# Official Journal C 276/2008

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 276 |
| | |
| English edition | Information and Notices | Volume 5131 October 2008 |

ISSN 1725-2423

Official Journal

of the European Union

C 276

English edition

Information and Notices

Volume 5131 October 2008

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2008/C 276/01 | Euro exchange rates | 1 |
| 2008/C 276/02 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 2008(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 2 |
| 2008/C 276/03 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 2008(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
  ) | 9 |
| | NOTICES FROM MEMBER STATES |
| 2008/C 276/04 | Extract from the winding-up measure concerning Kaupthing Bank Luxembourg SA decided under Article 9 of Directive 2001/24/EC of the European Parliament and of the Council on the reorganisation and winding-up of credit institutions | 74 |
| 2008/C 276/05 | 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
  ) | 75 |
| 2008/C 276/06 | 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
  ) | 79 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2008/C 276/01

Euro exchange rates

1

2008/C 276/02

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 2008(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  )

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council

)

2

2008/C 276/03

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 2008(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council

or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council

)

9

NOTICES FROM MEMBER STATES

2008/C 276/04

Extract from the winding-up measure concerning Kaupthing Bank Luxembourg SA decided under Article 9 of Directive 2001/24/EC of the European Parliament and of the Council on the reorganisation and winding-up of credit institutions

74

2008/C 276/05

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
  )

1

75

2008/C 276/06

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
  )

1

79

| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | Commission |
| 2008/C 276/07 | Invitation to tender published by Italy, pursuant to Article 4(1)(d) of Council Regulation (EEC) No 2408/92, for the operation of scheduled air services between Albenga and Roma Fiumicino and vice versa
   (
  1
  ) | 82 |
| 2008/C 276/08 | Invitation to tender published by Italy, pursuant to Article 4(1)(d) of Council Regulation (EEC) No 2408/92, for the operation of scheduled air services between Crotone and Milano Linate and vice versa
   (
  1
  ) | 86 |
| 2008/C 276/09 | Invitation to tender published by Italy, pursuant to Article 4(1)(d) of Council Regulation (EEC) No 2408/92, for the operation of scheduled air services between Crotone and Roma Fiumicino and vice versa
   (
  1
  ) | 90 |
| 2008/C 276/10 | Call for proposals — EACEA/29/08 — European associations active at European level in the field of education and training | 94 |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY |
| | Commission |
| 2008/C 276/11 | Prior notification of a concentration (Case COMP/M.5368 — MidAmerican/Constellation) — Candidate case for simplified procedure (
  1
  ) | 97 |

V   Announcements

ADMINISTRATIVE PROCEDURES

Commission

2008/C 276/07

Invitation to tender published by Italy, pursuant to Article 4(1)(d) of Council Regulation (EEC) No 2408/92, for the operation of scheduled air services between Albenga and Roma Fiumicino and vice versa
   (
  1
  )

vice versa

1

82

2008/C 276/08

Invitation to tender published by Italy, pursuant to Article 4(1)(d) of Council Regulation (EEC) No 2408/92, for the operation of scheduled air services between Crotone and Milano Linate and vice versa
   (
  1
  )

vice versa

1

86

2008/C 276/09

Invitation to tender published by Italy, pursuant to Article 4(1)(d) of Council Regulation (EEC) No 2408/92, for the operation of scheduled air services between Crotone and Roma Fiumicino and vice versa
   (
  1
  )

vice versa

1

90

2008/C 276/10

Call for proposals — EACEA/29/08 — European associations active at European level in the field of education and training

94

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

2008/C 276/11

Prior notification of a concentration (Case COMP/M.5368 — MidAmerican/Constellation) — Candidate case for simplified procedure (
  1
  )

1

97

| | |
| --- | --- |
| 2008/C 276/12 | Note to the reader(see page 3 of the cover) | s3 |

2008/C 276/12

Note to the reader(see page 3 of the cover)

Note to the reader

s3

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

---

(1)   Text with EEA relevance

1

| EN | |
| --- | --- |

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 31.10.2008 | EN | Official Journal of the European Union | C 276/1 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/1

---

Euro exchange rates (1)

30 October 2008

(2008/C 276/01)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,3035 |
| JPY | Japanese yen | 128,73 |
| DKK | Danish krone | 7,4478 |
| GBP | Pound sterling | 0,7907 |
| SEK | Swedish krona | 9,811 |
| CHF | Swiss franc | 1,48 |
| ISK | Iceland króna | 305 |
| NOK | Norwegian krone | 8,52 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 24,48 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 257,24 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7093 |
| PLN | Polish zloty | 3,565 |
| RON | Romanian leu | 3,6375 |
| SKK | Slovak koruna | 30,39 |
| TRY | Turkish lira | 1,9842 |
| AUD | Australian dollar | 1,9204 |
| CAD | Canadian dollar | 1,5697 |
| HKD | Hong Kong dollar | 10,1052 |
| NZD | New Zealand dollar | 2,2015 |
| SGD | Singapore dollar | 1,9141 |
| KRW | South Korean won | 1 665,72 |
| ZAR | South African rand | 13,0194 |
| CNY | Chinese yuan renminbi | 8,9133 |
| HRK | Croatian kuna | 7,1699 |
| IDR | Indonesian rupiah | 13 914,86 |
| MYR | Malaysian ringgit | 4,6046 |
| PHP | Philippine peso | 63,09 |
| RUB | Russian rouble | 34,7912 |
| THB | Thai baht | 45,381 |
| BRL | Brazilian real | 2,7521 |
| MXN | Mexican peso | 16,6978 |

Currency

Exchange rate

USD

US dollar

1,3035

JPY

Japanese yen

128,73

DKK

Danish krone

7,4478

GBP

Pound sterling

0,7907

SEK

Swedish krona

9,811

CHF

Swiss franc

1,48

ISK

Iceland króna

305

NOK

Norwegian krone

8,52

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

24,48

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

257,24

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7093

PLN

Polish zloty

3,565

RON

Romanian leu

3,6375

SKK

Slovak koruna

30,39

TRY

Turkish lira

1,9842

AUD

Australian dollar

1,9204

CAD

Canadian dollar

1,5697

HKD

Hong Kong dollar

10,1052

NZD

New Zealand dollar

2,2015

SGD

Singapore dollar

1,9141

KRW

South Korean won

1 665,72

ZAR

South African rand

13,0194

CNY

Chinese yuan renminbi

8,9133

HRK

Croatian kuna

7,1699

IDR

Indonesian rupiah

13 914,86

MYR

Malaysian ringgit

4,6046

PHP

Philippine peso

63,09

RUB

Russian rouble

34,7912

THB

Thai baht

45,381

BRL

Brazilian real

2,7521

MXN

Mexican peso

16,6978

---

(1)

Source: reference exchange rate published by the ECB.

---

| 31.10.2008 | EN | Official Journal of the European Union | C 276/2 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/2

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 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 276/02)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 12.9.2008 | Oprymea | Pramipexole | KRKA, d.d. |
| Šmarješka cesta 6 |
| SLO-8501 Novo mesto |

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

12.9.2008

Oprymea

Pramipexole

KRKA, d.d.

Šmarješka cesta 6

SLO-8501 Novo mesto

EU/1/08/469/001-025

Tablet

NO4BC05

15.9.2008

15.9.2008

Tevagrastim

Filgrastim

| Teva Generics GmbH |
| --- |
| Kandelstr. 10 |
| D-79199 Kirchzarten |

Teva Generics GmbH

Kandelstr. 10

D-79199 Kirchzarten

EU/1/08/445/001-008

Solution for injection or infusion

L03AA02

17.9.2008

15.9.2008

Biograstim

Filgrastim

| CT Arzneimittel GmbH |
| --- |
| Lengeder Straße 42a |
| D-13407 Berlin |

CT Arzneimittel GmbH

Lengeder Straße 42a

D-13407 Berlin

EU/1/08/450/001-008

Solution for injection or infusion

L03AA02

17.9.2008

15.9.2008

Ratiograstim

Filgrastim

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

EU/1/08/444/001-008

Solution for injection or infusion

L03AA02

17.9.2008

15.9.2008

Filgrastim ratiopharm

Filgrastim

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

EU/1/08/449/001-008

Solution for injection or infusion

L03AA02

17.9.2008

26.9.2008

Prepandemic influenza vaccine (H5N1) (split virion inactivated adjuvanted) GlaxoSmithKline Biologicals

Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut, 89 |
| B-1330 Rixensart |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut, 89

B-1330 Rixensart

EU/1/08/478/001

Suspension and emulsion for emulsion for injection

J07BB02

30.9.2008

30.9.2008

Xarelto

Rivaroxaban

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

EU/1/08/472/001-008

Film-coated tablet

B01AX06

2.10.2008

—   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 |
| --- | --- | --- | --- | --- |
| 1.9.2008 | Aranesp | Amgen Europe B.V. |
| Minervum 7061 |
| 4817 ZK Breda |
| Nederland |

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

1.9.2008

Aranesp

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/01/185/001-073

3.9.2008

1.9.2008

Adenuric

| Beaufour Ipsen Pharma |
| --- |
| 24, rue Erlanger |
| F-75781 Paris Cedex 16 |

Beaufour Ipsen Pharma

24, rue Erlanger

F-75781 Paris Cedex 16

EU/1/08/447/001-004

3.9.2008

| Ipsen Manufacturing Ireland Ltd (IMIL) |
| --- |
| Blanchardstown Industrial Park |
| Snugboro Road |
| Dublin 15 |
| Ireland |

Ipsen Manufacturing Ireland Ltd (IMIL)

Blanchardstown Industrial Park

Snugboro Road

Dublin 15

Ireland

3.9.2008

1.9.2008

Rotarix

| GlaxoSmithKline Biologicals s.a. |
| --- |
| rue de l'Institut, 89 |
| B-1330 Rixensart |

GlaxoSmithKline Biologicals s.a.

rue de l'Institut, 89

B-1330 Rixensart

EU/1/05/330/001-011

3.9.2008

1.9.2008

Zostavax

| Sanofi Pasteur MSD SNC |
| --- |
| 8, rue Jonas Salk |
| F-69007 Lyon |

Sanofi Pasteur MSD SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/341/001-013

3.9.2008

2.9.2008

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

4.9.2008

2.9.2008

Lucentis

| 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/1/06/374/001

4.9.2008

2.9.2008

Olanzapine Neopharma

| Neopharma Limited |
| --- |
| 57 High Street |
| Odiham |
| Hampshire RG29 1LF |
| United Kingdom |

Neopharma Limited

57 High Street

Odiham

Hampshire RG29 1LF

United Kingdom

EU/1/07/426/001-011

4.9.2008

2.9.2008

SonoVue

| Bracco International B.V. |
| --- |
| Strawinskylaan 3051 |
| 1077 ZX Amsterdam |
| Nederland |

Bracco International B.V.

Strawinskylaan 3051

1077 ZX Amsterdam

Nederland

EU/1/01/177/002

4.9.2008

2.9.2008

Gardasil

| Sanofi Pasteur MSD SNC |
| --- |
| 8, rue Jonas Salk |
| F-69007 Lyon |

Sanofi Pasteur MSD SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/357/001-021

5.9.2008

2.9.2008

Viramune

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/055/001-003

4.9.2008

2.9.2008

Ventavis

| Bayer Schering Pharma AG |
| --- |
| Müllerstraße 170-178 |
| D-13342 Berlin |

Bayer Schering Pharma AG

Müllerstraße 170-178

D-13342 Berlin

EU/1/03/255/001-006

4.9.2008

2.9.2008

Silgard

| 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/1/06/358/001-021

4.9.2008

2.9.2008

Cetrotide

| Serono Europe Limited |
| --- |
| 56 Marsh Wall |
| London E14 9TP |
| United Kingdom |

Serono Europe Limited

56 Marsh Wall

London E14 9TP

United Kingdom

EU/1/99/100/001-003

5.9.2008

2.9.2008

Olanzapine Teva -

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| DR Utrecht 3542 |
| Nederland |

Teva Pharma B.V.

Computerweg 10

DR Utrecht 3542

Nederland

EU/1/07/427/001-057

4.9.2008

2.9.2008

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Rinkebyvägen 11B |
| S-182 36 Danderyd |

Shire Human Genetic Therapies AB

Rinkebyvägen 11B

S-182 36 Danderyd

EU/1/06/365/001-003

4.9.2008

3.9.2008

Tysabri

| Elan Pharma International Ltd |
| --- |
| Monksland |
| Athlone |
| County Westmeath |
| Ireland |

Elan Pharma International Ltd

Monksland

Athlone

County Westmeath

Ireland

EU/1/06/346/001

8.9.2008

3.9.2008

Comtess

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |

Orion Corporation

Orionintie 1

FI-02200 Espoo

EU/1/98/082/001-003

EU/1/98/082/005

8.9.2008

3.9.2008

Aldara

| Meda AB |
| --- |
| Pipers väg 2A |
| S-170 73 Solna |

Meda AB

Pipers väg 2A

S-170 73 Solna

EU/1/98/080/001

5.9.2008

3.9.2008

Tamiflu

| 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/1/02/222/001-004

5.9.2008

3.9.2008

Mirapexin

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/051/001-006

EU/1/97/051/009-012

5.9.2008

3.9.2008

Aldara

| Meda AB |
| --- |
| Pipers väg 2A |
| S-170 73 Solna |

Meda AB

Pipers väg 2A

S-170 73 Solna

EU/1/98/080/001

5.9.2008

3.9.2008

Comtan

| 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/1/98/081/001-004

8.9.2008

3.9.2008

Cialis

| 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/1/02/237/001-008

5.9.2008

5.9.2008

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/1/07/400/017-021

9.9.2008

5.9.2008

Herceptin

| 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/1/00/145/001

9.9.2008

5.9.2008

Puregon

| Organon N.V. |
| --- |
| Kloosterstraat 6 |
| Postbus 20 |
| 5340 BH Oss |
| Nederland |

Organon N.V.

Kloosterstraat 6

Postbus 20

5340 BH Oss

Nederland

EU/1/96/008/038-041

9.9.2008

5.9.2008

Epivir

| Glaxo Group Ltd |
| --- |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/96/015/001-005

9.9.2008

8.9.2008

Evra

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 |
| B-2340 Beerse |

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/02/223/001-003

10.9.2008

9.9.2008

Herceptin

| 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/1/00/145/001

11.9.2008

12.9.2008

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

15.9.2008

15.9.2008

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/1/99/110/001-009

17.9.2008

15.9.2008

Glubrava

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| Arundel Great Court |
| 2 Arundel Street |
| London WC2R 3DA |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

Arundel Great Court

2 Arundel Street

London WC2R 3DA

United Kingdom

EU/1/07/421/001-009

17.9.2008

15.9.2008

Stalevo

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |

Orion Corporation

Orionintie 1

FI-02200 Espoo

EU/1/03/260/001-023

17.9.2008

16.9.2008

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

18.9.2008

17.9.2008

Optisulin

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/00/133/001-008

19.9.2008

17.9.2008

Lantus

| Sanofi-Aventis Deutschland GmbH |
| --- |
| D-65926 Frankfurt am Main |

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/00/134/001-037

19.9.2008

22.9.2008

Emtriva

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT |
| United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT

United Kingdom

EU/1/03/261/001-003

24.9.2009

22.9.2008

Emend

| 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/1/03/262/001-008

24.9.2008

26.9.2008

Aclasta

| 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/1/05/308/001-002

30.9.2008

26.9.2008

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

30.9.2008

29.9.2008

Mycamine

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

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

Nederland

EU/1/08/448/001-002

1.10.2008

| Astellas Pharma GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

1.10.2008

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004)

| 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 |
| --- | --- | --- | --- | --- |
| 26.9.2008 | Exubera | Pfizer Ltd |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

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

26.9.2008

Exubera

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/05/327/001-018

30.9.2008

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.9.2008 | Trocoxil | Mavacoxib | Pfizer Limited |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

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

9.9.2008

Trocoxil

Mavacoxib

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/2/08/084/001-005

Chewable tablets

QM01AH92

11.9.2008

—   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 |
| --- | --- | --- | --- | --- |
| 2.9.2008 | Advocate | Bayer Animal Health GmbH |
| D-51368 Leverkusen |

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

2.9.2008

Advocate

Bayer Animal Health GmbH

D-51368 Leverkusen

EU/2/03/039/001-030

4.9.2008

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

4.9.2008

5.9.2008

Profender

| Bayer Animal Health GmbH |
| --- |
| D-51368 Leverkusen |

Bayer Animal Health GmbH

D-51368 Leverkusen

EU/2/05/054/001-031

9.9.2008

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

9.9.2008

15.9.2008

Oxyglobin

| Biopure Netherlands B.V. |
| --- |
| Parnassustoren |
| Locatellikade 1 |
| 1076 AZ Amsterdam |
| Nederland |

Biopure Netherlands B.V.

Parnassustoren

Locatellikade 1

1076 AZ Amsterdam

Nederland

EU/2/99/015/002

17.9.2008

19.9.2008

DRAXXIN

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/2/03/041/001-005

23.9.2008

26.9.2008

PRAC-TIC

| Novartis Sanidad Animal S.L. |
| --- |
| Calle de la Marina, 206 |
| E-Barcelona 08013 |

Novartis Sanidad Animal S.L.

Calle de la Marina, 206

E-Barcelona 08013

EU/2/06/066/001-012

30.9.2008

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): Rejected

| 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 |
| --- | --- | --- | --- | --- |
| 26.9.2008 | Porcilis Pesti | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

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

26.9.2008

Porcilis Pesti

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/99/016/001-006

30.9.2008

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 |

The European Medicines Agency

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 31.10.2008 | EN | Official Journal of the European Union | C 276/9 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/9

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2008 to 30 September 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 276/03)

—   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 |
| --- | --- | --- | --- | --- |
| 3.9.2008 | Cozaar | See Annex I | See Annex I | 8.9.2008 |
| 3.9.2008 | Cozaar Comp | See Annex II | See Annex II | 8.9.2008 |
| 9.9.2008 | Arcoxia | See Annex III | See Annex III | 11.9.2008 |
| 9.9.2008 | Etoricoxib | See Annex IV | See Annex IV | 11.9.2008 |
| 11.9.2008 | Activelle | See Annex V | See Annex V | 15.9.2008 |
| 11.9.2008 | Rapinyl | See Annex VI | See Annex VI | 15.9.2008 |
| 15.9.2008 | Remeron | See Annex VII | See Annex VII | 17.9.2008 |
| 23.9.2008 | Gemzar | See Annex VIII | See Annex VIII | 24.9.2008 |
| 26.9.2008 | Sodium Salicylate | See Annex IX | See Annex IX | 29.9.2008 |
| 26.9.2008 | Toltrazuril | See Annex X | See Annex X | 29.9.2008 |
| 26.9.2008 | Aclasta | Novartis Europharm Limited |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

3.9.2008

Cozaar

See Annex I

See Annex I

8.9.2008

3.9.2008

Cozaar Comp

See Annex II

See Annex II

8.9.2008

9.9.2008

Arcoxia

See Annex III

See Annex III

11.9.2008

9.9.2008

Etoricoxib

See Annex IV

See Annex IV

11.9.2008

11.9.2008

Activelle

See Annex V

See Annex V

15.9.2008

11.9.2008

Rapinyl

See Annex VI

See Annex VI

15.9.2008

15.9.2008

Remeron

See Annex VII

See Annex VII

17.9.2008

23.9.2008

Gemzar

See Annex VIII

See Annex VIII

24.9.2008

26.9.2008

Sodium Salicylate

See Annex IX

See Annex IX

29.9.2008

26.9.2008

Toltrazuril

See Annex X

See Annex X

29.9.2008

26.9.2008

Aclasta

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

This Decision is addressed to the Member States

29.9.2008

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 9.9.2008 | Pulairmax | See Annex XI | See Annex XI | 11.9.2008 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

9.9.2008

Pulairmax

See Annex XI

See Annex XI

11.9.2008

—   Lift of suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 5.9.2008 | Suramox 15 % LA — Stabox 15 % LA | See Annex XII | See Annex XII | 9.9.2008 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

5.9.2008

Suramox 15 % LA — Stabox 15 % LA

See Annex XII

See Annex XII

9.9.2008

---

(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 FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | (Invented) Name
  Losartan potassium | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Merck Sharp & Dohme GmbH |
| Donau-City-Straße 6 |
| A-1220 Wien |

Member State

Marketing Authorisation Holder

(Invented) Name

Losartan potassium

Strength

Pharmaceutical Form

Route of administration

Austria

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Cosaar 12,5 mg — Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Austria

| Merck Sharp & Dohme GmbH |
| --- |
| Donau-City-Straße 6 |
| A-1220 Wien |

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Cosaar 50 mg — Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| Merck Sharp & Dohme GmbH |
| --- |
| Donau-City-Straße 6 |
| A-1220 Wien |

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Cosaar 100 mg — Filmtabletten

100 mg

Film-coated tablet

Oral use

Belgium

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

Belgium

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 50 MG

50 mg

Film-coated tablet

Oral use

Belgium

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Belgium

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar Cardio Start

21 X 12,5 mg + 14 X 50 mg

Film-coated tablet

Oral use

Belgium

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 100 mg

100 mg

Film-coated tablet

Oral use

Belgium

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 50 mg

50 mg

Film-coated tablet

Oral use

Belgium

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 12,50 mg

12,5 mg

Film-coated tablet

Oral use

Belgium

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan Cardio Start

21 X 12,5 mg + 14 X 50 mg

Film-coated tablet

Oral use

Bulgaria

| Merck Sharp & Dohme Bulgaria EOOD |
| --- |
| 55 Nikola Vaptzarov blvd. |
| EXPO 2000, east wing, sections B1 & B2, 1st fl. |
| BG-1407 Sofia |

Merck Sharp & Dohme Bulgaria EOOD

55 Nikola Vaptzarov blvd.

EXPO 2000, east wing, sections B1 & B2, 1st fl.

BG-1407 Sofia

Cozaar

50 mg

Film-coated tablet

Oral use

Cyprus

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

50 mg

Film-coated tablet

Oral use

Cyprus

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

100 mg

Film-coated tablet

Oral use

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

12,5 mg

Film-coated tablet

Oral use

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

50 mg

Film-coated tablet

Oral use

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

100 mg

Film-coated tablet

Oral use

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar Startpakke

12,5 mg + 50 mg

Film-coated tablet

Oral use

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi tee 46 |
| EE-11415 Tallinn |

Merck Sharp & Dohme OÜ

Peterburi tee 46

EE-11415 Tallinn

Cozaar

100 mg

Film-coated tablet

Oral use

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi tee 46 |
| EE-11415 Tallinn |

Merck Sharp & Dohme OÜ

Peterburi tee 46

EE-11415 Tallinn

Cozaar

50 mg

Film-coated tablet

Oral use

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi tee 46 |
| EE-11415 Tallinn |

Merck Sharp & Dohme OÜ

Peterburi tee 46

EE-11415 Tallinn

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

12,5 mg

Film-coated tablet

Oral use

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

12,5 mg and 50 mg (initiation pack)

Film-coated tablet

Oral use

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

50 mg

Film-coated tablet

Oral use

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

Postbus 581

2003 PC Haarlem

Nederland

Cozaar

100 mg

Film-coated tablet

Oral use

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, av. Hoche |
| F-75114 Paris Cedex 08 |

Merck Sharp Dohme Chibret

3, av. Hoche

F-75114 Paris Cedex 08

Cozaar 100 mg film-coated tablets

100 mg

Film-coated tablet

Oral use

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, av. Hoche |
| F-75114 Paris Cedex 08 |

Merck Sharp Dohme Chibret

3, av. Hoche

F-75114 Paris Cedex 08

Cozaar 50 mg scored coated tablets

50 mg

Scored coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Cardopal Start 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar Protect 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar Protect 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar Start 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Pinzaar 100 mg Filmtabletten

100 mg

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Pinzaar 50 mg Filmtabletten

50 mg

Film-coated tablet

Oral use

Germany

| VARIPHARM ARZNEIMITTEL GmbH |
| --- |
| Lindenplatz 1 |
| D-85540 Haar |

VARIPHARM ARZNEIMITTEL GmbH

Lindenplatz 1

D-85540 Haar

Lorzaar Varipharmstart 12,5 mg Filmtabletten

12,5 mg

Film-coated tablet

Oral use

Greece

| VIANEX A.E. |
| --- |
| Tatoiou Street |
| GR-14671 Nea Erythraia |

VIANEX A.E.

Tatoiou Street

GR-14671 Nea Erythraia

Cozaar

12,5 mg

Film-coated tablet

Oral use

Greece

| VIANEX A.E. |
| --- |
| Tatoiou Street |
| GR-14671 Nea Erythraia |

VIANEX A.E.

Tatoiou Street

GR-14671 Nea Erythraia

Cozaar

50 mg

Film-coated tablet

Oral use

Greece

| VIANEX A.E. |
| --- |
| Tatoiou Street |
| GR-14671 Nea Erythraia |

VIANEX A.E.

Tatoiou Street

GR-14671 Nea Erythraia

Cozaar

100 mg

Film-coated tablet

Oral use

Hungary

| Merck Sharp & Dohme Hungary Ltd |
| --- |
| 50, Alkotas u. |
| H-1123 Budapest |

Merck Sharp & Dohme Hungary Ltd

50, Alkotas u.

