FrancophonIA/ELRC3.0 huggingface dataset:
English: Opinions on maximum residue limits
Maltese: Opinjonijiet dwar limiti massimi ta' residwi
English: Three of the referrals were made under Article 33 and 3 were made under Article 35 of Directive 2001/82/EC.
Maltese: Tlieta mir-referenzi saru skond l-Artikolu 33 u 3 saru skond l-Artikolu 35 tad-Direttiva 2001/82/KE.
English: Czech Republic Denmark
Maltese: Repubblika Ceka Danimarka
English: Decision process
Maltese: Process ta' decizjoni
English: EMEA budget evolution (2002-2007)
Maltese: Evoluzzjoni tal-budget ta' l-EMEA (2002-2007)
English: New medicinal products (non-orphan)
Maltese: Prodotti medicinali godda (mhux orfni)
English: A total of 57 referrals were received in 2007: 40% more than in 2006.
Maltese: Fl-2007 kien riċevut total ta' 57 referenza: 40% aktar mill-2006.
English: 4.2 Certificates of medicinal products
Maltese: .2 Ċertifikati ta' prodotti mediċinali
English: A total of €4.89 million from the EU special contribution was used to grant fee reductions for orphan medicines in 2007.
Maltese: Total ta' €4.89 miljun mill-kontribuzzjoni speċjali ta' l-UE intuża biex jingħata tnaqqis fil-ħlasijiet għal mediċini orfni fl-2007.
English: In 2007, 212 companies requested SME status, and 172 requests were approved.
Maltese: Fl-2007, 212-il kumpannija talbu status ta' SME, u 172 talba ġiet approvata.
English: Average number of days for centralised procedures
Maltese: Numru ta' jiem medju fil-procedura centralizzata
English: Belgium Cyprus
Maltese: Belgju Cipru
English: Vaccination is seen as an important method of control.
Maltese: It-tilqim jidher li huwa metodu importanti ta' kontroll.
English: A total of 53 type-I variation applications were received, relating to 29 type-IA and 24 type-IB variations.
Maltese: Kien riċevut total ta' 53 varjazzjoni ta' applikazzjoni tat-tip I, relatati ma' 29 varjazzjoni tat-tip IA u 24 varjazzjoni tat-tip IB.
English: Generics, hybrid products, etc.
Maltese: Generici, pro do tti ibridi, ecc.
English: 4 INSPECTIONS
Maltese: 4 SPEZZJONIJIET
English: PIPs and waivers
Maltese: PIPs u dispensi
English: 3.5 Pharmacovigilance and maintenance activities
Maltese: 3.5 Attivitajiet ta' farmakoviġilanza u manteniment
English: 25% more adverse-drug-reaction reports received in 2007
Maltese: 25% aktar rapporti dwar reazzjonijiet mhux mixtieqin għall-mediċini riċevuti fl-2007
English: Average number of days for centralised procedures (positive opinions) (2005-2007)
Maltese: Numru ta' jiem medju ghal proceduri centralizzati (opinjonijiet posittivi) (2005-2007)
English: 2.6 Pharmacovigilance and maintenance activities
Maltese: 2.6 Attivitajiet ta' farmakoviġilanza u manteniment
English: Alimentary tract
Maltese: Kanal alimentari
English: Of these, 13 concerned pharmaceutical products and 34 concerned immunological products.
Maltese: Minn dawn, 13 ikkonċernaw prodotti farmaċewtiċi u 34 kkonċernaw prodotti immunoloġiċi.
English: 3.3 Establishment of maximum residue limits Applications for maximum residue limits (MRLs)
Maltese: 3.3 Iffissar ta' limiti massimi ta' residwi Applikazzjonijiet għal limiti massimi ta' residwi (MRLs)
English: EMEA/CHMP think-tank on innovative drug development: final report published
Maltese: Think-tank ta' l-EMEA/CHMP dwar l-iżvilupp innovattiv ta' mediċini: ippubblikat ir-rapport finali
English: For centrally authorised veterinary medicines, a total of 1,424 expedited spontaneous reports of suspected adverse reactions were reported within the 15-day legal timeframe in 2007.
