This document is an excerpt from the EUR-Lex website
Document C:2009:101:FULL
Official Journal of the European Union, C 101, 01 May 2009
Official Journal of the European Union, C 101, 01 May 2009
Official Journal of the European Union, C 101, 01 May 2009
Display all documents published in this Official Journal
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ISSN 1725-2423 doi:10.3000/17252423.C_2009.101.eng |
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Official Journal of the European Union |
C 101 |
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English edition |
Information and Notices |
Volume 52 |
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Notice No |
Contents |
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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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2009/C 101/01 |
Non-opposition to a notified concentration — (Case COMP/M.5432 — Credit Mutuel/Cofidis) ( 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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2009/C 101/02 |
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2009/C 101/03 |
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2009/C 101/04 |
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2009/C 101/05 |
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2009/C 101/06 |
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2009/C 101/07 |
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V Announcements |
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ADMINISTRATIVE PROCEDURES |
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Commission |
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2009/C 101/08 |
Specific call for proposals — EAC/24/09 — Erasmus University Charter — Lifelong Learning Programme |
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2009/C 101/09 |
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(1) Text with EEA relevance |
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EN |
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II Information
INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES
Commission
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1.5.2009 |
EN |
Official Journal of the European Union |
C 101/1 |
Non-opposition to a notified concentration
(Case COMP/M.5432 — Credit Mutuel/Cofidis)
(Text with EEA relevance)
2009/C 101/01
On 24 February 2009, 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 French 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 32009M5432. 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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1.5.2009 |
EN |
Official Journal of the European Union |
C 101/2 |
Euro exchange rates (1)
30 April 2009
2009/C 101/02
1 euro =
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Currency |
Exchange rate |
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USD |
US dollar |
1,3275 |
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JPY |
Japanese yen |
130,34 |
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DKK |
Danish krone |
7,4484 |
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GBP |
Pound sterling |
0,89335 |
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SEK |
Swedish krona |
10,6915 |
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CHF |
Swiss franc |
1,5066 |
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ISK |
Iceland króna |
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NOK |
Norwegian krone |
8,7245 |
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BGN |
Bulgarian lev |
1,9558 |
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CZK |
Czech koruna |
26,701 |
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EEK |
Estonian kroon |
15,6466 |
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HUF |
Hungarian forint |
289,73 |
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LTL |
Lithuanian litas |
3,4528 |
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LVL |
Latvian lats |
0,7093 |
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PLN |
Polish zloty |
4,3993 |
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RON |
Romanian leu |
4,1892 |
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TRY |
Turkish lira |
2,1145 |
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AUD |
Australian dollar |
1,8146 |
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CAD |
Canadian dollar |
1,5786 |
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HKD |
Hong Kong dollar |
10,2881 |
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NZD |
New Zealand dollar |
2,3378 |
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SGD |
Singapore dollar |
1,9620 |
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KRW |
South Korean won |
1 696,88 |
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ZAR |
South African rand |
11,2426 |
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CNY |
Chinese yuan renminbi |
9,0575 |
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HRK |
Croatian kuna |
7,4101 |
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IDR |
Indonesian rupiah |
14 071,50 |
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MYR |
Malaysian ringgit |
4,7259 |
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PHP |
Philippine peso |
63,924 |
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RUB |
Russian rouble |
43,8630 |
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THB |
Thai baht |
46,808 |
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BRL |
Brazilian real |
2,8850 |
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MXN |
Mexican peso |
18,2950 |
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INR |
Indian rupee |
66,2620 |
(1) Source: reference exchange rate published by the ECB.
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1.5.2009 |
EN |
Official Journal of the European Union |
C 101/3 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2009 to 31 March 2009
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
2009/C 101/03
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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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4.3.2009 |
CELVAPAN |
Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated) |
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EU/1/08/506/001 |
Suspension for injection |
J07BB01 |
6.3.2009 |
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6.3.2009 |
MEPACT |
mifamurtide |
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EU/1/08/502/001 |
Powder for suspension for infusion |
L03AX15 |
23.3.2009 |
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19.3.2009 |
Fertavid |
follitropin beta |
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EU/1/09/510/001-019 |
Solution for injection |
G03G A06 |
23.3.2009 |
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30.3.2009 |
Synflorix |
Pneumococcal polysaccharide conjugate vaccine (adsorbed) |
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EU/1/09/508/001-009 |
Suspension for injection |
J07AL52 |
31.3.2009 |
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31.3.2009 |
Ribavirin Teva |
Ribavirin |
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EU/1/09/509/001-004 |
Capsule, hard |
J05A B04 |
2.4.2009 |
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31.3.2009 |
IXIARO |
Japanese Encephalitis vaccine (inactivated, adsorbed) |
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EU/1/08/501/001-002 |
Suspension for injection |
J07BA02 |
2.4.2009 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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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2.3.2009 |
Fendrix |
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EU/1/04/299/001-003 |
4.3.2009 |
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2.3.2009 |
Cymbalta |
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EU/1/04/296/001-009 |
4.3.2009 |
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2.3.2009 |
Fareston |
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EU/1/96/004/001-002 |
4.3.2009 |
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2.3.2009 |
Nexavar |
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EU/1/06/342/001 |
4.3.2009 |
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2.3.2009 |
Irbesartan BMS |
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EU/1/06/375/001-033 |
4.3.2009 |
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2.3.2009 |
Aptivus |
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EU/1/05/315/001 |
4.3.2009 |
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2.3.2009 |
Ganfort |
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EU/1/06/340/001-002 |
5.3.2009 |
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4.3.2009 |
KOGENATE Bayer |
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EU/1/00/143/001-011 |
6.3.2009 |
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4.3.2009 |
Helixate NexGen |
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EU/1/00/144/001-004 |
6.3.2009 |
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4.3.2009 |
Gardasil |
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EU/1/06/357/001-021 |
6.3.2009 |
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4.3.2009 |
Cystadane |
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EU/1/06/379/001 |
6.3.2009 |
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4.3.2009 |
Photobarr |
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EU/1/04/272/001-002 |
6.3.2009 |
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6.3.2009 |
Silgard |
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EU/1/06/358/001-021 |
10.3.2009 |
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6.3.2009 |
BYETTA |
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EU/1/06/362/001-004 |
10.3.2009 |
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6.3.2009 |
IntronA |
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EU/1/99/127/001-044 |
10.3.2009 |
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6.3.2009 |
Remicade |
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EU/1/99/116/001-005 |
10.3.2009 |
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6.3.2009 |
Protelos |
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EU/1/04/288/001-006 |
10.3.2009 |
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6.3.2009 |
ATryn |
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EU/1/06/355/001-003 |
10.3.2009 |
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6.3.2009 |
Irbesartan Hydrochlorothiazide Winthrop |
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EU/1/06/377/001-028 |
10.3.2009 |
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9.3.2009 |
Optisulin |
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EU/1/00/133/001-032 |
11.3.2009 |
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9.3.2009 |
Osseor |
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EU/1/04/287/001-006 |
11.3.2009 |
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9.3.2009 |
Sustiva |
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EU/1/99/110/001-009 |
11.3.2009 |
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10.3.2009 |
DULOXETINE BOEHRINGER INGELHEIM |
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EU/1/08/471/001-012 |
12.3.2009 |
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17.3.2009 |
Pritor Plus |
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EU/1/02/215/001-021 |
19.3.2009 |
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17.3.2009 |
Irbesartan Winthrop |
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EU/1/06/376/001-033 |
19.3.2009 |
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17.3.2009 |
Pritor |
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EU/1/98/089/001-022 |
19.3.2009 |
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17.3.2009 |
Hycamtin |
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EU/1/96/027/001 EU/1/96/027/003-007 |
19.3.2009 |
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17.3.2009 |
Onsenal |
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EU/1/03/259/001-006 |
19.3.2009 |
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18.3.2009 |
Irbesartan HCT BMS |
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EU/1/06/369/001-028 |
20.3.2009 |
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18.3.2009 |
Atriance |
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EU/1/07/403/001 |
20.3.2009 |
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18.3.2009 |
Kinzalkomb |
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EU/1/02/214/001-015 |
20.3.2009 |
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18.3.2009 |
MicardisPlus |
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EU/1/02/213/001-023 |
20.3.2009 |
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18.3.2009 |
Kinzalmono |
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EU/1/98/091/001-014 |
20.3.2009 |
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19.3.2009 |
Regranex |
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EU/1/99/101/001 |
23.3.2009 |
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19.3.2009 |
Stalevo |
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EU/1/03/260/001-023 |
23.3.2009 |
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19.3.2009 |
Micardis |
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EU/1/98/090/001-020 |
23.3.2009 |
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19.3.2009 |
Vectibix |
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EU/1/07/423/001-003 |
23.3.2009 |
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23.3.2009 |
NovoSeven |
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EU/1/96/006/001-003 |
25.3.2009 |
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23.3.2009 |
Irbesartan BMS |
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EU/1/06/375/001-033 |
25.3.2009 |
|||||
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25.3.2009 |
Avastin |
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EU/1/04/300/001-002 |
27.3.2009 |
|||||
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25.3.2009 |
Enbrel |
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EU/1/99/126/001-018 |
27.3.2009 |
|||||
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25.3.2009 |
Telzir |
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EU/1/04/282/001-002 |
27.3.2009 |
|||||
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25.3.2009 |
Ariclaim |
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EU/1/04/283/001-012 |
27.3.2009 |
|||||
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25.3.2009 |
Exjade |
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EU/1/06/356/001-009 |
27.3.2009 |
|||||
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25.3.2009 |
Arixtra |
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EU/1/02/206/001-035 |
27.3.2009 |
|||||
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25.3.2009 |
Xenical |
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EU/1/98/071/001-006 |
27.3.2009 |
|||||
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25.3.2009 |
Cymbalta |
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EU/1/04/296/001-009 |
27.3.2009 |
|||||
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25.3.2009 |
Advagraf |
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EU/1/07/387/001-010 |
27.3.2009 |
|||||
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25.3.2009 |
Pradaxa |
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EU/1/08/442/001-008 |
27.3.2009 |
|||||
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25.3.2009 |
Zyprexa |
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EU/1/96/022/002 EU/1/96/022/004 EU/1/96/022/006 EU/1/96/022/008-012 EU/1/96/022/014 EU/1/96/022/016-017 EU/1/96/022/019-034 |
27.3.2009 |
|||||
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25.3.2009 |
ProQuad |
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EU/1/05/323/001-013 |
27.3.2009 |
|||||
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25.3.2009 |
Cetrotide |
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EU/1/99/100/001-003 |
27.3.2009 |
|||||
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25.3.2009 |
Tyverb |
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EU/1/07/440/001-002 |
27.3.2009 |
|||||
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25.3.2009 |
Lysodren |
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EU/1/04/273/001 |
27.3.2009 |
|||||
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25.3.2009 |
Zyprexa Velotab |
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EU/1/99/125/001-016 |
27.3.2009 |
|||||
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25.3.2009 |
Yondelis |
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EU/1/07/417/001-002 |
27.3.2009 |
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25.3.2009 |
Extavia |
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EU/1/08/454/001-002 EU/1/08/454/005 |
27.3.2009 |
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25.3.2009 |
Mabthera |
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EU/1/98/067/001-002 |
27.3.2009 |
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25.3.2009 |
Beromun |
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EU/1/99/097/001 |
27.3.2009 |
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25.3.2009 |
Dukoral |
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EU/1/03/263/001-003 |
30.3.2009 |
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25.3.2009 |
NeuroBloc |
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EU/1/00/166/001-003 |
30.3.2009 |
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25.3.2009 |
Xeristar |
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EU/1/04/297/001-008 |
27.3.2009 |
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27.3.2009 |
Aerinaze |
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EU/1/07/399/001-006 |
1.4.2009 |
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27.3.2009 |
Liprolog |
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EU/1/01/195/001-015 EU/1/01/195/022-025 |
1.4.2009 |
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27.3.2009 |
Karvezide |
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EU/1/98/085/001-034 |
1.4.2009 |
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27.3.2009 |
Irbesartan HCT Winthrop |
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EU/1/06/377/001-028 |
1.4.2009 |
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27.3.2009 |
Litak |
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EU/1/04/275/001-002 |
1.4.2009 |
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27.3.2009 |
Procoralan |
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EU/1/05/316/001-014 |
1.4.2009 |
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27.3.2009 |
Mimpara |
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EU/1/04/292/001-012 |
1.4.2009 |
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27.3.2009 |
TRIZIVIR |
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EU/1/00/156/002-003 |
1.4.2009 |
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27.3.2009 |
Dafiro |
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EU/1/06/371/001-036 |
1.4.2009 |
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27.3.2009 |
Copalia |
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EU/1/06/372/001-036 |
1.4.2009 |
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27.3.2009 |
Imprida |
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EU/1/06/373/001-036 |
1.4.2009 |
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27.3.2009 |
Exforge |
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EU/1/06/370/001-036 |
1.4.2009 |
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27.3.2009 |
Stalevo |
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EU/1/03/260/024-033 |
1.4.2009 |
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30.3.2009 |
Cholestagel |
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EU/1/03/268/001-004 |
1.4.2009 |
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31.3.2009 |
Rapilysin |
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EU/1/96/018/001 |
2.4.2009 |
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31.3.2009 |
Velcade |
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EU/1/04/274/001-002 |
2.4.2009 |
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31.3.2009 |
Aprovel |
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EU/1/97/046/001-039 |
2.4.2009 |
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31.3.2009 |
Karvea |
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EU/1/97/049/001-039 |
2.4.2009 |
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31.3.2009 |
CoAprovel |
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EU/1/98/086/001-034 |
2.4.2009 |
— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)
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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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17.3.2009 |
Dynepo |
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EU/1/02/211/001-005 EU/1/02/211/010-012 |
19.3.2009 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No (2) 726/2004): Accepted
|
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 |
||||
|
17.3.2009 |
BTVPUR Alsap 8 |
Bluetongue virus Serotype 8 Antigen |
|
EU/2/09/094/001-005 |
Suspension for injection |
Q104AA02 Q102AA08 |
19.3.2009 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Accepted
|
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 |
||||
|
6.3.2009 |
Econor |
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EU/2/98/010/004-006 EU/2/98/010/017-018 EU/2/98/010/021-024 |
10.3.2009 |
||||
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12.3.2009 |
Novem |
|
EU/2/04/042/003-004 |
16.3.2009 |
||||
|
18.3.2009 |
Aivlosin |
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EU/2/04/044/001-008 |
20.3.2009 |
||||
|
23.3.2009 |
Equilis Prequenza Te |
|
EU/2/05/057/001-004 |
25.3.2009 |
||||
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23.3.2009 |
Equilis Prequenza |
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EU/2/05/056/001-004 |
25.3.2009 |
||||
|
25.3.2009 |
Quadrisol |
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EU/2/97/005/002-004 EU/2/97/005/006-009 |
27.3.2009 |
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, 30.4.2004, p. 1.
(2) OJ L 136, 30.4.2004, p. 1.
|
1.5.2009 |
EN |
Official Journal of the European Union |
C 101/14 |
Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 March 2009 to 31 March 2009
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2009/C 101/04
— Issuing, maintenance or modification of a national marketing authorisation
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorisation |
Member State concerned |
Date of notification |
||||
|
4.3.2009 |
PhotoBarr |
|
This Decision is addressed to the Member States |
5.3.2009 |
||||
|
6.3.2009 |
Tritazide |
See Annex I |
See Annex I |
10.3.2009 |
||||
|
6.3.2009 |
Tritace |
See Annex II |
See Annex II |
10.3.2009 |
||||
|
6.3.2009 |
UMAN BIG |
See Annex III |
See Annex III |
9.3.2009 |
||||
|
12.3.2009 |
Bleomycin Pharmachemie |
See Annex IV |
See Annex IV |
16.3.2009 |
||||
|
12.3.2009 |
Sanohex |
See Annex V |
See Annex V |
16.3.2009 |
||||
|
12.3.2009 |
Sabumalin |
See Annex VI |
See Annex VI |
16.3.2009 |
||||
|
27.3.2009 |
Zoloft |
See Annex VII |
See Annex VII |
31.3.2009 |
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.
ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing authorisation holder |
(Invented) name |
Strength |
Pharmaceutical form |
Route of administration |
|||||||
|
Austria |
|
Tritazide 25 mg/125 mg Tabletten Tritazide 5 mg/25 mg Tabletten |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Austria |
|
HYPREN PLUS HYPREN PLUS FORTE |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablets |
Oral |
|||||||
|
Belgium |
|
TRITAZIDE 5 mg – 25 mg, tabletten |
5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Bulgaria |
|
TRITACE 2,5 PLUS |
2,5 mg/12,5 mg |
Tablet |
Oral |
|||||||
|
Bulgaria |
|
TRITACE 2,5 PLUS TRITACE 5 PLUS |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Cyprus |
|
TRIATEC PLUS |
5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Czech Republic |
|
TRITAZIDE 2,5/12,5 mg TRITAZIDE 5/25 mg |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Denmark |
|
TRIATEC COMP |
5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Estonia |
|
CARDACE COMP |
2,5 mg/12,5 mg |
Tablet |
Oral |
|||||||
|
Estonia |
|
CARDACE PLUS |
5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Finland |
|
CARDACE COMP |
2,5 mg/12,5 mg |
Tablet |
Oral |
|||||||
|
France |
|
COTRIATEC |
5 mg/12,5 mg |
Tablet |
Oral |
|||||||
|
Germany |
|
Delix 2,5 plus Delix 5 plus |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Germany |
|
Ramilich comp 2,5 mg/12,5 mg Tabletten Ramilich comp 5 mg/25 mg Tabletten |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Germany |
|
RamiWin comp 2,5 mg/12,5 mg Tabletten RamiWin comp 5 mg/25 mg Tabletten |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Germany |
|
Vesdil 2,5 Plus Vesdil 5 Plus |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Greece |
|
TRIATEC PLUS TRIATEC PLUS |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Hungary |
|
TRITACE HCT 2,5/12,5 Tabletta TRITACE HCT 5/25 Tabletta |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Hungary |
|
RAMIPRIL HCT – ZENTIVA 2,5 mg/12,5 mg RAMIPRIL HCT – ZENTIVA 5 mg/25 mg |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Iceland |
— |
|
|
|
|
|||||||
|
Ireland |
|
TRITAZIDE Tablets 2,5 mg/12.5 mg |
2,5 mg/12,5 mg |
Tablet |
Oral |
|||||||
|
Italy |
|
TRIATEC HCT 2,5 TRIATEC HCT 5 |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Italy |
|
RAMIPRIL E IDROCLORITIAZIDE SANOFI-AVENTIS 2,5 mg/12,5 mg RAMIPRIL E IDROCLORITIAZIDE SANOFI-AVENTIS 5 mg/25 mg |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Italy |
|
UNIPRIL DIUR 2,5 mg + 12,5 mg compresse UNIPRILDIUR 5 mg + 25 mg compresse |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Italy |
|
IDROQUARK IDROQUARK |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Latvia |
— |
|
|
|
|
|||||||
|
Lithuania |
— |
|
|
|
|
|||||||
|
Luxembourg |
|
TRITAZIDE |
5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Malta |
— |
|
|
|
|
|||||||
|
Netherlands |
|
TRITAZIDE Tabletten 5 mg/25 mg |
5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Norway |
— |
|
|
|
|
|||||||
|
Poland |
|
TRITACE 2,5 COMB TRITACE 5 COMB |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Portugal |
|
RAMICOR D 2,5 RAMICOR D 5 |
2,5 mg/12.,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Portugal |
|
TRIATEC COMPOSTO TRIATEC COMPOSTO FORTE |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Romania |
|
TRITACE 2,5 PLUS TRITACE 5 PLUS |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Slovak Republic |
|
TRITAZIDE TRITAZIDE |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Slovenia |
|
TRITAZIDE 2,5 5 mg/12,5 mg tablete TRITAZIDE 5 mg/25 mg tablete |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
Spain |
— |
|
|
|
|
|||||||
|
Sweden |
|
TRIATEC COMP MITE TRIATEC COMP |
2,5 mg/12,5 mg 5 mg/25 mg |
Tablet |
Oral |
|||||||
|
United Kingdom |
— |
|
|
|
|
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing Authorisation Holder |
(Invented) name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||||||||
|
Austria |
|
Tritace 1,25 mg — Tabletten Tritace 2,5 mg — Tabletten Tritace 5 mg — Tabletten Tritace 10 mg — Tabletten |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Austria |
|
HYPREN |
1,25 mg 2,5 mg 5 mg |
Capsule |
Oral |
|||||||||||||
|
Austria |
|
HYPREN |
10 mg |
Tablet |
Oral |
|||||||||||||
|
Belgium |
|
Tritace 1,25 mg, comprimés Tritace 2,5 mg, comprimés Tritace 5 mg, comprimés Tritace 10 mg, comprimés |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Belgium |
|
Tazko 5 mg, comprimés à liberation prolongée |
5 mg |
Prolonged-release tablet |
Oral |
|||||||||||||
|
Belgium |
|
Tazko 2,5 mg, comprimés à liberation prolongée |
2,5 mg |
Prolonged-release tablet |
Oral |
|||||||||||||
|
Belgium |
|
Tritace 10 |
10 mg |
Capsule |
Oral |
|||||||||||||
|
Belgium |
|
Ramace 1,25 mg Ramace 2,5 mg Ramace 5 mg |
1,25 mg 2,5 mg 5 mg |
Tablet |
Oral |
|||||||||||||
|
Bulgaria |
|
Tritace 2,5 Tritace 5 Tritace 10 |
2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Cyprus |
|
Triatec |
2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Czech Republic |
|
Tritace 1,25 Tritace 2,5 Tritace 5 Tritace 10 |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Czech Republic |
|
RAMIPRIL WINTHROP |
1,25 mg 2,5 mg 5 mg |
Capsule |
Oral |
|||||||||||||
|
Denmark |
|
Triatec |
1,25 mg 2,5 mg 5 mg |
Tablet |
Oral |
|||||||||||||
|
Denmark |
|
Triatec |
10 mg |
Capsule, hard |
Oral |
|||||||||||||
|
Estonia |
|
Cardace |
5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Estonia |
|
Cardace |
2,5 mg |
Tablet |
Oral |
|||||||||||||
|
Finland |
|
Cardace |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Finland |
|
Cardace |
10 mg |
Capsule |
Oral |
|||||||||||||
|
Finland |
|
Ramipril medgenerics 1,25 mg tabletti Ramipril medgenerics 2,5 mg tabletti Ramipril medgenerics 5 mg tabletti Ramipril medgenerics 10 mg tabletti |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
France |
|
Triatec 1,25 mg comprime Triatec 2,5 mg comprime sécable Triatec 5 mg comprime sécable Triatec 10 mg comprime sécable Triateckit, comprime sécable Ramikit, comprime sécable |
1,25 mg 2,5 mg 5 mg 10 mg 2,5 mg/5 mg/10 mg 2,5 mg/5 mg/10 mg |
Tablet |
Oral |
|||||||||||||
|
France |
|
Triatec faible 1,25 mg, gélule Triatec 2,5 mg, gélule Triatec 5 mg, gélule |
1,25 mg 2,5 mg 5 mg |
Capsule |
Oral |
|||||||||||||
|
France |
|
Ramipril winthrop 1,25 mg Ramipril winthrop 2,5 mg, comprime secable Ramipril winthrop 5 mg, comprime secable Ramipril winthrop 10 mg, comprime secable |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Germany |
|
Delix 2,5 mg Tabletten Delix 5 mg Tabletten Delix protect 10 mg Tabletten Delix HOPE 10 mg Tabletten Delix HOPE startset Delix protect startset |
2,5 mg 5 mg 10 mg 10 mg 2,5 mg/5 mg/10 mg 2,5 mg/5 mg/10 mg |
Tablet |
Oral |
|||||||||||||
|
Germany |
|
Ramipril protect 2,5 mg Tabletten Ramipril protect 5 mg Tabletten Ramipril protect 10 mg Tabletten Ramipril protect startset |
2,5 mg 5 mg 10 mg 2,5 mg/5 mg/10 mg |
Tablet |
Oral |
|||||||||||||
|
Germany |
|
Ramilich 2,5 mg Tabletten Ramilich 5 mg Tabletten Ramilich 10 mg Tabletten Ramilich startset |
2,5 mg 5 mg 10 mg 2,5 mg/5 mg/10 mg |
Tablet |
Oral |
|||||||||||||
|
Germany |
|
RamiWin 2,5 mg Tabletten RamiWin 5 mg Tabletten RamiWin 10 mg Tabletten |
2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Germany |
|
Delix 1,25 mg Tabletten |
1,25 mg |
Tablet |
Oral |
|||||||||||||
|
Germany |
|
Delix 1,25 mg Kapseln Delix P 2,5 mg Kapseln Delix P 5 mg Kapseln Delix P 10 mg Kapseln |
1,25 mg 2,5 mg 5 mg 10 mg |
Capsule, hard |
Oral |
|||||||||||||
|
Germany |
|
Vesdil 1,25 mg Kapseln Vesdil 2,5 mg kapseln Vesdil 5 mg Kapseln |
1,25 mg 2,5 mg 5 mg |
Capsule, hard |
Oral |
|||||||||||||
|
Germany |
|
Vesdil 1,25 mg Tabletten Vesdil 2,5 mg Tabletten Vesdil N 2,5 mg Tabletten Vedil 5 mg Tabletten Vesdil N 5 mg Tabletten Vesdil protect 10 mg Tabletten |
1,25 mg 2,5 mg 2,5 mg 5 mg 5 mg 10 mg |
Tablets |
Oral |
|||||||||||||
|
Greece |
|
Triatec |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Hungary |
|
Tritace mite 1,25 mg tablet Tritace 2,5 mg tablet Tritace 5 mg tablet Tritace 10 mg tablet |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Hungary |
|
Ramipril prevent 1,25 mg tablet Ramipril prevent 2,5 mg tablet Ramipril prevent 5 mg tablet Ramipril prevent 10 mg tablet |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Hungary |
|
Ramipril — Zentiva 1,25 mg Ramipril — Zentiva 2,5 mg Ramipril — Zentiva 5 mg Ramipril — Zentiva 10 mg |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Iceland |
— |
|
|
|
|
|||||||||||||
|
Ireland |
|
Tritace 1,25 mg tablets Tritace 2,5 mg tablets Tritace 5 mg tablets Tritace 10 mg tablets |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Ireland |
|
Tritace 1,25 mg capsules Tritace 2,5 mg capsules Tritace 5 mg capsules Tritace 10 mg capsules |
1,25 mg 2,5 mg 5 mg 10 mg |
Capsule |
Oral |
|||||||||||||
|
Ireland |
|
Loavel 1,25 mg Loavel 2,5 mg Loavel 5 mg Loavel 10 mg |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Ireland |
|
Loavel 1,25 mg capsules Loavel 2,5 mg capsules Loavel 5 mg capsules Loavel 10 mg capsules |
1,25 mg 2,5 mg 5 mg 10 mg |
Capsule |
Oral |
|||||||||||||
|
Ireland |
|
