# Official Journal C 101/2009

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2009.101.eng |
| --- | --- |
| Official Journal
  of the European Union | C 101 |
| | |
| English edition | Information and Notices | Volume 521 May 2009 |

ISSN 1725-2423

doi:10.3000/17252423.C_2009.101.eng

Official Journal

of the European Union

C 101

English edition

Information and Notices

Volume 521 May 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 101/01 | Non-opposition to a notified concentration — (Case COMP/M.5432 — Credit Mutuel/Cofidis) (
  1
  ) | 1 |

Notice No

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 101/01

Non-opposition to a notified concentration — (Case COMP/M.5432 — Credit Mutuel/Cofidis) (
  1
  )

1

1

| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 101/02 | Euro exchange rates | 2 |
| 2009/C 101/03 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2009 to 31 March 2009 — (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 3 |
| 2009/C 101/04 | Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 March 2009 to 31 March 2009 — (Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 14 |
| 2009/C 101/05 | Opinion of the Advisory Committee on mergers given at its meeting of 16 November 2007 regarding a draft decision relating to Case COMP/M.4647 — AEE/Lentjes — Rapporteur: Latvia | 43 |
| 2009/C 101/06 | Summary of Commission Decision — of 5 December 2007 — declaring a concentration compatible with the common market and the functioning of the EEA Agreement — (Case COMP/M.4647 — AEE/Lentjes) | 44 |
| 2009/C 101/07 | Final report of the Hearing Officer in Case COMP/M.4647 — AEE/Lentjes (Pursuant to Articles 15 and 16 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21) | 54 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 101/02

Euro exchange rates

2

2009/C 101/03

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2009 to 31 March 2009 — (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

3

2009/C 101/04

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 March 2009 to 31 March 2009 — (Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

or Article 38 of Directive 2001/82/EC

)

14

2009/C 101/05

Opinion of the Advisory Committee on mergers given at its meeting of 16 November 2007 regarding a draft decision relating to Case COMP/M.4647 — AEE/Lentjes — Rapporteur: Latvia

43

2009/C 101/06

Summary of Commission Decision — of 5 December 2007 — declaring a concentration compatible with the common market and the functioning of the EEA Agreement — (Case COMP/M.4647 — AEE/Lentjes)

44

2009/C 101/07

Final report of the Hearing Officer in Case COMP/M.4647 — AEE/Lentjes (Pursuant to Articles 15 and 16 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

(Pursuant to Articles 15 and 16 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

54

| | V   Announcements |
| --- | --- |
| | ADMINISTRATIVE PROCEDURES |
| | Commission |
| 2009/C 101/08 | Specific call for proposals — EAC/24/09 — Erasmus University Charter — Lifelong Learning Programme | 55 |

V   Announcements

ADMINISTRATIVE PROCEDURES

Commission

2009/C 101/08

Specific call for proposals — EAC/24/09 — Erasmus University Charter — Lifelong Learning Programme

55

| | |
| --- | --- |
| 2009/C 101/09 | Notice | s3 |

2009/C 101/09

Notice

Notice

s3

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

---

(1)   Text with EEA relevance

1

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

EN

---

II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 1.5.2009 | EN | Official Journal of the European Union | C 101/1 |
| --- | --- | --- | --- |

1.5.2009

EN

Official Journal of the European Union

C 101/1

---

Non-opposition to a notified concentration

(Case COMP/M.5432 — Credit Mutuel/Cofidis)

(Text with EEA relevance)

2009/C 101/01

On 24 February 2009, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in French and will be made public after it is cleared of any business secrets it may contain. It will be available:

| — | from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes, |
| --- | --- |

—

from the Europa competition website (http://ec.europa.eu/comm/competition/mergers/cases/). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

| — | in electronic form on the EUR-Lex website under document number 32009M5432. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu). |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32009M5432. EUR-Lex is the on-line access to European law (http://eur-lex.europa.eu).

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 1.5.2009 | EN | Official Journal of the European Union | C 101/2 |
| --- | --- | --- | --- |

1.5.2009

EN

Official Journal of the European Union

C 101/2

---

Euro exchange rates (1)

30 April 2009

2009/C 101/02

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,3275 |
| JPY | Japanese yen | 130,34 |
| DKK | Danish krone | 7,4484 |
| GBP | Pound sterling | 0,89335 |
| SEK | Swedish krona | 10,6915 |
| CHF | Swiss franc | 1,5066 |
| ISK | Iceland króna | |
| NOK | Norwegian krone | 8,7245 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 26,701 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 289,73 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,7093 |
| PLN | Polish zloty | 4,3993 |
| RON | Romanian leu | 4,1892 |
| TRY | Turkish lira | 2,1145 |
| AUD | Australian dollar | 1,8146 |
| CAD | Canadian dollar | 1,5786 |
| HKD | Hong Kong dollar | 10,2881 |
| NZD | New Zealand dollar | 2,3378 |
| SGD | Singapore dollar | 1,9620 |
| KRW | South Korean won | 1 696,88 |
| ZAR | South African rand | 11,2426 |
| CNY | Chinese yuan renminbi | 9,0575 |
| HRK | Croatian kuna | 7,4101 |
| IDR | Indonesian rupiah | 14 071,50 |
| MYR | Malaysian ringgit | 4,7259 |
| PHP | Philippine peso | 63,924 |
| RUB | Russian rouble | 43,8630 |
| THB | Thai baht | 46,808 |
| BRL | Brazilian real | 2,8850 |
| MXN | Mexican peso | 18,2950 |
| INR | Indian rupee | 66,2620 |

Currency

Exchange rate

USD

US dollar

1,3275

JPY

Japanese yen

130,34

DKK

Danish krone

7,4484

GBP

Pound sterling

0,89335

SEK

Swedish krona

10,6915

CHF

Swiss franc

1,5066

ISK

Iceland króna

NOK

Norwegian krone

8,7245

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

26,701

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

289,73

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,7093

PLN

Polish zloty

4,3993

RON

Romanian leu

4,1892

TRY

Turkish lira

2,1145

AUD

Australian dollar

1,8146

CAD

Canadian dollar

1,5786

HKD

Hong Kong dollar

10,2881

NZD

New Zealand dollar

2,3378

SGD

Singapore dollar

1,9620

KRW

South Korean won

1 696,88

ZAR

South African rand

11,2426

CNY

Chinese yuan renminbi

9,0575

HRK

Croatian kuna

7,4101

IDR

Indonesian rupiah

14 071,50

MYR

Malaysian ringgit

4,7259

PHP

Philippine peso

63,924

RUB

Russian rouble

43,8630

THB

Thai baht

46,808

BRL

Brazilian real

2,8850

MXN

Mexican peso

18,2950

INR

Indian rupee

66,2620

---

(1)  Source: reference exchange rate published by the ECB.

---

| 1.5.2009 | EN | Official Journal of the European Union | C 101/3 |
| --- | --- | --- | --- |

1.5.2009

EN

Official Journal of the European Union

C 101/3

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 March 2009 to 31 March 2009

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1)
  )

2009/C 101/03

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | INN
  (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.3.2009 | CELVAPAN | Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated) | Baxter AG |
| Industriestraße 67 |
| A - 1221 Wien |
| ÖSTERREICH |

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

4.3.2009

CELVAPAN

Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated)

Baxter AG

Industriestraße 67

A - 1221 Wien

ÖSTERREICH

EU/1/08/506/001

Suspension for injection

J07BB01

6.3.2009

6.3.2009

MEPACT

mifamurtide

| IDM Pharma S.A. |
| --- |
| 47 rue de Chaillot |
| 75116 Paris |
| FRANCE |

IDM Pharma S.A.

47 rue de Chaillot

75116 Paris

FRANCE

EU/1/08/502/001

Powder for suspension for infusion

L03AX15

23.3.2009

19.3.2009

Fertavid

follitropin beta

| SP Europe |
| --- |
| Rue de Stalle |
| 73 B-1180 Bruxelles |
| BELGIQUE |

SP Europe

Rue de Stalle

73 B-1180 Bruxelles

BELGIQUE

EU/1/09/510/001-019

Solution for injection

G03G A06

23.3.2009

30.3.2009

Synflorix

Pneumococcal polysaccharide conjugate vaccine (adsorbed)

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

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89

1330 Rixensart

BELGIQUE

EU/1/09/508/001-009

Suspension for injection

J07AL52

31.3.2009

31.3.2009

Ribavirin Teva

Ribavirin

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

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

NEDERLAND

EU/1/09/509/001-004

Capsule, hard

J05A B04

2.4.2009

31.3.2009

IXIARO

Japanese Encephalitis vaccine (inactivated, adsorbed)

| Intercell AG |
| --- |
| Campus Vienna Biocenter 3 |
| A-1030 Wien |
| ÖSTERREICH |

Intercell AG

Campus Vienna Biocenter 3

A-1030 Wien

ÖSTERREICH

EU/1/08/501/001-002

Suspension for injection

J07BA02

2.4.2009

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.3.2009 | Fendrix | GlaxoSmithKline Biologicals s.a. |
| rue de l'Institut 89 |
| Rixensart, B-1330 |
| BELGIQUE |

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

2.3.2009

Fendrix

GlaxoSmithKline Biologicals s.a.

rue de l'Institut 89

Rixensart, B-1330

BELGIQUE

EU/1/04/299/001-003

4.3.2009

2.3.2009

Cymbalta

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

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/296/001-009

4.3.2009

2.3.2009

Fareston

| Orion Corporation |
| --- |
| Orionintie 1 |
| FIN-02200 Espoo |
| SUOMI |

Orion Corporation

Orionintie 1

FIN-02200 Espoo

SUOMI

EU/1/96/004/001-002

4.3.2009

2.3.2009

Nexavar

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

Bayer HealthCare AG

D-51368 Leverkusen

DEUTSCHLAND

EU/1/06/342/001

4.3.2009

2.3.2009

Irbesartan BMS

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/06/375/001-033

4.3.2009

2.3.2009

Aptivus

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

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216

Ingelheim am Rhein

DEUTSCHLAND

EU/1/05/315/001

4.3.2009

2.3.2009

Ganfort

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road |
| Westport, Co. Mayo |
| IRELAND |

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport, Co. Mayo

IRELAND

EU/1/06/340/001-002

5.3.2009

4.3.2009

KOGENATE Bayer

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

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/00/143/001-011

6.3.2009

4.3.2009

Helixate NexGen

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

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/00/144/001-004

6.3.2009

4.3.2009

Gardasil

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

Sanofi Pasteur MSD

SNC, 8, rue Jonas Salk

69007 Lyon

FRANCE

EU/1/06/357/001-021

6.3.2009

4.3.2009

Cystadane

| Orphan Europe S.a.r.l. |
| --- |
| Immeuble Le Wilson |
| 70 Avenue du Général de Gaulle |
| 92800 Puteaux |
| FRANCE |

Orphan Europe S.a.r.l.

Immeuble Le Wilson

70 Avenue du Général de Gaulle

92800 Puteaux

FRANCE

EU/1/06/379/001

6.3.2009

4.3.2009

Photobarr

| Axcan Pharma International BV |
| --- |
| Engelenkampstraat 72 |
| 6131 JJ Sittard |
| NEDERLAND |

Axcan Pharma International BV

Engelenkampstraat 72

6131 JJ Sittard

NEDERLAND

EU/1/04/272/001-002

6.3.2009

6.3.2009

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

10.3.2009

6.3.2009

BYETTA

| 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/1/06/362/001-004

10.3.2009

6.3.2009

IntronA

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73 |
| 1180 Bruxelles |
| BELGIQUE |

Schering Plough Europe

Rue de Stalle, 73

1180 Bruxelles

BELGIQUE

EU/1/99/127/001-044

10.3.2009

6.3.2009

Remicade

| Centocor B.V. |
| --- |
| Einsteinweg 101 |
| 2333 CB Leiden |
| NEDERLAND |

Centocor B.V.

Einsteinweg 101

2333 CB Leiden

NEDERLAND

EU/1/99/116/001-005

10.3.2009

6.3.2009

Protelos

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

Les Laboratoires Servier

22, rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/04/288/001-006

10.3.2009

6.3.2009

ATryn

| LEO Pharma A/S |
| --- |
| Industriparken 55 |
| DK-2750 Ballerup |
| DANMARK |

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

DANMARK

EU/1/06/355/001-003

10.3.2009

6.3.2009

Irbesartan Hydrochlorothiazide Winthrop

| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC |
| --- |
| 174 avenue de France |
| F- 75013 Paris |
| FRANCE |

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174 avenue de France

F- 75013 Paris

FRANCE

EU/1/06/377/001-028

10.3.2009

9.3.2009

Optisulin

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

DEUTSCHLAND

EU/1/00/133/001-032

11.3.2009

9.3.2009

Osseor

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

Les Laboratoires Servier

22, rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/04/287/001-006

11.3.2009

9.3.2009

Sustiva

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/99/110/001-009

11.3.2009

10.3.2009

DULOXETINE BOEHRINGER INGELHEIM

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

Boehringer Ingelheim International GmbH

Binger Strasse 173 - D - 55216

Ingelheim am Rhein

DEUTSCHLAND

EU/1/08/471/001-012

12.3.2009

17.3.2009

Pritor Plus

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

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/02/215/001-021

19.3.2009

17.3.2009

Irbesartan Winthrop

| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC |
| --- |
| 174 avenue de France |
| F- 75013 Paris |
| FRANCE |

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174 avenue de France

F- 75013 Paris

FRANCE

EU/1/06/376/001-033

19.3.2009

17.3.2009

Pritor

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

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/98/089/001-022

19.3.2009

17.3.2009

Hycamtin

| SmithKline Beecham plc |
| --- |
| 980 Great West Road, Brentford |
| Middlesex,TW8 9GS |
| UNITED KINGDOM |

SmithKline Beecham plc

980 Great West Road, Brentford

Middlesex,TW8 9GS

UNITED KINGDOM

EU/1/96/027/001

EU/1/96/027/003-007

19.3.2009

17.3.2009

Onsenal

| Pfizer Limited |
| --- |
| Ramsgate Road, Sandwich |
| Kent CT13 9NJ |
| UNITED KINGDOM |

Pfizer Limited

Ramsgate Road, Sandwich

Kent CT13 9NJ

UNITED KINGDOM

EU/1/03/259/001-006

19.3.2009

18.3.2009

Irbesartan HCT BMS

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/06/369/001-028

20.3.2009

18.3.2009

Atriance

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

Glaxo Group Limited

Berkeley Avenue, Greenford

Middlesex UB6 0NN

UNITED KINGDOM

EU/1/07/403/001

20.3.2009

18.3.2009

Kinzalkomb

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

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/02/214/001-015

20.3.2009

18.3.2009

MicardisPlus

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

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216

Ingelheim am Rhein

DEUTSCHLAND

EU/1/02/213/001-023

20.3.2009

18.3.2009

Kinzalmono

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

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/98/091/001-014

20.3.2009

19.3.2009

Regranex

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

Janssen-Cilag International NV

Turnhoutseweg

30 - 2340 Beerse –

BELGIË

EU/1/99/101/001

23.3.2009

19.3.2009

Stalevo

| Orion Corporation |
| --- |
| Orionintie 1 |
| FIN-02200 Espoo |
| SUOMI |

Orion Corporation

Orionintie 1

FIN-02200 Espoo

SUOMI

EU/1/03/260/001-023

23.3.2009

19.3.2009

Micardis

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

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216

Ingelheim am Rhein

DEUTSCHLAND

EU/1/98/090/001-020

23.3.2009

19.3.2009

Vectibix

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

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

NEDERLAND

EU/1/07/423/001-003

23.3.2009

23.3.2009

NovoSeven

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

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsvaerd

DANMARK

EU/1/96/006/001-003

25.3.2009

23.3.2009

Irbesartan BMS

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road

Uxbridge UB8 1DH

UNITED KINGDOM

EU/1/06/375/001-033

25.3.2009

25.3.2009

Avastin

| 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/1/04/300/001-002

27.3.2009

25.3.2009

Enbrel

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

Wyeth Europa Limited

Huntercombe Lane South, Taplow

Maidenhead, Berkshire, SL6 0PH

UNITED KINGDOM

EU/1/99/126/001-018

27.3.2009

25.3.2009

Telzir

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

Glaxo Group Ltd.

Greenford Road, Greenford

Middlesex UB6 0NN

UNITED KINGDOM

EU/1/04/282/001-002

27.3.2009

25.3.2009

Ariclaim

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

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/283/001-012

27.3.2009

25.3.2009

Exjade

| 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/1/06/356/001-009

27.3.2009

25.3.2009

Arixtra

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

Glaxo Group Ltd.

Greenford Road, Greenford

Middlesex UB6 0NN

UNITED KINGDOM

EU/1/02/206/001-035

27.3.2009

25.3.2009

Xenical

| 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/1/98/071/001-006

27.3.2009

25.3.2009

Cymbalta

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

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/04/296/001-009

27.3.2009

25.3.2009

Advagraf

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

Astellas Pharma Europe B.V.

