FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregabalin Pfizer 75 mg hard capsules Each hard capsule also contains 8.25 mg lactose monohydrate.
Maltese: Pregabalin Pfizer 75 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 8.25 mg lactose monohydrate.
English: Pregabalin Pfizer 200 mg hard capsules Each hard capsule also contains 22 mg lactose monohydrate.
Maltese: Pregabalin Pfizer 200 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 22 mg lactose monohydrate.
English: Pregabalin Pfizer 225 mg hard capsules Each hard capsule also contains 24.75 mg lactose monohydrate.
Maltese: Pregabalin Pfizer 225 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 24.75 mg lactose monohydrate.
English: • Some patients taking Pregabalin Pfizer have reported symptoms suggesting an allergic reaction.
Maltese: • Xi pazjenti li jużaw Pregabalin Pfizer irrappurtaw sintomi li jindikaw reazzoni allerġika.
English: Pregabalin Pfizer 150 mg hard capsules EU/1/14/916/024-029
Maltese: Pregabalin Pfizer 150 mg kapsuli iebsin EU/1/14/916/024-029
English: Pregabalin Pfizer 225 mg hard capsules EU/1/14/916/034-037
Maltese: Pregabalin Pfizer 225 mg kapsuli iebsin EU/1/14/916/034-037
English: There have also been postmarketing reports of loss of consciousness, confusion and mental impairment.
Maltese: ħass ħażin, konfużjoni u indeboliment mentali.
English: 6.1 List of excipients Pregabalin Pfizer 25 mg, 50 mg, 150 mg hard capsules
Maltese: Pregabalin Pfizer 25 mg, 50 mg, 150 mg kapsuli iebsin
English: How to take Pregabalin Pfizer
Maltese: Tiħux Pregabalin Pfizer:
English: Pregabalin Pfizer 300 mg hard capsules EU/1/14/916/038-043
Maltese: Pregabalin Pfizer 300 mg kapsuli iebsin EU/1/14/916/038-043
English: Pregabalin Pfizer 200 mg hard capsules EU/1/14/916/030-033
Maltese: Pregabalin Pfizer 200 mg kapsuli iebsin EU/1/14/916/030-033
English: Pregabalin Pfizer 100 mg hard capsules EU/1/14/916/020-023
Maltese: Pregabalin Pfizer 100 mg kapsuli iebsin EU/1/14/916/020-023
English: If you are an elderly patient (over 65 years of age), you should take Pregabalin Pfizer normally except if you have problems with your kidneys.
Maltese: Jekk int pazjent anzjan ('il fuq minn 65 sena), inti għandek tieħu Pregabalin Pfizer b'mod normali ħlief jekk ikollok problemi bil-kliewi.
English: What Pregabalin Pfizer is and what it is used for Pregabalin Pfizer belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Pfizer jappartjeni għal grupp ta' mediċini li jintużaw għall-kura ta' l-epilessija, l-uġigħ nevrotiku u d-Disturb ta' Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) fl-adulti.
English: Pregabalin Pfizer 25 mg hard capsules Each hard capsule also contains 35 mg lactose monohydrate.
Maltese: Pregabalin Pfizer 25 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 35 mg lactose monohydrate.
English: Pregabalin Pfizer 75 mg hard capsules EU/1/14/916/014-019
Maltese: Pregabalin Pfizer 75 mg kapsuli iebsin EU/1/14/916/014-019
English: 200 hard capsules
Maltese: 200 kapsuli iebsa
English: Pregabalin Pfizer 50 mg hard capsules EU/1/14/916/008-013
Maltese: Pregabalin Pfizer 50 mg kapsuli iebsin EU/1/14/916/008-013
English: Other medicines and Pregabalin Pfizer
Maltese: Kif taħżen Pregabalin Pfizer
English: The safety and efficacy of Pregabalin Pfizer in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Pregabalin Pfizer fit-tfal ta' taħt it-12 -il sena u l-adoloxxenti (12-17 -il sena) ma ġewx determinati s'issa.
