FrancophonIA/ELRC3.0 huggingface dataset:
English: It must not be used in patients with tumours of the hypothalamus, pituitary gland, ovary, womb or breast.
Maltese: Ovitrelle ma għandux jintuża minn pazjenti li jkollhom tumuri fl-ipotalamu, fil-glandola pitwitarja, fl-ovarji, fil-ġuf jew fis-sider.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ovitrelle on 2 February 2001.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ovitrelle fit-2 ta' Frar 2001.
English: Because of its similarity to luteinising hormone (LH), Ovitrelle is also used to trigger ovulation.
Maltese: Minħabba li huwa simili għall-ormon lutejnizzanti (LH), Ovitrelle jintuża wkoll biex jikkawża lovulazzjoni.
English: How does Ovitrelle work?
Maltese: Għal xiex jintuża Ovitrelle?
English: Ovitrelle is used in women who have received treatment to stimulate their ovaries, to trigger ovulation (the release of eggs by the ovaries) and the development of a special structure on the ovary (the corpus luteum) that helps pregnancy.
Maltese: Ovitrelle jintuża fit-trattament ta' nisa li jkunu ngħataw trattament li jistimula l-ovarji, biex jikkawża lovulazzjoni (ir-rilaxx tal-bajd mill-ovarji) u l-iżvilupp ta' struttura speċjali ovarika (il-corpus luteum) li jgħin it-tqala.
English: Protection against IBD starts from between 24 to 28 days of age and lasts up to 43 days of age.
Maltese: Il-protezzjoni kontra l-IBD tibda mill-età ta' bejn 24 sa 28 jum u ddum sal-età ta' 43 jum.
English: Further information on Gumbohatch can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/gumbohatch.
Maltese: Aktar informazzjoni dwar Gumbohatch tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/veterinary/EPAR/gumbohatch.
English: Gumbohatch received a marketing authorisation valid throughout the EU on 12 November 2019.
Maltese: Gumbohatch irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fi 12/11/2019.
English: Gumbohatch was investigated in 5 laboratory and 3 field studies.
Maltese: Gumbohatch kien investigat f'5 studji fil-laboratorju u fi 3 studji fuq il-post.
English: Other information about Gumbohatch
Maltese: Informazzjoni oħra dwar Gumbohatch
English: Signs of chickens infected with Gumboro disease include trembling, ruffled feathers, poor appetite, dehydration, diarrhoea, huddling and depression.
Maltese: Sinjali ta' tiġieġ infettati bil-marda ta' Gumboro jinkludu rogħda, rix imħabbel, nuqqas ta' aptit, deidratazzjoni, dijarea, tgeddis (huddling) u depressjoni.
English: Gumbohatch is a vaccine.
Maltese: Gumbohatch huwa vaċċin.
English: Studies have shown the start of protection to be from between 24 days of age and 28 days of age.
Maltese: L-istudji wrew li l-bidu tal-protezzjoni huwa ta' età bejn 24 jum u 28 jum.
English: This overview was last updated in September 2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'Settembru 2019.
English: The laboratory studies involved chicks with maternal antibodies against IBD virus.
Maltese: L-istudji fil-laboratorju involvew flieles b'antikorpi materni kontra l-virus tal-IBD.
English: Virulent means that the virus is capable of producing severe disease.
Maltese: Virulenti tfisser li l-virus ikun kapaċi jipproduċi diversi mard.
English: Gumbohatch contains a live strain of IBD virus (strain 1052) that has been weakened so that it does not cause the disease.
Maltese: Gumbohatch fih razza ħajja tal-virus tal-IBD (ir-razza 1052), li ddgħajfet sabiex ma tikkawżax ilmarda.
English: Gumbohatch must not be used in flocks without maternal antibodies against IBD virus.
Maltese: Gumbohatch m'għandux jintuża f'qatgħat mingħajr antikorpi materni kontra l-virus tal-IBD.
English: The most common side effect with Gumbohatch (which may affect more than 1 in 10 animals) is a fall in the number of lymphocytes (a type of white blood cell which is part of the chicken's immune system) in the bursa of Fabricius, followed by an increase and recovery of the bursa of Fabricius.