Elisabethhof 19

NL-2353 EW Leiderdorp

NEDERLAND

EU/1/07/387/001-010

27.3.2009

25.3.2009

Pradaxa

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

Boehringer Ingelheim International GmbH

Binger Strasse 173

D-55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/08/442/001-008

27.3.2009

25.3.2009

Zyprexa

| 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/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/008-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-034

27.3.2009

25.3.2009

ProQuad

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

Sanofi Pasteur MSD

SNC, 8, rue Jonas Salk

69007 Lyon

FRANCE

EU/1/05/323/001-013

27.3.2009

25.3.2009

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

27.3.2009

25.3.2009

Tyverb

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

Glaxo Group Limited

Berkeley Avenue, Greenford

Middlesex UB6 0NN

UNITED KINGDOM

EU/1/07/440/001-002

27.3.2009

25.3.2009

Lysodren

| Laboratoire HRA Pharma |
| --- |
| 15, rue Béranger |
| 75003 Paris |
| FRANCE |

Laboratoire HRA Pharma

15, rue Béranger

75003 Paris

FRANCE

EU/1/04/273/001

27.3.2009

25.3.2009

Zyprexa Velotab

| 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/1/99/125/001-016

27.3.2009

25.3.2009

Yondelis

| Pharma Mar, S.A. |
| --- |
| Avda. de los Reyes 1 |
| Polígono Industrial La Mina |
| 28770 Colmenar Viejo (Madrid) |
| ESPAÑA |

Pharma Mar, S.A.

Avda. de los Reyes 1

Polígono Industrial La Mina

28770 Colmenar Viejo (Madrid)

ESPAÑA

EU/1/07/417/001-002

27.3.2009

25.3.2009

Extavia

| 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/1/08/454/001-002

EU/1/08/454/005

27.3.2009

25.3.2009

Mabthera

| 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/1/98/067/001-002

27.3.2009

25.3.2009

Beromun

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

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216

Ingelheim am Rhein

DEUTSCHLAND

EU/1/99/097/001

27.3.2009

25.3.2009

Dukoral

| SBL Vaccin AB |
| --- |
| S-105 21 Stockholm |
| SWEDEN |

SBL Vaccin AB

S-105 21 Stockholm

SWEDEN

EU/1/03/263/001-003

30.3.2009

25.3.2009

NeuroBloc

| Eisai Limited |
| --- |
| 3, Shortlands |
| London W6 8EE |
| UNITED KINGDOM |

Eisai Limited

3, Shortlands

London W6 8EE

UNITED KINGDOM

EU/1/00/166/001-003

30.3.2009

25.3.2009

Xeristar

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

Boehringer Ingelheim International GmbH

Binger Strasse 173- D - 55216

Ingelheim am Rhein

DEUTSCHLAND

EU/1/04/297/001-008

27.3.2009

27.3.2009

Aerinaze

| SP Europe |
| --- |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - |
| Stallestraat, 73 - 1180 Brussel |
| BELGIË |

SP Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique -

Stallestraat, 73 - 1180 Brussel

BELGIË

EU/1/07/399/001-006

1.4.2009

27.3.2009

Liprolog

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

Eli Lilly Nederland B.V.

Grootslag 1-5

3991 RA Houten

NEDERLAND

EU/1/01/195/001-015

EU/1/01/195/022-025

1.4.2009

27.3.2009

Karvezide

| 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/1/98/085/001-034

1.4.2009

27.3.2009

Irbesartan HCT Winthrop

| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC |
| --- |
| 174 avenue de France |
| F- 75013 Paris |
| FRANCE |

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174 avenue de France

F- 75013 Paris

FRANCE

EU/1/06/377/001-028

1.4.2009

27.3.2009

Litak

| Lipomed GmbH |
| --- |
| Schönaugasse 11 |
| D-79713 Bad Säckingen |
| DEUTSCHLAND |

Lipomed GmbH

Schönaugasse 11

D-79713 Bad Säckingen

DEUTSCHLAND

EU/1/04/275/001-002

1.4.2009

27.3.2009

Procoralan

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

Les Laboratoires Servier

22, rue Garnier

92200 Neuilly-sur-Seine

FRANCE

EU/1/05/316/001-014

1.4.2009

27.3.2009

Mimpara

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

Amgen Europe B.V.

Minervum 7061

NL-4817 ZK Breda

NEDERLAND

EU/1/04/292/001-012

1.4.2009

27.3.2009

TRIZIVIR

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

Glaxo Group Ltd.

Greenford Road, Greenford

Middlesex UB6 0NN

UNITED KINGDOM

EU/1/00/156/002-003

1.4.2009

27.3.2009

Dafiro

| 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/1/06/371/001-036

1.4.2009

27.3.2009

Copalia

| 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/1/06/372/001-036

1.4.2009

27.3.2009

Imprida

| 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/1/06/373/001-036

1.4.2009

27.3.2009

Exforge

| 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/1/06/370/001-036

1.4.2009

27.3.2009

Stalevo

| Orion Corporation |
| --- |
| Orionintie 1 |
| FIN-02200 Espoo |
| SUOMI |

Orion Corporation

Orionintie 1

FIN-02200 Espoo

SUOMI

EU/1/03/260/024-033

1.4.2009

30.3.2009

Cholestagel

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

Genzyme Europe B.V.

Gooimeer 10

NL-1411 DD Naarden

NEDERLAND

EU/1/03/268/001-004

1.4.2009

31.3.2009

Rapilysin

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjordur |
| ICELAND |

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

220 Hafnarfjordur

ICELAND

EU/1/96/018/001

2.4.2009

31.3.2009

Velcade

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

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

BELGIË

EU/1/04/274/001-002

2.4.2009

31.3.2009

Aprovel

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France -

75013 Paris

FRANCE

EU/1/97/046/001-039

2.4.2009

31.3.2009

Karvea

| 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/1/97/049/001-039

2.4.2009

31.3.2009

CoAprovel

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

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France -

75013 Paris

FRANCE

EU/1/98/086/001-034

2.4.2009

—   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 |
| --- | --- | --- | --- | --- |
| 17.3.2009 | Dynepo | Shire Pharmaceutical Contracts Ltd |
| Hampshire International Business Park, Chineham, Basingstoke |
| Hampshire RG24 8EP |
| 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

17.3.2009

Dynepo

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke

Hampshire RG24 8EP

UNITED KINGDOM

EU/1/02/211/001-005

EU/1/02/211/010-012

19.3.2009

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No (2) 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.3.2009 | BTVPUR Alsap 8 | Bluetongue virus Serotype 8 Antigen | MERIAL |
| 29 avenue Tony Garnier |
| 69007 LYON |
| FRANCE |

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

17.3.2009

BTVPUR Alsap 8

Bluetongue virus Serotype 8 Antigen

MERIAL

29 avenue Tony Garnier

69007 LYON

FRANCE

EU/2/09/094/001-005

Suspension for injection

Q104AA02

Q102AA08

19.3.2009

—   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 |
| --- | --- | --- | --- | --- |
| 6.3.2009 | Econor | Novartis Animal Health Austria GmbH |
| Biochemiestrasse 10 |
| 6250 Kundl |
| ÖSTERREICH |

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

6.3.2009

Econor

Novartis Animal Health Austria GmbH

Biochemiestrasse 10

6250 Kundl

ÖSTERREICH

EU/2/98/010/004-006

EU/2/98/010/017-018

EU/2/98/010/021-024

10.3.2009

12.3.2009

Novem

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/2/04/042/003-004

16.3.2009

18.3.2009

Aivlosin

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road New Malden |
| Surrey KT3 4QS |
| UNITED KINGDOM |

ECO Animal Health Ltd

78 Coombe Road New Malden

Surrey KT3 4QS

UNITED KINGDOM

EU/2/04/044/001-008

20.3.2009

23.3.2009

Equilis Prequenza Te

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| NEDERLAND |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/05/057/001-004

25.3.2009

23.3.2009

Equilis Prequenza

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| NEDERLAND |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/05/056/001-004

25.3.2009

25.3.2009

Quadrisol

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| NEDERLAND |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/97/005/002-004

EU/2/97/005/006-009

27.3.2009

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.

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

---

| 1.5.2009 | EN | Official Journal of the European Union | C 101/14 |
| --- | --- | --- | --- |

1.5.2009

EN

Official Journal of the European Union

C 101/14

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 March 2009 to 31 March 2009

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1)
  or Article 38 of Directive 2001/82/EC
   (2)
  )

2009/C 101/04

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 4.3.2009 | PhotoBarr | Axcan Pharma International BV, |
| Engelenkampstraat 72, |
| 6131 JJ Sittard, |
| Nederland |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

4.3.2009

PhotoBarr

Axcan Pharma International BV,

Engelenkampstraat 72,

6131 JJ Sittard,

Nederland

This Decision is addressed to the Member States

5.3.2009

6.3.2009

Tritazide

See Annex I

See Annex I

10.3.2009

6.3.2009

Tritace

See Annex II

See Annex II

10.3.2009

6.3.2009

UMAN BIG

See Annex III

See Annex III

9.3.2009

12.3.2009

Bleomycin Pharmachemie

See Annex IV

See Annex IV

16.3.2009

12.3.2009

Sanohex

See Annex V

See Annex V

16.3.2009

12.3.2009

Sabumalin

See Annex VI

See Annex VI

16.3.2009

27.3.2009

Zoloft

See Annex VII

See Annex VII

31.3.2009

---

(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, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | (Invented)
  name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | SANOFI-AVENTIS GMBH OSTERREICH |
| SATURN Tower |
| Leonard-Bernstein-Straße 10 |
| A-1220 Vienna |
| Austria |

Member State EU/EEA

Marketing authorisation holder

(Invented)

name

Strength

Pharmaceutical form

Route of administration

Austria

SANOFI-AVENTIS GMBH OSTERREICH

SATURN Tower

Leonard-Bernstein-Straße 10

A-1220 Vienna

Austria

Tritazide 25 mg/125 mg Tabletten

Tritazide 5 mg/25 mg Tabletten

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Austria

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

HYPREN PLUS

HYPREN PLUS FORTE

2,5 mg/12,5 mg

5 mg/25 mg

Tablets

Oral

Belgium

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

Sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem

Belgium

TRITAZIDE 5 mg – 25 mg, tabletten

5 mg/25 mg

Tablet

Oral

Bulgaria

| AVENTIS PHARMA DEUTSCHLAND GMBH |
| --- |
| D-65926 Frankfurt am Main |
| Germany |

AVENTIS PHARMA DEUTSCHLAND GMBH

D-65926 Frankfurt am Main

Germany

TRITACE 2,5 PLUS

2,5 mg/12,5 mg

Tablet

Oral

Bulgaria

| SANOFI-AVENTIS BULGARIA EOOD |
| --- |
| Alexandar Stamboliyski blvd. 103 |
| office building Sofia Tower, fl. 8, |
| Sofia 1303 |
| Bulgaria |

SANOFI-AVENTIS BULGARIA EOOD

Alexandar Stamboliyski blvd. 103

office building Sofia Tower, fl. 8,

Sofia 1303

Bulgaria

TRITACE 2,5 PLUS

TRITACE 5 PLUS

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Cyprus

| SANOFI-AVENTIS CYPRUS LTD |
| --- |
| 14, Charalambou Mouskou street |
| 2015 – Nicosia |
| Cyprus |

SANOFI-AVENTIS CYPRUS LTD

14, Charalambou Mouskou street

2015 – Nicosia

Cyprus

TRIATEC PLUS

5 mg/25 mg

Tablet

Oral

Czech Republic

| sanofi-aventis, s.r.o. |
| --- |
| Evropská 2590/33c |
| 16000 Praha 6 |
| Czech Republic |

sanofi-aventis, s.r.o.

Evropská 2590/33c

16000 Praha 6

Czech Republic

TRITAZIDE 2,5/12,5 mg

TRITAZIDE 5/25 mg

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Denmark

| sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| 2970 Hørsholm |
| Denmark |

sanofi-aventis Denmark A/S

Slotsmarken 13

2970 Hørsholm

Denmark

TRIATEC COMP

5 mg/25 mg

Tablet

Oral

Estonia

| SANOFI-AVENTIS DEUTSCHLAND GMBH |
| --- |
| 65926 Frankfurt am Main |
| Germany |

SANOFI-AVENTIS DEUTSCHLAND GMBH

65926 Frankfurt am Main

Germany

CARDACE COMP

2,5 mg/12,5 mg

Tablet

Oral

Estonia

| SANOFI-AVENTIS ESTONIA OÜ |
| --- |
| Pärnu mnt. 139 E/211317 Tallinn |
| Estonia |

SANOFI-AVENTIS ESTONIA OÜ

Pärnu mnt. 139 E/211317 Tallinn

Estonia

CARDACE PLUS

5 mg/25 mg

Tablet

Oral

Finland

| SANOFI-AVENTIS OY |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki |
| Finland |

SANOFI-AVENTIS OY

Huopalahdentie 24

00350 Helsinki

Finland

CARDACE COMP

2,5 mg/12,5 mg

Tablet

Oral

France

| SANOFI-AVENTIS France |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI-AVENTIS France

1-13 boulevard Romain Rolland

75014 Paris

France

COTRIATEC

5 mg/12,5 mg

Tablet

Oral

Germany

| SANOFI-AVENTIS DEUTSCHLAND GMBH |
| --- |
| Brüningstraße 50 |
| 65926 Frankfurt am Main |
| Germany |

SANOFI-AVENTIS DEUTSCHLAND GMBH

Brüningstraße 50

65926 Frankfurt am Main

Germany

Delix 2,5 plus

Delix 5 plus

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Germany

| WINTHROP ARZNEIMITTEL GMBH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

WINTHROP ARZNEIMITTEL GMBH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Ramilich comp 2,5 mg/12,5 mg Tabletten

Ramilich comp 5 mg/25 mg Tabletten

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Germany

| WINTHROP ARZNEIMITTEL GMBH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

WINTHROP ARZNEIMITTEL GMBH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

RamiWin comp 2,5 mg/12,5 mg Tabletten

RamiWin comp 5 mg/25 mg Tabletten

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Germany

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Germany |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

Vesdil 2,5 Plus

Vesdil 5 Plus

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| 348, Syggrou Avenue |
| Building A |
| 176-74 Kallithea |
| Greece |

SANOFI-AVENTIS AEBE

348, Syggrou Avenue

Building A

176-74 Kallithea

Greece

TRIATEC PLUS

TRIATEC PLUS

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Hungary

| SANOFI-AVENTIS PRIVATE CO LTD |
| --- |
| H-1045 Budapest Tó u. 1.-5. |
| Hungary |

SANOFI-AVENTIS PRIVATE CO LTD

H-1045 Budapest Tó u. 1.-5.

Hungary

TRITACE HCT 2,5/12,5 Tabletta

TRITACE HCT 5/25 Tabletta

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Hungary

| Zentiva HU Kft |
| --- |
| Népfürdő u. 22 |
| 1138 Budapest |
| Hungary |

Zentiva HU Kft

Népfürdő u. 22

1138 Budapest

Hungary

RAMIPRIL HCT – ZENTIVA 2,5 mg/12,5 mg

RAMIPRIL HCT – ZENTIVA 5 mg/25 mg

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Iceland

—

Ireland

| sanofi-aventis Ireland Ltd. |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

sanofi-aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

Ireland

TRITAZIDE Tablets 2,5 mg/12.5 mg

2,5 mg/12,5 mg

Tablet

Oral

Italy

| SANOFI-AVENTIS SPA |
| --- |
| Viale Bodio, 37/b |
| 20158 Milano |
| Italy |

SANOFI-AVENTIS SPA

Viale Bodio, 37/b

20158 Milano

Italy

TRIATEC HCT 2,5

TRIATEC HCT 5

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Italy

| SANOFI-AVENTIS SPA |
| --- |
| Viale Bodio, 37/b |
| 20158 Milano |
| Italy |

SANOFI-AVENTIS SPA

Viale Bodio, 37/b

20158 Milano

Italy

RAMIPRIL E IDROCLORITIAZIDE SANOFI-AVENTIS 2,5 mg/12,5 mg

RAMIPRIL E IDROCLORITIAZIDE SANOFI-AVENTIS 5 mg/25 mg

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Italy

| AstraZeneca S.p.A |
| --- |
| Palazzo Volta Via Francesco Sforza |
| 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A

Palazzo Volta Via Francesco Sforza

20080 Basiglio (MI)

Italy

UNIPRIL DIUR

2,5 mg + 12,5 mg compresse

UNIPRILDIUR 5 mg + 25 mg compresse

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Italy

| POLIFARMA SPA |
| --- |
| Viale dell′Arte 69 |
| 00144 Roma |
| Italy |

POLIFARMA SPA

Viale dell′Arte 69

00144 Roma

Italy

IDROQUARK

IDROQUARK

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Latvia

—

Lithuania

—

Luxembourg

| Sanofi-aventis Belgium |
| --- |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

Sanofi-aventis Belgium

Culliganlaan 1C

1831 Diegem

Belgium

TRITAZIDE

5 mg/25 mg

Tablet

Oral

Malta

—

Netherlands

| SANOFI-AVENTIS NETHERLANDS B.V. |
| --- |
| Kampenringweg 45 D-E (toren D en E) |
| NL-2803 PE Gouda |
| The Netherlands |

SANOFI-AVENTIS NETHERLANDS B.V.