Maltese: Għal mediċini veterinarji awtorizzati ċentralment, kienu rrapportati 1,424 rapport spontanju mgħaġġel ta' reazzjonijiet mhux mixtieqa suspetti fil-qafas ta' żmien legali ta' 15-il jum fl-2007.
English: In collaboration with IFAH-Global, the EMEA hosted a Global Animal Health Conference on 15-16 November 2007.
Maltese: B'kollaborazzjoni ma' l-IFAH-Globali, l-EMEA ospitat Konferenza Globali dwar Saħħet l-Annimali fil-15-16 ta' Novembru 2007.
English: The second vaccine for prophylaxis against high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to human papilloma virus (HPV) types 16 and 18.
Maltese: • It-tieni vaċċin għall-profilassi kontra n-neoplasija intraepiteljali ċervikali ta' grad għoli (gradi CIN 2 u 3) u l-kanċer ċervikali każwalment relatati mal-virus tal-papilloma uman (HPV) tipi 16 u 18.
English: Bulgaria and Romania joined the EU on 1 January 2007.
Maltese: Il-Bulgarija u r-Rumanija ssieħbu fl-UE fl-1 ta' Jannar 2007.
English: Opinions adopted
Maltese: Opinjonijiet adottati
English: The EMEA received 63,393 reports concerning investigational medicines, i.e. adverse drug reactions observed during clinical trials.
Maltese: L-EMEA rċeviet 63,393 rapport rigward mediċini investigatorji, jiġifieri reazzjonijiet mhux mixtieqa għall-mediċini osservati waqt provi kliniċi.
English: epoetins, both centrally authorised (Aranesp, Nespo, Dynepo, Mircera, NeoRecormon, Binokrit, Epoetin Alfa Hexal, Abseamed) and nationally authorised (Eprex).
Maltese: • epoetins, kemm awtorizzati fuq livell ċentrali (Aranesp, Nespo, Dynepo, Mircera, NeoRecormon, Binokrit, Epoetin Alfa Hexal, Abseamed) kif ukoll awtorizzati fuq livell nazzjonali (Eprex).
English: The numbers of initial parallel-distribution notifications and notifications of change exceeded the expected numbers, with 1,937 initial notifications (8% more than forecast) and 3,518 notifications of change (45% more than forecast) being received.
Maltese: In-numru ta' notifiki inizjali għal distribuzzjoni parallela u notifiki ta' bidla qabeż in-numri mistennija, billi kienu riċevuti 1,937 notifika inizjali (8% aktar milli previsti)
English: 2.7 Arbitration and Community referrals Number of referrals submitted to the EMEA continued to rise
Maltese: 2.7 Arbitraġġ u referenzi Komunitarji In-numru ta' referenzi ppreżentati lill-EMEA kompla jikber
English: Stimulating availability of veterinary medicines for limited markets
Maltese: Stimolu tad-disponibbiltà ta' mediċini veterinarji għal swieq limitati
English: a new safety warning for Tamiflu (oseltamivir phosphate) and the risk of neuropsychiatric adverse events;
Maltese: • twissija ta' sigurtà ġdida għat-Tamiflu (oseltamivir phosphate) u r-riskju ta' effetti avversi newropsikjatriċi;
English: Stocrin and Sustiva (efavirenz): deletion of the contra-indication for their co-administration with voriconazole.
Maltese: • Stocrin u Sustiva (efavirenz): tħassir tal-kontro-indikazzjoni għall-amministrazzjoni tagħhom malvoriconazole.
English: 1 PRIORITIES IN 2007
Maltese: 1 PRIJORITAJIET FL-2007
English: Greece
Maltese: Grecja
English: A new referral procedure - the procedure following Article 107(2) of Directive 2001/83/EC as amended - was used for the first time in 2007.
Maltese: Proċedura ġdida ta' referenza - il-proċedura skond l-Artikolu 107(2) tad-Direttiva 2001/83/KE kif emendata - intużat għall-ewwel darba fl-2007.