Maltese: L-effett sekondarju l-aktar komuni b'Gumbohatch (li jista' jaffettwa aktar minn annimal 1 minn kull 10) huwa tnaqqis fl-għadd ta' limfoċiti (tip ta' ċellola bajda tad-demm li hija parti mis-sistema immunitarja tal-flieles) fil-bursa ta' Fabricius, segwit minn żieda u rkupru tal-bursa ta' Fabricius.
English: When the chicken comes into contact with a similar IBD virus, these antibodies, together with other components of the chicken's immune system, will be able to fight the infection and help protect it against the disease.
Maltese: Meta t-tiġieġa tiġi f'kuntatt ma' virus tal-IBD simili, dawn l-antikorpi, flimkien ma' komponenti oħra tas-sistema immunitarja tat-tiġieġa, ikunu kapaċi jiġġieldu l-infezzjoni u jgħinu biex jipproteġu kontra l-marda.
English: What are the risks associated with Gumbohatch?
Maltese: X'inhuma r-riskji assoċjati ma' Gumbohatch?
English: Gumbohatch is a vaccine used to protect broiler chickens (reared for meat) against infectious bursal disease (IBD) virus infection caused by a very virulent IBD virus.
Maltese: Gumboatch huwa vaċċin li jintuża biex jipproteġi t-tiġieġ tas-simna (imrobbija għal-laħam) kontra infezzjoni tal-virus tal-mard infettiv tal-bursa (IBD) infezzjoni kkawżata minn virus tal-IBD virulenti ħafna.
English: The start of protection depends on the initial maternal antibody level of the batch of chickens and even then will be different for individual chickens.
Maltese: Il-bidu tal-protezzjoni jiddependi mil-livell inizjali ta' antikorpi materni tal-lott ta' tiġieġ u saħansitra mbagħad ikun differenti għal tiġieġ individwali.
English: IBD, also known as Gumboro disease, is a highly contagious (spreads easily) viral infection of young chickens that reduces their immunity (body's ability to fight disease) and can lead to their death at 3 to 6 weeks of age.
Maltese: L-IBD, magħrufa wkoll bħala l-marda ta' Gumboro, hija infezzjoni virali kontaġġjuża ħafna (tinfirex faċilment) ta' tiġieġ żgħar li tnaqqas l-immunità tagħhom (il-kapaċità tal-ġisem li jiġġieled il-mard) u li tista' twassal għall-mewt tagħhom fl-età ta' bejn 3 sa 6 ġimgħat.
English: Why is Gumbohatch authorised in the EU?
Maltese: Għalfejn Gumbohatch huwa awtorizzat fl-UE?
English: How does Gumbohatch work?
Maltese: Kif jintuża Gumbohatch?
English: The studies showed Gumbohatch to reduce clinical signs and damage to the bursa of Fabricius caused by very virulent (powerful) IBD virus infection, following vaccination of eggs or chicks.
Maltese: L-istudji wrew li Gumbohatch inaqqas is-sinjali kliniċi u l-ħsara fil-bursa ta' Fabricius ikkawżati minn infezzjoni tal-virus tal-IBD virulenti (qawwija) ħafna, wara t-tilqim ta' bajd jew flieles.
English: Allergy 2009; 64: 820-821.
Maltese: Isvezja 30 sena ilu) Allergy 2009; 64: 820-821.
English: 3 Johansson SGO et al. Pholcodine caused anaphylaxis in Sweden 30 years ago.
Maltese: Pholcodine caused anaphylaxis in Sweden 30 years ago.
English: 1 Johansson SGO et al. National pholcodine consumption and the prevalence of IgE-sensitisation; a multicenter study.
Maltese: National pholcodine consumption and the prevalence of IgE-sensitisation; a multicenter study.
English: Pholcodine has been marketed for decades in the European Union, where currently marketing authorisations exist in Belgium, France, Ireland, Lithuania, Luxembourg, Malta, Slovenia, Spain and United Kingdom, either subject to medical prescription or as non-prescription medicines.
Maltese: Il-folkodina ilha mqiegħda fis-suq għal għexieren ta' snin fl-Unjoni Ewropea, fejn attwalment jeżistu awtorizzazzjonijiet għat-tqegħid fis-suq fil-Belġju, fi Franza, fl-Irlanda, fil-Litwanja, fil-Lussemburgu, f'Malta, fis-Slovenja, fi Spanja, u fir-Renju Unit, kemm soġġetti għar-riċetta ta' tabib kif ukoll bħala mediċini mingħajr riċetta ta' tabib.