Kampenringweg 45 D-E (toren D en E)

NL-2803 PE Gouda

The Netherlands

| P.O. Box 2043 |
| --- |
| NL-2800 BD Gouda |
| The Netherlands |

P.O. Box 2043

NL-2800 BD Gouda

The Netherlands

TRITAZIDE Tabletten 5 mg/25 mg

5 mg/25 mg

Tablet

Oral

Norway

—

Poland

| SANOFI-AVENTIS DEUTSCHLAND GMBH |
| --- |
| D-65926 Frankfurt am Main |
| Germany |

SANOFI-AVENTIS DEUTSCHLAND GMBH

D-65926 Frankfurt am Main

Germany

TRITACE 2,5 COMB

TRITACE 5 COMB

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Portugal

| Sanofi-Aventis Produtos Farmacêuticos, s.a. |
| --- |
| Empreendimento Lagoas Park, |
| Edifício 7 - 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi-Aventis Produtos Farmacêuticos, s.a.

Empreendimento Lagoas Park,

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Portugal

RAMICOR D 2,5

RAMICOR D 5

2,5 mg/12.,5 mg

5 mg/25 mg

Tablet

Oral

Portugal

| Sanofi-Aventis Produtos Farmacêuticos, s.a. |
| --- |
| Empreendimento Lagoas Park, |
| Edifício 7 - 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi-Aventis Produtos Farmacêuticos, s.a.

Empreendimento Lagoas Park,

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Portugal

TRIATEC COMPOSTO

TRIATEC COMPOSTO FORTE

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Romania

| AVENTIS PHARMA DEUTSCHLAND GMBH |
| --- |
| Brüningstraße 50 |
| 65926 Frankfurt am Main |
| Germany |

AVENTIS PHARMA DEUTSCHLAND GMBH

Brüningstraße 50

65926 Frankfurt am Main

Germany

TRITACE 2,5 PLUS

TRITACE 5 PLUS

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Slovak Republic

| SANOFI-AVENTIS SLOVAKIA s.r.o., |
| --- |
| Žilinská 7-9 |
| 81105 Bratislava |
| Slovak Republic |

SANOFI-AVENTIS SLOVAKIA s.r.o.,

Žilinská 7-9

81105 Bratislava

Slovak Republic

TRITAZIDE

TRITAZIDE

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Slovenia

| SANOFI-AVENTIS D.O.O. |
| --- |
| Dunajska cesta 119 |
| 1000 Ljubljana |
| Slovenia |

SANOFI-AVENTIS D.O.O.

Dunajska cesta 119

1000 Ljubljana

Slovenia

TRITAZIDE 2,5 5 mg/12,5 mg tablete

TRITAZIDE 5 mg/25 mg tablete

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

Spain

—

Sweden

| sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

TRIATEC COMP MITE

TRIATEC COMP

2,5 mg/12,5 mg

5 mg/25 mg

Tablet

Oral

United Kingdom

—

---

ANNEX II

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

| Member State EU/EEA | Marketing Authorisation Holder | (Invented)
  name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | SANOFI-AVENTIS GMBH OSTERREICH |
| SATURN Tower |
| Leonard-Bernstein-Straße 10 |
| A-1220 Vienna |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

(Invented)

name

Strength

Pharmaceutical Form

Route of administration

Austria

SANOFI-AVENTIS GMBH OSTERREICH

SATURN Tower

Leonard-Bernstein-Straße 10

A-1220 Vienna

Austria

Tritace 1,25 mg — Tabletten

Tritace 2,5 mg — Tabletten

Tritace 5 mg — Tabletten

Tritace 10 mg — Tabletten

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Austria

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

HYPREN

1,25 mg

2,5 mg

5 mg

Capsule

Oral

Austria

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

HYPREN

10 mg

Tablet

Oral

Belgium

| SANOFI-AVENTIS BELGIUM |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM

Culliganlaan 1C

B-1831 Diegem

Belgium

Tritace 1,25 mg, comprimés

Tritace 2,5 mg, comprimés

Tritace 5 mg, comprimés

Tritace 10 mg, comprimés

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Belgium

| Aventis Pharma S.A. |
| --- |
| Boulevard de la Plaine, 9 |
| B-1050 Bruxelles |

Aventis Pharma S.A.

Boulevard de la Plaine, 9

B-1050 Bruxelles

Tazko 5 mg, comprimés à liberation prolongée

5 mg

Prolonged-release tablet

Oral

Belgium

| Aventis Pharma S.A. |
| --- |
| Boulevard de la Plaine, 9 |
| B-1050 Bruxelles |

Aventis Pharma S.A.

Boulevard de la Plaine, 9

B-1050 Bruxelles

Tazko 2,5 mg, comprimés à liberation prolongée

2,5 mg

Prolonged-release tablet

Oral

Belgium

| SANOFI-AVENTIS BELGIUM |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM

Culliganlaan 1C

B-1831 Diegem

Belgium

Tritace 10

10 mg

Capsule

Oral

Belgium

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Ramace 1,25 mg

Ramace 2,5 mg

Ramace 5 mg

1,25 mg

2,5 mg

5 mg

Tablet

Oral

Bulgaria

| SANOFI-AVENTIS BULGARIA EOOD |
| --- |
| Alexandar Stamboliyski blvd. 103 |
| office building Sofia Tower, fl. 8, Sofia 1303 |
| Bulgaria |

SANOFI-AVENTIS BULGARIA EOOD

Alexandar Stamboliyski blvd. 103

office building Sofia Tower, fl. 8, Sofia 1303

Bulgaria

Tritace 2,5

Tritace 5

Tritace 10

2,5 mg

5 mg

10 mg

Tablet

Oral

Cyprus

| SANOFI-AVENTIS CYPRUS LTD |
| --- |
| 14 Charalambou Mouskou street |
| 2015 – Nicosia |
| Cyprus |

SANOFI-AVENTIS CYPRUS LTD

14 Charalambou Mouskou street

2015 – Nicosia

Cyprus

Triatec

2,5 mg

5 mg

10 mg

Tablet

Oral

Czech Republic

| SANOFI-AVENTIS, S.R.O. |
| --- |
| Evropská 2590/33c |
| 16000 Praha 6 |
| Czech Republic |

SANOFI-AVENTIS, S.R.O.

Evropská 2590/33c

16000 Praha 6

Czech Republic

Tritace 1,25

Tritace 2,5

Tritace 5

Tritace 10

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Czech Republic

| AVENTIS PHARMA DEUTSCHLAND GMBH |
| --- |
| Industriepark Höchst |
| 65926 Frankfurt am Main |
| Germany |

AVENTIS PHARMA DEUTSCHLAND GMBH

Industriepark Höchst

65926 Frankfurt am Main

Germany

RAMIPRIL WINTHROP

1,25 mg

2,5 mg

5 mg

Capsule

Oral

Denmark

| SANOFI-AVENTIS DENMARK |
| --- |
| A/S Slotsmarken 13 |
| DK-2970 Hoersholm |
| Denmark |

SANOFI-AVENTIS DENMARK

A/S Slotsmarken 13

DK-2970 Hoersholm

Denmark

Triatec

1,25 mg

2,5 mg

5 mg

Tablet

Oral

Denmark

| SANOFI-AVENTIS DENMARK |
| --- |
| A/S Slotsmarken 13 |
| DK-2970 Hoersholm |
| Denmark |

SANOFI-AVENTIS DENMARK

A/S Slotsmarken 13

DK-2970 Hoersholm

Denmark

Triatec

10 mg

Capsule, hard

Oral

Estonia

| SANOFI-AVENTIS ESTONIA OÜ |
| --- |
| Pärnu mnt. 139 E/2 11317 Tallinn |
| Estonia |

SANOFI-AVENTIS ESTONIA OÜ

Pärnu mnt. 139 E/2 11317 Tallinn

Estonia

Cardace

5 mg

10 mg

Tablet

Oral

Estonia

| SANOFI-AVENTIS DEUTSCHLAND GMBH |
| --- |
| Industriepark Hoechst |
| D-65926 Frankfurt am Main |
| Germany |

SANOFI-AVENTIS DEUTSCHLAND GMBH

Industriepark Hoechst

D-65926 Frankfurt am Main

Germany

Cardace

2,5 mg

Tablet

Oral

Finland

| SANOFI-AVENTIS OY |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki |
| Finland |

SANOFI-AVENTIS OY

Huopalahdentie 24

00350 Helsinki

Finland

Cardace

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Finland

| SANOFI-AVENTIS OY |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki |
| Finland |

SANOFI-AVENTIS OY

Huopalahdentie 24

00350 Helsinki

Finland

Cardace

10 mg

Capsule

Oral

Finland

| SANOFI-AVENTIS OY |
| --- |
| Huopalahdentie 24 |
| 00350 Helsinki |
| Finland |

SANOFI-AVENTIS OY

Huopalahdentie 24

00350 Helsinki

Finland

Ramipril medgenerics 1,25 mg tabletti

Ramipril medgenerics 2,5 mg tabletti

Ramipril medgenerics 5 mg tabletti

Ramipril medgenerics 10 mg tabletti

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

France

| SANOFI- AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI- AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

Triatec 1,25 mg comprime

Triatec 2,5 mg comprime sécable

Triatec 5 mg comprime sécable

Triatec 10 mg comprime sécable

Triateckit, comprime sécable

Ramikit, comprime sécable

1,25 mg

2,5 mg

5 mg

10 mg

2,5 mg/5 mg/10 mg

2,5 mg/5 mg/10 mg

Tablet

Oral

France

| SANOFI- AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI- AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

France

Triatec faible 1,25 mg, gélule

Triatec 2,5 mg, gélule

Triatec 5 mg, gélule

1,25 mg

2,5 mg

5 mg

Capsule

Oral

France

| SANOFI- AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| F-75014 Paris |
| France |

SANOFI- AVENTIS FRANCE

1-13, boulevard Romain Rolland

F-75014 Paris

France

Ramipril winthrop 1,25 mg

Ramipril winthrop 2,5 mg, comprime secable

Ramipril winthrop 5 mg, comprime secable

Ramipril winthrop 10 mg, comprime secable

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Germany

| SANOFI-AVENTIS DEUTSCHLAND GMBH |
| --- |
| Industriepark Hoechst |
| D-65926 Frankfurt am Main |
| Germany |

SANOFI-AVENTIS DEUTSCHLAND GMBH

Industriepark Hoechst

D-65926 Frankfurt am Main

Germany

Delix 2,5 mg Tabletten

Delix 5 mg Tabletten

Delix protect 10 mg Tabletten

Delix HOPE 10 mg Tabletten

Delix HOPE startset

Delix protect startset

2,5 mg

5 mg

10 mg

10 mg

2,5 mg/5 mg/10 mg

2,5 mg/5 mg/10 mg

Tablet

Oral

Germany

| SANOFI-AVENTIS DEUTSCHLAND GMBH |
| --- |
| Industriepark Hoechst |
| D-65926 Frankfurt am Main |
| Germany |

SANOFI-AVENTIS DEUTSCHLAND GMBH

Industriepark Hoechst

D-65926 Frankfurt am Main

Germany

Ramipril protect 2,5 mg Tabletten

Ramipril protect 5 mg Tabletten

Ramipril protect 10 mg Tabletten

Ramipril protect startset

2,5 mg

5 mg

10 mg

2,5 mg/5 mg/10 mg

Tablet

Oral

Germany

| WINTHROP ARZNEIMITTEL GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

WINTHROP ARZNEIMITTEL GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

Ramilich 2,5 mg Tabletten

Ramilich 5 mg Tabletten

Ramilich 10 mg Tabletten

Ramilich startset

2,5 mg

5 mg

10 mg

2,5 mg/5 mg/10 mg

Tablet

Oral

Germany

| WINTHROP ARZNEIMITTEL GmbH |
| --- |
| Urmitzer Str. 5 |
| 56218 Mülheim-Kärlich |
| Germany |

WINTHROP ARZNEIMITTEL GmbH

Urmitzer Str. 5

56218 Mülheim-Kärlich

Germany

RamiWin 2,5 mg Tabletten

RamiWin 5 mg Tabletten

RamiWin 10 mg Tabletten

2,5 mg

5 mg

10 mg

Tablet

Oral

Germany

| AVENTIS PHARMA DEUTSCHLAND GmbH |
| --- |
| 65926 Frankfurt am Main |
| Germany |

AVENTIS PHARMA DEUTSCHLAND GmbH

65926 Frankfurt am Main

Germany

Delix 1,25 mg Tabletten

1,25 mg

Tablet

Oral

Germany

| AVENTIS PHARMA DEUTSCHLAND GmbH |
| --- |
| 65926 Frankfurt am Main |
| Germany |

AVENTIS PHARMA DEUTSCHLAND GmbH

65926 Frankfurt am Main

Germany

Delix 1,25 mg Kapseln

Delix P 2,5 mg Kapseln

Delix P 5 mg Kapseln

Delix P 10 mg Kapseln

1,25 mg

2,5 mg

5 mg

10 mg

Capsule, hard

Oral

Germany

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Germany |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

Vesdil 1,25 mg Kapseln

Vesdil 2,5 mg kapseln

Vesdil 5 mg Kapseln

1,25 mg

2,5 mg

5 mg

Capsule, hard

Oral

Germany

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Germany |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

Vesdil 1,25 mg Tabletten

Vesdil 2,5 mg Tabletten

Vesdil N 2,5 mg Tabletten

Vedil 5 mg Tabletten

Vesdil N 5 mg Tabletten

Vesdil protect 10 mg Tabletten

1,25 mg

2,5 mg

2,5 mg

5 mg

5 mg

10 mg

Tablets

Oral

Greece

| SANOFI-AVENTIS AEBE |
| --- |
| 348, Syngrou Av.-Building A |
| 176 74 Kallithea |
| Greece |

SANOFI-AVENTIS AEBE

348, Syngrou Av.-Building A

176 74 Kallithea

Greece

Triatec

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Hungary

| SANOFI-AVENTIS PRIVATE CO LTD |
| --- |
| H-1045 Budapest Tó u. 1.-5. |
| Hungary |

SANOFI-AVENTIS PRIVATE CO LTD

H-1045 Budapest Tó u. 1.-5.

Hungary

Tritace mite 1,25 mg tablet

Tritace 2,5 mg tablet

Tritace 5 mg tablet

Tritace 10 mg tablet

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Hungary

| SANOFI-AVENTIS PRIVATE CO LTD |
| --- |
| H-1045 Budapest Tó u. 1.-5. |
| Hungary |

SANOFI-AVENTIS PRIVATE CO LTD

H-1045 Budapest Tó u. 1.-5.

Hungary

Ramipril prevent 1,25 mg tablet

Ramipril prevent 2,5 mg tablet

Ramipril prevent 5 mg tablet

Ramipril prevent 10 mg tablet

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Hungary

| Zentiva HU Kft |
| --- |
| Népfürdo u.22 |
| 1138 Budapest |
| Hungary |

Zentiva HU Kft

Népfürdo u.22

1138 Budapest

Hungary

Ramipril — Zentiva 1,25 mg

Ramipril — Zentiva 2,5 mg

Ramipril — Zentiva 5 mg

Ramipril — Zentiva 10 mg

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Iceland

—

Ireland

| Sanofi-Aventis Ireland Ltd. |
| --- |
| Citywest Business Campus, |
| Dublin 24 |
| Ireland |

Sanofi-Aventis Ireland Ltd.

Citywest Business Campus,

Dublin 24

Ireland

Tritace 1,25 mg tablets

Tritace 2,5 mg tablets

Tritace 5 mg tablets

Tritace 10 mg tablets

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Ireland

| Sanofi-Aventis Ireland Ltd. |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-Aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

Ireland

Tritace 1,25 mg capsules

Tritace 2,5 mg capsules

Tritace 5 mg capsules

Tritace 10 mg capsules

1,25 mg

2,5 mg

5 mg

10 mg

Capsule

Oral

Ireland

| Sanofi-Aventis Ireland Ltd. |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-Aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

Ireland

Loavel 1,25 mg

Loavel 2,5 mg

Loavel 5 mg

Loavel 10 mg

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Ireland

| Sanofi-Aventis Ireland Ltd. |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-Aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

Ireland

Loavel 1,25 mg capsules

Loavel 2,5 mg capsules

Loavel 5 mg capsules

Loavel 10 mg capsules

1,25 mg

2,5 mg

5 mg

10 mg

Capsule

Oral

Ireland

| Sanofi-Aventis Ireland Ltd. |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-Aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

Ireland

Ramipril 1,25 mg tablets

Ramipril 2,5 mg tablets

Ramipril 5 mg tablets

Ramipril 10 mg tablets

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Ireland

| Sanofi-Aventis Ireland Ltd. |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Sanofi-Aventis Ireland Ltd.

Citywest Business Campus

Dublin 24

Ireland

Ramipril 1,25 mg capsules

Ramipril 2,5 mg capsules

Ramipril 5 mg capsules

Ramipril 10 mg capsules

1,25 mg

2,5 mg

5 mg

10 mg

Capsule

Oral

Italy

| SANOFI-AVENTIS SPA |
| --- |
| Viale Bodio, 37/b |
| 20158 Milano |
| Italy |

SANOFI-AVENTIS SPA

Viale Bodio, 37/b

20158 Milano

Italy

Triatec 1,25

Triatec

Triatec 5

Triatec

Ramipril sanofi-aventis

1,25 mg

2,5 mg

5 mg

10 mg

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Italy

| AstraZeneca S.p.A |
| --- |
| Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A

Palazzo Volta Via Francesco Sforza 20080 Basiglio (MI)

Italy

Unipril 1,25 mg compresse

Unipril 2,5 mg compresse

Unipril 5 mg compresse

Unipril 10 mg compresse

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Italy

| Polifarma S.p.A. |
| --- |
| Viale Dell’ Arte, 69 |
| I – 00144 Roma |
| Italy |

Polifarma S.p.A.

