# C_2006152EN.01001401.xml

| 30.6.2006 | EN | Official Journal of the European Union | C 152/14 |
| --- | --- | --- | --- |

30.6.2006

EN

Official Journal of the European Union

C 152/14

---

Summary of Community decisions on marketing authorisations in respect of medicinal products from 1.5.2006 to 31.5.2006

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

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

2

(2006/C 152/08)

—   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorisation | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 22.5.2006 | Atorvastatin | See Annex I | See Annex I | 23.5.2006 |
| 29.5.2006 | Pimecrolimus | See Annex II | See Annex II | 30.5.2006 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

22.5.2006

Atorvastatin

See Annex I

See Annex I

23.5.2006

29.5.2006

Pimecrolimus

See Annex II

See Annex II

30.5.2006

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

1

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

2

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ANNEX I

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Ges.m.b.H. | Sortis | 10 mg | Film-coated tablet | Oral use |
| Austria | Pfizer Corporation Austria Ges.m.b.H. | Sortis | 20 mg | Film-coated tablet | Oral use |
| Austria | Pfizer Corporation Austria Ges.m.b.H. | Sortis | 40 mg | Film-coated tablet | Oral use |
| Austria | Pfizer Corporation Austria Ges.m.b.H. | Sortis | 80 mg | Film-coated tablet | Oral use |
| Belgium | Pfizer S.A. | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Belgium | Pfizer S.A. | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Belgium | Pfizer S.A. | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Belgium | Pfizer S.A. | Lipitor | 80 mg | Film-coated tablet | Oral use |
| Denmark | Pfizer ApS | Zarator | 10 mg | Film-coated tablet | Oral use |
| Denmark | Pfizer ApS | Zarator | 20 mg | Film-coated tablet | Oral use |
| Denmark | Pfizer ApS | Zarator | 40 mg | Film-coated tablet | Oral use |
| Denmark | Pfizer ApS | Zarator | 80 mg | Film-coated tablet | Oral use |
| Finland | Pfizer Oy | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Finland | Pfizer Oy | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Finland | Pfizer Oy | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Finland | Pfizer Oy | Lipitor | 80 mg | Film-coated tablet | Oral use |
| Germany | PARKE-DAVIS GmbH | Sortis | 10 mg | Film-coated tablet | Oral use |
| Germany | PARKE-DAVIS GmbH | Sortis | 20 mg | Film-coated tablet | Oral use |
| Germany | PARKE-DAVIS GmbH | Sortis | 40 mg | Film-coated tablet | Oral use |
| Germany | PARKE-DAVIS GmbH | Sortis | 80 mg | Film-coated tablet | Oral use |
| Greece | Pfizer Hellas AE | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Greece | Pfizer Hellas AE | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Greece | Pfizer Hellas AE | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Greece | Pfizer Hellas AE | Lipitor | 80 mg | Film-coated tablet | Oral use |
| Italy | PARKE-DAVIS SpA | Xarator | 10 mg | Film-coated tablet | Oral use |
| Italy | PARKE-DAVIS SpA | Xarator | 20 mg | Film-coated tablet | Oral use |
| Italy | PARKE-DAVIS SpA | Xarator | 40 mg | Film-coated tablet | Oral use |
| Italy | PARKE-DAVIS SpA | Xarator | 80 mg | Film-coated tablet | Oral use |
| Luxembourg | Pfizer S.A. | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Luxembourg | Pfizer S.A. | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Luxembourg | Pfizer S.A. | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Luxembourg | Pfizer S.A. | Lipitor | 80 mg | Film-coated tablet | Oral use |
| Netherlands | Pfizer bv | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Netherlands | Pfizer bv | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Netherlands | Pfizer bv | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Netherlands | Pfizer bv | Lipitor | 80 mg | Film-coated tablet | Oral use |
| Portugal | Laboratórios Pfizer, Lda | Zarator | 10 mg | Film-coated tablet | Oral use |
| Portugal | Laboratórios Pfizer, Lda | Zarator | 20 mg | Film-coated tablet | Oral use |
| Portugal | Laboratórios Pfizer, Lda | Zarator | 40 mg | Film-coated tablet | Oral use |
| Portugal | Laboratórios Pfizer, Lda | Zarator | 80 mg | Film-coated tablet | Oral use |
| Spain | PARKE-DAVIS, S.L. | Zarator | 10 mg | Film-coated tablet | Oral use |
| Spain | PARKE-DAVIS, S.L. | Zarator | 20 mg | Film-coated tablet | Oral use |
| Spain | PARKE-DAVIS, S.L. | Zarator | 40 mg | Film-coated tablet | Oral use |
| Spain | PARKE-DAVIS, S.L. | Zarator | 80 mg | Film-coated tablet | Oral use |
| Sweden | Pfizer AB | Lipitor | 10 mg | Film-coated tablet | Oral use |
| Sweden | Pfizer AB | Lipitor | 20 mg | Film-coated tablet | Oral use |
| Sweden | Pfizer AB | Lipitor | 40 mg | Film-coated tablet | Oral use |
| Sweden | Pfizer AB | Lipitor | 80 mg | Film-coated tablet | Oral use |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

10 mg

Film-coated tablet

Oral use

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

20 mg

Film-coated tablet

Oral use

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

40 mg

Film-coated tablet

Oral use

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

80 mg

Film-coated tablet

Oral use

Belgium

Pfizer S.A.

Lipitor

10 mg

Film-coated tablet

Oral use

Belgium

Pfizer S.A.

Lipitor

20 mg

Film-coated tablet

Oral use

Belgium

Pfizer S.A.

Lipitor

40 mg

Film-coated tablet

Oral use

Belgium

Pfizer S.A.

Lipitor

80 mg

Film-coated tablet

Oral use

Denmark

Pfizer ApS

Zarator

10 mg

Film-coated tablet

Oral use

Denmark

Pfizer ApS

Zarator

20 mg

Film-coated tablet

Oral use

Denmark

Pfizer ApS

Zarator

40 mg

Film-coated tablet

Oral use

Denmark

Pfizer ApS

Zarator

80 mg

Film-coated tablet

Oral use

Finland

Pfizer Oy

Lipitor

10 mg

Film-coated tablet

Oral use

Finland

Pfizer Oy

Lipitor

20 mg

Film-coated tablet

Oral use

Finland

Pfizer Oy

Lipitor

40 mg

Film-coated tablet

Oral use

Finland

Pfizer Oy

Lipitor

80 mg

Film-coated tablet

Oral use

Germany

PARKE-DAVIS GmbH

Sortis

10 mg

Film-coated tablet

Oral use

Germany

PARKE-DAVIS GmbH

Sortis

20 mg

Film-coated tablet

Oral use

Germany

PARKE-DAVIS GmbH

Sortis

40 mg

Film-coated tablet

Oral use

Germany

PARKE-DAVIS GmbH

Sortis

80 mg

Film-coated tablet

Oral use

Greece

Pfizer Hellas AE

Lipitor

10 mg

Film-coated tablet

Oral use

Greece

Pfizer Hellas AE

Lipitor

20 mg

Film-coated tablet

Oral use

Greece

Pfizer Hellas AE

Lipitor

40 mg

Film-coated tablet

Oral use

Greece

Pfizer Hellas AE

Lipitor

80 mg

Film-coated tablet

Oral use

Italy

PARKE-DAVIS SpA

Xarator

10 mg

Film-coated tablet

Oral use

Italy

PARKE-DAVIS SpA

Xarator

20 mg

Film-coated tablet

Oral use

Italy

PARKE-DAVIS SpA

Xarator

40 mg

Film-coated tablet

Oral use

Italy

PARKE-DAVIS SpA

Xarator

80 mg

Film-coated tablet

Oral use

Luxembourg

Pfizer S.A.

Lipitor

10 mg

Film-coated tablet

Oral use

Luxembourg

Pfizer S.A.

Lipitor

20 mg

Film-coated tablet

Oral use

Luxembourg

Pfizer S.A.

Lipitor

40 mg

Film-coated tablet

Oral use

Luxembourg

Pfizer S.A.

Lipitor

80 mg

Film-coated tablet

Oral use

Netherlands

Pfizer bv

Lipitor

10 mg

Film-coated tablet

Oral use

Netherlands

Pfizer bv

Lipitor

20 mg

Film-coated tablet

Oral use

Netherlands

Pfizer bv

Lipitor

40 mg

Film-coated tablet

Oral use

Netherlands

Pfizer bv

Lipitor

80 mg

Film-coated tablet

Oral use

Portugal

Laboratórios Pfizer, Lda

Zarator

10 mg

Film-coated tablet

Oral use

Portugal

Laboratórios Pfizer, Lda

Zarator

20 mg

Film-coated tablet

Oral use

Portugal

Laboratórios Pfizer, Lda

Zarator

40 mg

Film-coated tablet

Oral use

Portugal

Laboratórios Pfizer, Lda

Zarator

80 mg

Film-coated tablet

Oral use

Spain

PARKE-DAVIS, S.L.

Zarator

10 mg

Film-coated tablet

Oral use

Spain

PARKE-DAVIS, S.L.

Zarator

20 mg

Film-coated tablet

Oral use

Spain

PARKE-DAVIS, S.L.

Zarator

40 mg

Film-coated tablet

Oral use

Spain

PARKE-DAVIS, S.L.

Zarator

80 mg

Film-coated tablet

Oral use

Sweden

Pfizer AB

Lipitor

10 mg

Film-coated tablet

Oral use

Sweden

Pfizer AB

Lipitor

20 mg

Film-coated tablet

Oral use

Sweden

Pfizer AB

Lipitor

40 mg

Film-coated tablet

Oral use

Sweden

Pfizer AB

Lipitor

80 mg

Film-coated tablet

Oral use

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ANNEX II

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

| Member State | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH, |
| Brunnerstraße 59, |
| A-1235 Wien |

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Novartis Pharma GmbH,

Brunnerstraße 59,

A-1235 Wien

Elidel

1%

Cream

Cutaneous use

Belgium

| Novartis Pharma |
| --- |
| N.V.Medialaan 40 |
| B-1800 Vilvoorde |

Novartis Pharma

N.V.Medialaan 40

B-1800 Vilvoorde

Elidel 1 %

10 mg/g

Cream

Cutaneous use

Belgium

| Novartis Pharma |
| --- |
| N.V.Medialaan 40 |
| B-1800 Vilvoorde |

Novartis Pharma

N.V.Medialaan 40

B-1800 Vilvoorde

Isaplic 1 %

10 mg/g

Cream

Cutaneous use

Czech Republic

| Novartis s.r.o Praha |
| --- |
| Nagano III |
| U Nákladového Nádraží 10 |
| CZ-130 00 Praha 3 |

Novartis s.r.o Praha

Nagano III

U Nákladového Nádraží 10

CZ-130 00 Praha 3

Elidel 1 % Krém

1%

Cream

Cutaneous use

Cyprus

| Demetriades & Papaellinas Ltd |
| --- |
| 21 Kassou street |
| P.O. Box 23490 Acropolis |
| CY-1683 Lefkosia |

Demetriades & Papaellinas Ltd

21 Kassou street

P.O. Box 23490 Acropolis

CY-1683 Lefkosia

Elidel cream 1 %

1%

Cream 15 g

Cutaneous use

Cyprus

| Demetriades & Papaellinas Ltd |
| --- |
| 21 Kassou street |
| P.O. Box 23490 Acropolis |
| CY-1683 Lefkosia |

Demetriades & Papaellinas Ltd

21 Kassou street

P.O. Box 23490 Acropolis

CY-1683 Lefkosia

Elidel cream 1 %

1%

Cream 30 g

Cutaneous use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Elidel

1%

Cream

Cutaneous use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Aregen

1%

Cream

Cutaneous use

Denmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø |

Novartis Healthcare A/S

Lyngbyvej 172

DK-2100 København Ø

Velov

1%

Cream

Cutaneous use

Estonia

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

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Elidel

1% cream

Cream

Cutaneous use

Finland

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

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Elidel

1%

Cream

Cutaneous use

France

| Novartis Pharma |
| --- |
| 2-4, rue Lionel Terray |
| F-92500 Rueil-Malmaison |

Novartis Pharma

2-4, rue Lionel Terray

F-92500 Rueil-Malmaison

Elidel

1%

Cream 15 g

Cutaneous use

France

| Novartis Pharma |
| --- |
| 2-4, rue Lionel Terray |
| F-92500 Rueil-Malmaison |

Novartis Pharma

2-4, rue Lionel Terray

F-92500 Rueil-Malmaison

Elidel

1%

Cream 30 g

Cutaneous use

France

| Novartis Pharma |
| --- |
| 2-4, rue Lionel Terray |
| F-92500 Rueil-Malmaison |

Novartis Pharma

2-4, rue Lionel Terray

F-92500 Rueil-Malmaison

Elidel

1%

Cream 60 g

Cutaneous use

France

| Novartis Pharma |
| --- |
| 2-4, rue Lionel Terray |
| F-92500 Rueil-Malmaison |

Novartis Pharma

2-4, rue Lionel Terray

F-92500 Rueil-Malmaison

Elidel

1%

Cream 100 g

Cutaneous use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Elidel 1 % Creme

10 mg/ 1g

Cream

Cutaneous use

Germany

| 3M Medica |
| --- |
| Zweigniederlassung der 3M Deutschland GmbH |
| Hammfelddamm 11 |
| D-41460 Neuss |

3M Medica

Zweigniederlassung der 3M Deutschland GmbH

Hammfelddamm 11

D-41460 Neuss

Douglan 1 % Creme

10 mg/ 1g

Cream

Cutaneous use

Germany

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Velov 1 % Crème

10 mg/ 1g

Cream

Cutaneous use

Greece

| Novartis (Hellas) AEBE |
| --- |
| 12 km Athens-Lamia |
| Metamorfosi |
| GR-14451 Athens |

Novartis (Hellas) AEBE

12 km Athens-Lamia

Metamorfosi

GR-14451 Athens

Elidel

1%

Cream

Cutaneous use

Greece

| Novartis (Hellas) AEBE |
| --- |
| 12 km Athens-Lamia |
| Metamorfosi |
| GR-14451 Athens |

Novartis (Hellas) AEBE

12 km Athens-Lamia

Metamorfosi

GR-14451 Athens

Aregen

1%

Cream

Cutaneous use

Hungary

| Novartis Hungária Kft. Pharma |
| --- |
| Bartók Béla út 43-47 |
| Bartók-Ház, V. em. |
| H-1114 Budapest |

Novartis Hungária Kft. Pharma

Bartók Béla út 43-47

Bartók-Ház, V. em.

H-1114 Budapest

Elidel 1 % krém

1% (10mg/g)

Cream

Cutaneous use

Iceland

| Novaris Healthcare A/S, |
| --- |
| Lyngbyvej 172 |
| DK-2100 København Ø, |

Novaris Healthcare A/S,

Lyngbyvej 172

DK-2100 København Ø,

Elidel cream 1 %

1%

Cream

Cutaneous use

Italy

| Novartis Farma S.p.A. |
| --- |
| Via Umberto Boccioni, 1 |
| I-21040 Origgio, Varese |

Novartis Farma S.p.A.

Via Umberto Boccioni, 1

I-21040 Origgio, Varese

Elidel

1%

Cream

Cutaneous use

Italy

| L.P.B. Istituto Farmaceutico S.p.A |
| --- |
| Via Umberto Boccioni, 1 |
| I-21040 Origgio, Varese |

L.P.B. Istituto Farmaceutico S.p.A

Via Umberto Boccioni, 1

I-21040 Origgio, Varese

Ombex

1%

Cream

Cutaneous use

Latvia

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

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Elidel

1%

Cream

Cutaneous use

Lithuania

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

Novartis Finland Oy

Metsänneidonkuja 10

FIN-02130 Espoo

Elidel

10 mg/g

Cream

Cutaneous use

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Elidel

1%

Cream

Cutaneous use

Malta

| Novartis Pharmaceuticals UK Ltd. |
| --- |
| Frimley Business Park, |
| Frimley, |
| Camberley, |
| Surrey GUI6 7SR, |
| United Kingdom |

Novartis Pharmaceuticals UK Ltd.

Frimley Business Park,

Frimley,

Camberley,

Surrey GUI6 7SR,

United Kingdom

Elidel

1% w/w

Cream

Cutaneous use

Norway

| Novartis Norge AS |
| --- |
| Postboks 237 Økern |
| N-0510 Oslo |

Novartis Norge AS

Postboks 237 Økern

N-0510 Oslo

Elidel

1%

Cream

Cutaneous use

Poland

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Elidel

10 mg/g

Cream

Cutaneous use

Portugal

| Laboratório Normal — Produtos Farmacêuticos, SA |
| --- |
| Rua do Centro Empresarial |
| Edifício 8 - |
| P-Quinta da Beloura 2710-444 |

Laboratório Normal — Produtos Farmacêuticos, SA

Rua do Centro Empresarial

Edifício 8 -

P-Quinta da Beloura 2710-444

Aregen

10 mg/g

Cream

Cutaneous use

Portugal

| Novartis Farma — Produtos Farmacêuticos, SA |
| --- |
| Rua do Centro Empresarial |
| Edifício 8 - |
| P-Quinta da Beloura 2710-444 |

Novartis Farma — Produtos Farmacêuticos, SA

Rua do Centro Empresarial

Edifício 8 -

P-Quinta da Beloura 2710-444

Elidel

10 mg/g

Cream

Cutaneous use

Slovak Republic

| Novartis s.r.o. |
| --- |
| U nákladového nádraží 10 |
| CZ-130 00 Praha 3 |

Novartis s.r.o.

U nákladového nádraží 10

CZ-130 00 Praha 3

Elidel 1 %

10mg in 1g (1%)

Cream

Cutaneous use

Slovenia

| Novartis Pharma GmbH |
| --- |
| Roonstraße 25 |
| D-90429 Nürnberg |

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nürnberg

Elidel

1%

Cream

Cutaneous use

Spain

| Novartis Farmaceutica, SA |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |

Novartis Farmaceutica, SA

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Elidel 1 % cream

1 %

Cream

Cutaneous use

Spain

| Novartis Farmaceutica, SA |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |

Novartis Farmaceutica, SA

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Pimecrolimus Novartis 1 % cream

1 %

Cream

Cutaneous use

Spain

| Novartis Farmaceutica, SA |
| --- |
| Gran Via de les Corts Catalanes, 764 |
| E-08013 Barcelona |

Novartis Farmaceutica, SA

Gran Via de les Corts Catalanes, 764

E-08013 Barcelona

Rizan 1 % cream

1 %

Cream

Cutaneous use

Sweden

| Novartis Sverige AB |
| --- |
| Box 1150 |
| S-183 11 Täby |

Novartis Sverige AB

Box 1150

S-183 11 Täby

Elidel

1% cream

Cream

Cutaneous use

The Netherlands

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| Nederland |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

Nederland

Elidel, crème 10 mg/g

10 mg per g

Cream

Cutaneous use

United Kingdom

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

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey GU16 7SR

United Kingdom

Elidel 1 % Cream

1% w/w

Cream

Cutaneous use

---