FrancophonIA/ELRC3.0 huggingface dataset:
English: • The radiolabelled medicine is used to treat adult patients with follicular B cell non Hodgkin's lymphoma.
Maltese: Il-mediċina radjummarkata tintuża għat-trattament ta' pazjenti adulti b'linfoma mhux ta' Hodgkin follikulari b'ċelluli B.
English: EMA/220635/2014 EMEA/H/C/003880
Maltese: EMEA/H/C/003880
English: The medicine can only be obtained with a prescription and is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg).
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta ta' tabib u hija disponibbli bħala kapsuli (25, 50, 75, 100, 150, 200, 225 u 300 mg).
English: This summary was last updated in 04-2014.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 04-2014.
English: The full EPAR and risk management plan summary for Pregabalin Pfizer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Pregabalin Pfizer jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended starting dose of Pregabalin Pfizer is 150 mg per day,
Maltese: Id-doża rakkomandata inizjali ta' Pregabalin Pfizer hija ta' 150 mg kuljum,
English: The active substance in Pregabalin Pfizer, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma-amino butyric acid (GABA), but has very different biological effects.
Maltese: Is-sustanza attiva f'Pregabalin Pfizer, pregabalin, hija simili fl-istruttura għall-aċidu butriku tal-gammaamino (GABA) ‘newrotrażmettitur' tal-ġisem stess, iżda għandha effetti bijoloġiċi differenti ħafna.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Pfizer on 10 April 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pregabalin Pfizer fl-10 ta' April 2014.
English: Pregabalin Pfizer is a medicine that contains the active substance pregabalin.
Maltese: Pregabalin Pfizer huwa mediċina li fiha s-sustanza attiva pregabalin.
English: Pregabalin Pfizer has been compared with placebo (a dummy treatment) in 22 studies.
Maltese: Pregabalin Pfizer tqabbel ma' plaċebo (kura finta) fi 22 studju.
English: In epilepsy, the benefits of Pregabalin Pfizer were evaluated in 3 studies involving 1,000 patients that looked at how much it reduced the number of seizures patients had after 11 to 12 weeks.
Maltese: F'każ ta' epilessija, il-benefiċċji ta' Pregabalin Pfizer ġew evalwati fi 3 studji li involvew 1,000 pazjent u li studjaw kemm naqqas in-numru ta' aċċessjonijiet li l-pazjenti kellhom wara 11 sa 12-il ġimgħa.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Pfizer.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pregabalin Pfizer.
English: About 45% of the patients taking 600 mg Pregabalin Pfizer a day and about 35% of those taking 300 mg Pregabalin Pfizer a day had a reduction in seizures of 50% or more.
Maltese: Madwar 45% tal-pazjenti li ħadu 60 mg ta' Pregabalin Pfizer u madwar 35% ta' dawk li ħadu 300 mg ta' Pregabalin Pfizer kuljum kellhom tnaqqis fl-aċċessjonijiet b'50% jew aktar, meta mqabbla ma' madwar 10% tal-pazjenti li ħadu plaċebo.
English: Other information about Pregabalin Pfizer
Maltese: Informazzjoni oħra dwar Pregabalin Pfizer:
English: In a smaller study involving 137 patients with central neuropathic pain due to a spinal cord injury, 22% of patients treated with Pregabalin Pfizer had a decrease in pain scores of 50% or more, compared with 8% of the patients treated with placebo.
Maltese: Fi studju iżgħar ieħor li involva 137 pazjent b'uġigħ newropatiku ċentrali minħabba ħsara fil-mudullun tas-sinsla tad-dahar, 22% tal-pazjenti kkurati bi Pregabalin Pfizer kellhom tnaqqis fil-punteġġi tal-uġigħ ta' 50% jew aktar, meta mqabbla ma' 8% tal-pazjenti kkurati bi plaċebo.
English: In 10 studies involving over 3,000 patients with peripheral neuropathic pain (either diabetic pain or shingles), 35% of the patients treated with Pregabalin Pfizer had a decrease in pain scores of 50% or more, compared with 18% of the patients treated with placebo.