H-1123 Budapest

Cozaar

12,5 mg

Film-coated tablet

Oral use

Hungary

| Merck Sharp & Dohme Hungary Ltd |
| --- |
| 50, Alkotas u. |
| H-1123 Budapest |

Merck Sharp & Dohme Hungary Ltd

50, Alkotas u.

H-1123 Budapest

Cozaar

50 mg

Film-coated tablet

Oral use

Hungary

| Merck Sharp & Dohme Hungary Ltd |
| --- |
| 50, Alkotas u. |
| H-1123 Budapest |

Merck Sharp & Dohme Hungary Ltd

50, Alkotas u.

H-1123 Budapest

Cozaar

100 mg

Film-coated tablet

Oral use

Ireland

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 50 mg Film-coated tablets

50 mg

Film-coated tablet

Oral use

Ireland

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 100 mg Film-coated tablets

100 mg

Film-coated tablet

Oral use

Ireland

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 12,5 mg Film-coated tablets

12,5 mg

Film-coated tablet

Oral use

Italy

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Lortaan 50 mg compresse rivestite con film

50 mg

Film-coated tablet

Oral use

Italy

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Lortaan 12,5 mg compresse rivestite con film

12,5 mg

Film-coated tablet

Oral use

Italy

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Lortaan 100 mg compresse rivestite con film

100 mg

Film-coated tablet

Oral use

Italy

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Neo-Lotan 50 mg compresse rivestite con film

50 mg

Film-coated tablet

Oral use

Italy

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Neo-Lotan 12,5 mg compresse rivestite con film

12,5 mg

Film-coated tablet

Oral use

Italy

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Neo-Lotan 100 mg compresse rivestite con film

100 mg

Film-coated tablet

Oral use

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare 47 |
| I-00144 Roma |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare 47

I-00144 Roma

Losaprex 50 mg compresse rivestite con film

50 mg

Film-coated tablet

Oral use

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare 47 |
| I-00144 Roma |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare 47

I-00144 Roma

Losaprex 12,5 mg compresse rivestite con film

12.5 mg

Film-coated tablet

Oral use

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare 47 |
| I-00144 Roma |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare 47

I-00144 Roma

Losaprex 100 mg compresse rivestite con film

100 mg

Film-coated tablet

Oral use

Latvia

| SIA Merck Sharp & Dohme Latvia |
| --- |
| Skanstes street 13 |
| LV-1013 Riga |

SIA Merck Sharp & Dohme Latvia

Skanstes street 13

LV-1013 Riga

Cozaar 50 mg film-coated tablets

50 mg

Film-coated tablet

Oral use

Latvia

| SIA Merck Sharp & Dohme Latvia |
| --- |
| Skanstes street 13 |
| LV-1013 Riga |

SIA Merck Sharp & Dohme Latvia

Skanstes street 13

LV-1013 Riga

Cozaar 100 mg film-coated tablets

100 mg

Film-coated tablet

Oral use

Lithuania

| UAB Merck Sharp & Dohme |
| --- |
| Geležinio Vilko 18A |
| LT-01112 Vilnius |

UAB Merck Sharp & Dohme

Geležinio Vilko 18A

LT-01112 Vilnius

Cozaar

(Losartan)

12,5 mg

Film-coated tablet

Oral use

Lithuania

| UAB Merck Sharp & Dohme |
| --- |
| Geležinio Vilko 18A |
| LT-01112 Vilnius |

UAB Merck Sharp & Dohme

Geležinio Vilko 18A

LT-01112 Vilnius

Cozaar

(Losartan)

50 mg

Film-coated tablet

Oral use

Lithuania

| UAB Merck Sharp & Dohme |
| --- |
| Geležinio Vilko 18A |
| LT-01112 Vilnius |

UAB Merck Sharp & Dohme

Geležinio Vilko 18A

LT-01112 Vilnius

Cozaar

(Losartan)

100 mg

Film-coated tablet

Oral use

Luxembourg

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

Luxembourg

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 50 MG

50 mg

Film-coated tablet

Oral use

Luxembourg

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar 12,5 mg

12,5 mg

Film-coated tablet

Oral use

Luxembourg

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar Cardio Start

21 X 12,5 mg + 14 X 50 mg

Film-coated tablet

Oral use

Luxembourg

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 100 mg

100 mg

Film-coated tablet

Oral use

Luxembourg

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 50 mg

50 mg

Film-coated tablet

Oral use

Luxembourg

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan 12,50 mg

12,5 mg

Film-coated tablet

Oral use

Luxembourg

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan Cardio Start

21 X 12,5 mg + 14 X 50 mg

Film-coated tablet

Oral use

Malta

| Merck Sharp & Dohme Ltd. |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Ltd.

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

“Cozaar 100 mg”

pilloli miksija b'rita

10 mg

Film-coated tablet

Oral use

Malta

| Merck Sharp & Dohme Ltd. |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Ltd.

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

“Cozaar 50 mg”

pilloli miksija b'rita

50 mg

Film-coated tablet

Oral use

The Netherlands

| Merck Sharp & Dohme |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

Postbus 581

2003 PC Haarlem

Nederland

Cozaar 50

50 mg

Film-coated tablet

Oral use

The Netherlands

| Merck Sharp & Dohme |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

Postbus 581

2003 PC Haarlem

Nederland

Cozaar 100

100 mg

Film-coated tablet

Oral use

Poland

| MSD Polska Sp. z o.o. |
| --- |
| Chłodna 51 |
| PL-00-867 Warszawa |

MSD Polska Sp. z o.o.

Chłodna 51

PL-00-867 Warszawa

Cozaar

12,5 mg

Film-coated tablet

Oral use

Poland

| MSD Polska Sp. z o.o. |
| --- |
| Chłodna 51 |
| PL-00-867 Warszawa |

MSD Polska Sp. z o.o.

Chłodna 51

PL-00-867 Warszawa

Cozaar

50 mg

Film-coated tablet

Oral use

Poland

| MSD Polska Sp. z o.o. |
| --- |
| Chłodna 51 |
| PL-00-867 Warszawa |

MSD Polska Sp. z o.o.

Chłodna 51

PL-00-867 Warszawa

Cozaar

100 mg

Film-coated tablet

Oral use

Portugal

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Cozaar

50 mg

Film-coated tablet

Oral use

Portugal

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

Portugal

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Cozaar IC

12,5 mg

Film-coated tablet

Oral use

Portugal

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Cozaar IC — Titulação

12,5 mg + 50 mg

Film-coated tablet

Oral use

Portugal

| LABORATÓRIO MEDINFAR |
| --- |
| Produtos Farmacêuticos, SA |
| Rua Manuel Ribeiro de Pavia, 1-1 |
| Venda Nova |
| P-2700-547 Amadora |

LABORATÓRIO MEDINFAR

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan IC

12,5 mg

Film-coated tablet

Oral use

Portugal

| LABORATÓRIO MEDINFAR |
| --- |
| Produtos Farmacêuticos, SA |
| Rua Manuel Ribeiro de Pavia, 1-1 |
| Venda Nova |
| PT-2700-547 Amadora |

LABORATÓRIO MEDINFAR

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

PT-2700-547 Amadora

Lortaan IC — Titulação

12,5 mg + 50 mg

Film-coated tablet

Oral use

Portugal

| LABORATÓRIO MEDINFAR |
| --- |
| Produtos Farmacêuticos, SA |
| Rua Manuel Ribeiro de Pavia, 1-1 |
| Venda Nova |
| P-2700-547 Amadora |

LABORATÓRIO MEDINFAR

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan

50 mg

Film-coated tablet

Oral use

Portugal

| LABORATÓRIO MEDINFAR |
| --- |
| Produtos Farmacêuticos, SA |
| Rua Manuel Ribeiro de Pavia, 1-1 |
| Venda Nova |
| P-2700-547 Amadora |

LABORATÓRIO MEDINFAR

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan 100 mg

100 mg

Film-coated tablet

Oral use

Romania

| Merck Sharp & Dohme Romania S.R.L. |
| --- |
| Bucharest Business Park |
| Şos. Bucureşti-Ploieşti, Nr. 1A |
| Clădirea C1, Etaj 3 |
| Sector 1, Bucureşti |
| România |

Merck Sharp & Dohme Romania S.R.L.

Bucharest Business Park

Şos. Bucureşti-Ploieşti, Nr. 1A

Clădirea C1, Etaj 3

Sector 1, Bucureşti

România

Cozaar, comprimate filmate, 50 mg

50 mg

Film-coated tablet

Oral use

Slovenia

| Merck Sharp & Dohme, inovativna zdravila d.o.o. |
| --- |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Cozaar 12,5 mg filmsko obložene tablete

12,5 mg

Film-coated tablet

Oral use

Slovenia

| Merck Sharp & Dohme, inovativna zdravila d.o.o. |
| --- |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Cozaar 50 mg filmsko obložene tablete

50 mg

Film-coated tablet

Oral use

Slovenia

| Merck Sharp & Dohme, inovativna zdravila d.o.o. |
| --- |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Cozaar 100 mg filmsko obložene tablete

100 mg

Film-coated tablet

Oral use

Spain

| Merck Sharp and Dohme de España, S.A. |
| --- |
| C/ Josefa Valcárcel, 38 |
| E-28027 Madrid |

Merck Sharp and Dohme de España, S.A.

C/ Josefa Valcárcel, 38

E-28027 Madrid

Cozaar 12,5 mg Inicio

12,5 mg

Film-coated tablet

Oral use

Spain

| Merck Sharp and Dohme de España, S.A. |
| --- |
| C/ Josefa Valcárcel, 38 |
| E-28027 Madrid |

Merck Sharp and Dohme de España, S.A.

C/ Josefa Valcárcel, 38

E-28027 Madrid

Cozaar 50 mg

50 mg

Film-coated tablet

Oral use

Spain

| Merck Sharp and Dohme de España, S.A. |
| --- |
| C/ Josefa Valcárcel, 38 |
| E-28027 Madrid |

Merck Sharp and Dohme de España, S.A.

C/ Josefa Valcárcel, 38

E-28027 Madrid

Cozaar 100 mg

100 mg

Film-coated tablet

Oral use

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar 12,5 mg filmdragerade tabletter

12,5 mg

Film-coated tablet

Oral use

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar 12,5 mg + 50 mg filmdragerade tabletter

12,5 + 50 mg

Film-coated tablet

Oral use

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar 50 mg filmdragerade tabletter

50 mg

Film-coated tablet

Oral use

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar 100 mg filmdragerade tabletter

100 mg

Film-coated tablet

Oral use

United Kingdom

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 50 mg Film-coated tablets

50 mg

Film-coated tablet

Oral use

United Kingdom

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 25 mg Film-coated tablets

25 mg

Film-coated tablet

Oral use

United Kingdom

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar 100 mg Film-coated tablets

100 mg

Film-coated tablet

Oral use

Iceland

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

12,5 mg

Film-coated tablet

Oral use

Iceland

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

50 mg

Film-coated tablet

Oral use

Iceland

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

100 mg

Film-coated tablet

Oral use

Norway

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

12,5 mg

Film-coated tablet

Oral use

Norway

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

50 mg

Film-coated tablet

Oral use

Norway

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar

100 mg

Film-coated tablet

Oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | (Invented) Name
  Losartan potassium and hydrochlorothiazide | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Merck Sharp & Dohme GmbH |
| Donau-City-Straße 6 |
| A-1220 Wien |

Member State

Marketing Authorisation Holder

(Invented) Name

Losartan potassium and hydrochlorothiazide

Strength

Pharmaceutical Form

Route of administration

Austria

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Cosaar Plus — Filmtabletten

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Austria

| Merck Sharp & Dohme GmbH |
| --- |
| Donau-City-Straße 6 |
| A-1220 Wien |

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Fortzaar-Filmtabletten

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Belgium

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar Plus Forte 100 mg/25 mg

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Belgium

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar Plus 50 mg/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Belgium

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan Plus Forte 100 mg/25 mg

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Belgium

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan Plus 50 mg/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Bulgaria

| Merck Sharp & Dohme Bulgaria EOOD |
| --- |
| 55 Nikola Vaptzarov blvd. |
| EXPO 2000, east wing, sections B1 & B2, 1st fl. |
| BG-1407 Sofia |

Merck Sharp & Dohme Bulgaria EOOD

55 Nikola Vaptzarov blvd.

EXPO 2000, east wing, sections B1 & B2, 1st fl.

BG-1407 Sofia

Hyzaar

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cyprus

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Fortzaar

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Cyprus

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Hyzaar

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar Comp.

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar Comp. Forte

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Cozaar Comp. 100 mg/12,5 mg

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Denmark

| Merck Sharp & Dohme BV |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

Postbus 581

2003 PC Haarlem

Nederland

Fortzaar

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablets

Oral use

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi tee 46 |
| EE-11415 Tallinn |

Merck Sharp & Dohme OÜ

Peterburi tee 46

EE-11415 Tallinn

Hyzaar

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi tee 46 |
| EE-11415 Tallinn |

Merck Sharp & Dohme OÜ

Peterburi tee 46

EE-11415 Tallinn

Fortzaar

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| P.O.Box 581 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

P.O.Box 581

2031 BN Haarlem

Nederland

Cozaar Comp

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| P.O.Box 581 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

P.O.Box 581

2031 BN Haarlem

Nederland

Cozaar Comp

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| P.O.Box 581 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

P.O.Box 581

2031 BN Haarlem

Nederland

Cozaar Comp Forte

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, av. Hoche |
| F-75114 Paris Cedex 08 |

Merck Sharp Dohme Chibret

3, av. Hoche

F-75114 Paris Cedex 08

Fortzaar 100 mg/25 mg comprimé pelliculé

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, av. Hoche |
| F-75114 Paris Cedex 08 |

Merck Sharp Dohme Chibret

3, av. Hoche

F-75114 Paris Cedex 08

Hyzaar 100 mg/25 mg comprimé pelliculé

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, av. Hoche |
| F-75114 Paris Cedex 08 |

Merck Sharp Dohme Chibret

3, av. Hoche

F-75114 Paris Cedex 08

Fortzaar 50 mg/12,5 mg comprimé pelliculé

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, av. Hoche |
| F-75114 Paris Cedex 08 |

Merck Sharp Dohme Chibret

3, av. Hoche

F-75114 Paris Cedex 08

Hyzaar 50 mg/12,5 mg comprimé pelliculé

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, av. Hoche |
| F-75114 Paris Cedex 08 |

Merck Sharp Dohme Chibret

3, av. Hoche

F-75114 Paris Cedex 08

Fortzaar 100 mg/12,5 mg comprimé pelliculé

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar Plus 50/12,5 mg Filmtabletten

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Cardopal Plus 50/12,5 mg Filmtabletten

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Germany

| VARIPHARM ARZNEIMITTEL GmbH |
| --- |
| Lindenplatz 1 |
| D-85540 Haar |

VARIPHARM ARZNEIMITTEL GmbH

Lindenplatz 1

D-85540 Haar

Lorzaar Varipharm Plus 50/12,5 mg Filmtabletten

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Fortzaar 100/25 mg Filmtabletten

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Germany

| VARIPHARM ARZNEIMITTEL GmbH |
| --- |
| Lindenplatz 1 |
| D-85540 Haar |

VARIPHARM ARZNEIMITTEL GmbH

Lindenplatz 1

D-85540 Haar

Fortzaar Varipharm 100/25 mg Filmtabletten

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Germany

| MSD Chibropharm GmbH |
| --- |
| Postfach 1202 |
| D-85530 Haar |

MSD Chibropharm GmbH

Postfach 1202

D-85530 Haar

Lorzaar Plus Forte 100/12,5 mg Filmtabletten

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Greece

| VIANEX A.E. |
| --- |
| Tatoiou Street |
| GR-14671 Nea Erythraia |

VIANEX A.E.

Tatoiou Street

GR-14671 Nea Erythraia

Hyzaar

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Greece

| VIANEX A.E. |
| --- |
| Tatoiou Street |
| GR-14671 Nea Erythraia |

VIANEX A.E.

Tatoiou Street

GR-14671 Nea Erythraia

Hyzaar 100/25

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hungary

| Merck Sharp & Dohme Hungary Ltd |
| --- |
| 50, Alkotas u. |
| H-1123 Budapest |

Merck Sharp & Dohme Hungary Ltd

50, Alkotas u.

H-1123 Budapest

Hyzaar 50/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Hungary

| Merck Sharp & Dohme Hungary Ltd |
| --- |
| 50, Alkotas u. |
| H-1123 Budapest |

Merck Sharp & Dohme Hungary Ltd

50, Alkotas u.

H-1123 Budapest

Hyzaar Forte 100/25 mg

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Iceland

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Cozaar' Comp 50 mg/12,5 mg film-coated tablets

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Iceland

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Cozaar' Comp 100 mg/25 mg film-coated tablets

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Iceland

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Hizaar 50 mg + 12,5 mg compresse rivestite con film

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Ireland

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Hizaar 100 mg + 25 mg compresse rivestite con film

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Ireland

| Merck Sharp & Dohme (Italia) S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme (Italia) S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Forzaar 100 mg + 25 mg compresse rivestite con film

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

| Neopharmed S.p.A. |
| --- |
| Via G. Fabbroni, 6 |
| I-00191 Roma |

Neopharmed S.p.A.

Via G. Fabbroni, 6

I-00191 Roma

Neo-Lotan Plus 50 mg + 12,5 mg compresse rivestite con film

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

| Neopharmed S.p.A. |
| --- |
| Via G. Fabbroni, 6 |
| I-00191 Roma |

Neopharmed S.p.A.

Via G. Fabbroni, 6

I-00191 Roma

Neo-Lotan Plus 100 mg + 25 mg compresse rivestite con film

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| viale Shakespeare 47 |
| I-00144 Roma |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

viale Shakespeare 47

I-00144 Roma

Losazid 50 mg + 12,5 mg compresse rivestite con film

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| viale Shakespeare 47 |
| I-00144 Roma |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

viale Shakespeare 47

I-00144 Roma

Losazid 100 mg + 25 mg compresse rivestite con film

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

| SIA Merck Sharp & Dohme Latvia |
| --- |
| Skanstes street 13 |
| LV-1013 Riga |

SIA Merck Sharp & Dohme Latvia

Skanstes street 13

LV-1013 Riga

Hyzaar 50 mg/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

| SIA Merck Sharp & Dohme Latvia |
| --- |
| Skanstes street 13 |
| LV-1013 Riga |

SIA Merck Sharp & Dohme Latvia

Skanstes street 13

LV-1013 Riga

Fortzaar 100 mg/25 mg

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Italy

| UAB Merck Sharp & Dohme |
| --- |
| Geležinio Vilko 18A |
| LT-01112 Vilnius |

UAB Merck Sharp & Dohme

Geležinio Vilko 18A

LT-01112 Vilnius

Fortzaar (Losartan/Hydrochlorothiazide)

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Latvia

| UAB Merck Sharp & Dohme |
| --- |
| Geležinio Vilko 18A |
| LT-01112 Vilnius |

UAB Merck Sharp & Dohme

Geležinio Vilko 18A

LT-01112 Vilnius

Hyzaar (Losartan/Hydrochlorothiazide)

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Latvia

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar Plus Forte 100 mg/25 mg

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Lithuania

| Merck Sharp & Dohme BV |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme BV

Chaussée de Waterloo, 1135

B-1180 Bruxelles

Cozaar Plus 50 mg/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Lithuania

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan Plus Forte 100 mg/25 mg

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Luxembourg

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem, 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem, 108

B-1180 Bruxelles

Loortan Plus 50 mg/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Luxembourg

| Merck Sharp & Dohme Ltd |
| --- |
| Hertfordshire Road |
| Hoddesdon |
| Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Ltd

Hertfordshire Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

“Cozaar Comp” 50/12,5 mg pilloli miksija b'rita

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Luxembourg

| Merck Sharp & Dohme Ltd |
| --- |
| Hertfordshire Road |
| Hoddesdon |
| Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Ltd

Hertfordshire Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

“Cozaar Comp” 100/25 mg pilloli miksija b'rita

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Luxembourg

| Merck Sharp & Dohme Ltd |
| --- |
| Hertfordshire Road |
| Hoddesdon |
| Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Ltd

Hertfordshire Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

“Cozaar Comp” 100/12,5 mg pilloli miksija b'rita

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Malta

| Merck Sharp & Dohme |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

Postbus 581

2003 PC Haarlem

Nederland

Cozaar Plus 100/12,5

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Malta

| Merck Sharp & Dohme |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

Postbus 581

2003 PC Haarlem

Nederland

Fortzaar 100/25

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Malta

| Merck Sharp & Dohme |
| --- |
| Postbus 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

Postbus 581

2003 PC Haarlem

Nederland

Hyzaar 50/12,5

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

The Netherlands

| MSD Polska Sp. z o.o. |
| --- |
| ul. Chłodna 51 |
| PL-00-867 Warszawa |

MSD Polska Sp. z o.o.

ul. Chłodna 51

PL-00-867 Warszawa

Hyzaar

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

The Netherlands

| MSD Polska Sp. z o.o. |
| --- |
| ul. Chłodna 51 |
| PL-00-867 Warszawa |

MSD Polska Sp. z o.o.

ul. Chłodna 51

PL-00-867 Warszawa

Hyzaar Forte

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

The Netherlands

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Cozaar Plus

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Norway

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Cozaar Plus

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Norway

| Merck Sharp & Dohme, Lda. |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda.

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Fortzaar

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Norway

| Heptafarma- Companhia Farmacêutica |
| --- |
| Sociedade Unipessoal, Lda |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Heptafarma- Companhia Farmacêutica

Sociedade Unipessoal, Lda

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Siaara

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Poland

| Laboratório Medinfar |
| --- |
| Produtos Farmacêuticos, SA |
| Rua Manuel Ribeiro de Pavia, 1-1 |
| Venda Nova |
| P-2700-547 Amadora |

Laboratório Medinfar

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan Plus

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Poland

| Laboratório Medinfar |
| --- |
| Produtos Farmacêuticos, SA |
| Rua Manuel Ribeiro de Pavia, 1-1 |
| Venda Nova |
| P-2700-547 Amadora |

Laboratório Medinfar

Produtos Farmacêuticos, SA

Rua Manuel Ribeiro de Pavia, 1-1

Venda Nova

P-2700-547 Amadora

Lortaan Plus

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

| Frosst Portuguesa |
| --- |
| Produtos Farmacêuticos, Lda. |
| Quinte da Fonte |
| Edificio Vasco da Gama, 19 |
| P.O. BOX 214 |
| Porto Salvo |
| P-2780-730 Paço d'Arcos |

Frosst Portuguesa

Produtos Farmacêuticos, Lda.

Quinte da Fonte

Edificio Vasco da Gama, 19

P.O. BOX 214

Porto Salvo

P-2780-730 Paço d'Arcos

Losartan + Hidroclorotiazida Frosst

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

| Merck Sharp & Dohme Romania S.R.L. |
| --- |
| Bucharest Business Park |
| Şos. Bucureşti-Ploieşti, Nr. 1A |
| Clădirea C1, Etaj 3 |
| Sector 1, Bucureşti |
| România |

Merck Sharp & Dohme Romania S.R.L.

Bucharest Business Park

Şos. Bucureşti-Ploieşti, Nr. 1A

Clădirea C1, Etaj 3

Sector 1, Bucureşti

România

Hyzaar® 50 mg/12,5 mg comprimate filmate

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

| Merck Sharp & Dohme Romania S.R.L. |
| --- |
| Bucharest Business Park |
| Şos. Bucureşti-Ploieşti, Nr. 1A |
| Clădirea C1, Etaj 3 |
| Sector 1, Bucureşti |
| România |

Merck Sharp & Dohme Romania S.R.L.

Bucharest Business Park

Şos. Bucureşti-Ploieşti, Nr. 1A

Clădirea C1, Etaj 3

Sector 1, Bucureşti

România

Fortzaar® 100/25 mg comprimate filmate

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

| Merck Sharp & Dohme, |
| --- |
| inovativna zdravila d.o.o. |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme,

inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Hyzaar

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

| Merck Sharp & Dohme, |
| --- |
| inovativna zdravila d.o.o. |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme,

inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Hyzaar

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

| Merck Sharp & Dohme, |
| --- |
| inovativna zdravila d.o.o. |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme,

inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Fortzaar

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Portugal

| Merck Sharp and Dohme de España, S.A. |
| --- |
| C/ Josefa Valcárcel, 38 |
| E-28027 Madrid |

Merck Sharp and Dohme de España, S.A.

C/ Josefa Valcárcel, 38

E-28027 Madrid

Cozaar Plus

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Romania

| Merck Sharp and Dohme de España, S.A. |
| --- |
| C/ Josefa Valcárcel, 38 |
| E-28027 Madrid |

Merck Sharp and Dohme de España, S.A.

