożi pulmonari, stomatite u bidliet fil- ġilda), għad hemm rwol għall- bleomiċina fit- trattament (neoadjuvant) tal- marda.
In addition to the documentation already provided during the decentralised procedure, supporting a modest but certain role for bleomycin in the treatment of SCCHN, a number of recent reports support the role of bleomycin in conjunction with other chemotherapeutic moieties, identifying both a recovery ratio (RR) of 34% in second line treatment and the improvement of loco-regional control and survival in patients with advanced HNC through concomitant postoperative radio- and chemotherapeutical treatment with mitomycin C and bleomycin.
Barra d - dokumentazzjoni diġà pprovduta waqt il- proċedura deċentralizzata, li tappoġġja rwol modest iżda ċert għall - bleomiċina fit- trattament ta ’ SCCHN, numru ta ’ rapporti reċenti jappoġġjaw ir- rwol tal- bleomiċina flimkien ma ’ moieties kemjoterapewtiċi oħrajn, li jidentifikaw kemm proporzjon ta ’ rkupru (RR) ta ’ 34% fit - trattament tat- tieni linja kif ukoll titjib fil- kontroll lokoreġjonali u sopravivenza f’ pazjenti b’ HNC avvanzat permezz ta ’ trattament konkomittanti radju - u kemjoterapewtiku postoperatorju b’ mitomiċina Ċ u bleomiċina.
Although bleomycin is currently not regarded as an essential component in the first line systemic treatment of SCCHN, it still constitutes a treatment option for (concomitant) chemotherapy, or in conjunction with RT, and can therefore not be considered obsolete for this indication.
Għalkemm l- bleomiċina, bħalissa, mhijiex meqjusa bħala komponent essenzjali fit- trattament sistemiku tal- ewwel linja ta ’ SCCHN, hija xorta tikkostitwixxi għażla ta ’ trattament għall- kemjoterapija (konkomittanti), jew flimkien ma ’ RT, u għaldaqstant ma jistax jiġi kkunsidrat li din l- indikazzjoni saret obsoleta.
The CHMP therefore considered the indication to be acceptable.
Għaldaqstant, is- CHMP qies li l- indikazzjoni hija aċċettabbli.
Regarding the indication in Epidermoid carcinoma of external genitalia, the CHMP noted that bleomycin is currently still in use in cervical cancer, and it was agreed that although the clinical efficacy is modest in
Rigward l- indikazzjoni ta ’ karċinoma epidermojde tal- ġenitali esterni, is- CHMP innota li l- bleomiċina bħalissa xorta għadha tintuża f’ kanċer taċ- ċerviċi, u sar qbil fuq il- fatt li għalkemm l- effikaċja klinika hija
7 this indication, as well as in penile cancer, several recent trials have illustrated the significance of bleomycin in these indications.
8 modesta f’ din l- indikazzjoni, kif ukoll f’ kanċer tal- pene, diversi provi reċenti wrew is- sinifikat tal - bleomiċina f’ dawn l- indikazzjonijiet.
The combination of bleomycin, vindesine, mitomycin C and cisplatin in patients with recurrent and/ or metastatic squamous cell carcinoma of the cervix was recently shown to be of benefit with regards to survival and a phase II study showed bleomycin to be part of a clinically relevant alternative treatment regimen for cisplatin, in patients with recurrent cervical cancer.
Dan l- aħħar intwera li l- kombinazzjoni tal- bleomiċina, vindesina (vindesine), mitomiċina Ċ u ċisplatinu f’ pazjenti b’ karċinoma b’ ċelloli squamous taċ- ċerviċi rikorrenti u/ jew metastatika hija ta ’ benefiċċju fir- rigward tas- sopravivenza u studju ta ’ fażi II wera li l- bleomiċina hija parti ta ’ reġim ta ’ trattament alternattiv klinikament rilevanti għal ċisplatinu, f’ pazjenti b’ kanċer taċ - ċerviċi rikorrenti.
Although response rates are in general higher with bleomycin containing regimens, the added toxicity is readily acknowledged.
Għalkemm ir- rati ta ’ reazzjoni huma ġeneralment ogħla b’ reġimi li fihom l- bleomiċina, iż - żieda fit- tossiċità tiġi rikonoxxuta minnufih.
Furthermore the difficulty to assess the sole efficacy of bleomycin when results are obtained with combination regimens is recognized, however the overall favourable efficacy of bleomycin containing regimen supports the indication for bleomycin.
Barra minn hekk, hija rikonoxxuta d- diffikultà biex tiġi vvalutata l- effikaċja waħdanija tal- bleomiċina meta jinkisbu riżultati b’ reġimi ta ’ kombinazzjoni, madankollu l- effikaċja favorevoli totali ta ’ reġim li fih il- bleomiċina tappoġġja l- indikazzjoni għall - bleomiċina.
