# Official Journal C 124/25 M

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 124 |
| | |
| English edition | Information and Notices | Volume 4925 May 2006 |

ISSN 1725-2423

Official Journal

of the European Union

C 124

English edition

Information and Notices

Volume 4925 May 2006

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| Notice No | Contents | page |
| --- | --- | --- |
| | I   Information |
| | Council |
| 2006/C 124/1 | Council Recommendation of 27 April 2006 on the drawing up of agreements between police, customs and other specialised law enforcement services in relation to the prevention and combating of crime | 1 |
| | Commission |
| 2006/C 124/2 | Euro exchange rates | 3 |
| 2006/C 124/3 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2006 to 30 April 2006(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 4 |
| 2006/C 124/4 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2006 to 30 April 2006(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 11 |
| 2006/C 124/5 | Prior notification of a concentration (Case COMP/M.4250 — Industri Kapital/Minimax) — Candidate case for simplified procedure (
  1
  ) | 32 |
| 2006/C 124/6 | Non-opposition to a notified concentration (Case COMP/M.3968 — Sovion/Südfleisch) (
  1
  ) | 33 |

Notice No

Contents

page

I   Information

Council

2006/C 124/1

Council Recommendation of 27 April 2006 on the drawing up of agreements between police, customs and other specialised law enforcement services in relation to the prevention and combating of crime

1

Commission

2006/C 124/2

Euro exchange rates

3

2006/C 124/3

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2006 to 30 April 2006(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)

4

2006/C 124/4

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2006 to 30 April 2006(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)

11

2006/C 124/5

Prior notification of a concentration (Case COMP/M.4250 — Industri Kapital/Minimax) — Candidate case for simplified procedure (
  1
  )

1

32

2006/C 124/6

Non-opposition to a notified concentration (Case COMP/M.3968 — Sovion/Südfleisch) (
  1
  )

1

33

| | III   Notices |
| --- | --- |
| | Commission |
| 2006/C 124/7 | Open call for proposals VP/2006/014 — 2006 — European Year of Workers' Mobility — Pilot Projects | 34 |

III   Notices

Commission

2006/C 124/7

Open call for proposals VP/2006/014 — 2006 — European Year of Workers' Mobility — Pilot Projects

34

| | Corrigenda |
| --- | --- |
| 2006/C 124/8 | Corrigendum to the communication of the European Centre for the Development of Vocational Training — Publication of the final accounts for the financial year 2004 (OJ C 269, 28.10.2005) | 35 |

Corrigenda

2006/C 124/8

Corrigendum to the communication of the European Centre for the Development of Vocational Training — Publication of the final accounts for the financial year 2004 (OJ C 269, 28.10.2005)

(OJ C 269, 28.10.2005)

35

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

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(1)   Text with EEA relevance

1

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

EN

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I Information

Council

| 25.5.2006 | EN | Official Journal of the European Union | C 124/1 |
| --- | --- | --- | --- |

25.5.2006

EN

Official Journal of the European Union

C 124/1

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COUNCIL RECOMMENDATION

of 27 April 2006

on the drawing up of agreements between police, customs and other specialised law enforcement services in relation to the prevention and combating of crime

(2006/C 124/01)

THE COUNCIL OF THE EUROPEAN UNION,

RECALLING that:

| (1) | one of the objectives of the European Union is the progressive establishment of an area of freedom, security and justice by developing common action among the Member States in the field of police and judicial cooperation in criminal matters; |
| --- | --- |

(1)

one of the objectives of the European Union is the progressive establishment of an area of freedom, security and justice by developing common action among the Member States in the field of police and judicial cooperation in criminal matters;

| (2) | this objective is to be achieved by preventing and combating crime, organised or otherwise, in particular terrorism, trafficking in persons and offences against children, illicit drug trafficking and illicit arms trafficking, corruption and fraud, notably through closer cooperation between police forces, customs authorities and other competent authorities in the Member States, there should also be increased cooperation with, and where appropriate between, EU bodies, Institutions and agencies such as the Commission (OLAF), Europol, Eurojust and Cepol; |
| --- | --- |

(2)

this objective is to be achieved by preventing and combating crime, organised or otherwise, in particular terrorism, trafficking in persons and offences against children, illicit drug trafficking and illicit arms trafficking, corruption and fraud, notably through closer cooperation between police forces, customs authorities and other competent authorities in the Member States, there should also be increased cooperation with, and where appropriate between, EU bodies, Institutions and agencies such as the Commission (OLAF), Europol, Eurojust and Cepol;

| (3) | the common action provided for by Article 30 of the Treaty on European Union in the field of police cooperation includes operational cooperation between the competent authorities, including the police, customs and other specialised law enforcement services of the Member States in relation to the prevention, detection and investigation of criminal offences; |
| --- | --- |

(3)

the common action provided for by Article 30 of the Treaty on European Union in the field of police cooperation includes operational cooperation between the competent authorities, including the police, customs and other specialised law enforcement services of the Member States in relation to the prevention, detection and investigation of criminal offences;

| (4) | in order to achieve this objective in the most efficient way, a high degree of cooperation is necessary at national level between the police, customs and other specialised law enforcement services; |
| --- | --- |

(4)

in order to achieve this objective in the most efficient way, a high degree of cooperation is necessary at national level between the police, customs and other specialised law enforcement services;

| (5) | the Hague programme on the strengthening of freedom, security and justice in the European Union, adopted by the European Council in November 2004, stressed that an optimal level of protection of the area of freedom, security and justice required multidisciplinary and concerted action both at EU level and at national level between the competent law enforcement authorities, especially police, customs and border guards; |
| --- | --- |

(5)

the Hague programme on the strengthening of freedom, security and justice in the European Union, adopted by the European Council in November 2004, stressed that an optimal level of protection of the area of freedom, security and justice required multidisciplinary and concerted action both at EU level and at national level between the competent law enforcement authorities, especially police, customs and border guards;

| (6) | the Commission issued Communications entitled ‘Enhancing police and customs cooperation in the European Union’, ‘Towards enhancing access to information by law enforcement agencies’, and ‘Developing a strategic concept on tackling organised crime’; |
| --- | --- |

(6)

the Commission issued Communications entitled ‘Enhancing police and customs cooperation in the European Union’, ‘Towards enhancing access to information by law enforcement agencies’, and ‘Developing a strategic concept on tackling organised crime’;

| (7) | different legal and administrative provisions or arrangements exist in Members States on the respective roles and functions of the police forces, customs authorities and other competent authorities in relation to the prevention and combating of crime; |
| --- | --- |

(7)

different legal and administrative provisions or arrangements exist in Members States on the respective roles and functions of the police forces, customs authorities and other competent authorities in relation to the prevention and combating of crime;

| (8) | in order to avoid duplication of efforts between police forces, customs authorities and other competent authorities and to make optimum use of their complementary resources, it is essential to promote and ensure a high level of liaison and cooperation, and an effective organisational response; |
| --- | --- |

(8)

in order to avoid duplication of efforts between police forces, customs authorities and other competent authorities and to make optimum use of their complementary resources, it is essential to promote and ensure a high level of liaison and cooperation, and an effective organisational response;

| (9) | the Council Resolution of 29 November 1996 on the drawing-up of police/customs agreements in the fight against drugs (1) urged Member States to establish agreements between police and customs services in the fight against drugs, and that the need to extend such agreements to other areas of crime has been recognised, |
| --- | --- |

(9)

the Council Resolution of 29 November 1996 on the drawing-up of police/customs agreements in the fight against drugs (1) urged Member States to establish agreements between police and customs services in the fight against drugs, and that the need to extend such agreements to other areas of crime has been recognised,

HEREBY RECOMMENDS THAT MEMBER STATES:

| 1. | take the necessary steps to establish, without prejudice to national legislative and administrative provisions, formal agreements or other arrangements at national level between police forces, customs authorities and other competent authorities in relation to the prevention and combating of crime; |
| --- | --- |

1.

take the necessary steps to establish, without prejudice to national legislative and administrative provisions, formal agreements or other arrangements at national level between police forces, customs authorities and other competent authorities in relation to the prevention and combating of crime;

| 2. | incorporate, in these agreements or other arrangements, in particular, provisions covering the following matters:






