Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2007 to 30 September 2007 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council)
Date: 2007-10-26
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation

C 251/16

EN

Official Journal of the European Union

26.10.2007

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 September 2007 to 30 September 2007

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

(2007/C 251/10)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the
decision

Name(s) of the
medicinal
product

Holder(s) of the marketing
authorization

Member State concerned

3.9.2007

Bicalutamide

See Annex I

See Annex I

7.9.2007

Gliolan

Medac Gesellschaft für klinische
Spezialpräparate mbH
Fehlandtstraße 3
D-20354 Hamburg

This Decision is addressed to
the Member States

7.9.2007

Piroxicam

See Annex II

18.9.2007

Lansoprazole

See Annex III

See Annex II

See Annex III

Date of
notification

5.9.2007

11.9.2007

11.9.2007

27.9.2007

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

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

ANNEX I

Marketing Authorisation Holders

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Austria

Austria

Austria

Belgium

Bulgaria

Czech Republic

Astra Zeneca Österreich GmbH
Schwarzenbergplatz 7
A-1037 Wien

Genericon Pharma Ges.m.b.H.
Hafnerstraße 211
A-8054 Graz

Genericon Pharma Ges.m.b.H.
Hafnerstraße 211
A-8054 Graz

Ratiopharm Arzneimittel Vertriebs-GmbH
Albert-Schweitzer Gasse 3
A-1140 Wien

NV AstraZeneca SA
Egide Van Ophemstraat 110
B-1180 Brussel

AstraZeneca UK Ltd
600 Capability Green
Luton
Bedfordshire LU1 3LU
United Kingdom

AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Bicalutamid „Genericon“

150 mg

Film-coated tablet

Oral use

Bicalutanorm „Genericon“

150 mg

Film-coated tablet

Oral use

Bicalutamid-ratiopharm

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Czech Republic

Ingers Industrial Solutions s.r.o. BRNO
Jeneweinova 51a
CZ-617 00 Brno

Bicaluplex

150 mg

Film-coated tablet

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
1
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Cyprus

Denmark

Greece

Greece

Greece

Greece

Estonia

Finland

Finland

Finland

AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom

AstraZeneca A/S
Roskildevej 22
DK-2620 Albertslund

AstraZeneca SA
4 Theotocopoulou & Astronauton
GR-151 25 Marousi-Athens

Dermos Meπε-pharmaceitica
25 Paraschou str.
Athens

Alvia SA
18th klm Athens-Marathon Ave
GR-153 44 Pallini Attiki

Genepharm SA
18th klm Marathon Ave
GR-153 44 Pallini Attiki

AstraZeneca UK Limited
Stanhope Gate 15
London W1K 1LN
United Kingdom

AstraZeneca Oy
Luomanportti 3
FI-02200 Espoo

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Verodex

150 mg

Film-coated tablet

Oral use

Bicalut

150 mg

Film-coated tablet

Oral use

Bicamide/Genepharm

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Lukasenomid

150 mg

Film-coated tablet

Oral use

Bicalutamid CT-Arzneimittel

150 mg

Film-coated tablet

Oral use

C

2
5
1
/
1
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Straße 3
D-89079 Ulm

Avansor Pharma Oy
Tekniikantie 14
FI-02150 Espoo

Synthon BV
Microweg 22
6545 GN Nijmegen
Nederland

Alternova Oy Ab
Rajatorpantie 41 C
FI-01640 Vantaa

Peseri Trading Limited
El Greco House
20 Queen Frederiks Street
Office 301
CY-1066 Nicosia

Peseri Trading Limited
El Greco House
20 Queen Frederiks Street
Office 301
CY-1066 Nicosia

Orion Corporation
Orionintie 1, PO Box 65
FI-02101 Espoo

Peseri Trading Limited
El Greco House
20 Queen Frederiks Street
Office 301
CY-1066 Nicosia

Bicalutamid Ratiopharm

150 mg

Film-coated tablet

Oral use

Bicalutamid Ribosepharm

150 mg

Film-coated tablet

Oral use

Bicavan

150 mg

Film-coated tablet

Oral use

Bikalutamidi Synthon

150 mg

Film-coated tablet

Oral use

Bicalutamid Alternova

150 mg

Film-coated tablet

Oral use

Alidex

150 mg

Film-coated tablet

Oral use

Bicadex

150 mg

Film-coated tablet

Oral use

Bicalutamid Orion

150 mg

Film-coated tablet

Oral use

Bicalutamide Peseri

150 mg

Film-coated tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
1
9

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Finland

Tad Pharma GmbH
Heinz-Lohmann-Straße 5
D-27472 Cuxhaven

Peseri Trading Limited
El Greco House
20 Queen Frederiks Street
Office 301
CY-1066 Nicosia

Helm Pharmaceuticals GmbH
Nordkanalstraße 28
D-20097 Hamburg

Helm Pharmaceuticals GmbH
Nordkanalstraße 28
D-20097 Hamburg

Helm Pharmaceuticals GmbH
Nordkanalstraße 28
D-20097 Hamburg

Helm Pharmaceuticals GmbH
Nordkanalstraße 28
D-20097 Hamburg

Helm Pharmaceuticals GmbH
Nordkanalstraße 28
D-20097 Hamburg

Helm Pharmaceuticals GmbH
Nordkanalstraße 28
D-20097 Hamburg

Helm Pharmaceuticals GmbH
Nordkanalstraße 28
D-20097 Hamburg

Helm Pharmaceuticals GmbH
Nordkanalstraße 28
D-20097 Hamburg

Bicatad

150 mg

Film-coated tablet

Oral use

Biclad

150 mg

Film-coated tablet

Oral use

Duralutamide

150 mg

Film-coated tablet

Oral use

Grelutamide

150 mg

Film-coated tablet

Oral use

Henlutamide

150 mg

Film-coated tablet

Oral use

Inatamide

150 mg

Film-coated tablet

Oral use

Konlutamide

150 mg

Film-coated tablet

Oral use

Saputamide

150 mg

Film-coated tablet

Oral use

Skylutamide

150 mg

Film-coated tablet

Oral use

Timutamide

150 mg

Film-coated tablet

Oral use

C

2
5
1
/
2
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Finland

France

Hungary

Hungary

Iceland

Italy

Lithuania

Luxembourg

Latvia

Peseri Trading Limited
El Greco House
20 Queen Frederiks Street
Office 301
CY-1066 Nicosia

AstraZeneca
1, place Renault
F-92844 Rueil-Malmaison Cedex

Pharmaconsult Kft.
Ráskay Lea u. 44.
H-1141 Budapest

AstraZeneca KFt.
Park u. 3.
H-2045 Törökbálint

AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom

AstraZeneca S.p.A.
Palazzo Volta
Via F. Sforza
I-20080 Basiglio (MI)

AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom

NV AstraZeneca SA
110 rue E. Van Ophem
B-1180 Bruxelles

AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom

Lutamide

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Bilutamid

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
2
1

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Norway

Poland

Portugal

Portugal

Portugal

Portugal

Romania

Slovakia

Slovenia

AstraZeneca AS
Boks 200 Vinderen
N-0319 Oslo

AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom

AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, 7
Valejas
P-2745-663 Barcarena

Generis Farmacêutica, S.A.
Office Park da Beloura
Edifício 4 Quinta da Beloura
P-2710-444 Sintra

Generis Farmacêutica, S.A.
Office Park da Beloura
Edifício 4 Quinta da Beloura
P-2710-444 Sintra

Farma-APS, Produtos Farmacêuticos, S.A.
Rua João de Deus, 19
Venda Nova
P-2700-487 Amadora

AstraZeneca UK Limited
600 Capability Green
Luton
Bedfordshire LU1 3LU
United Kingdom

AstraZeneca UK Limited
Silk Road Business Park
Macclesfield
Cheshire SK10 2NA
United Kingdom

AstraZeneca UK Limited
15 Stanhope Gate
London W1K 1LN
United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Bicalutamida Generis

150 mg

Film-coated tablet

Oral use

Bicalutamida Prostec

150 mg

Film-coated tablet

Oral use

Bicalutamida Etsi

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

C

2
5
1
/
2
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Sweden

United Kingdom

United Kingdom

AstraZeneca AB
Västra Mälarehamnen 9
S-151 85 Södertälje

AstraZeneca UK Limited
Horizon Place
600 Capability Green
Luton
Bedfordshire LU1 3LU
United Kingdom

AstraZeneca UK Limited
Horizon Place
600 Capability Green
Luton
Bedfordshire LU1 3LU
United Kingdom

Casodex

150 mg

Film-coated tablet

Oral use

Casodex

150 mg

Film-coated tablet

Oral use

Bicalutamide

150 mg

Film-coated tablet

Oral use

Member State

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Applicants

Austria

Austria

Czech Republic

Czech Republic

Denmark

Dr. Robert Heinz & Partner GmbH
Kaiserstraße 84/9
A-1070 Wien

Dermapharm GmbH
Türkenstraße 25/12
A-1090 Wien

Super Vision s.r.o.
Praha
Krohova 60
CZ-160 00 Praha 6

Genthon BV
Microweg 22
6545 Nijmegen
Nederland

Jacobsen Pharma A/S
Vemmingbund Strandvej 111
DK-6310 Broager

Bicaludex

150 mg

Film-coated tablet

Oral use

Bicalutamid „Dermapharm“

150 mg

Film-coated tablet

Oral use

Calumid

150 mg

Film-coated tablet

Oral use

Bicalutamidum Genthon

150 mg

Film-coated tablet

Oral use

Beluclas

150 mg

Film-coated tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
2
3

Member State

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

Denmark

Denmark

Germany

Germany

Greece

Greece

Estonia

Finland

Finland

Jacobsen Pharma A/S
Vemmingbund Strandvej 111
DK-6310 Broager

Jacobsen Pharma A/S
Vemmingbund Strandvej 111
DK-6310 Broager

Jacobsen Pharma A/S
Vemmingbund Strandvej 111
DK-6310 Broager

Hexal AG
Industriestraße 25
D-83607 Holzkirchen

mibe GmbH Arzneimittel
Münchener Straße 15
D-06796 Brehna

Pharmanel Pharmaceutical AE
Marathonos 106
GR-15344 Gerakas

Demo Abee
21st Km National Road
GR-14565 Athens-Lamia

Billev Pharma ApS
Elmegårdsvej 1A, Torslev
DK-3630 Jægerspris

Peseri Trading Limited
El Greco House
20 Queen Frederiks Street
Office 301
CY-1066 Nicosia

Copyfarm A/S
Energivej 15
DK-5260 Odense S

Crilame

150 mg

Film-coated tablet

Oral use

Helmalut

150 mg

Film-coated tablet

Oral use

Pecamid

150 mg

Film-coated tablet

Oral use

Bicalutamid Hexal

150 mg

Film-coated tablet

Oral use

Bicalutamid mibe

150 mg

Film-coated tablet

Oral use

Bicatin

150 mg

Film-coated tablet

Oral use

Zarmol

150 mg

Film-coated tablet

Oral use

Calumid

150 mg

Film-coated tablet

Oral use

Bicalutamide Relon Chem

150 mg

Film-coated tablet

Oral use

Bicalutamid Copyfarm

150 mg

Film-coated tablet

Oral use

C

2
5
1
/
2
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Finland

France

France

France

France

Hungary

Hungary

Poland

Slovakia

Slovakia

Helm Pharmaceuticals GmbH
Nordkanalstraße 28
D-20097 Hamburg

Wyvern Medical
Sterling House
3A New Street
Ledbury HR8 2DX
Herefordshire
United Kingdom

Delbert
56, Quai A. Le gallo
F-92100 Boulogne Billancourt

BioOrganics
PO Box 7071
6503 GN Nijmegen
Nederland

Sandoz S.A.S
49, ave. Georges Pompidou
F-92300 Levallois-Perret

Medico Uno Pharma Kft.
Viadukt utca 12.
H-2051 Biatorbágy

Richter Gedeon Rt.
Gyömrői út 19-21.
H-1103 Budapest

Diammed GmbH
Kaiser-Wilhelm-Ring 4-6
D-48145 Munster

Vale Pharmaceuticals Limited Tipperary
Jervis House
Parnell St
Clonmel, Co.
Ireland

Archie Samuel s.r.o.
Nivky 33
CZ-628 00 Brno

Krislutamide

150 mg

Film-coated tablet

Oral use

Bicalutamide Wyvern Medical

150 mg

Film-coated tablet

Oral use

Bicadel

150 mg

Film-coated tablet

Oral use

Bicalutamide BioOrganics

150 mg

Film-coated tablet

Oral use

Bicalutamide G GAM

150 mg

Film-coated tablet

Oral use

Bicalutamide-MedicoUno

150 mg

Film-coated tablet

Oral use

Calumid

150 mg

Film-coated tablet

Oral use

Calumid

150 mg

Film-coated tablet

Oral use

Calumid

150 mg

Film-coated tablet

Oral use

Bicaluplex

150 mg

Film-coated tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
2
5

Member State

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Tenlec Pharma Limited
Broadlands
Amberstone
Hailsham
East Sussex BN27 1PQ
United Kingdom

Tenlec Pharma Limited
Broadlands
Amberstone
Hailsham
East Sussex BN27 1PQ
United Kingdom

MPX International Limited
127 Shirland Road
London W9 2EP
United Kingdom

Kiron Pharmaceutica BV
Groesbeekseweg 11
6524 CK Nijmegen
Nederland

Bicasel

150 mg

Film-coated tablet

Oral use

Bicamale

150 mg

Film-coated tablet

Oral use

Bicalutamide

150 mg

Film-coated tablet

Oral use

Bicalutamide Kiron

150 mg

Film-coated tablet

Oral use

C

2
5
1
/
2
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

ANNEX II

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

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Pfizer Corporation Austria Gesmbh
Floridsdorfer Hauptstraße 1
A-1210 Wien

Pfizer Corporation Austria Gesmbh
Floridsdorfer Hauptstraße 1
A-1210 Wien

Pfizer Corporation Austria Gesmbh
Floridsdorfer Hauptstraße 1
A-1210 Wien

Pfizer Corporation Austria Gesmbh
Floridsdorfer Hauptstraße 1
A-1210 Wien

Pfizer Corporation Austria Gesmbh
Floridsdorfer Hauptstraße 1
A-1210 Wien

Pfizer Corporation Austria Gesmbh
Floridsdorfer Hauptstraße 1
A-1210 Wien

Ratiopharm Arzneimittel Vertriebs-Gmbh
Albert-Schweitzer-Gasse 3
A-1140 Wien

Ratiopharm Arzneimittel Vertriebs-Gmbh
Albert-Schweitzer-Gasse 3
A-1140 Wien

Ratiopharm Arzneimittel Vertriebs-Gmbh
Albert-Schweitzer-Gasse 3
A-1140 Wien

Hexal Pharma GmbH
Carlbergergasse 44
A-1235 Wien

Felden — Gel

Gel

Cutaneous use

Felden 20 mg — Ampullen

20 mg

Ampoule

Parenteral use

Felden 20 mg — KapseLN

10 mg

Capsule

Oral use

Felden 20 mg — KapseLN

20 mg

Capsule

Oral use

Felden 20 mg — Lösbare Tabletten

20 mg

Tablet

Oral use

Felden Quick — Solve 20 mg —
Lyotabletten

20 mg

Tablet

Oral use

Pirocam 20 mg — Ampullen

20 mg

Ampoule

Parenteral use

Pirocam 20 mg — Tabletten

20 mg

Tablet

Oral use

Pirocam 20 mg — Zäpfchen

20 mg

Suppository

Rectal use

Pirorheum 10 mg — Tabletten

10 mg

Tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
2
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Austria

Belgium

Hexal Pharma GmbH
Carlbergergasse 44
A-1235 Wien

Ci Pharma Arzneimittel Handelsgesmbh
Thimiggasse 25
A-1180 Wien

Stada Arzneimittel GmbH
Heiligenstädterstraße 52/2/8
A-1190 Wien

Stada Arzneimittel GmbH.
Heiligenstädterstraße 52/2/8
A-1190 Wien

Amat Pharma Trading GmbH
Walfischgasse 6/2/1/3
A-1010 Wien

Amat Pharma Trading GmbH
Walfischgasse 6/2/1/3
A-1010 Wien

Amat Pharma Trading GmbH
Walfischgasse 6/2/1/3
A-1010 Wien

Boehringer Ingelheim Austria GmbH
Dr. Boehringer-Gasse 5-11
A-1121 Wien

Torrex-Chiesi Pharma GmbH
Gonzagagasse 16/16
A-1010 Wien

Torrex-Chiesi Pharma GmbH
Gonzagagasse 16/16
A-1010 Wien

3ddd Pharma N.N.
Diestersteenweg 349
B-3510 Hasselt

Pirorheum 20 mg — Tabletten

20 mg

Tablet

Oral use

Piroxicam „Ci Pharma“ 20 mg — Brau-
sepulver

20 mg

Effervescent powder

Oral use

Piroxistad 10 mg Tabs — Lösbare
Tabletten

10 mg

Tablet

Oral use

Piroxistad 20 mg Tabs — Lösbare
Tabletten

20 mg

Tablet

Oral use

Pirox 10 mg — KapseLN

10 mg

Capsule

Oral use

Pirox 20 mg — KapseLN

20 mg

Capsule

Oral use

Pirox 0,2 % — Orale Suspension

2 mg/ml

Oral suspension

Oral use

Tonimed — Gel

Gel

Topical use

Brexin 20 mg — Tabletten

20 mg

Tablets

Oral use

Brexin-Pulver

20 mg

Oral powder

Oral use

Piromed

0,50 %

Gel

Transdermal use

C

2
5
1
/
2
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

3ddd Pharma N.N.
Diestersteenweg 349
B-3510 Hasselt

Aktuapharma N.V.
Ambachtenlaan 13e
B-3001 Leuven

Aktuapharma N.V.
Ambachtenlaan 13e
B-3001 Leuven

Aktuapharma N.V.
Ambachtenlaan 13e
B-3001 Leuven

Aktuapharma N.V.
Ambachtenlaan 13e
B-3001 Leuven

Aktuapharma N.V.
Ambachtenlaan 13e
B-3001 Leuven

Aktuapharma N.V.
Ambachtenlaan 13e
B-3001 Leuven

Aktuapharma N.V.
Ambachtenlaan 13e
B-3001 Leuven

Bexal S.P.R.L.
Avenue Jules Bordet 168
B-1140 Brussel

Bexal S.P.R.L.
Avenue Jules Bordet 168
B-1140 Brussel

Docpharma N.V.
Ambachtenlaan
B-3001 Heverlee

Piromed Dispers

20 mg

Tablet

Oral use

Brexine

Brexine

20 mg

Tablet

Oral use

20 mg

Tablet

Oral use

Feldene Dispersal

20 mg

Tablet

Oral use

Feldene

20 mg

Capsule

Oral use

Feldene Im

20 mg/ml

Solution for injection

Intramuscular use

Feldene Lyotabs

20 mg

Lyophilisat

Oral use

Piroxicam Eg

20 mg

Capsule

Oral use

Piroxicam Bexal

10 mg

Tablet

Oral use

Piroxicam Bexal

20 mg

Tablet

Oral use

Dociproxi Dispers Ex Piroxicam

20 mg

Dispersible tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
2
9

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Ethimed N.V.
Leuvensestraat 28 Bus 2
B-1800 Vilvoorde