C/ Josefa Valcárcel, 38

E-28027 Madrid

Fortzaar

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Romania

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar Comp 50 mg/12,5 mg filmdragerade tabletter

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Slovenia

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar Comp 100 mg/12,5 mg filmdragerade tabletter

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Slovenia

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar Comp Forte 100 mg/25 mg filmdragerade tabletter

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Slovenia

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar-Comp 50/12,5 mg film-coated tablets

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Spain

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar-Comp 100/25 mg film-coated tablets

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Spain

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Herts EN11 9BU |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Herts EN11 9BU

United Kingdom

Cozaar-Comp 100 mg/12,5 mg film-coated tablets

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar-Comp 50/12,5 mg

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar-Comp Forte

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

Sweden

| Merck Sharp & Dohme |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme

PO Box 581

2003 PC Haarlem

Nederland

Cozaar-Comp 100/12,5 mg

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

United Kingdom

| MSD BV |
| --- |
| Waarderweg 39 |
| 2031 BN Haarlem |
| Nederland |

MSD BV

Waarderweg 39

2031 BN Haarlem

Nederland

Cozaar Comp

50 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

United Kingdom

| MSD BV |
| --- |
| Waarderweg 39 |
| 2031 BN Haarlem |
| Nederland |

MSD BV

Waarderweg 39

2031 BN Haarlem

Nederland

Cozaar Comp

100 mg losartan potassium — 12,5 mg hydrochlorothiazide

Film-coated tablet

Oral use

United Kingdom

| MSD BV |
| --- |
| Waarderweg 39 |
| 2031 BN Haarlem |
| Nederland |

MSD BV

Waarderweg 39

2031 BN Haarlem

Nederland

Cozaar Comp Forte

100 mg losartan potassium — 25 mg hydrochlorothiazide

Film-coated tablet

Oral use

---

ANNEX III

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 adminitration |
| --- | --- | --- | --- | --- | --- |
| Austria | Merck Sharp & Dohme GmbH |
| Donau-City-Straße 6 |
| A-1220 Wien |

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of adminitration

Austria

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Arcoxia

90 mg

Film-coated tablets

Oral use

Belgium

| Merck Sharp and Dohme |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Brussels |

Merck Sharp and Dohme

Chaussée de Waterloo, 1135

B-1180 Brussels

Arcoxia

90 mg

Film-coated tablets

Oral use

Czech Republic

| Merck Sharp & Dohme B.V. |
| --- |
| Waanderweg 39 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waanderweg 39

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Cyprus

| Merck Sharp & Dohme B.V. |
| --- |
| Waanderweg 39 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waanderweg 39

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Denmark

| Merck Sharp & Dohme B.V. |
| --- |
| Waanderweg 39 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waanderweg 39

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi tee 46 |
| EE-11415 Tallinn |

Merck Sharp & Dohme OÜ

Peterburi tee 46

EE-11415 Tallinn

Arcoxia

90 mg

Film-coated tablets

Oral use

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| P.O Box 581 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

P.O Box 581

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, avenue Hoche |
| F-75114 Paris Cedex 8 |

Merck Sharp Dohme Chibret

3, avenue Hoche

F-75114 Paris Cedex 8

Arcoxia

90 mg

Film-coated tablets

Oral use

Germany

| MSD Sharp & Dohme GmbH |
| --- |
| Lindenplatz 1 |
| D-85540 Haar |

MSD Sharp & Dohme GmbH

Lindenplatz 1

D-85540 Haar

Arcoxia

90 mg

Film-coated tablets

Oral use

Greece

| VIANEX S.A. |
| --- |
| Tatoiou Street, |
| GR-14671 Nea Erythrea |

VIANEX S.A.

Tatoiou Street,

GR-14671 Nea Erythrea

Arcoxia

90 mg

Film-coated tablets

Oral use

Hungary

| Merck Sharp & Dohme |
| --- |
| Magyarország Kft. |
| Alkotás utca 50 |
| H-1123 Budapest |

Merck Sharp & Dohme

Magyarország Kft.

Alkotás utca 50

H-1123 Budapest

Arcoxia

90 mg

Film-coated tablets

Oral use

Iceland

| Merck Sharp & Dohme |
| --- |
| Regulatory Affairs Iceland |
| Smedeland 8 |
| DK-2600 Glostrup |

Merck Sharp & Dohme

Regulatory Affairs Iceland

Smedeland 8

DK-2600 Glostrup

Arcoxia

90 mg

Film-coated tablets

Oral use

Ireland

| Merck Sharp and Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9B4 |
| United Kingdom |

Merck Sharp and Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9B4

United Kingdom

Arcoxia

90 mg

Film-coated tablets

Oral use

Italy

| Merck Sharp & Dohme S.p.A. |
| --- |
| Via G. Fabbroni, 6 |
| I-00191 Roma |

Merck Sharp & Dohme S.p.A.

Via G. Fabbroni, 6

I-00191 Roma

Arcoxia

90 mg

Film-coated tablets

Oral use

Latvia

| SIA Merck Sharp & Dohme Latvija |
| --- |
| Skanstes 13 |
| LV-1013 Riga |

SIA Merck Sharp & Dohme Latvija

Skanstes 13

LV-1013 Riga

Arcoxia

90 mg

Film-coated tablets

Oral use

Lithuania

| UAB, Merck Sharp & Dohme |
| --- |
| Lenktoji str. 27/Kestucio str. 59 |
| LT-08124 Vilnius |

UAB, Merck Sharp & Dohme

Lenktoji str. 27/Kestucio str. 59

LT-08124 Vilnius

Arcoxia

90 mg

Film-coated tablets

Oral use

Luxembourg

| Merck Sharp & Dohme |
| --- |
| Chaussee de Waterloo, 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme

Chaussee de Waterloo, 1135

B-1180 Bruxelles

Arcoxia

90 mg

Film-coated tablets

Oral use

Malta

| Merck, Sharp & Dohme Ltd |
| --- |
| Hertfordshire Road |
| Hoddesdon |
| Hertsfordshire EN11 9BU |
| United Kindgdom |

Merck, Sharp & Dohme Ltd

Hertfordshire Road

Hoddesdon

Hertsfordshire EN11 9BU

United Kindgdom

Arcoxia

90 mg

Film-coated tablets

Oral use

The Netherlands

| Merck Sharp & Dohme B.V. |
| --- |
| Waanderweg 39 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waanderweg 39

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Norway

| Merck Sharp & Dohme B.V. |
| --- |
| Waanderweg 39 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waanderweg 39

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Poland

| MSD Polska Sp. z o.o. |
| --- |
| ul. Chłodna 51 |
| PL-00-867 Warszawa |

MSD Polska Sp. z o.o.

ul. Chłodna 51

PL-00-867 Warszawa

Arcoxia

90 mg

Film-coated tablets

Oral use

Portugal

| Merck Sharp & Dohme, Lda. PRT |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda. PRT

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Arcoxia

90 mg

Film-coated tablets

Oral use

Slovakia

| Merck Sharp & Dohme |
| --- |
| B.V.Waarderweg 39 |
| P.O. Box 581 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme

B.V.Waarderweg 39

P.O. Box 581

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Slovenia

| Merck Sharp & Dohme, |
| --- |
| inovativna zdravila d.o.o. |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme,

inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Arcoxia

90 mg

Film-coated tablets

Oral use

Spain

| Merck Sharp & Dohme de España, S.A. |
| --- |
| Josefa Valcárcel, 38 |
| E-28027 Madrid |

Merck Sharp & Dohme de España, S.A.

Josefa Valcárcel, 38

E-28027 Madrid

Arcoxia

90 mg

Film-coated tablets

Oral use

Sweden

| Merck Sharp & Dohme BV |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

PO Box 581

2003 PC Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

United Kingdom

| Merck Sharpe & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharpe & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Arcoxia

90 mg

Film-coated tablets

Oral use

---

ANNEX IV

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 |
| --- | --- | --- | --- | --- | --- |
| Austria | Merck Sharp & Dohme GmbH |
| Donau-City-Straße 6 |
| A-1220 Wien |

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Merck Sharp & Dohme GmbH

Donau-City-Straße 6

A-1220 Wien

Arcoxia

90 mg

Film-coated tablets

Oral use

Auxib

90 mg

Film-coated tablets

Oral use

Belgium

| Merck Sharp and Dohme |
| --- |
| Chaussée de Waterloo, 1135 |
| B-1180 Brussels |

Merck Sharp and Dohme

Chaussée de Waterloo, 1135

B-1180 Brussels

Arcoxia

90 mg

Film-coated tablets

Oral use

Ranacox

90 mg

Film-coated tablets

Oral use

Bulgaria

| Меrck Sharp & Dohme Bulgaria EOOD |
| --- |
| 55 Nikola Vaptzarov blvd. |
| EXPO 2000, east wing, section B1 & B2 1st fl. |
| BG-1407 Sofia |

Меrck Sharp & Dohme Bulgaria EOOD

55 Nikola Vaptzarov blvd.

EXPO 2000, east wing, section B1 & B2 1st fl.

BG-1407 Sofia

Arcoxia

90 mg

Film-coated tablets

Oral use

Czech Republic

| Merck Sharp & Dohme B.V. |
| --- |
| Waanderweg 39 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waanderweg 39

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Cyprus

| Merck Sharp & Dohme BV. |
| --- |
| Waarderweg 39 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme BV.

Waarderweg 39

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Denmark

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| 2031 BN, Haarlem |
| Postbox 581 |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN, Haarlem

Postbox 581

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Estonia

| Merck Sharp & Dohme OÜ |
| --- |
| Peterburi tee 46 |
| EE-11415 Tallinn |

Merck Sharp & Dohme OÜ

Peterburi tee 46

EE-11415 Tallinn

Arcoxia

90 mg

Film-coated tablets

Oral use

Finland

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| P.O Box 581 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

P.O Box 581

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Turox

90 mg

Film-coated tablets

Oral use

France

| Merck Sharp Dohme Chibret |
| --- |
| 3, avenue Hoche |
| F-75114 Paris Cedex 8 |

Merck Sharp Dohme Chibret

3, avenue Hoche

F-75114 Paris Cedex 8

Arcoxia

90 mg

Film-coated tablets

Oral use

Germany

| MSD Sharp & Dohme GmbH |
| --- |
| Lindenplatz 1 |
| D-85540 Haar |

MSD Sharp & Dohme GmbH

Lindenplatz 1

D-85540 Haar

Arcoxia

90 mg

Film-coated tablets

Oral use

Greece

| VIANEX S.A. |
| --- |
| Tatoiou Street, |
| GR-14671 Nea Erythrea |

VIANEX S.A.

Tatoiou Street,

GR-14671 Nea Erythrea

Arcoxia

90 mg

Film-coated tablets

Oral use

Hungary

| Merck Sharp & Dohme |
| --- |
| Magyarország Kft. |
| Alkotás utca 50 |
| H-1123 Budapest |

Merck Sharp & Dohme

Magyarország Kft.

Alkotás utca 50

H-1123 Budapest

Arcoxia

90 mg

Film-coated tablets

Oral use

Iceland

| Merck Sharp & Dohme |
| --- |
| Regulatory Affairs Iceland |
| Smedeland 8 |
| DK-2600 Glostrup |

Merck Sharp & Dohme

Regulatory Affairs Iceland

Smedeland 8

DK-2600 Glostrup

Arcoxia

90 mg

Film-coated tablets

Oral use

Ireland

| Merck Sharp and Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9B4 |
| United Kingdom |

Merck Sharp and Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire EN11 9B4

United Kingdom

Arcoxia

90 mg

Film-coated tablets

Oral use

Italy

| Merck Sharp & Dohme S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Merck Sharp & Dohme S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Arcoxia

90 mg

Film-coated tablet

Oral use

Italy

| Istituto Gentili S.p.A. |
| --- |
| Via Benedetto Croce 37 |
| I-56125 Pisa |

Istituto Gentili S.p.A.

Via Benedetto Croce 37

I-56125 Pisa

Algix

90 mg

Film-coated tablet

Oral use

Italy

| Neopharmed S.p.A. |
| --- |
| Via G. Fabbroni 6 |
| I-00191 Roma |

Neopharmed S.p.A.

Via G. Fabbroni 6

I-00191 Roma

Recoxib

90 mg

Film-coated tablets

Oral use

Italy

| Addenda Pharma S.r.l |
| --- |
| Viale Shakespeare 47 |
| I-00144 Roma |

Addenda Pharma S.r.l

Viale Shakespeare 47

I-00144 Roma

Tauxib

90 mg

Film-coated tablets

Oral use

Latvia

| SIA Merck Sharp & Dohme Latvija |
| --- |
| Skanstes 13 |
| LV-1013 Riga |

SIA Merck Sharp & Dohme Latvija

Skanstes 13

LV-1013 Riga

Arcoxia

90 mg

Film-coated tablets

Oral use

Lithuania

| UAB, Merck Sharp & Dohme |
| --- |
| Lenktoji str. 27/Kestucio str. 59 |
| LT-08124 Vilnius |

UAB, Merck Sharp & Dohme

Lenktoji str. 27/Kestucio str. 59

LT-08124 Vilnius

Arcoxia

90 mg

Film-coated tablets

Oral use

Luxembourg

| Merck Sharp & Dohme |
| --- |
| Chaussee de Waterloo 1135 |
| B-1180 Bruxelles |

Merck Sharp & Dohme

Chaussee de Waterloo 1135

B-1180 Bruxelles

Arcoxia

90 mg

Film-coated tablets

Oral use

Ranacox

90 mg

Film-coated tablets

Oral use

Malta

| Merck, Sharp & Dohme Ltd |
| --- |
| Hertfordshire Road |
| Hoddesdon |
| Hertsfordshire EN11 9BU |
| United Kindgdom |

Merck, Sharp & Dohme Ltd

Hertfordshire Road

Hoddesdon

Hertsfordshire EN11 9BU

United Kindgdom

Arcoxia

90 mg

Film-coated tablets

Oral use

The Netherlands

| Merck Sharp & Dohme B.V. |
| --- |
| Waanderweg 39 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waanderweg 39

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Auxib

90 mg

Film-coated tablets

Oral use

Norway

| Merck Sharp & Dohme B.V. |
| --- |
| Waarderweg 39 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Poland

| MSD Polska Sp. z o.o. |
| --- |
| ul. Chłodna 51 |
| PL-00-867 Warszawa |

MSD Polska Sp. z o.o.

ul. Chłodna 51

PL-00-867 Warszawa

Arcoxia

90 mg

Film-coated tablets

Oral use

Portugal

| Merck Sharp & Dohme, Lda. PRT |
| --- |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| P.O. Box 214 |
| P-2770-192 Paço d'Arcos |

Merck Sharp & Dohme, Lda. PRT

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

P.O. Box 214

P-2770-192 Paço d'Arcos

Arcoxia

90 mg

Film-coated tablets

Oral use

Portugal

| Laboratórios Bial — Portela & Ca, S.A. PRT |
| --- |
| Av. da Siderurgia Nacional |
| S. Mamede do Coronado |
| Portugal |

Laboratórios Bial — Portela & Ca, S.A. PRT

Av. da Siderurgia Nacional

S. Mamede do Coronado

Portugal

Exxiv

90 mg

Film-coated tablets

Oral use

Portugal

| Farmacox — Companhia |
| --- |
| Farmacêutica Sociedade Unipessoal, Lda. PRT |
| Quinta da Fonte |
| Edifício Vasco da Gama, 19 |
| Porto Salvo |
| Paço d'Arcos |
| Portugal |

Farmacox — Companhia

Farmacêutica Sociedade Unipessoal, Lda. PRT

Quinta da Fonte

Edifício Vasco da Gama, 19

Porto Salvo

Paço d'Arcos

Portugal

Turox

90 mg

Film-coated tablets

Oral use

Romania

| Merck Sharp & Dohme Romania S.R.L. |
| --- |
| Bucharest Business Park |
| Soseaua Bucuresti-Ploiesti nr. 1A |
| Corp C1, etaj 3, sector 1 |
| RO-013681 Bucharest |

Merck Sharp & Dohme Romania S.R.L.

Bucharest Business Park

Soseaua Bucuresti-Ploiesti nr. 1A

Corp C1, etaj 3, sector 1

RO-013681 Bucharest

Arcoxia

90 mg

Film-coated tablets

Oral use

Slovakia

| Merck Sharp & Dohme |
| --- |
| B.V.Waarderweg 39 |
| P.O. Box 581 |
| 2031 BN Haarlem |
| Nederland |

Merck Sharp & Dohme

B.V.Waarderweg 39

P.O. Box 581

2031 BN Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Slovenia

| Merck Sharp & Dohme, |
| --- |
| inovativna zdravila d.o.o. |
| Šmartinska cesta 140 |
| SLO-1000 Ljubljana |

Merck Sharp & Dohme,

inovativna zdravila d.o.o.

Šmartinska cesta 140

SLO-1000 Ljubljana

Arcoxia

90 mg

Film-coated tablets

Oral use

Spain

| Merck Sharp & Dohme de España, S.A. |
| --- |
| Josefa Valcárcel, 38 |
| E-28027 Madrid |

Merck Sharp & Dohme de España, S.A.

Josefa Valcárcel, 38

E-28027 Madrid

Arcoxia

90 mg

Film-coated tablets

Oral use

Spain

| Laboratorios Abello, S.A. |
| --- |
| Josefa Valcárcel, 38 |
| E-28027 Madrid |

Laboratorios Abello, S.A.

Josefa Valcárcel, 38

E-28027 Madrid

Exxiv

90 mg

Film-coated tablets

Oral use

Sweden

| Merck Sharp & Dohme BV |
| --- |
| PO Box 581 |
| 2003 PC Haarlem |
| Nederland |

Merck Sharp & Dohme BV

PO Box 581

2003 PC Haarlem

Nederland

Arcoxia

90 mg

Film-coated tablets

Oral use

Turox

90 mg

Film-coated tablets

Oral use

United Kingdom

| Merck Sharpe & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire EN11 9BU |
| United Kingdom |

Merck Sharpe & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire EN11 9BU

United Kingdom

Arcoxia

90 mg

Film-coated tablets

Oral use

Auxib 90

90 mg

Film-coated tablets

Oral use

Exxiv 90

90 mg

Film-coated tablets

Oral use

Turox 90

90 mg

Film-coated tablets

Oral use

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | | Novo Nordisk Pharma GmbH |
| Opernring 3-5 |
| A-1010 Wien |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Novo Nordisk Pharma GmbH

Opernring 3-5

A-1010 Wien

Noviana 0,5 mg/0,1 mg Filmtabletten

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Belgium

| Novo Nordisk Pharma N.V |
| --- |
| Boulevard International 55/6, |
| B-1070 Brussel |

Novo Nordisk Pharma N.V

Boulevard International 55/6,

B-1070 Brussel

Activelle minor comprimés pelliculés

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Bulgaria

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Eviana филмирани таблетки

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Czech Republic

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Noviana potahované tablety

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Denmark

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Activelle low filmovertrukne tabletter

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Estonia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Activelle

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Finland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Activelle 0,5 mg/0,1 mg tabl.

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

France

| Novo Nordisk Pharmaceutique S.A.S |
| --- |
| 30, rue De Valmy |
| F-92936 Paris La Défense Cedex |

Novo Nordisk Pharmaceutique S.A.S

30, rue De Valmy

F-92936 Paris La Défense Cedex

Activelle 0,5 mg/0,1 mg, comprimé pelliculé

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Germany

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Noviana

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Hungary

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Noviana filmtabletta

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Iceland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Activelle low 0,5 mg/0,1 mg tablets filmuhúðaðar töflur

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Ireland

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Activelle Tablets

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Italy

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Activelle 0,5 mg/0,1 mg compresse film-rivestite

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Latvia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Noviana 0,5 mg/0,1 mg apvalkotās tabletes

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Lithuania

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Activelle

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Luxembourg

| Novo Nordisk Pharma N.V |
| --- |
| Riverside Business Park |
| Boulevard International |
| B-1070 Brussels |

Novo Nordisk Pharma N.V

Riverside Business Park

Boulevard International

B-1070 Brussels

Activelle comprimés pelliculés

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

The Netherlands

| Novo Nordisk Farma B.V. |
| --- |
| Flemingweg 18 |
| 2408 AV Alphen a/d Rijn |
| Nederland |

Novo Nordisk Farma B.V.

Flemingweg 18

2408 AV Alphen a/d Rijn

Nederland

Activelle filmomhulde tabletten

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Norway

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Noviana 0,5 mg/0,1 mg tablett filmdrasjert

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Portugal

| Novo Nordisk, A/S DNK |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk, A/S DNK

Novo Allé

DK-2880 Bagsværd

Activelle

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Romania

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Noviana comprimate filmate

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Slovak Republic

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Noviana

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Slovenia

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Noviana filmsko obložene tablete

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Spain

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

Sweden

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| DK-2880 Bagsværd |

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Activelle

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

United Kingdom

| Novo Nordisk Pharma Ltd |
| --- |
| Broadfield Park |
| Brighton Road |
| RH11 9RT Crawley West Sussex |
| United Kingdom |

Novo Nordisk Pharma Ltd

Broadfield Park

Brighton Road

RH11 9RT Crawley West Sussex

United Kingdom

Noviana film-coated tablets

Estradiol (as hemihydrate) 0,5 mg + Norethisterone acetate 0,1 mg

Film-coated tablets

Oral use

---

ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | | ProStrakan Ltd |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Belgium

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Cyprus

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl (1)

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Czech Republic

| ProStrakan Ltd, |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd,

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Denmark

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Estonia

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Finland

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl (1)

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

France

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Germany

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Greece

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Hungary

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Iceland

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Ireland

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Italy

| ProStrakan Ltd |
| --- |
| Galabank Business Park, |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park,

Galashiels TD1 1QH

United Kingdom

Rapinyl (1)

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Latvia

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Lithuania

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Luxembourg

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Norway

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Poland

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Portugal

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Slovak Republic

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Slovenia

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Spain

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl (1)

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

Sweden

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Abstral

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

United Kingdom

| ProStrakan Ltd |
| --- |
| Galabank Business Park |
| Galashiels TD1 1QH |
| United Kingdom |

ProStrakan Ltd

Galabank Business Park

Galashiels TD1 1QH

United Kingdom

Rapinyl

50 μg

100 μg

200 μg

300 μg

400 μg

600 μg

800 μg

Sublingual tablet

Sublingual use

---

(1)  Name approval pending.

---

ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | INN | (Invented) Name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Organon GesmbH |
| Siebenbrunnengasse 21/D/IV |
| A-1050 Wien |

Member State

Marketing Authorisation Holder

INN

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

Organon GesmbH

Siebenbrunnengasse 21/D/IV

A-1050 Wien

Mirtazapine

Remeron SolTab Schmelztabletten

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab Schmelztabletten

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab Schmelztabletten

45 mg

Orodispersible tablets

Oral use

Belgium

| Organon Europe B.V. |
| --- |
| Kloosterstraat 6 |
| 5349AB Oss |
| Nederland |

Organon Europe B.V.

Kloosterstraat 6

5349AB Oss

Nederland

Delegation of power:

| Organon België n.v. |
| --- |
| Terhulpsesteenweg, 166 |
| B-1170 Brussels |

Organon België n.v.

Terhulpsesteenweg, 166

B-1170 Brussels

Mirtazapine

Remergon

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Cyprus

| C.A.Papaellinas & Co Ltd |
| --- |
| 179 Yiannos Kranidiotis Avenue |
| 2235 Latsia, Nicosia |
| Cyprus |

C.A.Papaellinas & Co Ltd

179 Yiannos Kranidiotis Avenue

2235 Latsia, Nicosia

Cyprus

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Czech Republic

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

REMERON 15 MG

15 mg

Film-coated tablets

Oral use

Mirtazapine

REMERON 30 MG

30 mg

Film-coated tablets

Oral use

Mirtazapine

REMERON 45 MG

45 mg

Film-coated tablets

Oral use

Mirtazapine

REMERON SOLTAB 15 MG

15 mg

Orodispersible tablets

Oral use

Mirtazapine

REMERON SOLTAB 30 MG

30 mg

Orodispersible tablets

Oral use

Mirtazapine

REMERON SOLTAB 45 MG

45 mg

Orodispersible tablets

Oral use

Denmark

| IMI Pharma A/S |
| --- |
| Literbuen 9 |
| DK-2740 Skovlunde |

IMI Pharma A/S

Literbuen 9

DK-2740 Skovlunde

Mirtazapine

Mitazon Smelt

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mitazon Smelt

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mitazon Smelt

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Mitazon

30 mg

Film-coated tablets

Oral use

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron Smelt

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Smelt

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Smelt

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Oral, opløsning

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Estonia

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

Finland

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron Soltab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Soltab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Soltab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

| Oy Organon Ab |
| --- |
| Maistraatinportti 2 |
| FI-00240 Helsinki |

Oy Organon Ab

Maistraatinportti 2

FI-00240 Helsinki

Mirtazapine

Mirtazon

30 mg

Film-coated tablets

Oral use

Mirtazapine

Mirtazon Smelt

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazon Smelt

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazon Smelt

45 mg

Orodispersible tablets

Oral use

France

| Organon S.A. |
| --- |
| Immeuble Optima |
| 10, rue Godefroy |
| F-92821 PUTEAUX Cedex |

Organon S.A.