Viale Dell’ Arte, 69

I – 00144 Roma

Italy

Quark

Quark

Quark

Quark

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Latvia

| Sanofi-Aventis Latvia SIA |
| --- |
| Kr.Valdemara 33-8 |
| LV1010 - Riga |
| Latvia |

Sanofi-Aventis Latvia SIA

Kr.Valdemara 33-8

LV1010 - Riga

Latvia

Cardace

2,5 mg

5 mg

10 mg

Tablet

Oral

Lithuania

| UAB SANOFI-AVENTIS LIETUVA |
| --- |
| A. Juozapavičiaus g. 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB SANOFI-AVENTIS LIETUVA

A. Juozapavičiaus g. 6/2

LT-09310 Vilnius

Lithuania

Cardace

2,5 mg

5 mg

10 mg

Tablet

Oral

Luxembourg

| SANOFI-AVENTIS BELGIUM |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM

Culliganlaan 1C

B-1831 Diegem

Belgium

Tritace 1,25 mg, comprimés

Tritace 2,5 mg, comprimés

Tritace 5 mg, comprimés

Tritace 10 mg, comprimés

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Luxembourg

| SANOFI-AVENTIS BELGIUM |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM

Culliganlaan 1C

B-1831 Diegem

Belgium

Tritace

10 mg

Capsule

Oral

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Ramace 1,25 mg

Ramace 2,5 mg

Ramace 5 mg

1,25 mg

2,5 mg

5 mg

Tablet

Oral

Malta

—

Netherlands

| SANOFI-AVENTIS NETHERLANDS B.V. |
| --- |
| Kampenringweg 45 D-E (toren D en E) |
| NL-2803 PE Gouda |
| The Netherlands |
| P.O. Box 2043 |
| NL-2800 BD Gouda |
| The Netherlands |

SANOFI-AVENTIS NETHERLANDS B.V.

Kampenringweg 45 D-E (toren D en E)

NL-2803 PE Gouda

The Netherlands

P.O. Box 2043

NL-2800 BD Gouda

The Netherlands

Tritace 1,25

Tritace 2,5

Tritace 5

Tritace 10

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Netherlands

| SANOFI-AVENTIS NETHERLANDS B.V. |
| --- |
| Kampenringweg |
| 45 D-E (toren D en E) |
| NL-2803 PE Gouda |
| The Netherlands |

SANOFI-AVENTIS NETHERLANDS B.V.

Kampenringweg

45 D-E (toren D en E)

NL-2803 PE Gouda

The Netherlands

Tritace 1,25

Tritace 2,5

Tritace 5

Tritace 10

1,25 mg

2,5 mg

5 mg

10 mg

Capsule

Oral

Norway

| SANOFI-AVENTIS NORGE AS |
| --- |
| Strandveien 15 |
| P.O.Box 133 |
| NO-1325 Lysaker |
| Norway |

SANOFI-AVENTIS NORGE AS

Strandveien 15

P.O.Box 133

NO-1325 Lysaker

Norway

Triatec

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Norway

| SANOFI-AVENTIS NORGE AS |
| --- |
| Strandveien 15 |
| P.O.Box 133 |
| NO-1325 Lysaker |
| Norway |

SANOFI-AVENTIS NORGE AS

Strandveien 15

P.O.Box 133

NO-1325 Lysaker

Norway

Triatec

10 mg

Capsule

Oral

Norway

| WINTHROP MEDICAMENTS |
| --- |
| 1-13 Boulevard Romain Rolland |
| F-75159 Paris, Cedex 14 |
| France |

WINTHROP MEDICAMENTS

1-13 Boulevard Romain Rolland

F-75159 Paris, Cedex 14

France

Ramipril winthrop

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Poland

| SANOFI-AVENTIS DEUTSCHLAND GMBH |
| --- |
| D-65926 Frankfurt am Main |
| Germany |

SANOFI-AVENTIS DEUTSCHLAND GMBH

D-65926 Frankfurt am Main

Germany

Tritace 2,5

Tritace 5

Tritace 10

2,5 mg

5 mg

10 mg

Tablet

Oral

Portugal

| Sanofi-Aventis Produtos Farmacêuticos, s.a. |
| --- |
| Empreendimento Lagoas Park, |
| Edifício 7 - 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi-Aventis Produtos Farmacêuticos, s.a.

Empreendimento Lagoas Park,

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Portugal

Triatec

2,5 mg

5 mg

10 mg

Tablet

Oral

Portugal

| Sanofi-Aventis Produtos Farmacêuticos, s.a. |
| --- |
| Empreendimento Lagoas Park, |
| Edifício 7 - 3o Piso |
| 2740-244 Porto Salvo |
| Portugal |

Sanofi-Aventis Produtos Farmacêuticos, s.a.

Empreendimento Lagoas Park,

Edifício 7 - 3o Piso

2740-244 Porto Salvo

Portugal

Triatec

1,25 mg

2,5 mg

5 mg

10 mg

Capsule

Oral

Romania

| AVENTIS PHARMA DEUTSCHLAND GMBH |
| --- |
| Brüningstraße 50 |
| 65926 Frankfurt am Main |
| Germany |

AVENTIS PHARMA DEUTSCHLAND GMBH

Brüningstraße 50

65926 Frankfurt am Main

Germany

Tritace

2,5 mg

5 mg

10 mg

Tablet

Oral

Romania

| SC ZENTIVA S.A. |
| --- |
| Bulevardul Theodor Pallady, nr. 50, sector 3 |
| Bucuresti |
| ROMANIA |

SC ZENTIVA S.A.

Bulevardul Theodor Pallady, nr. 50, sector 3

Bucuresti

ROMANIA

Zenra 2,5

Zenra 5

Zenra 10

2,5 mg

5 mg

10 mg

Tablet

Oral

Slovak Republic

| SANOFI-AVENTIS SLOVAKIA s.r.o. |
| --- |
| Žilinská 7-9 |
| 81105 Bratislava |
| Slovak Republic |

SANOFI-AVENTIS SLOVAKIA s.r.o.

Žilinská 7-9

81105 Bratislava

Slovak Republic

Tritace

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Slovenia

| SANOFI-AVENTIS D.O.O. |
| --- |
| Dunajska cesta 119 |
| 1000 Ljubljana |
| Slovenia |

SANOFI-AVENTIS D.O.O.

Dunajska cesta 119

1000 Ljubljana

Slovenia

Tritace 1,25 mg teblete

Tritace 2,5 mg tablete

Tritace 5 mg tablete

Tritace 10 mg tablete

Tritace Startset

1,25 mg

2,5 mg

5 mg

10 mg

2,5 mg/5 mg/10 mg

Tablet

Oral

Spain

| SANOFI-AVENTIS S.A. |
| --- |
| Josep Pla 2 |
| 08019 Barcelona |
| Spain |

SANOFI-AVENTIS S.A.

Josep Pla 2

08019 Barcelona

Spain

Acovil

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Sweden

| Sanofi-Aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sweden |

Sanofi-Aventis AB

Box 14142

167 14 Bromma

Sweden

Triatec

Triatec H.O.P

Triatec Start

1,25 mg

2,5 mg

5 mg

10 mg

2,5 mg/5 mg/10 mg

2,5 mg/5 mg/10 mg

Tablet

Oral

Sweden

| WINTHROP MEDICAMENTS |
| --- |
| 1-13, Boulevard Romain Roland |
| F-75014 Paris |
| France |

WINTHROP MEDICAMENTS

1-13, Boulevard Romain Roland

F-75014 Paris

France

Ramipril winthrop

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

Sweden

| AstraZeneca Sverige |
| --- |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Pramace

1,25 mg

2,5 mg

5 mg

10 mg

Start pack (1,25 + 2,5 + 5 mg)

Tablet

Oral

Sweden

| AstraZeneca Sverige |
| --- |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Pramace

10 mg

Capsule

Oral

United Kingdom

| AVENTIS PHARMA LTD |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent ME19 4AH |
| Trading as: Sanofi-aventis |
| One Onslow Street |
| Guildford |
| Surrey GU1 4YS |
| UK |

AVENTIS PHARMA LTD

50 Kings Hill Avenue

Kings Hill

West Malling

Kent ME19 4AH

Trading as: Sanofi-aventis

One Onslow Street

Guildford

Surrey GU1 4YS

UK

Tritace 1,25 mg tablets

Tritace 2,5 mg tablets

Tritace 5 mg Tablets

Tritace 10 mg tablets

1,25 mg

2,5 mg

5 mg

10 mg

Tablet

Oral

United Kingdom

| HOECHST MARION ROUSSEL LTD. |
| --- |
| Denham |
| Uxbridge UB9 5HP |
| Trading as: Aventis Pharma |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent ME19 4AH |

HOECHST MARION ROUSSEL LTD.

Denham

Uxbridge UB9 5HP

Trading as: Aventis Pharma

50 Kings Hill Avenue

Kings Hill

West Malling

Kent ME19 4AH

Or

| Sanofi-aventis |
| --- |
| One Onslow Street |
| Guildford |
| Surrey GU1 4YS |
| UK |

Sanofi-aventis

One Onslow Street

Guildford

Surrey GU1 4YS

UK

Tritace 1,25 mg

Tritace 2,5 mg

Tritace 5 mg

Tritace 10 mg

1,25 mg

2,5 mg

5 mg

10 mg

Capsule

Oral

United Kingdom

| AVENTIS PHARMA LTD |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent ME19 4AH |
| Trading as: Sanofi-aventis |
| One Onslow Street |
| Guildford |
| Surrey GU1 4YS |
| UK |

AVENTIS PHARMA LTD

50 Kings Hill Avenue

Kings Hill

West Malling

Kent ME19 4AH

Trading as: Sanofi-aventis

One Onslow Street

Guildford

Surrey GU1 4YS

UK

Tritace Titration Pack

2,5 mg/5 mg/10 mg

Tablet

Oral

United Kingdom

| AVENTIS PHARMA LTD |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent ME19 4AH |
| Trading as: Sanofi-aventis |
| One Onslow Street |
| Guildford |
| Surrey GU1 4YS |
| UK |

AVENTIS PHARMA LTD

50 Kings Hill Avenue

Kings Hill

West Malling

Kent ME19 4AH

Trading as: Sanofi-aventis

One Onslow Street

Guildford

Surrey GU1 4YS

UK

Tritace titration pack

2,5 mg

5,0 mg

10 mg

Capsule

Oral

United Kingdom

| AVENTIS PHARMA LTD |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling |
| Kent ME19 4AH |
| Trading as: Sanofi-aventis |
| One Onslow Street |
| Guildford |
| Surrey GU1 4YS |
| UK |

AVENTIS PHARMA LTD

50 Kings Hill Avenue

Kings Hill

West Malling

Kent ME19 4AH

Trading as: Sanofi-aventis

One Onslow Street

Guildford

Surrey GU1 4YS

UK

Tritace Tablet Titration Pack

2,5 mg

5,0 mg

10 mg

Tablet

Oral

---

ANNEX III

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

| Member State EU/EEA | Marketing authorisation holder | Applicant | (Invented)
  Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | | Kedrion S.p.A. |
| Loc Ai Conti 55051 |
| Castelvecchio Pascoli, |
| Barga (Lucca) — ITALY |

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented)

Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Kedrion S.p.A.

Loc Ai Conti 55051

Castelvecchio Pascoli,

Barga (Lucca) — ITALY

UMAN BIG 180 I.E./ml

Injektionslösung

180 IU/ml

Solution for injection

Intramuscular use

180 IU/ml

540 IU/3 ml

Denmark

| Kedrion S.p.A. |
| --- |
| Loc Ai Conti 55051 |
| Castelvecchio Pascoli, |
| Barga (Lucca) — ITALY |

Kedrion S.p.A.

Loc Ai Conti 55051

Castelvecchio Pascoli,

Barga (Lucca) — ITALY

UMAN BIG

180 IU/ml

Solution for injection

Intramuscular use

180 IU/ml

540 IU/3 ml

Germany

| Kedrion S.p.A. |
| --- |
| Loc Ai Conti 55051 |
| Castelvecchio Pascoli, |
| Barga (Lucca) — ITALY |

Kedrion S.p.A.

Loc Ai Conti 55051

Castelvecchio Pascoli,

Barga (Lucca) — ITALY

UMAN BIG

180 IU/ml

Solution for injection

Intramuscular use

180 IU/ml

540 IU/3 ml

Hungary

| Kedrion S.p.A. |
| --- |
| Loc Ai Conti 55051 |
| Castelvecchio Pascoli, |
| Barga (Lucca) — ITALY |

Kedrion S.p.A.

Loc Ai Conti 55051

Castelvecchio Pascoli,

Barga (Lucca) — ITALY

Umanbig 180 NE/ml

180 IU/ml

Solution for injection

Intramuscular use

180 IU/ml

540 IU/3 ml

Italy

| Kedrion S.p.A. |
| --- |
| Loc Ai Conti 55051 |
| Castelvecchio Pascoli, |
| Barga (Lucca) — ITALY |

Kedrion S.p.A.

Loc Ai Conti 55051

Castelvecchio Pascoli,

Barga (Lucca) — ITALY

UMAN BIG

180 IU/ml

Solution for injection

Intramuscular use

180 IU/ml

540 IU/3 ml

Poland

| Kedrion S.p.A. |
| --- |
| Loc Ai Conti 55051 |
| Castelvecchio Pascoli, |
| Barga (Lucca) — ITALY |

Kedrion S.p.A.

Loc Ai Conti 55051

Castelvecchio Pascoli,

Barga (Lucca) — ITALY

UMAN BIG

180 IU/ml

Solution for injection

Intramuscular use

180 IU/ml

540 IU/3 ml

Portugal

| Kedrion S.p.A. |
| --- |
| Loc Ai Conti 55051 |
| Castelvecchio Pascoli, |
| Barga (Lucca) — ITALY |

Kedrion S.p.A.

Loc Ai Conti 55051

Castelvecchio Pascoli,

Barga (Lucca) — ITALY

UMAN BIG

180 IU/ml

Solution for injection

Intramuscular use

180 IU/ml

540 IU/3 ml

Sweden

| Kedrion S.p.A. |
| --- |
| Loc Ai Conti 55051 |
| Castelvecchio Pascoli, |
| Barga (Lucca) — ITALY |

Kedrion S.p.A.

Loc Ai Conti 55051

Castelvecchio Pascoli,

Barga (Lucca) — ITALY

Umanbig 180 IU/ml solution for injection

180 IU/ml

Solution for injection

Intramuscular use

180 IU/ml

540 IU/3 ml

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | Applicant | (Invented)
  Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | | Pharmachemie B.V. |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented)

Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycin ‘Pharmachemie’15 000 I.E. - Pulver zur Herstellung einer Injektionslösung

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Local injection

15 U (USP)/vial

Belgium

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

BLEOMYCINE TEVA 15U poeder voor oplossing voor injectie

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Bulgaria

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycine Teva 15U, прах за инжекционен разтвор

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Czech Republic

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycin-Teva 15U, prášek pro přípravu injekčního roztoku

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Denmark

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycin ‘Teva’

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Estonia

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycin Teva

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

France

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycine TEVA 15 000 UI, poudre pour solution injectable

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Germany

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleo-TEVA 15 mg Pulver zur Herstellung einer Injektionslösung

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Intravenous administration

Intra-pleural injection

15 U (USP)/vial

Italy

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomicina TEVA, 15 U polvere per soluzione iniettabile

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Latvia

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycin Teva

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Lithuania

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycin Teva

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Luxembourg

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

BLEOMYCINE TEVA 15U poudre pour solution injectable

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Local/Intratumoral injections

15 U (USP)/vial

Netherlands

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycine 15 U (USP), poeder voor oplossing voor injectie

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Norway

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycin Teva, Pulver og væske til injeksjonsvæske, oppløsning

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Poland

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycin Teva

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Portugal

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomicina Teva

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Slovak Republic

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomycin-Teva prášok na injekčný roztok

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Slovenia

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomicin Teva 15 U (USP), prašek za raztopino za injiciranje

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

Spain

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| P.O. Box 552 |
| 2003 RN Haarlem, The Netherlands |

Pharmachemie B.V.

