qanastek/EMEA-V3 huggingface dataset:
From a clinical study there is some evidence for an increased risk of dementia among women older than 65 years, who started using another type of oestrogen/progestagen combination than the one in Activelle.
Minn studju kliniku hemm xi ftit eveidenza ta ’ żieda fir- riskju ta ’ demenzja fost in- nisa li għandhom iżjed minn 65 sena, li bdew jużaw tip ieħor ta ’ kombinazzjoni ta ’ estroġenu/ proġestoġen minn dak ta ’ Activelle.
It is not known whether these results also applies to women younger than 65 years when starting the treatment or to women taking other HRT preparations.
M’ huwiex magħruf jekk dawn ir- riżultati japplokawx għal nisa li għandhom inqas minn 65 sena meta jibdew il- kura jew għal nisa li jieħdu preparazzjonijiet oħra ta ’ HRT.
Gall bladder disease Gall bladder disease has been reported after treatment with oestrogen/progestagen.
Mard fil- bużżieqa tal- marrara Ġie rrappurtat mard fil- bużżieqa tal- marrara wara kura b’ estroġenu/ proġestaġen.
Effects on the skin Brown pigmented patches in the face, redness of the skin including inflammation on the hands or the legs (erythema multiforme), hump rose or a bruise-like rash.
Effetti fuq il- ġilda Tbabbar kannella fil- wiċċ, ħmura fil- ġilda li tinkludi infjammazzjoni fuq l- idejn jew saqajn (erythema multiforme), hump rose jew raxx li tidher qisa tbenġila.
HOW TO STORE ACTIVELLE
KIF TAĦŻEN ACTIVELLE
Do not use Activelle after the expiry date which is stated on the label and outer carton after “EXP”.
Tużax Activelle wara d- data ta ’ skadenza li tidher fuq it- tikketta u fuq il- kartuna ta ’ barra wara “ JIS ”.
Do not store above 25°C.
Taħżinx ’ l fuq minn 25°C.
FURTHER INFORMATION
X’ fih Activelle:
36 What Activelle contains • The active substances are estradiol and norethisterone acetate.
- Is- sustanzi attivi huma estradiol u norethisterone acetate.
Each tablet contains 0.5 mg estradiol (as hemihydrate) and 0.1 mg norethisterone acetate. • Other ingredients are:
Kull pillola fiha 0. mg estradiol
Lactose monohydrate, maize starch, hydroxypropylcellulose, magnesium stearate, hypromellose, triacetin and talc.
(bħala hemihydrate) u 0. 1 mg norethisterone acetate. – Is- sustanzi l- oħra huma Lactose monohydrate, maize starch, hydroxypropylcellulose, magnesium stearate, hypromellose, triacetin u talc.
What Activelle looks like and contents of the pack The film-coated tablets are white, round with a diameter of 6 mm.
Id- Dehra ta ’ Activelle u l- kontenuti tal- pakkett:
The tablets are imprinted NOVO 291 on one side and the Novo Nordisk logo (an Apis bull) on the other side.
Il- pilloli miksija b’ rita huma bojod u tondi b’ dijametru ta ’ 6 mm. Il- pilloli huma mnaqqxa fuq naħa waħda b’ NOVO 291 u l- logo ta ’ Novo Nordisk (Apis bull) fuq in- naħa l- oħra.
28 film-coated tablets 3 x 28 film-coated tablets Not all pack sizes may be marketed.
28 pillola miksija b’ rita 3 x 28 pillola miksija b’ rita Mhux id- daqsijiet tal- pakketti kollha jistgħu jkunu għal skop kummerċjali.
Marketing authorisation holder and manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
[See Annex I - To be completed nationally]
[Ara Anness I – Biex timtela mill- pajjiż partikolari]
This medicinal product is authorized in the Member States of the EEA under the following names:
Dan il- prodott mediinali huwa awtorizzat fl- istati membri ta 'l- EEA b' dawn l- ismijiet:
Austria - Noviana 0,5mg/0,1mg filmtabletten Belgium - Activelle minor comprimés pelliculés Bulgaria - Noviana™ филмирани таблетки Czech Republic - Noviana potahované tablety Denmark - Activelle low filmovertrukne tabletter Estonia - Activelle low 0,5 mg/0,1 mg õhukese polümeerikattega tablett Finland - Activelle 0,5 mg/0,1 mg tabl.
L- Awstrija - Noviana 0, 5mg/ 0, 1mg filmtabletten Il- Belġju - Activelle minor comprimés pelliculés Il- Bulgarija - Noviana™ филмирани таблетки Ir- Repubblika Ċeka - Noviana potahované tablety Id- Danimarka - Activelle low filmovertrukne tabletter L- Estonja - Activelle low 0, 5 mg/ 0, 1 mg õhukese polümeerikattega tablett Il- Finlandja - Activelle 0, 5 mg/ 0, 1 mg tabl.
France - Activelle 0,5 mg/0,1 mg comprimé pelliculé Germany - Noviana Hungary - Noviana filmtabletta Iceland - Activelle® low 0.5 mg/0.1 mg tablets filmuhúðaðar töflur Ireland - Activelle low 0.5mg/0.1mg film-coated tablets Italy - Activelle® 0,5 mg/0,1 mg compresse film-rivestite Latvia - Noviana 0,5 mg/0,1 mg apvalkotās tabletes Lithuania - Activelle 0,5 mg / 0,1 mg plėvele dengtos tabletės Luxembourg - Activelle minor comprimés pelliculés The Netherlands - Activelle filmomhulde tabletten Norway - Noviana 0,5 mg/0,1 mg tablett filmdrasjert Portugal - 0,5mg Estradiol + 0.1 mg Acetato de Noretisterona Comprimidos revestidos por película Romania – Noviana comprimate filmate Slovenia - Noviana™ filmsko obložene tablete Slovakia - Noviana filmom obalené tablety Spain - Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película Sweden - Activelle 0,5 mg/0,1 mg filmdragerade tabletter United Kingdom - Noviana film-coated tablets
Franza - Activelle 0, 5 mg/ 0, 1 mg comprimé pelliculé Il- Ġermanja - Noviana L- Ungerija - Noviana filmtabletta L- Islanda - Activelle® low 0. 5 mg/ 0. 1 mg tablets filmuhúðaðar töflur L- Irlanda - Activelle low 0. 5mg/ 0. 1mg film- coated tablets L- Italja - Activelle® 0, 5 mg/ 0, 1 mg compresse film- rivestite Il- Latvja - Noviana 0, 5 mg/ 0, 1 mg apvalkotās tabletes Il- Litwanja - Activelle 0, 5 mg / 0, 1 mg plėvele dengtos tabletės Il- Lussemburgu - Activelle minor comprimés pelliculés L- Olanda - Activelle filmomhulde tabletten In- Norveġja - Noviana 0, 5 mg/ 0, 1 mg tablett filmdrasjert Il- Portugall - 0, 5mg Estradiol + 0. 1 mg Acetato de Noretisterona Comprimidos revestidos por película Ir- Romanija – Noviana comprimate filmate Is- Slovenja - Noviana™ filmsko obložene tablete Is- Slovakkja - Noviana filmom obalené tablety
37 This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’
Detailed information on this medicine is available on the web site of {MA/Agency}[PIQ-QRD3]
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l - {MA/ Aġenzija} >
USER INSTRUCTIONS
ISTRUZZJONIJIET GĦAL MIN SE JAGĦMEL UŻU MINNU
How to use the calendar pack
Kif tuża l- pakkett b’ kalendarju
Set the day reminder Turn the inner disc to set the day of the week opposite the little plastic tab.
Issettja biex tiftakar il- ġurnata Dawwar id- disk ta ’ ġewwa biex tissettja l- ġurnata tal- ġimgħa fuq in- naħa oppost tas- siġill żgħir tal - plastik.
How to take the first tablet Break the plastic tab and tip out the first tablet.
Kif tieħu l- ewwel pillola Kisser is- siġill tal- plastik u oħroġ l- ewwel pillola.
Move the dial every day On the next day simply move the transparent dial clockwise one space as indicated by the arrow.
Mexxi id- dajal kuljum L- għada sempliċement mexxi d- dajal trasperarenti spazju wieħed lejn in- naħa tal- lemin kif indikat bil- vleġġa.
Tip out the next tablet.
Oħroġ il- pillola li jmiss.
Remember to take only one tablet once a day.
Ftakar biex tieħu pillola waħda darba kuljum.
You can only turn the transparent dial after the tablet in the opening has been removed.
Tista ’ biss iddawwar id- dajal trasparenti wara li l- pillola li kien hemm fil- fetħa tkun ġiet imneħħija.
London, 12 September 2008 EMEA/ CHMP/ 496102/ 2008
Londra, 12 ta ’ Settembru 2008 EMEA/ CHMP/ 496116/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
KUMITAT GĦALL- PRODOTTI MEDIĊINALI GĦALL- UŻU MILL- BNIEDEM (CHMP)
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Activelle and associated names
OPINJONI WARA RIFERIMENT SKOND L- ARTIKOLU 29( 4) 1 GĦAL Activelle u ismijiet assoċjati
International Non-Proprietary Name (INN):
Denominazzjoni Komuni Internazzjonali (DKI):
Estradiol and norethisterone acetate
Estradiol u norethisterone acetate
BACKGROUND INFORMATION
INFORMAZZJONI TA ’ SFOND
Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets is a continuous combined hormone replacement therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause.
Activelle u ismijiet assoċjati, estradiol 0. 5mg u norethisterone acetate 0. 1 mg pilloli miksijin b’ rita huwa kura ta ’ sostituzzjoni tal- ormoni (HRT) kombinata kontinwa għal sintomi ta ’ nuqqas ta ’ estroġenu f’ nisa aktar minn sena wara l- menopawża tagħhom.
Novo Nordisk A/ S submitted applications for mutual recognition of Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets on the basis of the marketing authorisation granted by Sweden on 3 August 2007.
Novo Nordisk A/ S ippreżentat applikazzjonijiet għar- rikonoxximent reċiproku ta ’ Activelle u ismijiet assoċjati, estradiol 0. 5mg u norethisterone acetate 0. 1 mg pilloli miksijin b’ rita fuq il- bażi tal - awtorizzazzjoni tat- tqegħid fis- suq mogħtija mill- Iżvezja fit- 3 ta ’ Awwissu 2007.
The Mutual Recognition Procedure started on 20 September 2007.
Il- Proċedura tar - Rikonoxximent Reċiproku bdiet fl- 20 ta ’ Settembru 2007.
The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Bulgaria, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Portugal, Romania, Slovenia, Slovak Republic and United Kingdom.
L- Istat Membru tar- Riferiment kien l- Iżvezja u l - Istati Membri Konċernati kienu l- Awstrija, il- Belġju, il- Bulgarija, ir- Repubblika Ċeka, id- Danimarka, l - Estonja, Spanja, il- Finlandja, Franza, l- Ungerija, l- Irlanda, l- Iżlanda, l- Italja, il- Litwanja, il- Lussemburgu, il - Latvija, l- Olanda, in- Norveġja, il- Portugall, ir- Rumanija, is- Slovenja, ir- Repubblika 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 setgħux jilħqu ftehim fir- rigward tar- Rikonoxximent Reċiproku tal - Awtorizzazzjoni għat- Tqegħid fis- Suq mogħtija mill- Istat Membru tar- Riferiment.
Sweden referred the reasons for disagreement to the EMEA on 3 March 2008.
L- Iżvezja irriferiet ir - raġunijiet għan- nuqqas ta ’ ftehim lill- EMEA fit- 3 ta ’ Marzu 2008.
Significant difference has been identified with regard to clinical safety.
Ġiet identifikata differenza sinifikanti fir- rigward tas- sigurtà klinika.
This refers to endometrial safety of Activelle 0.5 mg/ 0.1 mg, which had been insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/ CHMP/ 021/ 97 rev 1) and this was considered to be of serious public health concern.
Din tirreferi għas- sigurtà endometrijali ta ’ Activelle 0. 5 mg/ 0. 1 mg, li ma ntwerietx biżżejjed skont il- linja gwida tas- CHMP għall- prodotti HRT (EMEA/ CHMP/ 021/ 97 rev 1) u dan tqies bħala ta ’ tħassib serju għas- saħħa pubblika.
The arbitration procedure started on 19 March 2008 with the adoption of a list of questions.
Il- proċedura ta ’ arbitraġġ bdiet fid- 19 ta ’ Marzu 2008 bl- adozzjoni ta ’ lista ta ’ mistoqsijiet.
The Rapporteur was Dr Pierre Demolis (FR) as Rapporteur and Co-Rapporteur(s) was Dr Ingemar Persson (SE).
Ir- Rapporteur kien Dr Pierre Demolis (FR) bħala Rapporteur u Ko- Rapporteur( s) kien Dr Ingemar Persson (SE).
The Marketing Authorisation Holder provided written explanations on 5 May 2008.
Id - Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ta spjegazzjonijiet bil- miktub fil- 5 ta ’ Mejju 2008.
During their June 2008 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 Activelle and associated names, that the objections raised by France and 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.
Matul il- laqgħa tiegħu ta ’ Ġunju 2008, is- CHMP, fid- dawl tad- dejta ġenerali ippreżentata u tad- diskussjoni xejntifika fi ħdan il- Kumitat, kien tal- opinjoni li l- proporzjon bejn il- benefiċċju/ riskju kien wieħed favorevoli għal Activelle u ismijiet assoċjati, li l- oġġezzjonijiet imqajma minn Franza u mill- Ġermanja ma għandhomx jimpedixxu l- għoti ta ’ Awtorizzazzjoni għat- Tqegħid fis- Suq u li s- Sommarju tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif tal- Istat Membru ta ’ Riferiment għandhom jiġu emendati.
A positive opinion was adopted by majority on 26 June 2008.
Fis- 26 ta ’ Ġunju 2008 ġiet adottata opinjoni pożittiva b’ maġġoranza.
The list of the product names concerned is given in Annex I.
Il- lista tal- ismijiet tal- prodotti konċernati hija mogħtija fl- Anness I.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Il- konklużjonijiet xjentifiċi huma mogħtija fl- Anness II flimkien mas- Sommarju tal- Karatteristiċi tal- Prodott fl- Anness III.
The final opinion was converted into a Decision by the European Commission on 11 September 2008.
L- opinjoni finali inqelbet f’ Deċiżjoni mill- Kummissjoni Ewropea fil- 11 ta ’ Settembru 2008.
1 Article 29(4) of Directive 2001/ 83/ EC, as amended.
1 Artikolu 29( 4) tad- Direttiva 2001/ 83/ KE, kif emendata.
London, 1 October 2007 EMEA/ CHMP/ 432352/ 2007
Londra, 1 ta ’ Ottubru 2007 EMEA/ CHMP/ 432352/ 2007
COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 31 REFERRAL FOR Agreal and associated names (see annex I)
KUMITAT GĦAL PRODOTTI MEDIĊINALI GĦAL UŻU MILL- BNIEDEM (CHMP) OPINJONI WARA REFERENZA SKOND L’ ARTIKOLU 31 GĦAL Agreal u denominazzjonijiet oħra assoċjati (ara anness I)
International Non-Proprietary Name (INN):
Denominazzjoni Komuni Internazzjonali (INN - Internatinal Non- proprietary Name):
BACKGROUND INFORMATION*
INFORMAZZJONI ĠENERALI *
Veralipride was approved since 1979 for the indication of treatment of vasomotor symptoms (hot flushes) associated with the menopause.
Veralipride kien approvat mill- 1979 għall- indikazzjoni tal- kura tas- sintomi tal- vasomotor (fwawar (hot flushes)) assoċjati mal- menopawsa.
Veralipride was authorised in 6 European Member States:
Veralipride kien awtorizzat f’ 6 Stati Membri Ewropej:
Belgium, France, Italy, Luxembourg and Portugal.
Il- Belġju, Franza, l- Italja, il- Lussemburgu u l - Portugal.
Until June 2005, veralipride was also marketed in Spain.
Sa Ġunju 2005, veralipride kien tpoġġa wkoll fis- suq Spanjol.
On 7 September 2006, following the withdrawal of veralipride from the Spanish market due to reports of serious side effects affecting the nervous system, the European Commission referred the matter to the EMEA under Article 31 of Directive 2001/ 83/ EC.
Fis- 7 ta ’ Settembru 2006, wara l- irtirar ta ’ veralipride mis- suq Spanjol minħabba rapporti ta ’ effetti sekondarji serji li affettwaw is- sistema nervuża, il- Kummissjoni Ewropea irreferiet il- kwistjoni lill - EMEA skond l- Artikolu 31 tad- Direttiva 2001/ 83/ KE.
The referral procedure started on 21 September 2006.
Il- proċedura ta ’ referenza bdiet fil- 21 ta ’ Settembru 2006.
The Rapporteur and Co-Rapporteur appointed were:
Ir- Rapporteur u l- Co- Rapporteur appuntati kienu:
Eric Abadie and Barbara van Zwieten-Boot, respectively.
Eric Abadie u Barbara van Zwieten- Boot, rispettivament.
Written explanations were provided by the Marketing Authorisation Holder on 4 January 2007.
Spjegazzjonijiet bil- miktub ġew mogħtija mid- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq fl- 4 ta ’ Jannar 2007.
Oral explanations were given on 20 June 2007.
Spjegazzjonijiet orali ġew mogħtija fl- 20 ta ’ Ġunju 2007.
On 19 July 2007, based on evaluation of the currently available data and the Rapporteurs’ assessment reports, the CHMP considered that the benefit/ risk profile of veralipride-containing medicinal products is negative and therefore adopted an opinion recommending the withdrawal of the Marketing Authorisation for all medicinal products containing veralipride.
Fid- 19 ta ’ Lulju 2007, abbażi tal- valutazzjoni tad- dejta li hija disponibbli bħalissa u r- rapporti ta ’ stima tar- Rapporteurs, is- CHMP ikkunsidra li l- profil benefiċċju/ riskju ta ’ prodotti mediċinali li fihom veralipride huwa negattiv u għalhekk adotta opinjoni li tirrakkomanda l- irtirar ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq għall- prodotti mediċinali kollha li fihom veralipride.
The list of product names concerned is given in Annex I.
Il- lista ta ’ l- ismijiet tal- prodotti in kwistjoni hija mogħtija fl- Anness I.
The scientific conclusions are provided in Annex II.
Il- konklużjonijiet xjentifiċi huma disponibbli fl- Anness II.
The final opinion was converted into a Decision by the European Commission on 1 October 2007.
L- opinjoni finali kienet konvertita f’ Deċiżjoni mill- Kummissjoni Ewropea fil 1 ta ’ Ottubru 2007.
The information given in this document and Annexes reflects the CHMP Opinion dated 19 July 2007.
L- informazzjoni mogħtija f’ dan id- dokument u l- Annessi tirrifletti l- Opinjoni tas- CHMP datata 19 ta ’ Lulju 2007.
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTT MEDIĊINALI, MNEJN JINGĦATA, ID- DETENTURI TA` L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
©EMEA 2007
Stat Membru
Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq
Sanofi-Aventis France 1-13 Boulevard Anatole France France
Sanofi- Aventis France 1- 13 Boulevard Anatole France Franza
20154 Milano Italy
20154 Milano Italy Sanofi- Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c
Sanofi-Synthelabo, Twin Squares, Navona Building, Culliganlaan 1c, Luxembourg
Il- Lussemburgu
PRT Empreendimento Lagoas Park - Edifício 7 -
PRT Empreendimento Lagoas Park – Edificio 7 – 2° e 3° Porto Il- Portugall
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR WITHDRAWAL OF THE MARKETING AUTHORISATION PRESENTED BY THE EMEA
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- IRTIRAR TA ’ L - AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ IPPREŻENTATI MILL- EMEA
CHMP/ 309507/ 2007 SCIENTIFIC CONCLUSIONS
©EMEA 2007 CHMP/ 309507/ 2007 KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING VERALIPRIDE (see Annex I)
SOMMARJU TOTALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ PRODOTTI MEDIĊINALI LI FIHOM VERALIPRIDE (ara l- Anness I)
Veralipride is a benzamide neuroleptic medicine indicated in the treatment of vasomotor symptoms associated with the menopause.
Veralipride hija mediċina benzamide newrolettika indikata fit- trattament ta ’ sintomi vażomotorili assoċjati mal- menopawsa.
It was first authorised in 1979 and is currently authorised in the EU in Belgium, France, Italy, Luxembourg and Portugal under the names Agreal and Agradil.
Ġiet approvata għall- ewwel darba fl- 1979 u bħalissa hija awtorizzata fl- UE fil- Belġju, Franza, l- Italja, il- Lussemburgu u l- Portugall taħt l- ismijiet Agreal u Agradil.
Until June 2005, veralipride was authorised in Spain.
Sa Ġunju 2005, veralipride kienet awtorizzata fi Spanja.
Following reports of serious side effects affecting the nervous system, the Spanish National Competent Authority concluded that its benefits did not outweigh its potential risks.
Wara rapporti ta ’ reazzjonijiet sekondarji serji li affettwaw is- sistema nervuża, l- Awtorità Nazzjonali Kompetenti Spanjola ikkonkudiet li l- benefiċċji tal- mediċina ma kinux akbar mir- riskji potenzjali tagħha.
Spain therefore withdrew veralipride’ s marketing authorisation on 27 June 2005.
Għaldaqstant, Spanja irtirat l - awtorizzazzjoni tat- tqegħid fis- suq ta ’ veralipride fis- 27 ta ’ Ġunju 2005.
Regulatory actions were also taken in some other EU Member States where the product is authorised and veralipride’ s product information was restricted with the aim to reduce the risk of patients developing side effects.
Ittieħdu wkoll azzjonijiet regolatorji f’ xi Stati Membri ta ’ l- UE oħra fejn il- prodott huwa awtorizzat u t- tagħrif fuq il- prodott ta ’ veralipride kien limitat bil- għan li jitnaqqas ir- riskju ta ’ pazjenti li jiżviluppaw effetti sekondarji.
Consequently, the European Commission triggered a referral procedure on 7 September 2006 and requested the CHMP to give its opinion on whether the marketing authorisations for products containing veralipride should be maintained, varied, suspended or withdrawn across the European Union following the assessment of these safety risks their impact on the benefit/ risk assessment of veralipride.
Konsegwentement, fis- 7 ta ’ Settembru 2006, il- Kummissjoni Ewropea tat bidu għal proċedura ta ’ referenza u talbet lis- CHMP biex jagħti l- opinjoni tiegħu fuq jekk l- awtorizzazzjonijiet għat- tqegħid fis- suq għal prodotti li fihom veralipride għandhomx jinżammu, jiġu emendati, sospiżi jew irtirati madwar l- Unjoni Ewropea wara li tkun saret il- valutazzjoni ta ’ dawn ir- riskji fuq is- sigurtà u l- impatt tagħhom fuq il- valutazzjoni tal- benefiċċju/ riskju ta ’ veralipride.
Efficacy In this review, the CHMP assessed all of the available information on the safety and efficacy of veralipride.
Effikaċja F’ din ir- reviżjoni, is- CHMP ivvaluta t- tagħrif kollu disponibbli fuq is- sigurtà u l- effikaċja ta ’ veralipride.
This included mainly 11 studies involving around 600 women, in which veralipride was compared with placebo, and two studies in around 100 women where it was compared with conjugated oestrogens.
Dan kien jinkludi 11- il studju li involvew madwar 600 mara, li fihom veralipride tqabbel ma ’ plaċebo, u żewġ studji fuq madwar 100 mara fejn tqabbel ma ’ estroġeni ikkonġugati.
The CHMP also looked at other small studies.
Is- CHMP studja wkoll studji żgħar oħra.
Based on the submitted data, there appears to be an effect for veralipride in the treatment of vasomotor symptoms associated with the menopause.
Fuq il- bażi tat- tagħrif ippreżentat, jidher li hemm effett għal veralipride fit- trattament ta ’ sintomi vażomotorili assoċjati mal- menopawsa.
The benefit could be qualified as limited, however the effect size cannot be accurately quantified due to methodological deficiencies of available studies (e. g. in most cases baseline values were not stated, precluding an adequate assessment of the improvement observed; neither the statistical nor the clinical significance of this effect size could be precisely quantified, as the statistical plan was not clear or was absent; the presentation of the results was poor).
Il- benefiċċju jista ’ jkun ikkwalifikat bħala wieħed limitat, madankollu id- daqs ta ’ l- effett ma jistax jiġi ikkwantifikat b’ mod preċiż minħabba defiċjenzi metodoloġiċi ta ’ studji disponibbli (eż. fil- parti l- kbira tal- każijiet, valuri fil- linja bażi ma kinux iddikjarati, u b’ hekk ma setgħetx issir valutazzjoni adegwata tat- titjib osservat; la s- sinjifikat statistiku u lanqas dak kliniku tad- daqs ta ’ dan l- effett ma seta ’ jiġi ikkwantifikat b’ mod preċiż, minħabba li l- pjan statistiku ma kienx ċar jew kien assenti; il- preżentazzjoni tar- riżultati kienet dgħajfa).
In addition, the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
Barra minn hekk, it- tul ta ’ żmien tal- provi kien qasir wisq għal valutazzjoni adegwata tal - manteniment ta ’ l- effikaċja.
Few data are available beyond 3 months, mostly in non comparative studies.
Ftit tagħrif huwa disponibbli ’ l hinn minn 3 xhur, l- aktar fi studji mhux komparattivi.
The CHMP concluded that the data submitted showed only limited effect of veralipride in the treatment of vasomotor symptoms associated with the menopause.
Is- CHMP ikkonkluda li t- tagħrif sottomess wera biss effett limitat ta ’ veralipride fit- trattament ta ’ sintomi vażomotorili assoċjati mal- menopawsa.
In addition, the effect size cannot be accurately quantified due to methodological shortcomings and the duration of the trials was too short to allow for proper assessment of maintenance of efficacy.
Barra minn hekk, id- daqs ta ’ l- effett ma jistax jiġi ikkwantifikat b’ mod preċiż minħabba d- difetti metodoloġiċi u t- tul tal- provi li kien qasir wisq sabiex jippermetti valutazzjoni adegwata tal- manteniment ta ’ l- effikaċja.
It has to be noted that tardive dyskinesias are not predictable and can develop even after the treatment has been discontinued.
Sigurtà Il- perijodu ta ’ wara t- tqegħid fis- suq ta ’ 27 sena joffri perijodu twil ta ’ sorveljanza tal- profil ta ’ sigurtà.
It should be noted that in the evaluation of the causality assessment of veralipride in the psychiatric events, the role of veralipride is not always clear.
Episodji newroloġiċi avversi li saret referenza għalihom bħala sintomi ekstrapiramidali u b’ mod partikolari diżkajnijżji tardivi ġew irrapportati ma ’ veralipride u dawn jirrappreżentaw tħassib veru minħabba s- serjetà potenzjali u l- irriversibbilità tagħhom.
However, cases of tardive
Ġie innotat li diżkajnijżi tardivi ma jistgħux jitbassru minn qabel u saħansitra jistgħu jiżviluppaw wara li t- trattament ikun ġie imwaqqaf.
©EMEA 2007
Għandu jkun innotat li fl- evalwazzjoni tal- valutazzjoni tal- kawżalità fl- episodji psikjatriċi, ir- rwol ta ’ veralipride m’ huwiex dejjem ċar.
dyskinesia have also been reported within the first 3 months of treatment.
Sabiex ikunu evitati episodji psikjatriċi avversi, sintomi ektrapiramidali u diskajnijżji tardivi, il- MAH ippropona tul ta ’ żmien ta ’ trattament massimu permess ta ’ 3 xhur.
The proposal of close monitoring including neurological examination after each 20 day treatment cycle might reduce these risks, but is a measure of considerable burden to both patient and doctor.
Il- proposta ta ’ sorveljanza mill- qrib inkluż eżaminazzjoni newroloġika wara kull ċiklu ta ’ trattament ta ’ 20 jum tista ’ tnaqqas dawn ir- riskji, iżda hija miżura ta ’ piż konsiderevoli kemm għall- pazjent kif ukoll għat- tabib.
As for the other adverse events related with the blockage of the dopamine receptor, especially hyperprolactinemia is a concern.
Bħar- reazzjonijiet avversi oħra relatati ma ’ l- imblokkar tar- riċettur ta ’ dopamine, l- iperprolaktinimja hija ta ’ tħassib speċjali.
Veralipride treatment is contra-indicated in patients with prolactin- dependent tumours such as pituitary gland prolactinoma and breast cancer.
Trattament b’ veralipride huwa kontra- indikat f’ pazjenti b’ tumuri dipendenti fuq il- prolaktin bħalma huma prolaktinoma tal- glandola pitwitarja u l- kanċer tas- sider.
But the effect of hyperprolactinemia in women with history of breast cancer is not elucidated.
Iżda l- effett ta ’ l- iperprolaktinimja f’ nisa bi storja ta ’ kanċer tas- sider mhijiex ċara biżżejjed.
The proposed intermittent treatment of 20 days, followed by a 10 day period of non-treatment, may temper this effect on the prolactin level, but it is unknown whether this measure has any effect on the adverse event pattern.
It- trattament intermittenti propost ta ’ 20 jum, segwit minn perijodu ta ’ 10 ijiem ta ’ mingħajr trattament, jista ’ jtaffi dan l- effett fuq il- livell ta ’ prolaktin, iżda mhuwiex magħruf jekk din il- miżura għandhiex xi effett fuq il- forma ta ’ episodju avvers.
Lastly, QT-prolongation is a class-effect of dopamine-antagonists.
Fl- aħħarnett, wieħed mill- effetti tal- klassi ta ’ l- antagonisti tad- dopamine huwa l- prolungament tal- QT.
The absence of cases of suggestive QT-prolongation in the database is not sufficient to conclude that this effect does not occur with veralipride.
In- nuqqas ta ’ każijiet ta ’ prolungament tal- QT suġġestiv fid- database m’ huwiex suffiċjenti biex wieħed jikkonkludi li dan l- effett ma jseħħx b’ veralipride.
No studies were performed to evaluate whether veralipride has an effect on QT.
Ma sar l- ebda studju biex jevalwa jekk veralipride għandux effett fuq il- QT.
Benefit/ risk In view of the available clinical data the CHMP concluded that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause, mainly the neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) outweigh the limited benefits.
Benefiċċju/ riskju Minħabba t- tagħrif kliniku disponibbli, il- CHMP ikkonkluda li r- riskji assoċjati ma ’ l- użu ta ’ veralipride fit- trattament ta ’ fwawar assoċjati mal- menopawsa, b’ mod partikolari r- reazzjonijiet newroloġiċi (diżkajnijżja, disturb ektrapiramidali, is- sindromu ta ’ Parkinson) u reazzjonijiet psikjatriċi (dipressjoni, ansjetà, sindromu ta ’ irtirar) jegħlbu l- benefiċċji limitati.
Cases of not predictable and potentially irreversible tardive dyskinesia, as well as early extrapyramidal symptoms, depression, anxiety and withdrawal reactions have been reported with veralipride treatment; these risks together with the risk of hyperprolactinemia, and the class effect risk on QT- prolongation are considered a concern.
Każijiet ta ’ diżkajnijżja tardiva mhux prevedibbli u potenzjalment irriversibbli, kif ukoll sintomi ekstrapiramidali bikrija, dipressjoni, ansjetà u reazzjonijiet ta ’ irtirar ġew irrapportati bi trattament b’ veralipride; dawn ir- riskji flimkien mar- riskju ta ’ l- iperprolaktinimja, u r- riskju ta ’ l- effett tal- klassi fuq il- prolungament tal- QT huma ikkunsidrati ta ’ tħassib.
The CHMP took note of the MAH’ s proposals, some of which had already been introduced in some countries, in an effort to limit these risks like:
Il- CHMP ħa nota tal- proposti tal- MAH, xi wħud minn liema kienu diġà introdotti f’ xi pajjiżi, fi sforz biex jillimitaw dawn ir- riskji bħal:
-Restriction of the treatment duration to 3 months in combination with monthly examination in an effort to limit the psychiatric and neurological adverse events.
- Restrizzjoni tat- tul ta ’ żmien tat- trattament għal 3 xhur ikkumbinata ma ’ eżaminazzjoni ta ’ kull xahar fi sforz biex jiġu limitati l- episodji psikjattriċi u newroloġiċi avversi.
However, tardive dyskinesia may still occur within the first 3 months of treatment.
Madankollu, diżkajnijżja tardiva tista ’ xorta waħda sseħħ fi żmien l- ewwel 3 xhur tat- trattament.
-Introduction of the contraindications in patients with Parkinson’ s disease, or in combination with other neuroleptics and dopaminergic agonists.
- Introduzzjoni tal- kontra- indikazzjonijiet f’ pazjenti b’ marda tal- Parkinson, jew f’ kumbinazzjoni ma ’ newrolettiċi u agonisti dopaminerġiċi oħrajn.
-Introduction of warnings regarding class effects of neuroleptic medicines (neuroleptic malignant syndrome, QT prolongation, tardive dyskinesia) and withdrawal symptoms such as anxiety and depressive syndrome.
- Introduzzjoni ta ’ twissijiet rigward effetti tal- klassi ta ’ mediċini newrolettiċi (sindromu newrolettiku malinn, prolungament tal- QT, diżkajnijżja tardiva) u sintomi ta ’ irtirar bħal ma huwa s- sindromu ta ’ l - ansjetà u d- dipressjoni.
-Recommendations of medical breast monitoring and intermittent schedule (20 days followed by a 10- day period of non-treatment) to reduce the risk of hyperprolactinemia, aimed to improve the breast safety (however, it is unknown whether this measure has any effect on the observed adverse event pattern related to hyperprolactinemia like breast enlargement, galactorrhoea and risk for patients with prolactin-dependent tumours such as pituitary gland prolactinoma and breast cancer).
- Rakkomandazzjonijiet ta ’ monitoraġġ mediku tas- sider u skeda intermittenti (20 jum segwiti minn perijodu ta ’ 10 ijiem mingħajr trattament) biex inaqqsu r- riskju ta ’ iperprolaktinimja, immirati biex itejbu s- sigurtà tas- sider (madankollu, mhux magħruf jekk din il- miżura għandhiex xi effett fuq il - forma ta ’ episodju avvers osservat relatat ma ’ l- iperprolaktinimja bħal tkabbir tas- sider, galaktorreja u riskju għal pazjenti b’ tumuri dipendenti fuq il- prolaktin bħal ma huma prolaktinoma tal- glandola pitwitarja u kanċer tas- sider).
In addition, some of these side effects can occur not only during treatment, but also after it is stopped and it is also impossible to predict which women may be at risk.
©EMEA 2007 CHMP/ 309507/ 2007 Kollox ma ’ kollox, ir- restrizzjoni biex ikun limitat
CHMP/ 309507/ 2007
5/ 6 l- użu ta ’ veralipride għal 3 xhur f’ kumbinazzjoni
5/ 6
ma ’ eżaminazzjonijiet newroloġiċi mediċi u monitoraġġ tas- sider, m’ hijiex meqjusa adegwata biex ikun limitat ir- riskju ta ’ l- effetti avversi kollha irrapportati b’ veralipride u jkunu ttrattati adegwatament is- sintomi vażomotorili assoċjati mal- menopawsa.
©EMEA 2007
Barra minn hekk, xi wħud minn dawn l- effetti sekondarji jistgħu jseħħu mhux biss waqt it- trattament, iżda anke wara li jitwaqqaf u huwa impossibbli li tbassar liema nisa jistgħu jkunu f’ riskju.
The CHMP therefore concluded on 19 July 2007 that the benefit/ risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
Għaldaqstant, fid- 19 ta ’ Lulju 2007, is- CHMP ikkonkluda li l- bilanċ ta ’ riskju/ benefiċċju ta ’ prodotti mediċinali li fihom veralipride, m’ huwiex wieħed pożittiv taħt kundizzjonijiet ta ’ użu normali.
Therefore, the CHMP recommended the withdrawal of all Marketing Authorisations for medicinal products containing veralipride throughout Europe.
Għaldaqstant, is- CHMP irrikkomanda l- irtirar ta ’ l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq kollha għal prodotti mediċinali li fihom veralipride f’ kull parti ta ’ l- Ewropa.
GROUNDS FOR THE WITHDRAWAL OF THE MA
RAĠUNIJIET GĦALL- IRTIRAR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Whereas
Billi:
• The Committee considered the referral made under article 31 of Directive 2001/ 83/ EC, as amended, for medicinal products containing veralipride • The Committee considered that veralipride containing medicinal products only showed limited efficacy in the treatment of hot flushes associated with the menopause; • The Committee considered that neurological reactions (dyskinesia, extrapyramidal disorder, Parkinson syndrome) and psychiatric reactions (depression, anxiety, withdrawal syndrome) have been reported with veralipride, including tardive dyskinesia which may be potentially irreversible.
• Il- Kumitat ikkunsidra r- referenza magħmula taħt l- Artikolu 31 tad- Direttiva 2001/ 83/ KE, kif emendata, għal prodotti mediċinali li fihom veralipride; • Il- Kumitat ikkunsidra li prodotti mediċinali li fihom veralipride urew effikaċja limitata fit - trattament ta ’ fwawar assoċjati mal- menopawsa; • Il- Kumitat ikkunsidra li reazzjonijiet newroloġiċi (diżkajnijżja, disturb ekstrapiramidali, is - sindromu ta ’ Parkinson) u reazzjonijiet psikjattriċi (dipressjoni, ansjetà, sindromu ta ’ l- irtirar) ġew irrapportati b’ veralipride, inklużi diżkajnijżja tardiva li tista ’ tkun potenzjalment irriversibbli.
In addition, hyperprolactinemia and the risk of QT prolongation are also concerns; • The Committee concluded, in view of available data, that the risks associated with the use of veralipride in the treatment of hot flushes associated with the menopause outweigh the limited benefits.
Barra minn hekk, iperprolaktinimja u r- riskju ta ’ prolungament tal- QT huma wkoll ta ’ tħassib; • Minħabba t- tagħrif disponibbli, il- Kumitat ikkonkluda, li r- riskji assoċjati ma ’ l- użu ta ’ veralipride fit- trattament ta ’ fwawar assoċjati mal- menopawsa jegħlbu r- riskji tal- benefiċċji limitati.
In addition, the Committee considered that the proposed risk minimisation activities were not able to reduce the risks to an acceptable level or predict which women may be at risk; • The Committee, as a consequence, concluded that the benefit/ risk balance of veralipride containing medicinal products is not positive under normal conditions of use.
Barra minn hekk, il- Kumitat ikkonsidra li l- attivitajiet ta ’ minimizzazzjoni tar- riskju proposti ma setgħux inaqqsu r- riskji għal livell aċċettabbli jew ibassru liema nisa jistgħu jkunu f’ riskju; • Bħala konsegwenza ta ’ dan, il- Kumitat ikkonkluda li l- bilanċ ta ’ benefiċċju/ riskju ta ’ prodotti mediċinali li fihom veralipride m’ huwiex wieħed pożittiv taħt kundizzjonijiet normali ta ’ użu.
The CHMP has recommended the withdrawal of the Marketing Authorisations for the medicinal products containing veralipride referred to in Annex I.
Il- CHMP irrikmanda l- irtirar ta ’ l- Awtorizzazzjonijiet għat- Tqegħid fis- Suq għal prodotti mediċinali li fihom veralipride li hemm referenza għalihom fl- Anness I.
London, 14 July 2008 EMEA/ CHMP/ 151554/ 2008
Londra, 14 ta ’ Lulju 2008 EMEA/ CHMP/ 151554/ 2008
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP)
KUMITAT GĦAL PRODOTTI MEDIĊINALI GĦALL- UŻU MILL- BNIEDEM (CHMP)
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Alvesco and associated names
OPINJONI WARA RIFERIMENT TA ’ L- ARTIKOLU 29( 4) 1 GĦAL Alvesco u ismijiet assoċjati
International Non-Proprietary Name (INN): ciclesonide
Denominazzjoni Komuni Internazzjonali (DKI): ciclesonide
BACKGROUND INFORMATION
TAGĦRIF TA ’ SFOND
Alvesco and associated names, 40 µg, 80 µg and 160 µg pressurised inhalation, solution is a glucocorticoid used to treat obstructive airway disease.
Alvesco u ismijiet assoċjati, 40 µg, 80 µg u 160 µg soluzzjoni ta ’ inalazzjoni taħt pressjoni hija glukokortikojde wżata biex tittratta mard ostruttiv tal- passaġġi ta ’ l- arja.
The product contains ciclesonide which is delivered by a pressurized metered dose inhaler containing ethanolic hydrofluoroalkane-134A as a propellant.
Il- prodott fih ciclesonide li huwa fornut permezz ta ’ inalatur b’ doża mkejla taħt pressjoni li fih ethanolic hydrofluoroalkane- 134A bħala propellant.
Altana Pharma AG submitted applications for mutual recognition of Alvesco and associated names, 40µg, 80 µg and 160 µg pressurised inhalation, solution on the basis of the marketing authorisation granted by United Kingdom on 14 April 2004.
Altana Pharma AG ssottomettiet applikazzjonijiet għal rikonoxximent reċiproku ta ’ Alvesco u ismijiet assoċjati, 40 µg, 80 µg u 160 µg soluzzjoni ta ’ inalazzjoni taħt pressjoni fuq il- bażi ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq mogħtija mir- Renju Unit fl- 14 ta ’ April 2004.
The Mutual Recognition Procedure started on 2 May 2007.
Il- Proċedura ta ’ Rikonoxximent Reċiproku nbdiet fit- 2 ta ’ Mejju 2007.
The Reference Member State was United Kingdom and the Concerned Member States were:
L- Istat Membru ta ’ Referenza kien ir- Renju Unit u l- Istati Membri Kkonċernati kienu:
Belgium, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Slovak Republic, Slovenia and Sweden Repeat use:
L- ewwel mewġa: il- Belġju, ir- Repubblika Ċeka, id- Danimarka, l- Estonja, il- Finlandja, il- Ġermanja, il - Greċja, l- Ungerija, l- Iżlanda, l- Irlanda, il- Latvja, il- Litwanja, il- Lussemburgu, l- Olanda, in- Norveġja, il - Polonja, ir- Repubblika Slovakka, is- Slovenja u l- Iżvezja.
Austria, Bulgaria, Cyprus, Spain, France, Italy, Malta and Portugal
Użu rrepetut: l- Awstrija, il- Bulgarija, Ċipru, Spanja, Franza, l- Italja, Malta u l- Portugall.
These Member States and the applicant / MAH 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 u l- applikant / MAH ma setgħux jilħqu ftehim fir- rigward tar- Rikonoxximent Reċiproku ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq mogħtija mill- Istat Membru ta ’ Referenza.
The United Kingdom referred the reasons of disagreement to the EMEA on 25 October 2007.
Ir- Renju Unit irrefera r- raġunijiet għan- nuqqas ta ’ qbil lill- EMEA fil- 25 ta ’ Ottubru 2007.
Significant difference have been identified with regard to the currently approved posology for the control of exacerbations in severe asthma, and the need for a study comparing 160 µg, 320 µg and 640 µg/ daily to demonstrate a reduction in the frequency of exacerbations in patients with severe asthma at the higher doses.
Ġew identifikati differenzi sinjifikanti fir- rigward tal- pożoloġija approvata fil- preżent għall- kontroll ta ’ taħrixiet f’ ażżma severa, u l- ħtieġa għal studju li jqabbel 160 µg, 320 µg u 640 µg/ kuljum li juri tnaqqis fil - frekwenza tat- taħrixiet f’ pazjenti b’ ażżma severa f’ dożi ogħla.
The data supporting this application, as interpreted according with the CHMP guidance, did not support authorization of regular daily doses in excess of 160 µg in the treatment populations, and this was considered to be of serious public health concern.
It- tagħrif li jappoġġja din l- applikazzjoni, kif interpretat b’ mod konformi mal- gwida tas- CHMP, ma appoġġjax l- awtorizzazzjoni ta ’ dożi regolari ta ’ kuljum li jaqbżu 160 µg fil- popolazzjonijiet ikkurati, u dan kien ikkunsidrat li huwa ta ’ tħassib serju għas- saħħa pubblika.
The arbitration procedure started on 15 November 2007 with the adoption of a list of questions.
Il- proċedura ta ’ arbitraġġ bdiet fil- 15 ta ’ Novembru 2007 bl- adozzjoni ta ’ lista ta ’ mistoqsijiet.
The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Pierre Demolis.
Ir - Rapportatur kien Dr Ian Hudson u l- Korapportatur kien Dr Pierre Demolis.
The Marketing Authorisation Holder provided written explanations on 16 January 2008.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq ta spjegazzjonijiet bil- miktub fis- 16 ta ’ Jannar 2008.
A positive opinion was adopted by consensus on 19 March 2008.
Waqt il- laqgħa tiegħu f’ Marzu 2008, is- CHMP, fid- dawl tad- dejta totali sottomessa u d- diskussjoni xjentifika fi ħdan il- Kumitat, kien ta ’ l- opinjoni li l- proporzjon benefiċċju/ riskju kien favorevoli għal Alvesco u ismijiet assoċjati, li l- oġġezzjonijiet imqajmin minn Franza m’ għandhomx jimpedixxu l- għoti ta ’ Awtorizzazzjoni għat- Tqegħid fis- Suq u li s- Sommarju tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’
1 Article 29(4) of Directive 2001/ 83/ EC, as amended.
1 Artikolu 29( 4) tad- Direttiva 2001/ 83/ KE, kif emendat.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. tagħrif ta ’ l- Istat Membru ta ’ Referenza għandhom ikunu emendati.
In particular, the proposed wording for Section 4.2 at the end of CMDh procedure was amended to reflect that in severe asthmatics, a 12 week study provided by the applicant/ MAH has shown that a dose of 640µg/ d (given 320µg/ d twice daily) demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function.
B’ mod partikolari, il- kitba proposta għal Sezzjoni 4. 2 fi tmiem tal- proċedura CMDh kienet emendata biex tirrifletti li f’ ażżmatiċi severi, studju ta ’ 12- il ġimgħa pprovdut mill- applikant/ MAH wera li doża ta ’ 640µg/ kuljum (mgħotija 320µg/ kuljum darbtejn kuljum) uriet tnaqqis fil- frekwenza ta ’ taħrixiet iżda mingħajr titjib fil- funzjoni tal- pulmun.
The applicant/ MAH also accepted an updated wording for Section 5.1, which includes more detail on Study M1-140, at the end of the CMDh procedure, and a fully updated Package Leaflet.
L- applikant/ MAH aċċetta wkoll kitba aġġornata għal Sezzjoni 5. 1, li tinkludi iktar dettall fuq Studju M1- 140, fi tmiem il- proċedura CMDh, u Fuljett ta ’ Tagħrif aġġornat bis- sħiħ.
Additionally, the applicant/ MAH was requested to commit to obtaining scientific advice in relation to exploring a suitable study design, and executing such study(ies) to provide further information on the use of the higher dose of Alvesco in the control of severe asthma.
Barra minn hekk, l- applikant/ MAH kien mitlub li jimpenja ruħu li jikseb parir xjentifiku fir- rigward ta ’ l - esplorazzjoni ta ’ disinn ta ’ studju addattat, u li jagħmel studju( i) bħal da( w) n biex jipprovdi iktar tagħrif dwar l- użu tad- doża ogħla ta ’ Alvesco fil- kontroll ta ’ ażżma severa.
In light of this, the applicant/ MAH proposed a study which would resolve the outstanding question on the long term use of 320 µg and 640 µg daily.
Fid- dawl ta ’ dan, l- applikant/ MAH ippropona studju li jirrisolvi l- kwistjoni pendenti fuq l- użu fuq tul ta ’ żmien ta ’ 320 µg u 640 µg kuljum.
The list of the product names concerned is given in Annex I.
Il- lista ta ’ ismijiet ta ’ prodotti kkonċernati tingħata fl- Anness I.
The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Il- konklużjonijiet xjentifiċi jingħataw fl - Anness II, flimkien mas- Sommarju tal- Karatteristiċi tal- Prodott fl- Anness III.
The final opinion was converted into a Decision by the European Commission on 11 July 2008.
L- opinjoni finali nbidlet f’ Deċiżjoni mill- Kummissjoni Ewropea fil- 11 ta ’ Lulju 2008.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA (GĦAMLIET FARMAĊEWTIĊI), QAWWA (QAWWIET) TAL- PRODOTT( I) MEDIĊINALI, MNEJN JINGĦATA, L - APPLIKANT( I), ID- DETENTUR( I) TA` L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ FL- ISTATI MEMBRI
Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq
Route of adminitration
Mnjen jingħata
film-coated tablets
pilloli miksijin b’ rita
oral use
użu mill- ħalq
Cyprus
Ċipru
oral use
użu mill- ħalq Id- Danimarka
Estonia
L- Estonja
Finland
Il- Finlandja
2 France
Franza
film-coated tablets
Għamla farmaċewtika
oral use
Mnjen jingħata użu mill- ħalq
Germany
Il- Ġermanja
Greece
Il- Greċja
Hungary
L- Ungerija
Iceland
L- Iżlanda
3 Latvia
Il- Latvja
Lithuania
Il- Litwanja
Luxemburg
Il- Lussemburgu
Norway
In- Norveġja
Poland
Il- Polonja
Portugal Slovakia
Is- Slovakja
oral use
użu mill- ħalq L- Iżvezja
5 ANNEX II
5 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- EMENDA TAS- SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT U TAL- FULJETT TA ’ TAGĦRIF IPPREŻENTATI MILL- EMEA
6 SCIENTIFIC CONCLUSIONS
6 KONKLUŻJONIJIET XJENTIFIĊI
Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Etoricoxib huwa inibitur selettiv ta ’ COX- 2 (cyclooxygenase 2) indikat fis- serħan sintomatiku ta ’ l - osteoartrite (OA, 30- 60mg darba kuljum (od)), artrite rewmatojde (RA, 90mg od) u l- uġigħ u s- sinjali ta ’ infjammazzjoni assoċjata ma ’ artrite akuta tal- gotta (120mg od).
Etoricoxib was included in previous CHMP referrals on the safety of COX-2 selective inhibitors in which concluded in 2004 and 2005.
Etoricoxib kien inkluż fir- referenzi ta ’ qabel tas- CHMP dwar is- sigurtà ta ’ inibituri selettivi ta ’ COX - 2 li ġew konklużi fl- 2004 u fl- 2005.
Both referral procedures pertained to the safety of the COX-2 inhibitor products, including etoricoxib, with a particular focus on gastrointestinal (GI) and cardiovascular (CV) safety.
Iż- żewġ proċeduri ta ’ referenza kellhom x’ jaqsmu mas- sigurtà tal - prodotti inibituri COX- 2, inkluż etoricoxib, b’ fokus partikolari fuq is- sigurtà gastrointestinali (GI) u kardjovaskulari (KV).
These led to updates of the product information to include class warnings on the risk of CV thrombotic, GI and severe skin reactions with COX-2 selective inhibitors.
Dawn wasslu sabiex l- aġġornamenti tat- tagħrif tal- prodott jinkludu twissijiet tal- klassi fuq ir- riskju ta ’ reazzjonijiet KV trombotiċi, GI u tal- ġilda severi b’ inibituri selettivi ta ’ COX- 2.
In addition to class warnings and contraindications, introduced for all COX-2 selective inhibitors, a contraindication in patients with hypertension whose blood pressure is not adequately controlled was included specifically for etoricoxib because of evidence of higher rates of cardiorenal events than other COX-2 inhibitor products.
Barra mit- twissijiet tal- klassi u kontraindikazzjonijiet, introdotti għall- inibituri selettivi COX - 2 kollha, kienet inkluża kontraindikazzjoni f’ pazjenti li l- pressjoni tad- demm tagħhom mhijiex ikkontrollata b’ mod xieraq, speċifikament għal etoricoxib minħabba evidenza ta ’ rati ogħla ta ’ episodji kardjorenali milli bi prodotti inibituri COX- 2 oħrajn.