The CHMP considered that although bleomycin is not an obvious first line component for systemic treatment of cervical cancer, bleomycin remains a useful cytostatic drug that has to remain available to patients for this indication.
Is- CHMP jikkunsidra li għalkemm il- bleomiċina mhijiex komponent tal- ewwel linja evidenti għat- trattament sistemiku ta ’ kanċer taċ- ċerviċi, il- bleomiċina tibqa ’ mediċina ċitostatika li għandha tibqa ’ disponibbli għall- pazjenti għal din l- indikazzjoni.
The same is applicable for the indication penile cancer; the indication is supported by reports suggesting a modest efficacy for this disease.
L- istess huwa applikabbli għall- indikazzjoni ta ’ kanċer tal- pene, l - indikazzjoni hija appoġġjata minn rapporti li jissuġġerixxu effikaċja modesta għal din il- marda.
Therefore, despite overt toxicity and modest efficacy, the CHMP considered that bleomycin is a valuable treatment option for systemic treatment, if deemed necessary for these indications.
Għaldaqstant, minkejja tossiċità evidenti u effikaċja modesta, is- CHMP ikkunsidra li l- bleomiċina hija għażla ta ’ trattament siewi għat- trattament sistemiku, jekk meqjus meħtieġ għal dawn l- indikazzjonijiet.
In the combination therapy bleomycin is also of value, even though the evidence of the sole contribution of bleomycin is not assessable.
Fit - terapija ta ’ kombinazzjoni huwa wkoll siewi, anke jekk l- evidenza tal- kontribut waħdieni tal- bleomiċina ma jistax jiġi vvalutat.
The CHMP also noted that bleomycin is still in use and also mentioned in current treatment guidelines in Europe and North America, such as the SCCHN:
Is- CHMP innota wkoll li l- bleomiċina għadha tintuża u msemmija wkoll fil- linji gwida terapewtiċi attwalment fis- seħħ fl- Ewropa u fl- Amerika ta ’ Fuq, bħalma huma SCCHN:
Practice Guidelines in Oncology-v.2.2008 (HCCN, USA), the CCO (Cancer Care Ontario) Formulary, revised 2006/ 2007, and the Guidelines on penile cancer (March 2004) of the European Association of Urology.
Practice Guidelines in Oncology- v. 2. 2008 (HCCN, USA), CCO (Cancer Care Ontario) Formulary, reviżjoni tal- 2006/ 2007, u l - Guidelines on penile cancer (Marzu 2004) tal- Assoċjazzjoni Ewropea tal- Uroloġija.
In conclusion, the CHMP considered that this efficacy outweighs the toxicity of the product, and that the benefit/ risk balance is positive.
Fl- aħħar nett, is- CHMP ikkunsidra li din l- effikaċja tegħleb it- tossiċità tal- prodott, u li l- bilanċ bejn il - benefiċċju/ riskju huwa wieħed pożittiv.
Therefore the CHMP is of the opinion that bleomycin is still a valuable chemotherapeutic drug, and adopted the totality of the proposed indications, for Bleomycin Pharmachemie:
Għaldaqstant, is- CHMP huwa tal- opinjoni li l- bleomiċina xorta għadu mediċina kemjoterapewtika valida, u adotta l- indikazzjonijiet proposti kollha għal Bleomycin Pharmachemie:
Bleomycin is intended for the treatment of:
Il- bleomiċina hija destinata għat- trattament ta ’:
- Squamous cell carcinoma (SCC) of the head and neck, external genitalia and cervix.
- Karċinoma b’ ċelloli squamous (SCC) tar- ras u tal- għonq, il- ġenitali esterni u l- għonq tal- utru;
- Hodgkin’ s lymphoma.
- Linfoma ta ’ Hodgkin;.
- Non-Hodgkin’ s lymphoma of intermediate and high malignancy in adults.
- Linfoma mhux ta ’ Hodgkin fl- adulti ta ’ malinjità intermedja u għolja;
- Testis carcinoma (seminoma and non-seminoma).
- Karċinoma tat- testikolu (seminoma u mhux seminoma);
8 GROUNDS FOR OPINION
9 RAĠUNIJIET GĦALL- OPINJONI
- the observed toxicity risks are outweighed by the established efficacy of bleomycin,
- ir- riskji tat- tossiċità osservati huma megħlubin mill- effikaċja stabbilita tal- bleomiċina;
- the efficacy of bleomycin can be considered as established through published literature and current
- l- effikaċja tal- bleomiċina tista ’ tkun ikkunsidrata bħala stabbilita minn letteratura ppubblikata u linji gwida
treatment guidelines in Europe and North America
terapewtiċi attwalment fis- seħħ fl- Ewropa u fl- Amerika ta ’ Fuq;
- and taking into account the current therapeutic use of bleomycin,
- u wara li kkunsidra l- użu terapewtiku attwali tal- bleomiċina,
the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination Group procedure as mentioned in Annex III for Bleomycin Pharmachemie and associated names (see Annex I).
is- CHMP irrakkomanda l- għoti ta ’ Awtorizzazzjonijiet għat- Tqegħid fis- Suq li s- Sommarju tal- Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta ’ tagħrif tagħhom jibqgħu bħal fil- verżjonijiet finali miksubin waqt il - proċedura tal- Grupp ta ’ Koordinament kif imsemmi fl- Anness III għal Bleomycin Pharmachemie u ismijiet assoċjati (ara l- Anness I).
10 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
10 ANNESS III
11
11 Is- Sommarju tal- Karatteristiċi tal- Prodott, tikketta u l- fuljett tat- tagħrif huma l- verżjonijiet finali miksuba waqt il- proċedura tal- grupp ta ’ Koordinazzjoni.
Ref.
Londra, 17 ta ’ Marzu 2009 Dok ta ’ Ref.
EMEA/ CHMP/ 191900/ 2009 EMEA/ H/ A-29/ 1096
EMEA/ 189577/ 2009 EMEA/ H/ A- 29/ 1096
Questions and answers on the referral for Bleomycin, powder for solution for injection, 15 U/ Vial, from Pharmachemie BV
Mistoqsija u tweġiba dwar ir- referenza għal Bleomycin, trab għal soluzzjoni għall- injezzjoni, 15 U/ Kunjett, minn Pharmachemie BV
The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Bleomycin injection, from Pharmachemie BV.
L- Aġenzija Ewropea għall- Mediċini (EMEA) temmet proċedura ta ’ referenza wara nuqqas ta ’ qbil fost l- Istati Membri tal- Unjoni Ewropea fir- rigward tal- awtorizzazzjoni tal- mediċina Bleomycin injezzjoni, minn Pharmachemie BV.
The Agency’ s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Bleomycin injection, from Pharmachemie BV, outweigh its risks, and the marketing authorisation can be granted in the Member States of the European Union and the European Economic Area.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) tal - Aġenzija kkonkluda li l- benefiċċji ta ’ Bleomycin injezzjoni, minn Pharmachemie BV, huma akbar mir- riskji tiegħu, u li l- awtorizzazzjoni għat- tqegħid fis- suq tista ’ tingħata fl- Istati Membri tal- Unjoni Ewropea u fiż- Żona Ekonomika Ewropea.
The review was carried out under an ‘ Article 29’ referral1 procedure.
Ir- reviżjoni saret skont proċedura ta ’ referenza tal - ‘ Artikolu 29’ 1.
What is Bleomycin?
X’ inhu Bleomycin?
Bleomycin is an anti-cancer medicine used to treat certain forms of cancer of the head or the neck, cervix (the neck of the womb) and external sexual organs; certain forms of lymphoma (cancer of the lymphatic system) such as Hodgkin's disease; and to treat cancer of the testicles.
Bleomycin huwa mediċina kontra l- kanċer użat għat- trattament ta ’ ċerti forom ta ’ kanċer tar- ras jew tal- għonq, taċ- ċerviċi (l- għonq tal- utru) u tal- organi sesswali esterni; ċerti forom ta ’ linfoma (kanċer tas- sistema linfatika) bħalma hija l- marda ta ’ Hodgkin; u għat- trattament tal- kanċer tat- testikoli.
Bleomycin can also be used by injection directly inside the chest cavity to treat fluid accumulation in the lungs as a result of cancer.
Bleomycin jista ’ jintuża wkoll permezz ta ’ injezzjoni direttament ġol- kavità tas- sider għat- trattament tal - akkumulu ta ’ fluwidu fil- pulmun dovut għal kanċer.
Bleomycin is almost always used in combination with anti-cancer drugs or in combination with radiation.
Bleomycin jintuża kważi dejjem f’ kombinazzjoni ma ’ pilloli kontra l- kanċer jew f’ kombinazzjoni mar - radjazzjoni.
Bleomycin is a cytostatic substance; this means that it stops the growth of cells.
Bleomycin huwa sustanza ċitostatika; dan ifisser li jwaqqaf it- tkabbir taċ- ċelloli.
Bleomycin inserts itself within the strands of DNA, the genetic material of cells, making the strands break.
Bleomycin jidħol fil - faxex (strands) tad- DNA, il- materjal ġenetiku taċ- ċelloli, u jġiegħel lill- faxex jinkisru.
As a result the cells cannot multiply.
B’ riżultat ta ’ dan, iċ- ċelloli ma jkunux jistgħu jimmultiplikaw.
Why was Bleomycin reviewed?
Għaliex ġie rivedut Bleomycin?
