qanastek/EMEA-V3 huggingface dataset:
When prepared as directed, chemical and physical in-use stability of reconstituted solutions of gemcitabine were demonstrated for 24 hours at 30°C.
Meta ppreparat kif suppost, l- istabbilità waqt l- użu kemm kimika u kemm fiżika tas- soluzzjonijiet ta ’ gemcitacibine ġiet ippruvata għal 24 siegħa f’ temperatura ta ’ 30°C.
Further dilution by a healthcare provider may be done.
Tista ’ ssir aktar dilwizzjoni minn min qed jieħu ħsieb il- pazjent.
Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.
Soluzzjonijiet ta ’ gemcitabine rikostitwit m’ għandhomx jitqiegħdu fil- friġġ, għax jista ’ jkun hemm il- kristallizzazzjoni.
This medicine is for single use only; any unused solution should be discarded under the local requirements.
Din il- mediċina hi għall- użu ta ’ darba biss; kull fdal ta ’ soluzzjoni għandu jintrema kif jitolbu l- liġijiet lokali.
What Gemzar contains
X’ fih Gemzar:
The active substance is gemcitabine.
- Is- sustanza attiva hi gemcitabine.
Each vial contains 200 or 1000 mg of gemcitabine (as gemcitabine hydrochloride).
Kull kunjett fih 200 jew 1000 mg ta ’ gemcitabine (bħala
The other ingredients are mannitol (E421), sodium acetate, hydrochloric acid and sodium hydroxide.
gemcitabine hydrochloride). – Is- sustanza l- oħra huma mannitol (E421), sodium acetate, hydrochloric acid u sodium hydroxide.
What Gemzar looks like and contents of the pack
Id- Dehra ta ’ Gemzar u l- kontenuti tal- pakkett:
Gemzar is a white to off-white powder, for solution for infusion in a vial.
Gemzar huwa trab abjad jagħti fl- offwajt, għal soluzzjoni għall- infużjoni f’ kunjett.
Each vial contains 200 or 1000 mg of gemcitabine.
Kull kunjett fih 200 jew 1000 mg ta ’ gemcitabine.
Each pack of Gemzar contains 1 vial.
Kull pakkett ta ’ Gemzar fih kunjett 1.
Lilly France S.A.S., rue du Colonel Lilly, F-67640, Fegersheim, France
Lilly France S. A. S., rue du Colonel Lilly, F- 67640, Fegersheim, Franza
43 The following information is intended for medical or healthcare professionals only:
44 It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
Instructions for use, handling and disposal.
Istruzzjonijiet għall- użu, maniġġjar u rimi
Use aseptic techniques during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration.
Waqt ir- rikostituzzjoni u għal iżjed dilwizzjoni ta ’ gemcitabine għall- għoti ta ’ infużjoni minn ġol - vini uża teknika asettika.
Calculate the dose and the number of Gemzar vials needed.
Ikkalkula d- doża u n- numru ta ’ kunjetti ta ’ Gemzar li jkun hemm bżonn
Reconstitute 200 mg vials with 5 ml of 9 mg/ml (0.9%) sterile sodium chloride solution for injection, without preservative, or 25 ml sterile sodium chloride solution for injection, without preservative to the 1000 mg vial.
Irrikostitwixxi l- kunjetti ta ’ 200 mg b’ 5 ml ta ’ 9 mg/ ml (0. 9%) ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride sterili, mingħajr preservanti jew għall- kunjett ta ’ 1000 mg, 25 ml ta ’ soluzzjoni għall- injezzjoni ta ’ sodium chloride sterili mingħajr preservanti.
The total volume after reconstitution is 5.26 ml (200 mg vial) or 26.3 ml (1000 mg vial) respectively.
Il- volum totali wara r- rikostituzzjoni hu ta ’ 5. 26 ml (kunjett ta ’ 200 mg) jew ta ’ 26. 3 ml (kunjett ta ’ 1000 mg) rispettivament.
This dilution yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder.
Din id- dilwizzjoni tagħti konċentrazzjoni ta ’ gemcitabine ta ’ 38 mg/ ml, li jinkludi fih il- volum ta ’ spustament tat- trab lijofilizzat.
Further dilution with sterile sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative may be done.
Tista ’ ssir iżjed dilwizzjoni permezz ta ’ soluzzjoni għall- injezzjoni ta ’ 9 mg/ ml (0. 9%) ta ’ sodium chloride sterili mingħajr preservanti.
The resulting solution is clear and ranges in colour from colourless to light straw-coloured.
Is- soluzzjoni magħmula hija ċara u l- kulur ivarja minn bla kulur għal kulur it- tiben ċar.
Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur.
Soluzzjonijiet ta ’ gemcitabine rikostitwit m’ għandhomx jitqiegħdu fil- friġġ għax jista ’ jkun hemm il- kristallizzazzjoni.
Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
L- istabbilità waqt l- użu kemm kimika u kemm fiżika tas- soluzzjonijiet ta ’ gemcitacibine ġiet ippruvata għal 24 siegħa f’ temperatura ta ’ 30°C.
From a microbiological point of view, the product should be used immediately.
Mil- lat mikrobijoloġiku l - prodott għandu jintuża immedjatament.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, il- ħinijiet ta ’ ħażna waqt l- użu u l- kundizzjonijiet qabel l- użu huma r- responsabbiltà ta ’ min jużah u s- soltu ma jkunux iżjed minn 24 siegħa f’ temperatura ambjentali, sakemm ir- rikostituzzjoni/ dilwizzjoni ma tkunx saret f’ kundizzjonijiet asettiċi kontrollati u validati.
Gemcitabine solutions are for single use only.
Is- soluzzjonijiet ta ’ gemcitabine huma għall- użu ta ’ darba biss.
Preparation and administration precautions
Prekawzjonijiet fil- preparazzjoni u fl- għoti
The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution.
Il- prekawzjonijiet normali ta ’ sigurtà għas- sustanzi ċitostatiċi għandhom jiġu osservati waqt il - preparazzjoni u r- rimi tas- soluzzjoni għall- infużjoni.
If the preparation comes into contact with the eyes, this may cause serious irritation.
Jekk il- preparazzjoni tiġi f’ kuntatt ma ’ l- għajnejn, din tista ’ tikkawża irritazzjoni serja.
Disposal Any unused product should be disposed of in accordance with local requirements.
Rimi Kull fdal tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
London, 24 September 2008 Doc.
Londra, 24 ta ’ Settembru 2008 Dok.
EMEA/ CHMP/ 512295/ 2008
EMEA/ CHMP/ 511848/ 2008
OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Gemzar
OPINJONI WARA RIFERIMENT SKONT L- ARTIKOLU 30 GĦAL Gemzar
International Non-Proprietary Name (INN): gemcitabine
Denominazzjoni Komuni Internazzjonali (DKI): gemcitabine
Gemzar, 200 mg, 1000 mg, powder for solution for infusion, is a pyrimidine antagonist and is given in the management of solid tumours.
Gemzar, 200 mg, 1000 mg, trab għal soluzzjoni għal infużjoni, huwa antagonista ta ’ pyrimidine u jingħata fit- trattament ta ’ tumuri solidi.
It is indicated in bladder cancer, advanced non-small cell lung cancer, advanced pancreatic cancer, breast cancer and ovarian cancer.
Huwa indikat fil- kanċer tal- bużżieqa tal- awrina, kanċer avvanzat tal - pulmun ta ’ ċelloli mhux żgħar, kanċer avvanzat tal- frixa, kanċer tas- sider u kanċer tal- ovarji.
On 8 June 2007, the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/ 83/ EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Gemzar.
Fit- 8 ta ’ Ġunju 2007, il- Kummissjoni Ewropea ippreżentat lill- EMEA riferment skont l- Artikolu 30 tad - Direttiva 2001/ 83/ KE, kif emendata, sabiex jiġu armonizzati s- Sommarji tal- Karatteristiċi tal- Prodott (SPC), it- Tikketta u l- Fuljett ta ’ Tagħrif awtorizzati fuq livell nazzjonali, inkluż aspetti ta ’ kwalità tal - prodott mediċinali Gemzar.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Gemzar approved across EU Member States, mainly with respect to the approved indications, the posology, the contra-indications and the warnings.
Il- bażi tar- riferiment kienet li kien hemm diverġenzi fis- Sommarji tal- Karatteristiċi tal- Prodott (SPC) inkluż l- aspetti ta ’ kwalità ta ’ Gemzar approvati madwar l- Istati Membri tal- UE l- iktar fir- rigward tal - indikazzjonijiet approvati, il- pożoloġija, il- kontra- indikazzjonijiet u t- twissijiet.
This medicinal product belongs to the list of products for SPC harmonisation.
Dan il- prodott mediċinali jappartjeni għal- lista ta ’ prodotti għall- armonizzazzjoni tal- SPC.
The procedure started on 21 June 2007.
Il- proċedura bdiet fil- 21 ta ’ Ġunju 2007.
The Marketing Authorisation Holder provided supplementary information on 20 December 2007.
Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq ta informazzjoni supplimentari fl- 20 ta ’ Diċembru 2007.
During its June 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet including the quality aspects was acceptable and that they should be amended.
Matul il- laqgħa tiegħu ta ’ Ġunju 2008, is- CHMP, fid- dawl tad- dejta ġenerali ippreżentata u tad - diskussjoni xjentifika fi ħdan il- Kumitat, kien tal- opinjoni li l- proposta għall- armonizzazzjoni tal- SPC, it - Tikketta u l- Fuljett ta ’ Tagħrif kienet waħda aċċettabbli u li dawn għandhom jiġu emendati.
The CHMP gave a positive opinion on 26 June 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Gemzar.
Is- CHMP ta opinjoni pożittiva fis- 26 ta ’ Ġunju 2008 u rrakkomanda l- armonizzazzjoni tal- SPC, Tikketta u Fuljett ta ’ Tagħrif inkluż l- aspetti ta ’ kwalità għal Gemzar.
The list of product names concerned is given in Annex I.
Il- lista tal- ismijiet tal- prodotti konċernati tinsab fl- Anness I.
The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Il- konklużjonijiet xjentifiċi huma pprovduti fl- Anness II flimkien mal- SPC, it- Tikketta u l- Fuljett ta ’ Tagħrif emendati fl- Anness III.
A Decision was issued by the European Commission on 23 September 2008.
Inħarġet Deċiżjoni mill- Kummissjoni Ewropea fit- 23 ta ’ Settembru 2008.
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA` L- ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA U D- DETENTURI TA` L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
1 Member State EU/ EEA
1 Stat Membru EU/ EEA
Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat - tqegħid fis- suq
Applicant
L- Applikant
(Invented)
Isem (Ivvintat)
Name
Qawwa
Pharmaceutical Form Route of administration
Mnejn jingħata
Organon Kloosterstraat 6 PO Box 20 5349 AB, Oss The Netherlands
Organon Kloosterstraat 6 PO Box 20 5349 AB, Oss L- Olanda
Implant Subcutaneous use
Użu taħt il- ġilda
Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss The Netherlands
Organon Kloosterstraat 6 PO Box 20 5340 BH, Oss L- Olanda
Organon SA Immeuble Optima 10, rue Godefroy 92821 Puteaux Cedex, France
Organon SA Immeuble Optima 10, rue Godefroy 92821 Puteaux Cedex, Franza
Essex Pharma GmbH Thomas-Dehler-Straße 27 81737 Munich Germany
Essex Pharma GmbH Thomas- Dehler Straße 27 81737 Munich Il- Ġermanja
2 Member State EU/ EEA
2 Stat Membru EU/ EEA
Implant
Impjant
Organon Laboratories Ltd Cambridge Science Park Milton Road Cambridge CB4 0FL United Kingdom
Organon Laboratories Ltd Cambridge Science Park Milton Road Cambridge CB4 0FL Ir- Renju Unit
3
3 Stat Membru EU/ EEA
José Malhoa, 16B - 2° 1070-159 Lisboa Portugal
José Malhoa, 16B - 2° 1070- 159 Lisboa Il- Portugall
Slovak Republic
Ir- Repubblika Slovakka
Ctra. de Hospitalet, 147-149 Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona Spain
Ctra. de Hospitalet, 147- 149 Cityparc Ronda de Dalt Edificio Amsterdam 08940 Cornellá de Llobregat, Barcelona Spanja
Organon PO Box 20 5340 BH, Oss The Netherlands
Organon PO Box 20 5340 BH, Oss L- Olanda
SCIENTIFIC CONCLUSIONS
KONKLUŻJONIJIET XJENTIFIĊI
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF IMPLANON
SOMMARJU ĠENERALI TAL- EVALWAZZJONI XJENTIFIKA TA ’ IMPLANON
Implanon is a non-biodegradable, long-acting, progestagen-only contraceptive implant inserted subdermally.
Implanon huwa impjant kontraċettiv, ibbażat fuq proġestaġen biss, mhux bijodigradabbli, li jaħdem fit- tul li jiddaħħal taħt il- ġilda.
The indicated period of use is 3 years.
Il- perijodu indikat għall- użu huwa ta ’ 3 snin.
The implant is a single rod of 4 cm length and 2 mm in diameter and contains 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) co-polymer.
L- impjant huwa virga waħdanija twila 4 ċm u b’ dijametru ta ’ 2 mm u fiha 68 mg etonogestrel (ENG) mifrux f’ matriċi tal - kopolimer ethylene vinyl acetate (EVA).
The ENG dose released by Implanon is equivalent to 60-70 μ g/ day shortly after insertion and decreases to about 40 μ g/ day at the start of the second year, and to about 25-30 μ g/ day at the end of the 3rd year.
Id- doża ta ’ ENG merħija minn Implanon hija ekwivalenti għal 60- 70 μg/ kuljum ftit żmien wara li tiddaħħal u tonqos għal madwar 40 μg/ kuljum fil- bidu tat- tieni sena, u għal madwar 25- 30 μg/ kuljum fi tmiem tat- tielet sena.
The contraceptive action of Implanon is primarily achieved by inhibition of ovulation.
L- azzjoni kontraċettiva ta ’ Implanon tinkiseb primarjament permezz ta ’ impediment tal- ovulazzjoni.
Implanon was approved in the EU during a MR procedure with the Netherlands (NL) as reference member state (RMS) and has been marketed since 1998 with the indication “ contraception”.
Implanon kien approvat fl- UE matul proċedura ta ’ MR bl- Olanda (NL) bħala l- Istat Membru ta ’ referenza (SMR) u ilu fis- suq mill- 1998 bl - indikazzjoni “ kontraċettiv ”.
The first European renewal of Implanon was successfully completed in 2003.
L- ewwel tiġdid Ewropew ta ’ Implanon intemm b’ suċċess fl- 2003.
In total, about 5 million Implanon implants have been sold worldwide up to July 2008.
B’ kollox, sa Lulju 2008, inbiegħu madwar 5 miljun impjant ta ’ Implanon madwar id- dinja.
A second European renewal was initiated in September 2007, in which a majority of EU member states agreed that the benefit/ risk profile continues to be positive and supported the recommendation of the RMS to grant another 5-year renewal.
It- tieni tiġdid Ewropew inbeda f’ Settembru 2007, fejn il- maġġoranza tal- Istati Membri tal- UE qablu li l- profil benefiċċju/ riskju għadu wieħed pożittiv u appoġġjaw ir- rakkomandazzjoni tal- RMS biex iġedded l - awtorizzazzjoni għal Implanon għal 5 snin oħra.
However, a number of concerns were raised by the objecting CMS which did not consider the second renewal acceptable.
Madankollu, tqajmu għadd ta ’ punti ta ’ tħassib mis - CMS li oġġezzjonaw li ma qisux it- tieni tiġdid bħala wieħed aċċettabbli.
The issue was referred to the CMD (h) and an assessment was carried out by the RMS.
Il- kwistjoni ġiet riferuta lis - CMD( h) u saret valutazzjoni mill- RMS.
Because no agreement was reached at Day 60, the procedure was referred to the CHMP.
Il- proċedura ġiet irreferuta lis- CHMP, peress li ma ntlaħaq l - ebda qbil sa Jum 60.
The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Is- CHMP ivvaluta l- inkartament u d- dejta disponibbli, inklużi l- kwistjonijiet li tqajmu mis- CMS li oġġezzjona.
The CHMP considered that insertion, migration and removal related events (collectively known as IRREs) occur at a low and decreasing frequency.
Is- CHMP ikkunsidra li episodji relatati mal- inklużjoni, il- migrazzjoni u t- tneħħija (kolletivament magħrufin bħala IRREs) iseħħu fi frekwenza baxxa u li qed tonqos.
It is crucial - and should be self evident - that anyone, who performs insertions/ removals must be well trained and familiar with those procedures, as incorrect insertions will lead to removal problems.
Huwa kruċjali – u għandu jkun evidenti minnu nnifsu – li kull persuna, li tagħmel l- inklużjoni/ tneħħija għandha tkun imħarrġa sewwa u familjari ma ’ dawn il- proċeduri, peress li inklużjonijiet mhux korretti jwasslu għal problemi ta ’ tneħħija.
The CHMP considers that correct insertion is a simple procedure and that the IRRE problems can be prevented or reduced by compliance with updated instructions and training materials.
Is- CHMP ikkunsidra li l- inklużjoni korretta hija proċedura sempliċi u li l- problemi tal- IRRE jistgħu jkunu impeduti jew imnaqqsin b’ konformità mal- istruzzjonijiet aġġornati u mal- materjali ta ’ taħriġ.
The MAH was requested to report the results from the active monitoring program for IRREs in the USA.
L- MAH (Id- Detentur tal- Awtorizzazzjoni għat- Tqegħid fis- Suq) kien mitlub li jirrapporta r - riżultati mill- programm ta ’ sorveljanza attiva għall- IRREs fl- Istati Uniti.
Because the US AMP does not include the new inserter (Implanon NXT), the MAH is also requested to closely monitor the introduction and performance of the new inserter as a part of the RMP.
Minħabba li l- US AMP ma jinkludix l- inserter il- ġdid (Implanon NXT), l- MAH huwa wkoll mitlub biex jissorvelja mill- qrib l - introduzzjoni u l- eżekuzzjoni tal- inserter il- ġdid bħala parti mill- RMP.
The CHMP acknowledged the issue of underreporting but did not consider that any signals indicating an increased risk of breast cancer have been identified.
Is- CHMP irrikonoxxa l- kwistjoni ta ’ nuqqas ta ’ rapportar sħiħ iżda ma kkunsidrax li ġew identifikati xi sinjali li jindikaw żieda fir- riskju ta ’ kanċer tas- sider.
The difference between the observed and the expected numbers of cases is substantial and is unlikely to be explained by underreporting alone.
Id- differenza bejn in- numru ta ’ każijiet osservati u n- numru ta ’ każijiet mistennija hija sostanzjali u dan mhuwiex mistenni li jkun spjegat bin - nuqqas ta ’ rapportar biss.
Thus, the possibility of an excess risk is not supported by these post-marketing data.
Għalhekk, il- possibbilità ta ’ riskju miżjud mhijiex appoġġjata b’ din id- dejta ta ’ wara t- tqegħid fis- suq.
Furthermore, the degree of underreporting is assumed to be lower for Implanon compared to spontaneous ADR reporting in general, therefore the CHMP does not consider that spontaneous reports on breast cancer in users of Implanon give rise to a new signal of an adverse effect.
Barra dan, il- grad ta ’ nuqqas ta ’ rapportar sħiħ huwa mistenni li jkun iktar baxx għal Implanon meta mqabbel ma ’ rapportar spontanju tal- ADR b’ mod ġenerali, għaldaqstant is - CHMP ma jikkunsidrax li rapporti spontanji fuq kanċer tas- sider f’ dawk li jużaw Implanon jagħtu lok għal sinjal ġdid ta ’ effett avvers.
The information already included in section 4.4 of the SPC is considered sufficient.
L- informazzjoni diġà inkluża f’ sezzjoni 4. 4 tal- SPC hija meqjusa suffiċjenti.
The MAH has compiled data of available relevant studies and overall, the epidemiological data on the association between progestogen-only contraception (POC) and breast cancer risk are sparse and reflect mostly the use of injectable DMPA.
Il- MAH ġabar dejta ta ’ studji relevanti disponibbli u kollox ma ’ kollox, id- dejta epidemjoloġika fuq l - assoċjazzjoni bejn kontraċettiv ibbażat fuq proġestoġen biss (POC) u r- riskju ta ’ kanċer tas- sider huma skarsi u jirriflettu prinċipalment l- użu ta ’ DMPA injettabbli.
Thus, most data pertain to injectable POC, little data exist for other POCs, no data are available for Implanon.
Għalhekk, il- parti l- kbira tad- dejta tappartjeni għall- POC injettabbli, teżisti ftit dejta għall- POCs oħrajn, u ma hemm l- ebda dejta għal Implanon.
It is acknowledged that the available studies have limitations, e. g. the lack of data on the associations with POPs, limited power to examine risk relationships in subgroups, and further no meaningful data to examine the effects of implants.
Huwa rikonoxxut li l- istudji disponibbli għandhom il- limitazzjonijiet, ngħidu aħna, in - nuqqas ta ’ dejta fuq l- assoċjazzjonijiet mal- POPs, l- abbiltà limitata biex jiġu eżaminati relazzjonijiet ta ’ riskju fis- sottogruppi, u ebda dejta sinifikanti oħra biex jiġu eżaminati l- effetti tal- impjanti.
Of some relevance is the interim analysis data from the ongoing case-control study of the progestogen releasing contraceptive IUD (Mirena) (ICPE meeting report, 2008).
Hija ta ’ relevanza d- dejta tal- analiżi interim mill- istudju tal- kontroll tal- każ dejjem għaddej tal- kontraċettiv IUD (Mirena) li jerħi proġestoġen (rapport tal- laqgħa tal- ICPE, 2008).
Although Mirena releases levonorgestrel in a very low dose, the data would seem to be relevant also for implants.
Għalkemm Mirena terħi levonorgestrel f’ doża veru baxxa, id- dejta tidher li tkun relevanti wkoll għall- impjanti.
This is because Mirena represents a continuous and long-term systemic progestogen exposure in young women.
Dan minħabba li Mirena tirrappreżenta esponiment kontinwu u sistemiku fit- tul f’ nisa żgħar fl- età.
From the interim analysis, the study hypothesis of an adverse effect on breast cancer risk has no support.
Mill- analiżi interim, l- ipoteżi tal- istudju ta ’ effett avvers fuq ir- riskju ta ’ kanċer tas- sider m’ għandhiex sostenn.
The study includes correction for the age of the study population, enabling comparisons to the Implanon user population and therefore, the final results of this study will be of relevance also for Implanon.
L - istudju jinkludi wkoll korrezzjoni għall- età tal- popolazzjoni tal- istudju, li tippermetti li jsir tqabbil mal- popolazzjoni li tuża Implanon u għaldaqstant, ir- riżultati finali ta ’ dan l- istudju jkunu ta ’ relevanza wkoll għal Implanon.
In summary, the CHMP agreed that there is at this time no firm evidence of an association between Implanon exposure and an increased risk of breast cancer in young women.
6 Fil- qosor, is- CHMP qabel li bħalissa ma hemm l- ebda evidenza soda ta ’ assoċjazzjoni bejn l - esponiment ta ’ Implanon u żieda fir- riskju ta ’ kanċer tas- sider f’ nisa żgħar fl- età.
The final results of the Mirena study were deemed to be of relevance and should contribute to the evaluation of the safety for Implanon.
Ir- riżultati finali tal - istudju Mirena tqiesu li huma ta ’ relevanza u għandhom jikkontribwixxu għall- evalwazzjoni tas - sigurtà għal Implanon.
Furthermore, the reports on Implanon removals in breast cancer patients from the US AMP program are likely to yield
Barra minn hekk, ir- rapporti fuq tneħħijiet ta ’ Implanon f’ pazjenti b’ kanċer tas - sider mill- programm US AMP x’ aktarx li jipprovdu informazzjoni siewja minn serje ta ’ każijiet li huma mistennijin li jkunu relattivament lesti.
The Mirena study and reports from the US AMP should be included in the updated RMP.
L- istudju Mirena u rapporti mill- US AMP għandhom jiġu inklużi fl- RMP aġġornat.
The CHMP is of the opinion that a new epidemiological study of breast cancer in Implanon users is not justified at the present time.
Is- CHMP huwa tal- opinjoni li l- istudju epidemjoloġiku ġdid ta ’ kanċer tas- sider f’ dawk li jużaw Implanon bħalissa mhuwiex iġġustifikat.
The CHMP considered that bleeding irregularities are expected with all progestogen-only methods, in particular those that inhibit ovulation.
Is- CHMP ikkunsidra li huma mistennija irregolaritajiet fil- fsada bil- metodi proġestoġen biss kollha, b’ mod partikolari dawk li jimpedixxu l- ovulazzjoni.
This is well known and sometimes a reason for method discontinuation.
Dan huwa magħruf sew u xi kultant huwa r - raġuni għat- twaqqif tal- metodu.
However, although the bleeding pattern often is unpredictable, many women report reduction in episode frequency and total number of bleeding days compared to their normal menstrual pattern.
Madankollu, għalkemm il- metodu tal- fsada ta ’ spiss huwa imprevedibbli, ħafna nisa jirrapportaw tnaqqis fil- frekwenza tal- episodji u tan- numru totali ta ’ jiem ta ’ fsada meta mqabbla mal- mod mestrwali tagħhom.
Almost all women experience a decrease in the total amount of blood loss, even those with an increase in the number of bleeding days.
Kważi n- nisa kollha jesperjenzaw tnaqqis fl - ammont totali ta ’ telf ta ’ demm, anke dawk b’ żieda fin- numru ta ’ jiem ta ’ fsada.
Thus, many women actually experience a benefit with the bleeding pattern although the lack of predictability may remain a problem for some.
Għalhekk, ħafna nisa attwalment jesperjenzaw benefiċċju fil- mod kif isseħħ il- fsada iżda nuqqas ta ’ prevedibbiltà tista ’ tibqa ’ problema għal xi wħud.
The CHMP considers that bleeding pattern disturbance should not be considered as a serious health issue, as it disappears immediately upon discontinuation and is not associated with any known health risk to the woman.
Is- CHMP jikkunsidra li d- disturb fil- mod kif isseħħ il- fsada m’ għandux ikun ikkunsidrat bħala kwistjoni serja ta ’ saħħa, minħabba li dan jgħib minnufih mat- twaqqif u mhuwiex assoċjat ma ’ xi riskju għas- saħħa magħruf għall- mara.
All experience shows that careful information and counselling before method start as well as support counselling and bleeding diary during use are important for long-term acceptability and compliance.
L- esperjenza kollha turi li informazzjoni preċiża u għoti ta ’ parir attent qabel jibda l- metodu kif ukoll pariri ta ’ appoġġ u djarju tal- fsada waqt l- użu huma kollha importanti għall- aċċettabbilità u l- konformità fit- tul.
Similarly, the removal of Implanon due to irregular bleeding should not be regarded as a serious consequence since the “ surgical intervention” to remove Implanon must be considered minimal, requiring a 0,5-1cm superficial skin incision, after which the implant can be easily extracted.
Bl- istess mod, it- tneħħija ta ’ Implanon minħabba fsada irregolari m’ għandhiex titqies bħala konsegwenza serja minħabba li l - “ intervent kirurġiku ” biex jitneħħa Implanon huwa meqjus minimu, li jeħtieġ inċiżjoni superfiċjali tal- ġilda ta ’ 0. 5- 1ċm, wara liema, l- impjant ikun jista ’ jitneħħa faċilment.
The proposal by the MAH to further update bleeding data information in section 4.8 with new US data and to improve the information material on bleeding pattern was endorsed.
Il- proposta mill - MAH biex jaġġorna iktar l- informazzjoni fuq dejta dwar il- fsada f’ sezzjoni 4. 8 mad- dejta l- ġdida tal - Istati Uniti u biex itejjeb il- materjal tal- informazzjoni fuq il- mod kif isseħħ il- fsada ġiet approvata.
The CHMP was of the view that written informed consent in the EU is associated with products where there are established serious risks and that the introduction of a request for informed consent for Implanon, one of several widely used methods of contraception, is unjustified and would strongly signal a risk that is certainly not present.
Is- CHMP kien tal- opinjoni li kunsens infurmat bil- miktub fl- UE huwa assoċjat ma ’ prodotti fejn hemm riskji serji stabbiliti u li l- introduzzjoni ta ’ talba għal kunsens infurmat għal Implanon, wieħed minn diversi metodi ta ’ kontraċezzjoni użati b’ mod komuni, mhuwiex iġġustifikat u jimplika bil - qawwa sinjal ta ’ riskju li ċertament mhuwiex qiegħed hemm.
The main benefit of any contraceptive method is efficacy and the CHMP considered that Implanon shows excellent efficacy with no evidence of decline neither during the 3rd year of use nor in heavy women and that the current text in the SPC regarding efficacy and weight is appropriate.
Il- benefiċċju ewlieni ta ’ kull metodu ta ’ kontraċezzjoni huwa l- effikaċja u s- CHMP ikkunsidra li Implanon juri effikaċja eċċellenti bla ebda tnaqqis, la waqt it- tielet sena tal- użu u lanqas f’ nisa b’ piż żejjed u li t- test attwali fl- SPC rigward l- effikaċja u l- piż huwa xieraq.
One contraceptive method will not fulfil all requirements at all times and, therefore, a wide choice of methods appears to be necessary in order for each individual woman to find a method that suits the current needs.
Metodu ta ’ kontraċezzjoni wieħed ma jissodisfax il- ħtiġijiet kollha fiż- żminijiet kollha u, għaldaqstant, jidher li hemm bżonn ta ’ għażla wiesgħa ta ’ metodi sabiex jinstab metodu għal kull mara individwali li jissodisfa l- ħtiġijiet kurrenti.
The big advantage of implants is the absence of problems with compliance or gastro-intestinal disturbances that negatively affect contraceptive efficacy versus the disadvantages of irregular bleeding being there with all continuous progestogen-only methods that inhibit ovulation.
Il- vantaġġ kbir tal- impjanti huwa n- nuqqas ta ’ problemi mal- konformità jew disturbi gastro - intestinali li jaffettwaw b’ mod negattiv l- effikaċja kontraċettiva kontra l- iżvantaġġi ta ’ fsada irregolari li jkun hemm bil- metodi kollha ta ’ proġestoġen biss kontinwu li jimpedixxu l- ovulazzjoni.
The CHMP concluded that the contraceptive efficacy of Implanon is superior to that of other hormonal contraceptives and that the Pearl Indices obtained for Implanon are significantly lower than those obtained with other systemic hormonal contraceptives, and certainly lower than those obtained with combined oral contraceptives, especially as these are prone to non-compliance, and gastro- intestinal disturbances.
Is- CHMP ikkonkluda li l- effikaċja kontraċettiva ta ’ Implanon hija superjuri għal dik ta ’ kontraċettivi ormonali oħrajn u l- Indiċijiet Pearl miksubin għal Implanon huma ferm iktar baxxi milli dawk miksubin b’ kontraċettivi ormonali sistemika oħrajn, u ċertament inqas minn dawk miksubin b’ kontraċettivi orali kkombinati, b’ mod speċjali peress li dawn huma suxxettibbli għal nuqqas ta ’ konformità u disturbi gastrointestinali.
In conclusion, the CHMP considers Implanon to be an effective method of contraception with no apparent safety concerns and that the benefit-risk balance of Implanon is positive.
Bħala konklużjoni, is- CHMP qies li Implanon huwa metodu effikaċi ta ’ kontraċezzjoni mingħajr l- ebda thassib fir- rigward tas- sigurtà apparenti u li l- bilanċ benefiċċju/ riskju għal Implanon huwa wieħed pożittiv.
The additional data on this issue that will come from the active monitoring programme in the USA is welcome, in particular the data on efficacy in obese women.
Id- dejta addizzjonali fuq din il- kwistjoni li se tiġi mill- programm ta ’ sorveljanza attiva fl- Istati Uniti hija apprezzata, b’ mod partikolari d- dejta fuq l- effikaċja f’ nisa ħoxnin iżżejjed.
The CHMP, having considered the data submitted in the application is of the opinion that further risk minimisation activities are necessary for the safe and effective use of the medicinal product.
Wara li kkunsidra d- dejta ppreżentata fl- applikazzjoni, is- CHMP huwa tal- opinjoni li iktar attivitajiet ta ’ minimizzazzjoni tar- riskju huma neċessarji għall- użu sigur u effettiv ta ’ dan il- prodott mediċinali.
The RMP will be submitted to the RMS within 3 months and will include the activities mentioned in the conditions of the renewal of the Marketing Authorisation.
L- RMP se jiġi ppreżentat lill- RMS fi żmien 3 xhur u se jinkludi attivitajiet imsemmijin fil - kundizzjonjiet tat- tiġdid tal- Awtorizzazzjoni għat- Tqegħid fis- Suq.
GROUNDS FOR OPINION
7 RAĠUNIJIET GĦALL- OPINJONI
In conclusion, the CHMP considers Implanon to be an effective method of contraception with no apparent safety concerns and is therefore of the opinion that the benefit-risk profile of Implanon is positive.
Bħala konklużjoni, is- CHMP jikkunsidra li Implanon huwa metodu effikaċi ta ’ kontraċezzjoni mingħajr ebda tħassib ta ’ sigurtà apparenti u għaldaqstant huwa tal- opinjoni li l- profil benefiċċju/ riskju ta ’ Implanon huwa wieħed pożittiv.
The CHMP agreed on the following proposal for conditions of the renewal of the Marketing Authorisation previously presented by the RMS:
Is- CHMP qabel fuq il- proposta li ġejja għal kundizzjonijiet ta ’ tiġdid tal- Awtorizzazzjoni għat - Tqegħid fis- Suq ippreżentata qabel mill- RMS:
The renewal will be granted for 5 years with the following conditions:
It- tiġdid se jingħata għal 5 snin bil- kundizzjonijiet li ġejjin:
7  The marketing authorisation holder (MAH) will continue with the 12 monthly PSURs.  The MAH will continue with the 6-monthly reports of all unintended pregnancy and insertion/ removal related problems (IRRE) during the next 5 year renewal period.  With the 6 monthly IRRE report, the MAH will submit the latest results of the ongoing active monitoring program (AMP) in the USA.  The MAH will submit a type II variation in 2009 to introduce the new Implanon (Implanon NXT).
 Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq (MAH) se jkompli bil- PSURs ta ’ kull 12 - il xahar.  L- MAH se jkompli b’ rapporti ta ’ kull 6 xhur ta ’ kull tqala mhux intenzjonata u problemi relatati mal- inklużjoni/ tneħħija (IRRE) waqt il- perijodu ta ’ tiġdid tal- 5 snin li ġejjin.  Mar- rapport IRRE ta ’ kull 6 xhur, l- MAH se jissottometti l- aħħar riżultati tal- programm ta ’ sorveljanza attiva (AMP) għaddej il- ħin kollu fl- Istati Uniti.  Fl- 2009, l- MAH se jissottometti varjazzjoni ta ’ tip II biex jintroduċi Implanon il- ġdid (Implanon NXT).
A RMP proposal for Implanon NXT will be part of this variation.  The MAH will develop further information and counselling materials for the Health Care Professionals and the women about the bleeding patterns that may be experienced during use of Implanon, which can be presented to the woman when she is considering use of Implanon for contraception.
Proposta tal- RMP għal Implanon NXT se tkun parti minn din il- varjazzjoni.  L- MAH se jiżviluppa iktar informazzjoni u materjali għall- għoti tal- pariri għall- Professjonisti tal- Kura tas- Saħħa u n- nisa dwar il- modi kif isseħħ il- fsada li jistgħu jkunu esperjenzati waqt l- użu ta ’ Implanon, li jistgħu jkunu ppreżentati lill- mara meta tkun qiegħda tikkunsidra l- użu ta ’ Implanon għall- kontraċezzjoni.
Relevant parts of the above mentioned activities should be included in a RMP proposal presented by the MAH within three months.
Partijiet relevanti tal- attivitajiet imsemmija hawn fuq għandhom ikunu inklużi fil- proposta tal- RMP mill- MAH fi żmien tliet xhur.
In addition, the following issues should be included in the RMP proposal:
Barra minn hekk, il- kwistjonijiet li ġejjin għandhom ikunu inklużi fil - proposta tal- RMP:
 The body weight at the time of removal will be asked for in case of early removal (including pregnancy) in the AMP.  An update on bleeding in section 4.8 in the SPC and leaflet as proposed in the draft MAH labelling.
 Se jkun mitlub il- piż korporali fil- waqt tat- tneħħija fil- każ ta ’ tneħħija bikrija (inkluża tqala) fl- AMP.  Aġġornament fuq il- fsada f’ sezzjoni 4. 8 fl- SPC u l- fuljett kif propost fl- abbozz tat- tikketta tal - MAH.
- the obvious benefits are the long duration of use and the lack of compliance problems
- il- benefiċċji ovvji huma żmien tal- użu twil u nuqqas ta ’ problemi ta ’ konformità
- correct insertion is a simple procedure and IRRE problems can be prevented or reduced by compliance
- il- proċedura ta ’ inklużjoni korretta hija proċedura sempliċi u l- problemi tal- IRRE jistgħu jiġu
with updated instructions and training materials,
impeduti jew imnaqqsin permezz ta ’ konformità mal- istruzzjonijiet aġġornati u materjali ta ’ taħriġ,
- no signals of an increased risk of breast cancer have been identified,
- l- ebda sinjal ta ’ żieda fir- riskju ta ’ kanċer tas- sider ma ġie identifikat,
- bleeding pattern disturbances should not be considered as a serious health issue,
- disturbi fil- mod kif isseħħ il- fsada m’ għandhomx ikunu kkunsidrati bħala kwistjoni serja ta ’
- Implanon has clearly proven to be an effective method of contraception – including in obese women -
- Implanon wera b’ mod ċar li huwa metodu effikaċi ta ’ kontraċezzjoni – inkluż f’ nisa b’ piż
despite a low dose,
eċċessiv – minkejja doża baxxa,
the CHMP has recommended the renewal of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Implanon.
is- CHMP irrakkomanda t- tiġdid tal- Awtorizzazzjonijiet għat- Tqegħid fis- Suq għal liema s- Sommarju tal- Karatteristiċi tal- Prodott, tikketta u fuljett ta ’ tagħrif jinsabu fl- Anness III għal Implanon.
9 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
9 Is- sommarju tal- karatteristiċi tal- prodott, tikketta u fuljett ta ’ tagħrif validi huma l- verżjonijiet finali li intlaħqu waqt il- proċedura tal- grupp ta ’ koodinazzjoni.
10 ANNEX IV
10 ANNESS IV
CONDITIONS FOR THE RENEWAL OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET GĦAT- TIĠDID TAL- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
11 The National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
11 L- Awtoritajiet Nazzjonali Kompetenti, ikkoordinati mill- Istat Membru ta ’ Referenza, għandhom jassiguraw li l- kundizzjonijiet li ġejjin jiġu sodisfatti mid- Detenturi tal- Awtorizzazzjoni għat- Tqegħid fis- Suq:
 The marketing authorisation holder (MAH) will continue with the 12 monthly Periodic Safety Update Reports (PSURs).  The MAH will continue with the 6-monthly reports of all unintended pregnancy and insertion/ removal related problems (IRRE) during the next 5 year renewal period.  With the 6 monthly IRRE report, the MAH will submit the latest results of the ongoing active monitoring program (AMP) in the USA.  The MAH will submit a type II variation in 2009 to introduce the new Implanon (Implanon NXT).
 Id- detentur tal- awtorizzazzjoni għat- tqegħid fis- suq (MAH) se jkompli bir- Rapporti Perjodiċi ta ’ Aġġornament dwar is- Sigurtà (PSURs) ta ’ kull 12- il xahar.  L- MAH se jkompli b’ rapporti ta ’ kull 6 xhur ta ’ kull tqala mhux intenzjonata u problemi relatati mal- inklużjoni/ tneħħija (IRRE) waqt il- perijodu ta ’ tiġdid tal- 5 snin li ġejjin.  Mar- rapport IRRE ta ’ kull 6 xhur, l- MAH se jissottometti l- aħħar riżultati tal- programm ta ’ sorveljanza attiva (AMP) li għaddej il- ħin kollu fl- Istati Uniti.  L- MAH se jissottometti varjazzjoni tip II fl- 2009 biex jintroduċi Implanon il- ġdid (Implanon NXT).
A RMP proposal for Implanon NXT will be part of this variation.  The MAH will develop further information and counselling materials for the Health Care Professionals and the women about the bleeding patterns that may be experienced during use of Implanon, which can be presented to the woman when she is considering use of Implanon for contraception.
Proposta tal- RMP għal Implanon NXT se tkun parti minn din il- varjazzjoni.  L- MAH se jiżviluppa iktar informazzjoni u materjali għall- għoti tal- pariri għall- Professjonisti tal- Kura tas- Saħħa u n- nisa dwar il- modi kif isseħħ l- fsada li jistgħu jkunu esperjenzati waqt l - użu ta ’ Implanon, li jistgħu jkunu ppreżentati lill- mara meta tkun qiegħda tikkunsidra l- użu ta ’ Implanon għall- kontraċezzjoni.
Relevant parts of the above mentioned activities should be included in a Risk Management Plan (RMP) proposal presented by the MAH within three months.
Partijiet relevanti tal- attivitajiet imsemmijin hawn fuq għandhom ikunu inklużi fil- proposta ta ’ Pjan ta ’ Ġestjoni tar- Riskji (RMP) ippreżentat mill- MAH fi żmien tliet xhur.
In addition, the following issues should be included in the RMP proposal:
Barra minn hekk, il- kwistjonijiet li ġejjin għandhom ikunu inklużi fil- proposta tal- RMP:
 The body weight at the time of removal will be asked for in case of early removal (including pregnancy) in the AMP.  An update on bleeding in section 4.8 in the SPC and leaflet as proposed in the draft MAH labelling.
 Se jkun mitlub il- piż korporali fil- waqt tat- tneħħija fil- każ ta ’ tneħħija bikrija (inkluża tqala) fl- AMP.  Aġġornament fuq il- fsada f’ sezzjoni 4. 8 tal- SPC u l- fuljett kif propost fl- abbozz tat- tikketta tal- MAH.
Ref.
Londra, 09 ta ’ Frar 2009 Dok ta ’ Ref.
EMEA/ 124262/ 2009
EMEA/ 122010/ 2009
Questions and answers on the referral for Implanon subdermal implant etonogestrel 68 mg
Mistoqsija u tweġiba dwar ir- referenza għall- impjant taħt il- ġilda Implanon etonogestrel 68 mg
The European Medicines Agency (EMEA) has completed an arbitration procedure following a disagreement among Member States of the European Union regarding the authorisation of the medicine Implanon.
L- Aġenzija Ewropea dwar il- Mediċini (EMEA) temmet proċedura ta ’ arbitraġġ wara nuqqas ta ’ qbil fost l- Istati Membri tal- Unjoni Ewropea fir- rigward tal- awtorizzazzjoni tal- mediċina Implanon.
The Agency’ s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Implanon outweigh its risks, and that the marketing authorisation granted in the Netherlands can be recognised in other Member States of the European Union.
Il - Kumitat tal- Aġenzija għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l - benefiċċji ta ’ Implanon huma akbar mir- riskji tiegħu, u li l- awtorizzazzjoni għat- tqegħid fis- suq li ngħatat fl- Olanda tista ’ tiġi rikonoxxuta fi Stati Membri oħra tal- Unjoni Ewropea.
The review was carried out under an ‘ Article 29’ referral 1.
Ir- reviżjoni saret skont referenza tal - ‘ Artikolu 29 ’ 1.
What is Implanon?
X’ inhu Implanon?
Implanon is a female contraceptive.
Implanon huwa kontraċettiv għan- nisa.
It is presented as a small rod that is implanted by a doctor or a nurse using a special applicator just under the skin of the upper arm.
Jiġi bħala virga żgħira li tiddaħħal eżatt taħt il- ġilda fil- parti ta ’ fuq tad- drigħ minn tabib jew ners permezz ta ’ applikatur speċjali.
The active substance in Implanon, etonogestrel, is a synthetic female hormone resembling progesterone.
Is- sustanza attiva f’ Implanon, etonogestrel, hija ormon femminili sintetiku li jixbaħ lill- proġesteron.
Once implanted, the rod releases a small amount of etonogestrel continuously into the bloodstream.
Ladarba tiġi impjantata, il- virga tirrilaxxa ammont żgħir kontinwu ta ’ etonogestrel fil- fluss tad- demm tal- ġisem.
This changes the body’ s hormonal balance and help to prevent ovulation.
Dan jibdel il- bilanċ ormonali tal- ġisem u jgħin sabiex jimpedixxi l- ovulazzjoni.
Implanon can protect for up to three years; at the end of this period the implant must be removed.
Implanon jista ’ jipproteġi sa tliet snin; wara dan il- perijodu l- impjant għandu jitneħħa.
Why was Implanon reviewed?
Għalfejn ġie rivedut Implanon?
Organon submitted Implanon for a second renewal of the marketing authorisation through mutual recognition on the basis of the initial authorisation granted by the Netherlands on 25 August 1998.
Organon issottomettiet Implanon għat- tieni tiġdid tal- awtorizzazzjoni għat- tqegħid fis- suq permezz ta ’ rikonoxximent reċiproku fuq il- bażi tal- ewwel awtorizzazzjoni mogħtija mill- Olanda fil - 25 ta ’ Awwissu 1998.
The company wanted the renewal of authorisation to be recognised in all the EU Member States, as well as Norway and Iceland where the product is already authorised.
Il- kumpanija riedet li t- tiġdid tal- awtorizzazzjoni jkun rikonoxxut fl- Istati Membri kollha tal- UE, kif ukoll fin- Norveġja u fl- Iżlanda fejn il- prodott huwa diġà awtorizzat.
These member states were not able to reach an agreement.
Dawn l- Istati Membri ma setgħux jaslu għal ftehim.
On 6 October 2008, the Dutch regulatory agency referred the matter to the CHMP.
Fis- 6 ta ’ Ottubru 2008, l- aġenzija regolatorja Olandiża rreferiet il- kwistjoni lis- CHMP.
The grounds for the referral were concerns regarding the side effects related to insertion and removal of the implant, the risk of breast cancer, the incidence of irregular bleedings leading to premature removal of the implant.
Ir- raġuni għar- referenza kienet tħassib rigward l- effetti sekondarji relatati mad- dħul u t- tneħħija tal - impjant, ir- riskju ta ’ kanċer tas- sider, l- inċidenza ta ’ fsada irregolari li twassal għat- tneħħija prematura tal- impjant.
Additionally, the data on effectiveness in obese women in particular in the third year of use was considered insufficient.
Barra minn hekk, id- dejta dwar l- effikaċja f’ nisa ħoxnin b’ mod partikolari fi- tielet sena ta ’ użu ma kinitx meqjusa biżżejjed.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Implanon outweigh its risks, and therefore the renewal of the marketing authorisation for Implanon 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 kkonkluda li l- benefiċċji ta ’ Implanon huma akbar mir- riskju tiegħu, u għaldaqstant għandu jingħata t- tiġdid tal- awtorizzazzjoni għat- tqegħid fis- suq ta ’ Implanon fl- Istati Membri kollha kkonċernati.
The CHMP also endorsed the changes to the product information for the medicine as agreed by the Coordination Group for the Mutual and Decentralised Procedures.
Is- CHMP aċċetta wkoll il- bidliet fl- informazzjoni tal- prodott għall- mediċina kif miftiehem mill- Grupp ta ’ Koordinazzjoni għall- Għarfien Reċiproku u Proċeduri Deċentralizzati.
The European Commission issued a decision on 6 February 2009.
Il- Kummissjoni Ewropea ħarġet deċiżjoni fis- 6 ta ’ Frar 2009.
1 Article 29 of Directive 2001/ 83/ EC as amended, referral on the grounds of potential serious risk to public health 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
1 Artikolu 29 tad- Direttiva 2001/ 83/ KE kif emendat, referenza abbażi ta ’ riskju serju potenzjali għas- saħħa pubblika 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Co-rapporteur:
Ko- rapporteur:
Opinion date:
Data tal- Opinjoni:
Ingemar Persson 23 October 2008 20 November 2008
It- tabib Harald Enzmann Il- Profs Ingemar Persson 23 ta ’ Ottubru 2008 20 ta ’ Novembru 2008
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISTA TA` L- ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL- PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, D- DETENTURI TA` L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ FL- ISTATI MEMBRI
Marketing Authorisation Holder
Id- Detentur ta ’ l - Awtorizzazzjoni għat - tqegħid fis- suq
GlaxoSmithKline Pharma GmbH, Albert-Schweitzer-Gasse 6 A-1140 Wien Austria
GlaxoSmithKline Pharma GmbH, Albert- Schweitzer- Gasse 6, A- 1140 Wien Awstrija
Dispersible Tablet
Pillola li tinxtered
Oral use
Jittieħed mill - ħalq
Belgium
2 Belġju
Rue du Tilleul 13, B86 1332 Genval Belgium
Rue du Tilleul 13, B86 1332 Genval Belġju
2 Belgium
Belġju
Belgium
3 Belġju
3 Belgium
Belġju
Bulgaria
4 Bulgarija
4 Cyprus
Ċipru
Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN Renju Unit
Cyprus
5 Ċipru
5 Czech Republic
25 mg
Czech Republic
6 Repubblika Ċeka
The Wellcome Foundation Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN United Kingdom
The Wellcome Foundation Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN Renju Unit
Czech Republic
Repubblika Ċeka
6 Czech Republic
Repubblika Ċeka
Czech Republic
7 Repubblika Ċeka
GlaxoSmithKline Pharma A/ S Nykaer 68 DK-2605 Broendby Denmark
GlaxoSmithKline Pharma A/ S Nykaer 68 DK- 2605 Broendby Danimarka
7 Denmark
Danimarka
Denmark
8 Danimarka
8 Denmark
9 Danimarka
Glaxo Wellcome Operations Greenford Road Greenford Middlesex UB6 0NN United Kingdom
Glaxo Wellcome Operations Greenford Road Greenford Middlesex UB6 0NN Renju Unit
Estonia
10 Estonja
9 Estonia
Estonja
GlaxoSmithKline Oy Piispansilta 9 A 02230 Espoo Finland
GlaxoSmithKline Oy Piispansilta 9 A 02230 Espoo Finlandja
Finland
11 Finlandja
Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly-le-Roi Cedex France
Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly- le- Roi Cedex Franza
10 France
Franza
Lamictal 2
Lamictal
mg, comprimé dispersible 2 mg
2 mg, comprimé dispersible 2 mg
Lamictal 5 croquer
Lamictal
mg, comprimé dispersible ou à 5 mg
5 mg, comprimé dispersible ou à croquer 5 mg
Dispersible or chewable Tablet
Pillola li tinxtered jew li tomgħodha
France
12 Franza
Oral use
Jittieħed mill -
KG Theresienhöhe 11 80339 München Germany
KG Theresienhöhe 11 80339 München Ġermanja
11 Germany
Ġermanja
5 mg Tabletten zur Herstellung einer 5 mg
25 mg Tabletten zur Herstellung einer 25 mg
Germany
13 Ġermanja
KG Theresienhöhe 11 80339 München Germany
Lamictal
Lamictal 25 mg Tabletten zur Herstellung einer 25 mg Suspension zum Einnehmen
50 mg Tabletten zur Herstellung einer 50 mg
Germany
Co.
Lamictal 50 mg Tabletten zur Herstellung einer 50 mg Suspension zum Einnehmen
Suspension zum Einnehmen
Oral use
ħalq