FrancophonIA/ELRC3.0 huggingface dataset:
English: Since the benefit/risk reviews of dextropropoxyphene containing products were carried out in the UK, Sweden, France, and Ireland in 2005 - following which the fixed dose combination product (paracetamol + dextropropoxyphene) was withdrawn from the market in the UK, Sweden, and Ireland - a substantial body of important new safety information has become available.
Maltese: Minħabba li l-analiżijiet tal-benefiċċju u tar-riskju ta' prodotti li fihom dextropropoxyphene saru fir-Renju Unit, fl-Iżvezja, fi Franza u fl-Irlanda fl-2005 - u wara dawn l-analiżijiet, il-prodott ikkombinat b'doża fissa (paracetamol + dextropropoxyphene) ġie rtirat mis-suq fir-Renju Unit, fl-Iżvezja, u fl-Irlanda - sar disponibbli ammont sostanzjali ta' informazzjoni ta' sigurtà ġdida importanti.
English: The different figures provided by the available data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels.
Maltese: Iċ-ċifri differenti pprovduti mis-sorsi ta' dejta disponibbli (rapporti spontanji, ċentri forensiċi u tal-avvelenament, statistiċi nazzjonali tal-mortalità) urew, b'mod ġenerali, numru sinifikanti ta' każijiet ta' mewt li fihom dextropropoxyphene kien preżenti f'livelli tossiċi.
English: Across Member States, the authorised indications considerably vary from “moderate to severe pain”, “mild to moderate pain”, and “acute and chronic pains of different origins”.
Maltese: Fl-Istati Membri kollha, l-indikazzjonijiet awtorizzati jvajaw b'mod konsiderevoli minn “uġigħ moderat sa uġigħ qawwi”, “uġigħ ħafif sa uġigħ moderat”, u “uġigħ akut u kroniku ta' oriġini differenti”.
English: One possible risk minimisation measure, a reduced pack size (e.g. to only 10 tablets), is unlikely to be of any significant benefit in risk minimisation as the lethal dose (particularly when taken with alcohol) is under 10 tablets.
Maltese: Miżura ta' minimizzar tar-riskji possibbli, id-daqs iżgħar tal-pakkett (eż. sa 10 pilloli biss), aktarx li ma tkun ta' ebda benefiċċju sinifikanti fil-minimizzar tar-riskji minħabba li d-doża letali (b'mod partikolari meta tittieħed mal-alkoħol) hija taħt l-10 pilloli.
English: Risk Minimisation measures proposed by the MAHs included restriction of the use of the product (i.e. changes in SPC to restrict the population; pack size reduction), modification of the posology (e.g. reduction of posology in elderly population) and addition of further safety warnings (e.g. on concomitant use with alcohol, dependence and tolerance, combination with other central acting analgesics and overdose in children).
Maltese: Il-miżuri ta' Minimizzar tar-Riskji proposti mill-MAHs kienu jinkludu restrizzjoni tal-użu tal-prodott (jiġifieri bidliet fl-SPC sabiex tiġi ristretta l-popolazzjoni; daqs iżgħar tal-pakkett), tibdil fil-pożoloġija (eż. tnaqqis fil-pożoloġija fil-popolazzjoni anzjana) u ż-żieda ta' aktar twissijiet ta' sigurtà (eż. fuq l-użu konkomittanti mal-alkoħol, id-dipendenza u t-tolleranza, il-kombinazzjoni ma' analġeżiċi oħrajn li jaġixxu ċentralment u doża eċċessiva fit-tfal).
English: Available data showed only limited efficacy of the dextropropoxyphene medicinal products in the symptomatic treatment of pain.
Maltese: Id-dejta disponibbli uriet effikaċja limitata biss tal-prodotti mediċinali li fihom dextropropoxyphene filkura sintomatika tal-uġigħ.
English: In chronic pain, other combinations of paracetamol and an opioid (such as a fixed-dose combination of paracetamol and codeine phosphate), or a combination of a non-steroidal anti-inflammatory drug (NSAID) and an opioid other than dextropropoxyphene have been shown to be at least as effective as the fixed combination of dextropropoxyphene and paracetamol.
Maltese: Fl-uġigħ kroniku, taħlitiet oħra ta' paracetamol u opjojde (bħal taħlita ta' doża fissa ta' paracetamol u ta' codeine phosphate), jew taħlita ta' mediċina anti-infjammatorja mhux sterojde (NSAID) u opjojde li mhuwiex dextropropoxyphene urew li għandhom mill-inqas l-istess effett bħat-taħlita fissa ta' dextropropoxyphene u paracetamol.
