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ISSN 1725-2423 |
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Official Journal of the European Union |
C 18 |
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English edition |
Information and Notices |
Volume 50 |
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Notice No |
Contents |
page |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
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Commission |
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2007/C 018/01 |
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2007/C 018/02 |
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2007/C 018/03 |
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V Announcements |
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PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL AND COMPETITION POLICY |
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Commission |
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2007/C 018/04 |
Prior notification of a concentration (Case COMP/M.4558 — Alpha Private Equity Funds/Non Ferrous International Group) — Candidate case for simplified procedure ( 1 ) |
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2007/C 018/05 |
Prior notification of a concentration (Case COMP/M.4460 — ABN AMRO/Carlson/T.G.I. Friday's) — Candidate case for simplified procedure ( 1 ) |
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(1) Text with EEA relevance |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES
Commission
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26.1.2007 |
EN |
Official Journal of the European Union |
C 18/1 |
Euro exchange rates (1)
25 January 2007
(2007/C 18/01)
1 euro=
|
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Currency |
Exchange rate |
|
USD |
US dollar |
1,2978 |
|
JPY |
Japanese yen |
156,88 |
|
DKK |
Danish krone |
7,4541 |
|
GBP |
Pound sterling |
0,65850 |
|
SEK |
Swedish krona |
9,0750 |
|
CHF |
Swiss franc |
1,6154 |
|
ISK |
Iceland króna |
89,12 |
|
NOK |
Norwegian krone |
8,2120 |
|
BGN |
Bulgarian lev |
1,9558 |
|
CYP |
Cyprus pound |
0,5784 |
|
CZK |
Czech koruna |
28,148 |
|
EEK |
Estonian kroon |
15,6466 |
|
HUF |
Hungarian forint |
254,65 |
|
LTL |
Lithuanian litas |
3,4528 |
|
LVL |
Latvian lats |
0,6975 |
|
MTL |
Maltese lira |
0,4293 |
|
PLN |
Polish zloty |
3,8975 |
|
RON |
Romanian leu |
3,3926 |
|
SKK |
Slovak koruna |
35,178 |
|
TRY |
Turkish lira |
1,8403 |
|
AUD |
Australian dollar |
1,6639 |
|
CAD |
Canadian dollar |
1,5287 |
|
HKD |
Hong Kong dollar |
10,1308 |
|
NZD |
New Zealand dollar |
1,8468 |
|
SGD |
Singapore dollar |
1,9929 |
|
KRW |
South Korean won |
1 214,81 |
|
ZAR |
South African rand |
9,3114 |
|
CNY |
Chinese yuan renminbi |
10,0846 |
|
HRK |
Croatian kuna |
7,3800 |
|
IDR |
Indonesian rupiah |
11 803,49 |
|
MYR |
Malaysian ringgit |
4,5429 |
|
PHP |
Philippine peso |
63,469 |
|
RUB |
Russian rouble |
34,3940 |
|
THB |
Thai baht |
44,320 |
Source: reference exchange rate published by the ECB.
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26.1.2007 |
EN |
Official Journal of the European Union |
C 18/2 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2006 to 31 December 2006
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2007/C 18/02)
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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4.12.2006 |
Naglazyme |
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EU/1/05/324/001 |
6.12.2006 |
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4.12.2006 |
Kaletra |
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EU/1/01/172/001-005 |
8.12.2006 |
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11.12.2006 |
Rotarix |
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EU/1/05/330/001-004 |
13.12.2006 |
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18.12.2006 |
NeoSpect |
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EU/1/00/154/001-002 |
21.12.2006 |
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18.12.2006 |
Viracept |
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EU/1/97/054/003-004 EU/1/97/054/006 |
20.12.2006 |
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18.12.2006 |
ATryn |
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EU/1/06/355/001-003 |
20.12.2006 |
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19.12.2006 |
SonoVue |
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EU/1/01/177/001 |
21.12.2006 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
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18.12.2006 |
PRAC-TIC |
pyriprole |
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EU/2/06/066/001-012 |
Spot-on solution |
QP53AX26 |
20.12.2006 |
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20.12.2006 |
Medicinal Oxygen Air Liquide Santé |
Oxygen |
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EU/2/06/067/001-002 |
Inhalation gas |
QV03AN01 |
22.12.2006 |
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19.12.2006 |
ProMeris |
Metaflumizone |
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EU/2/06/064/001-004 |
Spot-on solution |
QP 53AX25 |
22.12.2006 |
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19.12.2006 |
ProMeris Duo |
Metaflumizone, Amitraz |
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EU/2/06/065/001-010 |
Spot-on solution |
QP 53AD51 |
21.12.2006 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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11.12.2006 |
Veraflox |
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- |
14.12.2006 |
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, Canary Wharf |
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London E14 4HB |
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United Kingdom |
(1) OJ L 136 of 30.4.2004, p. 1.
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26.1.2007 |
EN |
Official Journal of the European Union |
C 18/4 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2006 to 31 December 2006
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2007/C 18/03)
— Issuing, maintenance or modification of a national marketing authorisation
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Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
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13.12.2006 |
Glucomed |
See Annex I |
See Annex I |
14.12.2006 |
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13.12.2006 |
Agopton |
See Annex II |
See Annex II |
14.12.2006 |
— Suspension of a national marketing authorization
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Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
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19.12.2006 |
Cetirizine Nordic Drugs |
See Annex III |
See Annex III |
21.12.2006 |
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19.12.2006 |
Cetirizine Dermapharm |
See Annex IV |
See Annex IV |
21.12.2006 |
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19.12.2006 |
Cetirizine Apex |
See Annex V |
See Annex V |
21.12.2006 |
(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 FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
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Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
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Austria |
— |
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Flexove |
625 mg |
Tablet |
Oral use |
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Belgium |
— |
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Flexove |
625 mg |
Tablet |
Oral use |
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Cyprus |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Czech Republic |
— |
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Flexove |
625 mg |
Tablet |
Oral use |
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Denmark |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Estonia |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Finland |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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France |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Germany |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Greece |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Hungary |
— |
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Flexove |
625 mg |
Tablet |
Oral use |
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Ireland |
— |
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Flexove |
625 mg |
Tablet |
Oral use |
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Italy |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Latvia |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Lithuania |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Luxemburg |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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The Netherlands |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Poland |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Portugal |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Slovakia |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Spain |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Sweden |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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United Kingdom |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Iceland |
— |
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Glucomed |
625 mg |
Tablet |
Oral use |
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Norway |
— |
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Flexove |
625 mg |
Tablet |
Oral use |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
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Member State |
Marketing Authorisation Holder |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
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Austria |
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AGOPTON |
15 mg |
Capsule |
Oral use |
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AGOPTON |
30 mg |
Capsule |
Oral use |
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AGOPTON Rapid |
15 mg |
Oro-dispersible tablet |
Oral use |
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AGOPTON Rapid |
30 mg |
Oro-dispersible tablet |
Oral use |
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Belgium |
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DAKAR |
15mg |
Capsule |
Oral use |
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DAKAR |
30 mg |
Capsule |
Oral use |
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NIBITOR |
30 mg |
Capsule |
Oral use |
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Denmark |
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LANZO |
15 mg |
Capsule |
Oral use |
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LANZO |
30 mg |
Capsule |
Oral use |
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Finland |
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LANZO |
30 mg |
Capsule |
Oral use |
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LANZO |
15 mg |
Oro-dispersible tablet |
Oral use |
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LANZO |
30 mg |
Oro-dispersible tablet |
Oral use |
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France |
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OGAST |
15 mg |
Capsule |
Oral use |
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OGAST |
30 mg |
Capsule |
Oral use |
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LANZOR |
15 mg |
Capsule |
Oral use |
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LANZOR |
30 mg |
Capsule |
Oral use |
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Germany |
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AGOPTON |
15 mg |
Capsule |
Oral use |
||||||
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AGOPTON |
30 mg |
Capsule |
Oral use |
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LANZOR |
15 mg |
Capsule |
Oral use |
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LANZOR |
30 mg |
Capsule |
Oral use |
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Greece |
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LAPRAZOL |
15 mg |
Capsule |
Oral use |
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LAPRAZOL |
30 mg |
Capsule |
Oral use |
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LAPRAZOL FasTab |
15 mg |
Oro-dispersible tablet |
Oral use |
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LAPRAZOL FasTab |
30 mg |
Oro-dispersible tablet |
Oral use |
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Hungary |
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LANSONE |
30 mg |
Capsule |
Oral use |
||||||
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Ireland |
|
ZOTON |
15 mg |
Capsule |
Oral use |
||||||
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ZOTON |
30 mg |
Capsule |
Oral use |
||||||||
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ZOTON FasTab |
15 mg |
Oro-dispersible tablet |
Oral use |
||||||||
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ZOTON FasTab |
30 mg |
Oro-dispersible tablet |
Oral use |
||||||||
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ZOTON |
30mg |
Gastro-resistant granules for oral suspension |
Oral use |
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Italy |
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LANSOX |
15 mg |
Capsule |
Oral use |
||||||
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LANSOX |
30 mg |
Capsule |
Oral use |
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LANGAST |
15 mg |
Capsule |
Oral use |
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LANGAST |
30 mg |
Capsule |
Oral use |
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LANSOX |
15 mg |
Oro-dispersible tablet |
Oral use |
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LANSOX |
30 mg |
Oro-dispersible tablet |
Oral use |
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LIMPIDEX |
15 mg |
Capsule |
Oral use |
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LIMPIDEX |
30 mg |
Capsule |
Oral use |
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LIMPIDEX |
15 mg |
Oro-dispersible tablet |
Oral use |
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LIMPIDEX |
30 mg |
Oro-dispersible tablet |
Oral use |
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ZOTON |
15 mg |
Capsule |
Oral use |
|||||||
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ZOTON |
30 mg |
Capsule |
Oral use |
||||||||
|
ZOTON |
15 mg |
Oro-dispersible tablet |
Oral use |
||||||||
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ZOTON |
30 mg |
Oro-dispersible tablet |
Oral use |
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Luxembourg |
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DAKAR |
15 mg |
Capsule |
Oral use |
||||||
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DAKAR |
30 mg |
Capsule |
Oral use |
||||||||
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Netherlands |
|
PREZAL |
15 mg |
Capsule |
Oral use |
||||||
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PREZAL |
30 mg |
Capsule |
Oral use |
||||||||
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Portugal |
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OGASTO |
15 mg |
Capsule |
Oral use |
||||||
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OGASTO |
30 mg |
Capsule |
Oral use |
||||||||
|
OGASTO |
15 mg |
Oro-dispersible tablet |
Oral use |
||||||||
|
OGASTO |
30 mg |
Oro-dispersible tablet |
Oral use |
||||||||
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Spain |
|
OPIREN |
15 mg |
Capsule |
Oral use |
||||||
|
OPIREN |
30 mg |
Capsule |
Oral use |
||||||||
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BAMALITE |
15 mg |
Capsule |
Oral use |
||||||||
|
BAMALITE |
30 mg |
Capsule |
Oral use |
||||||||
|
OPIREN Flas |
15 mg |
Oro-dispersible tablet |
Oral use |
||||||||
|
OPIREN Flas |
30 mg |
Oro-dispersible tablet |
Oral use |
||||||||
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BAMALITE Flas |
15 mg |
Oro-dispersible tablet |
Oral use |
||||||||
|
BAMALITE Flas |
30 mg |
Oro-dispersible tablet |
Oral use |
||||||||
|
Sweden |
|
LANZO |
15 mg |
Capsule |
Oral use |
||||||
|
LANZO |
30 mg |
Capsule |
Oral use |
||||||||
|
LANZO |
15 mg |
Oro-dispersible tablet |
Oral use |
||||||||
|
LANZO |
30 mg |
Oro-dispersible tablet |
Oral use |
||||||||
|
United Kingdom |
|
ZOTON |
15 mg |
Capsule |
Oral use |
||||||
|
ZOTON |
30 mg |
Capsule |
Oral use |
||||||||
|
ZOTON |
30 mg |
Gastro-resistant granules for oral suspension |
Oral use |
||||||||
|
ZOTON FasTab |
15 mg |
Oro-dispersible Tablet |
Oral use |
||||||||
|
ZOTON FasTab |
30 mg |
Oro-dispersible Tablet |
Oral use |
||||||||
|
Iceland |
|
LANZO |
15 mg |
Capsule |
Oral use |
||||||
|
LANZO |
30 mg |
Capsule |
Oral use |
||||||||
|
ZOTON |
15 mg |
Capsule |
Oral use |
||||||||
|
ZOTON |
30 mg |
Capsule |
Oral use |
||||||||
|
LANZO |
15 mg |
Oro-dispersible tablet |
Oral use |
||||||||
|
LANZO |
30 mg |
Oro-dispersible tablet |
Oral use |
||||||||
|
Norway |
|
LANZO |
15 mg |
Capsule |
Oral use |
||||||
|
LANZO |
30 mg |
Capsule |
Oral use |
||||||||
|
LANZO |
15 mg |
Oro-dispersible tablet |
Oral use |
||||||||
|
LANZO |
30 mg |
Oro-dispersible tablet |
Oral use |
ANNEX III
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
CETIRIZINE DIHYDROCHLORIDE NORDIC DRUGS 10 mg AND ASSOCIATED NAMES
|
Member State |
Marketing Authorisation Holder |
Product Name |
Strength |
Pharmaceutical Form |
Route of administration |
||||
|
Denmark |
|
Gardex |
10 mg |
Film coated tablet |
Oral |
||||
|
Finland |
|
Gardex 10 mg tabletti, kalvopäällysteinen |
10 mg |
Film coated tablet |
Oral |
||||
|
Netherlands |
|
Cetirizine dihydrochloride Nordic Drugs 10 mg |
10 mg |
Film coated tablet |
Oral |
||||
|
Norway |
|
Acura |
10 mg |
Film coated tablet |
Oral |
||||
|
Sweden |
|
Acura |
10 mg |
Film coated tablet |
Oral |
ANNEX IV
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
CETIRIZINE DIHYDROCHLORIDE DERMAPHARM 10 mg AND ASSOCIATED NAMES
|
Member State |
Marketing Authorisation Holder |
Product Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||
|
Austria |
|
Cetiderm 10 mg Filmtabletten |
10 mg |
Film coated tablet |
Oral |
|||
|
Belgium |
|
Cetirizine dihydrochloride Dermapharm 10 mg filmomhulde tabletten |
10 mg |
Film coated tablet |
Oral |
|||
|
Germany |
|
Cetiderm 10 mg Filmtabletten |
10 mg |
Film coated tablet |
Oral |
|||
|
Netherlands |
|
Cetirizine dihydrochloride Dermapharm 10 mg tabletten |
10 mg |
Film coated tablet |
Oral |
ANNEX V
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
CETIRIZINE DIHYDROCHLORIDE APEX 10 mg AND ASSOCIATED NAMES
|
Member State |
Marketing Authorisation Holder |
Product Name |
Strength |
Pharmaceutical Form |
Route of administration |
||||||
|
Belgium |
|
Doccetiri |
10 mg |
Film coated tablet |
Oral |
||||||
|
Luxembourg |
|
Doccetiri-10 |
10 mg |
Film coated tablet |
Oral |
||||||
|
Netherlands |
|
Cetirizine dihydrochloride-APEX 10 mg |
10 mg |
Film coated tablet |
Oral |
V Announcements
PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMMON COMMERCIAL AND COMPETITION POLICY
Commission
|
26.1.2007 |
EN |
Official Journal of the European Union |
C 18/13 |
Prior notification of a concentration
(Case COMP/M.4558 — Alpha Private Equity Funds/Non Ferrous International Group)
Candidate case for simplified procedure
(Text with EEA relevance)
(2007/C 18/04)
|
1. |
On 19 January 2007, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Alpha Private Equity Funds (Channel Islands) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of Non Ferrous International Group consisting of Non Ferrous International NV/SA (Belgium) and DI Assets S.A. (Luxembourg), by way of purchase of shares. |
|
2. |
The business activities of the undertakings concerned are:
|
|
3. |
On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
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4. |
The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission. Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4558 — Alpha Private Equity Funds/Non Ferrous International Group, to the following address:
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26.1.2007 |
EN |
Official Journal of the European Union |
C 18/14 |
Prior notification of a concentration
(Case COMP/M.4460 — ABN AMRO/Carlson/T.G.I. Friday's)
Candidate case for simplified procedure
(Text with EEA relevance)
(2007/C 18/05)
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1. |
On 18 January 2007, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings ABN AMRO Capital BO Funds B.V. (‘AACBOF’, the Netherlands) belonging to the ABN AMRO group and Carlson Restaurants Worldwide Inc., a wholly owned subsidiary of Carlson Companies Inc. (‘Carlson’ USA) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the UK T.G.I. Friday's franchised restaurant business of Whitbread Group Plc. (‘Whitbread’, UK) by way of purchase of shares in a newly created company constituting a joint venture. |
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2. |
The business activities of the undertakings concerned are:
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3. |
On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
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4. |
The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission. Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4460 — ABN AMRO/Carlson/T.G.I. Friday's, to the following address:
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