  (a) | precise delineation of, and respect for, the competencies of each service; |
| --- | --- | --- |

2.

incorporate, in these agreements or other arrangements, in particular, provisions covering the following matters:

(a)

precise delineation of, and respect for, the competencies of each service;

| (b) | exchange and sharing of relevant information and strategic, tactical and operational intelligence, where appropriate, in particular by facilitating mutual direct or indirect access to databases, with due regard for individual rights and data protection rules; |
| --- | --- |

(b)

exchange and sharing of relevant information and strategic, tactical and operational intelligence, where appropriate, in particular by facilitating mutual direct or indirect access to databases, with due regard for individual rights and data protection rules;

| (c) | development and promotion of best practices; |
| --- | --- |

(c)

development and promotion of best practices;

| (d) | procedures for operational matters, and where appropriate:






  — | joint actions, |
| --- | --- | --- |

(d)

procedures for operational matters, and where appropriate:

—

joint actions,

| — | joint mobile patrol squads, |
| --- | --- |

—

joint mobile patrol squads,

| — | joint investigation teams, |
| --- | --- |

—

joint investigation teams,

| — | joint intelligence teams, |
| --- | --- |

—

joint intelligence teams,

| — | sharing of equipment between services and cooperation on the development, purchasing, deployment and use of technology; |
| --- | --- |

—

sharing of equipment between services and cooperation on the development, purchasing, deployment and use of technology;

| (e) | exchange of liaison officers at headquarters level of the police forces, customs authorities and other competent authorities, and also at the Europol National Unit and at the national desks in Europol, with a view to enhancing mutual trust and facilitating communication, where deemed necessary and in accordance with national law; |
| --- | --- |

(e)

exchange of liaison officers at headquarters level of the police forces, customs authorities and other competent authorities, and also at the Europol National Unit and at the national desks in Europol, with a view to enhancing mutual trust and facilitating communication, where deemed necessary and in accordance with national law;

| (f) | joint training for the competent authorities, where applicable, with the support of CEPOL; |
| --- | --- |

(f)

joint training for the competent authorities, where applicable, with the support of CEPOL;

| (g) | exchange of information on and, where applicable, common evaluation of the application of, analysis and investigative techniques; |
| --- | --- |

(g)

exchange of information on and, where applicable, common evaluation of the application of, analysis and investigative techniques;

| (h) | exchange of criminal statistical data and, where applicable, development of a common system for the collection of such data; |
| --- | --- |

(h)

exchange of criminal statistical data and, where applicable, development of a common system for the collection of such data;

| (i) | as appropriate, promotion of a multi-agency platform concept at national level, consisting of officers from police forces, customs authorities and other competent authorities, in particular for the international exchange of information; |
| --- | --- |

(i)

as appropriate, promotion of a multi-agency platform concept at national level, consisting of officers from police forces, customs authorities and other competent authorities, in particular for the international exchange of information;

| (j) | possible participation in multilateral permanent cooperation structures between police, customs and other law enforcement services in regions at the internal borders of the Member States; |
| --- | --- |

(j)

possible participation in multilateral permanent cooperation structures between police, customs and other law enforcement services in regions at the internal borders of the Member States;

| (k) | putting in place close liaison arrangements at local level; |
| --- | --- |

(k)

putting in place close liaison arrangements at local level;

| (l) | joint press statements in the case of joint actions; |
| --- | --- |

(l)

joint press statements in the case of joint actions;

| 3. | inform the Council through the General Secretariat within three years of the measures they have taken following this Recommendation; |
| --- | --- |

3.

inform the Council through the General Secretariat within three years of the measures they have taken following this Recommendation;

| 4. | give effect to this Recommendation in replacement of the Resolution of 29 November 1996 on the drawing-up of police/customs agreements in the fight against drugs. |
| --- | --- |

4.

give effect to this Recommendation in replacement of the Resolution of 29 November 1996 on the drawing-up of police/customs agreements in the fight against drugs.

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(1)  OJ C 375, 12.12.1996, p. 1.

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Commission

| 25.5.2006 | EN | Official Journal of the European Union | C 124/3 |
| --- | --- | --- | --- |

25.5.2006

EN

Official Journal of the European Union

C 124/3

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Euro exchange rates (1)

24 May 2006

(2006/C 124/02)

1 euro=

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,2851 |
| JPY | Japanese yen | 143,86 |
| DKK | Danish krone | 7,4563 |
| GBP | Pound sterling | 0,68285 |
| SEK | Swedish krona | 9,3189 |
| CHF | Swiss franc | 1,5509 |
| ISK | Iceland króna | 93,34 |
| NOK | Norwegian krone | 7,8255 |
| BGN | Bulgarian lev | 1,9558 |
| CYP | Cyprus pound | 0,5750 |
| CZK | Czech koruna | 28,210 |
| EEK | Estonian kroon | 15,6466 |
| HUF | Hungarian forint | 263,33 |
| LTL | Lithuanian litas | 3,4528 |
| LVL | Latvian lats | 0,6960 |
| MTL | Maltese lira | 0,4293 |
| PLN | Polish zloty | 3,9602 |
| RON | Romanian leu | 3,5565 |
| SIT | Slovenian tolar | 239,64 |
| SKK | Slovak koruna | 37,850 |
| TRY | Turkish lira | 1,9870 |
| AUD | Australian dollar | 1,7023 |
| CAD | Canadian dollar | 1,4418 |
| HKD | Hong Kong dollar | 9,9667 |
| NZD | New Zealand dollar | 2,0500 |
| SGD | Singapore dollar | 2,0392 |
| KRW | South Korean won | 1 220,33 |
| ZAR | South African rand | 8,5392 |
| CNY | Chinese yuan renminbi | 10,3104 |
| HRK | Croatian kuna | 7,2668 |
| IDR | Indonesian rupiah | 12 054,24 |
| MYR | Malaysian ringgit | 4,681 |
| PHP | Philippine peso | 67,956 |
| RUB | Russian rouble | 34,6500 |
| THB | Thai baht | 49,425 |

Currency

Exchange rate

USD

US dollar

1,2851

JPY

Japanese yen

143,86

DKK

Danish krone

7,4563

GBP

Pound sterling

0,68285

SEK

Swedish krona

9,3189

CHF

Swiss franc

1,5509

ISK

Iceland króna

93,34

NOK

Norwegian krone

7,8255

BGN

Bulgarian lev

1,9558

CYP

Cyprus pound

0,5750

CZK

Czech koruna

28,210

EEK

Estonian kroon

15,6466

HUF

Hungarian forint

263,33

LTL

Lithuanian litas

3,4528

LVL

Latvian lats

0,6960

MTL

Maltese lira

0,4293

PLN

Polish zloty

3,9602

RON

Romanian leu

3,5565

SIT

Slovenian tolar

239,64

SKK

Slovak koruna

37,850

TRY

Turkish lira

1,9870

AUD

Australian dollar

1,7023

CAD

Canadian dollar

1,4418

HKD

Hong Kong dollar

9,9667

NZD

New Zealand dollar

2,0500

SGD

Singapore dollar

2,0392

KRW

South Korean won

1 220,33

ZAR

South African rand

8,5392

CNY

Chinese yuan renminbi

10,3104

HRK

Croatian kuna

7,2668

IDR

Indonesian rupiah

12 054,24

MYR

Malaysian ringgit

4,681

PHP

Philippine peso

67,956

RUB

Russian rouble

34,6500

THB

Thai baht

49,425

---

(1)

Source: reference exchange rate published by the ECB.

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| 25.5.2006 | EN | Official Journal of the European Union | C 124/4 |
| --- | --- | --- | --- |

25.5.2006

EN

Official Journal of the European Union

C 124/4

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2006 to 30 April 2006

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

(2006/C 124/03)

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

—

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.4.2006 | ProQuad | Measles, Mumps, Rubella and Varicella Vaccine (Live) | Sanofi Pasteur MSD |
| SNC |
| 8, rue Jonas Salk |
| F-69007 Lyon |

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

6.4.2006

ProQuad

Measles, Mumps, Rubella and Varicella Vaccine (Live)

Sanofi Pasteur MSD

SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/05/323/001-011

Powder and solvent for suspension for injection

J07BD54

10.4.2006

12.4.2006

Omnitrope

Somatropin

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

EU/1/06/332/001-003

Powder and solvent for solution for injection

H01AC01

20.4.2006

24.4.2006

Valtropin

Somatropin

| BioPartners GmbH |
| --- |
| Eisenstraße 3 |
| D-65428 Rüsselsheim |

BioPartners GmbH

Eisenstraße 3

D-65428 Rüsselsheim

EU/1/06/335/001

Powder and solvent for solution for injection (multi-use)

H01A C01

26.4.2006

24.4.2006

Preotact

Parathyroid hormone

| Nycomed Danmark ApS |
| --- |
| Langebjerg 1 |
| DK-4000 Roskilde |

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

EU/1/06/339/001-002

powder and solvent for sol for injection

H05 AA03

26.4.2006

24.4.2006

DuoTrav

Travoprost/Timolol

| Alcon Laboratories (UK) Ltd |
| --- |
| Boundary Way |
| Hemel Hempstead |
| Herts HP2 7UD |
| United Kingdom |

Alcon Laboratories (UK) Ltd

Boundary Way

Hemel Hempstead

Herts HP2 7UD

United Kingdom

EU/1/06/338/001-003

Eye drops, solution

S01ED51

26.4.2006

24.4.2006

Tygacil

Tigecycline

| Wyeth Europa Ltd |
| --- |
| Huntercombe Lane South, Taplow |
| Maidenhead, Berkshire SL6 0PH |
| United Kingdom |

Wyeth Europa Ltd

Huntercombe Lane South, Taplow

Maidenhead, Berkshire SL6 0PH

United Kingdom

EU/1/06/336/001

Powder for solution for infusion

(Non applicable)

26.4.2006

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

—

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 |
| --- | --- | --- | --- | --- |
| 3.4.2006 | Kogenate Bayer | Bayer HealthCare AG |
| D-51368 Leverkusen |
| Bayer AG |
| D-51368 Leverkusen |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.4.2006

Kogenate Bayer

Bayer HealthCare AG

D-51368 Leverkusen

Bayer AG

D-51368 Leverkusen

EU/1/00/143/001-006

5.4.2006

3.4.2006

Helixate NexGen

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

Bayer HealthCare AG

D-51368 Leverkusen

Bayer AG

D-51368 Leverkusen

EU/1/00/144/001-003

5.4.2006

3.4.2006

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/1/99/126/001-011

5.4.2006

6.4.2006

NeuroBloc

| Solstice Neurosciences Ltd |
| --- |
| Fitzwilton House |
| Wilton Place, Dublin 2, |
| Ireland |

Solstice Neurosciences Ltd

Fitzwilton House

Wilton Place, Dublin 2,

Ireland

EU/1/00/166/001-003

10.4.2006

6.4.2006

Sifrol

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

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/050/001-006

EU/1/97/050/009-012

10.4.2006

6.4.2006

Rapamune

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

EU/1/01/171/001

EU/1/01/171/007-012

10.4.2006

6.4.2006

Kaletra

| Abbott laboratories Ltd |
| --- |
| Queenborough |
| Kent ME11 5EL |
| United Kingdom |

Abbott laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/01/172/001-003

10.4.2006

6.4.2006

Mirapexin

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

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/97/051/001-006

EU/1/97/051/009-012

10.4.2006

10.4.2006

Trizivir

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

Glaxo Group Ltd

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/156/001-002

13.4.2006

10.4.2006

Zerit

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge UD8 1DH |
| United Kingdom |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UD8 1DH

United Kingdom

EU/1/96/009/001-009

13.4.2006

12.4.2006

Prevenar

| Wyeth-Lederle Vaccines S.A. |
| --- |
| Rue du Bosquet 15 |
| B-1348 Louvain-La-Neuve |

Wyeth-Lederle Vaccines S.A.

Rue du Bosquet 15

B-1348 Louvain-La-Neuve

EU/1/00/167/001-007

19.4.2006

18.4.2006

Vaniqa

| Shire Pharmaceutical Contracts Ltd |
| --- |
| Hampshire International Business Park |
| Chineham, Basingstoke |
| Hampshire RG24 8EP |
| United Kingdom |

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park

Chineham, Basingstoke

Hampshire RG24 8EP

United Kingdom

EU/1/01/173/001-003

20.4.2006

18.4.2006

Orfadin

| Swedish Orphan International AB |
| --- |
| Drottninggatan 98 |
| S-111 60 Stockholm |

Swedish Orphan International AB

Drottninggatan 98

S-111 60 Stockholm

EU/1/04/303/001-003

20.4.2006

18.4.2006

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

20.4.2006

24.4.2006

Zavesca

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor |
| 389 Chiswick High Road |
| London W4 4AL |
| United Kingdom |

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High Road

London W4 4AL

United Kingdom

EU/1/02/238/001

26.4.2006

24.4.2006

SonoVue

| Bracco International BV |
| --- |
| Strawinskylaan 3051 |
| 1077 ZX Amsterdam |
| Nederland |

Bracco International BV

Strawinskylaan 3051

1077 ZX Amsterdam

Nederland

EU/1/01/177/001-002

26.4.2006

24.4.2006

Xigris

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

Eli Lilly Nederland BV

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/02/225/001-002

26.4.2006

24.4.2006

Ammonaps

| Swedish Orphan International AB |
| --- |
| Drottninggatan 98 |
| S-111 60 Stockholm |
| Orphan Europe, Immeuble ‘Le Guillaumet’ |
| F-92046 Paris La Défense |

Swedish Orphan International AB

Drottninggatan 98

S-111 60 Stockholm

Orphan Europe, Immeuble ‘Le Guillaumet’

F-92046 Paris La Défense

EU/1/99/120/001-004

26.4.2006

24.4.2006

Trazec

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/175/001, EU/1/01/175/004-008, EU/1/01/175/011-015 EU/1/01/175/018-021

26.4.2006

24.4.2006

Starlix

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/174/001-021

26.4.2006

24.4.2006

Trisenox

| Cephalon UK Ltd |
| --- |
| 20 Alan Turing Road |
| Surrey Research Park |
| Guildford |
| Surrey, GU2 7YF |
| United Kingdom |
| Cell Therapeutics (UK) Limited |
| 100 Pall Mall |
| London SW1Y 5HP |
| United Kingdom |

Cephalon UK Ltd

20 Alan Turing Road

Surrey Research Park

Guildford

Surrey, GU2 7YF

United Kingdom

Cell Therapeutics (UK) Limited

100 Pall Mall

London SW1Y 5HP

United Kingdom

EU/1/02/204/001

27.4.2006

24.4.2006

Zometa

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/01/176/001-006

26.4.2006

24.4.2006

TARGRETIN

| Ligand Pharmaceuticals UK Ltd |
| --- |
| Innovis House |
| 108 High Street, Crawley |
| West Sussex RH10 1BB |
| United Kingdom |

Ligand Pharmaceuticals UK Ltd

Innovis House

108 High Street, Crawley

West Sussex RH10 1BB

United Kingdom

EU/1/01/178/001

26.4.2006

24.4.2006

Xolair

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/05/319/001-004

26.4.2006

27.4.2006

Emtriva

| Gilead Sciences International Limited |
| --- |
| Cambridge CB1 6GT |
| United Kingdom |

Gilead Sciences International Limited

Cambridge CB1 6GT

United Kingdom

EU/1/03/261/001-002

2.5.2006

27.4.2006

Aldara

| Laboratoires 3M Santé |
| --- |
| Boulevard de l'Oise |
| F-95029 Cergy Pontoise Cedex |

Laboratoires 3M Santé

Boulevard de l'Oise

F-95029 Cergy Pontoise Cedex

EU/1/98/080/001

2.5.2006

27.4.2006

Comtess

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

Orion Corporation, Orionintie 1

FIN-02200 Espoo

EU/1/98/082/001-004

2.5.2006

27.4.2006

Rebetol

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73 |
| B-1180 Bruxelles, — Stallestraat, 73 — B-1180 Brussel |

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles, — Stallestraat, 73 — B-1180 Brussel

EU/1/99/107/001-005

2.5.2006

27.4.2006

Axura

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstr. 100-104, |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100-104,

