(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank. hallinan@imb. ie Internet: http://www. imb. ie

(353-1) 676 49 71 Fax (353-1) 676 78 36 E-mail: frank. hallinan@ imb. ie Internet: http: //www. imb. ie

http://www. imb. ieSeamus HEALY LIECHTENSTEIN Assistant Secretary Brigitte BATLINER Department of Agriculture, Food and Rural Development Amt für Lebensmittelkontrolle und Veterinärwesen Agriculture House Kontrollstelle für Arzneimittel Kildare Street

Agence Franaise de Scurit Sanitaire des Produits de Sant 143-147, boulevard Anatole France F ­ 93285 Saint-Denis CEDEX Τηλ.

(ES) Mr President, this accident is certainly not comparable to other incidents involving oil tankers, or even container vessels such as the Napoli, on which the IMB still has to take a decision.
http://www.europarl.europa.eu/

(ES) Κύριε Πρόεδρε, αυτό το ατύχημα δεν συγκρίνεται βέβαια με άλλα συμβάντα που σχετίζονται με πετρελαιοφόρα, ούτε καν με πλοία μεταφοράς εμπορευματοκιβωτίων όπως το Napoli, για το οποίο εκκρεμεί ακόμη απόφαση του IMB.
http://www.europarl.europa.eu/

Frank HALLINAN Chief Executive Officer Irish Medicines Board The Earlsfort Centre Earlsfort Terrace Dublin 2 Ireland Tel.(353-1) 676 49 71 Fax (353-1) 661 47 64 E-mail: frank. hallinan@imb. ie Internet: http://www. imb. ieSeamus HEALY Assistant Secretary Department of Agriculture, Food and Rural Development Agriculture House Kildare Street Dublin 2 Ireland Tel.

Seamus HEALY Assistant Secretary Department of Agriculture, Food and Forestry Agriculture House Kildare Street Dublin 2 Ireland Τηλ.

Tel.Fax E-mail:Internet:(353-1) 676 49 71(353-1) 676 78 36pat. omahony@imb. ie

(423) 236 73 25 Φαξ (423) 236 73 10 Ηλεκτρ. ταχ.: brigitte. batliner@ alkvw. llv. li ΓΑΛΛΙΑ Philippe DUNETON Directeur GnralMartin HIRSCH Directeur GnralΣελίδα 68/99ΙΡΛΑΝΔΙΑΕτήσια έκθεση

It shall apply as from a date established by the SG/HR upon consultation of the PSC and of the iMB/Military Committee and in principle before the end of June 2001.Until the date of application of this Decision, the Director General of the Military Staff (DGEUMS), who will take up its functions as from 1 March 2001(2), shall act as head of the military experts seconded from Member States to the Council Secretariat(3).

Η παρούσα απόφαση εφαρμόζεται από την ημερομηνία που θα καθορίσει ο Γενικός Γραμματέας/Ύπατος Εκπρόσωπος αφού διαβουλευθεί με την Επιτροπή Εξωτερικής Πολιτικής και Πολιτικής Ασφάλειας και το μεταβατικό Στρατιωτικό Όργανο/Στρατιωτική Επιτροπή, καταρχήν δε, πριν από τα τέλη του Ιουνίου του 2001.Μέχρι την ημερομηνία εφαρμογής της παρούσας απόφασης, ο Γενικός Διευθυντής του Στρατιωτικού Επιτελείου (DGEUMS), ο οποίος θα αναλάβει τα καθήκοντά του την 1η Μαρτίου 2001(2), θα ενεργεί ως επικεφαλής των στρατιωτικών εμπειρογνωμόνων που αποσπώνται από τα κράτη μέλη στη Γενική Γραμματεία του Συμβουλίου(3).