Ramipril 1,25 mg tablets Ramipril 2,5 mg tablets Ramipril 5 mg tablets Ramipril 10 mg tablets |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Ireland |
|
Ramipril 1,25 mg capsules Ramipril 2,5 mg capsules Ramipril 5 mg capsules Ramipril 10 mg capsules |
1,25 mg 2,5 mg 5 mg 10 mg |
Capsule |
Oral |
|||||||||||||
|
Italy |
|
Triatec 1,25 Triatec Triatec 5 Triatec Ramipril sanofi-aventis |
1,25 mg 2,5 mg 5 mg 10 mg 1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Italy |
|
Unipril 1,25 mg compresse Unipril 2,5 mg compresse Unipril 5 mg compresse Unipril 10 mg compresse |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Italy |
|
Quark Quark Quark Quark |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Latvia |
|
Cardace |
2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Lithuania |
|
Cardace |
2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Luxembourg |
|
Tritace 1,25 mg, comprimés Tritace 2,5 mg, comprimés Tritace 5 mg, comprimés Tritace 10 mg, comprimés |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Luxembourg |
|
Tritace |
10 mg |
Capsule |
Oral |
|||||||||||||
|
Luxembourg |
|
Ramace 1,25 mg Ramace 2,5 mg Ramace 5 mg |
1,25 mg 2,5 mg 5 mg |
Tablet |
Oral |
|||||||||||||
|
Malta |
— |
|
|
|
|
|||||||||||||
|
Netherlands |
|
Tritace 1,25 Tritace 2,5 Tritace 5 Tritace 10 |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Netherlands |
|
Tritace 1,25 Tritace 2,5 Tritace 5 Tritace 10 |
1,25 mg 2,5 mg 5 mg 10 mg |
Capsule |
Oral |
|||||||||||||
|
Norway |
|
Triatec |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Norway |
|
Triatec |
10 mg |
Capsule |
Oral |
|||||||||||||
|
Norway |
|
Ramipril winthrop |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Poland |
|
Tritace 2,5 Tritace 5 Tritace 10 |
2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Portugal |
|
Triatec |
2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Portugal |
|
Triatec |
1,25 mg 2,5 mg 5 mg 10 mg |
Capsule |
Oral |
|||||||||||||
|
Romania |
|
Tritace |
2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Romania |
|
Zenra 2,5 Zenra 5 Zenra 10 |
2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Slovak Republic |
|
Tritace |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Slovenia |
|
Tritace 1,25 mg teblete Tritace 2,5 mg tablete Tritace 5 mg tablete Tritace 10 mg tablete Tritace Startset |
1,25 mg 2,5 mg 5 mg 10 mg 2,5 mg/5 mg/10 mg |
Tablet |
Oral |
|||||||||||||
|
Spain |
|
Acovil |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Sweden |
|
Triatec Triatec H.O.P Triatec Start |
1,25 mg 2,5 mg 5 mg 10 mg 2,5 mg/5 mg/10 mg 2,5 mg/5 mg/10 mg |
Tablet |
Oral |
|||||||||||||
|
Sweden |
|
Ramipril winthrop |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
Sweden |
|
Pramace |
1,25 mg 2,5 mg 5 mg 10 mg Start pack (1,25 + 2,5 + 5 mg) |
Tablet |
Oral |
|||||||||||||
|
Sweden |
|
Pramace |
10 mg |
Capsule |
Oral |
|||||||||||||
|
United Kingdom |
|
Tritace 1,25 mg tablets Tritace 2,5 mg tablets Tritace 5 mg Tablets Tritace 10 mg tablets |
1,25 mg 2,5 mg 5 mg 10 mg |
Tablet |
Oral |
|||||||||||||
|
United Kingdom |
Or
|
Tritace 1,25 mg Tritace 2,5 mg Tritace 5 mg Tritace 10 mg |
1,25 mg 2,5 mg 5 mg 10 mg |
Capsule |
Oral |
|||||||||||||
|
United Kingdom |
|
Tritace Titration Pack |
2,5 mg/5 mg/10 mg |
Tablet |
Oral |
|||||||||||||
|
United Kingdom |
|
Tritace titration pack |
2,5 mg 5,0 mg 10 mg |
Capsule |
Oral |
|||||||||||||
|
United Kingdom |
|
Tritace Tablet Titration Pack |
2,5 mg 5,0 mg 10 mg |
Tablet |
Oral |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATE
|
Member State EU/EEA |
Marketing authorisation holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
Content (concentration) |
||||
|
Austria |
|
|
UMAN BIG 180 I.E./ml Injektionslösung |
180 IU/ml |
Solution for injection |
Intramuscular use |
180 IU/ml 540 IU/3 ml |
||||
|
Denmark |
|
|
UMAN BIG |
180 IU/ml |
Solution for injection |
Intramuscular use |
180 IU/ml 540 IU/3 ml |
||||
|
Germany |
|
|
UMAN BIG |
180 IU/ml |
Solution for injection |
Intramuscular use |
180 IU/ml 540 IU/3 ml |
||||
|
Hungary |
|
|
Umanbig 180 NE/ml |
180 IU/ml |
Solution for injection |
Intramuscular use |
180 IU/ml 540 IU/3 ml |
||||
|
Italy |
|
|
UMAN BIG |
180 IU/ml |
Solution for injection |
Intramuscular use |
180 IU/ml 540 IU/3 ml |
||||
|
Poland |
|
|
UMAN BIG |
180 IU/ml |
Solution for injection |
Intramuscular use |
180 IU/ml 540 IU/3 ml |
||||
|
Portugal |
|
|
UMAN BIG |
180 IU/ml |
Solution for injection |
Intramuscular use |
180 IU/ml 540 IU/3 ml |
||||
|
Sweden |
|
|
Umanbig 180 IU/ml solution for injection |
180 IU/ml |
Solution for injection |
Intramuscular use |
180 IU/ml 540 IU/3 ml |
ANNEX IV
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing authorisation holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
Content (concentration) |
||||
|
Austria |
|
|
Bleomycin ‘Pharmachemie’15 000 I.E. - Pulver zur Herstellung einer Injektionslösung |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local injection |
15 U (USP)/vial |
||||
|
Belgium |
|
|
BLEOMYCINE TEVA 15U poeder voor oplossing voor injectie |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Bulgaria |
|
|
Bleomycine Teva 15U, прах за инжекционен разтвор |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Czech Republic |
|
|
Bleomycin-Teva 15U, prášek pro přípravu injekčního roztoku |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Denmark |
|
|
Bleomycin ‘Teva’ |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Estonia |
|
|
Bleomycin Teva |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
France |
|
|
Bleomycine TEVA 15 000 UI, poudre pour solution injectable |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Germany |
|
|
Bleo-TEVA 15 mg Pulver zur Herstellung einer Injektionslösung |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Intravenous administration Intra-pleural injection |
15 U (USP)/vial |
||||
|
Italy |
|
|
Bleomicina TEVA, 15 U polvere per soluzione iniettabile |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Latvia |
|
|
Bleomycin Teva |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Lithuania |
|
|
Bleomycin Teva |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Luxembourg |
|
|
BLEOMYCINE TEVA 15U poudre pour solution injectable |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Netherlands |
|
|
Bleomycine 15 U (USP), poeder voor oplossing voor injectie |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Norway |
|
|
Bleomycin Teva, Pulver og væske til injeksjonsvæske, oppløsning |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Poland |
|
|
Bleomycin Teva |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Portugal |
|
|
Bleomicina Teva |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Slovak Republic |
|
|
Bleomycin-Teva prášok na injekčný roztok |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Slovenia |
|
|
Bleomicin Teva 15 U (USP), prašek za raztopino za injiciranje |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
||||
|
Spain |
|
|
Bleomicina Teva 15 UI polvo para solución inyectable EFG |
15 U (USP)/vial |
powder for solution for injection |
Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration Local/Intratumoral injections |
15 U (USP)/vial |
ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing Authorisation Holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
||||
|
Austria |
|
|
Salbutamol ‘Hexal’ 100 μg/Dosis — Dosieraerosol |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Germany |
|
|
SalbuHEXAL N Dosieraerosol |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Ireland |
|
|
Salbul 100 micrograms Pressurised Inhalation Suspension |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Spain |
|
|
Salbutamol Hexal 100 mcg/dosis suspensión para inhalación en envase a presión EFG |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Sweden |
|
|
Sanohex |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
ANNEX VI
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing authorisation holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
Content (concentration) |
||||
|
Belgium |
|
|
Salbutamol Sandoz 100 μg Aërosol, suspensie |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Denmark |
|
|
Salbutamol Sandoz |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Estonia |
|
|
Salbutamol Sandoz 100 mikrogrammi/annuses |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Finland |
|
|
Salbutamol Sandoz |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Germany |
|
|
Salbutamol Sandoz 100 mikrogramm Dosieraerosol Druckgas-inhalation, Suspension |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Greece |
|
|
Salbutamol/Sandoz |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Hungary |
|
|
Salbutamol Sandoz 100 μg túlnyomásos inhalációs szuszpenzió |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Italy |
|
|
Salbutamolo Sandoz |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Latvia |
|
|
Salbutamol Sandoz |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Lithuania |
|
|
Salbutamol Sandoz |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Netherlands |
|
|
Salbutamol Sandoz aërosol 100 μg/dosis, aërosol, suspensie 100 microgram per dosis |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Norway |
|
|
Salbutamol Sandoz |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Poland |
|
|
SalbuLEK |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Portugal |
|
|
Salbutamol Sandoz |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Slovenia |
|
|
Salbutamol Lek 100 mikrogramov inhalacijska suspenzija pod tlakom |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Spain |
|
|
Salbutamol Sandoz 100 mcg/dosis suspensión para inhalación en envase a presción EFG |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
Sweden |
|
|
Sabumalin |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
||||
|
United Kingdom |
|
|
Salbutamol 100 microgram per actuation pressurised inhalation, suspension |
100 μg/dose |
Pressurised inhalation, suspension |
Inhalation use |
|
ANNEX VII
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing Authorisation Holder |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (Concentration) |
||||||
|
Austria |
|
Tresleen 50 mg - Filmtabletten |
50 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Belgium |
|
Serlain |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Belgium |
|
Serlain |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Bulgaria |
|
Zoloft |
50 mg |
Film-coated tablets |
Oral use |
50 mg |
||||||
|
Cyprus |
|
Zoloft |
50 mg 100 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Czech Republic |
|
Zoloft 50 mg Zoloft 100 mg |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Denmark |
|
Zoloft |
25 mg 50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Denmark |
|
Zoloft |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Estonia |
|
Zoloft |
50 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Finland |
|
Zoloft |
50 mg 100 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Finland |
|
Zoloft |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
France |
|
Zoloft |
25 mg 50 mg 100 mg |
Capsules, hard |
Oral use |
|
||||||
|
France |
|
Zoloft |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
France |
|
Sertraline Pfizer |
25 mg 50 mg |
Capsules, hard |
Oral use |
|
||||||
|
France |
|
Sertraline Beral |
100 mg |
Capsules, hard |
Oral use |
|
||||||
|
France |
|
Sertraline Beral |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Germany |
|
Zoloft 50 mg Zoloft 100 mg |
50 mg 100 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Germany |
|
Zoloft Lösungskonzentrat |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Greece |
|
Zoloft |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Hungary |
|
Zoloft 50 mg film tabletta |
50 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Hungary |
|
Zoloft 20 mg/ml oldat |
20 mg/ml |
Concentrate for oral Solution |
Oral use |
20 mg/ml |
||||||
|
Iceland |
|
Zoloft |
25 mg 50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Iceland |
|
Zoloft |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Ireland |
|
Lustral |
50 mg 100 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Italy |
|
Zoloft |
25 mg 50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Italy |
|
Zoloft |
50 mg |
Capsules, hard |
Oral use |
|
||||||
|
Italy |
|
Zoloft |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Italy |
|
Tatig |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Italy |
|
Tatig |
50 mg |
Capsules, hard |
Oral use |
|
||||||
|
Italy |
|
Tatig |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Latvia |
|
Zoloft |
50 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Lithuania |
|
Zoloft |
50 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Luxembourg |
|
Serlain |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Luxembourg |
|
Serlain |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Malta |
|
Lustral |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Netherlands |
|
Zoloft 50 |
50 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Netherlands |
|
Zoloft 20 mg/ml |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Norway |
|
Zoloft |
25 mg 50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Norway |
|
Zoloft |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Poland |
|
Zoloft |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Poland |
|
Zoloft |
20 mg/ml |
Concentrate for Oral solution |
Oral use |
20 mg/ml |
||||||
|
Portugal |
|
Zoloft |
50 mg 100 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Portugal |
|
Zoloft |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Romania |
|
Zoloft 50 mg Zoloft 100 mg |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Romania |
|
Zoloft |
20 mg/ml |
Concentrate for Oral solution |
Oral use |
20 mg/ml |
||||||
|
Slovak Republic |
|
Zoloft |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Slovak Republic |
|
Zoloft OC |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Slovenia |
|
Zoloft |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
||||||
|
Slovenia |
|
Zoloft |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Spain |
|
Besitran |
50 mg 100 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Spain |
|
Besitran |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
Spain |
|
Sertralina Pfizer |
50 mg 100 mg |
Film-coated tablet |
Oral use |
|
||||||
|
Sweden |
|
Zoloft |
25 mg 50 mg 100 mg 25 + 50 mg (initiation pack) |
Film-coated tablets |
Oral use |
|
||||||
|
Sweden |
|
Zoloft |
20 mg/ml |
Concentrate for oral solution |
Oral use |
20 mg/ml |
||||||
|
United Kingdom |
|
Lustral |
50 mg 100 mg |
Film-coated tablets |
Oral use |
|
|
1.5.2009 |
EN |
Official Journal of the European Union |
C 101/43 |
Opinion of the Advisory Committee on mergers given at its meeting of 16 November 2007 regarding a draft decision relating to Case COMP/M.4647 — AEE/Lentjes
Rapporteur: Latvia
2009/C 101/05
|
1. |
The members of the Advisory Committee agree with the Commission that the notified operation constitutes a concentration within the meaning of the Merger Regulation (EEC) No 1394/2004. |
|
2. |
The members of the Advisory Committee agree with the Commission that although the notified operation The members of the not have a community dimension within the meaning of article 1 of the Merger Regulation, it is capable of being reviewed under the national competition law in Austria, Germany, Ireland and the United Kingdom. Therefore, it can be examined by the Commission pursuant to Article 4 (5) of the Merger Regulation. |
|
3. |
The members of the Advisory Committee agree with the Commission's definition of the relevant product markets of:
|
|
4. |
The members of the Advisory Committee agree with the Commission that all the above mentioned relevant product markets are EEA-wide in scope. |
|
5. |
The members of the Advisory Committee agree with the Commission that the proposed concentration The members of the not lead to horizontal competition concerns in the market for the supply of municipal waste incineration plants based on grate firing with a capacity of more than 4,5 t/h, as a result of which effective competition would be significantly impeded in the Common Market or in a substantial part of it. |
|
6. |
The members of the Advisory Committee agree with the Commission that the proposed concentration The members of the not lead to horizontal competition concerns in the market for the supply of thermal treatment plants based on fluidized bed technology with a capacity of less than 200 MWel, as a result of which effective competition would be significantly impeded in the Common Market or in a substantial part of it. |
|
7. |
The members of the Advisory Committee agree with the Commission that the proposed concentration The members of the not lead to vertical competition concerns in respect of the relationship between the upstream market for flue gas desulphurisation plants and the downstream market for thermal treatment plants based on fluidized bed technology with a capacity of less than 200 MWel, as a result of which effective competition would be significantly impeded in the Common Market or in a substantial part of it. |
|
8. |
The members of the Advisory Committee agree with the Commission that the proposed concentration should be declared compatible with the Common Market and with the EEA Agreement. |
|
9. |
The members of the Advisory Committee recommend the publication of its opinion in the Official Journal of the European Union. |
|
1.5.2009 |
EN |
Official Journal of the European Union |
C 101/44 |
Summary of Commission Decision
of 5 December 2007
declaring a concentration compatible with the common market and the functioning of the EEA Agreement
(Case COMP/M.4647 — AEE/Lentjes)
(Only the German version of the Decision is authentic)
2009/C 101/06
On 5 December 2007 the Commission adopted a Decision in a merger case under Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings (1), and in particular Article 8(1) of that Regulation. A non-confidential version of the full Decision can be found in the authentic language of the case and in the working languages of the Commission on the website of the Directorate-General for Competition, at the following address: http://ec.europa.eu/comm/competition/index_en.html
This summary only constitutes a simplified outline of the main aspects of the decision; it has no legal force and serves for information purposes only.
I. INTRODUCTION
|
1. |
On 29 June 2007 the Commission received notification, pursuant to Article 4(5), read in conjunction with Article 4(1) and (2), of Council Regulation (EC) No 139/2004 (‘the Merger Regulation’) of a proposed concentration by which Austrian Energy & Environment AG & Co KG (‘AEE’, Austria), which forms part of the Austrian A-Tec group (‘A-Tec’), acquires, within the meaning of Article 3(1)(b) of the Merger Regulation, sole control of Lentjes GmbH (‘Lentjes’, Germany, referred to jointly with AEE as ‘the parties’) by way of purchase of shares from the previous shareholder, the GEA group, an international technology group (engineering and chemicals). |
|
2. |
AEE, a subsidiary of the Austrian A-Tec group (‘A-Tec’), is active in the field of energy and environmental technology. Its product portfolio includes combustion systems based on grate and fluidised bed technology, grate-fired boilers for waste, biomass and coal combustion, flue gas cleaning and flue gas desulphurisation, as well as boilers. Within this product portfolio AEE offers development, production and assembly of components and plants. In addition, its parent company A-Tec is active in the fields of drive engineering, metals and mechanical engineering. |
|
3. |
Lentjes is also active in the supply of energy and environmental technology. It supplies complete waste-to-energy plants or lots for such plants (consisting at least of a combustion system), providing in particular the necessary process and basic engineering, but Lentjes does not manufacture the components for plants itself. Lentjes is currently controlled by the German GEA Group. |
|
4. |
The intended transaction concerns the acquisition by A-Tec through its wholly owned subsidiary AEE of sole control over Lentjes by way of purchase of shares from the seller GEA Group. |
|
5. |
Given the multiple filing requirements in at least three Member States and the cross-border nature of the transaction, the case was referred to the Commission under Article 4(5) of the EC Merger Regulation for the purpose of its competitive assessment. No Member State opposed to the referral (2). |
|
6. |
Having examined the notification, the Commission found that the notified proposal fell within the scope of the Merger Regulation. On 3 August 2007 it decided in accordance with Article 6(1)(c) of the Merger Regulation to initiate proceedings in this case and open a phase II investigation. |
II. RELEVANT MARKETS
A. THE RELEVANT PRODUCT MARKETS
|
7. |
The parties’ activities overlap in the supply of combustion systems and related technologies for municipal waste incineration plants and thermal treatment plants based on fluidised bed technology. Moreover, both parties also supply flue gas desulphurisation systems. |
|
8. |
In these areas, the parties are active as (a) suppliers of complete plants or lines (general contractor assuming responsibility for the functioning of the complete plant), and as (b) suppliers of lots for such plants, i.e. as suppliers of the combustion system and/or flue gas desulphurisation system (assuming responsibility for the functioning of this particular lot). |
1. Thermal treatment plants based on grate technology
Municipal waste incineration plants based on grate firing with a throughput of more than 4,5 t/h
|
9. |
In its previous decisions, the Commission has defined a relevant product market as market for municipal waste incineration plants (3). The parties argue that this product market definition was based on the fact that at the time there were no other waste incineration plants than those which treated municipal waste, whereas today the market should be considered as being wider, including all kinds of waste-to-energy plants based on grate firing. |
|
10. |
The market investigation confirmed that municipal waste incineration plants based on grate firing should be considered as a distinct product market. Moreover, it confirmed the distinction between very small plants with a throughput capacity of less than 4,5 t/h and such plants with higher throughput. |
Complete lines and lots
|
11. |
The initial market investigation revealed a need to draw a distinction between markets for the supply of complete plants/lines on a ‘turnkey’ basis and between the supplies of lots. The Phase II investigation brought clarification on the interaction between the two segments, in a sense that the supply of lots puts a significant competitive constraint on the suppliers of complete plants/lines, as will be elaborated further in the competitive assessment. It is, however, not necessary to draw a definitive conclusion on whether the supply of lots and complete plants/lines form separate markets. |
Upstream markets: detail engineering of municipal waste incineration plants and manufacturing of boiler components
|
12. |
A-Tec is also active in detail engineering and production of pressure parts for boilers and valves, activities which are upstream to the horizontally affected market for the supply of municipal waste incineration plants based on grate firing with a throughput of more than 4,5 t/h. The market investigation has broadly confirmed that these activities each constitute separate relevant product markets. Given that there are no competition concerns regarding this vertical relationship, the question of a further segmentation of these markets can ultimately be left open in the present case. |
2. Thermal treatment plants based on fluidised bed technology with a capacity below 200 MWel
|
13. |
The parties submit that combustion systems based on fluidised bed technology with a capacity below 200 MWel should be considered as a separate relevant product market. |
|
14. |
Lentjes supplies a special type of fluidised bed technology called ROWITEC, which is a combustion system modified and adapted to be used for the incineration of municipal waste and other residual material. The parties submit that it competes with grate-fired combustion systems for waste incineration plants. This was not confirmed by the market investigation results. It appears that ROWITEC systems belong to combustion systems based on fluidised bed technology and should not be included in the market for combustion systems based on grate technology. |
|
15. |
The market investigation also indicated that the market could be segmented into fluidised bed plants based on different technologies, which serve different purposes, i.e. bubbling (stationary) fluidised bed, circulating fluidised bed and the ROWITEC technology mentioned above. However, given that there are no competition concerns even on the basis of a narrower product market definition (due to the absence of any overlaps between the parties’ activities in ROWITEC and circulating fluidised bed, and only negligible overlaps regarding bubbling fluidised bed plants), the exact scope of the product market can ultimately be left open. |
|
16. |
The relevant product market is thus for the purposes of the present case defined as market for thermal treatment plants based on fluidised bed technology with a capacity below 200 MWel. |
3. Flue gas desulphurisation systems
|
17. |
In previous cases the Commission had defined an overall market for desulphurisation systems (4). The market investigation in Phase I of the present proceeding had — at a very late stage — revealed indications that the market for flue gas desulphurisation (mainly used for plants based on fluidised bed technology, in which coal is used as part of the fuel) should be further segmented according to three different methods, i.e. wet, semi-dry and dry flue gas desulphurisation. These indications have been broadly confirmed by the in-depth investigation in Phase II. |
|
18. |
Competition concerns had been voiced by two competitors of the parties on the downstream market for fluidised bed plants with regard to a specific semi-dry desulphurisation method, the so-called circulating dry scrubber (‘CDS’). The competitors claimed that systems based on this method could only be supplied by Lentjes and one other competitor, Alstom. They also claimed that these systems were a necessary input for their activities on the market for fluidised bed plants, since they had to offer these systems as part of an overall package for a complete plant or line with regard to certain types of multi-fuel plants. They were concerned that after the merger it would be more difficult for them to obtain these systems (or obtain them at a reasonable price), since Lentjes would then be vertically integrated with AEE, one of their main competitors on the downstream market. |
|
19. |
The in-depth market investigation in Phase 2 revealed that all semi-dry methods lead to comparable results. Respondents stated that even some technologies, which are commonly attributed to the area of dry methods (spray absorber technologies), can be alternatives for certain types of plants, in particular multi-fuel plants (5). It ultimately depends on the sulphur content in the fuels that a customer will burn, as well as on environmental norms (notably the emission standards, which can sometimes be stricter than the relevant EU standards (6), depending on the location of the plant), whether a customer chooses one or the other method. |
|
20. |
Niche applications exist within the broad categorisation mentioned above (wet, semi-dry and dry methods), such as Lentjes’ CDS, which appears to be very performing but expensive, and it is protected by intellectual property rights. |
|
21. |
Based on the above, it appears that within the product market for flue gas cleaning a general distinction between wet, semi-dry and dry technologies leads to a segmentation of the overall market, with potential niche segments for very specific applications. All major suppliers offer flue gas cleaning systems falling into these three categories, and since there are no competition concerns under any alternative product market definition, as will be outlined below, the market definition can ultimately be left open. |
B. THE RELEVANT GEOGRAPHIC MARKETS
|
22. |
The geographic scope of the affected market can be considered to be EEA-wide. The main players are active EEA-wide and no barriers to entry into different national areas have been identified. At the same time, however, the market investigation indicated that the market must be defined as being (as yet) no wider than the EEA, since competitors from outside the EEA take part in tenders in the EEA only very rarely unless they have European subsidiaries. |
III. COMPETITIVE ASSESSMENT
A. HORIZONTAL EFFECTS
1. Thermal treatment plants for municipal waste based on grate technology
Market shares
|
23. |
The Commission carried out an in-depth bidding analysis which also provided data to reconstruct the market. The information gathered in this investigation concerns (almost) all projects awarded in this area during 2002-2006 in the EEA. On this basis the market share figures for the parties for 107 projects, representing an almost complete coverage of the relevant market, are as follows: Table 1 Market share distribution for municipal waste incineration plants 2002-2006 — overall market, complete plants and plant parts
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24. |
If one were to distinguish separate segments for complete lines on the one hand and part plants (lots) on the other hand, the parties would be the clear market leader for complete lines/plants, followed by Martin/CNIM and KAB Takuma. For lots, the merger would lead to the number one, closely followed by several other players of roughly similar size (Fisia, Martin/CNIM and Volund). |
Bidding analysis
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25. |
The bidding analysis conducted by the Commission revealed that out of the total of 107 tenders, AEE and Lentjes were direct competitors in [10-15] bids. |
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26. |
First, it can be observed that when both AEE and Lentjes were bidding, they usually faced Martin/CNIM, Fisia, and KAB Takuma on a regular basis in these tenders. Comparing the participation rates for the [10-15] tenders with those for all projects shows that Fisia, Martin/CNIM as well as KAB Takuma participated more often in tenders in which AEE and Lentjes were present. This shows that in general the tenders in which both parties participate attract more alternative bidders than is usually the case in the industry. |
|
27. |
The Commission also analysed the success rates of the main competitors and made a comparison of the overall success rate in all projects during 2002-2006 and the success rate in tenders where AEE and Lentjes were both participating. Lentjes’ success rate in the tenders where AEE participated was significantly lower than its rate in all tenders. This observation also holds for complete lines. This seems to indicate that Lentjes did not reduce AEE’s success in tenders; quite to the contrary AEE’s presence is correlated with a bad performance on behalf of Lentjes. |
|
28. |
Furthermore, nor does an analysis of the second-placed competitor in the tenders that were won by AEE point to the elimination of a significant competitive factor. The customers were asked to inform the Commission about details of their tenders to assess who was the ‘runner-up’ to the winner in the projects where both parties participated and the award went to AEE. For these projects, Fisia seems to be almost as close as Lentjes. |
|
29. |
Although the in-depth bidding analysis provided more information, it was not possible to identify any specific features of those tenders in which the different players participated. Even though every company seems to have its own special strengths and own technologies, the overall picture is that all of the established players are able to execute large projects for complete plants/lines and that there is no particular technological advantage in the hands of the parties or other suppliers. There is no particular cluster of projects where the parties would have a particular advantage and where the remaining competitors would not be able to win a project or at least to exercise a significant competitive constraint on the merged entity. |
|
30. |
The Phase II investigation also clarified, that there are often more competitors in the pre-qualification phase than the bidders that actually submit an offer. Competitors participating in the market investigation explained that they themselves consider whether or not to submit the final offer in view of the attractiveness of the project and of the client (in terms of feasibility of the project, commercial conditions and guarantees required, relationships with client etc.) and notably in view of the anticipated chance to win the contract among the other competitors. Therefore, the relatively low average number of bidders participating in the final round thus does not accurately reflect the competitive constraints exercised by other bidders which could potentially bid and which often participated in earlier rounds of the tenders. |
Ranking of the suppliers
|
31. |
In addition to the bidding analysis, customers were asked during the in-depth market investigation to rank competitors relative to Lentjes according to several criteria which are essential for success in the industry: financial strength, reference projects, grate technologies, engineering know-how and project management know-how. |
|
32. |
The replies of customers who answered based on their experience with Lentjes revealed that AEE, Martin/CNIM, Fisia and Volund are viewed as stronger players than Lentjes in the market. Overall the replies indicate that AEE's close competitor is not Lentjes, but rather Martin/CNIM and Fisia. The same ranking was sent to planning and engineering firms or consultants. Their evaluation of the different suppliers in the area of municipal waste incineration mirror to a large extent the one of customers. They perceive AEE, Martin/CNIM and Fisia as the leading suppliers in the market followed by Lentjes. |
|
33. |
Customers further consider Volund stronger and Baumgarte as comparable to Lentjes (although Volund and Baumgarte tend to specialise on lots), followed by KAB Takuma. The general picture is confirmed that the main players for complete lines/plants are AEE, Martin/CNIM, Lentjes, Fisia and recently KAB Takuma, while other suppliers play only a minor role. In lots Baumgarte, Volund and ThyssenKrupp Xervon Energy are credible suppliers as well. |
Competitive constraints on complete plant suppliers from lots
|
34. |
The Phase II investigation also revealed that many customers, although they have a preference for a turnkey provider, can alternatively switch to a lot solution complemented by an engineering company or in-house resources for the turnkey function. The role played by engineering firms, which were not covered by the initial market investigation, appears to be crucial. Engineering companies allow customers to acquire knowledge about the market, structure the tender and evaluate bids and they compensate the lack of in-house engineering capacities of the one-off clients (such as municipalities). In addition, they provide the interlinking engineering services and thereby allow customers to choose between a complete line from a turnkey provider or a lot solution. |
|
35. |
On the basis of these replies and the information gathered from the engineering firms, it appears that unbundling a project into lots appears to be a credible alternative to a general contract for a complete line. Therefore, the threat coming from the suppliers of lots is a constraining force for the suppliers of complete plants. |
New entrants and alternative ‘turnkey’ suppliers
|
36. |
Because of the need of reference projects, financial strength and turn-key responsibility, new entry faces high barriers and can only be expected from companies that have strengths in one of the three mentioned aspects. This has been confirmed during the second phase market investigation which revealed potential credible entry coming from: companies with existing technology, financial strength and reference projects currently active outside the EEA; companies active within the EEA but focused on a particular region or a segment and finally companies with turn-key responsibility active in neighbouring product markets. |
Recent market entry
|
37. |
In the first phase investigation only KAB Takuma was mentioned by respondents as a new entrant in the market for waste incineration plants. However, despite its strong financial backing and credible technology, which already won it three contracts for complete plants/lines in Europe, its position did not seem to be as well-established as the position of the other main suppliers due to the lack of European reference projects. The in-depth investigation revealed that KAB Takuma is, nevertheless, considered as new credible player by specialised engineering consultants, and this is also expected to change customers’ perceptions. It can also be noted that with one exception all engineering companies, when asked how many credible suppliers were available for turnkey plants, mentioned at least four credible suppliers: AEE/Lentjes, Martin/CNIM, Fisia and KAB Takuma. |
|
38. |
The Phase II investigation also showed that other entrants in addition to KAB Takuma must be considered. The former Belgian company Seghers has — after the acquisition by the Singapore based company Keppel — re-entered the European market and has won some projects during the last two years. In addition, Seghers is currently competing for a turn-key project with established players. |
Potential new entrants
|
39. |
Regional European players can also be seen as potential entrants into the supply of complete plants/lines. The traditional suppliers of lots can also be seen as potential entrants into the supply of complete lines. It is not uncommon to see these suppliers teaming-up with other companies to form consortia and to bid for complete plant/line. |
|
40. |
Next, some alternative possibilities for turnkey supplies of complete plants from companies not having waste incineration technology as their core competence was also identified during the market investigation. One customer reported an ongoing tender where a turnkey provider with experience in construction in the oil business, but without any own technology in the area of municipal waste incineration organised a consortium to be at least runner-up. In the UK, a pure turnkey supplier without own technology has already won a turnkey project and participated in more tenders for complete plants, outsourcing the key technological parts of the project. |
Lentjes future market position
|
41. |
Germany has traditionally been the strongest market for Lentjes and for AEE and the historical market shares of the parties reflect their success in this key market. The market investigation, however, has revealed that since Germany started already during the 90s to restrict the landfill of waste, the relative importance of the waste-to energy market in Germany will be reduced as other parts of the EEA have only started in recent years following the EU Landfill Directive. Market growth is expected in Southern and in Eastern Europe, where similar legislation as in Germany has not yet entered in force. Indeed, the proportion of ongoing (not yet awarded) tenders in Germany compared to the overall EEA market is noticeably smaller than the German proportion within projects awarded in the past 5 years. This market development thus seems to weaken the relative position of the parties, which have traditionally been strong in Germany, on the EEA market in the future. |
|
42. |
Another aspect that plays a role in assessing the accuracy of previous market performance as a prediction of future market strength is the weakened financial position of Lentjes. Financial strength is considered as one of the key attributes necessary for a supplier of a waste incineration solution to be considered by customers, notably because of high guarantees required for the projects. Lentjes’ waste-to-energy business has been loss-making in the past years. GEA, the parent company of Lentjes, has tried without success to restructure the company and finally decided to sell Lentjes. Some customers have also perceived Lentjes as a company with less presence in the market recently and indeed no contracts have been awarded to it in 2006 and 2007. Lentjes thus seems not to be able to assert strong competitive pressure on the other suppliers in the future absent the merger. |
Conclusion on waste incineration plants
|
43. |
The indirect competitive pressure from suppliers of lots on the turn-key segment has been confirmed. Additional information about the bidding process shows that it is difficult to conclude that the parties are close competitors. Neither have the perceptions of market players with regard to the suppliers indicated that they view the parties as close competitors. Moreover, the potential for alternative suppliers is clearly broader than the first phase investigation indicated, and the historic market positions are not necessarily accurate indicators of future market strength in view of the changing framework conditions. |
2. Thermal treatment plants based on fluidised bed technology with a capacity below 200 MWel
|
44. |
On this market the merged entity would have an EEA-wide market share of approximately [25-35] % (AEE [20-30] %, Lentjes [5-10] %). Their main competitors are Foster Wheeler (approximately [30-40] %) and Metso/Kvaerner (approximately [30-40] %). Further competitors, each with an approximately [<5] % market share, mainly fluidised-bed-technology-based biomass heating plants. |
|
45. |
The in-depth Phase II market investigation, during which it was examined in particular whether and if so to what extent this market might be divided into further submarkets or segments, did not produce any evidence of anticompetitive horizontal effects due to the planned merger. |
B. VERTICAL EFFECTS
|
46. |
Competition concerns had been raised regarding Lentjes’ CDS technology for flue gas desulphurisation. Two competitors of AEE on the downstream market for fluidised bed plants were concerned that their — as they claim — only supplier of this technology with regard to multi-fuel plants based on circulating fluidised bed technology would not supply them any more after the merger, due to the fact that AEE is a strong competitor of them on the downstream market. |
1. Competitive situation on the upstream market for flue gas desulphurisation systems
|
47. |
On an overall market for flue gas desulphurisation systems, the combined market shares of the parties would be approximately [25-45] % (AEE: [15-25] %, Lentjes: [15-25] %), while their strongest competitors had market shares of approximately [20-30] % (Alstom), [15-25] % (Fisia), [10-20] % (Hitachi Power) and [5-10] % (Mitsubishi). Further competitors in this area include Wulff, LAB (CNIM group) and FLSmidth. |
2. No ability to foreclose downstream competitors
|
48. |
The complainants had raised concerns with regard to medium-sized multi-fuel plants. More precisely, the concerns regard such plants in a range between 30 and 50 MWel (7). |
Alternative desulphurisation methods
|
49. |
The overall majority of respondents in the market investigation confirmed that the type of flue gas desulphurisation system to be used in such a plant depends on the type of fuel (mix) that is burned and the emission standards. The majority of these respondents named other semi-dry or dry solutions as being comparable to the Lentjes and Alstom technology, namely those offered by AEE (Turbosorp), Wulff (Graf-Wulff-technology), LAB and Fisia Babcock. |
|
50. |
The in-depth investigation revealed that the Graf-Wulff technology appear to be almost identical with the technology offered by Lentjes. The Commission also contacted the customers in three ongoing projects mentioned by one of the complainants as crucial projects in this area. One of these customers stated that for its two projects there are alternative cleaning solutions (based on dry technology). The other customer confirmed that this type of fluidised cleaning method would be their preferred solution, but that they have alternative bids from other suppliers and are therefore not concerned about any anti-competitive effects of the intended transaction. |
Separate tenders for flue gas desulphurisation
|
51. |
Moreover, customers explained that they are now considering parallel tenders — one for the firing unit (i.e. the fluidised bed boiler), with an option to supply also the flue gas desulphurisation part, and one separate tender for the flue gas desulphurisation system, in order to get the best solution both in terms of technology as well as in terms of costs. Consequently, the merged entity could participate in submitting a bid for the complete boiler island, i.e. boiler and flue gas desulphurisation system, as well as a separate bid just for the desulphurisation system. As a consequence, the Lentjes technology would still be available for end-customers, which could combine it with a boiler from AEE's competitors, if necessary. |
Sufficient number of other vertically integrated competitors
|
52. |
Furthermore, even in cases where such plants are only tendered on the basis of bids for the complete plant (or at least the boiler island), the downstream market is a bidding market and customers have stated that there are other integrated suppliers which could participate in such bids. Therefore, the merged entity would still face competition from other integrated suppliers, such as Mitsubishi or SES TLMACE. The end-customer would thus still have the choice between a number of suppliers which could submit bids for such plants. |
Conclusion vertical effects
|
53. |
The merged entity does not have the ability to foreclose its downstream competitors. The merger accordingly gives rise to no competition concerns in respect of the relationship between the upstream market for flue gas desulphurisation plants and the downstream market for fluidised bed plants below 200 MWel. |
IV. CONCLUSION
|
54. |
The proposed concentration would not significantly impede effective competition in the common market or in a substantial part of it. Under Article 2(2) and Article 8(1) of the Merger Regulation, therefore, the transaction should be declared compatible with the common market and the functioning of the EEA Agreement. |
(2) The transaction would have been notifiable in the following Member States: Austria, Germany, Ireland and UK.
(3) See Case COMP/M.1552, Babcock Borsig/AE Energietechnik, decision of 30 June 1999, and Case COMP/M.1594, Preussag/Babcock Borsig, decision of 17 August 1999.
(4) See Case COMP/M.1552, Babcock Borsig/AE Energietechnik, decision of 30 June 1999, and Case COMP/M.1594, Preussag/Babcock Borsig, decision of 17 August 1999.
(5) The brands/methods that were mentioned as being comparable include Lentjes (CDS), Alstom (NID), AEE (Turbosorp), Wulff (Graf-Wulff-technology), LAB and Fisia Babcock; for more details see competitive assessment below.
(6) Directive 2000/76/EC on the incineration of waste and Directive 2001/80/EC on the large combustion plants.
(7) One of the complainants was mostly concerned regarding multi-fuel-plants in the range of above 100 MWel. However, the majority of respondents in the market investigation stated that for this segment the semi-dry methods could be substituted by wet desulphurisation methods.
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1.5.2009 |
EN |
Official Journal of the European Union |
C 101/54 |
Final report of the Hearing Officer in Case COMP/M.4647 — AEE/Lentjes
(Pursuant to Articles 15 and 16 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)
2009/C 101/07
On 29 June 2007, Austrian Energy & Environment AG (‘AEE’) sent a notification to the Commission of the intended acquisition of control over Lentjes GmbH (‘Lentjes’), following a referral under Article 4(5) of the Merger Regulation.
Upon examination of the notification, the Commission concluded that the notified operation raised serious doubts as to the compatibility of the notified acquisition with the common market with regard to the market for municipal waste incineration plants. On 3 August 2007, the Commission opened an in-depth investigation into this proposed merger of two suppliers of waste-to-energy plants.
Access to key documents was provided to the notifying party on 7 August 2007, in accordance with paragraph 45 of Competition DG's Best Practices on the conduct of EC merger control proceedings.
On the basis of the additional evidence gathered during the phase II investigation, the Commission services concluded that the proposed transaction would not significantly impede effective competition in the common market or a substantial part thereof and is therefore compatible with the common market and the EEA Agreement. Accordingly, no Statement of Objections was sent to the notifying party.
The Parties did not refer to me any concerns in terms of due process.
In the light of the above, I consider that the rights to be heard of all participants to the present proceeding have been respected.
Brussels, 29 November 2007.
Karen WILLIAMS
V Announcements
ADMINISTRATIVE PROCEDURES
Commission
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1.5.2009 |
EN |
Official Journal of the European Union |
C 101/55 |
SPECIFIC CALL FOR PROPOSALS — EAC/24/09
Erasmus University Charter
Lifelong Learning Programme
2009/C 101/08
1. OBJECTIVES AND DESCRIPTION
The Erasmus University Charter provides the general framework for the European cooperation activities a higher education institution (HEI) may carry out within the Erasmus programme as part of the Lifelong Learning Programme (LLP). The Erasmus University Charter must be awarded as a prerequisite for HEI to organise student mobility and teaching and other staff mobility, to carry out Erasmus intensive language courses and intensive programmes, and to apply for multilateral projects, networks, accompanying measures and to organise preparatory visits. Erasmus University Charter is based on the LLP Decision (1) which covers the 2007 to 2013 period. The specific objectives of the LLP are listed in Article 1.3 of the Decision.
2. ELIGIBLE APPLICANTS
The Erasmus University Charter applies to all Higher Education Institutions listed in Article 2.10 of the Decision.
Applicants must be established in one of the following countries:
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the 27 Member States of the European Union (as of 1 January 2007), |
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the EFTA-EEA countries: Iceland, Liechtenstein, Norway, |
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candidate countries: Turkey, Croatia, former Yugoslav Republic of Macedonia. |
3. DEADLINE FOR THE SUBMISSION OF APPLICATIONS
The deadline for submitting applications for the Erasmus University Charter is 30 June 2009.
4. FULL DETAILS
The information about the Erasmus programme — Erasmus University Charter can be found in the full text of the ‘LLP General Call for proposals 2008-2010’ and the ‘LLP Programme Guide’ (2) which can be found at the following Internet address:
http://ec.europa.eu/llp
Applications must be submitted on the forms provided by the Education, Audiovisual and Culture Executive Agency and available at the address:
http://eacea.ec.europa.eu/llp/index_en.htm
(1) Decision No 1720/2006/EC of the European Parliament and of the Council of 15 November 2006 establishing an action programme in the field of lifelong learning. See http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:327:0045:0068:EN:PDF
(2) The deadline for submitting applications for the Erasmus University Charter is 30 June 2009.
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1.5.2009 |
EN |
Official Journal of the European Union |
C 101/s3 |
NOTICE
On 1 May 2009, in Official Journal of the European Union C 101 A, the ‘Common catalogue of varieties of vegetable species — Third supplement to the 27th complete edition’ and the ‘Common catalogue of varieties of agricultural plant species — Fourth supplement to the 27th complete edition’ will be published.
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