# Il-Ġurnal Uffiċjali C 121/2009

| | ISSN 1725-5198
  doi:10.3000/17255198.C_2009.121.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 121 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5229 ta' Mejju 2009 |

ISSN 1725-5198

doi:10.3000/17255198.C_2009.121.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 121

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5229 ta' Mejju 2009

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | II   Komunikazzjonijiet |
| | KOMUNIKAZZJONIJIET MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni |
| 2009/C 121/01 | Ebda oppożizzjoni għal konċentrazzjoni notifikata – (Każ COMP/M.5483 – TOSHIBA/FUJITSU HDD BUSINESS) (
  1
  ) | 1 |

Avviż Nru

Werrej

Paġna

II   Komunikazzjonijiet

KOMUNIKAZZJONIJIET MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA

Il-Kummissjoni

2009/C 121/01

Ebda oppożizzjoni għal konċentrazzjoni notifikata – (Każ COMP/M.5483 – TOSHIBA/FUJITSU HDD BUSINESS) (
  1
  )

1

1

| | IV   Informazzjoni |
| --- | --- |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni |
| 2009/C 121/02 | Rata tal-kambju tal-euro | 2 |
| 2009/C 121/03 | Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1-ta’ April 2009 sat-30-ta’ April 2009(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
  ) | 3 |
| 2009/C 121/04 | Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 April 2009 sal-30 April 2009(Deċiżjonijiet meħuda skond l-Artikolu 34 tad-Direttiva 2001/83/KE
  jew Artikolu 38 tad-Direttiva 2001/82/KE
  ) | 14 |

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA

Il-Kummissjoni

2009/C 121/02

Rata tal-kambju tal-euro

2

2009/C 121/03

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1-ta’ April 2009 sat-30-ta’ April 2009(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
  )

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill

)

3

2009/C 121/04

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 April 2009 sal-30 April 2009(Deċiżjonijiet meħuda skond l-Artikolu 34 tad-Direttiva 2001/83/KE
  jew Artikolu 38 tad-Direttiva 2001/82/KE
  )

(Deċiżjonijiet meħuda skond l-Artikolu 34 tad-Direttiva 2001/83/KE

jew Artikolu 38 tad-Direttiva 2001/82/KE

)

14

| | V   Avviżi |
| --- | --- |
| | PROĊEDURI GĦALL-IMPLIMENTAZZJONI TAL-POLITIKA TAL-KOMPETIZZJONI |
| | Il-Kummissjoni |
| 2009/C 121/05 | Notifika minn qabel ta' konċentrazzjoni – (Każ COMP/M.5520 – Itochu/Mitsubishi/Enolia/JV) – Każ li jista' jiġi kkunsidrat għal proċedura simplifikata (
  1
  ) | 27 |

V   Avviżi

PROĊEDURI GĦALL-IMPLIMENTAZZJONI TAL-POLITIKA TAL-KOMPETIZZJONI

Il-Kummissjoni

2009/C 121/05

Notifika minn qabel ta' konċentrazzjoni – (Każ COMP/M.5520 – Itochu/Mitsubishi/Enolia/JV) – Każ li jista' jiġi kkunsidrat għal proċedura simplifikata (
  1
  )

1

27

| | Corrigendum |
| --- | --- |
| 2009/C 121/06 | Rettifika għall-Awtorizzazzjoni tal-għajnuna Statali fil-qafas tad-Dispożizzjonijiet tal-Artikoli 87 u 88 tat-Trattat tal-KE – Fir-rigward ta' dawn il-każijiet il-Kummissjoni ma tqajjimx oġġezzjonijiet (ĠU C 112 tas-16.5.2009) | 28 |

Corrigendum

2009/C 121/06

Rettifika għall-Awtorizzazzjoni tal-għajnuna Statali fil-qafas tad-Dispożizzjonijiet tal-Artikoli 87 u 88 tat-Trattat tal-KE – Fir-rigward ta' dawn il-każijiet il-Kummissjoni ma tqajjimx oġġezzjonijiet (ĠU C 112 tas-16.5.2009)

(ĠU C 112 tas-16.5.2009)

28

| | |
| --- | --- |
| | (1)   Test b’relevanza għaż-ŻEE |

---

(1)   Test b’relevanza għaż-ŻEE

1

| MT | |
| --- | --- |

MT

---

II Komunikazzjonijiet

KOMUNIKAZZJONIJIET MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA

Il-Kummissjoni

| 29.5.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 121/1 |
| --- | --- | --- | --- |

29.5.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 121/1

---

Ebda oppożizzjoni għal konċentrazzjoni notifikata

(Każ COMP/M.5483 – TOSHIBA/FUJITSU HDD BUSINESS)

(Test b’relevanza għaż-ŻEE)

2009/C 121/01

Fil-11 ta’ Mejju 2009, il-Kummissjoni ddeċidiet li ma topponix il-konċentrazzjoni notifikata msemmija hawn fuq u li tiddikjaraha kompatibbli mas-suq komuni. Din id-deċiżjoni hi bbażata fuq l-Artikolu 6(1)(b) tar-Regolament tal-Kunsill (KE) Nru 139/2004. It-test kollu tad-deċiżjoni jinsab bl-Ingliż u se jkun ippubblikat wara li jkun meħlus minn kwalunkwe sigrieti tan-negozju li jista' jkun fih. Hu jinstab:

| — | mill-websajt tal-kompetizzjoni tal-Europa (http://ec.europa.eu/comm/competition/mergers/cases/). Dan il-websajt jipprovdi faċilitajiet varji biex jgħinu jinstabu deċiżjonijiet individwali ta' fużjoni, inklużi l-kumpanija, in-numru tal-każ, id-data u indiċi settorali, |
| --- | --- |

—

mill-websajt tal-kompetizzjoni tal-Europa (http://ec.europa.eu/comm/competition/mergers/cases/). Dan il-websajt jipprovdi faċilitajiet varji biex jgħinu jinstabu deċiżjonijiet individwali ta' fużjoni, inklużi l-kumpanija, in-numru tal-każ, id-data u indiċi settorali,

| — | f'forma elettronika fil-websajt EUR-Lex fid-dokument numru 32009M5483. EUR-Lex hu l-aċċess fuq l-internet għal-liġi Ewropea (http://eur-lex.europa.eu). |
| --- | --- |

—

f'forma elettronika fil-websajt EUR-Lex fid-dokument numru 32009M5483. EUR-Lex hu l-aċċess fuq l-internet għal-liġi Ewropea (http://eur-lex.europa.eu).

---

IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA

Il-Kummissjoni

| 29.5.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 121/2 |
| --- | --- | --- | --- |

29.5.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 121/2

---

Rata tal-kambju tal-euro (1)

It-28 ta’ Mejju 2009

2009/C 121/02

1 euro =

| | Munita | Rata tal-kambju |
| --- | --- | --- |
| USD | Dollaru Amerikan | 1,3856 |
| JPY | Yen Ġappuniż | 134,38 |
| DKK | Krona Daniża | 7,4445 |
| GBP | Lira Sterlina | 0,87000 |
| SEK | Krona Żvediża | 10,7353 |
| CHF | Frank Żvizzeru | 1,5117 |
| ISK | Krona Iżlandiża | |
| NOK | Krona Norveġiża | 8,9615 |
| BGN | Lev Bulgaru | 1,9558 |
| CZK | Krona Ċeka | 26,761 |
| EEK | Krona Estona | 15,6466 |
| HUF | Forint Ungeriż | 284,75 |
| LTL | Litas Litwan | 3,4528 |
| LVL | Lats Latvjan | 0,7093 |
| PLN | Zloty Pollakk | 4,4910 |
| RON | Leu Rumen | 4,1975 |
| TRY | Lira Turka | 2,1775 |
| AUD | Dollaru Awstraljan | 1,7753 |
| CAD | Dollaru Kanadiż | 1,5544 |
| HKD | Dollaru ta' Hong Kong | 10,7427 |
| NZD | Dollaru tan-New Zealand | 2,2223 |
| SGD | Dollaru tas-Singapor | 2,0146 |
| KRW | Won tal-Korea t'Isfel | 1 736,18 |
| ZAR | Rand ta' l-Afrika t'Isfel | 11,2268 |
| CNY | Yuan ren-min-bi Ċiniż | 9,4610 |
| HRK | Kuna Kroata | 7,3305 |
| IDR | Rupiah Indoneżjan | 14 306,32 |
| MYR | Ringgit Malażjan | 4,8669 |
| PHP | Peso Filippin | 65,504 |
| RUB | Rouble Russu | 43,3105 |
| THB | Baht Tajlandiż | 47,685 |
| BRL | Real Brażiljan | 2,8136 |
| MXN | Peso Messikan | 18,3176 |
| INR | Rupi Indjan | 65,9680 |

Munita

Rata tal-kambju

USD

Dollaru Amerikan

1,3856

JPY

Yen Ġappuniż

134,38

DKK

Krona Daniża

7,4445

GBP

Lira Sterlina

0,87000

SEK

Krona Żvediża

10,7353

CHF

Frank Żvizzeru

1,5117

ISK

Krona Iżlandiża

NOK

Krona Norveġiża

8,9615

BGN

Lev Bulgaru

1,9558

CZK

Krona Ċeka

26,761

EEK

Krona Estona

15,6466

HUF

Forint Ungeriż

284,75

LTL

Litas Litwan

3,4528

LVL

Lats Latvjan

0,7093

PLN

Zloty Pollakk

4,4910

RON

Leu Rumen

4,1975

TRY

Lira Turka

2,1775

AUD

Dollaru Awstraljan

1,7753

CAD

Dollaru Kanadiż

1,5544

HKD

Dollaru ta' Hong Kong

10,7427

NZD

Dollaru tan-New Zealand

2,2223

SGD

Dollaru tas-Singapor

2,0146

KRW

Won tal-Korea t'Isfel

1 736,18

ZAR

Rand ta' l-Afrika t'Isfel

11,2268

CNY

Yuan ren-min-bi Ċiniż

9,4610

HRK

Kuna Kroata

7,3305

IDR

Rupiah Indoneżjan

14 306,32

MYR

Ringgit Malażjan

4,8669

PHP

Peso Filippin

65,504

RUB

Rouble Russu

43,3105

THB

Baht Tajlandiż

47,685

BRL

Real Brażiljan

2,8136

MXN

Peso Messikan

18,3176

INR

Rupi Indjan

65,9680

---

(1)  Sors: rata tal-kambju ta' referenza ppubblikata mill-Bank Ċentrali Ewropew.

---

| 29.5.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 121/3 |
| --- | --- | --- | --- |

29.5.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 121/3

---

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali

mill-1-ta’ April 2009 sat-30-ta’ April 2009

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (1)
  )

2009/C 121/03

—   Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) Aċċettat

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | INN (Isem internazzjonal Mhux Proprjetarju) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Forma Farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data tan-notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.4.2009 | Rivastigmine Teva | rivastigmine | Teva Pharma B.V. |
| Computerweg 10 |
| 3542 DR Utrecht |
| NEDERLAND |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

INN (Isem internazzjonal Mhux Proprjetarju)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Forma Farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data tan-notifika

17.4.2009

Rivastigmine Teva

rivastigmine

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/513/001-020

Kapsula, iebsa

N06DA03

21.4.2009

17.4.2009

CONBRIZA

bazedoxifene

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Wyeth Europa Limited

Huntercombe Lane

South Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/09/511/001-004

Pillola miksija b’rita

G03XC02

21.4.2009

20.4.2009

Removab

catumaxomab

| Fresenius Biotech GmbH |
| --- |
| Am Haag 6-7 |
| 82166 Graefelfing |
| DEUTSCHLAND |

Fresenius Biotech GmbH

Am Haag 6-7

82166 Graefelfing

DEUTSCHLAND

EU/1/09/512/001-002

Konċentrat għal soluzzjoni għall-infużjoni

L01XC09

22.4.2009

21.4.2009

Exalief

Eslicarbazepine acetate

| BIAL - Portela & Ca, SA, A |
| --- |
| Av. da Siderurgia Nacional |
| 4745-457 S. Mamede do Coronado |
| PORTUGAL |

BIAL - Portela & Ca, SA, A

Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

PORTUGAL

EU/1/09/520/001-020

Pillola

N03AF04

23.4.2009

21.4.2009

Zebinix

Eslicarbazepine acetate

| BIAL - Portela & Ca, SA, A |
| --- |
| Av. da Siderurgia Nacional |
| 4745-457 S. Mamede do Coronado |
| PORTUGAL |

BIAL - Portela & Ca, SA, A

Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

PORTUGAL

EU/1/09/514/001-020

Pillola

N03AF04

23.4.2009

—   Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) Rifjutata

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 27.4.2009 | Sovrima | Santhera Pharmaceuticals (Deutschland) GmbH |
| Wallbrunnstr. 24 |
| 79539 Lörrach |
| DEUTSCHLAND |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Data tan-notifika

27.4.2009

Sovrima

Santhera Pharmaceuticals (Deutschland) GmbH

Wallbrunnstr. 24

79539 Lörrach

DEUTSCHLAND

—

29.4.2009

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) Aċċettata

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 2.4.2009 | Xarelto | Bayer Schering Pharma AG |
| 13342 Berlin |
| DEUTSCHLAND |
| Bayer HealthCare AG |
| 51368 Leverkusen |
| DEUTSCHLAND |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Data tan-notifika

2.4.2009

Xarelto

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/08/472/001-008

6.4.2009

2.4.2009

Altargo

| Glaxo Group Limited Glaxo Wellcome House |
| --- |
| Berkely Avenue Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited Glaxo Wellcome House

Berkely Avenue Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/07/390/001-004

4.4.2009

2.4.2009

Neupro

| Schwarz Pharma Ltd |
| --- |
| Shannon Industrial Estate |
| Co. Clare |
| IRELAND |

Schwarz Pharma Ltd

Shannon Industrial Estate

Co. Clare

IRELAND

EU/1/05/331/001-055

6.4.2009

2.4.2009

Abraxane

| Abraxis BioScience Limited |
| --- |
| Hatfield |
| AL10 9NA |
| UNITED KINGDOM |

Abraxis BioScience Limited

Hatfield

AL10 9NA

UNITED KINGDOM

EU/1/07/428/001

6.4.2009

2.4.2009

Combivir

| Glaxo Group Ltd |
| --- |
| Greenford Road Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd

Greenford Road Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/98/058/001-002

4.4.2009

3.4.2009

Optimark

| Covidien Deutschland GmbH |
| --- |
| Gewerbepark 1 |
| 93333 Neustadt/Donau |
| DEUTSCHLAND |

Covidien Deutschland GmbH

Gewerbepark 1

93333 Neustadt/Donau

DEUTSCHLAND

EU/1/07/398/001-014

8.4.2008

3.4.2009

Intrinsa

| Procter & Gamble Pharmaceuticals UK Ltd |
| --- |
| Rusham Park Technical Centre |
| Whitehall Lane |
| Egham Surrey |
| TW20 9NW |
| UNITED KINGDOM |

Procter & Gamble Pharmaceuticals UK Ltd

Rusham Park Technical Centre

Whitehall Lane

Egham Surrey

TW20 9NW

UNITED KINGDOM

EU/1/06/352/001-003

8.4.2009

3.4.2009

Livensa

| Procter & Gamble Pharmaceuticals - Germany GmbH |
| --- |
| Dr Otto-Röhm-Strasse 2-4 |
| 64331 Weiterstadt |
| DEUTSCHLAND |

Procter & Gamble Pharmaceuticals - Germany GmbH

Dr Otto-Röhm-Strasse 2-4

64331 Weiterstadt

DEUTSCHLAND

EU/1/06/351/001-003

8.4.2009

3.4.2009

Riprazo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/409/001-020

8.4.2009

3.4.2009

Enviage

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/406/001-020

8.4.2009

3.4.2009

Sprimeo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/407/001-020

8.4.2009

3.4.2009

Tekturna

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/408/001-020

8.4.2009

3.4.2009

Rasilez

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/405/001-020

8.4.2009

3.4.2009

YENTREVE

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| NEDERLAND |

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/280/001-008

8.4.2009

3.4.2009

DULOXETINE BOEHRINGER INGELHEIM

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/08/471/001-012

8.4.2009

7.4.2009

Vectibix

| Amgen Europe B.V. |
| --- |
| Minervum 7061 |
| 4817 ZK Breda |
| NEDERLAND |

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

NEDERLAND

EU/1/07/423/001-003

9.4.2009

7.4.2009

ADROVANCE

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/06/364/001-009

14.4.2009

7.4.2009

FOSAVANCE

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/05/310/001-009

14.4.2009

7.4.2009

Champix

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT 13 9NJ

UNITED KINGDOM

EU/1/06/360/001-012

9.4.2009

7.4.2009

Volibris

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/08/451/001-004

9.4.2009

7.4.2009

Irbesartan

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/06/375/001-033

9.4.2009

7.4.2009

PritorPlus

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/02/215/001-021

9.4.2009

7.4.2009

KOGENATE Bayer

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |
| Bayer HealthCare AG |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/00/143/001-011

