ISSN 1725-2423
Official Journal
of the European Union
C 220
English edition
Information and Notices
Volume 51
29 August 2008
|
ISSN 1725-2423 |
||
|
Official Journal of the European Union |
C 220 |
|
|
|
||
|
English edition |
Information and Notices |
Volume 51 |
|
Notice No |
Contents |
page |
|
|
II Information |
|
|
|
INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
|
|
|
Commission |
|
|
2008/C 220/01 |
||
|
|
IV Notices |
|
|
|
NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
|
|
|
Commission |
|
|
2008/C 220/02 |
||
|
2008/C 220/03 |
||
|
2008/C 220/04 |
||
|
|
NOTICES FROM MEMBER STATES |
|
|
2008/C 220/05 |
Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 70/2001 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises ( 1 ) |
|
|
2008/C 220/06 |
Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 68/2001 on the application of Articles 87 and 88 of the EC Treaty to training aid ( 1 ) |
|
|
|
|
|
|
(1) Text with EEA relevance |
|
EN |
|
II Information
INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES
Commission
|
29.8.2008 |
EN |
Official Journal of the European Union |
C 220/1 |
Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty
Cases where the Commission raises no objections
(2008/C 220/01)
|
Date of adoption of the decision |
16.7.2008 |
||||||
|
Aid number |
NN 77/05 |
||||||
|
Member State |
France |
||||||
|
Region |
— |
||||||
|
Title (and/or name of beneficiary) |
Réduction du droit d'accise sur certains carburants et combustibles dans le secteur agricole |
||||||
|
Legal basis |
Loi de finances pour 2005, loi de finances rectificative 2004, loi de finances rectificative 2005 et lois suivantes |
||||||
|
Type of measure |
Aid scheme |
||||||
|
Objective |
Aid linked to tax exemptions under Directive 2003/96/EC |
||||||
|
Form of aid |
Reduced tax rates |
||||||
|
Budget |
For example, approximately EUR 142 million in 2006 |
||||||
|
Intensity |
— |
||||||
|
Duration |
2004 to the present day |
||||||
|
Economic sectors |
Agriculture |
||||||
|
Name and address of the granting authority |
|
||||||
|
Other information |
— |
The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:
http://ec.europa.eu/community_law/state_aids/
|
Date of adoption of the decision |
17.6.2008 |
|||
|
Reference number of the aid |
N 588/07 |
|||
|
Member State |
Latvia |
|||
|
Region |
— |
|||
|
Title (and/or name of the beneficiary) |
Atbalsts, lai kompensētu zaudējumus, kas radās augļu dārzos bakteriālās iedegas rezultātā |
|||
|
Legal basis |
Augu aizsardzības likums
|
|||
|
Type of measure |
Eradication of plant diseases |
|||
|
Objective |
Sectoral development |
|||
|
Form of aid |
Direct grant and subsidised services |
|||
|
Budget |
Overall budget: LVL 350 000 (around EUR 502 585) |
|||
|
Intensity |
Up to 100 % |
|||
|
Duration |
Until 30.12.2008 |
|||
|
Economic sectors |
Agricultural sector |
|||
|
Name and address of the granting authority |
|
|||
|
Other information |
— |
The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:
http://ec.europa.eu/community_law/state_aids/
|
Date of adoption of the decision |
2.7.2008 |
|||
|
Reference number of the aid |
N 643/07 |
|||
|
Member State |
Italy |
|||
|
Region |
Marche |
|||
|
Title (and/or name of the beneficiary) |
Tutela delle risorse genetiche vegetali |
|||
|
Legal basis |
Legge regionale 3 giugno 2003 n. 12 «Tutela delle risorse genetiche animali e vegetali del territorio marchigiano». Legge regionale 17 dicembre 2004 n. 28 «Integrazione e modifica della legge regionale 3 giugno 2003 n. 12 — Tutela delle risorse genetiche animali e vegetali del territorio marchigiano» |
|||
|
Type of measure |
Aid scheme |
|||
|
Objective |
Agri-environmental commitments aiming at preservation of plant genetic resources under threat of genetic erosion |
|||
|
Form of aid |
Direct grant |
|||
|
Budget |
EUR 20 000 per year |
|||
|
Intensity |
Variable, max. EUR 600/ha |
|||
|
Duration |
2008-2013 |
|||
|
Economic sectors |
Agricultural sector |
|||
|
Name and address of the granting authority |
|
|||
|
Other information |
— |
The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:
http://ec.europa.eu/community_law/state_aids/
|
Date of adoption of the decision |
22.7.2008 |
|
Reference number of the aid |
N 182/08 |
|
Member State |
Federal Republic of Germany |
|
Region |
Thüringen |
|
Title (and/or name of the beneficiary) |
Schutz des Waldbodens |
|
Legal basis |
§ 44 LHO |
|
Type of measure |
Aid scheme |
|
Objective |
Forest soil protection |
|
Form of aid |
Grant |
|
Budget |
EUR 975 000 per year |
|
Intensity |
100 % |
|
Duration |
Until 31.12.2013 |
|
Economic sectors |
Agriculture |
|
Name and address of the granting authority |
— |
|
Other information |
— |
The authentic text(s) of the decision, from which all confidential information has been removed, can be found at:
http://ec.europa.eu/community_law/state_aids/
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES
Commission
|
29.8.2008 |
EN |
Official Journal of the European Union |
C 220/4 |
Euro exchange rates (1)
28 August 2008
(2008/C 220/02)
1 euro=
|
|
Currency |
Exchange rate |
|
USD |
US dollar |
1,4771 |
|
JPY |
Japanese yen |
161,44 |
|
DKK |
Danish krone |
7,4584 |
|
GBP |
Pound sterling |
0,8047 |
|
SEK |
Swedish krona |
9,438 |
|
CHF |
Swiss franc |
1,6108 |
|
ISK |
Iceland króna |
121,81 |
|
NOK |
Norwegian krone |
7,917 |
|
BGN |
Bulgarian lev |
1,9558 |
|
CZK |
Czech koruna |
24,703 |
|
EEK |
Estonian kroon |
15,6466 |
|
HUF |
Hungarian forint |
238,56 |
|
LTL |
Lithuanian litas |
3,4528 |
|
LVL |
Latvian lats |
0,7035 |
|
PLN |
Polish zloty |
3,3498 |
|
RON |
Romanian leu |
3,5547 |
|
SKK |
Slovak koruna |
30,307 |
|
TRY |
Turkish lira |
1,7568 |
|
AUD |
Australian dollar |
1,7045 |
|
CAD |
Canadian dollar |
1,5456 |
|
HKD |
Hong Kong dollar |
11,5322 |
|
NZD |
New Zealand dollar |
2,0958 |
|
SGD |
Singapore dollar |
2,0917 |
|
KRW |
South Korean won |
1 597,85 |
|
ZAR |
South African rand |
11,3987 |
|
CNY |
Chinese yuan renminbi |
10,0849 |
|
HRK |
Croatian kuna |
7,163 |
|
IDR |
Indonesian rupiah |
13 530,24 |
|
MYR |
Malaysian ringgit |
5,0037 |
|
PHP |
Philippine peso |
67,5 |
|
RUB |
Russian rouble |
36,2855 |
|
THB |
Thai baht |
50,369 |
|
BRL |
Brazilian real |
2,3922 |
|
MXN |
Mexican peso |
14,9844 |
Source: reference exchange rate published by the ECB.
|
29.8.2008 |
EN |
Official Journal of the European Union |
C 220/5 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2008 to 31 July 2008
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
(2008/C 220/03)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 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 |
||||||
|
2.7.2008 |
RELISTOR |
Methylnaltrexone bromide |
|
EU/1/08/463/001-003 |
Solution for injection |
(Non applicable) |
4.7.2008 |
||||||
|
3.7.2008 |
Trevaclyn |
Nicotinic acid/laropiprant |
|
EU/1/08/458/001-011 |
Modified-release tablet |
C10AD52 |
7.7.2008 |
||||||
|
3.7.2008 |
Pelzont |
Nicotinic acid/laropiprant |
|
EU/1/08/460/001-011 |
Modified-release tablet |
C10AD52 |
7.7.2008 |
||||||
|
3.7.2008 |
Tredaptive |
Nicotinic acid/laropiprant |
|
EU/1/08/459/001-011 |
Modified-release tablet |
C10AD52 |
7.7.2008 |
||||||
|
9.7.2008 |
Latixa |
Ranolazine |
|
EU/1/08/462/001-006 |
Prolonged release tablet |
C01EB18 |
14.7.2008 |
||||||
|
11.7.2008 |
Firazyr |
Icatibant |
|
EU/1/08/461/001 |
Solution for injection |
(Non applicable) |
15.7.2008 |
||||||
|
16.7.2008 |
Clopidogrel BMS |
Clopidogrel |
|
EU/1/08/464/001-017 |
Film-coated tablet |
B01AC04 |
18.7.2008 |
||||||
|
16.7.2008 |
Clopidogrel Winthrop |
Clopidogrel |
|
EU/1/08/465/001-017 |
Film-coated tablet |
B01AC04 |
18.7.2008 |
||||||
|
16.7.2008 |
Janumet |
Sitagliptin/metformin hydrochloride |
|
EU/1/08/455/001-014 |
Film-coated tablet |
A10BD07 |
18.7.2008 |
||||||
|
16.7.2008 |
Efficib |
Sitagliptin/metformin hydrochloride |
|
EU/1/08/457/001-014 |
Film-coated tablet |
A10BD07 |
18.7.2008 |
||||||
|
16.7.2008 |
Velmetia |
Sitagliptin/metformin hydrochloride |
|
EU/1/08/456/001-014 |
Film-coated tablet |
A10BD07 |
18.7.2008 |
||||||
|
25.7.2008 |
Bridion |
Sugammadex |
|
EU/1/08/466/001-002 |
Solution for injection |
V03AB35 |
29.7.2008 |
||||||
|
25.7.2008 |
Doribax |
Doripenem |
|
EU/1/08/467/001 |
Powder for solution for infusion |
J01DH04 |
29.7.2008 |
— Modification of a marketing authorization (Article 13 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 |
|||||||
|
2.7.2008 |
PritorPlus |
|
EU/1/02/215/001-021 |
7.7.2008 |
|||||||
|
2.7.2008 |
Epivir |
|
EU/1/96/015/001-005 |
4.7.2008 |
|||||||
|
2.7.2008 |
Pritor |
|
EU/1/98/089/001-022 |
4.7.2008 |
|||||||
|
2.7.2008 |
INCRELEX |
|
EU/1/07/402/001 |
4.7.2008 |
|||||||
|
3.7.2008 |
Kinzalkomb |
|
EU/1/02/214/001-015 |
7.7.2008 |
|||||||
|
3.7.2008 |
Micardis |
|
EU/1/98/090/001-020 |
7.7.2008 |
|||||||
|
3.7.2008 |
Aranesp |
|
EU/1/01/185/001-073 |
7.7.2008 |
|||||||
|
3.7.2008 |
Nespo |
|
EU/1/01/184/001-073 |
7.7.2008 |
|||||||
|
4.7.2008 |
Mabthera |
|
EU/1/98/067/001-002 |
8.7.2008 |
|||||||
|
4.7.2008 |
Rotarix |
|
EU/1/05/330/001-004 |
8.7.2008 |
|||||||
|
4.7.2008 |
MabCampath |
|
EU/1/01/193/001-002 |
8.7.2008 |
|||||||
|
4.7.2008 |
Prezista |
|
EU/1/06/380/001 |
8.7.2008 |
|||||||
|
4.7.2008 |
MicardisPlus |
|
EU/1/02/213/001-023 |
8.7.2008 |
|||||||
|
4.7.2008 |
Kinzalmono |
|
EU/1/98/091/001-014 |
8.7.2008 |
|||||||
|
4.7.2008 |
Zometa |
|
EU/1/01/176/001-006 |
8.7.2008 |
|||||||
|
7.7.2008 |
TOVIAZ |
|
EU/1/07/386/001-012 |
9.7.2008 |
|||||||
|
7.7.2008 |
Vasovist |
|
EU/1/05/313/001-009 |
9.7.2008 |
|||||||
|
7.7.2008 |
Kepivance |
|
EU/1/05/314/001 |
9.7.2008 |
|||||||
|
7.7.2008 |
Telzir |
|
EU/1/04/282/001-002 |
9.7.2008 |
|||||||
|
7.7.2008 |
Invirase |
|
EU/1/96/026/001-002 |
9.7.2008 |
|||||||
|
7.7.2008 |
Tamiflu |
|
EU/1/02/222/001-004 |
9.7.2008 |
|||||||
|
7.7.2008 |
Siklos |
|
EU/1/07/397/001 |
9.7.2008 |
|||||||
|
7.7.2008 |
Enbrel |
|
EU/1/99/126/001-018 |
9.7.2008 |
|||||||
|
7.7.2008 |
Aldara |
|
EU/1/98/080/001 |
9.7.2008 |
|||||||
|
7.7.2008 |
Aptivus |
|
EU/1/05/315/001 |
9.7.2008 |
|||||||
|
8.7.2008 |
Zalasta |
|
EU/1/07/415/001-056 |
10.7.2008 |
|||||||
|
8.7.2008 |
Binocrit |
|
EU/1/07/410/001-020 |
10.7.2008 |
|||||||
|
8.7.2008 |
Fuzeon |
|
EU/1/03/252/001-003 |
10.7.2008 |
|||||||
|
8.7.2008 |
Epoetin alfa Hexal |
|
EU/1/07/411/001-020 |
10.7.2008 |
|||||||
|
8.7.2008 |
Busilvex |
|
EU/1/03/254/002 |
10.7.2008 |
|||||||
|
9.7.2008 |
Rasilez |
|
EU/1/07/405/001-020 |
11.7.2008 |
|||||||
|
9.7.2008 |
Exubera |
|
EU/1/05/327/001-018 |
11.7.2008 |
|||||||
|
9.7.2008 |
Cholestagel |
|
EU/1/03/268/001-003 |
11.7.2008 |
|||||||
|
9.7.2008 |
Circadin |
|
EU/1/07/392/001-002 |
11.7.2008 |
|||||||
|
9.7.2008 |
Pedea |
|
EU/1/04/284/001 |
11.7.2008 |
|||||||
|
9.7.2008 |
Sprimeo |
|
EU/1/07/407/001-020 |
11.7.2008 |
|||||||
|
9.7.2008 |
Enviage |
|
EU/1/07/406/001-020 |
11.7.2008 |
|||||||
|
9.7.2008 |
Tekturna |
|
EU/1/07/408/001-020 |
11.7.2008 |
|||||||
|
9.7.2008 |
