natgillin/translations-raw huggingface dataset:
For a single dose of dextropropoxyphene 65 mg in postoperative pain the number needed to treat to benefit for at least 50% pain relief was 7.7 (95% confidence interval 4.6 to 22) when compared with placebo over 4-6 hours.
Operatsioonijärgse valu raviks kasutatud dekstropropoksüfeeni ühe 65 mg annuse korral oli platseeboga võrreldes ravitoime avaldumist iseloomustav patsientide arv 7,7, kellel valu vähenes 4-6 tunni jooksul vähemalt 50% võrra (95% usaldusvahemik: 4,6-22).
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.
Kuigi spontaansed teated viitasid, et üleannustamise mõju ohutusele ei ole märkimisväärne, kinnitasid muud täielikumad andmed, eelkõige kohtuekspertiisikeskuste ja riikliku suremusstatistika andmed, et dekstropropoksüfeeni sisaldavate ravimitega seostatava juhusliku surmava üleannustamise risk ravimi kasutamisel tavapärastel tingimustel on raske probleem, peamiselt nende ravimite väikese terapeutilise indeksi ja suure letaalsuse tõttu.
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.
Olles kaalunud inimravimite komitee tõstatatud dekstropropoksüfeeni toksilisuse probleemi ning võttes arvesse toimeaine väikest terapeutilist indeksit ja kahjulikku mõju kardiorespiratoorsüsteemile, samuti teabe puudumist dekstropropoksüfeeni ainsa komponendina sisaldavate ravimite kasutamise kohta, nõustus Euroopa Komisjon 31. märtsil 2009 laiendama esildise ulatust nii, et see hõlmaks ka üksnes dekstropropoksüfeeni sisaldavaid müügiloaga ravimeid.
On the basis of the available data sources, the CHMP was of the opinion that spontaneous reporting was significantly underestimating the number of reported deaths associated with dextropropoxyphene.
Kättesaadavate andmeallikate põhjal jõudis inimravimite komitee arvamusele, et spontaansetes teadetes alahinnati märkimisväärselt dekstropropoksüfeeniga seotud teatatud surmajuhtumite arvu.
A substantial proportion of the fatal overdoses are accidental - occurring under normal conditions of use, for the licensed indication of painand there is a significant public health impact in relation to these cases alone.
Märkimisväärne osa surmavatest üleannustamistest on juhuslikud - need tekivad ravimi kasutamisel tavapärastel tingimustel registreeritud näidustuse (valu) raviks - ja ainuüksi nende juhtude mõju rahvatervisele on märkimisväärne.
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.
Kroonilise valu korral on muud paratsetamooli ja teatud opioidi kombinatsioonid (näiteks paratsetamooli ja kodeiinfosfaadi fikseeritud annuse kombinatsioon) või mittesteroidse põletikuvastase ravimi (NSAID) ja muu opioidi kui dekstropropoksüfeeni kombinatsioon osutunud vähemalt sama efektiivseks kui dekstropropoksüfeeni ja paratsetamooli fikseeritud kombinatsioon.
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.
Seetõttu otsustas inimravimite komitee enamushääletusega, et dekstropropoksüfeeni sisaldavate ravimite kasulikkuse ja riski suhe on negatiivne ning 25. juuni 2009 tehtud otsust dekstropropoksüfeeni sisaldavate oraalsete/rektaalsete ravimite kohta ei pea üle vaatama, ning soovitas komisjoni otsusele järgneva 15 kuu jooksul müügiload tagasi võtta, et võimaldada patsientidel üle minna ohutumatele alternatiivravimitele, arvestades dekstropropoksüfeeni sisaldavate ravimite ulatuslikku kliinilist kasutamist ja neid manustavate patsientide suurt arvu mõnes liikmesriigis.
In particular, more comprehensive mortality data at a national level from France, notably forensic toxicology results, provided evidence of a significantly greater number of deaths associated with the use of dextropropoxyphene-containing products than had previously been estimated.