English: - The Committee considered that dextropropoxyphene containing medicinal products showed only limited efficacy in the symptomatic treatment of pain;
Maltese: - Il-Kumitat ikkunsidra li l-prodotti mediċinali li fihom dextropropoxyphene urew biss effikaċja limitata fit-trattament sintomatiku tal-uġigħ;
English: Pharmacie Generiques 1115 Quai de Dion Bouton Immeuble Avant Seine 92816 Puteaux Cédex France
Maltese: Pharmacie Generiques 1115 Quai de Dion Bouton Immeuble Avant
English: Therefore, the CHMP concluded by majority that the benefit-risk balance of dextropropoxyphene containing medicinal products is negative and that its Opinion of 25 June 2009 should not be revised for oral/rectal dextropropoxyphene containing medicinal products and recommended the withdrawal of the Marketing Authorisations to be effective within the next 15 months of the Commission Decision in order to allow switching patients to safer alternatives, considering the extensive clinical use of dextropropoxyphene containing medicinal products and the wide patient exposure in some Member States.
Maltese: Għalhekk, is-CHMP ikkonkludiet b'maġġoranza li l-bilanċ bejn benefiċċju u riskju ta' prodotti mediċinali li fihom id-dextropropoxyphene huwa negattiv u li l-Opinjoni tiegħu tal-25 ta' Ġunju 2009 ma għandhiex tiġi riveduta għal prodotti mediċinali li fihom id-dextropropoxyphene u rrakkomandat l-irtirar talAwtorizzazzjonijiet għat-Tqegħid fuq is-Suq isir effettiv fi żmien il-15-il xahar li ġejjin mid-Deċiżjoni talKummissjoni sabiex tippermetti li pazjenti li jaqilbu għal alternattivi aktar siguri, , meta jiġi kkunsidrat lużu kliniku estensiv ta' prodotti mediċinali li fihom id-dextropropoxyphene u l-espożizzjoni wiesa talpazjent f'xi Stati Membri.
English: After reviewing all the available data, the CHMP considered that the different figures provided by the data sources (spontaneous reports, forensic and poison centres, national mortality statistics) showed overall a significant number of deaths in which dextropropoxyphene is present at toxic levels.
Maltese: Wara li eżamina mill-ġdid id-dejta kollha disponibbli, il-CHMP ikkunsidra li ċ-ċifri differenti pprovduti mis-sorsi tad-dejta (rapporti spontanji, ċentri forensiċi u tal-avvelenament, statistiċi nazzjonali talmortalità) urew b'mod ġenerali numru sinifikanti ta' każijiet ta' mewt li fihom dextropropoxyphene kien preżenti f'livelli tossiċi.
English: This means that one in every eight subjects with pain of moderate to severe intensity would experience at least 50% pain relief with dextropropoxyphene 65 mg who would not have done so with placebo.
Maltese: Dan ifisser li wieħed minn tmien suġġetti b'uġigħ ta' intensità moderata għal severa jesperjenza serħan ta' mill-inqas 50% mill-uġigħ b'dextropropoxyphene 65 mg li ma kienx ikollu l-istess effett bil-plaċebo.
English: However, the key safety concern with dextropropoxyphene is that it has a very narrow therapeutic index under normal conditions of use: following overdose, cardiac arrhythmias (which cannot be reversed using naloxone) and opioid side effects (such as respiratory depression) are rapid in onset and often fatal - there is evidence that the case fatality rate is higher than, for example, for tricyclic antidepressants.
Maltese: Madankollu, it-tħassib ewlieni fir-rigward tas-sigurtà b'dextropropoxyphene huwa li għandu indiċi terapewtiku dejjaq ħafna taħt kondizzjonijiet normali ta' użu: wara doża eċċessiva, arritmiji kardijaċi (li ma jistgħux jitreġġgħu lura b'naloxone) u effetti sekondarji opjojdi (bħal dipressjoni respiratorja) jitfaċċaw b'mod rapidu u spiss fatali - hemm evidenza li r-rata ta' każijiet fatali hija ogħla minn, pereżempju, dik tal-antidipressivi triċikliċi,
English: Ibuprofen has also shown to be more effective, as a single dose, in the management of severe postoperative pain; tramadol being equally effective in this setting.