D-60318 Frankfurt/Main

EU/1/02/218/001-011

2.5.2006

27.4.2006

Abilify

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Commonwealth House |
| 2 Chalkhill Road |
| Hammersmith |
| London W6 8DW |
| United Kingdom |

Otsuka Pharmaceutical Europe Ltd

Commonwealth House

2 Chalkhill Road

Hammersmith

London W6 8DW

United Kingdom

EU/1/04/276/033-035

2.5.2006

27.4.2006

Lumigan

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

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

EU/1/02/205/001-002

2.5.2006

27.4.2006

Ebixa

| H. Lundbeck A/S, Ottiliavej 9 |
| --- |
| DK-2500 Valby |

H. Lundbeck A/S, Ottiliavej 9

DK-2500 Valby

EU/1/02/219/001-013

1.5.2006

27.4.2006

Levviax

| Aventis Pharma SA |
| --- |
| 20 Avenue Raymond Aron |
| F-92160 Antony |

Aventis Pharma SA

20 Avenue Raymond Aron

F-92160 Antony

EU/1/01/192/001-005

2.5.2006

27.4.2006

Ketek

| Aventis Pharma SA |
| --- |
| 20 Avenue Raymond Aron |
| F-92160 Antony |

Aventis Pharma SA

20 Avenue Raymond Aron

F-92160 Antony

EU/1/01/191/001-005

2.5.2006

27.4.2006

Taxotere

| Aventis Pharma SA |
| --- |
| 20 avenue Raymond Aron |
| F-92165 Antony Cedex |

Aventis Pharma SA

20 avenue Raymond Aron

F-92165 Antony Cedex

EU/1/95/002/001-002

4.5.2006

27.4.2006

Fasturtec

| Sanofi-Aventis, |
| --- |
| 174 avenue de France |
| F-75013 Paris |

Sanofi-Aventis,

174 avenue de France

F-75013 Paris

EU/1/00/170/001-002

2.5.2006

27.4.2006

PegIntron

| Schering Plough Europe |
| --- |
| Rue de Stalle 73 |
| B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel |

Schering Plough Europe

Rue de Stalle 73

B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel

EU/1/00/131/001-050

2.5.2006

27.4.2006

ViraferonPeg

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73 |
| B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel |

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel

EU/1/00/132/001-050

2.5.2006

27.4.2006

Viraferon

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73 |
| B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel |

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel

EU/1/99/128/001-037

2.5.2006

27.4.2006

IntronA

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73 |
| B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel |

Schering Plough Europe

Rue de Stalle, 73

B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel

EU/1/99/127/001-044

2.5.2006

27.4.2006

Keppra

| UCB SA |
| --- |
| Allée de la recherche, 60 |
| B-1070 Bruxelles |

UCB SA

Allée de la recherche, 60

B-1070 Bruxelles

EU/1/00/146/001-030

2.5.2006

| — | Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004) — Accepted |
| --- | --- |

—

Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004) — Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.4.2006 | Flexicam | Meloxicam | Omnipharm Ltd, The Spire |
| Egypt Road |
| Nottingham NG7 7GD |
| United Kingdom |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

10.4.2006

Flexicam

Meloxicam

Omnipharm Ltd, The Spire

Egypt Road

Nottingham NG7 7GD

United Kingdom

EU/2/06/058/001-003

oral suspension

QM01AC06

13.4.2006

| — | Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004) — Accepted |
| --- | --- |

—

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 |
| --- | --- | --- | --- | --- |
| 10.4.2006 | Porcilis Porcoli | Intervet International BV (NL) |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

10.4.2006

Porcilis Porcoli

Intervet International BV (NL)

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

EU/2/96/001/001-010

13.4.2006

18.4.2006

Eurican Herpes 205

| Merial, 29 avenue Tony Garnier |
| --- |
| F-69007 Lyon |

Merial, 29 avenue Tony Garnier

F-69007 Lyon

EU/2/01/029/001-003

20.4.2006

24.4.2006

Sevoflo

| Abbott laboratories Ltd |
| --- |
| Queenborough |
| Kent ME11 5EL |
| United Kingdom |

Abbott laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/2/02/035/007

26.4.2006

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| London E14 4HB |
| United Kingdom |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

London E14 4HB

United Kingdom

---

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

---

| 25.5.2006 | EN | Official Journal of the European Union | C 124/11 |
| --- | --- | --- | --- |

25.5.2006

EN

Official Journal of the European Union

C 124/11

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 April 2006 to 30 April 2006

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

(2006/C 124/04)

Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 3.4.2006 | Nifedipine | See Annex I | See Annex I | 4.4.2006 |
| 3.4.2006 | Adartrel | See Annex II | See Annex II | 4.4.2006 |
| 10.4.2006 | Prograf | See Annex III | See Annex III | 12.4.2006 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

3.4.2006

Nifedipine

See Annex I

See Annex I

4.4.2006

3.4.2006

Adartrel

See Annex II

See Annex II

4.4.2006

10.4.2006

Prograf

See Annex III

See Annex III

12.4.2006

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

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

| Member State | Marketing Authorisation Holder | Applicant | Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | | International Pharmaceutical Services (IPS) |
| Jozef Nellenslei 10 |
| B-2100 Deurne |

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Belgium

International Pharmaceutical Services (IPS)

Jozef Nellenslei 10

B-2100 Deurne

Nifedipine TEVA 30/60 mg retard

30 mg/60 mg

prolonged-release tablets

Oral use

Netherlands

| Pharmamatch BV |
| --- |
| Stationsweg Oost 281-D |
| 3931 ER Woudenberg |
| The Netherlands |

Pharmamatch BV

Stationsweg Oost 281-D

3931 ER Woudenberg

The Netherlands

Nifedipine Pharmamatch retard 30/60 mg

30 mg/60 mg

prolonged-release tablets

Oral use

United Kingdom

| Neolab Ltd. |
| --- |
| 57 High Street |
| Odiham |
| Hants |
| RG29 1LF |
| United Kingdom |

Neolab Ltd.

57 High Street

Odiham

Hants

RG29 1LF

United Kingdom

Neozipine XL 30/60 mg

30 mg/60 mg

prolonged-release tablets

Oral use

---

ANNEX II

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

| MMember state | Marketing authorization Holder | Applicant | Invented name | Strengths | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | | Laboratoire GlaxoSmithKline |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

MMember state

Marketing authorization Holder

Applicant

Invented name

Strengths

Pharmaceutical form

Route of administration

Austria

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Austria

Laboratoire GlaxoSmithKline, 100 Route de Versailles, F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Austria

Laboratoire GlaxoSmithKline, 100 Route de Versailles, F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Austria

Laboratoire GlaxoSmithKline, 100 Route de Versailles, F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Belgium

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Belgium

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Belgium

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Belgium

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Cyprus

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Cyprus

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Cyprus

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Cyprus

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Czech Republic

| GlaxoSmithKline s.r.o. |
| --- |
| Na Pankráci 17/1685 |
| CZ-140 21 Praha 4 |

GlaxoSmithKline s.r.o.

Na Pankráci 17/1685

CZ-140 21 Praha 4

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Czech Republic

| GlaxoSmithKline s.r.o. |
| --- |
| Na Pankráci 17/1685 |
| CZ-140 21 Praha 4 |

GlaxoSmithKline s.r.o.

Na Pankráci 17/1685

CZ-140 21 Praha 4

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Czech Republic

| GlaxoSmithKline s.r.o. |
| --- |
| Na Pankráci 17/1685 |
| CZ-140 21 Praha 4 |

GlaxoSmithKline s.r.o.

Na Pankráci 17/1685

CZ-140 21 Praha 4

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Czech Republic

| GlaxoSmithKline s.r.o. |
| --- |
| Na Pankráci 17/1685 |
| CZ-140 21 Praha 4 |

GlaxoSmithKline s.r.o.