Immeuble Optima

10, rue Godefroy

F-92821 PUTEAUX Cedex

Mirtazapine

Norset

15 mg

Film-coated tablets

Oral use

Mirtazapine

Norset

30 mg

Film-coated tablets

Oral use

Mirtazapine

Norset

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Norset

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Norset

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Norset

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Germany

| Organon GmbH |
| --- |
| Mittenheimer Straße 62 |
| D-85764 Oberschleißheim |

Organon GmbH

Mittenheimer Straße 62

D-85764 Oberschleißheim

Mirtazapine

Remergil

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remergil

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remergil

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remergil SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergil SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergil SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergil

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

| STADApharm GmbH |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |

STADApharm GmbH

Stadastraße 2-18

D-61118 Bad Vilbel

Mirtazapine

Mirtazapin STADA

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapin STADA

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapin STADA

45 mg

Orodispersible tablets

Oral use

Greece

| Organon Hellas S.A. |
| --- |
| 122, Vouliagmenis Av. Helliniko |
| GR-167 77 Athens |

Organon Hellas S.A.

122, Vouliagmenis Av. Helliniko

GR-167 77 Athens

Mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Hungary

| N.V. Organon, |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon,

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

Iceland

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron Smelt

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Smelt

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Smelt

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron 15 mg/ml

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Ireland

| Organon Laboratories Ltd |
| --- |
| Cambridge Science Park |
| Milton Road CB4 0FL |
| United Kingdom |

Organon Laboratories Ltd

Cambridge Science Park

Milton Road CB4 0FL

United Kingdom

Mirtazapine

Zispin® film-coated tablets

15 mg

Film-coated tablets

Oral use

Mirtazapine

Zispin® film-coated tablets

30 mg

Film-coated tablets

Oral use

Mirtazapine

Zispin® film-coated tablets

45 mg

Film-coated tablets

Oral use

| Organon (Ireland) Limited |
| --- |
| PO Box 2857 |
| Drynam Road |
| Swords, Co. Dublin |
| Ireland |

Organon (Ireland) Limited

PO Box 2857

Drynam Road

Swords, Co. Dublin

Ireland

Mirtazapine

Zispin® Soltab® orodispersible tablets

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Zispin® Soltab® orodispersible tablets

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Zispin® Soltab® orodispersible tablets

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Zispin® oral solution

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Italy

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Mirtazapine

Remeron

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapina Organon

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapina Organon

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapina Organon

45 mg

Orodispersible tablets

Oral use

Latvia

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

Lithuania

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron Sol Tab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Sol Tab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron Sol Tab

45 mg

Orodispersible tablets

Oral use

Luxembourg

| Organon Europe B.V. |
| --- |
| Kloosterstraat 6 |
| 5349AB Oss |
| Nederland |

Organon Europe B.V.

Kloosterstraat 6

5349AB Oss

Nederland

Delegation of power:

| Organon België n.v. |
| --- |
| Terhulpsesteenweg, 166 |
| B-1170 Brussels |

Organon België n.v.

Terhulpsesteenweg, 166

B-1170 Brussels

Mirtazapine

Remergon

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remergon SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remergon

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

The Netherlands

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| Postbus 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

Postbus 20

5340 BH Oss

Nederland

Mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron drank

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Mirtazapine

Remeron SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapine orodispergeerbare tabletten

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapine orodispergeerbare tabletten

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapine orodispergeerbare tabletten

45 mg

Orodispersible tablets

Oral use

Norway

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron-S smeltetabletter

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron-S smeltetabletter

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron-S smeltetabletter

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron mikstur, oppløsning

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Poland

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Portugal

| Organon Portuguesa |
| --- |
| Produtos Químicos e Farmacêuticos, Lda |
| Av. José Malhoa, 16-B -2o |
| P-1070-159 Lisboa |

Organon Portuguesa

Produtos Químicos e Farmacêuticos, Lda

Av. José Malhoa, 16-B -2o

P-1070-159 Lisboa

Mirtazapine

Mirtazapina Organon

15 mg

Film-coated tablets

Oral use

Mirtazapine

Mirtazapina Organon

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron SolTab

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

| Aacifar |
| --- |
| Produtos Químicos e Farmacêuticos, Lda |
| Av. José Malhoa, 16-B -2o |
| P-1070-159 Lisboa |

Aacifar

Produtos Químicos e Farmacêuticos, Lda

Av. José Malhoa, 16-B -2o

P-1070-159 Lisboa

Mirtazapine

Mirtazon

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazon

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazon

45 mg

Orodispersible tablets

Oral use

Romania

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron SolTab 15 mg

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab 30 mg

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron SolTab 45 mg

45 mg

Orodispersible tablets

Oral use

Slovak Republic

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

REMERON 15 mg

15 mg

Film-coated tablets

Oral use

Mirtazapine

REMERON 30 mg

30 mg

Film-coated tablets

Oral use

Mirtazapine

REMERON 45 mg

45 mg

Film-coated tablets

Oral use

Mirtazapine

REMERON Soltab 15 mg

15 mg

Orodispersible tablets

Oral use

Mirtazapine

REMERON Soltab 30 mg

30 mg

Orodispersible tablets

Oral use

Mirtazapine

REMERON Soltab 45 mg

45 mg

Orodispersible tablets

Oral use

Spain

| Organon Española, S.A. |
| --- |
| Ctra. De Hospitalet, 147-149 |
| Cityparc Ronda de Dalt |
| Edificio Amsterdam |
| E-08940 Cornellá de Llobregat, Barcelona |

Organon Española, S.A.

Ctra. De Hospitalet, 147-149

Cityparc Ronda de Dalt

Edificio Amsterdam

E-08940 Cornellá de Llobregat, Barcelona

Mirtazapine

Rexer

15 mg

Film-coated tablets

Oral use

Mirtazapine

Rexer

30 mg

Film-coated tablets

Oral use

Mirtazapine

Rexer

45 mg

Film-coated tablets

Oral use

Mirtazapine

Rexer Flas

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Rexer Flas

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Rexer Flas

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Rexer

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Mirtazapina Organon

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapina Organon

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapina Organon

45 mg

Orodispersible tablets

Oral use

Sweden

| N.V. Organon |
| --- |
| Kloosterstraat 6 |
| P.O. Box 20 |
| 5340 BH Oss |
| Nederland |

N.V. Organon

Kloosterstraat 6

P.O. Box 20

5340 BH Oss

Nederland

Mirtazapine

Remeron

15 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

30 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

45 mg

Film-coated tablets

Oral use

Mirtazapine

Remeron

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Mirtazapine

Remeron-S

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron-S

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Remeron-S

45 mg

Orodispersible tablets

Oral use

Mirtazapine

Mirtazapin IP

15 mg

Film-coated tablets

Oral use

Mirtazapine

Mirtazapin IP

30 mg

Film-coated tablets

Oral use

Mirtazapine

Mirtazapin IP

45 mg

Film-coated tablets

Oral use

United Kingdom

| Organon Laboratories Ltd |
| --- |
| Cambridge Science Park |
| Milton Road |
| Cambridge CB4 0FL |
| United Kingdom |

Organon Laboratories Ltd

Cambridge Science Park

Milton Road

Cambridge CB4 0FL

United Kingdom

Mirtazapine

Mirtazapine 15 mg tablets

15 mg

Film-coated tablets

Oral use

Mirtazapine

Mirtazapine 30 mg tablets

30 mg

Film-coated tablets

Oral use

Mirtazapine

Mirtazapine 45 mg tablets

45 mg

Film-coated tablets

Oral use

Mirtazapine

Mirtazapine 15 mg/ml oral solution

15 mg/ml

Oral solution

Oral use

990 mg/66 ml

Mirtazapine

Zispin SolTab 15 mg orodispersible tablet

15 mg

Orodispersible tablets

Oral use

Mirtazapine

Zispin SolTab 30 mg orodispersible tablet

30 mg

Orodispersible tablets

Oral use

Mirtazapine

Zispin SolTab 45 mg orodispersible tablet

45 mg

Orodispersible tablets

Oral use

---

ANNEX VIII

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 | Eli Lilly Ges.m.b.H |
| Kölblgasse 8-10 |
| A-1030 Wien |

Member State

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Eli Lilly Ges.m.b.H

Kölblgasse 8-10

A-1030 Wien

Gemzar 200 mg — Trockensubstanz zur Infusionsbereitung

200 mg

Powder for solution for infusion

Intravenous use

Austria

| Eli Lilly Ges.m.b.H |
| --- |
| Kölblgasse 8-10 |
| A-1030 Wien |

Eli Lilly Ges.m.b.H

Kölblgasse 8-10

A-1030 Wien

Gemzar 1 g — Trockensubstanz zur Infusionsbereitung

1 000 mg

Powder for solution for infusion

Intravenous use

Belgium

| Eli Lilly Benelux s.a. |
| --- |
| Rue de L'Etuve, 52 |
| B-1000 Brussels |

Eli Lilly Benelux s.a.

Rue de L'Etuve, 52

B-1000 Brussels

Gemzar 1000

1 000 mg

Powder for solution for infusion

Intravenous use

Belgium

| Eli Lilly Benelux s.a. |
| --- |
| Rue de L'Etuve, 52 |
| B-1000 Brussels |

Eli Lilly Benelux s.a.

Rue de L'Etuve, 52

B-1000 Brussels

Gemzar 200

200 mg

Powder for solution for infusion

Intravenous use

Bulgaria

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

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Bulgaria

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

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

Nederland

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Czech Republic

| Eli Lilly ČR, s. r. o |
| --- |
| Pobřežní 1A |
| CZ-186 00 Praha 8 |

Eli Lilly ČR, s. r. o

Pobřežní 1A

CZ-186 00 Praha 8

Gemzar 1 g

1 g

Powder for solution for infusion

Intravenous use

Czech Republic

| Eli Lilly ČR, s. r. o |
| --- |
| Pobřežní 1A |
| CZ-186 00 Praha 8 |

Eli Lilly ČR, s. r. o

Pobřežní 1A

CZ-186 00 Praha 8

Gemzar 200 mg

200 mg

Powder for solution for infusion

Intravenous use

Cyprus

| PHADISCO LTD |
| --- |
| 185 Giannou Kranidioti Avenue |
| CY-2234 Latsia |

PHADISCO LTD

185 Giannou Kranidioti Avenue

CY-2234 Latsia

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Cyprus

| PHADISCO LTD |
| --- |
| 185 Giannou Kranidioti Avenue |
| CY-2234 Latsia |

PHADISCO LTD

185 Giannou Kranidioti Avenue

CY-2234 Latsia

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Denmark

| Eli Lilly Danmark A/S |
| --- |
| Nybrovej 110 |
| DK-2800 Kongens Lyngby |

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Denmark

| Eli Lilly Danmark A/S |
| --- |
| Nybrovej 110 |
| DK-2800 Kongens Lyngby |

Eli Lilly Danmark A/S

Nybrovej 110

DK-2800 Kongens Lyngby

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Estonia

| Eli Lilly Holdings Limited, |
| --- |
| Kingsclere Road, |
| Basingstoke, |
| Hampshire, |
| RG21 6XA |
| United Kingdom |

Eli Lilly Holdings Limited,

Kingsclere Road,

Basingstoke,

Hampshire,

RG21 6XA

United Kingdom

Gemzar 200 mg powder for solution for infusion

200 mg

Powder for solution for infusion

Intravenous use

Estonia

| Eli Lilly Holdings Limited |
| --- |
| Kingsclere Road |
| Basingstoke |
| Hampshire RG21 6XA |
| United Kingdom |

Eli Lilly Holdings Limited

Kingsclere Road

Basingstoke

Hampshire RG21 6XA

United Kingdom

Gemzar 1 g powder for solution for infusion

1 g

Powder for solution for infusion

Intravenous use

Finland

| Oy Eli Lilly Finland |
| --- |
| Ab Rajatorpantie 41 C |
| PL 16 |
| FI-01641 Vantaa |

Oy Eli Lilly Finland

Ab Rajatorpantie 41 C

PL 16

FI-01641 Vantaa

Gemzar 200 mg powder for solution for infusion

200 mg

Powder for solution for infusion

Intravenous use

Finland

| Oy Eli Lilly Finland |
| --- |
| Ab Rajatorpantie 41 C |
| PL 16 |
| FI-01641 Vantaa |

Oy Eli Lilly Finland

Ab Rajatorpantie 41 C

PL 16

FI-01641 Vantaa

Gemzar 1 g powder for solution for infusion

1 g

Powder for solution for infusion

Intravenous use

France

| LILLY France S.A.S. |
| --- |
| 13, rue Pagès |
| F-92158 Suresnes Cedex |

LILLY France S.A.S.

13, rue Pagès

F-92158 Suresnes Cedex

Gemzar 1 000 mg, poudre pour solution pour perfusion

1 000 mg

Powder for solution for infusion

Intravenous use

France

| LILLY France S.A.S. |
| --- |
| 13, rue Pagès |
| F-92158 Suresnes Cedex |

LILLY France S.A.S.

13, rue Pagès

F-92158 Suresnes Cedex

Gemzar 200 mg, poudre pour solution pour perfusion

200 mg

Powder for solution for infusion

Intravenous use

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| D-35396 Gießen |

Lilly Deutschland GmbH

Teichweg 3

D-35396 Gießen

Gemzar 200 mg Pulver zur Herstellung einer Infusionslösung

200 mg

Powder for solution for infusion

Intravenous use

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| D-35396 Gießen |

Lilly Deutschland GmbH

Teichweg 3

D-35396 Gießen

Gemzar 1 g Pulver zur Herstellung einer Infusionslösung

1 000 mg

Powder for solution for infusion

Intravenous use

Greece

| FARMASERVE LILLY S.A.Cl |
| --- |
| 15 Km National Road Athens-Lamia |
| GR-14564 Athens |

FARMASERVE LILLY S.A.Cl

15 Km National Road Athens-Lamia

GR-14564 Athens

ΓΚΕΜΖΑΡ

200 mg

Powder for solution for infusion

Intravenous use

Greece

| FARMASERVE LILLY S.A.Cl |
| --- |
| 15 Km National Road Athens-Lamia |
| GR-14564 Athens |

FARMASERVE LILLY S.A.Cl

15 Km National Road Athens-Lamia

GR-14564 Athens

ΓΚΕΜΖΑΡ

1 000 mg

Powder for solution for infusion

Intravenous use

Hungary

| Eli Lilly Nederland BV |
| --- |
| PO Box 379 |
| 3990 GD Houten |
| Nederland |

Eli Lilly Nederland BV

PO Box 379

3990 GD Houten

Nederland

Gemzar 1 g powder for injection

1 g

Powder for injection

Intravenous use

Hungary

| Eli Lilly Nederland BV |
| --- |
| PO Box 379 |
| 3990 GD Houten |
| Nederland |

Eli Lilly Nederland BV

PO Box 379

3990 GD Houten

Nederland

Gemzar 200 mg powder for injection

200 mg

Powder for injection

Intravenous use

Ireland

| Eli Lilly and Company Limited |
| --- |
| Lilly House |
| Priestley Road |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

Eli Lilly and Company Limited

Lilly House

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Gemzar 200 mg powder for solution for infusion

200 mg

Powder for solution for infusion

Intravenous use

Ireland

| Eli Lilly and Company Limited |
| --- |
| Lilly House |
| Priestley Road |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

Eli Lilly and Company Limited

Lilly House

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Gemzar 1 g powder for solution for infusion

1 g

Powder for solution for infusion

Intravenous use

Iceland

| Eli Lilly Denmark |
| --- |
| Nybrovej 110 |
| DK-2800 Lyngby |

Eli Lilly Denmark

Nybrovej 110

DK-2800 Lyngby

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Iceland

| Eli Lilly Denmark |
| --- |
| Nybrovej 110 |
| DK-2800 Lyngby |

Eli Lilly Denmark

Nybrovej 110

DK-2800 Lyngby

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Italy

| Eli Lilly Italia S.P.A. |
| --- |
| Via Gramsci 731/733 |
| I-50019 Sesto Fiorentino, Florence |

Eli Lilly Italia S.P.A.

Via Gramsci 731/733

I-50019 Sesto Fiorentino, Florence

Gemzar 200 mg powder for solution for infusion and intravesical instillation

200 mg

Powder for solution for infusion and intravesical instillation

Intravenous use and intravesical use

Italy

| Eli Lilly Italia S.P.A. |
| --- |
| Via Gramsci 731/733 |
| I-50019 Sesto Fiorentino, Florence |

Eli Lilly Italia S.P.A.

Via Gramsci 731/733

I-50019 Sesto Fiorentino, Florence

Gemzar 1 g powder for solution for infusion and intravesical instillation

1 g

Powder for solution for infusion and intravesical instillation

Intravenous use and intravesical use

Latvia

| Eli Lilly Holdings Limited |
| --- |
| Kingsclere Road |
| Basingstoke |
| Hampshire RG 216XA5 |
| United Kingdom |

Eli Lilly Holdings Limited

Kingsclere Road

Basingstoke

Hampshire RG 216XA5

United Kingdom

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Latvia

| Eli Lilly Holdings Limited |
| --- |
| Kingsclere Road |
| Basingstoke |
| Hampshire RG 216XA5 |
| United Kingdom |

Eli Lilly Holdings Limited

Kingsclere Road

Basingstoke

Hampshire RG 216XA5

United Kingdom

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Lithuania

| Eli Lilly Holdings Limited |
| --- |
| Kingsclere Road |
| Basingstoke |
| Hampshire RG 216XA5 |
| United Kingdom |

Eli Lilly Holdings Limited

Kingsclere Road

Basingstoke

Hampshire RG 216XA5

United Kingdom

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Lithuania

| Eli Lilly Holdings Limited |
| --- |
| Kingsclere Road |
| Basingstoke |
| Hampshire RG 216XA5 |
| United Kingdom |

Eli Lilly Holdings Limited

Kingsclere Road

Basingstoke

Hampshire RG 216XA5

United Kingdom

Gemzar

1 000 mg

Powder for solution for infusion

Intravenous use

Luxembourg

| Eli Lilly Benelux s.a. |
| --- |
| Rue de l'Etuve, 52 |
| B-1000 Bruxelles |

Eli Lilly Benelux s.a.

Rue de l'Etuve, 52

B-1000 Bruxelles

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Luxembourg

| Eli Lilly Benelux s.a. |
| --- |
| Rue de l'Etuve, 52 |
| B-1000 Bruxelles |

Eli Lilly Benelux s.a.

Rue de l'Etuve, 52

B-1000 Bruxelles

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Malta

| Eli Lilly and Company Limited |
| --- |
| Lilly House |
| Priestley Road |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

Eli Lilly and Company Limited

Lilly House

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Malta

| Eli Lilly and Company Limited |
| --- |
| Lilly House |
| Priestley Road |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

Eli Lilly and Company Limited

Lilly House

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Gemzar

1 g

Powder for solution for infusion

Intravenous use

The Netherlands

| Eli Lilly Nederland BV |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nederland |

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

The Netherlands

| Eli Lilly Netherlands BV |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nederland |

Eli Lilly Netherlands BV

Grootslag 1-5

3991 RA Houten

Nederland

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Norway

| Eli Lilly Norge AS |
| --- |
| Postboks 6090 Etterstad |
| N-0601 Oslo |

Eli Lilly Norge AS

Postboks 6090 Etterstad

N-0601 Oslo

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Norway

| Eli Lilly Norge AS |
| --- |
| Postboks 6090 Etterstad |
| N-0601 Oslo |

Eli Lilly Norge AS

Postboks 6090 Etterstad

N-0601 Oslo

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Poland

| Lilly France S.A.S. |
| --- |
| 2, rue du Colonel Lilly |
| F-67642 Fegersheim |

Lilly France S.A.S.

2, rue du Colonel Lilly

F-67642 Fegersheim

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Poland

| Lilly France S.A.S. |
| --- |
| 2, rue du Colonel Lilly |
| F-67642 Fegersheim |

Lilly France S.A.S.

2, rue du Colonel Lilly

F-67642 Fegersheim

Gemzar

1 g

Powder for solution for infusion

Intravenous use

Portugal

| Lilly Portugal — Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1 |
| Piso 1 |
| Arquiparque-Miraflores |
| P-1499-016 Algés |

Lilly Portugal — Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1

Piso 1

Arquiparque-Miraflores

P-1499-016 Algés

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Portugal

| Lilly Portugal — Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1 |
| Piso 1 |
| Arquiparque-Miraflores |
| P-1499-016 Algés |

Lilly Portugal — Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1

Piso 1

Arquiparque-Miraflores

P-1499-016 Algés

Gemzar

1 000 mg

Powder for solution for infusion

Intravenous use

Romania

| Lilly France S.A.S. |
| --- |
| 2, rue du Colonel Lilly |
| F-67642 Fegersheim |

Lilly France S.A.S.

2, rue du Colonel Lilly

F-67642 Fegersheim

Gemzar 1 g

1 000 mg

Powder for solution for infusion

Intravenous use

Romania

| Lilly France S.A.S. |
| --- |
| 2, rue du Colonel Lilly |
| F-67642 Fegersheim |

Lilly France S.A.S.

2, rue du Colonel Lilly

F-67642 Fegersheim

Gemzar 200 mg

200 mg

Powder for solution for infusion

Intravenous use

Slovakia

| Eli Lilly ČR, s. r. o. |
| --- |
| Pobřežní 1A |
| CZ-186 00 Praha 8 |

Eli Lilly ČR, s. r. o.

Pobřežní 1A

CZ-186 00 Praha 8

Gemzar 1 g

1 g

Powder for solution for infusion

Intravenous use

Slovakia

| Eli Lilly ČR, s. r. o. |
| --- |
| Pobřežní 1A |
| CZ-186 00 Praha 8 |

Eli Lilly ČR, s. r. o.

Pobřežní 1A

CZ-186 00 Praha 8

Gemzar 200 mg

200 mg

Powder for solution for infusion

Intravenous use

Slovenia

| Eli Lilly farmacevtska družba, d.o.o. |
| --- |
| Dunajska cesta 156 |
| SLO-1000 Ljubljana |

Eli Lilly farmacevtska družba, d.o.o.

Dunajska cesta 156

SLO-1000 Ljubljana

Gemzar 200 mg prašek za raztopino za infundiranje

200 mg

Powder for solution for infusion

Intravenous use

Slovenia

| Eli Lilly farmacevtska družba, d.o.o. |
| --- |
| Dunajska cesta 156 |
| SLO-1000 Ljubljana |

Eli Lilly farmacevtska družba, d.o.o.

Dunajska cesta 156

SLO-1000 Ljubljana

Gemzar 1 g prašek za raztopino za infundiranje

1 g

Powder for solution for infusion

Intravenous use

Spain

| Lilly S.A. |
| --- |
| Avenida de la Industria, 30 |
| E-28108 Alcobendas, Madrid |

Lilly S.A.

Avenida de la Industria, 30

E-28108 Alcobendas, Madrid

Gemzar 1 g powder for solution for injection

1 g

Powder for solution for injection

Intravenous use

Spain

| Lilly S.A. |
| --- |
| Avenida de la Industria, 30 |
| E-28108 Alcobendas, Madrid |

Lilly S.A.

Avenida de la Industria, 30

E-28108 Alcobendas, Madrid

Gemzar 200 mg powder for solution for injection

200 mg

Powder for solution for injection

Intravenous use

Sweden

| Eli Lilly Sweden AB |
| --- |
| Box 721 |
| S-169 27 Solna |

Eli Lilly Sweden AB

Box 721

S-169 27 Solna

Gemzar

200 mg

Powder for solution for infusion

Intravenous use

Sweden

| Eli Lilly Sweden AB |
| --- |
| Box 721 |
| S-169 27 Solna |

Eli Lilly Sweden AB

Box 721

S-169 27 Solna

Gemzar

1 g

Powder for solution for infusion

Intravenous use

United Kingdom

| Eli Lilly and Company Limited |
| --- |
| Lilly House |
| Priestley Road |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

Eli Lilly and Company Limited

Lilly House

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Gemzar 200 mg powder for solution for infusion

200 mg

Powder for solution for infusion

Intravenous use

United Kingdom

| Eli Lilly and Company Limited |
| --- |
| Lilly House |
| Priestley Road |
| Basingstoke |
| Hampshire RG24 9NL |
| United Kingdom |

Eli Lilly and Company Limited

Lilly House

Priestley Road

Basingstoke

Hampshire RG24 9NL

United Kingdom

Gemzar 1g powder for solution for infusion

1 g

Powder for solution for infusion

Intravenous use

---

ANNEX IX

NAME, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER/APPLICANT

| Member State/Marketing Authorisation Number | Marketing Authorisation Holder | Product invented name | Pharmaceutical Form | Strength/Active substance (INN) | Animal species |
| --- | --- | --- | --- | --- | --- |
| Austria
  (8-00694) | Chevita Tierarzneimittel Ges.m.b.H. | Asprimax 850 mg/g | Powder for oral solution | Sodium salicylate | Pigs |
| The Netherlands
  (REG NL 8913) | Dopharma Research B.V. | NA-SALICYLAAT, 100 %, powder for solution for oral administration | Powder for oral solution | Sodium salicylate | Calves and pigs |
| The Netherlands
  (REG NL 10411) | Dopharma Research B.V. | NA-SALICYLAAT, 80 % WSP | Powder for oral solution | Sodium salicylate | Calves and pigs |
| Decentralised procedure subject to an Article 33 Referral
  (CD 17 April 2008) | Eurovet Animal Health B.V. | SOLACYL 100 %, powder for oral solution for calves and pigs | Powder for oral solution | | Calves and pigs |

Member State/Marketing Authorisation Number

Marketing Authorisation Holder

Product invented name

Pharmaceutical Form

Strength/Active substance (INN)

Animal species

Austria

(8-00694)

Chevita Tierarzneimittel Ges.m.b.H.

