# C_2013350EN.01003001.xml

| 29.11.2013 | EN | Official Journal of the European Union | C 350/30 |
| --- | --- | --- | --- |

29.11.2013

EN

Official Journal of the European Union

C 350/30

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2013

(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

or Article 38 of Directive 2001/82/EC

2

)

2013/C 350/03

—   Issuing, maintenance or modification of a national marketing authorization

Issuing, maintenance or modification 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 |
| --- | --- | --- | --- | --- |
| 2.10.2013 | Suifertil 4 mg/ml | See Annex I | See Annex I | 3.10.2013 |
| 9.10.2013 | Methylphenidate Hexal | See Annex II | See Annex II | 11.10.2013 |
| 9.10.2013 | Methylphenidate Sandoz | See Annex III | See Annex III | 10.10.2013 |
| 18.10.2013 | Dexadreson 2 mg/ml | See Annex IV | See Annex IV | 21.10.2013 |
| 18.10.2013 | Micotil 300 | See Annex V | See Annex V | 21.10.2013 |
| 31.10.2013 | Sandimmun | See Annex VI | See Annex VI | 4.11.2013 |
| 31.10.2013 | Sandimmun Neoral | See Annex VII | See Annex VII | 4.11.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

2.10.2013

Suifertil 4 mg/ml

See Annex I

See Annex I

3.10.2013

9.10.2013

Methylphenidate Hexal

See Annex II

See Annex II

11.10.2013

9.10.2013

Methylphenidate Sandoz

See Annex III

See Annex III

10.10.2013

18.10.2013

Dexadreson 2 mg/ml

See Annex IV

See Annex IV

21.10.2013

18.10.2013

Micotil 300

See Annex V

See Annex V

21.10.2013

31.10.2013

Sandimmun

See Annex VI

See Annex VI

4.11.2013

31.10.2013

Sandimmun Neoral

See Annex VII

See Annex VII

4.11.2013

—   Suspension of a national marketing authorization

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 |
| --- | --- | --- | --- | --- |
| 11.10.2013 | Ketoconazole | See Annex VIII | See Annex VIII | 14.10.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

11.10.2013

Ketoconazole

See Annex VIII

See Annex VIII

14.10.2013

---

(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 NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State EU/EEA | Applicant | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | aniMedica GmbH |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

Member State EU/EEA

Applicant

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml Lösung zum Eingeben für Schweine

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

France

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Synchroplan 4 mg/ml solution buvable porcins

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

Germany

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

Hungary

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml belsőleges oldat sertések részére A.U.V.

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

The Netherlands

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml orale oplossing voor varkens

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

Poland

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

Romania

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

Spain

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml solución oral para porcino

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

United Kingdom

| aniMedica GmbH |
| --- |
| Im Südfeld 9 |
| 48308 Senden-Bösensell |
| Germany |

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

Suifertil 4 mg/ml Oral Solution for Pigs

Altrenogest

4 mg/ml

Oral solution

Pigs (sexually mature gilts)

For oral use as a top-dressing

---

ANNEX II

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

| Member State EU/EEA | Marketing authorisation holder company name, address | Applicant company name, address | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | Hexal A/S |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Member State EU/EEA

Marketing authorisation holder company name, address

Applicant company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Denmark

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate ‘Hexal’

18 mg

Prolonged-release tablet

Oral use

Denmark

| Hexal A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate ‘Hexal’

36 mg

Prolonged-release tablet

Oral use

Denmark

| Hexal A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate ‘Hexal’

54 mg

Prolonged-release tablet

Oral use

Germany

| Hexal A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid HEXAL 18 mg Retardtabletten

18 mg

Prolonged-release tablet

Oral use

Germany

| Hexal A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid HEXAL 36 mg Retardtabletten

36 mg

Prolonged-release tablet

Oral use

Germany

| Hexal A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Hexal A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid HEXAL 54 mg Retardtabletten

54 mg

Prolonged-release tablet

Oral use

Ireland

| Rowex Ltd |
| --- |
| Bantry |
| Co. Cork |
| Ireland |

Rowex Ltd

Bantry

Co. Cork

Ireland

Metidate XL 54 mg Prolonged-Release Tablets

54 mg

Prolonged-release tablet

Oral use

Ireland

| Rowex Ltd |
| --- |
| Bantry |
| Co. Cork |
| Ireland |

Rowex Ltd

Bantry

Co. Cork

Ireland

Metidate XL 18 mg Prolonged-Release Tablets

18 mg

Prolonged-release tablet

Oral use

Ireland

| Rowex Ltd |
| --- |
| Bantry |
| Co. Cork |
| Ireland |

Rowex Ltd

Bantry

Co. Cork

Ireland

Metidate XL 36 mg Prolonged-Release Tablets

36 mg

Prolonged-release tablet

Oral use

---

ANNEX III

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

| Member State EU/EEA | Marketing authorisation holder company name, address | Applicant company name, address | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | | Sandoz A/S |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Member State EU/EEA

Marketing authorisation holder company name, address

Applicant company name, address

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Belgium

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 18 mg tabletten met verlengde afgifte

18 mg

Prolonged-release tablet

Oral use

Belgium

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 36 mg tabletten met verlengde afgifte

36 mg

Prolonged-release tablet

Oral use

Belgium

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 54 mg tabletten met verlengde afgifte

54 mg

Prolonged-release tablet

Oral use

Cyprus

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Methylphenidate Sandoz

18 mg

Prolonged-release tablet

Oral use

Cyprus

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Methylphenidate Sandoz

36 mg

Prolonged-release tablet

Oral use

Cyprus

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Methylphenidate Sandoz

54 mg

Prolonged-release tablet

Oral use

Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate ‘Sandoz’

18 mg

Prolonged-release tablet

Oral use

Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate ‘Sandoz’

36 mg

Prolonged-release tablet

Oral use

Denmark

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate ‘Sandoz’

54 mg

Prolonged-release tablet

Oral use

Finland

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

18 mg

Prolonged-release tablet

Oral use

Finland

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

36 mg

Prolonged-release tablet

Oral use

Finland

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

54 mg

Prolonged-release tablet

Oral use

France

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Méthylphénidate Sandoz LP 18 mg, comprimé à liberation prolongée

18 mg

Prolonged-release tablet

Oral use

France

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Méthylphénidate Sandoz LP 36 mg, comprimé à libération prolongée

36 mg

Prolonged-release tablet

Oral use

France

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Méthylphénidate Sandoz LP 54 mg, comprimé à librétaion prolongée

54 mg

Prolonged-release tablet

Oral use

Germany

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid - 1 A Pharma 18 mg Retardtabletten

18 mg

Prolonged-release tablet

Oral use

Germany

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid - 1 A Pharma 36 mg Retardtabletten

36 mg

Prolonged-release tablet

Oral use

Germany

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidathydrochlorid - 1 A Pharma 54 mg Retardtabletten

54 mg

Prolonged-release tablet

Oral use

Iceland

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz, 18 mg, forðatöflur

18 mg

Prolonged-release tablet

Oral use

Iceland

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz, 36 mg, forðatöflur

36 mg

Prolonged-release tablet

Oral use

Iceland

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz, 54 mg, forðatöflur

54 mg

Prolonged-release tablet

Oral use

Luxembourg

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 18 mg comprimé à libération prolongée

18 mg

Prolonged-release tablet

Oral use

Luxembourg

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 36 mg comprimé à libération prolongée

36 mg

Prolonged-release tablet

Oral use

Luxembourg

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat Sandoz 54 mg comprimé à libération prolongée

54 mg

Prolonged-release tablet

Oral use

Malta

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 18 mg Prolonged-release Tablets

18 mg

Prolonged-release tablet

Oral use

Malta

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 36 mg Prolonged-release Tablets

36 mg

Prolonged-release tablet

Oral use

Malta

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 54 mg Prolonged-release Tablets

54 mg

Prolonged-release tablet

Oral use

Norway

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz 18 mg depottabletter

18 mg

Prolonged-release tablet

Oral use

Norway

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz 36 mg depottabletter

36 mg

Prolonged-release tablet

Oral use

Norway

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz 54 mg depottabletter

54 mg

Prolonged-release tablet

Oral use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Difumenil

18 mg

Prolonged-release tablet

Oral use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Difumenil

36 mg

Prolonged-release tablet

Oral use

Poland

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| 6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

Difumenil

54 mg

Prolonged-release tablet

Oral use

Portugal

| Sandoz Farmacêutica Lda. |
| --- |
| Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica Lda.

Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15

2710-693 Sintra

Portugal

Metilfenidato Sandoz

18 mg

Prolonged-release tablet

Oral use

Portugal

| Sandoz Farmacêutica Lda. |
| --- |
| Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica Lda.

Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15

2710-693 Sintra

Portugal

Metilfenidato Sandoz

36 mg

Prolonged-release tablet

Oral use

Portugal

| Sandoz Farmacêutica Lda. |
| --- |
| Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica Lda.

Alameda da Beloura, Edifício 1 – 2o Andar - Esc. 15

2710-693 Sintra

Portugal

Metilfenidato Sandoz

54 mg

Prolonged-release tablet

Oral use

Spain

| Sandoz Farmacéutica, S.A. |
| --- |
| Centro Empresarial Osa Mayor |
| Avda Osa Mayor no 4 |
| 28023 – Aravaca, Madrid |
| Spain |

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spain

Metilfenidato Sandoz 18 mg comprimidos de liberación prolongada EFG

18 mg

Prolonged-release tablet

Oral use

Spain

| Sandoz Farmacéutica, S.A. |
| --- |
| Centro Empresarial Osa Mayor |
| Avda Osa Mayor no 4 |
| 28023 – Aravaca, Madrid |
| Spain |

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spain

Metilfenidato Sandoz 36 mg comprimidos de liberación prolongada EFG

36 mg

Prolonged-release tablet

Oral use

Spain

| Sandoz Farmacéutica, S.A. |
| --- |
| Centro Empresarial Osa Mayor |
| Avda Osa Mayor no 4 |
| 28023 – Aravaca, Madrid |
| Spain |

Sandoz Farmacéutica, S.A.

Centro Empresarial Osa Mayor

Avda Osa Mayor no 4

28023 – Aravaca, Madrid

Spain

Metilfenidato Sandoz 54 mg comprimidos de liberación prolongada EFG

54 mg

Prolonged-release tablet

Oral use

Sweden

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

18 mg

Prolonged-release tablet

Oral use

Sweden

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

36 mg

Prolonged-release tablet

Oral use

Sweden

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylphenidate Sandoz

54 mg

Prolonged-release tablet

Oral use

The Netherlands

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat HCl Sandoz retard 18 mg, tabletten met verlengde afgifte

18 mg

Prolonged-release tablet

Oral use

The Netherlands

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat HCl Sandoz retard 36 mg, tabletten met verlengde afgifte

36 mg

Prolonged-release tablet

Oral use

The Netherlands

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Methylfenidaat HCl Sandoz retard 54 mg, tabletten met verlengde afgifte

54 mg

Prolonged-release tablet

Oral use

United Kingdom

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 18 mg Prolonged-release Tablets

18 mg

Prolonged-release tablet

Oral use

United Kingdom

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 36 mg Prolonged-release Tablets

36 mg

Prolonged-release tablet

Oral use

United Kingdom

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Denmark |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Denmark

Matoride XL 54 mg Prolonged-release Tablets

54 mg

Prolonged-release tablet

Oral use

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Applicant/marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Intervet GmbH |
| Siemensstraße 107 |
| AT-1210 Wien |
| AUSTRIA |

Member State EU/EEA

Applicant/marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Austria

Intervet GmbH

Siemensstraße 107

AT-1210 Wien

AUSTRIA

Hexadreson 2 mg/ml Injektionslösung für Pferde, Rinder, Schweine, Hunde

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Austria

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml Injektionslösung für Pferde, Rinder, Schweine, Katzen und Hunde

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Belgium

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON 2 MG/ML SOLUTION INJECTABLE

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Belgium

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

DEXA-JECT 2 MG/ML oplossing voor injectie voor runderen, paarden, varkens, honden en katten

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Cyprus

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXADRESON INJECTION 2 MG/ML

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Czech republic

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexadreson, 2 mg/ml Injekční roztok

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Czech republic

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON 2 mg/ml injekční roztok

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Denmark

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexadreson Vet

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses

Denmark

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexaject

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Denmark

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Finland

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon vet

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

France

| Intervet |
| --- |
| Rue Olivier De Serres |
| Angers Technopole |
| 49071 Beaucouze Cedex |
| FRANCE |

Intervet

Rue Olivier De Serres

Angers Technopole

49071 Beaucouze Cedex

FRANCE

Dexadreson

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, goat, pigs, dogs and cats.

France

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml solution injectable

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

France

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Cortadex 2 mg/ml solution injectable pour bovins, porcins, chiens et chats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats

France

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml solution injectable pour bovins, chevaux, porcins, chiens et chats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Germany

| Intervet Deutschland GmbH |
| --- |
| Feldstr. 1a |
| D-85716 Unterschleißheim |
| GERMANY |

Intervet Deutschland GmbH

Feldstr. 1a

D-85716 Unterschleißheim

GERMANY

Hexadreson

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Germany

| Albrecht GmbH |
| --- |
| Hauptstr. 6-8 |
| 88326 Aulendorf |
| GERMANY |

Albrecht GmbH

Hauptstr. 6-8

88326 Aulendorf

GERMANY

Rapidexon Albrecht 2 mg/ml

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Germany

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Greece

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXADRESON

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Greece

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Hungary

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexadreson injekció A.U.V.

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Hungary

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml injekció szarvasmarhák, lovak, sertések, kutyák és macskák részére A.U.V.

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Hungary

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml injekció A.U.V.

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Iceland

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexaject

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Ireland

| Intervet Ireland Ltd. |
| --- |
| Magna Drive, Magna Business Park |
| Citywest Road |
| Dublin 24 |
| IRELAND |

Intervet Ireland Ltd.

Magna Drive, Magna Business Park

Citywest Road

Dublin 24

IRELAND

Dexadresson 2 mg/ml solution for injection

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Ireland

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml solution for injection

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Ireland

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml solution for injection for cattle, horses, pigs, dogs and cats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Italy

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexadreson

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, goat, pigs, dogs and cats.

Latvia

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexacortin

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats

Lithuania

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXACORTIN 2 mg/ml solution for injection for cattle, swine, dogs and cats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats

Lithuania

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON 2 mg/ml, solution for injection

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Lithuania

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

DEXA-JECT 2 mg/ml solution for injection for cattle, horse, pigs, dogs and cats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

The Netherlands

| Intervet Nederland B.V. |
| --- |
| p.o. box 50 |
| 5830 AB Boxmeer |
| THE NETHERLANDS |

Intervet Nederland B.V.

p.o. box 50

5830 AB Boxmeer

THE NETHERLANDS

Dexadreson

Dexamethasone

2 mg/ml

Solution for injection

Cattle

The Netherlands

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon

Dexamethasone

2 mg/ml

Solution for injection

Cattle

The Netherlands

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

The Netherlands

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Norway

| Intervet AB |
| --- |
| Box 7121 |
| 192 07 Sollentuna |
| SWEDEN |

Intervet AB

Box 7121

192 07 Sollentuna

SWEDEN

Dexadreson vet.

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Poland

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXACORTIN 2 mg/ml roztwór do wstrzykiwań dla bydła, świń, psów i kotów

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats.

Poland

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON 2 mg/ml roztwór do wstrzykiwań

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Poland

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml roztwór do wstrzykiwań dla bydła, koni, świń, psów i kotów

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Portugal

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml, solução injectável

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores n.o 16 |
| 2735-557 Agualva-Cacém, |
| PORTUGAL |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores n.o 16

2735-557 Agualva-Cacém,

PORTUGAL

Dexacortin 2 mg/ml solução injectável para bovinos, suínos, cães e gatos

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats

Romania

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXADRESON

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, goat, pigs, dogs and cats

Slovakia

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

Dexadreson 2 mg/ml injekčný roztok

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Slovakia

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml injekčný roztok

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Slovenia

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

RAPIDEXON 2 mg/ml raztopina za injiciranje

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Slovenia

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831, AN Boxmeer |
| THE NETHERLANDS |

Intervet International B.V.

Wim de Körverstraat 35

5831, AN Boxmeer

THE NETHERLANDS

DEXACORTIN 2 mg/ml, raztopina za injiciranje za govedo, prašiče, pse in mačke

Dexamethasone

2 mg/ml

Solution for injection

Cattle, pigs, dogs and cats

Spain

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml solución inyectable

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Spain

| S.P. Veterinaria, S.A. |
| --- |
| Ctra. Reus-Vinyols, Km 4,1 |
| 43330 Riudoms, Tarragona |
| SPAIN |

S.P. Veterinaria, S.A.

Ctra. Reus-Vinyols, Km 4,1

43330 Riudoms, Tarragona

SPAIN

Dexavex

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Spain

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

Sweden

| Intervet AB |
| --- |
| Box 7121 |
| 192 07 Sollentuna |
| SWEDEN |

Intervet AB

Box 7121

192 07 Sollentuna

SWEDEN

Dexadreson vet.

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

United Kingdom

| Intervet UK Ltd |
| --- |
| Walton Manor, Walton |
| Milton Keynes MK7 7AJ |
| UNITED KINGDOM |

Intervet UK Ltd

Walton Manor, Walton

Milton Keynes MK7 7AJ

UNITED KINGDOM

Dexadreson 2 mg/ml Solution for Injection

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

United Kingdom

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| THE NETHERLANDS |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

THE NETHERLANDS

Dexa-ject 2 mg/ml Solution for Injection for Cattle, Horses, Pigs, Dogs and Cats

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

United Kingdom

| Eurovet Animal Health B.V. |
| --- |
| Handelsweg 25 |
| 5531 AE Bladel |
| THE NETHERLANDS |

Eurovet Animal Health B.V.

Handelsweg 25

5531 AE Bladel

THE NETHERLANDS

Rapidexon 2 mg/ml Solution for Injection

Dexamethasone

2 mg/ml

Solution for injection

Cattle, horses, pigs, dogs and cats

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| AUSTRIA |

Member State EU/EEA

Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Richter Pharma AG

Feldgasse 19

4600 Wels

AUSTRIA

Micotil 300 mg/ml - Injektionslösung für Rinder

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

Belgium

| ELI LILLY BENELUX N.V. |
| --- |
| Division Elanco Animal Health |
| Stoofstraat 52 |
| 1000 Brussel |
| BELGIUM |

ELI LILLY BENELUX N.V.

Division Elanco Animal Health

Stoofstraat 52

1000 Brussel

BELGIUM

Micotil 300 mg/ml

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep

Subcutaneous injection

Czech Republic

| EIi Lílly Regional Operations GmbH |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Wien |
| AUSTRIA |

EIi Lílly Regional Operations GmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Wien

AUSTRIA

Micotil 300 mg/ml injekční roztok pro skot (telata, mladý skot)

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| GERMANY |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

GERMANY

Micotil 300

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

France

| LILLY FRANCE |
| --- |
| 13 Rue Pages |
| 92158 Suresnes Cedex |
| FRANCE |

LILLY FRANCE

13 Rue Pages

92158 Suresnes Cedex

FRANCE

MICOTIL 300

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

Greece

| Eli Lilly Regional Operations GesmbH |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| AUSTRIA |

Eli Lilly Regional Operations GesmbH

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

AUSTRIA

MICOTIL 300

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep

Subcutaneous injection

Spain

| ELANCO VALQUÍMICA S.A, |
| --- |
| Avenida de la Industria 30 |
| 28108 Alcobendas |
| Madrid |
| SPAIN |

ELANCO VALQUÍMICA S.A,

Avenida de la Industria 30

28108 Alcobendas

Madrid

SPAIN

Micotil 300

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

Hungary

| Eli Lilly Regional Operations GmbH |
| --- |
| Elanco Animal Health Kölblgasse 8-10 |
| 1030 Vienna |
| AUSTRIA |

Eli Lilly Regional Operations GmbH

Elanco Animal Health Kölblgasse 8-10

1030 Vienna

AUSTRIA

Micotil 300 injekció

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

Ireland

| Eli Lilly and Company Ltd |
| --- |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| UNITED KINGDOM |

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

UNITED KINGDOM

Micotil 300 mg/ml Solution for Injection

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep

Subcutaneous injection

Italy

| ELI LILLY ITALIA S.p.A. |
| --- |
| Via A. Gramsci, 731/733 Sesto Fiorentino |
| ITALY |

ELI LILLY ITALIA S.p.A.

Via A. Gramsci, 731/733 Sesto Fiorentino

ITALY

Micotil 300

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep rabbit

Subcutaneous injection

The Netherlands

| Eli Lilly Nederland B.V./Elanco AnimalHealth |
| --- |
| Grootslag 1-5 |
| 3991 RA Houten |
| THE NETHERLANDS |

Eli Lilly Nederland B.V./Elanco AnimalHealth

Grootslag 1-5

3991 RA Houten

THE NETHERLANDS

MICOTIL 300 INJECTIE

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep

Subcutaneous injection

Portugal

| Lilly Portugal – Produtos Farmacêuticos, Lda. |
| --- |
| Rua Cesário Verde, 5 – piso 4 |
| Linda-a-Pastora |
| 2790-326 QUEIJAS |
| PORTUGAL |

Lilly Portugal – Produtos Farmacêuticos, Lda.

Rua Cesário Verde, 5 – piso 4

Linda-a-Pastora

2790-326 QUEIJAS

PORTUGAL

Micotil 300 mg/ml solução injectável

Tilmicosin

300 mg/ml

Solution for injection

Cattle

Subcutaneous injection

United Kingdom

| Eli Lilly & Company Ltd |
| --- |
| Elanco Animal Health |
| Lilly House |
| Priestley Road |
| Basingstoke |
| RG24 9NL |
| UNITED KINGDOM |

Eli Lilly & Company Ltd

Elanco Animal Health

Lilly House

Priestley Road

Basingstoke

RG24 9NL

UNITED KINGDOM

Micotil 300 mg/ml Solution for Injection

Tilmicosin

300 mg/ml

Solution for injection

Cattle, sheep

Subcutaneous injection

---

ANNEX VI

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

| Member State EU/EEA | Marketing authorisation holder | Invented Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Member State EU/EEA

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun

50 mg – Konzentrat zur Infusionsbereitung

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, bus 1 |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B-1800 Vilvoorde

Belgium

SANDIMMUN

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Prague 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Copenhagen |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

France

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

25 mg

Capsule, soft

Oral use

France

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

50 mg

Capsule, soft

Oral use

France

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

100 mg

Capsule, soft

Oral use

France

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

100 mg/ml

Oral solution

Oral use

100 mg/ml

France

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

SANDIMMUN

50 mg/ml

Solution for infusion

Intravenous use

50 mg/ml

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 25 mg Weichkapseln

25 mg

Capsule, soft

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg Weichkapseln

100 mg

Capsule, soft

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Oral solution

Oral use

100 mg/ml

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 25 mg Weichkapseln

25 mg

Capsule, soft

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 50 mg Weichkapseln

50 mg

Capsule, soft

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Immunosporin 100 mg Weichkapseln

100 mg

Capsule, soft

Oral use

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN

250 mg/5 ml amp

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN

50 mg/ml amp

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun 50 mg/ml koncentrátum oldatos infúzióhoz

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Iceland

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 |
| Köbenhavn S |
| Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003

Köbenhavn S

Denmark

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Ireland

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

25 mg

Capsule, soft

Oral use

Ireland

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

50 mg

Capsule, soft

Oral use

Ireland

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

100 mg

Capsule, soft

Oral use

Ireland

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

100 mg/ml

Oral Solution

Oral use

100 mg/ml

Ireland

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun

50 mg/1 ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Italy

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

25 mg

Capsule, soft

Oral use

Italy

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

50 mg

Capsule, soft

Oral use

Italy

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

100 mg

Capsule, soft

Oral use

Italy

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

100 mg/ml

Oral solution

Oral use

100 mg/ml

Italy

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

SANDIMMUN

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 25 mg Weichkapseln

25 mg

Capsule, soft

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg Weichkapseln

100 mg

Capsule, soft

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Oral solution

Oral use

100 mg/ml

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Netherlands

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Sandimmune, concentraat voor oplossing voor intraveneuze infusie 50 mg/ml

50 mg/ml

Concentrate for solution for intravenous infusion

Intravenous use

50 mg/ml

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous

50 mg/ml

Portugal

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| Prague 140 00 |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun 50 mg/ml

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun 50 mg/ml koncentrat za raztopino za infundiranje

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun 50 mg/ml concentrado para solución para perfusión

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun 250 mg/5 ml concentrado para solución para perfusión

250 mg/5 ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 25 mg

25 mg

Capsule, soft

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 50 mg

50 mg

Capsule, soft

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Soft Gelatin Capsules 100 mg

100 mg

Capsule, soft

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Oral Solution

100 mg/ml

Oral solution

Oral use

100 mg/ml

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

SANDIMMUN Concentrate for Solution for Infusion 50 mg/ml

50 mg/ml

Concentrate for solution for infusion

Intravenous use

50 mg/ml

---

ANNEX VII

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

| Member State EU/EEA | Marketing authorisation holder | Invented Name | Strength | Pharmaceutical form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Member State EU/EEA

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Content

(concentration)

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 10 mg Kapseln

10 mg

Capsule, soft

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 25 mg Kapseln

25 mg

Capsule, soft

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 50 mg Kapseln

50 mg

Capsule, soft

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 100 mg Kapseln

100 mg

Capsule, soft

Oral use

Austria

| Novartis Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17 |
| AT-1020 Wien |
| Austria |

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

AT-1020 Wien

Austria

Sandimmun - Neoral 100 mg/ml - Trinklösung

100 mg/ml

Oral solution

Oral use

100 mg/ml

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 10 mg

10 mg

Capsule

Oral use

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral-Sandimmun 100 mg

100 mg

Capsule

Oral use

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 25 mg

25 mg

Capsule

Oral use

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral - Sandimmun 50 mg

50 mg

Capsule

Oral use

Belgium

| N.V. Novartis Pharma S.A. |
| --- |
| Medialaan 40, |
| B-1800 Vilvoorde |
| Belgium |

N.V. Novartis Pharma S.A.

Medialaan 40,

B-1800 Vilvoorde

Belgium

Neoral-Sandimmun 100 mg/ml

100 mg/ml

Oral solution

Oral use

100 mg/ml

Bulgaria

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 25 mg capsule

25 mg

Capsule, soft

Oral use

Bulgaria

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 50 mg capsule

50 mg

Capsule, soft

Oral use

Bulgaria

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 100 mg capsule

100 mg

Capsule, soft

Oral use

Bulgaria

| Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg |
| --- |
| Germany |

Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg

Germany

Sandimmun Neoral 100 mg/ml oral solution

100 mg/ml

Oral solution

Oral use

100 mg/ml – 50 ml

Cyprus

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 25 mg

25 mg

Capsule, soft

Oral use

Cyprus

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 50 mg

50 mg

Capsule, soft

Oral use

Cyprus

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral 100 mg

100 mg

Capsule, soft

Oral use

Cyprus

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral Oral Solution 100 mg/ ml

100 mg/ml

Oral Solution

Oral use

100 mg/ml

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Prague 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 25 mg

25 mg

Capsule, soft

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Prague 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 50 mg

50 mg

Capsule, soft

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Prague 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 100 mg

100 mg

Capsule, soft

Oral use

Czech Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| 140 00 Prague 4 - Nusle |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

140 00 Prague 4 - Nusle

Czech Republic

Sandimmun Neoral 100 mg/ml

100 mg/ml

Oral solution

Oral use

100 mg/ml

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Copenhagen |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

10 mg

Capsule, soft

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Copenhagen |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Copenhagen |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Copenhagen |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 Copenhagen |
| Denmark |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 Copenhagen

Denmark

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Estonia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Estonia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

Estonia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Finland

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

France

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

10 mg

Capsule, soft

Oral use

France

| Novartis Pharma S.A.S. |
| --- |
| 2- 4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2- 4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

25 mg

Capsule, soft

Oral use

France

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

50 mg

Capsule, soft

Oral use

France

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

100 mg

Capsule, soft

Oral use

France

| Novartis Pharma S.A.S. |
| --- |
| 2-4, rue Lionel Terray |
| 92500 RUEIL-MALMAISON, |
| France |

Novartis Pharma S.A.S.

2-4, rue Lionel Terray

92500 RUEIL-MALMAISON,

France

NEORAL

100 mg/ml

Oral solution

Oral use

100 mg/ml

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 10 mg Weichkapseln

10 mg

Capsule, soft

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 25 mg Weichkapseln

25 mg

Capsule, soft

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 50 mg Weichkapseln

50 mg

Capsule, soft

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg Weichkapseln

100 mg

Capsule, soft

Oral use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Oral solution

Oral use

100 mg/ml

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

25 mg/cap

Capsule, soft

Oral use

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

50 mg/cap

Capsule, soft

Oral use

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

100 mg/cap

Capsule, soft

Oral use

Greece

| Novartis (Hellas) S.A.C.I. |
| --- |
| National Road No. 1 (12th Km) |
| Metamorphosis |
| GR-144 51 Athens |
| Greece |

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

Greece

SANDIMMUN NEORAL

500 mg/5 ml

Oral solution

Oral use

100 mg/ml

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 10 mg lágy kapszula

10 mg

Capsule, soft

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 25 mg lágy kapszula

25 mg

Capsule, soft

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 50 mg lágy kapszula

50 mg

Capsule, soft

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 100 mg lágy kapszula

100 mg

Capsule, soft

Oral use

Hungary

| Novartis Hungária Kft. Pharma részlege |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Hungary |

Novartis Hungária Kft. Pharma részlege

Bartók Béla út 43-47

H-1114 Budapest

Hungary

Sandimmun Neoral 100 mg/ml belsőleges oldat

100 mg/ml

Oral solution

Oral use

100 mg/ml

Iceland

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Iceland

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

Iceland

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Iceland

| Novartis Healthcare A/S |
| --- |
| Edward Thomsens Vej 14 2003 Köbenhavn S Denmark |

Novartis Healthcare A/S

Edward Thomsens Vej 14 2003 Köbenhavn S Denmark

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Ireland

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

25 mg

Capsule, soft

Oral use

Ireland

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

50 mg

Capsule, soft

Oral use

Ireland

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

100 mg

Capsule, soft

Oral use

Ireland

| Novartis Pharmaceuticals UNITED KINGDOM Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UNITED KINGDOM Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Italy

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

10 mg

Capsule, soft

Oral use

Italy

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Italy

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

Italy

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Italy

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

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Latvia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral 25 mg mīkstās kapsulas

25 mg

Capsule, soft

Oral use

Latvia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral 50 mg mīkstās kapsulas

50 mg

Capsule, soft

Oral use

Latvia

| Novartis Finland OY |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland OY

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral 100 mg mīkstās kapsulas

100 mg

Capsule, soft

Oral use

Lithuania

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Lithuania

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo, |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo,

Finland

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

Lithuania

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FIN-02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Finland

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 10 mg Weichkapseln

10 mg

Capsule, soft

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 25 mg Weichkapseln

25 mg

Capsule, soft

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 50 mg Weichkapseln

50 mg

Capsule, soft

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg Weichkapseln

100 mg

Capsule, soft

Oral use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Optoral 100 mg/ml Lösung zum Einnehmen

100 mg/ml

Oral solution

Oral use

100 mg/ml

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Sandimmun Neoral

100 mg/ml

Oral Solution

Oral use

100 mg/ml

Netherlands

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 25 mg, capsules

25 mg

Capsule, soft

Oral use

Netherlands

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 100 mg, capsules

100 mg

Capsule, soft

Oral use

Netherlands

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| The Netherlands |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

The Netherlands

Neoral 100 mg/ml, drank

100 mg/ml

Oral Solution

Oral use

100 mg/ml

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Norway

| Novartis Norge AS |
| --- |
| Nydalen Alle 37A |
| P.O Box 4284 |
| Nydalen, N-0401 Oslo |
| Norway |

Novartis Norge AS

Nydalen Alle 37A

P.O Box 4284

Nydalen, N-0401 Oslo

Norway

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

10 mg

Capsule, soft

Oral use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Portugal

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Portugal

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

Portugal

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Portugal

| Novartis Farma - Produtos Farmacêuticos S.A. |
| --- |
| Rua do Centro Empresarial, Edificio 8 |
| Quinta da Beloura |
| P-2710-444 Sintra |
| Portugal |

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P-2710-444 Sintra

Portugal

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL capsule moi, 25 mg

25 mg

Capsule, soft

Oral use

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL,capsule moi, 50 mg

50 mg

Capsule, soft

Oral use

Romania

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

SANDIMMUN NEORAL, solutie orala, 100 mg/ml

100 mg/ml

Oral solution

Oral use

100 mg/ml

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| Prague 140 00 |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 25 mg

25 mg

Capsule, soft

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| Prague 140 00 |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 50 mg

50 mg

Capsule, soft

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| Prague 140 00 |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 100 mg

100 mg

Capsule, soft

Oral use

Slovak Republic

| Novartis s.r.o. |
| --- |
| Na Pankráci 1724/129 |
| Prague 140 00 |
| Czech Republic |

Novartis s.r.o.

Na Pankráci 1724/129

Prague 140 00

Czech Republic

Sandimmun Neoral 100 mg/ml

100 mg/ml

Oral solution

Oral use

100 mg/ml

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 25 mg mehke kapsule

25 mg

Capsule, soft

Oral use

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 50 mg mehke kapsule

50 mg

Capsule, soft

Oral use

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 100 mg mehke kapsule

100 mg

Capsule, soft

Oral use

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Germany |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Germany

Sandimmun Neoral 100 mg/ml peroralna raztopina

100 mg/ml

Oral solution

Oral use

100 mg/ml

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 25 mg cápsulas blandas

25 mg

Capsule, soft

Oral use

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 50 mg cápsulas blandas

50 mg

Capsule, soft

Oral use

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 100 mg cápsulas blandas

100 mg

Capsule, soft

Oral use

Spain

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |
| Spain |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Spain

Sandimmun Neoral 100 mg/ml solución oral

100 mg/ml

Oral solution

Oral use

100 mg/ml

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

10 mg

Capsule, soft

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

25 mg

Capsule, soft

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

50 mg

Capsule, soft

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

100 mg

Capsule, soft

Oral use

Sweden

| Novartis Sverige AB |
| --- |
| Kemistvägen 1B / Box 1150 |
| SE-183 11 Täby |
| Sweden |

Novartis Sverige AB

Kemistvägen 1B / Box 1150

SE-183 11 Täby

Sweden

Sandimmun Neoral

100 mg/ml

Oral solution

Oral use

100 mg/ml

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 10 mg

10 mg

Capsule, soft

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 25 mg

25 mg

Capsule, soft

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 50 mg

50 mg

Capsule, soft

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Soft Gelatin Capsules 100 mg

100 mg

Capsule, soft

Oral use

United Kingdom

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

Neoral Oral solution

100 mg/ml

Oral Solution

Oral use

100 mg/ml

---

ANNEX VIII

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

| Member State (in EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Janssen-Cilag NV |
| Antwerpseweg 15-17 |
| 2340 Beerse |
| Belgium |

Member State (in EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

Janssen-Cilag NV

Antwerpseweg 15-17

2340 Beerse

Belgium

Nizoral 200 mg tabletten

200 mg

Tablet

Oral use

Bulgaria

| Jonson & Jonson D.O.O., |
| --- |
| Smartinska cesta 53, |
| 1000 Ljubljana, |
| Slovenia |

Jonson & Jonson D.O.O.,

Smartinska cesta 53,

1000 Ljubljana,

Slovenia

NIZORAL

200 mg

Tablet

Oral use

Cyprus

| Aegis Ltd |
| --- |
| 17 Athinon street |
| 2081 Lefkosia |
| Cyprus |

Aegis Ltd

17 Athinon street

2081 Lefkosia

Cyprus

KETOZAL TABLETS 200 mg

200 mg

Tablet

Oral use

Cyprus

| Remedica ltd |
| --- |
| Aharnon street |
| 3508 Lemesos |
| Cyprus |

Remedica ltd

Aharnon street

3508 Lemesos

Cyprus

KETROZOL TABLETS 200 mg

200 mg

Tablet

Oral use

Cyprus

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beers |
| Belgium |

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beers

Belgium

NIZORAL TABLETS 200 mg

200 mg

Tablet

Oral use

Cyprus

| Medochemie ltd |
| --- |
| 1-10 Constantinoupoleos street |
| 3505 Lemesos |
| Cyprus |

Medochemie ltd

1-10 Constantinoupoleos street

3505 Lemesos

Cyprus

TINUVIN TABLETS 200 mg

200 mg

Tablet

Oral use

Cyprus

| CDL Pharmaceutical Products ltd |
| --- |
| Agiou Spyridonos 12 |
| 7102 Larnaca |
| Cyprus |

CDL Pharmaceutical Products ltd

Agiou Spyridonos 12

7102 Larnaca

Cyprus

VAFLUSON TABLETS 200 mg

200 mg

Tablet

Oral use

Czech Republic

| Janssen-Cilag s.r.o. |
| --- |
| Karla Engliše 3201/6 |
| 15000 Praha 5 |
| Czech Republic |

Janssen-Cilag s.r.o.

Karla Engliše 3201/6

15000 Praha 5

Czech Republic

NIZORAL

200 mg

Tablet

Oral use

Estonia

| UAB Johnson & Johnson |
| --- |
| Gelezinio Vilko g. 18A |
| 08104 Vilnius |
| Lithuania |

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

NIZORAL

200 mg

Tablet

Oral use

Finland

| Janssen-Cilag Oy |
| --- |
| Vaisalantie 2 |
| 02130 Espoo |
| Finland |

Janssen-Cilag Oy

Vaisalantie 2

02130 Espoo

Finland

NIZORAL

200 mg

Tablet

Oral use

France

| Janssen Cilag |
| --- |
| 1, rue Camille Desmoulins TSA |
| 91003 92787 Issy-les-Moulineaux |
| Cedex 9 |
| France |

Janssen Cilag

1, rue Camille Desmoulins TSA

91003 92787 Issy-les-Moulineaux

Cedex 9

France

NIZORAL 200 mg, comprimé

200 mg

Tablet

Oral use

Greece

| Coup ABEE |
| --- |
| Agias Barbaras 53-55 |
| Dafni 15235 |
| Greece |

Coup ABEE

Agias Barbaras 53-55

Dafni 15235

Greece

MYCOFEBRIN

200 mg

Tablet

Oral use

Greece

| Demo ABEE |
| --- |
| 21ST Km National Highway |
| Athens - Lamia |
| Kryoneri 14568 |
| Greece |

Demo ABEE

21ST Km National Highway

Athens - Lamia

Kryoneri 14568

Greece

AQUARIUS

200 mg

Tablet

Oral use

Greece

| Rafarm AEBE |
| --- |
| Korinthou 12 |
| Neo Psychiko 15451 |
| Greece |

Rafarm AEBE

Korinthou 12

Neo Psychiko 15451

Greece

ILGEM

200 mg

Tablet

Oral use

Greece

| Angelini Pharma Hellas ABEE |
| --- |
| Achaias & Trizinias |
| Nea Kifissia 14564 |
| Athens |
| Greece |

Angelini Pharma Hellas ABEE

Achaias & Trizinias

Nea Kifissia 14564

Athens

Greece

SOSTATIN

200 mg

Tablet

Oral use

Greece

| Bros ltd |
| --- |
| Avgis & Galinis 15 |
| Nea Kifissia |
| Athens |
| Greece |

Bros ltd

Avgis & Galinis 15

Nea Kifissia

Athens

Greece

EBERSEPT

200 mg

Tablet

Oral use

Hungary

| Janssen-Cilag Kft. |
| --- |
| West Gate Business Park |
| Tó Park |
| 2045, Törökbálint |
| Hungary |

Janssen-Cilag Kft.

West Gate Business Park

Tó Park

2045, Törökbálint

Hungary

NIZORAL 200 mg tabletta

200 mg

Tablet

Oral use

Iceland

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| 192 07 Sollentuna |
| Sweden |

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Fungoral

200 mg

Tablet

Oral use

Latvia

| UAB Johnson & Johnson |
| --- |
| Gelezinio Vilko g. 18A |
| 08104 Vilnius |
| Lithuania |

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

Nizoral 200 mg tablets

200 mg

Tablet

Oral use

Lithuania

| UAB Johnson & Johnson |
| --- |
| Gelezinio Vilko g. 18A |
| 08104 Vilnius |
| Lithuania |

UAB Johnson & Johnson

Gelezinio Vilko g. 18A

08104 Vilnius

Lithuania

Nizoral

200 mg

Tablet

Oral use

Luxembourg

| Janssen Cilag NV |
| --- |
| 15-17 Antwerpseweg |
| B-2340 Beerse |
| Belgium |

Janssen Cilag NV

15-17 Antwerpseweg

B-2340 Beerse

Belgium

Nizoral 200 mg comprimés

200 mg

Tablet

Oral use

Norway

| Janssen-Cilag AS |
| --- |
| Postboks 144 |
| 1325 Lysaker |
| Norway |

Janssen-Cilag AS

Postboks 144

1325 Lysaker

Norway

Fungoral

200 mg

Tablet

Oral use

Poland

| Polfarmex S.A. |
| --- |
| Józefów 9 |
| 99-300 Kutno |
| Poland |

Polfarmex S.A.

Józefów 9

99-300 Kutno

Poland

Ketokonazol

200 mg

Tablet

Oral use

Portugal

| Janssen Farmacêutica Portugal, Lda. |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| 2734-503 Barcarena |
| Portugal |

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

2734-503 Barcarena

Portugal

Nizale

200 mg

Tablet

Oral use

Romania

| S.C. Arena Group S.A. |
| --- |
| Str. Ștefan Mihăileanu nr. 31 Sector 2, București |
| România |

S.C. Arena Group S.A.

Str. Ștefan Mihăileanu nr. 31 Sector 2, București

România

KETOCONAZOL ARENA 200 mg

200 mg

Tablet

Oral use

Romania

| Terapia SA |
| --- |
| Str. Fabricii nr. 124 |
| Cluj-Napoca |
| Romania |

Terapia SA

Str. Fabricii nr. 124

Cluj-Napoca

Romania

NIZORAL 200 mg

200 mg

Tablet

Oral use

Romania

| S.C. Magistra C&C |
| --- |
| Str. Aurel Vlaicu nr. 82A |
| 8700 Constanța |
| România |

S.C. Magistra C&C

Str. Aurel Vlaicu nr. 82A

8700 Constanța

România

KETOCONAZOL 200 mg

200 mg

Tablet

Oral use

Romania

| S.C. Slavia Pharm S.R.L. |
| --- |
| Bd.Theodor Pallady nr. 44C |
| Sector 3 |
| București |
| România |

S.C. Slavia Pharm S.R.L.

Bd.Theodor Pallady nr. 44C

Sector 3

București

România

KETOCONAZOL 200 mg

200 mg

Tablet

Oral use

Romania

| A.C. Helcor s.r.l. |
| --- |
| Str. Dr. Victor Babeș nr. 50 |
| Baia Mare |
| România |

A.C. Helcor s.r.l.

Str. Dr. Victor Babeș nr. 50

Baia Mare

România

KETOSTIN 200 mg

200 mg

Tablet

Oral use

Slovak Republic

| Johnson & Johnson s.r.o. |
| --- |
| Karadžičova 12 |
| 821 08 Bratislava |
| Slovak Republic |

Johnson & Johnson s.r.o.

Karadžičova 12

821 08 Bratislava

Slovak Republic

NIZORAL

200 mg

Tablet

Oral use

Spain

| Zeus, S.L. |
| --- |
| Collado mediano, s/n |
| 28230 Las Rozas |
| Madrid |
| Spain |

Zeus, S.L.

Collado mediano, s/n

28230 Las Rozas

Madrid

Spain

FUNGO ZEUS 200 mg comprimidos

200 mg

Tablet

Oral use

Spain

| Janssen-Cilag, S.A. |
| --- |
| Po de Las Doce Estrellas 5-7 |
| 28042 Madrid |
| Spain |

Janssen-Cilag, S.A.

Po de Las Doce Estrellas 5-7

28042 Madrid

Spain

FUNGAREST comprimidos

200 mg

Tablet

Oral use

Spain

| Ratiopharm Espana, S.A. |
| --- |
| C/ Anabel Segura, 11 |
| Edificio Albatros B 1a planta |
| 28108 Alcobendas (Madrid) |
| Spain |

Ratiopharm Espana, S.A.

C/ Anabel Segura, 11

Edificio Albatros B 1a planta

28108 Alcobendas (Madrid)

Spain

Ketoconazol ratiopharm 200 mg comprimidos

200 mg

Tablet

Oral use

Sweden

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| 192 07 Sollentuna |
| Sweden |

Janssen-Cilag AB

Box 7073

192 07 Sollentuna

Sweden

Fungoral®

200 mg

Tablet

Oral use

The Netherlands

| Janssen-Cilag B.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| 5026 RH TILBURG |
| The Netherlands |

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

5026 RH TILBURG

The Netherlands

Nizoral tabletten 200 mg

200 mg

Tablet

Oral use

United Kingdom

| Janssen-Cilag Limited |
| --- |
| 50-100 Holmers Farm Way |
| High Wycombe |
| Buckinghamshire HP12 4EG |
| United Kingdom |

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire HP12 4EG

United Kingdom

Nizoral 200 mg tablets

200 mg

Tablet

Oral use

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