Eurogenerics N.V.
Heizel Esplanade 22
B-1020 Brussel

Eurogenerics N.V.
Heizel Esplanade 22
B-1020 Brussel

Eurogenerics N.V.
Heizel Esplanade 22
B-1020 Brussel

Eurogenerics N.V.
Heizel Esplanade 22
B-1020 Brussel

Eurogenerics N.V.
Heizel Esplanade 22
B-1020 Brussel

Eurogenerics N.V.
Heizel Esplanade 22
B-1020 Brussel

Eurogenerics N.V.
Heizel Esplanade 22
B-1020 Brussel

Eurogenerics N.V.
Heizel Esplanade 22
B-1020 Brussel

Euro-Medic N.V.
Astridlaan 20
B-8620 Nieuwpoort

Euro-Medic N.V.
Astridlaan 20
B-8620 Nieuwpoort

Piroxymed

20 mg

Dispersible tablet

Oral use

Piroxicam Eg

10 mg

Capsule

Oral use

Piroxicam Eg

20 mg

Capsule

Oral use

Piroxicam Eg

20 mg

Dispersible tablet

Oral use

Piroxicam Eg

20 mg/ml

Solution for injection

Intramuscular use

Piroxicam Generix

20 mg

Dispersible tablet

Oral use

Piroxicam Generix

20 mg

Capsule

Oral use

Piroxicam-Ratiopharm

20 mg

Solution for injection

Intramuscular use

Piroxicamstada

20 mg

Capsule

Oral use

Brexine

20 mg

Tablet

Oral use

Feldene Lyotabs

20 mg

Tablet

Oral use

C

2
5
1
/
3
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Kela Laboratoria N.V.
Sint Lenaartseweg 48/4
B-2320 Hoogstraten

Laboratoires S.M.B S. S.A.
Rue De La Pastorale 16/28
B-1080 Brussel

Laboratoires S.M.B S. S.A.
Rue De La Pastorale 16/28
B-1080 Brussel

Merck N.V.
Brusselesteenweg 288
B-3090 Overijse

Nycomed Belgium N.V.
Gentsesteenweg 615
B-1080 Brussel

Nycomed Belgium N.V.
Gentsesteenweg 615
B-1080 Brussel

Nycomed Belgium N.V.
Gentsesteenweg 615
B-1080 Brussel

Nycomed Belgium N.V.
Gentsesteenweg 615
B-1080 Brussel

Nycomed Belgium N.V.
Gentsesteenweg 615
B-1080 Brussel

Nycomed Belgium N.V.
Gentsesteenweg 615
B-1080 Brussel

Pfizer S.A.
Boulevard de la Plaine 17
B-1050 Brussel

Piroxicam Kela Ex Revalat

20 mg

Dispersible tablet

Oral use

Solicam

Solicam

10 mg

Capsule

Oral use

20 mg

Capsule

Oral use

Merck-Piroxicam

20 mg

Capsule

Oral use

Brexine

10 mg

Tablet

Oral use

Brexine-Dryfiz Ex Piroxidex

20 mg

Tablet

Oral use

Brexine

Brexine

20 mg

Granules

Oral use

20 mg

Tablet

Oral use

Piroxidex

20 mg

Dispersible tablet

Oral use

Piroxidex

20 mg

Powder

Oral use

Feldene

20 mg

Capsule

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
3
1

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Pfizer S.A.
Boulevard de la Plaine 17
B-1050 Brussel

Pfizer S.A.
Boulevard de la Plaine 17
B-1050 Brussel

Pfizer S.A.
Boulevard de la Plaine 17
B-1050 Brussel

Pfizer S.A.
Boulevard de la Plaine 17
B-1050 Brussel

Pfizer S.A.
Boulevard de la Plaine 17
B-1050 Brussel

Pfizer S.A.
Boulevard de la Plaine 17
B-1050 Brussel

Pfizer S.A.
Boulevard de la Plaine 17
B-1050 Brussel

Pharmapartner NV
Kolonel Begaultlaan 16
B-3012 Leuven

Ratiopharm Belgium S.A.
Rue Saint-Lambert 141
B-1200 Bruxelles

Ratiopharm Belgium S.A.
Rue Saint-Lambert 141
B-1200 Bruxelles

Ratiopharm Belgium S.A.
Rue Saint-Lambert 141
B-1200 Bruxelles

Feldene

Feldene

Feldene

Feldene

10 mg

Capsule

Oral use

20 mg

Suppository

Rectal use

0,50 %

Gel

Transdermal use

20 mg/ml

Solution for injection

Intramuscular use

Feldene Dispersal

20 mg

Tablet

Oral use

Feldene Lyotabs

10 mg

Lyophilisat

Oral use

Feldene Lyotabs

20 mg

Lyophilisat

Oral use

Feldene Lyotabs

20 mg

Tablet

Oral use

Piroxicam-Ratiopharm

20 mg

Suppository

Rectal use

Piroxicam-Ratiopharm

10 mg

Tablet

Oral use

Piroxicam-Ratiopharm

20 mg

Tablet

Oral use

C

2
5
1
/
3
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Belgium

Bulgaria

Bulgaria

Bulgaria

Sandoz N.V.
Telecom Ardens
Medialaan 40
B-1800 Vilvoorde

Socobom N.V.
Luoizalaan 149 Bus 4
B-1050 Brussel

Teva Generics Belgium N.V.
Laarstraat 16
B-2610 Wilrijk

Teva Generics Belgium N.V.
Laarstraat 16
B-2610 Wilrijk

Teva Generics Belgium N.V.
Laarstraat 16
B-2610 Wilrijk

Teva Generics Belgium N.V.
Laarstraat 16
B-2610 Wilrijk

Topgen Esv
E. Demunterlaan 1/8
B-1090 Brussel

P.S.I. N.V.
Kraanlei 27-29
B-900 Gent

Alkaloid Ltd
21 „Tzar Boris III“ Blvd
BG-1000 Sofia

Sopharma AD
16 „Iliensko Shose“ str.
BG-1220 Sofia

Sopharma AD
16 „Iliensko Shose“ str.
BG-1220 Sofia

Piroxicam Sandoz

20 mg

Dispersible tablet

Oral use

Polydene

20 mg

Dispersible tablet

Oral use

Piroxicam Teva

10 mg

Capsule

Oral use

Piroxicam Teva

20 mg

Suppository

Rectal use

Piroxicam Teva

20 mg

Capsule

Oral use

Piroxicam Teva

20 mg

Dispersible tablet

Oral use

Piroxitop

20 mg

Tablet

Oral use

Veralgesic

20 mg

Dispersible tablet

Oral use

Piroxicam Alkaloid

20 mg

Capsule

Oral use

Piroxicam Sopharma

10 mg

Capsule, hard

Oral use

Piroxicam Sopharma

20 mg

Capsule, hard

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
3
3

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Bulgaria

Bulgaria

Bulgaria

Bulgaria

Bulgaria

Bulgaria

Bulgaria

Bulgaria

Bulgaria

Bulgaria

Bulgaria

Sopharma AD
16 „Iliensko Shose“ str.
BG-1220 Sofia

Sopharma AD
16 „Iliensko Shose“ str.
BG-1220 Sofia

Boehringer Ingelheim International GmbH
Binger Strasse 173
D-55216 Ingelheim am Rhein

Promedica S.p.A.
Via Palermo 26 A
I-43100 Parma

Promedica S.p.A.
Via Palermo 26 A
I-43100 Parma

Egis Pharmaceuticals Public Limited Company
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Public Limited Company
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Public Limited Company
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Public Limited Company
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Public Limited Company
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Public Limited Company
Keresztúri út 30-38.
H-1106 Budapest

Piroxicam Sopharma 1 %

1 g/100 g — 40 g

Gel

Cutaneous use

Piroxicam Sopharma 0,5 %

0,5 g/100 g — 40 g

Gel

Cutaneous use

Finalgel

0,5 g/100 g — 35 g; 50 g Gel

Cutaneous use

Flamexin

20 mg

Tablet

Oral use

Flamexin

20 mg

Powder for oral solution

Oral use

Hotemin 10 mg capsule

10 mg

Capsule

Oral use

Hotemin 20 mg capsule

20 mg

Capsule

Oral use

Hotemin Injection

20 mg/ml-1 ml

Solution for injection

Intramuscular use

Hotemin

20 mg

Suppository

Rectal use

Hotemin

10 mg

Suppository

Rectal use

Hotemin

0,5 g/50 g — 50 g

Cream

Cutaneous use

C

2
5
1
/
3
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Cyprus

Cyprus

Cyprus

Cyprus

Cyprus

Cyprus

Cyprus

Cyprus

Cyprus

Cyprus

Pfizer Hellas Ae
243 Mesogion Ave
GR-15451 N. Psychiko

Pfizer Hellas Ae
243 Mesogion Ave
GR-15451 N. Psychiko

Pfizer Hellas Ae
243 Mesogion Ave
GR-15451 N. Psychiko

Pfizer Hellas Ae
243 Mesogion Ave
GR-15451 N. Psychiko

Pfizer Hellas Ae
243 Mesogion Ave
GR-15451 N. Psychiko

Varnavas Hadjipanayis
7 Androcleous Str.
Pobox 21229
CY-1504 Lefkosia

Medochemie Ltd
Pobox 51409
CY-3505 Lemesos

Medochemie Ltd
Pobox 51409
CY-3505 Lemesos

Medochemie Ltd
Pobox 51409
CY-3505 Lemesos

Remedica Ltd
Limassol Industrial Estate
AHarnon Str.
P.O Box 51706
CY-3508 Limassol

Feldene

Feldene

Feldene

Feldene

Feldene

Brexin

Sotilen

Sotilen

Sotilen

10 mg

Tablet

Oral use

20 mg

Dispersible tablet

Oral use

20 mg

Suppository

Rectal use

0,50 %

Gel

External use

20 mg/ml 1 ml

Solution for injection

Intramuscular use

20 mg

Tablet

Oral use

10 mg

Capsule

Oral use

20 mg

Capsule

Oral use

1 %

Gel

External use

Roxitan

10 mg

Capsule

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
3
5

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Cyprus

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Czech Republic

Remedica Ltd
Limassol Industrial Estate
AHarnon Str.
P.O Box 51706
CY-3508 Limassol

Egis Pharmaceuticals Ltd
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Ltd
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Ltd
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Ltd
Keresztúri út 30-38.
H-1106 Budapest

Pro.Med.Cs Praha a.s.
Telčská 1
CZ-140 00 Praha 4

Pro.Med.Cs Praha a.s.
Telčská 1
CZ-140 00 Praha 4

Aliud Pharma GmbH & Co.Kg.
Gottlieb-Daimler-Strasse 19
D-89150 Laichingen

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Roxitan

20 mg

Capsule

Oral use

Hotemin

20 mg/ml

Solution for injection

Intramuscular use

Hotemin 10 mg

10 mg

Capsule, hard

Oral use

Hotemin 20 mg

20 mg

Capsule, hard

Oral use

Hotemin

10 mg/gm

Cream

Cutaneous use

Pro-Roxikam 10 mg

10 mg

Tablet

Oral use

Pro-Roxikam 20 mg

20 mg

Tablet

Oral use

Piroxicam Al 10

Piroxicam Al 20

Flamexin

10 mg

20 mg

20 mg

Tablet

Oral use

Tablet

Oral use

Flamexin

20 mg

Granules

Oral use

C

2
5
1
/
3
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Czech Republic

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Abz-Pharma GmbH
Dr. Georg-Spohn-Str. 7
D-89143 Blaubeuren

Abz-Pharma GmbH
Dr. Georg-Spohn-Str. 7
D-89143 Blaubeuren

Acis Arzneimittel GmbH
Bajuwarenring 14
D-82041 Oberhaching

Aliud Pharma GmbH & Co.Kg
Gottlieb-Daimler-Str. 19
D-89150 Laichingen

Aliud Pharma GmbH & Co.Kg
Gottlieb-Daimler-Str. 19
D-89150 Laichingen

Aliud Pharma GmbH & Co.Kg
Gottlieb-Daimler-Str. 19
D-89150 Laichingen

Aliud Pharma GmbH & Co.Kg
Gottlieb-Daimler-Str. 19
D-89150 Laichingen

Asche Chiesi GmbH
Gasstr. 6
D-22761 Hamburg

Asche Chiesi GmbH
Gasstr. 6
D-22761 Hamburg

Flamexin Eff

20 mg

Effervescent tablet

Oral use

Piro 10 mg Abz
10231.00.00

Piro 20 mg Abz
10231.01.00

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

Piroxicam Acis 20 mg Tabs
29562.00.00

20 mg

Tablet

Oral use

Piroxicam Al 10
30314.00.00

Piroxicam Al 20
29583.00.00

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

Piroxicam Al 20 Brausetabletten
31544.00.00

20 mg

Effervescent tablet

Oral use

Piroxicam Al 20 Zäpfchen
6412895.00.00

Brexidol 20 mg Granulat zur
Herstellung einer Lösung zum
Einnehmen
27116.00.01

Brexidol 20 mg Tabletten
27116.00.00

20 mg

Suppository

Rectal use

20 mg/3 g

Granules

Oral use

20 mg

Tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
3
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Asche Chiesi GmbH
Gasstr. 6
D-22761 Hamburg

Asche Chiesi GmbH
Gasstr. 6
D-22761 Hamburg

Bc Biochemie Pharma GmbH
Carl-Zeiss-Ring 3
D-85737 Ismaning

Bc Biochemie Pharma GmbH
Carl-Zeiss-Ring 3
D-85737 Ismaning

Betapharm Arzneimittel GmbH
Kobelweg 95
D-86156 Augsburg

Betapharm Arzneimittel GmbH
Kobelweg 95
D-86156 Augsburg

Ct-Arzneimittel GmbH
Lengeder Str. 42a
D-13407 Berlin

CT-Arzneimittel GmbH
Lengeder Str. 42a
D-13407 Berlin

Pc-Fice 20 mg Granulat zur
Herstellung einer Lösung zum
Einnehmen
28887.00.01

Pc-Fice 20 mg Tabletten
28887.00.00

Fasax 10 mg Tabs
26221.00.00

Fasax 20 mg Tabs
24902.00.00

Pirobeta 10
37338.00.00

Pirobeta 20
37338.01.00

Pirox-Ct 20 mg Tabletten
6156699.01.01

Pirox-CT 20 mg/1 ml Ampullen
6061697.00.00

Docpharm Arzneimittelvertrieb GmbH & Co.Kgaa
Reetzstr. 83
D-76327 Pfinztal

Piroxicam Pb 10 mg
26223.00.00

Docpharm Arzneimittelvertrieb GmbH & Co.Kgaa
Reetzstr. 83
D-76327 Pfinztal

Piroxicam Pb 20 mg
26223.01.00

Dr. Kade Pharmazeutische Fabrik GmbH
Rigistr. 2
D-12277 Berlin

Piro Kd 10 Tabs
36015.00.00

20 mg/3 g

Granules

Oral use

20 mg

Tablet

Oral use

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

20 mg

Tablet

Oral use

20 mg/1 ml

Solution for injection

Injection

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

10 mg

Tablet

Oral use

C

2
5
1
/
3
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Dr. Kade Pharmazeutische Fabrik GmbH
Rigistr. 2
D-12277 Berlin

Piro Kd 20 Tabs
34106.01.00

Heumann Pharma GmbH & Co. Generica Kg
Südwestpark 50
D-90449 Nürnberg

Piroxicam 10 Heumann
12426.00.00

Heumann Pharma GmbH & Co. Generica Kg
Südwestpark 50
D-90449 Nürnberg

Piroxicam 20 Heumann
12426.01.00

20 mg

Tablet

Oral use

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

A.M. Piroxicam 20
10013.00.00

Ig 20 I.M.
53304.00.00

20 mg

Suppository

Rectal use

20 mg/1 ml

Solution for injection

Injection

Maxiflam 20 I.M. 53303.00.00

20 mg/1 ml

Solution for injection

Injection

Piro 20 I.M.
53307.00.00

Pirorheum 20 I.M.
31511.00.01

Piroxicam Hexal 10 mg Tabs
9625.00.02

Piroxicam Hexal 20 I.M.
53306.00.00

20 mg/1 ml

Solution for injection

Injection

20 mg/1 ml

Solution for injection

Injection

10 mg

Tablet

Oral use

20 mg/1 ml

Solution for injection

Injection

Piroxicam Hexal 20 mg Brausetabletten
31511.00.00

20 mg

Effervescent tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
3
9

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Hexal Ag
Industriestr. 25
D-83607 Holzkirchen