Maltese: Ibuprofen wera wkoll li huwa aktar effikaċi, bħala doża unika, fil-ġestjoni tal-uġigħ sever ta' wara operazzjoni; tramadol kien effikaċi bl-istess mod f'din is-sitwazzjoni.
English: Sanofi-aventis France 1-13 Bd Romain Rolland 75014 Paris
Maltese: Sanofi-aventis France 1-13 Bd Romain Rolland 75014
English: Laboratories SMB s.a. 26-28 Rue de la Pastorale B-1080 Bruxelles Belgium
Maltese: Laboratories SMB s.a. 26-28
English: Member State Marketing Authorisation Holder Invented Name
Maltese: Stat Membru Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq
English: After considering the CHMP's major concerns over the toxicity of dextropropoxyphene, given its narrow therapeutic index and its adverse effects on the cardio - respiratory system as well as the lack of information in relation to the use of single component dextropropoxyphene medicinal products, the European Commission agreed on 31 March 2009 to the extension of the scope of the referral to also include authorised medicinal products containing only dextropropoxyphene.
Maltese: Wara li kkunsidrat it-tħassib ewlieni tal-CHMP dwar it-tossiċità ta' dextropropoxyphene, minħabba lindiċi terapewtiku dejjaq tiegħu u l-effetti avversi fuq is-sistema kardjo-respiratorja kif ukoll minħabba nnuqqas ta' informazzjoni fir-rigward tal-użu ta' prodotti mediċinali li fihom komponent uniku ta' dextropropoxyphene, fil-31 ta' Marzu 2009 il-Kummissjoni Ewropea qablet mal-estensjoni tal-iskop tarriferiment sabiex jinkludi wkoll prodotti mediċinali awtorizzati li fihom dextropropoxyphene biss.
English: Dextropropoxyphene containing medicinal products (as single component or combination with paracetamol or paracetamol/caffeine) are used in the symptomatic treatment of pain and are currently authorised in several Member States.
Maltese: Il-prodotti mediċinali li fihom dextropropoxyphene (bħala komponent uniku jew flimkien ma' paracetamol jew paracetamol/caffeine) jintużaw għall-kura sintomatika tal-uġigħ u attwalment huma awtorizzati f'bosta Stati Membri.
English: Similarly in Ireland, analysis in 2009 of further data from the Alcohol and Drug Research Unit of the Health Research Board revealed significant under-reporting of deaths associated with dextropropoxyphene-containing products - indicating fatality rates fifteen-fold higher than previously reported.
Maltese: Bl-istess mod, fl-Irlanda, l-analiżi ta' aktar dejta fl-2009 mill-Unità tar-Riċerka dwar l-Alkoħol u lMediċini tal-Bord tar-Riċerka dwar is-Saħħa żvelat nuqqas sinifikanti ta' rapportar ta' mwiet assoċjati ma' prodotti li fihom dextropropoxyphene - u indikat rati fatali ħmistax-il darba ogħla minn dak li kien ġie rrapportat qabel.
English: Sanofi- aventis France 1-13, boulevard Romain Rolland 75014 Paris
Maltese: Sanofi- aventis France 1-13, boulevard Romain Rolland 75014
English: Based on the limited efficacy and the significant risk of fatal overdose (in particular accidental overdose), the CHMP was of the opinion that the benefit/risk balance of dextropropoxyphene containing medicinal products was negative.
Maltese: Fuq il-bażi tal-effikaċja limitata u r-riskju sinifikanti ta' doża eċċessiva fatali (b'mod partikolari d-dożi eċċessivi aċċidentali), il-CHMP kien tal-opinjoni li l-bilanċ bejn il-benefiċċji u riskji tal-prodotti mediċinali li fihom dextropropoxyphene kien wieħed negattiv.
English: Risk Minimisation Measures
Maltese: Miżuri ta' Minimizzar tar-Riskji
English: Sanofi-aventis France 1-13, boulevard Romain Rolland75014 Paris France
Maltese: Sanofi-aventis France 1-13, boulevard Romain Rolland75014
English: The overall safety profile of the dextropropoxyphene containing medicinal products is based on an extensive post-marketing experience (over 40 years).
Maltese: Il-profil ġenerali tas-sigurtà tal-prodotti mediċinali li fihom dextropropoxyphene huwa bbażat fuq esperjenza kbira ta' wara t-tqegħid fis-suq (aktar minn 40 sena).
