# Official Journal C 119/30 A

| | ISSN 1725-2423 |
| --- | --- |
| Official Journal
  of the European Union | C 119 |
| | |
| English edition | Information and Notices | Volume 4730 April 2004 |

ISSN 1725-2423

Official Journal

of the European Union

C 119

English edition

Information and Notices

Volume 4730 April 2004

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| Notice No | Contents | page |
| --- | --- | --- |
| | I   Information |
| | Commission |
| 2004/C 119/1 | 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) | 1 |

Notice No

Contents

page

I   Information

Commission

2004/C 119/1

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)

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

1

| EN | |
| --- | --- |

EN

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I Information

Commission

| 30.4.2004 | EN | Official Journal of the European Union | C 119/1 |
| --- | --- | --- | --- |

30.4.2004

EN

Official Journal of the European Union

C 119/1

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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 2) or Article 38 of Directive 2001/82/EC (1 2))

(2004/C 119/01)

— Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s)
  of the marketing authorization | Member State concerned | 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 | Amlodipin Worwäg | See Annex III | See Annex III | 28.4.2004 |
| 27.4.2004 | Talam | See Annex IV | See Annex IV | 28.4.2004 |
| 27.4.2004 | Pidolma | 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 |

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

Amlodipin Worwäg

See Annex III

See Annex III

28.4.2004

27.4.2004

Talam

See Annex IV

See Annex IV

28.4.2004

27.4.2004

Pidolma

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

REVISED ANNEX I

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

| 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 |

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

Aulin

3%

Gel

Cutaneous use

Tube

30g,50g,100g, 15g

Aulin

100 mg

Granules

Oral use

Sachet

15, 30

Aulin

100 mg

Suppository

Rectal use

Strip

5, 10

Aulin

200 mg

Suppository

Rectal use

Strip

5, 10

Aulin

100 mg

Tablet

Oral use

Blister

6, 15, 30, 60

Mesulid

100 mg

Granules

Oral use

Sachet

15, 30

Mesulid

100 mg

Suppository

Rectal use

Strip

5, 10

Mesulid

200 mg

Suppository

Rectal use

Strip

5, 10

Mesulid

100 mg

Tablet

Oral use

Blister

15, 30, 60

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 |

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

100 mg

Tablet

Oral use

Blister

14 – 30 – 60

U.D. 30 – 60

AULIN

100 mg

Granules for oral suspension

Oral use

Sachet

14 – 30 – 60

MESULID

100 mg

Tablet

Oral use

Blister

14 – 30 – 60

U.D. 30 – 60

MESULID

100 mg

Granules for oral suspension

Oral use

Sachet

14 – 30 – 60

MESULID

30 mg/g (3%)

Gel

Cutaneous use

Tube

30 g - 50 g -100 g

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 |

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

100 mg

Tablet

Oral use

Blister

10, 30, 50, 100, 2

Nimed

3%

Gel

Cutaneous use

Tube

30 g, 50 g, 100g, 15 g

Nimed

100 mg

Granules

single-dose

Oral use

Sachet

20, 60

France

| 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 |

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

100 mg

Tablet

Oral use

Blister

3 X 10

Nexen

100 mg

Granules

Oral use

Sachet

30

| 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 |

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

Oxetian

100 mg

Tablet

Oral use

Blister

3 X 10

Oxetian

100 mg

Granules

Oral use

Sachet

30

Greece

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

Boehringer Ingelheim Hellas Ae

2 Elinixou Street - G-16777 Athens

Tel. +30 10 89 06 300 - Fax. +30 10 89 83 207

Mesulid

100 mg

Tablet

Oral use

Blister

2x10

3x10

Mesulid

200 mg

Suppository

Rectal use

Strip

1x6

Mesulid

100 mg

Granules

Oral use

Sachet

1x20

Mesulid

3%

Gel

Cutaneous use

Tube

15g, 30g, 50g, 100g

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

Farmedia Ae

G. Lira 25 – GR-14564 Kifisia - Athens

Tel. +30 10 62 01 075- Fax. +30 10 62 00 706

Multiformil

100 mg

Tablet

Oral use

Blister

2x10

3x10

5x10

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

Pharmaten Epe

Basil. Katsos-Derbenakion 6 - Pallini- Griekenland – GR 15351

Tel.+30 10 666 66 10 -Fax. +30 10 666 67 49

Bioxidol

100 mg

Granules

Oral use

Sachet

1x30

Bioxidol

100 mg

Tablet

Oral use

Blister

1x20

3x10

| 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 |

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

Specilid

100 mg

Tablet

Oral use

Blister

3x10

2x10

5x10

| Biospray Abee |
| --- |
| 45 V. ougo Street - GR-10437 Athens |
| Tel. +30 10 52 23 439 - 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