Kohne Pharma GmbH
Schallbruch 1
D-42781 Haan

Merck Dura GmbH
Alsfelder Str. 19
D-64289 Darmstadt

Merck Dura GmbH
Alsfelder Str. 19
D-64289 Darmstadt

Mibe GmbH Arzneimittel
Münchener Str. 15
D-06796 Brehna

Mibe GmbH Arzneimittel
Münchener Str. 15
D-06796 Brehna

Mibe GmbH Arzneimittel
Münchener Str. 15
D-06796 Brehna

Piroxicam Hexal 20 mg Tabs
9625.01.02

Piroxicam Hexal 20 mg Zäpfchen
9625.00.01

Piroxicam Hexal 20 mg/ml
3000887.00.00

Piroxiject 20 I.M.
53305.00.00

TraumAHexal 20
29785.00.00

Piroxicam 20 mg Ako
37588.00.00

Durapirox 20 mg
12638.00.00

Durapirox 20 mg Tabs
9627.01.01

Pirocutan 10 mg
29562.01.00

Pirocutan 20 mg
39340.00.00

Pirocutan Ampullen
6829336.00.00

20 mg

Tablet

Oral use

20 mg

Suppository

Rectal use

20 mg/1 ml

Solution for injection

Injection

20 mg/1 ml

Solution for injection

Injection

20 mg

Suppository

Rectal use

20 mg

Tablet

Oral use

20 mg

Capsule

Oral use

20 mg

Tablet

Oral use

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

20 mg/1 ml

Solution for injection

Injection

C

2
5
1
/
4
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Mibe GmbH Arzneimittel
Münchener Str. 15
D-06796 Brehna

Mibe Vertriebsgesellschaft Mbh
Otto-Schott-Str. 15
D-07745 Jena

Mibe Vertriebsgesellschaft Mbh
Otto-Schott-Str. 15
D-07745 Jena

Mibe Vertriebsgesellschaft Mbh
Otto-Schott-Str. 15
D-07745 Jena

Mibe Vertriebsgesellschaft Mbh
Otto-Schott-Str. 15
D-07745 Jena

Mibe Vertriebsgesellschaft Mbh
Otto-Schott-Str. 15
D-07745 Jena

Mibe Vertriebsgesellschaft Mbh
Otto-Schott-Str. 15
D-07745 Jena

Mibe Vertriebsgesellschaft Mbh
Otto-Schott-Str. 15
D-07745 Jena

Pfizer Pharma GmbH
Pfizerstr. 1
D-76139 Karlsruhe

Ratiopharm GmbH
Graf-Arco-Str. 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Str. 3
D-89079 Ulm

Pirocutan Ampullen Mibe
48754.00.00

Jenapirox I.M. 20 mg
6413185.00.00

Jenapirox Tabs 10 mg
12637.00.00

Jenapirox Tabs 20 mg
9628.00.00

20 mg/1 ml

Solution for injection

Injection

20 mg/1 ml

Solution for injection

Injection

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

Piroxicam-KapseLN 10 mg Jenapharm
41597.00.00

10 mg

Capsule

Oral use

Piroxicam-KapseLN 10 mg Jenapharm
6000413.01.00

10 mg

Capsule

Oral use

Piroxicam-KapseLN 20 mg Jenapharm
41597.01.00

20 mg

Capsule

Oral use

Piroxicam-KapseLN 20 mg Jenapharm
6000413.00.00

20 mg

Capsule

Oral use

Felden 20 mg Tabs
871.01.02

20 mg

Tablet

Oral use

Piroxicam-Ratiopharm 10 mg Tabs
6013244.01.00

10 mg

Tablet

Oral use

Piroxicam-Ratiopharm 20 mg
Injektioslösung
6362849.00.00

20 mg/1 ml

Solution for injection

Injection

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
4
1

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Ratiopharm GmbH
Graf-Arco-Str. 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Str. 3
D-89079 Ulm

Ratiopharm GmbH
Graf-Arco-Str. 3
D-89079 Ulm

Sandoz Pharmaceuticals GmbH
Carl-Zeiss-Ring 3
D-85737 Ismaning

Sandoz Pharmaceuticals GmbH
Carl-Zeiss-Ring 3
D-85737 Ismaning

Sandoz Pharmaceuticals GmbH
Carl-Zeiss-Ring 3
D-85737 Ismaning

Siemens & Co Heilwasser und Quellenprodukte des
Staatsbades Bad Ems GmbH & Co.Kg
Arzbacher Str. 78
D-56130 Bad Ems

Piroxicam-Ratiopharm 20 mg Tabs
6013244.00.00

20 mg

Tablet

Oral use

Piroxicam-Ratiopharm 20 Zäpfchen
6040355.00.00

20 mg

Suppository

Rectal use

Piroxicam-Ratiopharm 20 mg
Zäpfchen
10231.00.01

Piroxicam Sandoz Parenteral 20 mg
Injektionslösung
6139399.00.00

Piroxicam-Ac Suppos 20
30064.00.00

Piroxicam-Sandoz Parenteral 20 mg
Injektionslösung
53301.00.00

Piroxicam Hexal 10 mg Tabletten
9627.00.01

20 mg

Suppository

Rectal use

20 mg/1 ml

Solution for injection

Injection

20 mg

Suppository

Rectal use

20 mg/1 ml

Solution for injection

Injection

10 mg

Tablet

Oral use

Siemens & Co Heilwasser und Quellenprodukte des
Staatsbades Bad Ems GmbH & Co.Kg
Arzbacher Str. 78
D-56130 Bad Ems

Piroxicam Hexal 20 mg Tabletten
3000886.01.00

20 mg

Tablet

Oral use

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Piroxi 10 Stada Tabs
44091.00.00

Piroxi 20 Stada Tabs
44091.01.00

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

C

2
5
1
/
4
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Stada GmbH
Stadastr. 2-18
D-61118 Bad Vilbel

Tad Pharma GmbH
Heinz-Lohmann-Str. 5
D-27472 Cuxhaven

Tad Pharma GmbH
Heinz-Lohmann-Str. 5
D-27472 Cuxhaven

Piroxicam Stada
6346224.00.00

Piroxicam Stada 10 mg KapseLN
23046.00.00

Piroxicam Stada 10 mg Tabs
6068067.00.00

Piroxicam Stada 20 mg KapseLN
23046.01.00

20 mg/1 ml

Solution for injection

Injection

10 mg

Capsule

Oral use

10 mg

Tablet

Oral use

20 mg

Capsule

Oral use

Piroxicam Stada 20 mg Brausetabletten
39728.00.00

20 mg

Effervescent tablet

Oral use

Piroxicam Stada 20 mg Tabs
6068067.01.00

20 mg

Tablet

Oral use

Piroxistad Injektionslösung 20 mg/ml
48755.00.00

20 mg/1 ml

Solution for injection

Injection

Pxi-10 Stada Tabs
28449.00.00

Pxi-20 Stada Tabs
28449.01.00

Flexase 10 Tabs
6691665.00.00

Flexase 10 mg Tabs
9625.00.00

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
4
3

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Germany

Tad Pharma GmbH
Heinz-Lohmann-Str. 5
D-27472 Cuxhaven

Tad Pharma GmbH
Heinz-Lohmann-Str. 5
D-27472 Cuxhaven

Tad Pharma GmbH
Heinz-Lohmann-Str. 5
D-27472 Cuxhaven

Tad Pharma GmbH
Heinz-Lohmann-Str. 5
D-27472 Cuxhaven

Weimer Pharma GmbH
Im Steingerüst 30
D-76437 Rastatt

Wieb Pharm Vertriebs GmbH & Co.Kg
Diestraat 15
D-25870 Norderfriedrichskoog

Wieb Pharm Vertriebs GmbH & Co.Kg
Diestraat 15
D-25870 Norderfriedrichskoog

Wieb Pharm Vertriebs GmbH & Co.Kg
Diestraat 15
D-25870 Norderfriedrichskoog

Winthrop Arzneimittel GmbH
Industriestr. 10
D-82256 Fürstenfeldbruck

Winthrop Arzneimittel GmbH
Industriestr. 10
D-82256 Fürstenfeldbruck

Winthrop Arzneimittel GmbH
Industriestr. 10
D-82256 Fürstenfeldbruck

Flexase 20 mg Tabs
9626.00.00

Flexase Ampullen
53300.00.00

Flexase S
29786.00.00

Flexase Uno
6691665.01.00

20 mg

Tablet

Oral use

20 mg/1 ml

Solution for injection

Injection

20 mg

Suppository

Rectal use

20 mg

Tablet

Oral use

Piroxicam Weimer Injektionslösung
20 mg/ml
49635.00.00

20 mg/1 ml

Solution for injection

Injection

Pirowieb 20 Amp.
36620.00.00

Pirowieb 20 mg
12428.00.00

Pirowieb 20 mg Inj.-Lsg.
53302.00.00

Piroflam 10 mg
40937.00.00

Piroflam 10 mg Tabs Lichtenstein
6144727.00.00

Piroflam 20 mg Tabs Lichtenstein
6144727.01.00

20 mg/1 ml

Solution for injection

Injection

20 mg

Tablet

Oral use

20 mg/1 ml

Solution for injection

Injection

10 mg

Capsule

Oral use

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

C

2
5
1
/
4
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Germany

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Denmark

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Winthrop Arzneimittel GmbH
Industriestr. 10
D-82256 Fürstenfeldbruck

Piroflam Suppos Lichtenstein
6144779.00.00

20 mg

Suppository

Rectal use

.

2
6
1
0
2
0
0
7

.

Merck NM AB
Ynglingagatan 14
11347 Post Box 23033
S-10435 Stockholm

Merck NM AB
Ynglingagatan 14
11347 Post Box 23033
S-10435 Stockholm

Merck NM AB
Ynglingagatan 14
11347 Post Box 23033
S-10435 Stockholm

Merck NM AB
Ynglingagatan 14
11347 Post Box 23033
S-10435 Stockholm

Pfizer Aps
Lautrupvang 8
DK-2750 Ballerup

Pfizer Aps
Lautrupvang 8
DK-2750 Ballerup

Sandoz A/S
C.F. Tietgens Boulevard 40
DK-5220 Odense SØ

Sandoz A/S
C.F. Tietgens Boulevard 40
DK-5220 Odense SØ

Hexal A/S
Kanalholmen 8-12
DK-2650 Hvidovre

Piroxicam »Merck NM«

10 mg

Tablet

Oral use

Piroxicam »Merck NM«

20 mg

Tablet

Oral use

Piroxicam »Merck NM«

10 mg

Capsule

Oral use

Piroxicam »Merck NM«

20 mg

Capsule

Oral use

Felden

Felden

Pirom

Pirom

20 mg

Dispersible tablet

Oral use

0,5 %

Gel

Cutaneous use

10 mg

Tablet

Oral use

20 mg

Tablet

Oral use

Piroxigea

10 mg

Tablet

Oral use

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
4
5

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Denmark

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Hexal A/S
Kanalholmen 8-12
DK-2650 Hvidovre

DEMO ABEE
21st Km National Road
GR-14565 Athens-Lamia

DEMO ABEE
21st Km National Road
GR-14565 Athens-Lamia

DEMO ABEE
21st Km National Road
GR-14565 Athens-Lamia

DEMO ABEE
21st Km National Road
GR-14565 Athens-Lamia

Pfizer Hellas Ae
Mesogeion 243
GR-15451 New Psychiko

Pfizer Hellas Ae
Mesogeion 243
GR-15451 New Psychiko

Pfizer Hellas Ae
Mesogeion 243
GR-15451 New Psychiko

Pfizer Hellas Ae
Mesogeion 243
GR-15451 New Psychiko

Pfizer Hellas Ae
Mesogeion 243
GR-15451 New Psychiko

Pfizer Hellas Ae
Mesogeion 243
GR-15451 New Psychiko

Piroxigea

20 mg

Tablet

Oral use

Oximezin

10 mg/tab

Gastro resistant tablet

Oral use

Oximezin

20 mg/tab

Gastro resistant tablet

Oral use

Oximezin

20 mg/1ml

Solution for injection

Intramuscular use

Oximezin

0,50 %

Gel

External use

Feldene

Feldene

Feldene

Feldene

Feldene

Feldene

20 mg/sup

Suppository

Rectal use

20 mg/tab

Dispersible tablet

Oral use

10 mg/tab

Dispersible tablet

Oral use

0,5 %

Gel

External use

20 mg/1 ml

Solution for injection

Intramuscular use

10 mg/tab

Tablet rapid

Oral use

C

2
5
1
/
4
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Pfizer Hellas Ae
Mesogeion 243
GR-15451 New Psychiko

Biomedica-Chemica
G. Lyra 25
GR-14564 Kato Kifissia

Biomedica-Chemica
G. Lyra 25
GR-14564 Kato Kifissia

Biomedica-Chemica
G. Lyra 25
GR-14564 Kato Kifissia

Biomedica-Chemica
G. Lyra 25
GR-14564 Kato Kifissia

Remedina
Gounari 25 & Areos
GR-13451 Kamatero Attiki

Pharmaceutical Industry Proel Ae E.G. Koronis
Dilou 9
GR-12134 Peristeri

Pharmaceutical Industry Proel Ae E.G. Koronis
Dilou 9
GR-12134 Peristeri

Help Aebe
Valaoritou 10
GR-14452 Metamorfosi Attiki

Help Aebe
Valaoritou 10
GR-14452 Metamorfosi Attiki

Help Aebe
Valaoritou 10
GR-14452 Metamorfosi Attiki

Feldene

20 mg/tab

Tablet rapid

Oral use

Valopon

10 mg/cap

Hard capsules

Oral use

Valopon

20 mg/cap

Hard capsules

Oral use

Valopon

0,5 %

Gel

External use

Valopon

20 mg/1 ml

Solution for injection

Intramuscular use

Flodeneu

20 mg/cap

Hard capsules

Oral use

Zerospam

20 mg/cap

Hard capsules

Oral use

Zerospam

0,5 %

Gel

External use

Proponol

20 mg/cap

Hard capsules

Oral use

Proponol

10 mg/cap

Hard capsules

Oral use

Proponol

20 mg/sup

Suppository

Rectal use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
4
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Help Aebe
Valaoritou 10
GR-14452 Metamorfosi Attiki

Rafarm Aebe
Korinthou 12
GR-15451 New Psychiko

Rafarm Aebe
Korinthou 12
GR-15451 New Psychiko

Rafarm Aebe
Korinthou 12
New Psychiko 15451
Grèce

Rafarm Aebe
Korinthou 12
GR-15451 New Psychiko

Vilco Ae
Pefkon 121
GR-14122 Neo Irakleio

Vilco Ae
Pefkon 121
GR-14122 Neo Irakleio

Faran Abee
Achaias & Troizinias
GR-14564 New Kifissia

Faran Abee
Achaias & Troizinias
GR-14564 New Kifissia

MENTINOVA AE
16th Km Marathonos Avenue
GR-15344 Pallini Attiki

MENTINOVA AE
16th Km Marathonos Avenue
GR-15344 Pallini Attiki

Proponol

0,5 %

Gel

External use

Zitumex

20 mg/cap

Hard capsules

Oral use

Zitumex

20 mg/sup

Suppository

Rectal use

Zitumex

0,5 %

Gel

External use

Zitumex

20 mg/1 ml

Solution for injection

Intramuscular use

Pedifan

Pedifan

20 mg/cap

Hard capsules

Oral use

0,5 %

Gel

External use

Calmopyrol

20 mg/cap

Hard capsules

Oral use

Calmopyrol

20 mg/sup

Suppository

Rectal use

Conzila

Conzila

20 mg/tab

Tablet

Oral use

0,5 %

Gel

External use

C

2
5
1
/
4
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

GENEPHARM AE
18th Km Marathonos Avenue
GR-15351 Pallini Attiki

GENEPHARM AE
18th Km Marathonos Avenue
GR-15351 Pallini Attiki

Coup Oe Kouparoussos & Sia
Agias Varvaras 53
GR-17235 Dafni

Coup Oe Kouparoussos & Sia
Agias Varvaras 53
GR-17235 Dafni

Kleva Epe
Parnithos Avenue 189
GR-13671 Acharnai Attiki

Kleva Epe
Parnithos Avenue 189
GR-13671 Acharnai Attiki

Kleva Epe
Parnithos Avenue 189
GR-13671 Acharnai Attiki

Kleva Epe
Parnithos Avenue 189
GR-13671 Acharnai Attiki

Kleva Epe
Parnithos Avenue 189
GR-13671 Acharnai Attiki

Kleva Epe
Parnithos Avenue 189
GR-13671 Acharnai Attiki

Kleva Epe
Parnithos Avenue 189
GR-13671 Acharnai Attiki

Grecotens

20 mg/cap

Hard capsules

Oral use

Grecotens

0,5 %

Gel

External use

Ruvamed

20 mg/cap

Hard capsules

Oral use

Ruvamed

0,5 %

Gel

External use

Pyrcost

Pyrcost

Pyrcost

Pyrcost

Felcam

Felcam

Felcam

20 mg/cap

Hard capsules

Oral use

0,5 %

Gel

External use

20 mg/sup

Suppository

Rectal use

20 mg/1 ml

Solution for injection

Intramuscular use

10 mg/cap

Hard capsules

Oral use

20 mg/cap

Hard capsules

Oral use

0,5 %

Gel

External use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
4
9

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Greece

Kleva Epe
Parnithos Avenue 189
GR-13671 Acharnai Attiki

Viostam K. Mpougias & Sia E.E.
Padiamantopoulou 66
GR-15771 Zografou Athens

Norma Hellas Ae
Menandrou 54
GR-10431 Athens

Norma Hellas Ae
Menandrou 54
GR-10431 Athens

Anfarm Hellas Ae
K. Palaiologou & Perikleous 27
GR-15232 Chalandri

Anfarm Hellas Ae
K. Palaiologou & Perikleous 27
GR-15232 Chalandri

Gap Ae
Agisilaou 46
GR-17341 Agios Dimitrios

Gap Ae
Agisilaou 46
GR-17341 Agios Dimitrios

Chiesi Hellas Aebe
Anapafseos Avenue 30
GR-15235 Vrilissia

Chiesi Hellas Aebe
Anapafseos Avenue 30
GR-15235 Vrilissia

Chiesi Hellas Aebe
Anapafseos Avenue 30
GR-15235 Vrilissia

Felcam

20 mg/sup

Suppository

Rectal use

Painrelipt-D

0,5 %

Gel

External use

Neo Axedil

20 mg/cap

Hard capsules

Oral use

Neo Axedil

20 mg/1ml

Solution for injection

Intramuscular use

Bleduran

20 mg/cap

Hard capsules

Oral use

Bleduran

0,5 %

Gel

External use

Piroxicam/Gap

20 mg/cap

Hard capsules

Oral use

Piroxicam/Gap

10 mg/cap

Hard capsules

Oral use

Brexin

Brexin

Brexin

20 mg/sachet

Grannules for oral solu-
tion

Oral use

20 mg/tab

Tablets

Oral use

20 mg/tab

Effervescent tablets

Oral use

C

2
5
1
/
5
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Greece

Greece

Greece

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Pharmanel Pharmaceutical Ae
Marathonos 106
GR-15344 Gerakas

