qanastek/EMEA-V3 huggingface dataset:
Bayer HealthCare AG 51368 Leverkusen
Bayer HealthCare AG 51368 Leverkusen Ġermanja
Bayer Vital GmbH 51368 Leverkusen Germany
Bayer Vital GmbH 51368 Leverkusen Ġermanja
EE - Estonia
EE - Estonja
De Zeneta, 149 30588 Murcia
De Zeneta, 149 30588 Murcia Spanja
2 FI - Finland
2 FI - Finlandja
FR - France
FR - Franza
BAYER SANTE 13, rue Jean Jaurès 92807 PUTEAUX CEDEX France
BAYER SANTE 13, rue Jean Jaurès 92807 PUTEAUX CEDEX Franza
HU - Hungary
HU - Ungerija
Bayer Hungária Kft Alkotás ut.50 1123 Budapest Hungary
Bayer Hungária Kft Alkotás ut. 50 1123 Budapest Ungerija
IT - Italy
IT - Italja
Viale Certosa, 130 20156 Milano Italy
Viale Certosa, 130 20156 Milano Italja
LT - Lithuania
LT - Litwanja
Avenue Louise 143
Avenue Louise 143 B- 1050 Bruxelles Belgju
LV - Latvia
LV - Latvja
Bayer BV Energieweg 1 3641 RT Mijdrecht Nederland
Bayer BV Energieweg 1 3641 RT Mijdrecht Olanda
3 PL - Poland
3 PL - Polonja
Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Rua Quinta do Pinheiro, 5 2794- 003 Carnaxide Portugall
SI - Slovenia
SI - Slovenja
Bravnič arjeva 13 1000 Ljubljana Slovenija
Bravničarjeva 13 1000 Ljubljana Slovenja
SK - Slovakia
SK - Slovakkja
Bayer HealthCare AG 51 368 Leverkusen Germany
Bayer HealthCare AG 51 368 Leverkusen Ġermanja
UK - United Kingdom
UK – Renju Unit
4 ANNEX II
4 ANNESS II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDI TAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT U L- FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
5 SCIENTIFIC CONCLUSIONS
5 KONKLUŻJONIJIET XJENTIFIĊI
Avalox film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Il- pilloli miksijin b’ rita ta ’ Avalox fihom 400 mg moxifloxacin bħala idroklorur.
Avalox was initially approved in June 1999.
Avalox kien approvat inizjalment f’ Ġunju ta ’ l- 1999.
This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Avalox film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK and UK on 5 December 2006.
Din il- proċedura hija riferiment wara Proċedura ta ’ Għarfien Reċiproku dwar l- applikazzjoni tal - varjazzjoni msemmija fuq li ġiet sottomessa għall- pilloli miksijin b’ rita ta ’ Avalox lill- Ġermanja bħala Stat Membru ta ’ Referenza (RMS) u lill- Istati Membri Konċernati (CMS) AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK u UK fil- 5 ta ’ Diċembru ta ’ l - 2006.
The MRP variation application DE/ H/ 155/ 01/ II/ 38 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i. e. infections of upper genital tract, including salpingitis and endometritis.
L- applikazzjoni tal- varjazzjoni ta ’ l- MRP DE/ H/ 155/ 01/ II/ 38 kienet dwar estensjoni ta ’ l- indikazzjoni biex ikun inkluż it- trattament tal- marda infjammatorja tal- pelvis (PID) moderata jew severa, jiġifieri infezzjonijiet tal- parti ta ’ fuq tal- passaġġ ġenitali, inklużi s- salpinġite u l- endometrite.
Objections and concerns over the efficacy and safety of Avalox in the proposed indication were raised during the Mutual Recognition variation procedure.
Waqt il- proċedura tal- varjazzjoni tal- Għarfien Reċiproku tqajmu objezzjonijiet u tħassib dwar l - effikaċja u s- sigurtà ta ’ Avalox fl- indikazzjoni proposta.
6 The CHMP considered that due to the emergence of fluoroquinolone-resistant N. gonorrhoeae strains moxifloxacin should not be used in empirical monotherapy of mild to moderate PID, unless a resistance against moxifloxacin can be ruled out.
6 Is- CHMP ikkunsidra li minħabba t- tkattir ta ’ razez ta ’ N. gonorrhoeae reżistenti għal fluoroquinolone, moxifloxacin ma għandux jintuża fil- monoterapija empirika tal- PID ħafifa jew moderata, sakemm ma tkunx tista ’ tiġi eskluża reżistenza għal kontra moxifloxacin.
Information and recommendations regarding taking measures before prescribing moxifloxacin are adequately addressed in the ‘ contraindications’ and ‘ warnings-precaution of use’ sections of the SPC and PL.
7 teħid ta ’ miżuri qabel il- preskrizzjoni ta ’ moxifloxacin huma indirizzati b’ mod xieraq fis- sezzjonijiet tal - ‘ kontraindikazzjonijiet ’ u ‘ twissijiet- prekawzjonijiet għall- użu ’ ta ’ l- SPC u l- PL.
7 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
8 RAĠUNIJIET GĦALL- EMENDI TAS- SOMMARJU TAL- KARATTERISTIĊI TAL - PRODOTT U L- FULJETT TA ’ TAGĦRIF
No 1084/ 2003, for Avalox and associated names (See Annex 1).
Kummissjoni (KE) Nru 1084/ 2003, għal Avalox u ismijiet assoċjati (ara l- Anness 1).
- The Committee considered that robust data is available showing the efficacy of Avalox in the
- Il- Kumitat ikkunsidra li hemm dejta robusta li turi l- effikaċja ta ’ Avalox fl- indikazzjoni “ Trattament
Risk balance for Avalox and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i. e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable;
Benefiċċju u r- Riskju għal Avalox u ismijiet assoċjati fit - “ Trattament ta ’ mard infjammatorju tal - pelvis (PID) ħafif jew moderat, jiġifieri infezzjonijiet tal- passaġġ ġenitali ta ’ fuq, inklużi s- salpinġite u l- endometrite ” bir- restrizzjonijiet relatati mal- monoterapija empirika kien wieħed favorevoli;
Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Avalox and associated names (see Annex I).
Sommarju tal- Karatteristiċi tal- Prodott u s- sezzjonijiet relevanti tal- Fuljett ta ’ Tagħrif stabbiliti fl - Anness III għal Avalox u ismijiet assoċjati (ara l- Anness I).
9 SUMMARY OF PRODUCT CHARACTERISTICS
9 ANNESS III
10 4.
10 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
11 [Invented name] 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.
[Isem Ivvintat] 400 mg, pilloli miksija b’ rita ġew studjati fi provi kliniċi sa 14- il ġurnata ta ’ kura.
The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
12 Id- doża rrakkomandata (400 mg darba kuljum) u t- tul tat- terapija għall- indikazzjoni li qed tiġi kkurata m’ għandhomx jinqabżu.
Interference with culture test Moxifloxacin therapy may give false negative culture results for Mycobacterium spp. by suppression of mycobacterial growth.
14 Interferenza b’ test ta ’ kultura Terapija b’ moxifloxacin tista ’ tagħti riżultati tal- kultura negattivi foloz għal Mycobacterium spp. permeżż ta ’ sopressjoni tat- tkabbir tal- Mycobacteria.
14 Clinical and Laboratory Standards Institute™ (CLSI) MIC and disc diffusion breakpoints for Staphylococcus spp. and fastidious organisms (M100-S17, 2007) and MIC breakpoints for anaerobes (M11-A7, 2007):
Punti kritiċi ta ’ MIC u tad- diffużjoni tad- disk ta ’ l- Istitut ta ’ Kriterji Kliniċi u tal- Laboratorju™ (CLSI) għal Staphylococcus spp. u organiżmi fastidjużi (M100- S17, 2007) u punti kritiċi ta ’ MIC għal anerobi (M11- A7, 2007):
The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections.
15 Il- prevalenza ta ’ reżistenza miksuba tista ’ tvarja ġeografikament u maż- żmien għal speċi magħżula u nformazzjoni lokali tar- reżistenza hija mixtieqa, b’ mod partikolari meta qed jiġu kkurati infezzjonijiet severi.
15 Commonly susceptible species Aerobic Gram-positive micro-organisms Gardnerella vaginalis Staphylococcus aureus* (methicillin-susceptible) Streptococcus agalactiae (Group B) Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius) Streptococcus pneumoniae* Streptococcus pyogenes* (Group A) Aerobic Gram-negative micro-organisms Haemophilus influenzae* Haemophilus parainfluenzae* Klebsiella pneumoniae*# Moraxella (Branhamella) catarrhalis* Anaerobic micro-organisms Fusobacterium spp.
Speċi suxxettibli b’ mod komuni Mikro- organiżmi aerobiċi pożittivi għal Gram Gardnerella vaginalis Staphylococcus aureus * (suxxettibli għal methicillin) Streptococcus agalactiae (Grupp B) Grupp ta ’ Streptococcus milleri * (S. anginosus, S. constellatus u S. intermedius) Streptococcus pneumoniae * Streptococcus pyogenes * (Grupp A) Mikro- organiżmi aerobiċi negattiv għal Gram Haemophilus influenzae * Haemophilus parainfluenzae * Klebsiella pneumoniae * # Moraxella (Branhamella) catarrhalis * Mikro- organiżmi anaerobiċi Fusobacterium spp.
5.2 Pharmacokinetic properties
16 5. 2 Tagħrif farmakokinetiku
16 Distribution Moxifloxacin is distributed to extravascular spaces rapidly; after a dose of 400 mg an AUC of 35 m·gh/ l is observed.
Distribuzzjoni Moxifloxacin huwa distribwit malajr fl- ispazji ekstravaskulari; wara doża ta ’ 400 mg hija osservata AUC ta ’ 35 m· gh/ l.
After a 400 mg dose, recovery from urine (approximately 19% for unchanged drug, approximately 2.5% for M1, and approximately 14% for M2) and faeces (approximately 25% of unchanged drug, approximately 36% for M1, and no recovery for M2) totalled to approximately 96%.
17 Wara doża ta ’ 400 mg, l- irkupru mill- awrina (madwar 19% għall- mediċina mhux mibdula, madwar 2. 5% għal M1, u madwar 14% għal M2) u mill- purgar (madwar 25% għall- mediċina mhux mibdula, madwar 36% għal M1, u l- ebda rkupru għal M2) ammonta għal madwar 96%.
17 concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/ min/ 1.73 m2).
Kif il- funzjoni renali tonqos, il- konċentrazzjonijiet tal- metabolit M2 (glucuronide) tiżdied b’ fattur sa 2. 5 (bi tneħħija tal - krejatinina ta ’ < 30 ml/ min/ 1. 73 m2).
18 PACKAGE LEAFLET
18 FULJETT TA ’ TAGĦRIF
22 If you take more than the prescribed one tablet a day, seek medical advice immediately and, if possible, take any remaining tablets, the packaging or this leaflet with you to show the doctor or pharmacist what you have taken.
22 Jekk tinsa tieħu [Isem Ivvintat] 400mg pilloli miksija b’ rita:
London, 14 August 2008 EMEA/ CHMP/ 524251/ 2008
Londra, 14 ta ’ Awwissu 2008 EMEA/ CHMP/ 524260/ 2008
Avelox and associated names
Avelox u ismijiet assoċjati
Avelox film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Avelox pilloli miksijin b’ rita fihom 400 mg moxifloxacin bħala hydrochloride.
Avelox was initially approved in June 1999.
Avelox ġie approvat inizjalment f’ Ġunju 1999.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID- DETENTURI TA` L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
Marketing autorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat - tqegħid fis- suq
Invented Name
L- Applikant
Route of administration
Għamla Farmaċewtika
Austria
Awstrija
6 - 10 1160 Wien, Austria
6 - 10 1160 Wien, L- Awstrija
film-coated tablets
pilloli miksija b’ rita
Belgium
Belġju
143, Avenue Louise 1050 Brussel, Belgium
143, Avenue Louise 1050 Brussel, il- Belġju
Bayer Hellas AG 18-20 Sorou Str 15125 Amaroussion Athens, Greece
Bayer Hellas AG 18- 20 Sorou Str 15125 Amaroussion Athens, Il- Greċja
Czech Republic
Republika Ċeka
Denmark
Danimarka
Estonia
Estonja
Finland
Finlandja
Bayer Schering Pharma Oy Pansiontie 47, FI-20210 Turku Finland
Bayer Schering Pharma Oy Pansiontie 47, FI- 20210 Turku Il_ Finlandja
France
Franza
Bayer Santé 13, Rue Jean Jaurès 92807 Puteaux Cedex France
Bayer Santé 13, Rue Jean Jaurès 92807 Puteaux Cedex Franża
2 Germany
2 Ġermanja
15 D-07745 Jena Germany
Bayer Vital GmbH 51368 Leverkusen Il- Ġermanja
Greece
Greċja
Bayer Hellas AG 18-20 Sorou Str 15125 Amaroussion Athens Greece
Bayer Hellas AG 18- 20 Sorou Str 15125 Amaroussion Athens il- Greċja
Hungary
Ungerija
The Atrium, Blackthorn Road Dublin 18 Ireland
The Atrium, Blackthorn Road Dublin 18 L- Irlanda
Liofora
Aliane
Italy
Italja
Viale Certosa 130 20156 Milano Italy
Viale Certosa 130 20156 Milano l- Italja
Latvia
Latvja
Lithuania
Litwanja
Aliane
Liofora
Luxembourg
3 Lussemburgu
143, Avenue Louise 1050 Brussel
143, Avenue Louise 1050 Brussel il- Belġju
Aliane
Belanette
Energieweg 1 3641 RT Mijdrecht The Netherlands
Energieweg 1 3641 RT Mijdrecht L- Olanda
Belanette
Liofora
Norway
Norveġja
Poland
Polonja
Portugal
Portugall
Lusal, Produção Químico-Farmacêutica Luso-Alemã, Lda.