English: EU/1/14/916/038-040 EU/1/14/916/041 EU/1/14/916/043
Maltese: EU/1/14/916/041 EU/1/14/916/043
English: Pregabalin Pfizer 25 mg hard capsules Pregabalin
Maltese: Pregabalin Pfizer 25 mg kapsuli ibsin Pregabalin
English: In the postmarketing experience, there are reports of respiratory failure, coma and deaths in patients taking pregabalin and opioids and/or other central nervous system (CNS) depressant medicinal products.
Maltese: F' esperjenza ta' wara t-tqegħid fis-suq, kien hemm rapporti ta' insuffiċjenza respiratorja, koma u mwiet f' pazjenti li kienu qed jieħdu pregabalin u opjojdi u/jew prodotti mediċinali oħra dipressanti tas-sistema nervuża ċentrali (CNS).
English: EU/1/14/916/014-016 EU/1/14/916/017 EU/1/14/916/019
Maltese: EU/1/14/916/017 EU/1/14/916/019
English: EU/1/14/916/024-026 EU/1/14/916/027 EU/1/14/916/029
Maltese: EU/1/14/916/027 EU/1/14/916/029
English: Pregabalin clearance tends to decrease with increasing age.
Maltese: AnzjaniHemm tendenza li t-tneħħija ta' pregabalin tonqos aktar ma wieħed jikber fl-età.
English: Pregabalin Pfizer 100 mg hard capsules Each hard capsule also contains 11 mg lactose monohydrate.
Maltese: Pregabalin Pfizer 100 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 11 mg lactose monohydrate.
English: Pregabalin Pfizer 25 mg hard capsules EU/1/14/916/001-007
Maltese: Pregabalin Pfizer 25 mg kapsuli iebsin EU/1/14/916/001-007
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 100 x 1 hard capsules 112 hard capsules
Maltese: 14-il kapsuli iebsin 21 kapsuli iebsin 56 kapsuli iebsin 84 kapsuli iebsin 100 kapsuli iebsin 100 x 1 kapsuli iebsin 112il- kapsuli iebsin
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
Maltese: Kura kontra l-epilessija, kura oħra kontra l-epilessija, Kodiċi ATC:
English: Pregabalin Pfizer 200 mg hard capsules Light orange, marked “Pfizer” on the cap and “PGN 200” on the body with black ink.
Maltese: Pregabalin Pfizer 200 mg kapsuli iebsin Oranġjo ċar, immarkata “Pfizer” fuq il-parti ta' fuq u “PGN 200” fuq il-parti ewlenija b'linka sewda.
English: Carton of blister pack (14, 21, 56, 84, 100, and 112) and perforated unit dose blister pack (100) for 25 mg hard capsules.
Maltese: Kartuna tal- pakket bil-folji (14, 21, 56,84, 100 u 112) u pakkett b'folji ta' doża waħda perforati (100) għal 25 kapsuli iebsa.
English: Pregabalin Pfizer 150 mg hard capsules White marked “Pfizer” on the cap and “PGN 150” on the body with black ink.
Maltese: Pregabalin Pfizer 150 mg kapsuli iebsin Bajda, immarkata “Pfizer” fuq il-parti ta' fuq u “PGN 150” fuq il-parti ewlenija b'linka sewda.
English: 14 hard capsules 56 hard capsules 100 hard capsules 100 x 1 hard capsules 112 hard capsules
Maltese: 14-il kapsula iebsa 56 kapsula iebsa 100 kapsula iebsa 100 x 1 kapsula iebsa 112-il kapsula iebsa
English: Pregabalin Pfizer 225 mg hard capsules White and light orange marked “Pfizer” on the cap and “PGN 225” on the body with black ink.
Maltese: Kapsuli iebsin ta' lewn abjad u oranġjo ċar, bi “Pfizer” immarkata fuq ilparti ta' fuq u “PGN 225” fuq il-parti ewlenija.
English: Pregabalin Pfizer 75 mg hard capsules White and orange, marked “Pfizer” on the cap and “PGN 75” on the body with black ink.
Maltese: Kapsuli iebsin ta' lewn abjad u oranġjo, bi “Pfizer” immarkata fuq il-parti ta' fuq u “PGN 75” fuq il-parti ewlenija.
English: Carton of blister pack (21, 84 or 100) and perforated unit dose blister pack (100) for 100 mg hard capsules
Maltese: Kartuna tal-pakkett ta' folji (21 , 84 u 100) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 100 mg
English: Pregabalin Pfizer 225 mg hard capsules Pregabalin
Maltese: Pregabalin Pfizer 225 mg kapsuli iebsin Pregabalin
English: • A small number of people being treated with anti-epileptics such as Pregabalin Pfizer have had thoughts of harming or killing themselves.
Maltese: • Numru zgħir ta' pazjenti li jkunu qed jirċievu kura bi prodotti mediċinali kontra l-epilessija bħal-Pregabalin Pfizer, kellhom ħsibijiet li jweġġgħu lilhom infushom jew li jagħmlu suwiċidju.
English: Pregabalin Pfizer 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin.
Maltese: Pregabalin Pfizer 200 mg kapsuli iebsin Kull kapsula iebsa fiha 200 mg ta' pregabalin.
English: Blister pack (14, 21, 56, 84, 100, and 112) and perforated unit dose blister pack (100) for 25 mg hard capsules
Maltese: Pakkett ta' folji (14, 21, 56, 84, 100 u 112) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 25 mg
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Ma sarux studji speċifiċi dwar il-farmakokinetika f'pazjenti li għandhom funzjoni indebolita tal-fwied.
English: Pregabalin Pfizer 50 mg hard capsules Each hard capsule also contains 70 mg lactose monohydrate.
Maltese: Pregabalin Pfizer 50 mg kapsuli iebsin Kull kapsula iebsa fiha ukoll 70 mg lactose monohydrate.
English: Pregabalin Pfizer 50 mg hard capsules PVC/Aluminium blisters containing 14, 21, 56, 84, or 100 hard capsules.
Maltese: Pregabalin Pfizer 50 mg kapsuli iebsin Folji tal-PVC/Aluminju li fihom 14, 21, 56, 84, jew 100 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: Pregabalin Pfizer 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin.
Maltese: Pregabalin Pfizer 75 mg kapsuli iebsin Kull kapsula iebsa fiha 75 mg ta' pregabalin.
English: Pregabalin Pfizer 100 mg hard capsules Orange marked “Pfizer” on the cap and “PGN 100” on the body with black ink.
Maltese: Pregabalin Pfizer 100 mg kapsuli iebsin Oranġjo, immarkata “Pfizer” fuq il-parti ta' fuq u “PGN 100” fuq il-parti ewlenija b'linka sewda.
English: Blister pack (14, 56, 100 or 112) and perforated unit dose blister pack (100) for 75 mg hard capsules
Maltese: Pakkett ta' folji (14, 56, 100 u 112) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 75 mg
English: Pregabalin Pfizer 100 mg hard capsules Pregabalin
Maltese: Pregabalin Pfizer 100 mg kapsuli iebsin Pregabalin
English: Pregabalin Pfizer 300 mg hard capsules Pregabalin
Maltese: Pregabalin Pfizer 300 mg kapsuli iebsin Pregabalin
English: Pregabalin Pfizer 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin.
Maltese: Pregabalin Pfizer 300 mg kapsuli iebsin Kull kapsula iebsa fiha 300 mg ta' pregabalin.
English: Pregabalin Pfizer 300 mg hard capsules PVC/Aluminium blisters containing 14, 56, 100, or 112 hard capsules.
Maltese: Pregabalin Pfizer 300 mg kapsuli iebsin Folji tal-PVC/Aluminju li fihom 14, 56, 100 jew 112 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: Pregabalin Pfizer 225 mg hard capsules PVC/Aluminium blisters containing 14, 56, or 100 hard capsules.
Maltese: Pregabalin Pfizer 225 mg kapsuli iebsin Folji tal-PVC/Aluminju li fihom 14, 56, jew 100 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: Pregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Maltese: Pregabalin Pfizer huwa indikat bħala terapija aġġuntiva f'persuni adulti li jbatu minn aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: Pregabalin Pfizer 300 mg hard capsules White and orange, marked “Pfizer” on the cap and “PGN 300” on the body with black ink.
Maltese: Kapsuli iebsin ta' lewn abjad u oranġjo, bi “Pfizer” immarkata fuq il-parti ta' fuq u “PGN 300” fuq il-parti ewlenija.
English: Pregabalin Pfizer 200 mg hard capsules PVC/Aluminium blisters containing 21, 84, or 100 hard capsules.
Maltese: Pregabalin Pfizer 200 mg kapsuli iebsin Folji tal-PVC/Aluminju li fihom 21, 84, jew 100 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: Pregabalin Pfizer 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin.
Maltese: Pregabalin Pfizer 100 mg kapsuli iebsin Kull kapsula iebsa fiha 100 mg ta' pregabalin.
English: Pregabalin Pfizer 75 mg hard capsules PVC/Aluminium blisters containing 14, 56, 100, or 112 hard capsules.
Maltese: Pregabalin Pfizer 75 mg kapsuli iebsin Folji tal-PVC/Aluminju li fihom 14, 56, 100 jew 112 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: Pregabalin Pfizer 75 mg hard capsules Pregabalin
Maltese: Pregabalin Pfizer 75 mg kapsuli iebsin Pregabalin
English: Epilepsy: Pregabalin Pfizer is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Maltese: Pregabalin Pfizer tintuża sabiex tiġi kkurata ċerta forma ta' epilessija (aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja) fl-adulti.
English: What Pregabalin Pfizer looks like and contents of the pack 25 mg capsules
Maltese: Kif jidher Pregabalin Pfizer u l-kontenut tal-pakkett 25 mg kapsuli
English: Pregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.
Maltese: Uġigħ nevrotiku Pregabalin Pfizer huwa indikat għall-kura ta' uġigħ periferali u ċentrali f'persuni adulti.
English: Pregabalin Pfizer 150 mg hard capsules Pregabalin
Maltese: Pregabalin Pfizer 150 mg kapsuli iebsin Pregabalin
English: In the treatment of central neuropathic pain due to spinal cord injury the incidence of adverse reactions in general, CNS adverse reactions and especially somnolence was increased (see section 4.4).
Maltese: Fil-kura ta' uġigħ nevrotiku ċentrali minħabba leżjoni fil-korda spinali, l-inċidenza ta' reazzjonijiet avversi b'mod ġenerali, reazzjonijiet avversi ta' CNS u b'mod speċjali tan-ngħas żdiedet (ara sezzjoni 4.4).
English: Pregabalin Pfizer 100 mg hard capsules PVC/Aluminium blisters containing 21, 84, or 100 hard capsules.
Maltese: Pregabalin Pfizer 100 mg kapsuli iebsin Folji tal-PVC/Aluminju li fihom 21, 84, jew 100 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: Pregabalin Pfizer 25 mg hard capsules White marked “Pfizer” on the cap and “PGN 25” on the body with black ink.
Maltese: Pregabalin Pfizer 25 mg kapsuli iebsin Bajda, immarkata “Pfizer” fuq il-parti ta' fuq u “PGN 25” fuq il-parti ewlenija b'linka sewda.
English: In addition, Pregabalin Pfizer is available in an HDPE bottle containing 200 capsules for the 25 mg, 75 mg, 150 mg and 300 mg strengths.
Maltese: Barra minn hekk, Pregabalin Pfizer jinstab ukoll fi flixkun tal-HDPE li jesa' 200 kapsula għallqawwiet ta' 25 mg, 75 mg, 150 mg u 30 mg.
English: Pregabalin Pfizer is for oral use only.
Maltese: Pregabalin Pfizer huwa għal użu orali biss.
English: Pregabalin Pfizer 200 mg hard capsules Pregabalin
Maltese: Pregabalin Pfizer 200 mg kapsuli iebsin Pregabalin
English: Pregabalin Pfizer 150 mg hard capsules PVC/Aluminium blisters containing 14, 56, 100, or 112 hard capsules.
Maltese: Pregabalin Pfizer 150 mg kapsuli iebsin Folji tal-PVC/Aluminju li fihom 14, 56, 100 jew 112 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: PVC/Aluminium blisters containing 14, 21, 56, 84, 100, or 112 hard capsules.
Maltese: Pregabalin Pfizer 25 mg kapsuli iebsin Folji tal-PVC/Aluminju li fihom 14, 21, 56, 84, 100 jew 112 kapsula iebsa. 100 x 1 kapsula iebsa f'folji ta' doża waħda perforati tal-PVC/Aluminju.
English: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Pfizer is taken together with medicines containing:
Maltese: Il-livell ta' sturdament, irqad u konċentrazzjoni mnaqqsa jista' jiżdied jekk Pregabalin Pfizer jittieħed ma' mediċini oħra li fihom:
English: Pregabalin Pfizer 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin.
Maltese: Pregabalin Pfizer 225 mg kapsuli iebsin Kull kapsula iebsa fiha 225 mg ta' pregabalin.
English: Blister pack (14, 56, 100 or 112) and perforated unit dose blister pack (100) for 300 mg hard capsules
Maltese: Pakkett ta' folji (14, 56, 100 jew 112) u pakkett ta' folji ta' doża waħda (100) perforat għal kapsuli iebsin ta' 300 mg
English: Common: may affect up to 1 in 10 people
Maltese: Komuni ħafna: jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni:
English: 1 Directive 2004/24/EC of 31 March 2004.
Maltese: 1 Direttiva 2004/24/KE tal-31 ta' Marzu 2004.
English: b) Terms of reference
Maltese: b) Termini ta' Referenza
English: European Commission Isabel de la Mata Georgette Lalis
Maltese: Isabel de la Mata Georgette Lalis
English: − [EMA/MB/117221/2010] Note on veterinary products.
Maltese: [EMA/MB/117221/2010] Nota dwar prodotti veterinarji.
English: Annual report 2009
Maltese: Rapport Annwali 2009
English: • Agenda point 8bis_Amendment of the reimbursement rules for delegates.
Maltese: • Aġenda punt 8bis_Emenda tar-regoli dwar rimbors lid-delegati.
English: Prof. Lawrence Phillips of the London School of Economics led the sessions.
Maltese: Il-Prof. Lawrence Phillips mil-London School of Economics mexxa s-sessjonijiet.
English: Representative of veterinarians' organisations
Maltese: Rappreżentant talorganizzazzjonijiet veterinarji
English: Germany, Spain, The Netherlands and Mike O'Donovan.
Maltese: Il-President, l-Awstrija, l-Estonja, l-Irlanda, ilĠermanja, Spanja, l-Olanda u Mike O'Donovan.
English: Term of office of the Chair of the Board
Maltese: Mandat tal-President tal-Bord
English: to 25 February 2010.
Maltese: 26 ta' April 2010
English: • HMPC presentation.
Maltese: • Preżentazzjoni tal-HMPC.
English: [EMA/MB/6505/2010; EMA/MB/68936/201; EMA/MB/125880/2010] The Management Board adopted the preliminary work programme, preliminary draft budget (PDB) and draft staff policy plan for 2011.
Maltese: [EMA/MB/6505/2010; EMA/MB/68936/201; EMA/MB/125880/2010] Il-Bord ta' Tmexxija adotta lprogramm ta' ħidma preliminari, l-abbozz preliminari tal-baġit (PDB) u l-abbozz ta' pjan għall-politika dwar il-persunal għall-2011.
English: [EMA/MB/3790/2010] The agenda was adopted.
Maltese: [EMA/MB/3790/2010] L-aġenda ġiet adotta.
English: Revised delegate reimbursement rules
Maltese: Regoli riveduti dwar rimbors għad-delegati
English: • Benchmarking of European Medicines Agencies (BEMA).
Maltese: • benchmarking tal-Aġenziji Ewropej tal-Mediċini (BEMA).
English: • Capabilities & limitations of human judgement presentation.
Maltese: • Preżentazzjoni dwar kapaċitajiet u limitazzjonijiet tal-ġudizzju uman.
English: The budget represents an increase of €20.7 million (10.5%) over the 2010 budget.
Maltese: Il-baġit jirrappreżenta żieda ta' €20.7 miljun (10.5%) fuq il-baġit tal-2010.
English: − [EMA/78873/2010] Survey 2009 for medicinal products for human use;
Maltese: [EMA/78873/2010] Stħarriġ 2009 dwar prodotti mediċinali għall-użu mill-bniedem;
English: The PDB for 2011 totals €218.9 million, in line with the work programme.
Maltese: Il-PDB għall-2011 jammonta għal €218.9 miljun, b'rabta mal-programm ta' ħidma.
English: • [EMEA/MB/617640/2009] Summary of transfers of appropriations in the budget 2009.
Maltese: • [EMEA/MB/617640/2009] Sommarju tat-trasferimenti tal-approprjazzjonijiet fil-baġit 2009.
English: • The move of the Pharmaceutical Unit F2 (and Unit F3, cosmetics and medical devices) to DG
Maltese: F2 (u l-Unità F3, kosmetiċi u għodod mediċinali) għal DĠ Sanco.
English: The discussion is foreseen for the October meeting.
Maltese: Id-diskussjoni hija mbassra għal-laqgħa ta' Ottubru.
English: [EMA/MB/64422/2010] The Management Board adopted the terms of reference of the Management Board Telematics Committee.
Maltese: [EMA/MB/64422/2010] Il-Bord ta' Tmexxija adotta t-termini ta' referenza tal-Kumitat tal-Bord ta' Tmexxija dwar it-Telematika.
English: A number of countries chose not to participate in the pilot.
Maltese: Numru ta' pajjiżi għażlu li ma jipparteċipawx fil-proġett pilota.
English: Management Board Telematics Committee (MBTC)
Maltese: Il-Kumitat Telematiku tal-Bord ta' Tmexxija (MBTC)
English: • [EMA/61092/2010] Update report on the Agency's implementation of the EU telematics strategy.
Maltese: • [EMA/61092/2010] Rapport ta' aġġornament dwar l-implimentazzjoni tal-Aġenzija tal-istrateġija telematika tal-UE.
English: Sanco.
Maltese: EFSA.
English: [EMA/MB/281553/2007Rev.2] The Management Board adopted the revised procedure.
Maltese: [EMA/MB/281553/2007Rev.2] Il-Bord ta' Tmexxija adotta l-proċedura riveduta.
English: th meeting of the Management Board, held in London, 17-18 March 2010
Maltese: Lista tal-parteċipanti tas-66 laqgħa tal-Bord ta' Tmexxija, li saret f'Londra, 17-18 ta' Marzu 2010
English: [EMA/MB/183091/2010] The Management Board adopted the amendments to the reimbursement rules for delegates, whereby an allowance, corresponding to 35% of the maximum cost of a hotel night (€60 for London), is introduced to provide financial support to delegates where no accommodation invoices can be provided.