Pharmanel Pharmaceutical Ae
Marathonos 106
GR-15344 Gerakas

Pharmanel Pharmaceutical Ae
Marathonos 106
GR-15344 Gerakas

Nefox Farma S.A.
Avda. De Europa 20 B
E-28108 Alcobendas Madrid

Nefox Farma S.A.
Avda. De Europa 20 B
E-28108 Alcobendas Madrid

Nefox Farma S.A.
Avda. De Europa 20 B
E-28108 Alcobendas Madrid

Nefox Farma S.A.
Avda. De Europa 20 B
E-28108 Alcobendas Madrid

Nefox Farma S.A.
Avda. De Europa 20 B
E-28108 Alcobendas Madrid

Nefox Farma S.A.
Avda. De Europa 20 B
E-28108 Alcobendas Madrid

Nefox Farma S.A.
Avda. De Europa 20 B
E-28108 Alcobendas Madrid

Chiesi España S.A.
Av. Berlin 38-48 7a Planta
E-08029 Barcelona

Sinartrol

15 mg/tab

Tablets

Oral use

Sinartrol

1,5 %

Cream

External use

Sinartrol

30 mg/tab

Tablets

Oral use

Feldene

Feldene

Feldene

Feldene

Feldene

10 mg

Capsule, hard

Oral use

20 mg

Capsule, hard

Oral use

20 mg

Suppository

Rectal use

20 mg/ml

Solution for injection

Parenteral use

20 mg

Dispersible tablet

Oral use

Feldene Flas

20 mg

Liophilised

Oral use

Feldegel

Brexinil

10-60 g

Gel

Cutaneous use

20 mg

Tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
5
1

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Chiesi España S.A.
Av. Berlin 38-48 7a Planta
E-08029 Barcelona

Chiesi España S.A.
Av. Berlin 38-48 7a Planta
E-08029 Barcelona

Chiesi España S.A.
Av. Berlin 38-48 7a Planta
E-08029 Barcelona

Chiesi España S.A.
Av. Berlin 38-48 7a Planta
E-08029 Barcelona

Chiesi España S.A.
Av. Berlin 38-48 7a Planta
E-08029 Barcelona

Quimifar S.A.
Comadran 37
Barbera Del Valles
E-08210 Barcelona

Quimifar S.A.
Comadran 37
Barbera Del Valles
E-08210 Barcelona

Quimifar S.A.
Comadran 37
Barbera Del Valles
E-08210 Barcelona

Rottapharm S.L.
Carretera De Barcelona 2
E-46132 Almacera

Rottapharm S.L.
Carretera De Barcelona 2
E-46132 Almacera

Brexinil

20 mg

Effervescent tablet

Oral use

Brexinil Sobres

20 mg

Powder for oral solution

Oral use

Cycladol

20 mg

Tablet

Oral use

Cycladol Dref

20 mg

Effervescent tablet

Oral use

Cycladol

20 mg

Powder for oral solution

Oral use

Doblexan

20 mg

Suppository

Rectal use

Doblexan

10 mg

Capsule

Oral use

Doblexan

20 mg

Capsule

Oral use

Improntal

10 mg

Capsule

Oral use

Improntal

20 mg

Capsule

Oral use

C

2
5
1
/
5
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Rottapharm S.L.
Carretera De Barcelona 2
E-46132 Almacera

Rottapharm S.L.
Carretera De Barcelona 2
E-46132 Almacera

Rottapharm S.L.
Carretera De Barcelona 2
E-46132 Almacera

Laboratorios Cinfa S.A.
Olaz-Chipi 10. Polig. Areta
E-31620 Huarte Pamplona

Laboratorios Edigen S.A.
Chile 8 2o Oficina 203.
Edificio Euromadrid
Las Matas
E-28290 Madrid

Pharmagenus S.A.
Passeig De Gracia 55 5o 1a.
E-08007 Barcelona

Ratiopharm España S.A.
Avda. De Burgos 16 D-5a Planta
E-28036 Madrid

Ratiopharm España S.A.
Avda. De Burgos 16 D-5a Planta
E-28036 Madrid

Laboratorios Salvat
S.A. Gallo 30-36
E-08950 Barcelona

Laboratorios Salvat
S.A. Gallo 30-36
E-08950 Barcelona

Improntal

20 mg

Dispersible tablet

Oral use

Improntal

5 mg/g

Cream

Cutaneous use

Improntal

20 mg/ml

Suppository

Rectal use

Piroxicam Cinfa

20 mg

Dispersible tablet

Oral use

Piroxicam Edigen

20 mg

Dispersible tablet

Oral use

Piroxicam Pharmagenus

20 mg

Dispersible tablet

Oral use

Piroxicam Ratiopharm

20 mg

Capsule

Oral use

Piroxicam Ratiopharm

20 mg

Suppository

Rectal use

Salvacam

20 mg

Capsule

Oral use

Salvacam

0,5 %

Gel

Cutaneous use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
5
3

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Spain

Estonia

Estonia

Laboratorios Faes Farma Sa
Maximo Aguirre 14
E-48940 Lamiaco-Lejona

Laboratorios Faes Farma Sa
Maximo Aguirre 14
E-48940 Lamiaco-Lejona

Laboratorios Faes Farma Sa
Maximo Aguirre 14
E-48940 Lamiaco-Lejona

Laboratorios Faes Farma Sa
Maximo Aguirre 14
E-48940 Lamiaco-Lejona

Laboratorios Robert S.A.
Gran Via Carlos Iii 94
E-08028 Barcelona

Laboratorios Robert S.A.
Gran Via Carlos Iii 94
E-08028 Barcelona

Laboratorios Robert S.A.
Gran Via Carlos Iii 94
E-08028 Barcelona

Laboratorios Robert S.A.
Gran Via Carlos Iii 94
E-08028 Barcelona

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Sasulen

20 mg

Capsule

Oral use

Sasulen

20 mg

Dispersible tablet

Oral use

Sasulen

0,5 %

Gel

Cutaneous use

Sasulen

20 mg

Suppository

Rectal use

Vitaxicam

20 mg

Capsule

Oral use

Vitaxicam

20 mg

Suppository

Rectal use

Vitaxicam Topico

0,5 %

Gel

Cutaneous use

Vitaxicam

10 mg

Tablet

Oral use

Brexin

Brexin

20 mg

Tablet

Oral use

20 mg

Powder for oral solution

Oral use

C

2
5
1
/
5
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Estonia

Finland

Finland

Finland

Finland

Finland

Finland

France

France

France

Pfizer Europe Ma Eeig
Ramsgate Road
Sandwich
Kent Ct13 9nj
United Kingdom

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Pfizer Oy
Tietokuja 3
FI-00330 Helsinki

Pfizer Oy
Tietokuja 3
FI-00330 Helsinki

Pfizer Oy
Tietokuja 3
FI-00330 Helsinki

Alpharma A/S
Harbitzalleen 3
158 Skoyen
N-0212 Oslo

Merckle GmbH
Ludwig-Merckle-Strasse 3
P.O. Box 1161
D-89143 Blaubeuren

Ajc Pharma
18 Rue Du Docteur Ragnaud
F-16000 Angoulême

Biogaran
15 Boulevard Charles De Gaulle
F-92707 Colombes Cedex

Biogaran
15 Boulevard Charles De Gaulle
F-92707 Colombes Cedex

Feldene

0,5 %

Gel

Transdermal use

Brexidol

20 mg

Tablet

Oral use

Felden

Felden

Felden

Piroxal

0,5 %

Gel

Cutaneous use

20 mg

Capsule, hard

Oral use

20 mg

Tablet

Oral use

20 mg

Tablet

Oral use

Piroxin

0,5 %

Gel

Cutaneous use

Zofora 20 mg Suppositoire

20 mg

Suppository

Rectal use

Piroxicam Biogaran 10 mg Gélule

10 mg

Capsule, hard

Oral use

Piroxicam Biogaran 20 mg Gélule

20 mg

Capsule, hard

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
5
5

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France

France

France

France

France

France

France

France

France

France

Laboratoire Pharmy II
26 rue des Gaudines
F-78100 Saint-Germain-Laye

Laboratoire Pharmy II
26 rue des Gaudines
F-78100 Saint-Germain-Laye

Laboratoire Pharmy II
26 rue des Gaudines
F-78100 Saint-Germain-Laye

Cephalon France
20 Rue Charles Martigny
F-94701 Maisons-Alfort Cedex

Cephalon France
20 Rue Charles Martigny
F-94701 Maisons-Alfort Cedex

Chiesi
11 Avenue Dubonnet
F-92400 Courbevoie

Chiesi
11 Avenue Dubonnet
F-92400 Courbevoie

Chiesi
11 Avenue Dubonnet
F-92400 Courbevoie

Chiesi
11 Avenue Dubonnet
F-92400 Courbevoie

Dexo
179 Bureaux De La Colline
F-92213 Saint-Cloud Cedex

Zofora 20 mg Gélule

20 mg

Capsule, hard

Oral use

Zofora 20 mg/1 ml Solution Injectable
(I.M.)

20 mg

Solution for injection

Intramuscular use

Zofora 10 mg Gélule

10 mg

Capsule, hard

Oral use

Proxalyoc 20 mg Lyophilisat oral

20 mg

Lyophilisat

Oral use

Proxalyoc 10 mg Lyophilisat oral

10 mg

Lyophilisat

Oral use

Cycladol 20 mg Comprimé efferves-
cent

20 mg

Tablet

Oral use

Cycladol 20 mg Poudre pour suspen-
sion buvable en sachet

20 mg

Powder

Oral use

Cycladol 20 mg Comprimé sécable

20 mg

Tablet

Oral use

Cycladol 20 mg Suppositoire

20 mg

Suppository

Rectal use

Inflaced 10 mg Gélule

10 mg

Capsule, hard

Oral use

C

2
5
1
/
5
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France

France

France

France

France

France

France

France

France

Dexo
179 Bureaux De La Colline
F-92213 Saint-Cloud Cedex

Dexo
179 Bureaux De La Colline
F-92213 Saint-Cloud Cedex

Eg Labo — Laboratoires Eurogenerics
«Le Quintet» — Bâtiment A
12 Rue Danjou
F-92517 Boulogne Billancourt Cedex

Eg Labo — Laboratoires Eurogenerics
«Le Quintet» — Bâtiment A
12 Rue Danjou
F-92517 Boulogne Billancourt Cedex

Expanpharm International
6 rue de la Rochefoucauld
F-16000 Angouleme

Expanpharm International
6 rue de la Rochefoucauld
F-16000 Angouleme

Laboratories Fournier S.A.
42 Rue De Longvic
F-21300 Chenove

Innotech International
7-9 Avenue François-Vincent Raspail
Bp 32
F-94111 Arcueil Cedex

Innotech International
7-9 Avenue François-Vincent Raspail
Bp 32
F-94111 Arcueil Cedex

Inflaced 20 mg Gélule

20 mg

Capsule, hard

Oral use

Inflaced 20 mg Poudre effervescente
en sachet

20 mg

Powder

Oral use

Piroxicam Eg 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Eg 10 mg Gélule

10 mg

Capsule, hard

Oral use

Piroxicam Expanpharm 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Expanpharm 10 mg Gélule

10 mg

Capsule, hard

Oral use

Piroxicam Fournier 20 mg/ml Solution
injectable (Im)

20 mg

Solution for injection

Intramuscular use

Pirotec 20 mg/1 ml Solution injectable

20 mg

Solution for injection

Intramuscular use

Piroxicam Innotech International
20 mg/1 ml Solution injectable

20 mg

Solution for injection

Intramuscular use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
5
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France

France

France

France

France

France

France

France

France

France

Innotech International
7-9 Avenue François-Vincent Raspail
Bp 32
F-94111 Arcueil Cedex

Innotech International
7-9 Avenue François-Vincent Raspail
Bp 32
F-94111 Arcueil Cedex

Innotech International
7-9 Avenue François-Vincent Raspail
Bp 32
F-94111 Arcueil Cedex

Innotech International
7-9 Avenue François-Vincent Raspail
Bp 32
F-94111 Arcueil Cedex

Ivax Pharmaceuticals
34 Avenue Franklin Roosevelt
F-92150 Suresnes

Ivax Pharmaceuticals
34 Avenue Franklin Roosevelt
F-92150 Suresnes

Ivax Pharmaceuticals
34 Avenue Franklin Roosevelt
F-92150 Suresnes

Ivax Pharmaceuticals
34 Avenue Franklin Roosevelt
F-92150 Suresnes

Piroxicam Innotech International
20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Innotech International
10 mg Gélule

10 mg

Capsule, hard

Oral use

Pirotec 20 mg Suppositoire

20 mg

Suppository

Rectal use

Piroxicam Innothera 20 mg Supposi-
toire

20 mg

Suppository

Rectal use

Piroxicam Ivax 20 mg/1 ml Solution
injectable (Im)

20 mg

Solution for injection

Intramuscular use

Piroxicam Ivax 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Ivax 10 mg Gélule

10 mg

Capsule, hard

Oral use

Piroxicam Ivax 20 mg Suppositoire

20 mg

Suppository

Rectal use

Laboratoire Rpg — Ranbaxy Pharmacie Generiques
4 Place Louis Armand
F-75012 Paris

Laboratoire Rpg — Ranbaxy Pharmacie Generiques
4 Place Louis Armand
F-75012 Paris

Piroxicam Rpg 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Rpg 10 mg Gélule

10 mg

Capsule, hard

Oral use

C

2
5
1
/
5
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France

France

France

France

France

France

France

France

France

France

Merck Generiques
34 Rue Saint-Romain
F-69359 Lyon Cedex 08

Merck Generiques
34 Rue Saint-Romain
F-69359 Lyon Cedex 08

Merck Generiques
34 Rue Saint-Romain
F-69359 Lyon Cedex 08

Merck Generiques
34 Rue Saint-Romain
F-69359 Lyon Cedex 08

Merck Generiques
34 Rue Saint-Romain
F-69359 Lyon Cedex 08

Palbian
Eurasanté — Parc Galénis
85 C Rue Nelson Mandela
F-59120 Loos

Palbian
Eurasanté — Parc Galénis
85 C Rue Nelson Mandela
F-59120 Loos

Piroxicam Merck 10 mg Gélule

10 mg

Capsule, hard

Oral use

Piroxicam Merck 20 mg/1 ml Solution
Injectable (Im)

20 mg

Solution for injection

Intramuscular use

Piroxicam Merck 20 mg Comprimé
dispersible sécable

20 mg

Tablet

Oral use

Piroxicam Merck 20 mg Suppositoire

20 mg

Suppository

Rectal use

Piroxicam Merck 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Palbian 10 mg Gélule

10 mg

Capsule, hard

Oral use

Piroxicam Palbian 20 mg Gélule

20 mg

Capsule, hard

Oral use

Pfizer
23-25 Avenue Du Docteur Lannelongue
F-75668 Paris Cedex 14

Pfizer
23-25 Avenue Du Docteur Lannelongue
F-75668 Paris Cedex 14

Pfizer
23-25 Avenue Du Docteur Lannelongue
F-75668 Paris Cedex 14

Feldene 10 mg Gélule

10 mg

Capsule, hard

Oral use

Feldene 20 mg/1 ml Solution injectable
en ampoule (Im)