English: The number of staff employed at the EMEA was 441, in addition to which there were 124 seconded national experts and contract agents.
Maltese: In-numru ta' persunal impjegat mill-EMEA kien ta' 441, iżda barra dan kien hemm 124 espert nazzjonali ssekondati u aġenti kuntrattwali.
English: EU Telematics Controlled Terms (In pilot production)
Maltese: Termini kkontrollati tatTelematika ta' l-UE (Fi stadju ta' produzzjoni pilota)
English: 4.1 GMP, GCP, pharmacovigilance and GLP inspections Increased number of inspections
Maltese: 4.1 Spezzjonijiet ta' GMP, GCP, farmakoviġilanza u GLP Żjieda fin-numru ta' spezzjonijiet
English: Of these, 5 concerned pharmaceutical products and 4 concerned immunologicals.
Maltese: Minn dawn, 5 kkonċernaw prodotti farmakoloġiċi u 4 kkonċernaw prodotti immunoloġiċi.
English: High performance of EudraNet was achieved both in terms of system availability and quality of management, development and operation of EudraNet applications (EudraNet II, EudraLink, ECD, Experts Database, etc.).
Maltese: Il-prestazzjoni għolja ta' l-EudraNet intlaħqet kemm f'termini ta' disponibbiltà tas-sistema u l-kwalità tat-tmexxija, żvilupp u operat ta' l-applikazzjonijiet EudraNet (EudraNet II, EudraLink, ECD, Database ta' l-Esperti, eċċ.)
English: Clinical-trials conference
Maltese: Konferenza dwar provi kliniċi
English: Of the 1,424 reports received, 1,212 related to suspected adverse reactions in animals and 213 to reactions in humans following exposure to a veterinary medicinal product.
Maltese: Mill-1,424 rapport riċevuti, 1,212 kienu relatati ma' reazzjonijiet mhux mixtieqa suspetti fl-annimali u 213 ma' reazzjonijiet fil-bnedmin wara li gew esposti għal prodott mediċinali veterinarju.
English: In pregnancies up to 63 days, comparative studies between 200mg and 600mg mifepristone in combination with 1mg gemeprost delivered vaginally suggest that 200mg mifepristone may be as effective as 600mg mifepristone.
Maltese: Fi tqala sa 63 jum, studji komparattivi bejn 200mg u 600mg mifepristone f'kombinazzjoni ma' 1mg gemeprost mogħtija vaġinalment jissuġġerixxu li 200mg mifepristone jistgħu jkunu effettivi daqs 600mg mifepristone.
English: A total of 762 suspected signals concerning 139 intensively monitored medicines, and 349 suspected signals concerning 162 routinely monitored medicines, were identified.
Maltese: Kienu identifikati total ta' 762 sinjal ta' suspett rigward 139 mediċina mmonitorati b'mod intensiv, u 349 sinjal ta' suspett rigward 162 mediċina mmonitorati b'rutina.
English: Periodic safety update reports (PSURs)
Maltese: Rapporti perijodiċi ta' aġġornament dwar is-sigurtà (PSURs)
English: EudraCT Paediatrics Database (At inception)
Maltese: EudraCT Paediatrics Database (Għadha tibda)
English: Development of EudraVigilance Veterinary (EVV) delayed in 2007
Maltese: L-iżvilupp ta' l-EudraVigilance Veterinarju (EVV) jittardja fl-2007
English: Neurology/CNS
Maltese: Newrologija/SNC
English: Applications received (205-2007)
Maltese: Applikazzjonijiet ricevuti (2005-2007)
English: The CHMP concluded that the available data support the effectiveness of a 600mg dose of mifepristone, followed by the use of prostaglandin analogues, for the termination of pregnancy up to 63 days after the onset of amenorrhoea (absence of menstrual periods).
Maltese: Is-CHMP ikkonkluda li d-data disponibbli tappoġġja l-effikaċja tad-doża ta' 600mg ta' mefipristone, segwita mill-użu ta' analogi ta' prostaglandin, għat-terminazzjoni ta' tqala sa 63 jum wara l-bidu ta' l-amenorrea (assenza ta' perijodi menstruwali).
English: Of these, 90% and 86% related to line-extension and extension-of-indication applications respectively.
Maltese: Minn dawn, 90% u 86% kienu relatati ma' applikazzjonijiet ta' estensjoni tal-linja u ta' estensjoni ta' indikazzjoni rispettivament.
English: Good manufacturing practice (GMP) inspection numbers - including inspections in the context of plasma master files (PMFs) - showed a 32% increase compared with 2006 (110).
Maltese: In-numru ta' spezzjonijiet ta' prattika ta' manifattura tajba (GMP) - inklużi spezzjonijiet fil-kuntest tal-plasma master files (PMFs) - urew żieda ta' 32% meta mqabblin ma' l-2006 (110).
English: Musculo-skeletal
Maltese: M usko lu-skeletali
English: 3 MEDICINES FOR VETERINARY USE
Maltese: 3 MEDIĊINI GĦALL-UŻU VETERINARJU
English: The CHMP conducted a review of Viracept (nelfinavir), further to contamination during the manufacturing process of several batches of the active substance with ethyl mesilate, a known genotoxic substance.
Maltese: Is-CHMP wettaq reviżjoni tal-Viracept (nelfinavir), wara kontaminazzjoni waqt il-proċess ta' limmanifatturar ta' diversi lottijiet tas-sustanza attiva bl-ethly mesilate, sustanza ġenotossika magħrufa.
English: The Agency's total budget in 2007 was €163,113,000 - an increase of approximately 20% compared to 2006.
Maltese: Il-budget totali ta' l-Aġenzija fl-2007 kien ta' €163,113,000 - żjieda ta' madwar 20% meta mqabbel ma' l-2006.
English: 3.6 Arbitration and Community referrals Procedures started in 2007
Maltese: 3.6 Arbitraġġ u referenzi Komunitarji Proċeduri mibdijin fl-2007
English: 3.2 Initial evaluation Applications received
Maltese: 3.2 Valutazzjoni inizjali Applikazzjonijiet riċevuti
English: This is an increase of 18% compared to 2006.
Maltese: Din hija żieda ta' 18% meta mqabbla ma' l-2006.
English: Belgium
Maltese: Belgju
English: System or process (Status in 2006)
Maltese: Sistema jew proċess (Status fl-2006)
English: The Innovation Task Force (ITF) - an EMEA multidisciplinary group that includes scientific, regulatory and legal competences - held 18 briefing meetings with companies developing medicines in the area of emerging therapies and new technologies.
Maltese: It-Task Force għall-Innovazzjoni (ITF) - grupp multidixxiplinarju ta' l-EMEA li jinkludi kompetenzi xjentifiċi, regolatorji u legali - kellu 18-il laqgħa ta' briefing ma' kumpanniji li qed jiżviluppaw mediċini fil-qasam ta' terapiji li qegħdin jitfaċċaw u teknoloġiji ġodda.
English: The EMEA had adopted a decision on 4 of the 10 opinions by the end of 2007.
Maltese: L-EMEA kienet adottat deċiżjoni għal 4 mill-10 opinjonijiet sa l-aħħar ta' l-2007.
English: EU special contribution for orphan medicines
Maltese: Kontribuzzjoni speċjali ta' l-UE għal mediċini orfni
English: The CHMP adopted 41 opinions for new indications, providing additional treatment options for patients.
Maltese: Is-CHMP adotta 41 opinjoni għal indikazzjonijiet ġodda, li jipprovdu għażliet addizzjonali għall-kura ta' pazjenti.
English: I succeeded Professor Hannes Wahlroos, who had so successfully chaired the Management Board for the previous three years.
Maltese: Jien segwejt lill-Professur Hannes Wahlroos, li b'tant suċċess ippresieda lill-Bord ta' Tmexxija fit-tliet snin ta' qabel.
English: Piroxicam can still be prescribed for the symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Maltese: Il-piroxicam xorta jista' jiġi preskritt għat-titfija simptomatika ta' l-osteoartrite, artrite rewmatojde u l-ankylosing spondylitis.
English: A medicine belonging to a new class of antiretrovirals (CCR5 inhibitors).
Maltese: • Mediċina li tappartjeni għal klassi ġdida ta' antiretrovirali (inibituri CCR5).
English: The CHMP concluded more than 100 type-II variations relating to special warnings and precautions for use, including:
Maltese: Is-CHMP ikkonkluda aktar minn 100 varjazzjoni tat-tip II relatata ma' twissijiet speċjali u prekawzjonijiet għall-użu, inklużi:
English: EudraPharm (In production)
Maltese: EudraPharm (Fil-produzzjoni)
English: EudraVigilance (In production)
Maltese: EudraVigilance (Fil-produzzjoni)
English: Topics covered included gene-therapy medicines, diagnostics, oncology development, new approaches to quality assessment, and pandemic influenza.
Maltese: It-temi koperti kienu jinkludu mediċini għal terapija ġenetika, dijanjostika, żvilupp onkoloġiku, approċċi ġodda għall-valutazzjoni tal-kwalità, u l-influwenza pandemika.
English: Acomplia (rimonabant): ongoing major depressive illness and/or ongoing antidepressive treatment; Agenerase, Aptivus, Crixivan, Invirase, Kaletra, Norvir, Prezista, Reyataz, Telzir, Viracept (protease inhibitors): concomitant use with oral midazolam (while further directions concerning co administration with parenteral midazolam are provided in the SPC) (class labelling); Pegintron (peginterferon alpha 2b), Viraferonpeg (peginterferon alpha 2b) and Rebetol (ribavirin):
Maltese: • Agenerase, Aptivus, Crixivan, Invirase, Kaletra, Norvir, Prezista, Reyataz, Telzir, Viracept (inibituri protease): użu konkomitanti mal-midazolam orali (waqt li aktar direzzjonijiet rigward ilko-amminsitrazzjoni mal-midazolam permezz ta' injezzjoni huma pprovduti fis-SPC) (ittikkettjar skond il-klassi);
English: The first version of EudraGMP was launched in April 2007, and version 1.1 was released into production in December 2007.
Maltese: L-ewwel verżjoni ta' l-EudraGMP tnediet f'April 2007, u l-verżjoni 1.1 inħarġet għall-produzzjoni f'Diċembru 2007.
English: The EMEA coordinated the post-opinion linguistic review for 76 new applications and line extensions.
Maltese: L-EMEA kkordinat ir-reviżjoni lingwistika ta' wara l-opinjoni għal 76 applikazzjoni ġdida u estensjonijiet tal-linja.
English: EudraPharm was updated in 2007.
Maltese: L-EudraPharm ġie aġġornat fl-2007.
English: A medicine with a chemical structure resembling that of thalidomide.
Maltese: • Mediċina bi struttura kimika li tixbah lit-thalidomide.
English: Four entries to the list were released for public consultation (aniseed, calendula flower, eleutherococcus root and purple coneflower herb).
Maltese: Kienu maħruġa erba' daħliet fil-lista għal konsultazzjoni pubblika (aniseed żerriegħa tal-ħlewwa, fjura tal-kalendula, għerq ta' l-eleutherococcus u ħaxixa tal-purple coneflower).
English: The EMEA received 381,990 adverse-drug-reaction (ADR) reports in 2007 - an increase of more than 25% compared to the previous year.
Maltese: L-EMEA rċeviet 381,990 rapport ta' reazzjoni mhux mixtieqin għall-mediċina (ADR) fl-2007 - żieda ta' aktar minn 25% meta mqabblin mas-sena preċedenti.
English: Following further investigation, 22% (132) of suspected signals required follow-up for intensively monitored medicines, including involving the rapporteur for 43 signals.
Maltese: Wara aktar investigazzjoni, 22% (132) tas-sinjali ta' suspett kienu jeħtieġu segwitu għal mediċini mmonitorati b'mod intensiv, inkluż linvolviment ta' rapporteur għal 43 sinjal.
English: The Agency received a total of 15 initial marketing-authorisation applications for veterinary medicinal products, 8 of which were for pharmaceutical products and 7 for immunologicals.
Maltese: L-Aġenzija rċeviet total ta' 15-il applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq inizjali għal prodotti mediċinali veterinarji, li 8 minnhom kienu għal prodotti farmaċewtiċi u 7 għal immunoloġiċi.
English: The Committee for Orphan Medicinal Products (COMP) adopted 97 positive opinions on orphan designation - the highest number ever - and 1 negative opinion.
Maltese: Il-Kumitat għal Prodotti Mediċinali Orfni (COMP) adotta 97 opinjoni pożittiva dwar l-ikklassifikar ta' prodotti orfni - l-ogħla numru li qatt adotta - u opinjoni negattiva waħda.
English: Definition and implementation of EU Telematics controlled terms continued.
Maltese: Kompliet id-definizzjoni u l-implimentazzjoni tat-termini kkontrollati tat-Telematika ta' l-UE.
English: EudraGMP (In production)
Maltese: EudraGMP (Fil-produzzjoni)
English: The EudraVigilance Datawarehouse and Analysis System (EVDAS) was rolled out to the national competent authorities on 6 July 2007.
Maltese: Is-Sistema ta' Datawarehouse u ta' Analiżi ta' l-EudraVigilance (EVDAS) kienet mogħtija lillawtoritajiet kompetenti nazzjonali fis-6 ta' Lulju 2007.
English: EudraNet (In production)
Maltese: EudraNet (Fil-produzzjoni)
English: However, in pregnancies up to 49 days, comparative studies between 200mg and 600mg mifepristone in combination with 400μg misoprostol delivered orally cannot exclude a slightly higher risk of continuing pregnancies with the 200mg dose.
Maltese: Madankollu, fi tqala sa 49 jum, studji komparattivi bejn 200mg u 600mg mifepristone f'kombinazzjoni ma' 400µg misoprostol mogħtijin oralment ma jistgħux jeskludu riskju pjuttost aktar għoli li t-tqala tkompli bid-doża ta' 200mg.
English: The EMEA received a total of 92 requests for access to documents - an increase of more than 30% over 2006.
Maltese: L-EMEA rċeviet total ta' 92 talba għal aċċess għal dokumenti - żjieda ta' aktar minn 30 % fuq l-2006.
English: Type-IA variations
Maltese: Waqfien taz-zmien ghall-kumpanniji
English: Strengthening EudraVigilance to support proactive pharmacovigilance in the EU
Maltese: Tisħiħ ta' l-EudraVigilance biex tkun appoġġjata farmakoviġilanza proattiva fl-UE
English: New applications for veterinary medicines (2005-2007)
Maltese: Proceduri ghall-ikklassifikar ta' prodotti medicinali orfni (2005-2007)
English: 2 vaccines for pigs, against porcine circovirus type 2.
Maltese: • 2 vaċċini għall-ħnieżer, kontra ċ-ċirkovirus tal-ħnieżer tat-tip 2.
English: Applications for extension/modification of maximum residue limits (2005-2007)
Maltese: Applikazzjonijiet ghal estensjoni/modifika tal-limiti massimi ta' residwi (2005-2007)
English: The EMEA received applications for PIPs and full or partial waivers relating to 202 indications.
Maltese: L-EMEA rċeviet applikazzjonijiet għal PIPs u dispensi totali jew parzjali fir-rigward ta' 202 indikazzjoni.
English: The number of good clinical practice (GCP) and pharmacovigilance inspections in 2007 was more than twice the number in 2006.
Maltese: In-numru ta' spezzjonijiet ta' prattika klinika tajba (GCP) u ta' farmakoviġilanza fl-2007 kien aktar mid-doppju tan-numru fl-2006.
