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ISSN 1725-2423 |
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Official Journal of the European Union |
C 233 |
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English edition |
Information and Notices |
Volume 49 |
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III Notices |
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Commission |
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2006/C 233/3 |
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(1) Text with EEA relevance |
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EN |
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I Information
Commission
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28.9.2006 |
EN |
Official Journal of the European Union |
C 233/1 |
Euro exchange rates (1)
27 September 2006
(2006/C 233/01)
1 euro=
|
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Currency |
Exchange rate |
|
USD |
US dollar |
1,2684 |
|
JPY |
Japanese yen |
148,90 |
|
DKK |
Danish krone |
7,4595 |
|
GBP |
Pound sterling |
0,67105 |
|
SEK |
Swedish krona |
9,2770 |
|
CHF |
Swiss franc |
1,5796 |
|
ISK |
Iceland króna |
88,77 |
|
NOK |
Norwegian krone |
8,2650 |
|
BGN |
Bulgarian lev |
1,9558 |
|
CYP |
Cyprus pound |
0,5767 |
|
CZK |
Czech koruna |
28,413 |
|
EEK |
Estonian kroon |
15,6466 |
|
HUF |
Hungarian forint |
273,63 |
|
LTL |
Lithuanian litas |
3,4528 |
|
LVL |
Latvian lats |
0,6960 |
|
MTL |
Maltese lira |
0,4293 |
|
PLN |
Polish zloty |
3,9782 |
|
RON |
Romanian leu |
3,5350 |
|
SIT |
Slovenian tolar |
239,59 |
|
SKK |
Slovak koruna |
37,443 |
|
TRY |
Turkish lira |
1,8965 |
|
AUD |
Australian dollar |
1,6915 |
|
CAD |
Canadian dollar |
1,4143 |
|
HKD |
Hong Kong dollar |
9,8784 |
|
NZD |
New Zealand dollar |
1,9264 |
|
SGD |
Singapore dollar |
2,0156 |
|
KRW |
South Korean won |
1 196,86 |
|
ZAR |
South African rand |
9,6795 |
|
CNY |
Chinese yuan renminbi |
10,0229 |
|
HRK |
Croatian kuna |
7,3945 |
|
IDR |
Indonesian rupiah |
11 681,96 |
|
MYR |
Malaysian ringgit |
4,670 |
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PHP |
Philippine peso |
63,693 |
|
RUB |
Russian rouble |
33,9790 |
|
THB |
Thai baht |
47,603 |
Source: reference exchange rate published by the ECB.
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28.9.2006 |
EN |
Official Journal of the European Union |
C 233/2 |
Prior notification of a concentration
(Case COMP/M.4242 — Thermo Electron Corporation/Fisher Scientific International)
(2006/C 233/02)
(Text with EEA relevance)
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1. |
On 19 September 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Thermo Electron Corporation (‘Thermo’, USA) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking Fisher Scientific International (‘Fisher’, USA) by way of purchase of shares. |
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2. |
The business activities of the undertakings concerned are:
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3. |
On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. |
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4. |
The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission. Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4242 — Thermo Electron Corporation/Fisher Scientific International, to the following address:
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28.9.2006 |
EN |
Official Journal of the European Union |
C 233/3 |
Prior notification of a concentration
(Case COMP/M.4379 — Remondis/Cronimet/Alfa Acciai/TSR Group)
Candidate case for simplified procedure
(2006/C 233/03)
(Text with EEA relevance)
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1. |
On 20 September 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings ALFA Acciai s.p.a. (‘ALFA Acciai’, Italy), Cronimet Holding GmbH (‘Cronimet’, Germany), and Remondis AG & Co. KG (‘Remondis’, Germany) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertaking TSR Group (‘TSR’, Germany) by way of purchase of shares. |
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2. |
The business activities of the undertakings concerned are:
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3. |
On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
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4. |
The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission. Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4379 — Remondis/Cronimet/Alfa Acciai/TSR Group, to the following address:
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28.9.2006 |
EN |
Official Journal of the European Union |
C 233/4 |
Prior notification of a concentration
(Case COMP/M.4390 — PHL/IBFF)
Candidate case for simplified procedure
(2006/C 233/04)
(Text with EEA relevance)
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1. |
On 20 September 2006 the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which Liberator Bidco Ltd (‘Liberator’, UK), part of Permira Holdings, acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the European frozen food business of the Unilever Group (‘IBFF’, UK) by way of purchase of shares and assets. |
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2. |
The business activities of the undertakings concerned are:
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3. |
On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
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4. |
The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission. Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4390 — PHL/IBFF to the following address:
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28.9.2006 |
EN |
Official Journal of the European Union |
C 233/5 |
STATE AID — ITALY
State aid No C 31/2006 (ex N 612/2005) — Urgent measures to prevent bird flu
Invitation to submit comments pursuant to Article 88(2) of the EC Treaty
(2006/C 233/05)
By means of the letter dated of 4 July 2006, reproduced in the authentic language on the pages following this summary, the Commission notified Italy of its decision to initiate the procedure laid down in Article 88(2) of the EC Treaty concerning the abovementioned aid.
Interested parties may submit their comments on the aid in respect of which the Commission is initiating the procedure within one month of the date of publication of this summary and the following letter, to:
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European Commission |
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Directorate-General for Agriculture and Rural Development |
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Directorate H2 |
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Office: Loi 130 5/128 |
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B-1049 Brussels |
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Fax: (32-2) 296 76 72 |
These comments will be communicated to Italy. Confidential treatment of the identity of the interested party submitting the comments may be requested in writing, stating the reasons for the request.
SUMMARY
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The Italian authorities adopted urgent measures to prevent bird flu which will be in force until 1 January 2007 under the following legislation:
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Poultry farms, slaughterhouses and poultry meat processing companies, poultry meat warehouses and poultry-feed manufacturers may benefit from these measures. |
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Article 5 of LD 202/05, last amended by Article 1a(7) of Law 81/06 provides for:
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Article 1a, paragraphs 8, 10, 11 and 12 of Law 81/06 provides for an Emergency Poultry Fund (‘the Fund’) to be set up under the Ministry of Agricultural Policy for use in 2006:
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Article 1a(12) of Law 81/06 states that the implementing measures for aid funded by the Fund are to be adopted by a decree from the Ministry for Agricultural policy and the Ministry for Health. The Italian authorities undertook, in an e-mail dated 20 April 2006, to notify the above decrees to the Commission under Article 88(3) of the Treaty. The Commission notes that this Law does not constitute state aid ex se. Consequently these measures are not liable to distort competition or affect trade between Member States. The Italian authorities notified the Commission in an e-mail dated 23 May 2006 of a draft Ministerial Decree on the implementing measures for the aid financed by the Fund. As a result, this file in the dossier will examined as part of state aid No 322/2006. |
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At this stage, the Commission has doubts regarding the compatibility with the internal market of the measures provided for in Article 5 of Legislative Decree No 202/05, last amended by Article 1a(7) of Law No 81/06, as the Italian authorities have not provided any information justifying these measures in the light of the rules applicable to state aid, and in particular point 11.4 of the Community guidelines on state aid in the poultry sector (4), as well as the Community guidelines for state aid for rescuing and restructuring firms in difficulty (5). |
TEXT OF THE LETTER
‘Con la presente mi pregio informarLa che la Commissione, dopo aver esaminato le informazioni trasmesse dalle autorità italiane sulla misura di cui all'oggetto, ha deciso di avviare il procedimento previsto dall'articolo 88, paragrafo 2, del trattato CE.
1. PROCEDIMENTO
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1) |
Con lettera del 9 dicembre 2005, protocollata il 13 dicembre 2005, la Rappresentanza permanente d'Italia presso l'Unione europea ha notificato alla Commissione le misure in oggetto a norma dell'articolo 88, paragrafo 3, del trattato. |
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2) |
Con messaggio di posta elettronica del 2 marzo 2006, protocollato il 3 marzo 2006, le autorità italiane hanno notificato alla Commissione l'articolo 1 bis, paragrafi 8, 10, 11 e 12 del progetto di legge di conversione del decreto legge 10 gennaio 2006, n. 2 . |
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3) |
Con fax rispettivamente del 14 febbraio 2006 (rif. AGR 4535) e del 20 marzo 2006 (rif. AGR 7800) la Commissione ha chiesto informazioni complementari. |
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4) |
Con messaggio di posta elettronica del 20 aprile 2006, protocollato il 25 aprile 2005, le autorità italiane hanno trasmesso alcune informazioni complementari. |
2. DESCRIZIONE DETTAGLIATA DELLA MISURA
Titolo
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5) |
Misure urgenti per la prevenzione dell'influenza aviaria |
Fondamento giuridico
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6) |
Articolo 5 del decreto-legge 1o ottobre 2005, n. 202 (DL 202/05) convertito in legge 30 novembre 2005, n. 244 (legge 244/06) (6), modificato dall'articolo 1 bis, paragrafo 7, della legge 11 marzo 2006, n. 81 (legge 81/06) di conversione del decreto-legge 10 gennaio 2006, n. 2. |
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7) |
Decreto del Ministero delle politiche agricole e forestali del 13 gennaio 2006 (decreto 13 gennaio 2006) recante modalità per l'applicazione delle disposizioni in materia di ritiro dal mercato di carne avicola ai sensi dell'articolo 5, commi 1 e 2, della legge 244/2005 (7). |
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8) |
Articolo 1 bis, paragrafi 8, 10, 11 e 12 della legge 81/06 (8). |
Stanziamento
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9) |
Le risorse cui attingere per il finanziamento delle diverse misure provengono dal bilancio nazionale. Le autorità italiane hanno menzionato una dotazione finanziaria di 120 milioni di EUR così distribuiti: 20 milioni di EUR destinati agli aiuti alimentari e 100 milioni di EUR destinati all'istituzione del Fondo per l'emergenza avicola. |
Durata
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10) |
Fino al 1o gennaio 2007. |
Beneficiari
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11) |
Allevamenti avicoli, imprese di macellazione e di trasformazione di carne avicola, esercenti attività di commercio all'ingrosso di carni avicole e imprese di produzione di alimenti per il pollame. |
Misure
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12) |
L'articolo 5 del DL 202/05, modificato dall'articolo 1 bis, paragrafo 7, della legge 81/06, prevede:
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13) |
L'articolo 1 bis, commi 8, 10, 11 e 12, della legge 81/06 prevede l'istituzione presso il Ministero delle politiche agricole e forestali di un “Fondo per l'emergenza avicola” (il Fondo) con dotazione pari a 100 milioni di EUR per l'anno 2006, avente le seguenti finalità:
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14) |
L'articolo 1 bis, comma 12, della legge 81/06 stabilisce che le disposizione attuative degli aiuti finanziati dal Fondo saranno adottate con decreti del Ministero delle politiche agricole e forestali e del Ministero della sanità. Con messaggio di posta elettronica del 20 aprile 2006 le autorità italiane si sono impegnate a notificare alla Commissione i suddetti decreti, in applicazione dell'articolo 88, paragrafo 3, del trattato. |
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15) |
Con e-mail del 24 maggio 2006 le autorità italiane hanno notificato alla Commissione un progetto di decreto ministeriale comportante le misure attuative degli aiuti finanziati dal Fondo. Pertanto le misure previste dall'articolo 1-bis, comma 12, della legge 81/06 saranno esaminate dalla Commissione nell'ambito del fascicolo di aiuti di Stato N 322/2006. |
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16) |
La Commissione ha a più riprese raccomandato alle autorità italiane di non dare seguito alla misura prevista dall'articolo 5 del DL 202/05 in merito all'acquisto di carni congelate da destinare ad aiuti alimentari (9). Il decreto 13 gennaio 2006, che disciplina le modalità alle quali l'AGEA deve attenersi per l'acquisto dei prodotti avicoli di origine comunitaria, prevede i seguenti prezzi minimi d'acquisto:
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17) |
Può offrire i propri prodotti ad AGEA qualsiasi persona fisica o giuridica attiva nel settore dell'allevamento e della trasformazione delle carni avicole da più di dodici mesi a decorrere dall'entrata in vigore del decreto 13 gennaio 2006 ed iscritta, per le suddette attività, nel registro delle imprese tenuto dalla Camera di commercio. |
3. VALUTAZIONE DELLA MISURA
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18) |
In virtù dell'articolo 87, paragrafo 1, del trattato, sono incompatibili con il mercato comune, nella misura in cui incidano sugli scambi tra Stati membri, gli aiuti concessi dagli Stati, ovvero mediante risorse statali, sotto qualsiasi forma che, favorendo talune imprese o talune produzioni, falsino o minaccino di falsare la concorrenza. |
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19) |
L'articolo 1 bis, commi 8, 10, 11 e 12 della legge 81/06 prevede l'istituzione del Fondo da utilizzare per finanziare le misure descritte al punto 13, lettere a) — e), le cui modalità di concessione saranno fissate da decreti ad hoc del Ministero delle politiche. Le autorità italiane hanno notificato alla Commissione un progetto di decreto ministeriale comportante le misure attuative degli aiuti finanziati dal Fondo. Pertanto le misure previste dall'articolo 1-bis, comma 12, della legge 81/06 saranno esaminate dalla Commissione nell'ambito del fascicolo di aiuti di Stato N 322/2006. |
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20) |
Nella fase attuale le misure descritte ai punti 12, 16 e 17 sembrano invece corrispondere alla definizione di aiuto di Stato sopra menzionata nel senso che esse sono concesse mediante risorse statali sia sotto forma di mancato guadagno in termini di gettito fiscale per i pubblici poteri sia sotto forma di prezzi da corrispondere per l'acquisto di carni di pollame e nel senso che esse possono incidere sugli scambi a causa della posizione che l'Italia occupa nel comparto produttivo in parola (nel 2004 l'Italia era il quarto paese produttore di carni avicole nell'Unione). |
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21) |
Tuttavia, nei casi previsti dall'articolo 87, paragrafi 2 e 3, del trattato, alcune misure possono essere considerate, in deroga, compatibili con il mercato comune. |
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22) |
Nel caso in specie, tenuto conto delle informazioni disponibili, l'unica deroga che si potrebbe invocare è quella dell'articolo 87, paragrafo 3, lettera c), del trattato, secondo cui possono essere considerati compatibili con il mercato comune gli aiuti destinati ad agevolare lo sviluppo di talune attività o di talune regioni economiche, sempre che non alterino le condizioni degli scambi in misura contraria al comune interesse. |
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23) |
Affinché tale deroga sia applicabile, è necessario che la Commisione non nutra alcun dubbio in merito alla problematica della compatibilità delle misure previste. |
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24) |
Poiché attualmente le autorità italiane non hanno trasmesso nessuna informazione che giustifichi le suddette misure alla luce delle norme applicabili in materia di aiuti di Stato — segnatamente il punto 11.4 degli Orientamenti comunitari per gli aiuti di Stato nel settore agricolo (10) — e degli Orientamenti comunitari sugli aiuti di Stato per il salvataggio e la ristrutturazione di imprese in difficoltà (11), la Commissione nutre effettivamente dei dubbio per quanto riguarda la compatibilità della misura proposta con il mercato comune. |
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25) |
La Commissione ha pertanto deciso di avviare il procedimento di indagine previsto dall'articolo 88, paragrafo 2, del trattato. |
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26) |
Tenuto conto delle considerazioni sopra esposte, la Commissione invita le autorità italiane, nell'ambito del procedimento di cui all'articolo 88, paragrafo 2, del trattato, a presentare le proprie osservazioni ed a trasmettere qualsiasi informazione utile ai fini della valutazione della misura entro un mese a decorrere dalla data di ricezione della presente. Essa invita altresì le autorità del Suo paese a trasmettere immediatamente copia della presente ai potenziali beneficiari dell'aiuto. |
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27) |
La Commissione rammenta alle autorità italiane l'effetto sospensivo dell'articolo 88, paragrafo 3, del trattato CE e si richiama all'articolo 14 del regolamento (CE) n. 659/1999 del Consiglio secondo cui ogni aiuto illegale può costituire oggetto di recupero presso il beneficiario. |
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28) |
Con la presente, la Commissione avvisa le autorità italiane che informerà gli interessati tramite la pubblicazione della presente lettera e di un riepilogo della medesima nella Gazzetta ufficiale dell'Unione europea. Essa informerà altresì gli interessati nei paesi dell'EFTA che hanno firmato l'Accordo SEE tramite la pubblicazione nel supplemento SEE della Gazzetta ufficiale nonché l'Autorità di vigilanza EFTA tramite copia della presente. Tutti gli interessati sopra citati saranno invitati a presentare le proprie osservazioni entro un mese a decorrere dalla data della presente pubblicazione.’ |
(1) Official Gazette of the Italian Republic of 30.11.2005, general series No 279, p. 44.
(2) Official Gazette of the Italian Republic of 26.1.2006, general series No 21, p. 50.
(3) Official Gazette of the Italian Republic of 11.3.2006, ordinary supplement No 58.
(5) OJ C 244, 1.10.2004, p. 2.
(6) Gazzetta ufficiale della Repubblica italiana del 30.11.2006 — serie generale — n. 279, pag. 44.
(7) Gazzetta ufficiale della Repubblica italiana del 26.1.2006 — serie generale — n. 21, pag. 50.
(8) Gazzetta ufficiale della Repubblica italiana dell'11.3.2006; supplemento ordinario n. 58.
(9) Segnatamente con lettera D(2005)38372 del 12.12.2005 (rif. AGR 31606), con fax D(2006)9256 del 20.3.2006 (rif. AGRI 7800), entrambe della direzione generale dell'Agricoltura e dello sviluppo rurale e con lettera B4* D(2006)1927 del 12.4.2006 della direzione generale dello Sviluppo.
(10) GU C 28 dell'1.2.2000, pag. 2.
(11) GU C 244 dell'1.10.2004, pag. 2.
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28.9.2006 |
EN |
Official Journal of the European Union |
C 233/9 |
Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 68/2001 of 12 January 2001 on the application of Articles 87 and 88 of the EC Treaty to training aid
(2006/C 233/06)
(Text with EEA relevance)
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Aid No |
XT 3/06 |
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Member State |
Germany |
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Region |
Brandenburg |
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Title of aid scheme or name of company receiving individual aid |
INNOPUNKT 13 ‘Prospects for qualified young women in the Land of Brandenburg’ |
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Legal basis |
§§ 23, 44 Landeshaushaltsordnung des Landes Brandenburg |
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Annual expenditure planned or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount |
EUR 0,35 million |
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Loans guaranteed |
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Individual aid |
Overall aid amount |
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Loans guaranteed |
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Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
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Date of implementation |
5/2005 |
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Duration of the scheme or individual aid award |
Until 5.5.2007 (The adjustment period provided for in Article 8(2) of Regulation 68/2001 is being used in order to make any adjustment needed to bring the scheme into line with the block exemption regulation then applicable) |
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Objective of aid |
General training |
Yes |
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Specific training |
|
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Economic sectors concerned |
All sectors eligible for training aid |
Yes |
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Name and address of the granting authority |
Name: Landesagentur für Struktur und Arbeit Brandenburg GmbH |
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Address:
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|||||
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Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
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Aid No |
XT 4/06 |
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Member State |
Germany |
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Region |
Brandenburg |
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Title of aid scheme or name of company receiving individual aid |
INNOPUNKT 12 ‘Future prospects due to cluster-based regional interaction processes’ |
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Legal basis |
§§ 23, 44 Landeshaushaltsordnung des Landes Brandenburg |
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Annual expenditure planned or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount |
EUR 0,8 million |
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Loans guaranteed |
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||||
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Individual aid |
Overall aid amount |
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Loans guaranteed |
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||||
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Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
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Date of implementation |
11.2004 |
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Duration of the scheme or individual aid award |
Until 30.11.2006 |
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Objective of aid |
General training |
Yes |
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Specific training |
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||||
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Economic sectors concerned |
All sectors eligible for training aid |
Yes |
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Name and address of the granting authority |
Name: Landesagentur für Struktur und Arbeit Brandenburg GmbH |
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Address:
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Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
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Aid No |
XT 5/06 |
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Member State |
Germany |
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Region |
Brandenburg |
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Title of aid scheme or name of company receiving individual aid |
INNOPUNKT 14 ‘Alliances between the cultural and business sectors promote growth and employment in Brandenburg’ |
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Legal basis |
§§ 23, 44 Landeshaushaltsordnung des Landes Brandenburg |
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Annual expenditure planned or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount |
EUR 0,58 million |
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Loans guaranteed |
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Individual aid |
Overall aid amount |
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Loans guaranteed |
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||||
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Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
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Date of implementation |
8.2005 |
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Duration of the scheme or individual aid award |
Until 30.8.2007 (The adjustment period provided for in Article 8(2) of Regulation 68/2001 is being used in order to make any adjustment needed to bring the scheme into line with the block exemption regulation then applicable. Steps are being taken to ensure that after the deadline the scheme is in keeping with the block exemption regulation or corresponding rules then in force) |
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Objective of aid |
General training |
Yes |
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Specific training |
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Economic sectors concerned |
All sectors eligible for training aid |
Yes |
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Name and address of the granting authority |
Name: Landesagentur für Struktur und Arbeit Brandenburg GmbH |
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Address:
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Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
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Aid No |
XT 10/06 |
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Member State |
United Kingdom of Great Britain and Northern Ireland |
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Region |
Scotland (Local Authorities) |
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Title of aid scheme or name of company receiving individual aid |
Support for SMEs for training |
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Legal basis |
Section 20 of Local Government in Scotland Act 2003 |
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Annual expenditure planned under the scheme or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount |
GBP 2 million |
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Loans guaranteed |
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Individual aid |
Overall aid amount |
|
||||||
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Loans guaranteed |
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|||||||
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Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
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Date of implementation |
From 1.1.2006 |
|||||||
|
Duration of scheme or individual aid award |
Until 31.12.2006 |
|||||||
|
Objective of aid |
General training |
Yes |
||||||
|
Specific training |
Yes |
|||||||
|
Economic sectors concerned |
All sectors eligible for training aid |
Yes |
||||||
|
Name and address of the granting authority |
Name: Scottish Executive |
|||||||
|
Address:
|
||||||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
|
|||||
|
Aid No |
XT 11/06 |
||||||
|
Member State |
United Kingdom |
||||||
|
Region |
West Wales & The Valleys Objective 1 Region |
||||||
|
Title of aid scheme or name of company receiving individual aid |
Energy Tech Limited |
||||||
|
Legal basis |
Council Regulation (EC) No. 1260/99 The Structural Funds (National Assembly for Wales) Regulations 2000 (no./906/2000) The Structural Funds (National Assembly for Wales) Designation2000 |
||||||
|
Annual expenditure planned under the scheme or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount |
|
||||
|
Loans guaranteed |
|
||||||
|
Individual aid |
Overall aid amount |
GBP 19 600 |
|||||
|
Loans guaranteed |
|
||||||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
|
||||
|
Date of implementation |
From 17.1.2006 |
||||||
|
Duration of scheme or individual aid award |
Until 31.12.2006 NB. As noted above, the grant was committed prior to 31 December 2006. Payments against this commitment will, potentially (in line with N+2) continue until 30 April 2008 |
||||||
|
Objective of aid |
General training |
Yes |
|||||
|
Specific training |
No |
||||||
|
Economic sectors concerned |
Limited to specific sectors |
Yes |
|||||
|
Other services (Renewable Energy) |
Yes |
||||||
|
Name and address of the granting authority |
Name: National Assembly for Wales |
||||||
|
Address:
|
|||||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
|
||||
|
Aid No |
XT 12/06 |
||||||
|
Member State |
United Kingdom |
||||||
|
Region |
London |
||||||
|
Title of aid scheme or name of company receiving individual aid |
Kessler Limited (Lean Learning Academy) |
||||||
|
Legal basis |
Section 4 RDA Act 1998 |
||||||
|
Annual expenditure planned under the scheme or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount |
|
||||
|
Loans guaranteed |
|
||||||
|
Individual aid |
Overall aid amount |
GBP 123 000 |
|||||
|
Loans guaranteed |
|
||||||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
|
||||
|
Date of implementation |
From 21.3.2006 |
||||||
|
Duration of scheme or individual aid award |
Until 17.7.2006 |
||||||
|
Objective of aid |
General training |
Yes |
|||||
|
Specific training |
|
||||||
|
Economic sectors concerned |
All sectors eligible for training aid |
Yes |
|||||
|
Name and address of the granting authority |
Name: London Development Agency |
||||||
|
Address:
|
|||||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
|
||||
|
Aid No |
XT 14/06 |
||||
|
Member State |
Deutschland |
||||
|
Region |
Brandenburg |
||||
|
Title of aid scheme or name of company receiving individual aid |
IHK Projektgesellschaft mbH |
||||
|
Legal basis |
§§ 23, 44 Landeshaushaltsordnung des Landes Brandenburg |
||||
|
Annual expenditure planned or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount |
|
||
|
Loans guaranteed |
|
||||
|
Individual aid |
Overall aid amount |
EUR 0,28 million |
|||
|
Loans guaranteed |
|
||||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
|
||
|
Date of implementation |
23.2.2006 |
||||
|
Duration of the scheme or individual aid award |
Until 15.12.2007 (The adjustment period provided for in Article 8(2) of Regulation 68/2001 is being used in order to make any adjustment needed to bring the scheme into line with the block exemption regulation then applicable. Steps are being taken to ensure that after the deadline the scheme is in keeping with the block exemption regulation or corresponding rules then in force) |
||||
|
Objective of aid |
General training |
Yes |
|||
|
Specific training |
No |
||||
|
Economic sectors concerned |
All sectors eligible for training aid |
Yes |
|||
|
Name and address of the granting authority |
Name: Landesagentur für Struktur und Arbeit Brandenburg GmbH |
||||
|
Address:
|
|||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
|
||
|
Aid No |
XT 19/06 |
||||||
|
Member State |
United Kingdom |
||||||
|
Region |
London |
||||||
|
Title of aid scheme or name of company receiving individual aid |
Richard Edward Limited (Lean Learning Academy) |
||||||
|
Legal basis |
Section 4 RDA Act 1998 |
||||||
|
Annual expenditure planned under the scheme or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount |
|
||||
|
Loans guaranteed |
|
||||||
|
Individual aid |
Overall aid amount |
GBP 72 700 |
|||||
|
Loans guaranteed |
|
||||||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
|
||||
|
Date of implementation |
From 21.3.2006 |
||||||
|
Duration of scheme or individual aid award |
Until 17.7.2006 |
||||||
|
Objective of aid |
General training |
Yes |
|||||
|
Specific training |
|
||||||
|
Economic sectors concerned |
All sectors eligible for training aid |
Yes |
|||||
|
Name and address of the granting authority |
Name: London Development Agency |
||||||
|
Address:
|
|||||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
|
||||
|
Aid No |
XT 22/06 |
|||||
|
Member State |
United Kingdom |
|||||
|
Region |
West Midlands |
|||||
|
Title of aid scheme or name of company receiving individual aid |
Accelerate — Training Support for the West Midlands Automotive Cluster |
|||||
|
Legal basis |
Employment Act 1973 — Section 2(1) and 2(2) as substantiated by Section 25 of the Employment and Training Action1998 and the Industrial Development Act 1982, Section 7 & 11 Regional Development Agencies Act 1998 — Section 5 & 6 Greater London Authority Action 1999 Leasehold and Reform, Housing and Urban Act 1993 National Lottery Act, 1998 Local Government Act, 2000 — Section 2 Housing Grant Construction and Regeneration Act 1996 — Section 126 Employment and Training Act 1993 — Section 2 Leasehold, Housing and Urban Development Act 1993 — Part 3 Learning and Skills Council Act 2000 |
|||||
|
Annual expenditure planned under the scheme or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount |
GBP 25 million |
|||
|
Loans guaranteed |
|
|||||
|
Individual aid |
Overall aid amount |
GBP 150 000 |
||||
|
Loans guaranteed |
|
|||||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
|
|||
|
Date of implementation |
From 1.1.2006 |
|||||
|
Duration of scheme or individual aid award |
Until 31.12.2006 |
|||||
|
Objective of aid |
General training |
Yes |
||||
|
Specific training |
Yes |
|||||
|
Economic sectors concerned |
All sectors eligible for training aid |
No |
||||
|
Limited to specific sectors |
Yes |
|||||
|
Yes |
|||||
|
Name and address of the granting authority |
Name: Birmingham Chamber of Commerce and Industry |
|||||
|
Address:
|
||||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
|
|||
|
Aid No |
XT 24/06 |
||||||
|
Member State |
Belgium |
||||||
|
Region |
Vlaanderen |
||||||
|
Title of aid scheme or name of company receiving individual aid |
|
||||||
|
Legal basis |
Decreet van 31 januari 2003 |
||||||
|
Annual expenditure planned or overall amount of aid granted to the company |
Aid scheme |
Annual overall amount |
|
||||
|
Loans guaranteed |
|
||||||
|
Individual aid |
Overall aid amount |
EUR 953 063 |
|||||
|
Loans guaranteed |
|
||||||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
|
||||
|
Date of implementation |
12.5.2006 |
||||||
|
Duration of scheme or individual aid award |
Until 30.7.2008 |
||||||
|
Objective of aid |
General training |
Yes |
|||||
|
Specific training |
Yes |
||||||
|
Economic sectors concerned |
Limited to specific sectors |
Yes |
|||||
|
Motor vehicles |
Yes |
||||||
|
Name and address of the granting authority |
Name: Vlaamse Gewest |
||||||
|
Address:
|
|||||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
|
||||
|
Aid No |
XT 25/06 |
||||||
|
Member State |
Belgium |
||||||
|
Region |
Vlaanderen |
||||||
|
Title of aid scheme or name of company receiving individual aid |
|
||||||
|
Legal basis |
Decreet van 31 januari 2003 |
||||||
|
Annual expenditure planned or overall amount of aid granted to the company |
Aid scheme |
Annual overall amount |
|
||||
|
Loans guaranteed |
|
||||||
|
Individual aid |
Overall aid amount |
EUR 999 261 |
|||||
|
Loans guaranteed |
|
||||||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
|
||||
|
Date of implementation |
19.5.2006 |
||||||
|
Duration of scheme or individual aid award |
Until 30.8.2008 |
||||||
|
Objective of aid |
General training |
Yes |
|||||
|
Specific training |
|
||||||
|
Economic sectors concerned |
Limited to specific sectors |
Yes |
|||||
|
Maritime transport services |
Yes |
||||||
|
Name and address of the granting authority |
Name: Vlaamse Gewest |
||||||
|
Address:
|
|||||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
|
||||
|
28.9.2006 |
EN |
Official Journal of the European Union |
C 233/17 |
Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 68/2001 of 12 January 2001 on the application of Articles 87 and 88 of the EC Treaty to training aid
(2006/C 233/07)
(Text with EEA relevance)
|
Aid No |
XT 16/06 |
|||
|
Member State |
Hungary |
|||
|
Region |
Entire country |
|||
|
Title of aid scheme or name of company receiving an individual aid |
Training aid from the regional development appropriation |
|||
|
Legal basis |
A területfejlesztési célelőirányzat felhasználásának részletes szabályairól szóló, a 17/2006. (I. 26.) Korm. rendelettel módosított 26/2003. (III. 4.) Korm. rendelet 24/A. § |
|||
|
Annual expenditure planned or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount (2006) |
EUR 3 958 300 |
|
|
Annual overall amount (2007) |
EUR 1 227 985 |
|||
|
Loans guaranteed |
|
|||
|
Individual aid |
Overall aid amount |
|
||
|
Loans guaranteed |
|
|||
|
Maximum aid intensity |
In conformity with Article 4(2)-(6) of the Regulation |
Yes |
|
|
|
Date of implementation |
29.1.2006 |
|||
|
Duration of the scheme or individual aid award |
30.6.2007 |
|||
|
Objective of aid |
General training |
Yes |
||
|
Specific training |
Yes |
|||
|
Economic sectors concerned |
All sectors eligible for training aid |
Yes |
||
|
Name and address of the granting authority |
Name: Országos Területfejlesztési Hivatal, Regionális Fejlesztés Operatív Program és INTERREG Közösségi Kezdeményezés Irányító Hatósága |
|||
|
Address: H-Budapest — 1015. Hattyú u. 14. Contact person: Szigeti Ferenc Albert |
||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
||
|
Aid No |
XT 21/06 |
|
Member State |
Republic of Hungary |
|
Region |
Entire country |
|
Title of aid scheme or name of company receiving an individual aid |
EQUAL Community Initiative |
|
Legal basis |
Az EQUAL Közösségi Kezdeményezés fejezeti kezelésű előirányzat felhasználásával kapcsolatos szabályokról szóló 33/2004. (XII. 23.) FMM rendelet |
|
Annual expenditure planned or overall amount of individual aid granted to the company |
For 2005: EUR 13 649 200 (1) |
|
Maximum aid intensity |
For general education gross aid intensity cannot exceed 60% for large companies and 80% for micro-, small- and medium-sized enterprises. For special education gross aid intensity cannot exceed 35% for large companies and 45% for micro-, small- and medium-sized enterprises. For both general and special education aid intensity can be increased by a further 10% if it is for the education of a disadvantaged person |
|
Date of implementation |
Start of the aid programme: 1.1.2005 |
|
Duration of the scheme or individual aid award |
31.12.2006 |
|
Objective of aid |
The aim of the EQUAL Community Initiative is to develop innovative methods to tackle discrimination and inequalities on the labour market via the Development Partnership and with the help of economic operators, including undertakings. EQUAL helps to implement the European Employment Strategy |
|
Economic sectors concerned |
All sectors |
|
Name and address of the granting authority |
Name: Foglalkoztatáspolitikai és Munkaügyi Minisztérium Humánerőforrás-fejlesztési Operatív Program és EQUAL Program Irányító Hatóság |
|
Address: H-1054 Budapest, Alkotmány u. 3. |
|
Aid No |
XT 23/06 |
||||
|
Member State: |
Italy |
||||
|
Region |
Molise, with differing aid intensities according to the area where the measure is implemented |
||||
|
Title of aid scheme or name of company receiving individual aid Regional Economic Development Plan: |
Multiannual programme of measures designed to promote economic recovery in Molise following disasters — Open notice concerning the granting of aid to give integrated support to firms |
||||
|
Legal basis |
Ordinanza del Presidente del Consiglio dei Ministri n. 3268 del 12 marzo 2003, e successive, che ha nominato il Presidente della Regione Molise Commissario Delegato per gli eccezionali eventi sismici del 31 ottobre 2002 e per quelli meteorologici del gennaio 2003 ed ha previsto, all'art. 15, la predisposizione di un Programma pluriennale d'interventi diretti a favorire la ripresa produttiva nel territorio della Regione Molise. Tale Programma è stato approvato dalla Giunta regionale del Molise con Deliberazione n. 841 del 9 giugno 2004 e dal Comitato Interministeriale per la Programmazione Economica con Deliberazione n. 32 del 29 settembre 2004 (pubblicata nella Gazzetta Ufficiale della Repubblica Italiana n. 289 del 10 dicembre 2004). |
||||
|
For the legal basis, see the specific section on the multiannual economic regeneration programme for Molise, on the region's official website (www.regione.molise.it) |
|||||
|
Annual expenditure planned or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount Average over three years |
EUR 0,53 million |
||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
|
||
|
Date of implementation: |
16.2.2006 |
||||
|
Duration of scheme or individual aid award |
Until 30.6.2008 |
||||
|
Objective of aid |
General training |
Yes |
|||
|
Specific training |
Yes |
||||
|
Economic sectors concerned |
Limited to specific sectors |
Yes |
|||
|
Other manufacturing |
Yes |
||||
|
Other services |
Yes |
||||
|
Name and address of the granting authority |
Name: Commissario Delegato per l'Attuazione Operativa del Programma ex art. 15 |
||||
|
Address:
|
|||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
|
||
|
Aid No |
XT 56/04 |
|||||
|
Member State |
United Kingdom |
|||||
|
Region |
Northern Ireland |
|||||
|
Title of aid scheme or name of company receiving individual aid |
Company Development Programme |
|||||
|
Legal basis |
The Industrial Development (NI) Order 1982 |
|||||
|
Annual expenditure planned under the scheme or overall amount of individual aid granted to the company |
Aid scheme |
Annual overall amount |
GBP 7,5 million |
|||
|
Loans guaranteed |
|
|||||
|
Individual aid |
Overall aid amount |
|
||||
|
Loans guaranteed |
|
|||||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
Yes |
|
|||
|
Date of implementation |
From 2.2.2001 |
|||||
|
Duration of scheme or individual aid award |
Until 31.12.2006 |
|||||
|
Objective of aid |
General training |
Yes |
||||
|
Specific training |
Yes |
|||||
|
Economic sectors concerned |
All sectors eligible for training aid |
Yes |
||||
|
Name and address of the granting authority |
Name: Invest NI |
|||||
|
Address:
|
||||||
|
Large individual aid grants |
In conformity with Article 5 of the Regulation |
Yes |
|
|||
(1) Data contains the total annual budget for the EQUAL programme for 2005. The budget also contains measures not constituting State aid. (Calculated with exchange rate HUF 250 = EUR 1.)
EUROPEAN ECONOMIC AREA
Standing Committee of the EFTA States
|
28.9.2006 |
EN |
Official Journal of the European Union |
C 233/21 |
List of marketing authorisations granted by the EEA EFTA States for the first half of 2003
(2006/C 233/08)
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 10 March 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 January — 30 June 2003:
|
Annex I |
List of new marketing authorisations |
|
Annex II |
List of renewed marketing authorisations |
|
Annex III |
List of extended marketing authorisations |
|
Annex IV |
List of withdrawn marketing authorisations |
ANNEX I
1. New Marketing Authorisations:
The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January — 30 June 2003:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/00/131/031-050 |
PegIntron |
Liechtenstein |
31.1.2003 |
|
EU/1/00/134/013-021 |
Lantus |
Liechtenstein |
31.5.2003 |
|
EU/1/00/146/027 |
Keppra |
Liechtenstein |
31.3.2003 |
|
EU/1/00/147/001/NO-008/NO |
Hexavac |
Norway |
30.1.2003 |
|
EU/1/01/171/009-010 |
Rapamune |
Liechtenstein |
31.1.2003 |
|
EU/1/01/176/004-006 |
Zometa |
Liechtenstein |
31.5.2003 |
|
EU/1/01/179/001/NO |
Osteogent Protein 1 |
Norway |
24.4.2003 |
|
EU/1/01/183/001/NO-017/NO |
HBVAXPRO |
Norway |
5.3.2003 |
|
EU/1/01/188/004-006 |
Fabrazyme |
Liechtenstein |
31.1.2003 |
|
EU/1/01/195/008-015 |
Liprolog |
Liechtenstein |
31.3.2003 |
|
EU/1/02/201/005-006 |
Protopic |
Liechtenstein |
31.5.2003 |
|
EU/1/02/202/005-006 |
Protopy |
Liechtenstein |
31.5.2003 |
|
EU/1/02/216/002 |
Invanz |
Liechtenstein |
31.5.2003 |
|
EU/1/02/224/001/NO-005/NO |
Ambirix |
Norway |
8.1.2003 |
|
EU/1/02/226/001/IS |
InductOs |
Iceland |
19.3.2003 |
|
EU/1/02/233/001-015 |
Insulatard |
Liechtenstein |
31.1.2003 |
|
EU/1/02/238/001 |
Zavesca |
Liechtenstein |
31.1.2003 |
|
EU/1/02/239/001/NO-024/NO |
Bextra |
Norway |
9.4.2003 |
|
EU/1/02/239/001-010/IS |
Bextra tablets 10 mg* |
Iceland |
22.5.2003 |
|
EU/1/02/239/001-024 |
Bextra |
Liechtenstein |
31.5.2003 |
|
EU/1/02/239/011-020/IS |
Bextra tablets 20 mg* |
Iceland |
22.5.2003 |
|
EU/1/02/239/021-024/IS |
Bextra tablets 40 mg* |
Iceland |
22.5.2003 |
|
EU/1/02/240/001-003 |
Somavert |
Liechtenstein |
31.1.2003 |
|
EU/1/02/242/001/NO-024/NO |
Valdyn |
Norway |
9.4.2003 |
|
EU/1/02/242/001-024 |
Valdyn |
Liechtenstein |
31.5.2003 |
|
EU/1/02/244/001/NO-024/NO |
Kudeq |
Norway |
9.4.2003 |
|
EU/1/02/244/001-024 |
Kudeq |
Liechtenstein |
31.5.2003 |
|
EU/1/02/245/001 |
Theryttrex |
Liechtenstein |
31.1.2003 |
|
EU/1/02/245/001-002/IS |
Theryttrex radioact. precursor |
Iceland |
7.2.2002 |
|
EU/1/02/246/001/IS |
Carbaglu dispersible tabl. |
Iceland |
17.2.2003 |
|
EU/1/02/246/001/NO-002/NO |
Carbaglu |
Norway |
6.3.2003 |
|
EU/1/03/248/001/NO-012/NO |
Levitra |
Norway |
10.3.2003 |
|
EU/1/03/248/001-004/IS |
Levitra 5 mg |
Iceland |
24.3.2003 |
|
EU/1/03/248/001-012 |
Levitra |
Liechtenstein |
31.3.2003 |
|
EU/1/03/248/005-008/IS |
Levitra 10 mg |
Iceland |
24.3.2003 |
|
EU/1/03/248/009-012/IS |
Levitra 20 mg |
Iceland |
24.3.2003 |
|
EU/1/03/249/001/NO-012/NO |
Vivanza |
Norway |
26.5.2003 |
|
EU/1/03/249/001-004/IS |
Vivanza tabl. 5 mg |
Iceland |
24.3.2003 |
|
EU/1/03/249/001-012 |
Vivanza |
Liechtenstein |
31.3.2003 |
|
EU/1/03/249/005-008/IS |
Vivanza tabl. 10 mg |
Iceland |
24.3.2003 |
|
EU/1/03/249/009-012/IS |
Vivanza tabl. 20 mg |
Iceland |
24.3.2003 |
|
EU/1/03/250/001 |
Ytracis |
Liechtenstein |
31.5.2003 |
|
EU/1/03/250/001/IS |
Ytracis 1850 MBq/ml |
Iceland |
16.4.2003 |
|
EU/1/03/250/001/NO |
Ytracis 1850 MBq/ml |
Norway |
22.4.2003 |
|
EU/1/03/251/001 |
Hepsera |
Liechtenstein |
31.3.2003 |
|
EU/1/03/251/001/IS |
Hepsera tabl. 10 mg |
Iceland |
4.4.2003 |
|
EU/1/03/251/001/NO |
Hepsera |
Norway |
26.3.2003 |
|
EU/1/03/252/001/NO-003/NO |
Fuzeon |
Norway |
5.6.2003 |
|
EU/1/03/252/001-002/IS |
Fuzeon powder and solv. for sol. for inj. |
Iceland |
20.6.2003 |
|
EU/1/03/252/003/IS |
Fuzeon powder for sol. for inj. |
Iceland |
20.6.2003 |
|
EU/1/96/007/021-028 |
Humalog |
Liechtenstein |
31.1.2003 |
|
EU/1/96/011/001-004 |
Caelyx |
Liechtenstein |
31.3.2003 |
|
EU/1/97/054/001 and 003-005 |
Viracept |
Liechtenstein |
31.3.2003 |
|
EU/1/98/069/004a, 4b |
Plavix |
Liechtenstein |
31.3.2003 |
|
EU/1/98/070/004a, 4b |
Iscover |
Liechtenstein |
31.3.2003 |
|
EU/1/98/084/002 |
Simulect |
Liechtenstein |
31.3.2003 |
|
EU/1/99/103/004 |
ReFacto |
Liechtenstein |
31.1.2003 |
|
EU/2/00/021/001/NO-002/NO |
Rabigen |
Norway |
19.5.2003 |
|
EU/2/00/022/001/NO-004/NO |
Ibaflin |
Norway |
19.5.2003 |
|
EU/2/00/022/001a, b, 002a, b |
Ibaflin |
Liechtenstein |
31.3.2003 |
|
EU/2/00/022/003a, b, 004a, b |
Ibaflin |
Liechtenstein |
31.3.2003 |
|
EU/2/00/022/005-012 |
Ibaflin |
Liechtenstein |
31.3.2003 |
|
EU/2/00/024/001/NO |
Pruban |
Norway |
6.5.2003 |
|
EU/2.2.20033/001/NO |
Dexdomitor |
Norway |
16.1.2003 |
|
EU/2.2.20034/001/IS |
Nobivac Bb cat |
Iceland |
21.1.2003 |
|
EU/2.2.20035/001-006 |
SevoFlo |
Liechtenstein |
31.1.2003 |
|
EU/2.2.20036/001-002 |
Nobilis OR inac |
Liechtenstein |
31.1.2003 |
|
EU/2.2.20036/001-002 |
Nobilis OR inac |
Norway |
31.1.2003 |
|
EU/2.3.20037/001/NO-004/NO |
ProteqFlu |
Norway |
24.4.2003 |
|
EU/2.3.20037/001-004 |
ProteqFlu |
Liechtenstein |
31.3.2003 |
|
EU/2.3.20038/001/NO-004/NO |
ProteqFlu-Te |
Norway |
24.4.2003 |
|
EU/2.3.20038/001-004 |
ProteqFlu-Te |
Liechtenstein |
31.3.2003 |
|
EU/2.3.20039/001-012 |
Advocate |
Liechtenstein |
31.5.2003 |
|
EU/2.3.20039/013/NO-018/NO |
Advocate |
Norway |
25.6.2003 |
|
EU/2/97/004/001 and 003-008 |
Metacam |
Liechtenstein |
31.3.2003 |
|
EU/2/97/005/008-009 |
Quadrisol |
Liechtenstein |
31.1.2003 |
ANNEX II
2. Renewed Marketing Authorisations
The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January — 30 June 2003:
|
EU-Number |
Product |
Country |
Date of renewal |
|
EU/1/96/006/001/NO-003/NO |
NovoSeven |
Norway |
14.1.2003 |
|
EU/1/96/015/001/NO-002/NO |
Epivir |
Norway |
31.1.2003 |
|
EU/1/97/032/001/IS |
LeukoScan p.f. sol. for inj. |
Iceland |
29.1.2003 |
|
EU/1/97/039/001/NO-004/NO |
Cystagon |
Norway |
3.3.2003 |
|
EU/1/97/039/001-002/IS |
Cystagon capsule, hard |
Iceland |
29.1.2003 |
|
EU/1/97/039/003-004/IS |
Cystagon capsule, hard |
Iceland |
29.1.2003 |
|
EU/1/97/040/001-002/IS |
Teslascan 0,01 mmol/ml solution for infusion |
Iceland |
12.5.2003 |
|
EU/1/97/045/001, 006-007/IS |
Helicobacter INFAI powder for oral solution, 75 mg |
Iceland |
12.5.2003 |
|
EU/1/97/045/008/IS |
Helicobacter INFAI powder for oral solution, 45 mg |
Iceland |
12.5.2003 |
|
EU/1/97/046/001-003, -010, -013/IS |
Aprovel tabl. 75 mg |
Iceland |
18.2.2003 |
|
EU/1/97/046/004-006, -011, -014/IS |
Aprovel tabl. 150 mg |
Iceland |
18.2.2003 |
|
EU/1/97/046/007-009, 026, 030, 033/IS |
Aprovel tabl. 300 mg |
Iceland |
18.2.2003 |
|
EU/1/97/047/001/IS |
BeneFix powd. and solv. inj. 250 IU |
Iceland |
15.4.2003 |
|
EU/1/97/047/001-003 |
BeneFix |
Liechtenstein |
31.3.2003 |
|
EU/1/97/047/002/IS |
BeneFix powd. and solv. inj. 500 IU |
Iceland |
15.4.2003 |
|
EU/1/97/047/003/IS |
BeneFix powd. and solv. inj. 1000 IU |
Iceland |
15.4.2003 |
|
EU/1/97/048/001-014 |
Infanrix HepB |
Liechtenstein |
31.1.2003 |
|
EU/1/97/048/001-014/IS |
Infanrix HepB |
Iceland |
11.2.2003 |
|
EU/1/97/049/001-003, -010, 013/IS |
Karvea tabl. 75 mg |
Iceland |
12.2.2003 |
|
EU/1/97/049/004-006, -012, 015/IS |
Karvea tabl. 300 mg |
Iceland |
12.2.2003 |
|
EU/1/97/049/004-006, -011, 014/IS |
Karvea tabl. 150 mg |
Iceland |
12.2.2003 |
|
EU/1/97/050/001/NO |
Sifrol |
Norway |
6.1.2003 |
|
EU/1/97/050/009/NO-012/NO |
Sifrol |
Norway |
6.1.2003 |
|
EU/1/97/051/001-002/IS |
Mirapexin tab. 0,088 mg |
Iceland |
31.1.2003 |
|
EU/1/97/051/003-004/IS |
Mirapexin tab. 0,18 mg |
Iceland |
31.1.2003 |
|
EU/1/97/051/005-006/IS |
Mirapexin tab. 0,035 mg |
Iceland |
31.1.2003 |
|
EU/1/97/051/007-008/IS |
Mirapexin tab. 0,7 mg |
Iceland |
31.1.2003 |
|
EU/1/97/051/009-010/IS |
Mirapexin tab. 1,1 mg |
Iceland |
31.1.2003 |
|
EU/1/97/052/001/NO-006/NO |
Daquiran |
Norway |
28.1.2003 |
|
EU/1/97/052/009/NO-010/NO |
Daquiran |
Norway |
28.1.2003 |
|
EU/1/97/053/001/NO-005/NO |
Cerezyme |
Norway |
6.1.2003 |
|
EU/1/97/053/001-002/IS |
Cerezyme 200U |
Iceland |
10.2.2003 |
|
EU/1/97/053/001-005 |
Cerezyme |
Liechtenstein |
31.1.2003 |
|
EU/1/97/053/003-005/IS |
Cerezyme 400U |
Iceland |
10.2.2003 |
|
EU/1/97/054/001/IS |
Viracept 50 mg/g oral powder |
Iceland |
13.5.2003 |
|
EU/1/97/054/001/NO |
Viracept |
Norway |
18.2.2003 |
|
EU/1/97/054/003/IS |
Viracept tablets 250 mg |
Iceland |
13.5.2003 |
|
EU/1/97/054/003/NO-005/NO |
Viracept |
Norway |
18.2.2003 |
|
EU/1/97/054/005/IS |
Viracept film coated tablets 250 mg |
Iceland |
13.5.2003 |
|
EU/1/97/055/001/IS |
Viramune tabl. 200 mg |
Iceland |
10.4.2003 |
|
EU/1/97/055/001/NO-002/NO |
Viramune |
Norway |
6.3.2003 |
|
EU/1/97/055/001-002 |
Viramune |
Liechtenstein |
31.3.2003 |
|
EU/1/97/055/002/IS |
Viramune mixt. susp. 50 mg/5ml |
Iceland |
10.4.2003 |
|
EU/1/97/057/001 |
Quadramet |
Liechtenstein |
31.3.2003 |
|
EU/1/97/057/001/IS |
Quadramet solution for injection 1,3 GB/ml |
Iceland |
16.5.2003 |
|
EU/1/97/057/001/NO |
Quadramet |
Norway |
5.5.2003 |
|
EU/1/98/065/001/NO-002/NO |
Optison |
Norway |
20.6.2003 |
|
EU/1/98/065/001-002 |
Optison |
Liechtenstein |
31.5.2003 |
|
EU/1/98/065/001-002/IS |
Optison, solution for injection |
Iceland |
25.6.2003 |
|
EU/2/98/007/001-003 |
Clomicalm |
Liechtenstein |
31.5.2003 |
|
EU/2/98/008/001/NO-004/NO |
Neocolipor |
Norway |
18.6.2003 |
|
EU/2/98/008/001-004 |
Neocolipor |
Liechtenstein |
31.5.2003 |
ANNEX III
3. Extended Marketing Authorisations
The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January — 30 June 2003:
|
EU-Number |
Product |
Country |
Date of extention |
|
EU/1/00/146/027/NO |
Keppra |
Norway |
18.3.2003 |
|
EU/1/01/171/009-010/IS |
Rapamune filmc. tablets 2 mg |
Iceland |
11.6.2003 |
|
EU/1/01/171/009-010/NO |
Rapamune |
Norway |
29.1.2003 |
|
EU/1/01/176/004/NO-006/NO |
Zometa |
Norway |
29.4.2003 |
|
EU/1/01/176/004-006/IS |
Zometa, concentrate for sol. for infus |
Iceland |
22.3.2003 |
|
EU/1/96/015/003/NO |
Epivir |
Norway |
4.2.2003 |
|
EU/1/98/084/002/NO |
Simulect |
Norway |
18.3.2003 |
|
EU/1/99/103/004/NO |
ReFacto |
Norway |
13.3.2003 |
|
EU/1/99/127/040/NO-044/NO |
Introna |
Norway |
21.1.2003 |
|
EU/2/00/022/009/NO-12/NO |
Ibaflin |
Norway |
18.6.2003 |
ANNEX IV
4. Withdrawn Marketing Authorisations
The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January — 30 June 2003:
|
EU-Number |
Product |
Country |
Date of withdrawal |
|
EU/1/00/142/003/IS |
Novomix 30 Penfill |
Iceland |
1.1.2003 |
|
EU/1/00/142/003/NO |
Novomix 30 Penfil |
Norway |
12.3.2003 |
|
EU/1/00/142/006/IS |
Novomix 30 Novolet |
Iceland |
1.1.2003 |
|
EU/1/00/142/006/NO |
Novomix 30 Novolet |
Norway |
12.3.2003 |
|
EU/1/96/021/001/NO-010/NO |
Olansek |
Norway |
27.5.2003 |
|
EU/1/96/021/001-010 |
Olansek |
Liechtenstein |
31.3.2003 |
|
EU/2/00/019/004 |
Eurifel FelV |
Liechtenstein |
31.5.2003 |
|
EU/2/00/019/004/NO |
Eurifel FelV |
Norway |
27.5.2003 |
|
28.9.2006 |
EN |
Official Journal of the European Union |
C 233/28 |
List of marketing authorisations granted by the EEA EFTA States for the second half of 2003
(2006/C 233/09)
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 10 March 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 July — 31 December 2003:
|
Annex I |
List of new marketing authorisations |
|
Annex II |
List of renewed marketing authorisations |
|
Annex III |
List of extended marketing authorisations |
|
Annex IV |
List of withdrawn marketing authorisations |
ANNEX I
1. New Marketing Authorisations:
The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July — 31 December 2003:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/00/141/001/IS |
Myocet conc. F. inf. Liposomes |
Iceland |
31.7.2003 |
|
EU/1/00/150/011-015 |
Actos |
Liechtenstein |
30.9.2003 |
|
EU/1/00/151/009-013 |
Glustin |
Liechtenstein |
30.9.2003 |
|
EU/1/00/165/007 |
Ovitrelle |
Liechtenstein |
30.11.2003 |
|
EU/1/02/206/005-008 |
Arixtra |
Liechtenstein |
30.11.2003 |
|
EU/1/02/207/005-008 |
Quixidar |
Liechtenstein |
30.11.2003 |
|
EU/1/02/219/010-013 |
Ebixa |
Liechtenstein |
30.9.2003 |
|
EU/1/02/229/036-037 |
Actraphane |
Liechtenstein |
30.9.2003 |
|
EU/1/02/230/016-017 |
Actrapid |
Liechtenstein |
30.9.2003 |
|
EU/1/02/231/036-037 |
Mixtard |
Liechtenstein |
30.9.2003 |
|
EU/1/02/232/003 |
Velosulin |
Liechtenstein |
30.9.2003 |
|
EU/1/02/233/016-017 |
Insulatard |
Liechtenstein |
30.9.2003 |
|
EU/1/02/234/016-017 |
Protaphane |
Liechtenstein |
30.9.2003 |
|
EU/1/02/240/004 |
Somavert |
Liechtenstein |
30.9.2003 |
|
EU/1/02/242/001-010/IS |
Valdyn tablets 10 mg |
Iceland |
1.7.2003 |
|
EU/1/02/242/011-020/IS |
Valdyn tablets 20 mg |
Iceland |
1.7.2003 |
|
EU/1/02/242/021-024/IS |
Valdyn tablets 40 mg |
Iceland |
1.7.2003 |
|
EU/1/02/244/001-010/IS |
Kudeq tablets 10 mg |
Iceland |
1.7.2003 |
|
EU/1/02/244/011-020/IS |
Kudeq tablets 20 mg |
Iceland |
1.7.2003 |
|
EU/1/02/244/021-024/IS |
Kudeq tablets 40 mg |
Iceland |
1.7.2003 |
|
EU/1/03/247/001-002 |
Forsteo |
Liechtenstein |
31.7.2003 |
|
EU/1/03/247/001-002/IS |
Forsteo sol for inj. in prefilled pen |
Iceland |
8.7.2003 |
|
EU/1/03/252/001-003 |
Fuzeon |
Liechtenstein |
31.7.2003 |
|
EU/1/03/253/001-003 |
Aldurazyme |
Liechtenstein |
31.7.2003 |
|
EU/1/03/253/001-003/IS |
Aldurazyme conc. for sol. f. inf. 100 U/ml |
Iceland |
21.7.2003 |
|
EU/1/03/254/001 |
Busilvex |
Liechtenstein |
30.9.2003 |
|
EU/1/03/254/001/IS |
Busilvex 6 mg/ml conc.f. sol. f.inf. |
Iceland |
22.7.2003 |
|
EU/1/03/254/001/NO |
Busilvex |
Norway |
17.7.2003 |
|
EU/1/03/255/001/NO-003/NO |
Ventavis |
Norway |
30.10.2003 |
|
EU/1/03/255/001-003/IS |
Ventavis Nebul. sol.- Inhal. 10 microg/ml |
Iceland |
15.10.2003 |
|
EU/1/03/256/001/NO-006/NO |
Humira |
Norway |
11.9.2003 |
|
EU/1/03/256/001-006 |
Humira |
Liechtenstein |
30.9.2003 |
|
EU/1/03/256/001-006/IS |
Humira solution for injection |
Iceland |
25.9.2003 |
|
EU/1/03/257/001/NO-006/NO |
Trudexa |
Norway |
17.9.2003 |
|
EU/1/03/257/001-006 |
Trudexa |
Liechtenstein |
30.9.2003 |
|
EU/1/03/257/001-006/IS |
Trudexa solution for injection |
Iceland |
29.9.2003 |
|
EU/1/03/258/001/NO-006/NO |
Avandamet |
Norway |
18.11.2003 |
|
EU/1/03/258/001-003/IS |
Avandamet tabl. 1mg/500 mg |
Iceland |
19.11.2003 |
|
EU/1/03/258/001-006 |
Avandamet |
Liechtenstein |
30.11.2003 |
|
EU/1/03/258/004-006/IS |
Avandamet tabl. 2mg/500mg |
Iceland |
19.11.2003 |
|
EU/1/03/259/001/NO-006/NO |
Onsenal |
Norway |
5.11.2003 |
|
EU/1/03/259/001-004/IS |
Onsenal Hard capsules 200 mg |
Iceland |
16.12.2003 |
|
EU/1/03/259/001-006 |
Onsenal |
Liechtenstein |
30.11.2003 |
|
EU/1/03/259/005-006/IS |
Onsenal Hard capsules 400 mg |
Iceland |
16.12.2003 |
|
EU/1/03/260/001/NO-012/NO |
Stalevo |
Norway |
5.11.2003 |
|
EU/1/03/260/001-004/IS |
Stalevo tabl. 50/12.5/200 mg |
Iceland |
31.10.2003 |
|
EU/1/03/260/001-012 |
Stalevo |
Liechtenstein |
30.11.2003 |
|
EU/1/03/260/005-008/IS |
Stalevo tab. 100/25/200 mg |
Iceland |
31.10.2003 |
|
EU/1/03/260/009-012/IS |
Stalevo tabl. 150/37.5/200 mg |
Iceland |
31.10.2003 |
|
EU/1/03/261/001/NO-003/NO |
Emtriva |
Norway |
5.11.2003 |
|
EU/1/03/261/001-002/IS |
Emtriva hard caps. 200 mg |
Iceland |
8.11.2003 |
|
EU/1/03/261/001-003 |
Emtriva |
Liechtenstein |
30.11.2003 |
|
EU/1/03/261/003/IS |
Emtriva oral sol. 10mg/ml |
Iceland |
8.11.2003 |
|
EU/1/03/262/001/NO-006/NO |
Emend |
Norway |
15.12.2003 |
|
EU/1/03/262/001-003/IS |
Emend hard caps. 80 mg |
Iceland |
11.12.2003 |
|
EU/1/03/262/004-006/IS |
Emend hard caps. 80 mg and 125 mg (comb.) |
Iceland |
11.12.2003 |
|
EU/1/03/262/005/IS |
Emend hard caps. 125 mg |
Iceland |
11.12.2003 |
|
EU/1/96/012/001-013 |
Bondronat |
Liechtenstein |
30.11.2003 |
|
EU/1/96/015/004-005 |
Epivir |
Liechtenstein |
30.9.2003 |
|
EU/1/97/033/003 |
Avonex |
Liechtenstein |
31.7.2003 |
|
EU/1/98/064/001/NO |
Pylobactell |
Norway |
1.7.2003 |
|
EU/1/98/076/001/NO-002/NO, 004/NO-009/NO |
NovoNorm |
Norway |
15.8.2003 |
|
EU/1/98/076/011/NO-016/NO, 018/NO-021/NO |
NovoNorm |
Norway |
15.8.2003 |
|
EU/1/99/119/012-014 |
NovoRapid |
Liechtenstein |
31.7.2003 |
|
EU/2/00/025/001/NO-006/NO |
Bayovac CSF E2 |
Norway |
8.9.2003 |
|
EU/2/00/027/001/NO-003/NO |
Pirsue |
Norway |
2.9.2003 |
|
EU/2/01/030/001/IS |
Virbagen Omega powd. & solv. for susp. f. inj. 5 MU |
Iceland |
10.12.2003 |
|
EU/2/01/030/002/IS |
Virbagen Omega powd. & solv. for susp. f. inj. 10 MU |
Iceland |
10.12.2003 |
|
EU/2/02/035/001/NO-006/NO |
SevoFlo |
Norway |
2.9.2003 |
|
EU/2/02/035/001-006/IS |
SevoFlo Inhalation vapour, liquid for dogs |
Iceland |
1.8.2003 |
|
EU/2/03/039/001-004 & 013-014/IS |
Advocate spot on sol. for cats |
Iceland |
25.9.2003 |
|
EU/2/03/039/005-012 & 015-018/IS |
Advocate spot on sol for dogs |
Iceland |
25.9.2003 |
|
EU/2/03/039/013-018 |
Advocate |
Liechtenstein |
31.7.2003 |
|
EU/2/03/040/001 |
Gonazon |
Liechtenstein |
30.9.2003 |
|
EU/2/03/040/001/IS |
Gonazon solution injection 1.600 microg/ml |
Iceland |
30.10.2003 |
|
EU/2/03/040/001/NO |
Gonazon |
Norway |
18.8.2003 |
|
EU/2/03/041/001/NO-005/NO |
Draxxin |
Norway |
10.12.2003 |
|
EU/2/03/041/001-005 |
Draxxin |
Liechtenstein |
30.11.2003 |
|
EU/2/03/041/001-005/IS |
Draxxin sol for injection, cattle and pigs |
Iceland |
12.12.2003 |
|
EU/2/97/003/001-018 |
Dicural |
Liechtenstein |
30.9.2003 |
|
EU/2/97/004/009 |
Metacam |
Liechtenstein |
30.11.2003 |
ANNEX II
2. Renewed Marketing Authorisations
The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July — 31 December 2003:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/00/162/001-006/IS |
Prandin 0.5 mg tablets |
Iceland |
25.9.2003 |
|
EU/1/00/162/001-018 |
Prandin |
Liechtenstein |
30.9.2003 |
|
EU/1/00/162/001-018/NO |
Prandin |
Norway |
15.8.2003 |
|
EU/1/00/162/007-012/IS |
Prandin 1 mg tablets |
Iceland |
25.9.2003 |
|
EU/1/00/162/013-018/IS |
Prandin 2 mg tablets |
Iceland |
25.9.2003 |
|
EU/1/97/047/001/NO-003/NO |
Benefix |
Norway |
30.12.2003 |
|
EU/1/97/048/001/NO-014/NO |
InfanrixHep B |
Norway |
20.11.2003 |
|
EU/1/97/051/001/NO-006/NO, 009/NO-012/NO |
Mirapexin |
Norway |
1.9.2003 |
|
EU/1/98/058/001-002 |
Combivir |
Liechtenstein |
31.7.2003 |
|
EU/1/98/058/001-002/IS |
Combivir 150/300 mg film coated tablets |
Iceland |
16.9.2003 |
|
EU/1/98/058/001-002/NO |
Combivir |
Norway |
7.7.2003 |
|
EU/1/98/063/001-003/IS |
Rebif 22 microg/0.5 ml. solution for injection |
Iceland |
18.9.2003 |
|
EU/1/98/063/001-006 |
Rebif |
Liechtenstein |
31.7.2003 |
|
EU/1/98/063/001-006/NO |
Rebif |
Norway |
19.8.2003 |
|
EU/1/98/063/004-006/IS |
Rebif 44 microg/0.5 ml. solution for injection |
Iceland |
18.9.2003 |
|
EU/1/98/064/001 |
Pylobactell |
Liechtenstein |
31.7.2003 |
|
EU/1/98/064/001/IS |
Pylobactell 100 mg soluble tablet |
Iceland |
21.10.2003 |
|
EU/1/98/066/001-003/IS |
Exelon capsules hard, 1.5 mg |
Iceland |
26.8.2003 |
|
EU/1/98/066/001-013 |
Exelon |
Liechtenstein |
31.7.2003 |
|
EU/1/98/066/001-013/NO |
Exelon |
Norway |
15.7.2003 |
|
EU/1/98/066/004-006/IS |
Exelon capsules hard, 3 mg |
Iceland |
26.8.2003 |
|
EU/1/98/066/007-009/IS |
Exelon capsules hard, 4.5 mg |
Iceland |
26.8.2003 |
|
EU/1/98/066/010-012/IS |
Exelon capsules hard, 6 mg |
Iceland |
26.8.2003 |
|
EU/1/98/066/013/IS |
Exelon oral solution 2 mg/ml |
Iceland |
26.8.2003 |
|
EU/1/98/067/001/IS |
MabThera Concentrate for solution for infusion 100 mg |
Iceland |
13.10.2003 |
|
EU/1/98/067/001-002 |
Mabthera |
Liechtenstein |
30.9.2003 |
|
EU/1/98/067/001-002/NO |
Mabthera |
Norway |
6.8.2003 |
|
EU/1/98/067/002/IS |
MabThera Concentrate for solution for infusion 500 mg |
Iceland |
13.10.2003 |
|
EU/1/98/069/001-004/IS |
Plavix tablets 75 mg |
Iceland |
20.11.2003 |
|
EU/1/98/069/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b |
Plavix |
Liechtenstein |
30.11.2003 |
|
EU/1/98/069/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b/NO |
Plavix |
Norway |
7.11.2003 |
|
EU/1/98/070/001-004/IS |
Iscover tablets 75 mg |
Iceland |
20.11.2003 |
|
EU/1/98/070/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b |
Iscover |
Liechtenstein |
30.11.2003 |
|
EU/1/98/070/001a, 1b, 2a, 2b, 3a, 3b, 4a, 4b/NO |
Iscover |
Norway |
7.11.2003 |
|
EU/1/98/071/001-006 |
Xenical |
Liechtenstein |
30.11.2003 |
|
EU/1/98/071/001-006/IS |
Xenical hard capsules 120 mg |
Iceland |
1.12.2003 |
|
EU/1/98/071/001-006/NO |
Xenical |
Norway |
24.10.2003 |
|
EU/1/98/073/001-004 |
Evista |
Liechtenstein |
30.9.2003 |
|
EU/1/98/073/001-004/IS |
Evista film coated tablets 60 mg |
Iceland |
18.9.2003 |
|
EU/1/98/073/001-004/NO |
Evista |
Norway |
1.8.2003 |
|
EU/1/98/074/001-004 |
Optruma |
Liechtenstein |
30.9.2003 |
|
EU/1/98/074/001-004/IS |
Optruma film coated tablets 60 mg |
Iceland |
18.9.2003 |
|
EU/1/98/074/001-004/NO |
Optruma |
Norway |
1.8.2003 |
|
EU/1/98/075/001-002 |
Fortovase |
Liechtenstein |
30.9.2003 |
|
EU/1/98/075/001-002/IS |
Fortovase soft capsule 200 mg |
Iceland |
19.11.2003 |
|
EU/1/98/075/001-002/NO |
Fortovase |
Norway |
8.10.2003 |
|
EU/1/98/076/001-002, 004-007/IS |
NovoNorm 0.5 mg tablets |
Iceland |
25.9.2003 |
|
EU/1/98/076/001-002, 004-009 |
NovoNorm |
Liechtenstein |
30.9.2003 |
|
EU/1/98/076/008-009, 011-014/IS |
NovoNorm 1 mg tablets |
Iceland |
25.9.2003 |
|
EU/1/98/076/011-016, 018-021 |
NovoNorm |
Liechtenstein |
30.9.2003 |
|
EU/1/98/076/015-016, 018-021/IS |
NovoNorm 2 mg tablets |
Iceland |
25.9.2003 |
|
EU/1/98/077/001-012 |
Viagra |
Liechtenstein |
30.11.2003 |
|
EU/1/98/077/001-012/NO |
Viagra |
Norway |
11.12.2003 |
|
EU/1/98/080/001 |
Aldara |
Liechtenstein |
30.11.2003 |
|
EU/1/98/080/001/IS |
Aldara cream 5% |
Iceland |
3.12.2003 |
|
EU/1/98/080/001/NO |
Aldara |
Norway |
14.11.2003 |
|
EU/1/98/081/001-004 |
Comtan |
Liechtenstein |
30.11.2003 |
|
EU/1/98/081/001-004/IS |
Comtan filmcoated tablets |
Iceland |
16.12.2003 |
|
EU/1/98/081/001-004/NO |
Comtan |
Norway |
3.11.2003 |
|
EU/1/98/082/001-004 |
Comtess |
Liechtenstein |
30.11.2003 |
|
EU/1/98/082/001-004/IS |
Comtess filmcoated tablets |
Iceland |
27.11.2003 |
|
EU/1/98/082/001-004/NO |
Comtess |
Norway |
14.11.2003 |
|
EU/1/98/084/001-002 |
Simulect |
Liechtenstein |
30.11.2003 |
|
EU/1/98/084/001-002/NO |
Simulect |
Norway |
18.11.2003 |
|
EU/1/98/085/001/NO-010/NO |
Karvezide |
Norway |
18.12.2003 |
|
EU/1/98/086/001/NO-010/NO |
CoAprovel |
Norway |
19.12.2003 |
|
EU/1/98/092/001-003/IS |
Prometax capsules hard 1.5 mg |
Iceland |
29.8.2003 |
|
EU/1/98/092/001-013 |
Prometax |
Liechtenstein |
31.7.2003 |
|
EU/1/98/092/001-013/NO |
Prometax |
Norway |
15.7.2003 |
|
EU/1/98/092/004-006/IS |
Prometax capsules hard, 3 mg |
Iceland |
29.8.2003 |
|
EU/1/98/092/007-009/IS |
Prometax capsules hard, 4.5 mg |
Iceland |
29.8.2003 |
|
EU/1/98/092/010-012/IS |
Prometax capsules hard, 6 mg |
Iceland |
29.8.2003 |
|
EU/1/98/092/013/IS |
Prometax oral solution 2mg/ml |
Iceland |
29.8.2003 |
|
EU/2/96/002/001-003/IS |
Fevaxyn Pentofelsol. for inject. |
Iceland |
15.10.2003 |
|
EU/2/97/003/001-003/IS |
Dicural 100 mg/ml oral solution |
Iceland |
12.10.2003 |
|
EU/2/97/003/001-018/NO |
Dicural |
Norway |
21.8.2003 |
|
EU/2/97/003/004-015/IS |
Dicural 15 mg, 50 mg, 100 mg, 150 mg film coated tablets |
Iceland |
12.10.2003 |
|
EU/2/97/003/016-018/IS |
Dicural 50 mg/ml solution for inject. |
Iceland |
12.10.2003 |
|
EU/2/97/004/001/IS |
Metacam 5 mg/ml solution for injection for cattle |
Iceland |
8.7.2003 |
|
EU/2/97/004/003-005/IS |
Metacam 1.5 mg/ml oral suspension for dogs |
Iceland |
8.7.2003 |
|
EU/2/97/004/006/IS |
Metacam 5 mg/ml solution for injection for dogs and cats |
Iceland |
8.7.2003 |
|
EU/2/97/004/007-008/IS |
Metacam 20 mg/ml solution for injection for cattle |
Iceland |
8.7.2003 |
|
EU/2/97/005/001, 005/IS |
Quadrisol oral gel for horses 100 mg/ml |
Iceland |
27.10.2003 |
|
EU/2/97/005/002-003, 006-007/IS |
Quadrisol oral gel for dogs 5 mg/ml |
Iceland |
27.10.2003 |
|
EU/2/97/005/004/IS |
Quadrisol sol. for injection |
Iceland |
27.10.2003 |
|
EU/2/97/005/008-009/IS |
Quadrisol oral gel for dogs 1 mg/ml |
Iceland |
27.10.2003 |
|
EU/2/98/006/001-010 |
Nobilis IB 4-91 |
Liechtenstein |
30.9.2003 |
|
EU/2/98/006/001-010/IS |
Nobilis IB 4-91 sol. for injection |
Iceland |
21.10.2003 |
|
EU/2/98/006/001-010/NO |
Nobilis IB 4-91 |
Norway |
8.8.2003 |
|
EU/2/98/007/00/NO-003/NO |
Clomicalm |
Norway |
1.9.2003 |
|
EU/2/98/007/001-003/IS |
Clomicalm tablets 5 mg, 20 mg, 80 mg |
Iceland |
27.10.2003 |
|
EU/2/98/008/001-004/IS |
Neocolipor suspension for injection |
Iceland |
22.10.2003 |
ANNEX III
3. Extended Marketing Authorisations
The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July — 31 December 2003:
|
EU-Number |
Product |
Country |
Date of extention |
|
EU/1/00/146/027/IS |
Keppra oral solution |
Iceland |
19.8.2003 |
|
EU/1/00/150/011/NO-015/NO |
Actos |
Norway |
25.9.2003 |
|
EU/1/00/150/011-015/IS |
Actos tablets 45 mg |
Iceland |
27.11.2003 |
|
EU/1/00/165/007/IS |
Ovitrelle, sol. for inj. 250 microg/0.5 ml |
Iceland |
16.12.2003 |
|
EU/1/00/165/007/NO |
Ovitrelle |
Norway |
7.11.2003 |
|
EU/1/02/206/005/NO-008/NO |
Arixtra |
Norway |
21.11.2003 |
|
EU/1/02/206/005-008/IS |
Arixtra solution for injection, 1.5 mg/0.3 ml. |
Iceland |
4.12.2003 |
|
EU/1/02/207/00/NO-008/NO |
Quixidar |
Norway |
21.11.2003 |
|
EU/1/02/207/005-009/IS |
Quixidar solution for injection, 1.5 mg/0.3 ml |
Iceland |
4.12.2003 |
|
EU/1/96/009/010-017/IS |
Zerit caps. prolonged release |
Iceland |
9.10.2003 |
|
EU/1/96/012/009/NO-013/NO |
Bondronat |
Norway |
5.11.2003 |
|
EU/1/96/015/003/NO, EU/1/96/015/004/NO-005/NO |
Epivir |
Norway |
29.7.2003 |
|
EU/1/97/033/003/IS |
Avonex sol. for injection 30 microg/0.5 ml |
Iceland |
7.11.2003 |
|
EU/1/97/033/003/NO |
Avonex |
Norway |
4.7.2003 |
|
EU/2/97/004/009/IS |
Metacam oral suspention for horses |
Iceland |
29.10.2003 |
|
EU/2/97/004/009/NO |
Metacam |
Norway |
24.10.2003 |
ANNEX IV
4. Withdrawn Marketing Authorisations
The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July — 31 December 2003:
|
EU-Number |
Product |
Country |
Date of withdrawal |
|
EU/1/96/021/001-010/IS |
Olansek |
Iceland |
1.7.2003 |
|
28.9.2006 |
EN |
Official Journal of the European Union |
C 233/37 |
List of marketing authorisations granted by the EEA EFTA States for the first half of 2004
(2006/C 233/10)
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 10 March 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 January — 30 June 2004:
|
Annex I |
List of new marketing authorisations |
|
Annex II |
List of renewed marketing authorisations |
|
Annex III |
List of extended marketing authorisations |
|
Annex IV |
List of withdrawn marketing authorisations |
|
Annex V |
List of suspended marketing authorisations |
ANNEX I
1. New Marketing Authorisations:
The following marketing authorisations have been granted in the EEA EFTA States during the period 1 January — 30 June 2004:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/00/141/001/NO |
Myocet |
Norway |
22.1.2004 |
|
EU/1/00/164/003-005 |
NutropinAq |
Liechtenstein |
31.3.2004 |
|
EU/1/02/212/026 |
Vfend |
Liechtenstein |
31.3.2004 |
|
EU/1/02/215/001-010/IS |
PritorPlus tablets 40 mg and 80 mg |
Iceland |
10.2.2004 |
|
EU/1/03/263/001/NO-003/NO |
Dukoral |
Norway |
11.5.2004 |
|
EU/1/03/263/001-003 |
Dukoral |
Liechtenstein |
31.5.2004 |
|
EU/1/03/264/001 |
Zevalin |
Liechtenstein |
31.1.2004 |
|
EU/1/03/264/001/IS |
Zevalin 1.6 mg/ml kit for radiopharmaceut. prep. |
Iceland |
13.2.2004 |
|
EU/1/03/264/001/NO |
Zevalin |
Norway |
2.2.2004 |
|
EU/1/03/265/001/NO-002/NO |
Bonviva |
Norway |
24.3.2004 |
|
EU/1/03/265/001-002 |
Bonviva |
Liechtenstein |
31.5.2004 |
|
EU/1/03/265/001-002/IS |
Bonviva filmc. tabl. 2.5 mg |
Iceland |
23.3.2004 |
|
EU/1/03/266/001/NO-002/NO |
Ibandronic Acid Roche |
Norway |
24.3.2004 |
|
EU/1/03/266/001-002 |
Ibandronic Acid Roche |
Liechtenstein |
31.5.2004 |
|
EU/1/03/266/001-002/IS |
Ibandronic Acid Roche film. tabl. 2.5 mg |
Iceland |
23.3.2004 |
|
EU/1/03/267/001/NO-007/NO |
Reyataz |
Norway |
26.3.2004 |
|
EU/1/03/267/001-006/IS |
Reyataz capsule hard 100 mg, 150 mg, 200 mg |
Iceland |
30.3.2004 |
|
EU/1/03/267/001-007 |
Reyataz |
Liechtenstein |
31.3.2004 |
|
EU/1/03/267/007/IS |
Reyataz oral powder 50 mg/1.5 g |
Iceland |
30.3.2004 |
|
EU/1/03/268/001/NO-003/NO |
Cholestagel |
Norway |
24.3.2004 |
|
EU/1/03/268/001-003 |
Cholestagel |
Liechtenstein |
31.3.2004 |
|
EU/1/03/268/001-003/IS |
Cholestagel filmc. tabl. 625 mg |
Iceland |
5.4.2004 |
|
EU/1/03/269/001/IS |
Faslodex |
Iceland |
7.4.2004 |
|
EU/1/03/269/001/NO |
Faslodex |
Norway |
6.4.2004 |
|
EU/1/03/270/001/NO-002/NO |
Oxybutynin Nicobrand |
Norway |
28.6.2004 |
|
EU/1/03/271/001/IS |
Advate powder for sol. for inj. 250 IU, 500 IU, 1000 IU, 150 |
Iceland |
1.4.2004 |
|
EU/1/03/271/001/NO-004/NO |
Advate |
Norway |
29.3.2004 |
|
EU/1/03/271/001-004 |
Advate |
Liechtenstein |
31.5.2004 |
|
EU/1/04/272/001/NO-002/NO |
Photo Barr |
Norway |
23.4.2004 |
|
EU/1/04/272/001-002 |
Photo Barr |
Liechtenstein |
31.5.2004 |
|
EU/1/04/272/002/IS |
Photo Barr Powder for sol. for inj. 15 or 75 mg |
Iceland |
23.4.2004 |
|
EU/1/04/273/001 |
Lysodren |
Liechtenstein |
31.5.2004 |
|
EU/1/04/273/001/IS |
Lysodren tablets 500 mg |
Iceland |
19.5.2004 |
|
EU/1/04/273/001/NO |
Lysodren |
Norway |
26.5.2004 |
|
EU/1/04/274/001 |
Velcade |
Liechtenstein |
31.5.2004 |
|
EU/1/04/274/001/IS |
Velcade powder for sol. for inj. 3.5 mg |
Iceland |
26.5.2004 |
|
EU/1/04/274/001/NO |
Velcade |
Norway |
25.5.2004 |
|
EU/1/04/275/001/NO-002/NO |
Litak |
Norway |
14.5.2004 |
|
EU/1/04/275/001-002 |
Litak |
Liechtenstein |
31.5.2004 |
|
EU/1/04/275/001-002/IS |
Litak Solution for inj. 2 mg/ml |
Iceland |
14.5.2004 |
|
EU/1/04/276/001/NO-020/NO |
Abilify |
Norway |
24.6.2004 |
|
EU/1/04/278/001/NO-009/NO |
Levemir |
Norway |
14.6.2004 |
|
EU/1/04/278/001-009/IS |
Levemir Penfill/FlexPen/InnoLet, sol f. inj. |
Iceland |
25.6.2004 |
|
EU/1/95/001/032 |
Gonal |
Liechtenstein |
31.1.2004 |
|
EU/1/95/001/033-035 |
Gonal f |
Liechtenstein |
31.3.2004 |
|
EU/1/97/031/045-046 |
NeoRecormon |
Liechtenstein |
31.3.2004 |
|
EU/1/97/046/016-030 |
Aprovel |
Liechtenstein |
31.5.2004 |
|
EU/1/97/049/016-030 |
Karvea |
Liechtenstein |
31.5.2004 |
|
EU/1/97/054/006 |
Viracept |
Liechtenstein |
31.5.2004 |
|
EU/1/98/066/014-018 |
Exelon |
Liechtenstein |
31.3.2004 |
|
EU/1/98/085/011-020 |
Karvezide |
Liechtenstein |
31.5.2004 |
|
EU/1/98/086/011-020 |
CoAprovel |
Liechtenstein |
31.5.2004 |
|
EU/1/98/091/001-014 |
Kinzalmono |
Liechtenstein |
31.1.2004 |
|
EU/1/98/092/014-018 |
Prometax |
Liechtenstein |
31.3.2004 |
|
EU/1/99/099/001-006 |
Zerene |
Liechtenstein |
31.5.2004 |
|
EU/1/99/113/003-004 |
Paxene |
Liechtenstein |
31.1.2004 |
|
EU/2/00/022/009-012/IS |
Ibaflin oral gel 3% and 7.5% |
Iceland |
22.1.2004 |
|
EU/2/00/022/013-017 |
Ibaflin |
Liechtenstein |
31.3.2004 |
|
EU/2/02/032/001/IS |
Gallivac HVT IDB Frosen susp. And diluent for inj. |
Iceland |
13.4.2004 |
|
EU/2/04/042/001/NO-004/NO |
Novem |
Norway |
10.5.2004 |
|
EU/2/04/042/001-002/IS |
Novem sol. for inj. 5 mg/ml |
Iceland |
31.3.2004 |
|
EU/2/04/042/001-004 |
Novem |
Liechtenstein |
31.5.2004 |
|
EU/2/04/042/003-004/IS |
Novem sol. for inj. 20 mg/ml |
Iceland |
31.3.2004 |
|
EU/2/04/043/001/IS |
Equilis StrepE lyophilisate and solvent for suspension |
Iceland |
11.6.2004 |
|
EU/2/97/004/010 |
Metacam |
Liechtenstein |
31.3.2004 |
|
EU/2/98/010/001-024 |
Econor |
Liechtenstein |
31.5.2004 |
|
EU/2/99/011/001 |
Locatim |
Liechtenstein |
31.5.2004 |
|
EU/2/99/014/001-011 |
Stronghold |
Liechtenstein |
31.3.2004 |
ANNEX II
2. Renewed Marketing Authorisations
The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January — 30 June 2004:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/97/037/001/NO |
Vistide |
Norway |
31.3.2004 |
|
EU/1/98/084/001/IS |
Simulect, powder and solvent for sol. for injection, 20 mg |
Iceland |
27.1.2004 |
|
EU/1/98/084/002/IS |
Simulect, powder and solvent for sol. for injection, 10 mg |
Iceland |
27.1.2004 |
|
EU/1/98/085/001-010 |
Karvezide |
Liechtenstein |
31.1.2004 |
|
EU/1/98/086/001-003,007 and 009/IS |
CoAprovel, tablets, 150 mg/12,5 mg |
Iceland |
23.1.2004 |
|
EU/1/98/086/004-006,008 and 010/IS |
CoAprovel, tablets, 300 mg/12,5 mg |
Iceland |
23.1.2004 |
|
EU/1/98/086/001-010 |
CoAprovel |
Liechtenstein |
31.1.2004 |
|
EU/1/98/087/001/NO-003/NO |
Infergen |
Norway |
23.4.2004 |
|
EU/1/98/087/001-003 |
Infergen |
Liechtenstein |
31.5.2004 |
|
EU/1/98/087/001-003/IS |
Infergen solution for injection, 9 micrograms |
Iceland |
21.6.2004 |
|
EU/1/98/089/001-016/IS |
Pritor tablets, 20, 40 and 80 mg |
Iceland |
2.2.2004 |
|
EU/1/98/089/001-016/NO |
Pritor tablets, 20, 40 and 80 mg |
Norway |
30.1.2004 |
|
EU/1/98/089/001-016 |
Pritor |
Liechtenstein |
31.1.2004 |
|
EU/1/98/090/001/NO-014/NO |
Micardis |
Norway |
30.1.2004 |
|
EU/1/98/090/001-014 |
Micardis |
Liechtenstein |
31.1.2004 |
|
EU/1/98/090/001-014/IS |
Micardis tablets, 20, 40 and 80 mg |
Iceland |
2.2.2004 |
|
EU/1/98/091/001/NO-014/NO |
Kinzalmono |
Norway |
30.1.2004 |
|
EU/1/98/091/001-014/IS |
Kinzalmono tablets, 20, 40 and 80 mg |
Iceland |
2.2.2004 |
|
EU/1/98/095/001/NO-002/NO |
Emadine |
Norway |
5.4.2004 |
|
EU/1/98/095/001-004 |
Emadine |
Liechtenstein |
31.3.2004 |
|
EU/1/98/095/001-004/IS |
Emadine, eye drops, solution, 0,5 mg/ml |
Iceland |
1.4.2004 |
|
EU/1/98/096/001-002/IS |
Temodal, capsule, hard, 5 mg |
Iceland |
7.4.2004 |
|
EU/1/98/096/001/NO-008/NO |
Temodal |
Norway |
6.4.2004 |
|
EU/1/98/096/001-008 |
Temodal |
Liechtenstein |
31.3.2004 |
|
EU/1/98/096/003-004/IS |
Temodal, capsule, hard, 20 mg |
Iceland |
7.4.2004 |
|
EU/1/98/096/005-006/IS |
Temodal, capsule, hard, 100 mg |
Iceland |
7.4.2004 |
|
EU/1/98/096/007-008/IS |
Temodal, capsule, hard, 250 mg |
Iceland |
7.4.2004 |
|
EU/1/99/097/001/NO |
Beromun |
Norway |
8.6.2004 |
|
EU/1/99/098/001/NO-002/NO |
Zenapax |
Norway |
14.5.2004 |
|
EU/1/99/098/001-002 |
Zenapax |
Liechtenstein |
31.5.2004 |
|
EU/1/99/098/001-002/IS |
Zenepax concentrate for solution for infusion |
Iceland |
23.6.2004 |
|
EU/1/99/099/001-003/IS |
Zerene, capsule, hard, 5 mg |
Iceland |
28.4.2004 |
|
EU/1/99/099/004-006/IS |
Zerene, capsule, hard, 10 mg |
Iceland |
28.4.2004 |
|
EU/1/99/099/001-006/NO |
Zerene 5 mg, 10 mg capsules |
Norway |
29.4.2004 |
|
EU/1/99/101/001/NO |
Regranex |
Norway |
30.4.2004 |
|
EU/1/99/101/001 |
Regranex |
Liechtenstein |
31.5.2004 |
|
EU/1/99/101/001/IS |
Regranex, gel, 100 mcg/g |
Iceland |
30.4.2004 |
|
EU/1/99/102/001-003 and 007/IS |
Sonata, capsule, hard, 5 mg |
Iceland |
29.4.2004 |
|
EU/1/99/102/001/NO-008/NO |
Sonata |
Norway |
29.4.2004 |
|
EU/1/99/102/001-008 |
Sonata |
Liechtenstein |
31.5.2004 |
|
EU/1/99/102/004-006 and 008/IS |
Sonata, capsule, hard, 10 mg |
Iceland |
29.4.2004 |
|
EU/1/99/110/001/NO-009/NO |
Sustiva |
Norway |
24.5.2004 |
|
EU/1/99/110/001-009 |
Sustiva |
Liechtenstein |
31.5.2004 |
|
EU/1/99/110/001-009/IS |
Sustiva filmcoated tablets, capsules and oral sol. |
Iceland |
28.5.2004 |
|
EU/1/99/111/001-009/IS |
Stocrin tablets, capsules and oral sol. |
Iceland |
21.5.2004 |
|
EU/1/99/111/001/NO-009/NO |
Stocrin |
Norway |
24.5.2004 |
|
EU/1/99/111/001-009 |
Stocrin |
Liechtenstein |
31.5.2004 |
|
EU/1/99/111/002/IS |
Stocrin, capsule, hard, 100 mg |
Iceland |
21.5.2004 |
|
EU/1/99/111/003-004/IS |
Stocrin, capsule, hard, 200 mg |
Iceland |
21.5.2004 |
|
EU/1/99/111/005/IS |
Stocrin, oral solution, 30 mg/ml |
Iceland |
21.5.2004 |
|
EU/1/99/111/006-007/IS |
Stocrin, film-coated tablet, 300 mg |
Iceland |
21.5.2004 |
|
EU/1/98/085/004-006, 008, 010, 017-020/IS |
Karvezide, tablets, 150 mg/12,5 mg |
Iceland |
22.1.2004 |
|
EU/1/98/085/001-003, 007, 009, 011-015/IS |
Karvezide, tablets, 300 mg/12,5 mg |
Iceland |
22.1.2004 |
|
EU/2/98/009/001/NO-006/NO |
Suvaxyn Aujeszky 783+ O/W |
Norway |
14.4.2004 |
|
EU/2/98/009/001-006 |
Suvaxyn Aujeszky 783+ O/W |
Liechtenstein |
31.3.2004 |
|
EU/2/99/011/001/IS |
Locatim oral solution |
Iceland |
27.5.2004 |
|
EU/2/99/011/001/NO |
Locatim |
Norway |
28.5.2004 |
ANNEX III
3. Extended Marketing Authorisations
The following marketing authorisations have been extended in the EEA EFTA States during the period 1 January — 30 June 2004:
|
EU-Number |
Product |
Country |
Date of extention |
|
EU/1/01/198/007/NO-010/NO |
Glivec |
Norway |
5.1.2004 |
|
EU/1/01/198/007-010/IS |
Glivec 100 mg and 400 mg filmcoated tablets |
Iceland |
15.1.2004 |
|
EU/1/02/212/026/IS |
Vfend, powder for oral suspension 40 mg/ml |
Iceland |
18.6.2004 |
|
EU/1/02/212/026/NO |
Vfend |
Norway |
5.3.2004 |
|
EU/1/95/001/033/NO-035/NO |
Gonal-f |
Norway |
24.3.2004 |
|
EU/1/95/001/033-035/IS |
GONAL-f, solution for injection in prefilled pen |
Iceland |
19.3.2004 |
|
EU/1/96/012/009-010/IS |
Bondronat, film coated tablets 50 mg |
Iceland |
7.1.2004 |
|
EU/1/97/031/045/NO-046/NO |
NeoRecormon |
Norway |
23.3.2004 |
|
EU/1/97/031/045-046/IS |
NeoRecormon 30.000 IU Sol. for injection pref.syr. |
Iceland |
30.3.2004 |
|
EU/1/97/046/016/NO-030/NO |
Aprovel |
Norway |
30.3.2004 |
|
EU/1/97/049/016/NO-030/NO |
Karvea |
Norway |
30.3.2004 |
|
EU/1/97/054/006/IS |
Viracept 625 mg film-coated tablets |
Iceland |
28.5.2004 |
|
EU/1/97/054/006/NO |
Viracept |
Norway |
21.5.2004 |
|
EU/1/98/085/011/NO-020/NO |
Karvezide |
Norway |
23.6.2004 |
|
EU/1/98/086/011/NO-020/NO |
CoAprovel |
Norway |
23.6.2004 |
|
EU/2/00/022/013/NO-017/NO |
Ibaflin |
Norway |
24.3.2004 |
|
EU/2/97/004/010/NO |
Metacam |
Norway |
11.5.2004 |
ANNEX IV
4. Withdrawn Marketing Authorisations
The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 January — 30 June 2004:
|
EU-Number |
Product |
Country |
Date of withdrawal |
|
EU/1/00/158/001/NO-034/NO |
Opulis |
Norway |
29.3.2004 |
|
EU/1/00/158/001-034 |
Opulis |
Liechtenstein |
31.3.2004 |
|
EU/1/00/159/001/NO-034/NO |
Allex |
Norway |
29.3.2004 |
|
EU/1/00/159/001-034 |
Allex |
Liechtenstein |
31.3.2004 |
|
EU/1/00/159/001-034/IS |
Allex |
Iceland |
10.3.2004 |
|
EU/1/02/208/001/NO-008/NO |
Xapit |
Norway |
29.3.2004 |
|
EU/1/02/208/001-008 |
Xapit |
Liechtenstein |
31.3.2004 |
|
EU/1/02/242/001/NO-024/NO |
Valdyn |
Norway |
29.3.2004 |
|
EU/1/99/106/001-003 |
Cotronak |
Liechtenstein |
31.3.2004 |
ANNEX V
5. Suspended Marketing Authorisations
The following marketing authorisations have been suspended in the EEA EFTA States during the period 1 January — 30 June 2004:
|
EU-Number |
Product |
Country |
Date of suspension |
|
EU/1/98/093/002 |
Forcaltonin |
Liechtenstein |
31.5.2004 |
|
28.9.2006 |
EN |
Official Journal of the European Union |
C 233/45 |
List of marketing authorisations granted by the EEA EFTA States for the second half of 2004
(2006/C 233/11)
With reference to EEA Joint Committee Decision No 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 10 March 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 July — 31 December 2004:
|
Annex I |
List of new marketing authorisations |
|
Annex II |
List of renewed marketing authorisations |
|
Annex III |
List of extended marketing authorisations |
|
Annex IV |
List of withdrawn marketing authorisations |
ANNEX I
1. New Marketing Authorisations:
The following marketing authorisations have been granted in the EEA EFTA States during the period 1 July — 31 December 2004:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/00/134/022-029 |
Lantus |
Liechtenstein |
30.9.2004 |
|
EU/1/00/138/001/NO-012/NO |
Venvia |
Norway |
30.7.2004 |
|
EU/1/00/139/001/NO-012/NO |
Nyracta |
Norway |
30.7.2004 |
|
EU/1/00/143/004-006 |
Kogenate Bayer |
Liechtenstein |
30.9.2004 |
|
EU/1/01/178/001/NO |
Targretin |
Norway |
13.7.2004 |
|
EU/1/01/184/033-044 |
Nespo |
Liechtenstein |
30.11.2004 |
|
EU/1/01/185/033-044 |
Aranesp |
Liechtenstein |
30.11.2004 |
|
EU/1/01/189/004-006 |
Replagal |
Liechtenstein |
30.9.2004 |
|
EU/1/01/191/005 |
Ketek |
Liechtenstein |
30.11.2004 |
|
EU/1/01/192/005 |
Levviax |
Liechtenstein |
30.11.2004 |
|
EU/1/01/193/002 |
MabCampath |
Liechtenstein |
30.11.2004 |
|
EU/1/02/206/009-017 |
Arixtra |
Liechtenstein |
30.11.2004 |
|
EU/1/02/207/009-017 |
Quixidar |
Liechtenstein |
30.11.2004 |
|
EU/1/02/221/009-010 |
Pegasys |
Liechtenstein |
30.11.2004 |
|
EU/1/03/258/007-012 |
Avandamet |
Liechtenstein |
30.9.2004 |
|
EU/1/03/270/001-002 |
Oxybutynin |
Liechtenstein |
31.7.2004 |
|
EU/1/03/270/001-002/IS |
Oxybutynin Nicobrand transderm. patches, 3,9 mg/24hours |
Iceland |
28.7.2004 |
|
EU/1/04/276/001-005/IS |
Abilify, tablets, 5 mg |
Iceland |
1.7.2004 |
|
EU/1/04/276/001-020 |
Abilify |
Liechtenstein |
31.7.2004 |
|
EU/1/04/276/006-010/IS |
Abilify, tablets,10 mg |
Iceland |
1.7.2004 |
|
EU/1/04/276/011-015/IS |
Abilify, tablets, 15 mg |
Iceland |
1.7.2004 |
|
EU/1/04/276/016-020/IS |
Abilify, tablets, 30 mg |
Iceland |
1.7.2004 |
|
EU/1/04/277/001/IS |
TachoSil, medicated sponge, 5,5 mg + 2,0 IU |
Iceland |
8.7.2004 |
|
EU/1/04/277/001/NO-004/NO |
TachoSil |
Norway |
5.7.2004 |
|
EU/1/04/277/001-004 |
TachoSil |
Liechtenstein |
31.7.2004 |
|
EU/1/04/278/001-009 |
Levemir |
Liechtenstein |
31.7.2004 |
|
EU/1/04/279/001/NO-025/NO |
Lyrica |
Norway |
4.8.2004 |
|
EU/1/04/279/001-005/IS |
LYRICA, capsule, hard, 25 mg |
Iceland |
26.8.2004 |
|
EU/1/04/279/001-025 |
Lyrica |
Liechtenstein |
30.9.2004 |
|
EU/1/04/279/006-010/IS |
LYRICA, capsule, hard, 50 mg |
Iceland |
26.8.2004 |
|
EU/1/04/279/011-013/IS |
LYRICA, capsule, hard, 75 mg |
Iceland |
26.8.2004 |
|
EU/1/04/279/014-016/IS |
LYRICA, capsule, hard, 150 mg |
Iceland |
26.8.2004 |
|
EU/1/04/279/017-019/IS |
LYRICA, capsule, hard, 300 mg |
Iceland |
26.8.2004 |
|
EU/1/04/279/020-022/IS |
LYRICA, capsule, hard, 100 mg |
Iceland |
26.8.2004 |
|
EU/1/04/279/023-025/IS |
LYRICA, capsule, hard, 200 mg |
Iceland |
26.8.2004 |
|
EU/1/04/280/001/IS |
Yentreve, gastro-resistant capsule, hard, 20 mg |
Iceland |
9.9.2004 |
|
EU/1/04/280/001/NO-006/NO |
Yentreve |
Norway |
26.8.2004 |
|
EU/1/04/280/001-006 |
Yentreve |
Liechtenstein |
30.9.2004 |
|
EU/1/04/280/002-006/IS |
Yentreve, gastro-resistant capsule, hard, 40 mg |
Iceland |
9.9.2004 |
|
EU/1/04/281/001 |
Erbitux |
Liechtenstein |
31.7.2004 |
|
EU/1/04/281/001/IS |
Erbitux, solution for infusion, 2 mg/ml |
Iceland |
26.7.2004 |
|
EU/1/04/281/001/NO |
Erbitux |
Norway |
9.7.2004 |
|
EU/1/04/282/001/NO-002/NO |
Telzir |
Norway |
19.7.2004 |
|
EU/1/04/282/001-002 |
Telzir |
Liechtenstein |
30.9.2004 |
|
EU/1/04/282/001-002/IS |
Telzir tablets and oral susp. |
Iceland |
10.8.2004 |
|
EU/1/04/283/001/IS |
Ariclaim, gastro-resistant capsule, hard, 20 mg |
Iceland |
11.9.2004 |
|
EU/1/04/283/001/NO-006/NO |
Ariclaim |
Norway |
27.8.2004 |
|
EU/1/04/283/001-006 |
Ariclaim |
Liechtenstein |
30.9.2004 |
|
EU/1/04/283/002-006/IS |
Ariclaim, gastro-resistant capsule, hard, 40 mg |
Iceland |
11.9.2004 |
|
EU/1/04/284/001 |
Pedea |
Liechtenstein |
30.9.2004 |
|
EU/1/04/284/001/IS |
Pedea, solution for injection, 5mg/ml |
Iceland |
12.8.2004 |
|
EU/1/04/284/001/NO |
Pedea |
Norway |
18.8.2004 |
|
EU/1/04/285/001/NO-020/NO |
Apidra |
Norway |
25.10.2004 |
|
EU/1/04/285/001-004/IS |
Apidra, solution for injection,vial, 100 units/ml |
Iceland |
27.10.2004 |
|
EU/1/04/285/001-020 |
Apidra |
Liechtenstein |
30.11.2004 |
|
EU/1/04/285/005/012/IS |
Apidra, solution for injection,cartridge, 100 units/ml |
Iceland |
27.10.2004 |
|
EU/1/04/285/013-020/IS |
Apidra, solution for injection, pre-filled pen, 100 units/ml |
Iceland |
27.10.2004 |
|
EU/1/04/286/001/IS |
Wilzin, capsule, hard, 25 mg |
Iceland |
11.11.2004 |
|
EU/1/04/286/001/NO-002/NO |
Wilzin |
Norway |
12.11.2004 |
|
EU/1/04/286/001-002 |
Wilzin |
Liechtenstein |
30.11.2004 |
|
EU/1/04/286/002/IS |
Wilzin, capsule, hard, 50 mg |
Iceland |
11.11.2004 |
|
EU/1/04/287/001/NO-006/NO |
Osseor |
Norway |
18.10.2004 |
|
EU/1/04/287/001-006 |
Osseor |
Liechtenstein |
30.11.2004 |
|
EU/1/04/287/001-006/IS |
Osseor, powder for oral suspension, 2g |
Iceland |
27.10.2004 |
|
EU/1/04/288/001/NO-006/NO |
Protelos |
Norway |
18.10.2004 |
|
EU/1/04/288/001-006 |
Protelos |
Liechtenstein |
30.11.2004 |
|
EU/1/04/288/001-006/IS |
Protelos, powder for oral suspension, 2g |
Iceland |
20.10.2004 |
|
EU/1/04/289/001 |
Angiox |
Liechtenstein |
30.9.2004 |
|
EU/1/04/289/001/NO |
Angiox |
Norway |
8.10.2004 |
|
EU/1/04/290/001 |
Alimta |
Liechtenstein |
30.9.2004 |
|
EU/1/04/290/001/IS |
Alimta, concentrate for solution for infusion, 500 mg |
Iceland |
19.10.2004 |
|
EU/1/04/290/001/NO |
Alimta, concentrate for solution for infusion, 500 mg |
Norway |
19.10.2004 |
|
EU/1/04/291/001/NO-002/NO |
Raptiva |
Norway |
30.9.2004 |
|
EU/1/04/291/001-001/IS |
Raptiva 100 mg/ml Powder and solvent for solution for injection |
Iceland |
18.10.2004 |
|
EU/1/04/291/001-002 |
Raptiva |
Liechtenstein |
30.9.2004 |
|
EU/1/04/292/001/NO-012/NO |
Mimpara |
Norway |
11.11.2004 |
|
EU/1/04/292/001-004/IS |
Mimpara, film-coated tablet, 30 mg |
Iceland |
19.11.2004 |
|
EU/1/04/292/001-012 |
Mimpara |
Liechtenstein |
30.11.2004 |
|
EU/1/04/292/005-008/IS |
Mimpara, film-coated tablet, 60 mg |
Iceland |
19.11.2004 |
|
EU/1/04/292/009-012/IS |
Mimpara, film-coated tablet, 90 mg |
Iceland |
19.11.2004 |
|
EU/1/04/293/001/NO-012/NO |
Parareg |
Norway |
11.11.2004 |
|
EU/1/04/293/001-004/IS |
Parareg, film-coated tablet, 30 mg |
Iceland |
18.11.2004 |
|
EU/1/04/293/001-012 |
Parareg |
Liechtenstein |
30.11.2004 |
|
EU/1/04/293/005-008/IS |
Parareg, film-coated tablet, 60 mg |
Iceland |
18.11.2004 |
|
EU/1/04/293/009-012/IS |
Parareg, film-coated tablet, 90 mg |
Iceland |
18.11.2004 |
|
EU/1/04/294/001/NO-012/NO |
Emselex |
Norway |
16.11.2004 |
|
EU/1/04/294/001-006/IS |
Emselex 7,5 mg prolonged release tablets |
Iceland |
24.11.2004 |
|
EU/1/04/294/001-012 |
Emselex |
Liechtenstein |
30.11.2004 |
|
EU/1/04/294/007-012/IS |
Emselex 15 mg prolonged release tablets |
Iceland |
24.11.2004 |
|
EU/1/04/295/001 |
Xagrid |
Liechtenstein |
30.11.2004 |
|
EU/1/04/295/001/IS |
Xagrid, Capsules, hard, 0,5 mg |
Iceland |
29.12.2004 |
|
EU/1/04/295/001/NO |
Xagrid |
Norway |
15.12.2004 |
|
EU/1/96/008/040-041 |
Puregon |
Liechtenstein |
30.9.2004 |
|
EU/1/96/013/001-004 |
Destara |
Liechtenstein |
31.7.2004 |
|
EU/1/96/022/019-022 |
Zyprexa |
Liechtenstein |
30.11.2004 |
|
EU/1/97/044/001-006 |
Tasmar |
Liechtenstein |
30.11.2004 |
|
EU/1/99/104/001/NO |
Procomvax |
Norway |
17.9.2004 |
|
EU/2/04/043/001/NO |
Equilis StrepE |
Norway |
13.9.2004 |
|
EU/2/04/044/001/IS |
Aivlozin 42,5 mg/g premix for medicated feeding stuff for pigs |
Iceland |
22.9.2004 |
|
EU/2/04/044/001/NO |
Aivlosin |
Norway |
8.10.2004 |
|
EU/2/04/045/001/NO-004/NO |
Previcox |
Norway |
13.10.2004 |
|
EU/2/04/045/001-002/IS |
Previcox, chewable tablet, 57 mg |
Iceland |
4.10.2004 |
|
EU/2/04/045/001-004 |
Previcox |
Liechtenstein |
30.9.2004 |
|
EU/2/04/045/003-004/IS |
Previcox, chewable tablet, 227 mg |
Iceland |
4.10.2004 |
|
EU/2/04/046/001/NO-003/NO |
Nobivac Piro |
Norway |
2.10.2004 |
|
EU/2/04/046/001-003 |
Nobivac Piro-606 |
Liechtenstein |
30.9.2004 |
|
EU/2/96/001/009-010 |
Porcilis Porcoli |
Liechtenstein |
30.9.2004 |
ANNEX II
2. Renewed Marketing Authorisations
The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 July — 31 December 2004:
|
EU-Number |
Product |
Country |
Date of renewal |
|
EU/1/99/119/009/IS-011/IS |
NovoRapid FlexPen, solution for injection, 100 units/ml |
Iceland |
11.11.2004 |
|
EU/1/99/097/001 |
Beromun |
Liechtenstein |
31.7.2004 |
|
EU/1/99/097/001/IS |
Beromun, powder and solvent for solution for infusion, 1 mg |
Iceland |
9.8.2004 |
|
EU/1/99/100/001-002/IS |
Cetrotide, powder for solution for injection, 0,25 mg |
Iceland |
15.9.2004 |
|
EU/1/99/100/001-003 |
Cetrotide |
Liechtenstein |
30.9.2004 |
|
EU/1/99/100/003/IS |
Cetrotide, powder for solution for injection, 3 mg |
Iceland |
15.9.2004 |
|
EU/1/99/103/001/IS |
Refacto, powder and solvent for sol. for injection, 250 a.e. |
Iceland |
19.8.2004 |
|
EU/1/99/103/001/NO-004/NO |
ReFacto |
Norway |
16.8.2004 |
|
EU/1/99/103/001-004 |
ReFacto |
Liechtenstein |
30.9.2004 |
|
EU/1/99/103/002/IS |
Refacto, powder and solvent for sol. for injection, 500 a.e. |
Iceland |
19.8.2004 |
|
EU/1/99/103/003/IS |
Refacto, powder and solvent for sol. for injection, 1 000 a.e. |
Iceland |
19.8.2004 |
|
EU/1/99/103/004/IS |
Refacto, powder and solvent for sol. for injection, 2 000 a.e. |
Iceland |
19.8.2004 |
|
EU/1/99/104/001 |
Procomvax |
Liechtenstein |
30.9.2004 |
|
EU/1/99/104/001/IS |
Procomvax, suspension for injection |
Iceland |
2.9.2004 |
|
EU/1/99/107/001/IS |
Rebetol, capsule, hard, 200 mg |
Iceland |
29.9.2004 |
|
EU/1/99/107/001/NO-003/NO |
Rebetol |
Norway |
28.9.2004 |
|
EU/1/99/107/001-003 |
Rebetol |
Liechtenstein |
30.9.2004 |
|
EU/1/99/108/001 |
Ferriprox |
Liechtenstein |
30.9.2004 |
|
EU/1/99/108/001/IS |
Ferriprox, film coated tablet, 500 mg |
Iceland |
22.9.2004 |
|
EU/1/99/108/001/NO |
Ferriprox |
Norway |
27.9.2004 |
|
EU/1/99/109/001/IS |
Integrilin, solution for infusion, 0,75 mg/ml |
Iceland |
1.10.2004 |
|
EU/1/99/109/001/NO-002/NO |
Integrilin |
Norway |
28.9.2004 |
|
EU/1/99/109/001-002 |
Integrilin |
Liechtenstein |
30.9.2004 |
|
EU/1/99/109/002/IS |
Integrilin, solution for injection, 2 mg/ml |
Iceland |
1.10.2004 |
|
EU/1/99/111/001-009 |
Stocrin |
Liechtenstein |
31.7.2004 |
|
EU/1/99/112/001/IS |
Ziagen, film-coated tablet, 300 mg |
Iceland |
16.9.2004 |
|
EU/1/99/112/001/NO-002/NO |
Ziagen |
Norway |
18.9.2004 |
|
EU/1/99/112/002/IS |
Ziagen, oral liquid, 20 mg/ml |
Iceland |
16.9.2004 |
|
EU/1/99/113/001/NO-004/NO |
Paxene |
Norway |
11.11.2004 |
|
EU/1/99/113/001-004 |
Paxene |
Liechtenstein |
30.11.2004 |
|
EU/1/99/113/001-004/IS |
Paxene, concentrate foer solution for infusion, 6 mg/ml |
Iceland |
23.11.2004 |
|
EU/1/99/114/001/NO-003/NO |
Zeffix |
Norway |
18.11.2004 |
|
EU/1/99/114/001-002/IS |
Zeffix, film-coated tablet, 100 mg |
Iceland |
19.11.2004 |
|
EU/1/99/114/001-003 |
Zeffix |
Liechtenstein |
30.11.2004 |
|
EU/1/99/114/003/IS |
Zeffix, oral solution, 5 mg/ml |
Iceland |
19.11.2004 |
|
EU/1/99/116/001/NO-003/NO |
Remicade |
Norway |
11.10.2004 |
|
EU/1/99/116/001-003 |
Remicade |
Liechtenstein |
30.9.2004 |
|
EU/1/99/117/001/IS |
Synagis, powder and solvent fol sol. for injection, 50 mg/hgl |
Iceland |
7.10.2004 |
|
EU/1/99/117/001/NO-002/NO |
Synagis |
Norway |
8.10.2004 |
|
EU/1/99/117/001-002 |
Synagis |
Liechtenstein |
30.9.2004 |
|
EU/1/99/117/002/IS |
Synagis, powder and solvent fol sol. for injection, 100 mg/hgl |
Iceland |
7.10.2004 |
|
EU/1/99/118/001/NO-010/NO |
Arava |
Norway |
4.11.2004 |
|
EU/1/99/118/001-004/IS |
Arava, tablet, 10 mg |
Iceland |
8.11.2004 |
|
EU/1/99/118/001-010 |
Arava |
Liechtenstein |
30.11.2004 |
|
EU/1/99/118/005-009/IS |
Arava, tablet, 20 mg |
Iceland |
8.11.2004 |
|
EU/1/99/118/009/IS |
Arava, tablet, 100 mg |
Iceland |
8.11.2004 |
|
EU/1/99/119/001 |
NovoRapid |
Liechtenstein |
30.11.2004 |
|
EU/1/99/119/001/IS and 008/IS |
NovoRapid, solution for injection, 100 units/ml |
Iceland |
11.11.2004 |
|
EU/1/99/119/001/NO EU/1/99/119/003/NO EU/1/99/119/005/NO-014/NO |
NovoRapid |
Norway |
4.11.2004 |
|
EU/1/99/119/003 |
NovoRapid |
Liechtenstein |
30.11.2004 |
|
EU/1/99/119/003/IS and 006/IS |
NovoRapid Penfill, solution for injection, 100 units/ml |
Iceland |
11.11.2004 |
|
EU/1/99/119/005/IS and 007/IS |
NovoRapid NovoLet, solution for injection, 100 units/ml |
Iceland |
11.11.2004 |
|
EU/1/99/119/005-014 |
NovoRapid |
Liechtenstein |
30.11.2004 |
|
EU/1/99/119/012-014/IS |
NovoRapid InnoLet, solution for injection, 100 units/ml |
Iceland |
11.11.2004 |
|
EU/1/99/125/001/NO-008/NO |
Zyprexa Velotab |
Norway |
4.12.2004 |
|
EU/1/99/125/001-004/IS |
Zyprexa Velotab, orodispersible tablet |
Iceland |
1.12.2004 |
|
EU/2/98/009/001-006/IS |
Suvaxyn Aujezky 738+O/W, emulsion for injection, |
Iceland |
6.8.2004 |
|
EU/2/99/013/001/NO-002/NO |
Halocur |
Norway |
21.12.2004 |
ANNEX III
3. Extended Marketing Authorisations
The following marketing authorisations have been extended in the EEA EFTA States during the period 1 July — 31 December 2004:
|
EU-Number |
Product |
Country |
Date of extention |
|
EU/03/258/007-009/IS |
Avandamet 2 mg/1 000 mg, film-coated tablets |
Iceland |
20.10.2004 |
|
EU/03/258/010-012/IS |
Avandamet 4 mg/1 000 mg, film-coated tablets |
Iceland |
20.10.2004 |
|
EU/1/00/143/004/IS |
KOGENATE Bayer 250 IU Powder and solvent for solution for injection |
Iceland |
23.10.2004 |
|
EU/1/00/143/004/NO-006/NO |
Kogenate |
Norway |
21.10.2004 |
|
EU/1/00/143/005/IS |
KOGENATE Bayer 500 IU Powder and solvent for solution for injection |
Iceland |
23.10.2004 |
|
EU/1/00/143/006/IS |
KOGENATE Bayer 1 000 IU Powder and solvent for solution for injection |
Iceland |
23.10.2004 |
|
EU/1/01/193/002/IS |
MabCampath, conc. for sol. for inf. 30 mg/ml |
Iceland |
26.11.2004 |
|
EU/1/02/206/009/NO-017/NO |
Arixtra |
Norway |
8.12.2004 |
|
EU/1/02/207/009/NO-017/NO |
Quixidar |
Norway |
8.12.2004 |
|
EU/1/03/258/007/NO-012/NO |
Avandamet |
Norway |
24.9.2004 |
|
EU/1/97/046/016-030/IS |
Aprovel 75, 150 and 300 mg film-coated tablets |
Iceland |
25.8.2004 |
|
EU/1/97/049/016-030/IS |
Karvea 75, 150 and 300 mg film-coated tablets |
Iceland |
25.8.2004 |
|
EU/1/98/085/011-020/IS |
Karvezide, 150 mg/12,5 mg and 300 mg/12,5 mg film-coated tablets |
Iceland |
25.8.2004 |
|
EU/1/98/086/011-020/IS |
CoAprovel 150 mg/12,5 mg and 300 mg/12,5 mg film-coated tablets |
Iceland |
25.8.2004 |
ANNEX IV
4. Withdrawn Marketing Authorisations
The following marketing authorisations have been withdrawn in the EEA EFTA States during the period 1 July — 31 December 2004:
|
EU-Number |
Product |
Country |
Date of withdrawal |
|
EU/1/01/181/001-007 |
Ixense |
Liechtenstein |
30.11.2004 |
|
EU/1/01/181/001-007/IS |
Ixense |
Iceland |
8.11.2004 |
|
EU/1/01/182/001/NO-010/NO |
Taluvian |
Norway |
10.8.2004 |
|
EU/1/01/182/001-010 |
Taluvian |
Liechtenstein |
30.9.2004 |
|
EU/1/01/182/001-010/IS |
Taluvian |
Iceland |
26.10.2004 |
|
28.9.2006 |
EN |
Official Journal of the European Union |
C 233/54 |
List of marketing authorisations granted by the EEA EFTA States for the first half of 2005
(2006/C 233/12)
With reference to EEA Joint Committee Decision No. 74/1999 of 28 May 1999, the EEA Joint Committee is invited to note, at the meeting on 10 March 2006, the following lists concerning marketing authorisations for medicinal products for the period 1 January — 30 June 2005:
|
Annex I |
List of new marketing authorisations |
|
Annex II |
List of renewed marketing authorisations |
|
Annex III |
List of extended marketing authorisations |
|
Annex IV |
List of withdrawn marketing authorisations |
ANNEX I
1. New Marketing Authorisations:
The following marketing authorisations have been granted In the EEA EFTA States during the period 1 January — 30 June 2005:
|
EU-Number |
Product |
Country |
Date of authorisation |
|
EU/1/00/146/028-029 |
Keppra |
Liechtenstein |
31.3.2005 |
|
EU/1/00/149/001/NO |
Panretin |
Norway |
28.2.2005 |
|
EU/1/01/171/011-012 |
Rapamune |
Liechtenstein |
31.3.2005 |
|
EU/1/01/178/001/IS |
Targretin 75 mg, capsule, soft |
Iceland |
31.1.2005 |
|
EU/1/01/183/019 |
HBVAXPRO |
Liechtenstein |
31.5.2005 |
|
EU/1/01/184/045-056 |
Nespo |
Liechtenstein |
31.3.2005 |
|
EU/1/01/185/045-056 |
Aranesp |
Liechtenstein |
31.3.2005 |
|
EU/1/01/198/011-013 |
Glivec |
Liechtenstein |
31.1.2005 |
|
EU/1/02/227/002 |
Neulasta |
Liechtenstein |
31.3.2005 |
|
EU/1/02/228/002 |
Neupopeg |
Liechtenstein |
31.3.2005 |
|
EU/1/02/237/005 |
Cialis |
Liechtenstein |
31.1.2005 |
|
EU/1/02/239/025-030 |
Bextra |
Liechtenstein |
31.1.2005 |
|
EU/1/02/246/003 |
Carbaglu |
Liechtenstein |
31.5.2005 |
|
EU/1/04/285/021-028 |
Apidra |
Liechtenstein |
31.5.2005 |
|
EU/1/04/296/001/IS |
Cymbalta 30 mg, Gastro-resistant capsule, hard |
Iceland |
14.1.2005 |
|
EU/1/04/296/001/NO-004/NO |
Cymbalta |
Norway |
11.1.2005 |
|
EU/1/04/296/001-004 |
Cymbalta |
Liechtenstein |
31.1.2005 |
|
EU/1/04/296/002-005/IS |
Cymbalta 60 mg, Gastro-resistant capsule, hard |
Iceland |
14.1.2005 |
|
EU/1/04/297/001/IS |
Xeristar 30 mg, Gastro-resistant tablet hard |
Iceland |
14.1.2005 |
|
EU/1/04/297/001/NO-004/NO |
Xeristar |
Norway |
11.1.2005 |
|
EU/1/04/297/001-004 |
Xeristar |
Liechtenstein |
31.1.2005 |
|
EU/1/04/297/002-005/IS |
Xeristar 60 mg, Gastro-resistant tablet hard |
Iceland |
14.1.2005 |
|
EU/1/04/298/001/NO-002/NO |
Kivexa |
Norway |
11.1.2005 |
|
EU/1/04/298/001-002 |
Kivexa |
Liechtenstein |
31.1.2005 |
|
EU/1/04/298/001-002/IS |
Kivexa 600 mg, film-coated tablet |
Iceland |
11.1.2005 |
|
EU/1/04/299/001/NO-003/NO |
Fendrix |
Norway |
15.2.2005 |
|
EU/1/04/299/001-003 |
Fendrix |
Liechtenstein |
31.3.2005 |
|
EU/1/04/299/001-003/IS |
Fendrix 20 microg/0,5 ml, suspension for injection |
Iceland |
25.2.2005 |
|
EU/1/04/300/001/NO-002/NO |
Avastin |
Norway |
18.1.2005 |
|
EU/1/04/300/001-002 |
Avastin |
Liechtenstein |
31.1.2005 |
|
EU/1/04/300/001-002/IS |
Avastin 25 mg/ml, concentrate for sol. For infusion |
Iceland |
11.2.2005 |
|
EU/1/04/301/001/NO-005/NO |
Quintanrix |
Norway |
1.3.2005 |
|
EU/1/04/301/001-005 |
Quintanrix |
Liechtenstein |
31.3.2005 |
|
EU/1/04/301/001-005/IS |
Quintanrix, powder and solvent for susp. for injection |
Iceland |
14.3.2005 |
|
EU/1/04/302/001/NO-003/NO |
Prialt |
Norway |
17.3.2005 |
|
EU/1/04/302/001-003 |
Prialt |
Liechtenstein |
31.3.2005 |
|
EU/1/04/302/001-003/IS |
Prialt, solution for injection |
Iceland |
18.3.2005 |
|
EU/1/04/303/001/IS |
Orfadin 2 mg, capsule, hard |
Iceland |
19.3.2005 |
|
EU/1/04/303/003/IS |
Orfadin 10 mg, capsule, hard |
Iceland |
19.3.2005 |
|
EU/1/04/303/001/NO-003/NO |
Orfadin |
Norway |
17.3.2005 |
|
EU/1/04/303/001-003 |
Orfadin |
Liechtenstein |
31.3.2005 |
|
EU/1/04/303/002/IS |
Orfadin 5 mg, capsule, hard |
Iceland |
19.3.2005 |
|
EU/1/04/304/001/NO-007/NO |
Azilect |
Norway |
21.3.2005 |
|
EU/1/04/304/001-007 |
Azilect |
Liechtenstein |
31.3.2005 |
|
EU/1/04/304/001-007/IS |
Azilect 1 mg, tablet |
Iceland |
17.3.2005 |
|
EU/1/04/305/001 |
Truvada |
Liechtenstein |
31.3.2005 |
|
EU/1/04/305/001/IS |
Truvada 245/200 mg, film-coated tablet |
Iceland |
16.3.2005 |
|
EU/1/04/305/001/NO |
Truvada |
Norway |
7.3.2005 |
|
EU/1/04/306/001 |
Aloxi |
Liechtenstein |
31.5.2005 |
|
EU/1/04/306/001/IS |
Aloxi 0,25 mg/5 ml, solution for injection |
Iceland |
7.4.2005 |
|
EU/1/04/306/001/NO |
Aloxi |
Norway |
20.4.2005 |
|
EU/1/04/307/001/NO-004/NO |
Zonegran |
Norway |
9.4.2005 |
|
EU/1/04/307/001-004 |
Zonegran |
Liechtenstein |
31.5.2005 |
|
EU/1/04/307/003/IS |
Zonegran 25 mg, capsule, hard |
Iceland |
6.4.2005 |
|
EU/1/04/307/003/IS |
Zonegran 50 mg, capsule, hard |
Iceland |
6.4.2005 |
|
EU/1/05/308/001 |
Aclasta |
Liechtenstein |
31.5.2005 |
|
EU/1/05/308/001/IS |
Aclasta 5 mg/ml, solution for infusion |
Iceland |
9.5.2005 |
|
EU/1/05/308/001/NO |
Aclasta |
Norway |
10.5.2005 |
|
EU/1/97/044/001-006/IS |
Tasmar |
Iceland |
18.1.2005 |
|
EU/1/97/045/004 |
Helicobacter Test INFAI |
Liechtenstein |
31.3.2005 |
|
EU/1/99/107/004 |
Rebetol |
Liechtenstein |
31.3.2005 |
|
EU/1/99/120/001/NO-004/NO |
Ammonaps |
Norway |
21.4.2005 |
|
EU/1/99/123/011 |
Renagel |
Liechtenstein |
31.3.2005 |
|
EU/1/99/125/005-008 |
Zyprexa Velotab |
Liechtenstein |
31.3.2005 |
|
EU/1/99/126/004-005 |
Enbrel |
Liechtenstein |
31.3.2005 |
|
EU/1/99/126/006-011 |
Enbrel |
Liechtenstein |
31.5.2005 |
|
EU/2/00/019/005-007 |
Eurifel FeLV |
Liechtenstein |
31.5.2005 |
|
EU/2/03/037/001-004/IS |
ProteqFlu, powder and solvent for susp. for inj. |
Iceland |
9.5.2005 |
|
EU/2/03/038/001-004/IS |
ProteqFlu-Te, powder and solvent for susp. for inj. |
Iceland |
18.2.2005 |
|
EU/2/04/046/001-003/IS |
Nobivac Piro, suspension for injection |
Iceland |
12.5.2005 |
|
EU/2/04/047/001/NO-002/NO |
Purevax RCPCh FeLV |
Norway |
21.3.2005 |
|
EU/2/04/047/001-002 |
Purevax RCPCh FeLV |
Liechtenstein |
31.3.2005 |
|
EU/2/04/047/001-002/IS |
Purevax RCPCh Fel V |
Iceland |
30.6.2005 |
|
EU/2/04/048/001/NO-002/NO |
Purevax RCP FeLV |
Norway |
21.3.2005 |
|
EU/2/04/048/001-002 |
Purevax RCP FeLV |
Liechtenstein |
31.3.2005 |
|
EU/2/04/048/001-002/IS |
Purevax RCP FeL V |
Iceland |
30.6.2005 |
|
EU/2/04/049/001/NO-002/NO |
Purevax RCCh |
Norway |
21.3.2005 |
|
EU/2/04/049/001-002 |
Purevax RCCh |
Liechtenstein |
31.3.2005 |
|
EU/2/04/050/001/NO-002/NO |
Purevax RCPCh |
Norway |
21.3.2005 |
|
EU/2/04/050/001-002 |
Purevax RCPCh |
Liechtenstein |
31.3.2005 |
|
EU/2/04/051/001/NO-002/NO |
Purevax RC |
Norway |
21.3.2005 |
|
EU/2/04/051/001-002 |
Purevax RC |
Liechtenstein |
31.3.2005 |
|
EU/2/04/051/001-002/IS |
Purevax RC, powder and solvent for susp. for inj. |
Iceland |
30.6.2005 |
|
EU/2/04/052/001/NO-002/NO |
Purevax RCP |
Norway |
21.3.2005 |
|
EU/2/04/052/001-002 |
Purevax RCP |
Liechtenstein |
31.3.2005 |
|
EU/2/04/052/001-002/IS |
Purevax RCP, powder and solvent for susp. for injection |
Iceland |
30.6.2005 |
|
EU/2/04/49/001-002/IS |
Purevax RCCh, powder and solvent for susp. for inj. |
Iceland |
30.6.2005 |
|
EU/2/04/50/001-002/IS |
Purevax RCPCh, powder and solvent for susp. for inj. |
Iceland |
30.6.2005 |
|
EU/2/05/053/001/IS |
Naxel 100 mg/ml, suspension for injection |
Iceland |
9.6.2005 |
|
EU/2/05/053/001/NO |
Naxcel |
Norway |
17.6.2005 |
|
EU/2/99/014/012 |
Stronghold |
Liechtenstein |
31.1.2005 |
|
EU/2/99/015/001/NO |
Oxyglobin |
Norway |
5.1.2005 |
|
EU/2/99/017/001-006/IS |
Ibraxion, emulsion for injection |
Iceland |
10.5.2005 |
ANNEX II
2. Renewed Marketing Authorisations
The following marketing authorisations have been renewed in the EEA EFTA States during the period 1 January — 30 June 2005:
|
EU-Number |
Product |
Country |
Date of renewal |
|
EU/1/00/129/001/NO-003/NO |
Azopt |
Norway |
30.6.2005 |
|
EU/1/00/129/001-003/IS |
Azopt, eye drops, suspension, 1% |
Iceland |
30.6.2005 |
|
EU/1/00/130/001/NO-002/NO |
Orgalutran |
Norway |
4.4.2005 |
|
EU/1/00/130/001-002 |
Orgalutran |
Liechtenstein |
31.3.2005 |
|
EU/1/00/130/001-002/IS |
Orgalutran |
Iceland |
18.4.2005 |
|
EU/1/00/131/001/NO-050/NO |
PegIntron |
Norway |
24.6.2005 |
|
EU/1/00/131/001-050/IS |
PegIntron |
Iceland |
28.6.2005 |
|
EU/1/00/132/001/NO-050/NO |
ViraferonPeg |
Norway |
24.6.2005 |
|
EU/1/00/132/001-050/IS |
ViraferonPeg |
Iceland |
28.6.2005 |
|
EU/1/99/100/001/NO-003/NO |
Cetrotide |
Norway |
4.1.2005 |
|
EU/1/99/120/001-002/IS |
Ammonaps, tablets, 500 mg |
Iceland |
29.4.2005 |
|
EU/1/99/120/003-004/IS |
Ammonaps 940 mg/g, granules |
Iceland |
29.4.2005 |
|
EU/1/99/122/001/NO-002/NO |
Thyrogen |
Norway |
15.4.2005 |
|
EU/1/99/122/001-002/IS |
Thyrogen, powder for solution for injection, 0,9 mg |
Iceland |
14.4.2005 |
|
EU/1/99/123/001/NO-011/NO |
Renagel |
Norway |
4.2.2005 |
|
EU/1/99/123/001-004/IS |
Renagel, capsule, hard, 403 mg |
Iceland |
25.2.2005 |
|
EU/1/99/123/001-010 |
Renagel |
Liechtenstein |
31.3.2005 |
|
EU/1/99/123/005-007/IS |
Renagel, film-coated tablet, 400 mg |
Iceland |
25.2.2005 |
|
EU/1/99/123/008-011/IS |
Renagel, film-coated tablet, 800 mg |
Iceland |
25.2.2005 |
|
EU/1/99/124/001/IS |
Tractocile, solution for injection, 7,5 mg/ml |
Iceland |
1.3.2005 |
|
EU/1/99/124/001/NO-002/NO |
Tractocile |
Norway |
7.3.2005 |
|
EU/1/99/124/001-002 |
Tractocile |
Liechtenstein |
31.3.2005 |
|
EU/1/99/124/002/IS |
Tractocile, concentrate for solution for infusion, 7,5 mg/ml |
Iceland |
1.3.2005 |
|
EU/1/99/125/001-004 |
Zyprexa Velotab |
Liechtenstein |
31.3.2005 |
|
EU/1/99/126/001/NO-005/NO |
Enbrel |
Norway |
6.4.2005 |
|
EU/1/99/126/001-003 |
Enbrel |
Liechtenstein |
31.3.2005 |
|
EU/1/99/126/001-005/IS |
Enbrel |
Iceland |
15.4.2005 |
|
EU/1/99/127/001/NO-044/NO |
IntronA |
Norway |
20.6.2005 |
|
EU/1/99/127/001-044/IS |
IntronA |
Iceland |
27.6.2005 |
|
EU/1/99/128/001/NO-037/NO |
Viraferon |
Norway |
20.6.2005 |
|
EU/1/99/128/001-037/IS |
Viraferon |
Iceland |
27.6.2005 |
|
EU/2/00/018/001/IS |
Incurin, tablet, 1mg |
Iceland |
10.5.2005 |
|
EU/2/00/018/001/NO |
Incurin |
Norway |
16.6.2005 |
|
EU/2/00/019/001/NO-003/NO |
Eurifel FeLV |
Norway |
31.5.2005 |
|
EU/2/00/019/001-003 |
Eurifel FeLV |
Liechtenstein |
31.5.2005 |
|
EU/2/00/021/001/NO-002/NO |
Rabigen |
Norway |
23.5.2005 |
|
EU/2/00/021/001-002/IS |
RABIGEN SAG2, oral suspension |
Iceland |
9.5.2005 |
|
EU/2/99/013/001-002 |
Halocur |
Liechtenstein |
31.1.2005 |
|
EU/2/99/013/001-002/IS |
Halocur 0.5 mg/ml, oral solution |
Iceland |
18.2.2005 |
|
EU/2/99/014/001/NO-012/NO |
Stronghold |
Norway |
6.1.2005 |
|
EU/2/99/014/001-011 |
Stronghold |
Liechtenstein |
31.1.2005 |
|
EU/2/99/014/001-012/IS |
Stronghold spot on solution 6% and 12% |
Iceland |
7.1.2005 |
|
EU/2/99/015/001 |
Oxyglobin |
Liechtenstein |
31.1.2005 |
|
EU/2/99/015/001/IS |
Oxyglobin 13g/dl, solution for infusion |
Iceland |
5.1.2005 |
|
EU/2/99/017/001/NO-006/NO |
Ibraxion |
Norway |
2.6.2005 |
|
EU/2/99/017/001-006 |
Ibraxion |
Liechtenstein |
31.5.2005 |
ANNEX IV
4. Withdrawn Marketing Authorisations
The following marketing authorisations have been withdrawn in EEA EFTA States during the period 1 January — 31 June 2005:
|
EU-Number |
Product |
Country |
Date of extention |
|
EU/1/01/171/011/NO-012/NO |
Rapamune |
Norway |
2.2.2005 |
|
EU/1/01/171/011-012/IS |
Rapamune 5 mg filmcoated tablets |
Iceland |
1.3.2005 |
|
EU/1/02/206/009-011/IS |
Arixtra 5mg/0,4 ml solution for injection |
Iceland |
10.3.2005 |
|
EU/1/02/206/012-014/IS |
Arixtra 7,5mg/0,6 ml solution for injection |
Iceland |
10.3.2005 |
|
EU/1/02/206/015-017/IS |
Arixtra 10mg/0,8 ml solution for injection |
Iceland |
10.3.2005 |
|
EU/1/02/207/009-011/IS |
Quixidar 5mg/0,4 ml solution for injection |
Iceland |
9.3.2005 |
|
EU/1/02/207/012-014/IS |
Quixidar 7,5mg/0,6 ml solution for injection |
Iceland |
9.3.2005 |
|
EU/1/02/207/015-017/IS |
Quixidar 10mg/0,8 ml solution for injection |
Iceland |
9.3.2005 |
|
EU/1/96/026/002/NO |
Invirase |
Norway |
9.6.2005 |
|
EU/1/99/107/004/IS |
Rebetol, oral solution 40 mg/ml |
Iceland |
22.3.2005 |
|
EU/1/99/107/004/NO |
Rebetol |
Norway |
22.2.2005 |
|
EU/1/99/126/006/NO-011/NO |
Enbrel |
Norway |
19.5.2005 |
|
EU/1/99/126/006-011/IS |
Enbrel, 50 mg |
Iceland |
24.5.2005 |
|
EU/2/00/019/005/NO-007/NO |
Eurifel FeLV |
Norway |
15.4.2005 |
ANNEX IV
4. Withdrawn Marketing Authorisations
The following marketing authorisations have been withdrawn in EEA EFTA States during the period 1 January — 31 June 2005:
|
EU-Number |
Product |
Country |
Date of withdrawal |
|
EU/1/00/138/001/NO-012/NO |
Venvia |
Norway |
4.1.2005 |
|
EU/1/00/138/001-012 |
Venvia |
Liechtenstein |
31.1.2005 |
|
EU/1/00/139/001/NO-012/NO |
Nyracta |
Norway |
4.1.2005 |
|
EU/1/00/139/001-012 |
Nyracta |
Liechtenstein |
31.1.2005 |
|
EU/1/01/181/001/NO-007/NO |
Ixense |
Norway |
6.1.2005 |
|
EU/1/97/048/001/NO-014/NO |
Infanrix HepB |
Norway |
25.5.2005 |
|
EU/1/97/048/001-014 |
Infanrix HepB |
Liechtenstein |
31.5.2005 |
|
EU/1/97/048/001-014/IS |
Infanrix HepB |
Iceland |
15.6.2005 |
III Notices
Commission
|
28.9.2006 |
EN |
Official Journal of the European Union |
C 233/61 |
Notice of invitation to tender for the reduction in the import duty on maize imported from non-member countries
(2006/C 233/13)
I. SUBJECT
|
1. |
Notice is hereby given of an invitation to tender for the reduction in the duty on imports from non-member countries of maize falling within subheading 1005 90 00 of the Combined Nomenclature. |
|
2. |
The total quantity in respect of which the reduction in the import duty may be fixed is 200 000 tonnes. |
|
3. |
Contracts will be awarded in accordance with the provisions of Commission Regulation (EC) No 1421/2006 (1). |
II. TIME LIMITS
|
1. |
The period for submission of tenders for the first weekly invitation begins on 29.9.2006 and expires on 5.10.2006 at 10 a.m. |
|
2. |
The period for submission of tenders for subsequent weekly invitations begins on the Friday of each week and expires on the following Thursday at 10.00. This notice is published only in respect of the issue of this invitation to tender. Unless amended or replaced, this notice is valid for all weekly invitations issued during the period of validity of this invitation to tender. However, the submission of tenders will be suspended for weeks in which there is no meeting of the Management Committee for Cereals. |
III. TENDERS
|
1. |
Tenders must be submitted in writing and must either be delivered personally against a receipt or be sent by telefax or e-mail, arriving no later than the date and time stated in Title II, to the following address:
Tenders not submitted by fax or e-mail must be enclosed in a sealed envelope marked ‘Tender for the reduction in the import duty on maize — Regulation (EC) No 1421/2006’. This envelope must itself be enclosed in another sealed envelope bearing the address in question. Tenders submitted shall remain firm until the Member State concerned informs the interested party that his tender has been successful. |
|
2. |
The tender and the proof and declaration referred to in Article 6(3) of Commission Regulation (EC) No 1839/95 (2) shall be written in the official language, or one of the official languages, of the Member State whose competent authority has received the tender. |
IV. SECURITY FOR TENDER
The tendering security shall be made payable to the competent authority.
V. AWARD OF THE CONTRACT
The award of the contract shall establish:
|
(a) |
the successful tenderer's entitlement to be issued, in the Member State in which the tender was submitted, with an import licence stating the reduction in the import duty mentioned in the tender and awarded in respect of the quantity in question; |
|
(b) |
the successful tenderer's obligation to apply, in the Member State referred to in (a), for an import |
(1) OJ L 269, 28.9.2006, p. 6.
(2) OJ L 177, 28.7.1995, p. 4. Regulation as last amended by Reg. 1558/2005 (OJ L 249/2005, p. 6)