Lusal, Produção Químico- Farmacêutica Luso - Alemã, Lda.
Slovakia
Slovakkja
Slovenia
Slovenja
Spain
4 Spanja
Baix Llobregat, 3-5 08970 Sant Joan Despí, Barcelona Spain
Baix Llobregat, 3- 5 08970 Sant Joan Despí, Barcelona Spanja
4 Sweden
Sveżja
Liofora
Renju Unit
SCIENTIFIC CONCLUSIONS
KONLUŻJONIJIET XJENTIFIĊI
6 SCIENTIFIC CONCLUSIONS
6 KONLUŻJONIJIET XJENTIFIĊI
The Belanette blister is glued in a carton which is subsequently folded to a wallet configuration.
Il- folja ta ’ Belanette hija mwaħħla bil- kolla ma ’ kartuna li mbagħad tintlewa f’ forma ta ’ portafoll.
The wallet with the inserted blister is assembled with a package leaflet (PL) and all components are wrapped together with clear, transparent cellophane wrapping to form the unit pack which prevents the loss of individual components.
Il- portafoll bil- folja infilzata jiġi mmuntat b’ fuljett ta ’ tagħrif (PL) u l- komponenti kollha jitgeżwru flimkien b’ kisja ta ’ cellophane irqiq u trasparenti biex jifforma l- pakkett ta ’ l- unit li jipprevjeni t- telf ta ’ komponenti individwali.
The product is marketed in pack size of 3 x 21 film-coated tablets.
Il- prodott jitqiegħed fis- suq f’ pakketti ta ’ 3 x 21 pillola miksijin b’ rita.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BELANETTE AND ASSOCIATED NAMES (see Annex I)
SOMMARJU GLOBALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ BELANETTE U ISMIJIET ASSOĊJATI (ara l- Anness I)
The required basic information (how to use the product, what to do in case of missed dose, etc.), which ensures the safe use of the product is present on the cardboard wallets and visible through the cellophane wrapping.
It- tagħrif bażiku meħtieġ (kif tuża l- prodott, x’ tagħmel jekk taqbeż doża, eċċ.) li jiżgura l- użu sigur tal- prodott ikun preżenti fuq il- portafoll tal- kartun u jkun jidher mill- kisi tas- cellophane.
Once the cellophane wrapping is removed the safe use of the product is still ensured as the cardboard wallets contain the required information.
Ladarba l- kisi tas- cellophane jitneħħa, l- użu sigur tal- prodott ikun għadu żgurat għax il- portafolli tal- kartun ikun fihom it- tagħrif meħtieġ.
In addition it is not possible to separate blisters from cardboard wallets and therefore the users always have access to the required information.
Barra minn hekk ma jkunx possibbli tifred il- folji mill- portafolli tal- kartun u għalhekk min jużahom dejjem ikollu aċċess għat- tagħrif meħtieġ.
Moreover cardboard wallets protect blisters against damage.
Barra minn hekk il- portafolli tal- kartun jipproteġu l- folji mill- ħsara.
The risk resulting from the separation of a package leaflet from cardboard wallets is comparable with the risk resulting from separation of blisters from conventional external packaging (cardboard box).
Ir- riskju li jirriżulta mill- firda tal- fuljett ta ’ tagħrif mill- portafolli tal- kartun jista ’ jitqabbel mar- riskju li jirriżulta mill- firda tal- folji minn pakketti esterni konvenzjonali (kaxxi tal- kartun).
Although different observations in respect to readability of the Braille text through the cellophane wrapping have been made by blind users, it is assumed that before use of the product the cellophane wrapping will be removed and therefore blind person will be in a position to identify the product.
Għalkemm saru osservazzjonijiet differenti dwar il- possibilità ta ’ qari tal- kitba bil- Braille mill- kisi tas - cellophane minn persuni għomja, wieħed jassumi li qabel ma xi ħadd juża l- prodott, dan ineħħi l- kisi tas - cellophane u għalhekk il- persuna għamja tkun tista ’ tidentifika l- prodott.
It has also been confirmed by blind persons that the Braille text on the cardboard is palpable and readable.
Ġie kkonfermat ukoll minn persuni għomja li l- kitba bil- Braille fuq il- kartun tinħass u tista ’ tinqara.
Since it is a prescription medicine, the name of the product always will be known to the blind user as during the visit the physicians inform patients about medicinal product they are prescribing, including the name of the product.
Billi dan hu prodott li jista ’ jinkiseb biss b’ riċetta ta ’ tabib, l- isem tal- prodott dejjem ikun magħruf mill- persuni għomja li jużawh għax waqt iż- żjarat lit- tabib dan jgħarraf lill- pazjenti bil- prodott mediċinali li jkun qed jiktbilhom, inkluż l- isem tal- prodott.
Therefore blind users will be able to double check the information written on the cardboard wallets (Braille text) with the information obtained from a physician (during the visit).
Għalhekk persuni għomja li jużaw dan il- prodott ikunu jistgħu jiċċekkjaw doppjament it- tagħrif miktub (bil- Braille) fuq il- portafolli tal- kartun bit- tagħrif miksub mit- tabib (waqt iż - żjara).
Finally taking into account that the medicinal product is intended for long term use, the possible mistakes and misuse are further minimised.
Finalment, meta wieħed jikkunsidra li l- prodott mediċinali huwa intiż għal użu fit- tul, il- possibilità ta ’ żbalji u użu ħażin tkompli tonqos.
7 ANNEX III
7 ANNESS III
8 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
8 Is- Sommarju tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif huma l- verżjonijiet finali miksuba waqt il- proċedura tal- Koordinazzjoni tal- grupp.
London, 17 June 2008 EMEA/ CHMP/ 332403/ 2008
Londra, 17 ta 'Ġunju 2008 EMEA/ 332393/ 2008
OPINION FOLLOWING AN ARTICLE 5(11)1 REFERRAL FOR Belanette and associated names (see Annex I)
OPINJONI DWAR RIFERIMENT SKOND L- ARTIKOLU 5( 11) 1 GĦAL Belanette u ismijiet oħra assoċjati (ara anness I) Denominazzjoni Komuni Internazzjonali (DKI):
BACKGROUND INFORMATION
INFORMAZZJONI ĠENERALI
Belanette and associated names, is a combined oral contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
Belanette u l- ismijiet assoċjati, hija kontraċċettiv orali kombinat li fih 0. 02 mg ethinylestradiol u 3 mg drospirenone.
The MAH submitted variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the medicinal product in the framework of Article 5 of Commission Regulation (EC) No 1084/ 2003.
Id- detentur ta 'l- awtorizzazzjoni għat- tqegħid fuq is- suq (MAH) ippreżenta applikazzjoni għal varjazzjoni suġġetta għall- Proċedura ta' Rikonoxximent Reċiproku ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq tal - mediċinal fl- ambitu ta' l- Artikolu 5 tar- Regolament tal- Kummissjoni (KE) Nru 1984/ 2003.
The Mutual Recognition Procedure started on 18 June 2007.
Il- Proċedura ta 'Rikonoxximent Reċiproku bdiet fit- 18 ta' Ġunju 2007.
The Reference Member State was Netherlands and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain and Sweden.
L- Istat Membru ta 'referenza kienet l- Olanda u l- Istati Membri kkonċernati kienu l- Awstrija, il- Belġju, Ċipru, ir- Repubblika Ċeka, id- Danimarka, l- Estonja, il - Finlandja, Franza, il- Ġermanja, il- Greċja, l- Irlanda, l- Italja, il- Latvja, il- Litwanja, il- Lussemburgu, Malta, in - Norveġja, il- Polonja, il- Portugall, is- Slovakkja, is- Slovenja, Spanja, l- Ungerija u l- Iżvezja.
These Member States were not able to reach an agreement in respect of the variation to the Marketing Authorisation within the time frame as referred to in Article 5(6) of Commission Regulation (EC) No 1084/ 2003.
Dawn l- Istati Membri ma setgħux jilħqu qbil fir- rigward tal- varjazzjoni ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq saż - żmien previst mill- Artikolu 5( 6) tar- Regolament tal- Kummissjoni (KE) Nru 1084/ 2003.
Hungary referred the reasons for disagreement to the EMEA on 12 October 2007.
L- Ungerija rreferiet ir- raġunijiet għan- nuqqas ta 'qbil lill- EMEA fil- 12 ta' Ottubru 2007.
The proposed package concept, the so-called wallet with the product and package leaflet wrapped in transparent cellophane was considered to be a serious public concern.
Il- kunċett ta 'pakkett propost, l- hekk imsejħa kaxxa bil- prodott u l- fuljett ta' tagħrif imgeżwer fis- cellophane trasparenti tqis bħala problema pubblika serja.
The cellophane wrapping could not be accepted as an outer packaging due to the risk that during usage the product (wallets) would get separated from the package leaflet.
Il- kisi bis- cellophane ma setax ikun aċċettat bħala imballaġġ estern minħabba r- riskju li, waqt l- użu, il- prodott (kaxxi) jista 'jiġi sseparat mill- fuljett ta' tagħrif.
Furthermore the Braille text could not be read through the outer packaging as the cellophane is slippery and moves when touched.
Barra minn hekk, ma kienx possibbli li t- test bil- Braille jinqara mill- imballaġġ estern billi s- cellophane jiżloq u jiċċaqlaq mal- mess.
The arbitration procedure started on 18 October 2007.
Il- proċedura ta 'arbitraġġ bdiet fit- 18 ta' Ottubru 2007.
The Rapporteur was Dr Jean-Louis Robert and Co- Rapporteur was Dr Janos Borvendeg.
Ir- rapporteur kien Dr Jean- Luis Robert u l - korapporteur kien Dr Janos Borvendeg.
During their December 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 Yasminelle and associated names, that the objections raised by Hungary should not prevent the approval of the variation applied for and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be the final versions achieved during the Coordination group procedure.
Waqt il- laqgħa tiegħu f' Diċembru 2007, is- CHMP, fid- dawl tat- tagħrif kollu mressaq u fid- dawl tad - diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- fehma li l- bilanċ bejn il- benefiċċji u r- riskji huwa favorevoli għal Belanette u l- ismijiet assoċjati, li l- oġġezzjonijiet imqajma mill- Ungerija ma għandhomx jimpedixxu l- approvazzjoni tal- varjazzjoni li għalihom tressqet applikazzjoni u li s- Sommarju tal - Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta 'tagħrif ta' l- Istat Membru ta 'Referenza għandhom ikunu l - verżjonijiet finali milħuqa waqt il- proċedura tal- grupp ta' koordinament.
A positive opinion was adopted by majority on 13 December 2007.
Fit- 13 ta 'Diċembru 2007 ġiet adottata opinjoni pożittiva b' maġġoranza.
The list of the product names concerned is given in Annex I.
Il- lista ta 'ismijiet tal- prodott ikkonċernat qed tingħata fl- Anness I.
The final opinion was converted into a Decision by the European Commission on 17 June 2008.
L- opinjoni finali hija konvertita f' Deċiżjoni mill- Kummissjoni Ewropea fi 17 ta 'Ġunju 2008.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTT MEDIĊINALI, MNEJN JINGĦATA, SIDIEN TA` L- AWTORIŻŻAZZJONI TAL - KUMMERĊ TA` L- APPLIKANT F` L- ISTATI MEMBRI Stat Membru
(Invented)
Sid ta` l- Awtoriżżazzjoni tal- Kummerċ
Strength
Applikant
Pharmaceutical
Isem Ivvintat / Isem
State
Qawwa
Authorisation Holder
Għamla Farmaċewtika
Name
Kif jingħata
form
L- Awstrija
Jeneweinova 51a, 617 00 Brno, Czech Republic
Jeneweinova 51a 617 00 Brno Ir- Repubblika Ċeka
Denmark
Id- Danimarka
TEVA Sweden AB PO Box 1070, SE - 25110 Helsingborg Sweden
TEVA Sweden AB PO Box 1070 SE - 25110 Helsingborg L- Isvezja
2 Greece
Franza
Box 217 3640 AE Mijdrecht The Netherlands
1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 Franza
France
Il- Greċja
1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 France
Box 217 3640 AE Mijdrecht Olanda
TEVA Magyarország Rt Rákóczi út 70-72, Budapest, H-1074, Hungary
TEVA Magyarország Rt Rákóczi út 70- 72 Budapest, H- 1074, L- Ungerija
Italy
Qawwa
Richard 7, 20143 Milano Italy
Richard 7, 20143 Milano L- Italja
oral use
Għall- użu orali
Norway
Il- Norveġja
TEVA Pharma - Produtos Farmacêuticos Lda Lagoas Park, Edifício 1, Piso 3, 2740-264 Porto Salvo, Portugal
TEVA Pharma - Produtos Farmacêuticos Lda Lagoas Park, Edifício 1, Piso 3, 2740- 264 Porto Salvo Il- Portugall
Slovakia
Is- Slovakkja
150mg
Qawwa
Film-coated tablet
Bikalutamid TEVA
Oral use
150 mg
4 Slovenia
Għall- użu
150 mg
150 mg filmsko obložene tablete
Film-coated tablet
b’ rita
Oral use
orali
Ingers Industrial Solutions s. r. o., Jeneweinova 51 a 617 00 Brno, Tjeckien
Jeneweinova 51a 617 00 Brno Ir- Repubblika Ċeka
The United Kingdom
Ir- Renju Unit
5 ANNEX II
5 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BICALUTAMIDE 150 mg CONTAINING MEDICINAL PRODUCTS
SOMMARJU ĠENERALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ BICALUTAMIDE 150 mg LI FIH PRODOTTI MEDIĊINALI
Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s. r. o.) are generic preparations containing bicalutamide as the active substance.
Bicalutamide 150mg pilloli miksijin b’ rita (Ingers Industrial Solutions s. r. o) huma preparazzjonijiet ġeneriċi li fihom bicalutamide bħala s- sustanza attiva.
Bicalutamide is an oral-androgen used in the management of locally advanced prostate cancer, as an immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Bicalutamide huwa anti- androġen orali użat fit - trattament lokali tal- kanċer tal- prostata fi stadju avvanzat, bħala terapija immedjata waħidha jew bħala addizzjoni għat- trattament permezz ta ’ prostatektomija radikali jew radjoterapija.
The applicant has applied for a Marketing Authorisation in several member states through the Mutual Recognition Procedure with Czech Republic as reference member state (RMS).
L- applikant applika għal Awtorizzazzjoni għat- Tqegħid fis- Suq f’ diversi stati membri permezz tal - Proċedura għar- Rikonoxximent Reċiproku mar- Repubblika Ċeka bħala Stat Membru ta ’ referenza (RMS).
The Article 29 referral procedure was initiated due to concerns raised by Germany on the potential serious risk to public health regarding the benefit/ risk ratio of this product.
Il- proċedura ta ’ referenza skond l’ Artikolu 29 inbdiet minħabba t- tħassib li qajjmet il - Ġermanja dwar il- possibilità ta ’ riskju serju potenzjali għas- saħħa pubblika fir- rigward tal- proporzjon ta ’ riskju/ benefiċċju ta ’ dan il- prodott.
The bioequivalence between the reference and test products was sufficiently proven and was not questioned in this referral.
Il- bijoekwivalenza bejn il- prodotti ta ’ referenza u dawk ittestjati ġiet ippruvata b’ mod suffiċjenti u ma ġietx iddubitata waqt din ir- referenza.
The scope of Bicaluplex Article 29 Referral concerns the benefit/ risk ration of both indications: treatment of locally advanced prostatic cancer and monotherapy in early treatment or as adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostate cancer.
L- iskop tar- Referenza skond l’ Artikolu 29 dwar Bicaluplex tirrigwarda l- iskarsezza tar- razzjoni benefiċċju/ riskju taż- żewġ indikazzjonijiet: il- kura tal- kanċer tal- prostata avvanzat lokalment u monoterapija fil- kura bikrija jew bħala żjieda għall- kura bir- radjoterapija jew prostatektomija radikali f’ pazjenti li għandhom kanċer fil- prostata.
The Committee, considering the Casodex Referral (bicalutamide 150 mg) made under article 31 of Directive 2001/ 83/ EC for medicinal products containing bicalutamide, reached the conclusion that bicalutamide 150mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to: “ Bicalutamide 150mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression”.
Il- Kumitat, wara li ħa kont tar- Referenza ta ’ Casodex (bicalutamide 150 mg) skond l- Artikolu 31 tad - Direttiva 2001/ 83/ KE dwar il- prodotti mediċinali li fihom bicalutamide, wasal għall- konklużjoni li bicalutamide 150mg huwa effettiv fil- kura ta ’ kanċer tal- prostata avvanzat lokalment, iżda il- CHMP ikkunsidra li l- indikazzjoni terapewtika għandha tkun ristretta għal: “ Bicalutamide 150mg huwa indikat jew waħdu inkella flimkien ma ’ prostatektomija radikali jew radjoterapija f’ pazjenti b’ kanċer tal- prostatat avvanzat lokalment b’ riskju kbir ta ’ progressjoni tal- marda ”.
The CHMP also concluded that a potential association between the use of bicalutamide 150 mg and heart failure could not be ruled out and therefore considered that the need to further study cardiovascular morbidity and mortality remains.
Il- CHMP ikkonkluda wkoll li l- assoċjazzjoni potenzjali bejn l- użu ta ’ bicalutamide 150 mg u l- kollass tal- qalb ma tistax tiġi eskluża u għalhekk qies li għad hemm il- bżonn li jsiru aktar studji fuq il- morbidità kardjovaskulari u l - mortalità.
The CHMP concluded that the benefit/ risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.
Il- CHMP ikkonkluda li l- bilanċ tal- benefiċċju/ riskju ta ’ bicalutamide 150 mg li fih prodotti mediċinali fl- indikazzjoni ristretta miftehema huwa wieħed favorevoli.
Based on these conclusions, the CHMP considered generic Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s. r. o.) acceptable for registration based on a positive benefit/ risk ratio of bicalutamide 150mg containing products as recently assessed in the Casodex Article 31 Referral.
Skond dawn il- konklużjonijiet, il- CHMP ikkunsidra l- pilloli ġeneriċi Bicalutamide 150mg miksija b’ rita (Ingers Industrial Solutions s. r. o.) aċċettabbli għar- reġistrazzjoni skond il- porzjon pożittiv ta ’ benefiċċju/ riskju ta ’ bicalutamide 150mg li fih prodotti mediċinali kif eżaminati dan l- aħħar fir - Referenza Casodex skond l- Artikolu 31.
Therefore, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products and to grant Marketing Authorisations for all applications referred to in Annex I of the Opinion in accordance with the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet, set out in Annex III of the Opinion.
Għalhekk, il- CHMP irrakkomanda li jinżammu l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq għall - prodotti mediċinali kollha u li jingħataw Atorizzazzjonijiet għat- Tqegħid fis- Suq għall - applikazzjonijiet kollha kif hemm referenza għalihom fl- Anness 1 ta ’ l- Opinjoni skond l- emendi għat - taqsimiet relevanti tas- Sommarju tal- Karatteristiċi tal- Prodott u fil- Fuljett ta ’ Tagħrif, kif stabbiliti fl - Anness III ta ’ l- Opinjoni.
7 ANNEX III
7 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA‘ TAGĦRIF
8 SUMMARY OF PRODUCT CHARACTERISTICS
8 SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT
9 The valid summary of product characteristics is the final version achieved during the Coordination group procedure with the following amendments:
9 Is- Sommarju tal- Karatteistiċi tal- Prodott validu huwa l- verżjoni finali miksub waqt il- proċedura tal- grupp ta ’ Koordinazzjoni bl- amendi li ġejjin.
Bicaluplex 150 mg tablets are indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
Pilloli Bicaluplex 150 mg huma indikati għal prostatomija radikali jew radjuterapija f’ pazjenti b’ kanċer lokali tal- prostata b’ riskju għoli bi progressjoni tal- marda (ara sezzjoni 5. 1), kemm weħedhom u kemm miżjuda ma ’ kura oħra.
Pharmacotherapeutic group: anti-androgens, ATC code:
Kategorija farmakoterapewtika: anti- androġen, Kodiċi ATC:
L02BB03 Bicalutamide is a non-steroidal anti-androgen without any other endocrine activity.
L02BB03 Bicalutamide huwa anti- androġen mhux sterojdi mingħajr attivita endokrinali oħra.
It binds to androgen receptors without activating gene expression and thus inhibits androgen stimulation.
Huwa jingħaqad ma riċettaturi androġeni mingħajr ma jattiva l- espressjoni tal- ġene u għalhekk jimpedixxi l - istimulazzjoni androġenika.
Inhibition results in the regression of prostatic tumours.
L- impediment jirriżulta f’ rigressjoni ta ’ tumuri prostatiċi.
Treatment discontinuation may result in anti- androgen withdrawal syndrome in some patients.
It- twaqqif tat - trattament jista ’ jirriżulta f’ sindrome ta’ irtirar anti- androġenika f’ xi pazjenti.
Bicalutamide is a racemate, the (R)-enantiomer of which has most of the anti-androgen activity.
Bicalutamide huwa racemate, li l - (R) - enantiomer tiegħu għandha l- biċċa l- kbira ta ’ l- attività anti - androġenika.
Bicalutamide 150 mg was studied as a treatment for patients with localized (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer, in a combined analysis of 3 placebo-controlled double-blind studies in 8,113 patients, where the product was given as immediate hormone therapy or as adjuvant to radical prostatectomy or radiotherapy (primarily external beam radiation).
Bicalutamide 150 mg ġie studjat bħala kura għal pazjenti b’ kanċer mhux metastatiku lokalizzat (T1 - T2, N0 jew NX, M0) jew lokalment avvanzat (T3- T4, kull N, M0; T1- T2, N+, M0) tal- prostata, f’ analiżi kombinata ta ’ 3 studji double- blind b’ kontrolli bi plaċebo fuq 8, 113- il pazjent, fejn il- prodott ġie mogħti bħala terapija ormonali immedjata jew bħala mizjuda ma ’ kura oħra għal prostatomija radikali jew radjuterapija (prinċipalment radjazzjoni b’ raġġ estern).
At 7.4 years median follow-up, 27.4% of all bicalutamide-treated patients and 30.7% of all placebo-treated patients had experienced objective disease progression.
Wara osservazzjoni segwenti fuq medda medjana ta ’ 7. 4 snin, 27. 4% tal- pazjenti kollha trattati b’ bicalutamide u 30. 7% tal- pazjenti kollha trattati bi plaċebo kellhom progressjoni oġġettiva tal- marda.
A reduction in risk of objective disease progression was seen across most patient groups but was most evident in those at highest risk of disease progression.
Deher tnaqqis fir- riskju ta ’ progressjoni oġġettiva tal- marda fuq ħafna mill - gruppi ta ’ pazjenti imma li kienet l- aktar evidenti fuq dawk li jinsabu fl- ogħla riskju ta ’ progressjoni tal- marda.
Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.
Għalhekk, it - tobba għandhom mnejn jiddeċiedu li l- aħjar strateġija medika għal pazjent li jinsab f’ riskju baxx ta ’ progressjoni tal- marda, b’ mod partikolari fi sitwazzjoni fejn tingħata aktar min kura waħda wara prostatomija radikali, għandha mnejn tkun li t- terapija ormonali tiġi diferita sakemm jintwerew sinjali li l- marda qed tinfirex.
No overall survival difference was seen at 7.4 years median follow-up with 22.9% mortality (HR = 0.99; 95% confidence interval 0.91 to 1.09).
Ma ntweriet ebda differenza fis- sopravivenza globali wara 7. 4 snin ta ’ sussegwirsi medjan b’ mortalità ta ’ 22. 9% (HR = 0. 99; 95% intervall ta ’ kunfidenza 0. 91 sa 1. 09).
However some trends were apparent for patients in exploratory subgroup analyses.
Madankollu dehru xi xejriet għal pazjenti f’ analiżi esploratorja fis- sottogrupp.
Progression-free survival and overall survival data for patients with locally advanced disease are summarised in the following tables:
Sopravivenza mingħajr ma tinfirex il- marda u dejta dwar sopravivenza globali għal pazjenti b’ mard li avvanza lokalment huma mogħtija fil- qosor fit- tabelli li ġejjin:
Table 1 Progression-free survival in locally advanced disease by therapy sub-group
Tabella 1 Sopravivenza mingħajr firxa f’ mard lokalment avvanzat skond is- sottogrupp tat- terapija
Analysis population
Analiżi tal - popolazzjoni
Events (%) in Bicalutamide patients
Każijiet (%) f’ pazjenti fuq Bicalutamide
Events (%) in placebo patients
Każijiet (%) fuq pazjenti li ngħataw plaċebo
Hazard ratio (95% CI)
Proporzjon ta ’ Periklu (HR) (95% Intervall ta ‘ kunfidenza)
Watchful waiting Radiotherapy Radical prostatectomy
Stennija b’ attenzjoni Radjuterapija Prostetomija radikali
0.60 (0.49 to 0.73) 0.56 (0.40 to 0.78) 0.75 (0.61 to 0.91)
0. 60 (0. 49 sa 0. 73) 0. 56 (0. 40 sa 0. 78) 0. 75 (0. 61 sa 0. 91)
Deaths (%) in Deaths (%) in Bicalutamide patients placebo patients
Mewt (%) f’ pazjenti fuq Bicalutamide
Hazard ratio (95% CI)
Proporzjon ta ’ periklu (HR) (95% Intervall ta ’ kunfidenza)
Watchful waiting Radiotherapy Radical prostatectomy
Stennija b’ attenzjoni Radjuterapija Prostatomija radikali
0.81 (0.66 to 1.01) 0.65 (0.44 to 0.95) 1.09 (0.85 to 1.39)
0. 81 (0. 66 sa 1. 01) 0. 65 (0. 44 sa 0. 95) 1. 09 (0. 85 sa 1. 39)
For patients with localised disease, receiving bicalutamide alone, there was no significant difference in progression free survival.
Għal pazjenti b’ marda lokalizzata, it- teħid ta ’ bicalutamide waħdu, ma tagħmilx differenza sinifikanti fis- sopravivenza mingħajr firxa.
In these patients there was also a trend toward decreased survival compared with placebo patients (HR=1.16, 95% CI 0.99 to 1.37).
(HR=1. 16, 95% Intervall ta ’ kunfidenza 0. 99 sa 1. 37).
In view of this, the benefit-risk profile for the use of bicalutamide is not considered favourable in this group of patients.
Skond dan, il- profil dwar is- siwi- riskju għall- użu ta ’ bicalutamide mhux meqjus bħala favorevoli għal dan il- grupp ta ’ pazjenti.
The effectiveness of bicalutamide 150 mg in the treatment of patients with locally advanced prostatic carcinoma without metastases, for whom primary treatment with hormones was indicated, was evaluated separately using the meta-analysis of two studies comprising 480 patients with prostatic carcinoma without metastases (M0) who had not been treated before.
L- effettvità ta ’ bicalutamide 150 mg fit- trattament ta ’ pazjenti b’ karċinoma prostatika mingħajr metastasi lokalment avvanzata, li għalihom trattament prinċipali b’ ormoni kien indikat, ġiet evalwata separatament permezz ta ’ meta- analiżi ta ’ żewġ studji li jikkonsistu minn 480 pazjent b’ karċinoma prostatika mingħajr metastasi (M0) u li qatt ma ġew ittrattati qabel.
There was no significant difference in survival (HR=1.05 (CI=0.81-1.36), p=0.669) or in the interval until progression (HR=1.20 (CI 0.96-1.51), p=0.107) between the group treated with bicalutamide 150 mg and the group treated with castration.
Ma kienx hemm differenza sinifikanti fis- sopravivenza (HR=1. 05 (Intervall ta ’ kunfidenza, CI =0. 81- 1. 36), p=0. 669) jew fl - intervall sal- progressjoni (HR=1. 20 (CI 0. 96- 1. 51), p=0. 107) bejn il- grupp ittrattat b’ bicalutamide 150 mg u l- grupp ittrattat b’ kastrazzjoni.
A general trend with respect to quality of life in favour of bicalutamide 150 mg in comparison with castration was observed; the subgroups that provided these data showed significantly higher sexual appetence (p=0.029) and fitness (p=0.046).
Xejra ġenerali fir- rigward tal- kwalità tal- ħajja favur bicalutamide 150 mg meta mqabbel ma ’ kastrazzjoni ġiet osservata; is- sottogruppi li pproduċew din id- dejta wrew ħajra sesswali (p=0. 029) u forma fiżika (p=0. 046) sinifikament ogħla.
Combined analysis of 2 clinical studies comprising 805 patients with metastatic prostatic carcinoma, who had not been treated before with expected mortality 43%, showed that the treatment with bicalutamide 150 mg is less effective than castration as for the survival time (HR = 1.30 [confidence interval 1.04 – 1.65]).
Analiżi kombinata f’ 2 studji kliniċi li kienu jikkonsistu f’ 805 pazjenti b’ karċinoma metastatika tal - prostata, li ma ġewx ittrattati qabel b’ mortalità mistennija ta ’ 43%, urew li t- trattament b’ bicalutamide 150 mg huwa inqas effettiv minn kastrazzjoni rigward żmien ta ’ sopravivenza (HR = 1. 30 [intervall ta ’ kunfidenza 1. 04 – 1. 65]).
The estimated difference is 42 days while the mean survival time is 2 years.
Id- differenza stmata hi ta ’ 42 jum filwaqt li ż- żmien medju ta ’ sopravivenza hu ta ’ sentejn.
11 LABELLING
11 TIKKETTAR
12 The valid labelling text is the final version achieved during the Coordination group procedure.
12 It- tikkettar validu huwa l- verżjoni finali miksub waqt il- proċedura tal- grupp ta ’ Koordinazzjoni.
13 PACKAGE LEAFLET
13 FULJETT TA ’ TAGĦRIF
14 The valid package leaflet is the final version achieved during the Coordination group procedure with the following amendments:
14 Il- fuljett ta ’ tagħrif validu huwa l- verżjoni finali miksub waqt il- proċedura tal- grupp ta ’ Koordinazzjoni bl- amendi li ġejjin.
WHAT BICALUTAMIDE IS AND WHAT IT IS USED FOR
X’ INHU BICALUTAMIDE U GĦALXIEX JINTUŻA
Bicalutamide belongs to the group of anti-androgens.
Bicalutamide jappartjeni għall- grupp ta ’ anti- androġeni.
Anti-androgens act against the effects of androgens (male sex hormones).
Anti- androġeni jaġixxu kontra l- effetti ta ’ androġeni (ormoni sesswali tar- raġel).
Bicalutamide is used in adult men for the treatment of prostate cancer without metastases, when castration or other types of treatment are not indicated or unacceptable.
Bicalutamide jintuża minn irġiel adulti għal kura tal- kanċer mingħajr metstasi tal- prostata, meta kastrazzjoni jew tipi oħra ta ’ trattament mhumiex indikati jew accetabbli.
It may be used in combination with radiotherapy or prostate surgery in early treatment programmes.
Jista ’ jintuża f’ kombinazzjoni ma ’ radjuterapija jew kirurġija tal- prostata fi programmi ta ’ trattamenti bikrija.
15 ANNEX IV
15 ANNESS IV
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET GĦAL AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
16 CONDITIONS OF THE MARKETING AUTHORISATION
16 KUNDIZZJONIJIET GĦAL AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
National Competent Authorities, coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
L- Awtoritajiet Kompetenti Nazzjonali, immexxija mill- Istat Membru ta ’ Referenza (RMS), għandhom jiżguraw li d- Detenturi ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jissodisfaw dawn il- kondizzjonijiet li ġejjin:
- In addition to routine pharmacovigilance activities, identified and potential risks highlighted for
- Flimkien ma ’ l- attivitajiet ta ’ rutina ta ’ farmakoviġilanza, riskji potenzjali identifikati u
hepatic failure, interstitial lung disease, breast cancer, and reports concerning pregnancy in partners of patients taking bicalutamide.
enfasizzati għal aktar monitoraġġ u tkomplija għandhom jinkludu l- kollass tal- qalb, il - kollass epatiku, il- mard interstizjali fil- pulmun, il- kanċer tas- sider u r- rapporti ta ’ tqala fis- sieħba tal- pazjent li jkun qed jieħdu bicalutamide.
London, 22 November 2007 EMEA/ 433691/ 2007
Londra, 22 ta ’ Novembru 2007 EMEA/ 433691/ 2007
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Bicaluplex and associated names
OPINJONI SKOND L- ARTIKOLU 29( 4) 1 REFERENZA GĦAL Bicaluplex u ismijiet assoċjati
International Non-Proprietary Name (INN): bicalutamide
Denominazzjoni Komuni Internazzjonali (INN - Internatinal Non- proprietary Name): bicalutimade
BACKGROUND INFORMATION
TAGĦRIF DWAR L- ISFOND
Bicaluplex and associated names, 150 mg, film-coated tablet, is an oral anti-androgen used in the management of prostate cancer.
Bicaluplex u ismijiet assoċjati; pillola ta ’ 150 mg miksija b’ rita, hija anti- androġenu orali wżata fil- kura tal - kanċer tal- prostata.
Ingers Industrials Solutions s. r. o submitted applications for mutual recognition of Bicaluplex and associated names, 150 mg, film-coated tablet on the basis of the marketing authorisation granted by Czech Republic on 30 November 2005.
Ingers Industrials Solutions s. r. o daħħal applikazzjonijiet għar- rikonnoxximent reċiproku ta ’ Bicaluplex u ismijiet assoċjati, pillola ta ’ 150mg miksija b’ rita, abbażi ta ’ l- awtorizzazzjonijiet għat- tqegħid fis- suq mogħtija mir- repubblika Ċeka fit- 30 ta ’ Novembru 2005.
The Mutual Recognition Procedure started on 21 September 2006.
Il- Proċedura ta ’ Rikonoxximent Reċiproku bdiet fil- 21 ta ’ Settembru ta ’ l- 2006.
The Reference Member State was Czech Republic and the Concerned Member States were Austria, Denmark, Germany, Estonia, Greece, France, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovak Republic and the United Kingdom.
L- Istat Membru ta ’ Referenza kienu r- Repubblika Ċeka u l- Istati Membri Ikkunċernati kienu l- Awstrija, id- Danimarka, il- Ġermanja, l- Estonja, il- Greċja, Franza, l- Ungerija, l- Italja, il - Latvja, il- Litwanja, l- Olanda, in- Norverġja, il- Polonja, il- Portugall, l- Iżvezja, l- Islovenja, ir- Reppublika Slovakka u r- Renju Unit.
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 mogħtija mill- Istat Membru ta ’ Referenza.
Czech Republic referred the reasons for disagreement to the EMEA on 30 March 2007.
Ir - Repubblika Ċeka rreferiet ir- raġunijiet għan- nuqqas ta 'qbil lill- EMEA fit- 30 ta ’ Marzu ta' l- 2007.
Significant differences have been identified with regard to the benefit/ risk ratio of the product.
Ġew identifikati differenzi sinnifikattivi fir- rigward tal- bilanċ bejn il- benefiċċju u r- riskju tal- prodott.
This refers to two indications (treatment of locally advanced prostatic carcinoma without metastases, for which surgical castration or other type of medical intervention is not indicated or unacceptable; and as monotherapy in early treatment or as an adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostatic carcinoma (T3-T4, any Stage N, M0) and this was considered to be of serious public health concern.
Dawn jirreferu għal żewġ indikazzjonijiet (trattament tal- kanċer tal- prostata lokalment avvanzat mingħajr metastażi, fejn kastrazzjoni kirurġika jew tip ieħor ta ’ intervent mediku ma jkunx indikat jew ikun inaċċettabli, u bħala monoterapija f’ fażi bikrija tat- trattament jew bħala aġġunt ma ’ trattament bir- radjuterapija jew prostatektomija radikali f’ pazjenti b’ kanċer fil- prostata (T3- T4, kull Stadju N, M0) u dan ġie kkunsidrat bħala fattur serju ta’ tħassib pubbliku.
The arbitration procedure started on 26 April 2007 with the adoption of a list of questions.
Il- proċedura ta ’ l- arbitraġġ bdiet fis- 26 ta ’ April 2007 permezz ta ’ l- adozzjoni ta ’ lista ta ’ domandi.
The Rapporteur was Dr Ondrej Slanar and Co-Rapporteur was Dr Matthew Thatcher.
Ir - Rapporteur kien Dr Ondrej Slanar u l- Ko- Rapporteur kien Dr Matthew Thatcher.
The Marketing Authorisation Holder provided written explanations on 20 July 2007.
Id- Detentur ta ’ l - Awtorizzazzjoni għat- Tqegħid fis- Suq ta spjegazzjonijiet bil- miktub fl- 20 ta ’ Lulju 2007.
During their September 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 Bicaluplex and associated names, that the objections raised by Germany 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’ Settembru ta 'l- 2007, il- CHMP, fid- dawl tat- tagħrif sottomess kollu 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 Bicaluplex u ismijiet assoċjati, li l- objezzjonijiet imqajma mill- Ġermanja 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.