Summary of Community decisions on marketing authorizations in respect of medicinal products from 15.4.2004 to 30.4.2004(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2004-04-30
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

30.4.2004

EN

Official Journal of the European Union

C 119/1

I

(Informations)

COMMISSION

Summary of Community decisions on marketing authorizations in respect of medicinal products from
15.4.2004 to 30.4.2004

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

— Issuing, maintenance or modification of a national marketing authorisation

(2004/C 119/01)

Date of the decision

Name(s) of the
medicinal product

Holder(s)

of the marketing
authorization

Member State
concerned

Date of notification

26.4.2004

Nimesulide

See Annex I

See Annex I

27.4.2004

26.4.2004

Amlovita

See Annex II

See Annex II

27.4.2004

27.4.2004

27.4.2004

27.4.2004

Amlodipin
Worwäg

Talam

Pidolma

See Annex III

See Annex III

28.4.2004

See Annex IV

See Annex IV

28.4.2004

See Annex V

See Annex V

28.4.2004

28.4.2004

Rofecoxib

See Annex VI

See Annex VI

30.4.2004

28.4.2004

Etoricoxib

See Annex VII

See Annex VII

30.4.2004

28.4.2004

Loratadine /
pseudoephedrine

See Annex VIII

See Annex VIII

30.4.2004

28.4.2004

Loratadine

See Annex IX

See Annex IX

30.4.2004

28.4.2004

Zocord

See Annex X

See Annex X

30.4.2004

29.4.2004

Celecoxib

See Annex XI

See Annex XI

30.4.2004

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

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS,
ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS,
PACKAGING AND PACKAGE SIZES IN THE MEMBER STATES

REVISED ANNEX I

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Austria

CSC Pharmaceuticals Handels-
GmbH,
Heiligenstädter Strasse 395B -
A-1190 Wien
Tel +43-2243-30010-12/ Fax +43-
22 62 60 66 00

Belgium

Therabel Pharma SA
Rue Egide Van Ophem 108 -
B-1180 Brussels
Tel.: 00 32 2 370 46 00 - Fax.:
00 32 2 370 46 90

Aulin

Aulin

Aulin

Aulin

Aulin

Mesulid

Mesulid

Mesulid

Mesulid

AULIN

3%

Gel

Cutaneous use

100 mg

Granules

Oral use

100 mg

Suppository

Rectal use

200 mg

Suppository

Rectal use

100 mg

100 mg

100 mg

Tablet

Oral use

Granules

Oral use

Suppository

Rectal use

200 mg

Suppository

Rectal use

100 mg

100 mg

Tablet

Tablet

Oral use

Oral use

AULIN

100 mg

Granules for oral
suspension

Oral use

MESULID

100 mg

Tablet

Oral use

MESULID

100 mg

Granules for oral
suspension

Oral use

MESULID

30 mg/g (3%)

Gel

Cutaneous use

Finland

Aventis Pharma Oy
Huopalahdentie 24 - 00350 Finland
tel. +358 201 200 300/ tel.
+358 201 200 354 Liisa Hurme
Fax +358 201 200 495
email: liisa.hurme@aventis.com

Nimed

Nimed

Nimed

100 mg

3%

100 mg

Tablet

Gel

Oral use

Cutaneous use

Granules
single-dose

Oral use

Tube

Sachet

Strip

Strip

Blister

Sachet

Strip

Strip

Blister

Blister

Sachet

Blister

Sachet

Tube

Blister

Tube

Sachet

30g,50g,100g, 15g

15, 30

5, 10

5, 10

6, 15, 30, 60

15, 30

5, 10

5, 10

15, 30, 60

14 – 30 – 60
U.D. 30 – 60

14 – 30 – 60

14 – 30 – 60
U.D. 30 – 60

14 – 30 – 60

30 g - 50 g -100 g

10, 30, 50, 100, 2

30 g, 50 g, 100g, 15 g

20, 60

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Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

.

.

3
0
4
2
0
0
4

Laboratoires Therabel Lucien Pharma
123, rue Jules Guesde –
F-92309 Levallois-Perret Cedex
Tel.+33 1 47 56 69 00 -
Fax :+33 1 47 56 69 99

Nexen

Nexen

100 mg

Tablet

Oral use

100 mg

Granules

Oral use

Oxetian

100 mg

Tablet

Oral use

Oxetian

100 mg

Granules

Oral use

Sachet

France

Greece

Laboratoires Helsinn Healthcare S.A.
Via Pian Scairolo –CH- 6912 –
Pazzallo
Tel. +41 91 985 21 21 -
Fax :+41 91 993 21 22
GFU@helsinn.com -
RB@helsinn.com

Boehringer Ingelheim Hellas Ae
2 Elinixou Street - G-16777 Athens
Tel. +30 10 89 06 300 - Fax.
+30 10 89 83 207

Farmedia Ae
G. Lira 25 – GR-14564 Kifisia -
Athens
Tel. +30 10 62 01 075- Fax.
+30 10 62 00 706

Pharmaten Epe
Basil. Katsos-Derbenakion 6 - Pallini-
Griekenland – GR 15351
Tel.+30 10 666 66 10 -Fax.
+30 10 666 67 49

Specifar SA
T. Basilopoulos -El.Benizelou 11
AG. Barbara – Griekenland – GR
12351
Tel. +30 10 53 92 700/569 2700-
Fax. +30 10 56 21 520

Biospray Abee
45 V. ougo Street - GR-
10437 Athens
Tel. +30 10 52 23 439 - Fax.
+30 10 56 21 520

Mesulid

100 mg

Tablet

Oral use

Mesulid

Mesulid

Mesulid

200 mg

Suppository

Rectal use

100 mg

Granules

Oral use

Multiformil

100 mg

3%

Gel

Tablet

Cutaneous use

Oral use

Bioxidol

100 mg

Granules

Oral use

Bioxidol

100 mg

Tablet

Oral use

Specilid

100 mg

Tablet

Oral use

Blister

Flogostop

100 mg

Tablet

Oral use

Blister

Blister

Sachet

Blister

Blister

Strip

Sachet

Tube

Blister

Sachet

Blister

3 X 10

30

3 X 10

30

2x10
3x10

1x6

1x20

15g, 30g, 50g, 100g

2x10
3x10
5x10

1x30

1x20
3x10

3x10
2x10
5x10

2x10
3x10
5x10

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Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Greece
(cont’d)

Nimesulide/
Biomedica Chemica

100 mg

Tablet

Oral use

Blister

Ristolzit

100 mg

Tablet

Oral use

Blister

Myxina

100 mg

Tablet

Oral use

Blister

Nimelide

100mg

Tablet

Oral use

Blister

Discorid

100 mg

Tablet

Oral use

Blister

Ventor

Ventor

100 mg

Granules

Oral use

100 mg

Tablet

Oral use

Sachet

Blister

Alencast

100 mg

Tablet

Oral use

Blister

G-Revm

100 mg

Tablet

Oral use

Blister

Biomedica-Chemica S.A.
25, G. Lira Str. (parodos AG.
Fanouriou)
GR145-64 K. Kifissia, Athens
Tel. +30 10 62 01 075-6/
6200704-5/ Fax. +30 10 62 00 706

Leovan M. Aedn & Cia EE
22, Argonayton Str.
Argyroupoli T.K. GR- 164 52 Athens
Tel. +30 210 96 04 909 - Fax.
+30 210 960 30 95

Norma Hellas AE
Papazoglou-Menandrou 54 -GR-
10431 Athens
Tel. +30 10 522 6457- Fax.
+30 10 52 41 368

Genepharm S.A.18th oxil. Athens
Marathonos
GR-15351 Palini
Tel. +30 210 60 39 336 - Fax.
+30 210 60 39 402
Dr. Sgoura - d.sgoura@genepharm.gr

Bros E.P.E.
Il.Efthimopoulos- Avgis & Galinis 15
GR-15464 N. Kifissia
Tel. +30 10 80 72 450-71579/ Fax.
+30 10 62 02 211

Rafarm AEBE
Nik. Rassias - Kapodistriou and
Korintou 12
R-15451 N. Psichixo Athens
Tel. +30 10 67 76 550-1/ Fax.
+30 10 67 76 552-

Chrispa Alfa Pharma A.E.
Andr.Leon-Menandrou 58 - GR-
Athina
Tel. +30 10 52 42221-5223321-
6669711
Fax. +30 10 524 89 63

G.A. Pharmaceuticals SA
46 Agisilaou st. - GR-173-41 Agios
Dimitrios, Athens
Tel. +30 210 93 10 980-4/ Fax.
+30 210 93 38 759
Sassanis Nikolaos- Hatzi Ageliki
gap@ath.forthnet.gr

2x10
3x10
5x10

1x20
1x30

2x10
3x10

2x10
3x10
5x10

2x10
5x10

1x30

2x10
3x10

2x10
3x10
5x10

2x10
3x10

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Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Greece
(cont’d)

Viofar E.P.E.
Ethn. Antistaseos and triphilias 76A
Acharnai GR-13671
Tel. +30 210 24 68 725/ Fax.
+30 210 24 61 937
viofar@otenet.gr

Kleva E.P.E.
189 L. Parnithos Avenue/ GR-
13671 Acharnai Attiki
Tel. +30 210 24 0 2404-7/-
246373 Fax. +30 210 2460206
Eleni Polydefkidoy- Manolas Ioannis
kleva@hol.gr

Kleva E.P.E.
189 L. Parnithos Avenue
GR-13671 Acharnai Attiki
Tel. +30 210 24 0 2404-7
Fax. +30 210 2460206

Minerva Farmakeytikh A.E.
132Kifissou Avenue - Peristeri - GR-
121 31 Athens
Tel. +30 10 –5702199- Fax.
+30 10 57 28 215
www.minervapharm.gr

Anfarm Hellas A.E.
Ap.Nikolaou- K.Palaiologou &
Perikleous
Xalandri- 442 Acharnon – Athens -
GR-11143
Tel. +30 210 68 31 632 -21 81 901

Elpen Pharmaceuticals Co., Inc.
95, Marathonos Ave. GR-
19009 Pikermi Attikis
Tel. +30 210 60 39 326-9/ Fax.
+30 210 60 39 300
Kostas Pentafragas- Efie
Athanassopoulou
elpenmain@hol.gr

Antor Ltd.
4 Omirou Street - GR-
15126 Marousi
Tel. +30 10 61 96 856 - Fax.
+30 10 61 96 450

Volonten

100 mg

Tablet

Oral use

Blister

Elinap

100 mg

Tablet

Oral use

Blister

2x10
5x10

3x10
5x10
1x20

Elinap

100 mg

Powder

Oral use

Sachet

(1x20)x100mg

Min-A-Pon

100 mg

Tablet

Oral use

Blister

Lemesil

100 mg

Tablet

Oral use

Blister

Rolaket

100 mg

Tablet

Oral use

Blister

Rolaket

200 mg

Suppository

Rectal use

Strip

Melimont

100 mg

Tablet

Oral use

Blister

2x10
3x10

1x20
3x10

2x10
3x10

1x6

2x10

.

.

3
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4
2
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Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Greece
(cont’d)

Help E.P.E.
Evag.Zekkas-Balaoritou 4 - GR-
14452 Metamorfosi Attikis
Tel. +30 10 28 15 353-2843-479 -
Fax: +30 10 28 11 850

Foiniefarm E.P.E.
5 Anavritis street - GR-11143 Athens
Tel. +30 10 20 25 813- Fax.
+30 10 21 11 528

Proel Epam. G. Coronis SA
9, Dilou Street - GR-12134 Peristeri
Tel. +30 210 57 55711-12 / Fax.
+30 210 57 48 398
D. Dalls/ G. Coronis
registration@proel.gr

Remek A.E.
3 Koleti Str.- GR-
14452 Metamorphosi Attiki
Tel. +30 210 2843581-3/ Fax.
+30 210 2843580
apivita@apivita.gr

Iasis Chemipharma AE
Agiou Konstantinou - GR-
15124 Maroussi
Tel. +30 10 619 68 95/ Fax:
+30 10 61 96 896

Remedina A.E.
Gounari 23 and Areos - GR-
13451 Kamatero Attiki
Tel. +30 210 23 85 979/552 - Fax.
+30 210 23 11 355
Costantinos Theophanopoulos -
Irenen Stamopoulou
remedina@otenet.gr

Cosmopharm E.P.E
Kazarma Korinthou - P.O. Doos 42 –
GR-201 00 Korinthos
Tel. +30 2 741 02 53 70/ Fax.
+30 2 741 071 685
cosmofarm@hol.gr

Mosuolit

100 mg

Tablet

Oral use

Blister

Kartal

100 mg

Tablet

Oral use

Blister

Fladalgin

100 mg

Tablet

Oral use

Bottle

Mesupon

100 mg

Tablet

Oral use

Bottle

Mesupon

200 mg

Suppository

Rectal use

Chemisulide

100 mg

Tablet

Oral use

Strip

Blister

Amocetin

100 mg

Tablet

Oral use

Blister

Lizepat

100 mg

Tablet

Oral use

Blister

2x10
3x10

1x20
1x30

1x20
1x30

1x20
1x30

1x6

2x10
3x10

2x10
3x10

2x10
3x10

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Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Greece
(cont’d)

Demo Abee
St. Demos - 21 oxil Athinon-Lamias-
Krioneri
GR-14568 Athene
Tel. +30 210 81 61 824-802-880/
Fax. +30 210 81 61 587
Yannis Filippakis -
yphilippakis@demo.gr

Medhel Hellas AE
30st klm Athens Laurio-
MarkoPoyao - Attikis - Griekenland
19003
Tel. +30 2299022343- Fax.
+30 2299022347
medhel@oneway.gr - Mr. Vassilis
Kylicas

Novexal Ellas Ltd
Agiou Dimitriou 25
GR-174-55 Kalamaki
Tel. +30 210 982 88 76 Fax.
+30 210 982 72 11
novexal@otenet.gr

Beaka Hellas Aebe
12 Kapodistriou and Kirintou Street
N. Psichiko GR-15451
Tel.+30 10 67 76 550-1
Fax. +30 10 67 76 552

Doctum Pharmaceutical SA
K.T. Giokaris & Co./ Marko Pulu
1oxil km
GR-19002 Peania Attiki
Tel. +30 10 664 36 11/ Fax.
+30 10 66 43 614

Vocate Pharma AE
150 Gounari Street /
G-16674 Anoglyphada
Tel. +30 10 96 24 436/ Fax:
+30 10 96 46 582

Medichrom AE
6o xil Paiana-MarkoPoulos/ Attiki
G-19003 – Griekenland
tel. +30 210 66 24 560
Fax. +30 210 602 0118
medintl@otenet.gr

Ritamine

100 mg

Tablet

Oral use

Blister

Niberan

100 mg

Tablet

Oral use

Blister

Nimesulide Hexal

100 mg

Tablet

Oral use

Blister

Nimesulide Hexal

100 mg

Powder

Oral use

Naofid

100 mg

Tablet

Oral use

Sachet

Blister

Erlecit

100 mg

Tablet

Oral use

Blister

Tranzicalm

100 mg

Tablet

Oral use

Blister

2x10
3x10

2x10
3x10

2x10
3x10

1x20

2x10
3x10

2x10
3x10

2x10
3x10

Nimesul

100 mg

Tablet

Oral use

Blister

3x10

.

.

3
0
4
2
0
0
4

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Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Greece
(cont’d)

Faran Laboratories SA
Achaias & Trizinias/ GR-145 64 Nea
Kifissia - Athens
Tel. +30 10 80 70 002/
Fax.+30 10 80 71 688

P.N. Gerolymatos Health SA
13, Asklipiou str./GR-
145 68 Kryoneri
Tel. +30 21 816 11 07/ Fax.
+30 21 816 17 31
pharmaceuticals@gerolymatos.gr

S.G.IPHARMA C/O Chrispa
Andr. LEON Menandrou 58 –
Athens – GR-10432
Tel. +30 10 666 9711- Fax.
+30 10 6031746

Lavipharm Hellas AE
Agias Marinas Str. - GR-
19002 Peania Attikis
Tel.+30 210 66 91 396/ 395Fax.
+30 210 /6691309
Alavera Irene/ Tsiveriotou Maria/
ealavera@lavipharm.gr

Coup.
Xr.Kouparousos/ Ag.Barbaras 53 -
GR-17253 Dafni
Tel. +30 10 97 11 061-9714080/
Fax. +30 10 97 60 837

Faran Laboratories SA
Achaias & Trizinias- GR-145 64 Nea
Kifissia - Athens
Tel. +30 10 80 70 002 -
Fax.+30 10 80 71 688

Uni-Pharma Abee
Ioul.Tseti - 14 o xil.Ethnikis Odou 1/
GR-14564 Kifisia
Tel. +30 210 80 72 512- Fax.
+30 210 80 78 907
Elisabeth Prodromou/
registration@uni-pharma.gr

Aflogen

100 mg

Tablet

Oral use

Blister

2x10

Edrigyl

100 mg

Tablet

Oral use

Blister

Edrigyl

Edrigyl

Cliovyl

200 mg

Suppository

Rectal use

100 mg

100 mg

Granules

Oral use

Tablet

Oral use

Scaflam

100 mg

Tablet

Oral use

Scaflam

200 mg

Suppository

Rectal use

Scaflam

100 mg

Granules

Oral use

Melicat

100 mg

Tablet

Oral use

Strip

Sachet

Blister

Blister

Strip

Sachet

Blister

Lalide

100 mg

Tablet

Oral use

Blister

Dolostop

100 mg

Tablet

Oral use

Dolostop

100 mg

Granules

Oral use

Dolostop

200 mg

Suppository

Rectal use

Bottle

Sachet

Strip

1x20
2x10
2x20
4x10

1x6

1x20

2x10
3x10

2x10

1 x 6

1x20

2x10
3x10
6x10

2x10
3x10

1x20
1x30

1x20 (2 g)

1x6

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Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Greece
(cont’d)

Ireland

Italy

Iapharm O.E. - C/O: VILCO
Andr Kotsopoulos- PEFKON 121 -
Hraklio Attiki GR - 14122
Tel. +30 10 284 66 35/ Fax
+30 10 28 13 231

Aurora Pharmaceuticals Ltd.
105 Marathonos avenue Gerakas-
GR-15344
Tel. +30 10 60 49 970/ Fax
+30 10 60 49 971

Pharmanel Pharmaceuticals S A
106 Marathonos AV, - Gerakas GR-
153 44
Tel. +30-10-6048560/ Fax +30-10-
6613013

Med-One S.A.
211 Parnithos Avenue - GR-
13671 Acharnai - Attiki
Tel. +30 210240 24 05/ Fax.
+30 2102 46 02 06
Polydefkidoy Eleni

Helsinn Birex Pharmaceuticals
Damastown, Mulhuddart - Dublin
15/ Ierland
Tel. +353 1 822 54 04 - Fax
+353 1 822 54 10

Roche SpA
Via G.B. Stucchi 11020052 Monza
(Mi) Italië
tel. +39 039 2474620 - fax:
+39 039 2474740
Dr. Maurizio Giaracca- Sig.
Alessandro Chiariotti
Maurizio.giaracca@roche.com

Algover

100 mg

Tablet

Oral use

Blister

Auromelid

100 mg

Tablet

Oral use

Blister

2x10
3x10

3x10

Sudinet

100 mg

Tablet

Oral use

Blister

3x10

Algosulid

100 mg

Tablet

Oral use

Blister

Algosulid

100 mg

Powder

Oral use

Aulin

Aulin

Aulin

Mesulid

Mesulid

Mesulid

AULIN

AULIN

AULIN

AULIN

AULIN

AULIN

100 mg

100 mg

3%

100 mg

100 mg

3%

100 mg

3%

50 mg

100 mg

200 mg

3%

AULIN BETA

400 mg

Tablet

Granules

Gel

Granules

Tablet

Gel

Tablet

Gel

Oral use

Oral use

Cutaneous use

Oral use

Oral use

Cutaneous use

Oral use

Cutaneous use

Granules

Oral use

Granules

Oral use

Suppository

Rectal use

Gel

Tablet

Cutaneous use

Oral use

Sachet

Blister

Sachet

Tube

Sachet

Blister

Tube

Blister

Tube

Sachet

Sachet

Strip

Tube

Blister

1x20
1x30

1x20

15,30,60

30

15g, 30 g, 50g, 100 g

1x30

15,30,60

30 g, 50 g, 100 g

30

30,100 g.