English: However no consideration was given to the need for national mortality data, and in particular forensic pathology data, to ensure that any risk minimisation measures are working: it is not possible to use routinely-collected (spontaneous) data to assess the effectiveness of the risk minimisation measures, because of the significant under-reporting of even serious adverse events, including death.
Maltese: Madankollu ma ġietx ikkunsidrata l-ħtieġa għal dejta ta' mortalità nazzjonali, u b'mod partikolari dejta tal-patoloġija forensika, biex ikun żgurat li l-miżuri ta' minimizzar tar-riskji qegħdin jaħdmu: m'huwiex possibbli li tintuża dejta miġbura bħala rutina (spontanja) sabiex tiġi vvalutata l-effikaċja tal-miżuri ta' minimizzar tar-riskji, minħabba n-nuqqas ta' rapportar sinifikanti ta' saħansitra avvenimenti avversi serji, inkluż mewt.
English: However, there is no clear evidence from clinical trials of superiority of efficacy of the combination of dextropropoxyphene and paracetamol compared with normal therapeutic doses of paracetamol alone, the trials which have suggested superiority to paracetamol alone have used sub-therapeutic doses of paracetamol.
Maltese: Madankollu, m'hemm ebda evidenza ċara minn provi kliniċi tas-superjorità tal-effikaċja tat-taħlita ta' dextropropoxyphene u paracetamol meta mqabbla ma' dożi terapewtiċi normali ta' paracetamol waħdu, il-provi li ssuġġerixxu superjorità għal paracetamol waħdu użaw dożi sub-terapewtiċi ta' paracetamol.
English: - The Committee also considered that a significant number of deaths have been reported in which dextropropoxyphene is present at toxic levels confirming that the risk of accidental fatal overdose associated with dextropropoxyphene containing medicinal products and their narrow therapeutic index is of major concern;
Maltese: - Il-Kumitat ikkonkluda, wara li kkunsidra d-dejta disponibbli, li r-riskju ta' doża eċċessiva fatali aċċidentali assoċjat mal-użu ta' prodotti mediċinali li fihom dextropropoxyphene fit-trattament sintomatiku tal-uġigħ huwa ħafna akbar mill-benefiċċji.
English: Although spontaneous reporting suggested that the safety signal concerning the overdose was not significant, other more complete data, particularly from forensic centres and national mortality statistics confirmed that the risk of accidental fatal overdose under normal conditions of use associated with dextropropoxyphene containing products is of major concern, mainly due to their narrow therapeutic index and high case fatality.
Maltese: Għalkemm ir-rappurtar spontanju ssuġġerixxa li s-sinjal ta' sigurtà dwar id-doża eċċessiva ma kienx sinifikanti, dejta oħra aktar kompluta, b'mod partikolari minn ċentri forensiċi u minn statistiċi nazzjonali tal-mortalità kkonfermat li r-riskju ta' doża eċċessiva fatali aċċidentali taħt kundizzjonijiet normali ta' użu assoċjat ma' prodotti mediċinali li fihom dextropropoxyphene huwa ta' tħassib ewlieni, l-aktar minħabba l-indiċi terapewtiku żgħir tagħhom u l-għadd kbir ta' każijiet ta' fatalità.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF DEXTROPROPOXYPHENE CONTAINING MEDICINAL PRODUCTS (see Annex I)
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' PRODOTTI MEDIĊINALI LI FIHOM DEXTROPROPOXYPHENE (ara l-Anness I)
English: Available efficacy data are limited due to methodological shortcomings such as the absence of a sample size calculation in the majority of the double-blind studies in acute pain and the lack of long term efficacy data to support the use of the fixed combination of dextropropoxyphene and paracetamol as a prolonged treatment.
Maltese: Għalkemm il-meta-analiżi disponibbli inkludiet l-aktar studji b'doża unika, din id-dejta pprovdiet ukoll perspettivi oħra fl-effikaċja tal-prodotti mediċinali li fihom dextropropoxyphene.
English: Having considered the detailed grounds for re-examination provided by the group of MAHs in writing and in an oral explanation, the CHMP considered that the design of the proposed clinical study to demonstrate the superior efficacy for combination of dextropropoxyphene and paracetamol versus paracetamol alone was flawed, and even a well-designed study would not change the benefit-risk balance of the dextropropoxyphene medicinal products in view of the narrow therapeutic index.