Pharmachemie BV submitted a Marketing Authorisation Application for Bleomycin powder for solution for injection 15 U/ vial in the decentralised procedure on 10 July 2007, the Netherlands acting as the reference member state.
Pharmachemie BV issottomettiet Applikazzjoni għat- Tqegħid fis- Suq għal Bleomycin trab għal soluzzjoni għall- injezzjoni 15 U/ kunjett fil- proċedura deċentralizzata fl- 10 ta ’ Lulju 2007, bl- Olanda taġixxi bħala l- Istat Membru ta ’ referenza.
The company wanted the authorisation to be granted in Austria, Belgium, Bulgaria, the Czech Republic, Denmark, Estonia, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovakia, Slovenia and Spain (the concerned Member States).
Il- kumpanija riedet li l- awtorizzazzjoni tingħata fl - Awstrija, fil- Belġju, fil- Bulgarija, fir- Repubblika Ċeka, fid- Danimarka, fl- Estonja, fi Franza, fil - Ġermanja, fl- Italja, fil- Latvja, fil- Litwanja, fil- Lussemburgu, fin- Norveġja, fil- Polonja, fil- Portugall, fis- Slovakkja, fis- Slovenja u fi Spanja (l- Istati Membri kkonċernati).
These member states were not able to reach an agreement.
Dawn l- Istati Membri ma setgħux jaslu għal qbil.
On 3 November 2008, the Netherlands medicines regulatory agency, the Medicines Evaluation Board, referred the matter to the CHMP.
Fit- 3 ta ’ Novembru 2008, l- aġenzija regulatorja tal- mediċini Olandiża, il- Bord tal- Evalwazzjoni tal- Mediċini, irreferiet il- kwistjoni lis- CHMP.
The grounds for the referral were that Germany was not in a position to accept some of the anti-cancer indications because they were not recognised as acceptable for bleomycin in the country.
Ir- raġunijiet għar- referenza kienu li l- Ġermanja ma kinitx f’ pożizzjoni li taċċetta xi wħud mill - indikazzjonijiet ta ’ kontra l- kanċer minħabba li dawn ma kinux rikonoxxuti bħala aċċettabbli għal bleomycin fil- pajjiż.
The indications ‘ head and neck carcinoma’ and ‘ epidermoid carcinoma of external genitalia such as penile carcinoma, or cervix’ had been deleted from the authorised indications for all bleomycin-containing products in Germany because the balance of benefit/ risk for bleomycin in these indications was considered negative.
L- indikazzjonijiet ‘ karċinoma tar- ras u tal- għonq ’ u ‘ karċinoma epidermojde tal - ġenitali esterni bħall- karċinoma tal- pene jew taċ- ċerviċi ’ kienu tneħħew mill- indikazzjonijiet awtorizzati għall- prodotti kollha li fihom bleomycin fil- Ġermanja minħabba li l- bilanċ ta ’ benefiċċju/ riskju għal bleomycin f’ dawn l- indikazzjonijiet kien ikkunsidrat bħala wieħed negattiv.
Germany considered that the submitted data was insufficient for granting a marketing authorisation for the proposed indications.
Il - Ġermanja kkunsidrat li d- dejta sottomessa ma kinitx biżżejjed biex tingħata awtorizzazzjoni għat - tqegħid fis- suq għall- indikazzjonijiet proposti.
The RMS and the other positive CMSs were in favour of retaining these indications.
L- RMS u s- CMSs pożittivi l- oħrajn kienu favur li
1 Article 29 of Directive 2001/ 83/ EC as amended, referral on the grounds of potential serious risk to public health 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
1 Artikolu 29 tad- Direttiva 2001/ 83/ KE kif emendat, referenza abbażi ta ’ riskju potenzjali serju għas- saħħa pubblika 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. referred to the CHMP.
Reproduction is authorised provided the source is acknowledged. jżommu dawn l- indikazzjonijiet.
The CHMP assessed the available data in order to establish whether the two indications can be supported.
Minħabba li ma setax jintlaħaq kunsens, il- proċedura ġiet riferuta lis - CHMP.
What are the conclusions of the CHMP?
X’ inhuma l- konklużjonijiet tas- CHMP?
Based on evaluation of the currently available data, including published literature and current treatment guidelines, and the scientific discussion within the Committee, the CHMP concluded that the benefits of Bleomycin injection, from Pharmachemie BV, outweigh its risks, and therefore the marketing authorisation for Bleomycin should be granted in all concerned member states.
Abbażi tal- evalwazzjoni tad- dejta disponibbli fil- preżent, inkluż letteratura ppubblikata u l- linji gwida ta ’ trattament attwali, u d- diskussjoni xjentifika fi ħdan il- Kumitat, is- CHMP kkonkluda li l- benefiċċji ta ’ Bleomycin injezzjoni, minn Pharmachemie BV, huma akbar mir- riskji tiegħu, u għaldaqstant l - awtorizzazzjoni għat- tqegħid fis- suq għal Bleomycin għandha tingħata fl- Istati Membri kkonċernati kollha.