20 mg

Solution for injection

Intramuscular use

Feldene 20 mg Suppositoire

20 mg

Suppository

Rectal use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
5
9

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France

France

France

France

France

France

France

France

France

France

France

Pfizer
23-25 Avenue Du Docteur Lannelongue
F-75668 Paris Cedex 14

Pfizer
23-25 Avenue Du Docteur Lannelongue
F-75668 Paris Cedex 14

Pfizer
23-25 Avenue Du Docteur Lannelongue
F-75668 Paris Cedex 14

Pfizer Holding France
23-25 Avenue Du Docteur Lannelongue
F-75014 Paris

Pfizer Holding France
23-25 Avenue Du Docteur Lannelongue
F-75014 Paris

Pfizer Holding France
23-25 Avenue Du Docteur Lannelongue
F-75014 Paris

Pfizer Holding France
23-25 Avenue Du Docteur Lannelongue
F-75014 Paris

Pfizer Holding France
23-25 Avenue Du Docteur Lannelongue
F-75014 Paris

Pfizer Holding France
23-25 Avenue Du Docteur Lannelongue
F-75014 Paris

Pierre Fabre Medicament
45 Place Abel Gance
F-92654 Boulogne Cedex

Pierre Fabre Medicament
45 Place Abel Gance
F-92654 Boulogne Cedex

Feldene Dispersible 20 mg Comprimé
sécable

20 mg

Tablet

Oral use

Feldene 20 mg Gélule

20 mg

Capsule, hard

Oral use

Geldene 0,5 Pour Cent Gel pour appli-
cation locale

0,500 g

Gel

Cutaneous use

Piroxicam Beral 20 mg Suppositoire

20 mg

Suppository

Rectal use

Piroxicam Beral 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Beral Dispersible 20 mg
Comprimé dispersible sécable

20 mg

Tablet

Oral use

Piroxicam Beral 20 mg/1 ml Solution
injectable en ampoule (Im)

20 mg

Solution for injection

Intramuscular use

Piroxicam Beral 10 mg Gélule

10 mg

Capsule, hard

Oral use

Piroxicam Beral 0,5 Pour Cent Gel

0,5 g

Gel

Cutaneous use

Brexin 20 mg Poudre pour suspension
buvable

20 mg

Powder

Oral use

Brexin 20 mg Suppositoire

20 mg

Suppository

Rectal use

C

2
5
1
/
6
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France

France

France

France

France

France

France

France

France

Pierre Fabre Medicament
45 Place Abel Gance
F-92654 Boulogne Cedex

Pierre Fabre Medicament
45 Place Abel Gance
F-92654 Boulogne Cedex

Ratiopharm
5 Rue Charles Martigny
BP 42
F-94702 Maisons-Alfort Cedex

Sandoz
49 Avenue Georges Pompidou
F-92300 Levallois-Perret

Sandoz
49 Avenue Georges Pompidou
F-92300 Levallois-Perret

Teva Classics
Le Palatin 1,
1 Cours Du Triangle
F-92936 Paris La Défense Cedex

Teva Classics
Le Palatin 1,
1 Cours Du Triangle
F-92936 Paris La Défense Cedex

Teva Classics
Le Palatin 1,
1 Cours Du Triangle
F-92936 Paris La Défense Cedex

Teva Pharma B.V.
Industrieweg 23
Po Box 217
3640 Ae Mijdrecht
Nederland

Brexin 20 mg Comprimé effervescent

20 mg

Tablet

Oral use

Brexin 20 mg Comprimé sécable

20 mg

Tablet

Oral use

Piroxicam-Ratiopharm 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Sandoz 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Gnr 10 mg Gélule

10 mg

Capsule, hard

Oral use

Piroxicam Teva 10 mg Gélule

10 mg

Capsule, hard

Oral use

Piroxicam Teva 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Teva 20 mg/1 ml Solution
injectable (Im)

20 mg

Solution for injection

Intramuscular use

Piroxicam Teva Pharma 20 mg Gélule

20 mg

Capsule, hard

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
6
1

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France

France

France

France

France

France

France

France

France

France

Teva Pharma B.V.
Industrieweg 23
Po Box 217
3640 Ae Mijdrecht
Nederland

Meda Pharma
25 Boulevard de l'Amiral Bruix
F-75016 Paris

Meda Pharma
25 Boulevard de l'Amiral Bruix
F-75016 Paris

Meda Pharma
25 Boulevard de l'Amiral Bruix
F-75016 Paris

Meda Pharma
25 Boulevard de l'Amiral Bruix
F-75016 Paris

Meda Pharma
25 Boulevard de l'Amiral Bruix
F-75016 Paris

Winthrop Medicaments
1/13 Boulevard Romain Rolland
F-75014 Paris

Winthrop Medicaments
1/13 Boulevard Romain Rolland
F-75014 Paris

Winthrop Medicaments
1/13 Boulevard Romain Rolland
F-75014 Paris

Winthrop Medicaments
1/13 Boulevard Romain Rolland
F-75014 Paris

Piroxicam Teva Pharma 10 mg Gélule

10 mg

Capsule, hard

Oral use

Flexirox 20 mg/ml Solution injectable
(Im)

20 mg

Solution for injection

Intramuscular use

Flexirox 20 mg Gélule

20 mg

Capsule, hard

Oral use

Flexirox 20 mg Poudre effervescente en
sachet-dose

20 mg

Powder

Oral use

Flexirox 10 mg Gélule

10 mg

Capsule, hard

Oral use

Flexirox 2 mg/ml Suspension buvable
en flacon

200 mg

Suspension

Oral use

Piroxicam Winthrop 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Winthrop 10 mg Gélule

10 mg

Capsule, hard

Oral use

Olcam 10 mg Gélule

10 mg

Capsule, hard

Oral use

Olcam 20 mg Gélule

20 mg

Capsule, hard

Oral use

C

2
5
1
/
6
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France

France

Hungary

Hungary

Hungary

Hungary

Hungary

Hungary

Hungary

Hungary

Zydus France
25 rue des Peupliers
Zac Les Hautes Pâtures — Parc d'activités des Peupliers
F-92000 Nanterre

Zydus France
25 rue des Peupliers
Zac Les Hautes Pâtures — Parc d'activités des Peupliers
F-92000 Nanterre

Piroxicam Zydus 20 mg Gélule

20 mg

Capsule, hard

Oral use

Piroxicam Zydus 10 mg Gélule

10 mg

Capsule, hard

Oral use

Aliud Pharma GmbH & Co. Kg.
Gottlieb-Daimler Str. 19
D-89150 Laichingen

Aliud Pharma GmbH & Co. Kg.
Gottlieb-Daimler Str. 19
D-89150 Laichingen

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Torrex Chiesi Pharma GmbH
Gonzagagasse 16/16
A-1010 Wien

Egis Gyógyszergyár Nyrt.
Keresztúri út 30-38.
H-1106 Budapest

Egis Gyógyszergyár Nyrt.
Keresztúri út 30-38.
H-1106 Budapest

Egis Gyógyszergyár Nyrt.
Keresztúri út 30-38.
H-1106 Budapest

Egis Gyógyszergyár Nyrt.
Keresztúri út 30-38.
H-1106 Budapest

Piroxicam Al

10 mg

Tablet

Oral use

Piroxicam Al

20 mg

Tablet

Oral use

Flamexin

20 mg

Tablet

Oral use

Brexin

20 mg

Tablet

Oral use

Hotemin

10 mg

Suppository

Rectal use

Hotemin

20 mg

Suppository

Rectal use

Hotemin

10 mg

Capsule

Oral use

Hotemin

20 mg

Capsule

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
6
3

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Hungary

Hungary

Hungary

Hungary

Hungary

Hungary

Hungary

Hungary

Hungary

Hungary

Egis Gyógyszergyár Nyrt.
Keresztúri út 30-38.
H-1106 Budapest

Sandoz Hungaria Kft.
Tímár út 8.
H-1034 Budapest

Sandoz Hungaria Kft.
Tímár út 8.
H-1034 Budapest

Pfizer Kft.
Thurzó út 5/C
H-1133 Budapest

Pfizer Kft.
Thurzó út 5/C
H-1133 Budapest

Pfizer Kft.
Thurzó út 5/C
H-1133 Budapest

Biogal-Teva Pharma
Rákóczi út 70-72.
H-1074 Budapest

Biogal-Teva Pharma
Rákóczi út 70-72.
H-1074 Budapest

Teva Gyógyszergyár Zrt.
Pallagi út 13.
H-4042 Debrecen

Teva Gyógyszergyár Zrt.
Pallagi út 13.
H-4042 Debrecen

Hotemin

10 m/1 g

Cream

Topical use

Pirorheum

20 mg

Tablet

Oral use

Pirorheum

20 mg

Injection

Parenteral use

Feldene

10 mg

Capsule

Oral use

Feldene Dispersal

20 mg

Tablet

Oral use

Feldene Flash

20 mg

Tablet

Sublingual use

Piroxicam-B

20 mg

Capsule

Oral use

Piroxicam-B

10 mg

Capsule

Oral use

Huma-Pirocam

20 mg

Capsule

Oral use

Huma-Pirocam

10 mg

Capsule

Oral use

C

2
5
1
/
6
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Hungary

Slovakofarma AS
Nitrianská 100
SK-92027 Hlohovec

Reumador

5 mg/1 g

Gel

Transdermal use

Ireland

Ireland

Ireland

Ireland

Ireland

Ireland

Ireland

Trinity Chiesi Pharmaceuticals Ltd
Cheadle Royal Business Park
Highfield Cheadle SK8 3GY
United Kingdom

Trinity Chiesi Pharmaceuticals Ltd
Cheadle Royal Business Park
Highfield Cheadle SK8 3GY
United Kingdom

Pfizer Limited
Walton Oaks Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Pfizer Limited
Walton Oaks Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Pfizer Limited
Walton Oaks Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Pfizer Limited
Walton Oaks Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Pfizer Healthcare Ireland
9 Riverwalk
National Digital Park
Citywest Business Campus
Dublin 24
Ireland

Brexidol 20 mg Tablets

20 mg

Tablet

Oral use

Brexidol 20 mg Effervescent Tablets

20 mg

Tablet

Oral use

Feldene 10 mg Capsules

10 mg

Capsule, hard

Oral use

Feldene 20 mg Capsules

20 mg

Capsule, hard

Oral use

Feldene Suppositories 20 mg

20 mg

Suppository

Rectal use

Feldene Gel 0,5 %

0,5 %

Feldene Topigel

Gel

Gel

Topical use

Topical use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
6
5

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Iceland

Iceland

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Pfizer Aps
Lautrupvang 8
DK-2750 Ballerup

Pfizer Aps
Lautrupvang 8
DK-2750 Ballerup

Abc Farmaceutici S.p.A.
Corso Vittorio Emanuele II 72
I-10121 Torino

Abc Farmaceutici S.p.A.
Corso Vittorio Emanuele II 72
I-10121 Torino

Abc Farmaceutici S.p.A.
Corso Vittorio Emanuele II 72
I-10121 Torino

Aesculapius Farmaceutici S.r.l.
Via Cozzaglio 24
I-25125 Brescia

Bioprogress S.p.A.
Via Aurelia 58
I-00165 Roma

Bioprogress S.p.A.
Via Aurelia 58
I-00165 Roma

Bruschettini S.r.l.
Via Isonzo 6
I-16147 Genova

Bruschettini S.r.l.
Via Isonzo 6
I-16147 Genova

Bruschettini S.r.l.
Via Isonzo 6
I-16147 Genova

Felden

20 mg

Dispersible tablet

Oral use

Felden Gel

0,5 %

Gel

Topical use

Piroxicam Abc

20 mg

Capsule, hard

Oral use

Piroxicam Abc

20 mg

Suppository

Rectal use

Piroxicam Abc

Clevian

Oxicam

Oxicam

1 %

1 %

Gel

Gel

Cutaneous use

Cutaneous use

20 mg

Capsule, hard

Oral use

1 %

Gel

Cutaneous use

Bruxicam

20 mg

Capsule, hard

Oral use

Bruxicam

20 mg

Suppository

Rectal use

Bruxicam

1 %

Cream

Cutaneous use

C

2
5
1
/
6
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Bruschettini S.r.l.
Via Isonzo 6
I-16147 Genova

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Piroftal

0,5 %

Eye drops, solution

Ocular use

Brexidol

20 mg

Tablet

Oral use

Brexidol

20 mg

Effervescent tablet

Oral use

Brexidol

20 mg

Granules for oral solution Oral use

Brexidol

20 mg

Suppository

Rectal use

Brexin L

20 mg/2 ml

Powder and solvent for
solution for injection

Intramuscular use

Pivaloxicam

30 mg

Capsule, hard

Oral use

Pivaloxicam

2 %

Cream

Cutaneous use

Pivaloxicam

30 mg

Capsule, hard

Oral use

Pivaloxicam

Pivaloxicam

50 g

40 g

Cream

Cutaneous use

Cream

Cutaneous use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
6
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Copernico S.r.l.
Via Oria 32
I-72028 Torre Santa Susanna (Br)

Copernico S.r.l.
Via Oria 32
I-72028 Torre Santa Susanna (Br)

Copernico S.r.l.
Via Oria 32
I-72028 Torre Santa Susanna (Br)

Doc Generici S.r.l.
Via Manuzio 7
I-20124 Milano

Doc Generici S.r.l.
Via Manuzio 7
I-20124 Milano

Doc Generici S.r.l.
Via Manuzio 7
I-20124 Milano

Doc Generici S.r.l.
Via Manuzio 7
I-20124 Milano

Dorom S.r.l.
Viale G. Richard 7
I-20143 Milano

Dorom S.r.l.
Viale G. Richard 7
I-20143 Milano

Eg S.p.A.
Via Scarlatti Domenico 31
I-20124 Milano

Pivaloxicam

30 g

Cream

Cutaneous use

Euroxi

Euroxi

Spirox

20 mg

Capsule, hard

Oral use

50 g

Gel

Cutaneous use

20 mg/1 ml

Solution for injection

Intramuscular use

Piroxicam Doc

20 mg

Capsule, hard

Oral use

Piroxicam Doc

1 %

Cream

Cutaneous use

Piroxicam Doc

20 mg/ml

Solution for injection

Intramuscular use

Piroxicam Doc Generici

20 mg

Capsule, hard

Oral use

Piroxicam

10 mg

Capsule, hard

Oral use

Piroxicam

20 mg

Suppository

Rectal use

Piroxicam Eg

20 mg/ml

Solution for injection

Intramuscular use

C

2
5
1
/
6
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Eg S.p.A.
Via Scarlatti Domenico 31
I-20124 Milano

Eg S.p.A.
Via Scarlatti Domenico 31
I-20124 Milano

Epifarma S.r.l.
Via S. Rocco 6
I-85033 Episcopia Pz

Epifarma S.r.l.
Via S. Rocco 6
I-85033 Episcopia Pz

Epifarma S.r.l.
Via S. Rocco 6
I-85033 Episcopia Pz

Epifarma S.r.l.
Via S. Rocco 6
I-85033 Episcopia Pz

F.I.R.M.A. S.p.A.
Via di Scandicci 37
I-50143 Firenze

F.I.R.M.A. S.p.A.
Via di Scandicci 37
I-50143 Firenze

F.I.R.M.A. S.p.A.
Via di Scandicci 37
I-50143 Firenze

F.I.R.M.A. S.p.A.
Via di Scandicci 37
I-50143 Firenze

Farma 1 S.r.l.
Via privata Maria Teresa 11
I-20123 Milano

Piroxicam Eg

20 mg

Capsule, hard

Oral use

Piroxicam Eg

20 mg

Soluble tablet

Oral use

Ipsoflog

20 mg

Capsule, hard

Oral use

Ipsoflog

1 %

Cream

Cutaneous use

Ipsoflog

20 mg/ 1 ml

Solution for injection

Intramuscular use

Ipsoflog

20 mg

Soluble tablet

Oral use

Antiflog

10 mg

Capsule, soft

Oral use

Antiflog

20 mg

Capsule, soft

Oral use

Antiflog

20 mg

Suppository

Rectal use

Antiflog

1 %

Gel

Cutaneous use

Flodol

20 mg

Capsule, hard

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
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n
a
l

o
f

t
h
e

E
u
r
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p
e
a
n
U
n
o
n

i

C

2
5
1
/
6
9

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Farma 1 S.r.l.
Via Privata Maria Teresa 11
I-20123 Milano

Farmaceutici Caber S.p.A.
Viale Città d'Europa 681
I-00100 Roma

Farmaceutici Caber S.p.A.
Viale Città d'Europa 681
I-00100 Roma

Hexal S.p.A.
Centro Direzionale Colleoni
Palazzo Andromeda
Via Paracelso 16
I-20041 Agrate Brianza (Mi)

Hexal S.p.A.
Centro Direzionale Colleoni
Palazzo Andromeda
Via Paracelso 16
I-20041 Agrate Brianza (Mi)

Hexal S.p.A.
Centro Direzionale Colleoni
Palazzo Andromeda
Via Paracelso 16
I-20041 Agrate Brianza (Mi)

Jet Generici S.r.l.
Via Mario Lalli 8
I-56127 Pisa

K.B.R. Kroton Biologic Researches S.r.l.
Corso V. Emanuele 73
I-88074 Crotone (Kr)

K.B.R. Kroton Biologic Researches S.r.l.
Corso V. Emanuele 73
I-88074 Crotone (Kr)

Flodol

Roxenil

1 %

1 %

Gel

Cutaneous use

Cream

Cutaneous use

Roxenil

20 mg

Capsule, hard

Oral use

Piroxicam Hexal

10 mg

Tablet

Oral use

Piroxicam Hexal

20 mg

Tablet

Oral use

Piroxicam Hexal

20 mg

Solution for injection

Intramuscular use

Piroxicam

20 mg

Capsule, hard

Oral use

Reumagil

1 %

Cream

Cutaneous use

Reumagil

20 mg/1 ml

Solution for injection

Intramuscular use

C

2
5
1
/
7
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Laboratori Alter S.r.l.
Via Egadi 7
I-20144 Milano

