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 or Article 38 of Directive 2001/82/EC)
Date: 2006-06-30
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, medicinal product, pharmaceutical legislation

C 152/14

EN

Official Journal of the European Union

30.6.2006

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))

(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

29.5.2006

Pimecrolimus

See Annex II

See Annex II

23.5.2006

30.5.2006

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

30.6.2006

EN

Official Journal of the European Union

C 152/15

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

ANNEX I

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

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

20 mg

Film-coated tablet

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

40 mg

Film-coated tablet

Austria

Pfizer Corporation Austria Ges.m.b.H.

Sortis

80 mg

Film-coated tablet

Belgium

Pfizer S.A.

Belgium

Pfizer S.A.

Belgium

Pfizer S.A.

Belgium

Pfizer S.A.

Lipitor

Lipitor

Lipitor

Lipitor

10 mg

Film-coated tablet

20 mg

Film-coated tablet

40 mg

Film-coated tablet

80 mg

Film-coated tablet

Denmark

Pfizer ApS

Zarator

10 mg

Film-coated tablet

Denmark

Pfizer ApS

Zarator

20 mg

Film-coated tablet

Denmark

Pfizer ApS

Zarator

40 mg

Film-coated tablet

Denmark

Pfizer ApS

Zarator

80 mg

Film-coated tablet

Lipitor

Lipitor

Lipitor

Lipitor

Sortis

Sortis

Sortis

Sortis

Lipitor

Lipitor

Lipitor

Lipitor

10 mg

Film-coated tablet

20 mg

Film-coated tablet

40 mg

Film-coated tablet

80 mg

Film-coated tablet

10 mg

Film-coated tablet

20 mg

Film-coated tablet

40 mg

Film-coated tablet

80 mg

Film-coated tablet

10 mg

Film-coated tablet

20 mg

Film-coated tablet

40 mg

Film-coated tablet

80 mg

Film-coated tablet

Finland

Pfizer Oy

Finland

Pfizer Oy

Finland

Pfizer Oy

Finland

Pfizer Oy

Germany

PARKE-DAVIS GmbH

Germany

PARKE-DAVIS GmbH

Germany

PARKE-DAVIS GmbH

Germany

PARKE-DAVIS GmbH

Pfizer Hellas AE

Pfizer Hellas AE

Pfizer Hellas AE

Pfizer Hellas AE

Greece

Greece

Greece

Greece

Italy

Italy

Italy

Italy

PARKE-DAVIS SpA

Xarator

10 mg

Film-coated tablet

PARKE-DAVIS SpA

Xarator

20 mg

Film-coated tablet

PARKE-DAVIS SpA

Xarator

40 mg

Film-coated tablet

PARKE-DAVIS SpA

Xarator

80 mg

Film-coated tablet

Luxembourg

Pfizer S.A.

Luxembourg

Pfizer S.A.

Lipitor

Lipitor

10 mg

Film-coated tablet

20 mg

Film-coated tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C 152/16

EN

Official Journal of the European Union

30.6.2006

Member State

Marketing Authorisation Holder

Invented
name

Strength

Pharmaceutical form

Route of
administration

Luxembourg

Pfizer S.A.

Luxembourg

Pfizer S.A.

Netherlands

Pfizer bv

Netherlands

Pfizer bv

Netherlands

Pfizer bv

Netherlands

Pfizer bv

Portugal

Laboratórios Pfizer, Lda

Portugal

Laboratórios Pfizer, Lda

Portugal

Laboratórios Pfizer, Lda

Portugal

Laboratórios Pfizer, Lda

Spain

Spain

Spain

Spain

Sweden

Sweden

Sweden

PARKE-DAVIS, S.L.

PARKE-DAVIS, S.L.

PARKE-DAVIS, S.L.

PARKE-DAVIS, S.L.

Pfizer AB

Pfizer AB

Pfizer AB

Sweden

Pfizer AB

Lipitor

Lipitor

Lipitor

Lipitor

Lipitor

Lipitor

Zarator

Zarator

Zarator

Zarator

Zarator

Zarator

Zarator

Zarator

Lipitor

Lipitor

Lipitor

Lipitor

40 mg

Film-coated tablet

80 mg

Film-coated tablet

10 mg

Film-coated tablet

20 mg

Film-coated tablet

40 mg

Film-coated tablet

80 mg

Film-coated tablet

10 mg

Film-coated tablet

20 mg

Film-coated tablet

40 mg

Film-coated tablet

80 mg

Film-coated tablet

10 mg

Film-coated tablet

20 mg

Film-coated tablet

40 mg

Film-coated tablet

80 mg

Film-coated tablet

10 mg

Film-coated tablet

20 mg

Film-coated tablet

40 mg

Film-coated tablet

80 mg

Film-coated tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

30.6.2006

EN

Official Journal of the European Union

C 152/17

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

Belgium

Belgium

Czech Republic

Cyprus

Cyprus

Denmark

Denmark

Denmark

Estonia

Finland

France

France

Novartis Pharma GmbH,
Brunnerstraße 59,
A-1235 Wien

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

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

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

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

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

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

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

Novartis Finland Oy
Metsänneidonkuja 10
FIN-02130 Espoo

Novartis Finland Oy
Metsänneidonkuja 10
FIN-02130 Espoo

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

Cutaneous use

Elidel 1 %

10 mg/g

Cream

Cutaneous use

Isaplic 1 %

10 mg/g

Cream

Cutaneous use

Elidel 1 % Krém

1%

Cream

Cutaneous use

Elidel cream 1 %

1%

Cream 15 g

Cutaneous use

Elidel cream 1 %

1%

Cream 30 g

Cutaneous use

Elidel

Aregen

Velov

1%

1%

1%

Cream

Cutaneous use

Cream

Cutaneous use

Cream

Cutaneous use

Elidel

1% cream

Cream

Cutaneous use

Elidel

Elidel

Elidel

1%

1%

1%

Cream

Cutaneous use

Cream 15 g

Cutaneous use

Cream 30 g

Cutaneous use

C 152/18

EN

Official Journal of the European Union

30.6.2006

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of
administration

France

France

Germany

Germany

Germany

Greece

Greece

Hungary

Iceland

Italy

Italy

Latvia

Lithuania

Luxembourg

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

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

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

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

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

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

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

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

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

Novartis Farma 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

Novartis Finland Oy
Metsänneidonkuja 10
FIN-02130 Espoo

Novartis Finland Oy
Metsänneidonkuja 10
FIN-02130 Espoo

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

Elidel

Elidel

1%

1%

Cream 60 g

Cutaneous use

Cream 100 g

Cutaneous use

Elidel 1 % Creme

10 mg/ 1g

Cream

Cutaneous use

Douglan 1 %
Creme

10 mg/ 1g

Cream

Cutaneous use

Velov 1 % Crème

10 mg/ 1g

Cream

Cutaneous use

Elidel

1%

Cream

Cutaneous use

Aregen

1%

Cream

Cutaneous use

Elidel 1 % krém

1% (10mg/g)

Cream

Cutaneous use

Elidel cream 1 %

1%

Cream

Cutaneous use

Elidel

Ombex

Elidel

1%

1%

1%

Cream

Cutaneous use

Cream

Cutaneous use

Cream

Cutaneous use

Elidel

10 mg/g

Cream

Cutaneous use

Elidel

1%

Cream

Cutaneous use

30.6.2006

EN

Official Journal of the European Union

C 152/19

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of
administration

Malta

Norway

Poland

Portugal

Portugal

Slovak Republic

Slovenia

Spain

Spain

Spain

Sweden

The Netherlands

United Kingdom

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

Novartis Norge AS
Postboks 237 Økern
N-0510 Oslo

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

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

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

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

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nürnberg

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

Elidel

1% w/w

Cream

Cutaneous use

Elidel

1%

Cream

Cutaneous use

Elidel

10 mg/g

Cream

Cutaneous use

Aregen

10 mg/g

Cream

Cutaneous use

Elidel

10 mg/g

Cream

Cutaneous use

Elidel 1 %

10mg in 1g (1%)

Cream

Cutaneous use

Elidel

1%

Cream

Cutaneous use

Elidel 1 % cream

1 %

Cream

Cutaneous use

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

Pimecrolimus
Novartis 1 %
cream

1 %

Cream

Cutaneous use

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

Novartis Sverige AB
Box 1150
S-183 11 Täby

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

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

Rizan 1 % cream

1 %

Cream

Cutaneous use

Elidel

1% cream

Cream

Cutaneous use

Elidel, crème
10 mg/g

10 mg per g

Cream

Cutaneous use

Elidel 1 % Cream

1% w/w

Cream

Cutaneous use