The European Commission issued a decision on 12 March 2009.
Il- Kummissjoni Ewropea adottat deċiżjoni fit- 12 ta ’ Marzu 2009.
Co-rapporteur:
Korapporteur:
Referral start date:
Data tal- bidu tar- referenza:
Opinion date:
Data tal- opinjoni:
Barbara van Zwieten-Boot (NL) Harald Enzmann (DE) 20 November 2008 18 December 2008
Barbara van Zwieten- Boot (NL) Harald Enzmann (DE) 20 ta ’ Novembru 2008 18 ta ’ Diċembru 2008
London, 22 August 2007 EMEA/ CHMP/ 248862/ 2007
Londra, 22 ta ’ Awwissu 2007 EMEA/ CHMP/ 248862/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
OPINJONI SKOND L- ARTIKOLU 29( 4) 1 REFERENZA GĦAL
Cefuroximaxetil and associated names International Non-Proprietary Name (INN): cefuroxime (as axetil)
Cefuroximaxetil u ismijiet assoċjati Denominazzjoni Komuni Internazzjonali (INN - Internatinal Non- proprietary Name): cefuroxime (bħal axetil)
BACKGROUND INFORMATION Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets is a cephalosporin (β - lactam group of antibiotics), indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as:
INFORMAZZJONI ĠENERALI Cefuroximaxetil u ismijiet asso ċjati, 125mg, 250 mg u 500 mg, pilloli miksija b’ rita huma cephalosporin (antibijotiċi tal- grupp β- lactam), indikati għat- trattament ta ’ infezzjonijiet ħfaf sa kemmxejn severi li huma kkawwżati minn mikro- organiżmi suxxettibbli għaċ- cefuroxime, bħal:
- upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis
minn ġewwa, sinusitis, tonsillitis u farinġitis
- acute bronchitis, acute exacerbations of chronic bronchitis
- bronkite akuta, tqanqiliet akuti ta ’ bonkite kronika
- lower uncomplicated urinary tract infections: cystitis
- infezzjonijiet ħfaf tal- parti ta ’ isfel tal- passaġġ ta ’ l- awrina:
- skin and soft tissue infections: furunculosis, pyoderma and impetigo
- Infezzjonijiet tal- ġilda u tat- tessut artab: furunculosis, pyoderma u impetigo
- uncomplicated gonorrhoea: urethritis and cervicitis
Urethritis u Cervicitis
- treatment of early stage Lyme disease (stadium I) and subsequent prevention of late complications in
- Trattament tal- marda ta ’ Lyme fi stadju bikri (stadju 1) u prevenzjoni sussegwenti ta ’
adults and children above 12 years of age.
kumplikazzjonijiet avvanzati f’ adulti u tfal ta ’ l- fuq minn 12 – il sena.
Sandoz B. V. submitted applications for mutual recognition of Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets on the basis of the marketing authorisation granted by the Netherlands on 1 October 2004.
Sandoz B. V. issottomettiet applikazzjonijet għar- rikonoxximent reċiproku taċ- Cefuroximaxetil u ismijiet assoċjati, 125mg, 250mg u 500 mg, pilloli miksija b’ rita abbażi ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq mogħtija mill- Olanda fl- 1 ta ’ Ottubru 2004.
The repeat-use Mutual Recognition Procedure started on 17 May 2006.
L- użu ripetut tal- Proċedura ta ’ Rikonoxximent Reċiproku beda fis- 17 ta ’ Mejju 2006.
The Reference Member State was the Netherlands and the Concerned Member States were Estonia, Greece, Portugal and Spain.
L- Istat Membru ta ’ Referenza kien l- Olanda u l- Istati Membri Konċernati kienu l - Estonja, il- Greċja, il- Portugall u Spanja.
These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Dawn l- Istati Membri ma kienux kapaċi jilħqu ftehim rigward ir - Rikonoxximent Reċiproku ta ’ l- Awtorizzazzjoni tat- Tqegħid fis- Suq mogħtoija mill- Istat Membru ta ’ referenza.
Spain referred the reasons for disagreement to the EMEA on 25 September 2006.
Spanja rreferiet għar- raġunijiet ta ’ nuqqas ta ’ qbil lill- EMEA fil- 25 ta ’ Settembru 2006.
Significant difference was identified with regard to the indication “ uncomplicated gonorrhoea: urethritis and cervicitis”.
Urethritis u Cervicitis ”.
This refers to the safety and efficacy of cefuroximaxetil in uncomplicated gonorrhoea and risk- benefit balance for this sought indication and this was considered to be a serious public health concern.