Riprazo |
|
EU/1/07/409/001-020 |
11.7.2008 |
|||||||
|
10.7.2008 |
Bonviva |
|
EU/1/03/265/003-004 |
14.7.2008 |
|||||||
|
10.7.2008 |
Bondenza |
|
EU/1/03/266/003-004 |
14.7.2008 |
|||||||
|
10.7.2008 |
Optaflu |
|
EU/1/07/394/001-009 |
14.7.2008 |
|||||||
|
10.7.2008 |
ViraferonPeg |
|
EU/1/00/132/001-050 |
14.7.2008 |
|||||||
|
10.7.2008 |
Remicade |
|
EU/1/99/116/001-003 |
14.7.2008 |
|||||||
|
10.7.2008 |
Silgard |
|
EU/1/06/358/001-021 |
14.7.2008 |
|||||||
|
10.7.2008 |
PegIntron |
|
EU/1/00/131/001-050 |
14.7.2008 |
|||||||
|
10.7.2008 |
Gardasil |
|
EU/1/06/357/001-021 |
15.7.2008 |
|||||||
|
11.7.2008 |
Sustiva |
|
EU/1/99/110/001-009 |
15.7.2008 |
|||||||
|
11.7.2008 |
Stocrin |
|
EU/1/99/111/001-011 |
15.7.2008 |
|||||||
|
11.7.2008 |
Liprolog |
|
EU/1/01/195/022-027 |
15.7.2008 |
|||||||
|
17.7.2008 |
Zimulti |
|
EU/1/06/345/001-011 |
23.7.2008 |
|||||||
|
17.7.2008 |
Humira |
|
EU/1/03/256/001-010 |
23.7.2008 |
|||||||
|
17.7.2008 |
Erbitux |
|
EU/1/04/281/001-005 |
23.7.2008 |
|||||||
|
17.7.2008 |
ACOMPLIA |
|
EU/1/06/344/001-011 |
23.7.2008 |
|||||||
|
22.7.2008 |
Silapo |
|
EU/1/07/432/001-022 |
24.7.2008 |
|||||||
|
22.7.2008 |
Sprycel |
|
EU/1/06/363/001-009 |
24.7.2008 |
|||||||
|
22.7.2008 |
CUBICIN |
|
EU/1/05/328/001-002 |
24.7.2008 |
|||||||
|
23.7.2008 |
Prandin |
|
EU/1/00/162/003-005 EU/1/00/162/009-011 EU/1/00/162/015-017 EU/1/00/162/019-021 |
25.7.2008 |
|||||||
|
23.7.2008 |
Exjade |
|
EU/1/06/356/001-006 |
25.7.2008 |
|||||||
|
23.7.2008 |
NovoNorm |
|
EU/1/98/076/004-006 EU/1/98/076/011-013 EU/1/98/076/018-020 EU/1/98/076/022-024 |
25.7.2008 |
|||||||
|
23.7.2008 |
Quadramet |
|
EU/1/97/057/001 |
25.7.2008 |
|||||||
|
24.7.2008 |
Keppra |
|
EU/1/00/146/030 |
28.7.2008 |
|||||||
|
25.7.2008 |
Keppra |
|
EU/1/00/146/001-030 |
29.7.2008 |
|||||||
|
25.7.2008 |
REYATAZ |
|
EU/1/03/267/001-009 |
29.7.2008 |
|||||||
|
25.7.2008 |
Trisenox |
|
EU/1/02/204/001 |
29.7.2008 |
|||||||
|
25.7.2008 |
Myfenax |
|
EU/1/07/438/001-004 |
29.7.2008 |
|||||||
|
25.7.2008 |
Valtropin |
|
EU/1/06/335/001 |
— |
|||||||
|
25.7.2008 |
Zeffix |
|
EU/1/99/114/001-003 |
29.7.2008 |
|||||||
|
25.7.2008 |
Mycophenolate mofetil Teva |
|
EU/1/07/439/001-004 |
29.7.2008 |
|||||||
|
28.7.2008 |
Cymbalta |
|
EU/1/04/296/001-009 |
30.7.2008 |
|||||||
|
28.7.2008 |
Zyprexa |
|
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 |
30.7.2008 |
|||||||
|
28.7.2008 |
NovoMix |
|
EU/1/00/142/004-005 EU/1/00/142/009-022 |
30.7.2008 |
|||||||
|
28.7.2008 |
Xeristar |
|
EU/1/04/297/001-008 |
30.7.2008 |
|||||||
|
28.7.2008 |
Zostavax |
|
EU/1/06/341/001-013 |
30.7.2008 |
|||||||
|
28.7.2008 |
Zyprexa Velotab |
|
EU/1/99/125/001-016 |
30.7.2008 |
|||||||
|
28.7.2008 |
Prezista |
|
EU/1/06/380/001 |
30.7.2008 |
|||||||
|
28.7.2008 |
Vivanza |
|
EU/1/03/249/001-012 |
30.7.2008 |
|||||||
|
28.7.2008 |
Levitra |
|
EU/1/03/248/001-012 |
30.7.2008 |
|||||||
|
28.7.2008 |
Ventavis |
|
EU/1/03/255/001-006 |
30.7.2008 |
|||||||
|
28.7.2008 |
Viracept |
|
EU/1/97/054/001 EU/1/97/054/004-005 |
30.7.2008 |
|||||||
|
29.7.2008 |
Tracleer |
|
EU/1/02/220/001-005 |
31.7.2008 |
|||||||
|
29.7.2008 |
Remicade |
|
EU/1/99/116/001-003 |
31.7.2008 |
|||||||
|
29.7.2008 |
Velcade |
|
EU/1/04/274/001-002 |
31.7.2008 |
|||||||
|
29.7.2008 |
Angiox |
|
EU/1/04/289/001-002 |
31.7.2008 |
|||||||
|
29.7.2008 |
INCRELEX |
|
EU/1/07/402/001 |
31.7.2008 |
|||||||
|
29.7.2008 |
Naglazyme |
|
EU/1/05/324/001-002 |
31.7.2008 |
|||||||
|
29.7.2008 |
Circadin |
|
EU/1/07/392/001-002 |
31.7.2008 |
|||||||
|
29.7.2008 |
Telzir |
|
EU/1/04/282/001-002 |
31.7.2008 |
|||||||
|
29.7.2008 |
Pylobactell |
|
EU/1/98/064/001 |
1.8.2008 |
|||||||
|
31.7.2008 |
Revlimid |
|
EU/1/07/391/001-004 |
5.8.2008 |
|||||||
|
31.7.2008 |
DuoTrav |
|
EU/1/06/338/001-003 |
5.8.2008 |
|||||||
|
31.7.2008 |
ADROVANCE |
|
EU/1/06/364/001-009 |
5.8.2008 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 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 |
|||||
|
8.7.2008 |
Reconcile |
Fluoxétine |
|
EU/2/08/080/001-004 |
Chewable tablets |
QN06AB03 |
16.7.2008 |
|||||
|
24.7.2008 |
ZACTRAN |
Gamithromycine |
|
EU/2/08/082/001-003 |
Solution for injection |
QJ01FA95 |
28.7.2008 |
— 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 |
|||||
|
11.7.2008 |
Equilis Te |
|
EU/2/05/055/001-002 |
15.7.2008 |
|||||
|
11.7.2008 |
Equilis Prequenza Te |
|
EU/2/05/057/001-004 |
15.7.2008 |
|||||
|
11.7.2008 |
ProMeris |
|
EU/2/06/064/001-004 |
15.7.2008 |
|||||
|
31.7.2008 |
Poulvac FluFend H5N3 RG |
|
EU/2/06/060/001-002 |
5.8.2008 |
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, 30.4.2004, p. 1.