Maltese: F'10 studji li involvew ‘il fuq minn 3,000 pazjent b'uġigħ newropatiku periferali (jew uġigħ dijabetiku jew ħruq ta' Sant'Antnin), 35% tal-pazjenti kkurati bi Pregabalin Pfizer kellhom tnaqqis fil-punteġġi tal-uġigħ ta' 50% jew aktar meta mqabbla ma' 18% talpazjenti kkurati bi plaċebo.
English: Pregabalin Pfizer was more effective than placebo in generalised anxiety disorder: in 8 studies involving over 3,000 patients, 52% of the patients taking Pregabalin Pfizer had an improvement of 50% or more in their anxiety measured with a standard anxiety questionnaire, compared with 38% of the patients taking placebo.
Maltese: F'każ ta' disturb tal-ansjetà ġeneralizzat, Pregabalin Pfizer kien aktar effikaċi mill-plaċebo: fi 8 studji li involvew aktar minn 3,000 pazjent, 52% tal-pazjenti li ħadu Pregabalin Pfizer kellhom titjib b'50% jew aktar fl-ansjetà mkejla bi kwestjonarju tal-ansjetà standard, meta mqabbla ma' 38% tal-pazjenti li ħadu plaċebo.
English: This medicine is the same as Lyrica, which is already authorised in the European Union (EU).
Maltese: Din il-mediċina hija l-istess bħal Lyrica, li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: The company that makes Lyrica has agreed that its scientific data can be used for Pregabalin Pfizer (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Lyrica qablet li d-dejta xjentifika tagħha tista' tintuża għal Pregabalin Pfizer (“kunsens infurmat”).
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Maltese: • uġigħ newropatiku (uġigħ dovut għal ħsara fin-nervituri) inkluż uġigħ newropatiku periferiku, bħal uġigħ esperjenzat minn pazjenti b'dijabete jew li għandhom il-herpes zoster (ħruq ta' Sant'Antnin), u wġigħ newropatiku ċentrali, bħalma huwa wġigħ esperjenzat minn pazjenti li kellhom ħsara filmudullun tas-sinsla tad-dahar;
English: Why is Pregabalin Pfizer approved?
Maltese: Għaliex ġie approvat Pregabalin Pfizer?
English: The capsules should be swallowed whole with water.
Maltese: Il-kapsuli għandhom jinbelgħu sħaħ mal-ilma.
English: Pregabalin Pfizer pregabalin
Maltese: Kif jintuża Pregabalin Pfizer?
English: In neuropathic pain, the benefits of Pregabalin Pfizer were evaluated for up to 12 weeks using a standard pain questionnaire.
Maltese: Għall-uġigħ newropatiku, il-benefiċċji ta' Pregabalin Pfizer ġew evalwati għal massimu ta' 12-il ġimgħa bl-użu ta' kwestjonarju standard dwar l-uġigħ.
English: What are the risks associated with Pregabalin Pfizer?
Maltese: X'inhuma r-riskji assoċjati ma' Pregabalin Pfizer?
English: Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Maltese: Innewrotrażmettituri huma sustanzi kimiċi li jippermettu liċ-ċelluli nervużi jikkomunikaw ma' xulxin.
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in pain, epilepsy and anxiety.
Maltese: Dan inaqqas l-attività ta' xi ċelluli nervużi fil-moħħ u filmudullun tas-sinsla tad-dahar, billi jnaqqas ir-rilaxx ta' newrotrażmettituri oħrajn li huma involuti fluġigħ, l-epilessija u l-ansjetà.
English: How does Pregabalin Pfizer work?
Maltese: Kif jaħdem Pregabalin Pfizer?
English: References.
Maltese: Referenzi.
English: 30 September 2014 EMA/631408/2014
Maltese: EMA/631408/2014
English: • a meta-analysis of three WHO studies3,4,5, which primarily included African and Asian women.
Maltese: • meta-analiżi ta' tliet studji tal-WHO3,4,5, li primarjament inkludew nisa Afrikani u Ażjatiċi.
English: Contact our press officers Monika Benstetter or Martin Harvey
Maltese: Ikkuntattja l-ufficjali tal-istampa tagħna Monika Benstetter jew Martin Harvey
English: Glasier A et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized noninferiority trial and meta-analysis.