Asprimax 850 mg/g

Powder for oral solution

Sodium salicylate

Pigs

The Netherlands

(REG NL 8913)

Dopharma Research B.V.

NA-SALICYLAAT, 100 %, powder for solution for oral administration

Powder for oral solution

Sodium salicylate

Calves and pigs

The Netherlands

(REG NL 10411)

Dopharma Research B.V.

NA-SALICYLAAT, 80 % WSP

Powder for oral solution

Sodium salicylate

Calves and pigs

Decentralised procedure subject to an Article 33 Referral

(CD 17 April 2008)

Eurovet Animal Health B.V.

SOLACYL 100 %, powder for oral solution for calves and pigs

Powder for oral solution

Calves and pigs

---

ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Invented name | Marketing Authorisation Holder
  Company Name and Address | Animal species | Pharmaceutical Form | Strength | Indications |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Baycox 25 mg/ml Lösung zum Eingeben für Hühner und Puten | Bayer Austria Ges.m.b.H |
| Herbststraße 6-10 |
| A-1160 Wien |

Member State

Invented name

Marketing Authorisation Holder

Company Name and Address

Animal species

Pharmaceutical Form

Strength

Indications

Austria

Baycox 25 mg/ml Lösung zum Eingeben für Hühner und Puten

Bayer Austria Ges.m.b.H

Herbststraße 6-10

A-1160 Wien

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Belgium

Baycox 2,5 % orale oplossing

| Bayer SA-NV |
| --- |
| Health Care |
| Animal Health |
| Louizalaan 143, Avenue Louise |
| B-1050 Brussel |

Bayer SA-NV

Health Care

Animal Health

Louizalaan 143, Avenue Louise

B-1050 Brussel

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Bulgaria

Baycox 2,5 % solution

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Bulgaria

Cevazuril oral solution

| Ceva Santé Animale |
| --- |
| La Balastrière |
| F-33501 Libourne Cedex |

Ceva Santé Animale

La Balastrière

F-33501 Libourne Cedex

Broilers, breeders, pullets and turkeys

Oral solution

25 mg/ml

Prevention and treatment of coccidiosis

Cyprus

Baycox 2,5 % oral solution

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Broilers and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Czech Republic

Baycox 2,5 % sol. ad us. vet.

| Bayer s. r. o. |
| --- |
| Litvínovská 609/3 |
| CZ-190 21 Praha 9 |

Bayer s. r. o.

Litvínovská 609/3

CZ-190 21 Praha 9

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

France

Baycox 2,5 %

| BAYER SANTE |
| --- |
| 13, rue Jean Jaurès |
| F-92807 Puteaux |

BAYER SANTE

13, rue Jean Jaurès

F-92807 Puteaux

Chickens: broilers, pullets and breeders

Oral solution

25 mg/ml

Prevention and treatment of coccidiosis

France

CEVAZURIL

| Ceva Santé Animale |
| --- |
| La Balastrière |
| F-33501 Libourne Cedex |

Ceva Santé Animale

La Balastrière

F-33501 Libourne Cedex

Chickens: broilers, pullets and breeders

Oral solution

25 mg/ml

Prevention and treatment of coccidiosis

Germany

Baycox 2,5 %

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |

Bayer Vital GmbH

D-51368 Leverkusen

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Greece

Baycox 2,5 % oral solution

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Broilers and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Hungary

Baycox 2,5 % solution A.U.V.

| Bayer Hungaria Kft.Co. Ltd. |
| --- |
| Alkotás u. 50 |
| H-1123 Budapest |

Bayer Hungaria Kft.Co. Ltd.

Alkotás u. 50

H-1123 Budapest

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Ireland

Baycox 2,5 % Solution

| Bayer Ltd |
| --- |
| Animal Health Division |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Ltd

Animal Health Division

The Atrium

Blackthorn Road

Dublin 18

Ireland

Chickens

Oral solution

25 mg/ml

Treatment and control of coccidiosis

Italy

Baycox soluzione 2,5 %

| Bayer S.p.A. |
| --- |
| Viale Certosa 130 |
| I-20156 Milano |

Bayer S.p.A.

Viale Certosa 130

I-20156 Milano

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Italy

Cevazuril (1)

| CEVA VETEM S.p.A. |
| --- |
| Via Colleoni 15 |
| Agrate Brianza |
| Italia |

CEVA VETEM S.p.A.

Via Colleoni 15

Agrate Brianza

Italia

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Poland

Baycox 2,5 %

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Broilers, breeders, turkeys and pigeons

Oral solution

25 mg/ml

Chickens and turkeys: treatment of coccidiosis

Pigeons: Treatment and prevention of coccidiosis

Portugal

Baycox 2,5 % oral solution

| Bayer Portugal S.A |
| --- |
| Rua Da Quinta do Pinheiro, No 5 |
| P-2794-003 Carnaxide |

Bayer Portugal S.A

Rua Da Quinta do Pinheiro, No 5

P-2794-003 Carnaxide

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Romania

Cevazuril

| Ceva Santé Animale |
| --- |
| La Balastrière |
| F-33501 Libourne Cedex |

Ceva Santé Animale

La Balastrière

F-33501 Libourne Cedex

Broilers, breeders, pullets and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Slovakia

Baycox 2,5 % sol. a.u.v.

| Bayer s. r. o. |
| --- |
| Litvínovská 609/3 |
| CZ-190 21 Praha 9 |

Bayer s. r. o.

Litvínovská 609/3

CZ-190 21 Praha 9

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

Slovenia

Baycox 2,5 % w/v oral solution

| Bayer d.o.o. |
| --- |
| Bravničarjeva ulica 13 |
| SLO-1000 Ljubljana |

Bayer d.o.o.

Bravničarjeva ulica 13

SLO-1000 Ljubljana

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

The Netherlands

Baycox 2,5 %

| Bayer BV |
| --- |
| HealthCare |
| Animal Health |
| Postbus 80 |
| 3640 AB Mijdrecht |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| Nederland |

Bayer BV

HealthCare

Animal Health

Postbus 80

3640 AB Mijdrecht

Energieweg 1

3641 RT Mijdrecht

Nederland

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

The Netherlands

Baycox oplossing 2,5 %

| Bayer BV |
| --- |
| HealthCare |
| Animal Health |
| Postbus 80 |
| 3640 AB Mijdrecht |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| Nederland |

Bayer BV

HealthCare

Animal Health

Postbus 80

3640 AB Mijdrecht

Energieweg 1

3641 RT Mijdrecht

Nederland

Chickens and turkeys

Oral solution

25 mg/ml

Treatment of coccidiosis

United Kingdom

Baycox 2,5 % oral solution

| 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

Broilers and broiler breeders

Oral solution

25 mg/ml

Treatment of coccidiosis

---

(1)  The marketing authorisation is suspended on 12 June 2007.

---

ANNEX XI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH(S) OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | | IVAX Pharmaceuticals UK Ltd |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 μg/Dosis Pulver zur Inhalation

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 μg/Dosis Pulver zur Inhalation

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 μg/Dosis Pulver zur Inhalation

400 μg

Inhalation powder

Inhalation use

400 micrograms

Belgium

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 μg inhalatiepoeder

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 μg inhalatiepoeder

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 μg inhalatiepoeder

400 μg

Inhalation powder

Inhalation use

400 micrograms

Cyprus

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 μg Σκόνη για εισπνοή

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 μg Σκόνη για εισπνοή

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 μg Σκόνη για εισπνοή

400 μg

Inhalation powder

Inhalation use

400 micrograms

Czech Republic

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulmax 100 μg Prášek k inhalaci

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulmax 200 μg Prášek k inhalaci

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulmax 400 μg Prášek k inhalaci

400 μg

Inhalation powder

Inhalation use

400 micrograms

Denmark

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax

400 μg

Inhalation powder

Inhalation use

400 micrograms

Estonia

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax

400 μg

Inhalation powder

Inhalation use

400 micrograms

Finland

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 μg inhalaatiojauhe

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 μg inhalaatiojauhe

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 μg inhalaatiojauhe

400 μg

Inhalation powder

Inhalation use

400 micrograms

Germany

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 Mikrogramm/Dosis Pulver zur Inhalation

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 Mikrogramm/Dosis Pulver zur Inhalation

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 Mikrogramm/Dosis Pulver zur Inhalation

400 μg

Inhalation powder

Inhalation use

400 micrograms

Greece

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 μg Κόνις για εισπνοή

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 μg Κόνις για εισπνοή

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 μg Κόνις για εισπνοή

400 μg

Inhalation powder

Inhalation use

400 micrograms

Ireland

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 μg Inhalation Powder

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 μg Inhalation Powder

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 μg Inhalation Powder

400 μg

Inhalation powder

Inhalation use

400 micrograms

Italy

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 polvere per inalazione

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 mcg polvere per inalazione

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 mcg polvere per inalazione

400 μg

Inhalation powder

Inhalation use

400 micrograms

Latvia

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax

400 μg

Inhalation powder

Inhalation use

400 micrograms

Lithuania

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax

400 μg

Inhalation powder

Inhalation use

400 micrograms

Luxembourg

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 μg poudre pour inhalation

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 μg poudre pour inhalation

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 μg poudre pour inhalation

400 μg

Inhalation powder

Inhalation use

400 micrograms

Malta

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 μg Trab li jittiehed bin-nifs

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 μg Trab li jittiehed bin-nifs

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 μg Trab li jittiehed bin-nifs

400 μg

Inhalation powder

Inhalation use

400 micrograms

The Netherlands

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulmax 100 mg, inhalatiepoeder

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulmax 200 mg, inhalatiepoeder

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulmax 400 mg, inhalatiepoeder

400 μg

Inhalation powder

Inhalation use

400 micrograms

Norway

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulairmax 100 μg inhalasjonspulver

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax 200 μg inhalasjonspulver

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax 400 μg inhalasjonspulver

400 μg

Inhalation powder

Inhalation use

400 micrograms

Poland

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulmax 100 μg proszek do inhalacji

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulmax 200 μg proszek do inhalacji

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulmax 400 μg proszek do inhalacji

400 μg

Inhalation powder

Inhalation use

400 micrograms

Portugal

| Teva Pharma — Produtos Farmaceuticos, Lda. |
| --- |
| Lagoas Park |
| Edificio 1, Piso 3 |
| P-2740-264 Porto Salvo |

Teva Pharma — Produtos Farmaceuticos, Lda.

Lagoas Park

Edificio 1, Piso 3

P-2740-264 Porto Salvo

Pulmax, 100 μg pó para inalação

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulmax, 200 μg pó para inalação

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulmax, 400 μg pó para inalação

400 μg

Inhalation powder

Inhalation use

400 micrograms

Slovak Republic

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Pulmax 100 mcg

Inhalačný prášok

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulmax 200 mcg

Inhalačný prášok

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulmax 400 mcg

Inhalačný prášok

400 μg

Inhalation powder

Inhalation use

400 micrograms

Spain

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| United Kingdom |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

United Kingdom

Budesonida TEVA 100 microgramos polvo para inhalación EFG

100 μg

Inhalation powder

Inhalation use

100 micrograms

Budesonida TEVA 200 microgramos polvo para inhalación EFG

200 μg

Inhalation powder

Inhalation use

200 micrograms

Budesonida TEVA 400 microgramos polvo para inhalación EFG

400 μg

Inhalation powder

Inhalation use

400 micrograms

Sweden

| IVAX Pharmaceuticals UK Ltd |
| --- |
| IVAX Quays |
| Albert Basin |
| Royal Docks |
| London E16 2QJ |
| Royaume-Uni |

IVAX Pharmaceuticals UK Ltd

IVAX Quays

Albert Basin

Royal Docks

London E16 2QJ

Royaume-Uni

Pulairmax

100 μg

Inhalation powder

Inhalation use

100 micrograms

Pulairmax

200 μg

Inhalation powder

Inhalation use

200 micrograms

Pulairmax

400 μg

Inhalation powder

Inhalation use

400 micrograms

---

ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ANIMAL SPECIES, FREQUENCY AND ROUTES OF ADMINISTRATION, RECOMMENDED DOSES, WITHDRAWAL PERIODS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES CONCERNED BY THE REFERRAL

| Member State | Marketing Authorisation Holder | (Invented) Name | Pharmaceutical Form | Strength | Animal species | Frequency and route of administration | Recommended dose | Withdrawal period
  (meat and milk) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Czech Republic | Virbac S.A. |
| 1ère Avenue |
| 2056 M Lid |
| F-06516 Carros Cedex |

Member State

Marketing Authorisation Holder

(Invented) Name

Pharmaceutical Form

Strength

Animal species

Frequency and route of administration

Recommended dose

Withdrawal period

(meat and milk)

Czech Republic

Virbac S.A.

1ère Avenue

2056 M Lid

F-06516 Carros Cedex

Suramox 15 % LA

Suspension for injection

150 mg/ml

Cattle, pigs

Two intramuscular injections at 48 hours interval

15 mg amoxicillin/kg bw (equivalent to 1 ml/10 kg)

Meat and offal:

Cattle: 58 days

Pigs: 35 days

Milk: 2,5 days

Spain (1)

| Virbac S.A. |
| --- |
| 1ère Avenue |
| 2056 M Lid |
| F-06516 Carros Cedex |

Virbac S.A.

1ère Avenue

2056 M Lid

F-06516 Carros Cedex

Stabox 15 % LA

Suspension for injection

150 mg/ml

Cattle, pigs

Two intramuscular injections at 48 hours interval

15 mg amoxicillin/kg bw (equivalent to 1 ml/10 kg)

Meat and offal:

Cattle: 58 days

Pigs: 35 days

Milk: 2,5 days

Italy

| Virbac S.A. |
| --- |
| 1ère Avenue |
| 2056 M Lid |
| F-06516 Carros Cedex |

Virbac S.A.

1ère Avenue

2056 M Lid

F-06516 Carros Cedex

Stabox 15 % LA

Suspension for injection

150 mg/ml

Cattle, pigs

Two intramuscular injections at 48 hours interval

15 mg amoxicillin/kg bw (equivalent to 1 ml/10 kg)

Meat and offal:

Cattle: 58 days

Pigs: 35 days

Milk: 2,5 days

France (2)

| Virbac S.A. |
| --- |
| 1ère Avenue |
| 2056 M Lid |
| F-06516 Carros Cedex |

Virbac S.A.

1ère Avenue

2056 M Lid

F-06516 Carros Cedex

Suramox 15 % LA

Suspension for injection

150 mg/ml

Cattle, pigs

Two intramuscular injections at 48 hours interval

15 mg amoxicillin/kg bw (equivalent to 1 ml/10 kg)

Meat and offal:

Cattle: 58 days

Pigs: 35 days

Milk: 2,5 days

---

(1)  Marketing Authorisation not granted.

(2)  Reference Member State for the Mutual recognition Procedure.

---

NOTICES FROM MEMBER STATES

| 31.10.2008 | EN | Official Journal of the European Union | C 276/74 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/74

---

Extract from the winding-up measure concerning Kaupthing Bank Luxembourg SA decided under Article 9 of Directive 2001/24/EC of the European Parliament and of the Council on the reorganisation and winding-up of credit institutions

(2008/C 276/04)

SUSPENSION OF PAYMENTS

In its judgment of 9 October 2008 at 17.00, the District Court of Luxembourg, hearing commercial cases, ordered that the public limited company Kaupthing Bank Luxembourg SA, entered in the Commercial and Companies Register in Luxembourg under Section B, number 63997 and with its headquarters at 35a, avenue J.F. Kennedy, L-1855 Luxembourg, be made subject to the suspension of payments procedure as provided for in Part IV of the law of 5 April 1993 on the financial sector, as amended, and declares Article 60.2(15) of this law to be applicable, according to which the written authorisation of the administrators is required for all acts and decisions concerning Kaupthing Bank Luxembourg SA, failing which they shall be considered void, and by virtue of which the administrators may submit any proposals they deem appropriate to the management bodies of Kaupthing Bank Luxembourg SA for debate. They may attend debates at the shareholders' general meeting and those of the administrative, managerial or supervisory bodies of Kaupthing Bank Luxembourg SA.

The same judgment appoints the limited company PricewaterhouseCoopers SARL as administrators, represented by Ms Emmanuelle Caruel-Henniaux and Mr Franz Fayot, lawyer, to monitor the management of the assets of Kaupthing Bank Luxembourg SA, and limits the suspension of payments procedure to six months.

The Financial Sector Supervisory Commission and Kaupthing Bank Luxembourg SA may lodge an appeal within 15 days of notification of the judgment, in accordance with paragraph 9 of Article 60.2 of the law of 5 April 1993 on the financial sector, as amended, namely following notification of the judgment by registered letter from the Registrar of the District Court of Luxembourg hearing commercial cases. The appeal shall be lodged by way of declaration to the Registrar.

This judgment may not be the subject of an application to set aside nor of third-party proceedings for a re-hearing.

Copy certified as correct,

The administrators

PricewaterhouseCoopers SARL, represented by Ms Emmanuelle Caruel-Henniaux and Mr Franz Fayot, lawyer

---

| 31.10.2008 | EN | Official Journal of the European Union | C 276/75 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/75

---

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 276/05)

| Aid No | XS 193/08 |
| --- | --- |
| Member State | Republic of Bulgaria |
| Region | District under Article 87(3)(a) of the EC Treaty |
| Title of aid scheme or name of company receiving individual aid | Scheme for granting non-repayable aid under the measure ‘Adding value to agricultural and forestry products’ in the context of the Rural Development Programme for 2007-2013 for:






  — | supporting investments by micro-enterprises for processing and/or marketing forestry products, |

Aid No

XS 193/08

Member State

Republic of Bulgaria

Region

District under Article 87(3)(a) of the EC Treaty

Title of aid scheme or name of company receiving individual aid

Scheme for granting non-repayable aid under the measure ‘Adding value to agricultural and forestry products’ in the context of the Rural Development Programme for 2007-2013 for:

—

supporting investments by micro-enterprises for processing and/or marketing forestry products,

| — | supporting investments by micro, small and medium-sized enterprises processing products specified in Annex I to the Treaty establishing the European Community (except fishery products) into products not included in Annex I |
| --- | --- |

—

supporting investments by micro, small and medium-sized enterprises processing products specified in Annex I to the Treaty establishing the European Community (except fishery products) into products not included in Annex I

Legal basis

EU legislation:

| — | Commission Decision C(2008) 755 of 19 February 2008, |
| --- | --- |

—

Commission Decision C(2008) 755 of 19 February 2008,

| — | Commission Regulation (EC) No 70/2001 of 12 January 2001 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises (OJ L 10, 13.1.2001), including subsequent amendments. |
| --- | --- |

—

Commission Regulation (EC) No 70/2001 of 12 January 2001 on the application of Articles 87 and 88 of the EC Treaty to State aid to small and medium-sized enterprises (OJ L 10, 13.1.2001), including subsequent amendments.

Legislation of the Republic of Bulgaria:

| — | Rural Development Programme for 2007-2013, approved by Council of Ministers Decision under point 30 of minutes No 8 held on 1 March 2007, approved by Commission Decision C(2008) 755 of 19 February 2008, |
| --- | --- |

—

Rural Development Programme for 2007-2013, approved by Council of Ministers Decision under point 30 of minutes No 8 held on 1 March 2007, approved by Commission Decision C(2008) 755 of 19 February 2008,

| — | Ordinance No 18 of 26 June 2008 on the conditions and procedure for granting non-repayable financial aid under the measure ‘Adding value to agricultural and forestry products’ in the context of the Rural Development Programme for 2007-2013 |
| --- | --- |

—

Ordinance No 18 of 26 June 2008 on the conditions and procedure for granting non-repayable financial aid under the measure ‘Adding value to agricultural and forestry products’ in the context of the Rural Development Programme for 2007-2013

Annual expenditure planned under the scheme or overall amount of individual aid granted to the company

Aid scheme

Annual overall amount

EUR 34,4 million (1)

Loans guaranteed

Individual aid

Overall aid amount

Loans guaranteed

Maximum aid intensity

Pursuant to Article 4(2)-(6) and Article 5 of the Regulation

Yes

(maximum 50 %)

Date of implementation

After approval by the European Commission of the amendment to Chapter 9 ‘Elements needed for assessment under competition rules and the list of aid schemes authorised under Articles 87, 88 and 89 of the Treaty’ of the Rural Development Programme for 2007-2013 and the inclusion of the registration number of this State aid in Chapter 9

Duration of scheme or individual aid award

Until 31.12.2013

Purpose of the aid

Aid to small and medium-sized enterprises (SMEs)

Yes

Economic sectors concerned

Limited to specific sectors

Yes

Other manufacturing

Yes (2)

Name and address of the granting authority

| Министерство на земеделието и продоволствието |
| --- |
| Бул. ‘Христо Ботев’ 55 |
| BG-София 1040 |

Министерство на земеделието и продоволствието

Бул. ‘Христо Ботев’ 55

BG-София 1040

| Държавен фонд ‘Земеделие’ |
| --- |
| Бул. ‘Цар Борис III’ 136 |
| BG-1618София |

Държавен фонд ‘Земеделие’

Бул. ‘Цар Борис III’ 136

BG-1618София

Large individual aid grants

In conformity with Article 6 of the Regulation

No

| Aid No | XS 201/08 |
| --- | --- |
| Member State | Italy |
| Region | Sardegna |
| Title of aid scheme or name of company receiving individual aid | Contributi per impianti fotovoltaici |
| Legal basis | Articolo 24, L.R. 29 maggio 2007, n. 2
  Deliberazioni Giunta Regionale n. 21/37 del 8.4.2008 e n. 34/22 del 19.6.2008 DDS n. 366 del 25.6.2008 |
| Type of measure | Scheme |
| Budget | Annual budget: EUR 10 million |
| Maximum aid intensity | In conformity with Article 4(2) to (6) and Article 5 of the Regulation:
  The aid granted to the companies located in the parts of Sardinia qualifying for aid according to the 2007-2013 regional aid map published in OJ C 90, 11.4.2008 consists of a capital grant not exceeding 20 % of the eligible costs for the installation of the photovoltaic power system.
  In the case of the companies located in the specific cadastral sections of the region that are not eligible, as indicated in the 2007-2013 regional aid map, the maximum aid intensity is restricted to:






  (a) | 15 % for small enterprises; |

Aid No

XS 201/08

Member State

Italy

Region

Sardegna

Title of aid scheme or name of company receiving individual aid

Contributi per impianti fotovoltaici

Legal basis

Articolo 24, L.R. 29 maggio 2007, n. 2

Deliberazioni Giunta Regionale n. 21/37 del 8.4.2008 e n. 34/22 del 19.6.2008 DDS n. 366 del 25.6.2008

Type of measure

Scheme

Budget

Annual budget: EUR 10 million

Maximum aid intensity

In conformity with Article 4(2) to (6) and Article 5 of the Regulation:

The aid granted to the companies located in the parts of Sardinia qualifying for aid according to the 2007-2013 regional aid map published in OJ C 90, 11.4.2008 consists of a capital grant not exceeding 20 % of the eligible costs for the installation of the photovoltaic power system.

In the case of the companies located in the specific cadastral sections of the region that are not eligible, as indicated in the 2007-2013 regional aid map, the maximum aid intensity is restricted to:

(a)

15 % for small enterprises;

| (b) | 7,5 % for medium-sized enterprises. |
| --- | --- |

(b)

7,5 % for medium-sized enterprises.

