# C_2007288EN.01001401.xml

| 30.11.2007 | EN | Official Journal of the European Union | C 288/14 |
| --- | --- | --- | --- |

30.11.2007

EN

Official Journal of the European Union

C 288/14

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2007 to 31 October 2007

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
   (1)
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
   (2)
  )

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

1

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

2

)

(2007/C 288/05)

—   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 |
| --- | --- | --- | --- | --- |
| 3.10.2007 | Aclasta | Novartis Europharm Limited |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

3.10.2007

Aclasta

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

This Decision is addressed to all Member States

5.10.2007

23.10.2007

Fentanyl Matrixplaster

See Annex I

See Annex I

26.10.2007

23.10.2007

Fentanyl TTS

See Annex II

See Annex II

26.10.2007

24.10.2007

Xeomin

See Annex III

See Annex III

25.10.2007

—   Revocation of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 1.10.2007 | Veralipride | See Annex IV | See Annex IV | 3.10.2007 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

1.10.2007

Veralipride

See Annex IV

See Annex IV

3.10.2007

---

(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 FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | (Invented)
  Name | Strength | Pharmaceutical form | Route of administration | Content
  (Concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Germany | ratiopharm GmbH |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Member State

Marketing Authorisation Holder

Applicant

(Invented)

Name

Strength

Pharmaceutical form

Route of administration

Content

(Concentration)

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratiopharm 25 μg/h Matrixpflaster

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratiopharm 50 μg/h Matrixpflaster

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratiopharm 75 μg/h Matrixpflaster

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratiopharm 100 μg/h Matrixpflaster

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

Austria

| ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-Gasse 3

A-1140 Wien

Fentanyl-ratiopharm 25 μg/h transdermales Matrixpflaster

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

Austria

| ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-Gasse 3

A-1140 Wien

Fentanyl-ratiopharm 50 μg/h transdermales Matrixpflaster

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

Austria

| ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-Gasse 3

A-1140 Wien

Fentanyl-ratiopharm 75 μg/h transdermales Matrixpflaster

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

Austria

| ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-Gasse 3

A-1140 Wien

Fentanyl-ratiopharm 100 μg/h transdermales Matrixpflaster

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

France

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl ratiopharm 25 μg/h, dispositif transdermique

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

France

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl ratiopharm 50 μg/h, dispositif transdermique

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

France

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl ratiopharm 75 μg/h, dispositif transdermique

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

France

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl ratiopharm 100 μg/h, dispositif transdermique

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

The Netherlands

| ratiopharm Nederland bv |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| Nederland |

ratiopharm Nederland bv

Ronde Tocht 11

1507 CC Zaandam

Nederland

Fentanyl ratiopharm 25 μg/uur, pleister voor transdermaal gebruik

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

The Netherlands

| ratiopharm Nederland bv |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| Nederland |

ratiopharm Nederland bv

Ronde Tocht 11

1507 CC Zaandam

Nederland

Fentanyl ratiopharm 50 μg/uur, pleister voor transdermaal gebruik

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

The Netherlands

| ratiopharm Nederland bv |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| Nederland |

ratiopharm Nederland bv

Ronde Tocht 11

1507 CC Zaandam

Nederland

Fentanyl ratiopharm 75 μg/uur, pleister voor transdermaal gebruik

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

The Netherlands

| ratiopharm Nederland bv |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| Nederland |

ratiopharm Nederland bv

Ronde Tocht 11

1507 CC Zaandam

Nederland

Fentanyl ratiopharm 100 μg/uur, pleister voor transdermaal gebruik

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

Spain

| ratiopharm España, S.A. |
| --- |
| Avenida de Burgos 16D |
| 5o Planta |
| E-28036 Madrid |

ratiopharm España, S.A.

Avenida de Burgos 16D

5o Planta

E-28036 Madrid

Fentanilo Matrix ratiopharm 25 microgramos/h parches transdérmicos EFG

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

Spain

| ratiopharm España, S.A. |
| --- |
| Avenida de Burgos 16D |
| 5o Planta |
| E-28036 Madrid |

ratiopharm España, S.A.

Avenida de Burgos 16D

5o Planta

E-28036 Madrid

Fentanilo Matrix ratiopharm 50 microgramos/h parches transdérmicos EFG

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

Spain

| ratiopharm España, S.A. |
| --- |
| Avenida de Burgos 16D |
| 5o Planta |
| E-28036 Madrid |

ratiopharm España, S.A.

Avenida de Burgos 16D

5o Planta

E-28036 Madrid

Fentanilo Matrix ratiopharm 75 microgramos/h parches transdérmicos EFG

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

Spain

| ratiopharm España, S.A. |
| --- |
| Avenida de Burgos 16D |
| 5o Planta |
| E-28036 Madrid |

ratiopharm España, S.A.

Avenida de Burgos 16D

5o Planta

E-28036 Madrid

Fentanilo Matrix ratiopharm 100 microgramos/h parches transdérmicos EFG

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

United Kingdom

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Telfanyl 25 microgram/hr Transdermal patch (pending)

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

United Kingdom

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Telfanyl 50 microgram/hr Transdermal patch (pending)

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

United Kingdom

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Telfanyl 75 microgram/hr Transdermal patch (pending)

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

United Kingdom

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Telfanyl 100 microgram/hr Transdermal patch (pending)

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

---

ANNEX II

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

| Member State | Marketing Authorisation Holder | Applicant | (Invented)
  Name | Strength | Pharmaceutical form | Route of administration | Content
  (Concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Germany | ratiopharm GmbH |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

Member State

Marketing Authorisation Holder

Applicant

(Invented)

Name

Strength

Pharmaceutical form

Route of administration

Content

(Concentration)

Germany

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratiopharm 25 μg/h TTS

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratiopharm 50 μg/h TTS

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratiopharm 75 μg/h TTS

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratiopharm 100 μg/h TTS

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

Austria

| ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-Gasse 3

A-1140 Wien

Fenturogenox 25 μg/h — transdermales Matrixpflaster

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

Austria

| ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-Gasse 3

A-1140 Wien

Fenturogenox 50 μg/h — transdermales Matrixpflaster

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

Austria

| ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-Gasse 3

A-1140 Wien

Fenturogenox 75 μg/h — transdermales Matrixpflaster

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

Austria

| ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-Gasse 3 |
| A-1140 Wien |

ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-Gasse 3

A-1140 Wien

Fenturogenox 100 μg/h — transdermales Matrixpflaster

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

France

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratio 25 μg/h, dispositif transdermique

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

France

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratio 50 μg/h, dispositif transdermique

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

France

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratio 75 μg/h, dispositif transdermique

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

France

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl-ratio 100 μg/h, dispositif transdermique

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

The Netherlands

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl ratiopharm 25, pleister voor transdermaal gebruik 25 μg/uur

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

The Netherlands

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl ratiopharm 50, pleister voor transdermaal gebruik 50 μg/uur

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

The Netherlands

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl ratiopharm 75, pleister voor transdermaal gebruik 75 μg/uur

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

The Netherlands

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Fentanyl ratiopharm 100, pleister voor transdermaal gebruik 100 μg/uur

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

Spain

| ratiopharm España, S.A. |
| --- |
| Avenida de Burgos 16D |
| 5o Planta |
| E-28036 Madrid |

ratiopharm España, S.A.

Avenida de Burgos 16D

5o Planta

E-28036 Madrid

Fentanilo Matrix ratiomed 25 microgramos/h parches transdérmicos EFG

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

Spain

| ratiopharm España, S.A. |
| --- |
| Avenida de Burgos 16D |
| 5o Planta |
| E-28036 Madrid |

ratiopharm España, S.A.

Avenida de Burgos 16D

5o Planta

E-28036 Madrid

Fentanilo Matrix ratiomed 50 microgramos/h parches transdérmicos EFG

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

Spain

| ratiopharm España, S.A. |
| --- |
| Avenida de Burgos 16D |
| 5o Planta |
| E-28036 Madrid |

ratiopharm España, S.A.

Avenida de Burgos 16D

5o Planta

E-28036 Madrid

Fentanilo Matrix ratiomed 75 microgramos/h parches transdérmicos EFG

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

Spain

| ratiopharm España, S.A. |
| --- |
| Avenida de Burgos 16D |
| 5o Planta |
| E-28036 Madrid |

ratiopharm España, S.A.

Avenida de Burgos 16D

5o Planta

E-28036 Madrid

Fentanilo Matrix ratiomed 100 microgramos/h parches transdérmicos EFG

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

United Kingdom

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Ribofen 25 microgram/hr Transdermal patch (pending)

25 μg/h

Transdermal patch

Transdermal use

4,125 mg/7,5 cm2 which release 25 μg fentanyl per hour

United Kingdom

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Ribofen 50 microgram/hr Transdermal patch

(pending)

50 μg/h

Transdermal patch

Transdermal use

8,25 mg/15 cm2 which release 50 μg fentanyl per hour

United Kingdom

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Ribofen 75 microgram/hr Transdermal patch

(pending)

75 μg/h

Transdermal patch

Transdermal use

12,375 mg/22,5 cm2 which release 75 μg fentanyl per hour

United Kingdom

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Ribofen 100 microgram/hr Transdermal patch

(pending)

100 μg/h

Transdermal patch

Transdermal use

16,5 mg/30 cm2 which release 100 μg fentanyl per hour

---

ANNEX III

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

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration | Content
  (Concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Germany | Merz Pharmaceuticals GmbH |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Content

(Concentration)

Germany

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

Denmark

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

Sweden

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

Austria

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

Spain

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

Finland

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

France

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

Italy

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

Luxembourg

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

Norway

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

Poland

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

Portugal

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

United Kingdom

| Merz Pharmaceuticals GmbH |
| --- |
| Eckenheimer Landstraße 100 |
| D-60318 Frankfurt/Main |

Merz Pharmaceuticals GmbH

Eckenheimer Landstraße 100

D-60318 Frankfurt/Main

Xeomin

100 LD50 units

Powder for solution for injection

For intramuscular use

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ANNEX IV

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Sanofi-Synthelabo S.A. |
| Avenue de la Métrologie 5 |
| B-1130 Bruxelles |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Belgium

Sanofi-Synthelabo S.A.

Avenue de la Métrologie 5

B-1130 Bruxelles

Agreal

100 mg

Capsule, hard

Oral use

France

| Sanofi-Aventis France |
| --- |
| 1-13, Boulevard Anatole France |
| F-75014 Paris |

Sanofi-Aventis France

1-13, Boulevard Anatole France

F-75014 Paris

Agreal

100 mg

Capsule, hard

Oral use

Italy

| Sanofi-Synthelabo S.P.A. |
| --- |
| via Messina, 38 |
| I-20154 Milano |

Sanofi-Synthelabo S.P.A.

via Messina, 38

I-20154 Milano

Agradil

100 mg

Capsule, hard

Oral use

Luxembourg

| Sanofi-Synthelabo |
| --- |
| Twin Squares, Navona Building |
| Culliganlaan 1c |
| B-1831 Diegem |

Sanofi-Synthelabo

Twin Squares, Navona Building

Culliganlaan 1c

B-1831 Diegem

Agreal

100 mg

Capsule, hard

Oral use

Portugal

| Sanofi-Synthelabo |
| --- |
| Produtos Farmacêuticos, S.A. PRT |
| Empreendimento Lagoas Park |
| Edifício 7, 2o e 3o |
| PT-2740-244 Porto Salvo |

Sanofi-Synthelabo

Produtos Farmacêuticos, S.A. PRT

Empreendimento Lagoas Park

Edifício 7, 2o e 3o

PT-2740-244 Porto Salvo

Agreal

100 mg

Capsule, hard

Oral use

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