Maltese: Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized noninferiority trial and meta-analysis.
English: 4. von Hertzen H et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
Maltese: Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial.
English: 3. von Hertzen H et al. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception.
Maltese: Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception.
English: Lancet 1998; 352: 428-33.
Maltese: Lancet 1998; 352: 428-33. 4. von Hertzen H et al.
English: • a meta-analysis of two published studies1,2, which primarily included Caucasian women, where a reduced contraceptive efficacy was observed with increased bodyweight or BMI (pregnancy rate was 0.96% [CI: 0.44-1.82] in women with BMI 18.5-25; 2.36% [CI: 1.02-4.60] in women with BMI 25-30; and 5.19% [CI: 2.62-9.09] in women with BMI ≥30).
Maltese: • meta-analiżi ta' żewġ studji ppubblikati1,2, li primarjament inkludew nisa Kawkasi, fejn effikaċja mnaqqsa ta' kontraċezzjoni ġiet osservata b'żieda fil-piż tal-ġisem jew BMI (rata ta' tqala kienet 0.96% [CI: 0.44-1.82] f'nisa b'BMI 18.5-25; 2.36% [CI: 1.02-4.60] f'nisa b'BMI 25-30; u 5.19% [CI: 2.62-9.09] f'nisa b'BMI ≥30).
English: The results of this analysis conflict with the results above and show no trend for a reduced efficacy with increasing bodyweight/BMI (pregnancy rate was 0.99% [CI: 0.70-1.35] in women with BMI 18.525; 0.57% [CI: 0.21-1.24] in women with BMI 25-30; and 1.17% [CI: 0.24-3.39] in women with BMI ≥30).
Maltese: Ir-riżultati ta' din l-analiżi ma jaqblux mar-riżultati hawn fuq u ma juru ebda tendenza għal tnaqqis fl-effikaċja ma' żieda fil-piż tal-ġisem/BMI (rata ta' tqala kienet 0.99% [CI: 0.70-1.35] f'nisa b'BMI 18.5-25; 0.57% [CI: 0.21-1.24] f'nisa b'BMI 25-30; u 1.17% [CI: 0.24-3.39] f'nisa b'BMI ≥30).
English: In November 2013, following a national procedure, the product information of one emergency contraceptive containing levonorgestrel, Norlevo, was updated on the basis of results from two clinical studies to state that Norlevo is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg. An EU-wide review was then started to assess whether similar information should be included in the product information for other emergency contraceptives that contain levonorgestrel, and for ellaOne, an emergency contraceptive that contains ulipristal acetate.
Maltese: F'Novembru 2013, wara proċedura nazzjonali, l-informazzjoni dwar il-prodott ta' kontraċettiv ta' emerġenza wieħed li fih levonorgestrel, Norlevo, ġiet aġġornata fuq il-bażi ta' riżultati minn żewġ studji kliniċi sabiex tgħid li Norlevo huwa inqas effettiv f'nisa li jiżnu 75 kg jew aktar u mhux effettiv f'nisa li jiżnu aktar minn 80 kg.
English: The emergency contraceptives included in this review are medicines containing levonorgestrel, such as Norlevo, Levonelle/Postinor and Levodonna, which have been authorised in the EU through national procedures.
Maltese: Il-kontraċettivi ta' emerġenza inklużi f'din ir-reviżjoni huma mediċini li fihom levonorgestrel, bħal Norlevo, Levonelle/Postinor u Levodonna, li ġew awtorizzati fl-UE permezz ta' proċeduri nazzjonali.
English: The review of emergency contraceptives containing levonorgestrel and ulipristal acetate was initiated in January 2014 at the request of Sweden, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni tal-kontraċettivi ta' emerġenza li fihom levonorgestrel u ulipristal acetate inbdiet f'Jannar 2014 fuq it-talba tal-Isvezja, skont l-Artiklu 31 tad-Direttiva 2001/83/KE.
English: Both meta-analyses did not include off-label use (i.e. intake later than 72 hours after unprotected sexual intercourse).
Maltese: Iż-żewġ meta-analiżi ma inkludewx użu off-label (jiġifieri teħid aktar tard minn 72 siegħa wara att sesswali mhux protett).