|
29.8.2008 |
EN |
Official Journal of the European Union |
C 220/17 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2008 to 31 July 2008
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council (1) or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council (2) )
(2008/C 220/04)
— 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 |
||||||
|
9.7.2008 |
Latixa |
|
This Decision is addressed to the Member States |
10.7.2008 |
||||||
|
11.7.2008 |
Alvesco |
See Annex I |
See Annex I |
14.7.2008 |
||||||
|
11.7.2008 |
Singulair |
See Annex II |
See Annex II |
14.7.2008 |
||||||
|
14.7.2008 |
Octegra |
See Annex III |
See Annex III |
15.7.2008 |
||||||
|
14.7.2008 |
Actira |
See Annex IV |
See Annex IV |
16.7.2008 |
||||||
|
14.7.2008 |
Avalox |
See Annex V |
See Annex V |
16.7.2008 |
||||||
|
22.7.2008 |
Oracea |
See Annex VI |
See Annex VI |
23.7.2008 |
||||||
|
23.7.2008 |
Lamictal |
See Annex VII |
See Annex VII |
28.7.2008 |
||||||
|
31.7.2008 |
Revlimid |
|
This Decision is addressed to the Member States |
4.8.2008 |
(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, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT(S), MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Invented Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||
|
Austria |
|
|
Alvesco 40 Mikrogramm Dosieraerosol |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Austria |
|
|
Alvesco 80 Mikrogramm Dosieraerosol |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Austria |
|
|
Alvesco 160 Mikrogramm Dosieraerosol |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Austria |
|
|
Amavio 40 Mikrogramm Dosieraerosol |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Austria |
|
|
Amavio 80 Mikrogramm Dosieraerosol |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Austria |
|
|
Amavio 160 Mikrogramm Dosieraerosol |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Belgium |
|
|
Alvesco 40 microgram, aërosol, oplossing |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Belgium |
|
|
Alvesco 80 microgram, aërosol, oplossing |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Belgium |
|
|
Alvesco 160 microgram, aërosol, oplossing |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Bulgaria |
|
|
Alvesco 40 Inhaler |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Bulgaria |
|
|
Alvesco 80 Inhaler |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Bulgaria |
|
|
Alvesco 160 Inhaler |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Cyprus |
|
|
Alvesco 40 micrograms Inhaler |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Cyprus |
|
|
Alvesco 80 micrograms Inhaler |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Cyprus |
|
|
Alvesco 160 micrograms Inhaler |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Czech Republic |
|
|
Alvesco 80 Inhaler |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Czech Republic |
|
|
Alvesco 160 Inhaler |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Denmark |
|
|
Alvesco 40 micrograms pressurised inhalation, solution |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Denmark |
|
|
Alvesco 80 micrograms pressurised inhalation, solution |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Denmark |
|
|
Alvesco 160 micrograms pressurised inhalation, solution |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Estonia |
|
|
Alvesco 40 micrograms pressurised inhalation, solution |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Estonia |
|
|
Alvesco 80 micrograms pressurised inhalation, solution |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Estonia |
|
|
Alvesco 160 micrograms pressurised inhalation, solution |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Finland |
|
|
Alvesco 40 micrograms pressurised inhalation, solution |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Finland |
|
|
Alvesco 80 micrograms pressurised inhalation, solution |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Finland |
|
|
Alvesco 160 micrograms pressurised inhalation, solution |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
France |
|
|
Alvesco 40 microgrammes, dose solution pour inhalation en flacon pressurisé |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
France |
|
|
Alvesco 80 microgrammes, dose solution pour inhalation en flacon pressurisé |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
France |
|
|
Alvesco 160 microgrammes, dose solution pour inhalation en flacon pressurisé |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Germany |
|
|
Alvesco 40 Mikrogramm Druckgasinhalation, Lösung |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Germany |
|
|
Alvesco 80 Mikrogramm Druckgasinhalation, Lösung |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Germany |
|
|
Alvesco 160 Mikrogramm Druckgasinhalation, Lösung |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Greece |
|
|
Alvesco 80 mcg/Dose |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Greece |
|
|
Alvesco 160 mcg/Dose |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Greece |
|
|
Freathe 80 mcg/Dose |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Greece |
|
|
Freathe 160 mcg/Dose |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Greece |
|
|
Amavio 80 mcg/Dose |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Greece |
|
|
Amavio 160 mcg/Dose |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Hungary |
|
|
Alvesco 40 mikrogramm túlnyomásos inhalációs oldat |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Hungary |
|
|
Alvesco 80 mikrogramm túlnyomásos inhalációs oldat |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Hungary |
|
|
Alvesco 160 mikrogramm túlnyomásos inhalációs oldat |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Iceland |
|
|
Alvesco 40 innúdalyf |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Iceland |
|
|
Alvesco 80 innúdalyf |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Iceland |
|
|
Alvesco 160 innúdalyf |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Ireland |
|
|
Alvesco 40 micrograms pressurised inhalation solution |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Ireland |
|
|
Alvesco 80 micrograms pressurised inhalation solution |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Ireland |
|
|
Alvesco 160 micrograms pressurised inhalation solution |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Italy |
|
|
Alvesco |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Italy |
|
|
Alvesco |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Italy |
|
|
Alvesco |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Latvia |
|
|
Alvesco 40 inhalators |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Latvia |
|
|
Alvesco 80 inhalators |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Latvia |
|
|
Alvesco 160 inhalators |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Lithuania |
|
|
Alvesco |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Lithuania |
|
|
Alvesco |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Lithuania |
|
|
Alvesco |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Luxembourg |
|
|
Alvesco 40 Aérosol doseur |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Luxembourg |
|
|
Alvesco 80 Aérosol doseur |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Luxembourg |
|
|
Alvesco 160 Aérosol doseur |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Malta |
|
|
Alvesco 40 Inhaler |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Malta |
|
|
Alvesco 80 Inhaler |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Malta |
|
|
Alvesco 160 Inhaler |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Netherlands |
|
|
Alvesco 40 Inhalator |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Netherlands |
|
|
Alvesco 80 Inhalator |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Netherlands |
|
|
Alvesco 160 Inhalator |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Norway |
|
|
Alvesco 40 micrograms/dose inhalasjonsaerosol, oppløsing |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Norway |
|
|
Alvesco 80 micrograms/dose inhalasjonsaerosol, oppløsing |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Norway |
|
|
Alvesco 160 micrograms/dose inhalasjonsaerosol, oppløsing |
160 μg |
Pressurised inhalation, Solution |
Inhalation use |
|||||
|
Poland |
|
|
Alvesco 40 |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Poland |
|
|
Alvesco 80 |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Poland |
|
|
Alvesco 160 |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Portugal |
|
|
Alvesco 40 Inalador |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Portugal |
|
|
Alvesco 80 Inalador |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Portugal |
|
|
Alvesco 160 Inalador |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Romania |
|
|
Alvesco 40 Inhaler |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Romania |
|
|
Alvesco 80 Inhaler |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Romania |
|
|
Alvesco 160 Inhaler |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Slovakia |
|
|
Alvesco 40 Inhalátor |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Slovakia |
|
|
Alvesco 80 Inhalátor |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Slovakia |
|
|
Alvesco 160 Inhalátor |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Slovenia |
|
|
Alvesco 40 μg inhalacijska raztopina pod tlakom |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Slovenia |
|
|
Alvesco 80 μg inhalacijska raztopina pod tlakom |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Slovenia |
|
|
Alvesco 160 μg inhalacijska raztopina pod tlakom |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Spain |
|
|
Alvesco 40 mcg solución para inhalación en envase a presión |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Spain |
|
|
Alvesco 80 mcg solución para inhalación en envase a presión |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Spain |
|
|
Alvesco 160 mcg solución para inhalación en envase a presión |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Sweden |
|
|
Alvesco |
40 μg/dose |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Sweden |
|
|
Alvesco |
80 μg/dose |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
Sweden |
|
|
Alvesco |
160 μg/dose |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
United Kingdom |
|
|
Alvesco 40 Inhaler |
40 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
United Kingdom |
|
|
Alvesco 80 Inhaler |
80 μg |
Pressurised inhalation, solution |
Inhalation use |
|||||
|
United Kingdom |
|
|
Alvesco 160 Inhaler |
160 μg |
Pressurised inhalation, solution |
Inhalation use |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
(Invented) name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
||||||
|
Austria |
|
Singulair 4 mg — Kautabletten für Kleinkinder |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Belgium |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Bulgaria |
|
Singulair |
4 mg |
Granules |
Oral use |
|
||||||
|
Bulgaria |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Cyprus |
|
Singulair |
4 mg |
Granules |
Oral use |
|
||||||
|
Cyprus |
|
Singulair Paediatric |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Czech Republic |
|
Singulair 4 Mini |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Denmark |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Estonia |
|
Singulair Mini 4 mg |
4 mg |
Granules |
Oral use |
|
||||||
|
Estonia |
|
Singulair 4 mg |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Finland |
|
Singulair |
4 mg |
Granules |
Oral use |
|
||||||
|
Finland |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Germany |
|
Singulair mini 4 mg Granulat |
4 mg |
Granules |
Oral use |
|
||||||
|
Germany |
|
Singulair mini 4 mg Kautabletten |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Greece |
|
Singulair |
4 mg |
Granules |
Oral use |
|
||||||
|
Greece |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Hungary |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Iceland |
|
Singulair |
4 mg |
Granules |
Oral use |
|
||||||
|
Iceland |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Ireland |
|
Singulair Paediatric |
4 mg |
Granules |
Oral use |
|
||||||
|
Ireland |
|
Singulair Paediatric |
4 mg |
Chewable Tablets |
Oral use |
4 mg |
||||||
|
Italy |
|
Singulair |
4 mg |
Granules |
Oral use |
|
||||||
|
Italy |
|
Montegen |
4 mg |
Granules |
Oral use |
|
||||||
|
Italy |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Italy |
|
Montegen |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Latvia |
|
Singulair mini 4 mg granulas |
4 mg |
Granules |
Oral use |
|
||||||
|
Latvia |
|
Singulair 4 mg košļājamās tabletes |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Lithuania |
|
Singulair Mini |
4 mg |
Granules |
Oral use |
|
||||||
|
Lithuania |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Luxembourg |
|
Singulair Mini |
4 mg |
Granules |
Oral use |
|
||||||
|
Luxembourg |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Malta |
|
Singulair Paediatric 4 mg Granules |
4 mg |
Granules |
Oral use |
|
||||||
|
Malta |
|
Singulair Paediatric 4 mg |
4 mg |
Chewable Tablets |
Oral use |
4 mg |
||||||
|
Netherlands |
|
Singulair Kleuter |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Norway |
|
Singulair |
4 mg |
Granules |
Oral use |
|
||||||
|
Norway |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Poland |
|
Singulair 4 |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Portugal |
|
Singulair Infantil 4 mg Granulado |
4 mg |
Granules |
Oral use |
|
||||||
|
Portugal |
|
Singulair Infantil |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Romania |
|
Singulair, granule, 4 mg/plic |
4 mg |
Granules |
Oral use |
|
||||||
|
Romania |
|
Singulair 4 mg, comprimate masticabile |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Slovenia |
|
Singulair 4 mg zrnca |
4 mg |
Granules |
Oral use |
|
||||||
|
Slovenia |
|
Singulair 4 mg žvečljive tablete |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Slovakia |
|
Singulair 4 mg |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Spain |
|
Singulair 4 mg granulado |
4 mg |
Granules |
Oral use |
|
||||||
|
Spain |
|
Singulair 4 mg comprimidos masticables |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
Sweden |
|
Singulair |
4 mg |
Granules |
Oral use |
|
||||||
|
Sweden |
|
Singulair |
4 mg |
Chewable tablets |
Oral use |
4 mg |
||||||
|
United Kingdom |
|
Singulair Paediatric 4 mg Granules |
4 mg |
Granules |
Oral use |
|
||||||
|
United Kingdom |
|
Singulair Paediatric 4 mg Chewable tablets |
4 mg |
Chewable Tablets |
Oral use |
4 mg |
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 |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
||||
|
Austria |
|
Octegra 400 mg — Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
||||
|
Belgium |
|
Proflox 400 mg |
400 mg |
Film-coated tablet |
Oral use |
||||
|
Germany |
|
Octegra 400 mg Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
||||
|
Greece |
|
Octegra |
400 mg |
Film-coated tablet |
Oral use |
||||
|
Spain |
|
Octegra 400 mg comprimidos recubiertos con película |
400 mg |
Film-coated tablet |
Oral use |
||||
|
France |
|
Octegra 400 mg, comprimé pelliculé |
400 mg |
Film-coated tablet |
Oral use |
||||
|
Italy |
|
Octegra |
400 mg |
Film-coated tablet |
Oral use |
||||
|
Luxembourg |
|
Proflox |
400 mg |
Film-coated tablet |
Oral use |
||||
|
Netherlands |
|
Octegra 400 mg tabletten |
400 mg |
Film-coated tablet |
Oral use |
||||
|
Portugal |
|
Proflox |
400 mg |
Film-coated tablet |
Oral use |
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 |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
|
Austria |
|
Actira 400 mg — Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Belgium |
|
Actira 400 mg |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Germany |
|
Actira 400 mg Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Denmark |
|
Actira |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Greece |
|
Proflox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Spain |
|
Actira 400 mg comprimidos recubiertos con película |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Finland |
|
Actira |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Actira |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Luxembourg |
|
Actira |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Portugal |
|
Actira |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Sweden |
|
Actira |
400 mg |
Film-coated tablet |
Oral use |
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 |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
|
Austria |
|
Avelox 400 mg — Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Belgium |
|
Avelox 400 mg |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Cyprus |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Czech Republic |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Germany |
|
Avalox 400 mg Filmtabletten |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Denmark |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Estonia |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Greece |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Spain |
|
Havelox 400 mg comprimidos recubiertos con película |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Finland |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
France |
|
Izilox 400 mg, comprimé pelliculé |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Hungary |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Ireland |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Italy |
|
Avalox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Lithuania |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Luxembourg |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Latvia |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Malta |
|
Avalox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Netherlands |
|
Avelox 400 mg tabletten |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Poland |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Portugal |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Sweden |
|
Avelox |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Slovenia |
|
Avelox 400 mg filmsko obložene tablete |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
Slovakia |
|
Avelox 400 |
400 mg |
Film-coated tablet |
Oral use |
|||||||
|
United Kingdom |
|
Avelox 400 mg Tablets |
400 mg |
Film-coated tablet |
Oral use |
ANNEX VI
LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Applicant |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
|||
|
Austria |
|
|
Oracea |
40 mg |
Modified-release capsule, hard |
Oral use |
|||
|
Finland |
|
|
Oracea |
40 mg |
Prolonged-release capsule, hard |
Oral use |
|||
|
Germany |
|
|
Oracea |
40 mg |
Prolonged-release capsule, hard |
Oral use |
|||
|
Ireland |
|
|
Oracea (1) |
40 mg |
Modified-release capsule, hard |
Oral use |
|||
|
Italy |
|
|
Oracea |
40 mg |
Prolonged-release capsule, hard |
Oral use |
|||
|
Luxembourg |
|
|
Oracea |
40 mg |
Prolonged-release capsule, hard |
Oral use |
|||
|
Netherlands |
|
|
Oracea (1) |
40 mg |
Prolonged-release capsule, hard |
Oral use |
|||
|
Sweden |
|
|
Oracea |
40 mg |
Modified-release capsule, hard |
Oral use |
|||
|
United Kingdom |
|
|
Oracea |
40 mg |
Prolonged-release capsule, hard |
Oral use |
(1) Name approval pending.
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 |
Marketing Authorisation Holder |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
||||||||||||
|
Austria |
|
Lamictal 5 mg — lösliche Tabletten |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Austria |
|
Lamictal 25 mg — lösliche Tabletten |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Austria |
|
Lamictal 50 mg — lösliche Tabletten |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Austria |
|
Lamictal 100 mg — lösliche Tabletten |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Austria |
|
Lamictal 200 mg — lösliche Tabletten |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal Dispersible 25 mg Starter-Pack Mono |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal Dispersible 25 mg Starter-Pack Add-on |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal Dispersible 50 mg Starter-Pack add-on |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal dispersible |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal dispersible |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal dispersible |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal dispersible |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal dispersible |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Belgium |
|
Lamictal dispersible |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Bulgaria |
|
Lamictal |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Bulgaria |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Bulgaria |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Bulgaria |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Cyprus |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Cyprus |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Cyprus |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Cyprus |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Cyprus |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Czech Republic |
|
Lamictal 25 mg |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Czech Republic |
|
Lamictal 50 mg |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Czech Republic |
|
Lamictal 100 mg |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Czech Republic |
|
Lamictal 2 mg |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Czech Republic |
|
Lamictal 5 mg |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Czech Republic |
|
Lamictal 25 mg |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Czech Republic |
|
Lamictal 50 mg |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Czech Republic |
|
Lamictal 100 mg |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Denmark |
|
Lamictal |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Denmark |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Denmark |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Denmark |
|
Lamictal |
200 mg |
Tablet |
Oral use |
||||||||||||
|
Denmark |
|
Lamictal |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Denmark |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Denmark |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Denmark |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Denmark |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Denmark |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Estonia |
|
Lamictal |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Estonia |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Estonia |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Estonia |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Estonia |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Estonia |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Finland |
|
Lamictal |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Finland |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Finland |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Finland |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Finland |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Finland |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
France |
|
Lamicstart 25 mg, comprimé |
25 mg |
Tablet |
Oral use |
||||||||||||
|
France |
|
Lamicstart 50 mg, comprimé |
50 mg |
Tablet |
Oral use |
||||||||||||
|
France |
|
Lamictal 2 mg, comprimé dispersible |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
France |
|
Lamictal 5 mg, comprimé dispersible ou à croquer |
5 mg |
Dispersible or chewable tablet |
Oral use |
||||||||||||
|
France |
|
Lamictal 25 mg, comprimé dispersible ou à croquer |
25 mg |
Dispersible or chewable tablet |
Oral use |
||||||||||||
|
France |
|
Lamictal 50 mg, comprimé dispersible ou à croquer |
50 mg |
Dispersible or chewable tablet |
Oral use |
||||||||||||
|
France |
|
Lamictal 100 mg, comprimé dispersible ou à croquer |
100 mg |
Dispersible or chewable tablet |
Oral use |
||||||||||||
|
France |
|
Lamictal 200 mg, comprimé dispersible ou à croquer |
200 mg |
Dispersible or chewable tablet |
Oral use |
||||||||||||
|
Germany |
|
Lamictal 2 mg Tabletten zur Herstellung einer Suspension zum Einnehmen |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Germany |
|
Lamictal 5 mg Tabletten zur Herstellung einer Suspension zum Einnehmen |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Germany |
|
Lamictal 25 mg Tabletten zur Herstellung einer Suspension zum Einnehmen |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Germany |
|
Lamictal 50 mg Tabletten zur Herstellung einer Suspension zum Einnehmen |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Germany |
|
Lamictal 100 mg Tabletten zur Herstellung einer Suspension zum Einnehmen |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Germany |
|
Lamictal 200 mg Tabletten zur Herstellung einer Suspension zum Einnehmen |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Greece |
|
Lamictal |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Greece |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Greece |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Greece |
|
Lamictal |
200 mg |
Tablet |
Oral use |
||||||||||||
|
Greece |
|
Lamictal |
2 mg |
Dispersible/Chewable tablets |
Oral use |
||||||||||||
|
Greece |
|
Lamictal |
5 mg |
Dispersible/Chewable tablets |
Oral use |
||||||||||||
|
Greece |
|
Lamictal |
25 mg |
Dispersible/Chewable tablets |
Oral use |
||||||||||||
|
Greece |
|
Lamictal |
50 mg |
Dispersible/Chewable tablets |
Oral use |
||||||||||||
|
Greece |
|
Lamictal |
100 mg |
Dispersible/Chewable tablets |
Oral use |
||||||||||||
|
Greece |
|
Lamictal |
200 mg |
Dispersible/Chewable tablets |
Oral use |
||||||||||||
|
Hungary |
|
Lamictal |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Hungary |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Hungary |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Hungary |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Hungary |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Iceland |
|
Lamictal |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Iceland |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Iceland |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Iceland |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Iceland |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Iceland |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Ireland |
|
Lamictal tablets 25 mg |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Ireland |
|
Lamictal tablets 50 mg |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Ireland |
|
Lamictal tablets 100 mg |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Ireland |
|
Lamictal tablets 200 mg |
200 mg |
Tablet |
Oral use |
||||||||||||
|
Ireland |
|
Lamictal 2 mg dispersible tablets |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Ireland |
|
Lamictal dispersible tablets 5 mg |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Ireland |
|
Lamictal dispersible tablets 25 mg |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Ireland |
|
Lamictal dispersible tablets 50 mg |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Ireland |
|
Lamictal dispersible tablets 100 mg |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Ireland |
|
Lamictal dispersible tablets 200 mg |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Italy |
|
Lamictal |
5 mg |
Dispersible Tablet |
Oral use |
||||||||||||
|
Italy |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Italy |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Italy |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Italy |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Latvia |
|
Lamictal 2 mg dispersible tablets |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Latvia |
|
Lamictal 5 mg dispersible tablets |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Latvia |
|
Lamictal 25 mg dispersible tablets |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Latvia |
|
Lamictal 50 mg dispersible tablets |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Latvia |
|
Lamictal 100 mg dispersible tablets |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Latvia |
|
Lamictal 200 mg dispersible tablets |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Lithuania |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Lithuania |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Lithuania |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Lithuania |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Lithuania |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal Dispersible 25mg Starter-Pack Mono |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal Dispersible 25mg Starter-Pack Add-on |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal Dispersible 50mg Starter-Pack add-on |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal dispersible |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal dispersible |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal dispersible |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal dispersible |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal dispersible |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Luxembourg |
|
Lamictal dispersible |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Malta |
|
Lamictal |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Malta |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Malta |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Malta |
|
Lamictal |
2 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Malta |
|
Lamictal |
5 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Malta |
|
Lamictal |
25 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Netherlands |
|
Lamictal 2 Dispers |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Netherlands |
|
Lamictal 5 Dispers |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Netherlands |
|
Lamictal 25 Dispers |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Netherlands |
|
Lamictal 50 Dispers |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Netherlands |
|
Lamictal 100 Dispers |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Netherlands |
|
Lamictal 200 Dispers |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Norway |
|
Lamictal |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Norway |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Norway |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Norway |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Norway |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Norway |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Poland |
|
Lamitrin |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Poland |
|
Lamitrin |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Poland |
|
Lamitrin |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Poland |
|
Lamitrin S |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Poland |
|
Lamitrin S |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Poland |
|
Lamitrin S |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Poland |
|
Lamitrin S |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Poland |
|
Lamitrin S |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Poland |
|
Lamitrin S |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Portugal |
|
Lamictal |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Portugal |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Portugal |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Portugal |
|
Lamictal |
200 mg |
Tablet |
Oral use |
||||||||||||
|
Portugal |
|
Lamictal |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Portugal |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Portugal |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Portugal |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Portugal |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Portugal |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Romania |
|
Lamictal 25 mg |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Romania |
|
Lamictal 50 mg |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Romania |
|
Lamictal 100 mg |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Romania |
|
Lamictal 2 mg |
2 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Romania |
|
Lamictal 5 mg |
5 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Romania |
|
Lamictal 25 mg |
25 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Romania |
|
Lamictal 100 mg |
100 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Slovakia |
|
Lamictal 25 mg |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Slovakia |
|
Lamictal 50 mg |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Slovakia |
|
Lamictal 100 mg |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Slovakia |
|
Lamictal 2 mg |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Slovakia |
|
Lamictal 5 mg |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Slovakia |
|
Lamictal 25 mg |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Slovakia |
|
Lamictal 100 mg |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Slovenia |
|
Lamictal 25 mg tablete |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Slovenia |
|
Lamictal 50 mg tablete |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Slovenia |
|
Lamictal 100 mg tablete |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Slovenia |
|
Lamictal 200 mg tablete |
200 mg |
Tablet |
Oral use |
||||||||||||
|
Slovenia |
|
Lamictal 5 mg disperzibilne/žvečljive tablete |
5 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Slovenia |
|
Lamictal 25 mg disperzibilne/žvečljive tablete |
25 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Slovenia |
|
Lamictal 50 mg disperzibilne/žvečljive tablete |
50 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Slovenia |
|
Lamictal 100 mg disperzibilne/žvečljive tablete |
100 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Slovenia |
|
Lamictal 200 mg disperzibilne/žvečljive tablete |
200 mg |
Dispersible/Chewable tablet |
Oral use |
||||||||||||
|
Spain |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Spain |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Spain |
|
Lamictal |
200 mg |
Tablet |
Oral use |
||||||||||||
|
Spain |
|
Lamictal |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Spain |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Spain |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Spain |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Spain |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Spain |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
Sweden |
|
Lamictal |
25 mg |
Tablet |
Oral use |
||||||||||||
|
Sweden |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
Sweden |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
Sweden |
|
Lamictal |
200 mg |
Tablet |
Oral use |
||||||||||||
|
Sweden |
|
Lamictal |
2 mg |
Soluble tablet |
Oral use |
||||||||||||
|
Sweden |
|
Lamictal |
5 mg |
Soluble tablet |
Oral use |
||||||||||||
|
Sweden |
|
Lamictal |
25 mg |
Soluble tablet |
Oral use |
||||||||||||
|
Sweden |
|
Lamictal |
50 mg |
Soluble tablet |
Oral use |
||||||||||||
|
Sweden |
|
Lamictal |
100 mg |
Soluble tablet |
Oral use |
||||||||||||
|
Sweden |
|
Lamictal |
200 mg |
Soluble tablet |
Oral use |
||||||||||||
|
United Kingdom |
|
Lamictal |
25 mg |
Tablet |
Oral use |
||||||||||||
|
United Kingdom |
|
Lamictal |
50 mg |
Tablet |
Oral use |
||||||||||||
|
United Kingdom |
|
Lamictal |
100 mg |
Tablet |
Oral use |
||||||||||||
|
United Kingdom |
|
Lamictal |
200 mg |
Tablet |
Oral use |
||||||||||||
|
United Kingdom |
|
Lamictal |
2 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
United Kingdom |
|
Lamictal |
5 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
United Kingdom |
|
Lamictal |
25 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
United Kingdom |
|
Lamictal |
50 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
United Kingdom |
|
Lamictal |
100 mg |
Dispersible tablet |
Oral use |
||||||||||||
|
United Kingdom |
|
Lamictal |
200 mg |
Dispersible tablet |
Oral use |
NOTICES FROM MEMBER STATES
|
29.8.2008 |
EN |
Official Journal of the European Union |
C 220/63 |
Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 70/2001 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises
(Text with EEA relevance)
(2008/C 220/05)
|
Aid No |
XS 136/08 |
|||
|
Member State |
Poland |
|||
|
Region |
Mazowieckie |
|||
|
Title of aid scheme or name of company receiving individual aid |
Przedsiębiorstwo techniczno handlowe Certech Jan Kuca, Jerzy Motyka Sp. z. o.o. |
|||
|
Legal basis |
Ustawa z dnia 8 października 2004 r. o zasadach finansowania nauki art. 10, Rozporządzenie Ministra Nauki i Szkolnictwa Wyższego, (Dz.U. 221 z 14.11.2007 r.), § 3 ust. 1, umowa nr II-191/P-226/2008 |
|||
|
Type of measure |
Ad hoc |
|||
|
Budget |
Overall budget: EUR 74 680 |
|||
|
Maximum aid intensity |
In conformity with Articles 4(2)-(6) and 5 of the Regulation |
|||
|
Date of implementation |
2.4.2008 |
|||
|
Duration |
2.4.2008 |
|||
|
Objective |
Small and medium-sized enterprises |
|||
|
Economic sectors |
All sectors eligible for aid to SMEs |
|||
|
Name and address of the granting authority |
|
|
Aid No |
XS 145/08 |
|||
|
Member State |
Estonia |
|||
|
Region |
— |
|||
|
Title of aid scheme or name of company receiving individual aid |
Teadus- ja arendustegevuse projektide toetamine |
|||
|
Legal basis |
Majandus- ja kommunikatsiooniministri 15. mai 2008. a määrus nr 40 „Teadus- ja arendustegevuse projektide toetamise tingimused ja kord” (RTL, 22.05.2008, 40, 560) https://www.riigiteataja.ee/ert/act.jsp?id=12962956 |
|||
|
Type of measure |
Aid scheme |
|||
|
Budget |
Annual budget: EUR 15 million |
|||
|
Maximum aid intensity |
In conformity with Articles 4(2)-(6) and 5 of the Regulation |
|||
|
Date of implementation |
25.5.2008 |
|||
|
Duration |
31.12.2013 |
|||
|
Objective |
Small and medium-sized enterprises |
|||
|
Economic sectors |
All manufacturing, Processing and marketing of agricultural products, All services |
|||
|
Name and address of the granting authority |
|
|
Aid No |
XS 147/08 |
|||||
|
Member State |
Lithuania |
|||||
|
Region |
— |
|||||
|
Title of aid scheme or name of company receiving individual aid |
Priemone „Idėja LT“ |
|||||
|
Legal basis |
2008 m. birželio 13 d. įsakymas Nr. 4-247 „Dėl priemones „Idėja LT“ projektu finansavimo sąlygų aprašo patvirtinimo“ (Žin., 2008, Nr. 70-2668) |
|||||
|
Type of measure |
Aid scheme |
|||||
|
Budget |
Annual budget: LTL 20 million |
|||||
|
Maximum aid intensity |
In conformity with Articles 4(2)-(6) and 5 of the Regulation |
|||||
|
Date of implementation |
19.6.2008 |
|||||
|
Duration |
31.12.2008 |
|||||
|
Objective |
Small and medium-sized enterprises |
|||||
|
Economic sectors |
All sectors eligible for aid to SMEs |
|||||
|
Name and address of the granting authority |
|
|
Aid No |
XS 151/08 |
|||
|
Member State |
Spain |
|||
|
Region |
La Rioja |
|||
|
Title of aid scheme or name of company receiving individual aid |
Bases reguladoras de la concesión de subvenciones a la inversión destinadas a pymes del sector industrial, comercio mayorista y de servicios |
|||
|
Legal basis |
Orden no 7/2008 de 3 de junio de 2008, de la Consejería de Industria, Innovación y Empleo, por la que se aprueban las Bases reguladoras de la concesión de subvenciones por la Agencia de Desarrollo Económico de La Rioja a la inversión destinadas a pymes del sector industrial, comercio mayorista y de servicios, en régimen de concurrencia competitiva (B.O.R. no 75/2008, de 7 de junio) |
|||
|
Type of measure |
Aid scheme |
|||
|
Budget |
Annual budget: EUR 4,45 million |
|||
|
Maximum aid intensity |
In conformity with Articles 4(2)-(6) and 5 of the Regulation |
|||
|
Date of implementation |
7.6.2008 |
|||
|
Duration |
31.12.2013 |
|||
|
Objective |
Small and medium-sized enterprises |
|||
|
Economic sectors |
All sectors eligible for aid to SMEs |
|||
|
Name and address of the granting authority |
Dirección Internet publicación régimen de ayuda: http://www.larioja.org/npRioja/default/defaultpage.jsp?idtab=449883 |
|
Aid No |
XS 155/08 |
|||
|
Member State |
Germany |
|||
|
Region |
Freie und Hansestadt Hamburg |
|||
|
Title of aid scheme or name of company receiving individual aid |
|
|||
|
Legal basis |
Verordnung (EG) Nr. 70/2001 der Kommission vom 12. Januar 2001 über die Anwendung der Artikel 87 und 88 des EG-Vertrags auf staatliche Beihilfen an kleine und mittlere Unternehmen (ABl. L 10 vom 13.1.2001, S. 33 verlängert durch ABl. L 368 vom 23.12.2006, S. 85); Gesetz über die Kreditkommission vom 29.4.1997 (Hamburgisches Gesetz- und Verordnungsblatt 1997, Nr. 18, Seite 133) |
|||
|
Type of measure |
Individual aid |
|||
|
Budget |
Overall budget: EUR 4 000 |
|||
|
Maximum aid intensity |
In conformity with Articles 4(2)-(6) and 5 of the Regulation |
|||
|
Date of implementation |
29.5.2008 |
|||
|
Duration |
29.11.2008 |
|||
|
Objective |
Small and medium-sized enterprises |
|||
|
Economic sectors |
Other services |
|||
|
Name and address of the granting authority |
|
|
29.8.2008 |
EN |
Official Journal of the European Union |
C 220/66 |
Information communicated by Member States regarding State aid granted under Commission Regulation (EC) No 68/2001 on the application of Articles 87 and 88 of the EC Treaty to training aid
(Text with EEA relevance)
(2008/C 220/06)
|
Reference number of the aid |
XT 70/08 |
|
Member State |
Portugal |
|
Region |
Todas as NUTS II de Portugal: Norte, Centro, Lisboa, Alentejo, Algarve, Região Autónoma dos Açores, Região Autónoma da Madeira |
|
Title (and/or name of the beneficiary) |
SI Inovação SI PME |
|
Legal basis |
Endereço do regime notificado http://www.pofc.qren.pt/ResourcesUser/Legislacao/Apoios_FormacaoProfissional.pdf (Está em curso a correcção do artigo 14.o do Regulamento notificado, substituindo «… regulamento referido no artigo 17.o, …» para «… regulamento referido no artigo 18.o, …») SI Inovação — Portaria n.o 1464/2007 Endereço http://www.pofc.qren.pt/ResourcesUser/Legislacao/P1464_07.pdf SI PME — Portaria n.o 1463/2007 Endereço http://www.pofc.qren.pt/ResourcesUser/Legislacao/Portaria1463_07.pdf |
|
Type of measure |
Aid scheme |
|
Budget |
Annual budget: EUR 200 million |
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
|
Date of implementation |
5.2.2008 |
|
Duration |
31.12.2013 |
|
Objective |
General training; Specific training |
|
Economic sectors |
Motor vehicles, Other manufacturing, Other transport services, Other services |
|
Name and address of the granting authority |
Programa Operacional Temático Factores de Competitividade (www.pofc.qren.pt) Programa Operacional Regional do Norte (www.ccdr-n.pt/novonorte) Programa Operacional Regional do Centro (http://www.ccdrc.pt/po-centro-2007-2013) Programa Operacional Regional de Lisboa (www.porlisboa.qren.pt) Programa Operacional Regional do Alentejo (www.ccdr-a.gov.pt/poaqren/) Programa Operacional Regional do Algarve (www.ccdr-alg.pt) Programa Operacional Regional da Madeira (www.idr.gov-madeira.pt/pt/legis_intervir.asp) Programa Operacional Regional dos Açores (www.proconvergencia.azores.gov.pt) |
|
Reference number of the aid |
XT 71/08 |
||
|
Member State |
Sweden |
||
|
Region |
— |
||
|
Title (and/or name of the beneficiary) |
Stöd till insatser på livsmedelsområdet |
||
|
Legal basis |
8 § förordningen (2008:80) om stöd till insatser på livsmedelsområdet |
||
|
Type of measure |
Aid scheme |
||
|
Budget |
Annual budget: SEK 21,48 million |
||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
||
|
Date of implementation |
1.5.2008 |
||
|
Duration |
31.12.2010 |
||
|
Objective |
General training |
||
|
Economic sectors |
Other manufacturing |
||
|
Name and address of the granting authority |
|
|
Reference number of the aid |
XT 72/08 |
|||
|
Member State |
Italy |
|||
|
Region |
Provincia autonoma di Trento |
|||
|
Title (and/or name of the beneficiary) |
Finanziamento di iniziative formative a favore dei lavoratori delle imprese riferibili alla gestione dei fondi di cui all'art. 9, comma 3, della legge 19 luglio 1993, n. 236 per l'anno 2008 — D. D. del ministero del Lavoro e della previdenza sociale 40/Cont/V/2007 |
|||
|
Legal basis |
Deliberazione della Giunta provinciale n. 1260 di data 23.5.2008 pubblicata sul Bollettino della Regione Trentino Alto Adige n. 23 di data 3.6.2008 |
|||
|
Type of measure |
Aid scheme |
|||
|
Budget |
Annual budget: EUR 1,70 million |
|||
|
Maximum aid intensity |
In conformity with Article 4(2)-(7) of the Regulation |
|||
|
Date of implementation |
3.6.2008 |
|||
|
Duration |
30.6.2008 |
|||
|
Objective |
Specific training |
|||
|
Economic sectors |
All sectors eligible for training aid |
|||
|
Name and address of the granting authority |
|