Swensweg 5

P.O. Box 552

2003 RN Haarlem, The Netherlands

Bleomicina Teva 15 UI polvo para solución inyectable EFG

15 U (USP)/vial

powder for solution for injection

Intramuscular injection

Subcutaneous injection

Intravenous administration

Intra-arterial administration

Intra-pleural injection

Intraperitoneal administration

Local/Intratumoral injections

15 U (USP)/vial

---

ANNEX V

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

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented)
  Name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | | Hexal AG |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented)

Name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol ‘Hexal’ 100 μg/Dosis — Dosieraerosol

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Germany

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

SalbuHEXAL N Dosieraerosol

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Ireland

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbul 100 micrograms Pressurised Inhalation Suspension

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Spain

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Hexal 100 mcg/dosis suspensión para inhalación en envase a presión EFG

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Sweden

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Sanohex

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

---

ANNEX VI

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

| Member State EU/EEA | Marketing authorisation holder | Applicant | (Invented)
  Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Belgium | | Hexal AG |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Member State EU/EEA

Marketing authorisation holder

Applicant

(Invented)

Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Belgium

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz 100 μg Aërosol, suspensie

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Denmark

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Estonia

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz 100 mikrogrammi/annuses

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Finland

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Germany

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz 100 mikrogramm Dosieraerosol Druckgas-inhalation, Suspension

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Greece

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol/Sandoz

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Hungary

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz 100 μg túlnyomásos inhalációs szuszpenzió

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Italy

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamolo Sandoz

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Latvia

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Lithuania

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Netherlands

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz aërosol 100 μg/dosis, aërosol, suspensie 100 microgram per dosis

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Norway

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Poland

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

SalbuLEK

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura - Edifício 1, Piso 2 - Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura - Edifício 1, Piso 2 - Escritório 15

2710-693 Sintra

Portugal

Salbutamol Sandoz

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Slovenia

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Lek 100 mikrogramov inhalacijska suspenzija pod tlakom

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Spain

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol Sandoz 100 mcg/dosis suspensión para inhalación en envase a presción EFG

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

Sweden

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Sabumalin

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

United Kingdom

| Hexal AG |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestr. 25

83607 Holzkirchen

Germany

Salbutamol 100 microgram per actuation pressurised inhalation, suspension

100 μg/dose

Pressurised inhalation, suspension

Inhalation use

---

ANNEX VII

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

| Member State EU/EEA | Marketing Authorisation Holder | (Invented) Name | Strength | Pharmaceutical Form | Route of administration | Content
  (Concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria GmbH |
| Floridsdorfer Hauptstr 1, |
| 1210 Wien |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Content

(Concentration)

Austria

Pfizer Corporation Austria GmbH

Floridsdorfer Hauptstr 1,

1210 Wien

Tresleen 50 mg - Filmtabletten

50 mg

Film-coated tablets

Oral use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Serlain

50 mg

100 mg

Film-coated tablets

Oral use

Belgium

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Serlain

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Bulgaria

| PFIZER EUROPE MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |

PFIZER EUROPE MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

Zoloft

50 mg

Film-coated tablets

Oral use

50 mg

Cyprus

| Pfizer Hellas A.E., |
| --- |
| 243 Messoghion Ave., |
| 154 51 Ν. Psychiko, Athens |
| Greece |

Pfizer Hellas A.E.,

243 Messoghion Ave.,

154 51 Ν. Psychiko, Athens

Greece

Zoloft

50 mg

100 mg

Film-coated tablet

Oral use

Czech Republic

| Pfizer s.r.o., |
| --- |
| Stroupežnického 17 |
| 150 00 Praha 5 |
| Czech Republic |

Pfizer s.r.o.,

Stroupežnického 17

150 00 Praha 5

Czech Republic

Zoloft 50 mg

Zoloft 100 mg

50 mg

100 mg

Film-coated tablets

Oral use

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Zoloft

25 mg

50 mg

100 mg

Film-coated tablets

Oral use

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Zoloft

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Estonia

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Zoloft

50 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |

Pfizer Oy

Tietokuja 4

00330 Helsinki

Zoloft

50 mg

100 mg

Film-coated tablet

Oral use

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |

Pfizer Oy

Tietokuja 4

00330 Helsinki

Zoloft

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

France

| Pfizer Holding France |
| --- |
| 23-25 avenue du Dr Lannelongue |
| 75014 Paris |

Pfizer Holding France

23-25 avenue du Dr Lannelongue

75014 Paris

Zoloft

25 mg

50 mg

100 mg

Capsules, hard

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25 avenue du Dr Lannelongue |
| 75014 Paris |

Pfizer Holding France

23-25 avenue du Dr Lannelongue

75014 Paris

Zoloft

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

France

| Pfizer Holding France |
| --- |
| 23-25 avenue du Dr Lannelongue |
| 75014 Paris |

Pfizer Holding France

23-25 avenue du Dr Lannelongue

75014 Paris

Sertraline Pfizer

25 mg

50 mg

Capsules, hard

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25 avenue du Dr Lannelongue |
| 75014 Paris |

Pfizer Holding France

23-25 avenue du Dr Lannelongue

75014 Paris

Sertraline Beral

100 mg

Capsules, hard

Oral use

France

| Pfizer Holding France |
| --- |
| 23-25 avenue du Dr Lannelongue |
| 75014 Paris |

Pfizer Holding France

23-25 avenue du Dr Lannelongue

75014 Paris

Sertraline Beral

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Germany

| Pfizer Pharma GmbH |
| --- |
| Linkstr. 10 |
| 10785 Berlin |

Pfizer Pharma GmbH

Linkstr. 10

10785 Berlin

Zoloft 50 mg

Zoloft 100 mg

50 mg

100 mg

Film-coated tablet

Oral use

Germany

| Pfizer Pharma GmbH |
| --- |
| Linkstr. 10 |
| 10785 Berlin |

Pfizer Pharma GmbH

Linkstr. 10

10785 Berlin

Zoloft Lösungskonzentrat

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Greece

| Pfizer Hellas A.E., |
| --- |
| 243 Messoghion Ave., |
| 154 51 Ν. Psychiko Athens |
| Greece |

Pfizer Hellas A.E.,

243 Messoghion Ave.,

154 51 Ν. Psychiko Athens

Greece

Zoloft

50 mg

100 mg

Film-coated tablets

Oral use

Hungary

| Pfizer Kft. |
| --- |
| 1123 Budapest |
| Alkotás u. 53. |
| MOM Park F Épület |

Pfizer Kft.

1123 Budapest

Alkotás u. 53.

MOM Park F Épület

Zoloft 50 mg film tabletta

50 mg

Film-coated tablets

Oral use

Hungary

| Pfizer Kft. |
| --- |
| 1123 Budapest |
| Alkotás u. 53. |
| MOM Park F Épület |

Pfizer Kft.

1123 Budapest

Alkotás u. 53.

MOM Park F Épület

Zoloft 20 mg/ml oldat

20 mg/ml

Concentrate for oral Solution

Oral use

20 mg/ml

Iceland

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Zoloft

25 mg

50 mg

100 mg

Film-coated tablets

Oral use

Iceland

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |

Pfizer ApS

Lautrupvang 8

DK-2750 Ballerup

Zoloft

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Ireland

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

Lustral

50 mg

100 mg

Film-coated tablet

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156, Km 50 |
| 04010 Borgo San Michele (LT) |

Pfizer Italia S.r.l.

S.S. 156, Km 50

04010 Borgo San Michele (LT)

Zoloft

25 mg

50 mg

100 mg

Film-coated tablets

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156, Km 50 |
| 04010 Borgo San Michele (LT) |

Pfizer Italia S.r.l.

S.S. 156, Km 50

04010 Borgo San Michele (LT)

Zoloft

50 mg

Capsules, hard

Oral use

Italy

| Pfizer Italia S.r.l. |
| --- |
| S.S. 156, Km 50 |
| 04010 Borgo San Michele (LT) |

Pfizer Italia S.r.l.

S.S. 156, Km 50

04010 Borgo San Michele (LT)

Zoloft

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Italy

| Bioindustria Farmaceutici S.r.l. |
| --- |
| S.S. 156, Km 50 |
| 04010 Borgo San Michele (LT) |

Bioindustria Farmaceutici S.r.l.

S.S. 156, Km 50

04010 Borgo San Michele (LT)

Tatig

50 mg

100 mg

Film-coated tablets

Oral use

Italy

| Bioindustria Farmaceutici S.r.l. |
| --- |
| S.S. 156, Km 50 |
| 04010 Borgo San Michele (LT) |

Bioindustria Farmaceutici S.r.l.

S.S. 156, Km 50

04010 Borgo San Michele (LT)

Tatig

50 mg

Capsules, hard

Oral use

Italy

| Bioindustria Farmaceutici S.r.l. |
| --- |
| S.S. 156, Km 50 |
| 04010 Borgo San Michele (LT) |

Bioindustria Farmaceutici S.r.l.

S.S. 156, Km 50

04010 Borgo San Michele (LT)

Tatig

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Latvia

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Zoloft

50 mg

Film-coated tablets

Oral use

Lithuania

| Pfizer Limited, UK, |
| --- |
| Ramsgate Road, |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited, UK,

Ramsgate Road,

Sandwich

Kent CT13 9NJ

United Kingdom

Zoloft

50 mg

Film-coated tablets

Oral use

Luxembourg

| PFIZER S.A |
| --- |
| Boulevard de la Plaine, 17 1050 Brussels |

PFIZER S.A

Boulevard de la Plaine, 17 1050 Brussels

Serlain

50 mg

100 mg

Film-coated tablets

Oral use

Luxembourg

| PFIZER S.A. |
| --- |
| Boulevard de la Plaine, 17 |
| 1050 Brussels |

PFIZER S.A.

Boulevard de la Plaine, 17

1050 Brussels

Serlain

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Malta

| Pfizer Hellas A.E., |
| --- |
| 243 Messoghion Ave., |
| 154 51 Ν. Psychiko |
| Athens |
| Greece |

Pfizer Hellas A.E.,

243 Messoghion Ave.,

154 51 Ν. Psychiko

Athens

Greece

Lustral

50 mg

100 mg

Film-coated tablets

Oral use

Netherlands

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

Zoloft 50

50 mg

Film-coated tablet

Oral use

Netherlands

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

Zoloft 20 mg/ml

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Norway

| Pfizer AS |
| --- |
| POBox 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

POBox 3

1324 Lysaker

Norway

Zoloft

25 mg

50 mg

100 mg

Film-coated tablets

Oral use

Norway

| Pfizer AS |
| --- |
| POBox 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

POBox 3

1324 Lysaker

Norway

Zoloft

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Poland

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Zoloft

50 mg

100 mg

Film-coated tablets

Oral use

Poland

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9 NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9 NJ

United Kingdom

Zoloft

20 mg/ml

Concentrate for Oral solution

Oral use

20 mg/ml

Portugal

| Laboratórios Pfizer Lda. |
| --- |
| Lagoas Park |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer Lda.

Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Zoloft

50 mg

100 mg

Film-coated tablet

Oral use

Portugal

| Laboratórios Pfizer Lda. |
| --- |
| Lagoas Park |
| Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer Lda.

Lagoas Park

Edifício 10

2740-271 Porto Salvo

Portugal

Zoloft

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Romania

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9 NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9 NJ

United Kingdom

Zoloft 50 mg

Zoloft 100 mg

50 mg

100 mg

Film-coated tablets

Oral use

Romania

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9 NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9 NJ

United Kingdom

Zoloft

20 mg/ml

Concentrate for Oral solution

Oral use

20 mg/ml

Slovak Republic

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Zoloft

50 mg

100 mg

Film-coated tablets

Oral use

Slovak Republic

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Zoloft OC

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| Rond-Point du Kirchberg 51 |
| Avenue J.F. Kennedy |
| L-1855 Luxembourg |

Pfizer Luxembourg SARL

Rond-Point du Kirchberg 51

Avenue J.F. Kennedy

L-1855 Luxembourg

Zoloft

50 mg

100 mg

Film-coated tablets

Oral use

Slovenia

| Pfizer Luxembourg SARL |
| --- |
| Rond-Point du Kirchberg 51 |
| Avenue J.F. Kennedy |
| L-1855 Luxembourg |

Pfizer Luxembourg SARL

Rond-Point du Kirchberg 51

Avenue J.F. Kennedy

L-1855 Luxembourg

Zoloft

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Spain

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

Pfizer S.A.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid) Spain

Besitran

50 mg

100 mg

Film-coated tablet

Oral use

Spain

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

Pfizer S.A.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid) Spain

Besitran

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

Spain

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

Pfizer S.A.

Avda. de Europa, 20 B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid) Spain

Sertralina Pfizer

50 mg

100 mg

Film-coated tablet

Oral use

Sweden

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

Zoloft

25 mg

50 mg

100 mg

25 + 50 mg (initiation pack)

Film-coated tablets

Oral use

Sweden

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna

Sweden

Zoloft

20 mg/ml

Concentrate for oral solution

Oral use

20 mg/ml

United Kingdom

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

Lustral

50 mg

100 mg

Film-coated tablets

Oral use

---

| 1.5.2009 | EN | Official Journal of the European Union | C 101/43 |
| --- | --- | --- | --- |

1.5.2009

EN

Official Journal of the European Union

C 101/43

---

Opinion of the Advisory Committee on mergers given at its meeting of 16 November 2007 regarding a draft decision relating to Case COMP/M.4647 — AEE/Lentjes

Rapporteur: Latvia

2009/C 101/05

| 1. | The members of the Advisory Committee agree with the Commission that the notified operation constitutes a concentration within the meaning of the Merger Regulation (EEC) No 1394/2004. |
| --- | --- |

1.

The members of the Advisory Committee agree with the Commission that the notified operation constitutes a concentration within the meaning of the Merger Regulation (EEC) No 1394/2004.

| 2. | The members of the Advisory Committee agree with the Commission that although the notified operation The members of the not have a community dimension within the meaning of article 1 of the Merger Regulation, it is capable of being reviewed under the national competition law in Austria, Germany, Ireland and the United Kingdom. Therefore, it can be examined by the Commission pursuant to Article 4 (5) of the Merger Regulation. |
| --- | --- |

2.

The members of the Advisory Committee agree with the Commission that although the notified operation The members of the not have a community dimension within the meaning of article 1 of the Merger Regulation, it is capable of being reviewed under the national competition law in Austria, Germany, Ireland and the United Kingdom. Therefore, it can be examined by the Commission pursuant to Article 4 (5) of the Merger Regulation.

| 3. | The members of the Advisory Committee agree with the Commission's definition of the relevant product markets of:






  (a) | the market for the supply of municipal waste incineration plants based on grate firing with a capacity of more than 4,5 t/h. |
| --- | --- | --- |

3.

The members of the Advisory Committee agree with the Commission's definition of the relevant product markets of:

(a)

the market for the supply of municipal waste incineration plants based on grate firing with a capacity of more than 4,5 t/h.

| (b) | the market for the manufacture of boiler pressure components. |
| --- | --- |

(b)

the market for the manufacture of boiler pressure components.

| (c) | the market for the supply of thermal treatment plants based on fluidized bed technology with a capacity of less than 200 MWel, whereby a further sub-segmentation can be left open in the present case. |
| --- | --- |

(c)

the market for the supply of thermal treatment plants based on fluidized bed technology with a capacity of less than 200 MWel, whereby a further sub-segmentation can be left open in the present case.

| (d) | the market for flue gas desulphurisation systems, whereby a further sub-segmentation can be left open in the present case. |
| --- | --- |

(d)

the market for flue gas desulphurisation systems, whereby a further sub-segmentation can be left open in the present case.

| 4. | The members of the Advisory Committee agree with the Commission that all the above mentioned relevant product markets are EEA-wide in scope. |
| --- | --- |

4.

The members of the Advisory Committee agree with the Commission that all the above mentioned relevant product markets are EEA-wide in scope.

| 5. | The members of the Advisory Committee agree with the Commission that the proposed concentration The members of the not lead to horizontal competition concerns in the market for the supply of municipal waste incineration plants based on grate firing with a capacity of more than 4,5 t/h, as a result of which effective competition would be significantly impeded in the Common Market or in a substantial part of it. |
| --- | --- |

5.

The members of the Advisory Committee agree with the Commission that the proposed concentration The members of the not lead to horizontal competition concerns in the market for the supply of municipal waste incineration plants based on grate firing with a capacity of more than 4,5 t/h, as a result of which effective competition would be significantly impeded in the Common Market or in a substantial part of it.

| 6. | The members of the Advisory Committee agree with the Commission that the proposed concentration The members of the not lead to horizontal competition concerns in the market for the supply of thermal treatment plants based on fluidized bed technology with a capacity of less than 200 MWel, as a result of which effective competition would be significantly impeded in the Common Market or in a substantial part of it. |
| --- | --- |

6.

The members of the Advisory Committee agree with the Commission that the proposed concentration The members of the not lead to horizontal competition concerns in the market for the supply of thermal treatment plants based on fluidized bed technology with a capacity of less than 200 MWel, as a result of which effective competition would be significantly impeded in the Common Market or in a substantial part of it.

| 7. | The members of the Advisory Committee agree with the Commission that the proposed concentration The members of the not lead to vertical competition concerns in respect of the relationship between the upstream market for flue gas desulphurisation plants and the downstream market for thermal treatment plants based on fluidized bed technology with a capacity of less than 200 MWel, as a result of which effective competition would be significantly impeded in the Common Market or in a substantial part of it. |
| --- | --- |

7.

The members of the Advisory Committee agree with the Commission that the proposed concentration The members of the not lead to vertical competition concerns in respect of the relationship between the upstream market for flue gas desulphurisation plants and the downstream market for thermal treatment plants based on fluidized bed technology with a capacity of less than 200 MWel, as a result of which effective competition would be significantly impeded in the Common Market or in a substantial part of it.

| 8. | The members of the Advisory Committee agree with the Commission that the proposed concentration should be declared compatible with the Common Market and with the EEA Agreement. |
| --- | --- |

8.