Maltese: [EMA/MB/183091/2010] Il-Bord ta' Tmexxija adotta l-emendi għar-regoli dwar ir-rimbors għaddelegati, fejn ġie introdott benefiċċju, li jikkorrispondi għal 35% tal-ispiża massima ta' lejl f'lukanda (€60 għal Londra), sabiex tipprovdi appoġġ finanzjarju lid-delegati meta ma jkunux jistgħu jiġu pprovduti rċevuti ta' akkomodazzjoni.
English: The budget includes estimated fee revenue of €163 million and a requested Community contribution of €47.1 million, which the Commission representative indicated was beyond the current EU financial perspectives.
Maltese: Il-baġit jinkludi stima ta' dħul ta' ħlasijiet ta' €163 miljun u talba għal kontribuzzjoni Komunitarja ta' €47.1 miljun, li r-rappreżentant talKummissjoni indika li kienet ogħla mill-perspettivi finanzjarji attwali tal-UE.
English: • Creation of a task force on corporate social responsibility of the pharmaceutical industry.
Maltese: • Ħolqien ta' task force dwar ir-responsabilità soċjali korporattiva tal-industrija farmaċewtika.
English: • implementation of the e-submissions system across the EU and the future workshop on this topic;
Maltese: • implimentazzjoni tas-sistema tas-sottomissjonijiet elettroniċi madwar l-UE u l-workshop futur fuq dan is-suġġett;
English: Preliminary draft budget 2011 (PDB)
Maltese: Abbozz preliminari tal-baġit 2011 (PDB)
English: The action plan will now be discussed at the Heads of Medicines Agencies in April.
Maltese: Il-pjan ta' azzjoni issa sejjer jiġi diskuss mill-Kapijiet ta' Aġenziji tal-Mediċini f'April.
English: • Progress on the pharmaceutical package (legislative proposals on pharmacovigilance, falsified medicines and the proposal on provision of information to patients).
Maltese: • Progress dwar il-pakkett farmaċewtiku (proposti leġislattivi dwar il-farmakoviġilanza, mediċini foloz u l-proposta dwar l-għoti ta' informazzjoni lill-pazjenti).
English: • [EMA/MB/121058/2010] Minutes from the first MBTC meeting, held on 9 December 2009, adopted on 9 February 2010.
Maltese: • [EMA/MB/121058/2010] Minuti mill-ewwel laqgħa tal-MBTC, li saret fid-9 ta' Diċembru 2009,
English: 26 April 2010 EMA/MB/194352/2010
Maltese: EMA/440606/2011
English: The Board also commented that the quality of dossiers may be a significant factor, and it is likely that a number of the products that received a negative opinion could have been approved if the dossiers had been of a higher standard.
Maltese: Il-Bord ikkummenta wkoll li l-kwalità tad-dossiers jista' jkun fattur sinifikanti, u huwa probabbli li għadd ta' prodotti li rċevew opinjoni negattiva setgħu ġew approvati li kieku d-dossiers kienu ta' standard ogħla.
English: The amendments may concern the reduction of fee income due to revised inflation rate, possible use of part of the surplus from 2008, increase in orphan medicinal products budget, financing ICT expenditure, and consultancy services aimed to identify options for future accommodation for the Agency.
Maltese: L-emendi jistgħu jkunu jikkonċernaw it-tnaqqis tad-dħul mid-drittijiet minħabba rata riveduta tal-inflazzjoni, użu possibli ta' parti mill-qligħ mill-2008, żieda fil-baġit għal prodotti mediċinali orfni, liffinanzjar ta' spiża għall-ICT, u servizzi ta' konsulenza immirati sabiex jidentifikaw għażliet għal akkomodazzjoni futura għall-Aġenzija.
English: Gro Ramsten Wesenberg (Norway) Brigitte Batliner (Liechtenstein)
Maltese: Brigitte Batliner (Il-Liechtenstein)
English: • Future revision of the transparency directive, with a view to promoting competitiveness of industry and innovation.
Maltese: • Reviżjoni futura tad-direttiva dwar it-trasparenza, bil-għan li tippromwovi l-kompetittività tal industrija u l-innovazzjoni.