The aid is granted on condition that the investment is maintained in the region for at least five years and that the beneficiary's own resources are not less than 25 % of the eligible investment. The grant is compatible with the measures to encourage the generation of electricity using photovoltaic power systems provided for in the Ministerial Order of 28 July 2005, as amended by the Ministerial Orders of 6 February 2006 and 19 February 2007 (the ‘energy account’). This grant may not be combined with any other grants from the Region, the State or the Community

Date of implementation

18.7.2008

Duration

18.9.2008

Purpose

SMEs

Economic sectors

All sectors eligible for aid to SMEs

Name and address of the granting authority

| Regione Autonoma della Sardegna Assessorato dell'Industria — Servizio Energia |
| --- |
| Viale Trento 69 |
| I-09123 Cagliari |
| Tel. (39-70) 60 62 156 |
| Fax (39-70) 60 62 338 |
| e-mail: ind.energia@regione.sardegna.it |

Regione Autonoma della Sardegna Assessorato dell'Industria — Servizio Energia

Viale Trento 69

I-09123 Cagliari

Tel. (39-70) 60 62 156

Fax (39-70) 60 62 338

e-mail: ind.energia@regione.sardegna.it

Other information

The measure will be implemented through a public call for applications, with the applications being evaluated and ranked. Priority will be given to applications requiring less public aid than the maximum of 20 %. In the case of the companies located in areas that are not eligible for regional aid, the reduction in aid intensity is in line with the aid ceiling provided for in Regulation (EC) No 70/2001

| Aid No | XS 209/08 |
| --- | --- |
| Member State | Greece |
| Region | — |
| Title of aid scheme or name of company receiving individual aid | «ΕΝΙΣΧΥΣΗ ΤΗΣ ΑΝΤΑΓΩΝΙΣΤΙΚΟΤΗΤΑΣ ΚΑΙ ΤΗΣ ΚΑΙΝΟΤΟΜΙΑΣ ΤΩΝ ΜΙΚΡΟΜΕΣΑΙΩΝ ΕΠΙΧΕΙΡΗΣΕΩΝ ΣΤΟΥΣ ΤΟΜΕΙΣ ΤΗΣ ΜΕΤΑΠΟΙΗΣΗΣ ΚΑΙ ΤΟΥ ΤΟΥΡΙΣΜΟΥ» (3η προκήρυξη)
  [«ENISHYSI TIS ANTAGONISTIKOTITAS KAI TIS KAINOTOMIAS TON MIKROMESAION EPIHEIRISEON STOYS TOMEIS TIS METAPOIISIS KAI TOY TOYRISMOY» (3i prokiryksi)] |
| Legal basis | Άρθρο 35 του Ν. 3016/2002 (ΦΕΚ 110 Α'/17-05-2002)
  ΥΑ 41630/ΕΥΣ9450/7.11.2005 (ΦΕΚ 1651/B'/29.11.05)
  ΚΥΑ 14871/EYΣ3047/20.4.2005 (ΦΕΚ 575/ΤΒ/28.04.2005)
  ΥΑ 39059/ΕΥΣ9047/14.10.2005 (ΦΕΚ 1539/Β/8.11.2005)
  ΚΥΑ 1707/ΕΥΣ443/17.01.2006 (ΦΕΚ 42/Β/19.01.2006) |
| Type of measure | Aid scheme |
| Budget | Annual budget: EUR 400 million |
| Maximum aid intensity | In conformity with Articles 4(2)-(6) and 5 of the Regulation |
| Date of implementation | 15.3.2006 |
| Duration | 30.6.2007 |
| Objective | Small and medium-sized enterprises |
| Economic sectors | All manufacturing, tourism |
| Name and address of the granting authority | Υπουργείο Οικονομίας και Οικονομικών και Περιφέρειες (13) |
| Νίκης 5-7 |
| GR-101 80 Αθήνα |
| Τηλ. (30) 210 33 32 009 |

Aid No

XS 209/08

Member State

Greece

Region

—

Title of aid scheme or name of company receiving individual aid

«ΕΝΙΣΧΥΣΗ ΤΗΣ ΑΝΤΑΓΩΝΙΣΤΙΚΟΤΗΤΑΣ ΚΑΙ ΤΗΣ ΚΑΙΝΟΤΟΜΙΑΣ ΤΩΝ ΜΙΚΡΟΜΕΣΑΙΩΝ ΕΠΙΧΕΙΡΗΣΕΩΝ ΣΤΟΥΣ ΤΟΜΕΙΣ ΤΗΣ ΜΕΤΑΠΟΙΗΣΗΣ ΚΑΙ ΤΟΥ ΤΟΥΡΙΣΜΟΥ» (3η προκήρυξη)

[«ENISHYSI TIS ANTAGONISTIKOTITAS KAI TIS KAINOTOMIAS TON MIKROMESAION EPIHEIRISEON STOYS TOMEIS TIS METAPOIISIS KAI TOY TOYRISMOY» (3i prokiryksi)]

Legal basis

Άρθρο 35 του Ν. 3016/2002 (ΦΕΚ 110 Α'/17-05-2002)

ΥΑ 41630/ΕΥΣ9450/7.11.2005 (ΦΕΚ 1651/B'/29.11.05)

ΚΥΑ 14871/EYΣ3047/20.4.2005 (ΦΕΚ 575/ΤΒ/28.04.2005)

ΥΑ 39059/ΕΥΣ9047/14.10.2005 (ΦΕΚ 1539/Β/8.11.2005)

ΚΥΑ 1707/ΕΥΣ443/17.01.2006 (ΦΕΚ 42/Β/19.01.2006)

Type of measure

Aid scheme

Budget

Annual budget: EUR 400 million

Maximum aid intensity

In conformity with Articles 4(2)-(6) and 5 of the Regulation

Date of implementation

15.3.2006

Duration

30.6.2007

Objective

Small and medium-sized enterprises

Economic sectors

All manufacturing, tourism

Name and address of the granting authority

Υπουργείο Οικονομίας και Οικονομικών και Περιφέρειες (13)

Νίκης 5-7

GR-101 80 Αθήνα

Τηλ. (30) 210 33 32 009

| (Ypoyrgeio Oikonomias kai Oikonomikon kai Perifereies (13) |
| --- |
| Nikis 5-7 |
| GR-101 80 Athina |
| Til. (30) 210 33 32 009) |
| Εmail: zgeorgopoulou@mnec.gr |

(Ypoyrgeio Oikonomias kai Oikonomikon kai Perifereies (13)

Nikis 5-7

GR-101 80 Athina

Til. (30) 210 33 32 009)

Εmail: zgeorgopoulou@mnec.gr

| Aid No | XS 211/08 |
| --- | --- |
| Member State | Germany |
| Region | Freie und Hansestadt Hamburg |
| Title of aid scheme or name of company receiving individual aid | Schmücker Klöpner GmbH |
| Bullerdeich 14 |
| D-20537 Hamburg |

Aid No

XS 211/08

Member State

Germany

Region

Freie und Hansestadt Hamburg

Title of aid scheme or name of company receiving individual aid

Schmücker Klöpner GmbH

Bullerdeich 14

D-20537 Hamburg

Legal basis

Verordnung (EG) Nr. 70/2001 der Kommission vom 12. Januar 2001 über die Anwendung der Artikel 87 und 88 EG-Vertrag auf staatliche Beihilfen an kleine und mittlere Unternehmen (ABl. EG 13.1.2001 L 10/33 verlängert durch ABl. EU 23.12.2006 L 368/85); Gesetz über die Kreditkommission vom 29.4.1997 (Hamburgisches Gesetz- und Verordnungsblatt 1997, Nr. 18, S. 133)

Type of measure

Ad hoc

Budget

Overall budget: EUR 3 450

Maximum aid intensity

In conformity with Articles 4(2)-(6) and 5 of the Regulation

Date of implementation

14.8.2008

Duration

14.2.2009

Objective

Small and medium-sized enterprises

Economic sectors

Other services

Name and address of the granting authority

| Behörde für Wirtschaft und Arbeit |
| --- |
| Alter Steinweg 4 |
| D-20459 Hamburg |

Behörde für Wirtschaft und Arbeit

Alter Steinweg 4

D-20459 Hamburg

| Aid No | XS 212/08 |
| --- | --- |
| Member State | Germany |
| Region | Freie und Hansestadt Hamburg |
| Title of aid scheme or name of company receiving individual aid | Paul Opländer-Haustechnik GmbH & Co. KG |
| Brauhausstraße 42 |
| D-22041 Hamburg |

Aid No

XS 212/08

Member State

Germany

Region

Freie und Hansestadt Hamburg

Title of aid scheme or name of company receiving individual aid

Paul Opländer-Haustechnik GmbH & Co. KG

Brauhausstraße 42

D-22041 Hamburg

Legal basis

Verordnung (EG) Nr. 70/2001 der Kommission vom 12. Januar 2001 über die Anwendung der Artikel 87 und 88 EG-Vertrag auf staatliche Beihilfen an kleine und mittlere Unternehmen (ABl. EG 13.1.2001 L 10/33 verlängert durch ABl. EU 23.12.2006 L 368/85); Gesetz über die Kreditkommission vom 29.4.1997 (Hamburgisches Gesetz- und Verordnungsblatt 1997, Nr. 18, S. 133)

Type of measure

Ad hoc

Budget

Overall budget: EUR 6 750

Maximum aid intensity

In conformity with Articles 4(2)-(6) and 5 of the Regulation

Date of implementation

31.7.2008

Duration

31.1.2009

Objective

Small and medium-sized enterprises

Economic sectors

Other services

Name and address of the granting authority

| Behörde für Wirtschaft und Arbeit |
| --- |
| Alter Steinweg 4 |
| D-20459 Hamburg |

Behörde für Wirtschaft und Arbeit

Alter Steinweg 4

D-20459 Hamburg

---

(1)  The annual amount is indicative and is calculated on the basis of the budget provided for measure 123 ‘Adding value to agricultural and forestry products’ in the context of the Rural Development Programme for 2007-2013 (EUR 241 million at current prices).

(2)  The following sectors concerned with the processing and/or marketing of products specified in Annex I of the EC Treaty are eligible for aid:

| — | Milk and dairy products (mainly NACE 15.5), |
| --- | --- |

—

Milk and dairy products (mainly NACE 15.5),

| — | Meat and meat products (mainly NACE 15.1), |
| --- | --- |

—

Meat and meat products (mainly NACE 15.1),

| — | Fruit and vegetables, including mushrooms (mainly NACE 15.3), |
| --- | --- |

—

Fruit and vegetables, including mushrooms (mainly NACE 15.3),

| — | Processing of honey (there is no clear NACE classification, but it can relate to NACE 15.89), |
| --- | --- |

—

Processing of honey (there is no clear NACE classification, but it can relate to NACE 15.89),

| — | Grains, mill products and starch products (mainly NACE 15.6), |
| --- | --- |

—

Grains, mill products and starch products (mainly NACE 15.6),

| — | Vegetable and animal oils and fats (mainly NACE 15.4), |
| --- | --- |

—

Vegetable and animal oils and fats (mainly NACE 15.4),

| — | Processing of technical and medical cultures, including roses that contain oil, herbs and raw tobacco (there is no clear NACE classification, but partially covered by NACE 24.63), |
| --- | --- |

—

Processing of technical and medical cultures, including roses that contain oil, herbs and raw tobacco (there is no clear NACE classification, but partially covered by NACE 24.63),

| — | Prepared feeds for farm animals (fodder) (mainly NACE 15.71), |
| --- | --- |

—

Prepared feeds for farm animals (fodder) (mainly NACE 15.71),

| — | Grape must, vine and vinegar (mainly NACE 15.87 and 15.93). |
| --- | --- |

—

Grape must, vine and vinegar (mainly NACE 15.87 and 15.93).

All sectors concerned with energy production through processing plant and animal products of primary and secondary biomass that are specified in Annex I of the EC Treaty and that do not include fishery products (there is no clear NACE classification),

| — | Sectors processing and/or marketing forestry products, excluding furniture manufacturing (mainly NACE 20.10, 20.30, 20.40, 20.51). |
| --- | --- |

—

Sectors processing and/or marketing forestry products, excluding furniture manufacturing (mainly NACE 20.10, 20.30, 20.40, 20.51).

---

| 31.10.2008 | EN | Official Journal of the European Union | C 276/79 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/79

---

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 276/06)

| Aid No | XS 213/08 |
| --- | --- |
| Member State | United Kingdom |
| Region | East Midlands |
| Title of aid scheme or name of company receiving individual aid | Hathersage Developments Ltd |
| Legal basis | RDA Act 1998 |
| Type of measure | Ad hoc |
| Budget | Overall budget: GBP 0,33 million |
| Maximum aid intensity | In conformity with Articles 4(2)-(6) and 5 of the Regulation |
| Date of implementation | 14.1.2008 |
| Duration | 31.3.2009 |
| Objective | Small and medium-sized enterprises |
| Economic sectors | Professional, scientific and technical activities |
| Name and address of the granting authority | Derby & Derbyshire Economic Partnership |
| PO Box 6512 |
| Town Hall |
| Ripley |
| Derbyshire DE5 3YS |
| United Kingdom |

Aid No

XS 213/08

Member State

United Kingdom

Region

East Midlands

Title of aid scheme or name of company receiving individual aid

Hathersage Developments Ltd

Legal basis

RDA Act 1998

Type of measure

Ad hoc

Budget

Overall budget: GBP 0,33 million

Maximum aid intensity

In conformity with Articles 4(2)-(6) and 5 of the Regulation

Date of implementation

14.1.2008

Duration

31.3.2009

Objective

Small and medium-sized enterprises

Economic sectors

Professional, scientific and technical activities

Name and address of the granting authority

Derby & Derbyshire Economic Partnership

PO Box 6512

Town Hall

Ripley

Derbyshire DE5 3YS

United Kingdom

| Aid No | XS 214/08 |
| --- | --- |
| Member State | United Kingdom |
| Region | North East England |
| Title of aid scheme or name of company receiving individual aid | Python Properties |
| Legal basis | Industrial Development Act 1982 sections 7 and 11
  Local Government Act 2000 section 2 |
| Type of measure | Aid scheme |
| Budget | Annual budget: GBP 0,3 million |
| Maximum aid intensity | In conformity with Articles 4(2)-(6) and 5 of the Regulation |
| Date of implementation | 3.3.2008 |
| Duration | 31.12.2008 |
| Objective | Small and medium-sized enterprises |
| Economic sectors | All manufacturing, Other services |
| Name and address of the granting authority | GONE Citygate |
| Gallowgate |
| Newcastle on Tyne NEI 4 WH |
| United Kingdom |

Aid No

XS 214/08

Member State

United Kingdom

Region

North East England

Title of aid scheme or name of company receiving individual aid

Python Properties

Legal basis

Industrial Development Act 1982 sections 7 and 11

Local Government Act 2000 section 2

Type of measure

Aid scheme

Budget

Annual budget: GBP 0,3 million

Maximum aid intensity

In conformity with Articles 4(2)-(6) and 5 of the Regulation

Date of implementation

3.3.2008

Duration

31.12.2008

Objective

Small and medium-sized enterprises

Economic sectors

All manufacturing, Other services

Name and address of the granting authority

GONE Citygate

Gallowgate

Newcastle on Tyne NEI 4 WH

United Kingdom

| Aid No | XS 215/08 |
| --- | --- |
| Member State | United Kingdom |
| Region | West Midlands |
| Title of aid scheme or name of company receiving individual aid | Premium Vehicles Centres of Excellence Projects — Warwick University |
| Legal basis | Regional Development Agencies Act 1998 |
| Type of measure | Aid scheme |
| Budget | Annual budget: GBP 2,2 million |
| Maximum aid intensity | In conformity with Articles 4(2)-(6) and 5 of the Regulation |
| Date of implementation | 15.8.2008 |
| Duration | 31.12.2013 |
| Objective | Small and medium-sized enterprises |
| Economic sectors | All manufacturing |
| Name and address of the granting authority | Advantage West Midlands |
| 3 Priestley Wharf |
| Holt Street |
| Aston Science Park |
| Birmingham B7 4BN |
| United Kingdom |

Aid No

XS 215/08

Member State

United Kingdom

Region

West Midlands

Title of aid scheme or name of company receiving individual aid

Premium Vehicles Centres of Excellence Projects — Warwick University

Legal basis

Regional Development Agencies Act 1998

Type of measure

Aid scheme

Budget

Annual budget: GBP 2,2 million

Maximum aid intensity

In conformity with Articles 4(2)-(6) and 5 of the Regulation

Date of implementation

15.8.2008

Duration

31.12.2013

Objective

Small and medium-sized enterprises

Economic sectors

All manufacturing

Name and address of the granting authority

Advantage West Midlands

3 Priestley Wharf

Holt Street

Aston Science Park

Birmingham B7 4BN

United Kingdom

| Aid No | XS 219/08 |
| --- | --- |
| Member State | Netherlands |
| Region | — |
| Title of aid scheme or name of company receiving individual aid | Subsidieregeling innovatiekredieten-module van de Experimentele kaderregeling subsidies innovatieprojecten |
| Legal basis | Kaderwet EZ subsidies |
| Type of measure | Aid scheme |
| Budget | Annual budget: EUR 20,3 million |
| Maximum aid intensity | In conformity with Articles 4(2)-(6) and 5 of the Regulation |
| Date of implementation | 5.7.2008 |
| Duration | 5.7.2012 |
| Objective | Small and medium-sized enterprises |
| Economic sectors | All sectors eligible for aid to SMEs |
| Name and address of the granting authority | Ministerie van Economische Zaken |
| Bezuidenhoutseweg 20 |
| 2500 EC Den Haag |
| Nederland |

Aid No

XS 219/08

Member State

Netherlands

Region

—

Title of aid scheme or name of company receiving individual aid

Subsidieregeling innovatiekredieten-module van de Experimentele kaderregeling subsidies innovatieprojecten

Legal basis

Kaderwet EZ subsidies

Type of measure

Aid scheme

Budget

Annual budget: EUR 20,3 million

Maximum aid intensity

In conformity with Articles 4(2)-(6) and 5 of the Regulation

Date of implementation

5.7.2008

Duration

5.7.2012

Objective

Small and medium-sized enterprises

Economic sectors

All sectors eligible for aid to SMEs

Name and address of the granting authority

Ministerie van Economische Zaken

Bezuidenhoutseweg 20

2500 EC Den Haag

Nederland

---

V Announcements

ADMINISTRATIVE PROCEDURES

Commission

| 31.10.2008 | EN | Official Journal of the European Union | C 276/82 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/82

---

Invitation to tender published by Italy, pursuant to Article 4(1)(d) of Council Regulation (EEC) No 2408/92, for the operation of scheduled air services between Albenga and Roma Fiumicino and vice versa

(Text with EEA relevance)

(2008/C 276/07)

INTRODUCTION

The Italian government (Ministry of Infrastructure and Transport), in accordance with Article 4 of Regulation (EEC) No 2408/92 and with the decisions taken during the inter-departmental conference chaired by the Region of Liguria, has approved this invitation to tender for a concession to operate scheduled air services between: Albenga-Roma Fiumicino and vice versa.

The terms of this public service obligation were published in
  Official Journal of the European Union C 241 of 20.9.2008.

If within 30 days of the publication of this obligation no air carrier has applied to introduce scheduled air services on the abovementioned route in accordance with the obligation and without requesting financial compensation, the Italian government (Ministry of Infrastructure and Transport), following the procedure laid down in Article 4(1)(d) of Regulation (EEC) No 2408/92, has decided to limit access to only one air carrier selected on the basis of an invitation to tender for the provision of the air service in question in accordance with the provisions of the above Regulation.

GENERAL PROVISIONS

This invitation to tender sets out the subject of the tender, the rules for participation, the rules governing the duration of, changes to and expiry of the contract, the penalties to be applied for failure to comply with the provisions, the guarantees to support the tender and the performance of the contract.

The right to operate the service on the route in question will be granted by means of a public tender on the basis of the most economically advantageous tender, taking into account the amount of financial compensation indicated in Section 6 of this invitation to tender.

1.   Subject of the invitation to tender

The operation of scheduled air services on the route between Albenga to Roma Fiumicino and vice versa under the public service obligation published in
  Official Journal of the European Union C 241 of 20.9.2008, in accordance with the provisions of Regulation (EEC) No 2408/92.

2.   Participation

All Community air carriers as defined in Article 2(b) of Regulation (EEC) No 2408/92 that meet the following requirements may apply to participate.

General requirements

| 1. | they are not bankrupt or being compulsorily wound up, have not entered into an arrangement with creditors and are not the subject of any such proceedings; |
| --- | --- |

1.

they are not bankrupt or being compulsorily wound up, have not entered into an arrangement with creditors and are not the subject of any such proceedings;

| 2. | they have not been banned under Article 9(2) of Legislative Decree No 231/2001 and are not subject to any other ban on concluding a contract with a public administration; |
| --- | --- |

2.

they have not been banned under Article 9(2) of Legislative Decree No 231/2001 and are not subject to any other ban on concluding a contract with a public administration;

| 3. | they have fulfilled their employment obligations relating to the payment of social security contributions; |
| --- | --- |

3.

they have fulfilled their employment obligations relating to the payment of social security contributions;

| 4. | they have not made misrepresentations concerning the requirements for participation in other tender procedures for the operation of scheduled air services under a public service obligation. |
| --- | --- |

4.

they have not made misrepresentations concerning the requirements for participation in other tender procedures for the operation of scheduled air services under a public service obligation.

For the purpose of checking that the above requirements are met, applicants must attest their compliance with point 3 with a certificate issued by INPS or INAIL indicating that they are up-to-date with their obligations and the certification required by Article 17 of Law No 68 of 12 March 1999 on disabled persons' right to work. For points 1, 2 and 4, applicants must send a statement equivalent to a certificate of compliance with Articles 46 and 47 of Decree No 445 of the President of the Republic of 28 December 2000.

For applicants from European Union Member States other than Italy, certificates or statements must be issued by the administrations or bodies of their country of origin and be accompanied by an Italian translation certified by the Italian consulate to be a true representation of the original.

Technical requirements

| 1. | an air operating licence issued in accordance with Regulation (EEC) No 2407/92; |
| --- | --- |

1.

an air operating licence issued in accordance with Regulation (EEC) No 2407/92;

| 2. | mandatory insurance against accidents, particularly in respect of passengers, baggage, goods transported and third parties, in compliance inter alia with Regulation (EC) No 785/2004; |
| --- | --- |

2.

mandatory insurance against accidents, particularly in respect of passengers, baggage, goods transported and third parties, in compliance inter alia with Regulation (EC) No 785/2004;

| 3. | an air operator's certificate (AOC) in accordance with Community legislation; |
| --- | --- |

3.

an air operator's certificate (AOC) in accordance with Community legislation;

| 4. | non-inclusion on the blacklist of airlines that fail to satisfy European safety standards, as published on the following website: http://ec.europa.eu/transport/air-ban; |
| --- | --- |

4.

non-inclusion on the blacklist of airlines that fail to satisfy European safety standards, as published on the following website: http://ec.europa.eu/transport/air-ban;

| 5. | an analytical accounting system that identifies the relevant costs (including fixed costs and income). |
| --- | --- |

5.

an analytical accounting system that identifies the relevant costs (including fixed costs and income).

If, after having submitted an application to take part in the tender procedure, a carrier no longer meets these requirements, its tender will be automatically excluded from assessment.

If, after having concluded the agreement referred to in Section 5, a carrier no longer meets these requirements, the provisions contained in Sections 14 and 15 (penultimate paragraph) of this invitation to tender will apply.

3.   Procedure

This invitation to tender is subject to the provisions of Article 4(1)(d), (e), (f), (h) and (i) of Regulation (EEC) No 2408/92.

4.   Tender dossier

Together with the model of the agreement referred to in Section 5, the complete tender dossier, which sets out the specific rules applicable to the invitation to tender, the period of validity of the tenders and all other relevant information, constitutes, in every respect, an integral part of this invitation to tender and may be requested, free of charge, from the following address: ENAC, Direzione Trasporto Aereo, viale del Castro Pretorio, 118, I-00185 Roma, or by e-mail from the following address: trasporto.aereo@enac.rupa.it.

5.   Service agreement

The service will be governed by an agreement between the carrier and ENAC, drawn up according to the model which forms part of the tender dossier.

6.   Financial compensation

The maximum amount of financial compensation available under the tender for a concession to operate air transport services on the route in question will be EUR 979 112,85 (nine hundred and seventy-nine thousand, one hundred and twelve euro and eighty-five cents), including VAT.

Tenders must be drawn up as specified in the tender dossier and, on the Section of the form setting out the bid, must specifically indicate the maximum amount of compensation requested to operate the service in question, within the above ceiling.

The exact amount of compensation granted will be determined retrospectively at the end of the year of validity of the agreement on the basis of the costs actually incurred and the revenue actually generated by the service, on presentation of supporting documents and within the limit of the amount indicated in the tender, as specified in the tender dossier.

In no event may the air carrier request, by way of financial compensation, an amount in excess of the upper limit specified in the agreement, given the nature of the payment, which does not constitute a consideration but is compensation for providing a service which is subject to a public service obligation.

The payments for the year of validity of the agreement will be made in the form of instalments and a final balance, in accordance with the provisions set out in the tender dossier, without prejudice to any checks carried out by ENAC to verify the actual destination of the compensation granted and on condition that the successful air carrier continues to comply with the set requirements. The final balance will be paid only after a detailed examination of the accounts submitted by the carrier for the route in question and verification that the actual service provision is in line with that specified in the agreement.

7.   Fares

Tenders must specify the proposed fares, as indicated in the notice on the imposition of a public service obligation published in
  Official Journal of the European Union C 241 of 20.9.2008.

8.   Commencement of operation of the route

Operation of the route must commence within 15 (fifteen) days of conclusion of the agreement and must be attested with a service commencement report signed by the successful carrier and by ENAC.

9.   Duration of the agreement

The agreement will be valid for one year commencing on the date on which operation of the scheduled air services on the route in question commences.

The air carrier must undertake to make available to ENAC the staff, technical and accounting documents, instruments and anything else necessary to supervise and monitor the proper fulfilment, application and performance of the provisions laid down in the Commission notice, the Decree on the obligation, this invitation to tender, the agreement and the tender dossier.

Failure to comply with the obligations referred to above will give rise to penalties in accordance with Section 11 below.

10.   Withdrawal from the agreement

Either party may withdraw from the agreement before it is due to expire by giving 6 months' notice.

If the carrier interrupts the service it will be deemed to have withdrawn without notice unless it resumes the service in accordance with the public service obligation within 30 (thirty) days of being served notice by ENAC to comply fully with the said obligation.

If the carrier withdraws from the agreement, ENAC reserves the right to carry out the checks needed to propose to the Ministry of Infrastructure and Transport that a new agreement be concluded with the carrier ranked immediately below on the list of tenderers. The conditions for operating the service and the proportional level of compensation, will be the same as those set when the public service obligation was first assigned.

11.   Non-fulfilment and penalties

Interruption of the service for the following reasons will not constitute non-fulfilment attributable to the carrier:

| — | hazardous weather conditions, |
| --- | --- |

—

hazardous weather conditions,

| — | closure of one of the airports indicated in the operating programme, |
| --- | --- |

—

closure of one of the airports indicated in the operating programme,

| — | safety concerns, |
| --- | --- |

—

safety concerns,

| — | industrial action, |
| --- | --- |

—

industrial action,

| — | force majeure. |
| --- | --- |

—

force majeure.

Interruption of the service for these reasons will give rise to a reduction in the amount of compensation proportional to the flights that are not operated.

Where the services and obligations laid down in the agreement are not performed, ENAC will be entitled to impose penalties on the carrier, the level of which will increase in proportion to the number of infringements committed, as detailed in the model agreement.

The amount of penalties may in no case exceed 50 % of the maximum amount of financial compensation laid down in Section 6 of the invitation for tender, with the understanding that, if this limit is exceeded, ENAC will be entitled to terminate the agreement for non-fulfilment, resulting in the immediate cancellation of any compensation due.

The number of flights cancelled for reasons directly attributable to the carrier must not exceed 2 % of the number of flights scheduled in any year.

Above this limit, the carrier will have to pay ENAC a penalty of EUR 3 000,00 (three thousand euro) for each cancellation over the 2 % limit, subject to formal notice being given to the carrier within ten days of knowledge of the event. The carrier will be allowed up to seven days to present any counter-arguments.

In addition, ENAC will review the amount of financial compensation in proportion to the flights operated. The proceeds will be allocated to the improvement of transport links to and from Albenga.

Failure to give the notice referred to in Section 10 will give rise to a penalty calculated on the basis of the compensation provided for and the missed period of notice starting from the date on which the service is interrupted, under the terms specified in Section 10, and using the following formula:

Image

where:

| P | = | penalty |
| --- | --- | --- |
| CA | = | annual compensation |
| GG | = | number of days in the year in question (365 or 366) |
| gg | = | days in the missed notice period |

P

=

penalty

CA

=

annual compensation

GG

=

number of days in the year in question (365 or 366)

gg

=

days in the missed notice period

The penalties specified in this Article may be cumulated with the penalty arrangements laid down in Community regulations and in national legislation and regulatory provisions.

12.   Guarantees to provide with the tender

To demonstrate that their tenders are genuine and reliable, carriers participating in this tender procedure must submit a guarantee equal to 2 % of the maximum amount of financial compensation referred to in Section 6 in the form of a deposit or bank or insurance guarantee, as chosen by the tenderer.

The methods of lodging the above guarantee will be set out in the tender dossier and may also be repeated in the agreement.

The guarantee must be valid for at least 180 (one hundred and eighty) days from the closing date for submitting tenders, and the carrier must undertake to renew the guarantee, at the request of ENAC during the procedure, if the tender has not been awarded by the time the guarantee lapses.

When ENAC notifies carriers that they have been unsuccessful in the award procedure, it will release them from the guarantee.

13.   Performance guarantee and insurance cover

The carrier awarded the operation of air services subject to a public service obligation under this invitation to tender must lodge a bank or insurance guarantee of EUR 400 000,00 (four hundred thousand euro) in favour of ENAC, which reserves the right to use it to ensure the continuation of the service concerned.

The guarantee will be automatically released, without the need for ENAC's approval, provided the examination referred to in the last paragraph of Section 6 above is favourable.

14.   Forfeiture and revocation of the financial compensation

Failure to fulfil, at any time after the agreement is signed, the general and technical requirements set out in Section 2 of this invitation to tender and the requirements set out in the tender dossier will give rise to forfeiture of the right to operate the route, the revocation of the right to financial compensation and the recovery of any unduly paid amounts, plus statutory interest.

After the forfeiture of the right to operate the route, ENAC may be authorised by the Ministry of Infrastructure and Transport to conclude another agreement for the remaining period of scheduled air services with the next highest carrier on the ranking list resulting from the tender procedure.

In this case, the duration of the agreement will start on the date on which the service commences and will end on the expiry date set in the terminated agreement, in line with the operating plan approved when the tender submitted by the successful tenderer was assessed.

15.   Termination of the agreement

If the carrier fails to comply with the provisions set out in the notice published in
  Official Journal of the European Union C 241 of 20.9.2008, the corresponding Decree, the agreement, this invitation to tender and the tender dossier, ENAC may, in accordance with Article 1454 of the Civil Code, send written notice giving the carrier 15 (fifteen) days from receipt of such notice to remedy this non-compliance.

If it fails to do so within that period, ENAC will have the right to consider the agreement automatically terminated and to definitively retain the guarantee amount indicated in Section 13 above and to claim compensation from the carrier for damages.

In addition, if the carrier fails to perform the obligations and services accepted in the agreement, this invitation to tender and the tender dossier, ENAC, in accordance with Article 1456 of the Civil Code, has the right to terminate the agreement, subject to written notice to the carrier.

If the agreement is terminated, ENAC may be authorised by the Ministry of Infrastructure and Transport to conclude another agreement for the remaining period of scheduled air services with the next highest carrier on the ranking list resulting from the tender procedure for the award of the route.

In this case, the duration of the agreement will start on the date on which the service commences and will end on the expiry date set in the terminated agreement, in line with the operating plan approved when the tender submitted by the successful tenderer was assessed.

16.   Submission of tenders

Tenders, which in order to be valid must be drawn up in accordance with the provisions of the tender dossier, must reach the following address no later than 30 (thirty) days after the date of publication of this invitation to tender in the Official Journal of the European Union either by registered letter with acknowledgement of receipt or by hand delivery against receipt: ENAC, Direzione Generale, viale del Castro Pretorio, 118, I-00185 Roma.

In order to be valid, tenders must be submitted in three closed and sealed envelopes.

The outer envelope, closed, sealed and initialled on both sides, must contain two inner envelopes, both sealed and initialled on both sides, and must bear the following wording: ‘Offerta per la gara in oneri di servizio pubblico sulla rotta: Albenga-Roma Fiumicino e viceversa’.

The documents to be enclosed in these three envelopes are specified in the tender dossier referred to in Section 4 of this invitation to tender.

It should be noted that the sender will have sole liability in the event that, for whatever reason, the package fails to arrive at its destination by the closing date specified above.

If only one valid tender is submitted, the award procedure may still go ahead.

17.   Expiry of tenders

180 (one hundred and eighty) days from the closing date for submission of tenders.

18.   Contract award

ENAC will complete the tender procedure through a committee set up for this purpose, composed of a director of ENAC delegated by the Director-General, an expert in the field of air transport appointed by the Region of Liguria and a chairman appointed by common agreement between ENAC and the Region of Liguria. Secretariat support will be provided by an ENAC official.

19.   Processing of personal data

All personal data will be used and processed solely for official purposes and their protection and confidentiality will be ensured in accordance with prevailing legislation. To this end, the successful carrier will need to sign the relevant authorisation to process personal data in accordance with Legislative Decree No 196/2003 as amended and supplemented.

20.   Processing of sensitive data

Sensitive data contained in the tenders submitted by carriers will be processed in accordance with the Regulation for processing sensitive and legal data approved by ENAC's executive board on 2 March 2006 and available on ENAC's website at: ‘enac-italia.it’.

---

| 31.10.2008 | EN | Official Journal of the European Union | C 276/86 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/86

---

Invitation to tender published by Italy, pursuant to Article 4(1)(d) of Council Regulation (EEC) No 2408/92, for the operation of scheduled air services between Crotone and Milano Linate and vice versa

(Text with EEA relevance)

(2008/C 276/08)

INTRODUCTION

The Italian government (Ministry of Infrastructure and Transport), in accordance with Article 4 of Regulation (EEC) No 2408/92 and with the decisions taken during the inter-departmental conference chaired by the Region of Calabria, has approved this invitation to tender for a concession to operate scheduled air services between Crotone and Milano Linate and vice versa.

The terms of this public service obligation were published in
  Official Journal of the European Union C 241 of 20.9.2008.

If within 30 days of the publication of this obligation no air carrier has applied to introduce scheduled air services on the abovementioned route in accordance with the obligation and without requesting financial compensation, the Italian government (Ministry of Infrastructure and Transport), following the procedure laid down in Article 4(1)(d) of Regulation (EEC) No 2408/92, has decided to limit access to only one air carrier selected on the basis of an invitation to tender for the provision of the air service in question in accordance with the provisions of the above Regulation.

GENERAL PROVISIONS

This invitation to tender sets out the subject of the tender, the rules for participation, the rules governing the duration of, changes to and expiry of the contract, the penalties to be applied for failure to comply with the provisions, the guarantees to support the tender and the performance of the contract.

The right to operate the service on the route in question will be granted by means of a public tender on the basis of the most economically advantageous tender, taking into account the amount of financial compensation indicated in Section 6 of this invitation to tender.

1.   Subject of the invitation to tender

The operation of scheduled air services on the route between Crotone and Milano Linate and vice versa under the public service obligation published in
  Official Journal of the European Union C 241 of 20.9.2008, in accordance with the provisions of Regulation (EEC) No 2408/92.

2.   Participation

All Community air carriers as defined in Article 2(b) of Regulation (EEC) No 2408/92 that meet the following requirements may apply to participate.

General requirements

| 1. | they are not bankrupt or being compulsorily wound up, have not entered into an arrangement with creditors and are not the subject of any such proceedings; |
| --- | --- |

1.

they are not bankrupt or being compulsorily wound up, have not entered into an arrangement with creditors and are not the subject of any such proceedings;

| 2. | they have not been banned under Article 9(2) of Legislative Decree No 231/2001 and are not subject to any other ban on concluding a contract with a public administration; |
| --- | --- |

2.

they have not been banned under Article 9(2) of Legislative Decree No 231/2001 and are not subject to any other ban on concluding a contract with a public administration;

| 3. | they have fulfilled their employment obligations relating to the payment of social security contributions; |
| --- | --- |

3.

they have fulfilled their employment obligations relating to the payment of social security contributions;

| 4. | they have not made misrepresentations concerning the requirements for participation in other tender procedures for the operation of scheduled air services under a public service obligation. |
| --- | --- |

4.

they have not made misrepresentations concerning the requirements for participation in other tender procedures for the operation of scheduled air services under a public service obligation.

For the purpose of checking that the above requirements are met, applicants must attest their compliance with point 3 with a certificate issued by INPS or INAIL indicating that they are up-to-date with their obligations and the certification required by Article 17 of Law No 68 of 12 March 1999 on disabled persons' right to work. For points 1, 2 and 4, applicants must send a statement equivalent to a certificate of compliance with Articles 46 and 47 of Decree No 445 of the President of the Republic of 28 December 2000.

For applicants from European Union Member States other than Italy, certificates or statements must be issued by the administrations or bodies of their country of origin and be accompanied by an Italian translation certified by the Italian consulate to be a true representation of the original.

Technical requirements

| 1. | an air operating licence issued in accordance with Regulation (EEC) No 2407/92; |
| --- | --- |

1.

an air operating licence issued in accordance with Regulation (EEC) No 2407/92;

| 2. | mandatory insurance against accidents, particularly in respect of passengers, baggage, goods transported and third parties, in compliance inter alia with Regulation (EC) No 785/2004; |
| --- | --- |

2.

mandatory insurance against accidents, particularly in respect of passengers, baggage, goods transported and third parties, in compliance inter alia with Regulation (EC) No 785/2004;

| 3. | an air operator's certificate (AOC) in accordance with Community legislation; |
| --- | --- |

3.

an air operator's certificate (AOC) in accordance with Community legislation;

| 4. | non-inclusion on the blacklist of airlines that fail to satisfy European safety standards, as published on the following website: http://ec.europa.eu/transport/air-ban; |
| --- | --- |

4.

non-inclusion on the blacklist of airlines that fail to satisfy European safety standards, as published on the following website: http://ec.europa.eu/transport/air-ban;

| 5. | an analytical accounting system that identifies the relevant costs (including fixed costs and income). |
| --- | --- |

5.

an analytical accounting system that identifies the relevant costs (including fixed costs and income).

If, after having submitted an application to take part in the tender procedure, a carrier no longer meets these requirements, its tender will be automatically excluded from assessment.

If, after having concluded the agreement referred to in Section 5, a carrier no longer meets these requirements, the provisions contained in Sections 14 and 15 (penultimate paragraph) of this invitation to tender will apply.

3.   Procedure

This invitation to tender is subject to the provisions of Article 4(1)(d), (e), (f), (h) and (i) of Regulation (EEC) No 2408/92.

4.   Tender dossier

Together with the model of the agreement referred to in Section 5, the complete tender dossier, which sets out the specific rules applicable to the invitation to tender, the period of validity of the tenders and all other relevant information, constitutes, in every respect, an integral part of this invitation to tender and may be requested, free of charge, from the following address: ENAC, Direzione Trasporto Aereo, viale del Castro Pretorio, 118, I-00185 Roma, or by e-mail from the following address: trasporto.aereo@enac.rupa.it.

5.   Service agreement

The service will be governed by an agreement between the carrier and ENAC, drawn up according to the model which forms part of the tender dossier.

6.   Financial compensation

The maximum amount of financial compensation available under the tender for a concession to operate air transport services on the route in question will be EUR 1 258 178,33, including VAT, per year.

Tenders must be drawn up as specified in the tender dossier and, on the Section of the form setting out the bid with an annual breakdown, must specifically indicate the maximum amount of compensation requested to operate the service in question, within the above ceiling.

The exact amount of compensation granted will be determined retrospectively each year on the basis of the costs actually incurred and the revenue actually generated by the service, on presentation of supporting documents and within the limit of the amount indicated in the tender, as specified in the tender dossier.

In no event may the air carrier request, by way of financial compensation, an amount in excess of the upper limit specified in the agreement, given the nature of the payment, which does not constitute a consideration but is compensation for providing a service which is subject to a public service obligation.

The annual payments will be made in the form of instalments and a final balance, in accordance with the provisions set out in the tender dossier, without prejudice to any checks carried out by ENAC to verify the actual destination of the compensation granted and on condition that the successful air carrier continues to comply with the set requirements. The final balance will be paid only after a detailed examination of the accounts submitted by the carrier for the route in question and verification that the actual service provision is in line with that specified in the agreement.

7.   Fares

Tenders must specify the proposed fares, as indicated in the notice on the imposition of a public service obligation published in
  Official Journal of the European Union C 241 of 20.9.2008.

8.   Commencement of operation of the route

Operation of the route must commence within 15 days of conclusion of the agreement and must be attested with a service commencement report signed by the successful carrier and by ENAC.

9.   Duration of the agreement

The agreement will be valid for two years commencing on the date on which operation of the scheduled air services on the route in question commences.

The air carrier must undertake to make available to ENAC the staff, technical and accounting documents, instruments and anything else necessary to supervise and monitor the proper fulfilment, application and performance of the provisions laid down in the Commission notice, the Decree on the obligation, this invitation to tender, the agreement and the tender dossier.

Failure to comply with the obligations referred to above will give rise to penalties in accordance with Section 11 below.

10.   Withdrawal from the agreement

Either party may withdraw from the agreement before it is due to expire, with no obligation of compensation or indemnity, by giving 6 months' notice; however, no notice may be given in the first 12 months following the commencement of the service.

If the carrier interrupts the service it will be deemed to have withdrawn without notice unless it resumes the service in accordance with the public service obligation within 30 days of being served notice by ENAC to comply fully with the said obligation.

If the carrier withdraws from the agreement, ENAC reserves the right to carry out the checks needed to propose to the Ministry of Infrastructure and Transport that a new agreement be concluded with the carrier ranked immediately below on the list of tenderers. The conditions for operating the service and the proportional level of compensation, will be the same as those set when the public service obligation was first assigned.

11.   Non-fulfilment and penalties

Interruption of the service for the following reasons will not constitute non-fulfilment attributable to the carrier:

| — | hazardous weather conditions, |
| --- | --- |

—

hazardous weather conditions,

| — | closure of one of the airports indicated in the operating programme, |
| --- | --- |

—

closure of one of the airports indicated in the operating programme,

| — | safety concerns, |
| --- | --- |

—

safety concerns,

| — | industrial action, |
| --- | --- |

—

industrial action,

| — | force majeure. |
| --- | --- |

—

force majeure.

Interruption of the service for these reasons will give rise to a reduction in the amount of compensation proportional to the flights that are not operated.

Where the services and obligations laid down in the agreement are not performed, ENAC will be entitled to impose penalties on the carrier, the level of which will increase in proportion to the number of infringements committed, as detailed in the model agreement.

The amount of penalties may in no case exceed 50 % of the maximum amount of financial compensation laid down in Section 6 of the invitation for tender, with the understanding that, if this limit is exceeded, ENAC will be entitled to terminate the agreement for non-fulfilment, resulting in the immediate cancellation of any compensation due.

The number of flights cancelled for reasons directly attributable to the carrier must not exceed 2 % of the number of flights scheduled in any year.

Above this limit, the carrier will have to pay ENAC a penalty of EUR 3 000,00 for each cancellation over the 2 % limit, subject to formal notice being given to the carrier within ten days of knowledge of the event. The carrier will be allowed up to seven days to present any counter-arguments.

In addition, ENAC will review the amount of financial compensation in proportion to the flights operated. The proceeds will be allocated to the improvement of transport links to and from Crotone.

Failure to give the notice referred to in Section 10 will give rise to a penalty calculated on the basis of the annual compensation and the missed period of notice starting from the date on which the service is interrupted, under the terms specified in Section 10, and using the following formula:

P = CA/GG × gg

where:

| P | = | penalty |
| --- | --- | --- |
| CA | = | annual compensation |
| GG | = | number of days in the year in question (365 or 366) |
| Gg | = | days in the missed notice period |

P

=

penalty

CA

=

annual compensation

GG

=

number of days in the year in question (365 or 366)

Gg

=

days in the missed notice period

The penalties specified in this Article may be cumulated with the penalty arrangements laid down in Community regulations and in national legislation and regulatory provisions.

12.   Guarantees to provide with the tender

To demonstrate that their tenders are genuine and reliable, carriers participating in this tender procedure must submit a guarantee equal to 2 % of the maximum amount of financial compensation referred to in Section 6 in the form of a deposit or bank or insurance guarantee, as chosen by the tenderer.

The methods of lodging the above guarantee will be set out in the tender dossier and may also be repeated in the agreement.

The guarantee must be valid for at least 180 days from the closing date for submitting tenders, and the carrier must undertake to renew the guarantee, at the request of ENAC during the procedure, if the tender has not been awarded by the time the guarantee lapses.

When ENAC notifies carriers that they have been unsuccessful in the award procedure, it will release them from the guarantee.

13.   Performance guarantee and insurance cover

The carrier awarded the operation of air services subject to a public service obligation under this invitation to tender must lodge a bank or insurance guarantee of EUR 700 000,00 in favour of ENAC, which reserves the right to use it to ensure the continuation of the service concerned.

The guarantee will be automatically released, without the need for ENAC's approval, provided the examination referred to in the last paragraph of Section 6 above is favourable.

14.   Forfeiture and revocation of the financial compensation

Failure to fulfil, at any time after the agreement is signed, the general and technical requirements set out in Section 2 of this invitation to tender and the requirements set out in the tender dossier will give rise to forfeiture of the right to operate the route, the revocation of the right to financial compensation and the recovery of any unduly paid amounts, plus statutory interest.

After the forfeiture of the right to operate the route, ENAC may be authorised by the Ministry of Infrastructure and Transport to conclude another agreement for the remaining period of scheduled air services with the next highest carrier on the ranking list resulting from the tender procedure.

In this case, the duration of the agreement will start on the date on which the service commences and will end on the expiry date set in the terminated agreement, in line with the operating plan approved when the tender submitted by the successful tenderer was assessed.

15.   Termination of the agreement

If the carrier fails to comply with the provisions set out in the notice published in
  Official Journal of the European Union C 241 of 20.9.2008, the corresponding Decree, the agreement, this invitation to tender and the tender dossier, ENAC may, in accordance with Article 1454 of the Civil Code, send written notice giving the carrier 15 days from receipt of such notice to remedy this non-compliance.

If it fails to do so within that period, ENAC will have the right to consider the agreement automatically terminated and to definitively retain the guarantee amount indicated in Section 13 above and to claim compensation from the carrier for damages.

In addition, if the carrier fails to perform the obligations and services accepted in the agreement, this invitation to tender and the tender dossier, ENAC, in accordance with Article 1456 of the Civil Code, has the right to terminate the agreement, subject to written notice to the carrier.

If the agreement is terminated, ENAC may be authorised by the Ministry of Infrastructure and Transport to conclude another agreement for the remaining period of scheduled air services with the next highest carrier on the ranking list resulting from the tender procedure for the award of the route.

In this case, the duration of the agreement will start on the date on which the service commences and will end on the expiry date set in the terminated agreement, in line with the operating plan approved when the tender submitted by the successful tenderer was assessed.

16.   Submission of tenders

Tenders, which in order to be valid must be drawn up in accordance with the provisions of the tender dossier, must reach the following address no later than 30 days after the date of publication of this invitation to tender in the Official Journal of the European Union either by registered letter with acknowledgement of receipt or by hand delivery against receipt: ENAC, Direzione Generale, viale del Castro Pretorio, 118, I-00185 Roma.

In order to be valid, tenders must be submitted in three closed and sealed envelopes.

The outer envelope, closed, sealed and initialled on both sides, must contain two inner envelopes, both sealed and initialled on both sides, and must bear the following wording: ‘Offerta per la gara in oneri di servizio pubblico sulla rotta Crotone-Milano Linate e viceversa’.

The documents to be enclosed in these three envelopes are specified in the tender dossier referred to in Section 4 of this invitation to tender.

It should be noted that the sender will have sole liability in the event that, for whatever reason, the package fails to arrive at its destination by the closing date specified above.

If only one valid tender is submitted, the award procedure may still go ahead.

17.   Expiry of tenders

180 days from the closing date for submission of tenders.

18.   Contract award

ENAC will complete the tender procedure through a committee set up for this purpose, composed of a director of ENAC delegated by the Director-General, an expert in the field of air transport appointed by the Region of Calabria and a chairman appointed by common agreement between ENAC and the Region of Calabria. Secretariat support will be provided by an ENAC official.

19.   Processing of personal data

All personal data will be used and processed solely for official purposes and their protection and confidentiality will be ensured in accordance with prevailing legislation. To this end, the successful carrier will need to sign the relevant authorisation to process personal data in accordance with Legislative Decree No 196/2003 as amended and supplemented.

20.   Processing of sensitive data

Sensitive data contained in the tenders submitted by carriers will be processed in accordance with the Regulation for processing sensitive and legal data approved by ENAC's executive board on 2 March 2006 and available on ENAC's website at: ‘enac-italia.it’.

---

| 31.10.2008 | EN | Official Journal of the European Union | C 276/90 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/90

---

Invitation to tender published by Italy, pursuant to Article 4(1)(d) of Council Regulation (EEC) No 2408/92, for the operation of scheduled air services between Crotone and Roma Fiumicino and vice versa

(Text with EEA relevance)

(2008/C 276/09)

INTRODUCTION

The Italian government (Ministry of Infrastructure and Transport), in accordance with Article 4 of Regulation (EEC) No 2408/92 and with the decisions taken during the inter-departmental conference chaired by the Region of Calabria, has approved this invitation to tender for a concession to operate scheduled air services between Crotone and Roma Fiumicino and vice versa.

The terms of this public service obligation were published in
  Official Journal of the European Union C 241 of 20.9.2008.

If within 30 days of the publication of this obligation no air carrier has applied to introduce scheduled air services on the abovementioned route in accordance with the obligation and without requesting financial compensation, the Italian government (Ministry of Infrastructure and Transport), following the procedure laid down in Article 4(1)(d) of Regulation (EEC) No 2408/92, has decided to limit access to only one air carrier selected on the basis of an invitation to tender for the provision of the air service in question in accordance with the provisions of the above Regulation.

GENERAL PROVISIONS

This invitation to tender sets out the subject of the tender, the rules for participation, the rules governing the duration of, changes to and expiry of the contract, the penalties to be applied for failure to comply with the provisions, the guarantees to support the tender and the performance of the contract.

The right to operate the service on the route in question will be granted by means of a public tender on the basis of the most economically advantageous tender, taking into account the amount of financial compensation indicated in Section 6 of this invitation to tender.

1.   Subject of the invitation to tender

The operation of scheduled air services on the route between Crotone and Roma Fiumicino and vice versa under the public service obligation published in
  Official Journal of the European Union C 241 of 20.9.2008, in accordance with the provisions of Regulation (EEC) No 2408/92.

2.   Participation

All Community air carriers as defined in Article 2(b) of Regulation (EEC) No 2408/92 that meet the following requirements may apply to participate.

General requirements

| 1. | they are not bankrupt or being compulsorily wound up, have not entered into an arrangement with creditors and are not the subject of any such proceedings; |
| --- | --- |

1.

they are not bankrupt or being compulsorily wound up, have not entered into an arrangement with creditors and are not the subject of any such proceedings;

| 2. | they have not been banned under Article 9(2) of Legislative Decree No 231/2001 and are not subject to any other ban on concluding a contract with a public administration; |
| --- | --- |

2.

they have not been banned under Article 9(2) of Legislative Decree No 231/2001 and are not subject to any other ban on concluding a contract with a public administration;

| 3. | they have fulfilled their employment obligations relating to the payment of social security contributions; |
| --- | --- |

3.

they have fulfilled their employment obligations relating to the payment of social security contributions;

| 4. | they have not made misrepresentations concerning the requirements for participation in other tender procedures for the operation of scheduled air services under a public service obligation. |
| --- | --- |

4.

they have not made misrepresentations concerning the requirements for participation in other tender procedures for the operation of scheduled air services under a public service obligation.

For the purpose of checking that the above requirements are met, applicants must attest their compliance with point 3 with a certificate issued by INPS or INAIL indicating that they are up-to-date with their obligations and the certification required by Article 17 of Law No 68 of 12 March 1999 on disabled persons' right to work. For points 1, 2 and 4, applicants must send a statement equivalent to a certificate of compliance with Articles 46 and 47 of Decree No 445 of the President of the Republic of 28 December 2000.

For applicants from European Union Member States other than Italy, certificates or statements must be issued by the administrations or bodies of their country of origin and be accompanied by an Italian translation certified by the Italian consulate to be a true representation of the original.

Technical requirements

| 1. | an air operating licence issued in accordance with Regulation (EEC) No 2407/92; |
| --- | --- |

1.

an air operating licence issued in accordance with Regulation (EEC) No 2407/92;

| 2. | mandatory insurance against accidents, particularly in respect of passengers, baggage, goods transported and third parties, in compliance inter alia with Regulation (EC) No 785/2004; |
| --- | --- |

2.

mandatory insurance against accidents, particularly in respect of passengers, baggage, goods transported and third parties, in compliance inter alia with Regulation (EC) No 785/2004;

| 3. | an air operator's certificate (AOC) in accordance with Community legislation; |
| --- | --- |

3.

an air operator's certificate (AOC) in accordance with Community legislation;

| 4. | non-inclusion on the blacklist of airlines that fail to satisfy European safety standards, as published on the following website: http://ec.europa.eu/transport/air-ban; |
| --- | --- |

4.

non-inclusion on the blacklist of airlines that fail to satisfy European safety standards, as published on the following website: http://ec.europa.eu/transport/air-ban;

| 5. | an analytical accounting system that identifies the relevant costs (including fixed costs and income). |
| --- | --- |

5.

an analytical accounting system that identifies the relevant costs (including fixed costs and income).

If, after having submitted an application to take part in the tender procedure, a carrier no longer meets these requirements, its tender will be automatically excluded from assessment.

If, after having concluded the agreement referred to in Section 5, a carrier no longer meets these requirements, the provisions contained in Sections 14 and 15 (penultimate paragraph) of this invitation to tender will apply.

3.   Procedure

This invitation to tender is subject to the provisions of Article 4(1)(d), (e), (f), (h) and (i) of Regulation (EEC) No 2408/92.

4.   Tender dossier

Together with the model of the agreement referred to in Section 5, the complete tender dossier, which sets out the specific rules applicable to the invitation to tender, the period of validity of the tenders and all other relevant information, constitutes, in every respect, an integral part of this invitation to tender and may be requested, free of charge, from the following address: ENAC, Direzione Trasporto Aereo, viale del Castro Pretorio, 118, I-00185 Roma, or by e-mail from the following address: trasporto.aereo@enac.rupa.it.

5.   Service agreement

The service will be governed by an agreement between the carrier and ENAC, drawn up according to the model which forms part of the tender dossier.

6.   Financial compensation

The maximum amount of financial compensation available under the tender for a concession to operate air transport services on the route in question will be EUR 1 724 666,00, including VAT, per year.

Tenders must be drawn up as specified in the tender dossier and, on the Section of the form setting out the bid with an annual breakdown, must specifically indicate the maximum amount of compensation requested to operate the service in question, within the above ceiling.

The exact amount of compensation granted will be determined retrospectively each year on the basis of the costs actually incurred and the revenue actually generated by the service, on presentation of supporting documents and within the limit of the amount indicated in the tender, as specified in the tender dossier.

In no event may the air carrier request, by way of financial compensation, an amount in excess of the upper limit specified in the agreement, given the nature of the payment, which does not constitute a consideration but is compensation for providing a service which is subject to a public service obligation.

The annual payments will be made in the form of instalments and a final balance, in accordance with the provisions set out in the tender dossier, without prejudice to any checks carried out by ENAC to verify the actual destination of the compensation granted and on condition that the successful air carrier continues to comply with the set requirements. The final balance will be paid only after a detailed examination of the accounts submitted by the carrier for the route in question and verification that the actual service provision is in line with that specified in the agreement.

7.   Fares

Tenders must specify the proposed fares, as indicated in the notice on the imposition of a public service obligation published in
  Official Journal of the European Union C 241 of 20.9.2008.

8.   Commencement of operation of the route

Operation of the route must commence within 15 days of conclusion of the agreement and must be attested with a service commencement report signed by the successful carrier and by ENAC.

9.   Duration of the agreement

The agreement will be valid for two years commencing on the date on which operation of the scheduled air services on the route in question commences.

The air carrier must undertake to make available to ENAC the staff, technical and accounting documents, instruments and anything else necessary to supervise and monitor the proper fulfilment, application and performance of the provisions laid down in the Commission notice, the Decree on the obligation, this invitation to tender, the agreement and the tender dossier.

Failure to comply with the obligations referred to above will give rise to penalties in accordance with Section 11 below.

10.   Withdrawal from the agreement

Either party may withdraw from the agreement before it is due to expire, with no obligation of compensation or indemnity, by giving 6 months' notice; however, no notice may be given in the first 12 months following the commencement of the service.

If the carrier interrupts the service it will be deemed to have withdrawn without notice unless it resumes the service in accordance with the public service obligation within 30 days of being served notice by ENAC to comply fully with the said obligation.

If the carrier withdraws from the agreement, ENAC reserves the right to carry out the checks needed to propose to the Ministry of Infrastructure and Transport that a new agreement be concluded with the carrier ranked immediately below on the list of tenderers. The conditions for operating the service and the proportional level of compensation, will be the same as those set when the public service obligation was first assigned.

11.   Non-fulfilment and penalties

Interruption of the service for the following reasons will not constitute non-fulfilment attributable to the carrier:

| — | hazardous weather conditions, |
| --- | --- |

—

hazardous weather conditions,

| — | closure of one of the airports indicated in the operating programme, |
| --- | --- |

—

closure of one of the airports indicated in the operating programme,

| — | safety concerns, |
| --- | --- |

—

safety concerns,

| — | industrial action, |
| --- | --- |

—

industrial action,

| — | force majeure. |
| --- | --- |

—

force majeure.

Interruption of the service for these reasons will give rise to a reduction in the amount of compensation proportional to the flights that are not operated.

Where the services and obligations laid down in the agreement are not performed, ENAC will be entitled to impose penalties on the carrier, the level of which will increase in proportion to the number of infringements committed, as detailed in the model agreement.

The amount of penalties may in no case exceed 50 % of the maximum amount of financial compensation laid down in Section 6 of the invitation for tender, with the understanding that, if this limit is exceeded, ENAC will be entitled to terminate the agreement for non-fulfilment, resulting in the immediate cancellation of any compensation due.

The number of flights cancelled for reasons directly attributable to the carrier must not exceed 2 % of the number of flights scheduled in any year.

Above this limit, the carrier will have to pay ENAC a penalty of EUR 3 000,00 for each cancellation over the 2 % limit, subject to formal notice being given to the carrier within ten days of knowledge of the event. The carrier will be allowed up to seven days to present any counter-arguments.

In addition, ENAC will review the amount of financial compensation in proportion to the flights operated. The proceeds will be allocated to the improvement of transport links to and from Crotone.

Failure to give the notice referred to in Section 10 will give rise to a penalty calculated on the basis of the annual compensation and the missed period of notice starting from the date on which the service is interrupted, under the terms specified in Section 10, and using the following formula:

P = CA/GG × gg

where:

| P | = | penalty |
| --- | --- | --- |
| CA | = | annual compensation |
| GG | = | number of days in the year in question (365 or 366) |
| gg | = | days in the missed notice period |

P

=

penalty

CA

=

annual compensation

GG

=

number of days in the year in question (365 or 366)

gg

=

days in the missed notice period

The penalties specified in this Article may be cumulated with the penalty arrangements laid down in Community regulations and in national legislation and regulatory provisions.

12.   Guarantees to provide with the tender

To demonstrate that their tenders are genuine and reliable, carriers participating in this tender procedure must submit a guarantee equal to 2 % of the maximum amount of financial compensation referred to in Section 6 in the form of a deposit or bank or insurance guarantee, as chosen by the tenderer.

The methods of lodging the above guarantee will be set out in the tender dossier and may also be repeated in the agreement.

The guarantee must be valid for at least 180 days from the closing date for submitting tenders, and the carrier must undertake to renew the guarantee, at the request of ENAC during the procedure, if the tender has not been awarded by the time the guarantee lapses.

When ENAC notifies carriers that they have been unsuccessful in the award procedure, it will release them from the guarantee.

13.   Performance guarantee and insurance cover

The carrier awarded the operation of air services subject to a public service obligation under this invitation to tender must lodge a bank or insurance guarantee of EUR 700 000,00 in favour of ENAC, which reserves the right to use it to ensure the continuation of the service concerned.

The guarantee will be automatically released, without the need for ENAC's approval, provided the examination referred to in the last paragraph of Section 6 above is favourable.

14.   Forfeiture and revocation of the financial compensation

Failure to fulfil, at any time after the agreement is signed, the general and technical requirements set out in Section 2 of this invitation to tender and the requirements set out in the tender dossier will give rise to forfeiture of the right to operate the route, the revocation of the right to financial compensation and the recovery of any unduly paid amounts, plus statutory interest.

After the forfeiture of the right to operate the route, ENAC may be authorised by the Ministry of Infrastructure and Transport to conclude another agreement for the remaining period of scheduled air services with the next highest carrier on the ranking list resulting from the tender procedure.

In this case, the duration of the agreement will start on the date on which the service commences and will end on the expiry date set in the terminated agreement, in line with the operating plan approved when the tender submitted by the successful tenderer was assessed.

15.   Termination of the agreement

If the carrier fails to comply with the provisions set out in the notice published in
  Official Journal of the European Union C 241 of 20.9.2008, the corresponding Decree, the agreement, this invitation to tender and the tender dossier, ENAC may, in accordance with Article 1454 of the Civil Code, send written notice giving the carrier 15 days from receipt of such notice to remedy this non-compliance.

If it fails to do so within that period, ENAC will have the right to consider the agreement automatically terminated and to definitively retain the guarantee amount indicated in Section 13 above and to claim compensation from the carrier for damages.

In addition, if the carrier fails to perform the obligations and services accepted in the agreement, this invitation to tender and the tender dossier, ENAC, in accordance with Article 1456 of the Civil Code, has the right to terminate the agreement, subject to written notice to the carrier.

If the agreement is terminated, ENAC may be authorised by the Ministry of Infrastructure and Transport to conclude another agreement for the remaining period of scheduled air services with the next highest carrier on the ranking list resulting from the tender procedure for the award of the route.

In this case, the duration of the agreement will start on the date on which the service commences and will end on the expiry date set in the terminated agreement, in line with the operating plan approved when the tender submitted by the successful tenderer was assessed.

16.   Submission of tenders

Tenders, which in order to be valid must be drawn up in accordance with the provisions of the tender dossier, must reach the following address no later than 30 days after the date of publication of this invitation to tender in the Official Journal of the European Union either by registered letter with acknowledgement of receipt or by hand delivery against receipt: ENAC, Direzione Generale, viale del Castro Pretorio, 118, I-00185 Roma.

In order to be valid, tenders must be submitted in three closed and sealed envelopes.

The outer envelope, closed, sealed and initialled on both sides, must contain two inner envelopes, both sealed and initialled on both sides, and must bear the following wording: ‘Offerta per la gara in oneri di servizio pubblico sulla rotta Crotone-Roma Fiumicino e viceversa’.

The documents to be enclosed in these three envelopes are specified in the tender dossier referred to in Section 4 of this invitation to tender.

It should be noted that the sender will have sole liability in the event that, for whatever reason, the package fails to arrive at its destination by the closing date specified above.

If only one valid tender is submitted, the award procedure may still go ahead.

17.   Expiry of tenders

180 days from the closing date for submission of tenders.

18.   Contract award

ENAC will complete the tender procedure through a committee set up for this purpose, composed of a director of ENAC delegated by the Director-General, an expert in the field of air transport appointed by the Region of Calabria and a chairman appointed by common agreement between ENAC and the Region of Calabria. Secretariat support will be provided by an ENAC official.

19.   Processing of personal data

All personal data will be used and processed solely for official purposes and their protection and confidentiality will be ensured in accordance with prevailing legislation. To this end, the successful carrier will need to sign the relevant authorisation to process personal data in accordance with Legislative Decree No 196/2003 as amended and supplemented.

20.   Processing of sensitive data

Sensitive data contained in the tenders submitted by carriers will be processed in accordance with the Regulation for processing sensitive and legal data approved by ENAC's executive board on 2 March 2006 and available on ENAC's website at: ‘enac-italia.it’.

---

| 31.10.2008 | EN | Official Journal of the European Union | C 276/94 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/94

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CALL FOR PROPOSALS — EACEA/29/08

European associations active at European level in the field of education and training

(2008/C 276/10)

1.   Objectives and description

The purpose of this call for proposals is to support the activities of European associations in the field of education and training or which pursue an objective which is part of an EU policy.

The action programme in the field of lifelong learning (the ‘Lifelong Learning Programme’) (1) and more specifically its ‘Jean Monnet sub-programme’ constitute the legal basis.

In the implementation of key activity 3 of the Jean Monnet programme, the objectives of this call for proposals are:

| — | to support the existence of high-quality European Associations active in the field of education and training, |
| --- | --- |

—

to support the existence of high-quality European Associations active in the field of education and training,

| — | to support European Associations contributing to the implementation of the Education and Training 2010 work programme (2), |
| --- | --- |

—

to support European Associations contributing to the implementation of the Education and Training 2010 work programme (2),

| — | to support European Associations contributing to increasing knowledge and awareness on the European integration process through education and training. |
| --- | --- |

—

to support European Associations contributing to increasing knowledge and awareness on the European integration process through education and training.

Community financing under this call for proposals takes the form of one-year operating grants for 2009 to support certain operational and administrative expenditure of the selected European Associations.

The Education, Audiovisual and Culture Agency (‘the Agency’), acting under powers delegated from the European Commission (‘the Commission’), is responsible for the management of this call for proposals.

2.   Eligible applicants

A European Association is eligible if it satisfies the following conditions. The organisation:

| — | is a non-profit making organisation, |
| --- | --- |

—

is a non-profit making organisation,

| — | is located and has legal personality and seat for more than two years (on 23 December 2008) in one of the eligible countries (the 27 EU Member States, Iceland, Liechtenstein, Norway and Turkey), |
| --- | --- |

—

is located and has legal personality and seat for more than two years (on 23 December 2008) in one of the eligible countries (the 27 EU Member States, Iceland, Liechtenstein, Norway and Turkey),

| — | undertakes the majority of its activities in the Member States of the European Union, in countries belonging to the European Economic Area and/or in the candidate countries, |
| --- | --- |

—

undertakes the majority of its activities in the Member States of the European Union, in countries belonging to the European Economic Area and/or in the candidate countries,

| — | exists as a body pursuing an aim of general European interest as defined in Article 162 of the implementing rules for the Financial Regulation laid down by Commission Regulation (EC, Euratom) No 2342/2002 (3); most recently modified by Regulation (EC) No 478/2007, |
| --- | --- |

—

exists as a body pursuing an aim of general European interest as defined in Article 162 of the implementing rules for the Financial Regulation laid down by Commission Regulation (EC, Euratom) No 2342/2002 (3); most recently modified by Regulation (EC) No 478/2007,

| — | operates in the field of education and training at European level and pursues clear and well-defined objectives laid down in the articles its official statutes, |
| --- | --- |

—

operates in the field of education and training at European level and pursues clear and well-defined objectives laid down in the articles its official statutes,

| — | conducts activities that are compatible with the priorities of the ‘Education and training 2010’ work programme and/or contributes to increasing knowledge and awareness on the European integration process through education and training, |
| --- | --- |

—

conducts activities that are compatible with the priorities of the ‘Education and training 2010’ work programme and/or contributes to increasing knowledge and awareness on the European integration process through education and training,

| — | includes member-associations having their seat in at least 12 different EU Member States (4). Such member-associations should have ‘full member’ status (associate members and observers are not counted as ‘full members’) at transnational, national, regional or local level. |
| --- | --- |

—

includes member-associations having their seat in at least 12 different EU Member States (4). Such member-associations should have ‘full member’ status (associate members and observers are not counted as ‘full members’) at transnational, national, regional or local level.

Please note: Private individuals, individual contractors, individual higher education institutions, or public bodies and institutions that are part of the administrative structure of the Member States are not considered to be ‘associations’.

3.   Award criteria

Eligible applications will be assessed on the basis of the quality of a detailed 12 months work programme for 2009 and the following award criteria will be applied:

| — | the relevance, clarity and coherence of the short-term objectives (12 months), |
| --- | --- |

—

the relevance, clarity and coherence of the short-term objectives (12 months),

| — | the quality of the management of the work programme (clarity and coherence of the activities and the budget proposed to achieve the objectives, timetable), |
| --- | --- |

—

the quality of the management of the work programme (clarity and coherence of the activities and the budget proposed to achieve the objectives, timetable),

| — | the probable impact of the activities on education and/or training at European level (in particular the degree to which the applicant European Associations contribute to the implementation of the Education and Training 2010 work programme and/or to increasing knowledge and awareness on the European integration process). |
| --- | --- |

—

the probable impact of the activities on education and/or training at European level (in particular the degree to which the applicant European Associations contribute to the implementation of the Education and Training 2010 work programme and/or to increasing knowledge and awareness on the European integration process).

A more detailed description of information to be provided by the applicant for each award criteria is available at: http://eacea.ec.europa.eu/index.htm and should be read carefully.

4.   Budget and project duration

The total indicative Community budget for the co-financing of European Associations under this call is EUR 600 000.

The maximum operating grant per association for an annual work programme of 12 months (corresponding to one budget year) shall not exceed EUR 100 000.

Applicant organisations can choose between two systems of co-financing:

| (a) | budget based financing: the traditional eligible costs financing for which the Community financial support may not exceed 75 % of the total eligible costs set out in the budget for the association's work programme; |
| --- | --- |

(a)

budget based financing: the traditional eligible costs financing for which the Community financial support may not exceed 75 % of the total eligible costs set out in the budget for the association's work programme;

| (b) | flat rate financing: flat rate based financing for which the Community financial support may not exceed 75 % of the summary of provisional expenditure and income statement for the relevant year. |
| --- | --- |

(b)

flat rate financing: flat rate based financing for which the Community financial support may not exceed 75 % of the summary of provisional expenditure and income statement for the relevant year.

The period of eligibility of costs for a work programme of maximum 12 months shall start between 1 January 2009 and 1 April 2009 and may not extend beyond the end of the beneficiary's budgetary year.

5.   Deadline And submisstion of proposals

The deadline for submission of applications is 23 December 2008 (date as postmark) and applications must be sent to the following address:

| Education, Audiovisual and Culture Executive Agency |
| --- |
| Lifelong Learning: Erasmus, Jean Monnet |
| Call for proposal — EACEA/29/08 |
| Mr Ralf RAHDERS |
| Office: BOUR 2/61 |
| Avenue du Bourget 1 |
| B-1140 Brussels |

Education, Audiovisual and Culture Executive Agency

Lifelong Learning: Erasmus, Jean Monnet

Call for proposal — EACEA/29/08

Mr Ralf RAHDERS

Office: BOUR 2/61

Avenue du Bourget 1

B-1140 Brussels

Only applications submitted on the official application form, duly signed by the person entitled to enter into legally binding commitments on behalf of the applicant organisation and containing all the information and annexes specified in the guidelines for applicants will be accepted. Applications sent by fax or e-mail will be rejected.

6.   Further information

The guidelines for applicants and the application form are available on the website of the Agency: http://eacea.ec.europa.eu

Further information can be obtained from:

| Education, Audiovisual and Culture Executive Agency |
| --- |
| Ms Ilona POKORNA |
| E-mail: Ilona.Pokorna@ec.europa.eu |
| Tel. (direct line) (32-2) 295 83 94 |

Education, Audiovisual and Culture Executive Agency

Ms Ilona POKORNA

E-mail: Ilona.Pokorna@ec.europa.eu

Tel. (direct line) (32-2) 295 83 94

---

(1)  See Decision No 1720/2006/EC of the European Parliament and of the Council of 15 November 2006 establishing an action programme in the field of lifelong learning.

http://eur-lex.europa.eu/LexUriServ/site/en/oj/2006/c_327/c_32420061230en00590067.pdf

(2)  See http://ec.europa.eu/education/policies/2010/et_2010_en.html

(3)  According to this definition, an organisation pursuing an aim of general European interest is:

| — | a European body involved in education, training, information or research and study in European policies or a European standards body, or |
| --- | --- |

—

a European body involved in education, training, information or research and study in European policies or a European standards body, or

| — | a European network representing non-profit bodies active in the Member States or in the candidate countries and promoting principles and policies consistent with the objectives of the Treaties. |
| --- | --- |

—

a European network representing non-profit bodies active in the Member States or in the candidate countries and promoting principles and policies consistent with the objectives of the Treaties.

(4)  In addition, the European association may include member-associations based in other LLP participating countries (non-EU Member States).

---

PROCEDURES RELATING TO THE IMPLEMENTATION OF THE COMPETITION POLICY

Commission

| 31.10.2008 | EN | Official Journal of the European Union | C 276/97 |
| --- | --- | --- | --- |

31.10.2008

EN

Official Journal of the European Union

C 276/97

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Prior notification of a concentration

(Case COMP/M.5368 — MidAmerican/Constellation)

Candidate case for simplified procedure

(Text with EEA relevance)

(2008/C 276/11)

| 1. | On 23 October 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which MidAmerican Energy Holdings Company (‘MidAmerican’, USA) controlled by Berkshire Hathaway acquires within the meaning of Article 3(1)(b) of the Council Regulation control over Constellation Energy group Inc. (‘Constellation’, USA) by way of purchase of shares. |
| --- | --- |

1.

On 23 October 2008, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which MidAmerican Energy Holdings Company (‘MidAmerican’, USA) controlled by Berkshire Hathaway acquires within the meaning of Article 3(1)(b) of the Council Regulation control over Constellation Energy group Inc. (‘Constellation’, USA) by way of purchase of shares.

| 2. | The business activities of the undertakings concerned are:






  — | for MidAmerican Energy Holdings Company (‘MidAmerican’, USA): different energy businesses, |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for MidAmerican Energy Holdings Company (‘MidAmerican’, USA): different energy businesses,

| — | for Berkshire Hathaway: diverse range of business activities, including property and casualty insurance and reinsurance, utilities and energy, finance, manufacturing, retailing and services, |
| --- | --- |

—

for Berkshire Hathaway: diverse range of business activities, including property and casualty insurance and reinsurance, utilities and energy, finance, manufacturing, retailing and services,

| — | for Constellation Energy group Inc. (‘Constellation’, USA): power generation and energy supply. |
| --- | --- |

—

for Constellation Energy group Inc. (‘Constellation’, USA): power generation and energy supply.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5368 — MidAmerican/Constellation, to the following address:





  European Commission |
| --- | --- |
| Directorate-General for Competition |
| Merger Registry |
| J-70 |
| B-1049 Bruxelles/Brussel |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax ((32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.5368 — MidAmerican/Constellation, to the following address:

European Commission

Directorate-General for Competition

Merger Registry

J-70

B-1049 Bruxelles/Brussel

---

(1)  OJ L 24, 29.1.2004, p. 1.

(2)  OJ C 56, 5.3.2005, p. 32.

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31.10.2008

| 31.10.2008 | EN | Official Journal of the European Union | C 276/s3 |
| --- | --- | --- | --- |

EN

Official Journal of the European Union

C 276/s3

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NOTE TO THE READER

The institutions have decided no longer to quote in their texts the last amendment to cited acts.

Unless otherwise indicated, references to acts in the texts published here are to the version of those acts currently in force.

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