The members of the Advisory Committee agree with the Commission that the proposed concentration should be declared compatible with the Common Market and with the EEA Agreement.

| 9. | The members of the Advisory Committee recommend the publication of its opinion in the Official Journal of the European Union. |
| --- | --- |

9.

The members of the Advisory Committee recommend the publication of its opinion in the Official Journal of the European Union.

---

| 1.5.2009 | EN | Official Journal of the European Union | C 101/44 |
| --- | --- | --- | --- |

1.5.2009

EN

Official Journal of the European Union

C 101/44

---

Summary of Commission Decision

of 5 December 2007

declaring a concentration compatible with the common market and the functioning of the EEA Agreement

(Case COMP/M.4647 — AEE/Lentjes)

(Only the German version of the Decision is authentic)

2009/C 101/06

On 5 December 2007 the Commission adopted a Decision in a merger case under Council Regulation (EC) No 139/2004 of 20 January 2004 on the control of concentrations between undertakings
   (1), and in particular Article 8(1) of that Regulation. A non-confidential version of the full Decision can be found in the authentic language of the case and in the working languages of the Commission on the website of the Directorate-General for Competition, at the following address: http://ec.europa.eu/comm/competition/index_en.html

This summary only constitutes a simplified outline of the main aspects of the decision; it has no legal force and serves for information purposes only.

I.   INTRODUCTION

| 1. | On 29 June 2007 the Commission received notification, pursuant to Article 4(5), read in conjunction with Article 4(1) and (2), of Council Regulation (EC) No 139/2004 (‘the Merger Regulation’) of a proposed concentration by which Austrian Energy & Environment AG & Co KG (‘AEE’, Austria), which forms part of the Austrian A-Tec group (‘A-Tec’), acquires, within the meaning of Article 3(1)(b) of the Merger Regulation, sole control of Lentjes GmbH (‘Lentjes’, Germany, referred to jointly with AEE as ‘the parties’) by way of purchase of shares from the previous shareholder, the GEA group, an international technology group (engineering and chemicals). |
| --- | --- |

1.

On 29 June 2007 the Commission received notification, pursuant to Article 4(5), read in conjunction with Article 4(1) and (2), of Council Regulation (EC) No 139/2004 (‘the Merger Regulation’) of a proposed concentration by which Austrian Energy & Environment AG & Co KG (‘AEE’, Austria), which forms part of the Austrian A-Tec group (‘A-Tec’), acquires, within the meaning of Article 3(1)(b) of the Merger Regulation, sole control of Lentjes GmbH (‘Lentjes’, Germany, referred to jointly with AEE as ‘the parties’) by way of purchase of shares from the previous shareholder, the GEA group, an international technology group (engineering and chemicals).

| 2. | AEE, a subsidiary of the Austrian A-Tec group (‘A-Tec’), is active in the field of energy and environmental technology. Its product portfolio includes combustion systems based on grate and fluidised bed technology, grate-fired boilers for waste, biomass and coal combustion, flue gas cleaning and flue gas desulphurisation, as well as boilers. Within this product portfolio AEE offers development, production and assembly of components and plants. In addition, its parent company A-Tec is active in the fields of drive engineering, metals and mechanical engineering. |
| --- | --- |

2.

AEE, a subsidiary of the Austrian A-Tec group (‘A-Tec’), is active in the field of energy and environmental technology. Its product portfolio includes combustion systems based on grate and fluidised bed technology, grate-fired boilers for waste, biomass and coal combustion, flue gas cleaning and flue gas desulphurisation, as well as boilers. Within this product portfolio AEE offers development, production and assembly of components and plants. In addition, its parent company A-Tec is active in the fields of drive engineering, metals and mechanical engineering.

| 3. | Lentjes is also active in the supply of energy and environmental technology. It supplies complete waste-to-energy plants or lots for such plants (consisting at least of a combustion system), providing in particular the necessary process and basic engineering, but Lentjes does not manufacture the components for plants itself. Lentjes is currently controlled by the German GEA Group. |
| --- | --- |

3.

Lentjes is also active in the supply of energy and environmental technology. It supplies complete waste-to-energy plants or lots for such plants (consisting at least of a combustion system), providing in particular the necessary process and basic engineering, but Lentjes does not manufacture the components for plants itself. Lentjes is currently controlled by the German GEA Group.

| 4. | The intended transaction concerns the acquisition by A-Tec through its wholly owned subsidiary AEE of sole control over Lentjes by way of purchase of shares from the seller GEA Group. |
| --- | --- |

4.

The intended transaction concerns the acquisition by A-Tec through its wholly owned subsidiary AEE of sole control over Lentjes by way of purchase of shares from the seller GEA Group.

| 5. | Given the multiple filing requirements in at least three Member States and the cross-border nature of the transaction, the case was referred to the Commission under Article 4(5) of the EC Merger Regulation for the purpose of its competitive assessment. No Member State opposed to the referral (2). |
| --- | --- |

5.

Given the multiple filing requirements in at least three Member States and the cross-border nature of the transaction, the case was referred to the Commission under Article 4(5) of the EC Merger Regulation for the purpose of its competitive assessment. No Member State opposed to the referral (2).

| 6. | Having examined the notification, the Commission found that the notified proposal fell within the scope of the Merger Regulation. On 3 August 2007 it decided in accordance with Article 6(1)(c) of the Merger Regulation to initiate proceedings in this case and open a phase II investigation. |
| --- | --- |

6.

Having examined the notification, the Commission found that the notified proposal fell within the scope of the Merger Regulation. On 3 August 2007 it decided in accordance with Article 6(1)(c) of the Merger Regulation to initiate proceedings in this case and open a phase II investigation.

II.   RELEVANT MARKETS

A.   THE RELEVANT PRODUCT MARKETS

| 7. | The parties’ activities overlap in the supply of combustion systems and related technologies for municipal waste incineration plants and thermal treatment plants based on fluidised bed technology. Moreover, both parties also supply flue gas desulphurisation systems. |
| --- | --- |

7.

The parties’ activities overlap in the supply of combustion systems and related technologies for municipal waste incineration plants and thermal treatment plants based on fluidised bed technology. Moreover, both parties also supply flue gas desulphurisation systems.

| 8. | In these areas, the parties are active as (a) suppliers of complete plants or lines (general contractor assuming responsibility for the functioning of the complete plant), and as (b) suppliers of lots for such plants, i.e. as suppliers of the combustion system and/or flue gas desulphurisation system (assuming responsibility for the functioning of this particular lot). |
| --- | --- |

8.

In these areas, the parties are active as (a) suppliers of complete plants or lines (general contractor assuming responsibility for the functioning of the complete plant), and as (b) suppliers of lots for such plants, i.e. as suppliers of the combustion system and/or flue gas desulphurisation system (assuming responsibility for the functioning of this particular lot).

1.   Thermal treatment plants based on grate technology

Municipal waste incineration plants based on grate firing with a throughput of more than 4,5 t/h

| 9. | In its previous decisions, the Commission has defined a relevant product market as market for municipal waste incineration plants
   (3). The parties argue that this product market definition was based on the fact that at the time there were no other waste incineration plants than those which treated municipal waste, whereas today the market should be considered as being wider, including all kinds of waste-to-energy plants based on grate firing. |
| --- | --- |

9.

In its previous decisions, the Commission has defined a relevant product market as market for municipal waste incineration plants
   (3). The parties argue that this product market definition was based on the fact that at the time there were no other waste incineration plants than those which treated municipal waste, whereas today the market should be considered as being wider, including all kinds of waste-to-energy plants based on grate firing.

| 10. | The market investigation confirmed that municipal waste incineration plants based on grate firing should be considered as a distinct product market. Moreover, it confirmed the distinction between very small plants with a throughput capacity of less than 4,5 t/h and such plants with higher throughput. |
| --- | --- |

10.

The market investigation confirmed that municipal waste incineration plants based on grate firing should be considered as a distinct product market. Moreover, it confirmed the distinction between very small plants with a throughput capacity of less than 4,5 t/h and such plants with higher throughput.

Complete lines and lots

| 11. | The initial market investigation revealed a need to draw a distinction between markets for the supply of complete plants/lines on a ‘turnkey’ basis and between the supplies of lots. The Phase II investigation brought clarification on the interaction between the two segments, in a sense that the supply of lots puts a significant competitive constraint on the suppliers of complete plants/lines, as will be elaborated further in the competitive assessment. It is, however, not necessary to draw a definitive conclusion on whether the supply of lots and complete plants/lines form separate markets. |
| --- | --- |

11.

The initial market investigation revealed a need to draw a distinction between markets for the supply of complete plants/lines on a ‘turnkey’ basis and between the supplies of lots. The Phase II investigation brought clarification on the interaction between the two segments, in a sense that the supply of lots puts a significant competitive constraint on the suppliers of complete plants/lines, as will be elaborated further in the competitive assessment. It is, however, not necessary to draw a definitive conclusion on whether the supply of lots and complete plants/lines form separate markets.

Upstream markets: detail engineering of municipal waste incineration plants and manufacturing of boiler components

| 12. | A-Tec is also active in detail engineering and production of pressure parts for boilers and valves, activities which are upstream to the horizontally affected market for the supply of municipal waste incineration plants based on grate firing with a throughput of more than 4,5 t/h. The market investigation has broadly confirmed that these activities each constitute separate relevant product markets. Given that there are no competition concerns regarding this vertical relationship, the question of a further segmentation of these markets can ultimately be left open in the present case. |
| --- | --- |

12.

A-Tec is also active in detail engineering and production of pressure parts for boilers and valves, activities which are upstream to the horizontally affected market for the supply of municipal waste incineration plants based on grate firing with a throughput of more than 4,5 t/h. The market investigation has broadly confirmed that these activities each constitute separate relevant product markets. Given that there are no competition concerns regarding this vertical relationship, the question of a further segmentation of these markets can ultimately be left open in the present case.

2.   Thermal treatment plants based on fluidised bed technology with a capacity below 200 MWel

| 13. | The parties submit that combustion systems based on fluidised bed technology with a capacity below 200 MWel should be considered as a separate relevant product market. |
| --- | --- |

13.

The parties submit that combustion systems based on fluidised bed technology with a capacity below 200 MWel should be considered as a separate relevant product market.

| 14. | Lentjes supplies a special type of fluidised bed technology called ROWITEC, which is a combustion system modified and adapted to be used for the incineration of municipal waste and other residual material. The parties submit that it competes with grate-fired combustion systems for waste incineration plants. This was not confirmed by the market investigation results. It appears that ROWITEC systems belong to combustion systems based on fluidised bed technology and should not be included in the market for combustion systems based on grate technology. |
| --- | --- |

14.

Lentjes supplies a special type of fluidised bed technology called ROWITEC, which is a combustion system modified and adapted to be used for the incineration of municipal waste and other residual material. The parties submit that it competes with grate-fired combustion systems for waste incineration plants. This was not confirmed by the market investigation results. It appears that ROWITEC systems belong to combustion systems based on fluidised bed technology and should not be included in the market for combustion systems based on grate technology.

| 15. | The market investigation also indicated that the market could be segmented into fluidised bed plants based on different technologies, which serve different purposes, i.e. bubbling (stationary) fluidised bed, circulating fluidised bed and the ROWITEC technology mentioned above. However, given that there are no competition concerns even on the basis of a narrower product market definition (due to the absence of any overlaps between the parties’ activities in ROWITEC and circulating fluidised bed, and only negligible overlaps regarding bubbling fluidised bed plants), the exact scope of the product market can ultimately be left open. |
| --- | --- |

15.

The market investigation also indicated that the market could be segmented into fluidised bed plants based on different technologies, which serve different purposes, i.e. bubbling (stationary) fluidised bed, circulating fluidised bed and the ROWITEC technology mentioned above. However, given that there are no competition concerns even on the basis of a narrower product market definition (due to the absence of any overlaps between the parties’ activities in ROWITEC and circulating fluidised bed, and only negligible overlaps regarding bubbling fluidised bed plants), the exact scope of the product market can ultimately be left open.

| 16. | The relevant product market is thus for the purposes of the present case defined as market for thermal treatment plants based on fluidised bed technology with a capacity below 200 MWel. |
| --- | --- |

16.

The relevant product market is thus for the purposes of the present case defined as market for thermal treatment plants based on fluidised bed technology with a capacity below 200 MWel.

3.   Flue gas desulphurisation systems

| 17. | In previous cases the Commission had defined an overall market for desulphurisation systems (4). The market investigation in Phase I of the present proceeding had — at a very late stage — revealed indications that the market for flue gas desulphurisation (mainly used for plants based on fluidised bed technology, in which coal is used as part of the fuel) should be further segmented according to three different methods, i.e. wet, semi-dry and dry flue gas desulphurisation. These indications have been broadly confirmed by the in-depth investigation in Phase II. |
| --- | --- |

17.

In previous cases the Commission had defined an overall market for desulphurisation systems (4). The market investigation in Phase I of the present proceeding had — at a very late stage — revealed indications that the market for flue gas desulphurisation (mainly used for plants based on fluidised bed technology, in which coal is used as part of the fuel) should be further segmented according to three different methods, i.e. wet, semi-dry and dry flue gas desulphurisation. These indications have been broadly confirmed by the in-depth investigation in Phase II.

| 18. | Competition concerns had been voiced by two competitors of the parties on the downstream market for fluidised bed plants with regard to a specific semi-dry desulphurisation method, the so-called circulating dry scrubber (‘CDS’). The competitors claimed that systems based on this method could only be supplied by Lentjes and one other competitor, Alstom. They also claimed that these systems were a necessary input for their activities on the market for fluidised bed plants, since they had to offer these systems as part of an overall package for a complete plant or line with regard to certain types of multi-fuel plants. They were concerned that after the merger it would be more difficult for them to obtain these systems (or obtain them at a reasonable price), since Lentjes would then be vertically integrated with AEE, one of their main competitors on the downstream market. |
| --- | --- |

18.

Competition concerns had been voiced by two competitors of the parties on the downstream market for fluidised bed plants with regard to a specific semi-dry desulphurisation method, the so-called circulating dry scrubber (‘CDS’). The competitors claimed that systems based on this method could only be supplied by Lentjes and one other competitor, Alstom. They also claimed that these systems were a necessary input for their activities on the market for fluidised bed plants, since they had to offer these systems as part of an overall package for a complete plant or line with regard to certain types of multi-fuel plants. They were concerned that after the merger it would be more difficult for them to obtain these systems (or obtain them at a reasonable price), since Lentjes would then be vertically integrated with AEE, one of their main competitors on the downstream market.

| 19. | The in-depth market investigation in Phase 2 revealed that all semi-dry methods lead to comparable results. Respondents stated that even some technologies, which are commonly attributed to the area of dry methods (spray absorber technologies), can be alternatives for certain types of plants, in particular multi-fuel plants (5). It ultimately depends on the sulphur content in the fuels that a customer will burn, as well as on environmental norms (notably the emission standards, which can sometimes be stricter than the relevant EU standards (6), depending on the location of the plant), whether a customer chooses one or the other method. |
| --- | --- |

19.

The in-depth market investigation in Phase 2 revealed that all semi-dry methods lead to comparable results. Respondents stated that even some technologies, which are commonly attributed to the area of dry methods (spray absorber technologies), can be alternatives for certain types of plants, in particular multi-fuel plants (5). It ultimately depends on the sulphur content in the fuels that a customer will burn, as well as on environmental norms (notably the emission standards, which can sometimes be stricter than the relevant EU standards (6), depending on the location of the plant), whether a customer chooses one or the other method.

| 20. | Niche applications exist within the broad categorisation mentioned above (wet, semi-dry and dry methods), such as Lentjes’ CDS, which appears to be very performing but expensive, and it is protected by intellectual property rights. |
| --- | --- |

20.

Niche applications exist within the broad categorisation mentioned above (wet, semi-dry and dry methods), such as Lentjes’ CDS, which appears to be very performing but expensive, and it is protected by intellectual property rights.

| 21. | Based on the above, it appears that within the product market for flue gas cleaning a general distinction between wet, semi-dry and dry technologies leads to a segmentation of the overall market, with potential niche segments for very specific applications. All major suppliers offer flue gas cleaning systems falling into these three categories, and since there are no competition concerns under any alternative product market definition, as will be outlined below, the market definition can ultimately be left open. |
| --- | --- |

21.

Based on the above, it appears that within the product market for flue gas cleaning a general distinction between wet, semi-dry and dry technologies leads to a segmentation of the overall market, with potential niche segments for very specific applications. All major suppliers offer flue gas cleaning systems falling into these three categories, and since there are no competition concerns under any alternative product market definition, as will be outlined below, the market definition can ultimately be left open.

B.   THE RELEVANT GEOGRAPHIC MARKETS

| 22. | The geographic scope of the affected market can be considered to be EEA-wide. The main players are active EEA-wide and no barriers to entry into different national areas have been identified. At the same time, however, the market investigation indicated that the market must be defined as being (as yet) no wider than the EEA, since competitors from outside the EEA take part in tenders in the EEA only very rarely unless they have European subsidiaries. |
| --- | --- |

22.