Laboratori Prodotti Farmaceutici Boniscontro e
Gazzone S.r.l.
Via Pavia 6
I-20136 Milano

Laboratori Prodotti Farmaceutici Boniscontro e
Gazzone S.r.l.
Via Pavia 6
I-20136 Milano

Laboratori Prodotti Farmaceutici Boniscontro e
Gazzone S.r.l.
Via Pavia 6
I-20136 Milano

Laboratori Prodotti Farmaceutici Boniscontro e
Gazzone S.r.l.
Via Pavia 6
I-20136 Milano

Laboratorio Farmaceutico C.T. S.r.l.
Strada Solaro 75/77
I-18038 Villa Sayonara — Sanremo (Im)
Italie

Laboratorio Farmaceutico C.T. S.r.l.
Strada Solaro 75/77
I-18038 Villa Sayonara — Sanremo (Im)

Laboratorio Farmaceutico C.T. S.r.l.
Strada Solaro 75/77
I-18038 Villa Sayonara — Sanremo (Im)

Laboratorio Farmaceutico C.T. S.r.l.
Strada Solaro 75/77
I-18038 Villa Sayonara — Sanremo (Im)

Lampugnani Farmaceutici S.p.A.
Bianca Maria Visconti 33
I-20100 Milano

Piroxicam Alter

20 mg/1 ml

Solution for injection

Intramuscular use

Roxiden

20 mg

Capsule, hard

Oral use

Roxiden

20 mg

Suppository

Rectal use

Roxiden

1 %

Gel

Cutaneous use

Roxiden

20 mg

Solution for injection

Intramuscular use

Reucam

10 mg

Capsule, hard

Oral use

Reucam

Reucam

Reucam

Lampoflex

20 mg

Capsule, hard

Oral use

20 mg

Suppository

Rectal use

1 %

1 %

Cream

Cutaneous use

Cream

Cutaneous use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
7
1

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Lampugnani Farmaceutici S.p.A.
Bianca Maria Visconti 33
I-20100 Milano

Lampugnani Farmaceutici S.p.A.
Bianca Maria Visconti 33
I-20100 Milano

Lampoflex

20 mg

Capsule, hard

Oral use

Lampoflex

1 %

Cutaneous foam

Cutaneous use

Master Pharma S.r.l.
Via Giacomo Chiesi
I-43100 Parma

Master Pharma S.r.l.
Via Giacomo Chiesi
I-43100 Parma

Master Pharma S.r.l.
Via Giacomo Chiesi
I-43100 Parma

Master Pharma S.r.l.
Via Giacomo Chiesi
I-43100 Parma

Master Pharma S.r.l.
Via Giacomo Chiesi
I-43100 Parma

Master Pharma S.r.l.
Via Giacomo Chiesi
I-43100 Parma

Mayne Pharma S.r.l.
Via Orazio 20/22
I-80122 Napoli

Mayne Pharma S.r.l.
Via Orazio 20/22
I-80122 Napoli

Mayne Pharma S.r.l.
Via Orazio 20/22
I-80122 Napoli

Cicladol

Cicladol

Cicladol

Cicladol

20 mg

Granules for oral solution Oral use

20 mg

Suppository

Rectal use

20 mg

Tablet

Oral use

20 mg

Effervescent tablet

Oral use

Ciclafast

30 mg

Capsule, hard

Oral use

Ciclafast

2 %

Cream

Cutaneous use

Polipirox

20 mg

Capsule, hard

Oral use

Polipirox

20 mg

Suppository

Rectal use

Polipirox

20 mg/ml

Solution for injection

Intramuscular use

C

2
5
1
/
7
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Merck Generics Italia S.p.A.
Via Aquileia 35
I-20092 Cinisello Balsamo (Mi)

Officina Farmaceutica Fiorentina S.r.l.
Quartiere Varignano 12-13-14
I-55049 Viareggio (Lu)

Officina Farmaceutica Fiorentina S.r.l.
Quartiere Varignano 12-13-14
I-55049 Viareggio (Lu)

Officina Farmaceutica Fiorentina S.r.l.
Quartiere Varignano 12-13-14
I-55049 Viareggio (Lu)

Officina Farmaceutica Fiorentina S.r.l.
Quartiere Varignano 12-13-14
I-55049 Viareggio (Lu)

Pfizer Consumer Health Care S.r.l.
Strada Statale 156 Km 50
I-04010 Borgo San Michele (Lt)

Pfizer Italia S.r.l.
S.S. 156 Km 50
I-04010 Borgo San Michele (Lt)

Pfizer Italia S.r.l.
S.S. 156 Km 50
I-04010 Borgo San Michele (Lt)

Pfizer Italia S.r.l.
S.S. 156 Km 50
I-04010 Borgo San Michele (Lt)

Pfizer Italia S.r.l.
S.S. 156 Km 50
I-04010 Borgo San Michele (Lt)

Pfizer Italia S.r.l.
S.S. 156 Km 50
I-04010 Borgo San Michele (Lt)

Piroxicam

20 mg/1 ml

Solution for injection

Intramuscular use

Dexicam

10 mg

Capsule

Oral use

Dexicam

20 mg

Capsule

Oral use

Dexicam

20 mg

Suppository

Rectal use

Dexicam

1 %

Gel

Cutaneous use

Raia

Feldene

Feldene

Feldene

Feldene

20 mg

Sublingual tablet

Oral use

20 mg

Capsule, hard

Oral use

20 mg

Suppository

Rectal use

20 mg

Soluble tablet

Oral use

20 mg/1 ml

Solution for injection

Intramuscular use

Feldene Cremadol

1 %

Cream

Cutaneous use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
7
3

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Pfizer Italia S.r.l.
S.S. 156 Km 50
I-04010 Borgo San Michele (Lt)

Pfizer Italia S.r.l.
S.S. 156 Km 50
I-04010 Borgo San Michele (Lt)

Pfizer Italia S.r.l.
S.S. 156 Km 50
I-04010 Borgo San Michele (Lt)

Pliva Pharma S.p.A.
Via Tranquillo Cremona 10
I-20092 Cinisello Balsamo (Mi)

Pliva Pharma S.p.A.
Via Tranquillo Cremona 10
I-20092 Cinisello Balsamo (Mi)

Pliva Pharma S.p.A.
Via Tranquillo Cremona 10
I-20092 Cinisello Balsamo (Mi)

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Feldene Fast

20 mg

Tablet

Oral use

Feldene Fast

20 mg

Sublingual tablet

Oral use

Feldene Lipo

Roxene

Roxene

Roxene

Brexin

Brexin

Brexin

Brexin

1 %

1 %

Gel

Cutaneous use

Cream

Cutaneous use

20 mg/1 ml

Solution for injection

Intramuscular use

20 mg

Soluble tablet

Oral use

20 mg

Granules for oral solution Oral use

20 mg

Suppository

Rectal use

20 mg

Tablet

Oral use

20 mg

Effervescent tablet

Oral use

Brexivel

2 ml

Powder and solvent for
solution for injection

Intramuscular use

C

2
5
1
/
7
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Promedica S.r.l.
Via Palermo 26 A
I-43100 Parma

Ratiopharm GmbH
Graf-Arco Straße 3
D-89070 Ulm

Ratiopharm GmbH
Graf-Arco Straße 3
D-89070 Ulm

Ratiopharm GmbH
Graf-Arco Straße 3
D-89070 Ulm

Brexivel

Brexivel

Brexivel

Brexivel

Riacen

Riacen

Riacen

Riacen

20 mg

Capsule, hard

Oral use

20 mg

Suppository

Rectal use

1 %

Cream

Cutaneous use

20 mg/1 ml

Solution for injection

Intramuscular use

10 mg

Capsule, hard

Oral use

20 mg

Capsule, hard

Oral use

20 mg

Suppository

Rectal use

1 %

Cream

Cutaneous use

Piroxicam Ratiopharm

20 mg/ml

Solution for injection

Intramuscular use

Piroxicam Ratiopharm

20 mg

Capsule, hard

Oral use

Piroxicam Ratiopharm

20 mg

Soluble tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
7
5

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Italy

Sandoz S.p.A.
Largo Boccioni 1
I-21040 Origgio (Va)

Sandoz S.p.A.
Largo Boccioni 1
I-21040 Origgio (Va)

Sandoz S.p.A.
Largo Boccioni 1
I-21040 Origgio (Va)

So.Se.Pharm S.r.l. Società di servizio per l'industria
Farmaceutica ed affini
Via dei Castelli Romani 22
I-00040 Pomezia (Rm)

So.Se.Pharm S.r.l. Società di servizio per l'industria
Farmaceutica ed affini
Via dei Castelli Romani 22
I-00040 Pomezia (Rm)

So.Se.Pharm S.r.l. Società di servizio per l'industria
Farmaceutica ed affini
Via dei Castelli Romani 22
I-00040 Pomezia (Rm)

So.Se.Pharm S.r.l. Società di servizio per l'industria
Farmaceutica ed affini
Via dei Castelli Romani 22
I-00040 Pomezia (Rm)

Tad Pharma Italia S.r.l.
Via Felice Casati 16
I-20124 Milano

Teva Pharma Italia S.r.l.
Viale G. Richard 7
I-20143 Milano

Winthrop Pharmaceuticals Italia S.r.l.
Viale Bodio 37 B
I-20158 Milano

Piroxicam Sandoz

20 mg

Suppository

Rectal use

Piroxicam Sandoz

20 mg

Capsule, hard

Oral use

Piroxicam Sandoz

1 %

Cream

Cutaneous use

Artroxicam

20 mg

Capsule

Oral use

Artroxicam

20 mg

Suppository

Rectal use

Artroxicam

Artroxicam

1 %

1 %

Cream

Topical use

Cutaneous foam

Cutaneous use

Errekam

20 mg

Solution for injection

Intramuscular use

Piroxicam

1 %

Cream

Cutaneous use

Piroxicam Winthrop

20 mg

Capsule, hard

Oral use

C

2
5
1
/
7
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Lithuania

Lithuania

Lithuania

Lithuania

Lithuania

Lithuania

Lithuania

Lithuania

Luxembourg

Luxembourg

Luxembourg

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Boehringer Ingelheim International GmbH
Binger Straβe 173
D-55216 Ingelheim am Rhein

Egis Pharmaceuticals Ltd
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Ltd
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Ltd
Keresztúri út 30-38.
H-1106 Budapest

Pharmaceutical Works Jelfa Sa
ul. W. Pola 21
PL-58-500 Jelenia Gora

Pharmaceutical Works Jelfa Sa
ul. W. Pola 21
PL-58-500 Jelenia Gora

Pfizer S.A.
17 Boulevards de la Plaine
B-1050 Bruxelless

Pfizer S.A.
17 Boulevards de la Plaine
B-1050 Bruxelless

Pfizer S.A.
17 Boulevards de la Plaine
B-1050 Bruxelless

Brexin

Brexin

20 mg

Tablet

Oral use

20 mg/3 mg

Granules for oral solution Oral use

Finalgel Sport

0,5 g/100 g

Gel

Cutaneous use

Hotemin

20 mg

Capsule

Oral use

Hotemin

20 mg/ml

Solution for injection

Intramuscular use

Hotemin

500 mg/50 g

Cream

Cutaneous use

Piroxicam

20 mg

Coated tablet

Oral use

Piroxicam

10 mg

Coated tablet

Oral use

Feldene

Feldene

Feldene

20 mg

Tablet

Oral use

10 mg

Capsule

Oral use

20 mg

Capsule

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
7
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Pfizer S.A.
17 Boulevards de la Plaine
B-1050 Bruxelless

Pfizer S.A.
17 Boulevards de la Plaine
B-1050 Bruxelless

Pfizer S.A.
17 Boulevards de la Plaine
B-1050 Bruxelless

Eurogenerics S.A.
Esplanade Heysel, B 22
B-1020 Bruxelless

Eurogenerics S.A.
Esplanade Heysel B 22
B-1020 Bruxelless

Eurogenerics S.A.
Esplanade Heysel B 22
B-1020 Bruxelless

Nycomed Belgium S.A.
615 Chaussée de Gand
B-1080 Bruxelless

Nycomed Belgium S.A.
615 Chaussée de Gand
B-1080 Bruxelless

Nycomed Belgium S.A.
615 Chaussée de Gand
B-1080 Bruxelless

Nycomed Belgium S.A.
615 Chaussée de Gand
B-1080 Bruxelless

Smb Laboratories
26-28 Rue de la Pastorale
B-1080 Bruxelless

Feldene

Feldene

20 mg

Suppository

Rectal use

20 mg/ml

Solution for injection

Intramuscular use

Feldene Dispersal

20 mg

Dispersible tablet

Oral use

Lampoflex

10 mg

Capsule

Oral use

Lampoflex

20 mg

Capsule

Oral use

Lampoflex

0,50 %

Gel

Cutaneous use

Brexine

Brexine

Brexine

Brexine

20 mg

Tablet

Oral use

20 mg

Granules

Oral use

10 mg

Tablet

Oral use

20 mg

Effervescent tablet

Oral use

Solicam

10 mg

Capsule

Oral use

C

2
5
1
/
7
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Luxembourg

Latvia

Latvia

Latvia

Latvia

Smb Laboratories
26-28 Rue de la Pastorale
B-1080 Bruxelless

Docpharma S.A.
Ambachtenlaan 13h
B-3001 Heverlee

Rationpharm GmbH
Postfach 3380
D-89070 Ulm

Rationpharm GmbH
Postfach 3380
D-89070 Ulm

Hexal AG
Industriestraße 25
D-83607 Holzkirchen

Hexal Ag
Industriestraße 25
D-83607 Holzkirchen

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Cipla (Uk) Limited
53a High Street Esher
Surrey KT10 9QR
United Kingdom

Cipla (Uk) Limited
53a High Street Esher
Surrey KT10 9QR
United Kingdom

Solicam

20 mg

Capsule

Oral use

Docpiroxi Dispers

20 mg

Dispersible tablet

Oral use

Piroxicam-Rpm

10 mg

Tablet

Oral use

Piroxicam-Rpm

20 mg

Tablet

Oral use

Piroxicam-HEXAL

10 mg

Tablet

Oral use

Piroxicam-Hexal

20 mg

Tablet

Oral use

Brexin

Brexin

20 mg

Granules

Oral use

20 mg

Tablet

Oral use

Pirox Gel

0,5 %

Gel

Dermal use

Pirox-20

20 mg

Capsule

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
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r
n
a
l

