# C_2006124EN.01001101.xml

| 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))

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1

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.

1

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

2

---

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

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