# C_2007144EN.01001101.xml

| 29.6.2007 | EN | Official Journal of the European Union | C 144/11 |
| --- | --- | --- | --- |

29.6.2007

EN

Official Journal of the European Union

C 144/11

---

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

(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

(2007/C 144/07)

—   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 |
| --- | --- | --- | --- | --- |
| 22.5.2007 | Doxyprex | See Annex I | See Annex I | 24.5.2007 |
| 22.5.2007 | Thelin | This Decision is addressed to the Member States | This Decision is addressed to the Member States | 24.5.2007 |
| 29.5.2007 | Xefo | See Annex II | See Annex II | 30.5.2007 |
| 30.5.2007 | Remicade | This Decision is addressed to the Member States | This Decision is addressed to the Member States | 31.5.2007 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

22.5.2007

Doxyprex

See Annex I

See Annex I

24.5.2007

22.5.2007

Thelin

This Decision is addressed to the Member States

This Decision is addressed to the Member States

24.5.2007

29.5.2007

Xefo

See Annex II

See Annex II

30.5.2007

30.5.2007

Remicade

This Decision is addressed to the Member States

This Decision is addressed to the Member States

31.5.2007

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 2.5.2007 | Alendros 70 | See Annex III | See Annex III | 4.5.2007 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

2.5.2007

Alendros 70

See Annex III

See Annex III

4.5.2007

---

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

1

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

2

---

ANNEX I

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER

| Member State | Applicant or Marketing Authorisation Holder | Product invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia | Industrial Veterinaria, S.A. |
| Esmeralda, 19-4o |
| E-08950 Esplugues de Llobregat (Barcelona) |

Member State

Applicant or Marketing Authorisation Holder

Product invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Belgium, Czech Republic, Germany, Greece, Spain, France, Italy, The Netherlands, Poland, Portugal and Slovakia

Industrial Veterinaria, S.A.

Esmeralda, 19-4o

E-08950 Esplugues de Llobregat (Barcelona)

DOXYPREX

Premix

100 mg/g

Pigs (after weaning)

In feed use

10 mg/kg .bw

---

ANNEX II

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration | Content |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Nycomed Austria GmbH |
| St. Peter Straße 25 |
| A-4020 Linz |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Content

Austria

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Artok

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Lornox

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Artok

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo Rapid

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Lornoxicam ‘Nycomed’

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Belgium

| Nycomed Christians |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Christians

Gentsesteenweg 615

B-1080 Brussel

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Christians |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Christians

Gentsesteenweg 615

B-1080 Brussel

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Christians |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Christians

Gentsesteenweg 615

B-1080 Brussel

Xefo Acute

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Christians |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Christians

Gentsesteenweg 615

B-1080 Brussel

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Bulgaria

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Czech Republic

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Denmark

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Lornoxicam ‘Nycomed’

4 mg

Film-coated tablet

Oral

4 mg

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Xefo

4 mg

Film-coated tablet

Oral

4 mg

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Lornoxicam ‘Nycomed’

8 mg

Film-coated tablet

Oral

8 mg

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Xefo

8 mg

Film-coated tablet

Oral

8 mg

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Xefo Rapid

8 mg

Film-coated tablet

Oral

8 mg

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Lornoxicam ‘Nycomed’

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Estonia

| Nycomed SEFA |
| --- |
| Jaama 55B |
| EE-63308 Pölva |

Nycomed SEFA

Jaama 55B

EE-63308 Pölva

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed SEFA |
| --- |
| Jaama 55B |
| EE-63308 Pölva |

Nycomed SEFA

Jaama 55B

EE-63308 Pölva

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed SEFA |
| --- |
| Jaama 55B |
| EE-63308 Pölva |

Nycomed SEFA

Jaama 55B

EE-63308 Pölva

Xefo Rapid

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed SEFA |
| --- |
| Jaama 55B |
| EE-63308 Pölva |

Nycomed SEFA

Jaama 55B

EE-63308 Pölva

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Germany

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Lornoxicam ‘Nycomed’

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Pharma GmbH |
| --- |
| Edisonstraße 16 |
| D-85716 Unterschleissheim |

Nycomed Pharma GmbH

Edisonstraße 16

D-85716 Unterschleissheim

Telos

4 mg

Film-coated tablet

Oral

4 mg

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

Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Lornoxicam ‘Nycomed’

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Pharma GmbH |
| --- |
| Edisonstraße 16 |
| D-85716 Unterschleissheim |

Nycomed Pharma GmbH

Edisonstraße 16

D-85716 Unterschleissheim

Telos

8 mg

Film-coated tablet

Oral

8 mg

Greece

| Nycomed Hellas S.A. |
| --- |
| Λεωφ. Κηφισίας 196 |
| GR-152 31 Αθήνα |

Nycomed Hellas S.A.

Λεωφ. Κηφισίας 196

GR-152 31 Αθήνα

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Hellas S.A. |
| --- |
| Λεωφ. Κηφισίας 196 |
| GR-152 31 Αθήνα |

Nycomed Hellas S.A.

Λεωφ. Κηφισίας 196

GR-152 31 Αθήνα

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Hellas S.A. |
| --- |
| Λεωφ. Κηφισίας 196 |
| GR-152 31 Αθήνα |

Nycomed Hellas S.A.

Λεωφ. Κηφισίας 196

GR-152 31 Αθήνα

Xefo Rapid

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Hellas S.A. |
| --- |
| Λεωφ. Κηφισίας 196 |
| GR-152 31 Αθήνα |

Nycomed Hellas S.A.

Λεωφ. Κηφισίας 196

GR-152 31 Αθήνα

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Hungary

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Italy

| Nycomed Italy S.r.l. |
| --- |
| Via Carducci 125 |
| Edificio A |
| I-20099 Sesto San Giovanni |

Nycomed Italy S.r.l.

Via Carducci 125

Edificio A

I-20099 Sesto San Giovanni

Taigalor

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Italy S.r.l. |
| --- |
| Via Carducci 125 |
| Edificio A |
| I-20099 Sesto San Giovanni |

Nycomed Italy S.r.l.

Via Carducci 125

Edificio A

I-20099 Sesto San Giovanni

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Italy S.r.l. |
| --- |
| Via Carducci 125 |
| Edificio A |
| I-20099 Sesto San Giovanni |

Nycomed Italy S.r.l.

Via Carducci 125

Edificio A

I-20099 Sesto San Giovanni

Taigalor

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

| Nycomed Italy S.r.l. |
| --- |
| Via Carducci 125 |
| Edificio A |
| I-20099 Sesto San Giovanni |

Nycomed Italy S.r.l.

Via Carducci 125

Edificio A

I-20099 Sesto San Giovanni

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Latvia

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed SEFA |
| --- |
| Jaama 55B |
| EE-63308 Pölva |

Nycomed SEFA

Jaama 55B

EE-63308 Pölva

Xefo Rapid

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Lithuania

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed SEFA |
| --- |
| Jaama 55B |
| EE-63308 Pölva |

Nycomed SEFA

Jaama 55B

EE-63308 Pölva

Xefo Rapid

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Luxembourg

| Nycomed Christians |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Christians

Gentsesteenweg 615

B-1080 Brussel

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Christians |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Christians

Gentsesteenweg 615

B-1080 Brussel

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Christians |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Christians

Gentsesteenweg 615

B-1080 Brussel

Xefo Acute

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Christians |
| --- |
| Gentsesteenweg 615 |
| B-1080 Brussel |

Nycomed Christians

Gentsesteenweg 615

B-1080 Brussel

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Portugal

| Euro-Labor SA |
| --- |
| Rua Alfredo da Silva n.o 16 |
| P-2610-016 Amadora |

Euro-Labor SA

Rua Alfredo da Silva n.o 16

P-2610-016 Amadora

Acabel

4 mg

Film-coated tablet

Oral

4 mg

| Euro-Labor SA |
| --- |
| Rua Alfredo da Silva n.o 16 |
| P-2610-016 Amadora |

Euro-Labor SA

Rua Alfredo da Silva n.o 16

P-2610-016 Amadora

Bosporon

4 mg

Film-coated tablet

Oral

4 mg

| Euro-Labor SA |
| --- |
| Rua Alfredo da Silva n.o 16 |
| P-2610-016 Amadora |

Euro-Labor SA

Rua Alfredo da Silva n.o 16

P-2610-016 Amadora

Acabel

8 mg

Film-coated tablet

Oral

8 mg

| Euro-Labor SA |
| --- |
| Rua Alfredo da Silva n.o 16 |
| P-2610-016 Amadora |

Euro-Labor SA

Rua Alfredo da Silva n.o 16

P-2610-016 Amadora

Bosporon

8 mg

Film-coated tablet

Oral

8 mg

| Euro-Labor SA |
| --- |
| Rua Alfredo da Silva n.o 16 |
| P-2610-016 Amadora |

Euro-Labor SA

Rua Alfredo da Silva n.o 16

P-2610-016 Amadora

Acabel Rapid

8 mg

Film-coated tablet

Oral

8 mg

| Euro-Labor SA |
| --- |
| Rua Alfredo da Silva n.o 16 |
| P-2610-016 Amadora |

Euro-Labor SA

Rua Alfredo da Silva n.o 16

P-2610-016 Amadora

Bosporon Rapid

8 mg

Film-coated tablet

Oral

8 mg

| Euro-Labor SA |
| --- |
| Rua Alfredo da Silva n.o 16 |
| P-2610-016 Amadora |

Euro-Labor SA

Rua Alfredo da Silva n.o 16

P-2610-016 Amadora

Acabel

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

| Euro-Labor SA |
| --- |
| Rua Alfredo da Silva n.o 16 |
| P-2610-016 Amadora |

Euro-Labor SA

Rua Alfredo da Silva n.o 16

P-2610-016 Amadora

Bosporon

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Romania

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed Austria GmbH |
| --- |
| St. Peter Straße 25 |
| A-4020 Linz |

Nycomed Austria GmbH

St. Peter Straße 25

A-4020 Linz

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Spain

| Laboratorios Andromaco S.A. |
| --- |
| Doctor Zamenhof 36 |
| E-29027 Madrid |

Laboratorios Andromaco S.A.

Doctor Zamenhof 36

E-29027 Madrid

Acabel

4 mg

Film-coated tablet

Oral

4 mg

| Tedec Meiji Farma, S.A. |
| --- |
| Ctra. M-300 |
| Km 30,500 |
| E-28802 Alcalá de Henares, Madrid |

Tedec Meiji Farma, S.A.

Ctra. M-300

Km 30,500

E-28802 Alcalá de Henares, Madrid

Bosporon

4 mg

Film-coated tablet

Oral

4 mg

| Laboratorios Andromaco S.A. |
| --- |
| Doctor Zamenhof 36 |
| E-29027 Madrid |

Laboratorios Andromaco S.A.

Doctor Zamenhof 36

E-29027 Madrid

Acabel

8 mg

Film-coated tablet

Oral

8 mg

| Tedec Meiji Farma, S.A. |
| --- |
| Ctra. M-300 |
| Km 30,500 |
| E-28802 Alcalá de Henares, Madrid |

Tedec Meiji Farma, S.A.

Ctra. M-300

Km 30,500

E-28802 Alcalá de Henares, Madrid

Bosporon

8 mg

Film-coated tablet

Oral

8 mg

| Laboratorios Andromaco S.A. |
| --- |
| Doctor Zamenhof 36 |
| E-29027 Madrid |

Laboratorios Andromaco S.A.

Doctor Zamenhof 36

E-29027 Madrid

Acabel Rapid

8 mg

Film-coated tablet

Oral

8 mg

| Tedec Meiji Farma, S.A. |
| --- |
| Ctra. M-300 |
| Km 30,500 |
| E-28802 Alcalá de Henares, Madrid |

Tedec Meiji Farma, S.A.

Ctra. M-300

Km 30,500

E-28802 Alcalá de Henares, Madrid

Bosporon Rapid

8 mg

Film-coated tablet

Oral

8 mg

| Laboratorios Andromaco S.A. |
| --- |
| Doctor Zamenhof 36 |
| E-29027 Madrid |

Laboratorios Andromaco S.A.

Doctor Zamenhof 36

E-29027 Madrid

Acabel

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

Sweden

| Nycomed AB |
| --- |
| Tegeluddsvägen 17-21 |
| S-102 53 Stockholm |

Nycomed AB

Tegeluddsvägen 17-21

S-102 53 Stockholm

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed AB |
| --- |
| Tegeluddsvägen 17-21 |
| S-102 53 Stockholm |

Nycomed AB

Tegeluddsvägen 17-21

S-102 53 Stockholm

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed AB |
| --- |
| Tegeluddsvägen 17-21 |
| S-102 53 Stockholm |

Nycomed AB

Tegeluddsvägen 17-21

S-102 53 Stockholm

Xefo Akut

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed AB |
| --- |
| Tegeluddsvägen 17-21 |
| S-102 53 Stockholm |

Nycomed AB

Tegeluddsvägen 17-21

S-102 53 Stockholm

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

United Kingdom

| Nycomed UK Ltd |
| --- |
| The Magdalen Centre Oxford Science Park |
| OX4 4GA Oxford |
| United Kingdom |

Nycomed UK Ltd

The Magdalen Centre Oxford Science Park

OX4 4GA Oxford

United Kingdom

Xefo

4 mg

Film-coated tablet

Oral

4 mg

| Nycomed UK Ltd |
| --- |
| The Magdalen Centre Oxford Science Park |
| OX4 4GA Oxford |
| United Kingdom |

Nycomed UK Ltd

The Magdalen Centre Oxford Science Park

OX4 4GA Oxford

United Kingdom

Xefo

8 mg

Film-coated tablet

Oral

8 mg

| Nycomed UK Ltd |
| --- |
| The Magdalen Centre Oxford Science Park |
| OX4 4GA Oxford |
| United Kingdom |

Nycomed UK Ltd

The Magdalen Centre Oxford Science Park

OX4 4GA Oxford

United Kingdom

Xefo

4 mg/ml

Powder and solvent for solution for injection

Intravenous use/Intramuscular use

8 mg

---

ANNEX III

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

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Czech Republic | Zentiva, a.s. |
| U kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Czech Republic

Zentiva, a.s.

U kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Alendros 70

70 mg

Tablet

Oral use

Estonia

| Zentiva, a.s. |
| --- |
| U kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva, a.s.

U kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Alendros 70

70 mg

Tablet

Oral use

Hungary

| Zentiva, a.s. |
| --- |
| U kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva, a.s.

U kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Alendros 70

70 mg

Tablet

Oral use

Latvia

| Zentiva, a.s. |
| --- |
| U kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva, a.s.

U kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Alendros 70

70 mg

Tablet

Oral use

Lithuania

| Zentiva, a.s. |
| --- |
| U kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva, a.s.

U kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Alendros 70

70 mg

Tablet

Oral use

Poland

| Zentiva, a.s. |
| --- |
| U kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva, a.s.

U kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Alendros 70

70 mg

Tablet

Oral use

Slovakia

| Zentiva, a.s. |
| --- |
| U kabelovny 130 |
| Dolní Měcholupy |
| CZ-102 37 Praha 10 |

Zentiva, a.s.

U kabelovny 130

Dolní Měcholupy

CZ-102 37 Praha 10

Alendros 70

70 mg

Tablet

Oral use

---