30

30

10

50 g

30

.

.

3
0
4
2
0
0
4

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
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Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Italy
(cont’d)

AULIN BETA

400 mg

Granules

Oral use

Novartis Farma SpA
S.S. 233 (Varesina) Km 20,5 -
21040 Origgio (VA) – Italië
tel: +39 02 96542214 /
fax:+39 02 9659066

MESULID

100 mg

Tablet

MESULID MITE

50 mg

MESULID

MESULID

MESULID

100 mg

200 mg

3%

Granules

Granules

Oral use

Oral use

Oral use

Suppository

Rectal use

Gel

Cutaneous use

MESULID FAST

400 mg

Granules

MESULID FAST

400 mg

Tablet

NIMEDEX

400 mg

Granules

Oral use

Oral use

Oral use

NIMEDEX

400 mg

Tablet

Oral use

Italfarmaco SpA
Via Dei Lavoratori, 54 -
20092 Cinisello Balsamo (MI) – Italië
tel. + 39 02 64432500 / fax. +
39 02 64432503

ALGOLIDER

100 mg

Tablet

Oral use

Sachet

Blister

Sachet

Sachet

Strip

Tube

Sachet

Blister

Sachet

Blister

Blister

SIAR PHARMA
Via Verdi 33- 20060 Bussero (Milan)
Italië
Dr.ssa Sonia Macchelli/ S.ra Marina
Pasqualini
+39 02 95 33 4270/
+39 02 95 40 91 81 siarpharma@libero.it

ALGOLIDER

100 mg

Granules

Oral use

Sachet

Istituto Chimico Internazionale Dr.
Giuseppe Rende S.r.l.
Via Salaria, 1240-I-00138 Roma
tel: +39 06 8889655 -
fax:39 06 8889849

Laboratori Prodotti Farmaceutici
Boniscontro e Gazzone SRL
Via Tiburtina, 1004- I-00156 Roma
tel. +39 06 4111087 - fax:
+39 06 4111603

Farmaceutici Caber SpA.
Viale Città d’Europa, 681-
I-00144 Roma tel.
+39 06 52207244 - fax.
+39 06 52205488
Dr. Roberto Rosso - info@caber.it

RESULIN

RESULIN

RESULIN

LEDOREN

LEDOREN

100 mg

100 mg

200 mg

100 mg

100 mg

Tablet

Granules

Oral use

Oral use

Suppository

Rectal use

Tablet

Granules

Oral use

Oral use

NIMS

100 mg

Tablet

Oral use

SULIDAMOR

100 mg

Granules

Oral use

Blister

Sachet

Strip

Blister

Sachet

Blister

Sachet

30

30

30

30

10

30 g, 50 g
100 g

30; 8;

30

30

30

30

30

30

30

10

30

30

30

30

C
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E
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O

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f
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a
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J
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n
a
l

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

i

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

.

.

3
0
4
2
0
0
4

SULIDAMOR

200 mg

Suppository

Rectal use

Strip

Italy
(cont’d)

Farmaceutici Damor SpA
Via E. Scaglione, 27 - I-80145 Napoli
tel. +39 081 2389001 - fax.
+39 081 7405172

NCSN Farmaceutici srl
Via Svetonio 15 –I- 00136 Roma
Tel+Fax. +39 06 35497 652

I.BIR.N. – Istituto Bioterapico
Nazionale Srl
Via V. Grassi, 9/11/13/15 –
I-00155 Roma
tel. +39 06 2291945 - fax.
+39 06 2290849
F. Giannantoni - Ibirn1@infinito.it

Laboratorio Farmaceutico C.T. S.r.l.
Via Dante Alighieri, 71 –
I-18038 Sanremo (IM)
tel. +39 0184 59241 - fax.
+39 0184 5924216
Dr. Lorenza Guano/ Dr. Roberto
Cacciaglia
Direz.scientifica@labct.it

Vecchi & C. Piam SPA
Via Padre G. Semeria, 5 –
I-16131 Genova
tel. +39 010 357234/237/241 - fax.
+39 010 355734

UCB PHARMA SpA
Via Praglia, 15 – I-10044 Pianezza
(Torino)
tel. +39 011 966 01 - fax.
+39 011 9660237
Dr. Walter Bianchi- Dr. Laura
Chiodini
Walter.bianchi@UCB-Group.com

FANSIDOL

FANSIDOL

NIDE

NIDE

100 mg

100 mg

100 mg

100 mg

Capsule

Oral use

Granules

Oral use

Hard capsule

Oral use

Granules for oral
solution

Oral use

FLOLID

100 mg

Tablet

Oral use

FLOLID

200 mg

Suppository

Rectal use

FLOLID

100 mg

Granules for oral
solution

Oral use

REMOV

100 mg

Tablet

Oral use

REMOV

100 mg

Granules

Oral use

NIMESULIDE UCB

100 mg

Tablet

Oral use

NIMESULIDE UCB

100 mg

Granules for oral
suspension

Oral use

Essetti Farmaceutici SpA
Via Cavalli di Bronzo, 41 - S. Giorgio
a Cremano (Napoli)
I-80046
tel. +39 081 5658111 - fax.
+39 081 482834

LAIDOR

50 mg

LAIDOR

100 mg

Granules for oral
suspension

Oral use

Granules for oral
suspension

Oral use

LAIDOR

100 mg

Tablet

Oral use

Blister

Sachet

Blister

Sachet

Blister

Strip

Sachet

Blister

Sachet

Blister

Sachet

Sachet

Sachet

Blister

10

30

30

30

30

30

10

30

30

30

30

30

30

30

30

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
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a
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U
n
o
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i

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Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Italy
(cont’d)

Laboratori Guidotti SpA
Via Trieste, 40 - 56126 Pisa – Italië
tel. + 39 050 505211 - fax.
+39 050 49340

Francia Farmaceutici Industria
Farmaco Biologica Srl
Via dei Pestagalli, 7/ I-20138 Milano
tel. +39 02 502290 / fax.
+39 02 58012252
Nastro.FranciaFarm@iol.it -
Cassis.FranciaFarm@iol.it

Infosint SpA
Centro Direzionale Colleoni
Palazz o Pegaso, 2 - Agrate Brianza
(MI) - I-20041
tel. +39 039 689 22 07 - fax.
+39 039 689 22 46
Dr. Vincenzo Olgiati

ERREKAPPA Euroterapici SpA
Via Ciro Menotti 1/A –
I-20129 Milano
tel. +39 02 7491345 -fax.
+39 02 715734

Mipharm SpA
Via Bernardo Quaranta, 12 –
I-20141 Milano
tel. +39 02 535481 - fax.
+39 02 53548010
www.mipharm.it - Dr. Giorgio
Corsico

Istituto Luso Farmaco d’Italia SpA
Via Carnia, 26- I-20132 Milano
tel. +39 02 2803232 /
+39022828485
fax. +39 02 2803286

Istituto Biochimico Nazionale Savio
Srl
Viale Città d’Europa, 681 –
I-00144 Roma tel.
+39 06 –52207244 - fax.
+39 06 52205488
Dr. Roberto Rosso - info@caber.it

NIMESULENE

100 mg

Tablet

Oral use

NIMESULENE

100 mg

Powder for oral
solution

Oral use

NIMESULENE

200 mg

Suppository

Rectal use

ALGIMESIL

100 mg

Granules for oral
solution

Oral use

ALGIMESIL

100 mg

Tablet

Oral use

SULIDE

SULIDE

SULIDE

SULMEDIL

SULMEDIL

SULMEDIL

TEONIM

100 mg

Tablet

Oral use

100 mg

Granules

Oral use

200 mg

Suppository

Rectal use

100 mg

100 mg

200 mg

100 mg

Tablet

Granules

Oral use

Oral use

Suppository

Rectal use

Granules

Oral use

Blister

Sachet

Strip

Sachet

Blister

Blister

Sachet

Strip

Blister

Sachet

Strip

Sachet

TEONIM

100 mg

Tablet

Oral use

Blister

NIMESIL

100 mg

Granules

Oral use

Sachet

EUDOLENE

100 mg

Granules

Oral use

Sachet

30

30

10

30

30

30

30

10

30

30

10

30

30

30

30

C
1
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E
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O

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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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

.

.

3
0
4
2
0
0
4

Italy
(cont’d)

Levofarma Srl
Via Conforti, 42 - 84083 Castel San
Giorgio (SA) – Italië
Tel. +39 081 5162315 - fax.
+39 081 5161590
Angelo Mele - mail@farma.uno.it

So.Se. Pharm Srl
Via dei Castelli Romani, 22-
I-00040 Pomezia (Roma)
tel. +39 06 91140153 - fax.
+39 06 91603462

Selvi Laboratorio Bioterapico SpA
Via Proio 28 Fiano Romano
I-00065 Roma
Tel: 39 076 545 5718- Fax:
39 0765 455 633

GNR SpA
S.S. 233 Varesina - Km 20,5 –I-
21040 Origgio (Va)
tel +39 02 9654 3483 - Fax.
+39 02 9654 3495

Dompè Farmaceutici SpA
Via San Martino 12 – 12/A –
I-20122 Milano
tel. +39 02 58383256 - fax.
+39 02 58383324
enrico.bosone@dompe.it - Roberta
Villa

Pulitzer Italiana Srl
Via Tiburtina 1004
I-00156 Roma
tel +39 06 4111087 - fax
+39 06 4111603

Magis Farmaceutici SpA
Via Cacciamali 34-36-38/A –
I-25125 Brescia
tel. +39 030 349761 - fax. +39 030-
349352

Lampugnani Farmaceutici SpA
Via Gramsci, 4 – I-20014 Nerviano
(MI)
tel. +39 0331 587354 - fax.
+39 0331 585588

NOALGOS

100 mg

Granules

Oral use

Sachet

NOALGOS

100 mg

Tablet

Oral use

DOMES

DOMES

DOMES

ANTALGO

100 mg

100 mg

100 mg

100 mg

Granules

Oral use

Tablet soluble

Oral use

Tablet

Tablet

Oral use

Oral use

Oral use

ANTALGO

100 mg

Granules for oral
solution

NIMESULIDE

100 mg

Granules for oral
solution

Oral use

NIMESULIDE

100 mg

Hard capsule

Oral use

NISAL

100 mg

Granules

Oral use

Blister

Sachet

Blister

Blister

Blister

Sachet

Sachet

Blister

Sachet

NISAL

100 mg

Capsule

Oral use

Blister

LEDOLID

100 mg

Tablet

Oral use

LEDOLID

100 mg

Granules

Oral use

ISODOL

100 mg

Granule for oral
suspension

Oral use

ISODOL

100 mg

Tablet

Oral use

NOXALIDE

5%

Oral suspension

Oral use

NOXALIDE

100 mg

Granules

Oral use

Blister

Sachet

Sachet

Blister

Bottle

Sachet

30

30

30

30

30

30

30

30

30

30

30

30

30

30

30

60 ml

30

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
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o
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a
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U
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o
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i

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Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Italy
(cont’d)

Kruger Pharma Srl
Via Volturno, 10-12
I-50019 Sesto Fiorentino (FI)
tel. +39 055 3024503 - fax.
+39 055 3025015

A.C.R.A.F. SpA
Aziende Chimiche Riunite Angelini
Frankrijksco-
Piazzale della Stazione, snc
I-00040 S. Palomba Pomezia (Roma)
tel +39 06 91045244 - fax.
+39 06 91045299

MDM SpA
Via Volturno 29/B – I-20052 Monza
(MI)
tel. +39 039 322270 - fax.
+39 039 322168
mdm@mdmspa.com - M. Trognoni

Aesculapius Farmaceutici Srl
Via Cozzaglio, 24 – I-25125 Brescia
tel. +39 030 3532013 - fax.
+39 030 349352

LA.FA.RE. Laboratorio Farmaceutico
Reggiano S.r.l.
Via Benedetto. Cozzolino, 77-
I-Ercolano Resina (NA)
I-80056
Tel. +39 081 7390596 - fax.
+39 081 7321462

Dorom Srl
Via Volturno, 48
I-20089 Quinto de Stampi Rozzano
(MI)
tel. +39 06-59290330 - fax.
+39 06 5913128

Teva Pharma Italia Srl
V.le Richard, 7 – I-20143 Milano
tel. +39 02 8917981 - fax. +
39 02 89179825

NIMENOL

100 mg

Granules for oral
suspension

Oral use

Sachet

NIMEXAN

100 mg

Granules

Oral use

Sachet

NIMEXAN

200 mg

Suppository

Rectal use

Strip

SOLVING

100 mg

Tablet

Oral use

SOLVING

100 mg

Granules for oral
suspension

Oral use

EFRIDOL

100 mg

Granules for oral
suspension

Oral use

EFRIDOL

DIMESUL

100 mg

100 mg

Tablet

Tablet

Oral use

Oral use

DIMESUL

100 mg

Granules for oral
suspension

Oral use

Blister

Sachet

Sachet

Blister

Blister

Sachet

NIMESULIDE

100 mg

Powder for oral
solution

Oral use

Sachet

NIMESULIDE

200 mg

Suppository

Rectal use

NIMESULIDE

100 mg

Tablet

NIMESULIDE

100 mg

Granules for oral
suspension

Oral use

Oral use

Strip

Blister

Sachet

NIMESULIDE

200 mg

Suppository

Rectal use

Strip

15
30

30

10

30

30

30

30

30

30

30

10

30

30

10

C
1
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1
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Italy
(cont’d)

Merck-Generics Italia SpA
Via Aquileia, 35 - Cisinello Balsamo-
(Mi)
I-20092 tel + 39 02 6124691 - fax.
+39 02 61294448
Dr. Maurizio Schiassi - Dr. Stefania
Pulimeno
spulimeno@merckgenericsitalia.com

NIMESULIDE

100 mg

Tablet

Oral use

NIMESULIDE

100 mg

Granules for oral
suspension

Oral use

NIMESULIDE

200 mg

Suppository

Rectal use

Nimesulide

100 mg

Suppository

Rectal use

NERELID

100 mg

Capsule

Oral use

NERELID

100 mg

NIMESULIDE

100 mg

Granules for oral
solution

Oral use

Granules for oral
suspension

Oral use

Blister

Sachet

Strip

Strip

Blister

Sachet

Sachet

30

30

10

10

30

30

New Research Srl P/zza Don Luigi
Sturzo 34- I-04011 Aprilia (LT)
tel. +39 06 92727688 - fax.
+39 06 92727688

I.B.N. – Istituto Biologico Nazionale
Srl
Viale Città d’Europa, 681-
I-00144 Roma
tel. +39-6-52205466 - fax. +39-6-
52205488
development@ibnsavio.it

Sintactica Srl
Viale Ercole Marelli, 352 –
I-20099 Sesto San Giovanni (MI)
tel. +39 02 95344147 - fax.
+39 02 95343990
Dr. Massimiliano Borsa -
info@sintactica.it

Robin Srl
Piazzale Durante Frankrijksco, 11 –
I-20131 Milano
tel. +39 039 2474435 - fax.
+39 039 2474630

Farmaceutici Ecobi SAS.
Via E. Bazzano, 26 - Ronco Scrivia
(GE)- I-16019
tel. +39 010 9651010 - fax.
+39 010 9350679

DOLXTREN

5%

Oral suspension

Oral use

Bottle

60 ml

NIMESULIDE

100 mg

Granules for oral
suspension

Oral use

NIMESULIDE

100 mg

Tablet

Oral use

AREUMA

100 mg

Tablet

Oral use

AREUMA

100 mg

Granules for oral
suspension

Oral use

Sachet

Blister

Blister

Sachet

AREUMA

200 mg

Suppository

Rectal use

Strip

30

30

30

30

10

.

.

3
0
4
2
0
0
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

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5

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Italy
(cont’d)

DOC Generici Srl
Via Manuzio, 7 – I-20124 Milano
tel. +39 02 655341 - fax.
+39 02 6590611
Franco Cotti - Tiziana Alessi
Tiziana.alessi@genericidoc.it

EG SpA
Via Rondoni, 1 – I-20146 Milano
Tel. +39 02 8310371 - Fax :
+39 02 831 03776

Ratiopharm GmbH
Via Accademia, 26 - I-20131 Milano
tel. +39 02 288771 - fax.
+39 02 28 877 22

F.D. Farmaceutici Srl
Via Donatori del sangue 22 –I-
26020 Corte de’ Cortesi con
Cignone (CR)
Tel. +39 0372 925050 - Fax
+39 0372 925080
Fd.mara@tin.it

S.I.F.I. – Società Farmaceutica Italiana
SpA
Via Ercole Patti, 36
I-65020 Lavinaio – Aci S.Antonio
(CT)
tel. +39 095 7922111 - fax. +39-
095-7922250

Pliva Pharma SpA
Via dei Giardini, 7 – I-20100 Milano
tel. +39 02 66043234 - fax
+39 02 61293592

NIMESULIDE

100 mg

Tablet

Oral use

NIMESULIDE

100 mg

Granules for oral
suspension

Oral use

NIMESULIDE′

200 mg

Suppository

Rectal use

NIMESULIDE

100 mg

Tablet

NIMESULIDE

100 mg

NIMESULIDE

100 mg

Granules for oral
suspension

Effervescent
tablet

NIMESULIDE

100 mg

Tablet

NIMESULIDE

100 mg

NIMESULIDE

100 mg

Granules for oral
suspension

Effervescent
tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

DOLESIDE

100 mg

Tablet

Oral use

DOLESIDE

100 mg

Granules for oral
suspension

Oral use

EDEMAX

100 mg

Tablet

Oral use

EDEMAX

100 mg

Granules for oral
suspension

Oral use

NIMESULIDE

100 mg

Tablet

Oral use

NIMESULIDE

100 mg

Granules

Oral use

MIGRALESS

100 mg

Tablet for oral
suspension

Oral use

Blister

Sachet

Strip

Blister

Sachet

Blister

Blister

Sachet

Blister

Blister

Sachet

Blister

Sachet

Blister

Sachet

Blister

30

30

10

30

30

30

30

30

30

30

30

30

30

30

30

30

C
1
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E
N

O

f
f
i
c
i
a
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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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

.

.

3
0
4
2
0
0
4

Italy
(cont’d)

Sofar SpA
Via Firenze, 40 –I- 20060 Trezzano
Rosa (MI)
tel. +39 02 90937212 - fax.
+39 02 9096 7239

FANSULIDE

100 mg

FANSULIDE

100 mg

Tablet

Oral use

Alterna Farmaceutici Srl
Via dei Pestagalli Pietro e Giuseppe, 7
I-20138 Milano
Tel. -Fax.