Eelkõige andsid ülevaatlikumad suremuse andmed, mis pärinevad riiklikul tasemel Prantsusmaalt, nimelt kohtutoksikoloogilised tulemused, tõendeid märkimisväärselt suurema hulga dekstropropoksüfeeni sisaldavate preparaatide kasutamisega seotud surmajuhtumite kohta, kui oli hinnatud seni.
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.
Ravimi vähese efektiivsuse ja surmava üleannustamise (eelkõige juhusliku üleannustamise) märkimisväärse riski tõttu oli inimravimite komitee arvamusel, et dekstropropoksüfeeni sisaldavate ravimite kasulikkuse ja riski suhe on negatiivne.
- 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;
- komitee leidis samuti, et on teatatud märkimisväärselt suurest arvust surmajuhtumitest, mille korral on tuvastatud toksilises koguses dekstropropoksüfeeni; see kinnitab, et dekstropropoksüfeeni sisaldavate ravimitega seotud juhusliku surmava üleannustamise risk ja ravimite väike terapeutiline indeks on raske probleem;
The CHMP, having considered the matter as set out in the appended referral assessment report recommended the withdrawal of all the Marketing Authorisations for all oral/rectal medicinal products referred to in Annex I to be effective within the next 15 months after Commission Decision in order to allow switching patients to safer alternatives in particular, considering the extensive clinical use of dextropropoxyphene containing medicinal products and the wide patient exposure in some Member States.
Inimravimite komitee soovitas pärast esildise hindamisaruandes lisatud küsimuse kaalumist võtta tagasi I lisas nimetatud oraalsete/rektaalsete ravimite kõik müügiload komisjoni otsusele järgneva 15 kuu jooksul, et võimaldada patsientidel üle minna ohutumatele alternatiivravimitele, arvestades dekstropropoksüfeeni sisaldavate ravimite ulatuslikku kliinilist kasutamist ja neid manustavate patsientide suurt arvu mõnes liikmesriigis.
In acute pain, the fixed combination of dextropropoxyphene and paracetamol appeared to be an effective analgesic; this is to be expected, as paracetamol alone is an effective analgesic.
Ägeda valu korral osutus dekstropropoksüfeeni ja paratsetamooli fikseeritud kombinatsioon efektiivseks valuvaigistiks, mis oli ootuspärane, sest paratsetamool on ise efektiivne valuvaigisti.
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.
Tugeva operatsioonijärgse valu leevendamisel on efektiivsemaks osutunud ka ühe annusena manustatud ibuprofeen; tramadool on nendes tingimustes sama efektiivne.
Because of this, the most reliable data come from forensic analysis and national mortality statistics, and complete review of the fatal overdoses associated with dextropropoxyphene (alone and in combination with paracetamol/caffeine) supported the major concern over the fatal toxicity of dextropropoxyphene containing products under normal conditions of use due to their narrow therapeutic index.
Sel põhjusel on kõige usaldusväärsemad kohtuekspertiisianalüüsides ja riiklikus suremusstatistikas sisalduvad andmed ning täielik ülevaade dekstropropoksüfeeniga (nii ainsa toimeainena kui ka koos paratsetamooli/kofeiiniga) seotud surmavatest üleannustustest süvendasid ettevaatlikkust dekstropropoksüfeeni sisaldavate ravimite surmava toksilisuse ja väikese terapeutilise indeksi osas nende kasutamisel tavapärastes annustes.
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
LISA I RAVIMI(TE) NIMETUSTE, RAVIMVORMI(DE), TUGEVUS(T)E, MANUSTAMISVIISI(DE), MÜÜGILOA HOIDJA(TE) LOETELU LIIKMESRIIKIDES
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.
Olles läbi vaadanud kõik kättesaadavad andmed, leidis inimravimite komitee, et andmeallikatelt (spontaansed teated, kohtuekspertiisikeskused, mürgistusteabekeskused, riiklik suremusstatistika) saadud andmed näitavad üldiselt märkimisväärselt suurt surmajuhtumite arvu, mille korral on tuvastatud dekstropropoksüfeeni toksilised kogused.