Dan jirreferi għas- sigurtà u l- effikaċja taċ- cefuroximaxetil f’ gonorrea ħafifa u bilanċ tar- riskju u l- benefiċċju għal din l- indikazzjoni imfittxija u dan kien ikkonsidrat bħala konċern serju għas- saħħa pubblika.
The arbitration procedure started on 18 October 2006 with the adoption of a list of questions.
Il- proċedura ta ’ l- arbitraġġ bdiet fit- 22 ta ’ Frar 2007 permezz ta ’ l- adozzjoni ta ’ lista ta ’ domandi.
The Rapporteur was Dr Frits Lekkerkerker and Co-Rapporteur was Dr Gonzalo Calvo Rojas.
Frits Lekkerkerker u l- Ko- Rapporteur( s) kien Dr Gonzalo Calvo Rojas.
The Marketing Authorisation Holder provided written explanations on 15 January 2007.
Il- Pussessur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ta ’ spjegazzjonijiet bil- miktub fid- 15 ta ’ Jannar 2007.
During their April 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 objections raised by Spain could be agreed and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Matul il- laqgħa ta ’ April 2007, is- CHMP, fid- dawl tad- dejta gobali sottomessa u d- diskussjoni xjentifika fi ħdan il- Kumitat, kien ta ’ l- opinjoni li l- oġġezzjonijiet imqajjma minn Spanja jistgħu jiġu ffissati u li Sommarju tal- Karatteristiċi tal- Prodotti, l- ittikkettjar u l- fuljett ta ’ tagħrif ta ’ l- Istat Membru ta ’ Referenza għandhom jiġu emendati.
Existing Marketing Authorisations should be varied and pending Marketing Authorisation Applications should be granted to include these amendments.
Awtorizzazzjonijiet għat- Tqegħid fis- Suq eżistenti għandhom ikunu varjati sakemm jiġu diskussi l- Applikazzjonijiet għat- Tqegħid fis- Suq jiġu mogħtija sabiex jiġu inklużi dawn l - emendi.
An opinion was adopted by consensus on 26 April 2007.
Ġiet adottata opinjoni pożittiva permezz ta ’ kunsens fis- 26 ta ’ April 2007.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The list of the product names concerned is given in Annex I.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 13 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Il- lista ta ’ ismijiet tal- prodotti hija mogħtija fl- Anness I.
The final opinion was converted into a Decision by the European Commission on 22 August 2007.
L- opinjoni finali hija konvertita f’ Deċiżjoni mill- Kummissjoni Ewropea fit- 22 ta ’ Awwissu 2007.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER / APPLICANTS IN THE MEMBER STATES
LISTA TA 'ISMIJIET, GĦAMLA FARMAĊEWTIKA, IL- QAWWA TAL- PRODOTTI MEDIĊINALI, MNEJN GĦANDHOM JINGĦATAW, ID- DETENTUR TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ / APPLIKANTI FL- ISTATI MEMBRI
Marketing
Id- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis - Suq
Invented name
Applikant
Pharmaceutical
Isem ivvintat Isem
Member State Authorisation Holder
Għamla Farmaċewtika
Applicant
Kif jingħata
Strength
Olanda
Veluwezoom 22 1327 Almere The Netherlands
Veluwezoom 22 1327 Almere Olanda
Coated tablets
Pilloli miksija
oral use
użu orali
1A Pharma GmbH Keltenring 1 + 3 D-82041 Oberhaching Germany
1A Pharma GmbH Keltenring 1 + 3 D- 82041 Oberhaching Ġermanja
15 2710-693 Sintra Portugal
15 2710- 693 Sintra Portugall
Gran Vía de les Corts Catalanes, 764 08013 Barcelona Spain
Gran Vía de les Corts Catalanes, 764 08013 Barcelona Spanja
2 ANNEX II
2 ANNESS II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦAL EMENDI TAS - SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT, TAT- TIKKETTA U TAL - FULJETT TA ’ TAGĦRIF IPPREŻENTAT MILL- EMEA
3 SCIENTIFIC CONCLUSIONS
3 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CEFUROXIMAXETIL (see Annex I)
CEFUROXIMAXETIL (ara l- Anness I)
The active substance, cefuroxime axetil, owes its in vivo bactericidal activity to the parent compound cefuroxime.
Is- sustanza attiva, cefuroxime axetil, taf l- attività batteriċidjali tagħha lill- kompost li tnisslet minnu, jiġifieri cefuroxime.
All cephalosporins (β -lactam antibiotics) inhibit cell wall production and are selective inhibitors of peptidoglycan synthesis.
Is- Cephalosporins (antibijotiċi tat- tip β- lactam) kollha jinibixxu l- produzzjoni tas- cell wall u huma inibituri selettivi tas- sintesi ta ’ peptidoglycan.