IDEALID

IDEALID

100 mg

100 mg

Granules for oral
suspension

Oral use

Tablet

Granules for oral
suspension

Oral use

Oral use

Hexan SpA
Piazzale della Stazione –
I-00040 Santa Palomba (Roma)
tel +39 06 91045244 - fax.
+39 06 91045299

A.G.I.P.S. Farmaceutici SpA
Via Amendola, 4 - 16035 Rapallo
(GE) – Italië
tel. + 39 0185 58223/4 - fax. +
39 0185 60374

P.R.C. Srl
Via Conforti, 42 – I-84083 Castel
San Giorgio (SA)
Tel. +39 081 5162315 -
Fax.+39 081 5161590
mail@farmauno.it

NIMESULIDE

100 mg

Tablet

Oral use

NIMESULIDE

100 mg

Granules for oral
solution

Oral use

DELFOS

100 mg

Tablet

Oral use

DELFOS

100 mg

Granules for oral
suspension

Oral use

LIDERSOLV

100 mg

Tablet

Oral use

LIDERSOLV

100 mg

Granules for oral
suspension

Oral use

Nobel Farmaceutici Srl
Via Tiburtina, 1004 - I-00156 Roma
Tel +39 06 4111087- Fax.
+39 06 4111603

LIDENIX

LIDENIX

100 mg

Tablet

100 mg

Granules for oral
suspension

Oral use

Oral use

Janssen Cilag SpA
Via M. Buonarroti 23 –I-
20293 Cologno Monzese (Mi)
Tel. +39 02 25101 - Fax.
+39 02 2670 8196

Farmaceutici Formenti SpA
Via Correggio 43 – I-20149 Milano
Tel. +39 02 43051 - Fax.
+39 02 430555
Email: dg@formenti.it

BEIOND

100 mg

Tablet

Oral use

BEIOND

100 mg

Granules

Oral use

NIMESULIDE

100 mg

Tablet

Oral use

NIMESULIDE

100 mg

Granules for oral
suspension

Oral use

Blister

Sachet

Blister

Sachet

Blister

Sachet

Blister

Sachet

Blister

Sachet

Blister

Sachet

Blister

Sachet

Blister

Sachet

30

30

30

30

30

30

30

30

30

30

30

30

30

30

30

30

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e
E
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U
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o
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1
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/
1
7

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Italy
(cont’d)

L. Molteni & C. dei F.lli Allitti SpA
SS 67- Fraz. Granatieri –
I-50018 Scandicci (Fi) Italië
Tel. +39 055 7361278
Fax. +39 0557 20057/
+39 055 7361272
p.baccetti@moltenifarma.it

Polifarma SpA
Via Tor Sapienza 138 -
I-00155 Roma
Tel. +39 06 227420 - Fax.
+39 06 227 422 61

GET S.r.l.Via Dante Alighieri 73
I-18038 Sanremo (IM) Italië
Tel. +39 0184 59 241 - Fax.
+39 0184 5924216
Dr. Lorenza Guano - Dr. Roberto
Cacciaglia
Direz.scientifica@labct.it

Prodotti Formenti SRL
Via Coreggio 43 – I-20149 Milano
Tel. +39 02 43051- Fax.
+39 02 430555

Novartis Consumer Health SpA
Largo U. Boccioni 1 –
I-21040 Origgio (VA)
Tel. +39 02 96 47 9586 - Fax.
+39 02 96479656
Dr. Maria Carla Baggio - Dr. Carlo
Candiani
Maria_carla.baggio@ch.novartis.com

Nidemol

100 mg

Sachet

Oral use

Sachet

Nidemol

200 mg

Suppository

Rectal use

Strip

Nimesulide

100 mg

Tablet

Oral use

Nimesulide

100 mg

Granules for oral
suspension

Oral use

Blister

Sachet

Nimesulide

100 mg

Tablet

Oral use

Blister

Nimesulide

100 mg

Granules for oral
suspension

Oral use

FLAMINIDE

100 mg

Tablet

Oral use

FLAMINIDE

100 mg

Reumalide

100 mg

Granules for oral
suspension

Oral use

Granules for oral
suspension

Oral use

Sachet

Blister

Sachet

Sachet

Reumalide

200 mg

Suppository

Rectal use

Strip

30

10

30

30

30

30

30

30

30

10

Luxembourg

Therabel Pharma SA.
108, rue E. Van Ophem -
B-1180 Bruxelles
Tel. +32 2 370 46 38 - Fax.
+32 2 370 46 88

Mesulid

100 mg

Tablet

Oral use

Mesulid

Mesulid

100 mg

Granules

Oral use

3%

Gel

Cutaneous use

blister

sachet

Tube

14,30,60 tablets in blister
and 30,60 in unit dose

14,30,60

30g, 50g, 100g

C
1
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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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Portugal

Jaba Farmacêutica, SA
Apartado 165 - Zona Industrial da
Abrunheira
P- 2711 901 Sintra
T:
00351214329648 F:00351219151930
Maria Joao Marruz - Julio Carvalhal
Maria.marruz@jaba.pt
Head office: rua da Tapada Grande
2 – Zona Industrial da Abrunheira
P-2710-089 Sintra

Nimesulida Jaba
100 mg granulado
para solução oral

100 mg

Granules for oral
solution

Oral use

Sachet

10; 30 and 60

Angelini Farmacêutica, Lda.
Rua João Chagas n. 53
3° Piso
P- 1495-072 Algés- Portugal
T: 00351214148300 F:
00351214142981

Aulin

Aulin

Aulin

100 mg

200 mg

100mg

Aulin Gel

30 mg/g

Donulide

Donulide

100 mg

100 mg

Tablet

Oral use

Suppository

Rectal use

Granules for oral
solution

Oral use

Gel

Tablet

Granules for oral
solution

Cutaneous use

Oral use

Oral use

Donulide Gel

30 mg/g

Gel

Cutaneous use

Flamisul

100 mg

Tablet

Oral use

Blister

Strip

Sachet

Tube

Blister

Sachet

Tube

Blister

14; 30 and 60

10 and 12

14; 30 and 60

30; 50 and 100g

14; 20; 30 and 60

14; 20; 30 and 60

30; 50 and 100g

10; 30 and 60

Flamisul

100 mg

Granules

Oral use

Sachet

10; 20; 30 and 60

Gerilide

100 mg

Tablet

Oral use

Blister

10; 20; 30 and 60

Gerilide

200 mg

Suppository

Rectal use

Strip

10

Gerilide

100mg

Granules

Oral use

Sachet

10; 20 and 30

Wyeth Lederle Portugal (Farma), Lda.
PRT
Rua Dr. António Loureiro Borges, 2 -
Arquiparque
Miraflores Algés 1495-131
T: 00351214128200 F:
00351214120111

Farmoz - Sociedade Técnico-
Medicinal, SA
Rua Prof. Henrique de Barros, Edif.
Sagres, 3° A
2685- 338 Prior Velho
T: 00351210414100 - Fax.
00351219410839
Ana Real - Augusto Filipe
tecnimedicina@mail.telepac.pt

Companhia Portuguesa de Higiene,
SA
Rua dos Bem Lembrados, 141 –
Manique
2645 – 471 Alcabideche Portugal
T:0035121444 96 00 F:
0035121444 96 99/
pharmacovigilance 444 96 40
Francisco Freire-de-andrade, MD -
Isabel Machado, Ph
fandrade@cph.pt

.

.

3
0
4
2
0
0
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

C
1
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1
9

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Portugal
(cont’d)

Tecnimede - Sociedade Técnico-
Medicinal, SA
Rua Prof. Henrique de Barros - Edf.
Sagres, 3º A Prior Velho 2685 338
T: 00351210414100 - F:
00351219410839Ana Real -
Augusto Filipe
tecnimedicina@mail.telepac.pt

Jaba Farmacêutica, SA
Apartado 165 - Zona Industrial da
Abrunheira
P- 2711 Sintra
T:
00351214329648 F:00351219151930
Head office: rua da tapada grande,
2 Zona Industrial da Abrunheira
P- 2710 089 Sintra
Maria Joao Marruz -Julio Carvalhal
Maria-marruz@jaba.pt

Tecnimede - Sociedade Técnico-
Medicinal, SA
Rua Prof. Henrique de Barros - Edf.
Sagres, 3º A Prior Velho 2685 338
T: 00351210414100 - F:
00351219410839Ana Real -
Augusto Filipe
tecnimedicina@mail.telepac.pt

Labesfal - Laboratórios Almiro, SA
P-3465-051 Campo de Besteiros
T: 00351232831100 F:
00351232831112
Alda Rodrigues -
labesfal@mail.telepac.pt

Mediquímica - Produtos Químicos,
Especialidades Farmacêuticas, Lda.
Vala do Carregado
P-2600-726 Castanheira do Ribatejo
T: 0351263856800 F:
0351263855020

Isartrox

100mg

Tablet

Oral use

Blister

10; 12; 20; 30 and 60

Isartrox

100mg

Granules

Oral use

Sachet

10; 12; 20; 30 and 60

Jabasulide

100mg

Tablet

Oral use

Blister

10;
, 30 and 60

Jabasulide

100mg

Granules for oral
solution

Oral use

Sachet

10; 30 and 60

Neuride

100mg

Tablet

Oral use

Blister

10; 30 and 60

Neuride

100mg

Granules

Oral use

Sachet

10; 20; 30 and 60

Nimalge

100mg

Nimalge

Nimalge

Nimartin

200mg

100mg

100mg

Granules for oral
suspension

Oral use

Suppository

Rectal use

Tablet

Oral use

Coated Tablet

Oral use

Sachet

Strip

Blister

Blister

Strip

Blister

Sachet

Tube

10; 20; 30 and 60

10

10; 20; 30 and 60

10; 20; 30 and 60

10

14; 20; 30 and 60

14; 20; 30 and 60

30; 50 and 100g

Aventis Pharma, Lda.
Estrada Nacional 249
Po Doos 39 Km 15 Mem Martins
2726-922
T: 00351219269540 F:
00351219269696

Nimed

Nimed

Nimed

200 mg

Suppository

Rectal use

100mg

100mg

Coated Tablet

Oral use

Granules

Oral use

Nimed Gel

30 mg/g

Gel

Cutaneous use

C
1
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9
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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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Portugal
(cont’d)

Laboratori Guidotti, SpA
Via Trieste, 40 56126 Pisa
T: 0039050505211 F:
003905040250

Nimesulene

100mg

Granules for oral
suspension

Oral use

Sachet

10;20 and 30

Clintex - Produtos Farmacêuticos,
Lda.
Rua João de Deus 19, Venda Nova
P-2700487 Amadora
T.00351214998933 F:
00351214998932

Angelini Farmacêutica, Lda.
Rua João Chagas n. 53, 3° Piso
P- 1495-072 Algés
T: 00351214148300 F:
00351214142981

Nimesulida

100mg

Granules for oral
suspension

Oral use

Nimesulida Clintex

200 mg

Suppository

Rectal use

Nimesulida Clintex

100mg

Tablet

Oral use

Nimesulide HPF

200mg

Suppository

Rectal use

Nimesulide HPF

100mg

Granules for oral
suspension

Oral use

Nimesulide HPF

100mg

Tablet

Oral use

Nimesulide HPF Gel

30 mg/g

Gel

Cutaneous use

Sachet

Strip

Blister

Strip

Sachet

Blister

Tube

10; 20; 30 and 60

10

10; 20; 30 and 60

12

14, 30, 60

14, 30, 60

30, 50 and 100g

Labesfal - Laboratórios Almiro, SA
P-3465-051 Campo de Besteiros
T: 00351232831100 F:
00351232831112
Alda Rodrigues -
labesfal@mail.telepac.pt

Nimesulida Labesfal

100mg

Granulado para
suspensão oral

Via oral

Saqueta

10, 30 e, 60

Nimesulida Labesfal

200 mg

Supositórios

Via rectal

Fita contentora

10

Nimesulida Labesfal

100 mg

Comprimidos

Via oral

Mepha, Investigação ,
Desenvolvimento e Fabricação LDA
Rua Elias Garcia, n.º 28 - C, Apart.
6617
P-2701-355 Amadora
T: 00351 21 476 75 50 - F:
00351214763667

Polyfen

Polyfen

100mg

Tablet

Oral use

100mg

Granules for oral
suspension

Oral use

Polyfen

200mg

Suppository

Rectal use

Pronidal - 100

100mg

Tablet

Oral use

Pronidal - 100

100mg

Granules for oral
suspension

Oral use

Blister

Blister

Sachet

Strip

Blister

Sachet

10, 20, 30 e 60

10, 20; 30 and 60

10, 20; 30 and 60

10

10, 20; 30 and 60

10, 20; 30 and 60

Pronidal - 200

200 mg

Suppository

Rectal use

Strip

10

.

.

3
0
4
2
0
0
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
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o
p
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a
n
U
n
o
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1
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2
1

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Portugal
(cont’d)

Spain

Farmácia Nova Rua Elias Garcia
10-G Venda Nova
P- 2700 Amadora
T: 00351 2638 56800 F:
0351263855020/1

Laboratórios Inibsa, SA
Apartado 24
Rua do Cotão Velho, S. Marcos
Cacém 2735-501
Head office: Sintra Business Park-
Zona Industrial da Abrunheira
–Edifício 1-2° I/ 2710 089 Sintra
T: 00351 21 911 27 30 - F:
00351 21 911 20 23

Pentafarma – Sociedade Técnico
Medicinal, S.ª
Rua Prof. Henrique de Barros,
Edif.Sagres, 3rd
Piso A – 2685 338 Prior Velho
T: 00351 21 942 3672 Fax.
00351 21 942 4043
Ana Real Augusto Filipe
tecnimedicina@mail.telepac.pt

Laboratórios Vitória, SA
Rua Elias Garcia nº 28, Venda Nova
P-2700-327 Amadora
T: +35121475 83 00 - F:
+351214747070
Dina Caldeira - Elisabete Goncalves
Dina.c@labvitoria.pt

Jabafarma Produtos Farmacêuticos,
SA
Apartado 165 - Zona Industrial da
Abrunheira
P- 2711 Sintra
T:
00351214329648 F:00351219151930
Head office: rua da tapada grande,
2 Zona Industrial da Abrunheira
2710 089 Sintra
Maria Joao Marruz - Julio Carvalhal
Maria-marruz@jaba.pt

Alcala Farma SL
CTRA.M-300, Km. 29.902
E- 28802 Alcala de Henares
Tel. ++34 91 88 90 600 - Fax.
+34 91 889 05 02

Ribantil

100mg

Coated Tablet

Oral use

Blister

10; 20; 30 and 60

Sulimed

100mg

Tablet

Oral use

Blister

10; 30 and 60

Sulinime

100 mg

Tablet

Oral use

Blister

10 ;12 ;20 ; 30; 60

Sulinime

100mg

Granules

Oral use

Sachet

10; 12; 20; 30 and 60

Vitolide

100mg

Tablet

Oral use

Blister

10 and 30

Zulide

100mg

Tablet

Oral use

Blister

10, 30 and 60

Zulide

100 mg

Granules for oral
solution

Oral use

Sachets

10, 30 and 60

Guaxan

100 mg

Granules

Oral use

Guaxan

100 mg

Tablet

Oral use

Sachet

Blister

30, 500

30, 500

C
1
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E
N

O

f
f
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c
i
a
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J
o
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n
a
l

o
f

t
h
e
E
u
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p
e
a
n
U
n
o
n

i

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Spain
(cont’d)

Belgium

France

Greece

Laboratorios Alter SA
Mateo Inurria, 30 - E-28036 Madrid
Tel. +34 91 35 92 000 - Fax.
+34 91 35 01 165

Antifloxil

P.S.I. NV Kraanlei 27-29 9000 Gent
Tel. +32 9233 1404
Fax. +32 92 33 00 16

NIMESULIDE/SI
100 mg
ZAKJES

Antifloxil

100 mg

Tablet

Oral use

100 mg

100 mg

Granules

Oral use

Granules for oral
suspension

Oral use

Blister

Sachet

Sachet

30

30

30

NIMESULIDE/ SI
100 mg
Tabletten

100 mg

Tablet

Oral use

Blister

Nimesulide Arrow

100 mg

Tablet

Oral use

Blister

Nimesulide Merck

100 mg

Tablet

Oral use

Blister

Ventor

50 mg/ 5 ml

Oral Suspension

Oral use

Sachet

Elinap

Elinap

Lalide

Lalide

3%

3%

Cream

Cutaneous use

Gel

Cutaneous use

100 mg/ 5ml

Oral Suspension

Oral use

Tube

Tube

Sachet

3%

Gel

Cutaneous use

Tube

30g;50g; 100g.

Lasazin

100 mg

Tablet

Oral use

Blister

2X10
3X10

Laboratoires Arrow Génériques
66, cours Charlemagne
F-69286 Lyon Cedex 02
Tel. +33 4 78 38 53 10 -
Fax :+33 4 78 37 52 93
Anne-Sophie Garcia

Merck Generiques
34, rue Saint-Romain
F-69 359 Lyon Cedex 08
Tel. +33 4 72 78 27 35 -
Fax.+33 4 72 78 26 27
ouardia.messili@merckgeneriques.fr
delphine.besse@merckgeneriques.fr

Rafarm Aebe
Kirinthou 12 - 15451, N. Psyhiko
Tel. +30 10 677 65 50/ Fax.
+30 10 677 65 52

Kleva Epe
L. Parnithos 189- Aharne Attikis
Tel. +30 10 24 63 737 / Fax.
+30 10 24 60 206

Pharmacypria Hellas
Paster 6 - Ampelokipoi GR-11521
Tel. +30 10 65 13 436/ Fax.
+30 10 644 5375

Leovan M. Aedn & Cia EE
22, Argonayton Str.
Argyroupoli T.K. 164 52 Athens
Tel. +30 210 96 04 909 - Fax.
+30 210 960 30 95

.

.

3
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4
2
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4

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O

f
f
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a
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J
o
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a
l

o
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t
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3

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Greece
(cont’d)

Pharmachem Epe
Imitou 73 - Vrilissia Attikis - GR-
15235
Tel. +30 210 524 74 08/ Fax.
+30 210 5244847

Antonios Polixronis Tou Marinou
Thivon 3 / GR-15562 Holargos
Tel. +30 10 65 42 360/ Fax.
+30 10 6561006

Zwitter Pharmaceuticals Ltd.
L. Pentelis 34-36 - Athens GR-15234
Tel. +30 210 6821098/ Fax..
+30 210 6821098
zwitter@hol.gr

Med-One SA
211 Parnithos Avenue - GR-
13671 Acharnai - Attiki
Tel. +30 210240 24 05/ Fax.
+30 2102 46 02 06
Polydefkidoy Eleni

Lamda Pharmaceutical AE
6, Thermopylon Str/ GR-
15233 Halandri
Tel. +30 210 68 56 741 –2/ Fax.
+30 210 68 46 829
Stefania Staikou - Vaggelis Karras
info@lamdapharmaceuticals.gr

Medicon Pharmaceutical SA
Karaiskaki 115°A/ GR-26500 Aktaio
–Rio Patron
Tel.: +30 6932200188 - Fax.
+30 2610 99 38 08
chrodopoulos@yahoo.gr

Farmamust Epe
Plateia Pantazopoulou 7/ GR-
10443 Kolonos Attikis

Nimesulide
Pharmakem

100 mg

Tablet

Oral use

Blister

Omnibus

100 mg

Tablet

Oral use

Blister

Rhemid

100 mg

Tablet

Oral use

Blister

1X20
1X30

1X20
1X30

Algosulid

3%

Cream

Cutaneous use

Tube

Algosulid

100 mg

Tablet

Oral use

Blister

Nimesoral

50 mg/ 5ml

Oral Suspension

Oral use

Bottle

1X100ml

Nimegel

3%

Gel

Cutaneous use

Tube

Nimesulide Medicon

100 mg

Tablet

Oral use

Blister

1x30g
1x50g
1x100g

2x10
3x10

Lovirem

100 mg

Tablet

Oral use

Blister

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation Holder (Name,
address, phone and fax numbers)

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Pack Size

Spanje

Italy

Laboratorios Alcala Farma
S.L.Ctra. M-300, Km. 29,920
E-28802 Alcala’ de Henares (Madrid)
Tel. +34 91 889 06 00 - Fax.
+34 91 889 05 02

Novartis Farma S.p.A
S.S. 233 (Varesina) Km 20,5 -
21040 Origgio (VA) – Itália
tel: +39 tel: 02 96542214 -
fax:+39 02 9659066

.