Maltese: Wara li kkunsidra r-raġunijiet dettaljati għal eżami mill-ġdid ipprovduti mill-grupp tal-MAHs bil-miktub u bi spjegazzjoni orali, is-CHMP ikkunsidra li d-disinn tal-istudju kliniku propost sabiex juri effikaċja superjuri għat-taħlita ta' dextropropoxyphene u paracetamol vs. paracetamol waħdu kien difettuż u anki. prova mfassla sew tista' ma tbiddilx il-bilanċ bejn benefiċċju u riskju tal-prodotti mediċinali dextropoxypheneminħabba l-indiċi terapewtiku dejjaq..
English: In view of the complex context in which cases of fatal overdose occurred under normal conditions of use and in view of the narrow therapeutic index and the potential for rapid death, the CHMP was of the opinion that the above proposed risk minimisation activities of narrowing the indication, reducing the pack sizes and/or introducing further safety warnings and contraindications (including those beyond the Product Information) would not be able to reduce the risks to an acceptable level.
Maltese: Minħabba l-kuntest kumpless li fih seħħew każijiet ta' doża eċċessiva fatali taħt kundizzjonijiet normali ta' użu u minħabba l-indiċi terapewtiku dejjaq u l-potenzjal ta' mewt malajr, il-CHMP kien tal-opinjoni li l-attivitajiet ta' limitazzjoni tal-indikazzjoni proposti hawn fuq għall-minimizzar tar-riskji , it-tnaqqis ddaqsijiet tal-pakketti u/jew l-introduzzjoni ta' aktar avviżi ta' sigurtà u kontra-indikazzjonijiet (inklużi dawk minbarra t-Tagħrif dwar il-Prodott) mhumiex sejrin ikunu jistgħu jnaqqsu r-riskji għal livell aċċettabbli.
English: 08041 Barcelona Spain
Maltese: 08041 Barcelona Spanja
English: Nurnberg D-90449 Germany
Maltese: Nurnberg D-90449
English: Baarnsche Dijk 1 3741 LN Baarn The Netherlands
Maltese: Baarnsche Dijk 1 3741 LN Baarn L-Olanda
English: Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Maltese: Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560
English: Rowex Ltd Bantry Co Cork Ireland
Maltese: Rowex Ltd Bantry Co Cork L-Irlanda
English: Via Cesarea 11/10 16121 Genova Italy
Maltese: Via Cesarea 11/10 16121 Genova L-Italja
English: Johnson & Johnson D.O.O Smartinska cesta 53 1000 Ljubljana Slovenia domperidone Motilium
Maltese: Johnson & Johnson D.O.O Smartinska cesta 53 1000 Ljubljana Slovenja domperidone Motilium
English: Via San Rocco 685033 Episcopia - Potenza Italy
Maltese: Via San Rocco 685033 Episcopia - Potenza L-Italja
English: 3062 CE Rotterdam The Netherlands
Maltese: 3062 CE Rotterdam L-Olanda
English: Faribérica, Productos Farmacêuticos, SA Estrada da Luz, 90-9° CDE 1600-160 Lissabon Portugal
Maltese: Faribérica, Productos Farmacêuticos, SA Estrada da Luz, 90-9° CDE 1600-160 Lissabon Il-Portugall
English: Alternova A/S Lodhusvej 11
Maltese: Id-Danimarka Alternova A/S Lodhusvej 11
English: SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini
Maltese: DEVELOPPEMENT 8, rue Bellini
English: United Kingdom Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
Maltese: Ir-Renju Unit Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
English: Str. Fabricii nr. 124, Cluj Napoca, Romania
Maltese: Fabricii nr. 124, Cluj Napoca, Ir-Rumanija
English: Via Pontina, 5 km 29 - 00040 Pomezia - Roma - Italy
Maltese: Via Pontina, 5 km 29 - 00040 Pomezia - Roma - L-Italja
English: Luxembourg eurogenerics SA esplanade heysel b22
Maltese: Il-Lussemburgu eurogenerics SA esplanade heysel b22
English: 3335 LH Zwijndrecht The Netherlands
Maltese: 3335 LH Zwijndrecht L-Olanda
English: Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien
Maltese: Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020
English: United Kingdom Manx Healthcare Limited Taylor Group House
Maltese: Ir-Renju Unit Manx Healthcare Limited Taylor Group House
English: United Kingdom Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co.
Maltese: Ir-Renju Unit Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co.