o
f

t
h
e

E
u
r
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p
e
a
n
U
n
o
n

i

C

2
5
1
/
7
9

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Latvia

Latvia

Latvia

Latvia

Latvia

Malta

Malta

Malta

Malta

The Netherlands

Sopharma Ad
Iliensko Shose Str. 16
BG-1220 Sofia

Sopharma Ad
Iliensko Shose Str. 16
BG-1220 Sofia

Pharmaceutical Works Jelfa S.A.
ul. Wincentego Pola 21
PL-58-500 Jelenia Gora

Pharmaceutical Works Jelfa S.A.
ul. Wincentego Pola 21
PL-58-500 Jelenia Gora

Tallinna Farmaatsiatehase AS
Tondi 33
EE-11316 Tallinn

Bruschettini S.r.l.
Via Isonzo 4
I-16147 Genova

Bruschettini S.r.l.
Via Isonzo 4
I-16147 Genova

Alta Care Laboratories Ltd
Via Ilderbrando Vivanti 188
I-00144 Roma

Alta Care Laboratories Ltd
Via Ilderbrando Vivanti 188
I-00144 Roma

Actavis B.V.
Postbus 313
3740 AH Baarn
Baarnsche Dijk 1
3741 LN Baarn
Nederland

Piroxicam

10 mg

Capsule

Oral use

Piroxicam

20 mg

Capsule

Oral use

Piroxicam 10 mg

10 mg

Film-coated tablet

Oral use

Piroxicam 20 mg

20 mg

Film-coated tablet

Oral use

Piroxicam Tft

20 mg

Tablet

Oral use

Bruxicam

1 g

Cream

Topical use

Bruxicam

20 mg

Capsule

Oral use

Flodol

Flodol

1 g

Gel

Topical use

20 mg

Capsule

Oral use

Piroxicam Actavis Disper 20 mg

20 mg

Dispersible tablet

Oral use

C

2
5
1
/
8
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

Actavis B.V.
Postbus 313
3740 AH Baarn
Baarnsche Dijk 1
3741 LN Baarn
Nederland

Actavis B.V.
Postbus 313
3740 AH Baarn
Baarnsche Dijk 1
3741 LN Baarn
Nederland

Centrafarm Services B.V.
Postbus 289
4870 AG Etten Leur
Nederland

Centrafarm Services B.V.
Postbus 289
4870 AG Etten Leur
Nederland

Centrafarm Services B.V.
Postbus 289
4870 AG Etten Leur
Nederland

Sandoz B.V
Veluwezoon 22
1327 AH Almere
Nederland

Sandoz B.V
Veluwezoon 22
1327 AH Almere
Nederland

Sandoz B.V
Veluwezoon 22
1327 AH Almere
Nederland

Piroxicam Actavis 10 mg

10 mg

Capsule

Oral use

Piroxicam Actavis 20 mg

20 mg

Capsule

Oral use

Piroxicam Cf 10 mg

10 mg

Capsule

Oral use

Piroxicam Cf 20 mg

20 mg

Capsule

Oral use

Piroxicam Disper Cf 20 mg

20 mg

Dispersible tablet

Oral use

Piroxicam Sandoz Disper 10 mg

10 mg

Dispersible tablet

Oral use

Piroxicam Sandoz Disper 20 mg

20 mg

Dispersible tablet

Oral use

Piroxicam Sandoz 20 mg Zetpil

20 mg

Suppository

Rectal use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
8
1

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

Karib Ltd,
Karib House
63-65 Imperial Way
CR9 4QY Croydon Surrey
United Kingdom

Karib Ltd,
Karib House
63-65 Imperial Way
CR9 4QY Croydon Surrey
United Kingdom

Katwijk Farma B.V.
Postbus 408
2300 AK Leiden
Nederland

Nycomed Nederland B.V.
Nikkelstraat 5
4823 AE Breda
Nederland

Nycomed Nederland B.V.
Nikkelstraat 5
4823 AE Breda
Nederland

Nycomed Nederland B.V.
Nikkelstraat 5
4823 AE Breda
Nederland

Pharmachemie B.V.
Postbus 552
2003 RN Haarlem
Nederland

Pharmachemie B.V.
Postbus 552
2003 RN Haarlem
Nederland

Piroxicam Flx 10 mg

10 mg

Capsule

Oral use

Piroxicam Flx 20 mg,

20 mg

Capsule

Oral use

Piroxicam Katwijk 20 mg Dispers
Tabletten

20 mg

Dispersible tablet

Oral use

Brexine Bruis

20 mg

Effervescent tablet

Oral use

Brexine

20 mg

Oral powder

Oral use

Brexine

20 mg

Tablet

Oral use

Piroxicam Disp. 10 PCH

10 mg

Dispersible tablet

Oral use

Piroxicam Disp. 20 PCH

20 mg

Dispersible tablet

Oral use

C

2
5
1
/
8
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

The Netherlands

Pharmachemie B.V.
Postbus 552
2003 RN Haarlem
Nederland

Pharmachemie B.V.
Postbus 552
2003 RN Haarlem
Nederland

Ratiopharm Nederland B.V.
Postbus 2062
1500 GB Zaandam
Nederland

Ratiopharm Nederland B.V.
Postbus 2062
1500 GB Zaandam
Nederland

Ratiopharm Nederland B.V.
Postbus 2062
1500 GB Zaandam
Nederland

Ratiopharm Nederland B.V.
Postbus 2062
1500 GB Zaandam
Nederland

Ratiopharm Nederland B.V.
Postbus 2062
1500 GB Zaandam
Nederland

Sanofi-Synthelabo B.V.
Postbus 2043
2800 BD Gouda
Nederland

Sanofi-Synthelabo B.V.
Postbus 2043
2800 BD Gouda
Nederland

Piroxicam 10 PCH

10 mg

Capsule

Oral use

Piroxicam 20 PCH

20 mg

Capsule

Oral use

Piroxicam Ratiopharm Dispergeerbaar
20 mg

20 mg

Dispersible tablet

Oral use

Piroxicam Ratiopharm 10 mg

10 mg

Capsule

Oral use

Piroxicam Ratiopharm 10 mg

10 mg

Capsule

Oral use

Piroxicam Ratiopharm 20 mg

20 mg

Capsule

Oral use

Piroxicam Ratiopharm 20 mg

20 mg

Capsule

Oral use

Piroxicam Albic 10 mg

10 mg

Capsule

Oral use

Piroxicam Albic 20 mg

20 mg

Capsule

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
8
3

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

The Netherlands

The Netherlands

Norway

Norway

Norway

Norway

Norway

Poland

Poland

Wise Pharmaceuticals Ltd
Hamwells Business Park
Unit No.7 Hardicker Street
M19 2RB Manchester
United Kingdom

Wise Pharmaceuticals Ltd
Hamwells Business Park
Unit No.7 Hardicker Street
M19 2RB Manchester
United Kingdom

Pfizer
PO Box 3
N-1324 Lysaker

Nycomed Pharma As
P.O. Box 205 N-1372 Asker
N-0010 Oslo

Nycomed Pharma As
P.O. Box 205 N-1372 Asker
N-0010 Oslo

Alpharma
P.O. Box
158 Skøyen
N-0212 Oslo

Merck NM
P.O.Box 23033
S-10435 Stockholm

Apotex Europe Ltd
Rowan House
41 London Street
Reading Berkshire RG1 4PS
United Kingdom

Apotex Europe Ltd
Rowan House
41 London Street
Reading Berkshire RG1 4PS
United Kingdom

Piroxicam 10 mg

10 mg

Capsule

Oral use

Piroxicam 20 mg

20 mg

Capsule

Oral use

Felden

20 mg

Tablet

Oral use

Brexidol

20 mg

Tablet

Oral use

Brexidol

20 mg

Oral powder in sachet

Oral use

Pirox

20 mg

Tablet

Oral use

Piroxicam Merck Nm

20 mg

Tablet

Oral use

Apo-Piroxicam 10

10 mg

Capsule

Oral use

Apo-Piroxicam 20

20 mg

Capsule

Oral use

C

2
5
1
/
8
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Poland

Poland

Poland

Poland

Poland

Poland

Poland

Poland

Poland

Poland

Poland

Pfizer Europe MA EEIG
Sandwich
Kent Ct13 9nj
United Kingdom

Glaxosmithkline Pharmaceuticals S.A.
Grunwaldzka St. 189
PL-60-322 Poznań

Glaxosmithkline Pharmaceuticals S.A.
Grunwaldzka St. 189
PL-60-322 Poznań

Glaxosmithkline Pharmaceuticals S.A.
Grunwaldzka St. 189
PL-60-322 Poznań

Glaxosmithkline Pharmaceuticals S.A.
Grunwaldzka St. 189
PL-60-322 Poznań

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
Wincentego St. Pola 21
PL-58-500 Jelenia Góra

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
Wincentego St. Pola 21
PL-58-500 Jelenia Góra

Egis Pharmaceuticals Ltd
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Ltd
Keresztúri út 30-38.
H-1106 Budapest

Egis Pharmaceuticals Ltd
Keresztúri út 30-38.
H-1106 Budapest

Torrex Chiesi Polska Sp. z o.o.
ul. Biala 3
PL-00-895 Warszawa

Feldene

20 mg/ml

Solution for injection

Parenteral use

Piroxicam 10

10 mg

Suppository

Rectal use

Piroxicam 20

20 mg

Suppository

Rectal use

Piroxicam

50 mg/g

Ointment

Cutaneous use

Piroxicam

50 mg/g

Gel

Cutaneous use

Piroxicam Jelfa

10 mg

Film-coated tablet

Oral use

Piroxicam Jelfa

20 mg

Film-coated tablet

Oral use

Hotemin

10 mg

Capsule

Oral use

Hotemin

20 mg

Capsule, hard

Oral use

Hotemin

20 mg/ml

Solution for injection

Parenteral use

Flamexin

20 mg

Powder for solution for
injection

Parenteral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
8
5

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Poland

Poland

Poland

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Torrex Chiesi Polska Sp. z o.o.
ul. Biala 3
PL-00-895 Warszawa

Boehringer Ingelheim International GmbH
Binger Str. 173
D-55216 Ingelheim am Rhein

Sankyo Pharma GmbH
Zielstattstr. 48
D-81379 München

Neo-Farmacêutica Lda
Av. D. João II
Lote 1.02.2.1 D-2o
P-1990-090 Lisboa

Neo-Farmacêutica Lda
Av. D. João II
Lote 1.02.2.1 D-2o
P-1990-090 Lisboa

Neo-Farmacêutica Lda
Av. D. João II
Lote 1.02.2.1 D-2o
P-1990-090 Lisboa

Laboratórios Pfizer Lda
Empreendimento Lagoas Park
Edifício 10
P-2740-271 Porto Salvo

Laboratórios Pfizer Lda
Empreendimento Lagoas Park
Edifício 10
P-2740-271 Porto Salvo

Laboratórios Pfizer Lda
Empreendimento Lagoas Park
Edifício 10
P-2740-271 Porto Salvo

Flamexin

20 mg

Tablet

Oral use

Finalgel Sport

5 mg/g

Gel

Cutaneous use

Mobilat P Crème

5 mg/g

Cream

Cutaneous use

Brexin

20 mg

Tablet

Oral use

Brexin

20 mg

Effervescent tablet

Oral use

Brexin

20 mg

Granules

Oral use

Feldene

20 mg

Capsule

Oral use

Feldene

20 mg

Dispersible tablet

Oral use

Feldene

5 mg/g

Gel

Cutaneous use

C

2
5
1
/
8
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Laboratórios Pfizer Lda
Empreendimento Lagoas Park
Edifício 10
P-2740-271 Porto Salvo

Laboratórios Pfizer Lda
Empreendimento Lagoas Park
Edifício 10
P-2740-271 Porto Salvo

A. Menarini Portugal
Farmacêutica S.A. Quinta Da Fonte
Edifício D. Manuel I
Piso 2
Rua dos Malhões n.o 1
P-2770-071 Paço De Arcos

A. Menarini Portugal
Farmacêutica S.A. Quinta Da Fonte
Edifício D. Manuel I
Piso 2
Rua dos Malhões n.o 1
P-2770-071 Paço De Arcos

A. Menarini Portugal
Farmacêutica S.A. Quinta Da Fonte
Edifício D. Manuel I
Piso 2
Rua dos Malhões n.o 1
P-2770-071 Paço De Arcos

A. Menarini Portugal
Farmacêutica S.A. Quinta Da Fonte
Edifício D. Manuel I
Piso 2
Rua dos Malhões n.o 1
P-2770-071 Paço De Arcos

A. Menarini Portugal
Farmacêutica S.A.
Rua General Ferreira Martins 8
7.o Miraflores
P-1495-137 Algés

Feldene

20 mg/1 ml

Solution for injection

Intramuscular use

Feldene

20 mg

Suppository

Rectal use

Flexar

20 mg

Capsule

Oral use

Flexar

20 mg

Dispersible tablet

Oral use

Flexar

5 mg/g

Gel

Cutaneous use

Flexar

20 mg

Suppository

Rectal use

Flexar

20 mg/1 ml

Solution for injection

Intramuscular use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
8
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Laboratórios Azevedos — Indústria Farmacêutica S.A.
Estrada Nacional 117-2
Edifícios Azevedos — Alfragide
P-2724-503 Amadora

Laboratórios Azevedos
Indústria Farmacêutica S.A.
Estrada Nacional 117-2
Edifícios Azevedos
Alfragide
P-2724-503 Amadora

Ratiopharm
Comércio E Indústria De Produtos Farmacêuticos Lda
Rua Quinta Do Pinheiro
Edifício Tejo
6.o Piso
P-2790-143 Carnaxide

Ratiopharm
Comércio E Indústria De Produtos Farmacêuticos Lda
Rua Quinta Do Pinheiro
Edifício Tejo
6.o Piso
P-2790-143 Carnaxide

Laboratório Medinfar
Produtos Farmacêuticos S.A.
Rua Manuel Ribeiro De Pavia 1
1.o Venda Nova
P-2700-547 Amadora

Laboratório Medinfar
Produtos Farmacêuticos S.A.
Rua Manuel Ribeiro De Pavia 1
1.o Venda Nova
P-2700-547 Amadora

Laboratório Medinfar
Produtos Farmacêuticos S.A.
Rua Manuel Ribeiro De Pavia 1
1.o Venda Nova
P-2700-547 Amadora

Flogocan 10

10 mg

Capsule

Oral use

Flogocan 20

20 mg

Capsule

Oral use

Piroxicam Ratiopharm 10 mg Compri-
midos

10 mg

Tablet

Oral use

Piroxicam Ratiopharm 20 mg Compri-
midos

20 mg

Tablet

Oral use

Reumoxican

10 mg

Capsule

Oral use

Reumoxican

20 mg

Capsule

Oral use

Reumoxican

10 mg

Dispersible tablet

Oral use

C

2
5
1
/
8
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Portugal

Laboratório Medinfar
Produtos Farmacêuticos S.A.
Rua Manuel Ribeiro De Pavia 1
1.o Venda Nova
P-2700-547 Amadora

Laboratório Medinfar
Produtos Farmacêuticos S.A.
Rua Manuel Ribeiro De Pavia 1
1.o Venda Nova
P-2700-547 Amadora

Biosaúde
Produtos Farmacêuticos Lda
Av. José Malhoa
Edifício Malhoa Plaza n.o 2
Piso-Escritório 2.2
P-1070-325 Lisboa

Laboratório Medinfar
Produtos Farmacêuticos S.A.
Rua Manuel Ribeiro De Pavia 1
1.o Venda Nova
P-2700-547 Amadora

Laboratório Medinfar
Produtos Farmacêuticos S.A.
Rua Manuel Ribeiro De Pavia 1
1.o Venda Nova
P-2700-547 Amadora

Laboratórios Basi
Indústria Farmacêutica S.A.
Rua Do Padrão 98
P-3000-312 Coimbra

Laboratório Medinfar
Produtos Farmacêuticos S.A.
Rua Manuel Ribeiro De Pavia 1
1.o Venda Nova
P-2700-547 Amadora

Reumoxican

20 mg

Dispersible tablet

Oral use

Reumoxican

10 mg/g

Cream

Cutaneous use

Remisil

5 mg/g

Gel

Cutaneous use

Reumoxican

20 mg/1 ml

Solution for injection

Intramuscular use

Reumoxican

20 mg

Suppository

Rectal use

Roxazin

20 mg

Capsule

Oral use

Reumoxican S.A.

20 mg

Capsule

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
8
9

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Portugal

Romania

Romania

Romania

Romania

Romania

Romania

Romania

Romania

Cinfa Portugal Lda
Av. Tomás Ribeiro 43
Bloco 2 3.o F
Edifício Neopark
P-2790-221 Carnaxide

Bruschettini S.r.l.
Via Isonzo 6
I-16147 Genova

Egis Pharmaceuticals Plc
Keresztúri út 30-38.
H-1106 Budapest

Pfizer Europe MA EEIG
Ramsgate Road
Sandwich
Kent CT 13 9 NJ
United Kingdom

Piroxicam Cinfa 20 mg Comprimidos
Dispersíveis

20 mg

Dispersible tablet

Oral use

Bruxicam 0,5 %

0,50 %

Eye drops, solution

Ocular use

Hotemin

20 mg/ml — 1 ml

Solution for injection

Intramuscular use

FELDENE 20 mg/ml

20 mg/ml — 1 ml

Solution for injection

Intramuscular use

Boehringer Ingelheim Pharma GmbH & Co.Kg,
Binger Straße 173
D-55216 Ingelheim am Rhein

Finalgel

5 mg/G

Gel

Cutaneous use

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

S.C. Slavia Pharm S.r.l.
Str. Stirbei Vodă Nr. 53-55
Sector 1, Bucureşti
România

Flamexin

20 mg

Tablet

Oral use

Flamexin

20 mg

Effervescent tablet

Oral use

Flamexin

20 mg

Powder for oral solution

Oral use

Piroxsal Gel 0,5 g %

0,5 g %

Gel

Cutaneous use

C

2
5
1
/
9
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Romania

Romania

Romania

Romania

Romania

Romania

Romania

Romania

S.C. Meduman S.A.
Aleea Eroilor Nr. 28
Vişeu De Sus
Jud. Maramureş
România

S.C. Antibiotice S.A.
Str. Valea Lupului Nr. 1
Iaşi
România

S.C. Laropharm S.r.l.
Şos. Alexandriei 145a
Comuna Bragadiru
Jud. Ilfov
România

S.C. Antibiotice S.A.
Str. Valea Lupului Nr. 1
Iaşi
România

S.C. Antibiotice S.A.
Str. Valea Lupului Nr. 1
Iaşi
România

S.C. Sintofarm S.A.
Str. Ziduri Între Vii Nr. 22
Sector 2, Bucureşti
România

S.C. Sintofarm S.A.
Str. Ziduri Între Vii Nr. 22
Sector 2, Bucureşti
România

S.C. Terapia S.A.
Str. Fabricii Nr. 124
Cluj-Napoca
Jud. Cluj
România

N-Piroxicam 20 mg

20 mg

Tablet

Oral use

Piroxicam

3 %

Cream

Local use

Piroxicam

20 mg

Tablet

Oral use

Piroxicam

0,50 %

Gel

Cutaneous use

Piroxicam 20 mg

20 mg

Suppository

Rectal use

Piroxicam 20 mg

20 mg

Suppository

Rectal use

Piroxicam 20 mg

20 mg

Tablet

Oral use

Piroxicam

20 mg

Tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
9
1

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Romania

Romania

Romania

Romania

Romania

Romania

Romania

Romania

Romania

S.C. Fabiol S.A.
B-ul Timişoara Nr. 50
Sector 6, Bucureşti
România

S.C. Ac Helcor S.r.l.
Str. Victor Babeş Nr. 50
Baia Mare, Jud. Maramureş
România

S.C. Arena Group S.A.
Str. Ştefan Mihăileanu Nr. 31
Etaj 1, Ap. 1
Sector 2, Bucureşti
România

S.C. Antibiotice S.A.
Str. Valea Lupului Nr. 1
Iaşi
România

S.C. Labormed-Pharma S.A.
Splaiul Independenţei Nr. 319e
Sector 6, Bucureşti
România