English: In France, data from spontaneous reporting suggests a 25% increase in the number of anaphylactic shocks to NMBAs in the period 2008/2009 when compared to the 2003/2004 period.
Maltese: Fi Franza, id-dejta minn rapportar spontanju tissuġġerixxi żieda ta' 25% fl-għadd ta' reazzjonijiet anafilattiċi għal NMBAs fil-perjodu 2008/2009 meta mqabbel mal-perjodu 2003/2004.
English: On 28 January 2011, France triggered a referral under Article 31 of Directive 2001/83/EC, as amended.
Maltese: Fit-28 ta' Jannar 2011, Franza tat bidu għal riferiment skont l-Artikolu 3 tad-Direttiva 2001/83/KE, kif emendata.
English: Allergy 2010
Maltese: Anness II
English: Allergy 2011; 66: 955-960.
Maltese: (Is-sensitizzazzjoni tal-IgE għall-folkodina li trażżan is-sogħla u leffetti tal-irtirar tagħha mis-suq Norveġiż) Allergy 2011; 66: 955-960.
English: The concerns of the French Medicines Agency arose from the potential risk that pholcodine may lead to IgEsensitisation to neuromuscular blocking agents (NMBAs).
Maltese: It-tħassib tal-Aġenzija Franċiża għall-Mediċini tqajjem mir-riskju potenzjali li l-folkodina tista' twassal għas-sensitizzazzjoni tal-IgE għal sustanzi li jimblukkaw in-nervituri u l-muskoli (neuromuscular blocking agents - NMBAs).
English: The most recent study conducted by Zambon and published in 2006, comparing pholcodine and dextrometorphan in a randomised and blinded design, showed they had similar efficacy in reducing day and night-time cough frequencies in adult patients suffering with acute non-productive cough.
Maltese: L-aktar studju reċenti li sar minn Zambon u li kien ippubblikat fl-2006, li qabbel il-folkodina maddestrometorfanu f'metodu każwali u mingħajr l-għarfien ta' dawk involuti, wera li kellhom effikaċja simili fit-tnaqqis tal-frekwenza tas-sogħla kemm ta' bil-lejl kif ukoll ta' bi nhar f'pazjenti adulti li jbatu minn sogħla akuta mhux produttiva.
English: This coincides with a 9% increase in the consumption of pholcodine-containing products in France between the two periods.
Maltese: Dan jikkoinċidi ma' żieda ta' 9% fil-konsum ta' prodotti mediċinali li fihom il-folkodina fi Franza bejn iż-żewġ perjodi.
English: An ad-hoc expert group composed mainly of immunologists and anaesthesiologists was consulted to provide advice to CHMP on this issue.
Maltese: Grupp ta' esperti ad-hoc magħmul prinċipalment minn esperti fl-immunità u fl-anestesija ġew ikkonsultati sabiex jagħtu parir lis-CHMP dwar din il-kwistjoni.
English: The majority of the adverse events reported in clinical trials, literature and post-marketing experience are gastrointestinal disorders and psychiatric disorders, which are adverse events known and commonly reported with opiates.
Maltese: Il-parti l-kbira tal-avvenimenti avversi rrapportati fil-provi kliniċi, fid-dokumentazzjoni u fl-esperjenza ta' wara t-tqegħid fis-suq huma disturbi gastrointestinali u disturbi psikjatriċi, li huma avvenimenti avversi magħrufa u rrapportati spiss fil-każ ta' sustanzi li fihom il-loppju.
English: Other experts questioned the specificity of the tests used by the Norwegian research team to detect IgE sensitisation to pholcodine, referred to the lack of a rigorous inclusion criterion for anaphylaxis (ie permitting cases undergoing spontaneous recovery, or a 'mild' presentation) in the investigations, and reference was also made to the use of spontaneously reported adverse events to determine incidence of NMBA-related anaphylaxis.
Maltese: Esperti oħrajn urew dubji rigward l-ispeċifiċità tat-testijiet użati mit-tim ta' riċerka Norveġiż sabiex jindividwaw is-sensitizzazzjoni tal-IgE għall-folkodina, semmew innuqqas ta' kriterju strett ta' inklużjoni għall-anafilassi (jiġifieri li jippermetti każi li għaddejjin minn irkupru spontanju, jew preżentazzjoni ‘ħafifa') fl-investigazzjonijiet, u saret ukoll referenza għallużu ta' avvenimenti avversi rrapportati b'mod spontanju sabiex tiġi ddeterminata l-inċidenza ta' anafilassi relatata mal-NMBAs.
English: Overall summary of the scientific evaluation of pholcodine-containing products (see Annex I) Background information
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti li fihom il-folkodina (ara Anness I)
English: In countries with small populations such as Norway (4.8 million) and Sweden (9.3 million), confounding factors such as a change in anaesthetic procedures, type of products used in anaesthesia and overall use of NMBAs could play a role in explaining the findings.
Maltese: F'pajjiżi b'popolazzjonijiet żgħar bħan-Norveġja (4.8 miljuni) u l-Isvezja (9.3 miljuni), fatturi li jistgħu jfixklu bħall-bidla fil-proċeduri tal-anestesija, it-tipi ta' prodotti użati fl-anestesija u l-użu globali ta' NMBAs jistgħu jkollhom rwol fl-ispjegazzjoni ta' dawn is-sejbiet.
English: Taking into account all of the above, the CHMP concluded that the evidence of a link between pholcodine and NMBA-related anaphylaxis is circumstantial, not entirely consistent and does not support the conclusion that there is a significant risk of cross-sensitisation to NMBAs and subsequent development of anaphylaxis during surgery.
Maltese: Wara li kkunsidra dan kollu, is-CHMP ikkonkluda li l-evidenza ta' rabta bejn il-folkodina u lanafilassi relatata mal-NMBAs hija ċirkostanzjali, mhux għal kollox konsistenti u ma tappoġġax ilkonklużjoni li hemm xi riskju sinifikanti ta' sensitizzazzjoni parallela għal NMBAs u żvilupp sussegwenti ta' anafilassi waqt il-kirurġija.
English: Literature has been published suggesting a link between pholcodine consumption and cross sensitisation to NMBAs, resulting in anaphylactic reactions during surgery.
Maltese: Ġew ippubblikati xogħlijiet li jissuġġerixxu rabta bejn il-konsum talfolkodina u s-sensitizzazzjoni parallela għal NMBAs, li jikkawżaw reazzjonijiet anafilattiċi waqt ilkirurġija.
English: Nevertheless, the existing data is consistent and supportive of the efficacy of pholcodine in the treatment of acute non-productive cough.
Maltese: Madankollu d-dejta eżistenti hija konsistenti u tappoġġa l-effikaċja tal-folkodina fil-kura ta' sogħla akuta mhux produttiva.
English: The absence of any report of IgE-mediated anaphylactic reaction to NMBAs in Sweden since 1990 raises further questions on the reliability of the data, as regardless of pholcodine use NMBAs would still be expected to cause anaphylactic reactions and the Swedish data does not appear to reflect this expected background rate.
Maltese: In-nuqqas ta' kwalunkwe rapport ta' reazzjoni anafilattika medjata mill-IgE għal NMBAs fl-Isvezja mill-1990 iqajjem aktar mistoqsijiet rigward l-affidabbiltà tad-dejta, peress li rrispettivament millużu tal-folkodina l-NMBAs huma xorta waħda mistennija li jikkawżaw reazzjonijiet anafilattiċi u ddejta Svediża ma tidhirx li tirrifletti din ir-rata ta' sfond mistennija.
English: Based on immunological analyses determining the prevalence of antibodies to these active substances in different populations, and reporting rates for NMBA-related anaphylaxis during anaesthesia, researchers concluded that withdrawal of pholcodine from the market in Norway significantly lowered within 1-2 years levels of IgE and IgE antibodies to pholcodine and, within 3 years, the frequency of NMBA suspected anaphylaxis.
Maltese: Ġew espressi opinjonijiet differenti dwar is-saħħa tal-evidenza epidemjoloġika, ibbażata fuq l-esperjenzi Svediżi u Norveġiżi u l-kważi esperiment li rriżulta millwaqfien tal-mediċina fiż-żewġ pajjiżi fi żminijiet differenti u l-plawsibbiltà bijoloġika tal-ipotesi.
English: The Committee considered that evidence of an association between pholcodine use and development of NMBA-related anaphylaxis is circumstantial, not entirely consistent and therefore does not support the conclusion that there is a significant risk of cross-sensitisation to NMBAs and subsequent development of anaphylaxis during surgery.
Maltese: Il-Kumitat ikkunsidra li l-evidenza ta' assoċjazzjoni bejn l-użu tal-folkodina u l-iżvilupp ta' anafilassi relatata mal-NMBAs hija ċirkostanzjali, mhux għal kollox konsistenti u għaldaqstant ma tappoġġax il-konklużjoni li hemm xi riskju sinifikanti ta' sensitizzazzjoni parallela għal NMBAs u żvilupp sussegwenti ta' anafilassi waqt il-kirurġija.
English: The evidence in support of this derives from ecological studies conducted by a single research team relying on spontaneously reported adverse reactions to NMBAs.
Maltese: Il-provi li jappoġġaw dan ġejjin minn studji ekoloġiċi li saru minn tim wieħed ta' riċerkaturi li jiddependu fuq reazzjonijiet avversi għal NMBAs irrapportati b'mod spontanju.
English: Even assuming that there is some biological plausibility for the pholcodine-sensitisation and that the spontaneously reported cases reflect the actual prevalence of anaphylactic reactions during surgery, a broad range of other agents may also be responsible.
Maltese: Anki jekk wieħed jassumi li hemm xi plawsibbiltà bijoloġika għas-sensitizzazzjoni minħabba lfolkodina u li l-każi rrapportati b'mod spontanju jirriflettu l-prevalenza reali ta' reazzjonijiet anafilattiċi waqt il-kirurġija, hemm firxa wiesgħa ta' sustanzi oħrajn li jistgħu jkunu responsabbli ukoll.
English: In recent years the Norwegian network for anaphylaxis under general anaesthesia, which collects these reports, has been subject to less intense promotion, and therefore it is possible that the observed decrease in reporting does not actually reflect lower occurrence.
Maltese: li jiġbor dawn ir-rapporti, kien soġġett għal promozzjoni inqas intensiva, u għalhekk jista' jkun li ttnaqqis osservat fir-rapportar mhux bilfors jirrifletti tnaqqis fl-okkorrenza.
English: The Committee therefore concluded that, based on currently available information, the benefits of pholcodine in the treatment of non-productive cough outweigh the risks, and that the benefit-risk balance of pholcodinecontaining products in the treatment of non-productive cough is positive under normal conditions of use.
Maltese: Il-Kumitat għaldaqstant ikkonkluda li, skont informazzjoni disponibbli attwalment, il-bilanċ bejn ilbenefiċċju u r-riskju ta' prodotti mediċinali li fihom il-folkodina fil-kura tas-sogħla mhux produttiva huwa pożittiv f'kundizzjonijiet normali tal-użu.
English: Pholcodine is an opiate with central antitussive action used for treatment of cough and cold symptoms in children and adults.
Maltese: Il-folkodina hija sustanza li fiha l-loppju (opiate) b'azzjoni ċentrali kontra s-sogħla, użata għall-kura tas-sogħla u tas-sintomi tal-irjiħat fit-tfal u fl-adulti.
English: Co-rapporteur(s):
Maltese: Ko-rapporteur(s):
English: Patrick Salmon (Ireland)
Maltese: Patrick Salmon (Irlanda)
English: Opinion date:
Maltese: Data tal-opinjoni:
English: 26 November 2009
Maltese: 26 ta' Novembru 2009
English: Ian Hudson (United Kingdom)
Maltese: Ian Hudson (Renju Unit)
English: What is Prevora?
Maltese: X'inhu Prevora?
English: The active substance in Prevora, chlorhexidine, is an antiseptic.
Maltese: Is-sustanza attiva fi Prevora, klorideksin hija antisettiku.
English: CHX Technologies Europe Limited submitted Prevora for mutual recognition on the basis of the initial authorisation granted by Ireland on 5 May 2006.
Maltese: CHX Technologies Europea Limited ippreżenta Prevora għal għarfien reċiproku abbażi talawtorizzazzjoni inizzjali mogħtija mill-Irlanda fil-5 ta' Mejju 2006.
English: 28 July 2010, 15 September 2010
Maltese: 28 ta' Lulju 2010, 15 ta' Settembru 2010
English: Prevora is a dental solution used to reduce dental caries (tooth decay) in permanent teeth of adolescents and adults.
Maltese: Prevora huwa soluzzjoni dentali użata sabiex tnaqqas il-karje dentali (tħassir tas-snien) fi snien permanenti tal-adoloxxenti u l-adulti.
English: 23 September 2010
Maltese: 23 ta' Settembru 2010
English: However, the Member States were not able to reach an agreement and the Irish medicines regulatory agency referred the matter to the CHMP for arbitration on 26 November 2009.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal ftehim u l-aġenzija ta' regolamentazzjoni talmediċini Franċiża rreferiet il-kwistjoni lill-CHMP għall-arbitraġġ fis-26 ta' Novembru 2009.
English: Prevora is applied to the surface of permanent teeth by a dental professional in two stages.
Maltese: Prevora huwa applikat fuq is-superfiċje ta' snien permanenti minn professjonist dentali f'żewġ fażijiet.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Prevora.
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMEA) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost lIstati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-mediċina Prevora.
English: 03 December 2010
Maltese: 3 ta' Diċembru 2010
English: Based on evaluation of the newly available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Prevora outweigh its risks in the prevention of coronal and root caries in adult patients at high-risk of dental caries.
Maltese: Abbażi tal-valutazzjoni tad-dejta ġdida disponibbli u d-diskussjoni xjentifika fi ħdan il-Kumitat, is-CHMP ikkonkluda li l-benefiċċji bi Prevora jegħlbu r-riskji fil-prevenzjoni ta' karje koronali u tal-għerq f'pazjenti adulti b'riskju għoli ta' karje dentali.
English: The company wanted the authorisation to be recognised in United Kingdom (the ‘concerned Member State').
Maltese: Il-kumpannija riedet lawtorizzazzjoni sabiex tkun magħrufa fir-Renju Unit (‘l-Istat Membru konċernat').
English: The grounds for the referral were that the United Kingdom could not approve the proposed indication, prevention of root caries in adult patients at high-risk of dental caries.
Maltese: Ir-raġunijiet għar-referenza kienu li r-Renju Unit ma setgħax japprova l-indikazzjoni proposta, ilprevenzjoni ta' karje tal-għerq f'pazjenti aduti b'risku għoli ta' karje dentali.
English: First a chlorhexidine coating solution is applied followed immediately by an inert sealant coating.
Maltese: L-ewwel bħala kisja ta' soluzzjoin ta' klorideksin segwita immedjatament b'kisja ta' inert tal-isiġillar.
English: Company responses provided on:
Maltese: Data tal-bidu tal-proċedura:
English: BACKGROUND INFORMATION
Maltese: INFORMAZZJONI ĠENERALI
English: London, 17 June 2008 EMEA/337156/2008
Maltese: Londra, 17 ta' Ġunju 2008 EMEA/337148/2008
English: The Reference Member State was Netherlands and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and United Kingdom.
Maltese: L-Istat Membru ta' referenza kienet l-Olanda u l-Istati Membri kkonċernati kienu l-Awstrija, il-Belġju, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, ilFinlandja, Franza, il-Ġermanja, il-Greċja, l-Irlanda, l-Italja, l-Iżlanda il-Latvja, il-Litwanja, il-Lussemburgu, Malta, in-Norveġja, il-Polonja, il-Portugall, is-Slovakkja, is-Slovenja, Spanja, ir-Renju Unit, l-Ungerija u lIżvezja.
English: The Rapporteur was Dr Jean-Louis Robert and CoRapporteur was Dr Janos Borvendeg.
Maltese: Ir-rapporteur kien Dr Jean-Luis Robert u lkorapporteur kien Dr Janos Borvendeg.
English: International Non-Proprietary Name (INN): Drospirenone + Ethinylestradiol
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): Drospirenone + Ethinylestradiol
English: Yasminelle and associated names, is a combined oral contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
Maltese: Yasminelle u l-ismijiet assoċjati, hija kontraċċettiv orali kombinat li fih 0.02 mg ethinylestradiol u 3 mg drospirenone.
English: OPINION FOLLOWING AN ARTICLE 5(11)1 REFERRAL FOR
Maltese: OPINJONI DWAR RIFERIMENT SKOND L-ARTIKOLU 5(11)1 GĦAL