Similarly, proposals to limit supplies for each prescription to at most 15 days, or one month, before review is needed by the prescriber, are unlikely to be of any significant benefit in risk minimisation: the patient will still have access to significant large quantity in excess of the lethal dose.
Samas ei ole tõenäoline, et riski minimeerimise seisukohalt oleks kasulik mõju ka ettepanekul piirata iga retsepti kestust kuni 15 päevani või ühe kuuni: patsiendil säilib siiski juurdepääs ravimi märkimisväärselt suurele kogusele, mis ületab surmavat annust.
While some patients find these products helpful in managing pain, results from clinical trials do not provide evidence for the superior efficacy of dextropropoxyphene alone or in combination with paracetamol, when compared with normal therapeutic doses of simple analgesics.
Kuigi mõne patsiendi arvates on nendest ravimitest valu leevendamisel kasu, ei kinnita kliiniliste uuringute tulemused lihtsate valuvaigistite tavaliste terapeutiliste annuste mõjuga võrreldes dekstropropoksüfeeni suuremat efektiivsust ei iseseisva ravimina ega ka kombinatsioonis paratsetamooliga.
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.
Olles kaalunud kõiki müügiloa hoidjate kirjalike ja suuliste selgitustena esitatud andmeid, otsustas inimravimite komitee, et soovitatud kliinilise uuringu ülesehitus, mis tõendaks dekstropropoksüfeeni ja paratsetamooli kombinatsiooni suuremat efektiivsust võrreldes üksnes paratsetamooli manustamisega, oli puudulik ja isegi hea ülesehitusega kliiniline uuring ei muudaks dekstropropoksüfeeni kasulikkuse ja riski suhet selle väikese terapeutilise indeksi tõttu.
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.
Kättesaadavatest andmeallikatest (spontaansed teated, kohtuekspertiisikeskuste ja mürgistusteabekeskuste andmed, riiklik suremusstatistika) pärinevad andmed näitavad üldiselt märkimisväärselt suurt surmajuhtumite sagedust, mille korral on tuvastatud dekstropropoksüfeeni toksilises koguses.
Modified release capsule Oral use
Toimeainet modifitseeritult vabastav kapsel
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.
Kliinilistes uuringutes ei ole aga saadud selgeid tõendeid, et dekstropropoksüfeeni ja paratsetamooli kombinatsioon oleks efektiivsem kui ainult paratsetamooli tavalised terapeutilised annused - ainult paratsetamooli suuremale efektiivsusele viitavates uuringutes kasutati paratsetamooli subterapeutilisi annuseid.
España
Hispaania
- The Committee considered that dextropropoxyphene containing medicinal products showed only limited efficacy in the symptomatic treatment of pain;
- komitee leidis, et dekstropropoksüfeeni sisaldavate ravimite efektiivsus valu sümptomaatilises ravis on piiratud;
Available data showed only limited efficacy of the dextropropoxyphene medicinal products in the symptomatic treatment of pain.
Kättesaadavad andmed näitasid, et valu sümptomaatilises ravis oli dekstropropoksüfeeni sisaldavate ravimite efektiivsus piiratud.
Prolonged-release capsule, hard
Toimeainet prolongeeritult vabastav kapsel
Apart from the strengthened warnings, and more extensive contra-indications, proposed by several MAHs, the other proposals for changes in the SPCs and PLs - for example, in relation to indication - reflected the existing variations across Europe and were often not internally consistent: for example, the proposal that chronic pain should be explicitly contra-indicated, in the context of a SPC also having instructions in relation to repeat prescriptions “which should not exceed three months”.
Peale rangemate hoiatuste ja ulatuslikumate vastunäidustuste, mida pakkusid välja mitu müügiloa hoidjat, kajastasid teised ravimi omaduste kokkuvõtte ja pakendi infolehe muudatused - nt seoses näidustusegaolemasolevat varieeruvust Euroopas.
Rua Consiglieri Pedroso 123 Queluz de Baixo Apartado 1001 2731 901 Barcarena Portugal
2731 901 Barcarena Portugal
Prolonged-release capsule Oral use
Toimeainet prolongeeritult vabastav kõvakapsel
Rectal use
Rektaalsuposiit
Pº de Las Doce Estrellas, 5-7 28042 Madrid
P° de Las Doce Estrellas, 5-7 28042 Madrid
United Kingdom Manx Healthcare Limited Taylor Group House
Ühendkuningriik Manx Healthcare Limited Taylor Group House
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Ravimi nimetuste, ravimvormide, tugevuste, manustamisviiside, müügiloa hoidjate loetelu liikmesriikides
Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4
Parque Expo, Edificio Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4
United Kingdom Wockhardt UK Limited Ash Road North
Ühendkuningriik Wockhardt UK Limited Ash Road North
Quinta da Fonte, Rua Vitor Câmara, 2 - Edifício D. Amélia, Piso 1, Ala B
Quinta da Fonte, Rua Vitor Câmara, 2 - Edificio D. Amélia, Piso 1, Ala B
M19 2RB Manchester United Kingdom
M19 2RB Manchester
United Kingdom Bristol Laboratories Limited Unit 3, Canalside
Ühendkuningriik Bristol Laboratories Limited Unit 3, Canalside
Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16º Piso, Amoreiras
Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16° Piso, Amoreiras
United Kingdom Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
Ühendkuningriik Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar,
RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3
Prantsusmaa RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3
Luxembourg eurogenerics SA esplanade heysel b22
Luksemburg eurogenerics SA esplanade heysel b22
Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart
Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium
United Kingdom Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co.
Ühendkuningriik Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co.
3062 CE Rotterdam The Netherlands
3062 CE Rotterdam
SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini
Prantsusmaa SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini
Slovak Republic Medochemie Ltd. 1-10 Constantinoupoleos St. P.O.
Slovaki Vabariik Medochemie Ltd. 1-10 Constantinoupoleos St. P.O.
3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette FRANCE
Prantsusmaa ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette FRANCE
United Kingdom Focus Pharmaceuticals Limited Unit 5, Faraday Court
Ühendkuningriik Focus Pharmaceuticals Limited Unit 5, Faraday Court
Bellwood Pharmaceuticals Ltd. First Floor 69, St. Patricks Road Dalkey, Co. Dublin Ireland
Madalmaad Bellwood Pharmaceuticals Ltd. First Floor 69, St. Patricks Road Dalkey, Co. Dublin
Samenwerkende Apothekers Nederland B.V.
Madalmaad Samenwerkende Apothekers Nederland B.V.
Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal domperidone Domperidona Ratiopharm
Lagoas Park, Edificio 5 A, Piso 2 2740-245 Porto Salvo Portugal domperidone Domperidona Ratiopharm
United Kingdom Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
Ühendkuningriik Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire
United Kingdom McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
Ühendkuningriik McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG,
Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal domperidone Remotil
Edificios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal domperidone Remotil
150 00 Praha 5 - Smíchov Czech Republic domperidone Motilium
150 00 Praha 5 - Smichov Czech Republic domperidone Motilium
Rua Manuel Ribeiro de Pavia, 11º - Venda Nova 2700-547 Amadora Portugal domperidone Cinet
Rua Manuel Ribeiro de Pavia, 11° - Venda Nova 2700-547 Amadora Portugal domperidone Cinet
1, rue Camille Desmoulins TSA 91003
Prantsusmaa Janssen-Cilag 1, rue Camille Desmoulins TSA 91003
10 mg/10 ml suspension
10 mg/10 ml suspensioon
mg/100 ml syrup
mg/100 ml siirup
KELA Pharma nv Industriepark West 68 9100 Sint-Niklaas Belgium
Kela Pharma nv Industriepark 68 9100 Sint-Niklaas Belgium
Faribérica, Productos Farmacêuticos, SA Estrada da Luz, 90-9° CDE 1600-160 Lissabon Portugal
Estrada da Luz, 90-9° CDE 1600-160 Lissabon
United Kingdom Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidone maleate
Ühendkuningriik Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom domperidone maleate
Belgium Kela Pharma nv Industriepark 68
Madalmaad KELA Pharma nv Industriepark West 68
MEDOCHEMIE LTD 1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos Cyprus domperidone COSTI TABLETS 10MG
MEDOCHEMIE LTD 1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos Cyprus domperidone COSTI TABLETS 10MG 10 mg tablett
JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA
JOHNSON & JOHNSON HEΛΛAƩ CONSUMER SA
United Kingdom Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate
Ühendkuningriik Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stokeon-Trent, Staffordshire ST3 7UN United Kingdom domperidone maleate
Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal domperidone Domperidona Labesfal
Labesfal Genéricos, S.A Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal domperidone Domperidona Labesfal 10 mg tablett
Belgium Apotex NV Av Etienne Demunter 5/8 1090 Brussels
Av Etienne Demunter 5/8 1090 Brussels Belgium
Hamwells Business Park Unit No7, Hardicker Street
Madalmaad Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No7, Hardicker Street
Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal domperidone Domperidona Actavis
Actavis A/S Sucursal Rua Virgilio Correia, 11 - A 1600-219 Lisboa Portugal domperidone Domperidona Actavis 10 mg tablett
1 mg/ml suspension
1 mg/ml suspensioon
20 mg/ 19 mg tablet
20 mg/ 19 mg tablett
United Kingdom Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom domperidone maleate
Ühendkuningriik Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD,
Rua Alto do Montijo, 13 - 1º DtoEdifício Monsanto 2790-012 Portela de Carnaxide Portugal domperidone Domperidona Germed
Rua Alto do Montijo, 13 - 1° DtoEdificio Monsanto 2790-012 Portela de Carnaxide Portugal domperidone Domperidona Germed 10 mg õhukese polümeerikattega tablett
20 mg / 15 mg tablet
20 mg / 15 mg tablett
Baldacci - Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal domperidone Domperidona Baldacci
Baldacci - Portugal, S.A. Rua Candido de Figueiredo, 84-B 1549-005 Lisboa Portugal domperidone Domperidona Baldacci 10 mg õhukese polümeerikattega tablett
United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom domperidone Domperidone 1mg/ml Oral
Ühendkuningriik Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom domperidone Domperidone 1mg/ml Oral Suspension
United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidone maleate
Ühendkuningriik Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom domperidone maleate
Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom
Madalmaad Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom
ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France domperidone DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé
Prantsusmaa ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France domperidone DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé
Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal domperidone Domperidona Generis
Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal domperidone Domperidona Generis 10 mg õhukese polümeerikattega tablett
Domperidone Motilium Tropfen 10 mg oral drops, suspension
Domperidone Motilium Tropfen 10 mg suukaudsed tilgad, suspensioon
CRISTERS 22 quai Gallieni 92150 Suresnes France domperidone DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible
Prantsusmaa CRISTERS 22 quai Gallieni 92150 Suresnes France domperidone DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible
Sandoz B.V.
Madalmaad Sandoz B.V.
Hertogswetering 159 3543 AS Utrecht The Netherlands
3543 AS Utrecht
2794-093 Carnaxide Portugal domperidone Domperidona ToLife 10 mg tablet
2794-093 Carnaxide Portugal domperidone Domperidona ToLife 10 mg tablett
1070-274 Lisboa Portugal domperidone Domperidona Wynn 10 mg tablet
1070-274 Lisboa Portugal domperidone Domperidona Wynn 10 mg tablett
2700-451 Amadora Portugal domperidone Domperidona GP 10 mg tablet
2700-451 Amadora Portugal domperidone Domperidona GP 10 mg tablett
2770-229 Paço de Arcos Portugal domperidone Domperidona Ciclum 10 mg tablet
2770-229 Paço de Arcos Portugal domperidone Domperidona Ciclum 10 mg tablett
ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France domperidone DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé
Prantsusmaa ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre