ISSN 1725-2423
Official Journal
of the European Union
C 144
English edition
Information and Notices
Volume 50
29 June 2007
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ISSN 1725-2423 |
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Official Journal of the European Union |
C 144 |
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English edition |
Information and Notices |
Volume 50 |
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Notice No |
Contents |
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I Resolutions, recommendations, guidelines and opinions |
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OPINIONS |
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Council |
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2007/C 144/01 |
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II Information |
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INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
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Commission |
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2007/C 144/02 |
Non-opposition to a notified concentration (Case COMP/M.4569 — GE/Abbott Diagnostics Division) ( 1 ) |
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2007/C 144/03 |
Non-opposition to a notified concentration (Case COMP/M.4674 — KKR/Stefano Pessina/Alliance Boots) ( 1 ) |
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2007/C 144/04 |
Non-opposition to a notified concentration (Case COMP/M.4599 — RWE Power/Carbon/JV) ( 1 ) |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
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Commission |
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2007/C 144/05 |
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2007/C 144/06 |
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2007/C 144/07 |
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V Announcements |
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ADMINISTRATIVE PROCEDURES |
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European Parliament |
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2007/C 144/08 |
Call for proposals (No VIII-2008/01) — Grants to political parties at European level |
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PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
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Commission |
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2007/C 144/09 |
Prior notification of a concentration (Case COMP/M.4688 — Nestlé/Gerber) ( 1 ) |
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(1) Text with EEA relevance |
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EN |
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I Resolutions, recommendations, guidelines and opinions
OPINIONS
Council
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29.6.2007 |
EN |
Official Journal of the European Union |
C 144/1 |
Notice for the attention of the persons, groups and entities on the list provided for in Article 2(3) of Council Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism (see Annex to Council Decision 2007/445/EC of 28 June 2007)
(2007/C 144/01)
The following information is brought to the attention of the persons, groups and entities listed in Council Decision 2007/445/EC of 28 June 2007 (1).
The Council of the European Union has determined that the reasons for including the persons, groups and entities that appear on the above-mentioned list of persons, groups and entities subject to the restrictive measures provided for under Council Regulation (EC) No 2580/2001 of 27 December 2001, on specific restrictive measures directed against certain persons and entities with a view to combating terrorism (2), are still valid. Consequently, the Council has decided to maintain those persons, groups and entities on the list.
Regulation (EC) No 2580/2001 provides for a freezing of all funds, other financial assets and economic resources belonging to the persons, groups and entities concerned and that no funds, other financial assets and economic resources may be made available to them, whether directly or indirectly.
The attention of the persons, groups and entities concerned is drawn to the possibility of making an application to the competent authorities of the relevant Member State(s) as listed in the Annex to the Regulation in order to obtain an authorisation to use frozen funds for essential needs or specific payments in accordance with Article 5(2) of that Regulation. An updated list of competent authorities is available on the web at the following address:
http://ec.europa.eu/comm/external_relations/cfsp/sanctions/measures.htm
The persons, groups and entities concerned may submit a request to obtain the Council's statement of reasons for maintaining them on the above-mentioned list (unless the statement of reasons has already been communicated to them), to the following address: Council of the European Union (Attn: CP 931 designations) rue de la Loi 175 B-1048 Brussels.
The persons, groups and entities concerned may submit at any time a request to the Council, together with any supporting documentation, that the decision to include and maintain them on the list should be reconsidered, to the address provided above. Such requests will be considered when they are received. In this respect, the attention of the persons, groups and entities concerned is drawn to the regular review by the Council of the list according to Article 1(6) of Common Position 2001/931/CFSP. In order for requests to be considered at the next review, they should be submitted within two months from the date of publication of this notice.
The attention of the persons, groups and entities concerned is also drawn to the possibility of challenging the Council's decision before the Court of First Instance of the European Communities, in accordance with the conditions laid down in Article 230(4) and (5) of the Treaty establishing the European Community.
(2) OJ L 344, 28.12.2001, p. 70.
II Information
INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES
Commission
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29.6.2007 |
EN |
Official Journal of the European Union |
C 144/2 |
Non-opposition to a notified concentration
(Case COMP/M.4569 — GE/Abbott Diagnostics Division)
(Text with EEA relevance)
(2007/C 144/02)
On 24 April 2007, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:
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from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
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in electronic form on the EUR-Lex website under document number 32007M4569. EUR-Lex is the on-line access to European law. (http://eur-lex.europa.eu) |
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29.6.2007 |
EN |
Official Journal of the European Union |
C 144/2 |
Non-opposition to a notified concentration
(Case COMP/M.4674 — KKR/Stefano Pessina/Alliance Boots)
(Text with EEA relevance)
(2007/C 144/03)
On 18 June 2007, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:
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— |
from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
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in electronic form on the EUR-Lex website under document number 32007M4674. EUR-Lex is the on-line access to European law. (http://eur-lex.europa.eu) |
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29.6.2007 |
EN |
Official Journal of the European Union |
C 144/3 |
Non-opposition to a notified concentration
(Case COMP/M.4599 — RWE Power/Carbon/JV)
(Text with EEA relevance)
(2007/C 144/04)
On 18 June 2007, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in German and will be made public after it is cleared of any business secrets it may contain. It will be available:
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— |
from the Europa competition web site (http://ec.europa.eu/comm/competition/mergers/cases/). This web site provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
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— |
in electronic form on the EUR-Lex website under document number 32007M4599. EUR-Lex is the on-line access to European law. (http://eur-lex.europa.eu) |
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES
Commission
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29.6.2007 |
EN |
Official Journal of the European Union |
C 144/4 |
Euro exchange rates (1)
28 June 2007
(2007/C 144/05)
1 euro=
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Currency |
Exchange rate |
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USD |
US dollar |
1,3467 |
|
JPY |
Japanese yen |
165,61 |
|
DKK |
Danish krone |
7,4425 |
|
GBP |
Pound sterling |
0,67215 |
|
SEK |
Swedish krona |
9,2415 |
|
CHF |
Swiss franc |
1,6544 |
|
ISK |
Iceland króna |
84,1 |
|
NOK |
Norwegian krone |
7,952 |
|
BGN |
Bulgarian lev |
1,9558 |
|
CYP |
Cyprus pound |
0,5837 |
|
CZK |
Czech koruna |
28,633 |
|
EEK |
Estonian kroon |
15,6466 |
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HUF |
Hungarian forint |
247,44 |
|
LTL |
Lithuanian litas |
3,4528 |
|
LVL |
Latvian lats |
0,6962 |
|
MTL |
Maltese lira |
0,4293 |
|
PLN |
Polish zloty |
3,782 |
|
RON |
Romanian leu |
3,1666 |
|
SKK |
Slovak koruna |
33,832 |
|
TRY |
Turkish lira |
1,7796 |
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AUD |
Australian dollar |
1,5918 |
|
CAD |
Canadian dollar |
1,4293 |
|
HKD |
Hong Kong dollar |
10,5264 |
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NZD |
New Zealand dollar |
1,7513 |
|
SGD |
Singapore dollar |
2,0649 |
|
KRW |
South Korean won |
1 248,19 |
|
ZAR |
South African rand |
9,572 |
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CNY |
Chinese yuan renminbi |
10,2553 |
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HRK |
Croatian kuna |
7,3042 |
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IDR |
Indonesian rupiah |
12 224,67 |
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MYR |
Malaysian ringgit |
4,6683 |
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PHP |
Philippine peso |
62,42 |
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RUB |
Russian rouble |
34,742 |
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THB |
Thai baht |
42,859 |
Source: reference exchange rate published by the ECB.
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29.6.2007 |
EN |
Official Journal of the European Union |
C 144/5 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2007/C 144/06)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
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2.5.2007 |
Focetria |
A/Viet Nam/1194/2004 (H5N1) virus surface inactivated antigen |
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EU/1/07/385/001-004 |
Suspension for injection |
J07BB02 |
4.5.2007 |
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21.5.2007 |
ORENCIA |
abatacept |
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EU/1/07/389/001-003 |
Powder for concentrate for solution for infusion |
L04AA24 |
23.5.2007 |
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24.5.2007 |
Altargo |
retapamulin |
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EU/1/07/390/001-004 |
Ointment |
D06AX13 |
29.5.2007 |
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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22.5.2007 |
Mycograb |
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— |
29.5.2007 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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2.5.2007 |
Aranesp |
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EU/1/01/185/001-073 |
4.5.2007 |
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2.5.2007 |
Liprolog |
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EU/1/01/195/001-015 |
4.5.2007 |
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2.5.2007 |
BeneFIX |
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EU/1/97/047/001-003 |
4.5.2007 |
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2.5.2007 |
Vfend |
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EU/1/02/212/001-026 |
4.5.2007 |
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2.5.2007 |
Nespo |
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EU/1/01/184/001-073 |
4.5.2007 |
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2.5.2007 |
Invirase |
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EU/1/96/026/001-002 |
4.5.2007 |
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2.5.2007 |
Norvir |
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EU/1/96/016/001 EU/1/96/016/003-004 |
4.5.2007 |
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2.5.2007 |
Viramune |
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EU/1/97/055/001-003 |
4.5.2007 |
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2.5.2007 |
Viread |
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EU/1/01/200/001 |
4.5.2007 |
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2.5.2007 |
Osigraft |
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EU/1/01/179/001 |
4.5.2007 |
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2.5.2007 |
Sustiva |
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EU/1/99/110/001-009 |
4.5.2007 |
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2.5.2007 |
Stocrin |
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EU/1/99/111/001-011 |
4.5.2007 |
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3.5.2007 |
Protopy |
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EU/1/02/202/001-006 |
7.5.2007 |
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3.5.2007 |
Crixivan |
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EU/1/96/024/001-005 EU/1/96/024/007-008 EU/1/96/024/010 |
8.5.2007 |
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3.5.2007 |
Protopic |
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EU/1/02/201/001-006 |
7.5.2007 |
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3.5.2007 |
Infanrix Hexa |
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EU/1/00/152/001-018 |
7.5.2007 |
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3.5.2007 |
Infanrix Penta |
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EU/1/00/153/001-010 |
7.5.2007 |
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3.5.2007 |
Humalog |
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EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010-011 EU/1/96/007/015-021 EU/1/96/007/023-030 |
7.5.2007 |
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11.5.2007 |
Prialt |
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EU/1/04/302/001-004 |
15.5.2007 |
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14.5.2007 |
PritorPlus |
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EU/1/02/215/001-014 |
16.5.2007 |
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14.5.2007 |
Hepsera |
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EU/1/03/251/001-002 |
16.5.2007 |
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14.5.2007 |
Humira |
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EU/1/03/256/001-010 |
16.5.2007 |
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14.5.2007 |
Trudexa |
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EU/1/03/257/001-010 |
16.5.2007 |
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15.5.2007 |
Omnitrope |
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EU/1/06/332/001-006 |
18.5.2007 |
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15.5.2007 |
Iscover |
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EU/1/98/070/001a–006a EU/1/98/070/001b-006b |
17.5.2007 |
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15.5.2007 |
Plavix |
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EU/1/98/069/001a-006a EU/1/98/069/001b-006b |
21.5.2007 |
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15.5.2007 |
Xagrid |
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EU/1/04/295/001 |
17.5.2007 |
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22.5.2007 |
Thelin |
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EU/1/06/353/001-005 |
25.5.2007 |
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22.5.2007 |
Zavesca |
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EU/1/02/238/001 |
25.5.2007 |
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22.5.2007 |
Teslascan |
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EU/1/97/040/001-002 |
25.5.2007 |
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22.5.2007 |
Opatanol |
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EU/1/02/217/001-002 |
24.5.2007 |
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30.5.2007 |
Xolair |
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EU/1/05/319/001-004 |
1.6.2007 |
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30.5.2007 |
Caelyx |
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EU/1/96/011/001-004 |
1.6.2007 |
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30.5.2007 |
Ventavis |
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EU/1/03/255/001-005 |
1.6.2007 |
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30.5.2007 |
Remicade |
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EU/1/99/116/001-003 |
1.6.2007 |
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30.5.2007 |
LeukoScan |
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EU/1/97/032/001 |
1.6.2007 |
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30.5.2007 |
Ziagen |
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EU/1/99/112/001-002 |
1.6.2007 |
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30.5.2007 |
Kivexa |
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EU/1/04/298/001-002 |
1.6.2007 |
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30.5.2007 |
AVANDIA |
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EU/1/00/137/002-018 |
1.6.2007 |
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30.5.2007 |
Viramune |
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EU/1/97/055/001-003 |
1.6.2007 |
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30.5.2007 |
Avaglim |
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EU/1/06/349/001-010 |
1.6.2007 |
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31.5.2007 |
Ketek |
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EU/1/01/191/001-005 |
4.6.2007 |
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31.5.2007 |
Levviax |
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EU/1/01/192/001-005 |
5.6.2007 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
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14.5.2007 |
Nobilis Influenza H7N1 |
Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of ≥ 6,0 log2 as tested according to the potency test. |
Intervet International B.V. |
EU/2/07/073/001-004 |
Emulsion for injection |
QI01AA23 |
16.5.2007 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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15.5.2007 |
METACAM |
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EU/2/97/004/007-008 EU/2/97/004/014-015 EU/2/97/004/027-028 |
18.5.2007 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
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The European Medicines Agency |
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7, Westferry Circus |
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Canary Wharf |
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London E14 4HB |
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United Kingdom |
(1) OJ L 136 of 30 April 2004, page 1
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29.6.2007 |
EN |
Official Journal of the European Union |
C 144/11 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2007/C 144/07)
— Issuing, maintenance or modification of a national marketing authorisation
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
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22.5.2007 |
Doxyprex |
See Annex I |
See Annex I |
24.5.2007 |
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22.5.2007 |
Thelin |
This Decision is addressed to the Member States |
This Decision is addressed to the Member States |
24.5.2007 |
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29.5.2007 |
Xefo |
See Annex II |
See Annex II |
30.5.2007 |
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30.5.2007 |
Remicade |
This Decision is addressed to the Member States |
This Decision is addressed to the Member States |
31.5.2007 |
— Suspension of a national marketing authorization
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
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2.5.2007 |
Alendros 70 |
See Annex III |
See Annex III |
4.5.2007 |
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.
ANNEX I
NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
|
Member State |
Applicant or Marketing Authorisation Holder |
Product invented name |
Pharmaceutical form |
Strength |
Animal species |
Frequency and route of administration |
Recommended dose |
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Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia |
|
DOXYPREX |
Premix |
100 mg/g |
Pigs (after weaning) |
In feed use |
10 mg/kg .bw |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
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Member State |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
Content |
||||
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Austria |
|
Artok |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
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Lornox |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Artok |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Lornoxicam ‘Nycomed’ |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Belgium |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Acute |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Bulgaria |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Czech Republic |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Denmark |
|
Lornoxicam ‘Nycomed’ |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Lornoxicam ‘Nycomed’ |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Lornoxicam ‘Nycomed’ |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Estonia |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Germany |
|
Lornoxicam ‘Nycomed’ |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Telos |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Lornoxicam ‘Nycomed’ |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Telos |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Greece |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Hungary |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Italy |
|
Taigalor |
8 mg |
Film-coated tablet |
Oral |
8 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Taigalor |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Latvia |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Lithuania |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Luxembourg |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Acute |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Portugal |
|
Acabel |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Bosporon |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Acabel |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Bosporon |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Acabel Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Bosporon Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Acabel |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Bosporon |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Romania |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Spain |
|
Acabel |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Bosporon |
4 mg |
Film-coated tablet |
Oral |
4 mg |
|||||
|
Acabel |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Bosporon |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Acabel Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Bosporon Rapid |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Acabel |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
Sweden |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo Akut |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
|||||
|
United Kingdom |
|
Xefo |
4 mg |
Film-coated tablet |
Oral |
4 mg |
||||
|
Xefo |
8 mg |
Film-coated tablet |
Oral |
8 mg |
|||||
|
Xefo |
4 mg/ml |
Powder and solvent for solution for injection |
Intravenous use/Intramuscular use |
8 mg |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
||||
|
Czech Republic |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Estonia |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Hungary |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Latvia |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Lithuania |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Poland |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
||||
|
Slovakia |
|
|
Alendros 70 |
70 mg |
Tablet |
Oral use |
V Announcements
ADMINISTRATIVE PROCEDURES
European Parliament
|
29.6.2007 |
EN |
Official Journal of the European Union |
C 144/22 |
CALL FOR PROPOSALS (No VIII-2008/01)
Grants to political parties at European level
(2007/C 144/08)
1. OBJECTIVES
1.1 Background
Article 191 of the Treaty establishing the European Community says the political parties at European level are important factor for integration within the Union. They contribute to forming a European awareness and expressing the political will of the citizens of the Union. In this context, Regulation (EC) No 2004/2003 of the European Parliament and of the Council (1) lays down the regulations governing political parties at European level and the rules regarding their funding. The Regulation provides, in particular, for an annual grant from the European Parliament, in the form of an operating subsidy, to political parties which apply and which satisfy the conditions laid down in the Regulation.
1.2 Objective of the call for proposals
Under Article 2 of the Decision of the Bureau of the European Parliament of 29 March 2004 laying down the procedures for implementing Regulation (EC) No 2004/2003 (2), ‘The European Parliament shall publish each year, before the end of the first half of the year, a call for proposals with a view to the awarding of grants to fund political parties at European level.’ This call for proposals relates to grant applications for the financial year 2008 covering the period of activity from 1.1.2008 to 31.12.2008.
2. CRITERIA AND SUPPORTING DOCUMENTS
2.1. Admissibility
Applications will not be admissible unless they are submitted in writing on the grant application form in Annex 1 of the above Decision of the Bureau of the European Parliament of 29 March 2004, forwarded to the President of the European Parliament by the closing date and meet the conditions for the submission of applications set out below.
2.2. Eligibility criteria
In order to be eligible for a grant, a political party at European level must satisfy the conditions laid down in Article 3 of Regulation (EC) No 2004/2003, i.e.:
|
(a) |
it must have legal personality in the Member State in which its seat is located; |
|
(b) |
it must be represented, in at least one quarter of Member States, by Members of the European Parliament or in the national Parliaments or regional Parliaments or in the regional assemblies, or it must have received, in at least one quarter of the Member States, at least three per cent of the votes cast in each of those Member States at the most recent European Parliament elections; |
|
(c) |
it must observe, in particular in its programme and in its activities, the principles on which the European Union is founded, namely the principles of liberty, democracy, respect for human rights and fundamental freedoms, and the rule of law; |
|
(d) |
it must have participated in elections to the European Parliament, or have expressed the intention to do so. |
2.3 Exclusion criteria
Applicants must also certify that they do not find themselves in any of the circumstances described in Articles 93 and 94 of the Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (3).
2.4. Selection criteria
Applicants must provide evidence that they possess the legal and financial viability required to carry out the programme of activities set out in the application for funding and that they have the technical capability and management skills needed to carry out successfully the programme activities for which they are applying for a grant.
2.5 Award criteria
In accordance with Article 10 of Regulation (EC) No 2004/2003, the available appropriations for the financial year 2008 will be distributed as follows among the political parties at European level which have obtained a positive decision on their application for funding on the basis of the admissibility, eligibility, exclusion and selection criteria:
|
(a) |
15 % will be distributed in equal shares; |
|
(b) |
85 % will be distributed among those which have elected members in the European Parliament, in proportion to the number of elected members. |
2.6 Supporting documents
For the purpose of assessing the above criteria, applicants must provide the following supporting documents:
|
(a) |
Original covering letter |
|
(b) |
Application form in Annex 1 of the Decision of the Bureau of the European Parliament of 29 March 2004 duly completed and signed (including the written solemn declaration) |
|
(c) |
Statutes of the political party |
|
(d) |
Official certificate of registration |
|
(e) |
Recent proof of existence of the political party |
|
(f) |
List of the directors/members of the Management Board (names and forenames, titles or functions within the applicant party) |
|
(g) |
Documents certifying that the applicant meets the conditions laid down in Articles 3 (b), (c) and (d) and 10(1)(b) (4) of Regulation (EC) No 2004/2003 (or declaration that there have been no changes to documents already forwarded) |
|
(h) |
Programme of the political party |
|
(i) |
Comprehensive financial statement for 2006 certified by an external auditing body (5) |
|
(j) |
Provisional operating budget for the period concerned (1.1.2008 to 31.12.2008) indicating expenditure eligible for funding from the Community budget. |
3. COMMUNITY FUNDING
The budget for the financial year 2008 is estimated at a total of EUR 10 645 000, subject to approval by the budgetary authority.
The maximum amount paid to the beneficiary by the European Parliament may not exceed 75 % of the eligible operating costs of political parties at European level. The burden of proof shall lie with the political party concerned.
Community funding shall take the form of an operating grant as provided for by the Financial Regulation and the Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities (6). The arrangements for paying the grant and the obligations governing its use will be set out in a grant award agreement, a specimen of which appears in Annex 2 to the Decision of the Bureau of the European Parliament of 29 March 2004.
4. PROCEDURE
4.1 Closing date and submission of applications
The closing date for forwarding the applications is 14.11.2007. Applications forwarded after that date will not be considered.
Applications must:
|
— |
be made on the grant application form; |
|
— |
be signed, without fail, by the applicant or his duly authorised agent; |
|
— |
be submitted under double cover; the two envelopes must be sealed. In addition to the address of the recipient department as given in the call for proposals, the inner envelope must bear the following: ‘Call for proposals — 2008 grants to political parties at European level NOT TO BE OPENED BY THE MAIL SERVICE OR BY ANY OTHER UNAUTHORISED PERSON’ If self-adhesive envelopes are used, they must be sealed with adhesive tape with the signature of the sender affixed across it. The signature of the sender shall be deemed to comprise not only his hand-written signature, but also his organisation's stamp; |
|
— |
be forwarded at the latest on the closing date laid down in the call for proposals either by registered mail, as evidenced by the postmark or by courier service as evidenced by the date of the deposit slip, The outer envelope must be addressed to:
This envelope must also show the sender's address. The inner envelope must be addressed to:
|
4.2 Timetable for implementing the programme of activities
The eligible period for cofinancing of operating expenditure of political parties at European level in 2008 runs from 1.1.2008 until 31.12.2008.
4.3 Award procedure and timetable
The following procedure and timetable will apply to the awarding of grants to political parties at European level:
|
(a) |
Forwarding of the application to the European Parliament (no later than 14.11.2007) |
|
(b) |
Consideration and selection by the European Parliament's departments. Only the applications deemed admissible will be examined on the basis of the eligibility, exclusion and selection criteria set out in the call for proposals. |
|
(c) |
Adoption of the final decision by the Bureau of the European Parliament (before 15.2.2008) and notification of applicants. |
|
(d) |
Signature of grant award agreement (within 30 days following the Bureau decision) |
|
(e) |
Payment of an advance of 80 % (within 15 days following the signing of the agreement). |
4.4 Further information
The following texts are available on the European Parliament's Internet site at the following address:
http://www.europarl.europa.eu/tenders/invitations.htm:
|
(a) |
Regulation (EC) No 2004/2003 of the European Parliament and of the Council of 4 November 2003 on the regulations governing political parties at European level and the rules regarding their funding; |
|
(b) |
Decision of the Bureau of the European Parliament of 29 March 2004 laying down procedures for implementing Regulation (EC) No 2004/2003 of the European Parliament and of the Council on the regulations governing political parties at European level and the rules regarding their funding; |
|
(c) |
Grant application form; |
|
(d) |
Specimen agreement. |
Any questions relating to this call for proposals with a view to the awarding of grants should be sent by e-mail, quoting the publication reference, to the following address:
Helmut.Betz@europarl.europa.eu
(1) OJ L 297, 15.11.2003, p. 1
(2) OJ C 155, 12.6.2004, p. 1. Decision as amended by the Bureau on 1 February 2006 (OJ C 150, 28.6.2006, p. 9).
(3) OJ L 248, 16.9.2002, p. 1. Regulation as last amended by Regulation (EC, Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1).
(4) Including the lists of elected persons referred to in Articles 3(b), first subparagraph, and 10(1)(b).
(5) Unless the political party at European level was established during the current year.
(6) OJ L 357, 31.12.2002, p. 1. Regulation as amended by Regulation (EC, Euratom) No 478/2007 (OJ L 111, 28.4.2007, p. 13).
PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY
Commission
|
29.6.2007 |
EN |
Official Journal of the European Union |
C 144/25 |
Prior notification of a concentration
(Case COMP/M.4688 — Nestlé/Gerber)
(Text with EEA relevance)
(2007/C 144/09)
|
1. |
On 22 June 2007, 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 Nestlé S.A. (‘Nestlé’, Switzerland) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the Gerber business (‘Gerber, US’), belonging to Novartis AG (‘Novartis’, Switzerland), by way of purchase of shares and assets. |
|
2. |
The business activities of the undertakings concerned are:
|
|
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. |
|
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.4688 — Nestlé/Gerber, to the following address:
|