.

3
0
4
2
0
0
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

C
1
1
9
/
2
5

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

ANNEX II

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Sweden

Germany

Perivita A/S
Håndverksveien 2
N-1403, Langhus
Norway

Amlovita

Amlovita

Amlovita

Amlovita

5 mg

10 mg

5 mg

10 mg

Tablet

Tablet

Tablet

Tablet

oral use

oral use

oral use

oral use

Perivita A/S
Håndverksveien 2
N-1403, Langhus
Norway

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

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

ANNEX III

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Sweden

Germany

Wörwag Pharma GmbH &
Co. KG
Calwer Str. 7
71034 Böblingen
Germany

Amlodipin
Wörwag

Amlodipin
Wörwag

Amlodipin
Wörwag

Amlodipin
Wörwag

5 mg

10 mg

5 mg

10 mg

Tablet

Tablet

Tablet

Tablet

Wörwag Pharma GmbH &
Co. KG
Calwer Str. 7
71034 Böblingen
Germany

oral use

oral use

oral use

oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
2
7

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

ANNEX IV

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Sweden

Germany

Laboratoires Delbert
56, Quai A. Le Gallo
92100 Boulogne
Billancourt
France

Talam

Talam

Talam

Talam

5 mg

10 mg

5 mg

10 mg

Tablet

Tablet

Tablet

Tablet

oral use

oral use

oral use

oral use

Laboratoires Delbert
56, Quai A. Le Gallo
92100 Boulogne
Billancourt
France

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

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

ANNEX V

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Sweden

Germany

Laboratoires Delbert
56, Quai A. Le Gallo
92100 Boulogne
Billancourt
France

Pidolma

Pidolma

Pidolma

Pidolma

5 mg

10 mg

5 mg

10 mg

Tablet

Tablet

Tablet

Tablet

oral use

oral use

oral use

oral use

Laboratoires Delbert
56, Quai A. Le Gallo
92100 Boulogne
Billancourt
France

.

.

3
0
4
2
0
0
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

C
1
1
9
/
2
9

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

ANNEX VI

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Merck Sharp & Dohme
GmbH.
Donau-City-Straße 6
A-1220 Wien
Austria

Ceoxx 25 mg
tabletten

Ceoxx 50 mg
tabletten

Coxxil 12,
5 mg/5 ml orale
suspension

Coxxil
25 mg/5 ml
orale suspension

Coxxil 12, 5 mg
tabletten

Coxxil 25 mg
tabletten

Vioxx 12,5 mg
tabletten

Vioxx 25 mg
tabletten

Vioxx 12,
5 mg/5 ml orale
suspension

Vioxx
25 mg/5 ml
orale suspension

Vioxx Dolor
25 mg tabletten

Vioxx Dolor
50 mg tabletten

25 mg

50 mg

Tablet

Tablet

Oral use

Oral use

12, 5 mg/5 ml

Oral suspension

Oral use

25 mg/5 ml

Oral suspension

Oral use

12, 5 mg

25 mg

12,5 mg

25 mg

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

12, 5 mg/5 ml

Oral suspension

Oral use

25 mg/5 ml

Oral suspension

Oral use

25 mg

50 mg

Tablet

Tablet

Oral use

Oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

.

.

3
0
4
2
0
0
4

Belgium

Merck Sharp & Dohme, B.V.
Chaussée de Waterloo
Waterloosesteenweg, 1135
B-1180 Bruxelles
Belgium

Denmark

Merck Sharp & Dohme B.V.
Waarderweg 39, Post Bus
581
2003 PC Haarleem
The Netherlands

Vioxx

Vioxx

Vioxx

Vioxx

Flogoxxa

Flogoxxa

Foldoxx

Foldoxx

Foldoxx

Foldoxx

Vioxxdolor

Vioxxdolor

Vioxx

Vioxx

Vioxx

Vioxx

Meroxx

Meroxx

Meroxx

Meroxx

Vioxxalt

Vioxxalt

Rofecoxib, MSD

Rofecoxib, MSD

12, 5 mg

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/ 5 ml

Oral suspension

25 mg

25 mg

50 mg

12, 5 mg

25 mg

Tablet

Tablet

Tablet

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

25 mg

50 mg

12, 5 mg

25 mg

Tablet

Tablet

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

12, 5 mg

25 mg

Tablet

Tablet

12, 5 ml/5 ml

Oral suspension

25 ml/5 ml

Oral suspension

25 mg

50 mg

25 mg

50 mg

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

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
1
1
9
/
3
1

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Finland

France

Merck Sharp & Dohme B.V.
Waarderweg 39, Post Bus
581
2003 PC Haarleem
The Netherlands

Laboratoires Merck Sharp &
Dohme – Chibret
3, avenue Hoche
75114 Paris cedex 08
France

Germany

MSD Sharp & Dohme
GmbH
Lindenplatz 1
D-85540 Haar
Germany

Ceoxxa

Ceoxxa

Vioxx

Vioxx

Vioxx

Vioxx

Vioxxakut

Vioxxakut

Vioxx

Vioxx

Vioxx

Vioxx

Meoroxx

Meoroxx

Meoroxx

Meoroxx

Vioxx Dolor
25 mg Tabletten

Vioxx Dolor
50 mg Tabletten

Ceoxx 25 mg
Tabletten

Ceoxx 50 mg
Tabletten

Rofecoxib MSD
12,5 mg/5 ml
Suspension zum
Einnehmen

25 mg

50 mg

12, 5 mg

25 mg

Tablet

Tablet

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

25 mg

50 mg

12, 5 mg

Tablet

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg

Tablet

25 mg/5 ml

Oral suspension

12, 5 mg

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg

Tablet

25 mg/5 ml

Oral suspension

25 mg

50 mg

25 mg

50 mg

Tablet

Tablet

Tablet

Tablet

12,5 mg/5 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

.

.

3
0
4
2
0
0
4

Germany
(cont’d)

Greece

Vianex S.A.
Pharmaceuticals & Cosmetic
Industry
Licensee/Distributor of
Merck Sharp & Dohme
Tatoiou Street. 18th Km
Athens-Lamia National Road
14671 Nea Erythrea, Athens
Greece

Rofecoxib MSD
25 mg/5 ml
Suspension zum
Einnehmen

Rofecoxib MSD
12, 5 mg
Tabletten

Rofecoxib MSD
25 mg Tabletten

Vioxx
12,5 mg/5 ml
Suspension zum
Einnehmen

Vioxx
25 mg/5 ml
Suspension zum
Einnehmen

Vioxx 12, 5 mg
Tabletten

Vioxx 25 mg
Tabletten

Vioxx

Vioxx

Vioxx

Vioxx

Peroxx

Peroxx

Peroxx

Peroxx

25 mg/5 ml

Oral suspension

Oral use

12, 5 mg

Tablet

25 mg

Tablet

Oral use

Oral use

12,5 mg/5 ml

Oral suspension

Oral use

25 mg/5 ml

Oral suspension

Oral use

12, 5 mg

25 mg

12, 5 mg

25 mg

Tablet

Tablet

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

12, 5 mg

25 mg

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

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
1
1
9
/
3
3

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Iceland

Ireland

Italy

Merck Sharp & Dohme B.V.,
Waarderweg 39, Post Bus
581, 2003 P.C., Haarlem,
The Netherlands

Merck Sharp & Dohme
Limited; Hertford Road,
Hoddesdon, Hertfordshire
EN11 9BU
United Kingdom

Merck Sharp E Dohme
(Italia) S.p.A.
Via G. Fabbroni, 6
00191 Rome
Italy

Neopharmed S.p.A.
Via G. Fabbroni, 6
00191 Rome
Italy

Vioxx

Vioxx

Vioxx

Vioxx

Vioxxakut

Vioxxakut

Ceoxx

Ceoxx

Ceoxx

Ceoxx

Vioxx

Vioxx

Vioxx

Vioxx

Vioxx

Vioxx

Vioxx

Vioxx

Arofexx

Arofexx

Arofexx

Arofexx

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

12, 5 mg

25 mg

25 mg

50 mg

25 mg

50 mg

25 mg

50 mg

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

12, 5 mg

25 mg

12, 5 mg

25 mg

Tablet

Tablet

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

12, 5 mg

25 mg

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

.

.

3
0
4
2
0
0
4

Italy
(cont’d)

Istituto Gentili S.p.A.
Via Mazzini, 112
56125 Pisa
Italy

Merck Sharp E Dohme
(Italia) S.p.A.
Via G. Fabbroni, 6
00191 Rome
Italy

Neopharmed S.p.A.
Via G. Fabbroni, 6
00191 Rome
Italy

Istituto Gentili S.p.A.
Via Mazzini, 112
I-56100 Pisa
Italy

Merck Sharp & Dohme B.V.
Chaussée de Waterloo
Waterloosesteenweg 1135
B-1180 Brussels
Belgium

Luxembourg

Coxxil

Coxxil

Coxxil

Coxxil

Dolcoxx

Dolcoxx

Miraxx

Miraxx

Dolostop

Dolostop

Vioxx

Vioxx

Vioxx

Vioxx

Foldoxx

Foldoxx

Foldoxx

Foldoxx

Flogoxxa

Flogoxxa

Vioxxdolor

Vioxxdolor

12, 5 mg

25 mg

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

25 mg

50 mg

25 mg

50 mg

25 mg

50 mg

12, 5 mg

25 mg

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

12, 5 mg

25 mg

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

25 mg

50 mg

25 mg

50 mg

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

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
1
1
9
/
3
5

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

The Netherlands

Merck Sharp & Dohme BV,
Waarderweg 39, Post Bus
581
2003 P.C. Haarlem
The Netherlands

Norway

Merck Sharp & Dohme BV,
Waarderweg 39, Post Bus
581
2003 P.C. Haarlem
The Netherlands

Vioxx 12, 5 mg
tabletten

Vioxx 25 mg
tabletten

Vioxx 12,
5 mg/5 ml
suspensie

Vioxx
25 mg/5 ml
suspensie

Balasys 12, 5 mg
tabletten

Balasys 25 mg
tabletten

Balasys 12,
5 mg/5 ml
suspensie

Balasys
25 mg/5 ml
suspensie

Ceoxx 25 mg
tabletten

Ceoxx 50 mg
tabletten

Vioxx acute pijn
25 mg tabletten

Vioxx acute pijn
50 mg tabletten

Vioxx

Vioxx

Vioxx

Vioxx

Vioxx

Ceoxx

12, 5 mg

25 mg

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

Oral use

Oral use

Oral use

25 mg/5 ml

Oral suspension

Oral use

12, 5 mg

25 mg

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

Oral use

Oral use

Oral use

25 mg/5 ml

Oral suspension

Oral use

25 mg

50 mg

25 mg

50 mg

12, 5 mg/ml

25 mg/ml

12,5 mg

12,5 mg

25 mg

25 mg

Tablet

Tablet

Tablet

Tablet

Oral suspension

Oral suspension

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Norway
(cont’d)

Portugal

Ceoxx

Vioxx AC

Vioxx AC

Acoxxin

Acoxxin

Acoxxin

Acoxxin

Ceoxx

Ceoxx

Coxxil

Coxxil

Coxxil

Coxxil

Dolocoxx

Dolocoxx

Trioxx

Trioxx

Laboratórios Químico-
Farmacêuticos Chibret, Lda.
Quinta da Fonte
Edifício Vasco da Gama 19
P.O Box 214
Porto Salvo
2770-192 Paço d’Arcos
Portugal

Merck Sharp & Dohme, Lda.
Quinta da Fonte, Edifício
Vasco da Gama 19
P.O Box 214
Porto Salvo
2770-192 Paço d’ Arcos -
Portugal

Ferraz Lynce, S.A.
Rua Consiglieri Pedroso,
123 Queluz de Baixo
P.O Box 1001
2745-557 Barcarena
Portugal

Laboratórios Químico-
Farmacêuticos Chibret, Lda.
Quinta da Fonte Edifício
Vasco da Gama 19 P.O Box
214 Porto Salvo
2770-192 Paço d’Arcos -
Portugal

Farmacox - Companhia
Farmacêutica, Lda Quinta da
Fonte, Edifício Vasco da
Gama, 19 - P.O. Box 214
Porto Salvo
2770-192 Paço d’Arcos -
Portugal

50 mg

25 mg

50 mg

12, 5 mg

25 mg

Tablet

Tablet

Tablet

Tablet

Tablet

12, 5 mg/ml

Oral suspension

25 mg/ml

25 mg

50 mg

12, 5 mg

25 mg

Oral suspension

Tablet

Tablet

Tablet

Tablet

12, 5 mg/ml

Oral suspension

25 mg/ml

Oral suspension

25 mg

50 mg

25 mg

50 mg

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
3
7

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Portugal
(cont’d)

Spain

Merck Sharp & Dohme, Lda.
Quinta da Fonte, Edifício
Vasco da Gama 19, P.O. Box
214
Porto Salvo
2770-192 Paço d’ Arcos –
Portugal

Laboratorios Abello S.A
Josefa Valcarcel, 38
28027 Madrid
Spain

Sweden

Merck Sharp & Dohme B.V.
Waarderweg 39, Post Bus
581
2003 P.C. Haarlem
The Netherlands

Vioxx

Vioxx

Vioxx

Vioxx

Movtor 25 mg

Movtor 50 mg

Ceoxx 25 mg

Ceoxx 50 mg

Vioxx 12,
5 mg/5 ml

Vioxx
25 mg/5 ml

Vioxx

Vioxx

Recox 12, 5 mg

Recox 25 mg

Recox 12,
5 mg/5ml

Recox
25 mg/5ml

Vioxx

Vioxx

Vioxx

Vioxx

Ceoxx

Ceoxx

Vioxxakut

12, 5 mg/ml

Oral suspension

25 mg/ml

12, 5 mg

12, 5 mg

25 mg

50 mg

25 mg

50 mg

Oral suspension

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

12, 5 mg

25 mg

12, 5 mg

25 mg

Tablet

Tablet

Tablet

Tablet

12, 5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

12, 5 mg

25 mg

12,5 mg/ml

25 mg/ml

25 mg

50 mg

25 mg

Tablet

Tablet

Oral suspension

Oral suspension

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Sweden
(cont’d)

United Kingdom

Merck Sharp & Dohme
Limited Hertford Road,
Hoddesdon Hertfordshire,
EN11 9BU
United Kingdom

Vioxxakut

Axxelor

Axxelor

Axxelor

Axxelor

Coxxid

Coxxid

Coxxid

Coxxid

Ceoxx

Ceoxx

Movtor

Movtor

Vioxx

Vioxx

Vioxx

Vioxx

Vioxxacute

Vioxxacute

50mg

12,5 mg

25 mg

Tablet

Tablet

Tablet

12,5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

12, 5 mg

25 mg

Tablet

Tablet

12,5 mg/5 ml

Oral suspension

25 mg/5 ml

Oral suspension

25 mg

50 mg

25 mg

50 mg

Tablet

Tablet

Tablet

Tablet

12,5 mg/5 ml

Oral suspension

25 mg/5 ml

12, 5 mg

25 mg

25 mg

50 mg

Oral suspension

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
3
9

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

ANNEX VII

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Belgium

Denmark

Merck Sharp & Dohme
GmbH.
Donau-City Strasse 6
A-1220 Wien
Austria

Merck Sharp & Dohme B.V.
Chaussée de Waterloo, 1135
B- 1180 Bruxelles
Belgium

Merck Sharp & Dohme B.V.
Waarderweg 39, Post Bus
581
2003 PC Haarleem
The Netherlands

Arcoxia

Arcoxia

Arcoxia

Auxib

Auxib

Auxib

Arcoxia

Arcoxia

Arcoxia

Ranacox

Ranacox

Ranacox

Arcoxia

Arcoxia

Arcoxia

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablets

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Finland

Greece

Iceland

Ireland

Merck Sharp & Dohme B.V.
Waarderweg 39, Post Bus
581
2003 P.C. Haarlem
The Netherlands

Vianex S.A.
Pharmaceuticals & Cosmetic
Industry
Licensee/Distributor of
Merck Sharp & Dohme
Tatoiou Street. 18th Km
Athens-Lamia National Road
14671Nea Erythrea, Athens
Greece

Merck Sharp & Dohme B.V.,
Waaderweg 39, Post Bus
581
2003 P.C. Haarlem
The Netherlands

Merck Sharp & Dohme Ltd
Hertford Road, Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Arcoxia

Arcoxia

Arcoxia

Turox

Turox

Turox

Arcoxia

Arcoxia

Arcoxia

Turox

Turox

Turox

Arcoxia

Arcoxia

Arcoxia

Arcoxia

Arcoxia

Arcoxia

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
4
1

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy

Merck Sharp & Dohme Italia
S.p.A.
Via G. Fabbroni, 6
I-00191 Roma
Italy

Istituto Gentili S.p.A.
Via Mazzini, 112
I-56125 Pisa
Italy

Neopharmed S.p.A.
Via G. Fabbroni, 6
I-00191 Roma
Italy

Addenda Pharma S.r.l.
Viale Shakespeare, 47
00100 Roma
Italy

Luxembourg

Merck Sharp & Dohme B.V.
Chaussée de Waterloo 1135
B-1180 Bruxelles
Belgium

Arcoxia

Arcoxia

Arcoxia

Algix

Algix

Algix

Recoxib

Recoxib

Recoxib

Tauxib

Tauxib

Tauxib

Arcoxia

Arcoxia

Arcoxia

Ranacox

Ranacox

Ranacox

60 mg

90 mg

120 mg

60 mg

90mg

120 mg

60 mg

90mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

The Netherlands

Merck Sharp & Dohme BV
Waarderweg 39
P.O. Box 581
2003 PC Haarlem
Netherlands

Arcoxia 60

Arcoxia 90

60 mg

90mg

Film-coated tablet

Film-coated tablet

Arcoxia 120

120 mg

Film-coated tablet

Norway

Portugal

Merck Sharp & Dohme BV
Waarderweg 39, Post Bus
581
2003 PC Haarlem
The Netherlands

Merck Sharp & Dohme,
(Portugal) Lda. Quinta da
Fonte, Edifício Vasco da
Gama n.º 19, Porto Salvo
2780-730 Paço d’ Arcos
Portugal