Na Pankráci 17/1685

CZ-140 21 Praha 4

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Denmark

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Denmark

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Denmark

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Denmark

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Estonia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Estonia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Estonia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Estonia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Finland

| GlaxoSmithKline Oy |
| --- |
| Piispansilta 9 A |
| FIN-02230 Espoo |

GlaxoSmithKline Oy

Piispansilta 9 A

FIN-02230 Espoo

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Finland

| GlaxoSmithKline Oy |
| --- |
| Piispansilta 9 A |
| FIN-02230 Espoo |

GlaxoSmithKline Oy

Piispansilta 9 A

FIN-02230 Espoo

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Finland

| GlaxoSmithKline Oy |
| --- |
| Piispansilta 9 A |
| FIN-02230 Espoo |

GlaxoSmithKline Oy

Piispansilta 9 A

FIN-02230 Espoo

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Finland

| GlaxoSmithKline Oy |
| --- |
| Piispansilta 9 A |
| FIN-02230 Espoo |

GlaxoSmithKline Oy

Piispansilta 9 A

FIN-02230 Espoo

ADARTREL

2,0 mg

Film-coated tablet

Oral use

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Germany

| GlaxoSmithKline GmbH & Co. KG |
| --- |
| Theresienhöhe 11 |
| D-80339 München |

GlaxoSmithKline GmbH & Co. KG

Theresienhöhe 11

D-80339 München

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Germany

| GlaxoSmithKline GmbH & Co. KG |
| --- |
| Theresienhöhe 11 |
| D-80339 München |

GlaxoSmithKline GmbH & Co. KG

Theresienhöhe 11

D-80339 München

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Germany

| GlaxoSmithKline GmbH & Co. KG |
| --- |
| Theresienhöhe 11 |
| D-80339 München |

GlaxoSmithKline GmbH & Co. KG

Theresienhöhe 11

D-80339 München

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Germany

| GlaxoSmithKline GmbH & Co. KG |
| --- |
| Theresienhöhe 11 |
| D-80339 München |

GlaxoSmithKline GmbH & Co. KG

Theresienhöhe 11

D-80339 München

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Greece

| GlaxoSmithKline α.ε.β.ε |
| --- |
| Κηφισίας 266, 152 32 |
| Χαλάνδρι |
| Αθήνα |
| Ελλάδα |

GlaxoSmithKline α.ε.β.ε

Κηφισίας 266, 152 32

Χαλάνδρι

Αθήνα

Ελλάδα

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Greece

| GlaxoSmithKline α.ε.β.ε |
| --- |
| Κηφισίας 266, 152 32 |
| Χαλάνδρι |
| Αθήνα |
| Ελλάδα |

GlaxoSmithKline α.ε.β.ε

Κηφισίας 266, 152 32

Χαλάνδρι

Αθήνα

Ελλάδα

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Greece

| GlaxoSmithKline α.ε.β.ε |
| --- |
| Κηφισίας 266, 152 32 |
| Χαλάνδρι |
| Αθήνα |
| Ελλάδα |

GlaxoSmithKline α.ε.β.ε

Κηφισίας 266, 152 32

Χαλάνδρι

Αθήνα

Ελλάδα

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Greece

| GlaxoSmithKline α.ε.β.ε |
| --- |
| Κηφισίας 266, 152 32 |
| Χαλάνδρι |
| Αθήνα |
| Ελλάδα |

GlaxoSmithKline α.ε.β.ε

Κηφισίας 266, 152 32

Χαλάνδρι

Αθήνα

Ελλάδα

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Hungary

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Hungary

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Hungary

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Hungary

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Iceland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Iceland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Iceland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Iceland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Ireland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Ireland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Ireland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Ireland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Italy

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Italy

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Italy

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Italy

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Latvia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Latvia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Latvia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Latvia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Lithuania

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Lithuania

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Lithuania

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Lithuania

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Luxembourg

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Luxembourg

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Luxembourg

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Luxembourg

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Malta

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Malta

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Malta

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Malta

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Netherlands

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Netherlands

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Netherlands

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Netherlands

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Norway

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Norway

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Norway

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Norway

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Poland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Poland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Poland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Poland

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Portugal

| Beecham Portuguesa |
| --- |
| Produtos Farmacêuticos e Químicos, Lda. |
| Rua Dr. António Loureiro Borges, n.o 3 |
| Arquiparque — Miraflores |
| P-1495-131 Algés |

Beecham Portuguesa

Produtos Farmacêuticos e Químicos, Lda.

Rua Dr. António Loureiro Borges, n.o 3

Arquiparque — Miraflores

P-1495-131 Algés

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Portugal

| Beecham Portuguesa |
| --- |
| Produtos Farmacêuticos e Químicos, Lda. |
| Rua Dr. António Loureiro Borges, n.o 3 |
| Arquiparque — Miraflores |
| P-1495-131 Algés |

Beecham Portuguesa

Produtos Farmacêuticos e Químicos, Lda.

Rua Dr. António Loureiro Borges, n.o 3

Arquiparque — Miraflores

P-1495-131 Algés

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Portugal

| Beecham Portuguesa |
| --- |
| Produtos Farmacêuticos e Químicos, Lda. |
| Rua Dr. António Loureiro Borges, n.o 3 |
| Arquiparque — Miraflores |
| P-1495-131 Algés |

Beecham Portuguesa

Produtos Farmacêuticos e Químicos, Lda.

Rua Dr. António Loureiro Borges, n.o 3

Arquiparque — Miraflores

P-1495-131 Algés

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Portugal

| Beecham Portuguesa |
| --- |
| Produtos Farmacêuticos e Químicos, Lda. |
| Rua Dr. António Loureiro Borges, n.o 3 |
| Arquiparque — Miraflores |
| P-1495-131 Algés |

Beecham Portuguesa

Produtos Farmacêuticos e Químicos, Lda.

Rua Dr. António Loureiro Borges, n.o 3

Arquiparque — Miraflores

P-1495-131 Algés

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Slovakia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Slovakia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Slovakia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Slovakia

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Knezov stradon 90 |
| SLO-1000 Ljubljana |

GSK d.o.o., Ljubljana

Knezov stradon 90

SLO-1000 Ljubljana

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Knezov stradon 90 |
| SLO-1000 Ljubljana |

GSK d.o.o., Ljubljana

Knezov stradon 90

SLO-1000 Ljubljana

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Knezov stradon 90 |
| SLO-1000 Ljubljana |

GSK d.o.o., Ljubljana

Knezov stradon 90

SLO-1000 Ljubljana

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Knezov stradon 90 |
| SLO-1000 Ljubljana |

GSK d.o.o., Ljubljana

Knezov stradon 90

SLO-1000 Ljubljana

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Spain

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Spain

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Spain

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Spain

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

Sweden

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

Sweden

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

Sweden

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

Sweden

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

UK

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,25 mg

Film-coated tablet

Oral use

UK

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

0,5 mg

Film-coated tablet

Oral use

UK

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

1,0 mg

Film-coated tablet

Oral use

UK

| Laboratoire GlaxoSmithKline |
| --- |
| 100 Route de Versailles |
| F-78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100 Route de Versailles

F-78163 Marly-le-Roi Cedex

ADARTREL

2,0 mg

Film-coated tablet

Oral use

---

ANNEX III

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Astellas Pharma Ges.m.b.H |
| Linzerstr. 221-227 |
| A-1140 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Astellas Pharma Ges.m.b.H

Linzerstr. 221-227

A-1140 Wien

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenoius use

Austria

| Astellas Pharma Ges.m.b.H |
| --- |
| Linzerstr. 221-227 |
| A-1140 Wien |

Astellas Pharma Ges.m.b.H

Linzerstr. 221-227

A-1140 Wien

Prograf

0,5 mg

Hard Capsules

Oral use

Austria

| Astellas Pharma Ges.m.b.H |
| --- |
| Linzerstr. 221-227 |
| A-1140 Wien |

Astellas Pharma Ges.m.b.H

Linzerstr. 221-227

A-1140 Wien

Prograf

1 mg

Hard Capsules

Oral use

Austria

| Astellas Pharma Ges.m.b.H |
| --- |
| Linzerstr. 221-227 |
| A-1140 Wien |

Astellas Pharma Ges.m.b.H

Linzerstr. 221-227

A-1140 Wien

Prograf

5 mg

Hard Capsules

Oral use

Belgium

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograft

0,5 mg

Hard Capsules

Oral use

Belgium

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograft

1 mg

Hard Capsules

Oral use

Belgium

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograft

5 mg

Hard Capsules

Oral use

Belgium

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograft

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Cyprus

| Medilink Pharmaceuticals Ltd. |
| --- |
| 30 Armenias |
| P.O. Box 25676 |
| 2003 Strovolos |
| 1640 Nikosia |
| Cyprus |

Medilink Pharmaceuticals Ltd.

30 Armenias

P.O. Box 25676

2003 Strovolos

1640 Nikosia

Cyprus

Prograf

1 mg

Hard Capsules

Oral use

Cyprus

| Medilink Pharmaceuticals Ltd. |
| --- |
| 30 Armenias |
| P.O. Box 25676 |
| 2003 Strovolos |
| 1640 Nikosia |
| Cyprus |

Medilink Pharmaceuticals Ltd.

30 Armenias

P.O. Box 25676

2003 Strovolos

1640 Nikosia

Cyprus

Prograf

5 mg

Hard Capsules

Oral use

Cyprus

| Medilink Pharmaceuticals Ltd. |
| --- |
| 30 Armenias |
| P.O. Box 25676 |
| 2003 Strovolos |
| 1640 Nikosia |
| Cyprus |

Medilink Pharmaceuticals Ltd.

30 Armenias

P.O. Box 25676

2003 Strovolos

1640 Nikosia

Cyprus

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Czech Republic

| Astellas Pharma s.r.o |
| --- |
| Meteor Office Centre Park |
| Sokolovská 100/94 |
| CZ-186 00 Praha 8 |

Astellas Pharma s.r.o

Meteor Office Centre Park

Sokolovská 100/94

CZ-186 00 Praha 8

Prograf

0,5 mg

Hard Capsules

Oral use

Czech Republic

| Astellas Pharma s.r.o |
| --- |
| Meteor Office Centre Park |
| Sokolovská 100/94 |
| CZ-186 00 Praha 8 |

Astellas Pharma s.r.o

Meteor Office Centre Park

Sokolovská 100/94

CZ-186 00 Praha 8

Prograf

1 mg

Hard Capsules

Oral use

Czech Republic

| Astellas Pharma s.r.o |
| --- |
| Meteor Office Centre Park |
| Sokolovská 100/94 |
| CZ-186 00 Praha 8 |

Astellas Pharma s.r.o

Meteor Office Centre Park

Sokolovská 100/94

CZ-186 00 Praha 8

Prograf

5 mg

Hard Capsules

Oral use

Czech Republic

| Astellas Pharma s.r.o |
| --- |
| Meteor Office Centre Park |
| Sokolovská 100/94 |
| CZ-186 00 Praha 8 |

Astellas Pharma s.r.o

Meteor Office Centre Park

Sokolovská 100/94

CZ-186 00 Praha 8

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Germany

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

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

Prograf

0,5 mg

Hard Capsules

Oral use

Germany

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

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

Prograf

1 mg

Hard Capsules

Oral use

Germany

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

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

Prograf

5 mg

Hard Capsules

Oral use

Germany

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

Astellas Pharma GmbH

Neumarkter Str. 61

D-81673 München

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Denmark

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

0,5 mg

Hard Capsules

Oral use

Denmark

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

1 mg

Hard Capsules

Oral use

Denmark

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

5 mg

Hard Capsules

Oral use

Denmark

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Greece

| Vianex S.A. |
| --- |
| Tatoiou Street |
| Lamia National Road |
| EL-14671 Nea Erythrea |

Vianex S.A.

Tatoiou Street

Lamia National Road

EL-14671 Nea Erythrea

Prograf

0,5 mg

Hard Capsules

Oral use

Greece

| Vianex S.A. |
| --- |
| Tatoiou Street |
| Lamia National Road |
| EL-14671 Nea Erythrea |

Vianex S.A.

Tatoiou Street

Lamia National Road

EL-14671 Nea Erythrea

Prograf

1 mg

Hard Capsules

Oral use

Greece

| Vianex S.A. |
| --- |
| Tatoiou Street |
| Lamia National Road |
| EL-14671 Nea Erythrea |

Vianex S.A.

Tatoiou Street

Lamia National Road

EL-14671 Nea Erythrea

Prograf

5 mg

Hard Capsules

Oral use

Greece

| Vianex S.A. |
| --- |
| Tatoiou Street |
| Lamia National Road |
| EL-14671 Nea Erythrea |

Vianex S.A.

Tatoiou Street

Lamia National Road

EL-14671 Nea Erythrea

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Spain

| Astellas Pharma S.A. |
| --- |
| Paseo del Club Deportivo |
| no 1, Bloque 14 |
| E-28223 Pozuelo de Alarcón (Madrid) |

Astellas Pharma S.A.

Paseo del Club Deportivo

no 1, Bloque 14

E-28223 Pozuelo de Alarcón (Madrid)

Prograf

0,5 mg

Hard Capsules

Oral use

Spain

| Astellas Pharma S.A. |
| --- |
| Paseo del Club Deportivo |
| no 1, Bloque 14 |
| E-28223 Pozuelo de Alarcón (Madrid) |

Astellas Pharma S.A.

Paseo del Club Deportivo

no 1, Bloque 14

E-28223 Pozuelo de Alarcón (Madrid)

Prograf

1 mg

Hard Capsules

Oral use

Spain

| Astellas Pharma S.A. |
| --- |
| Paseo del Club Deportivo |
| no 1, Bloque 14 |
| E-28223 Pozuelo de Alarcón (Madrid) |

Astellas Pharma S.A.

Paseo del Club Deportivo

no 1, Bloque 14

E-28223 Pozuelo de Alarcón (Madrid)

Prograf

5 mg

Hard Capsules

Oral use

Spain

| Astellas Pharma S.A. |
| --- |
| Paseo del Club Deportivo |
| no 1, Bloque 14 |
| E-28223 Pozuelo de Alarcón (Madrid) |

Astellas Pharma S.A.

Paseo del Club Deportivo

no 1, Bloque 14

E-28223 Pozuelo de Alarcón (Madrid)

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Finland

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

0,5 mg

Hard Capsules

Oral use

Finland

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

1 mg

Hard Capsules

Oral use

Finland

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

5 mg

Hard Capsules

Oral use

Finland

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

France

| Astellas Pharma S.A.S. |
| --- |
| 114 rue Victor Hugo |
| F-92300 Levallois Perret |

Astellas Pharma S.A.S.

114 rue Victor Hugo

F-92300 Levallois Perret

Prograf

0,5 mg

Hard Capsules

Oral use

France

| Astellas Pharma S.A.S. |
| --- |
| 114 rue Victor Hugo |
| F-92300 Levallois Perret |

Astellas Pharma S.A.S.

114 rue Victor Hugo

F-92300 Levallois Perret

Prograf

1 mg

Hard Capsules

Oral use

France

| Astellas Pharma S.A.S. |
| --- |
| 114 rue Victor Hugo |
| F-92300 Levallois Perret |

Astellas Pharma S.A.S.

114 rue Victor Hugo

F-92300 Levallois Perret

Prograf

5 mg

Hard Capsules

Oral use

France

| Astellas Pharma S.A.S. |
| --- |
| 114 rue Victor Hugo |
| F-92300 Levallois Perret |

Astellas Pharma S.A.S.

114 rue Victor Hugo

F-92300 Levallois Perret

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Hungary

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

0,5 mg

Hard Capsules

Oral use

Hungary

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

1 mg

Hard Capsules

Oral use

Hungary

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

5 mg

Hard Capsules

Oral use

Hungary

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Ireland

| Astellas Pharma Co. Ltd. |
| --- |
| 25, The Courtyard |
| Kilcarbery Business Park |
| Clondalkin, Dublin 22 |
| Ireland |

Astellas Pharma Co. Ltd.

25, The Courtyard

Kilcarbery Business Park

Clondalkin, Dublin 22

Ireland

Prograf

0,5 mg

Hard Capsules

Oral use

Ireland

| Astellas Pharma Co. Ltd. |
| --- |
| 25, The Courtyard |
| Kilcarbery Business Park |
| Clondalkin, Dublin 22 |
| Ireland |

Astellas Pharma Co. Ltd.

25, The Courtyard

Kilcarbery Business Park

Clondalkin, Dublin 22

Ireland

Prograf

1 mg

Hard Capsules

Oral use

Ireland

| Astellas Pharma Co. Ltd. |
| --- |
| 25, The Courtyard |
| Kilcarbery Business Park |
| Clondalkin, Dublin 22 |
| Ireland |

Astellas Pharma Co. Ltd.

25, The Courtyard

Kilcarbery Business Park

Clondalkin, Dublin 22

Ireland

Prograf

5 mg

Hard Capsules

Oral use

Ireland

| Astellas Pharma Co. Ltd. |
| --- |
| 25, The Courtyard |
| Kilcarbery Business Park |
| Clondalkin, Dublin 22 |
| Ireland |

Astellas Pharma Co. Ltd.

25, The Courtyard

Kilcarbery Business Park

Clondalkin, Dublin 22

Ireland

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Italy

| Astellas Pharma S.p.A |
| --- |
| Via delle Industrie 1 |
| I-20061 Carugate (Milano) |

Astellas Pharma S.p.A

Via delle Industrie 1

I-20061 Carugate (Milano)

Prograf

0,5 mg

Hard Capsules

Oral use

Italy

| Astellas Pharma S.p.A |
| --- |
| Via delle Industrie 1 |
| I-20061 Carugate (Milano) |

Astellas Pharma S.p.A

Via delle Industrie 1

I-20061 Carugate (Milano)

Prograf

1 mg

Hard Capsules

Oral use

Italy

| Astellas Pharma S.p.A |
| --- |
| Via delle Industrie 1 |
| I-20061 Carugate (Milano) |

Astellas Pharma S.p.A

Via delle Industrie 1

I-20061 Carugate (Milano)

Prograf

5 mg

Hard Capsules

Oral use

Italy

| Astellas Pharma S.p.A |
| --- |
| Via delle Industrie 1 |
| I-20061 Carugate (Milano) |

Astellas Pharma S.p.A

Via delle Industrie 1

I-20061 Carugate (Milano)

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Luxembourg

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograft

0,5 mg

Hard Capsules

Oral use

Luxembourg

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograft

1 mg

Hard Capsules

Oral use

Luxembourg

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograft

5 mg

Hard Capsules

Oral use

Luxembourg

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograft

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

The Netherlands

| Astellas Pharma B.V. |
| --- |
| Postbus 108 |
| 2350 AC Leiderdorp |
| The Netherlands |

Astellas Pharma B.V.

Postbus 108

2350 AC Leiderdorp

The Netherlands

Prograft

0,5 mg

Hard Capsules

Oral use

The Netherlands

| Astellas Pharma B.V. |
| --- |
| Postbus 108 |
| 2350 AC Leiderdorp |
| The Netherlands |

Astellas Pharma B.V.

Postbus 108

2350 AC Leiderdorp

The Netherlands

Prograft

1 mg

Hard Capsules

Oral use

The Netherlands

| Astellas Pharma B.V. |
| --- |
| Postbus 108 |
| 2350 AC Leiderdorp |
| The Netherlands |

Astellas Pharma B.V.

Postbus 108

2350 AC Leiderdorp

The Netherlands

Prograft

5 mg

Hard Capsules

Oral use

The Netherlands

| Astellas Pharma B.V. |
| --- |
| Postbus 108 |
| 2350 AC Leiderdorp |
| The Netherlands |

Astellas Pharma B.V.

Postbus 108

2350 AC Leiderdorp

The Netherlands

Prograft

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Norway

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

0,5 mg

Hard Capsules

Oral use

Norway

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

1 mg

Hard Capsules

Oral use

Norway

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

5 mg

Hard Capsules

Oral use

Norway

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Poland

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

0,5 mg

Hard Capsules

Oral use

Poland

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

1 mg

Hard Capsules

Oral use

Poland

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

5 mg

Hard Capsules

Oral use

Poland

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Portugal

| Astellas Farma Limitada |
| --- |
| Edifício Cinema |
| Rua José Fontana, n°1, 1o andar |
| P-2770-101 Paço de Arcos |

Astellas Farma Limitada

Edifício Cinema

Rua José Fontana, n°1, 1o andar

P-2770-101 Paço de Arcos

Prograf

0,5 mg

Hard Capsules

Oral use

Portugal

| Astellas Farma Limitada |
| --- |
| Edifício Cinema |
| Rua José Fontana, n°1, 1o andar |
| P-2770-101 Paço de Arcos |

Astellas Farma Limitada

Edifício Cinema

Rua José Fontana, n°1, 1o andar

P-2770-101 Paço de Arcos

Prograf

1 mg

Hard Capsules

Oral use

Portugal

| Astellas Farma Limitada |
| --- |
| Edifício Cinema |
| Rua José Fontana, n°1, 1o andar |
| P-2770-101 Paço de Arcos |

Astellas Farma Limitada

Edifício Cinema

Rua José Fontana, n°1, 1o andar

P-2770-101 Paço de Arcos

Prograf

5 mg

Hard Capsules

Oral use

Portugal

| Astellas Farma Limitada |
| --- |
| Edifício Cinema |
| Rua José Fontana, n°1, 1o andar |
| P-2770-101 Paço de Arcos |

Astellas Farma Limitada

Edifício Cinema

Rua José Fontana, n°1, 1o andar

P-2770-101 Paço de Arcos

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Slovakia

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

1 mg

Hard Capsules

Oral use

Slovakia

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

5 mg

Hard Capsules

Oral use

Slovakia

| Fujisawa GmbH |
| --- |
| Neumarkter Str. 61 |
| D-81673 München |

Fujisawa GmbH

Neumarkter Str. 61

D-81673 München

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

Slovenia

| PharmaSwiss d.o.o. |
| --- |
| Wolfova 1 |
| SLO-1000 Ljubljana |

PharmaSwiss d.o.o.

Wolfova 1

SLO-1000 Ljubljana

Prograf

1 mg

Hard Capsules

Oral use

Slovenia

| PharmaSwiss d.o.o. |
| --- |
| Wolfova 1 |
| SLO-1000 Ljubljana |

PharmaSwiss d.o.o.

Wolfova 1

SLO-1000 Ljubljana

Prograf

5 mg

Hard Capsules

Oral use

Sweden

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

0,5 mg

Hard Capsules

Oral use

Sweden

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

1 mg

Hard Capsules

Oral use

Sweden

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

5 mg

Hard Capsules

Oral use

Sweden

| Astellas Pharma a/s |
| --- |
| Naverland 4 |
| DK-2600 Glostrup |

Astellas Pharma a/s

Naverland 4

DK-2600 Glostrup

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

United Kingdom

| Astellas Pharma Ltd. |
| --- |
| Lovett House, Lovett Road |
| Staines |
| Middlesex, TW18 3AZ |
| United Kingdom |

Astellas Pharma Ltd.

Lovett House, Lovett Road

Staines

Middlesex, TW18 3AZ

United Kingdom

Prograf

0,5 mg

Hard Capsules

Oral use

United Kingdom

| Astellas Pharma Ltd. |
| --- |
| Lovett House, Lovett Road |
| Staines |
| Middlesex, TW18 3AZ |
| United Kingdom |

Astellas Pharma Ltd.

Lovett House, Lovett Road

Staines

Middlesex, TW18 3AZ

United Kingdom

Prograf

1 mg

Hard Capsules

Oral use

United Kingdom

| Astellas Pharma Ltd. |
| --- |
| Lovett House, Lovett Road |
| Staines |
| Middlesex, TW18 3AZ |
| United Kingdom |

Astellas Pharma Ltd.

Lovett House, Lovett Road

Staines

Middlesex, TW18 3AZ

United Kingdom

Prograf

5 mg

Hard Capsules

Oral use

United Kingdom

| Astellas Pharma Ltd. |
| --- |
| Lovett House, Lovett Road |
| Staines |
| Middlesex, TW18 3AZ |
| United Kingdom |

Astellas Pharma Ltd.

Lovett House, Lovett Road

Staines

Middlesex, TW18 3AZ

United Kingdom

Prograf

5 mg/ml

Concentrate for Solution for Infusion

Intravenous use

---

| 25.5.2006 | EN | Official Journal of the European Union | C 124/32 |
| --- | --- | --- | --- |

25.5.2006

EN

Official Journal of the European Union

C 124/32

---

Prior notification of a concentration

(Case COMP/M.4250 — Industri Kapital/Minimax)

Candidate case for simplified procedure

(2006/C 124/05)

(Text with EEA relevance)

| 1. | On 17 may 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Industri Kapital B.V. acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking Minimax Beteiligungs GmbH (‘Minimax’, Germany), controlled by MIMX B.V. (The Netherlands) by way of purchase of shares |
| --- | --- |

1.

On 17 may 2006, the Commission received a notification of a proposed concentration pursuant to Article 4 of Council Regulation (EC) No 139/2004 (1) by which the undertaking Industri Kapital B.V. acquires within the meaning of Article 3(1)(b) of the Council Regulation control of the whole of the undertaking Minimax Beteiligungs GmbH (‘Minimax’, Germany), controlled by MIMX B.V. (The Netherlands) by way of purchase of shares

| 2. | The business activities of the undertakings concerned are:






  — | for Industri Kapital B.V.: European private equity investment firm; |
| --- | --- | --- |

2.

The business activities of the undertakings concerned are:

—

for Industri Kapital B.V.: European private equity investment firm;

| — | for Minimax: manufacture and sale of fire protection systems. |
| --- | --- |

—

for Minimax: manufacture and sale of fire protection systems.

| 3. | On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice. |
| --- | --- |

3.

On preliminary examination, the Commission finds that the notified transaction could fall within the scope of Regulation (EC) No 139/2004. However, the final decision on this point is reserved. Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2) it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

| 4. | The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.
  Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4250 — Industri Kapital/Minimax, to the following address:





  European Commission |
| --- | --- |
| Competition DG |
| Merger Registry |
| J-70 |
| B-1049 Brussels |

4.

The Commission invites interested third parties to submit their possible observations on the proposed operation to the Commission.

Observations must reach the Commission not later than 10 days following the date of this publication. Observations can be sent to the Commission by fax (No (32-2) 296 43 01 or 296 72 44) or by post, under reference number COMP/M.4250 — Industri Kapital/Minimax, to the following address:

European Commission

Competition DG

Merger Registry

J-70

B-1049 Brussels

---

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

(2)  OJ C 56, 5.3.2005, p. 32.

---

| 25.5.2006 | EN | Official Journal of the European Union | C 124/33 |
| --- | --- | --- | --- |

25.5.2006

EN

Official Journal of the European Union

C 124/33

---

Non-opposition to a notified concentration

(Case COMP/M.3968 — Sovion/Südfleisch)

(2006/C 124/06)

(Text with EEA relevance)

On 21 December 2005, the Commission decided not to oppose the above notified concentration and to declare it compatible with the common market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004. The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

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

—

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 32005M3968. EUR-Lex is the on-line access to European law. (http://ec.europa.eu/eur-lex/lex) |
| --- | --- |

—

in electronic form on the EUR-Lex website under document number 32005M3968. EUR-Lex is the on-line access to European law. (http://ec.europa.eu/eur-lex/lex)

---

III Notices

Commission

| 25.5.2006 | EN | Official Journal of the European Union | C 124/34 |
| --- | --- | --- | --- |

25.5.2006

EN

Official Journal of the European Union

C 124/34

---

OPEN CALL FOR PROPOSALS VP/2006/014

2006 — European Year of Workers' Mobility

Pilot Projects

(2006/C 124/07)

The purpose of the present call for proposals is the co-funding of a limited number of pilot projects in order to:

| — | develop and test innovative instruments which facilitate the geographic and labour market mobility of workers and their families and remove existing obstacles to mobility; |
| --- | --- |

—

develop and test innovative instruments which facilitate the geographic and labour market mobility of workers and their families and remove existing obstacles to mobility;

| — | transfer between sectors, regions and countries or mainstream existing successful instruments and practices in the area of mobility. |
| --- | --- |

—

transfer between sectors, regions and countries or mainstream existing successful instruments and practices in the area of mobility.

All projects need to evidence a clear European added value and should be able to be reproduced in other contexts. They should involve relevant stakeholders and should have the potential to lead to new policy initiatives.

Proposals must be developed and implemented by a partnership, preferably at transnational level, and must involve at least two relevant stakeholders potentially interested in the objectives of the call (i.e. public authorities and social partner organisations, non governmental organisations, public-private partnerships, academia, municipalities, etc).

The budget available for the present call is EUR 2 million. The Commission will co-finance projects up to a maximum of 85 % of the total eligible costs. Depending on the quality of the applications the Commission expects to fund between 5 and 8 projects (average grant EUR 300 000).

The deadline for the submission of applications is 17.7.2006.

Full information regarding the call for proposals, including the guide for applicants and all relevant documentation can be downloaded at the following address:

http://ec.europa.eu/employment_social/emplweb/tenders/index_en.cfm

Please note that enquiries should be made by e-mail only to:

empl-e-vp/2006/014@ec.europa.eu

---

Corrigenda

| 25.5.2006 | EN | Official Journal of the European Union | C 124/35 |
| --- | --- | --- | --- |

25.5.2006

EN

Official Journal of the European Union

C 124/35

---

Corrigendum to the communication of the European Centre for the Development of Vocational Training — Publication of the final accounts for the financial year 2004

(
  Official Journal of the European Union C 269 of 28 October 2005
  )

On page 31, table 2, Revenue and expenditure account for the financial years 2004 and 2003 should read as follows:

‘Table 2

Revenue and expenditure account for the financial years 2004 and 2003

| (1000 EUR) |
| --- |
| | 2004 | 2003 |
| Revenue |
| Commission subsidies | 13 700 | 14 500 |
| Revenue from previous financial years | 0 | 0 |
| Miscellaneous revenue | 42 | 3 |
| Assigned revenue (Phare and third countries) | 724 | 792 |
| Financial revenue | 0 | 0 |
| Total revenue (a) | 14 466 | 15 295 |
| Budgetary expenditure for the financial year |
| Staff — Title I of the budget |
| Payments | 8 579 | 7 554 |
| Appropriations carried over | 466 | 443 |
| Administration — Title II of the budget |
| Payments | 768 | 778 |
| Appropriations carried over | 542 | 358 |
| Operating activities — Title III of the budget (except for assigned revenue) |
| Payments | 2 508 | 2 381 |
| Payments on RAL (outstanding commitments)at 31.12.2003 | 2 702 | |
| Appropriations carried over | 0 | 3 138 |
| Assigned revenue (Phare and third countries) |
| Payments | 416 | 546 |
| Appropriations carried over | 309 | 246 |
| Total expenditure (b) | 16 290 | 15 444 |
| Outturn for the financial year (a - b) | – 1 824 | – 149 |
| Balance carried over from the previous financial year | – 993 | – 545 |
| Appropriations carried over and cancelled | 56 | 399 |
| Neutralisation of the carry-over n-1 in Title 3 linked to the change to differentiated appropriations | 3 138 | |
| Sums for reuse from the previous financial year not used | 1 | 10 |
| Refunds to the Commission | | – 716 |
| Exchange-rate differences | – 4 | 8 |
| Balance for the financial year | 374 | – 993’ |

(1000 EUR)

2004

2003

Revenue

Commission subsidies

13 700

14 500

Revenue from previous financial years

0

0

Miscellaneous revenue

42

3

Assigned revenue (Phare and third countries)

724

792

Financial revenue

0

0

Total revenue (a)

14 466

15 295

Budgetary expenditure for the financial year

Staff — Title I of the budget

Payments

8 579

7 554

Appropriations carried over

466

443

Administration — Title II of the budget

Payments

768

778

Appropriations carried over

542

358

Operating activities — Title III of the budget (except for assigned revenue)

Payments

2 508

2 381

Payments on RAL (outstanding commitments)at 31.12.2003

2 702

Appropriations carried over

0

3 138

Assigned revenue (Phare and third countries)

Payments

416

546

Appropriations carried over

309

246

Total expenditure (b)

16 290

15 444

Outturn for the financial year (a - b)

– 1 824

– 149

Balance carried over from the previous financial year

– 993

– 545

Appropriations carried over and cancelled

56

399

Neutralisation of the carry-over n-1 in Title 3 linked to the change to differentiated appropriations

3 138

Sums for reuse from the previous financial year not used

1

10

Refunds to the Commission

– 716

Exchange-rate differences

– 4

8

Balance for the financial year

374

– 993’

---