9.4.2009

7.4.2009

Tasigna

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/422/001-004

9.4.2009

7.4.2009

Irbesartan HCT BMS

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/06/369/001-028

9.4.2009

7.4.2009

Helixate NexGen

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |
| Bayer HealthCare AG |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/00/144/001-004

9.4.2009

7.4.2009

Kinzalkomb

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/02/214/001-015

9.4.2009

7.4.2009

Nexavar

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |
| Bayer HealthCare AG |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/06/342/001

9.4.2009

7.4.2009

Fluticasone furoate GSK

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex |
| UB6 ONN |
| UNITED KINGDOM |

Glaxo Group Ltd

Greenford

Middlesex

UB6 ONN

UNITED KINGDOM

EU/1/08/474/001-003

9.4.2009

7.4.2009

Protopic

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19 |
| 2353 EW Leiderdorp |
| NEDERLAND |
| Astellas Pharma GmbH |
| Neumarkter Str. 61 |
| 81673 München |
| DEUTSCHLAND |

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

NEDERLAND

Astellas Pharma GmbH

Neumarkter Str. 61

81673 München

DEUTSCHLAND

EU/1/02/201/001-006

9.4.2009

7.4.2009

MIRCERA

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| UNITED KINGDOM |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/07/400/001-021

9.4.2009

7.4.2009

Integrilin

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/99/109/001-002

9.4.2009

7.4.2009

Ziagen

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/99/112/001-002

9.4.2009

7.4.2009

Avamys

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/07/434/001-003

9.4.2009

7.4.2009

MicardisPlus

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/02/213/001-023

9.4.2009

7.4.2009

Thyrogen

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10 |
| 1411 DD Naarden |
| NEDERLAND |

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/99/122/001-002

9.4.2009

8.4.2009

Irbesartan Winthrop

| Sanofi Pharma Bristol Myers Squibb SNC |
| --- |
| 174 avenue de France |
| 75013 Paris |
| FRANCE |

Sanofi Pharma Bristol Myers Squibb SNC

174 avenue de France

75013 Paris

FRANCE

EU/1/06/376/001-033

15.4.2009

8.4.2009

PEGASYS

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| UNITED KINGDOM |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/02/221/001-010

15.4.2009

16.4.2009

ReFacto AF

| Wyeth Europa Ltd |
| --- |
| Huntercombe Lane South Taplow |
| Maidenhead Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Wyeth Europa Ltd

Huntercombe Lane South Taplow

Maidenhead Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/99/103/001-004

20.4.2009

16.4.2009

Levemir

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| 2880 Bagsvaerd |
| DANMARK |

Novo Nordisk A/S

Novo Allé

2880 Bagsvaerd

DANMARK

EU/1/04/278/001-009

20.4.2009

16.4.2009

Thelin

| Encysive (UK) Limited |
| --- |
| Alder Castle House |
| 10 Noble Street |
| London |
| EC2V 7QJ |
| UNITED KINGDOM |

Encysive (UK) Limited

Alder Castle House

10 Noble Street

London

EC2V 7QJ

UNITED KINGDOM

EU/1/06/353/001-005

21.4.2009

17.4.2009

CUBICIN

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/05/328/001-002

21.4.2009

17.4.2009

Mirapexin

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/97/051/001-006

EU/1/97/051/009-012

21.4.2009

17.4.2009

Irbesartan HCT Winthrop

| Sanofi Pharma Bristol Myers Squibb SNC |
| --- |
| 174 avenue de France |
| 75013 Paris |
| FRANCE |

Sanofi Pharma Bristol Myers Squibb SNC

174 avenue de France

75013 Paris

FRANCE

EU/1/06/377/001-028

21.4.2009

17.4.2009

Sifrol

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/97/050/001-006

EU/1/97/050/009-012

21.4.2009

21.4.2009

Trisenox

| Cephalon Europe |
| --- |
| 5 Rue Charles Martigny |
| 94700 Maisons Alfort |
| Cedex |
| FRANCE |

Cephalon Europe

5 Rue Charles Martigny

94700 Maisons Alfort

Cedex

FRANCE

EU/1/02/204/001

23.4.2009

21.4.2009

Kivexa

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/04/298/001-003

23.4.2009

21.4.2009

Prepandrix

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals s.a.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/453/001

23.4.2009

21.4.2009

Tasigna

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/422/001-004

23.4.2009

21.4.2009

Pandemrix

| GlaxoSmithKline Biologicals s.a. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals s.a.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/08/452/001

23.4.2009

21.4.2009

Angiox

| The Medicines Company UK Ltd |
| --- |
| 115 L Milton Park |
| Abingdon |
| Oxfordshire |
| OX14 4SA |
| UNITED KINGDOM |

The Medicines Company UK Ltd

115 L Milton Park

Abingdon

Oxfordshire

OX14 4SA

UNITED KINGDOM

EU/1/04/289/001-002

23.4.2009

21.4.2009

Abilify

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House |
| Highbridge Business Park |
| Oxford Road |
| Uxbridge |
| Middlesex |
| UB8 1HU |
| UNITED KINGDOM |

Otsuka Pharmaceutical Europe Ltd

Hunton House

Highbridge Business Park

Oxford Road

Uxbridge

Middlesex

UB8 1HU

UNITED KINGDOM

EU/1/04/276/001-020

EU/1/04/276/024-036

23.4.2009

21.4.2009

ISENTRESS

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/436/001-002

23.4.2009

21.4.2009

Renagel

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10 |
| 1411 DD Naarden |
| NEDERLAND |

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/99/123/005-012

23.4.2009

22.4.2009

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge |
| CB21 6GT |
| UNITED KINGDOM |

Gilead Sciences International Limited

Cambridge

CB21 6GT

UNITED KINGDOM

EU/1/01/200/001-002

24.4.2009

22.4.2009

Liprolog

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| NEDERLAND |

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/01/195/022-027

24.4.2009

22.4.2009

Sustiva

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/99/110/001-005

EU/1/99/110/008-010

24.4.2009

22.4.2009

Stocrin

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/99/111/001-005

EU/1/99/111/008-011

24.4.2009

22.4.2009

BeneFIX

| Wyeth Europa Ltd |
| --- |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Wyeth Europa Ltd

Huntercombe Lane

South Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/97/047/001-007

24.4.2009

22.4.2009

Rebif

| Serono Europe Limited |
| --- |
| 56 Marsh Wall |
| London |
| E14 9TP |
| UNITED KINGDOM |

Serono Europe Limited

56 Marsh Wall

London

E14 9TP

UNITED KINGDOM

EU/1/98/063/001-010

24.4.2009

22.4.2009

Cervarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| Rue de l'Institut 89 |
| 1330 Rixensart |
| BELGIQUE |

GlaxoSmithKline Biologicals S.A.

Rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/07/419/001-012

24.4.2009

22.4.2009

Enviage

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/406/001-020

24.4.2009

22.4.2009

Riprazo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/409/001-020

24.4.2009

22.4.2009

Tekturna

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/408/001-020

24.4.2009

22.4.2009

Rasilez

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/405/001-020

24.4.2009

22.4.2009

Sprimeo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/07/407/001-020

27.4.2009

23.4.2009

Rebetol

| Schering Plough Europe |
| --- |
| Rue de Stalle 73/Stallestraat 73 |
| 1180 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

Schering Plough Europe

Rue de Stalle 73/Stallestraat 73

1180 Bruxelles/Brussel

BELGIQUE/BELGIË

EU/1/99/107/001-005

28.4.2009

23.4.2009

Corlentor

| Les Laboratoires Servier |
| --- |
| 22, rue Garnier |
| 92200 Neuilly-sur-Seine |
| FRANCE |

Les Laboratoires Servier

22, rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/05/317/001-014

7.5.2009

23.4.2009

Procoralan

| Les Laboratoires Servier |
| --- |
| 22, rue Garnier |
| 92200 Neuilly-sur-Seine |
| FRANCE |

Les Laboratoires Servier

22, rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/05/316/001-014

7.5.2009

23.4.2009

INTELENCE

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIË |

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/08/468/001

28.4.2009

23.4.2009

EVICEL

| OMRIX biopharmaceuticals S.A./N.V. |
| --- |
| 200 Chaussée de Waterloo/Waterloosesteenweg 200 |
| 1640 Rhode-St-Genèse/1640 Sint-Genesius-Rode |
| BELGIQUE/BELGIË |

OMRIX biopharmaceuticals S.A./N.V.

200 Chaussée de Waterloo/Waterloosesteenweg 200

1640 Rhode-St-Genèse/1640 Sint-Genesius-Rode

BELGIQUE/BELGIË

EU/1/08/473/001-003

28.4.2009

24.4.2009

KOGENATE Bayer

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/00/143/001-011

28.4.2009

24.4.2009

Helixate NexGen

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/00/144/001-004

28.4.2009

27.4.2009

Advagraf

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19 |
| 2353 EW Leiderdorp |
| NEDERLAND |

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

NEDERLAND

EU/1/07/387/001-013

29.4.2009

29.4.2009

Glivec

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex |
| RH12 5AB |
| UNITED KINGDOM |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

UNITED KINGDOM

EU/1/01/198/001-013

5.5.2009

29.4.2009

Evoltra

| Genzyme Europe BV |
| --- |
| Gooimeer 10 |
| 1411 DD Naarden |
| NEDERLAND |

Genzyme Europe BV

Gooimeer 10

1411 DD Naarden

NEDERLAND

EU/1/06/334/001-004

5.5.2009

29.4.2009

Rapamune

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane |
| South Taplow |
| Maidenhead |
| Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Wyeth Europa Limited

Huntercombe Lane

South Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/01/171/001

EU/1/01/171/007-010

5.5.2009

30.4.2009

NovoRapid

| Novo Nordisk A/S, Novo Allé |
| --- |
| 2880 Bagsvaerd |
| DANMARK |

Novo Nordisk A/S, Novo Allé

2880 Bagsvaerd

DANMARK

EU/1/99/119/001

EU/1/99/119/003

EU/1/99/119/005-015

5.5.2009

30.4.2009

TachoSil

| Nycomed Austria GmbH |
| --- |
| St.-Peter-Strasse 25 |
| 4020 Linz |
| ÖSTERREICH |

Nycomed Austria GmbH

St.-Peter-Strasse 25

4020 Linz

ÖSTERREICH

EU/1/04/277/001-004

5.5.2009

30.4.2009

Xagrid

| Shire Pharmaceutical Contracts Ltd |
| --- |
| Hampshire International Business Park |
| Chineham |
| Basingstoke |
| Hampshire |
| RG24 8EP |
| UNITED KINGDOM |

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham

Basingstoke

Hampshire

RG24 8EP

UNITED KINGDOM

EU/1/04/295/001

5.5.2009

30.4.2009

Kentera

| Nicobrand Limited |
| --- |
| 189 Castleroe Road |
| Coleraine |
| Northern Ireland |
| BT51 3 RP |
| UNITED KINGDOM |

Nicobrand Limited

189 Castleroe Road

Coleraine

Northern Ireland

BT51 3 RP

UNITED KINGDOM

EU/1/03/270/001-003

5.5.2009

—   Sospensjoni ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 20 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 17.4.2009 | Raptiva | Serono Europe Limited |
| 56 Marsh Wall |
| London |
| E14 9TP |
| UNITED KINGDOM |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Data tan-notifika

17.4.2009

Raptiva

Serono Europe Limited

56 Marsh Wall

London

E14 9TP

UNITED KINGDOM

EU/1/04/291/001-003

21.4.2009

—   Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) Aċċettat

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | INN (Isem internazzjonal Mhux Proprjetarju) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Forma Farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data tan-notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.4.2009 | Netvax | Toksojd Clostridium perfringens tip A alpha | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| NEDERLAND |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

INN (Isem internazzjonal Mhux Proprjetarju)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Forma Farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data tan-notifika

16.4.2009

Netvax

Toksojd Clostridium perfringens tip A alpha

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/09/093/001-002

Emulsjoni għall-injezzjoni

QI01A08

20.4.2009

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) Aċċettata

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 27.4.2009 | Equilis StrepE | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| NEDERLAND |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Data tan-notifika

27.4.2009

Equilis StrepE

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/04/043/001

29.4.2009

Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika fuq il-prodotti mediċinali in kwistjoni u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| L-Aġenzija Ewropea tal-Mediċini |
| --- |
| 7 Westferry Circus |
| Canary Wharf |
| Londra |
| E14 4HB |
| UNITED KINGDOM |

L-Aġenzija Ewropea tal-Mediċini

7 Westferry Circus

Canary Wharf

Londra

E14 4HB

UNITED KINGDOM

---

(1)  ĠU L 136, 30.4.2004, p 1.

---

| 29.5.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 121/14 |
| --- | --- | --- | --- |

29.5.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 121/14

---

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 April 2009 sal-30 April 2009

(Deċiżjonijiet meħuda skond l-Artikolu 34 tad-Direttiva 2001/83/KE
   (1)
  jew Artikolu 38 tad-Direttiva 2001/82/KE
   (2)
  )

2009/C 121/04

—   Ħruġ, manteniment jew modifikazzjoni ta’ l-awtorizazzjonijiet nazzjonali tat-tqegħid fis-suq

| Data tad-Deċiżjoni | Isem(ijiet) tal-prodott mediċinali | Detentur(i) ta’ l-awtorizazzjoni għat-tqegħid fis-suq | Stat Membru konċernat | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 17.4.2009 | Thelin | Encysive (UK) Limited |
| Alder Castle House |
| 10 Noble Street |
| London |
| EC2V 7QJ |
| UNITED KINGDOM |

Data tad-Deċiżjoni

Isem(ijiet) tal-prodott mediċinali

Detentur(i) ta’ l-awtorizazzjoni għat-tqegħid fis-suq

Stat Membru konċernat

Data tan-notifika

17.4.2009

Thelin

Encysive (UK) Limited

Alder Castle House

10 Noble Street

London

EC2V 7QJ

UNITED KINGDOM

Din id-Deċiżjoni hija indirizzata lill-Istati Membri

21.4.2009

30.4.2009

alpha2-adrenoreceptor agonist (romifidine, xylazine, detomidine jew medetomidine)

Ara l-Anness I

Ara l-Anness I

5.5.2009

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS I

PAJJIŻ, ISEM IVVINTAT TAL-PRODOTT, SUSTANZA ATTIVA, NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ, DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ IKKONĊERNAT MILL-PROĊEDURA

| Pajjiż | Isem ivvintat tal-prodott | Sustanza attiva | Numru tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq |
| --- | --- | --- | --- | --- |
| AT | Rompun | Xylazine | 14840 | Bayer Austria GmbH |
| AT | Chanazine 2 % | Xylazine | 8-00448 | Chanelle Pharmaceuticals Manufacturing Ltd |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Pajjiż

Isem ivvintat tal-prodott

Sustanza attiva

Numru tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

AT

Rompun

Xylazine

14840

Bayer Austria GmbH

AT

Chanazine 2 %

Xylazine

8-00448

Chanelle Pharmaceuticals Manufacturing Ltd

Dublin Road

Loughrea

Co. Galway

IRELAND

AT

Domosedan

Detomidine

8-00128

| Pfizer Animal Health BV |
| --- |
| Postbus 37 |
| 2900 AA Capell a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Postbus 37

2900 AA Capell a/d Ijssel

THE NETHERLANDS

AT

Domitor

Medetomidine

8-00144

| Pfizer Animal Health B, |
| --- |
| Postbus 37 |
| 2900 AA Capell a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health B,

Postbus 37

2900 AA Capell a/d Ijssel

THE NETHERLANDS

BE

Rompun 2 %

Xylazine hydrochloride

0187IS0155F012

| BAYER N.V. |
| --- |
| Louizalaan 143 |
| 1050 Brussel |
| BELGIUM |

BAYER N.V.

Louizalaan 143

1050 Brussel

BELGIUM

BE

Rompun Droge Stof

Xylazine hydrochloride

0187IS0120F012

| BAYER N.V. |
| --- |
| Louizalaan 143 |
| 1050 Brussel |
| BELGIUM |

BAYER N.V.

Louizalaan 143

1050 Brussel

BELGIUM

BE

Domosedan 10 mg/ml

Detomidine hydrochloride

0419IS0001F012

| PFIZER ANIMAL HEALTH S.A. |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain La Neuve |
| BELGIUM |

PFIZER ANIMAL HEALTH S.A.

Rue Laid Burniat 1

1348 Louvain La Neuve

BELGIUM

BE

Domitor 1 mg/ml

Medetomidine hydrochloride

0419IS0003F012

| PFIZER ANIMAL HEALTH S.A. |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain La Neuve |
| BELGIUM |

PFIZER ANIMAL HEALTH S.A.

Rue Laid Burniat 1

1348 Louvain La Neuve

BELGIUM

BE

Sedivet 10 mg/ml

Romifidine hydrochloride

0205IS0127F012

| SCS BOEHRINGER INGELHEIM COMM.V |
| --- |
| Vesalius Science Park |
| Avenue, Ariane, 16 |
| 1200 Bruxelles |
| BELGIUM |

SCS BOEHRINGER INGELHEIM COMM.V

Vesalius Science Park

Avenue, Ariane, 16

1200 Bruxelles

BELGIUM

CY

Sedivet 1 % Solution for injection 10mg/ml

Romifidine

CY004V-E

Boehringer Ingelheim Vetmedica GmbH

CZ

Domitor

Medetomidine hydrochloride

96/731/96-C

| Pfizer Animal Health S.A. |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health S.A.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

CZ

Xylazine 2 % Alfasan

Xylazine hydrochloride

96/025/00-C

| ALFASAN INTERNATIONAL B.V. |
| --- |
| P.O. BOX 78 |
| 3440 AB Woerden |
| THE NETHERLANDS |

ALFASAN INTERNATIONAL B.V.

P.O. BOX 78

3440 AB Woerden

THE NETHERLANDS

CZ

Sedivet 1 %

Romifidine hydrochloride

96/039/01-C

| BOEHRINGER INGELHEIM VETMEDICA GMBH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| GERMANY |

BOEHRINGER INGELHEIM VETMEDICA GMBH

Binger Strasse 173

55216 Ingelheim am Rhein

GERMANY

CZ

Domosedan inj.

Detomidine hydrochloride

96/730/96-C

| Pfizer Animal Health S.A. |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain-la-Neuve |
| BELGIUM |

Pfizer Animal Health S.A.

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

DE

Sedivet

Romifidine hydrochloride

23715.00.00

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55218 Ingelheim |
| GERMANY |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55218 Ingelheim

GERMANY

DE

Rompun TS

Xylazine hydrochloride

6293723.00.00

| Bayer Vital GmbH |
| --- |
| 51368 Leverkusen |
| GERMANY |

Bayer Vital GmbH

51368 Leverkusen

GERMANY

DE

Rompun 2 %

Xylazine hydrochloride

6293841.00.00

| Bayer Vital GmbH |
| --- |
| 51368 Leverkusen |
| GERMANY |

Bayer Vital GmbH

51368 Leverkusen

GERMANY

DE

Domosedan

Detomidine hydrochloride

15912.00.00

| Pfizer GmbH |
| --- |
| Pfizerstr. 1 |
| 76139 Karlsruhe |
| GERMANY |

Pfizer GmbH

Pfizerstr. 1

76139 Karlsruhe

GERMANY

DE

Domitor

Medetomidine hydrochloride

32457.00.00

| Pfizer GmbH |
| --- |
| Pfizerstr. 1 |
| 76139 Karlsruhe |
| GERMANY |

Pfizer GmbH

Pfizerstr. 1

76139 Karlsruhe

GERMANY

DE

Xylazin 2 %

Xylazine hydrochloride

6324464.00.00

| CEVA TIERGESUNDHEIT GmbH |
| --- |
| Kanzlerstr. 4 |
| 40472 Düsseldorf |
| GERMANY |

CEVA TIERGESUNDHEIT GmbH

Kanzlerstr. 4

40472 Düsseldorf

GERMANY

DK

Sedivet Vet.

Romifidine

14896

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55218 Ingelheim |
| GERMANY |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55218 Ingelheim

GERMANY

DK

Rompun Vet.

Xylazine

05669

Bayer A/S ,

Bayer HealthCare

ES

Rompun

Xylazine

7532 A

Química Farmacéutica Bayer

ES

Sedivet

Romifidine

1107 ESP

| Boehringer Ingelheim España S.A. |
| --- |
| Prat de la Riva s/n |
| 08190 Sant Cugat del Valles |
| Barcelona |
| SPANJA |

Boehringer Ingelheim España S.A.

Prat de la Riva s/n

08190 Sant Cugat del Valles

Barcelona

SPANJA

ES

Domosedan

Detomidine hydrochloride

9059 I

| Pfizer S.A. |
| --- |
| Avda. Europa,20 B. |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |
| SPANJA |

Pfizer S.A.

Avda. Europa,20 B.

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

SPANJA

ES

Domitor

Medetomidine hydrochloride

933 ESP

| Pfizer S.A. |
| --- |
| Avda. Europa,20 B. |
| Parque Empresarial La Moraleja |
| 28108 Alcobendas (Madrid) |
| SPANJA |

Pfizer S.A.

Avda. Europa,20 B.

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

SPANJA

FI

Rompun vet

Xylazine hydrochloride

6047

| Bayer HealthCare AG |
| --- |
| Animal Health Division |
| 51368, Leverkusen |
| GERMANY |

Bayer HealthCare AG

Animal Health Division

51368, Leverkusen

GERMANY

FI

Domosedan

Detomidine hydrochloride

8546

| Orion oyj |
| --- |
| P.O. Box 65 |
| 02201 Espoo |
| FINLAND |

Orion oyj

P.O. Box 65

02201 Espoo

FINLAND

FI

Domitor vet

Medetomidine hydrochloride

9501

| Orion oyj |
| --- |
| P.O. Box 65 |
| 02201 Espoo |
| FINLAND |

Orion oyj

P.O. Box 65

02201 Espoo

FINLAND

FR

Rompun 2 %

Xylazine chlorhydrate

255

BAYER SANTE

FR

Rompun Lyophilise

Xylazine chlorhydrate

8061

BAYER SANTE

FR

Domosedan

Detomidine chlorhydrate

10076

PFIZER

FR

Sedivet

Romifidine Chlorhydrate

11004

BOEHRINGER INGELHEIM FRANCE

FR

Domitor

Medetomidine Chlorhydrate

10718

PFIZER

GR

Domitor

Medetomidine

46335/06-12-00

PFIZER HELLAS

GR

Rompun 2 %

Xylazine

19605/23-06-93

ALAPIS

GR

Chanazine

Xylazine

11188/30-03-99

FARMAZAC SYNVET

GR

Sedivet

Romifidine

44613/22-11-00

BOEHRINGER INGELHEIM VETMEDICA GMBH., GERMANY

HU

Rompun

Xylazine

411/1991.

| Bayer Hungária Ltd. |
| --- |
| 1123 Budapest |
| Alkotás u. 50 |
| HUNGARY |

Bayer Hungária Ltd.

1123 Budapest

Alkotás u. 50

HUNGARY

HU

Domosedan

Detomodine hydrochloride

2079/2006.

| Pfizer Co. Ltd. |
| --- |
| 1123 Budapest |
| Alkotás u. 53 |
| HUNGARY |

Pfizer Co. Ltd.

1123 Budapest

Alkotás u. 53

HUNGARY

HU

Domitor

Medetomidine hydrochloride

891/1999.

| Pfizer Co. Ltd. |
| --- |
| 1123 Budapest |
| Alkotás u. 53 |
| HUNGARY |

Pfizer Co. Ltd.

1123 Budapest

Alkotás u. 53

HUNGARY

HU

Primazin 2 % injection

Xylazine

743/1997.

| Alfasan International B.V. |
| --- |
| 3449 JA Woerden |
| THE NETHERLANDS |

Alfasan International B.V.

3449 JA Woerden

THE NETHERLANDS

IE

Sedivet

Romifidine

10007/023/001

| Boehringer Ingelheim Ltd |
| --- |
| Ellesfield, Avenue Bracknell |
| Berkshire RG12 8YS |
| RENJU UNIT |

Boehringer Ingelheim Ltd

Ellesfield, Avenue Bracknell

Berkshire RG12 8YS

RENJU UNIT

IE

Chanazine 2 % Solution for Injection

Xylazine

10987/030/001

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

IRELAND

IE

Chanazine 10 % Solution for Injection

Xylazine

10987/031/001

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

IRELAND

IE

Domosedan Injection

Detomidine hydrochloride

10019/025/001

| Pfizer Animal Health |
| --- |
| Ringaskiddy |
| Co. Cork |
| IRELAND |

Pfizer Animal Health

Ringaskiddy

Co. Cork

IRELAND

IE

Domitor Injection

Medetomodine hydrochloride

10019/026/001

| Pfizer Animal Health |
| --- |
| Ringaskiddy |
| Co. Cork |
| IRELAND |

Pfizer Animal Health

Ringaskiddy

Co. Cork

IRELAND

IS

Domosedan, vet.

Detomidine

890003

| Orion Corporation |
| --- |
| Orionintie 1 |
| 0220 Espoo |
| FINLAND |

Orion Corporation

Orionintie 1

0220 Espoo

FINLAND

IS

Chanazine 2 %, vet.

Xylazine

IS/2/01/003/02

| Icepharma hf. |
| --- |
| Lynhálsi 13 |
| 110 Reykjavík |
| ICELAND |

Icepharma hf.

Lynhálsi 13

110 Reykjavík

ICELAND

IS

Chanazine 10 %, vet.

Xylazine

IS/2/01/003/01

| Icepharma hf. |
| --- |
| Lynhálsi 13 |
| 110 Reykjavík |
| ICELAND |

Icepharma hf.

Lynhálsi 13

110 Reykjavík

ICELAND

IS

Rompun, vet.

Xylazine

691254

| Bayer HealthCare AG |
| --- |
| Animal Health Division |
| 51368, Leverkusen |
| GERMANY |

Bayer HealthCare AG

Animal Health Division

51368, Leverkusen

GERMANY

IT

Sedivet

Romifidine

102196

| Boehringer Ingelheim |
| --- |
| Località Prulli 103/c |
| 50066 Regello |
| ITALJA |

Boehringer Ingelheim

Località Prulli 103/c

50066 Regello

ITALJA

IT

Rompum

Xylazine

100390032

| Bayer |
| --- |
| Viale Certosa 130 |
| 20156 Milano |
| ITALJA |

Bayer

Viale Certosa 130

20156 Milano

ITALJA

IT

Rompum 2 %

Xylazine

100390018

| Bayer |
| --- |
| Viale Certosa 130 |
| 20156 Milano |
| ITALJA |

Bayer

Viale Certosa 130

20156 Milano

ITALJA

IT

Domosedan

Detomidine

100102

Orion

IT

Domitor

Medetomidine

100103

Orion Corporation animal helth

LV

Xylazine 2 %

Xylazine

NRP/VFP-00544-05

| Alfasan International B.V. |
| --- |
| Kuipersweg 9 |
| P.O. Box 78 |
| 3440 AB Woerden |
| THE NETHERLANDS |

Alfasan International B.V.

Kuipersweg 9

P.O. Box 78

3440 AB Woerden

THE NETHERLANDS

LV

Domitor

Medetomidine

NRP/VFP-01453-07

| Alfasan International B.V. |
| --- |
| Kuipersweg 9 |
| P.O. Box 78 |
| 3440 AB Woerden |
| THE NETHERLANDS |

Alfasan International B.V.

Kuipersweg 9

P.O. Box 78

3440 AB Woerden

THE NETHERLANDS

NL

Sedivet

Romifidine

7232

| Boehringer Ingelheim |
| --- |
| Postbus 8037 |
| 1802 KA Alkmaar |
| THE NETHERLANDS |

Boehringer Ingelheim

Postbus 8037

1802 KA Alkmaar

THE NETHERLANDS

NL

Xylalin

Xylazine

3886

| CEVA Santé BV |
| --- |
| Tiendweg 8c |
| 2671 SB Naaldwijk |
| THE NETHERLANDS |

CEVA Santé BV

Tiendweg 8c

2671 SB Naaldwijk

THE NETHERLANDS

NL

Rompun droog

Xylazine

5407

| Bayer BV Animal Health |
| --- |
| Postbus 80 |
| 3640 AB Mijdrecht |
| THE NETHERLANDS |

Bayer BV Animal Health

Postbus 80

3640 AB Mijdrecht

THE NETHERLANDS

NL

Rompun

Xylazine

5409

| Bayer BV Animal Health |
| --- |
| Postbus 80 |
| 3640 AB Mijdrecht |
| THE NETHERLANDS |

Bayer BV Animal Health

Postbus 80

3640 AB Mijdrecht

THE NETHERLANDS

NL

Xylazine 5'+mg

Xylazine

7695

| Dopharma Research BV |
| --- |
| Postbus 205 |
| 4940 AE Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research BV

Postbus 205

4940 AE Raamsdonksveer

THE NETHERLANDS

NL

Aescoket Plus

Xylazine, Ketamine, Atropine

7986

| Aesculaap BV |
| --- |
| Mijlstraat 35 |
| 5281 LJ Boxtel |
| THE NETHERLANDS |

Aesculaap BV

Mijlstraat 35

5281 LJ Boxtel

THE NETHERLANDS

NL

Sedazine 20 Inj.

Xylazine

8066

| A.S.T. Farma BV |
| --- |
| Willeskop 206a |
| 4321 GW Oudewater |
| THE NETHERLANDS |

A.S.T. Farma BV

Willeskop 206a

4321 GW Oudewater

THE NETHERLANDS

NL

Rompun 2 % Injectievloeistof

Xylazine

8210

| Bayer BV Animal Health |
| --- |
| Postbus 80 |
| 3640 AB Mijdrecht |
| THE NETHERLANDS |

Bayer BV Animal Health

Postbus 80

3640 AB Mijdrecht

THE NETHERLANDS

NL

A.A. Xylazine P.I.

Xylazine

9759

| CEVA Santé BV |
| --- |
| Tiendweg 8c |
| 2671 SB Naaldwijk |
| THE NETHERLANDS |

CEVA Santé BV

Tiendweg 8c

2671 SB Naaldwijk

THE NETHERLANDS

NL

Xylazine 20 Inj.

Xylazine

10080

| Kepro BV |
| --- |
| Maadgenburgstraat 38 |
| 7421 ZE Deventer |
| THE NETHERLANDS |

Kepro BV

Maadgenburgstraat 38

7421 ZE Deventer

THE NETHERLANDS

NL

Xylasan 2 % Pro Inj.

Xylazine

10253

| Alfasan Nederland BV |
| --- |
| Postbus 78 |
| 3440 AB Woerden |
| NETHERLANDS |

Alfasan Nederland BV

Postbus 78

3440 AB Woerden

NETHERLANDS

NL

Chanazine 2 %

Xylazine

7756

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

Dublin Road

Loughrea

Co. Galway

IRELAND

NL

Domosedan

Detomidine

2973

| Pfizer Animal Health BV |
| --- |
| Postbus 37 |
| 2900 AA Capell a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Postbus 37

2900 AA Capell a/d Ijssel

THE NETHERLANDS

NL

Domosedan

Detomidine

9713

| Equi Products Holland BV |
| --- |
| Hermelijnkoog 44 |
| 1822 CB Alkmaar |
| THE NETHERLANDS |

Equi Products Holland BV

Hermelijnkoog 44

1822 CB Alkmaar

THE NETHERLANDS

NL

Domosedan

Detomidine

10032

| Equi Products Holland BV |
| --- |
| Hermelijnkoog 44 |
| 1822 CB Alkmaar |
| THE NETHERLANDS |

Equi Products Holland BV

Hermelijnkoog 44

1822 CB Alkmaar

THE NETHERLANDS

NL

Domosedan

Detomidine

10131

| Equi Products Holland BV |
| --- |
| Hermelijnkoog 44 |
| 1822 CB Alkmaar |
| THE NETHERLANDS |

Equi Products Holland BV

Hermelijnkoog 44

1822 CB Alkmaar

THE NETHERLANDS

NL

Domosedan

Detomidine

10295

| Novivet BV |
| --- |
| Albert Cuyplaan 2B |
| 7482 JA Haaksbergen |
| THE NETHERLANDS |

Novivet BV

Albert Cuyplaan 2B

7482 JA Haaksbergen

THE NETHERLANDS

NL

Domosedan

Detomidine

10403

| Wirtz Farma BV |
| --- |
| Albert Cuyplaan 2B |
| 7482 JA Haaksbergen |
| THE NETHERLANDS |

Wirtz Farma BV

Albert Cuyplaan 2B

7482 JA Haaksbergen

THE NETHERLANDS

NL

Domitor

Medetomidine

7823

| Pfizer Animal Health BV |
| --- |
| Postbus 37 |
| 2900 AA Capell a/d Ijssel |
| THE NETHERLANDS |

Pfizer Animal Health BV

Postbus 37

2900 AA Capell a/d Ijssel

THE NETHERLANDS

NL

Domitor

Medetomidine

10354

| Wirtz Farma BV |
| --- |
| Albert Cuyplaan 2B |
| 7482 JA Haaksbergen |
| THE NETHERLANDS |

Wirtz Farma BV

Albert Cuyplaan 2B

7482 JA Haaksbergen

THE NETHERLANDS

NO

Sedivet vet

Romifidine

0000/7913

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| GERMANY |

Boehringer Ingelheim Vetmedica GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

GERMANY

NO

Rompun vet

Xylazine

0000/05588

| Bayer Healthcare AG |
| --- |
| Animal Health Division |
| 51368 Leverkusen |
| GERMANY |

Bayer Healthcare AG

Animal Health Division

51368 Leverkusen

GERMANY

PL

Sedivet 1 %

Romifidine

P-1257/02

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55218 Ingelheim |
| GERMANY |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55218 Ingelheim

GERMANY

PL

Domosedan

Detomidine hydrochloride

P3-0505/98

| Orion Corporation Orion Pharma |
| --- |
| Tengstromink 8 |
| Box 65 |
| Turku, 0101 |
| FINLAND |

Orion Corporation Orion Pharma

Tengstromink 8

Box 65

Turku, 0101

FINLAND

PL

Domitor

Medetomidine hydrochloride

P2-0118/95

| Orion Corporation Orion Pharma, |
| --- |
| Tengstromink 8 |
| Box 65 |
| Turku, 0101 |
| FINLAND |

Orion Corporation Orion Pharma,

Tengstromink 8

Box 65

Turku, 0101

FINLAND

PT

Romidys 1 mg/ml Solução Injectável para cães e gatos

Romifidine

51498

| Virbac S.A. |
| --- |
| 1ère avenue – |
| 2065 m – L.I.D. |
| 06516 Carros Cedex |
| FRANCE |

Virbac S.A.

1ère avenue –

2065 m – L.I.D.

06516 Carros Cedex

FRANCE

PT

Domitor

Medetomidine

50855P

| Laboratórios Pzifer |
| --- |
| AS Laboratórios Pfizer |
| Lda Lagoas Park |
| Edifício 10 |
| 2740-271 Porto Salvo |
| PORTUGAL |

Laboratórios Pzifer

AS Laboratórios Pfizer

Lda Lagoas Park

Edifício 10

2740-271 Porto Salvo

PORTUGAL

PT

Domosedan

Detomidine

50820P

| Laboratórios Pzifer |
| --- |
| AS Laboratórios Pfizer |
| Lda Lagoas Park |
| Edifício 10 |
| 2740-271 Porto Salvo |
| PORTUGAL |

Laboratórios Pzifer

AS Laboratórios Pfizer

Lda Lagoas Park

Edifício 10

2740-271 Porto Salvo

PORTUGAL

PT

Chanazine 2 %

Xylazine

51188

| Agrovete |
| --- |
| Organização Técnica Agro Pecuária |
| S.A R. Alto B Vista Pavilhão 40, Agualva-Cacém |
| 2735-340 Agualva-Cacém |
| Lisbon |
| PORTUGAL |

Agrovete

Organização Técnica Agro Pecuária

S.A R. Alto B Vista Pavilhão 40, Agualva-Cacém

2735-340 Agualva-Cacém

Lisbon

PORTUGAL

PT

Rompun

Xylazine

4770

| Bayer Portugal |
| --- |
| S.A Rua da Quinta do Pinheiro 5 |
| 2794-003 Carnaxide |
| PORTUGAL |

Bayer Portugal

S.A Rua da Quinta do Pinheiro 5

2794-003 Carnaxide

PORTUGAL

RO

Xylazine 2 % xylazine

Xylazine

161895/3 of 6.12.2002 (skaduta)

| ALFASAN INTERNATIONAL B.V. |
| --- |
| Kuipersweg 9 |
| 3449, JA Woerden |
| THE NETHERLANDS |

ALFASAN INTERNATIONAL B.V.

Kuipersweg 9

3449, JA Woerden

THE NETHERLANDS

RO

Domosedan

Detomidine

221972/2 of 23.1.2004 (valid until 23.1.2009)

| PFIZER GLOBAL MANUFACTURING |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain La Nueve |
| BELGIUM |

PFIZER GLOBAL MANUFACTURING

Rue Laid Burniat 1

1348 Louvain La Nueve

BELGIUM

(Variation IA,1 – pending

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| RENJU UNIT) |

Pfizer Animal Health MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

RENJU UNIT)

RO

Domitor

Medetomidine

221972/3 of 23.1.2004 (valid until 23.1.2009)

| PFIZER GLOBAL MANUFACTURING |
| --- |
| Rue Laid Burniat 1 |
| 1348 Louvain La Nueve |
| BELGIUM |

PFIZER GLOBAL MANUFACTURING

Rue Laid Burniat 1

1348 Louvain La Nueve

BELGIUM

(Variation IA,1 – pending

| Pfizer Animal Health MA EEIG |
| --- |
| Ramsgate Road, |
| Sandwich, |
| Kent CT13 9NJ |
| RENJU UNIT) |

Pfizer Animal Health MA EEIG

Ramsgate Road,

Sandwich,

Kent CT13 9NJ

RENJU UNIT)

SE

Sedivet vet.

Romifidine hydrochloride

11753

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| Binger Str. 173 |
| 55218 Ingelheim |
| GERMANY |

Boehringer Ingelheim Vetmedica GmbH

Binger Str. 173

55218 Ingelheim

GERMANY

SE

Rompun vet.

Xylazine hydrochloride

8534

Bayer HealthCare AG

SE

Domosedan vet.

Detomidine hydrochloride

10243

| Orion Corporation |
| --- |
| Box 65 |
| 02101 Esbo |
| FINLAND |

Orion Corporation

Box 65

02101 Esbo

FINLAND

SE

Domitor vet.

Medetomidine hydrochloride

10574

| Orion Corporation |
| --- |
| Box 65 |
| 02101 Esbo |
| FINLAND |

Orion Corporation

Box 65

02101 Esbo

FINLAND

SK

Chanazine 2 %

Xylazine

96/174/00-S

| Chanelle Pharmaceuticals Manufacturing Ltd. |
| --- |
| Dublin Road |
| Loughrea |
| Co. Galway |
| IRELAND |

Chanelle Pharmaceuticals Manufacturing Ltd.

Dublin Road

Loughrea

Co. Galway

IRELAND

SL

Chanazine 2 %

Xylazine

323-03-8/01-42

| VET4VET |
| --- |
| Gerbičeva 50 |
| 1000 Ljubljana |
| SLOVENIA |

VET4VET

Gerbičeva 50

1000 Ljubljana

SLOVENIA

SL

Domitor

Medetomidine

5363-783/2005

| Pfizer Luxembourg SARL PFIZER |
| --- |
| podružnica Ljubljana |
| Letališka 3 c |
| 1000 Ljubljana |
| SLOVENIA |

Pfizer Luxembourg SARL PFIZER

podružnica Ljubljana

Letališka 3 c

1000 Ljubljana

SLOVENIA

SL

Domosedan

Detomodine

5363-959/2004

| Pfizer Luxembourg SARL PFIZER |
| --- |
| podružnica Ljubljana |
| Letališka 3 c |
| 1000 Ljubljana |
| SLOVENIA |

Pfizer Luxembourg SARL PFIZER

podružnica Ljubljana

Letališka 3 c

1000 Ljubljana

SLOVENIA

UK

Sedivet 10 mg/ml Solution for Injection

Romifidine

00015/4033

| Boehringer Ingelheim Ltd |
| --- |
| Ellesfield Avenue |
| Bracknell |
| Berkshire RG12 8YS |
| RENJU UNIT |

Boehringer Ingelheim Ltd

Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

RENJU UNIT

UK

Domosedan 10 mg/ml Injection

Detomidine hydrochloride

03649/4000

| Orion Corporation Orion Pharma |
| --- |
| Tengstromink 8 |
| Box 65 |
| Turku 20101 |
| FINLAND |

Orion Corporation Orion Pharma

Tengstromink 8

Box 65

Turku 20101

FINLAND

UK

Domosedan 10 mg/ml Injection

Detomidine hydrochloride

24939/4001

| Globalmed Ltd |
| --- |
| Ground Floor |
| 134 Church Hill |
| Loughton |
| Essex IG10 1LH |
| RENJU UNIT |

Globalmed Ltd

Ground Floor

134 Church Hill

Loughton

Essex IG10 1LH

RENJU UNIT

UK

Domosedan 10 mg/ml Injection

Detomidine hydrochloride

20860/4005

| Quvera Ltd |
| --- |
| Unit 8 |
| Brember Road |
| Harrow |
| Middlesex HA2 8AX |
| RENJU UNIT |

Quvera Ltd

Unit 8

Brember Road

Harrow

Middlesex HA2 8AX

RENJU UNIT

UK

Domitor 1 mg/ml Solution for Injection

Medetomidine hydrochloride

03649/4001

| Orion Corporation Orion Pharma |
| --- |
| Tengstromink 8 |
| Box 65 |
| Turku 20101 |
| FINLAND |

Orion Corporation Orion Pharma

Tengstromink 8

Box 65

Turku 20101

FINLAND

UK

Domitor Injection (Strength 1 mg/ml)

Medetomidine hydrochloride

20860/4002

| Quvera Ltd |
| --- |
| Unit 8 |
| Brember Road |
| Harrow |
| Middlesex HA2 8AX |
| RENJU UNIT |

Quvera Ltd

Unit 8

Brember Road

Harrow

Middlesex HA2 8AX

RENJU UNIT

UK

Chanazine 10 % Solution for Injection

Xylazine

11990/4006

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool L1 9HZ |
| RENJU UNIT |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool L1 9HZ

RENJU UNIT

UK

Chanazine 2 % Solution for Injection

Xylazine

11990/4005

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool L1 9HZ |
| RENJU UNIT |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool L1 9HZ

RENJU UNIT

UK

Rompun 2 % w/v Solution for Injection

Xylazine

00010/4093

| Bayer plc |
| --- |
| Animal Health Division |
| Bayer House |
| Strawberry Hill |
| Newbury |
| Berkshire RG14 1JA |
| UNITED KINGDOM |

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

UNITED KINGDOM

---

V Avviżi

PROĊEDURI GĦALL-IMPLIMENTAZZJONI TAL-POLITIKA TAL-KOMPETIZZJONI

Il-Kummissjoni

| 29.5.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 121/27 |
| --- | --- | --- | --- |

29.5.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 121/27

---

Notifika minn qabel ta' konċentrazzjoni

(Każ COMP/M.5520 – Itochu/Mitsubishi/Enolia/JV)

Każ li jista' jiġi kkunsidrat għal proċedura simplifikata

(Test b’relevanza għaż-ŻEE)

2009/C 121/05

| 1. | Fid-19 ta’ Mejju 2009, il-Kummissjoni rċeviet notifika ta' konċentrazzjoni proposta skont l-Artikolu 4 tar-Regolament tal-Kunsill (KE) Nru 139/2004 (1) li permezz tagħha l-impriżi Access Itochu Corporation (“Itochu”, il-Ġappun), Mitsubishi Heavy Industries Ltd. (“Mitsubishi”, il-Ġappun) u Enolia Energy S.A. (“Enolia”, il-Greċja) ) jiksbu, skont it-tifsira tal-Artikolu 3(1)(b) tar-Regolament tal-Kunsill, il-kontroll konġunt ta' Enolia Solar Systems S.A., il-Ġreċja (“JV”) permezz ta' xiri ta' ishma. |
| --- | --- |

1.

Fid-19 ta’ Mejju 2009, il-Kummissjoni rċeviet notifika ta' konċentrazzjoni proposta skont l-Artikolu 4 tar-Regolament tal-Kunsill (KE) Nru 139/2004 (1) li permezz tagħha l-impriżi Access Itochu Corporation (“Itochu”, il-Ġappun), Mitsubishi Heavy Industries Ltd. (“Mitsubishi”, il-Ġappun) u Enolia Energy S.A. (“Enolia”, il-Greċja) ) jiksbu, skont it-tifsira tal-Artikolu 3(1)(b) tar-Regolament tal-Kunsill, il-kontroll konġunt ta' Enolia Solar Systems S.A., il-Ġreċja (“JV”) permezz ta' xiri ta' ishma.

| 2. | L-attivitajiet kummerċjali tal-impriżi kkonċernati huma:






  — | għal Itochu: l-importazzjoni u l-esportazzjoni f'oqsma ta' prodotti diversifikati, |
| --- | --- | --- |

2.

L-attivitajiet kummerċjali tal-impriżi kkonċernati huma:

—

għal Itochu: l-importazzjoni u l-esportazzjoni f'oqsma ta' prodotti diversifikati,

| — | għal Mitsubishi: manifattura diversifikata, |
| --- | --- |

—

għal Mitsubishi: manifattura diversifikata,

| — | għal Enolia: il-ġenerazzjoni ta' elettriku rinnovabbli, |
| --- | --- |

—

għal Enolia: il-ġenerazzjoni ta' elettriku rinnovabbli,

| — | għal JV: il-fornitura ta' moduli fotovoltajċi u l-integrazzjoni u l-istallazzjoni ta' sistemi fotovoltajċi. |
| --- | --- |

—

għal JV: il-fornitura ta' moduli fotovoltajċi u l-integrazzjoni u l-istallazzjoni ta' sistemi fotovoltajċi.

| 3. | Wara eżami preliminari, il-Kummissjoni ssib li l-operazzjoni nnotifikata tista' taqa' fl-ambitu tar-Regolament (KE) Nru 139/2004. Madankollu, id-deċiżjoni finali dwar dan il-punt hija riżervata. Skont l-Avviż tal-Kummissjoni dwar proċedura simplifikata għat-trattament ta' ċerti konċentrazzjonijiet taħt ir-Regolament tal-Kunsill (KE) Nru 139/2004 (2) ta' min jinnota li dan il-każ jista' jiġi kkunsidrat għat-trattament taħt il-proċedura stipulata fl-Avviż. |
| --- | --- |

3.

Wara eżami preliminari, il-Kummissjoni ssib li l-operazzjoni nnotifikata tista' taqa' fl-ambitu tar-Regolament (KE) Nru 139/2004. Madankollu, id-deċiżjoni finali dwar dan il-punt hija riżervata. Skont l-Avviż tal-Kummissjoni dwar proċedura simplifikata għat-trattament ta' ċerti konċentrazzjonijiet taħt ir-Regolament tal-Kunsill (KE) Nru 139/2004 (2) ta' min jinnota li dan il-każ jista' jiġi kkunsidrat għat-trattament taħt il-proċedura stipulata fl-Avviż.

| 4. | Il-Kummissjoni tistieden lill-partijiet terzi interessati biex iressqu kwalunkwe kummenti li jistgħu jkollhom dwar it-tranżizzjoni proposta.
  Il-kummenti jridu jaslu għand il-Kummissjoni mhux aktar tard minn għaxart ijiem wara d-data ta' din il-pubblikazzjoni. Il-kummenti jistgħu jintbagħtu lill-Kummissjoni bil-faks (+32 2 2964301 jew 2967244) jew bil-posta, taħt in-numru ta' referenza COMP/M.5520 – Itochu/Mitsubishi/Enolia/JV, fl-indirizz li ġej:





  Il-Kummissjoni Ewropea |
| --- | --- |
| Direttorat Ġenerali għall-Kompetizzjoni |
| Reġistru tal-Amalgamazzjonijiet |
| J-70 |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

Il-Kummissjoni tistieden lill-partijiet terzi interessati biex iressqu kwalunkwe kummenti li jistgħu jkollhom dwar it-tranżizzjoni proposta.

Il-kummenti jridu jaslu għand il-Kummissjoni mhux aktar tard minn għaxart ijiem wara d-data ta' din il-pubblikazzjoni. Il-kummenti jistgħu jintbagħtu lill-Kummissjoni bil-faks (+32 2 2964301 jew 2967244) jew bil-posta, taħt in-numru ta' referenza COMP/M.5520 – Itochu/Mitsubishi/Enolia/JV, fl-indirizz li ġej:

Il-Kummissjoni Ewropea

Direttorat Ġenerali għall-Kompetizzjoni

Reġistru tal-Amalgamazzjonijiet

J-70

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  ĠU L 24, 29.1.2004, p. 1.

(2)  ĠU C 56, 5.3.2005, p. 32.

---

Corrigendum

| 29.5.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 121/28 |
| --- | --- | --- | --- |

29.5.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 121/28

---

Rettifika għall-Awtorizzazzjoni tal-għajnuna Statali fil-qafas tad-Dispożizzjonijiet tal-Artikoli 87 u 88 tat-Trattat tal-KE – Fir-rigward ta' dawn il-każijiet il-Kummissjoni ma tqajjimx oġġezzjonijiet

(
  Il-Ġurnal Uffiċjali tal-Unjoni Ewropea C 112 tas-16 ta’ Mejju 2009
  )

2009/C 121/06

F’paġna 2, it-tieni ringiela:

minflok:

“In-numru ta' referenza tal-għajnuna | N 733/07”;

aqra:

“In-numru ta' referenza tal-għajnuna | N 733/08”.

---