In the Reference Member State, Cefuroxime axetil tablets are indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as:
Fl- Istat Membru ta ’ Referenza, il- pilloli ta ’ Cefuroxime axetil huma indikati għat- trattament ta ’ infezzjonijiet ta ’ qawwa moderata jew severa ikkawżati minn mikro- organiżmi suxxettibbli għal cefuroxime, bħal:
- upper respiratory tract infections: acute otitis media, sinusitis, tonsillitis and pharyngitis
- infezzjonijiet fin- naħa ta ’ fuq tas- sistema tan- nifs: otitis media akuta, sinusite, tonsillite
- acute bronchitis, acute exacerbations of chronic bronchitis
- bronkite kronika, tqanqiliet akuti tal- bronkite kronika
- lower uncomplicated urinary tract infections: cystitis
- infezzjonijiet mhux ikkomplikati tan- naħa t’ isfel tas- sistema urinarja: infezzjonijiet fil -
- skin and soft tissue infections: furunculosis, pyoderma and impetigo
- infezzjonijiet fil- ġilda u fit- tessuti rotob: furunculosis, pyoderma u impetiġini
- uncomplicated gonorrhoea: urethritis and cervicitis
- gonorroea: infezzjonijiet fl- uretra u infezzjonijiet f’ għonq l- utru
- treatment of early stage Lyme disease (stadium I) and subsequent prevention of late
- it- trattament tal- fażi bikrija ta ’ Lyme disease (stadium I) u l- prevenzjoni sussegwenti
complications in adults and children above 12 years of age.
tal- komplikazzjonijiet iktar tard fl- adulti u t- tfal ta ’ iktar minn 12- il sena.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Għandha tingħata kunsiderazzjoni għall- gwida uffiċjali dwar l- użu xieraq ta ’ l- aġenti antibatteriċi.
During CMD (h) referral, Member States could agree on the indications, except the one referring to gonococcal infections.
Matul ir- riferiment tas- CMD (h), l- Istati Membri qablu fuq l- indikazzjonijiet, ħlief fuq dik li tirreferi għall- infezzjonijiet tal- gonorrea.
During CHMP arbitration, the applicant was asked to further justify the indication “ uncomplicated gonorrhoea: urethritis and cervicitis”.
Matul l- arbitraġġ tas- CHMP, l- applikant intalab jagħti ġustifikazzjoni aħjar ta ’ l- indikazzjoni “ gonorroea: infezzjonijiet fl- uretra u infezzjonijiet f’ għonq l- utru ”.
The applicant had to address the safety and efficacy of cefuroximaxetil in uncomplicated gonorrhoea and to conclude on the risk-benefit balance for this sought indication.
L- applikant kellu jindirizza s- sigurtà u l- effikaċja ta ’ cefuroxim axetil għall- gonorrea mingħajr kumplikazzjonijiet u jwassal il- konklużjonijiet tiegħu dwar il- bilanċ bejn il- benefiċċju u r - riskju għal din l- indikazzjoni mfittxa.
To address the concerns of the CHMP, the Applicant submitted an extensive review of the literature supporting the efficacy of cefuroxime axetil in the treatment of uncomplicated gonorrhoea and specifically in cervicitis and urethritis.
Biex jindirizza t- tħassib tas- CHMP, l- Applikant issottometta analiżi estensiva tal- litteratura li tappoġġja l- effikaċja ta ’ cefuroxime axetil għat- trattament ta ’ infezzjonijiet tal- gonorrea mingħajr kumpikazzjonijiet u speċifikament fl- għonq ta ’ l- utru u fl- uretra.
The experience with cefuroxime axetil in limited numbers of patients with uncomplicated anorectal gonorrhoea or pharyngeal gonorrhoea is not sufficient and the efficacy is not established and therefore not acceptable and should not be included in the product information.
L- esperjenza ta ’ l - użu ta ’ cefuroxime axetil f’ numru limitat ta ’ pazjenti b’ gonorrea anorettali jew gonorrea faringali mingħajr kumplikazzjonijiet mhix biżżejjed u l- effikaċja mhix stabbilita u allura mhux aċċettabbli u m’ għandhiex tkun inkluża fil- fuljett ta ’ tagħrif tal- prodott.
Taking into account the originator SPCs of cefuroxime axetil and recommendations from the literature on the use of cefuroxime in the treatment of uncomplicated gonorrhoea, it was argued that the inclusion of this indication is fully justified from a clinical and pharmacological point of view.
Meta wieħed jikkunsidra l- SPCs oriġinali ta ’ cefuroxime axetil u r- rakkomandazzjonijiet mil - litteratura dwar l- użu ta ’ cefuroxime fit- trattament ta ’ gonorrea mingħajr kumplikazzjonijiet, tqajjem l- argument li mill- aspett kliniku u farmakoloġiku, l- inklużjoni ta ’ din l- indikazzjoni hija ġġustifikata għal kollox.