It was subsequently licensed via a Mutual Recognition Procedure (MRP) in December 1998 with Sweden as Reference Member State (RMS); the Concerned Member States were Austria, Belgium, Germany, Denmark, Greece, Spain, Finland, France, Ireland, Italy, Luxembourg, Portugal, the Netherlands and United Kingdom.In September 2001, the Marketing Authorisation Holders (MAHs) applied for a Type II variation through MRP to include chronic obstructive pulmonary disease (COPD) as a therapeutic indication for the fixed-dose combination of salmeterol/FP 50/500 µg twice daily.The RMS reached a negative view on use in COPD even after the proposed treatment population was restricted to patients with moderate to severe COPD as indicated by an FEV1 of 50% or less of predicted normal.The separate components of the salmeterol/FP combination are not approved for use in the treatment of chronic obstructive pulmonary disease (COPD) in all EU Member States.On 19 April 2002, Ireland via the Irish Medicines Board (IMB) triggered a referral to the EMEA under Article 7(5) of Commission Regulation (EC) No 541/95.The IMB believed that having both components as a fixed dose combination could represent a convenience and compliance advantage to patients suffering from this common condition (i. e.COPD) , as is recognised in the CPMP Note for Guidance for Fixed Combination Medicinal Products (section 1.2. b ­ a simplification of therapy) .Moreover, the IMB considered that this aspect has not been sufficiently taken into consideration when the RMS, reached its opinion that the clinical benefit of the combination was marginal and that the efficacy advantage of the combination had not been convincingly demonstrated with respect to that of the separate components.The IMB therefore requested the CPMP to give an opinion on the scope of this variation application, i. e. the indication of treatment of COPD.The referral procedure started on 26 April 2002.The Rapporteur and Co-Rapporteur appointed were:Dr.D.Lyons and Dr.P.Arlett, respectively.Written explanations were provided by the MAHs on 13 August 2002.Supplementary information was provided by the MAHs on 16 December 2002.Oral explanations were given by MAHs on 21 January 2003.Based on re-evaluation of the currently available information on the above-concerned medicinal products, the CPMP considered that overall the balance of risks and benefits of the above-concerned medicinal product is favourable for the new restricted indication, and therefore adopted by majority an opinion on 23 January 2003 recommending the granting of the variation of the Marketing Authorisations for the fixed combination medicinal products containing salmeterol and fluticasone propionate for the indication of " the symptomatic treatment of patients with severe COPD (FEV1 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy " and the amendment of the summary of product characteristics 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.(44-20) 74 18 84 00 Fax (44-20) 74 18 86 68 E-mail: mail@emea. eu. int http://www. emea. eu. int EMEA 2003 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged The list of product names concerned is given in the Annex I.The scientific conclusions are provided in the Annex II together with the amended Summary of Product Characteristics in the Annex III.The final opinion was converted into a Decision by the European Commission on 21 May 2003.* Notes:The information given in this document and Annexes reflect only the CPMP Opinion dated 23 January 2003.The Member States competent authorities will continue to keep the product under regular review.EMEA 2003CPMP/1327/03ANNEX I2/18LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS, PACKAGING AND PACKAGE SIZES IN THE MEMBER STATES

Τα κείμενα ήταν τότε έγκυρα.Μετά την Απόφαση της Επιτροπής, οι Αρμόδιες Αρχές του Κράτους Μέλους θα ενημερώσουν τις πληροφορίες του προϊόντος όπως απαιτείται.Ως εκ τούτου, το παρόν SPC πιθανά να μην αντανακλάEMEA 2003CPMP/1327/031/10 1.ΟΝΟΜΑΣΙΑ ΤΟΥ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣΌνομα σκευάσματος 50/100 μικρογραμμάρια/δόση κόνις για εισπνοή σε δόσεις. Όνομα σκευάσματος 50/250 μικρογραμμάρια/δόση κόνις για εισπνοή σε δόσεις. Όνομα σκευάσματος 50/500 μικρογραμμάρια/δόση κόνις για εισπνοή σε δόσεις.