The geographic scope of the affected market can be considered to be EEA-wide. The main players are active EEA-wide and no barriers to entry into different national areas have been identified. At the same time, however, the market investigation indicated that the market must be defined as being (as yet) no wider than the EEA, since competitors from outside the EEA take part in tenders in the EEA only very rarely unless they have European subsidiaries.

III.   COMPETITIVE ASSESSMENT

A.   HORIZONTAL EFFECTS

1.   Thermal treatment plants for municipal waste based on grate technology

Market shares

| 23. | The Commission carried out an in-depth bidding analysis which also provided data to reconstruct the market. The information gathered in this investigation concerns (almost) all projects awarded in this area during 2002-2006 in the EEA. On this basis the market share figures for the parties for 107 projects, representing an almost complete coverage of the relevant market, are as follows:

  Table 1


  Market share distribution for municipal waste incineration plants 2002-2006 — overall market, complete plants and plant parts









  Company | Overall market | Complete plants | Plant parts |
| --- | --- | --- | --- | --- |
| AEE | [25-35] % | [30-40] % | [20-30] % |
| Lentjes | [10-20] % | [20-30] % | [5-10] % |
| AEE/Lentjes | [35-55] % | [50-70] % | [25-40] % |
| CNIM/Martin | [20-30] % | [20-30] % | [15-25] % |
| Fisia | [10-20] % | < 5 % | [15-25] % |
| Vølund | [5-10] % | 0 % | [15-25] % |
| KAB Takuma | [5-10] % | [10-20] % | 0 % |
| Baumgarte | < 5 % | 0 % | < 5 % |
| Stiefel | < 5 % | < 5 % | < 5 % |
| Keppel Seghers | < 5 % | 0 % | < 5 % |
| Oschatz | < 5 % | < 5 % | 0 % |
| Vinci | < 5 % | < 5 % | < 5 % |
| Wulff | < 1 % | < 5 % | 0 % |
| Energos | < 1 % | < 1 % | 0 % |
| Source: Form CO and market investigation. |

23.

The Commission carried out an in-depth bidding analysis which also provided data to reconstruct the market. The information gathered in this investigation concerns (almost) all projects awarded in this area during 2002-2006 in the EEA. On this basis the market share figures for the parties for 107 projects, representing an almost complete coverage of the relevant market, are as follows:

Table 1

Market share distribution for municipal waste incineration plants 2002-2006 — overall market, complete plants and plant parts

Company

Overall market

Complete plants

Plant parts

AEE

[25-35] %

[30-40] %

[20-30] %

Lentjes

[10-20] %

[20-30] %

[5-10] %

AEE/Lentjes

[35-55] %

[50-70] %

[25-40] %

CNIM/Martin

[20-30] %

[20-30] %

[15-25] %

Fisia

[10-20] %

< 5 %

[15-25] %

Vølund

[5-10] %

0 %

[15-25] %

KAB Takuma

[5-10] %

[10-20] %

0 %

Baumgarte

< 5 %

0 %

< 5 %

Stiefel

< 5 %

< 5 %

< 5 %

Keppel Seghers

< 5 %

0 %

< 5 %

Oschatz

< 5 %

< 5 %

0 %

Vinci

< 5 %

< 5 %

< 5 %

Wulff

< 1 %

< 5 %

0 %

Energos

< 1 %

< 1 %

0 %

Source: Form CO and market investigation.

| 24. | If one were to distinguish separate segments for complete lines on the one hand and part plants (lots) on the other hand, the parties would be the clear market leader for complete lines/plants, followed by Martin/CNIM and KAB Takuma. For lots, the merger would lead to the number one, closely followed by several other players of roughly similar size (Fisia, Martin/CNIM and Volund). |
| --- | --- |

24.

If one were to distinguish separate segments for complete lines on the one hand and part plants (lots) on the other hand, the parties would be the clear market leader for complete lines/plants, followed by Martin/CNIM and KAB Takuma. For lots, the merger would lead to the number one, closely followed by several other players of roughly similar size (Fisia, Martin/CNIM and Volund).

Bidding analysis

| 25. | The bidding analysis conducted by the Commission revealed that out of the total of 107 tenders, AEE and Lentjes were direct competitors in [10-15] bids. |
| --- | --- |

25.

The bidding analysis conducted by the Commission revealed that out of the total of 107 tenders, AEE and Lentjes were direct competitors in [10-15] bids.

| 26. | First, it can be observed that when both AEE and Lentjes were bidding, they usually faced Martin/CNIM, Fisia, and KAB Takuma on a regular basis in these tenders. Comparing the participation rates for the [10-15] tenders with those for all projects shows that Fisia, Martin/CNIM as well as KAB Takuma participated more often in tenders in which AEE and Lentjes were present. This shows that in general the tenders in which both parties participate attract more alternative bidders than is usually the case in the industry. |
| --- | --- |

26.

First, it can be observed that when both AEE and Lentjes were bidding, they usually faced Martin/CNIM, Fisia, and KAB Takuma on a regular basis in these tenders. Comparing the participation rates for the [10-15] tenders with those for all projects shows that Fisia, Martin/CNIM as well as KAB Takuma participated more often in tenders in which AEE and Lentjes were present. This shows that in general the tenders in which both parties participate attract more alternative bidders than is usually the case in the industry.

| 27. | The Commission also analysed the success rates of the main competitors and made a comparison of the overall success rate in all projects during 2002-2006 and the success rate in tenders where AEE and Lentjes were both participating. Lentjes’ success rate in the tenders where AEE participated was significantly lower than its rate in all tenders. This observation also holds for complete lines. This seems to indicate that Lentjes did not reduce AEE’s success in tenders; quite to the contrary AEE’s presence is correlated with a bad performance on behalf of Lentjes. |
| --- | --- |

27.

The Commission also analysed the success rates of the main competitors and made a comparison of the overall success rate in all projects during 2002-2006 and the success rate in tenders where AEE and Lentjes were both participating. Lentjes’ success rate in the tenders where AEE participated was significantly lower than its rate in all tenders. This observation also holds for complete lines. This seems to indicate that Lentjes did not reduce AEE’s success in tenders; quite to the contrary AEE’s presence is correlated with a bad performance on behalf of Lentjes.

| 28. | Furthermore, nor does an analysis of the second-placed competitor in the tenders that were won by AEE point to the elimination of a significant competitive factor. The customers were asked to inform the Commission about details of their tenders to assess who was the ‘runner-up’ to the winner in the projects where both parties participated and the award went to AEE. For these projects, Fisia seems to be almost as close as Lentjes. |
| --- | --- |

28.

Furthermore, nor does an analysis of the second-placed competitor in the tenders that were won by AEE point to the elimination of a significant competitive factor. The customers were asked to inform the Commission about details of their tenders to assess who was the ‘runner-up’ to the winner in the projects where both parties participated and the award went to AEE. For these projects, Fisia seems to be almost as close as Lentjes.

| 29. | Although the in-depth bidding analysis provided more information, it was not possible to identify any specific features of those tenders in which the different players participated. Even though every company seems to have its own special strengths and own technologies, the overall picture is that all of the established players are able to execute large projects for complete plants/lines and that there is no particular technological advantage in the hands of the parties or other suppliers. There is no particular cluster of projects where the parties would have a particular advantage and where the remaining competitors would not be able to win a project or at least to exercise a significant competitive constraint on the merged entity. |
| --- | --- |

29.

Although the in-depth bidding analysis provided more information, it was not possible to identify any specific features of those tenders in which the different players participated. Even though every company seems to have its own special strengths and own technologies, the overall picture is that all of the established players are able to execute large projects for complete plants/lines and that there is no particular technological advantage in the hands of the parties or other suppliers. There is no particular cluster of projects where the parties would have a particular advantage and where the remaining competitors would not be able to win a project or at least to exercise a significant competitive constraint on the merged entity.

| 30. | The Phase II investigation also clarified, that there are often more competitors in the pre-qualification phase than the bidders that actually submit an offer. Competitors participating in the market investigation explained that they themselves consider whether or not to submit the final offer in view of the attractiveness of the project and of the client (in terms of feasibility of the project, commercial conditions and guarantees required, relationships with client etc.) and notably in view of the anticipated chance to win the contract among the other competitors. Therefore, the relatively low average number of bidders participating in the final round thus does not accurately reflect the competitive constraints exercised by other bidders which could potentially bid and which often participated in earlier rounds of the tenders. |
| --- | --- |

30.

The Phase II investigation also clarified, that there are often more competitors in the pre-qualification phase than the bidders that actually submit an offer. Competitors participating in the market investigation explained that they themselves consider whether or not to submit the final offer in view of the attractiveness of the project and of the client (in terms of feasibility of the project, commercial conditions and guarantees required, relationships with client etc.) and notably in view of the anticipated chance to win the contract among the other competitors. Therefore, the relatively low average number of bidders participating in the final round thus does not accurately reflect the competitive constraints exercised by other bidders which could potentially bid and which often participated in earlier rounds of the tenders.

Ranking of the suppliers

| 31. | In addition to the bidding analysis, customers were asked during the in-depth market investigation to rank competitors relative to Lentjes according to several criteria which are essential for success in the industry: financial strength, reference projects, grate technologies, engineering know-how and project management know-how. |
| --- | --- |

31.

In addition to the bidding analysis, customers were asked during the in-depth market investigation to rank competitors relative to Lentjes according to several criteria which are essential for success in the industry: financial strength, reference projects, grate technologies, engineering know-how and project management know-how.

| 32. | The replies of customers who answered based on their experience with Lentjes revealed that AEE, Martin/CNIM, Fisia and Volund are viewed as stronger players than Lentjes in the market. Overall the replies indicate that AEE's close competitor is not Lentjes, but rather Martin/CNIM and Fisia. The same ranking was sent to planning and engineering firms or consultants. Their evaluation of the different suppliers in the area of municipal waste incineration mirror to a large extent the one of customers. They perceive AEE, Martin/CNIM and Fisia as the leading suppliers in the market followed by Lentjes. |
| --- | --- |

32.

The replies of customers who answered based on their experience with Lentjes revealed that AEE, Martin/CNIM, Fisia and Volund are viewed as stronger players than Lentjes in the market. Overall the replies indicate that AEE's close competitor is not Lentjes, but rather Martin/CNIM and Fisia. The same ranking was sent to planning and engineering firms or consultants. Their evaluation of the different suppliers in the area of municipal waste incineration mirror to a large extent the one of customers. They perceive AEE, Martin/CNIM and Fisia as the leading suppliers in the market followed by Lentjes.

| 33. | Customers further consider Volund stronger and Baumgarte as comparable to Lentjes (although Volund and Baumgarte tend to specialise on lots), followed by KAB Takuma. The general picture is confirmed that the main players for complete lines/plants are AEE, Martin/CNIM, Lentjes, Fisia and recently KAB Takuma, while other suppliers play only a minor role. In lots Baumgarte, Volund and ThyssenKrupp Xervon Energy are credible suppliers as well. |
| --- | --- |

33.

Customers further consider Volund stronger and Baumgarte as comparable to Lentjes (although Volund and Baumgarte tend to specialise on lots), followed by KAB Takuma. The general picture is confirmed that the main players for complete lines/plants are AEE, Martin/CNIM, Lentjes, Fisia and recently KAB Takuma, while other suppliers play only a minor role. In lots Baumgarte, Volund and ThyssenKrupp Xervon Energy are credible suppliers as well.

Competitive constraints on complete plant suppliers from lots

| 34. | The Phase II investigation also revealed that many customers, although they have a preference for a turnkey provider, can alternatively switch to a lot solution complemented by an engineering company or in-house resources for the turnkey function. The role played by engineering firms, which were not covered by the initial market investigation, appears to be crucial. Engineering companies allow customers to acquire knowledge about the market, structure the tender and evaluate bids and they compensate the lack of in-house engineering capacities of the one-off clients (such as municipalities). In addition, they provide the interlinking engineering services and thereby allow customers to choose between a complete line from a turnkey provider or a lot solution. |
| --- | --- |

34.

The Phase II investigation also revealed that many customers, although they have a preference for a turnkey provider, can alternatively switch to a lot solution complemented by an engineering company or in-house resources for the turnkey function. The role played by engineering firms, which were not covered by the initial market investigation, appears to be crucial. Engineering companies allow customers to acquire knowledge about the market, structure the tender and evaluate bids and they compensate the lack of in-house engineering capacities of the one-off clients (such as municipalities). In addition, they provide the interlinking engineering services and thereby allow customers to choose between a complete line from a turnkey provider or a lot solution.

| 35. | On the basis of these replies and the information gathered from the engineering firms, it appears that unbundling a project into lots appears to be a credible alternative to a general contract for a complete line. Therefore, the threat coming from the suppliers of lots is a constraining force for the suppliers of complete plants. |
| --- | --- |

35.

On the basis of these replies and the information gathered from the engineering firms, it appears that unbundling a project into lots appears to be a credible alternative to a general contract for a complete line. Therefore, the threat coming from the suppliers of lots is a constraining force for the suppliers of complete plants.

New entrants and alternative ‘turnkey’ suppliers

| 36. | Because of the need of reference projects, financial strength and turn-key responsibility, new entry faces high barriers and can only be expected from companies that have strengths in one of the three mentioned aspects. This has been confirmed during the second phase market investigation which revealed potential credible entry coming from: companies with existing technology, financial strength and reference projects currently active outside the EEA; companies active within the EEA but focused on a particular region or a segment and finally companies with turn-key responsibility active in neighbouring product markets. |
| --- | --- |

36.

Because of the need of reference projects, financial strength and turn-key responsibility, new entry faces high barriers and can only be expected from companies that have strengths in one of the three mentioned aspects. This has been confirmed during the second phase market investigation which revealed potential credible entry coming from: companies with existing technology, financial strength and reference projects currently active outside the EEA; companies active within the EEA but focused on a particular region or a segment and finally companies with turn-key responsibility active in neighbouring product markets.

Recent market entry

| 37. | In the first phase investigation only KAB Takuma was mentioned by respondents as a new entrant in the market for waste incineration plants. However, despite its strong financial backing and credible technology, which already won it three contracts for complete plants/lines in Europe, its position did not seem to be as well-established as the position of the other main suppliers due to the lack of European reference projects. The in-depth investigation revealed that KAB Takuma is, nevertheless, considered as new credible player by specialised engineering consultants, and this is also expected to change customers’ perceptions. It can also be noted that with one exception all engineering companies, when asked how many credible suppliers were available for turnkey plants, mentioned at least four credible suppliers: AEE/Lentjes, Martin/CNIM, Fisia and KAB Takuma. |
| --- | --- |

37.

In the first phase investigation only KAB Takuma was mentioned by respondents as a new entrant in the market for waste incineration plants. However, despite its strong financial backing and credible technology, which already won it three contracts for complete plants/lines in Europe, its position did not seem to be as well-established as the position of the other main suppliers due to the lack of European reference projects. The in-depth investigation revealed that KAB Takuma is, nevertheless, considered as new credible player by specialised engineering consultants, and this is also expected to change customers’ perceptions. It can also be noted that with one exception all engineering companies, when asked how many credible suppliers were available for turnkey plants, mentioned at least four credible suppliers: AEE/Lentjes, Martin/CNIM, Fisia and KAB Takuma.

| 38. | The Phase II investigation also showed that other entrants in addition to KAB Takuma must be considered. The former Belgian company Seghers has — after the acquisition by the Singapore based company Keppel — re-entered the European market and has won some projects during the last two years. In addition, Seghers is currently competing for a turn-key project with established players. |
| --- | --- |

38.

The Phase II investigation also showed that other entrants in addition to KAB Takuma must be considered. The former Belgian company Seghers has — after the acquisition by the Singapore based company Keppel — re-entered the European market and has won some projects during the last two years. In addition, Seghers is currently competing for a turn-key project with established players.

Potential new entrants

| 39. | Regional European players can also be seen as potential entrants into the supply of complete plants/lines. The traditional suppliers of lots can also be seen as potential entrants into the supply of complete lines. It is not uncommon to see these suppliers teaming-up with other companies to form consortia and to bid for complete plant/line. |
| --- | --- |

39.

Regional European players can also be seen as potential entrants into the supply of complete plants/lines. The traditional suppliers of lots can also be seen as potential entrants into the supply of complete lines. It is not uncommon to see these suppliers teaming-up with other companies to form consortia and to bid for complete plant/line.

| 40. | Next, some alternative possibilities for turnkey supplies of complete plants from companies not having waste incineration technology as their core competence was also identified during the market investigation. One customer reported an ongoing tender where a turnkey provider with experience in construction in the oil business, but without any own technology in the area of municipal waste incineration organised a consortium to be at least runner-up. In the UK, a pure turnkey supplier without own technology has already won a turnkey project and participated in more tenders for complete plants, outsourcing the key technological parts of the project. |
| --- | --- |

40.

Next, some alternative possibilities for turnkey supplies of complete plants from companies not having waste incineration technology as their core competence was also identified during the market investigation. One customer reported an ongoing tender where a turnkey provider with experience in construction in the oil business, but without any own technology in the area of municipal waste incineration organised a consortium to be at least runner-up. In the UK, a pure turnkey supplier without own technology has already won a turnkey project and participated in more tenders for complete plants, outsourcing the key technological parts of the project.