Official guidance should be sought for its use and data on resistance just like for the other recommended antibiotics for this indication.
Trid issir referenza għall- gwida uffiċjali fir- rigward ta ’ l- użu tagħha u tat- tagħrif dwar ir- reżistenza hekk kif isir għal antibijotiċi oħra rakkomandati għal din l- indikazzjoni.
In order to comply with the NfG on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections (CPMP/ EWP/ 558/ 95 rev.1), the applicant accepted that proposed SPC should be updated in due time to include EUCAST breakpoints.
4 Biex ikun konformi ma ’ NfG dwar il- Valutazzjoni tal- Prodotti Mediċinali Indikati għat - Trattament ta ’ l- Infezzjonijiet Batterjali (CPMP/ EWP/ 558/ 95 rev. 1), l- applikant aċċetta li l - SPC propost jiġi aġġornat fi żmien xieraq biex jinkludi il- valuri kritiċi ta ’ l- EUCAST.
The CHMP nonetheless considered that not sufficient evidence supported the optimal efficacy of cefuroxime axetil in treating uncomplicated gonorrhoea, restricted to urethritis and cervicitis.
Minkejja dan, is- CHMP ikkunsidra li ma kienx hemm biżżejjed evidenza li ssaħħaħ l- effikaċja
The efficacy of cefuroxime axetil on other anatomical locations, (which often remain asymptomatic), is highly questionable and consequently treatment with cefuroxime axetil might not curtail further transmission of the infection.
ottimali ta ’ cefuroxime axetil fit- trattament ta ’ gonorrea mingħajr kumplikazzjonijiet, ristretta
Therefore, the inclusion of uncomplicated gonococcal disease is a matter of major concern from a public health perspective, both at individual and community level.
Għalhekk, l- inklużjoni tal- gonorrea mingħajr kumplikazzjonijiet hi materja ta ’ tħassib
4 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
RAĠUNIJIET GĦALL- EMENDI TAS- SOMMARJU TAL- KARATTERISTIĊI TAL - PRODOTT, TAT- TIKKETTA U TAL- FULJETT TA ’ TAGĦRIF
CMD(h) referral agreed on all therapeutic indications, except uncomplicated gonorrhoea: urethritis and cervicitis.
ir- riferiment tas- CMD( h) qabel fuq l- indikazzjonijiet terapewtiċi kollha ħlief dawk għal infezzjonijiet tal- gonorrea mingħajr kumplikazzjonijiet: fl- uretra u fl- għonq ta ’ l- utru. l- iskop tar- riferiment kien li jindirizza s- sigurtà u l- effikaċja ta ’ cefuroxime axetil fl - infezzjonijiet tal- gonorrea (fl- uretra u fl- għonq ta ’ l- utru) mingħajr kumplikazzjonijiet u li jikkonkludi dwar il- bilanċ bejn ir- riskju u l- benefiċċji għal din l- indikazzjoni mfittxa. is- Sommarju tal- Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta ’ tagħrif proposti mill - applikant ġew valutati skond id- dokumentazzjoni sottomessa u skond id- diskussjoni xjentifika fil- Kumitat,
The scope of the referral was to address the safety and efficacy of cefuroxime axetil in uncomplicated gonorrhoea (cervicitis and urethritis) and to conclude on the risk-benefit balance for this sought indication The Summary of Products Characteristic, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee. the CHMP has recommended by consensus that the indication pertaining uncomplicated gonorrhoea (cervicitis and urethritis) should not be included in the product information.
is- CHMP irrakkomanda b’ konsensus li l- indikazzjoni relatata ma ’ l- infezzjonijiet tal- gonorrea (fl- uretra u fl- għonq ta ’ l- utru) mingħajr kumplikazzjonijiet m’ għandhiex tkun inkluża fit - tagħrif dwar il- prodott.
Consequently, the Summary of Product Characteristics and package leaflet should be amended as set out in Annex III.
Konsegwentament, is- Sommarju tal- Karatteristiċi tal- Prodott u l- fuljett ta ’ tagħrif għandhom jiġu emendati kif imfisser fl- Anness III.
Existing Marketing Authorisations should be varied and pending Marketing Authorisation Applications (see Annex I) should be granted to include these amendments.
L- awtorizzazzjonijiet għat - tqegħid fis- suq eżistenti għandhom jinbidlu u l- Applikazzjonijiet għall- Awtorizzazzjoni għat - Tqegħid fis- Suq pendenti (ara l- Anness I) għandhom jingħataw b’ mod li jinkludu dawn l - emendi.
5 ANNEX III
5 ANNESS III
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
6 SUMMARY OF PRODUCT CHARACTERISTICS
6 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT