FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with Avamys, see the Package Leaflet.
Maltese: Għal lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Avamys, ara l-Fuljett ta' Tagħrif.
English: How has Avamys been studied?
Maltese: Kif ġie studjat Avamys?
English: This leads to a reduction the release of substances that are involved in the inflammation process, such as histamine, reducing the symptoms of allergy.
Maltese: Dan iwassal għal tnaqqis fir-rilaxx ta' sustanzi li huma involuti fil-proċess ta' infjammazzjoni, bħal istamina, li tnaqqas is-sintomi ta' allerġija.
English: Avamys was more effective than placebo at reducing symptoms of allergic rhinitis in patients aged six years and over.
Maltese: Sabiex il-mediċina tintuża sal-massimu tagħha, għandha tintuża regolarment u fl-istess ħin kuljum.
English: Other information about Avamys:
Maltese: Aktar tagħrif dwar Avamys:
English: Fields of activity include: the implementation of initiatives relating to clinical trials and manufacturing of active ingredients in China and India, and to international work-sharing activities in the field of GMP and GCP inspections; further collaboration with non-EU regulators in the context of confidentiality arrangements and mutual-recognition agreements; and contribution to international standardisation activities.
Maltese: Loqsma ta' attività jinkludu: l-implimentazzjoni tal-inizjattivi relatati mal-provi kliniċi u l-manifattura ta' ingredjenti attivi fiċ-Ċina u fl-Indja, u mal-attivitajiet internazzjonali ta' qsim tax-xogħol filqasam tal-ispezzjonijiet tal-GMP u l-GCP; aktar kollaborazzjoni ma' regolaturi mhux tal-UE fil kuntest tal-arranġamenti ta' kunfidenzjalità u l-ftehimiet ta' rikonoxximent reċiproku; ukontribuzzjoni għal attivitajiet ta' standardizzazzjoni internazzjonali.
English: Research Fellow, Institute of Clinical Immunology, Department of Internal Medicine III, NikolausFiebiger-Institut of Molecular Medicine, Erlangen.
Maltese: Fl-istess ħin, l-esperti tal-Aġenzija jikkontribwixxu għall-Inizjattiva dwar il-Mediċini Innovattivi (IMI) - il-ħidma pan-Ewropea mmirata biex tappoġġja l-innovazzjoni.
English: This work will result in the provision of better and more useful information to interested parties, including the health-technologyassessment bodies.
Maltese: Din il-ħidma sejra tirriżulta flgħoti ta' informazzjoni aħjar u aktar utli lill-partijiet interessati, inklużi l-korpi għall-valutazzjoni tat-teknoloġija tas-saħħa.
English: Community herbal monograph on Rosmarini aetheroleum
Maltese: Programm ta' ħidma 2010 tal-Aġenzija Ewropea talMediċini
English: Some of the topics relevant for 2010 include: current novel H1N1 influenza pandemic, research on and development of off-patent paediatric medicines, rare diseases, risk assessment, database on medicinal products to be used against bioterrorism agents, harmonisation of vaccination schedules, surveillance and pharmacovigilance of vaccines, antimicrobial resistance, cooperation to ensure consistency of scientific opinions, anti counterfeiting, provision of information, contribution to discussions on added therapeutic value, use of medicines in the food chain and for zoonotic diseases.
Maltese: Uħud minn dawn l-oqsma li sejrin jinfluwenzaw id-distribuzzjoni tar-riżorsi tal-Aġenzija fl-2010 jinkludu interazzjonijiet kumplessi bejn is-sitt kumitati xjentifiċi tal-Aġenzija, żidiet fil-post-awtorizzazzjoni, riferiment, attivitajiet relatati mas-sigurtà tal-mediċini u l-għoti ta' informazzjoni.
English: Multidisciplinary guideline: involved WPs are EWP-V, SWP-V and QWP
Maltese: L-implimentazzjoni tas-sistema l-ġdida ta' rimunerazzjoni tista' sseħħ fl-2010, wara lproġett pilota li tlesta fl-2009.
English: • fostering communication, provision of information and increasing transparency;
Maltese: • it-trawwim tal-komunikazzjoni, l-għoti ta' informazzjoni u ż-żieda tat-trasparenza;
English: Annex 1 Establishment plan 2008-2010..................................................52 Annex 2 Revenue and expenditure overview 2008-2010.........................53 Annex 3 Working-party guidelines..........................................................55 Annex 4 Personality profiles....................................................................82
Maltese: Għalhekk, ilvolum tal-attivitajiet, kif ukoll il-kumplessità tagħhom, qiegħed jikber minn sena għal oħra, u jrid jiġi akkomodat mill-Aġenzija u min-netwerk ta' msieħba tagħha.
English: • continuing to improve the safety-monitoring of medicines;
Maltese: • it-tkomplija tat-titjib tal-monitoraġġ tas-sigurtà tal-mediċini;
English: The focus in 2010 will include further implementation of the European risk-management strategy (ERMS), data-quality improvement in EudraVigilance, and support to the European Network of Centres for Pharmacovigilance and Pharmacoepidemiology.
Maltese: L-enfasi fl-2010 sejra tinkludi l-implimentazzjoni ulterjuri talistrateġija Ewropea dwar il-ġestjoni tar-riskji (ERMS), titjib fil-kwalità tad-dejta fl-EudraViġilanza, u appoġġ għan-Netwerk Ewropew taċ-Ċentri għall-Farmakoviġilanza u l-Farmakoepidemjoloġija.
English: Metabolism study to determine the quantity and identify the nature of residues (VICH GL 46) Comparative metabolism studies in laboratory animals (VICH GL 47) Marker residue depletion studies to establish product withdrawal periods (VICH GL48)
Maltese: Wara l-leġiżlazzjoni riċenti dwar il-prodotti mediċinali ta' terapija avvanzata, numru ta' bidliet leġiżlattivi addizzjonali diġà daħlu fis-seħħ, jew mistennija jidħlu fis-seħħ dalwaqt.
English: Community herbal monograph on Vitis viniferae folium
Maltese: L-Aġenzija sejra tibda wkoll it-tħejjijiet għal bidliet leġiżlattivi possibbli filfutur fl-oqsma tal-farmakoviġilanza u l-mediċini foloz.
English: At international level, the European Medicines Agency participates in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (including work with Standards Development Organisations (SDOs) and the Council for International Organizations of Medical Sciences (CIOMS)), works with the World Health Organization (WHO), the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), the Codex Alimentarius, the World Organisation for Animal Health (OIE), the US Food and Drug Administration (US FDA), the US Department of Agriculture (USDA) and the Japanese, Canadian and Australian authorities and with other non-ICH regulatory authorities.
Maltese: Dawn jinkludu rreviżjoni tar-Regolament dwar il-Varjazzjonijiet, li jġib modi ġodda ta' kif jingħataw ilvarjazzjonijiet, iżda li għandu wkoll implikazzjonijiet għall-finanzjament tal-Aġenzija, u rRegolament rivedut tal-Limiti Massimi ta' Residwi (MRL), li jippromwovi l-estrapolazzjoni tal-MRL u jestendi l-ambitu sabiex jiġu koperti prodotti bijoċidali, kif ukoll prodotti li jintużaw taħt il‘kategorija' preskrittiva.
English: ICH-E2C(R2)
Maltese: • it-tisħiħ tan-netwerk Ewropew tal-mediċini;
English: Education: Doctorate in physical sciences from Montpellier University; PhD in physical organic chemistry from Montpellier University, qualified in research management from Montpellier University; Masters degree in physical organic chemistry from Montpellier University; Degree in biochemistry from Nice University.
Maltese: Matul din is-sena għandha titlesta l-implimentazzjoni tal-istrateġija fit-tul tal-Aġenzija (Pjan Direzzjonali sal-2010) adottata mill-Bord ta' Tmexxija f'Diċembru 2004, u li tħejji bażi tajba għad-dokument tal-istrateġija l-ġdida, li sejra tkun mifruxa sal-2015.
English: The following activities also contribute to innovation and availability of medicines: continued implementation of orphan, advanced therapy and paediatric medicines policies, reinforcement of activities on medicines for geriatric populations, provision of scientific advice, operation of procedures shortening regulatory timeframes, stimulation of applications for products intended for non-EU markets in the context of cooperation with the WHO, support to veterinary pharmaceutical companies developing products indicated for minor uses/minor species (MUMS)/limited markets, contribution to the implementation of the action plans arising from the Heads of Medicines Agencies' Taskforce on Availability of Veterinary Medicinal Products and the Community Animal Health Strategy.
Maltese: Minħabba n-natura tal-ħidma tal-Aġenzija, wara l-awtorizzazzjoni ta' prodotti mediċinali ġodda, hemm żieda kumulattiva fil-ħidma meħtieġa sabiex jiġu ssorveljati dawk il-prodotti, jitwettqu attivitajiet ta' farmakoviġilanza u jitwettqu kompiti oħrajn ta' wara l-awtorizzazzjoni.
English: Community herbal monograph on Plantaginis lanceolatae folium
Maltese: Il-programm ta' ħidma għall-2010 huwa mfassal fi sfond dinamiku ta' bidliet fl-ambjent leġiżlattiv u kummerċjali tal-Aġenzija.
English: Certified Chartered Accountant from Chamber of Statutory Auditors and Certified Public Internal Auditor (CGAP) from Institute of Internal Auditors, Certified Validator of IA Quality Assessment from Institute of Internal Auditors Career to date: Mrs Weidlich held several posts in the Hungarian Civil Service, serving in the Ministry of Industry and Trade, Ministry of Finance as Commissioner to the Minister, Government Audit Office as Vice President.
Maltese: L-Aġenzija sejra tniedi l-websajt pubblika tagħha ddisinjata mill-ġdid, li għandha tipprovdi aċċess aktar faċli għall-informazzjoni li tingħata lill-pazjenti, il-professjonisti talkura tas-saħħa u l-intrapriżi.
English: • Inspection of clinical trials in collaboration with international partners.
Maltese: • il-kooperazzjoni mal-imsieħba internazzjonali u l-kontribut f'attivitajiet internazzjonali;
English: His areas of expertise include: quality and safety of biological medicines, including ATMP; clinical trials and risk mitigation strategies for first-in-man clinical trials; non-clinical development of biotechnology-derived medicinal products; unwanted immunogenicity of therapeutic proteins; concepts for comparability exercise for biotechnological medicinal products.
Maltese: Bħala parti minn dan il-kontribut, l-Aġenzija tmexxi proġett kollaborattiv Ewropew ta' ħames snin bil-għan li tiżviluppa metodi innovattivi fil-farmakoepidemjoloġija u l-farmakoviġilanza.
English: Questions and answers on diclofenac epolamine 50 mg tablets EMA/490203/2016 Rev. 1
Maltese: Mistoqsijiet u tweġibiet dwar il-pilloli diclofenac epolamine ta' 50 mg EMA/490203/2016 Rev.
English: EMA/490203/2016 Rev. 1 EMEA/H/A-29/1434
Maltese: EMA/490203/2016
English: The European Commission issued a decision on this opinion on 22-09-2016.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fi 22-09-2016.
English: Diclofenac epolamine (50 mg tablets) is a generic medicine based on a ‘reference medicine', Flector, which is authorised in France.
Maltese: Diclofenac epolamine (pilloli ta' 50 mg) huwa mediċina ġenerika bbażata fuq 'mediċina ta' referenza', Flector, li hija awtorizzata fi Franza.
English: Altergon Italia srl submitted diclofenac epolamine (50 mg tablets) to the UK medicines regulatory agency for a decentralised procedure.
Maltese: Altergon Italia srl ippreżentat diclofenac epolamine (pilloli ta' 50 mg) lill-aġenzija regolatorja talmediċini tar-Renju Unit għal proċedura deċentralizzata.
English: Diclofenac is a ‘non-steroidal anti-inflammatory drug' (NSAID) which reduces the body's production of substances called prostaglandins.
Maltese: Id-diclofenac hija "mediċina antiinfjammatorja nonsterojdali" (NSAID) li tnaqqas ilproduzzjoni ta' sustanzi msejħa prostaglandini fil-ġisem.
English: What is diclofenac epolamine (50 mg tablets)?
Maltese: X'inhu diclofenac epolamine (pilloli ta' 50 mg)?
English: On 21 July 2016, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine diclofenac epolamine (50 mg tablets).
Maltese: Fil-21 ta' Jannar 2016, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina diclofenac epolamine (pilloli ta' 50 mg).
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the UK) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Czech Republic, France and Slovakia).
Maltese: Din hija proċedura fejn Stat Membru wieħed (‘l-Istat Membru ta' referenza', f'dan il-każ ir-Renju Unit) jivvaluta mediċina bil-ħsieb li tingħata lawtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (‘l-Istati Membri kkonċernati', f'dan il-każ ir-Repubblika Ċeka, Franza u s-Slovakkja).
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to the CHMP for arbitration on 5 February 2016.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal ftehim u l-aġenzija regolatorja tal-mediċini tarRenju Unit irreferiet il-kwistjoni lis-CHMP għal arbitraġġ fil-5 ta' Ġunju 2016.
English: Because diclofenac epolamine (50 mg tablets) is a generic medicine, a study has been carried out to show that it is bioequivalent to the reference medicine, Flector, which is available as diclofenac
Maltese: Minħabba li diclofenac epolamine (pilloli ta' 50 mg) huwa mediċina ġenerika, sar studju sabiex jintwera li hija bijoekwivalenti għall-mediċina ta' referenza, Flector, li hija disponibbli bħala granuli ta' diclofenac
English: Questions and answers on diclofenac epolamine 50 mg tablets
Maltese: Mistoqsijiet u tweġibiet dwar il-pilloli diclofenac epolamine ta' 50 mg
English: The active substance in this medicine, diclofenac, is used for relief of pain and inflammation.
Maltese: Is-sustanza attiva f'din il-mediċina, id-diclofenac, tintuża għal serħan mill-uġigħ u minn infjammazzjoni.
English: Since some prostaglandins are involved in causing pain and inflammation at sites of injury or damage in the body, reduced prostaglandin production reduces pain and inflammation.
Maltese: Peress li xi prostaglandini huma involuti filkawża ta' uġigħ u infjammazzjoni f'siti ta' korriment jew ħsara fil-ġisem, tnaqqis fil-produzzjoni ta' prostaglandini jnaqqas l-uġigħ u l-infjammazzjoni.
English: The CHMP concluded that the benefits of these diclofenac epolamine 50 mg tablets do not outweigh their risks and recommended that marketing authorisation should not be granted in the UK or in the concerned Member States.
Maltese: Is-CHMP ikkonkluda li l-benefiċċji ta' dawn il-pilloli diclofenac epolamine ta' 50 mg ma jegħlbux ir-riskji tagħhom u rrakkomanda li lawtorizzazzjoni għat-tqegħid fis-suq ma għandhiex tingħata fl-Istati Membri kkonċernati.
English: The medicine was to be marketed as Diclofenac.
Maltese: Il-mediċina kellha titqiegħed fis-suq bħala Diclofenac.
English: A review of scientific literature showed variable reductions in the uptake of different forms of diclofenac when taken with food.
Maltese: Rieżami tal-letteratura xjentifika wriet tnaqqis varjabbli fit-teħid ta' forom differenti ta' diclofenac meta jittieħed mal-ikel.
English: Sweden Nycomed AB Box 27264
Maltese: Nycomed AB Box 27264
English: 102 53 Stockholm Sweden
Maltese: 102 53 Stockholm
English: Dhali Industrial Zone 1685 Nicosia
Maltese: Dhali Industrial Zone 1685
English: Quinta da Fonte Edificio Gil Eanes Paço D´Arcos 2770-192 Paço D` Arcos Portugal
Maltese: Quinta da Fonte Edificio Gil Eanes Paço D´Arcos 2770-192 Paço D` Arcos Il-Portugall
English: 2745-751 QUELUZ Portugal
Maltese: 2745-751 QUELUZ Il-Portugall
English: Nycomed Pharma Sp.z o.o.
Maltese: Nycomed Pharma Sp.z o.o. Al.
English: Al. Jerozolimskie 146A 02-305 Warsaw Poland
Maltese: Jerozolimskie 146A 02-305 Warsaw Il-Polonja
English: Nycomed France 13, rue Watt 75013 Paris France
Maltese: Nycomed France 13, rue Watt 75013 Paris Franza
English: Denmark Nycomed Denmark ApS Langebjerg 1
Maltese: Id-Danimarka Nycomed Denmark ApS Langebjerg 1
English: Almirall S.p.A via Messina, 38 Torre C 20154 Milan Italy
Maltese: Almirall S.p.A via Messina, 38 Torre C 20154 Milan L-Italja
English: Via Temolo 4 20126 Milan Italy
Maltese: Via Temolo 4 20126 Milan L-Italja
English: Germany Byk Tosse Arzneimittel GmbH, Moltkestr.
Maltese: Il-Ġermanja Byk Tosse Arzneimittel GmbH, Moltkestr.
English: Nycomed Italia S.r.l via Libero Temolo 4 20126 Milan Italy
Maltese: Nycomed Italia S.r.l via Libero Temolo 4 20126 Milan L-Italja
English: Somac 40 mg injektiokuivaaine, liuosta varten
Maltese: Somac 40 mg injektiokuiva-aine, liuosta varten
English: 78467 Konstanz Germany
Maltese: 78467 Konstanz
English: 78467 Constance
Maltese: 78467 Konstance
English: Luxembourg Nycomed Belgium SCA/CVA
Maltese: Il-Lussemburgu Nycomed Belgium SCA/CVA
English: Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse 5 1120 Vienna Austria
Maltese: L-Awstrija Nycomed Pharma GmbH Euro Plaza Gebäude F Technologiestrasse 5
English: Belgium Nycomed Belgium SCA/CVA Gentsesteenweg 615
Maltese: Nycomed Belgium SCA/CVA Gentsesteenweg 615
English: Recordati Industria Chimica e Farmaceutica S.p.A Via M. Civitali 1
Maltese: Via M. Civitali 1
English: 2132 HK Hoofddorp Netherlands
Maltese: Nycomed bv Jupiterstraat 250 2132 HK Hoofddorp L-Olanda
English: Zurcal 40 mg -Trockenstechampulle
Maltese: Zurcal 40 mgTrockenstechampulle
English: Luxembourg Nycomed Belgium SCA/CVA Gentsesteenweg 615
Maltese: Il-Lussemburgu Nycomed Belgium SCA/CVA Gentsesteenweg 615
English: Mundipharma Pharmaceuticals Ltd. Othellos str. 13
Maltese: Othellos str. 13
English: Pantoprazol NYC 20 mg 20 mg Gastro-resistant tablet
Maltese: Pantoprazol NYC 20 mg 20 mg Pillola gastro-reżistenti
English: Pantoprazol NYC 40 mg 40 mg Gastro-resistant tablet
Maltese: Pantoprazol NYC 40 mg 40 mg Pillola gastro-reżistenti
English: Somac 40 mg enterotabletti 40 mg Gastro-resistant tablet
Maltese: Somac 40 mg enterotabletti
English: Anagastra 20 mg Blister
Maltese: Anagastra 20 mg Blister 20 mg Pillola gastro-reżistenti
English: Somac 20 mg enterotabletti 20 mg Gastro-resistant tablet
Maltese: Somac 20 mg enterotabletti
English: Ulcotenal 40 mg Blister
Maltese: Ulcotenal 40 mg Blister 40 mg Pillola gastro-reżistenti
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: ANNESS I LISTA TA' L-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATAW, L-APPLIKANT(I), ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID
English: Anagastra 40 mg blister
Maltese: Anagastra 40 mg blister 40 mg Pillola gastro-reżistenti
English: Nycomed GmbH Byk-Gulden-Str.2 78467 Constance Germany
Maltese: Nycomed GmbH Byk-Gulden-Str.2 78467 Constance
English: Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Germany
Maltese: Nycomed GmbH Byk-Gulden-Str.2 78467 Konstanz Il-Ġermanja
English: Norway Nycomed GmbH Byk-Gulden-Str.2
Maltese: In-Norvegja Nycomed GmbH Byk-Gulden-Str.2
English: Slovenia Nycomed GmbH Byk-Gulden-Str.2
Maltese: Is-Slovenja Nycomed GmbH Byk-Gulden-Str.2
English: Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Germany
Maltese: Nycomed GmbH Byk-Gulden-Str.2 78467 Konstance Il-Ġermanja
English: Pantecta 40 mg Blister
Maltese: Pantecta 40 mg Blister 40 mg Pillola gastro-reżistenti
English: Pantoprazol 20 mg Byk
Maltese: Pantoprazol 20 mg Byk 20 mg Pillola gastro-reżistenti
English: Bulgaria Nycomed GmbH Byk-Gulden-Str.2
Maltese: Il-Bulgarija Nycomed GmbH Byk-Gulden-Str.2
English: Romania Nycomed GmbH Byk-Gulden-Str.2
Maltese: Ir-Rumanija Nycomed GmbH Byk-Gulden-Str.2
English: Hungary Nycomed GmbH Byk-Gulden-Str.2
Maltese: Il-Finlandja Nycomed GmbH Byk-Gulden-Str.2
English: • The risk of opportunistic infections and tuberculosis (TB) in patients treated with Remicade.
Maltese: • Bir-riskju ta' infezzjonijiet opportunistiċi u tuberkulożi (TB) f'pazjenti ikkurati b'Remicade.
English: • The risk of acute infusion related reactions and delayed hypersensitivity reactions.
Maltese: • Ir-riskju ta' reazzjonijiet akuti relatati ma' l-infużjoni u reazzjonijiet ta' sensittività eċċessiva ritardati.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED BY THE MEMBER STATES The Member States should ensure that the MAH provides an educational programme for Remicade to ensure that physicians who intend to prescribe Remicade to paediatric Crohn's disease patients are aware of:
Maltese: KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TA' L-UŻU MINGĦAJR PERIKLU U EFFETTIV TAL-PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU INDIRIZZATI
English: SanoSwiss UAB Litauen
Maltese: Sverige SanoSwiss UAB
English: Merckle GmbH Ludwig-Merckle Strasse 3 89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle Strasse 3 89143 Blaubeuren Il-Ġermanja
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 March 2012
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 26 ta' Marzu 2012
English: 4042 Debrecen
Maltese: 4042 Debrecen L-Ungerija
English: Manufacturer:
Maltese: Manufattur:
English: 98, 112 or 196 tablets.
Maltese: 98 u 112 jew 196 pillola.
English: Alvogen ehf.
Maltese: Ísland Alvogen ehf.
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, ACE inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Maltese: Kważi s-soġġetti kollha (95%) kienu qed jirċievu prodotti mediċinali kardjovaskulari (imblokkaturi beta, inibituri ACE, antagonisti ta' angiotensin II, imblokkaturi tal-kanali tal-kalċju, nitrati, dijuretiċi, aspirina, statins, fibrates).
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Maltese: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG Ir-Renju Unit
English: Tel: +370 700 01320
Maltese: Litauen Tel: +370 700 01320
English: Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12506 patients, 0.15%) than in control groups (7 cases from 10212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, P=0.029).
Maltese: Każijiet ta' kanċer tal-bużżieqa tal-awrina kienu rrappurtati b'mod aktar frekwenti f'meta-analiżi ta' provi kliniċi kkontrollati b'pioglitazone (19-il każ minn 12506 pazjent, 0.15%) milli fil-gruppi ta' kontroll (7 każijiet minn 10212 pazjent, 0.07%) HR = 2.64 (95% CI 1.11-6.31, p = 0.029).
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa< 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Pioglitazone Teva Pharma 15 mg tablets Pioglitazone Teva Pharma 30 mg tablets Pioglitazone Teva Pharma 45 mg tablets
Maltese: Pioglitazone Teva Pharma 15 mg pilloli Pioglitazone Teva Pharma 30 mg pilloli Pioglitazone Teva Pharma 45 mg pilloli
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Maltese: Ilpopolazzjoni taħt studju kellha eta' medja ta' 62 sena; it-tul medju tad-dijabete kienet ta' 9.5 snin.
English: Date of latest renewal: 17 February 2017
Maltese: Data tal-aħħar tiġdid: 17 ta' Frar 2017
English: Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
Maltese: Dupnitsa 2600, Il-Bulgarija
English: Nederland
Maltese: Nederland Teva
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Maltese: Folji tal-aluminju/aluminju, pakketti ta' 14, 28, 30, 50, 56, 84, 90, 98, 112 u 196 pillola.
English: Gastrointestinal disorders flatulence uncommon common
Maltese: Disturbi gastrointestinali gass mhux