Lentjes future market position

| 41. | Germany has traditionally been the strongest market for Lentjes and for AEE and the historical market shares of the parties reflect their success in this key market. The market investigation, however, has revealed that since Germany started already during the 90s to restrict the landfill of waste, the relative importance of the waste-to energy market in Germany will be reduced as other parts of the EEA have only started in recent years following the EU Landfill Directive. Market growth is expected in Southern and in Eastern Europe, where similar legislation as in Germany has not yet entered in force. Indeed, the proportion of ongoing (not yet awarded) tenders in Germany compared to the overall EEA market is noticeably smaller than the German proportion within projects awarded in the past 5 years. This market development thus seems to weaken the relative position of the parties, which have traditionally been strong in Germany, on the EEA market in the future. |
| --- | --- |

41.

Germany has traditionally been the strongest market for Lentjes and for AEE and the historical market shares of the parties reflect their success in this key market. The market investigation, however, has revealed that since Germany started already during the 90s to restrict the landfill of waste, the relative importance of the waste-to energy market in Germany will be reduced as other parts of the EEA have only started in recent years following the EU Landfill Directive. Market growth is expected in Southern and in Eastern Europe, where similar legislation as in Germany has not yet entered in force. Indeed, the proportion of ongoing (not yet awarded) tenders in Germany compared to the overall EEA market is noticeably smaller than the German proportion within projects awarded in the past 5 years. This market development thus seems to weaken the relative position of the parties, which have traditionally been strong in Germany, on the EEA market in the future.

| 42. | Another aspect that plays a role in assessing the accuracy of previous market performance as a prediction of future market strength is the weakened financial position of Lentjes. Financial strength is considered as one of the key attributes necessary for a supplier of a waste incineration solution to be considered by customers, notably because of high guarantees required for the projects. Lentjes’ waste-to-energy business has been loss-making in the past years. GEA, the parent company of Lentjes, has tried without success to restructure the company and finally decided to sell Lentjes. Some customers have also perceived Lentjes as a company with less presence in the market recently and indeed no contracts have been awarded to it in 2006 and 2007. Lentjes thus seems not to be able to assert strong competitive pressure on the other suppliers in the future absent the merger. |
| --- | --- |

42.

Another aspect that plays a role in assessing the accuracy of previous market performance as a prediction of future market strength is the weakened financial position of Lentjes. Financial strength is considered as one of the key attributes necessary for a supplier of a waste incineration solution to be considered by customers, notably because of high guarantees required for the projects. Lentjes’ waste-to-energy business has been loss-making in the past years. GEA, the parent company of Lentjes, has tried without success to restructure the company and finally decided to sell Lentjes. Some customers have also perceived Lentjes as a company with less presence in the market recently and indeed no contracts have been awarded to it in 2006 and 2007. Lentjes thus seems not to be able to assert strong competitive pressure on the other suppliers in the future absent the merger.

Conclusion on waste incineration plants

| 43. | The indirect competitive pressure from suppliers of lots on the turn-key segment has been confirmed. Additional information about the bidding process shows that it is difficult to conclude that the parties are close competitors. Neither have the perceptions of market players with regard to the suppliers indicated that they view the parties as close competitors. Moreover, the potential for alternative suppliers is clearly broader than the first phase investigation indicated, and the historic market positions are not necessarily accurate indicators of future market strength in view of the changing framework conditions. |
| --- | --- |

43.

The indirect competitive pressure from suppliers of lots on the turn-key segment has been confirmed. Additional information about the bidding process shows that it is difficult to conclude that the parties are close competitors. Neither have the perceptions of market players with regard to the suppliers indicated that they view the parties as close competitors. Moreover, the potential for alternative suppliers is clearly broader than the first phase investigation indicated, and the historic market positions are not necessarily accurate indicators of future market strength in view of the changing framework conditions.

2.   Thermal treatment plants based on fluidised bed technology with a capacity below 200 MWel

| 44. | On this market the merged entity would have an EEA-wide market share of approximately [25-35] % (AEE [20-30] %, Lentjes [5-10] %). Their main competitors are Foster Wheeler (approximately [30-40] %) and Metso/Kvaerner (approximately [30-40] %). Further competitors, each with an approximately [<5] % market share, mainly fluidised-bed-technology-based biomass heating plants. |
| --- | --- |

44.

On this market the merged entity would have an EEA-wide market share of approximately [25-35] % (AEE [20-30] %, Lentjes [5-10] %). Their main competitors are Foster Wheeler (approximately [30-40] %) and Metso/Kvaerner (approximately [30-40] %). Further competitors, each with an approximately [<5] % market share, mainly fluidised-bed-technology-based biomass heating plants.

| 45. | The in-depth Phase II market investigation, during which it was examined in particular whether and if so to what extent this market might be divided into further submarkets or segments, did not produce any evidence of anticompetitive horizontal effects due to the planned merger. |
| --- | --- |

45.

The in-depth Phase II market investigation, during which it was examined in particular whether and if so to what extent this market might be divided into further submarkets or segments, did not produce any evidence of anticompetitive horizontal effects due to the planned merger.

B.   VERTICAL EFFECTS

| 46. | Competition concerns had been raised regarding Lentjes’ CDS technology for flue gas desulphurisation. Two competitors of AEE on the downstream market for fluidised bed plants were concerned that their — as they claim — only supplier of this technology with regard to multi-fuel plants based on circulating fluidised bed technology would not supply them any more after the merger, due to the fact that AEE is a strong competitor of them on the downstream market. |
| --- | --- |

46.

Competition concerns had been raised regarding Lentjes’ CDS technology for flue gas desulphurisation. Two competitors of AEE on the downstream market for fluidised bed plants were concerned that their — as they claim — only supplier of this technology with regard to multi-fuel plants based on circulating fluidised bed technology would not supply them any more after the merger, due to the fact that AEE is a strong competitor of them on the downstream market.

1.   Competitive situation on the upstream market for flue gas desulphurisation systems

| 47. | On an overall market for flue gas desulphurisation systems, the combined market shares of the parties would be approximately [25-45] % (AEE: [15-25] %, Lentjes: [15-25] %), while their strongest competitors had market shares of approximately [20-30] % (Alstom), [15-25] % (Fisia), [10-20] % (Hitachi Power) and [5-10] % (Mitsubishi). Further competitors in this area include Wulff, LAB (CNIM group) and FLSmidth. |
| --- | --- |

47.

On an overall market for flue gas desulphurisation systems, the combined market shares of the parties would be approximately [25-45] % (AEE: [15-25] %, Lentjes: [15-25] %), while their strongest competitors had market shares of approximately [20-30] % (Alstom), [15-25] % (Fisia), [10-20] % (Hitachi Power) and [5-10] % (Mitsubishi). Further competitors in this area include Wulff, LAB (CNIM group) and FLSmidth.

2.   No ability to foreclose downstream competitors

| 48. | The complainants had raised concerns with regard to medium-sized multi-fuel plants. More precisely, the concerns regard such plants in a range between 30 and 50 MWel (7). |
| --- | --- |

48.

The complainants had raised concerns with regard to medium-sized multi-fuel plants. More precisely, the concerns regard such plants in a range between 30 and 50 MWel (7).

Alternative desulphurisation methods

| 49. | The overall majority of respondents in the market investigation confirmed that the type of flue gas desulphurisation system to be used in such a plant depends on the type of fuel (mix) that is burned and the emission standards. The majority of these respondents named other semi-dry or dry solutions as being comparable to the Lentjes and Alstom technology, namely those offered by AEE (Turbosorp), Wulff (Graf-Wulff-technology), LAB and Fisia Babcock. |
| --- | --- |

49.

The overall majority of respondents in the market investigation confirmed that the type of flue gas desulphurisation system to be used in such a plant depends on the type of fuel (mix) that is burned and the emission standards. The majority of these respondents named other semi-dry or dry solutions as being comparable to the Lentjes and Alstom technology, namely those offered by AEE (Turbosorp), Wulff (Graf-Wulff-technology), LAB and Fisia Babcock.

| 50. | The in-depth investigation revealed that the Graf-Wulff technology appear to be almost identical with the technology offered by Lentjes. The Commission also contacted the customers in three ongoing projects mentioned by one of the complainants as crucial projects in this area. One of these customers stated that for its two projects there are alternative cleaning solutions (based on dry technology). The other customer confirmed that this type of fluidised cleaning method would be their preferred solution, but that they have alternative bids from other suppliers and are therefore not concerned about any anti-competitive effects of the intended transaction. |
| --- | --- |

50.

The in-depth investigation revealed that the Graf-Wulff technology appear to be almost identical with the technology offered by Lentjes. The Commission also contacted the customers in three ongoing projects mentioned by one of the complainants as crucial projects in this area. One of these customers stated that for its two projects there are alternative cleaning solutions (based on dry technology). The other customer confirmed that this type of fluidised cleaning method would be their preferred solution, but that they have alternative bids from other suppliers and are therefore not concerned about any anti-competitive effects of the intended transaction.

Separate tenders for flue gas desulphurisation

| 51. | Moreover, customers explained that they are now considering parallel tenders — one for the firing unit (i.e. the fluidised bed boiler), with an option to supply also the flue gas desulphurisation part, and one separate tender for the flue gas desulphurisation system, in order to get the best solution both in terms of technology as well as in terms of costs. Consequently, the merged entity could participate in submitting a bid for the complete boiler island, i.e. boiler and flue gas desulphurisation system, as well as a separate bid just for the desulphurisation system. As a consequence, the Lentjes technology would still be available for end-customers, which could combine it with a boiler from AEE's competitors, if necessary. |
| --- | --- |

51.

Moreover, customers explained that they are now considering parallel tenders — one for the firing unit (i.e. the fluidised bed boiler), with an option to supply also the flue gas desulphurisation part, and one separate tender for the flue gas desulphurisation system, in order to get the best solution both in terms of technology as well as in terms of costs. Consequently, the merged entity could participate in submitting a bid for the complete boiler island, i.e. boiler and flue gas desulphurisation system, as well as a separate bid just for the desulphurisation system. As a consequence, the Lentjes technology would still be available for end-customers, which could combine it with a boiler from AEE's competitors, if necessary.

Sufficient number of other vertically integrated competitors

| 52. | Furthermore, even in cases where such plants are only tendered on the basis of bids for the complete plant (or at least the boiler island), the downstream market is a bidding market and customers have stated that there are other integrated suppliers which could participate in such bids. Therefore, the merged entity would still face competition from other integrated suppliers, such as Mitsubishi or SES TLMACE. The end-customer would thus still have the choice between a number of suppliers which could submit bids for such plants. |
| --- | --- |

52.

Furthermore, even in cases where such plants are only tendered on the basis of bids for the complete plant (or at least the boiler island), the downstream market is a bidding market and customers have stated that there are other integrated suppliers which could participate in such bids. Therefore, the merged entity would still face competition from other integrated suppliers, such as Mitsubishi or SES TLMACE. The end-customer would thus still have the choice between a number of suppliers which could submit bids for such plants.

Conclusion vertical effects

| 53. | The merged entity does not have the ability to foreclose its downstream competitors. The merger accordingly gives rise to no competition concerns in respect of the relationship between the upstream market for flue gas desulphurisation plants and the downstream market for fluidised bed plants below 200 MWel. |
| --- | --- |

53.

The merged entity does not have the ability to foreclose its downstream competitors. The merger accordingly gives rise to no competition concerns in respect of the relationship between the upstream market for flue gas desulphurisation plants and the downstream market for fluidised bed plants below 200 MWel.

IV.   CONCLUSION

| 54. | The proposed concentration would not significantly impede effective competition in the common market or in a substantial part of it. Under Article 2(2) and Article 8(1) of the Merger Regulation, therefore, the transaction should be declared compatible with the common market and the functioning of the EEA Agreement. |
| --- | --- |

54.

The proposed concentration would not significantly impede effective competition in the common market or in a substantial part of it. Under Article 2(2) and Article 8(1) of the Merger Regulation, therefore, the transaction should be declared compatible with the common market and the functioning of the EEA Agreement.

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(1)  OJ L 24, 29.1.2004, p. 1.

(2)  The transaction would have been notifiable in the following Member States: Austria, Germany, Ireland and UK.

(3)  See Case COMP/M.1552, Babcock Borsig/AE Energietechnik, decision of 30 June 1999, and Case COMP/M.1594, Preussag/Babcock Borsig, decision of 17 August 1999.

(4)  See Case COMP/M.1552, Babcock Borsig/AE Energietechnik, decision of 30 June 1999, and Case COMP/M.1594, Preussag/Babcock Borsig, decision of 17 August 1999.

(5)  The brands/methods that were mentioned as being comparable include Lentjes (CDS), Alstom (NID), AEE (Turbosorp), Wulff (Graf-Wulff-technology), LAB and Fisia Babcock; for more details see competitive assessment below.

(6)  Directive 2000/76/EC on the incineration of waste and Directive 2001/80/EC on the large combustion plants.

(7)  One of the complainants was mostly concerned regarding multi-fuel-plants in the range of above 100 MWel. However, the majority of respondents in the market investigation stated that for this segment the semi-dry methods could be substituted by wet desulphurisation methods.

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| 1.5.2009 | EN | Official Journal of the European Union | C 101/54 |
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Official Journal of the European Union

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Final report of the Hearing Officer in Case COMP/M.4647 — AEE/Lentjes

(Pursuant to Articles 15 and 16 of Commission Decision (2001/462/EC, ECSC) of 23 May 2001 on the terms of reference of Hearing Officers in certain competition proceedings — OJ L 162, 19.6.2001, p. 21)

2009/C 101/07

On 29 June 2007, Austrian Energy & Environment AG (‘AEE’) sent a notification to the Commission of the intended acquisition of control over Lentjes GmbH (‘Lentjes’), following a referral under Article 4(5) of the Merger Regulation.

Upon examination of the notification, the Commission concluded that the notified operation raised serious doubts as to the compatibility of the notified acquisition with the common market with regard to the market for municipal waste incineration plants. On 3 August 2007, the Commission opened an in-depth investigation into this proposed merger of two suppliers of waste-to-energy plants.

Access to key documents was provided to the notifying party on 7 August 2007, in accordance with paragraph 45 of Competition DG's Best Practices on the conduct of EC merger control proceedings.

On the basis of the additional evidence gathered during the phase II investigation, the Commission services concluded that the proposed transaction would not significantly impede effective competition in the common market or a substantial part thereof and is therefore compatible with the common market and the EEA Agreement. Accordingly, no Statement of Objections was sent to the notifying party.

The Parties did not refer to me any concerns in terms of due process.

In the light of the above, I consider that the rights to be heard of all participants to the present proceeding have been respected.

Brussels, 29 November 2007.

Karen WILLIAMS

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V Announcements

ADMINISTRATIVE PROCEDURES

Commission

| 1.5.2009 | EN | Official Journal of the European Union | C 101/55 |
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SPECIFIC CALL FOR PROPOSALS — EAC/24/09

Erasmus University Charter

Lifelong Learning Programme

2009/C 101/08

1.   OBJECTIVES AND DESCRIPTION

The Erasmus University Charter provides the general framework for the European cooperation activities a higher education institution (HEI) may carry out within the Erasmus programme as part of the Lifelong Learning Programme (LLP). The Erasmus University Charter must be awarded as a prerequisite for HEI to organise student mobility and teaching and other staff mobility, to carry out Erasmus intensive language courses and intensive programmes, and to apply for multilateral projects, networks, accompanying measures and to organise preparatory visits. Erasmus University Charter is based on the LLP Decision (1) which covers the 2007 to 2013 period. The specific objectives of the LLP are listed in Article 1.3 of the Decision.

2.   ELIGIBLE APPLICANTS

The Erasmus University Charter applies to all Higher Education Institutions listed in Article 2.10 of the Decision.

Applicants must be established in one of the following countries:

| — | the 27 Member States of the European Union (as of 1 January 2007), |
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the 27 Member States of the European Union (as of 1 January 2007),

| — | the EFTA-EEA countries: Iceland, Liechtenstein, Norway, |
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the EFTA-EEA countries: Iceland, Liechtenstein, Norway,

| — | candidate countries: Turkey, Croatia, former Yugoslav Republic of Macedonia. |
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candidate countries: Turkey, Croatia, former Yugoslav Republic of Macedonia.

3.   DEADLINE FOR THE SUBMISSION OF APPLICATIONS

The deadline for submitting applications for the Erasmus University Charter is 30 June 2009.

4.   FULL DETAILS

The information about the Erasmus programme — Erasmus University Charter can be found in the full text of the ‘LLP General Call for proposals 2008-2010’ and the ‘LLP Programme Guide’ (2) which can be found at the following Internet address:

http://ec.europa.eu/llp

Applications must be submitted on the forms provided by the Education, Audiovisual and Culture Executive Agency and available at the address:

http://eacea.ec.europa.eu/llp/index_en.htm

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(1)  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. See http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:327:0045:0068:EN:PDF

(2)  The deadline for submitting applications for the Erasmus University Charter is 30 June 2009.

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1.5.2009

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NOTICE

On 1 May 2009, in Official Journal of the European Union C 101 A, the ‘Common catalogue of varieties of vegetable species — Third supplement to the 27th complete edition’ and the ‘Common catalogue of varieties of agricultural plant species — Fourth supplement to the 27th complete edition’ will be published.

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