English: The CHMP opinion was then forwarded to the European Commission, which issued a final legally binding decision on 30 September 2014.
Maltese: L-opinjoni tas-CHMP imbagħad ġiet mgħoddija lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali li torbot legalment fit-30 ta' Settembru 2014.
English: Information for women
Maltese: Informazzjoni għan-nisa
English: The review also included a centrally-authorised medicine, ellaOne, which contains ulipristal acetate and was granted a marketing authorisation in the EU in 2009.
Maltese: Ir-reviżjoni inkludiet ukoll mediċina li ġiet awtorizzata b'mod ċentrali, ellaOne, li fiha ulipristal acetate u ngħatat awtorizzazzjoni għat-tqegħid fissuq fl-UE fl-2009.
English: • Emergency contraceptives can continue to be used to prevent unintended pregnancy in women of any weight or body mass index (BMI).
Maltese: • Kontraċettivi ta' emerġenza jistgħu jibqgħu jintużaw biex tiġi evitata tqala mhux intenzjonata f'nisa ta' kwalunkwe piż jew ta' kwalunkwe indiċi tal-massa tal-ġisem (BMI).
English: Similarly, for ulipristal acetate, although limited data from clinical trials suggest a possible trend for a reduced contraceptive effect, the data are too limited and insufficiently precise to draw definite conclusions.
Maltese: Bl-istess mod, għal ulipristal acetate, għalkemm dejta limitata minn provi kliniċi tissuġġerixxi tendenza possibbli għal effett kontraċettiv imnaqqas, id-dejta hija limitata wisq u mhux preċiża biżżejjed biex jinstiltu konklużjonijiet definiti.
English: For emergency contraceptives containing levonorgestrel, the Agency considered the following data:
Maltese: Għal kontraċettivi ta' emerġenza li fihom levonorgestrel, l-Aġenzija kkunsidrat id-dejta li ġejja:
English: Those containing levonorgestrel can be used up to 72 hours after unprotected sexual intercourse or contraceptive failure, while ulipristal acetate can be used up to 120 hours.
Maltese: Dawk li fihom levonorgestrel jistgħu jintużaw sa 72 siegħa wara att sesswali mhux protett jew falliment talkontraċettiv, filwaqt li ulipristal acetate jista' jintuża sa 120 siegħa.
English: On 24 July 2014, the European Medicines Agency concluded its review of emergency contraceptives containing levonorgestrel or ulipristal acetate to assess whether increased bodyweight affects the effectiveness of these medicines in preventing unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
Maltese: Fl-24 ta' Lulju 2014, l-Aġenzija Ewropea għall-Mediċini temmet ir-reviżjoni tagħha tal-kontraċettivi ta' emerġenza li fihom levonorgestrel jew ulipristal acetate biex tevalwa jekk żieda fil-piż tal-ġisem taffettwax l-effikaċja ta' dawn il-mediċini fil-prevenzjoni ta' tqala mhux intenzjonata wara att sesswali bla protezzjoni jew falliment tal-kontraċettiv.
English: For ulipristal acetate, the Agency considered the following data:
Maltese: Għal ulipristal acetate, l-Aġenzija kkunsidrat id-dejta li ġejja:
English: The available data are limited and not robust enough to support with certainty the previous conclusion of decreased contraceptive effect with increased bodyweight/BMI.
Maltese: Id-dejta disponibbli hija limitata u mhux b'saħħitha biżżejed biex tappoġġa b'ċertezza l-konklużjoni preċedenti ta' effett kontraċettiv imnaqqas b'żieda fil-piż tal-ġisem/BMI.
English: Emergency contraceptives are contraceptives used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
Maltese: Kontraċettivi ta' emerġenza huma kontraċettivi użati għall-prevenzjoni ta' tqala mhux intenzjonata wara att sesswali mhux protett jew falliment tal-kontraċettiv.
English: • Emergency contraceptives are used to prevent unintended pregnancy following unprotected sexual intercourse or contraceptive failure.
Maltese: • Kontraċettivi ta' emerġenza jintużaw biex tiġi evitata tqala mhux intenzjonata wara att sesswali mhux protett jew falliment tal-kontraċettiv.