S.C. Mark Pharmaceutics S.r.l.
Str. Moara De Foc Nr. 35
Iaşi, Jud. Iaşi
România

S.C. Mark Pharmaceutics S.r.l.
Str. Moara De Foc Nr. 35
Iaşi, Jud. Iaşi
România

S.C. Slavia Pharm S.r.l.
Str. Stirbei Vodă Nr. 53-55
Sector 1, Bucureşti
România

S.C. Slavia Pharm S.r.l.
Str. Stirbei Vodă Nr. 53-55
Sector 1, Bucureşti
România

Piroxicam

20 mg

Tablet

Oral use

Piroxicam 20 mg

20 mg

Tablet

Oral use

Piroxicam 20 mg

20 mg

Tablet

Oral use

Piroxicam 40mg

40 mg

Suppository

Rectal use

Piroxicam LPH 20 mg

20 mg

Tablet

Oral use

Piroxicam Mk Crema

Piroxicam Mk Gel

3 %

1 %

Cream

Cutaneous use

Gel

Cutaneous use

Piroxsal

20 mg

Tablet

Oral use

Piroxsal Gel 0,5 g %

0,5 g %

Gel

Cutaneous use

C

2
5
1
/
9
2

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Romania

Romania

Romania

Sweden

Sweden

Sweden

Sweden

Slovakia

Slovakia

Ozone Laboratories Ltd
38 Princes Court
88 Brompton Road
Knightsbridge SW3 1ES London
United Kingdom

Ozone Laboratories Ltd
38 Princes Court
88 Brompton Road
Knightsbridge SW3 1ES London
United Kingdom

Ozone Laboratories Ltd
38 Princes Court
88 Brompton Road
Knightsbridge SW3 1ES London
United Kingdom

Nycomed Ab
Box 27264
S-102 53 Stockholm

Nycomed Ab
Box 27264
S-102 53 Stockholm

Merck Nm Ab
Box 23033
S-104 35 Stockholm

Merck Nm Ab
Box 23033
S-104 35 Stockholm

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Chiesi Farmaceutici S.p.A.
Via Palermo 26 A
I-43100 Parma

Piroxicam 1 %

1 %

Gel

Cutaneous use

Piroxicam 20 mg

20 mg

Tablet

Oral use

Piroxicam 3 %

3 %

Cream

Cutaneous use

Brexidol

20 mg

Tablet

Oral use

Brexidol

20 mg

Powder for oral solution

Oral use

Piroxicam Merck Nm

10 mg

Tablet

Oral use

Piroxicam Merck Nm

20 mg

Tablet

Oral use

Flamexin 20 mg

20 mg

Granules

Oral use

Flamexin 20 mg

20 mg

Tablet

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
9
3

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Slovakia

Slovakia

Slovakia

Slovakia

Slovakia

Slovenia

Slovenia

Slovenia

Slovenia

United Kingdom

Egis Gyógyszergyár Nyrt.
Keresztúri út 30-38.
H-1106 Budapest

Egis Gyógyszergyár Nyrt.
Keresztúri út 30-38.
H-1106 Budapest

Egis Gyógyszergyár Nyrt.
Keresztúri út 30-38.
H-1106 Budapest

Pro.Med.Cs Praha a.s.
Telčská 1
CZ-140 00 Praha 4

Pro.Med.Cs Praha a.s.
Telčská 1
CZ-140 00 Praha 4

Krka tovarna zdravil, d.d.
Šmarješka cesta 6
SLO-8501 Novo Mesto

Krka tovarna zdravil, d.d.
Šmarješka cesta 6
SLO-8501 Novo Mesto

Krka tovarna zdravil, d.d.
Šmarješka cesta 6
SLO-8501 Novo Mesto

Krka tovarna zdravil, d.d.
Šmarješka cesta 6
SLO-8501 Novo Mesto

Pfizer Limited
Walton Oaks
Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Hotemin

1x50 g/0,5 g

Cream

Topical use

Hotemin

10 mg

Capsule

Oral use

Hotemin 20 mg

20 mg

Solution for injection

Parenteral use

Pro-Roxikam 10 mg

10 mg

Tablet

Oral use

Pro-Roxikam 20 mg

20 mg

Tablet

Oral use

Erazon

Erazon

Erazon

Erazon

20 mg

Capsule, hard

Oral use

10 mg/1 g

Cream

Cutaneous use

10 mg/1 g

Gel

Cutaneous use

20 mg

Suppository

Rectal use

Feldene Capsules 10 mg

10 mg

Capsule

Oral use

C

2
5
1
/
9
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Pfizer Limited
Walton Oaks
Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Pfizer Limited
Walton Oaks
Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Pfizer Limited
Walton Oaks
Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Pfizer Limited
Walton Oaks
Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Pfizer Limited
Walton Oaks
Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Pfizer Limited
Walton Oaks
Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Actavis Uk Limited
Whiddon Vally
Barnstaple
Devon Ex32 8NS
United Kingdom

Feldene 20 (20 mg Capsules)

20 mg

Capsule

Oral use

Feldene Dispersable Tablets 10 mg

10 mg

Tablet for oral solution

Oral use

Feldene Dispersible Tablets-20 mg

20 mg

Tablet for oral solution

Oral use

Feldene Gel 0,5 % W/W

0,5 % w/w

Gel

Cutaneous use

Feldene Intramuscular Injection 20 mg/
ml

20 mg/ml

Solution for injection

Intramuscular use

Feldene Melt 20 mg Tablets

20 mg

Tablet for oral solution

Oral use

Piroxicam Capsules 10 mg

10 mg

Capsule

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
9
5

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Actavis Uk Limited
Whiddon Vally
Barnstaple
Devon Ex32 8ns
United Kingdom

Clonmel Healthcare Limited
Waterford Road
Clonmel Co. Tipperary
Ireland

Clonmel Healthcare Limited
Waterford Road
Clonmel Co. Tipperary
Ireland

Sandoz Limited
Unit 37
Woolmer Way
Bordon
Hampshire Gu35 9QE
United Kingdom

Sandoz Limited
Unit 37
Woolmer Way
Bordon
Hampshire Gu35 9QE
United Kingdom

Pharmvit Limited
Unit 13
Metropolitan Centre
Derby Road
Greenford
Middlesex UB6 8UJ
United Kingdom

Pharmvit Limited
Unit 13
Metropolitan Centre
Derby Road
Greenford
Middlesex UB6 8UJ
United Kingdom

Piroxicam Capsules 20 mg

20 mg

Capsule

Oral use

Kentene,Piroflam Piroflex

10 mg

Capsule, hard

Oral use

Kentene,Piroflam Piroflex

20 mg

Capsule, hard

Oral use

Piroxicam 10 mg Capsules

10 mg

Capsule

Oral use

Piroxicam 20 mg Capsules

20 mg

Capsule

Oral use

Piroxicam 10 mg Capsules Bp

10 mg

Capsule, hard

Oral use

Piroxicam 20 mg Capsules Bp

20 mg

Capsule, hard

Oral use

C

2
5
1
/
9
6

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Generics Uk Limited
Albany Gate
Darkes Lane
Potters Bar
Herts EN6 1AG
United Kingdom

Generics Uk Limited
Albany Gate
Darkes Lane
Potters Bar
Herts EN6 1AG
United Kingdom

Generics Uk Limited
Albany Gate
Darkes Lane
Potters Bar
Herts EN6 1AG
United Kingdom

Generics Uk Limited
Albany Gate
Darkes Lane
Potters Bar
Herts EN6 1AG
United Kingdom

Waymade Plc
Sovereign House
Miles Gray Road
Basildon
Essex SS14 3FR
United Kingdom

Neolab Limited
57 High Street
Odiham
Hampshire RG29 1LF
United Kingdom

Neolab Limited
57 High Street
Odiham
Hampshire RG29 1LF
United Kingdom

Piroxicam Capsules 10 mg

10 mg

Capsule

Oral use

Piroxicam Capsules 20 mg

20 mg

Capsule

Oral use

Piroxicam Dispersible Tablets 10 mg

10 mg

Tablet for oral solution

Oral use

Piroxicam Dispersible Tablets 20 mg

20 mg

Tablet for oral solution

Oral use

Piroxicam 0,5 % Gel

0,5 % w/w

Gel

Cutaneous use

Piroxicam 0,5 % Gel

0,5 % w/w

Gel

Cutaneous use

Piroxicam 0,5 % Gel

0,5 % w/w

Gel

Cutaneous use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
9
7

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Dr Reddy's Laboratories (Uk) Limited
6 Riverview Road
Beverley
E Yorks HU17 0LD
United Kingdom

Trinity-Chiesi Pharmaceuticals Limited
Cheadlw Royal Business Park
Highfield
Cheadle SK8 3GY
United Kingdom

Trinity-Chiesi Pharmaceuticals Limited
Cheadlw Royal Business Park
Highfield
Cheadle SK8 3GY
United Kingdom

Pliva Pharma Limited
Vision House Bedford Road
Petersfield
Hampsire GU32 3QB
United Kingdom

Tillomed Laboratories Limited
3 Howard Road Eaton Socon
St. Neots
Cambs PE19 3ET
United Kingdom

Tillomed Laboratories Limited
3 Howard Road Eaton Socon
St. Neots
Cambs PE19 3ET
United Kingdom

Manx Healthcare
Taylor Group House
Wedgnock Lane
Warwick CV34 5YA
United Kingdom

Teva Pharma B.V.
Industrieweg 23
PO Box 217
3640 AE Mijdrecht
Nederland

Piroxicam 0,5 % Gel

0,5 % w/w

Gel

Cutaneous use

Brexidol 20 mg Tablets

20 mg

Tablet

Oral use

Brexidol 20 mg Effervescent Tablets

20 mg

Effervescent tablet

Oral use

Piroxicam 0,5 % Gel

0,5 % w/w

Gel

Cutaneous use

Pirozip 10

10 mg

Capsule

Oral use

Pirozip 20

20 mg

Capsule

Oral use

Piroxicam Gel 0,5 %W/W

0,5 % w/w

Gel

Cutaneous use

Flamatrol 10 mg Capsules

10 mg

Capsule

Oral use

C

2
5
1
/
9
8

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

United Kingdom

Teva Pharma B.V.
Industrieweg 23
PO Box 217
3640 AE Mijdrecht
Nederland

Pfizer Consumer Healthcare
Walton Oaks
Dorking Road
Walton-on-the-Hill
Surrey KT20 7NS
United Kingdom

Crescent Pharma Limited
Units 3&4
Quidhampton Business Units
Polhampton Lane
Overton
Hampshire RG25 3ED
United Kingdom

Crescent Pharma Limited
Units 3&4
Quidhampton Business Units
Polhampton Lane
Overton
Hampshire RG25 3ED
United Kingdom

Strides Arcolab International Limited
201 Jersey Road
Isleworth
Middx TW7 4QJ
United Kingdom

Strides Arcolab International Limited
201 Jersey Road
Isleworth
Middx TW7 4QJ
United Kingdom

Flamatrol 20 mg Capsules

20 mg

Capsule

Oral use

Feldene P Gel

0,5 % w/w

Gel

Cutaneous use

Piroxicam Capsules Bp 10 mg

10 mg

Capsule

Oral use

Piroxicam Capsules Bp 20 mg

20 mg

Capsule

Oral use

Piroxicam 10 mg Capsules

10 mg

Capsule

Oral use

Piroxicam 20 mg Capsules

20 mg

Capsule

Oral use

.

2
6
1
0
2
0
0
7

.

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

C

2
5
1
/
9
9

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

ANNEX III

Member State

Marketing Authorisation
Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Austria

Belgium

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

IPS N.V.
Jozef Nellenslei 10
B-2100 Deurne

Lansoprazol TEVA 15 mg Kapseln

15 mg

Gastro-resistant capsule,
hard

Oral use

Lansoprazol TEVA 30 mg Kapseln

30 mg

Gastro-resistant capsule,
hard

Oral use

Lansoprazol IPS 15 mg maagsapresis-
tente capsules

15 mg

Gastro-resistant capsule,
hard

Oral use

Lansoprazol IPS 30 mg maagsapresis-
tente capsules

30 mg

Gastro-resistant capsule,
hard

Oral use

Czech Republic

Teva Pharmaceuticals CR, s.r.o.
Drážní 7
CZ-627 00 Brno

Lansoprazol TEVA 15 mg

15 mg

Gastro-resistant capsule,
hard

Oral use

Germany

Denmark

Spain

TEVA Generics GmbH
Kandelstraße 10
D-79199 Kirchzarten

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

TEVA Genéricos Española S.L.
C/Guzmán El Bueno, 133
Ed. Britannia 4o Izda.
E-28003 Madrid

Lansoprazol TEVA 30 mg

30 mg

Gastro-resistant capsule,
hard

Oral use

Lansoprazol TEVA® 15 mg magensaft-
resistente Hartkapseln

15 mg

Gastro-resistant capsule,
hard

Oral use

Lansoprazol TEVA® 30 mg magensaft-
resistente Hartkapseln

30 mg

Gastro-resistant capsule,
hard

Oral use

Lansoprazol TEVA 15 mg entero-
kapsler

Lansoprazol TEVA 30 mg entero-
kapsler

15 mg

30 mg

Gastro-resistant capsule,
hard

Oral use

Gastro-resistant capsule,
hard

Oral use

Lansoprazol TEVAGEN 15 mg cápsulas
duras gastrorresistentes EFG

15 mg

Gastro-resistant capsule,
hard

Oral use

Lansoprazol TEVAGEN 30 mg cápsulas
duras gastrorresistentes EFG

30 mg

Gastro-resistant capsule,
hard

Oral use

C

2
5
1
/
1
0
0

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.

Member State

Marketing Authorisation
Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Finland

France

Hungary

Ireland

The Netherlands

Norway

Poland

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

TEVA Classics S.A.
1, cours du Triangle
Immeuble Palatin 1
F-92936 Paris La Défense cedex 12

TEVA Magyarország Rt.
Rákóczi út 70-72.
H-1074 Budapest

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

Pharmachemie B.V.
Swensweg 5
Postbus 552
2003 RN Haarlem
Nederland

Teva Pharma B.V.
Industrieweg 23
P.O. Box 217
3640 AE Mijdrecht
Nederland

Lansoprazol Teva, 15 mg entero-
kapseli, kova

Lansoprazol Teva, 30 mg entero-
kapseli, kova

15 mg

30 mg

Gastro-resistant capsule,
hard

Oral use

Gastro-resistant capsule,
hard

Oral use

Lansoprazole TEVA 15 mg microgra-
nules gastro résistantes en gélule

15 mg

Gastro-resistant capsule,
hard

Oral use

Lansoprazole TEVA 30 mg microgra-
nules gastro résistantes en gélule

30 mg

Gastro-resistant capsule,
hard

Oral use

Lansoflux Teva 15 mg kapszula

15 mg

Gastro-resistant capsule,
hard

Oral use

Lansoflux Teva 30 mg kapszula

30 mg

Gastro-resistant capsule,
hard

Oral use

Lansoprazole TEVA 15 mg Gastro-
resistant Capsules

Lansoprazole TEVA 30 mg Gastro-
resistant Capsules

Lansoprazol 15 mg PCH, maagsap-
resistente capsule

Lansoprazol 30 mg PCH, maagsap-
resistente capsule

Lansoprazol TEVA 15 mg entero-
kapseler, harde

Lansoprazol TEVA 30 mg entero-
kapseler, harde

15 mg

30 mg

15 mg

30 mg

15 mg

30 mg

Gastro-resistant capsule,
hard

Oral use

Gastro-resistant capsule,
hard

Oral use

Gastro-resistant capsule,
hard

Oral use

Gastro-resistant capsule,
hard

Oral use

Gastro-resistant capsule,
hard

Oral use

Gastro-resistant capsule,
hard

Oral use

Teva Pharmaceuticals Polska Sp. z o.o.
E. Plater 53
PL-00-113 Warsaw

LansoTEVA 15 mg kapsulka dojelitowa
twarda

15 mg

Gastro-resistant capsule,
hard

Oral use

LansoTEVA 30 mg kapsulka dojelitowa
twarda

30 mg

Gastro-resistant capsule,
hard

Oral use

.

2
6
1
0
2
0
0
7

.

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N

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Member State

Marketing Authorisation
Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of
administration

Portugal

Sweden

Slovak Republic

United Kingdom

TEVA Pharma-Produtos Farmacêuticos Lda
Lagoas Park
Edifício 1
Piso 3
P-2740-264 Porto Salvo

Lansoprazol TEVA 15 mg cápsula
gastro-resistente

Lansoprazol TEVA 30 mg cápsula
gastro-resistente

TEVA Sweden AB
PO Box 1070
S-25110 Helsingborg

Teva Pharmaceuticals CR, s.r.o.
Drážní 7
CZ-627 00 Brno

TEVA UK Limited
Brampton Road
Hampden Park
Eastbourne
East Sussex BN22 9AG
United Kingdom

TEVA UK Limited
Brampton Road
Hampden Park
Eastbourne
East Sussex BN22 9AG
United Kingdom

Lansoprazol TEVA 15 mg entero-
kapslar, hårda

Lansoprazol TEVA 30 mg entero-
kapslar, hårda

Lansoprazol TEVA 15 mg

Lansoprazol TEVA 30 mg

Lansoprazole 15 mg Gastro-resistant
Capsules

Lansoprazole 30 mg Gastro-resistant
Capsules

15 mg

30 mg

15 mg

30 mg

15 mg

30 mg

15 mg

30 mg

Gastro-resistant capsule,
hard

Gastro-resistant capsule,
hard

Gastro-resistant capsule,
hard

Gastro-resistant capsule,
hard

Gastro-resistant capsule,
hard

Gastro-resistant capsule,
hard

Gastro-resistant capsule,
hard

Gastro-resistant capsule,
hard

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C

2
5
1
/
1
0
2

E
N

O

f
f
i
c
i
a
l

J
o
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r
n
a
l

o
f

t
h
e

E
u
r
o
p
e
a
n
U
n
o
n

i

.

2
6
1
0
2
0
0
7

.