qanastek/EMEA-V3 huggingface dataset:
When given by inhalation as in Sabumalin, salbutamol directly activates the beta2-receptors in the respiratory system.
Meta mogħti b’ inalazzjoni bħal f’ Sabumalin, salbutamol jattiva direttament ir- riċetturi- beta2 fis- sistema respiratorja.
This makes the airways widen, allowing the air to flow more freely.
Dan iġiegħel lill- passaġġi tal- arja jitwessgħu, sabiex l- arja tkun tista ’ tgħaddi b’ mod iktar liberu.
Sabumalin is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD).
Sabumalin jintuża biex jittratta d- diffikultajiet fit- teħid tan- nifs ikkawżati mill- ażżma u minn mard pulmonari ostruttiv kroniku (COPD).
It can also be used to prevent asthma symptoms caused by exercise or other triggering factors, such as house dust, pollen, cats, dogs and cigarette smoke.
Jista ’ jintuża wkoll biex jipprevjeni sintomi ta ’ ażżma ikkawżati bl- eżerċizzju jew fatturi oħrajn li jikkawżaw dan, bħal trab domestiku, polline, qtates, klieb u dħaħen tas- sigaretti.
Sabumalin is used to relieve symptoms, and its use should not delay the use of inhaled steroids.
Sabumalin jintuża biex itaffi sintomi, u l- użu tiegħu ma għandux idewwem l- użu ta ’ sterojdi li jittieħdu man- nifs.
Sabumalin is a ‘ generic medicine’.
Sabumalin huwa ‘ mediċina ġenerika ’.
This means that Sabumalin is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Sultanol inhaler.
Dan ifisser li Sabumalin huwa simili għal ‘ mediċina ta ’ referenza ’ li hija diġà awtorizzata fl- Unjoni Ewropea (UE) imsejħa Sultanol inalatur.
Why was Sabumalin reviewed?
Għaliex ġie rivedut Sabumalin?
Hexal AG submitted Sabumalin to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
Hexal AG issottomettiet Sabumalin lill- aġenzija regolatorja tal- mediċini Żvediża għal proċedura deċentralizzata fil- 5 ta ’ Diċembru 2006.
This is a procedure when one Member State (the ‘ reference Member State’, in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘ concerned Member States’, in this instance Belgium, Denmark, Estonia, Finland, Germany, Greece, Hungary, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovenia, Spain and the United Kingdom).
Din hija proċedura meta Stat Membru (l - ‘ Istat Membru ta ’ referenza, f’ dan il- każ l- Iżvezja) jevalwa mediċina bil- għan li jagħti awtorizzazzjoni għat- tqegħid fis - suq li tkun valida f’ dan il- pajjiż kif ukoll fi Stati Membri oħrajn (l - ‘ Istati Membri konċernati ’, f’ dan il - każ, il- Belġju, id- Danimarka, l- Estonja, il- Finlandja, il- Ġermanja, il- Greċja, l- Ungerija, l- Italja, il - Latvja, il- Litwanja, l- Olanda, in- Norveġja, il- Polonja, il- Portugall, is- Slovenja, Spanja u r- Renju Unit).
On 4 March 2008, the Swedish medicines regulatory agency referred the matter to the CHMP.
Fl- 4 ta ’ Marzu 2008, l- aġenzija regolatorja tal - mediċini tal- Iżvezja rriferiet il- kwistjoni lis- CHMP.
The grounds for the referral were concerns regarding that there was not enough data showing that Sabumalin is equivalent to the reference medicine.
Ir- raġunijiet għar- referenza kienu tħassib dwar il- fatt li ma kienx hemm biżżejjed dejta li turi li Sabumalin huwa ekwivalenti għall- mediċina ta ’ referenza.
Concerns were also raised regarding how to store the inhaler and the effect of the orientation of the inhaler on the delivery of the medicine.
Tqajjem ukoll tħassib dwar il- mod kif jinħażen l- inalatur u l- effett tal- orjentazzjoni tal- inalatur mal- kunsinna tal- mediċina.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sabumalin outweigh its risks, and that therefore the marketing authorisation for Sabumalin should be granted in all concerned member states.
Abbażi tal- evalwazzjoni tad- dejta disponibbli fil- preżent u d- diskussjoni xjentifika fi ħdan il- Kumitat, is- CHMP ikkonkluda li l- benefiċċji ta ’ Sabumalin huma akbar mir- riskji tiegħu, u li għaldaqstant l -
1 Article 29 of Directive 2001/ 83/ EC as amended, referral on the grounds of potential serious risk to public health 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
1 Artikolu 29 tad- Direttiva 2001/ 83/ KE kif emendata, referenza abbażi ta ’ riskju potenzjali serju għas- saħħa pubblika 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. awtorizzazzjoni għat- tqegħid fis- suq għal Sabumalin għandha tingħata fl- Istati Membri kkonċernati kollha.
The European Commission issued a decision on 12 March 2009.
Il- Kummissjoni Ewropea ħarġet deċiżjoni fit- 12 ta ’ Marzu 2009.
Opinion date:
It- tweġibiet tal- kumpanija ngħataw Data tal- opinjoni:
Prof Michal Piroż ynski (Poland) Dr Gonzalo Calvo Rojas (Spain) 19 March 2008 30 May 2008, 20 October 2008 18 December 2008
Prof Michal Pirożynski (Il- Polonja) Dr Gonzalo Calvo Rojas (Spanja) 19 ta ’ Marzu 2008 30 ta ’ Mejju 2008, 20 ta ’ Ottubru 2008 18 ta ’ Diċembru 2008
Pressurised
L- Awstrija
100 µg/ Dosis - Dosieraerosol
Salbutamol "Hexal" 100 µg/ doża 100 µg/ Dosis -
100 μ g/ dose
Sustanza taħt pressjoni Għal biex jinġibed għolja li tittieħed man - man
inhalation, suspension
83607 Holzkirchen Il- Ġermanja
SalbuHEXAL N
nifs, suspensjoni
Pressurised
Il- Ġermanja
Salbul 100 micrograms
SalbuHEXAL N 100 µg/ doża Dosieraerosol
Pressurised
83607 Holzkirchen Il- Ġermanja
Ireland
nifs, suspensjoni
Salbutamol Hexal 100
100 µg/ doża
Spain
nifs, suspensjoni
Inhalation use
µg/ doża
Hexal AG
Sustanza taħt pressjoni Għal biex jinġibed għolja li tittieħed man - man- nifs
Sanohex
Spanja
Inhalation use
nifs, suspensjoni
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SANOHEX AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU ĠENERALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ SANOHEX U ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
Sanohex is a metered dose aerosol inhaler containing a suspension formulation of salbutamol sulphate 100 µg/ spray, with HFA 134a as propellant.
Sanohex huwa inalatur aerosol ta ’ doża mkejla li fih formulazzjoni ta ’ sospensjoni ta ’ salbutamol sulfat 100 µg/ sprej, b’ HFA 134a bħala propellent.
The new formal protocol of the performed retrospective analysis and the new final report on the in vitro data indicated that the 90% CI remained outside the 15% or 20% acceptance range for stage 0, stage 1 and stage 2 and within the 20% CI but outside the 15% CI for stage 3 the 90% CI.
Is- CHMP ma qabilx li dan l- ammont ta ’ mediċina huwa
The CHMP did not agree that this amount of drug is too small to be relevant and could furthermore not support the Applicant claim that stage 1 is related only to safety.
4 żgħir wisq biex ikun rilevanti u barra dan ma setax jappoġġja l- affermazzjoni tal- Applikant li stadju 1 huwa relatat biss mas- sigurtà.
4 Question 2 - The Applicant´s justification of the selected pooling of stages is not acceptable.
Mistoqsija 2 - Il- ġustifikazzjoni tal- Applikant tar- raggruppament tal- istadji magħżula mhijiex aċċettabbli.
c) Pooling of stages is justified based on safety and efficacy, taking into account the particularities of salbutamol and its site of action.
5 c) Ir- raggruppament tal- istadji huwa ġġustifikat abbażi tas- sigurtà u l- effikaċja, bit- teħid f’ kunsiderazzjoni tal- partikolaritajiet ta ’ salbutamol u s- sit tal- azzjoni tiegħu.
The CHMP stated that the draft guideline proposed a more conservative approach to the applied acceptance range mainly due to lack of experience in this filed and the fact that pooling may mask the differences in the evaluated products, as is the case for the current product.
6 Is- CHMP iddikjara li l- abbozz tal- linja gwida ppropona approċċ iktar konservattiv għall- medda ta ’ approvazzjoni applikata prinċiplament minħabba nuqqas ta ’ esperjenza f’ dan ippreżentata u l- fatt li raggruppament jista ’ jgħatti d- differenzi fil- prodotti evalwati, kif inhu l- każ għall- prodott attwali.
6 The Applicant provided raw data obtained under humid condition clearly demonstrating that the aerodynamic characteristic of salbutamol sulphate particles do not change under humid conditions.
L- Applikant ipprovda dejta mhux ipproċessata miksuba f’ kundizzjonijiet umdi li turi b’ mod ċar li l - karatteristika ajrudinamika ta ’ partiċelli ta ’ salbutamol sulfat ma tinbidilx f’ kundizzjonijiet umdi.
Regarding the storage stability, the Applicant complemented the already submitted repriming study with comparative data from inverted storage and found that all investigated shots for the generic product comply with the specified delivered dose up to a storage period of 7 days.
7 Rigward l- istabbilità waqt il- ħażna, l- Applikant ikkumplimenta l- istudju ta ’ riattivazzjoni (repriming) diġà sottomess ma ’ dejta ta ’ tqabbil minn ħażna bil- prodott rasu ‘ l isfel u sab li s- shots kollha investigati għall- prodott ġeneriku jikkonformaw mad- doża speċifikata mwassla sa perjodu ta ’ ħażna ta ’ 7 ijiem.
During drug product development, the Applicant optimised the applicator, modifying the shape of the device to make it possible to store the applicator in the two identified required storage orientations.
Waqt l- iżvilupp tal- prodott tal- mediċina, l- Applikant ottimizza l- applikatur, immodifika l - forma tal- apparat biex jagħmilha possibbli li l- applikatur jinħażen fiż- żewġ pożizzjonijiet ta ’ ħażna meħtieġa identifikati.
The functionality of the applicator is not affected and therefore the aerosol cloud and the
Il- funzjonalità tal- applikatur mhijiex affettwata u għaldaqstant is- sħaba tal - aerosol u d- distribuzzjoni ajrudinamika tad- daqs tal- partiċelli jibqgħu l- istess.
The CHMP acknowledged the improved device design and agreed with the Applicant response, the issue was considered resolved.
Mistoqsija 7 - Sabiex jintemm l- istudju ta ’ tqabbil bejn il- prodotti ta ’ referenza u tat- test, għandu jsir studju ta ’ riattivazzjoni (repriming) ta ’ tqabbil wara ħażna fil- pożizzjoni mimduda (0°C) (stadju inizjali tal- ħajja tal- bott u tal- bott parzjalment żvujtat) biex jikkonferma x- xebh tal- imġiba tagħhom.
Question 7 - In order to complete the comparative study between the reference and the test products, a comparative repriming study after storage at lying position (0°C) (initial stage of can life and partially emptied can) should be carried out to confirm their similarity of behaviour.
Kif iddikjarat qabel, l- Applikant ipprovda studji ta ’ riattivazzjoni (repriming) inizjali fuq il- prodott tat - test li kienu kkumplimentati bi studju ta ’ riattivazzjoni (repriming) bil- prodott ta ’ referenza u s- CHMP kkunsidra li waqt li d- dejta turi l- effett tal- pożizzjoni tal- MDI fuq id- doża ddepożitata, dan l- effett kien osservat kemm fil- prodott tat- test kif ukoll f’ dak ta ’ referenza.
8 GROUNDS FOR POSITIVE OPINION
8 RAĠUNIJIET GĦAL OPINJONI POŻITTIVA
The pharmacokinetic bioequivalence data also confirmed that Sanohex and the reference product possess the same systemic safety profile since bioequivalence in systemic levels (AUC and Cmax) have been shown, when used with or without a spacer.
Id- dejta ta ’ bijoekwivalenza farmakokinetika kkonfermat ukoll li Salbumalin u l- prodott ta ’ referenza għandhom l- istess profil ta ’ sigurtà sistemika minħabba li ntweriet il- bijoekwivalenza f’ livelli sistemiċi (AUC u Cmax), meta użati bi jew mingħajr spejser.
- the CHMP considered that Sanohex and the reference product possess the same systemic safety profile, as
- is- CHMP ikkunsidra li Salbumalin u l- prodott ta ’ referenza għandhom l- istess profil ta ’ sigurtà
demonstrated by the bioequivalence in systemic levels (AUC and Cmax),
sistemika minħabba li ntweriet il- bijoekwivalenza f’ livelli sistemiċi (AUC u Cmax),
the CHMP has recommended the granting of the Marketing Authorisations for which the valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure are set out in Annex III for Sanohex and associated names (see Annex I).
is- CHMP irrakkomanda l- għoti ta ’ Awtorizzazzjonijiet għat- Tqegħid fis- Suq li s- Sommarju tal - Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif għalihom validi huma l- verżjonijiet finali miksubin waqt il- proċedura tal- grupp ta ’ Koordinament kif stabbiliti fl- Anness III għal Sanohex u ismijiet assoċjati (ara l- Anness I).
10 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
10 Is- Sommarju tal- Karatteristiċi tal- Prodott, l- ittikkettar u l- fuljett ta ’ tagħrif fil- pakkett validi huma l - verżjonijiet finali miksuba waqt il- proċedura tal- Grupp tal- Koordinazzjoni.
EMEA/ CHMP/ 194790/ 2009 EMEA/ H/ A-29/ 991
EMEA/ CHMP/ 194671/ 2009 EMEA/ H/ A- 29/ 991
Questions and answers on the referral for Sanohex salbutamol, metered dose aerosol inhaler, 100 μ g/ dose
Mistoqsija u tweġiba dwar ir- referenza għal Sanohex salbutamol, inalatur ajrosol b’ doża mkejla, 100 μg/ doża
The European Medicines Agency (EMEA) has completed a referral procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Sanohex.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) temmet proċedura ta ’ referenza wara nuqqas ta ’ qbil fost l- Istati Membri tal- Unjoni Ewropea fir- rigward tal- awtorizzazzjoni tal- mediċina Sanohex.
The Agency’ s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Sanohex outweigh its risks, and that the marketing authorisation can be granted in Sweden as well as in the following Member States of the European Union:
Il - Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) tal- Aġenzija ikkonkluda li l - benefiċċji ta ’ Sanohex huma akbar mir- riskji tiegħu, u li l- awtorizzazzjoni għat- tqegħid fis- suq tista ’ tingħata fl- Iżvezja kif ukoll fl- Istati Membri tal- Unjoni Ewropea li ġejjin.
Austria, Germany, Ireland and Spain.
L- Awstrija, il- Ġermanja, l - Irlanda u Spanja.
What is Sanohex?
X’ inhu Sanohex?
Sanohex is a medicine in a pressurised inhaler that contains salbutamol as active substance.
Sanohex hija mediċina f’ inalatur taħt pressjoni li fiha salbutamol bħala sustanza attiva.
When given by inhalation as in Sanohex, salbutamol directly activates the beta2-receptors in the respiratory system.
Meta mogħti b’ inalazzjoni bħal f’ Sanohex, salbutamol jattiva direttament ir- riċetturi- beta2 fis - sistema respiratorja.
Sanohex is used to treat the breathing difficulties caused by asthma and chronic obstructive pulmonary disease (COPD).
Sanohex jintuża biex jittratta d- diffikultajiet fit- teħid tan- nifs ikkawżati mill- ażżma u minn mard pulmonari ostruttiv kroniku (COPD).
Sanohex is used to relieve symptoms, and its use should not delay the use of inhaled steroids.
Sanohex jintuża biex itaffi sintomi, u l- użu tiegħu ma għandux idewwem l- użu ta ’ sterojdi li jittieħdu man- nifs.
Sanohex is a ‘ generic medicine’.
Sanohex huwa ‘ mediċina ġenerika ’.
This means that Sanohex is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Sultanol inhaler.
Dan ifisser li Sanohex huwa simili għal ‘ mediċina ta ’ referenza ’ li hija diġà awtorizzata fl- Unjoni Ewropea (UE) imsejħa Sultanol inalatur.
Why was Sanohex reviewed?
Għaliex ġie rivedut Sanohex?
Hexal AG submitted Sanohex to the Swedish medicines regulatory agency for a decentralised procedure on 5 December 2006.
Hexal AG issottomettiet Sanohex lill- aġenzija regolatorja tal- mediċini Żvediża għal proċedura deċentralizzata fil- 5 ta ’ Diċembru 2006.
This is a procedure when one Member State (the ‘ reference Member State’, in this instance Sweden) assesses a medicine with a view of granting a marketing authorisation that will be valid in this country as well as in other member states (the ‘ concerned Member States’, in this instance Austria, Germany, Ireland and Spain).
Din hija proċedura meta Stat Membru (l - ‘ Istat Membru ta ’ referenza, f’ dan il- każ l- Iżvezja) jevalwa mediċina bil- għan li jagħti awtorizzazzjoni għat- tqegħid fis - suq li tkun valida f’ dan il- pajjiż kif ukoll fi Stati Membri oħrajn (l - ‘ Istati Membri konċernati ’, f’ dan il - każ, l- Awstrija, il- Ġermanja, l- Irlanda u Spanja).
On 4 March 2008, the Swedish medicines regulatory agency referred the matter to the CHMP.
Fl- 4 ta ’ Marzu 2008, l- aġenzija regolatorja tal- mediċini tal- Iżvezja rriferiet il- kwistjoni lis- CHMP.
The grounds for the referral were concerns regarding that there was not enough data showing that Sanohex is equivalent to the reference medicine.
Ir- raġunijiet għar- referenza kienu tħassib dwar il- fatt li ma kienx hemm biżżejjed dejta li turi li Sanohex huwa ekwivalenti għall- mediċina ta ’ referenza.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Sanohex outweigh its risks, and that therefore the marketing authorisation for Sanohex should be granted in all concerned member states.
Abbażi tal- evalwazzjoni tad- dejta disponibbli fil- preżent u d- diskussjoni xjentifika fi ħdan il- Kumitat, is- CHMP ikkonkluda li l- benefiċċji ta ’ Sanohex huma akbar mir- riskji tiegħu, u li għaldaqstant l - awtorizzazzjoni għat- tqegħid fis- suq għal Sanohex għandha tingħata fl- Istati Membri kkonċernati kollha.
Co-rapporteur:
Co- rapporteur:
1 Member State
1 Stat Membru Id- Detentur ta ’ l - Awtorizzazzjoni għat - tqegħid fis- suq
(Invented) name
Isem Ivvintat
Merck Sharp & Dohme
Merck Sharp & Dohme Singulair
Chewable tablets Oral use
Użu orali
GmbH Donau-City-Straße 6 1220 Wien Austria
GmbH Donau- City- Straße 6 1220 Vjenna L- Awstrija
Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Merck Sherp & Dohme Singulair Chaussée de Waterloo 1135 B- 1180 Brussell Il- Belġju
Singulair 4 mg
4 mg
Chewable tablets
Pilloli li tomgħodhom
Merck Sharp and Dohme Bulgaria EOOD 55, Nikola Vaptzarov blvd.
Merck Sharp and Dohme Singulair Bulgaria EOOD 55, Nikola Vaptzarov blvd.
1407 Sofia Bulgaria
1407 Sofia Il- Bulgarija
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem The Netherlands
Merck Sharp & Dohme B. V., Singulair Postbox 581, Waarderweg 39, NL- 2031 BN, Haarlem L- Olanda
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem The Netherlands
Merck Sharp & Dohme B. V., Singulair Paediatric Postbox 581, Waarderweg 39, NL- 2031 BN, Haarlem L- Olanda
Czech Republic
Mnjen jingħata
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem The Netherlands
Il- Kontenut (Konċentrat)
SINGULAIR
Ir- Repubblika
4 Mini
Merck Sharp & Dohme B. V., Singulair 4 mini
Chewable tablets
Pilloli li
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem The Netherlands
Postbox 581, Waarderweg 39, NL- 2031 BN, Haarlem L- Olanda
Singulair
Merck Sharp & Dohme B. V., Singulair
Estonia
tomgħodhom
Merck Sharp & Dohme OÜ Peterburi tee 46 11415 Tallinn Estonia
Merck Sharp & Dohme OÜ Singulair L- Estonja Peterburi tee 46 11415 Tallinn L- Estonja
Mini 4mg
Mini
4mg
4 mg 4 mg
Waarderweg 39 P. O. BOX 581 2031 BN Haarlem The Netherlands
Singulair Waarderweg 39 P. O. BOX 581 2031 BN Haarlem L- Olanda
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem, The Netherlands
Merck Sharp & Dohme B. V., Singulair Postbox 581, Waarderweg 39, NL- 2031 BN, Haarlem, L- Olanda
Singulair
Użu orali
Chewable tablets
Il- Ġermanja
Dieckmann Arzneimittel GmbH, Lindenplatz 1 85540 Haar Germany
Dieckmann Arzneimittel GmbH, Lindenplatz 1 85540 Haar Il- Ġermanja
Singulair mini
Singulair mini Kautabletten
Tatoiou Street, Nea Erythrea, 146 71, Greece
Tatoiou Street, Nea Erythrea, 146 71, Il- Greċja
50., Hungary
50., L- Ungerija
Merck Sharp & Dohme Ltd; Hertford Road, Hoddesdon, Hertfordshire EN119BU, United Kingdom
Merck Sharp & Dohme Ltd; Singulair Paediatric Hertford Road, Hoddesdon, Hertfordshire EN119BU, Ir- Renju Unit
(Invented) name
Granuli
Strength
Orali
Merck Sharp & Dohme Ltd; Hertford Road, Hoddesdon, Hertfordshire EN119BU United Kingdom
Merck Sharp & Dohme Ltd; Singulair Paediatric Hertford Road, Hoddesdon, Hertfordshire EN119BU Ir- Renju Unit
Chewable Tablets
Pilloli li tomgħodhom
Merck Sharp E Dohme (Italia) S. p. A.
Merck Sharp E Dohme Singulair (Italia) S. p. A.
Fabbroni, 6 00191 Roma Italy
Fabbroni, 6 00191 Ruma L- Italja
Istituto Gentili S. p. A Via B.
Istituto Gentili S. p. A Montegen Via B.
Croce, 37 56125 Pisa Italy
Croce, 37 56125 Pisa L- Italja
MONTEGEN
4 mg granulato
SIA « Merck Sharp & Dohme Latvija » Skanstes 13, second floor, LV- 1013, Riga Latvia
SIA « Merck Sharp & Dohme Singulair mini Latvija » Granulas Skanstes 13, second floor, LV - 1013, Riga Il- Latvja
Singulair mini 4 mg granulas
košļājamās 4 mg
Latvia
Il- Litwanja
SIA « Merck Sharp & Dohme Latvija » Skanstes 13, second floor, LV- 1013, Riga Latvia
59/ 27 LT- 08124 Vilnius Il- Litwanja
Singulair 4mg košļā jamā s tabletes
“ Merck Sharp & Dohme ”, Singulair UAB, Kestucio str.
Lithuania
Il - Lussemburgu
59/ 27 LT-08124 Vilnius Lithuania
Merck Sherp & Dohme Singulair Mini Chaussée de Waterloo 1135 B- 1180 Brussell Il- Belġju
Lithuania
Il -
“ Merck Sharp & Dohme”, UAB, Kestucio str.
Merck Sharp & Dohme B. V.
Merck Sherp & Dohme Chaussée de Waterloo 1135 B-1180 Brussels Belgium
Chaussée de Waterloo 1135 B - 1180 Brussell Il- Belġju
SINGULAIR MINI
tomgħodhom
Chaussée de Waterloo 1135 B- 1180 Brussels Belgium
Merck Sharp & Dohme Singulair Paediatric Hertfordshire Road, Hoddesdon, Hertfordshire, EN11 9BU Ir- Renju Unit
Granules
L- Olanda
Merck Sharp & Dohme Hertfordshire Road,
Merck Sharp & Dohme B. V., Singulair Kleuter Postbox 581, Waarderweg 39, NL- 2031 BN, Haarlem, L- Olanda
6 Member State
6 Stat Membru Id- Detentur ta ’ l - Awtorizzazzjoni għat - tqegħid fis- suq
The Netherlands
In- Norveġja
Chł odna 51 00-867 Warszawa Poland
Chłodna 51 00- 867 Warszawa Il- Polonja
Box 214 2770-192 Paço d 'Arcos Portugal
Box 214 2770- 192 Paço d 'Arcos Il- Portugall
7 Member State
7 Stat Membru Id- Detentur ta ’ l - Awtorizzazzjoni għat - tqegħid fis- suq
MERCK SHARP & DOHME ROMANIA S. R. L.
MERCK SHARP & DOHME Singulair, granule, 4 mg/ plic 4 mg ROMANIA S. R. L.
1A, Corp clă dire C1, Etaj 3, Sector 1, Bucureş ti Romania
1A, Corp clădire C1, Etaj 3, Sector 1, Bucureşti Ir- Rumanija
MERCK SHARP &
Ir- Rumanija
4 mg, 4 mg
MERCK SHARP & DOHME Singulair 4 mg, 4 mg ROMANIA S. R. L. comprimate masticabile Bucharest Business Park Şos.
Chewable tablets Oral use
Pilloli li tomgħodhom
Singulair 4 mg zrnca 4 mg
Merck Sharp & Dohme, Singulair 4 mg zrnca 4 mg Smartinska 140, SI- 1000 Ljubljana Is- Slovenja
Singulair 4 mg zvecljive 4 mg tablete
Merck Sharp & Dohme, Singulair 4 mg zvecljive 4 mg Smartinska 140, SI- 1000 tablete Ljubljana Is- Slovenja
Waarderweg 39, 2031 BN Haarlem P. O.
Singulair 4 mg 4 mg Waarderweg 39, 2031 BN Haarlem P. O.
8 Member State
8 Stat Membru Id- Detentur ta ’ l - Awtorizzazzjoni għat - tqegħid fis- suq
Merck Sharp and Dohme de España, SA Josefa Valcarcel, 38 28027 – Madrid Spain
Merck Sharp and Dohme de Singulair España, SA Josefa Valcarcel, 38 28027 – Madrid Spanja
Spain
L- Isvezja
Merck Sharp and Dohme de España, SA Josefa Valcarcel, 38 28027- Madrid Spain
Merck Sharp & Dohme B. V., Singulair Postbox 581, Waarderweg 39, NL- 2031 BN, Haarlem L- Olanda
Singulair 4 mg comprimidos masticables
4 mg
Chewable tablets
Ir- Renju Unit
Oral use
Merck Sharp & Dohme Singulair Paediatric Limited Granules Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Ir - Renju Unit
Oral
Użu orali
Merck Sharp & Dohme B. V., Postbox 581, Waarderweg 39, NL-2031 BN, Haarlem The Netherlands
Merck Sharp & Dohme Singulair Paediatric
Granules
Pilloli li
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL- EMENDI TAS- SOMMARJI TAL- KARATTERISTIĊI TAL- PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SINGULAIR AND ASSOCIATED NAMES (SEE ANNEX I)
SOMMARJU GLOBALI TA ’ L- EVALWAZZJONI XJENTIFIKA TA ’ SINGULAIR U ISMIJIET ASSOĊJATI (ARA L- ANNESS I)
The present referral procedure sought harmonisation of the product information for Singulair 4 mg chewable tablets and 4 mg oral granules with the indications already approved for children 2-5 years old and 6 months to 2 years old in Mutual Recognition Procedures, with Finland acting as the reference member state.
Il- proċedura ta ’ referenza attwali ppruvat tikseb armonizzazzjoni tat- tagħrif tal- prodott għal Singulair 4 mg pilloli li jintmagħdu u 4 mg granuli orali bl- indikazzjonijiet diġà approvati għal tfal ta ’ bejn sentejn u ħames snin u bejn 6 xhur u sentejn fil- Proċeduri ta ’ Rikonoxximent Reċiproku, bil- Finlandja tagħmilha ta ’ Stat Membru ta ’ referenza.
Simultaneously, the MAH updated module 3 was updated to CTD format in this referral procedure.
Fl- istess ħin, il- modulu 3 aġġornat mill- MAH ġie aġġornat għall- format CTD f’ din il- proċedura ta ’ referenza.
The active substance in Singulair products is montelukast sodium.
Is- sustanza attiva fil- prodotti Singulair hija montelukast sodium.
It is a leukotriene-1 receptor antagonist.
Dan huwa antagonist tar- riċettur ta ’ leukotriene- 1.
Montelukast sodium has been used for the add-on treatment (concomitantly with inhaled steroids) and to prevent exercise-induced bronchoconstriction.
Montelukast sodium intuża għat- trattament addizzjonali (flimkien ma ’ l- isterojdi inalati) u biex jipprevjeni d- djuq tal- pajpijiet tan- nifs (bronkokostrizzjoni) imqanqla mill- eżerċizzju.
Formulations for paediatric use, 4 mg chewable tablets and 4 mg oral granules, have been available since 2000 and 2002, respectively.
Formulazzjonijiet għal użu fit- tfal, pilloli jintmagħdu ta ’ 4 mg u granuli orali ta ’ 4 mg, ilhom jeżistu mill- 2000 u l- 2002 rispettivament.
Since 2002, the MRP indications also include the monotherapy of 4 mg paediatric formulations in the treatment of mild asthma in exceptional cases, i. e. when inhaled corticosteroids cannot be used.
Mill- 2002, l- indikazzjonijiet ta ’ l- MRP jinkludu wkoll il - monoterapija ta ’ formulazzjonijiet pedjatriċi ta ’ 4 mg fit- trattament ta ’ ażżma ħafifa f’ każijiet eċċezzjonali, jiġifieri meta l- kortikosterojdi li jittieħdu man- nifs ma jkunux jistgħu jintużaw.
Singulair 4 mg chewable tablets is available in all current EU member states (and in IS and NO) except in FR since the approval given in Mutual Recognition Procedure in 2000.
Il- pilloli jintmagħdu Singulair ta ’ 4 mg jinstabu fl- Istati Membri attwali kollha ta ’ l- UE (u f’ IS u f’ NO) ħlief fi FR sa mill- approvazzjoni mogħtija fil- Proċedura tal- Għarfien Reċiproku fl- 2000.
Singulair 4 mg oral granules was approved by 16 member states (not by AT, BE, CZ, DK, FR, HU, NL, PL, SK) in MRP in 2002.
Il - granuli orali ta ’ Singulair ta ’ 4 mg kienu approvati minn 16- il Stat Membru (mhux minn AT, BE, CZ, DK, FR, HU, NL, PL, SK) fl- MRP fl- 2002.
Also IS and NO have granted marketing authorisation to this formulation.
Anki IS u NO taw l- awtorizzazzjoni għat- tqegħid fis- suq għal din il- formolazzjoni.
Quality The MAH provided harmonised modules 3 in CTD format for Singulair 4 mg granules and 4 mg chewable tablets.
Il- kwalità Il- MAH ipprovda moduli armonizzati 3 fil- format CTD għal Singulair 4 mg granuli u 4 mg pilloli jintmagħdu.
Moreover the MAH submitted a proposal for harmonised chemical-pharmaceutical sections of the SPC and PL.
Barra minn hekk, il- MAH issottometta proposta għal sezzjonijiet kimiċi- farmaċewtiċi ta ’ l- SPC u tal- PIL.
SPC Harmonisation The MAH selected the sections which presented major divergences and were the scope of the harmonisation through the referral procedure.
Armonizzazzjoni ta ’ l- SPC Il- MAH għażel is- sezzjonijiet li ppreżentaw diverġenzi maġġuri u kienu l- iskop ta ’ l- armonizzazzjoni matul il- proċedura ta ’ referenza.
All other sections of the SPCs will be harmonised as approved in the Mutual Recognition Procedure.
Is- sezzjonijiet l- oħra kollha ta ’ l- SPCs sejrin jiġu armonizzati kif approvat fil- Proċedura ta ’ Rikonoxximent Reċiproku.
The following sections of the SPCs were presented for harmonisation:
Dawn is- sezzjonijiet ta ’ l- SPCs kienu ppreżentati għall- armonizzazzjoni:
4.1 Therapeutic Indications, 4.2 Posology and method of administration, 4.3 Contraindications, 4.4 Special Warnings and Precautions for Use, 4.8 Undesirable effects, and 6.5 Shelf life.
4. 1 Inkidazzjonjiet Terapewtiċi, 4. 2 Pożoloġija u metodu ta ’ kif jingħata, 4. 3 Kontra- indikazzjonijiet, 4. 4 Twissijiet Speċjali u Prekawzjonijiet għall- Użu, 4. 8 Effetti mhux mixtieqa, u 6. 5 Żmien kemm idum tajjeb il - prodott mediċinali.
The SPCs proposed by the MAH were those approved through the MRP in the "old" member states and in CY and IS.
L- SPCs proposti mill- MAH kienu dawk approvati mill- MRP fl- Istati Membri l - “ antiki ” u f’ CY u fl - IS.
The indications given in these SPCs are the most restrictive among the approved indications in EU member states, and are approved in the most number of countries.
L- indikazzjonijiet mogħtija f’ dawn l- SPCs huma l- iktar restrittivi fost l- indikazzjonijiet approvati fl- Istati Membri ta ’ l- UE, u huma approvati fl- akbar numru ta ’ pajjiżi.
Furthermore, the latest variation procedure was finalised on 10th September 2007, and the SPCs that were then approved are in line with the proposals of the MAH in this referral.
Barra minn hekk, l- iktar proċedura tal- varjazzjoni riċenti ġiet iffinalizzata fl- 10 ta ’ Settembru 2007, u l- SPCs li ġew approvati huma konformi mal- proposti tal- MAH f’ din ir- referenza.
Clinical Efficacy:
Effikaċja Klinika:
Add-on use Singulair is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “ as-needed” short acting β -agonists provide inadequate clinical control of asthma, in patients aged 6 months to 5 years.
Użu miżjud Singulair hu indikat fit- trattament ta ’ l- ażżma u bħala terapija miżjuda f’ dawk il- pazjenti b’ ażżma persistenti ħafifa jew moderata li ma jkunux ikkontrollati adegwatament bil- kortikosterodji inalati u li fihom l- agonisti- β b’ effett qasir li jittieħdu “ skond il- bżonn ” jipprovdu kontroll kliniku inadegwat ta ’ l- ażżma, f’ pazjenti ta ’ bejn 6 xhur u 5 snin.
The Applicant/ MAH provided supportive documentation for this indication of 4mg OG in children aged 6 month to 2 years based on pharmacokinetic data PN 136/ 138, supportive safety data PN 176, and the extrapolation of efficacy to this age group from the efficacy demonstrated in older children (2- 5 years old, 6-14 years old) according to ICH E11 guideline.
L- applikant/ MAH ipprovda dokumentazzjoni ta ’ appoġġ għal din l- indikazzjoni ta ’ OG ta ’ 4mg fi tfal ta ’ bejn 6 xhur u sentejn abbażi tad- dejta farmakokinetika PN 136/ 138, dejta tas- sigurtà ta ’ appoġġ
Further efficacy reports of two clinical 11 studies (P176 and P072-02; double-blind, randomized, placebo-controlled, parallel group) were presented for both 4mg OG and CT formulations.
Rapporti oħra ta ’ l- effikaċja ta ’ żewġ studji kliniċi (P176 u P072- 02; grupp parallel, double- blind, randomatizzat, ikkontrollat bi plaċebo) ġew ippreżentati għall- formolazzjonijiet ta ’ OG u CT4mg.
Montelukast showed improvement in the variables of asthma as compared to placebo.
Montelukast wera titjib fil- fatturi relatati ma ’ l- ażżma meta mqabbla mal- plaċebo.
The effect of montelukast on asthma was modest, but consistent across the spectrum of variables, and in line with results obtained from studies on adults and older children.
L- effett ta ’ montelukast fuq l- ażżma kien wieħed modest, iżda konsistenti mal- firxa kollha tal- karatteristiċi u b’ mod konformi mar- riżultati miksuba mill- istudji fl- adulti u fit- tfal ikbar.
The Applicant/ MAH also made reference to an original application concerning the 10 mg film-coated tablet and 5 mg CT, which presents the results of two placebo-controlled clinical studies in more than 1600 adult patients with mild-to-moderate asthma.
L- Applikant/ MAH għamel referenza wkoll għal applikazzjoni oriġinali dwar il- pilloli miksija b’ rita tal - 10 mg u CT tal- 5 mg, li tippreżenta r- riżultati ta ’ żewġ studji kliniċi kkontrollati bi plaċebo f’ iktar minn 1600 pazjent adult b’ ażżma ħafifa jew moderata.
Montelukast (10 mg once daily at bedtime) was shown to improve respiratory functions, reduce asthma symptoms and beta-agonist use, and to improve quality of life as compared to placebo.
Intwera li Montelukast (10 mg darba kuljum f’ ħin l - irqad) itejjeb il- funzjonijiet respiratorji, inaqqas is- sintomi ta ’ l- ażżma u l- użu ta ’ l- agonisti- beta, u jtejjeb il- kwalità tal- ħajja meta mqabbel mal- plaċebo.
In three active-controlled studies, in nearly 1000 adult patients with mild-to-moderate asthma, the effect of montelukast (10 mg once daily) was shown to be better than that obtained with placebo, but less than that obtained with inhaled beclometasone dipropionate (400 µg/ day).
Fi tliet studji bl- attività kkontrollata, fi kważi 1000 pazjent adult b’ ażżma ħafifa jew moderata, intwera li l- effett ta ’ montelukast (10 mg darba kuljum) kien aħjar minn dak miksub mill- plaċebo, iżda inqas minn dak miksub minn beclometasone dipropionate li jittieħed man- nifs (400 µg kuljum).
The Applicant/ MAH also made reference to an original application concerning 5 mg CT, which presented the results of a study in 336 paediatric patients (age 6 to 14 years).
L- Applikant/ MAH għamel referenza wkoll għal applikazzjoni oriġinali dwar CT tal- 5 mg CT, li ppreżentat ir- riżultati ta ’ studju fi 336 pazjent pedjatriku (ta ’ bejn 6 u 14- il sena).
Montelukast (5 mg once daily) was shown to exert an anti-asthmatic effect that was larger than the effect obtained with placebo.
Montelukast (5 mg darba kuljum) intwera li kellu effett anti- ażżmatiku ikbar mill- effett miksub bil- plaċebo.
However, there were no data of studies comparing montelukast with active treatments in paediatric patients.
Madankollu, ma kienx hemm dejta minn studji li jqabblu montelukast mat- trattamenti attivi f’ pazjenti pedjatriċi.
Given that the efficacy data from children aged 6 months to 2 years of age is not considered very robust, the CHMP requested, that the Applicant/ MAH should give a more detailed instruction in Section 4.2 as to how the treatment effect should be monitored and evaluated.
Ladarba d- dejta ta ’ l- effikaċja minn tfal ta ’ bejn 6 xhur u xahrejn mhix ikkunsidrata wisq robusta, is - CHMP talab, li l- Applikant/ MAH għandu jagħti istruzzjoni iktar dettaljata fis- Sezzjoni 4. 2 dwar kif l - effett tat- trattament għandu jiġi sorveljat u evalwat.
The following revision to Section 4.2 of Singulair 4 mg OG SPC was finally accepted:
Ir- reviżjoni li ġejja għas- Sezzjoni 4. 2 ta ’ l- SPC ta ’ Singulair 4 mg OG kienet finalment aċċettata:
Efficacy data from clinical trials in paediatric patients 6 months to 2 years of age with persistent asthma are limited.
Id- dejta ta ’ l- effikaċja mill- istudji kliniċi f’ pazjenti pedjatriċi ta ’ bejn 6 xhur u sentejn b’ ażżma persistenti hija limitata.
Patients should be evaluated after 2 to 4 weeks for response to montelukast.
Il- pazjenti għandhom jiġu evalwati mill- ġdid wara bejn ġimagħtejn u erba ’ ġimgħat għar- rispons għal montelukast.
Treatment should be discontinued if lack of response is observed.
It- trattament għandu jitwaqqaf jekk jiġi osservat nuqqas ta ’ rispons.
Subsequently, Section 4.4 of Singulair 4mg OG SPC was revised to include the following wording:
Sussegwentament, is- Sezzjoni 4. 4 ta ’ l- SPC ta ’ Singulair OG ta ’ 4mg ġiet riveduta biex tinkludi dan il- kliem:
The diagnosis of persistent asthma in very young children (6 months – 2 years) should be established by a paediatrician or pulmonologist.
Id- dijanjożi ta ’ ażżma persistenti fi tfal żgħar ħafna (bejn 6 xhur u sentejn) għandha tiġi stabbilita minn speċjalista tat- tfal jew tal- pulmun.
After careful deliberations, the CHMP considered that the clinical data to support the add-on therapy in very young children are sufficient for approval, taking into account that this formulation was approved for use in children aged 6 months to 2 years in approximately 52 countries, including 17 of 27 European Union (EU) Member States (first approval in 2002) plus Iceland and Norway.
Wara deliberazzjonijiet bir- reqqa, is- CHMP ikkunsidra li d- dejta klinika b’ appoġġ għat- terapija miżjuda fi tfal żgħar ħafna hija suffiċjenti għall- approvazzjoni, meta wieħed iqis li din il - formulazzjoni ġiet approvata għall- użu fi tfal ta ’ bejn 6 xhur u sentejn f’ madwar 52 pajjiż, inklużi 17 mis- 27 Stat Membru ta ’ l- Unjoni Ewropea (UE) (l- ewwel approvazzjoni fl- 2002) kif ukoll fl- Iżlanda u fin- Norveġja.
In a trend voting after the Applicant/ MAH’ s Oral Explanation, the majority of the CHMP (26+2 positive, 3 negative votes) was in favour of accepting the indication as proposed by the Applicant/ MAH, including the treatment of very young patients (6 months to 2 year old) when diagnosis of persistent asthma has been established.
F’ votazzjoni tat- tendenza wara l- Ispjegazzjoni Orali ta ’ l- Applikant/ MAH, il - maġġoranza tas- CHMP (26+2 pożittivi, 3 voti negattivi) kienet favur l- aċċettazzjoni ta ’ l- indikazzjoni kif proposta mill- Applikant/ MAH, inkluż it- trattament ta ’ pazjenti żgħar ħafna (ta ’ bejn 6 xhur u sentejn) meta tkun ġiet stabbilita d- dijanjożi ta ’ ażżma persistenti.
Therefore, the CHMP agreed with the following proposed indication for 4mg chewable tablets:
Għalhekk, is- CHMP qabel ma ’ l- indikazzjoni proposta li ġejja għal pilloli jintmagħdu ta ’ 4mg:
"SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom" as-needed "short acting β -agonists provide inadequate clinical control of asthma".
"SINGULAIR huwa indikat għat- trattament ta ’ l- ażżma bħala terapija addizzjonali f’ dawk il- pazjenti ta ’ bejn sentejn u 5 snin b’ ażżma persistenti ħafifa jew moderata li ma jkunux ikkontrollati b’ mod adegwat b’ kortikosterojdi li jittieħdu man- nifs u li fihom l- agonisti- β li jaġixxu f’ ħin qasir meħudin “ skond il- bżonn ” jipprovdu kontroll kliniku mhux adegwat ta ’ l- ażżma".
The CHMP agreed with the following proposed indication for 4mg oral granules:
Is- CHMP qabel ma ’ l- indikazzjoni proposta li ġejja għall- granuli orali ta ’ l- 4mg:
"SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 6 months to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom" as-needed "short acting β -agonists provide inadequate clinical control of asthma".
12 "SINGULAIR huwa indikat għat- trattament ta ’ l- ażżma bħala terapija addizzjonali f’ dawk il- pazjenti b’ eta ’ ta ’ bejn is- 6 xhur u 5 snin b’ ażżma persistenti ħafifa jew moderata li ma jkunux ikkontrollati b’ mod adegwat b’ kortikosterojdi li jittieħdu man- nifs u li fihom l- agonisti- β li jaġixxu f’ ħin qasir meħudin “ skond il- bżonn ” jipprovdu kontroll kliniku mhux adegwat ta ’ l- ażżma".
12 Clinical Efficacy:
Effikaċja Klinika:
2 to 5 year old) with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.
Monoterapija ta ’ l- ażżma Singulair jista ’ jkun ukoll opzjoni ta ’ trattament alternattiv għall- kortikosterojdi li jittieħdu man- nifs b’ doża baxxa (4 mg OG, CT: bejn sentejn u 5 snin) b’ ażżma persistenti ħafifa li ma jkollhomx storja riċenti ta ’ attakki serji ta ’ l- ażżma li kienu jeħtieġu l- użu ta ’ kortikosterojdi orali, u li wrew li mhumiex kapaċi jużaw kortikosterojdi li jittieħdu man- nifs.
Two long term studies to support the monotherapy indication were presented.
Ġew ippreżentati żewġ studji fit- tul b’ appoġġ għall- indikazzjoni tal- monoterapija.
Both were of double- blind, randomised, parallel-group type.
It- tnejn kienu tat - tip double- blind, randomizzati, bi gruppi paralleli.
Study P910 (treatment duration 52 weeks) was carried out in 6 to 14-year old paediatric patients, study P907 in patients 2 to 6 years old.
L- istudju P910 (bi trattament ta ’ 52 ġimgħa) sar f’ pazjenti ta ’ bejn 6 u 14- il sena, studju P907 f’ pazjenti ta ’ bejn sentejn u sitt snin.
The results of P910 suggest that with montelukast, as good benefit-risk ratio can be achieved in the treatment of paediatric mild, persistent asthma as with inhaled fluticasone.
Ir- riżultati ta ’ P910 jissuġġerixxu li ma 'montelukast, jista ’ jinkiseb bilanċ bejn il- benefiċċju u r- riskju tajjeb daqs fluticasone li jittieħed man- nifs fit- trattament ta ’ ażżma persistenti ħafifa fit- tfal.
The treatment effect by montelukast is smaller than that achieved with fluticasone, but the difference is small enough to be clinically not significant, and it can be compensated with better treatment compliance due to oral, once daily administration of montelukast as opposed to twice-daily inhalation of fluticasone.
L- effett tat - trattament b’ montelukast huwa iżgħar minn dak miksub bi fluticasone, iżda d- differenza hija żgħira wisq biex tkun klinikament mhux sinjifikanti, u jista ’ jiġi kkumpensat b’ konformità aħjar mat - trattament b’ amministrazzjoni orali darba kuljum ta ’ montelukast kuntrarju għall- inalazzjoni darbtejn kuljum ta ’ fluticasone.
Lack of effect on growth rate is also a benefit of montelukast.
In- nuqqas ta ’ effett fuq ir- rata tat- tkabbir huwa wkoll benefiċċju ta ’ montelukast.
Results of P907 showed efficacy over placebo.
Ir- riżultati ta ’ P907 wrew effikaċja meta mqabbla mal- plaċebo.
Given the lack of efficacy data for this indication in patients younger than 2 years, the CHMP consulted with the Paediatric Committee regarding the extrapolation of data from studies conducted in older paediatric patients to assess the safety/ efficacy of montelukast in very young paediatric patients.
Minħabba n- nuqqas ta ’ dejta dwar l- effikaċja għal din l- indikazzjoni f’ pazjenti ta ’ inqas minn sentejn, is- CHMP ikkonsulta mal- Kumitat Pedjatriku dwar l- estrapolazzjoni tad- dejta minn studji li saru f’ pazjenti pedjatriċi ikbar biex jivvaluta s- sigurtà/ l- effikaċja ta ’ montelukast f’ pazjenti pedjatriċi żgħar ħafna.
The PDCO, basing its decision on the GINA paediatric handbook 2006 and expert intervention, concluded that, due to a shortage of clinical data in patients aged 6 months – 2 years with asthma, pharmacokinetic data from patients aged 2-5 years diagnosed with asthma cannot be extrapolated to younger patients aged 6 months- 2 years presenting with the same symptoms.
Il- PDCO, ibbaża d- deċiżjoni tiegħu fuq il- gwida pedjatrika GINA ta ’ l- 2006 u intervent espert, u kkonkluda li, minħabba nuqqas ta ’ dejta klinika f’ pazjenti ta ’ bejn 6 xhur u sentejn bl- ażżma, dejta farmakokinetika minn pazjenti ta ’ bejn sentejn u 5 snin b’ dijanjożi ta ’ l- ażżma ma tistax tiġi estrapolata għal pazjenti iżgħar ta ’ bejn 6 xhur u sentejn bl- istess sintomi.
The wheezing observed in the younger age group could be attributed to a number of diagnoses (viral infection, RSV bronchiolitis, or early symptoms of classic asthma).
It- tisfir osservat fil- grupp ta ’ età iżgħar jista ’ jiġi attribwit għal numru ta ’ dijanjożi (infezzjoni virali, bronkjolite RSV, jew sintomi bikrija ta ’ l- ażżma klassika).
Therefore, the PDCO expressed the need to conduct studies to precisely define the patient population that should receive montelukast sodium for the treatment of mild persistent asthma.
Għalhekk, il- PDCO esprima l- bżonn li jsiru studji biex jiddefinixxu bi preċiżjoni l- popolazzjoni tal- pazjenti li għandhom jirċievu montelukast sodium għat - trattament ta ’ l- ażżma persistenti ħafifa.
However, the Applicant/ MAH only seeks to maintain the indication for montelukast as monotherapy in mild to moderate persistent asthma in children aged 2 years to 5 years.
Madankollu, l- Applikant/ MAH qed jipprova biss iżomm l- indikazzjoni għal montelukast bħala monoterapija fl- ażżma persistenti ħafifa jew moderata fit- tfal ta ’ bejn sentejn u ħames snin.
Therefore, the CHMP agreed with the following proposed indication for 4mg chewable tablets and 4mg oral granules: “ Singulair may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids”
Għalhekk, is- CHMP qabel ma ’ l- indikazzjoni proposta li ġejja għall- pilloli li jintmagħdu ta ’ 4mg u granuli orali ta ’ 4mg: “ Singulair jista ’ jkun ukoll opzjoni ta ’ trattament alternattiv għall- kortikosterojdi b’ doża baxxa li jittieħdu man- nifs għal pazjenti ta ’ bejn sentejn u 5 snin b’ ażżma persistenti ħafifa li ma jkollhomx storja riċenti ta ’ attakki ta ’ l- ażżma li tkun tirrikjedi użu ta ’ kotikosterojdi orali, u li jkunu wrew li mhumiex kapaċi jużaw kortikosterojdi li jittieħdu man- nifs ”
Exercise-induced asthma Singulair is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction.
Ażżma mqanqla mill- eżerċizzju Singulair huwa indikat ukoll fil- prevenzjoni ta ’ l- ażżma li fiha, il- komponent predominanti huwa t - tidjiq tal- pajpijiet tan- nifs imqanqal mill- eżerċizzju.
In double-blind, randomised studies it was also shown that the anti-asthmatic effect of montelukast can be shown against exercise-induced asthma in adults.
Fi studji double- blind, randomizzati intwera wkoll li l- effett anti- ażmatiku ta ’ montelukast jista ’ jintwera kontra l- ażżma mqanqla mill- eżerċizzju fl- adulti.
The effect was seen over 12 weeks of therapy.
L- effett deher fuq perjodu ta ’ trattament ta ’ 12- il ġimgħa.
There were no gender or race-related differences in the effect.
Ma kienx hemm differenzi bejn l- irġiel u n- nisa jew relatati mar- razza f’ dan l- effett.
In a small study on 27 paediatric patients it was also shown that montelukast seems to protect paediatric patients against exercise-induced broncho- constriction.
Din l- indikazzjoni relatata ma ’ pazjenti
This indication with regard to younger paediatric patients is largely based on these data, taking into account the pharmacokinetics of montelukast (rapid absorption) and data in adults showing the rapid onset of effect.
13 pedjatriċi iżgħar hija bbażata prinċiparjament fuq din id- dejta, u tqis il- farmakokinetika ta ’ montelukast (assorbiment rapidu) u dejta fl- adulti li turi li l- effetti jibdew malajr.
Given that activity limitation due to asthma is difficult to assess in very young children (aged < 2 years), the Applicant/ MAH revised the indication to state that it refers only to children 2 years of age or older.
Billi l- limitazzjoni ta ’ l- attività dovuta għall- ażżma hija diffiċli biex tiġi vvalutata fit- tfal żgħar (ta ’ inqas minn sentejn), l- Applikant/ MAH irreveda l- indikazzjoni biex jiddikjara li din tirrefreri biss għal tfal ta ’ sentejn jew iktar.
Therefore the final revised indication for 4mg CT and 4mg OG is as follows:
Għalhekk l- indikazzjoni finali riveduta għal CT ta ’ 4mg u OG ta ’ 4mg hija kif ġej:
13 “ Singulair is also indicated in the prophylaxis of asthma from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction”.
“ Singulair huwa indikat ukoll fil- prevenzjoni ta ’ l- ażżma minn sentejn ’ il fuq li fiha l- komponent prinċipali jkun it- tidjiq fil- pajpijiet tan- nifs ikkawżat mill- eżerċizzju ”.
Additionally, the CHMP requested, that the Applicant/ MAH should give a more detailed instruction in Section 4.2 as to how the treatment effect should be monitored and evaluated.
Barra minn hekk, is- CHMP talab, li l- Applikant/ MAH għandu jagħti struzzjoni iktar dettaljata fis - Sezzjoni 4. 2 dwar kif l- effett tat- trattament għandu jiġi sorveljat u valutat.
The following wording was therefore accepted for Section 4.2, 4 mg CT and 4 mg OG:
Il- kliem li ġej għalhekk ġie aċċettat għas- Sezzjoni 4. 2, CT ta ’ 4mg u OG ta ’ 4 mg: