FrancophonIA/ELRC3.0 huggingface dataset:
English: • Any patients with new onset or worsening signs and symptoms suggestive of PML should be considered for neurological referral at a center equipped to diagnose PML.
Maltese: • Kull pazjenti b'bidu ġdid jew aggravar ta' sinjali u sintomi li jissuġġerixxu PML għandu jiġi kkunsidrat għal referenza newroloġiku f'ċentru mgħammar għad-dijanjosi ta' PML.
English: The patient is to be given a Patient Alert Card (see section 4.2).
Maltese: Il-pazjent għandu jingħata Kartuna ta' Twissija għall-Pazjent (ara sezzjoni 4.2).
English: Entyvio passes into breast milk.
Maltese: Kull pakkett fih kunjett wieħed.
English: • high fever or rash
Maltese: • uġigħ fid-driegħ/riġel
English: • bloated stomach
Maltese: • imnieħer imblukkat
English: • sudden, severe allergic reaction which can cause breathing difficulty, swelling, fast heartbeat, sweating, drop in blood pressure, light-headedness, loss of consciousness and collapse (anaphylactic reaction and anaphylactic shock)
Maltese: • reazzjoni allerġika f'daqqa u serja li tista' tikkawża diffikultajiet fit-teħid tan-nifs, nefħa, qalb tħabbat b'mod mgħaġġel, għaraq, tnaqqis fil-pressjoni tad-demm, telf mis-sensi u kollass (reazzjoni anafilattika u xokk anafilattiku)
English: • muscle weakness
Maltese: • tħossok imdardar
English: The following information is intended for healthcare professionals only:
Maltese: Kellem lit-tabib jew lill-infermier tiegħek qabel tingħata Entyvio:
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Entyvio (ara sezzjoni 4.4).
English: Medicinal product subject to restricted medical prescription.
Maltese: TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: • moderately to severely active Crohn's disease.
Maltese: • marda ta' Crohn attiva b'mod moderat sa sever
English: The plasma protein binding of vedolizumab has not been evaluated.
Maltese: It-twaħħil ta' vedolizumab mal-proteini tal-plażma ma ġiex evalwat.
English: Injection site reactions (with symptoms such as dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) have also been reported in patients treated with vedolizumab.
Maltese: Reazzjonijiet fis-sit tal­injezzjoni (b'sintomi bħal qtugħ ta' nifs, bronkospażmu, urtikarja, fwawar, raxx, u żieda fil-pressjoni tad-demm u fir-rata tat-taħbit tal-qalb) ukoll ġew irrappurtati f'pazjenti kkurati b'vedolizumab.
English: These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Maltese: Dawn kollha jistgħu jkunu sintomi ta' kondizzjoni serja u potenzjalment fatali tal-moħħ magħrufa bħala lewkoenċefalopatija multifokali progressiva (PML - progressive multifocal leukoencephalopathy).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 300 mg
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI INDIVIDWALI 300 mg
English: In patients administered 300 mg vedolizumab as a 30 minute intravenous infusion on weeks 0 and 2, mean serum trough concentrations at week 6 were 27.9 mcg/mL (SD ± 15.51) in ulcerative colitis and 26.8 mcg/mL (SD ± 17.45) in Crohn's disease.
Maltese: il-konċentrazzjonijiet medji l-aktar baxxi fis-serum f'ġimgħa 6 kienu ta' 27.9 mcg/mL (SD ± 15.
English: Immunomodulatory medicinal products may increase the risk of malignancy (see section 4.8).
Maltese: Leukoencephalopathy) (ara sezzjoni 4.4).
English: Patients previously exposed to natalizumab should normally wait a minimum of 12 weeks prior to initiating therapy with Entyvio, unless otherwise indicated by the patient's clinical condition.
Maltese: Pazjent esposti minn qabel għal natalizumab normalment għandhom jistennew minimu ta' 12-il ġimgħat qabel ma jibdew terapija b'Entyvio, sakemm ma jkunx indikat mod ieħor mill-kondizzjoni klinika tal-pazjent.
English: Pneumonia
Maltese: Artralġja
English: You must not be given Entyvio:
Maltese: X'għandek tkun taf qabel ma tingħata Entyvio M'għandekx tingħata Entyvio:
English: In these patients, clinical remission was achieved in 23% of patients at week 28 and 32% of patients at week 52.
Maltese: F'dawn il-pazjenti, remissjoni klinika inkisbet f'23% tal-pazjenti f'ġimgħa 28 u fi 32% tal-pazjenti f'ġimgħa 52.
English: Vedolizumab 450 mg administered intravenously was not detected in the cerebrospinal fluid of healthy subjects.
Maltese: għall-injezzjoni mill-borża tal-infużjoni qabel jiżdied Entyvio).
English: Overall, results from the clinical program to date do not suggest an increased risk for malignancy with vedolizumab treatment; however, the number of malignancies was small and long-term exposure was limited.
Maltese: B'mod globali, riżultati mill-programm kliniku s'issa ma jissuġġerixxux żieda fir-riskju ta' tumuri malinni b'kura ta' vedolizumab; madankollu, in-numru ta' tumuri malinni kien żgħir u l-esponiment fit-tul kien limitat.
English: Induction of remission in Crohn's disease
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: 2 This time assumes the reconstituted solution is immediately diluted in the sodium chloride 9 mg/mL (0.9%) solution for injection and held in the infusion bag only.
Maltese: 2 Dan il-ħin jassumi li s-soluzzjoni rikostitwita tiġi dilwita immedjatament fis-soluzzjoni ta' sodium chloride 9 mg/mL (0.9%) għall-injezzjoni u li tinżamm fil-borża tal-infużjoni biss.
English: The recommended dose regimen of Entyvio is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
Maltese: F'pazjenti li ngħataw 300 mg vedolizumab bħala infużjoni fil-vini fuq 30 minuta f'ġimgħat 0 u 2,
English: Adverse Reaction(s)
Maltese: Reazzjoni(jiet) avversa(i)
English: 3 This period may include up to 12 hours at 20 °C-25 °C.
Maltese: 3 Dan il-perjodu jista' jinkludi sa 12-il siegħa f'temperatura ta' 20 °C-25 °C.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for vedolizumab, the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal vedolizumab,
English: Among these patients, 37% receiving vedolizumab every eight weeks, 35% receiving vedolizumab every four weeks, and 5% receiving placebo achieved clinical remission at week 52.
Maltese: Fost dawn il-pazjenti, 37% li kienu qed jirċievu vedolizumab kull tmien ġimgħat, 35% li kienu qed jirċievu vedolizumab kull erba' ġimgħat, u 5% li kienu qed jirċievu plaċebo kisbu remissjoni klinika f'ġimgħa 52.
English: Immunocompromised subjects
Maltese: Individwi immunokompromessi
English: The CHMP concluded
Maltese: Is-CHMP ikkonkluda
English: Rubella vaccines: WHO position paper.301-316.15-7-2011.
Maltese: Dokument dwar il-pożizzjoni tad-WHO.301-316.15-7-2011.
English: Available on http://www.who.int/wer/2011/wer8629.pdf 29(86) Ref Type: Internet Communication
Maltese: Disponibbli fuq://www.who.int/wer/2011/wer8629.pdf 29(86)
English: World Health Organization.
Maltese: Organizzazzjoni Dinjija tas-Saħħa.
English: There is an estimated theoretical risk of severe malformations attributed to the rubella containing vaccine that varies between 0.5% and 1.3%.
Maltese: Hemm riskju teoretiku stmat ta' malformazzjonijiet severi attribwiti għall-vaċċin li fih ir-rubella li jvarja bejn 0.5% u 1.3%.
English: • the CHMP considered the referral under Article 31 of Directive 2001/83/EC for monovalent and multivalent measles, mumps, rubella and varicella containing vaccines.
Maltese: • is-CHMP ikkunsidra r-riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal vaċċini monovalenti u multivalenti li fihom il-ħosba, il-gattone, ir-rubella u l-ġidri r-riħ.
English: Evidence from post marketing surveillance and published literature that focused on risk of spontaneous abortion, miscarriage, stillbirth, immaturity and low birth weight in women susceptible to measles, mumps, rubella and/or varicella, risk of malformation and congenital rubella syndrome (CRS) in offspring of such women, and risk of congenital varicella syndrome (CVS) were considered for the review of the contraindication on pregnancy.
Maltese: Evidenza minn sorveljanza wara t-tqegħid fis-suq u minn riċensjoni ppubblikata li ffokat fuq ir-riskju ta' abort spontanju, korriment, twelid ta' trabi mejta, immaturità u piż baxx fit-twelid f'nisa suxxettibbli għall-ħosba, gattone, rubella u/jew ġidri r-riħ, ir-riskju tas-sindromu ta' rubella konġenitali (CRS) fi trabi ta' nisa bħal dawn, u r-riskju tas-sindromu ta' variċella konġenitali (CVS) ġew ikkunsidrati għarreviżjoni tal-kontraindikazzjoni fit-tqala.
English: The CHMP acknowledged that MMRV vaccines should remain contraindicated in patients with severely impaired humoral and/or cellular immune systems such as severe combined immunodeficiency (SCID) and agammaglobulinemia.
Maltese: Is-CHMP irrikonoxxa li vaċċini tal-MMRV għandhom jibqgħu kontraindikati f'pazjenti b'indeboliment sever tas-sistemi immuni ċellulari u/jew umorali bħal immunodefiċjenza kombinata severa (SCID) u agammaglobulinimja.
English: The contraindication in this patient population was also further defined by inclusion of age specific %CD4+ for HIV-infected patients.
Maltese: Il-kontraindikazzjoni f'din il-popolazzjoni ta' pazjenti ġiet ulterjorment definita bl-inklużjoni ta' %CD4+ speċifiku għall-età għal pazjenti infettati bl-HIV.
English: Monovalent and multivalent measles, mumps, rubella and/or varicella containing vaccines (MMRV) are live attenuated vaccines which are indicated in vaccination of adults and children against these viruses.
Maltese: Vaċċini monovalenti u multivalenti li fihom il-ħosba, il-gattone, ir-rubella u/jew il-ġidri r-riħ (MMRV) huma vaċċini ħajjin attenwati indikati fit-tilqim ta' adulti u tfal kontra dawn il-vajrusis.
English: When considering the data from studies in the literature and the data from post-marketing surveillance the CHMP concluded that although a theoretical risk cannot be excluded, no case of CRS has been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated against rubella.
Maltese: Meta kkunsidra d-dejta minn studji fir-riċensjoni u d-dejta minn sorveljanza wara t-tqegħid fis-suq, isCHMP ikkonkluda li għalkemm riskju teoretiku ma jistax jiġi eskluż, l-ebda każ ta' CRS ma ġie rrapportat f'aktar minn 3500 mara suxxettibbli li mingħajr ma kienu jafu, kienu fi stadji bikrija ta' tqala meta ġew imlaqqma kontra r-rubella.
English: Moreover, a warning should be added as vaccination may be considered in patients with selected immune deficiencies (e.g. IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases), if the benefit outweighs the risk of vaccination.
Maltese: Barra minn hekk, għandha tiżdied twissija peress li t-tilqim jista' jiġi kkunsidrat f'pazjenti b'defiċjenzi immuni magħżula (eż. defiċjenzi tas-sub-klassi tal-IgG, newtropenja konġenitali, mard granulomatiku kroniku, u mard b'defiċjenzi tal-komplement), jekk il-benefiċċju jegħleb ir-riskju ta' tilqim.
English: Regarding the contraindication on immunocompromised subjects, an assessment of the safety of MMRV vaccines (based on experience to date) in subjects with various types of immune deficiencies (e.g. T-cell defects, sub-class deficiencies etc.) was provided by the Marketing Authorisation Holders (MAHs).
Maltese: Rigward il-kontraindikazzjoni fuq individwi immunokompromessi, id-Detenturi tal-Awtorizzazzjoni għatTqegħid fis-Suq (MAHs) ipprovdew evalwazzjoni tas-sigurtà ta' vaċċini tal-MMRV (abbażi tal-esperjenza sa llum) fuq individwi b'diversi tipi ta' defiċjenzi immuni (eż. difetti taċ-ċelloli T, defiċjenzi tas-subklassi eċċ.).
English: However, the CHMP concluded that the current contraindication for use of MMRV vaccines in immunocompromised subjects should be amended to clarify that, according to WHO guidelines and scientific data, for HIV-infected patients age specific %CD4+ is to be included.
Maltese: Madankollu, is-CHMP ikkonkluda li l-kontraindikazzjoni attwali għall-użu ta' vaċċini tal-MMRV f'individwi immunokompromessi għandha tiġi emendata biex tiċċara li, skont il-linji gwida tal-WHO u dejta xjentifika, għal pazjenti infettati bl-HIV għandu jiġi inkluż %CD4+ speċifiku għall-età.
English: • the CHMP reviewed all available data regarding use in pregnant women and in immunocompromised patients of rubella containing vaccines, including the most recent publications and data from post-marketing surveillance for monovalent and multivalent measles, mumps, rubella and varicella vaccines.
Maltese: • is-CHMP irreveda d-dejta kollha disponibbli dwar l-użu ta' vaċċini li fihom ir-rubella f'nisa tqal u f'pazjenti immunokompromessi, inkluż l-aktar pubblikazzjonijiet riċenti u dejta minn sorveljanza wara t-tqegħid fis-suq għal vaċċini monovalenti u multivalenti tal-ħosba, talgattone, tar-rubella u tal-ġidri r-riħ.
English: Based on the low theoretical teratogenic risk and the fact that no case of CRS has been reported, it should also be mentioned in the SmPC that inadvertent vaccination of unknowingly pregnant women with monovalent or multivalent mumps, measles and rubella containing vaccines should not be a reason for termination of pregnancy.
Maltese: Abbażi tar-riskju teratoġeniku teoretiku baxx u l-fatt li l-ebda każ ta' CRS ma ġie rrapportat, għandu jissemma' wkoll fl-SmPC li tilqim aċċidentali ta' nisa li ma jafux li huma tqal b'vaċċini monovalenti jew multivalenti tal-gattone, ħosba u rubella ma għandux ikun raġuni għal terminazzjoni ta' tqala.
English: • that the data provided were too limited and poorly documented to draw any conclusion and therefore without any sufficient data monovalent and multivalent MMRV vaccines should remain contraindicated during pregnancy.
Maltese: • li d-dejta pprovduta kienet limitata wisq u dokumentata wisq ħażin biex tinġibed xi konklużjoni u għalhekk mingħajr dejta suffiċjenti, vaċċini monovalenti u multivalenti tal-MMRV għandhom jibqgħu kontraindikati waqt it-tqala.
English: Because of this theoretical teratogenic risk, the World Health Organization (WHO) recommended in 2011 that vaccination against rubella should be avoided in principle in pregnant women and women who intend to become pregnant should be advised to delay for 1 month following rubella vaccination1.
Maltese: Minħabba dan ir-riskju teratoġeniku teoretiku, fl-2011, l-Organizzazzjoni Dinjija tas-Saħħa (WHO) irrakkomandat li fil-prinċipju, it-tilqim kontra r-rubella għandu jiġi evitat f'nisa tqal u nisa li bi ħsiebhom joħorġu tqal għandhom jiġu avżati biex jistennew xahar wara t-tilqima tar-rubella1.
English: Current data indicate that rubella IgM after vaccination peaks around 30 days after vaccination and IgG is also detectable.
Maltese: Dejta attwali tindika li l-IgM tar-rubella wara tilqima jilħaq il-quċċata madwar 30 ġurnata wara tilqima u l-IgG huwa wkoll traċċabbli.
English: Based on the above, Belgium national competent authorities triggered a referral under Article 31 of Directive 2001/83/EC on 9 March 2012, requesting the CHMP to review the benefit/risk of these vaccines in the above mentioned populations, i.e. pregnant women and subjects with immune deficiencies.
Maltese: Abbażi ta' dan ta' hawn fuq, l-awtoritajiet nazzjonali kompetenti tal-Belġju taw bidu għal riferimenti skont l-Artikolu 31 tad-Direttiva 2001/83/KE fid-9 ta' Marzu 2012, fejn talbu lis-CHMP sabiex jirrevedi l-benefiċċju/riskju ta' dawn il-vaċċini fil-popolazzjonijiet imsemmija hawn fuq, jiġifieri nisa tqal u individwi b'defiċjenzi immuni.
English: Taking into account that rubella and varicella vaccination induce a fast immune response that make post-exposure prophylaxis possible, based on available evidence and as reflected in WHO recommendation, the CHMP considered that there are sufficient data to reduce the period post-vaccination where pregnancy should be avoided.
Maltese: Wara li kkunsidra li t-tilqim tar-rubella u l-ġidri r-riħ jikkawża rispons immuni mgħaġġel li jagħmel profilassi wara esponiment possibbli, abbażi tal-evidenza disponibbli u kif rifless fir-rakkomandazzjoni tad-WHO, is-CHMP ikkunsidra li hemm biżżejjed dejta biex il-perjodu ta' wara t-tilqim, fejn it-tqala għandha tiġi evitata, jitnaqqas.
English: The CHMP also considered that the most recent published data regarding vaccination against rubella in pregnant women should be reflected in the summary of product characteristics of the monovalent rubella vaccines and multivalent MMR vaccines.
Maltese: Is-CHMP ikkunsidra wkoll li l-aktar dejta riċenti ppubblikata dwar it-tilqim kontra r-rubella f'nisa tqal għandha tiġi riflessa fis-sommarju tal-karatteristiċi tal-prodott tal-vaċċini monovalenti tar-rubella u tal-vaċċini multivalenti tal-MMR.
English: Similar biological products
Maltese: Prodotti biologici simili
English: 302 Translation
Maltese: 302 Traduzzjonijiet
English: 305 Community programmes
Maltese: 305 Programmi komunitarji
English: 2.11 Coordination group
Maltese: 2.11 Grupp ta' Koordinazzjoni
English: 2.7 Arbitration and Community referrals
Maltese: 2.7 Arbitraġġ u referenzi Komunitarji
English: GMP (including PMF) GCP (including pharmacovigilance) GLP
Maltese: GMP (inkluż PMF) GCP (inkluż farmakoviġilanza) GLP
English: Community programmes
Maltese: Programmi Komunitarji
English: Parallel-distribution notifications transferred from 2005 to 2006 Parallel-distribution notifications
Maltese: Notifiki ta' distribuzzjoni parallela trasferiti mill-2005 għall-2006 Notifiki ta' distribuzzjoni parallela
English: Provision of additional EudraNet back-up systems.
Maltese: Il-provvista ta' sistemi ta' back-up addizzjonali għal EudraNet.
English: Generic, hybrid products, etc.
Maltese: Prodotti generici, ibridi, eċċ.
English: General EU contribution EU contribution for SME policy EU contribution for Paediatrics policy n/a 0.00 2,647 1.71
Maltese: Kontribut ta' l-UE għall-politika pedjatrika n/a 0.00 2,647 1.71
English: TEMPORARY POSTS
Maltese: POSTIJIET TEMPORANJI
English: 3.1 GMP, GCP, GLP and pharmacovigilance inspections
Maltese: 3.1 GMP, GCP, GLP u spezzjonijiet tal-farmakoviġilanza
English: The Agency estimates an increase in the number of reimbursed meetings by 30% and the number of reimbursed delegates by 25% in 2007.
Maltese: L-Aġenzija tistima żieda ta' 30% fin-numru ta' laqgħat rimborsati u ta' 25% fin-numru ta' delegati rimborsati fl-2007.
English: 7 Good clinical practice (GCP).
Maltese: 7 Prattika klinika tajba (GCP).
English: 3.2 Certificates of medicinal products
Maltese: 3.2 Ċertifikati ta' prodotti mediċinali
English: Arbitration and Community referrals (Veterinary medicines)
Maltese: Arbitraġġ u riferenzi Komunitarji (Mediċini veterinarji)
English: A renomination of the majority of the CHMP, CVMP and HMPC members will take place in May 2007, following completion of their three-year term.
Maltese: Renominazzjoni tal-maġġoranza tal-membri tas-CHMP, CVMP u HMPC ser isir f'Mejju 2007, wara t-tkomplija tat-terminu ta' tliet snin tagħhom.
English: 1.6 Preparations for future enlargement
Maltese: 1.6 Preparazzjonijiet għat-tkabbir fil-futur
English: IQM adviser
Maltese: Konsulent ta' l-IQM
English: 1.2 Transparency, communication and provision of information
Maltese: 1.2 Trasparenza, komunikazzjoni u l-proviżjon ta' informazzjoni
English: The volume of translations is expected to increase to 40,950 pages - 95% more than in 2006.
Maltese: Il-volum ta' traduzzjonijiet huwa mistenni jiżdied għal 40,950 paġna - 95% aktar mill-2006.
English: 303 Studies and consultants 304 Publications
Maltese: 304 Pubblikazzjonijiet
English: It is expected that over 70 centrally authorised veterinary products will be available by 2007.
Maltese: Huwa mistenni li aktar minn 70 prodotti veterinarji awtorizzati ċentralment ikunu disponibbli sa l-2007.
English: EudraGMP (In final testing)
Maltese: EudraGMP (Fl-istadju ta' ttestjar finali)
English: Plasma master file (PMF).
Maltese: Fajl prinċipali tal-plażma (PMF).
English: Integrated quality management - Internal audit
Maltese: Ġestjoni integrata tal-kwalità - Verfika interna
English: Final accounts 2005 10 Appropriation/Budget 2006 as of 31 December 2006 Appropriation/Budget 2007 as adopted by the Management Board on 19 December 2006
Maltese: Kontabbiltà finali 2005 10 Approprjazzjoni/Budget 2006 fil-31 ta' Diċembru 2006 Approprjazzjoni/Budget 2007 kif adottat mill-Bord ta' Tmexxija fid-19 ta' Diċembru 2006
English: Reimbursed meetings Videoconferences
Maltese: Laqgħat rimborsati vidjokonferenzi
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea.europa.eu www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09 E-mail: mail@emea.europa.eu www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged
English: 1.7 International cooperation
Maltese: 1.7 Kooperazzjoni Internazzjonali
English: 21 Expenditure on data processing 22 Movable property and asset costs 23 Other administrative expenditure 24 Postage and communications 25 Expenditure on formal and other meetings
Maltese: 21 Infiq fuq proċessar ta' data 22 Propjetà mobbli u spejjeż ta' assi 23 Infiq amministrattiv ieħor 24 Posta u komunikazzjonijiet 25
English: AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5 Total Function Group AD AST 11 AST 10 AST 9 AST 8 AST 7 AST 6 AST 5 AST 4 AST 3 AST 2 AST 1 Total Function Group AST Total Staff
Maltese: AD 16 AD 15 AD 14 AD 13 AD 12 AD 11 AD 10 AD 9 AD 8 AD 7 AD 6 AD 5
English: EMEA/MB/442095/2006
Maltese: EMEA/119312/2007
English: EudraCT-Paediatrics Database (At inception)
Maltese: Database talEudraCT-Pedjatrija (Fl-istadju inizjali)
English: Transparency, communication and provision of information
Maltese: Trasparenza, komunikazzjoni u forniment ta' informazzjoni
English: 5.1 Infrastructure services at the EMEA
Maltese: 5.1 Servizzi ta' l-infrastruttura fl-EMEA
English: 2.6 Pharmacovigilance and maintenance activities
Maltese: 2.6 Farmakoviġilanza u attivitajiet ta' manutenzjoni
English: A wide range of documents are published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Maltese: Firxa wiesgħa ta' dokumenti huma ppubblikati mill-EMEA, inkluż stqarrijiet għall-istampa, dokumenti ta' informazzjoni ġenerali, rapporti annwali u programmi ta' ħidma.
English: Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: press@emea.europa.eu
Maltese: Martin HARVEY ALLCHURCH Telefon dirett (44-20) 74 18 84 27 E-mail: press@emea.europa.eu
English: For product quality defects and other recalls see www.emea.europa.eu/inspections/defectinstructions.html for instructions and contact points.
Maltese: Għal difetti fil-kwalità tal-prodott u sejħiet lura oħrajn ara www.emea.europa.eu/inspections/defectinstructions.html għal istruzzjonijiet u punti ta' kuntatt.
English: Number of videoconferences and reimbursed meetings
Maltese: Numru ta' vidjokonferenzi u laqgħat rimborsati
English: EU reports (centrally authorised products) Non-EU reports (centrally authorised products) EU reports (nationally authorised products) Non-EU reports (nationally authorised products)
Maltese: Rapporti mill-UE (prodotti awtorizzati ċentralment) Rapporti minn barra l-UE (prodotti awtorizzati ċentralment) Rapporti mill-UE (prodotti awtorizzati nazzjonalment) Rapporti minn barra l-UE (prodotti awtorizzati nazzjonalment)
English: PRE-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Patrick Le Courtois
Maltese: AWTORIZZAZZJONI TA' QABEL IL-VALUTAZZJONI TA' MEDIĊINI GĦALL-UŻU TAL-BNIEDEM Kap: Patrick Le Courtois
English: on the Internet at www.emea.europa.eu by email request to info@emea.europa.eu by fax to (44-20) 7418 8670 by writing to:
Maltese: fl-Internet fuq www.emea.europa.eu b'talba bl-email lil info@emea.europa.eu b'fax lil (44-20) 7418 8670 bil-miktub lil:
English: Annex 2 EMEA establishment plan 2005-2007
Maltese: Pjan ta' stabbiliment ta' l-EMEA 2005-2007 Grupp ta' Funzjoni &
English: 5.3 Meetings and conferences at the EMEA
Maltese: 5.3 Laqgħat u konferenzi fl-EMEA