ISSN 1725-2423 |
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Official Journal of the European Union |
C 287 |
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English edition |
Information and Notices |
Volume 49 |
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(1) Text with EEA relevance |
EN |
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I Information
Commission
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/1 |
Euro exchange rates (1)
23 November 2006
(2006/C 287/01)
1 euro=
|
Currency |
Exchange rate |
USD |
US dollar |
1,2953 |
JPY |
Japanese yen |
150,61 |
DKK |
Danish krone |
7,4547 |
GBP |
Pound sterling |
0,67650 |
SEK |
Swedish krona |
9,0595 |
CHF |
Swiss franc |
1,5843 |
ISK |
Iceland króna |
91,78 |
NOK |
Norwegian krone |
8,2600 |
BGN |
Bulgarian lev |
1,9558 |
CYP |
Cyprus pound |
0,5779 |
CZK |
Czech koruna |
27,950 |
EEK |
Estonian kroon |
15,6466 |
HUF |
Hungarian forint |
258,63 |
LTL |
Lithuanian litas |
3,4528 |
LVL |
Latvian lats |
0,6974 |
MTL |
Maltese lira |
0,4293 |
PLN |
Polish zloty |
3,8211 |
RON |
Romanian leu |
3,4874 |
SIT |
Slovenian tolar |
239,66 |
SKK |
Slovak koruna |
35,653 |
TRY |
Turkish lira |
1,9080 |
AUD |
Australian dollar |
1,6725 |
CAD |
Canadian dollar |
1,4769 |
HKD |
Hong Kong dollar |
10,0822 |
NZD |
New Zealand dollar |
1,9321 |
SGD |
Singapore dollar |
2,0057 |
KRW |
South Korean won |
1 205,21 |
ZAR |
South African rand |
9,3050 |
CNY |
Chinese yuan renminbi |
10,1836 |
HRK |
Croatian kuna |
7,3433 |
IDR |
Indonesian rupiah |
11 826,74 |
MYR |
Malaysian ringgit |
4,7117 |
PHP |
Philippine peso |
64,396 |
RUB |
Russian rouble |
34,3820 |
THB |
Thai baht |
47,319 |
Source: reference exchange rate published by the ECB.
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/2 |
Publication of an application pursuant to Article 6(2) of Council Regulation (EC) No 510/2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs
(2006/C 287/02)
This publication confers the right to object to the application pursuant to Article 7 of Council Regulation (EC) No 510/2006. Statements of objection must reach the Commission within six months from the date of this publication.
SUMMARY
COUNCIL REGULATION (EC) No 510/2006
Application for registration according to Article 5 and Article 17(2)
‘PIMENTÓN DE LA VERA’
EC No: ES/PDO/005/0321/29.10.2003
PDO ( X ) PGI ( )
This summary has been drawn up for information only. For full details, interested parties are invited to consult the full version of the product specification obtainable from the national authorities indicated in section 1 or from the European Commission (1).
1. Responsible department in the Member State:
Name: |
Subdirección General de Calidad y Promoción Agroalimentaria — Dirección General de Industria Agroalimentaria y Alimentación — Secretaría General de Agricultura y Alimentación del Ministerio de Agricultura, Pesca y Alimentación de España. |
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Address: |
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Tel.: |
(34) 913 47 53 94 |
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Fax: |
(34) 913 47 54 10 |
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e-mail: |
sgcaproagro@mapya.es |
2. Group:
Name: |
D. Manuel Fernández Amor, con D.N.I. no 5.602.884-S, y otros. |
Address: |
«Unión de Productores de Pimentón, Sociedad Cooperativa» Polígono Industrial «El Pocito», Calle E, Parcela E-7, E-10400 Jaraíz de la Vera (Cáceres) |
Tel.: |
(34) 927 46 00 12 |
Fax: |
(34) 927 17 00 71 |
e-mail: |
— |
Composition: |
Producers/processors ( X ) Other ( ) |
3. Type of product:
Class 1.8 — Other Annex II products (spices) — Paprika
4. Specification (summary of requirements under Article 4(2))
4.1. Name: ‘Pimentón de la Vera’
4.2. Description: Paprika with the Protected Designation of Origin ‘Pimentón de la Vera’ means the product from grinding the totally red fruits of the Jaranda, Jariza and Jeromín varieties of the ‘Ocales’ group, and the Bola variety, of the botanical species Capsicum annum L. and Capsicum longum L. collected when they are ripe, healthy and clean and have the colour typical of the variety, free of pests or disease, dried using oak and/or holm oak wood in the traditional fashion of the Vera, and which comes from the designated area of production.
La Vera paprika is a product with a smoky taste and aroma which is made intense and penetrating by the process of drying the chillies using smoke. It is deep red in colour and shiny. It imparts its colour vigorously, more in the case of the varieties from the Ocales group than the Bola variety. Taste, aroma and colour are very stable over time, mainly because of the slow and gentle drying process used.
Depending on taste, the paprika may be divided into three groups:
Sweet paprika: gentle taste, completely sweet. Made from the Bola and Jaranda varieties.
Ocal or sweet/hot paprika: slightly sharp on the palate. Made from the Jaranda and Jariza varieties.
Hot paprika: decidedly hot on the palate. Made from the Jeromín, Jariza and Jaranda varieties.
Physico-chemical characteristics: Pimentón de la Vera is defined by the following physical-chemical characteristics:
Size of the seed: the paprika seed must be milled so that it passes through a No 16 sieve or screen on the ASTM scale (equivalent to a 1,19 mm mesh).
Analytical characteristics:
Maximum water content |
14 |
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Maximum ether extract of dry matter |
23 |
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Maximum raw fibre in dry matter |
28 |
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Maximum ash in dry matter: |
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9 |
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1 |
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Colour (2), ASTA units: minimum |
90 |
Food ingredients: edible sunflower oil (a maximum of 3 % by weight of the dry product) may occasionally be added to the powdered paprika to give the final product consistency and shine. The addition of oil does not affect the specific character of the paprika and so no specific geographical origin is specified for the oil.
The prepared product must be totally free from seeds, veins, flower heads and stalks from varieties of chillies other than those authorised for each of the three groups of paprika, artificial colouring matters and other substances affecting the parameters defining this spice.
The proportion of seeds, veins, flower heads and stalks from the authorised varieties of chillies must be less than that of the rest of the fruit.
4.3. Geographical area: The area of production of chillies for the production of paprika under the ‘Pimentón de la Vera’ Protected Designation of Origin comprises the following municipalities of the natural areas known as La Vera, Campo Arañuelo, Valle del Ambroz and Valle del Alagón, in the north of the Province of Cáceres: Abadía, Aldeanueva de la Vera, Aldeanueva del Camino, Aldehuela del Jerte, Arroyomolinos de la Vera, Carcaboso, Casas del Monte, Casatejada, Casillas de Coria, Cilleros, Collado, Coria, Cuacos de Yuste, El Toril, Galisteo, Garganta la Olla Gargantilla, Granja de Granadilla, Guijo de Galisteo, Guijo de Granadilla, Guijo de Santa Bárbara, Holguera, Jaraíz de la Vera, Jarandilla de la Vera, Losar de la Vera, Madrigal de la Vera, Majadas de Tiétar, Malpartida de Plasencia, Montehermoso, Moraleja, Morcillo, Navalmoral de la Mata, Pasarón de la Vera, Plasencia, Riolobos, Robledillo de la Vera, Rosalejo, Saucedilla, Segura de Toro, Serrejón, Talaveruela de la Vera, Talayuela, Tejeda de Tiétar, Torrejoncillo, Torremenga, Valdeobispo, Valverde de la Vera, Viandar de la Vera, Villanueva de la Vera, Zarza de Granadilla.
The area for preparation and packaging fully coincides with the area of production.
All the procedures for the production of ‘Pimentón de la Vera’ must be carried out in the municipalities listed above, i.e. growing, drying and processing all take place within this geographical area. This requirement is intended to provide greater guarantees of the origin, traceability and quality of the final product.
4.4. Proof of origin: Protected la Vera paprika is produced in registered establishments from dried chillies from registered holdings in the area of production; once it has passed the checks laid down, it is marketed under the Protected Designation of Origin ‘Pimentón de la Vera’ with a numbered secondary label. The chillies used come from the Jaranda, Jariza and Jeromín varieties in the ‘Ocales’ group and from the Bola variety.
4.5. Method of production: This begins with seed planting from the end of February to early April, to secure chilli plants which will be finally planted out roughly between 15 May and 10 June.
The land where they are to be planted out is first properly prepared to provide the best conditions with any hard subsurface layers and clods broken up, hoeing and the addition of organic and mineral fertilisers and the shaping of the soil.
Planting is carried out by hand or using mechanical transplanters. The plants are then watered copiously to promote good root formation.
Depending on the holding, this is done by gravity, sprinkling or in some cases local irrigation systems.
Once the fruit is ripe it is harvested by hand and taken for drying on the holding itself. Water is removed by means of a vertical current of air with a fire beneath (smoke-drying). This is done by the farmer himself.
This system is conducive to slow, gentle, non-aggressive drying so that within 10 to 15 days the water content of the fruit falls from 80 % to under 15 %. The final product obtained (‘cáscara’) has a smoky taste and aroma and a very stable colour — these are features of the system of drying used.
The ‘cáscara’ is then taken to local mills for grinding on emery stones. The ground paprika is then passed through horizontally positioned stones known as ‘piedras de transmitir’. Occasionally, vegetable oil is added at this point up to the maximum proportion laid down in point 4.2.1.3 of this Summary. The addition of oil does not affect the specific character of the paprika. Finally, it is packaged and labelled and so is ready for marketing
4.6. Link: The first references to the cultivation of La Vera paprika date from the sixteenth-century, when it was cultivated in the Monastery of Yuste (Cuacos de Yuste, La Vera district) by the Hieronymite friars.
Cultivation gradually spread from La Vera to neighbouring areas, the Campo Arañuelo, Valle del Ambroz and Valle del Alagón, becoming steadily more valued by farmers because of its profitability.
The industrial process for obtaining paprika began at the end of the seventeenth-century and expanded substantially in the mid-eighteenth-century. At that time the chillies were ground in water-powered flour mills located by streams. The coming of electricity to La Vera meant that electric mills could be used, leading to substantial improvements in the industry, which began to concentrate on producing paprika.
The varieties of chilli used for producing paprika are native ones belonging to the botanical species Capsicum annum L. and Capsicum longum L., the former being slightly oblate and the latter longer. The first group includes the Bola varieties-population and the second the Ocales varieties-population, also known as Agridulce de la Vera. These are very hardy varieties and very well adapted to the soil and climate of the area. Their splendid acclimatisation is the reason why they have not been replaced by varieties from elsewhere. Another important factor justifying the use of local vegetative material is that it is completely adapted to the system of drying by smoke, used in La Vera from the seventeenth-century to the present day.
The protection provided by the Sierra de Gredos, the properties of the soils, which are loose and totally free from salt, the quality of the water used for irrigation, which is also salt-free, and the features of the microclimate of the area of production permit cultivation of these indigenous varieties which produce fruit which gives a particular taste to the paprika obtained from them.
To the taste of the variety is added that of the smoking, a system of drying related to the climatic features of the area, where sun-drying is not possible, and which gives the paprika its characteristic taste and aroma as well as very stable colour.
The use of indigenous varieties, smoke-drying and the use of stone mills in La Vera since the seventeenth-century differentiates the paprika produced there from that produced elsewhere in the world. It has its own personality, so that the paprika produced in the north of Cáceres using the system described above is known as La Vera paprika.
4.7. Inspection body:
Name: |
Consejo Regulador de la Denominación de Origen Protegida «Pimentón de la Vera» |
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Address: |
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Tel.: |
(34) 927 17 02 72 |
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Fax: |
(34) 927 17 02 72 |
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e-mail: |
info@pimentonvera-origen.com |
The inspection body for the ‘Pimentón de la Vera’ PDO satisfies standard UNE-EN 45.011.
4.8. Labelling: Commercial labels used by each producing industry must be approved by the inspection body. They must bear the words: ‘Denominación de Origin Protegida “Pimentón de la Vera”’.
All La Vera paprika certified as having a Protected Designation of Origin put up for consumption must be identified by the logo registered and owned by the Regulatory Board and the numbered secondary label — otherwise it may not be sold. It must be impossible to reuse the numbered secondary label.
4.9. National requirements:
— |
Law No 25/1970 of 2 December 1970 laying down rules on vineyards, wine and spirit drinks and the implementing rules approved by Decree No 835/1972 of 23 March 1972. |
— |
Decree No 835/1972 of 28 March 1972 laying down detailed rules for the application of Law No 25/1970. |
— |
Order of 25 January 1994 establishing the correspondence between Spanish legislation and Regulation (EEC) No 2081/92 on designations of origin and geographical indications for food products. |
— |
Royal Decree No 1643/99 of 22 October 1999 on the procedure for submitting applications for entry on the Community Register of Protected Designations of Origin and Protected Geographical Indications. |
(1) European Commission, Directorate-General for Agriculture and Rural Development, Agricultural Product Quality Policy, B-1049 Brussels.
(2) At the time of milling
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/7 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2006/C 287/03)
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
|||||||
4.10.2006 |
Abilify |
|
EU/1/04/276/036 |
6.10.2006 |
|||||||
4.10.2006 |
Abilify |
|
EU/1/04/276/036 |
6.10.2006 |
|||||||
6.10.2006 |
Travatan |
|
EU/1/01/199/001-002 |
10.10.2006 |
|||||||
11.10.2006 |
Invirase |
|
EU/1/96/026/001-002 |
13.10.2006 |
|||||||
17.10.2006 |
Cetrotide |
|
EU/1/99/100/001-003 |
19.10.2006 |
|||||||
19.10.2006 |
Zometa |
|
EU/1/01/176/001-006 |
23.10.2006 |
|||||||
19.10.2006 |
Zevalin |
|
EU/1/03/264/001 |
23.10.2006 |
|||||||
20.10.2006 |
Herceptin |
|
EU/1/00/145/001 |
24.10.2006 |
|||||||
20.10.2006 |
PritorPlus |
|
EU/1/02/215/001-012 |
24.10.2006 |
|||||||
20.10.2006 |
Enbrel |
|
EU/1/99/126/001-018 |
24.10.2006 |
|||||||
20.10.2006 |
Caelyx |
|
EU/1/96/011/001-004 |
24.10.2006 |
|||||||
20.10.2006 |
Avonex |
|
EU/1/97/033/001-003 |
24.10.2006 |
|||||||
20.10.2006 |
Faslodex |
|
EU/1/03/269/001 |
24.10.2006 |
|||||||
20.10.2006 |
ViraferonPeg |
|
EU/1/00/132/001-050 |
24.10.2006 |
|||||||
23.10.2006 |
Taxotere |
Aventis Pharma S.A., 20 Avenue Raymond Aron, Antony Cedex 92165, France |
EU/1/95/002/001-002 |
25.10.2006 |
|||||||
23.10.2006 |
PhotoBarr |
|
EU/1/04/272/001-002 |
25.10.2006 |
|||||||
23.10.2006 |
Dynepo |
|
EU/1/02/211/001-005 |
26.10.2006 |
|||||||
24.10.2006 |
PegIntron |
|
EU/1/00/131/001-050 |
25.10.2006 |
|||||||
24.10.2006 |
AVANDIA |
|
EU/1/00/137/002-018 |
26.10.2006 |
|||||||
24.10.2006 |
Aclasta |
|
EU/1/05/308/001-002 |
26.10.2006 |
|||||||
24.10.2006 |
Prometax |
|
EU/1/98/092/001-018 |
26.10.2006 |
|||||||
24.10.2006 |
Invanz |
|
EU/1/02/216/001-002 |
26.10.2006 |
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24.10.2006 |
Apidra |
|
EU/1/04/285/013-020 |
26.10.2006 |
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24.10.2006 |
Fuzeon |
|
EU/1/03/252/001-003 |
26.10.2006 |
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24.10.2006 |
Avandamet |
|
EU/1/03/258/001-022 |
26.10.2006 |
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26.10.2006 |
Ketek |
|
EU/1/01/191/001-005 |
30.10.2006 |
|||||||
26.10.2006 |
Levviax |
|
EU/1/01/192/001-005 |
30.10.2006 |
|||||||
26.10.2006 |
Actos |
|
EU/1/00/150/001-024 |
30.10.2006 |
|||||||
26.10.2006 |
Glustin |
|
EU/1/00/151/001-022 |
30.10.2006 |
|||||||
26.10.2006 |
Sustiva |
|
EU/1/99/110/001-009 |
30.10.2006 |
|||||||
26.10.2006 |
Stocrin |
|
EU/1/99/111/001-009 |
30.10.2006 |
|||||||
26.10.2006 |
Exelon |
|
EU/1/98/066/001-018 |
30.10.2006 |
|||||||
26.10.2006 |
Helixate NexGen |
|
EU/1/00/144/001-003 |
30.10.2006 |
|||||||
26.10.2006 |
Vfend |
|
EU/1/02/212/001-026 |
30.10.2006 |
|||||||
27.10.2006 |
Pritor |
|
EU/1/98/089/001-019 |
31.10.2006 |
|||||||
27.10.2006 |
Ariclaim |
|
EU/1/04/283/001-007 |
31.10.2006 |
|||||||
27.10.2006 |
Rebetol |
|
EU/1/99/107/001-005 |
31.10.2006 |
|||||||
27.10.2006 |
Remicade |
|
EU/1/99/116/001-003 |
31.10.2006 |
|||||||
27.10.2006 |
Avaglim |
|
EU/1/06/349/001-008 |
31.10.2006 |
|||||||
27.10.2006 |
Viramune |
|
EU/1/97/055/001-003 |
31.10.2006 |
|||||||
27.10.2006 |
Invirase |
|
EU/1/96/026/001-002 |
31.10.2006 |
|||||||
27.10.2006 |
Tracleer |
|
EU/1/02/220/001-005 |
31.10.2006 |
|||||||
30.10.2006 |
FOSAVANCE |
|
EU/1/05/310/001-005 |
1.11.2006 |
|||||||
30.10.2006 |
Lyrica |
|
EU/1/04/279/001-035 |
1.11.2006 |
|||||||
30.10.2006 |
NutropinAq |
|
EU/1/00/164/003-005 |
1.11.2006 |
|||||||
30.10.2006 |
Keppra |
|
EU/1/00/146/001-030 |
3.11.2006 |
|||||||
30.10.2006 |
Noxafil |
|
EU/1/05/320/001 |
2.11.2006 |
|||||||
30.10.2006 |
Posaconazole SP |
|
EU/1/05/321/001 |
2.11.2006 |
|||||||
30.10.2006 |
Nespo |
|
EU/1/01/184/001-068 |
2.11.2006 |
|||||||
30.10.2006 |
Aranesp |
|
EU/1/01/185/001-068 |
1.11.2006 |
|||||||
31.10.2006 |
Lantus |
|
EU/1/00/134/001-037 |
14.11.2006 |
|||||||
31.10.2006 |
Insuman |
|
EU/1/97/030/065-084 |
6.11.2006 |
|||||||
31.10.2006 |
Optruma |
|
EU/1/98/074/001-004 |
6.11.2006 |
|||||||
31.10.2006 |
Evista |
|
EU/1/98/073/001-004 |
6.11.2006 |
|||||||
31.10.2006 |
Telzir |
|
EU/1/04/282/001-002 |
7.11.2006 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
The European Medicines Agency |
7, Westferry Circus, Canary Wharf |
London E14 4HB |
United Kingdom |
(1) OJ L 136 of 30 April 2004, page 1
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/12 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1.10.2006 to 31.10.2006
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2006/C 287/04)
— Issuing, maintenance or modification of a national marketing authorisation
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
11.10.2006 |
Doxastad (doxazosin) Art 29 |
See Annex I |
See Annex I |
13.10.2006 |
11.10.2006 |
Doxazosin Winthrop (doxazosin) Art 29 - |
See Annex II |
See Annex II |
13.10.2006 |
11.10.2006 |
Cardoreg (doxazosin) Art 29 |
See Annex III |
See Annex III |
13.10.2006 |
11.10.2006 |
Doxagamma (doxazosin) Art 29 |
See Annex IV |
See Annex IV |
13.10.2006 |
11.10.2006 |
Doxazosin Retard Arrow (doxazosin) Art 29 |
See Annex V |
See Annex V |
13.10.2006 |
13.10.2006 |
Cobactan DC Art 39 |
See Annex VI |
See Annex VI |
16.10.2006 |
(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(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
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Estonia |
|
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Doxalfa 4 mg toimeainet prolongeeritult vabastavad tabletid |
4 mg |
Prolonged-release tablet |
Oral |
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Latvia |
|
|
Doxalfa 4 mg ilgstošās darbības tabletes |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
Lithuania |
|
|
Doxalfa 4 mg pailginto atpalaidavimo tabletės |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
Netherlands |
|
|
Doxazosine retard CF 4mg, tabletten met gereguleerde afgifte |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
Spain |
|
|
DOXAZOSINA NEO STADA 4 mg comprimidos de liberación prolongada EEG |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
Sweden |
|
|
Doxastad 4mg depottablett |
4 mg |
Prolonged-release tablet |
Oral |
|||||||
United Kingdom |
|
|
Doxadura XL 4 mg |
4 mg |
Prolonged-release tablet |
Oral |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Member State |
Marketing Authorisation Holder |
Applicant |
Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
Denmark |
|
|
Doxazosin ‘Winthrop’ |
4 mg |
Prolonged release tablets |
Oral |
|||||||
Germany |
|
|
Doxazosin Winthrop 4 mg Retardtabletten |
4 mg |
Prolonged release tablets |
Oral |
|||||||
Hungary |
|
|
Doxazosin Winthrop 4mg Tablettes |
4 mg |
Prolonged release tablets |
Oral |
|||||||
Poland |
|
|
DOXAWIN XL |
4 mg |
Prolonged release tablets |
Oral |
|||||||
Slovakia |
|
|
Doxazosin Winthrop XL 4 mg |
4 mg |
Prolonged release tablets |
Oral |
|||||||
Spain |
|
|
Doxazosina WINTHROP 4 mg comprimidos de liberación prolongada EFG |
4 mg |
Prolonged release tablets |
Oral |
|||||||
United Kingdom |
|
|
Slocinx XL 4mg Tablets |
4 mg |
Prolonged release tablets |
Oral |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/ MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||
Czech Republic |
|
|
Lansoprazol-ratiopharm 4 mg Hartkapseln |
4 mg |
Prolonged release tablets |
Oral |
|||||
Denmark |
|
|
Cardoreg 4 mg depottabletter |
4 mg |
Prolonged release tablets |
Oral |
|||||
Hungary |
|
|
Doxazosin-ratiopharm retard 4 mg tabletta |
4 mg |
Prolonged release tablets |
Oral |
|||||
Poland |
|
|
Doxazosin-ratiopharm retard PR4 |
4 mg |
Prolonged release tablets |
Oral |
|||||
Slovakia |
|
|
Doxazosin-ratiopharm retard 4 mg |
4 mg |
Prolonged release tablets |
Oral |
|||||
United Kingdom |
|
|
DoxaCard XL 4 mg prolonged release tablets |
4 mg |
Prolonged release tablets |
Oral |
ANNEX IV
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
Denmark |
|
|
Doxagamma |
4mg |
Prolonged-release tablet |
oral |
|||||||
United Kingdom |
|
|
Doxzogen XL 4mg Tablets |
4mg |
Prolonged-release tablet |
oral |
ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Member State |
Marketing Authorisation Holder |
Applicant |
Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
Denmark |
|
|
Doxazosin ‘Arrow’, 4mg depottabletter |
4 mg |
Prolonged release tablets |
Oral |
|||||||
Portugal |
|
|
Doxazosin Arrow 4mg comprimido de libertaçao prolongada |
4 mg |
Prolonged release tablets |
Oral |
|||||||
Slovenia |
|
|
Doksazosin Arrow 4mg tablete s podaljšanim sproščanjem |
4 mg |
Prolonged release tablets |
Oral |
|||||||
United Kingdom |
|
|
Cardozin XL 4mg |
4 mg |
Prolonged release tablets |
Oral |
ANNEX VI
LIST OF NAMES, PHARMACEUTICAL FORM OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Member State |
Marketing Authorisation Holder |
Product invented name |
Pharmaceutical form |
Animal species |
Frequency |
Recommended dose |
Withdrawal period (meat and milk) |
|||||
Belgium |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Czech Republic |
|
Cobactan DC intramam susp. Ad us. Vet |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Germany |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Estonia |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Greece |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Spain |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
France |
|
Cobactan DC suspension intramammaire |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Ireland |
|
Cephaguard DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Italy |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Cyprus |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Latvia |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Lithuania |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Luxembourg |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Austria |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Poland |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Portugal |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Slovenia |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
Slovakia |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
|||||
United Kingdom |
|
Cobactan DC |
Intramammary ointment |
Dairy cows |
Single dose |
150 mg cefquinome |
Meat and offal: 2 days Milk: 49 days |
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/20 |
Publication of decisions by Member States to grant or revoke operating licenses pursuant to Article 13(4) of Regulation No 2407/92 on licensing of air carriers (1) (2)
(2006/C 287/05)
(Text with EEA relevance)
AUSTRIA
Operating licences revoked
Category B: Operating licences including the restriction of Article 5(7)(a) of Regulation No 2407/92
Name of air carrier |
Address of air carrier |
Permitted to carry |
Decision effective since |
Top Speed Verband der allgemeinen Luftfahrt |
A-1030 Wien, Weissgerberlände 50/12 |
passengers, mail, cargo |
11/10/06 |
Flyers GmbH — Fläche |
A-8073 Feldkirchen bei Graz — Flughafen Graz, Bürogebäude neu, 2.OG |
passengers, mail, cargo |
9.10.2006 |
SPAIN
Operating licences granted
Category B: Operating licences including the restriction of Article 5(7)(a) of Regulation No 2407/92
Name of air carrier |
Address of air carrier |
Permitted to carry |
Decision effective since |
||
Aeródromo de la Mancha, S.I |
|
passengers, mail, cargo |
17.7.2006 |
PORTUGAL
Operating licences revoked
Category A: Operating licences without the restriction of Article 5(7)(a) of Regulation No 2407/92
Name of air carrier |
Address of air carrier |
Permitted to carry |
Decision effective since |
||
Air Luxor, SA |
|
Passangers, cargo, freight |
15.09.06 |
SWEDEN
Operating licences granted
Category A: Operating licences without the restriction of Article 5(7)(a) of Regulation No 2407/92
Name of air carrier |
Address of air carrier |
Permitted to carry |
Decision effective since |
||
Nordic Airways AB 556647-3541 |
|
passengers, mail, cargo |
30/06/06 |
Operating licences revoked
Category A: Operating licences without the restriction of Article 5(7)(a) of Regulation No 2407/92
Name of air carrier |
Address of air carrier |
Permitted to carry |
Decision effective since |
||
Falcon Air AB 556204-3702 |
|
passengers, mail, cargo |
25/09/06 |
||
Swe Fly AB 556490-0271 |
|
passengers, mail, cargo |
25/09/06 |
(1) OJ L 240, 24.8.1992, p. 1.
(2) Communicated to the European Commission before 31.8.2005
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/22 |
Commission communication in the framework of the implementation of the Council Directive 87/404/EEC of 25 June 1987 on the harmonization of the laws of the Member States relating to simple pressure vessels
(2006/C 287/06)
(Text with EEA relevance)
(Publication of titles and references of harmonised standards under the directive)
ESO (1) |
Reference and title of the harmonised standard (and reference document) |
Reference of superseded standard |
Date of cessation of presumption of conformity of superseded standard Note 1 |
CEN |
EN 286-1:1998 Simple unfired pressure vessels designed to contain air or nitrogen — Part 1: Pressure vessels for general purposes |
EN 286-1:1991 |
Date Expired (31.8.1998) |
EN 286-1:1998/A1:2002 |
Note 3 |
Date Expired (31.1.2003) |
|
EN 286-1:1998/A2:2005 |
Note 3 |
Date Expired (30.4.2006) |
|
EN 286-1:1998/AC:2002 |
|
|
|
CEN |
EN 286-2:1992 Simple unfired pressure vessels designed to contain air or nitrogen — Part 2: Pressure vessels for air braking and auxiliary systems for motor vehicles and their trailers |
— |
|
EN 286-2:1992/AC:1992 |
|
|
|
CEN |
EN 286-3:1994 Simple unfired pressure vessels designed to contain air or nitrogen — Part 3: Steel pressure vessels designed for air braking equipment and auxiliary pneumatic equipment for railway rolling stock |
— |
|
CEN |
EN 286-4:1994 Simple unfired pressure vessels designed to contain air or nitrogen — Part 4: Aluminium alloy pressure vessels designed for air braking equipment and auxiliary pneumatic equipment for railway rolling stock |
— |
|
CEN |
EN 287-1:2004 Qualification test of welders — Fusion welding — Part 1: Steels |
— |
|
EN 287-1:2004/A2:2006 |
Note 3 |
Date Expired (30.9.2006) |
|
EN 287-1:2004/AC:2004 |
|
|
|
CEN |
EN 571-1:1997 Non destructive testing — Penetrant testing — Part 1: General principles |
— |
|
CEN |
EN 583-1:1998 Non-destructive testing — Ultrasonic examination — Part 1: General principles |
— |
|
CEN |
EN 970:1997 Non-destructive examination of fusion welds — Visual examination |
— |
|
CEN |
EN 1011-1:1998 Welding — Recommendations for welding of metallic materials — Part 1: General guidance for arc welding |
— |
|
CEN |
EN 1290:1998 Non-destructive examination of welds — Magnetic particle examination of welds |
— |
|
CEN |
EN 1330-3:1997 Non-destructive testing — Terminology — Part 3: Terms used in industrial radiographic testing |
— |
|
CEN |
EN 1714:1997 Non-destructive examination of welds — Ultrasonic examination of welded joints |
— |
|
CEN |
EN ISO 6520-1:1998 Welding and allied processes — Classification of geometric imperfections in metallic materials — Part 1: Fusion welding (ISO 6520-1:1998) |
EN 26520:1991 |
Date Expired (30.4.1999) |
CEN |
EN 10207:2005 Steels for simple pressure vessels — Technical delivery requirements for plates, strips and bars |
— |
|
CEN |
EN 12062:1997 Non-destructive examination of welds — General rules for metallic materials |
— |
|
CEN |
EN ISO 15614-1:2004 Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 1: Arc and gas welding of steels and arc welding of nickel and nickel alloys (ISO 15614-1:2004) |
— |
|
CEN |
EN ISO 15614-2:2005 Specification and qualification of welding procedures for metallic materials — Welding procedure test — Part 2: Arc welding of aluminium and its alloys (ISO 15614-2:2005) |
— |
|
Note 1 |
Generally the date of cessation of presumption of conformity will be the date of withdrawal (‘dow’), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise. |
Note 3 |
In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard (column 3) therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential requirements of the directive. |
NOTE:
— |
Any information concerning the availability of the standards can be obtained either from the European Standardisation Organisations or from the national standardisation bodies of which the list is annexed to the Directive 98/34/EC (2) of the European Parliament and Council amended by the Directive 98/48/EC (3). |
— |
Publication of the references in the Official Journal of the European Union does not imply that the standards are available in all the Community languages. |
— |
This list replaces all the previous lists published in the Official Journal of the European Union. The Commission ensures the updating of this list. |
More information about harmonised standards on the Internet at
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/
(1) (1) ESO: European Standardisation Organisation:
— |
CEN: rue de Stassart 36, B-1050 Brussels, Tel. (32-2) 550 08 11; fax (32-2) 550 08 19 (http://www.cenorm.be) |
— |
CENELEC: rue de Stassart 35, B-1050 Brussels, Tel. (32-2) 519 68 71; fax (32-2) 519 69 19 (http://www.cenelec.org) |
— |
ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel. (33) 492 94 42 00; fax (33) 493 65 47 16 (http://www.etsi.org) |
(2) OJ L 204, 21.7.1998, p.37.
(3) OJ L 217, 5.8.1998, p. 18.
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/25 |
Prior notification of a concentration
(Case COMP/M.4464 — Goldman Sachs/Cerberus/Harpen)
Candidate case for simplified procedure
(2006/C 287/07)
(Text with EEA relevance)
1. |
On 10 November 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertakings Goldman Sachs Group Inc. (‘Goldman Sachs’, USA) and Cerberus Group (‘Cerberus’, USA) acquire within the meaning of Article 3(1)(b) of the Council Regulation joint control of the undertakings Harpen Immobilien GmbH & Co. KG and Harpen Immobilien Verwaltungsgesellschaft mbH (together ‘Harpen’, Germany) by way of purchase of shares in a newly created company constituting a joint venture. |
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. |
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 (fax No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4464 — Goldman Sachs/Cerberus/Harpen, to the following address:
|
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/26 |
Guidelines on National Regional aid for 2007-2013 (1) — National regional State aid map: Latvia
(2006/C 287/08)
N 447/2006 — LATVIA
National regional State aid map 1.1.2007-31.12.2013
(Approved by the Commission on 13.09.2006)
Zone Code |
Zone Name |
Ceiling for regional investment aid (2) (applicable to large enterprises) |
1. Regions eligible for aid under Article 87(3)(a) of the EC Treaty until 31.12.2013 |
||
LV 0 |
LATVIA |
50 % |
(2) For investment projects with eligible expenditure not exceeding EUR 50 million, this ceiling is increased by 10 percentage points for medium sized companies and 20 percentage points for small companies as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36). For large investment projects with eligible expenditure exceeding EUR 50 million, this ceiling is subject to adjustment in accordance with paragraph 67 of the Guidelines on national regional aid for 2007-2013.
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/27 |
Prior notification of a concentration
(Case COMP/M.4168 — Österreichische Post/trans-o-flex)
Candidate case for simplified procedure
(2006/C 287/09)
(Text with EEA relevance)
1. |
On 14 November 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Österreichische Post AG (Austria) acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of trans-o-flex GmbH (Germany) 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. |
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 (fax No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4168 — Österreichische Post/ trans-o-flex, to the following address:
|
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/28 |
Non-opposition to a notified concentration
(Case COMP/M.4350 — Hewlett Packard/Mercury Interactive)
(2006/C 287/10)
(Text with EEA relevance)
On 20 October 2006, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:
— |
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. |
— |
in electronic form on the EUR-Lex website under document number 32006M4350. EUR-Lex is the on-line access to European law. (http://ec.europa.eu/eur-lex/lex) |
24.11.2006 |
EN |
Official Journal of the European Union |
C 287/28 |
Notice concerning a request in accordance with Article 30 of Directive 2004/17/EC
(2006/C 287/11)
Request made by a Member State
On 24 October 2006 the Commission received a request in accordance with Article 30(4) of Directive 2004/17/EC of the European Parliament and of the Council of 31 March 2004 coordinating the procurement procedures of entities operating in the water, energy, transport and postal services sectors (1).
This request, which comes from the United Kingdom, concerns the supply of electricity and gas in that country, with the exception of Northern Ireland (the request therefore concerns the supply of electricity and gas in England, Scotland and Wales). The request was published in OJ C 270 of 7 November 2006. The initial period expires on 25 January 2007.
Given that the Commission departments need to obtain and examine further information and in compliance with the provisions laid down in the third sentence of Article 30(6), the period within which the Commission must take a decision on this request is extended by one month.
The final period will therefore expire on 26 February 2006.
(1) OJ L 134, 30.4.2004, p. 1.