Laboratórios BIA-Portela
S.A.
Av. Da Siderurgia Nacional,
4745-457 S. Mamede do
Coronado
Portugal

Auxib 60

Auxib 90

Auxib 120

Arcoxia

Arcoxia

Arcoxia

Arcoxia

Arcoxia

Arcoxia

Exxiv

Exxiv

Exxiv

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
4
3

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Portugal
(cont’d)

Spain

Sweden

Farmacox - Companhia
Farmacêutica, Lda Quinta da
Fonte, Ed. Vasco da Gama,
19 - Porto Salvo 2780-
730 Paço D’Arcos
Portugal

Merck Sharp & Dohme de
Espana, S.A.
c/ Josefa Valcarcel 38
28027 Madrid
Spain

Laboratorios Abello
c/ Josefa Valcarcel 38
28027 Madrid
Spain

Merck Sharp & Dohme BV
Waarderweg 39, Post Bus
581
2003 PC Haarlem
The Netherlands

Turox

Turox

Turox

Arcoxia

Arcoxia

Arcoxia

Exxiv

Exxiv

Exxiv

Arcoxia

Arcoxia

Arcoxia

Turox

Turox

60 mg

Film-coated tablet

Oral use

90mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

Film-coated tablet

Oral use

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Film-coated tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Sweden
(cont’d)

United Kingdom

Merck, Sharp & Dohme Ltd
Hertford Road, Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Turox

Arcoxia

Arcoxia

Arcoxia

Auxib

Auxib

Auxib

Exxiv

Exxiv

Exxiv

Turox

Turox

Turox

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

60 mg

90 mg

120 mg

Film-coated tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
4
5

LIST OF THE INVENTED NAMES, PHARMACAUTICAL FORMS, STRENGTHS OF THE MEDICINAL
PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS,
PACKAGING AND PACKAGE SIZES IN THE MEMBER STATES

ANNEX VIII

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

AU

BE

FI

FR

Aesca chem.pharm. Fabrik GmbH.,
Badner Straße 23,
A-2514 Traiskirchen,
Austria

Clarinase -
Manteldragees

Schering Plough N.V.
Rue de Stalle 73
B-1180 Brussels
Belgium

Schering-Plough Europe,
73, Rue De Stalle,
B-1180 Brussels,
Belgium

Schering Plough
92, rue Baudin
F-92307 Levallois Perret Cedex,
France

Clarinase retard
Dragees

Clarinase 120/5
(Repetabs)

Clarinase
240/10 once daily

Prospel

Clarinase

CLARINASE

CLARINASE
REPETABS

5 mg
loratadine
+120 mg
pseudoephedrine

10 mg loratadine
+ 240 mg
psuedoephedrine

5 mg loratadine
(+ Pseudo-
ephedrine sulfate
120 mg)

10 mg loratadine
(+ Pseudo-
ephedrine sulfate
240 mg)

5 mg loratadine
(+ Pseudo-
ephedrine sulfate
120 mg)

10 mg
loratadine/
240 mg
pseudoeph-
edrine

10 mg loratadine
+ 240 mg
pseudo-
ephedrine
sulphate

5 mg loratadine
+ 120 mg
pseudoephedrine

Coated tablet

Oral use

Blister

Coated tablet

Oral use

Blister

10

10

Prolonged-
release tablet

Prolonged-
release tablet

Prolonged-
release tablet

Prolonged-
release tablet

Oral use

Blister

14
10, 14, 20, 28, 30, 50,
100 – for export

Oral use

Blister

1, 7, 10, 14, 20, 28, 30, 50,
100

Oral use

Blister

Oral use

Blister

10, 14,
4, 10, 20, 28, 30, 50, 100 –
for export

1, 7, 10, 14, 20, 28, 30, 50,
100

Prolonged-
release tablet

Oral use

Blister
(PVC/Alu)

1, 7, 10, 14, 20, 28, 30, 50,
100

LORATADINE/
SULFATE de
PSEUDOEPHEDRINE

5 mg loratadine
+ 120 mg
pseudoephedrine

Modified-release
tablet

Oral use

Modified-release
tablet

Oral use

Blister
(PVC/Alu)

Blister
(PVC/Alu)

10, 14, 20

10, 14, 20

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

GR

IC

IT

LU

PT

Schering Plough A.Φ.B.E.E.
63 Agiou Dimitriou
GR-17456 Alimos
Greece

Schering-Plough Europe,
Rue de Stalle,
B-1180 Brussels
Belgium

Italfarmaco SPA
Via Dei Lavoratori, 54
I-20092 Cinisello Balsamo
Milano
Italy

Schering Plough SPA
Via Ripamonti, 89
I-20141 Milano,
Italy

SCHERING-PLOUGH s.a.
73, Rue de Stalle
B-1180 Brussels
Belgium

Schering-Plough Farma, Lda.
Rua Agualva dos Açores 16
P-2735-557 Agualva- Cacém
Portugal

5 + 120 mg
pseudoe-phine
phri-nesulphate

10 + 240 mg
pseudo-
epinephrine
sulphate

Modified-release
tablet

Oral use

Blister

Prolonged-
release tablet

Oral use

Blister

10 mg loratadine
+ 240 mg
pseudoephedrine

Prolonged-
release tablet

Oral use

Blister

Modified-release
coated tablet

Oral use

Modified-release
coated tablet

Oral use

Blister

Blister

14

7, 14

10

20

20

Clarityne D

Clarityne-D

Clarinase

Frinase

Clarinase

Narinex

Narinex

Loratadine
5 mg/
pseudoephedrine
sulph 120 mg

Loratadine
5 mg/
pseudoephedrine
sulph 120 mg

Loratadine
10 mg/
pseudoephedrine
sulph 240 mg

Loratadine
10 mg/
pseudoephedrine
sulph 240 mg

Prolonged-
release tablet

Prolonged-
release tablet

Oral use

Blister (ACLAR/PE/PVC)

100

Oral use

Blister (ACLAR/PE/PVC)

1, 7, 10, 14, 20, 28, 30, 50

Clarinase 120/5

5 mg + 120 mg
pseudoephedrine

Prolonged-
release tablet

Clarinase
240/10 once daily

10 mg + 240 mg
pseudoephedrine

Prolonged-
release tablet

Oral use

Oral use

Modified-release
tablet

Oral use

Claridon

Claridon QD

5 mg loratadine
+ 120 mg
pseudo-
ephedrine

10 mg loratadine
+ 240 mg
pseudo-
ephedrine

Blister

Blister

Blister

14

7, 10, 20

14, 20

Prolonged-
release tablet

Oral use

Blister

7, 14

.

.

3
0
4
2
0
0
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

C
1
1
9
/
4
7

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

SP

Laboratorios Lesvi S.A.
C/Argent 1. Pol. Ind. Can Pelegri
ES-08755 Castellbisbal, Barcelona,
Spain

Schering-Plough S.A.
Km 36 Carret Nacional 1
ES-28750 San Agustin de Guadalix
Madrid,
Spain

Rinociveran

Loratadine10 mg/
pseudoephedrine
sulphate 240 mg

Prolonged-
release tablet

Oral use

Blister (PVC/AL)

Narine Repetabs

Narine Retard

Loratadina
5 mg/
pseudoephedrine
sulphate 120 mg

Loratadina
10 mg/
pseudoephedrine
240 mg

Modified-release
tablet

Oral use

Blister

Prolonged-
release tablet

Oral use

Blister

10

20

10

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

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

ANNEX IX

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

.

.

3
0
4
2
0
0
4

AU

Aesca chem.pharm.
Fabrik GmbH.,
Badner Straße 23,
A-2514 Traiskirchen,
Austria

Arcana Arzneimittel
GmbH.,
Zimbagasse 5,
A-1147 Wien
Austria

Lannacher
Heilmittelwerke GmbH,
Schloßplatz 1,
A-8502 Lannach
Austria

Liconsa S.A. Gran Via
Carlos III, 98
ES-08028 Barcelona
Spain

Clarityn 10 mg -
lösliche Tabletten

Clarityn 10 mg -
Lyotabletten

Clarityn 10 mg
Tabletten

Clarityn 5mg/5ml
– Sirup

Loratadin Aesca
10mg - Tabletten

Loratadin Aesca
5mg/5ml - Sirup

10 mg

Soluble tablet

Oral use

Tablet container

10, 30

10 mg

Oral lyophilisate Oral use

10 mg

Tablet

Oral use

Blister

Blister

10, 30

10, 30

5 mg/5 ml

Syrup

Oral use

Bottle (glass)

60 ml

10 mg

Tablet

Oral use

Blister

10, 30

5 mg/5 ml

Syrup

Oral use

Bottle (glass)

60 ml

Loratyn 10 mg -
Brausetabletten

10 mg

Effervescent
tablet

Oral use

Tablet container

10

Loratyn 10 mg -
Lyotabletten

10 mg

Oral lyophilisate Oral use

Loratadin arcana
10 mg-
Filmtabletten

10 mg

Film-coated
tablet

Oral use

Blister

Blister

10, 30

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

Lorat 10 mg -
Tabletten

Chemotadin
10 mg - Tabletten

10 mg

Tablet

Oral use

Blister

7, 10, 20, 30, 50, 100

10 mg

Tablet

Oral use

Blister

7, 10, 20, 30, 50, 100

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e
E
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p
e
a
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U
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o
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i

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1
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/
4
9

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

AU
(cont’d)

BE

Lindopharm GmbH.,
Neustraße 82,
D-40721 Hilden
Germany

Ratiopharm Arzneimittel
Vertriebs-GmbH, Alöbert
Schweitzer Gasse 3,
A-1147 Wien
Austria

Sandoz GmbH.,
A-6250 Kundl/Tirol
Austria

Stada Arzneimittel
GmbH,
Heiligenstädterstraße
52/8,
A-1190 Wien,
Austria

Omega Pharma N.V.
Venecoweg 26
B-9810 Nazareth
Belgium

Laboratoires Irex
Avenue galilee
F-92350 Le Plessis-
Robinson, Cedex
France

Merck NV
Brusselsesteenweg 288
B-3090 Overijse
Belgium

Loratadin
Lindopharm
10 mg Tabletten

Loratadin
ratiopharm 10 mg
- Tabletten

Lictyn 10 mg -
Tabletten

Loratadine “Stada”
10 mg Tabletten

Loratadine “Stada”
1 mg/ml Sirup

Loratadin
Genericon 10 mg
– Tabletten

Genericon Pharma
GesmbH,
Schloßplatz 1,
A-8502 Lannach
Austria

10 mg

Tablet

Oral use

Blister

7, 10, 20, 30, 50, 100

10 mg

Tablet

Oral use

Blister

7, 20, 50, 100

10 mg

Tablet

Oral use

Blister

10 mg

Tablet

Oral use

Blister

7, 10, 14, 20, 21, 30, 50,
60, 100, 250

1, 5, 7, 10, 14, 15, 20,
21, 30, 50, 60, 90, 100,
250

5mg/5 ml

Syrup

Oral use

Bottle (glass)

50, 60, 100, 120, 150ml

10 mg

Tablet

Oral use

Blister

Sanelor

10 mg

Tablet

Oral use

Blister

10

10

Loratadine irex

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

7, 20, 30, 50, 100

Merck-loratadine

10 mg

Film-coated
tablet

Oral use

Blister
(PVC/Alu)

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

BE
(cont’d)

Schering Plough N.V.
Rue de Stalle 73
B-1180 Brussels
Belgium

Claritine

10 mg

Tablet

Oral use

Blister

Claritine

10 mg

Effervescent
tablet

Oral use

Blister

Claritine

1 mg/ml

Syrup

Oral use

Bottle

7, 21
1, 2, 5, 7, 10, 14, 20, 21,
28, 30, 42, 50, 56, 100,
500 - for export

10, 21
10, 14, 15, 21, 30 - for
export

100 ml
50, 60, 100, 120,
150 ml – for export

DK

1A Farma
Herstedøstervej 27-29
DK-2620 Albertslund.
Denmark

A/S GEA Farmaceutiske
Fabrik,
Holger Danskes Vej 89,
DK-2000 Frederiksberg,
Denmark

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

Durascan Medicinal
Products A/S
Svendborgvej 243,
DK-5260 Odense S,
Denmark

HEXAL AG
Industriestr. 25
D-83607 Holzkirchen
Germany

Lichtenstein
Pharmazeutica GmbH
Industriestrasse 10
D-56218 Mulheim-
Karlich
Germany

Claritine Reditabs

10 mg

Oral Lyophilisate Oral use

Loratadin 1A
Pharma

10 mg

Tablet

Oral use

Blister

Blister

10, 20, 30

10, 30, 100

Geklimon

10 mg

Tablet

Oral use

Blister

10, 30, 100

Loratadin ct

10 mg

Tablet

Oral use

Blister

Not marketed at the
moment

Oratyn

10 mg

Tablet

Oral use

Blister

5, 10, 30, 100

Medallerg

10 mg

Tablet

Oral use

Blister

Loratadin
Lichtenstein

10 mg

Tablet

Oral use

Blister

Not marketed at the
moment

Not marketed at the
moment

.

.

3
0
4
2
0
0
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

C
1
1
9
/
5
1

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

DK
(cont’d)

Linconsa SA.
Gran Via Carlos III 98,
7 Planta
ES-08028 Barcelona
Spain

Chemolorat

10 mg

Tablet

Oral use

Chemotadin

10 mg

Tablet

Oral use

Licatidin

10 mg

Tablet

Oral use

Loralic

10 mg

Tablet

Oral use

Lorat

10 mg

Tablet

Oral use

Loratadin
″Liconsa″

10 mg

Tablet

Oral use

Tifitadin

10 mg

Tablet

Oral use

Medis Danmark A/S
Havelse Mølle 14
DK-3600 Frederikssund
Denmark

Solamed

1 mg/ml

Oral solution

Oral use

Delor

10 mg

Tablet

Oral use

Loratadin Medis

1mg/ml

Oral suspension

Oral use

Loratabs

10 mg

Tablet

Oral use

Loarev

1 mg/ml

Oral suspension

Oral use

Lorafluid

1 mg/ml

Oral suspension

Oral use

Loramix

1 mg/ml

Oral suspension

Oral use

Lorfuse

1 mg/ml

Oral suspension

Oral use

Lorasol

1 mg/ml

Oral suspension

Oral use

Blister

Blister

Blister

Blister

Blister

Blister

Blister

Bottle

Blister

Bottle

Blister

Bottle

Bottle

Bottle

Bottle

Bottle

Deloradin

10 mg

Tablet

Oral use

Blister

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Ongoing. Packsizes not
decided

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

DK
(cont’d)

NM Pharma A/S.
Overgaden Neden Vandet
7,
DK-1414 København K
Denmark

PharmaCo Dane
Marielund vej 46A
DK-2730 Herlev
Denmark

Ratiopharm GmbH,
Graf-Acro-Strasse 3,
D-89079 Ulm,
Germany

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl
Austria

Schering Plough Europe
Rue de Stalle 73
B-1180 Brussels
Belgium

Schering-Plough A/S
Hvedemarken 12
DK-3520 Farum
Denmark

STADA Arzneimittel AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

Alerzid

1 mg/ml

Oral suspension

Oral use

Loratadin ″NM″

10 mg

Film-coated
tablet

Oral use

Bottle

Blister

Not marketed at the
moment

10, 30

Loratadin ″PCD″

1 mg/ml

Oral suspension

Oral use

Bottle

Not marketed at the
moment

10 mg

Tablet

Oral use

Blister

10, 30, 100

10 mg

Tablet

Oral use

Blister

10, 30, 100

Loratadin
Ratiopharm

Loratadin
Biochemie

Clarityn

Clarityn

Clarityn

10 mg

Tablet

Oral use

1 mg/ml

Oral Solution

Oral use

10 mg

Effervescent
tablet

Oral use

Clarityn

10 mg

Oral lyophilisate Oral use

Versal

10 mg

Tablet

Oral use

Allergostad

10 mg

Tablet

Oral use

Loratadin STADA

10 mg

Loradis

10 mg

Tablet

Tablet

Oral use

Oral use

Lorapharm

10 mg

Tablet

Oral use

Blister

Bottle

Blister

Blister

Blister

Blister

Blister

Blister

Blister

5, 10, 30, 100

1 x 100 ml

10

Not marketed at the
moment

Not marketed at the
moment

Not marketed at the
moment

10, 30, 50, 100

Not marked at the
moment

Not marked at the
moment

.

.

3
0
4
2
0
0
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

C
1
1
9
/
5
3

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

DK
(cont’d)

FI

Sterwin Medicines Ltd
1 Onslow Street,
Guildford
Surrey
GU1 4YS,
United Kingdom

Wörwag Pharma GmbH
& Co. KG.
Calwerstrasse 7
D-71034 Böblingen,
Germany

A/S Gea Farmaceutisk
Fabrik,
Holger Danskes Vej 89,
DK-2000 Frederiksberg,
Denmark

DuraScan Medical
Products AS,
Svendborgvej 243,
DK-5260 Odense S,
Denmark

Generics (UK) Limited,
Station Close,
Potters Bar,
Herts EN6 1TL,
United Kingdom

Laboratoires SMB S.A.,
Rue de la Pastorale 26-28,
B-1080 Brussels,
Belgium

Ratiopharm GmbH,
Graf-Arco-Strasse 3,
D-89079 Ulm,
Germany

Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria

Schering-Plough Europe,
73, Rue De Stalle,
B-1180 Brussels,
Belgium

Lorafile

10 mg

Tablet

Oral use

Blister

LORATAGAMMA

10 mg

Tablet

Oral use

Blister

Not marketed at the
moment

Not marketed at the
moment

Geklimon

10 mg

Tablet

Oral use

Blister

7, 10, 20, 21, 30, 100

Loratadin
Durascan

10 mg

Tablet

Oral use

Blister

5, 7, 10, 14, 20, 30, 40,
100, 105

Loratadin Generics

10 mg

Film-coated
tablet

Oral use

Blister

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

Histadin

10 mg

Tablet

Oral use

Blister

10, 30, 100

Loratadin-
ratiopharm

Loratadin
Biochemie

Clarityn

Clarityn

Clarityn-S

10 mg

Tablet

Oral use

Blister

2, 7, 10, 20, 30, 50, 100

10 mg

Tablet

Oral use

Blister and tablet
container

7, 10, 14, 20, 21, 30, 50,
60, 100,
100x1,250

1 mg/ml

Oral solution

Oral use

10 mg

10 mg

Tablet

Oral use

Oral lyophilisate Oral use

Bottle

Blister

Blister

120 ml

10, 30, 100

8, 10, 30, 100,

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

.

.