English: Janssen-Cilag (TIBOTEC) Hammerbakken 19
Maltese: Id-Danimarka Janssen-Cilag (TIBOTEC) Hammerbakken 19
English: Via Michelangelo buonarroti 23 20093 Cologno Monzese - Milano Italy
Maltese: Via Michelangelo buonarroti 23 20093 Cologno Monzese - Milano L-Italja
English: Archimedesweg 2 2333 CN Leiden The Netherlands
Maltese: Archimedesweg 2 2333 CN Leiden L-Olanda
English: 4230 Skaelskoer Denmark domperidone Domperidon "Alternova"
Maltese: 4230 Skaelskoer Id-Danimarka domperidone Domperidon "Alternova"
English: ABC FARMACEUTICI S.P.A., Corso Vittorio Emanuele II 72 , 10121 Torino
Maltese: S.P.A., Corso Vittorio Emanuele II 72 , 10121 Torino
English: United Kingdom Bristol Laboratories Limited Unit 3, Canalside
Maltese: Ir-Renju Unit Bristol Laboratories Limited Unit 3, Canalside
English: Actavis Nordic A/S Ornegardsvej 16 2820 Gentofte Denmark
Maltese: Actavis Nordic A/S Ornegardsvej 16 2820
English: United Kingdom Wockhardt UK Limited Ash Road North
Maltese: Ir-Renju Unit Wockhardt UK Limited Ash Road North
English: UAB „Johnson & Johnson“ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania
Maltese: UAB „Johnson & Johnson“ Geležinio Vilko g. 18A LT-08104 Vilnius Il-Litwanja
English: Via Firenze, 40 20060 Trezzano Rosa - Milano Italy
Maltese: Via Firenze, 40 20060 Trezzano Rosa - Milano L-Italja
English: Via Winckelmann 1 20146 Milano Italy
Maltese: Via Winckelmann 1 20146
English: 20092 Cinisello Balsamo - MilanoItaly
Maltese: 20092 Cinisello Balsamo - MilanoL-Italja
English: Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal domperidone Domperidona Actavis
Maltese: Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Il-Portugall domperidone Domperidona Actavis
English: United Kingdom McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
Maltese: Ir-Renju Unit McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
English: United Kingdom Focus Pharmaceuticals Limited Unit 5, Faraday Court
Maltese: Ir-Renju Unit Focus Pharmaceuticals Limited Unit 5, Faraday Court
English: Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B
Maltese: Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D.
English: McNeil Healthcare (Ireland) Limited Airton Road
Maltese: McNeil Healthcare (L-Irlanda) Limited
English: Athens, Greece domperidone OROPERIDYS
Maltese: Athens, Il-Greċja domperidone OROPERIDYS
English: Rua Manuel Ribeiro de Pavia, 11º - Venda Nova 2700-547 Amadora Portugal domperidone Cinet
Maltese: Rua Manuel Ribeiro de Pavia, 11º - Venda Nova 2700-547 Amadora
English: 10 mg capsule, hard
Maltese: 10 mg kapsula, iebsa
English: FARMAKOPEA S.P.A Via Cavriana 14 20134 Milano Italy
Maltese: FARMAKOPEA S.P.A Via Cavriana 14 20134
English: United Kingdom Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
Maltese: Ir-Renju Unit Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
English: 25 83607 Holzkirchen Germany
Maltese: 83607 Holzkirchen Il-Ġermanja
English: Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4
Maltese: João II, Lote 1.06.2.2 C - 7.3 e 7.4
English: M19 2RB Manchester United Kingdom
Maltese: M19 2RB Manchester Ir-Renju Unit
English: 10 mg/10 ml suspension
Maltese: 10 mg/10 ml suspensjoni
English: Slovak Republic Medochemie Ltd. 1-10 Constantinoupoleos St. P.O.
Maltese: Is-Slovakkja Medochemie Ltd. 1-10 Constantinoupoleos
English: 20060 Trezzano Rosa (MI) Italy
Maltese: Trezzano Rosa (MI) L-Italja
English: Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Portugal domperidone Domperidona Germed
Maltese: Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Il-Portugall domperidone Domperidona Germed
English: Via Ippolito Rossellini 12 20124 Milano Italy
Maltese: Via Ippolito Rossellini 12 20124
English: Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal domperidone Domperidona Baldacci
Maltese: Baldacci - Il-Portugall, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Il-Portugall domperidone Domperidona Baldacci
English: Hertogswetering 159 3543 AS Utrecht The Netherlands
Maltese: Mediq Farma B.V. Hertogswetering 159 3543 AS Utrecht L-Olanda