English: Daniel Brasseur, former Chair of the Committee for Medicinal Products for Human Use (CHMP) and of the former Paediatric Working Party, was elected Chair; Gérard Pons was elected Vice-chair.
Maltese: Daniel Brasseur, l-ex-Chairperson tal-Kumitat għall-Prodotti Mediċinali għall-Użu tal-Bniedem (CHMP) u ta' l-ex Grupp ta' Ħidma Pedjatriku, inħatar Chairperson;
English: The Agency paid a total of €53.6 million to the national competent authorities for the provision of services in the evaluation of medicines for human and veterinary use.
Maltese: L-Aġenzija ħallset total ta' €53.6 miljun lill-awtoritajiet kompetenti nazzjonali għall-għoti ta' servizzi fil-valutazzjoni ta' mediċini għall-użu tal-bniedem u veterinarju.
English: An antidote medicinal product used for treating cyanide poisoning.
Maltese: • Prodott mediċinali antidotu użat għall-kura ta' l-ivvelenar bis-cyanide.
English: In 2007, the CVMP adopted a total of 9 positive opinions for initial marketing-authorisation applications - 4 fewer than in 2006.
Maltese: Fl-2007, il-CVMP adotta total ta' 9 opinjonijiet pożittivi għal applikazzjonijiet għal awtorizzazzjoni għat-tqegħid fis-suq inizjali - 4 inqas mill-2006.
English: 2.8 Herbal medicines Community herbal monographs
Maltese: 2.8 Mediċini magħmulin mill-ħxejjex Monografi Komunitarji dwar ħxejjex
English: Two mock-up pandemic-influenza vaccines intended for the prevention of influenza during an officially declared pandemic situation.
Maltese: • Żewġ tilqimiet bi prova għall-influwenza pandemika maħsuba għall-prevenzjoni ta' l-influwenza waqt sitwazzjoni ddikjarata uffiċjalment bħala pandemika.
English: About 10% (33) of signals were followed up for routinely monitored medicines, with involvement of the rapporteur in 21 cases.
Maltese: Madwar 10% (33) tas-sinjali kienu segwiti għal mediċini mmonitorati b'rutina, bl-involviment tar-rapporteur f'21 każ.
English: The Agency's Committee on Herbal Medicinal Products (HMPC) released for consultation 16 draft Community herbal monographs for traditional and well-established herbal medicines (birch leaf, butcher's broom, calendula flower, elder flower, eleutherococcus root, European goldenrod, hop strobiles, horsetail herb, melilot, mullein flower, nettle herb, oat fruit, oat herb, peppermint leaf, purple coneflower herb and willow bark).
Maltese: Il-Kumitat dwar il-Prodotti Mediċinali Magħmulin mill-Ħxejjex (HMPC) ta' l-Aġenzija ħareġ għallkonsultazzjoni 16-il abbozz ta' monografu Komunitarju dwar il-ħxejjex għal mediċini tradizzjonali magħmulin mill-ħxejjex u stabbiliti sewwa (werqa tal-betula, butcher's broom, fjura tal-kalendula, fjura ta' l-elder, għerq ta' l-eleutherococcus, European goldenrod, hop strobiles, ħaxixa ta'denb iżżiemel, melilot, fjura tal-mullein, ħurrieq, frott tal-ħafur, ħaxixa tal-ħafur, werqa tal-peppermint, ħaxixa tal-purple coneflower u qoxra taż-żafżafa).
English: The CVMP adopted 3 positive opinions for the establishment of new MRLs.
Maltese: Il-CVMP adotta 3 opinjonijiet pożittivi għall-iffissar ta' MRLs ġodda.
English: Based on the available published data, the benefit/risk profile of mifepristone in combination with oral misoprostol for pregnancy from 50 to up to 63 days is unfavourable due to poor efficacy.
Maltese: Abbażi tad-data ppubblikata disponibbli, il-profil tal-benefiċċju/riskju tal-mifepristone f'kombinazzjoni ma' misoprostol orali għal tqala minn 50 sa 63 jum mhuwiex favorevoli minħabba effikaċja batuta.