3
0
4
2
0
0
4

FI
(cont’d)

FR

STADA Arzneimittel AG,
Stadastrasse 2-18,
D-61118 Bad Vilbel,
Germany

Verman Oy Ab,
Vanhankyläntie 44 B,
FIN-04401 Järvenpää,
Finland

ENDWELL
Elm House
Ashbourne Industrial
Estate
Ashbourne - County
Meath
Ireland

Generics
28 Station Close
Potters Bar
EN6 1TL Hertfordshire,
United Kingdom

MADAUS
Immeuble Mercure III
55 bis, Quai de Grenelle
F-75015 Paris,
France

Schering Plough
92, rue Baudin
F-92307 Levallois Perret
Cedex,
France

Loratadin Stada

10 mg

Tablet

Oral use

Blister

Loratadin Stada

1 mg/ml

Oral solution

Oral use

Tuulix

Tuulix

LORATADINE
ENDWELL

10 mg

Tablet

Oral use

1 mg/ml

Oral solution

Oral use

10 mg

Tablet

Oral use

Bottle

Blister

Bottle

Blister
(PVC/Alu)

1, 5, 7, 10, 14, 15, 20,
21, 30, 50, 60, 90, 100,
250

50, 60, 100, 120,
150 ml

1, 10, 30, 100

60, 100, 200 ml

15, 28, 30, 100

LORATADINE

10 mg

Film-coated
tablet

Oral use

Blister
(PVC/Alu)

5, 7, 10, 14, 15

LORATADINE
MADAUS

10 mg

Tablets

Oral use

Blister (PVC/Alu)

15, 28, 30

CLARITYNE

0.1 g/100ml

Syrup

Oral use

CLARITYNE

10 mg

Tablet

Oral use

CLARITYNE

10 mg

Effervescent
tablet

Oral use

Glass
(brown)

Blister
(PVC/Alu)

Blister
(Alu/Alu)

60, 120 ml

10, 15, 20

7, 10, 14, 15, 20, 21, 30

LORATADINE
SCHERING
PLOUGH

LORATADINE
SCHERING
PLOUGH

LORATADINE
SCHERING
PLOUGH

0.10 %

Syrup

Oral use

Bottle (glass)

60, 125ml

10 mg

Effervescent
tablet

Oral use

Blister (Alu/Alu)

7, 10, 14, 15, 20, 21, 30

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

10, 15, 20

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
1
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9
/
5
5

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

FR
(cont’d)

GE

VIARO

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

5, 7, 10, 15

MADAUS
Immeuble Mercure III
55 bis, Quai de Grenelle
F-75015 Paris,
France

LORATADINE
MADAUS

0.1 g/100ml

Syrup

Oral use

Bottle (glass)

60, 120 ml

1 A Pharma GmbH
Keltenring 1+3
D-82041 Oberaching
Germany

Loratad 10 mg

10 mg

Tablet

Oral use

Loratad 10

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

7, 20, 50, 100

7, 10, 14, 20, 21, 30, 50,
100

20, 30, 50, 100

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

Blister
(PVC/PVDC/Alu)

20, 50, 100

Loratadin-1A
Pharma

Loratadin Acis
10 mg

Chemotadin
10 mg Tabletten

Lorat 10 mg
Tabletten

Loratadin AL
10 mg Tabletten

Loratadin AL
1 1 mg/ml saft

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

1 mg/1ml

Syrup

Oral use

LORA-PUREN

10 mg

Tablet

Oral use

Enatin

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Bottle
(PE)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

7, 10, 20, 30, 50, 100

7, 10, 20, 30, 50, 100

7, 20, 50, 100

50, 60, 100, 120,
150 ml

7, 10, 20, 50, 100, 500

10, 20, 50, 100

Acis Arzneimittel Vertrieb
AG
Bajuwarenring 14
D-82041 Oberhachling
Germany

Alfred E.Tiefenbacher
GmbH & Co.
Van-der-Schmissen-Str 1
D-22767 Hamburg
Germany

Aliud Pharma GmbH &
Co KG
Gottlieb-Daimler Str 19
D-89150 Laichingen
Germany

Alpharma-ISIS GmbH &
Co KG
Elisabeth-Selbert-Str. 1
D-40764 Langenfeld
Germany

Altana Consumer Health
GmbH
Bargkoppelweg 66
D-22145 Hamburg
Germany

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

.

.

3
0
4
2
0
0
4

GE
(cont’d)

AWD.pharma GmbH &
Co. KG
Leipziger Str. 7-13
D-01097 Dresden
Germany

Basics GmbH
Hemmelrather Weg 201
D-51377 Leverkusen
Germany

Sandoz Pharmaceutical
GmbH
Carl-Zeiss-Ring 3
D-85737 Ismaning
Germany

Betapharm Arzneimittel
GmbH
Kobelweg 95
D-86156 Augsburg
Germany

ct-Arzneimittel GmbH
Lengeder Str. 42a
D-13407 Berlin
Germany

Dermapharm AG
Luise-Ullrich-Str. 6
D-82031 Gruenwald
Germany

Dr.August Wolff GmbH &
Co. Arzneimittel
Sudbrackstr. 56
D-33611 Bielefeld
Germany

Dr.Gerhard Mann Chem.-
pharm.Fabrik GmbH
Brunsbuetteler Damm
165-173
D-13581 Berlin
Germany

Dr.R.Pfleger Chemische
Fabrik GmbH
Emil-Kemmer-Str. 33
D-96103 Hallstadt
Germany

Loralerg

10 mg

Tablet

Oral use

!LORA BASICS

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

Blister
(PVC/Alu)

7, 20, 50, 100, 500

7, 20, 50, 100

TRILOR 10 mg
Tabletten

10 mg

Tablet

Oral use

Blister
(PVC/AL,PVC/AL/PVDC,PVC/PE,PVDC/AL)

7, 10, 20, 50, 100

Betalora 10

10 mg

Tablet

Oral use

Lobeta gegen
Allergien

10 mg

Tablet

Oral use

Loratadin von ct

10 mg

Tablet

Oral use

Loraderm

10 mg

Tablet

Oral use

Loradino 10 mg
Tabletten

10 mg

Tablet

Oral use

Lora Rhinol 10 mg
Tabletten

Vividrin Tabletten
Wirkstoff
Loratadin

Lantamed 10 mg
Tabletten

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(Alu)

Blister
(PVC/Alu)

7, 10, 20, 30, 50, 100

7, 20, 50, 100

7, 20, 50, 100

7, 20, 50, 100

7, 20, 50, 100

7, 20, 50, 100

7, 14, 28, 56

7, 20, 50, 100

E
N

O

f
f
i
c
i
a
l

J
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a
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E
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5
7

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

GE
(cont’d)

Essex Pharma GmbH
Thomas-Dehler-Str. 27
D-81737 Muenchen
Germany

GALENpharma GmbH
Wittland 13
D-24109 Kiel
Germany

Hermal Kurt Herrmann
GmbH & Co.
Scholtzstr. 3
D-21465 Reinbek
Germany

Heumann Pharma GmbH
Suedwestpark 50
D-90449 Nuernberg
Germany

HEXAL AG
Industriestr. 25
D-83607 Holzkirchen
Germany

Krewel Meuselbach
GmbH
Krewelstr. 25
D-3783 Eitorf
Germany

KSK – Pharma Vertriebs
AG
Roggenbackstr. 4
D-76133 Karlsruhe
Germany

Lisino

10 mg

Tablet

Oral use

Lisino Brause
Brausetabletten

10 mg

Effervescent
tablet

Oral use

Lisino extra
schnellaufloesende
Tabletten

10 mg

Tablet

Oral use

Lisino S

Loratadin Brause
Brausetabletten

10 mg

10 mg

Tablet

Effervescent
tablet

Oral use

Oral use

LORAGALEN

10 mg

Tablet

Oral use

Blister

Blister

Blister

Blister

Blister

20, 50, 100

10, 30

8, 10, 20, 50, 60

7

10

Blister
(PVC/Alu)

7, 20, 50, 100, 500

10 mg

Tablet

Oral use

Blister strips
(PVC/Alu)

7, 20, 50, 100

Loratadindura
10 mg
Filmtabletten

Loratadin
10 Heumann

10 mg

Tablet

Oral use

Loratadina 10 mg

10 mg

Tablet

Oral use

Lorano

10 mg

Tablet

Oral use

Lorano akut

10 mg

Tablet

Oral use

Loraclar

10 mg

Tablet

Oral use

Loratadin KSK

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

7, 20, 50, 100, 500

7, 20, 50, 100

7, 10, 20, 30, 50, 100

7, 14, 20, 50, 100

7, 20, 50, 100, 500

7, 20, 30, 50, 100

C
1
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9
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5
8

E
N

O

f
f
i
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i
a
l

J
o
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n
a
l

o
f

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

i

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

GE
(cont’d)

Lichtenstein
Pharmazeutica GmbH &
Co.
Industriestr. 26
D-56218 Muelheim-
Kaerlich
Germany

Lindopharm GmbH
Neustr. 82
D-40721 Hilden
Germany

Medis Danmark A/S
Havelse Mølle 14
DK-3600 Fredrikssund
Denmark

PROMEDIPHARM GmbH
Berliner Ring 89
D-64625 Bensheim
Germany

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

Sandoz Pharmaceutical
GmbH
Carl-Zeiss-Ring
D-85737 Ismaning
Germany

Lora-Lich 10 mg
Tabletten

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

7, 20, 50, 100

Loravis 10 mg
Tabletten

10 mg

Tablet

Oral use

Alerisa

10 mg

Tablet

Oral use

Lorasan

10 mg

Tablet

Oral use

Loratadura 10mg

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

7, 20, 50, 100

7, 10, 14, 20, 50, 100

7, 20, 50, 100, 500

7, 20, 50, 100, 500

20, 50, 100

7, 20, 50, 100

10 mg

Tablet

Oral use

Blister
(PVC/PVDC/Alu)

20, 50, 100

10 mg

Tablet

Oral use

Blister
(PVC/PVDC/Alu)

20, 50, 100

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

Blister
(PVC/PVDC/Alu)

20, 50, 100

Blister
(PVC/Alu)

7, 10, 20, 50, 100

Blister
(PVC/AL,PVC/AL/PVDC,
PVC/PE,PVDC/AL)

7, 10, 20, 50, 100

Lora-ratiopharm
10 mg Tabletten

Loratadin-
ratiopharm 10 mg
Tabletten

Loratadin-
ratiopharm
(10 mg Tabletten)
bei Allergien

Loratadinum von
ratio 10 mg
Tabletten

Loratadin-ratio
10 mg Tabletten

Loratadin
Azupharma 10mg
Tabletten

Loratadine AZU
10 mg Tabletten

.

.

3
0
4
2
0
0
4

E
N

O

f
f
i
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i
a
l

J
o
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r
n
a
l

o
f

t
h
e
E
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a
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U
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5
9

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

GE
(cont’d)

GR

Stadapharm GmbH
Stadastr. 2-18
D-61118 Bad Vilbel
Germany

Woelm Pharma GmbH &
Co.
Rhoendorfer Str. 80
D-53604 Bad Honnef
Germany

Woerwag Pharma GmbH
& Co.
Calwer Str. 7
D-71034 Boeblingen
Germany

ANΦΑΡΜ ΕΛΛΑΣ Α.Ε.
442 Acharnon Str
GR-11143 Athens
Greece

Biomedica-Chemica S.A.
Liolios-Parodos G. Lyra
25-K. Kifisia,
Greece

BIOSPRAY ABEE
10, Aristotelous str.
GR-104 32 Athens
Greece

Coup OE
Kouparousos
Ag. Barbaras 53,
GR-172 35 Dafni
Greece

DOCTUM S.A.
5, Dorilaiou str.
GR-115 21 Athens
Greece

Faran ABEE
Ahaias kai Trizinias
145 64 N. Kifisia,
Greece

Loratadin STADA
allerg 10 mg
Tabletten

Livotab direkt
Tabletten

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

Loragamma 10 mg
Tabletten

10 mg

Tablet

Oral use

Blister
(PVC/Alu)

Blister
(PVC/Alu)

Blister
(PVC/Alu)

PROMEDIPHARM GmbH
Berliner Ring 89
D-64625 Bensheim
Germany

Lorasol Loesung

10 mg/10 ml

Oral solution

Oral use

Bottle (glass)

7, 20, 50, 100

7, 10, 14, 28

7, 10, 20, 50, 100

Packsize not determined
yet

Latoren

10 mg

Tablet

Oral use

Blister

14, 28

Zelmar

10 mg

Tablet

Oral use

Blister

14, 21

Loratab

10 mg

Tablet

Oral use

Blister

14, 21, 42

Ralinet

10 mg

Tablet

Oral use

Blister

14, 21

Allergofact

10 mg

Tablet

Oral use

Blister

14, 20

Difmedol

10 mg

Tablet

Oral use

Blister

14

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

.

.

3
0
4
2
0
0
4

GR
(cont’d)

Finixfarm
Ant. Polyxronis
Anabrytis 11
Athens,
Greece

HELP ABEE
4 Valaoritou Str
GR-14452 Metamorphosi
Greece

KLEVA E.Π.E.
189 Parnithos Ave
GR-13671 Acharnai
Greece

LAMDA
PHARMACEUTICAL
6 Thermopilon str.
152 33 Chalandri
Athens
Greece

LEOVAN
10, Chrisanthou
Trapezountos str.
166 77 Elliniko
Athens
Greece

MED-ONE S.A.
ΕΛΛΑΣ
211 Parnithos Ave
GR-13671 Acharnal
Athens
Greece

Novartis (Hellas) A.E.B.E
120 xlm Ethnikis Odou
Athinon-Lamias
GR-14410 Metamorfosi
Greece

Novexal Hellas
25 AgDimitriou Str
174 55 Kalamaki,
Athens
Greece

Lora

10 mg

Tablet

Oral use

Blister

14, 21, 28

Helporigin

10 mg

Tablet

Oral use

Blister

14

Horestyl

10 mg

Tablet

Oral use

Horestyl

5 mg/ 5 ml

Syrup

Oral use

Loralerg

10 mg

Effervescent
tablet

Oral use

Blister

Bottle

Blister

Ristotadin

10 mg

Tablet

Oral use

Blister

Allerdrug

5 mg/5 ml

Syrup

Oral use

Allerdrug

10 mg

Tablet

Oral use

Bottle

Blister

Loratadine/
Biochemie

10 mg

Tablet

Oral use

Blister (PVC/AL, PVC/PE,
PVC)

14, 21

120 ml

21

21

120 ml

14

7, 10, 14, 20, 21, 30, 50,
60, 100x1, 100,
250 (PVC/AL)
7 (PVC/PE)
10, 14, 20, 21, 30, 50,
60, 100x1, 100,
250 (PVC)

Loratadine /
Novexal

Loratadine /
Novexal

5 mg/5 ml

Syrup

Oral use

10 mg

tablet

Oral use

Bottle

Blister

120 ml

14

E
N

O

f
f
i
c
i
a
l

J
o
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r
n
a
l

o
f

t
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E
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a
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U
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i

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6
1

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

GR
(cont’d)

IC

Relyo Hellas ΕΠΕ
Pan. Kabbadas
Fabicrou 48
Athens,
Greece

Schering Plough
A.Φ.B.E.E.
63 Agiou Dimitriou
GR-17456 Alimos
Greece

VELKA HELLAS AEBE
12 Korinthou str.
154 51 Psychiko
Athens
Greece

VIOFAR EPE
Terma Evaggelistrias
GR-136 71 Acharnai
Athens
Greece

ΦΑΡΜΑΤΕΝ Ε.Π.Ε
68 Menandrou Str
GR-10432 Athens
Greece

ΦΑΡΜΕΞ Α.Ε.
156 Aylonos Str
Sepolia GR-1044
Greece

Delta hf.
Reykjavíkurvegi 78
IS-220 Hafnarfjörður
Ísland

NM Pharma,
Reykjavíkurvegi 78
IS-220 Hafnarfjörður
Ísland

Novacloxab

10 mg

Tablet

Oral use

Blister

10, 14

Clarityne

10 mg

Tablet

Oral use

Clarityne

5 mg/5 ml

Syrup

Oral use

Clarityne

10 mg

Effervescent
tablet

Oral use

Clarityne

10 mg

Oral lyophilisate Oral use

Igir

10 mg

Tablet

Oral use

Bollinol

10 mg

Tablet

Oral use

Bollinol

5 mg/5 ml

Syrup

Oral use

Biliranin

10 mg

Tablet

Oral use

Utel

Utel

10 mg

Tablet

Oral use

5 mg/5 ml

Syrup

Oral use

Lóritín

10 mg

Tablet

Oral use

Blister

Bottle

Blister

Blister

Blister

Blister

Bottle

Blister

Blister

Bottle

Blister

10, 14, 21

120 ml

10, 21

10, 20

21

20

120 ml

14

10, 14, 21

120 ml

10, 30, 100

Loratadine NM
Pharma

10 mg

Tablet

Oral use

Blister

10, 30, 100

C
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O

f
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a
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J
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n
a
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o
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E
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a
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U
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o
n

i

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

.

.

3
0
4
2
0
0
4

IC
(cont’d)

IR

Schering-Plough Europe,
Rue de Stalle,
B-1180 Brussels
Belgium

McDermott Laboratories
Ltd
35 Baldoyle Industrial
Estate,
Grange Road
Baldoyle
Dublin 13,
Ireland

Olinka UK Ltd
38-40 Chamberlayne
Road
London, NW10 3JE,
United Kingdom

Schering-Plough Ltd
Schering-Plough House
Shire Park
Welwyn Garden City
Hertfordshire, AL7 1TW,
United Kingdom

IT

Essex Italia SPA
Via Serio, 1
I-20139 Milano,
Italy

F.I.R.M.A. SPA
Via Dio Scandicci, 37
I-50143 Firenze,
Italy

Clarityn

10 mg

Effervescent
tablet

Oral use

Clarityn

Clarityn

Histaclar

1 mg/ml

Oral solution

Oral use

10 mg

10 mg

Tablet

Tablet

Oral use

Oral use

Blister

Bottle

Blister

Blister

Histaclar Allergy
Tablet

10 mg

Tablet

Oral use

Blister

Loratadine

10 mg

Tablet

Oral use

Blister

10

100 ml

10, 30, 100

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

7, 10, 14, 28, 30, 56, 60,
84, 90, 100, 120, 150

Clarityn

Clarityn

10 mg

Tablet

1 mg/ ml

Syrup

Clarityn Rapide

10 mg

Clarityn Rapide
Allergy Tablets

10 mg

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Alorin

Alorin

Alorin

Alorin

Fristamin

10 mg

Tablet

Oral use

1 mg/ml

Oral solution

Oral use

10 mg

10 mg

10 mg

Effervescent
tablet

Oral use

Oral lyophilisate Oral use

Tablet

Oral use

Fristamin

1 mg/ml

Oral solution

Oral use

Fristamin

10 mg

Effervescent
tablet

Oral use

Fristamin

10 mg

Oral lyophilisate Oral use

Blister

5, 7, 10, 30

Bottle (glass)

100, 200ml

Strip

Strip

Blister

Bottle

Blister

Blister

Blister

Bottle

Blister

Blister

30

7, 10

5, 7, 10, 20

100 ml

20

20

5, 7, 10, 20

100 ml

20

20

E
N

O

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f
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J
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Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

IT
(cont’d)

Schering Plough SPA
Via Ripamonti, 89
I-20141 Milano,
Italy

LU

Merck s.a.,
Brusselsesteenweg 288,
B-3090 Overijse,
Belgium

Ratiopharm GmbH
Graf-Arco-Strasse 3
D-89079 Ulm,
Germany

SCHERING-PLOUGH s.a.
73, Rue de Stalle
B-1180 Brussels,
Belgium

Clarityn

10 mg

Tablet

Oral use

Clarityn

Clarityn

1mg/ml

Oral Solution

Oral use

10 mg

Effervescent
tablet

Oral use

Clarityn

10 mg

Oral lyophilisate Oral use

Lorastad 10 mg

10 mg

Tablet

Oral use

Lorastad 1mg/ml

1mg/ml

Syrup

Oral use

Merck-Loratadine

10 mg

Tablet

Oral use

Loratadine
Ratiopharm

10 mg

Tablet

Oral use

Claritine

10 mg

Effervescent
tablet

Claritine

10 mg

Tablet

Claritine
Pédiatrique

1 mg/ ml

Syrup

Sanelor

10 mg

Loratadine B.C.

10 mg

Tablet

Tablet

Oral use

Oral use

Oral use

Oral use

Oral use

Blister

Bottle

Blister

Blister

Blister
(PVC)

Bottle
(amber)

Blister
(PVC/AL)

Blister
(PVC/Al)

Blister

Blister

Bottle

Blister

Blister

5, 7, 10, 20

100 ml

20

20

1, 5, 7, 10, 14, 15, 20,
21, 30, 50, 60, 90, 100,
250

50, 60, 100, 120,
150 ml

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

7, 20, 50, 100

10, 21

7, 21

100 ml

10

7, 21

Loratadine EG

10 mg

Tablet

Oral use

Blister

1, 5, 7, 10, 14, 15, 20,
21, 30, 50, 60, 90, 100,
250

Loratadine EG

1 mg/ml

Syrup

Bottle
(glass)

50, 60, 100, 120,
150 ml

Stada Arzneimittel AG
Stadastrasse 2-18
D-6118 Bad Vilbel
Germany

Multipharma B.V.
Postbus 216
NL-1380 AE Weesp,
Netherlands

STADA Arzneimittel AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

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E
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i

.

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3
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4
2
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0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

NL

Centrafarm Services B.V.
Postbus 289
NL-4870 AG Ehen-Leur
Netherlands

Disphar International B.V.
Postbus 100
NL-7255 ZK Hengelo
(Gld),
Netherlands

Genfarma B.V.
P.O. Box 2062
NL-1500 GB Zaandam
Netherlands

Hexal Pharma Nederland
B.V.
Postbus 251
NL-2180 AG Hillegom,
Netherlands

Katwijk Farma B.V.
Postbus 408
NL-2300 AK Leiden,
Netherlands

Merck Generics B.V.
Dieselweg 26
NL 3752 LB Bunschoten
Netherlands

Multipharma B.V.
Postbus 216
NL-1380 AE Weesp,
Netherlands

Schering-Plough B.V.
Postbus 1364
NL-3600 BJ Maarssen,
Netherlands

Loratadine CF
1 mg/ml

Loratadine CF
10 mg

Loratadine
Disphar 10

Loratadine Gf
10 mg

Loratadine 10 mg
Hexal

Loratadine
1mg/ml Katwijk

Loratadine 10 mg
Katwijk

Loratadine Merck
10 mg

1 mg/ml

Syrup

Oral use

10 mg

Tablet

Oral use

Bottle

Blister

50, 60, 100, 120,
150 ml

1, 5, 7, 10, 14, 15, 20,
21, 30, 50, 60, 90, 100,
250

10 mg

Tablet

Oral use

Blister

30

10 mg

Tablet

Oral use

Blister

7, 10, 20, 21, 30, 50,
100

10 mg

Tablet

Oral use

Blister

7, 10, 20, 21, 30, 100

1 mg/ml

Syrup

Oral use

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

Loratadine 10

10 mg

MP-Loratadine

10 mg

Tablet

Tablet

Oral use

Oral use

Claritine
Reditabs

Claritine

Claritine

Claritine

10 mg

Oral Lyophilisate Oral use

1 mg/ml

10 mg

10 mg

Syrup

Tablet

Effervescent
tablet

Oral use

Oral use

Oral use

Sanelor

10 mg

Tablet

Oral use

Bottle

Blister

Blister

Blister

Blister

Blister

Bottle

Blister

Blister

Blister

60, 120 ml

10, 30, 250

5, 7, 10, 14,
15, 20, 21, 30, 50, 100

7, 10, 20, 50, 100, 250

7, 10, 14, 20, 21, 30, 50,
60, 100, 250

10, 20, 30

60, 120 ml

2, 5, 7, 10, 30

7, 10, 30

10

.

.

3
0
4
2
0
0
4

E
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O

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J
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r
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a
l

o
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Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

NL
(cont’d)

NO

Stada Arzneimittel AG
Stadastrasse 2-18
D-61118 Bad Vilbel,
Germany

A/S GEA Farmaceutisk
Fabrik,
Holger Danskes vej 89,
DK-2000 Frederiksberg,
Denmark

Sandoz GmbH,
Biochemiestrasse 10,
A-6250 Kundl,
Austria

Duranor AS,
Hoffsv. 70 B,
N-0319 Oslo,
Norway

NM Pharma AS,
Lilleakerv. 2 B,
N-0283 Oslo,
Norway

Ratiopharm GmbH,
Graf-Arco-Str 3,
DE-89079 Ulm,
Germany

Schering-Plough AS,
Ankerveien 209,
N-1359 Eiksmarka,
Norway

Schering-Plough Europe,
73, Rue de Stalle,
B-1180 Brussels,
Belgium

Stada Arzneimittel AG,
Stadastrasse 2-18.
D-61118 Bad Vilbel,
Germany

Lorastad
1 mg/ml

1 mg/ml

Syrup

Oral use

Lorastad 10 mg

10 mg

Tablet

Oral use

Bottle

Blister

50, 60, 100, 120,
150 ml

1, 5, 7, 10, 14, 15, 20,
21, 30, 50, 60, 90, 100,
250

Loratadin Gea

10 mg

Tablet

Oral use

Blister

7, 10, 20, 21, 30, 100

Loraratidin
Biochemie

10 mg

Tablet

Oral use

Blister

7, 10, 14, 20, 21, 30, 50,
60, 100, 100x1, 250

Loratadin Duranor

10 mg

Tablet

Oral use

Blister

Loratadin

10 mg

Tablet

Oral use

Blister

Loratadin
Ratiopharm

10 mg

Tablet

Oral use

Blister

5, 7, 10, 14, 20, 30, 40,
100, 105

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

2, 7, 10, 20, 20x1, 21,
30, 50, 100, 100x1

Versal

10 mg

Tablet

Oral use

Blister

10, 30, 60, 100

Clarityn

Clarityn

Clarityn-S

1 mg/ml

Oral solution

Oral use

10 mg

10 mg

Tablet

Oral use

Oral lyophilisate Oral use

Loratadin Stada

1 mg/ml

Oral solution

Oral use

Loratadin Stada

10 mg

Tablet

Oral use

Bottle

Blister

Blister

Bottle

Blister

120 ml

7, 30, 100

10, 30, 100

50, 60, 100, 120,
150 ml

10, 20, 28, 30, 50, 56,
60, 90, 100

C
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E
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O

f
f
i
c
i
a
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J
o
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n
a
l

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

i

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

.

.

3
0
4
2
0
0
4

PT

Sandoz, GmbH
Biochemiestraße 10
A-6250 Kundl
Austria

Decomed Farmacêutica,
S.A. Rua Sebastião e Silva,
56
P-2745-838 Massamá
Portugal

Euro-Labor, Laboratórios
de Síntese Química e
Especialidades
Farmacêuticas, S.A. Rua
Alfredo da Silva, 16
P.º Box 60270
P-2720-028 Amadora
Portugal

Farmalavi - Produtos
Farmacêuticos, Sociedade
Unipessoal,
Lda. Rua Elias Garcia,
28 Venda Nova
P-2700-327 Amadora
Portugal

Farmoz - Sociedade
Técnico-Medicinal, S.A.
Rua Prof. Henrique de
Barros, Edifício Sagres,
3ºA
P-2685-338 Prior Velho
Portugal

Generis Farmacêutica,
S.A. Rua José Galhardo,
n.º 3
P-1750-131 Lisboa
Portugal

Irex - Promoção e
Comercialização de
Produtos Farmacêuticos,
Lda
Praça Duque de Saldanha
n° 1-4°E
P-1050-094 Lisboa
Portugal

Loratadina
Biochemie 10 mg
Comprimidos

10 mg

Tablet

Oral use

Blister

7, 10, 14, 20, 21, 30, 50,
60, 100, 100x1, 250

Loratin

10 mg

Tablet

Oral use

Blister

Loristine

10 mg

Tablet

Oral use

Blister

20

20

Loratadina
Farmalavi 10 mg
comprimidos

10 mg

Tablet

Oral use

Blister

20

Evertine

10 mg

Tablet

Oral use

Blister

10, 20

Evertine

1 mg/ml

Syrup

Oral use

Bottle

100ml

Loratadina Generis
10 mg
Comprimidos

Loratadina Irex
10 mg
comprimidos

10 mg

Tablet

Oral use

Blister

20

10 mg

Tablet

Oral use

Blister

7, 20, 50, 100

E
N

O

f
f
i
c
i
a
l

J
o
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r
n
a
l

o
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t
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e
E
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a
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U
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7

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

PT
(cont’d)

Labesfal - Laboratórios
Almiro,
S.A. , Avenida Dr Afonso
Costa
P-3465-051 Campo de
Besteiros
Portugal

Merck Genéricos -
Produtos Farmacêuticos,
Lda. Rua Alfredo da Silva,
3 - C - 4º
P-1300-040 Lisboa
Portugal

Pentafarma - Sociedade
Técnico-Medicinal, S.A.
Rua Prof. Henrique de
Barros, Edif. Sagres, 5ºA
P-2685-338 Prior Velho
Portugal

Plough Farma, Lda.
Rua Agualva dos Açores
no 16
P-2735-557 Agualva -
Cacém
Portugal

Produfarma, Lda.
(Laboratório Scientia)
Estrada de Benfica, 403-B
P-1500-077 Lisboa
Portugal

Ratiopharm - Comércio e
Indústria de Produtos
Farmacêuticos, Lda.
Edifício Tejo - 6º Piso Rua
Quinta do Pinheiro
P-2790-145 Carnaxide
Portugal

Schering-Plough Farma,
Lda.
Rua Agualva dos Açores
16
P-2735-557 Agualva-
Cacém
Portugal

Loratadina
Labesfal 10 mg
Comprimidos

10 mg

Tablet

Oral use

Blister

Crizin

10 mg

Tablet

Oral use

10 mg

Coated tablet

Oral use

Loratadina Merck
Genéricos 10 mg
Comprimidos
Revestidos

Zolargene

10 mg

Tablet

Oral use

Zolargene

1 mg/ml

Syrup

Oral use

Alertrin

Alertrin

10 mg

10 mg

Tablet

Effervescent
tablet

Oral use

Oral use

Alertrin Zydis

10 mg

Oral lyophilisate Oral use

Alertrin

1mg/ml

Alerdaune

10 mg

Syrup

Tablet

Oral use

Oral use

Alerdaune

1 mg/ml

Oral Suspension Oral use

10 mg

Tablet

Oral use

Loratadina
Ratiopharm
10 mg
Comprimidos

Claritine

Claritine

10 mg

10 mg

Tablet

Effervescent
tablet

Oral use

Oral use

Claritine

1 mg/ml

Syrup

Oral use

Blister

Blister

Blister

Bottle

Blister

Blister

Blister

Bottle

Blister

Bottle

Blister

Blister

Blister

Bottle

20

20

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

10, 20

100 ml

10, 20

10, 20

10, 20

100, 200ml

20

100ml

7, 10, 20, 20x1, 50, 100,
100x1

20

10, 20

100, 200ml

C
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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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

.

.

3
0
4
2
0
0
4

PT
(cont’d)

SP

Stada Arzneimittel A.G.
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

Tecnimede - Sociedade
Técnico-Medicinal, S.A.
Rua Prof. Henrique de
Barros - Edf. Sagres, 3º A
P-2685-338 Prior Velho
Portugal

Bexal Farmaceutica S.A.
Ventura Rodriguez 7
5ª Plta,
ES-28008 Madrid,
Spain

Combino Pharma
Fructuoso Gelabert 6-8
ES-08970 San Juan Despi
Barcelona,
Spain

Industrial Farmacéutica
Cantabria
Carretera Cazoña-Ardazo
s/n
ES-39011 Santander,
Spain

Ipsen Pharma S.A.
Ctra. Laureà Miró 395
ES-08980 Sant Feliu de
Llobregat
Barcelona,
Spain

Kern Pharma S.L.
Pol. Ind. Colon II
Venus 72,
ES-08228 Terrassa
Barcelona,
Spain

Claritine Zydis

10 mg

Oral lyophilisate Oral use

Loratadina Stada
1 mg/ml Xarope

Loratadina Stada
10 mg
Comprimidos

1 mg/ml

Syrup

Oral use

10 mg

Tablet

Oral use

Blister

Bottle

Blister

10, 20

50, 60, 100, 120,
150 ml

1, 5, 7, 10, 14, 15, 20,
21, 30, 50, 60, 90, 100,
250

Profenox

10 mg

Tablet

Oral use

Blister

10, 20

Profenox

1 mg/ml

Syrup

Oral use

Bottle

100 ml

Loratadina Bexal

10 mg

Tablet

Oral use

Blister

Loratadine
Combino Pharm

10 mg

Tablet

Oral use

Blister

Fadina

10 mg

Tablet

Oral use

Blister

Loratadina UR

10 mg

Tablet

Oral use

Blister

Loratadina Lasa

10 mg

Tablet

Oral use

Blister

Loratadina Kern

10 mg

Tablet

Oral use

Blister

20

20

20

20

20

20

E
N

O

f
f
i
c
i
a
l

J
o
u
r
n
a
l

o
f

t
h
e
E
u
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a
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U
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o
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6
9

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

SP
(cont’d)

Laboratorio Bayvit
Av. Frederic Mompou 5
ES-08960 Sant Just
Desvern
Barcelona,
Spain

Laboratorios Cinfa
C/ Olaz-Chipi 10
ES-31620 Huarte,
Pamplona,
Spain

Laboratorios Davur S.L.
C/ Teide, 4
Parque Empresarial “La
Marina”
ES-28700 San Sebastian
de los Reyes
Madrid,
Spain

Laboratorios Geminis
S.A.
Gran Via de Les Cortes
Catalanes 7674
ES-08013 Barcelona,
Spain

Laboratorios Lesvi S.A.
C/ Argent, 1
Pol. Ind. Can Pelegri
ES-08755 Castellbisbal,
Barcelona,
Spain

Laboratorios Normon
S.A.
Nieremberg 10
ES-28002 Madrid,
Spain

Laboratorios Rimafar S.L.
Poligono Malpica c/C 4
ES-50016 Zaragoza,
Spain

Loratadina Bayvit

10 mg

Coated tablet

Oral use

Blister

20

Loratadina Bayvit

1 mg/ml

Syrup

Oral use

Loratadina Cinfa

10 mg

Coated tablet

Oral use

Bottle

Blister

Loratadina Davur

10 mg

Tablet

Oral use

Blister

Loratadina
Geminis

10 mg

Tablet

Oral use

Blister

Loratadine Genpril

10 mg

Tablet

Oral use

Blister (PVC/AL)

Civeran Flas

10 mg

Oral lyophilisate Oral use

Blister

Loratadina
Normon

Loratadina
Normon

Loratadina
Rimafar

10 mg

Tablet

Oral use

1 mg/ml

Syrup

Oral use

10 mg

Tablet

Oral use

Blister

Bottle

Blister

120 ml

20

20

20

20

30

20

120 ml

20

C
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/
7
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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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

SP
(cont’d)

Laboratorios Vita S.A.
Avda Barcelona 69
Sant Joan Despi
ES-08970 Barcelona,
Spain

Civeran

10 mg

Tablet

Oral use

Blister (PVC/AL)

20

Civeran

1 mg/ml

Syrup

Oral use

Bottle

120 ml

Velodan

10 mg

Tablet

Oral use

Blister (PVC/AL)

20

Pharmagenus S.A.
Paseo de Gracia 55 1ª
ES-08007 Barcelona,
Spain

PLIVA Pharma Iberia, S.A.
c/Geológicas 72, Pol. Ind.,
Urtinsa II,
ES-28923 Alcorcón,
Spain

Schering-Plough S.A.
Km 36 Carret Nacional 1
ES-28750 San Agustin de
Guadalix
Madrid,
Spain

Tamarang S.A.
Balmes 84 4º 2ª
ES-08008 Barcelona,
Spain

Universal Farma S.L.
Gran Via Carlos III, 98
7ª planta
ES-08028 Barcelona,
Spain

Velodan

1 mg/ml

Syrup

Oral use

Loratadina
Pharmagenus

10 mg

Tablet

Oral use

Bottle

Blister

Loratadine Pliva

10 mg

Tablet

Oral use

Blister

Claritine Flas

10 mg

Oral lyophilisate Oral use

Clarityne

10 mg

Tablet

Oral use

Clarityne

1 mg/ml

Syrup

Oral use

Optimin

10 mg

Tablet

Oral use use

Optimin

1 mg/ml

Syrup

Oral use

Loratadina
Tamarang

Loratadina
Tamarang

1 mg/ml

Syrup

Oral use

10 mg

Tablet

Oral use

Loratadina Merk

10 mg

Tablet

Oral use

Blister

Blister

Bottle

Blister

Bottle

Bottle

Blister

Blister

120 ml

20

20

30

20

120 ml

20

120 ml

120 ml

20

20

.

.

3
0
4
2
0
0
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
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p
e
a
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U
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o
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i

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/
7
1

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

SP
(cont’d)

Vegal Farmacéutica
S.L. Tramontana, 44
ES-28223 Pozuelo de
Alarcon
Madrid,
Spain

SW

A/S GEA Farmaceutisk
Fabrik
Holger Danskes Vej 89
DK-2000 Fredriksberg
Denmark

Astra Zeneca AB
S-151 85 Södertälje
Sweden

Generics (UK) Ltd
12 Station Close
Potters Bar
Herts
EN6 1TL
United Kingdom

Pro Medica AB
Box 271 90
S-10252 Stockholm,
Sweden

Sandoz GmbH
Biochemiestraße 10
A-6250 Kundl
Austria

Agen Genéricos
Farmacéuticos S.L.
Avda. Conde de
Guadalhorce nº 43
Nave 2
Avilés,
Spain

Multipharma B.V.
Gemeen schapspolder
weg 28
1382 GR Weesp,
Netherlands

Ratiopharma GmbH
Graf-Arco Str. 3
D-89079 ULM,
Germany

RCA S.L.
C/ Pez Volador nº15 1ºB
28007 Madrid,
Spain

Loratadina Vegal

1 mg/ ml

Syrup

Oral use

Loratadina Agen

10 mg

Tablet

Oral use

Bottle

Blister

120 ml

20

Loratadina
Multipharma

10 mg

Tablet

Oral use

Blister PVC/AL

20

Loramed

10 mg

Tablet

Oral use

Blister PVC/AL

7, 20, 100

Loratadina RCA

10 mg

Tablet

Oral use

Blister

20

Loratadin GEA

10 mg

Tablet

Oral use

Blister

7, 10, 20, 21, 30, 100

Loratadin Astra
Zeneca

10 mg

Tablet

Oral use

Blister

5, 7, 10, 14, 20, 30, 40,
100, 105

Loratadin NM
Pharma

10 mg

Film-coated
tablet

Oral use

Blister

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

Versal

10 mg

Tablet

Oral use

Blister

7, 14

Loratadin
Biochemie

10 mg

Tablet

Oral use

Blister
Bottle

7, 10, 14, 20, 21, 30, 50,
60, 100, 250
7, 10, 14, 20, 21, 30, 50,
60, 100, 250

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

Clarityn

10 mg

Tablet

Oral use

Clarityn

Clarityn

1mg/ml

Oral solution

Oral use

10 mg

Effervescent
tablet

Oral use

Clarityn-S

10 mg

Oral lyophilisate Oral use

Loratadin Stada

10 mg

Tablet

Oral use

Blister

Bottle

Tube

Blister

Blister

Loratadin Stada

1 mg/ml

Syrup

Oral use

Bottle (glass)

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

Loratadin
ratiopharm

10 mg

Tablet

Oral use

Blister

10 mg

Tablet

Oral use

1mg/ml

Oral solution

Oral use

10 mg

Tablet

Oral use

Blister
Strip

Bottle

Blister

1 mg/ml

Syrup

Oral use

Bottle

Alpharma
Loratadine Tablets

Loratadine
5mg/5ml Syrup

Loratadine 10 mg
Tablets

Loratadine
1mg/1ml Oral
Solution

Loratadine
10 mg Tablets

10 mg

Tablet

Oral use

Blister

30

Loratadine 10 mg
film-coated Tablets

10 mg

Film-coated
Tablets

Oral use

Blister

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

10, 14, 28, 30 and 100

120 ml

10, 100

12, 30, 100

1, 5, 7, 10, 14, 15, 20,
21, 30, 50, 60, 90, 100,
250

50, 60, 100, 120,
150 ml

2, 7, 10, 20, 21, 30, 50,
100

7, 10, 14, 15, 20, 28, 30,
50, 56, 60, 100, 500

50, 70, 100, 125, 150,
500ml

5, 7, 10, 15, 20, 28, 30,
50, 100

50, 60, 100, 120, 150,
200ml

.

.

3
0
4
2
0
0
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
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i

C
1
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7
3

SW
(cont’d)

Schering-Plough Europe
Rue de Stalle 73
B-1180 Brussels,
Belgium

UK

Stada Arzneimittel AG
Stadastraße 2-18
D-61118 Bad Vibel
Germany

Alpharma Limited
Whiddon Valley
Barnstaple
EX32 8NS
UK

Approved Prescription
Services Ltd
41 Brampton Road
Hampden Park,
Eastbourne
East Sussex, BN22 9AG,
UK

Egis Pharmaceuticals UK
Limited
127 Shirland Road
London
W9 2EP,
UK

Generics (UK) Limited
Station Close
Potters Bar
EN6 1TL
UK

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

UK
(cont’d)

Lagap Pharmaceuticals
Limited
Unit 37, Woolmer Way
Bordon, Hampshire,
GU35 9QE,
UK

Medis Danmark A/S
Havelse Mølle 14
DK-3600 Frederikssund
Denmark

Niche Generics Limitd
Waterford Road
Clonmel
Co. Tipperary,
Ireland

Norton Healthcare
Limited
Ivax Quays, Albert Basin
Armada Way, Royal
Docks
London, E16 2QJ
UK

Rockspring Healthcare
Ltd
Nerin House
26 Bridgeway Street
Douglas
IM1 1EL – Isle of Man
UK

Schering Plough Ltd
Shire Park
Welwyn Garden City
AL7 1TW
UK

Sterwin Medicines
Limited
One Onslow Street
Guilford
Surrey GU1 4YW
UK

Loratadine 10 mg
tablets

Loratadine 10 mg
tablets

Bioglan Generics
Loratadin Tablets

Hay-Rite Allergy
Tablets

10 mg

Tablet

Oral use

Blister

7, 10, 30

10 mg

Tablet

Oral use

Blister

10 mg

Tablet

Oral use

Blister

7, 10, 14, 20, 30, 50,
100

7, 10, 14, 28, 30, 50, 56,
60, 84, 90, 100, 125,
150

10 mg

Tablet

Oral use

Blister

7

Hayrite Tablets

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

Blister

Blister

20, 30

7, 10, 14, 28, 30, 56, 60,
84, 90, 100, 120, 150

10 mg

Tablet

Oral use

Blister

7

10 mg

Tablet

Oral use

Clarityn Syrup

1 mg/ml

Oral solution

Oral use

Clarityn Tablets

10 mg

Loratadine 10 mg
Tablets

10 mg

Tablet

Tablet

Oral use

Oral use

10 mg

Tablet

Oral use

Blister

Bottle

Blister

Blister

Blister

1, 7, 8, 10, 30

50, 60, 100, 200 ml

2, 5, 7, 10, 14, 20, 21, 30

7, 10, 14, 28, 30, 56, 60,
84, 90, 100, 120, 150

7

Loratadine 10 mg
tablets

Loratadine 10 mg
tablets

Clarityn Rapide
Tablets

Allergy and
Hayfever Relief
tablets

Loratadine 10 mg
Tablets

10 mg

Tablet

Oral use

Blister

7, 20, 30, 50, 100

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

.

.

3
0
4
2
0
0
4

UK
(cont’d)

Teva Pharma BV
3640 AE Mijdrecht
Netherlands

Waymade Plc
Miles Gray Road
Basildon
SS14 3FR
UK

Teva Loratadine
Tablets

Teva Pharma
Loratadine
Syrup

Waymade
Loratadine Tablets

10 mg

Tablet

Oral use

1 mg/ml

Syrup

Oral use

10 mg

Tablet

Oral use

Tractyn Tablets

10 mg

Tablet

Oral use

Blister

Bottle

Blister

Blister

5, 7, 10, 15, 20, 28, 30,
50, 100

50, 60, 100, 120, 150,
200 ml

30

7, 28, 30

Loratadine
10 mg Tablets

10 mg

Film-coated
tablet

Oral use

Blister

5, 7, 10, 14, 15, 20, 21,
30, 50, 100

Loratadine
1mg/1ml Syrup

Loratadine
10 mg Tablets

Hay-Rite Allergy
Syrup

1 mg/ml

Syrup

Oral use

Bottle

120 ml

10 mg

Tablet

Oral use

Blister

7, 10, 30

1mg/ml

Syrup

Oral use

Bottle

50, 100 ml

Loratadine Syrup

1mg/ml

Syrup

Oral use

Bottle

120, 200ml

Calao s.r.l.
Via Grassi, 15
I-20157 Milano
Italy

Co-Pharma Limited
Unit 4, Metro Centre
Tolpits Lane
Watford
Hertfordshire
WD1 8SS
UK

Generics UK Ltd
Station Close
Potters Bar
Herts, EN6 1TL,
UK

Karib Kemi-Pharm
Limited
63-65 Imperial Way,
Croydon, Surrey,
CR0 4RR
UK

Norton Healthcare
Limited
Ivax Quays, Albert Basin
Armada Way, Royal
Docks
London, E16 2QJ
UK

Ratiopharm GmbH
Graf-Arco Strasse 3
D-89079 Ulm,
Germany

Loratadine
10 mg Tablets

10 mg

Tablet

Oral use

Blister

7, 20, 50, 100

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
1
1
9
/
7
5

Member State

Marketing Authorisation
Holder

Applicant

Invented Name

Strength

Pharmaceutical
Form

Route of administration

Packaging

Package size

UK
(cont’d)

Stada Arzneimittel AG
Stadastrasse 2-18
D-61118 Bad Vilbel
Germany

Ranbaxy UK Ltd
97-107 Uxbridge Road
Ealing London
UK

Loratadine
10 mg Tablets

Loratadine
5mg/5ml Syrup

Loratadine
10 mg Tablets

Loratadine
10 mg Tablets

10 mg

Tablet

Oral use

Blister

1 mg/ml

Syrup

Oral use

10 mg

Tablet

Oral use

10 mg

Tablet

Oral use

Bottle

Blister
Strip

Blister
Strip

1, 5, 7, 10, 14, 15, 20,
21, 30, 50, 60, 90, 100,
250

50, 60, 100, 120, 150

7, 30

7, 10, 14, 21

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

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

ANNEX X

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Belgium

Denmark

Merck Sharp & Dohme
G.m.b.H.
Donau-City Strasse 6
1220 - Wien, Austria

Merck Sharp & Dohme B.V.
Succursale belge
Chaussée de Waterloo 1135
1180 Bruxelles
Belgique

Merck Sharp & Dohme B.V.
P.O. Box 581
2003PC Haarlem, The
Netherlands

ZOCORD

ZOCORD

ZOCORD

ZOCORD

ZOCORD

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

5 mg

10 mg

20 mg

40 mg

80 mg

5 mg

10 mg

20 mg

40 mg

80 mg

5 mg

10 mg

20 mg

40 mg

80 mg

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

tablets

tablets

tablets

tablets

tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
7
7

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Finland

France

Merck Sharp & Dohme B.V.
P.O. Box 581
2003 PC Haarlem, The
Netherlands

Oy Leiras Finland Ab
Yliopistonkatu 34 A
20100 Turku, Finland

Laboratoires Merck Sharp &
Dohme Chibret
3, Avenue Hoche
75008 Paris, France

Laboratoires SANOFI-
SYNTHELABO FRANCE
174, Avenue de France
75013 Paris, France

Germany

Dieckmann Arzneimittel
GmBH
Lindenplatz 1
85540 Haar, Germany

ZOCOR

ZOCOR

ZOCOR

ZOCOR

COROLIN

COROLIN

COROLIN

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

LODALES

LODALES

LODALES

LODALES

LODALES

ZOCOR

ZOCOR

ZOCOR

10 mg

20 mg

40 mg

80 mg

10 mg

20 mg

40 mg

5 mg

10 mg

20 mg

40 mg

80 mg

5 mg

10 mg

20 mg

40 mg

80 mg

5 mg

10 mg

20 mg

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

film coated tablets

film coated tablets

film coated tablets

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Germany
(cont’d)

ZOCOR FORTE

40 mg

film coated tablets

oral use

MSD Sharp & Dohme
GmbH
Lindenplatz 1
85540 Haar, Germany

Boehringer Ingelheim
Pharma KG
Binger Strasse 173
55216 Ingelheim am Rhein,
Germany

ZOCOR FORTE
XL

LIPOCARD

LIPOCARD

LIPOCARD

LIPOCARD

ZEMOX

ZEMOX

ZEMOX

ZEMOX

ZEMOX

DENAN

DENAN

DENAN

DENAN

DENAN

80 mg

5 mg

10 mg

20 mg

40 mg

5 mg

10 mg

20 mg

40 mg

80 mg

5 mg

10 mg

20 mg

40 mg

80 mg

film coated tablets

oral use

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
7
9

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Greece

Iceland

Ireland

Italy

Marketing Authorization
Holder
Merck & Co., INC
Whitehouse Station, N.J.
USA

VIANEX S.A.
Tatoioy Street
P.O. Box 52894
146 10N. Erithrea, Greece

Merck Sharp & Dohme B.V.
P.O. Box 581
2003 PC Haarlem, The
Netherlands

Merck Sharp & Dohme
Limited
Hertford Road, Hoddesdon
Herts EN11 9BU
United Kingdom

Merck Sharp & Dohme
(Italia) SpA.
Via G. Fabbroni 6
00191 Rome, Italy

Neopharmed SpA
Via G. Fabbroni 6
00191 Rome, Italy

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

SINVACOR

SINVACOR

SINVACOR

ZOCOR

ZOCOR

ZOCOR

5 mg

10 mg

20 mg

40 mg

80 mg

10 mg

20 mg

40 mg

80 mg

5 mg

10 mg

20 mg

40 mg

80 mg

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy
(cont’d)

Istituto Gentili SpA.
Via Mazzini 112
56125 Pisa, Italy

Sigma Tau SpA
Via Pontina Km 30, 400
Pomezia (Rome) Italy

Mediolanum SpA
Via S.G. Cottolengo 15
20143 Milano, Italy

Luxembourg

Merck Sharp & Dohme B.V.
Succursale belge
Chaussée de Waterloo 1135
1180 Bruxelles/Brussel,
Belgique

Netherlands

Merck Sharp & Dohme B.V.
P.O. Box 581
2003 PC Haarlem, The
Netherlands

LIPONORM

LIPONORM

LIPONORM

SIVASTIN

SIVASTIN

SIVASTIN

MEDIPO

MEDIPO

MEDIPO

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

BOZARA

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

5 mg

10 mg

20 mg

40 mg

80 mg

5 mg

10 mg

20 mg

40 mg

80 mg

5 mg

10 mg

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

film coated tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
8
1

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Netherlands
(cont’d)

Norway

Portugal

Spain

Merck Sharp & Dohme B.V.
P.O. Box 581
2003 PC Haarlem, The
Netherlands

Merck Sharp & Dohme, Lda,
Quinta da Fonte
Edifício Vasco da Gama, 19
P.O. Box 214
Porto Salvo
2780-730 Paço de Arcos,
Portugal

Laboratórios Químico-
Farmacêuticos Chibret, Lda.
Quinta da Fonte
Edifício Vasco da Gama, 19
P.O. Box 216
Porto Salvo
P-2780-730 Paço de Arcos,
Portugal

Merck Sharp & Dohme de
España SA
C/Josefa Valcárcel, 38
28027 Madrid, Spain

LACER, SA
Sardenya, 350
080254 Barcelona, Spain

BOZARA

BOZARA

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

VACOLEST

20 mg

40 mg

10 mg

20 mg

40 mg

80 mg

10 mg

20 mg

40 mg

10 mg

tablets

tablets

tablets

tablets

tablets

tablets

film-coated tablets

film-coated tablets

film-coated tablets

film-coated tablets

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

VACOLEST

20 mg

film-coated tablets

oral use

ZOCO

ZOCOR

ZOCOR

PANTOK

PANTOK

PANTOK

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

film-coated tablets

film-coated tablets

film-coated tablets

film-coated tablets

film-coated tablets

film-coated tablets

oral use

oral use

oral use

oral use

oral use

oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Spain
(cont’d)

Sweden

United Kingdom

J. Uriach & Cia SA
Avda Camí Reial, 51-57
08184 Palau-solitá I
Plegamans-Barcelona, Spain

Merck Sharp & Dohme B.V.
P.O. Box 581
2003 PC Haarlem, The
Netherlands

Merck Sharp & Dohme
Limited
Hertford Road
Hoddesdon Herts EN11 9BU
United Kingdom

COLEMIN

COLEMIN

COLEMIN

ZOCORD

ZOCORD

ZOCORD

ZOCORD

ZOCOR

ZOCOR

ZOCOR

ZOCOR

ZOCOR

10 mg

20 mg

40 mg

10 mg

20 mg

40 mg

80 mg

5 mg

10 mg

20 mg

40 mg

80 mg

film-coated tablets

film-coated tablets

film-coated tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

tablets

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
8
3

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

ANNEX XI

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Belgium

Denmark

Finland

France

Pharmacia Austria
Ges.m.b.H.,
Oberlaaerstraße 247-251
A-1100 Wien
AUSTRIA

Pharmacia Twin Squares
Culliganllaan, 1 c
B-1831 DIEGEM
Belgium

Pharmacia S.A.
Rijksweg 12
B-2870 Puurs
Belgium

Pfizer Aps
Lautrupvang 8
DK-2750 Ballerup
Denmark

Pharmacia Oy
P.O Box 45
02601 ESPOO
FINLAND

PHARMACIA SAS
1 rue Antoine Lavoisier
F-78280 GUYANCOURT
FRANCE

Celebrex 100 mg
Hartkapseln

Celebrex 200 mg
Hartkapseln

Solexa 100 mg
Hartkapseln

Solexa 200 mg
Hartkapseln

Celebrex

Celebrex

Solexa

Solexa

Celebra

Celebra

Solexa

Solexa

Celebra

Celebra

Solexa

Solexa

Celebrex

Celebrex

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule Hard

Capsule Hard

Capsule Hard

Capsule Hard

Capsule

Capsule

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

France
(cont’d)

Germany

Greece

Ireland

Italy

CARDEL
1 rue Antoine Lavoisier
F-78280 GUYANCOURT
France

Pharmacia GmbH
Am Wolfsmantel 46
D-91059 Erlangen
GERMANY

Pfizer Hellas AE
5 Alketou St
116 33 Athens
GREECE

Pharmacia hellas
2 Kalavriton
145 62 Nea kifisia
Athens
GREECE

Monsanto Plc
PO Box 53
Lane End Road
High Wycombe
Buckinghamshire
HP12 4 HL
UNITED KINGDOM

Pharmacia Italia S.p.A.
Via Robert Kock, 1-2
I-20152 Milano
ITALY

Sefarma S.r.l.
Via Robert Kock, 1-2
I-20152 Milano
ITALY

Pharmacia Italia S.p.A.
Via Robert Kock, 1-2
I-20152 Milano
ITALY

Solexa

Solexa

Celebra 100 mg
Hartkapseln

Celebra 200 mg
Hartkapseln

Celebrex 100 mg
Hartkapseln

Celebrex 200 mg
Hartkapseln

Aclarex

Aclarex

Celebrex

Celebrex

Celebrex

Celebrex

Solexa

Solexa

Artilog

Artilog

Artrid

Artrid

Celebrex

Celebrex

100 mg

200 mg

100

200

100

200

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

200 mg

100 mg

100 mg

200 mg

Capsule

Capsule

Capsule Hard

Capsule Hard

Capsule Hard

Capsule Hard

Capsule hard

Capsule hard

Capsule hard

Capsule hard

Capsule hard

Capsule hard

Capsule hard

Capsule hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Capsule, hard

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
8
5

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Italy
(cont’d)

Luxembourg

Pfizer Italiana S.p.A.
Via Valbondione, 113
I-00188 Roma
ITALY

Pharmacia S.A.
Rijksweg 12
B-2870 Puurs
BELGIUM

Solexa

Solexa

Celebrex

Celebrex

Solexa

Solexa

The Netherlands

Pfizer bv
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
The Netherlands

Celebrex 100 mg

Celebrex 200 mg

Solexa

Solexa

Celebra

Celebra

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

Capsule, hard

Capsule, hard

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule, hard

Capsule, hard

Norway

Portugal

Spain

Pharmacia Norge AS
Lilleakerveien. 2 B
N-0283 Oslo
NORWAY

Laboratórios Pfizer, Lda.
Estrada Nacional 10, Km
16,Porto Zemouto
2830-411 Coina
Portugal

Laboratório Medinfar -
Produtos Farmacêuticos,
S.A.
Rua Manuel Ribeiro de
Pavia, 1
1º - Venda Nova
2700-547 Amadora
PORTUGAL

Pharmacia Spain S.A.
Avda. de Europa 20-B
Parque Empresarial La
Moraleja
E-28108 Alcobendas,
Madrid
SPAIN

Celebrex 100 mg

100 mg

Capsule, hard

Celebrex 200 mg

200 mg

Capsule, hard

Solexa 100 mg

100 mg

Capsule, hard

Solexa 200 mg

200 mg

Capsule, hard

Oral use

Artilog 100 mg

Artilog 200 mg

Celebrex 100 mg

Celebrex 200 mg

100 mg

200 mg

100 mg

200 mg

Capsule

Capsule

Capsule

Capsule

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

C
1
1
9
/
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

.

.

3
0
4
2
0
0
4

Member State

Marketing Authorisation
Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Sweden

Pharmacia Sverige AB
S-112 87 Stockholm
SWEDEN

United Kingdom

Pharmacia Ltd
Davy Avenue
Milton Keynes
Buckinghamshire MK5 8PH
UK

Aclarix

Aclarix

Celebra

Celebra

Celora

Celora

Solexa

Solexa

Celebrex

Celebrex

Solexa

Solexa

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

100 mg

200 mg

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule

Capsule

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

Oral use

.

.

3
0
4
2
0
0
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

C
1
1
9
/
8
7