FrancophonIA/ELRC3.0 huggingface dataset:
English: Denmark 3.57 % Estonia 0.77 % Finland 2.04 % France
Maltese: Id-Danimarka 3.57 % L-Estonja 0.77 %Il-Finlandja 2.04 % Franza
English: Hepatitis B virus surface antigen (rDNA) (S protein) !
Maltese: Fendrix Hepatitis B virus surface antigen (rDNA) (S protein)
English: 1.7 Corporate governance - Integrated management system
Maltese: 1.7 Il-Governanza Korporattiva - sistema ta' ġestjoni integrata
English: Ravila Str 19
Maltese: Str 19
English: ICH S7B The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals
Maltese: ICH S7B - The non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by
English: Eudra Common Directory (ECD)
Maltese: Direttorju Komuni Eudra (ECD)
English: Competing risk analysis P-value = 0.02
Maltese: Analizi tar-riskju ta' kompetizzjoni P-valur = 0.02
English: CY 1417 Nicosia
Maltese: Street CY - 1417 Nicosia
English: • Harrie J J SEEVERENS (Netherlands)
Maltese: • Harrie J J Seeverens (Olanda)
English: Treatment of idiopathic Parkinsons disease (PD) in patients with end-of-dose fluctuations
Maltese: Treatment of idiopathic Parkinson's disease (PD) in patients with end-of-dose fluctuations
English: Division de la Pharmacie et des Médicaments Villa Louvigny 1er étage Parc de la Ville Allée Marconi L 2120 Luxembourg
Maltese: Division de la Pharmacie et des Médicaments Villa Louvigny - 1er étage Parc de la Ville - Allée Marconi L - 2120
English: Fergus SWEENEY (chair)
Maltese: Fergus SWEENEY (President)
English: • Sigurður B THORSTEINSSON (Iceland)
Maltese: • Sigurður B Thorsteinsson (Islanda)
English: Interested parties
Maltese: Partijiet interessati
English: Infrastructure
Maltese: Infrastruttura
English: Mechanisms to Trigger Investigations of the Safety of Veterinary Medicinal Products by EU Competent Authorities
Maltese: Mechanisms to Trigger Investigations of the Safety of Veterinary Medicinal Products by UE Competent Authorities
English: 1417 Athalassas Street
Maltese: 1417 Athalassas
English: Gloria GARCÍA LORENTE (Spain) Alternate: Adela VELÁZQUEZ
Maltese: Gloria GARCÍA LORENTE (Spanja) Sostituta: Adela Velázquez
English: • Patrick SALMON2 (Ireland)
Maltese: • Patrick SALMON2 (Irlanda)
English: • Barbara VAN ZWIETEN-BOOT (Netherlands) Alternate: Frits LEKKERKERKER
Maltese: • Barbara VAN ZWIETEN-BOOT (Olanda) Sostitut: Frits LEKKERKERKER
English: • Heidrun BOSCH TRABERG (Denmark)
Maltese: • Heidrun Bosch Traberg (Danimarka)
English: Treatment to mobilise progenitor cells prior to stemcell transplantation
Maltese: Treatment to mobilise progenitor cells prior to stem-cell transplantation
English: 6.1 Administration
Maltese: 6.1 Amministrazzjoni
English: Scientific advice (n=48)
Maltese: Parir xjentifiku (n=48)
English: • Veijo SAANO (Finland)
Maltese: • Veijo Saano (Finlandja)
English: Personnel
Maltese: Personal
English: MT CMR 02 Marsa
Maltese: MT - CMR 02 Marsa Tel.
English: Members
Maltese: Membri
English: Guideline on submission of marketing authorisation applications for pandemic influenza vaccines through the centralised procedure
Maltese: Guideline on submission of market authorisation applications for pandemic influenza vaccines through the centralised procedure
English: Wojciech DYMOWSKI (Poland) Alternate: Elżbieta WOJTASIK
Maltese: Wojciech DYMOWSKI (Polonja) Sostituta: Elżbieta WOJTASIK
English: • Patricia VELLA BONANNO9 (Malta) Alternate: John Joseph BORG10
Maltese: • Patricia VELLA BONANNO9 (Malta) Sostitut: John Joseph BORG10
English: • Johannes PETRUS HOOGLAND (Netherlands) (vice-chairman)
Maltese: • Johannes PETRUS HOOGLAND (Olanda) (viċi president)
English: Emer COOKE (chair)
Maltese: Emer COOKE (President)
English: • Lars GRAMSTAD (Norway)
Maltese: • Lars Gramstad (Norveġja)
English: Guideline on dossier structure and content for pandemic influenza vaccine marketing authorisation application
Maltese: Guideline on dossier structure and content for pandemic influenza vaccine market authorisation application
English: Christian CUSCHIERI (Malta) Alternate: Caroline ATTARD
Maltese: Christian Cuschieri (Malta) Sostituta: Caroline ATTARD
English: • Domenica TARUSCIO (Italy)
Maltese: • Domenica TARUSCIO (Italja)
English: • Gonzalo CALVO ROJAS (Spain) Alternate: Fernando DE ANDRES-TRELLES
Maltese: • Gonzalo CALVO ROJAS (Spanja) Sostitut: Fernando DE ANDRÉS-TRELLES
English: Parallel distribution notifications 2002-2004
Maltese: Notifiki ta' distribuzzjoni parallela 2002-2004
English: Specifications: Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products
Maltese: Test procedures and acceptance criteria for new biotechnological/biological Prodotti mediċinali veterinarji
English: • George STATHOPOULOS (Greece)
Maltese: • George STATHOPOULOS (Greċja)
English: CVMP General
Maltese: CVMP Generali
English: A total of 87 requests were received and 77 were finalised.
Maltese: Waslu total ta' 87 talba u 77 ġew finalizzati.
English: Arbitration and Community referrals 1995-2004
Maltese: Arbitra?? u riferenzi Komunitarji 1995-2004
English: 3 Veterinary medicines
Maltese: 3 Mediċini Veterinarji
English: No scientific advice (n=171)
Maltese: Ebda parir xjentifiku (n=171)
English: • Gabriel BEECHINOR (Ireland)
Maltese: • Gabriel BEECHINOR (Irlanda)
English: Treatment of peripheral neuropathic pain in adults; and treatment of epilepsy as adjunctive therapy in adults with partial seizures
Maltese: N03A (pending) Treatment of peripheral neuropathic pain in adults; and treatment of epilepsy as adjunctive therapy in adults with partial seizures
English: Allergan Pharmaceuticals Ireland
Maltese: Allergan Pharmaceuticals
English: • Pekka KURKI1 (Finland) (co-opted)
Maltese: • Pekka KURKI1 (Finlandja) (co-opted)
English: Státní ústav pro kontrolu léčiv robárová 48
Maltese: Státní ústav pro kontrolu léčiv Šrobárová 48
English: PPD Global Ltd Treatment of Myasthenia Gravis
Maltese: PPD Global Ltd Treatment of Myasthenia
English: Ústav tátnej kontroly veterinárnych biopreparátov a liečiv Biovetská 4
Maltese: Ústav štátnej kontroly veterinárnych biopreparátov a liečiv Biovetská 4
English: Alternate: Josef SUKO
Maltese: Josef SUKO
English: • Ivo CLAASEN (Netherlands) (co-opted)
Maltese: • Ivo CLAASEN (Olanda) (co-opted)
English: • Sigurður ÖRN HANSSON (Iceland) Alternate: Halldór RUNÓLFSSON
Maltese: • Sigurður ÖRN HANSSON (Islanda) Sostitut: Halldór RUNÓLFSSON
English: CellCure ApS Treatment of MART-1 positive malignant melanoma in HLAA2 positive patients
Maltese: CellCure ApS Treatment of MART-1 positive malignant melanoma in
English: • Birthe BYSKOV HOLM (patients organisation representative)
Maltese: • Birthe Byskov Holm (rappreżentant ta' l organizzazzjoni tal-pazjenti)
English: Wilson s disease
Maltese: Treatment of Wilson's disease
English: • Beatriz SILVA LIMA (Portugal) Alternate: Cristina SAMPAIO
Maltese: • Beatriz SILVA LIMA (Portugall) Sostituta: Cristina SAMPAIO
English: Note for guidance on the inclusion of appendices to clinical study reports in marketing authorisation applications
Maltese: Note for guidance on the inclusion of appendices to clinical study reports in market authorisation applications
English: Anti-infectives
Maltese: Anti-infettivi
English: Core SPC for human normal immunoglobulin for intravenous administration (IVIg) - Revision 2
Maltese: Core SPC for human normal immunoglobulin for intravenous Amministrazzjoni (IVIg)Revision 2
English: EGFRexpressing metastatic colorectal cancer in combination with irinotecan after failure of irinotecancontaining therapy
Maltese: Treatment of patients with EGFRexpressing metastatic colorectal cancer in combination with irinotecan after failure of irinotecancontaining therapy
English: HemeBiotech A/S Treatment of alphaMannosidosis
Maltese: HemeBiotech A/S Treatment of alpha
English: In 2004, the EMEA validated 402 initial parallel distribution notifications and finalised 373 initial notifications.
Maltese: Fl-2004, l-EMEA vvalidat 402 notifiki ta' distribuzzjoni parallela inizzjali u ffinalizzat 373 notifika inizzjali.
English: Position paper on control of impurities of pharmacopoeial substances: Compliance with the European Pharmacopoeia general monograph Substances for pharmaceutical use and general chapter Control of impurities in substances for pharmaceutical use
Maltese: Compliance with the European Pharmacopoeia general monograph ‘Substances for pharmaceutical use' and general chapter ‘Control of impurities in substances for pharmaceutical use'
English: EC-Canada MRA
Maltese: MRA KE-Kanada
English: • Rory BREATHNACH (Irland) (co-opted)
Maltese: • Rory BREATHNACH (Irlanda) (co-opted)
English: • Cancer (5 new products)
Maltese: • Kanċer (5 prodotti ġodda)
English: Reflection paper on the regulatory guidance for the use of healthrelated quality of life (HRQL) measures in the evaluation of medicinal products
Maltese: Reflection paper on the Gwida regolatorja for the use of healthrelated quality of life (HRQL) measures in the evaluation of medicinal products
English: Salaries
Maltese: Salarji
English: Specifications: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: Chemical substances
Maltese: Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products:
English: • Emmanuel HÉRON (France)
Maltese: • Emmanuel HÉRON (Franza)
English: Total title 1
Maltese: Total titolu 1
English: • Judita HEDEROVÁ (Slovakia)
Maltese: • Judita HEDEROVÁ (Slovakkja)
English: 3.3 Maximum residue limits
Maltese: 3.3 Limiti massimi ta' residwi
English: Aginus A W KALIS (Alternate: Pim KAPITEIN)
Maltese: Aginus A W KALIS (Sostitut:
English: Expenditure on data processing 9 517 000 11.31 % 14 015 000 14.15 % 8 931 000 8.10 % Other capital expenditure
Maltese: Nefqa fuq l-ipproċessar tad-data 9 517 000 11.31 % 14 015 000 14.15 % 8 931 000 8.10 % Infiq kapitali ieħor
English: Hormones
Maltese: Ormoni
English: • Jolanta WIECKOWSKA (Poland)
Maltese: • Jolanta WIECKOWSKA (Polonja)
English: Mariette BACKES-LIES (Luxembourg) Alternate: Jacqueline GENOUX-HAMES
Maltese: Mariette BACKES-LIES (Lussemburgu) Sostituta: Jacqueline GENOUX-HAMES
English: 39 days phenylenebis (methylene)]-bis tetraazacyclotetradec ane
Maltese: Data taddeċiżjoni phenylenebis (methylene)]-bis tetraazacyclotetradec ane
English: Caitríona Fisher chaired the meetings during the Irish EU presidency and Truus Janse-de Hoog chaired the meetings during the Dutch EU presidency.
Maltese: Caitríona Fisher ippresediet il-laqgħat matul il-presidenza Irlandiża ta' l-UE u Truus Janse-de Hoog ppresjeda l-laqgħat matul il-presidenza Olandiża ta' l-UE.
English: • Arthur ISSEYEGH (Cyprus) Alternate: Panayiota KOKKINOU
Maltese: • Arthur ISSEYEGH (Ċipru) Sostituta: Panayiota KOKKINOU
English: Respiratory system
Maltese: Sistema respiratorja
English: • Jean-Claude ROUBY (France) Alternate: Michael HOLZHAUSERALBERTI
Maltese: • Jean-Claude ROUBY (Franza) Sostitut: Michael HOLZHAUSER-ALBERTI
English: • Christian FRIIS (Denmark) (co-opted)
Maltese: • Christian FRIIS (Danimarka) (co-opted)
English: 24 May 2004 - Extraordinary meeting
Maltese: 24 ta' Mejju 2004 - Laqgħa straordinarja
English: • Kristina PAVLOVSKA (Latvia)
Maltese: • Kristina PAVLOVSKA (Latvja)
English: • Metoda LIPNIK-STANGELJ (Slovenia) Alternate: Barbara RAZINGER-MIHOVEC
Maltese: • Metoda LIPNIK-STANGELJ (Slovenja) Sostituta: Barbara RAZINGER-MIHOVEC
English: There were also regular bilateral meetings between the EMEA and the secretaries of various interested parties.
Maltese: Kien hemm ukoll laqgħat regolari bilaterali bejn l-EMEA u s-segretarji tad-diversi partijiet interessati.
English: Archiving and backup of data
Maltese: Arkivjar u back-up ta' data
English: Jytte LYNGVIG (vice-chairman) (Alternate: Paul SCHÜDER)
Maltese: Jytte LYNGVIG (viċi-president) (Sostitut: Paul SCHÜDER)
English: emtricitabine + tenofovir disoproxil fumarate !
Maltese: Truvada emtricitabine + tenofovir disoproxil fumarate Part B
English: GMP database
Maltese: Database talGMP
English: Respiratory
Maltese: Respiratorji
English: Applications for extension/modification of maximum residue limits 2002-2004
Maltese: Applikazzjonijiet g?al estensjoni/modifika tal-limiti massimi ta' residwi 2002-2004
English: • Reinhard KROKER (Germany) Alternate: Manfred MOOS
Maltese: • Reinhard KROKER (Ġermanja) Sostitut: Manfred MOOS
English: Enrico GARACI President
Maltese: Enrico GARACI
English: FL 9494 Schaan
Maltese: FL - 9494
English: Consumers expect that residues be avoided as far as possible, and, where not possible, that they be safe.
Maltese: Il-konsumaturi jippretendu illi l-residwi jiġu evitati kemm jista' jkun, u, fejn ma jkunx possibbli, li jkunu siguri.
English: • Algirdas UTKUS (Lithuania)
Maltese: • Algirdas UTKUS (Litwanja)
English: Phase-I Phase-II Phase-III Phase-IV
Maltese: Fażi-I Fażi-II Fażi-III Fażi-IV
English: 3.7 Arbitration and Community referrals
Maltese: 3.7 Arbitraġġ u Referenzi Komunitarji
English: EMEA contact: Isabelle MOULON
Maltese: Kuntatt fl-EMEA: Isabelle MOULON
English: 2.6 Arbitration and Community referrals
Maltese: 2.6 Arbitraġġ u referenzi Komunitarji
English: • Arvils JAKOVSKIS (Latvia)
Maltese: • Arvils JAKOVSKIS (Latvja)
English: The CVMP adopted 10 positive opinions for veterinary medicines, including 8 vaccines.
Maltese: Is-CVMP adotta 10 opinjonijiet pożittivi għal mediċini veterinarji, inklużi 8 prodotti għat-tilqim.
English: • Rembert ELBERS (Germany)
Maltese: • Rembert ELBERS (Ġermanja)
English: Anna-Liisa ENKOVAARA (Finland) Alternate: Sari KOSKI
Maltese: ENKOVAARA (Finlandja) Sostitut: Sari KOSKI
English: Genito-urinary
Maltese: Genito-urinarja
English: Total title 3
Maltese: Total titolu 3
English: • Kateřina KUBÁČKOVÁ (Czech Republic)
Maltese: • Kateřina KUBÁČKOVÁ (Repubblika
English: • EudraNet II in operation by May 2004
Maltese: • EudraNet II ser tkun qed taħdem sa Mejju 2004
English: Anticoagulant in patients undergoing percutaneous coronary intervention (PCI)
Maltese: B01A (pending) Anticoagulant in patients undergoing percutaneous coronary intervention (PCI)
English: Zsuzsanna BIRÓ-SÁNDOR (Hungary) Alternate: Gyöngyi BACS
Maltese: Zsuzsanna BIRÓ-SÁNDOR (Ungerija) Sostitut: Gyöngyi BACS
English: Tel. (420-267) 31 11 53 Fax (420-272) 73 99 95 E-mail: smid@sukl.cz Internet: http://www.sukl.cz
Maltese: (420-267) 31 11 53 Fax (420-272) 73 99 95 E-mail: smid@sukl.cz Internet: http://www.sukl.cz
English: Human Fibrinogen + Human Thrombin !
Maltese: TachoSil Human Fibrinogen + Human Thrombin Part B
English: Feline leukaemia
Maltese: Cats Feline leukaemia
English: CHMP/QWP/2054/03 (Annex II to CHMP/QWP/848/99 & EMEA/CVMP/395/03)
Maltese: CHMP/QWP/2054/03 (Anness II to CHMP/QWP/848/99 & EMEA/CVMP/395/03)
English: Security
Maltese: Sigurtà
English: Treatment of systemic monochloroacetate poisoning
Maltese: Treatment of systemic monochloroacetat e poisoning
English: • Psoriasis
Maltese: • Psorijażi
English: A 1030 Wien
Maltese: A - 1030
English: • Judit EGGENHOFER (Hungary)
Maltese: • Judit EGGENHOFER (Ungerija)
English: ICH S8 Immunotoxicology studies
Maltese: Status human pharmaceuticals ICH S8 - Immunotoxicology studies
English: Number of certificates
Maltese: Numru ta' certifikati
English: • André LHOIR (Belgium)
Maltese: • André LHOIR (Belġju)
English: Article 29
Maltese: Artikolu 29
English: 6.4 Document management and publishing...............................................................................76 Annexes
Maltese: 6.4 Ġestjoni u pubblikazzjoni ta' dokumenti.............................................................................75 Annessi
English: Number of reimbursed meetings Number of reimbursed delegates
Maltese: Numru ta' laqghat rimborsati Numru ta' delegati rimborsati
English: Immunotherapy and oncology Musculo-skeletal
Maltese: Immunoterapija u onkolo?ija Muskoluskeletriku
English: The COMP adopted 4 negative opinions in 2004.
Maltese: Il-COMP adotta 4 opinjonijiet negattivi fl-2004.
English: on the Internet at: www.emea.eu.int by e-mail request to: info@emea.eu.int by fax to: (44-20) 74 18 86 70 by writing to: EMEA Documentation service European Medicines Agency 7 Westferry Circus Canary Wharf UK London E14 4HB
Maltese: mill-Internet fuq: www.EMEA.eu.int permezz ta' talba bl-email lil: info@EMEA.eu.int permexx ta' fax lil: (44-20) 74 18 86 70 billi tikteb lil: EMEA Documentation service European Medicines Agency 7 Westferry Circus Canary Wharf UK - London E14 4HB
English: Spiros VAMVAKAS (from midOctober 2004)
Maltese: Spiros VAMVAKAS (minn nofs Ottubru 2004)
English: Chair: Hannes WAHLROOS EMEA contact: Martin HARVEY ALLCHURCH
Maltese: Hannes WAHLROOS Kuntatt fl-EMEA: Martin HARVEY ALLCHURCH
English: 6 Support activities
Maltese: 6 Attivitajiet ta' sostenn
English: • Kerstin WESTERMARK (Sweden)
Maltese: • Kerstin WESTERMARK (Svezja)
English: Horizontal telematics services
Maltese: Servizzi orizzontali ta' telematika
English: One PMF was finalised.
Maltese: PMF waħda ġiet finalizzata.
English: Gro Ramsten WESENBERG Director General
Maltese: WESENBERG Director General
English: • Gianmartino BENZI (EMEA representative)
Maltese: • Gianmartino BENZI (rappreżentant ta' l
English: Useful website: EudraVigilance http://eudravigilance.emea.eu.int
Maltese: EudraVigilance http://eudravigilance.EMEA.eu.int
English: Three Article 6(12) referrals were withdrawn.
Maltese: Tlett referenzi taħt l-Artikolu 6(12) ġew irtirati.
English: In 2004, the Agency had a record 25 551 visitors.
Maltese: Fl-2004, l-Aġenzija kellha rekord ta' 25 551 viżitatur.
English: • Yann LE CAM (patients organisation representative) (vice-chairman)
Maltese: • Yann LE CAM (rappreżentant ta' l organizzazzjoni tal-pazjenti) (viċi president)
English: • The Experts database, comprising more than 3 500 European experts, was upgraded.
Maltese: • Id-database ta' l-esperti, li tinkludi aktar minn 3 500 espert Ewropew, ġiet aġġornata.
English: • Martin MO INA (Slovenia) • José Félix OLALLA MARAÑÓN (Spain)
Maltese: • José Félix Olalla Marañón (Spanja)
English: I 00144 Roma
Maltese: I - 00144
English: Reference number
Maltese: Numru ta' referenza
English: The provision of interpretation was reviewed and tailored to real needs, and thus interpretation days were reduced by 68 % compared to the previous year.
Maltese: Il-forniment ta' servizzi ta' interpretazzjoni ġie rivedut u adattat skond il-ħtiġijiet reali u b'hekk ilġranet ta' interpretazzjoni tnaqqsu bi 68 % meta mqabbla mas-sena ta' qabel.
English: Isabelle MOULON (until midOctober 2004)
Maltese: Isabelle MOULON (sa nofs Ottubru 2004)
English: Referrals concluded
Maltese: Referenzi konklużi
English: Metacam 20mg/ml solution for injection !
Maltese: Metacam 20mg/ml solution for injection Meloxicam Part BExtension
English: Director-General Valsts zāļu aģentūra Jersikas iela 15
Maltese: Jãnis OZOLINŠ Director-General Valsts zāļu aģentūra Jersikas iela 15
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.eu.int http://www.emea.eu.int EMEA 2005 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@EMEA.eu.int http://www.EMEA.eu.int©EMEA 2005 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: VICH Topic GL40
Maltese: VICH Topic GL40Specifications:
English: Treatment of gammasarcoglycanopathies
Maltese: Treatment of gammasarcoglycanopathi es
English: New applications for maximum residue limits 2002-2004
Maltese: Applikazzjonijiet ?odda g?al limiti massimi ta' residwi 2002-2004
English: Article 35
Maltese: Artikolu 35
English: In 2004, 2 referrals were received; no arbitration was submitted.
Maltese: Fl-2004, intbagħtu 2 referenzi; ebda arbitraġġ ma ġie preżentat.
English: Translation
Maltese: Traduzzjoni
English: Sensory organs
Maltese: Organi tas-sensi
English: • Alistair KENT (patients organisation representative)
Maltese: • Alistair KENT (rappreżentant ta' l organizzazzjoni tal-pazjenti)
English: Jãnis OZOLIN (Alternate: Inguna ADOVICA)
Maltese: Jãnis OZOLINŠ (Sostituta:
English: Arbitration and Community referrals received/forecast (Input)
Maltese: Arbitra?? u referenzi Komunitarji ricevuti/imbassra (Dehlin)
English: Walter SCHWERDTFEGER (Alternate: Ilse-Dore SCHÜTT)
Maltese: Walter SCHWERDTFEGER (Sostituta:
English: Neurology/CNS
Maltese: Newrolo?ija/CNS
English: Biosimilar products
Maltese: Prodotti bijosimili
English: • Ingemar PERSSON1 (Sweden) (co-opted)
Maltese: • Ingemar PERSSON1 (Svezja)
English: Of all type-II variation opinions adopted in 2004, 5.3 % related to extension of indication, 46.3 % related to changes in the SPC and 48.4 % related to quality.
Maltese: Mill-alternattivi kollha ta' varjazzjoni tat-tip-II li ġew adottati fl-2004, 5.3 % kienu relatati ma' lestensjoni ta' indikazzjoni, 46.3 % kienu relatati ma' bidliet fl-SPC u 48.4 % kienu relatati malkwalità.
English: PSURs, specific obligations and follow-up measures
Maltese: PSURs, obbligi spe?ifi?i u miżuri ta' follow-up
English: Working Group with Patients' Organisations Chair: Frits LEKKERKERKER/Noël WATHION
Maltese: President: Frits LEKKERKERKER/Noël WATHION
English: • Approved nominations from Member States for new composition of the CHMP and CVMP
Maltese: • Approva nomini minn Stati Membri għal kompożizzjoni ġdida tas-CHMP u s-CVMP
English: Vaccine against
Maltese: Vaccine Part A
English: New centralised applications
Maltese: Applikazzjonijiet centralizzati godda
English: • HIV/AIDS (3 new combinations of products)
Maltese: • HIV/AIDS (3 taħlitiet ġodda ta' prodotti)
English: Musculo-skeletal system
Maltese: Sistema muskoluskeletrika
English: Article 30
Maltese: Artikolu 30
English: Biotechnology Quality Pre-clinical Clinical
Maltese: Bijoteknolo?ija Kwalita' Pre-klinika Klinika
English: This total includes 3 applications for biosimilar products and 6 multiple applications.
Maltese: Dan it-total jinkludi 3 applikazzjonijiet għal prodotti bijosimili u 6 applikazzjonijiet multipli.
English: Centralised applications - Negative opinions
Maltese: Applikazzjonijiet ċentralizzati - Opinjonijiet negattivi
English: During the procedure, new clinical trials data for the COX-2 inhibitor celecoxib became available, indicating an increased cardiovascular risk.
Maltese: kliniċi għall-impeditur tal-COX-2 celecoxib, li tindika żjieda fir-riskju kardjovaskulari.
English: This number is 31 % higher than the figure for 2003, and 27.5 % higher than the forecast number of 40.
Maltese: Dan in-numru huwa 31 % ogħla miċ-ċifra għall-2003, u 27.5 % ogħla minnumru mbassar ta' 40.
English: • The Meeting Management System (MMS) was upgraded, including a new range of services.
Maltese: • Is-Sistema ta' Ġestjoni tal-Laqgħat (Meeting Management System- MMS) ġiet aġġornata, inkluża firxa ġdida ta' servizzi.
English: Experts
Maltese: Esperti
English: Mariette BACKES-LIES (Alternate: Claude A HEMMER)
Maltese: Mariette BACKES-LIES (Sostitut:
English: 2.2 Scientific advice and protocol assistance
Maltese: 2.2 Parir xjentifiku u assistenza għall-protokoll
English: VICH Topic GL39
Maltese: VICH Topic GL39Specifications:
English: Milan MÍD
Maltese: Milan ŠMÍD
English: 3.8 Regulatory guidance
Maltese: 3.8 Gwida regolatorja
English: • Eva SKOVLUND (Norway) Alternate: Liv MATHIESEN
Maltese: • Eva SKOVLUND (Norveġja) Sostituta:
English: Scientific advice and protocol assistance requests (finalised)
Maltese: Talbiet g?al parir xjentifiku u assistenza g?all-protokoll (finalizzati)
English: Alimentary tract
Maltese: Apparat alimentari
English: The EMEA received a total of 19 type-I variation applications (14 type-IA and 5 type-IB) less than half of the original 40 forecast.
Maltese: L-EMEA rċeviet total ta' 19-il applikazzjoni ta' varjazzjoni tat-tip-I (14 tip-IA u 5 tip-IB) - inqas minn nofs l-40 mbassra oriġinarjament.
English: The other referral concerned the veterinary medicinal product Micotil 300 (tilmicosin).
Maltese: Ir-referenza l-oħra kienet tirrigwarda l-prodott mediċinali veterinarju Micotil 300 (tilmicosin).
English: Medicines and Healthcare products Regulatory Agency
Maltese: Medicines u Healthcare Products Regulatory Agency