English: 90 (3 x 30 x 1) capsules (unit dose) (multipack)
Maltese: 90 (3 x 30 x 1) kapsula (doża waħda)
English: 30 x 1 capsules (unit dose)
Maltese: 30 x 1 kapsula (doża waħda)
English: (Invented) name
Maltese: (pakkett ta' ħafna)
English: EMA/759491/2012
Maltese: 19 ta' Novembru 2012 EMA/759491/2012
English: International non-proprietary names (inn): clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole
Maltese: Ismijiet mhux proprjetarji internazzjonali (inn): clorsulon, closantel, nitroxinil, rafoxanide u triclabendazole
English: The referral started on 9 March 2011.
Maltese: Ir-riferiment beda fid-9 ta' Marzu 2011.
English: Opinion following an Article 35 referral for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk and which are intended for use in ruminants EMA/759491/2012
Maltese: Opinjoni wara riferiment skont l-Artikolu 35 għall-prodotti mediċinali veterinarji kollha li fihom sustanzi attivi li jagħmlu parti mill-klassi ta' flukicides li għalihom l-ebda limitu massimu ta' residwi ma ġie stabbilit fil-ħalib u li huma maħsuba għall-użu fl-annimali li jixtarru EMA/759491/2012
English: Oral explanations were given by MERIAL on 16 May 2012.
Maltese: Spjegazzjonijiet orali ngħataw minn MERIAL fis16 ta' Mejju 2012.
English: Supplementary information was provided by some of the applicants/marketing authorisation holders by 26 August 2011.
Maltese: Informazzjoni supplimentari ġiet ipprovduta minn xi wħud millapplikanti/detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq sas-26 ta' Awwissu 2011.
English: The Committee appointed Mr G. J. Schefferlie as rapporteur and Dr B. Urbain as co-rapporteur.
Maltese: Urbain bħala ko-rapporteur.
English: On 14 June 2012 the CVMP adopted a final opinion confirming the recommendation, included in its opinion of 8 March 2012, that variations are necessary in the marketing authorisations for the veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as a single active substance and for the veterinary medicinal products administered as pour-on to cattle containing triclabendazole and moxidectin in order to amend the summaries of product characteristics and package leaflets in line with recommended by the CVMP changes in the product information.
Maltese: Fl-14 ta' Ġunju 2012, is-CVMP adotta opinjoni finali li kkonfermat ir-rakkomandazzjoni, inkluża flopinjoni tiegħu tat-8 ta' Marzu 2012, li hemm il-ħtieġa ta' varjazzjonijiet fl-awtorizzazzjonijiet għattqegħid fis-suq għall-prodotti mediċinali veterinarji li fihom clorsulon, closantel, nitroxinil, rafoxanide jew triclabendazole bħala sustanza attiva unika u għall-prodotti mediċinali veterinarji mogħtija bħala soluzzjoni li titferra' lill-baqar li fihom triclabendazole u moxidectin sabiex jiġu emendati s-sommarji tal-karatteristiċi tal-prodott u l-fuljetti ta' tagħrif skont it-tibdil rakkomandat mis-CVMP fl-informazzjoni dwar il-prodott.
English: On 23 March 2012, MERIAL notified the Agency of their intention to request a re-examination of the CVMP opinion of 8 March 2012.
Maltese: Fit-23 ta' Marzu 2012, MERIAL innotifikat lill-Aġenzija bl-intenzjoni tagħha li titlob eżaminazzjoni millġdid tal-opinjoni tas-CVMP tat-8 ta' Marzu 2012.
English: Flukicidal substances are anthelmintics which are active against parasites belonging to the class of trematodes.
Maltese: Sustanzi flukicidal huma antelmintiċi li huma attivi kontra parassiti li jagħmlu parti mill-klassi ta' trematodes.
English: The flukicidal substances for which a maximum residue limit has not been established in milk and that are included as active substances in authorised veterinary medicinal products in the Member States (EU/EEA) are clorsulon, closantel, nitroxinil, rafoxanide and triclabendazole.
Maltese: Is-sustanzi flukicidal li għalihom limitu massimu ta' residwi ma ġiex stabbilit fil-ħalib u li huma inklużi bħala sustanzi attivi fi prodotti mediċinali veterinarji awtorizzati fl-Istati Membri (UE/ŻEE) huma clorsulon, closantel, nitroxinil, rafoxanide u triclabendazole.
English: Based on the evaluation of the available data, the CVMP adopted, on 8 March 2012, an opinion recommending variations of the marketing authorisations for the veterinary medicinal products containing clorsulon, closantel, nitroxinil, rafoxanide or triclabendazole as a single active substance and for the veterinary medicinal products administered as pour-on to cattle containing triclabendazole and moxidectin.
Maltese: Abbażi tal-evalwazzjoni tad-dejta disponibbli, fit-8 ta' Marzu 2012 is-CVMP adotta opinjoni li tirrakkomanda varjazzjonijiet tal-awtorizzazzjonijiet għat-tqegħid fis-suq għall-prodotti mediċinali veterinarji li fihom clorsulon, closantel, nitroxinil, rafoxanide jew triclabendazole bħala sustanza attiva unika u għall-prodotti mediċinali veterinarji mgħotija bħala soluzzjoni li titferrgħa lill-baqar li fihom triclabendazole u moxidectin.
English: The issues considered during the reexamination related to the recommended amendments of section 4.11 Withdrawal period(s) of the summaries of product characteristics for the veterinary medicinal products containing nitroxinil that are administered to cattle.
Maltese: Il-kwistjonijiet ikkunsidrati matul l-eżaminazzjoni mill-ġdid kienu relatati mal-emendi rakkomandati ta' sezzjoni 4.11 Perjodu(i) ta' Tiżmim tas-sommarji tal-karatteristiċi tal-prodott għall-prodotti mediċinali veterinarji li fihom nitroxinil li jingħataw lill-baqar.
English: During its meeting of 11-13 April 2012 the CVMP appointed Dr C. Muñoz as the rapporteur and Dr E. Persson as the co-rapporteur for the re-examination procedure.
Maltese: Matul il-laqgħa tiegħu tal-11-13 ta' April 2012, is-CVMP ħatar lil Dr C.
English: The final opinion was converted into a Decision by the European Commission on 19 November 2012.
Maltese: L-opinjoni finali ġiet ikkonvertita f'Deċiżjoni mill-Kummissjoni Ewropea fid-19 ta' Novembru 2012.
English: Oral explanations were given by a group of marketing authorisation holders on 8 February 2012.
Maltese: Spjegazzjonijiet orali ngħataw minn grupp ta' detenturi tal-awtorizzazzjoni għattqegħid fis-suq fit-8 ta' Frar 2012.
English: On 14 February 2011, the European Commission initiated a referral procedure under Article 35 of Directive 2001/82/EC, as amended, for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk intended for use in all ruminants producing milk for human consumption.
Maltese: Fl-14 ta'Frar 2011, il-Kummissjoni Ewropea tat bidu għal proċedura ta' riferiment skont l-Artikolu 35 tad-Direttiva 2001/82/KE, kif emendata, għall-prodotti mediċinali veterinarji kollha li fihom sustanzi attivi li jagħmlu parti mill-klassi ta' flukicides li għalihom l-ebda limitu massimu ta' residwi ma ġie stabbilit fil-ħalib maħsub għall-użu fl-annimali kollha li jixtarru li jipproduċu ħalib għall-konsum uman.
English: The detailed grounds for the re-examination request were submitted by MERIAL on 2 May 2012.
Maltese: Il-proċedura ta' eżaminazzjoni mill-ġdid bdiet fit-3 ta' Mejju 2012.
English: Opinion following an Article 351 referral for all veterinary medicinal products containing active substances belonging to the class of flukicides for which no maximum residue limit has been established in milk and which are intended for use in ruminants producing milk for human consumption
Maltese: għallprodotti mediċinali veterinarji kollha li fihom sustanzi attivi li jagħmlu parti mill-klassi ta' flukicides li għalihom l-ebda limitu massimu ta' residwi ma ġie stabbilit fil-ħalib u li huma maħsuba għall-użu fl-annimali li jixtarru li jipproduċu ħalib għall-konsum uman