Flogostop

100 mg

Tablet

Oral use

Blister

2x10

3x10

5x10

| 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 |

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

Nimesulide/ Biomedica Chemica

100 mg

Tablet

Oral use

Blister

2x10

3x10

5x10

| 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 |

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

Ristolzit

100 mg

Tablet

Oral use

Blister

1x20

1x30

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

Norma Hellas AE

Papazoglou-Menandrou 54 -GR-10431 Athens

Tel. +30 10 522 6457- Fax. +30 10 52 41 368

Myxina

100 mg

Tablet

Oral use

Blister

2x10

3x10

| 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 |

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

Nimelide

100mg

Tablet

Oral use

Blister

2x10

3x10

5x10

| 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 |

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

Discorid

100 mg

Tablet

Oral use

Blister

2x10

5x10

| 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- |

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-

Ventor

100 mg

Granules

Oral use

Sachet

1x30

Ventor

100 mg

Tablet

Oral use

Blister

2x10

3x10

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

Chrispa Alfa Pharma A.E.

Andr.Leon-Menandrou 58 - GR-Athina

Tel. +30 10 52 42221-5223321-6669711

Fax. +30 10 524 89 63

Alencast

100 mg

Tablet

Oral use

Blister

2x10

3x10

5x10

| 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 |

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

G-Revm

100 mg

Tablet

Oral use

Blister

2x10

3x10

| 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 |

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

Volonten

100 mg

Tablet

Oral use

Blister

2x10

5x10

| 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/-246373 Fax. +30 210 2460206

Eleni Polydefkidoy- Manolas Ioannis

kleva@hol.gr

Elinap

100 mg

Tablet

Oral use

Blister

3x10

5x10

1x20

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

Kleva E.P.E.

189 L. Parnithos Avenue

GR-13671 Acharnai Attiki

Tel. +30 210 24 0 2404-7

Fax. +30 210 2460206

Elinap

100 mg

Powder

Oral use

Sachet

(1x20)x100mg

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

Minerva Farmakeytikh A.E.

132Kifissou Avenue - Peristeri - GR-121 31 Athens

Tel. +30 10 –5702199- Fax. +30 10 57 28 215

www.minervapharm.gr

Min-A-Pon

100 mg

Tablet

Oral use

Blister

2x10

3x10

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

Anfarm Hellas A.E.

Ap.Nikolaou- K.Palaiologou & Perikleous

Xalandri- 442 Acharnon – Athens - GR-11143

Tel. +30 210 68 31 632 -21 81 901

Lemesil

100 mg

Tablet

Oral use

Blister

1x20

3x10

| 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 |

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

Rolaket

100 mg

Tablet

Oral use

Blister

2x10

3x10

Rolaket

200 mg

Suppository

Rectal use

Strip

1x6

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

Antor Ltd.

4 Omirou Street - GR-15126 Marousi

Tel. +30 10 61 96 856 - Fax. +30 10 61 96 450

Melimont

100 mg

Tablet

Oral use

Blister

2x10

| 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 |

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

Mosuolit

100 mg

Tablet

Oral use

Blister

2x10

3x10

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

Foiniefarm E.P.E.

5 Anavritis street - GR-11143 Athens

Tel. +30 10 20 25 813- Fax. +30 10 21 11 528

Kartal

100 mg

Tablet

Oral use

Blister

1x20

1x30

| 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 |

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

Fladalgin

100 mg

Tablet

Oral use

Bottle

1x20

1x30

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

Remek A.E.

3 Koleti Str.- GR-14452 Metamorphosi Attiki

Tel. +30 210 2843581-3/ Fax. +30 210 2843580

apivita@apivita.gr

Mesupon

100 mg

Tablet

Oral use

Bottle

1x20

1x30

Mesupon

200 mg

Suppository

Rectal use

Strip

1x6

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

Iasis Chemipharma AE

Agiou Konstantinou - GR-15124 Maroussi

Tel. +30 10 619 68 95/ Fax: +30 10 61 96 896

Chemisulide

100 mg

Tablet

Oral use

Blister

2x10

3x10

| 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 |

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

Amocetin

100 mg

Tablet

Oral use

Blister

2x10

3x10

| 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 |

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

Lizepat

100 mg

Tablet

Oral use

Blister

2x10

3x10

| 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 |

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

Ritamine

100 mg

Tablet

Oral use

Blister

2x10

3x10

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

Medhel Hellas AE

30st klm Athens Laurio- MarkoPoyao - Attikis - Griekenland 19003

Tel. +30 2299022343- Fax. +30 2299022347

medhel@oneway.gr - Mr. Vassilis Kylicas

Niberan

100 mg

Tablet

Oral use

Blister

2x10

3x10

| 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 |

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

Nimesulide Hexal

100 mg

Tablet

Oral use

Blister

2x10

3x10

Nimesulide Hexal

100 mg

Powder

Oral use

Sachet

1x20

| 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 |

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

Naofid

100 mg

Tablet

Oral use

Blister

2x10

3x10

| 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 |

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

Erlecit

100 mg

Tablet

Oral use

Blister

2x10

3x10

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

Vocate Pharma AE

150 Gounari Street / G-16674 Anoglyphada

Tel. +30 10 96 24 436/ Fax: +30 10 96 46 582

Tranzicalm

100 mg

Tablet

Oral use

Blister

2x10

3x10

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

Medichrom AE

6o xil Paiana-MarkoPoulos/ Attiki G-19003 – Griekenland

tel. +30 210 66 24 560

Fax. +30 210 602 0118

medintl@otenet.gr

Nimesul

100 mg

Tablet

Oral use

Blister

3x10

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

Faran Laboratories SA

Achaias & Trizinias/ GR-145 64 Nea Kifissia - Athens

Tel. +30 10 80 70 002/ Fax.+30 10 80 71 688

Aflogen

100 mg

Tablet

Oral use

Blister

2x10

| 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 |

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

Edrigyl

100 mg

Tablet

Oral use

Blister

1x20

2x10

2x20

4x10

Edrigyl

200 mg

Suppository

Rectal use

Strip

1x6

Edrigyl

100 mg

Granules

Oral use

Sachet

1x20

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

S.G.IPHARMA C/O Chrispa

Andr. LEON Menandrou 58 – Athens – GR-10432

Tel. +30 10 666 9711- Fax. +30 10 6031746

Cliovyl

100 mg

Tablet

Oral use

Blister

2x10

3x10

| 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 |

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

Scaflam

100 mg

Tablet

Oral use

Blister

2x10

Scaflam

200 mg

Suppository

Rectal use

Strip

1 x 6

Scaflam

100 mg

Granules

Oral use

Sachet

1x20

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

Coup.

Xr.Kouparousos/ Ag.Barbaras 53 - GR-17253 Dafni

Tel. +30 10 97 11 061-9714080/ Fax. +30 10 97 60 837

Melicat

100 mg

Tablet

Oral use

Blister

2x10

3x10

6x10

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

Faran Laboratories SA

Achaias & Trizinias- GR-145 64 Nea Kifissia - Athens

Tel. +30 10 80 70 002 - Fax.+30 10 80 71 688

Lalide

100 mg

Tablet

Oral use

Blister

2x10

3x10

| 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 |

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

Dolostop

100 mg

Tablet

Oral use

Bottle

1x20

1x30

Dolostop

100 mg

Granules

Oral use

Sachet

1x20 (2 g)

Dolostop

200 mg

Suppository

Rectal use

Strip

1x6

| 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 |

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

Algover

100 mg

Tablet

Oral use

Blister

2x10

3x10

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

Aurora Pharmaceuticals Ltd.

105 Marathonos avenue Gerakas- GR-15344

Tel. +30 10 60 49 970/ Fax +30 10 60 49 971

Auromelid

100 mg

Tablet

Oral use

Blister

3x10

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

Pharmanel Pharmaceuticals S A

106 Marathonos AV, - Gerakas GR-153 44

Tel. +30-10-6048560/ Fax +30-10-6613013

Sudinet

100 mg

Tablet

Oral use

Blister

3x10

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

Med-One S.A.

211 Parnithos Avenue - GR-13671 Acharnai - Attiki

Tel. +30 210240 24 05/ Fax. +30 2102 46 02 06

Polydefkidoy Eleni

Algosulid

100 mg

Tablet

Oral use

Blister

1x20

1x30

Algosulid

100 mg

Powder

Oral use

Sachet

1x20

Ireland

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

Helsinn Birex Pharmaceuticals

Damastown, Mulhuddart - Dublin 15/ Ierland

Tel. +353 1 822 54 04 - Fax +353 1 822 54 10

Aulin

100 mg

Tablet

Oral use

Blister

15,30,60

Aulin

100 mg

Granules

Oral use

Sachet

30

Aulin

3%

Gel

Cutaneous use

Tube

15g, 30 g, 50g, 100 g

Mesulid

100 mg

Granules

Oral use

Sachet

1x30

Mesulid

100 mg

Tablet

Oral use

Blister

15,30,60

Mesulid

3%

Gel

Cutaneous use

Tube

30 g, 50 g, 100 g

Italy

| 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 |

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

AULIN

100 mg

Tablet

Oral use

Blister

30

AULIN

3%

Gel

Cutaneous use

Tube

30,100 g.

AULIN

50 mg

Granules

Oral use

Sachet

30

AULIN

100 mg

Granules

Oral use

Sachet

30

AULIN

200 mg

Suppository

Rectal use

Strip

10

AULIN

3%

Gel

Cutaneous use

Tube

50 g

AULIN BETA

400 mg

Tablet

Oral use

Blister

30

AULIN BETA

400 mg

Granules

Oral use

Sachet

30

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

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

Oral use

Blister

30

MESULID MITE

50 mg

Granules

Oral use

Sachet

30

MESULID

100 mg

Granules

Oral use

Sachet

30

MESULID

200 mg

Suppository

Rectal use

Strip

10

MESULID

3%

Gel

Cutaneous use

Tube

30 g, 50 g

100 g

MESULID FAST

400 mg

Granules

Oral use

Sachet

30; 8;

MESULID FAST

400 mg

Tablet

Oral use

Blister

30

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

Italfarmaco SpA

Via Dei Lavoratori, 54 - 20092 Cinisello Balsamo (MI) – Italië

tel. + 39 02 64432500 / fax. + 39 02 64432503

NIMEDEX

400 mg

Granules

Oral use

Sachet

30

NIMEDEX

400 mg

Tablet

Oral use

Blister

30

| 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 |

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

Tablet

Oral use

Blister

30

ALGOLIDER

100 mg

Granules

Oral use

Sachet

30

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

Istituto Chimico Internazionale Dr. Giuseppe Rende S.r.l.

Via Salaria, 1240-I-00138 Roma

tel: +39 06 8889655 - fax:39 06 8889849

RESULIN

100 mg

Tablet

Oral use

Blister

30

RESULIN

100 mg

Granules

Oral use

Sachet

30

RESULIN

200 mg

Suppository

Rectal use

Strip

10

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

Laboratori Prodotti Farmaceutici Boniscontro e Gazzone SRL

Via Tiburtina, 1004- I-00156 Roma

tel. +39 06 4111087 - fax: +39 06 4111603

LEDOREN

100 mg

Tablet

Oral use

Blister

30

LEDOREN

100 mg

Granules

Oral use

Sachet

30

Farmaceutici Caber SpA.

| 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 |

Viale Città d’Europa, 681- I-00144 Roma tel. +39 06 52207244 - fax. +39 06 52205488

Dr. Roberto Rosso - info@caber.it

NIMS

100 mg

Tablet

Oral use

Blister

30

SULIDAMOR

100 mg

Granules

Oral use

Sachet

30

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

Farmaceutici Damor SpA

Via E. Scaglione, 27 - I-80145 Napoli

tel. +39 081 2389001 - fax. +39 081 7405172

SULIDAMOR

200 mg

Suppository

Rectal use

Strip

10

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

NCSN Farmaceutici srl

Via Svetonio 15 –I- 00136 Roma

Tel+Fax. +39 06 35497 652

FANSIDOL

100 mg

Capsule

Oral use

Blister

30

FANSIDOL

100 mg

Granules

Oral use

Sachet

30

| 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 |

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

NIDE

100 mg

Hard capsule

Oral use

Blister

30

NIDE

100 mg

Granules for oral solution

Oral use

Sachet

30

| 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 |

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

FLOLID

100 mg

Tablet

Oral use

Blister

30

FLOLID

200 mg

Suppository

Rectal use

Strip

10

FLOLID

100 mg

Granules for oral solution

Oral use

Sachet

30

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

Vecchi & C. Piam SPA

Via Padre G. Semeria, 5 – I-16131 Genova

tel. +39 010 357234/237/241 - fax. +39 010 355734

REMOV

100 mg

Tablet

Oral use

Blister

30

REMOV

100 mg

Granules

Oral use

Sachet

30

| 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 |

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

NIMESULIDE UCB

100 mg

Tablet

Oral use

Blister

30

NIMESULIDE UCB

100 mg

Granules for oral suspension

Oral use

Sachet

30

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

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

Granules for oral suspension

Oral use

Sachet

30

LAIDOR

100 mg

Granules for oral suspension

Oral use

Sachet

30

LAIDOR

100 mg

Tablet

Oral use

Blister

30

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

Laboratori Guidotti SpA

Via Trieste, 40 - 56126 Pisa – Italië

tel. + 39 050 505211 - fax. +39 050 49340

NIMESULENE

100 mg

Tablet

Oral use

Blister

30

NIMESULENE

100 mg

Powder for oral solution

Oral use

Sachet

30

NIMESULENE

200 mg

Suppository

Rectal use

Strip

10

| 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 |

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

ALGIMESIL

100 mg

Granules for oral solution

Oral use

Sachet

30

ALGIMESIL

100 mg

Tablet

Oral use

Blister

30

| 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 |

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

SULIDE

100 mg

Tablet

Oral use

Blister

30

SULIDE

100 mg

Granules

Oral use

Sachet

30

SULIDE

200 mg

Suppository

Rectal use

Strip

10

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

ERREKAPPA Euroterapici SpA

Via Ciro Menotti 1/A – I-20129 Milano

tel. +39 02 7491345 -fax. +39 02 715734

SULMEDIL

100 mg

Tablet

Oral use

Blister

30

SULMEDIL

100 mg

Granules

Oral use

Sachet

30

SULMEDIL

200 mg

Suppository

Rectal use

Strip

10

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

Mipharm SpA

Via Bernardo Quaranta, 12 – I-20141 Milano

tel. +39 02 535481 - fax. +39 02 53548010

www.mipharm.it - Dr. Giorgio Corsico

TEONIM

100 mg

Granules

Oral use

Sachet

30

TEONIM

100 mg

Tablet

Oral use

Blister

30

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

Istituto Luso Farmaco d’Italia SpA

Via Carnia, 26- I-20132 Milano

tel. +39 02 2803232 / +39022828485

fax. +39 02 2803286

NIMESIL

100 mg

Granules

Oral use

Sachet

30

| 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 |

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

EUDOLENE

100 mg

Granules

Oral use

Sachet

30

| 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 |

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

NOALGOS

100 mg

Granules

Oral use

Sachet

30

NOALGOS

100 mg

Tablet

Oral use

Blister

30

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

So.Se. Pharm Srl

Via dei Castelli Romani, 22- I-00040 Pomezia (Roma)

tel. +39 06 91140153 - fax. +39 06 91603462

DOMES

100 mg

Granules

Oral use

Sachet

30

DOMES

100 mg

Tablet soluble

Oral use

Blister

30

DOMES

100 mg

Tablet

Oral use

Blister

30

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

Selvi Laboratorio Bioterapico SpA

Via Proio 28 Fiano Romano I-00065 Roma

Tel: 39 076 545 5718- Fax: 39 0765 455 633

ANTALGO

100 mg

Tablet

Oral use

Blister

30

ANTALGO

100 mg

Granules for oral solution

Oral use

Sachet

30

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

GNR SpA

S.S. 233 Varesina - Km 20,5 –I-21040 Origgio (Va)

tel +39 02 9654 3483 - Fax. +39 02 9654 3495

NIMESULIDE

100 mg

Granules for oral solution

Oral use

Sachet

30

NIMESULIDE

100 mg

Hard capsule

Oral use

Blister

30

| 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 |

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

NISAL

100 mg

Granules

Oral use

Sachet

30

NISAL

100 mg

Capsule

Oral use

Blister

30

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

Pulitzer Italiana Srl

Via Tiburtina 1004

I-00156 Roma

tel +39 06 4111087 - fax +39 06 4111603

LEDOLID

100 mg

Tablet

Oral use

Blister

30

LEDOLID

100 mg

Granules

Oral use

Sachet

30

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

Magis Farmaceutici SpA

Via Cacciamali 34-36-38/A – I-25125 Brescia

tel. +39 030 349761 - fax. +39 030-349352

ISODOL

100 mg

Granule for oral suspension

Oral use

Sachet

30

ISODOL

100 mg

Tablet

Oral use

Blister

30

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

Lampugnani Farmaceutici SpA

Via Gramsci, 4 – I-20014 Nerviano (MI)

tel. +39 0331 587354 - fax. +39 0331 585588

NOXALIDE

5%

Oral suspension

Oral use

Bottle

60 ml

NOXALIDE

100 mg

Granules

Oral use

Sachet

30

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

Kruger Pharma Srl

Via Volturno, 10-12

I-50019 Sesto Fiorentino (FI)

tel. +39 055 3024503 - fax. +39 055 3025015

NIMENOL

100 mg

Granules for oral suspension

Oral use

Sachet

15

30

| 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 |

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

NIMEXAN

100 mg

Granules

Oral use

Sachet

30

NIMEXAN

200 mg

Suppository

Rectal use

Strip

10

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

MDM SpA

Via Volturno 29/B – I-20052 Monza (MI)

tel. +39 039 322270 - fax. +39 039 322168

mdm@mdmspa.com - M. Trognoni

SOLVING

100 mg

Tablet

Oral use

Blister

30

SOLVING

100 mg

Granules for oral suspension

Oral use

Sachet

30

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

Aesculapius Farmaceutici Srl

Via Cozzaglio, 24 – I-25125 Brescia

tel. +39 030 3532013 - fax. +39 030 349352

EFRIDOL

100 mg

Granules for oral suspension

Oral use

Sachet

30

EFRIDOL

100 mg

Tablet

Oral use

Blister

30

| 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 |

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

DIMESUL

100 mg

Tablet

Oral use

Blister

30

DIMESUL

100 mg

Granules for oral suspension

Oral use

Sachet

30

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

Dorom Srl

Via Volturno, 48

I-20089 Quinto de Stampi Rozzano (MI)

tel. +39 06-59290330 - fax. +39 06 5913128

NIMESULIDE

100 mg

Powder for oral solution

Oral use

Sachet

30

NIMESULIDE

200 mg

Suppository

Rectal use

Strip

10

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

Teva Pharma Italia Srl

V.le Richard, 7 – I-20143 Milano

tel. +39 02 8917981 - fax. + 39 02 89179825

NIMESULIDE

100 mg

Tablet

Oral use

Blister

30

NIMESULIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

NIMESULIDE

200 mg

Suppository

Rectal use

Strip

10

| 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 |

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

Blister

30

NIMESULIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

NIMESULIDE

200 mg

Suppository

Rectal use

Strip

10

Nimesulide

100 mg

Suppository

Rectal use

Strip

10

New Research Srl P/zza Don Luigi Sturzo 34- I-04011 Aprilia (LT)

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

tel. +39 06 92727688 - fax. +39 06 92727688

NERELID

100 mg

Capsule

Oral use

Blister

NERELID

100 mg

Granules for oral solution

Oral use

Sachet

30

| 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 |

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

NIMESULIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

| 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 |

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

DOLXTREN

5%

Oral suspension

Oral use

Bottle

60 ml

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

Robin Srl

Piazzale Durante Frankrijksco, 11 – I-20131 Milano

tel. +39 039 2474435 - fax. +39 039 2474630

NIMESULIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

NIMESULIDE

100 mg

Tablet

Oral use

Blister

30

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

Farmaceutici Ecobi SAS.

Via E. Bazzano, 26 - Ronco Scrivia (GE)- I-16019

tel. +39 010 9651010 - fax. +39 010 9350679

AREUMA

100 mg

Tablet

Oral use

Blister

30

AREUMA

100 mg

Granules for oral suspension

Oral use

Sachet

30

AREUMA

200 mg

Suppository

Rectal use

Strip

10

| 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 |

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

NIMESULIDE

100 mg

Tablet

Oral use

Blister

30

NIMESULIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

NIMESULIDE`

200 mg

Suppository

Rectal use

Strip

10

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

EG SpA

Via Rondoni, 1 – I-20146 Milano

Tel. +39 02 8310371 - Fax : +39 02 831 03776

NIMESULIDE

100 mg

Tablet

Oral use

Blister

30

NIMESULIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

NIMESULIDE

100 mg

Effervescent tablet

Oral use

Blister

30

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

Ratiopharm GmbH

Via Accademia, 26 - I-20131 Milano

tel. +39 02 288771 - fax. +39 02 28 877 22

NIMESULIDE

100 mg

Tablet

Oral use

Blister

30

NIMESULIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

NIMESULIDE

100 mg

Effervescent tablet

Oral use

Blister

30

| 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 |

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

DOLESIDE

100 mg

Tablet

Oral use

Blister

30

DOLESIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

| 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 |

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

EDEMAX

100 mg

Tablet

Oral use

Blister

30

EDEMAX

100 mg

Granules for oral suspension

Oral use

Sachet

30

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

Pliva Pharma SpA

Via dei Giardini, 7 – I-20100 Milano

tel. +39 02 66043234 - fax +39 02 61293592

NIMESULIDE

100 mg

Tablet

Oral use

Blister

30

NIMESULIDE

100 mg

Granules

Oral use

Sachet

30

MIGRALESS

100 mg

Tablet for oral suspension

Oral use

Blister

30

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

Sofar SpA

Via Firenze, 40 –I- 20060 Trezzano Rosa (MI)

tel. +39 02 90937212 - fax. +39 02 9096 7239

FANSULIDE

100 mg

Tablet

Oral use

Blister

30

FANSULIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

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

Alterna Farmaceutici Srl

Via dei Pestagalli Pietro e Giuseppe, 7

I-20138 Milano

Tel. -Fax.

IDEALID

100 mg

Tablet

Oral use

Blister

30

IDEALID

100 mg

Granules for oral suspension

Oral use

Sachet

30

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

Hexan SpA

Piazzale della Stazione – I-00040 Santa Palomba (Roma)

tel +39 06 91045244 - fax. +39 06 91045299

NIMESULIDE

100 mg

Tablet

Oral use

Blister

30

NIMESULIDE

100 mg

Granules for oral solution

Oral use

Sachet

30

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

A.G.I.P.S. Farmaceutici SpA

Via Amendola, 4 - 16035 Rapallo (GE) – Italië

tel. + 39 0185 58223/4 - fax. + 39 0185 60374

DELFOS

100 mg

Tablet

Oral use

Blister

30

DELFOS

100 mg

Granules for oral suspension

Oral use

Sachet

30

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

P.R.C. Srl

Via Conforti, 42 – I-84083 Castel San Giorgio (SA)

Tel. +39 081 5162315 - Fax.+39 081 5161590

mail@farmauno.it

LIDERSOLV

100 mg

Tablet

Oral use

Blister

30

LIDERSOLV

100 mg

Granules for oral suspension

Oral use

Sachet

30

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

Nobel Farmaceutici Srl

Via Tiburtina, 1004 - I-00156 Roma

Tel +39 06 4111087- Fax. +39 06 4111603

LIDENIX

100 mg

Tablet

Oral use

Blister

30

LIDENIX

100 mg

Granules for oral suspension

Oral use

Sachet

30

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

Janssen Cilag SpA

Via M. Buonarroti 23 –I- 20293 Cologno Monzese (Mi)

Tel. +39 02 25101 - Fax. +39 02 2670 8196

BEIOND

100 mg

Tablet

Oral use

Blister

30

BEIOND

100 mg

Granules

Oral use

Sachet

30

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

Farmaceutici Formenti SpA

Via Correggio 43 – I-20149 Milano

Tel. +39 02 43051 - Fax. +39 02 430555

Email: dg@formenti.it

NIMESULIDE

100 mg

Tablet

Oral use

Blister

30

NIMESULIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

| 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 |

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

Nidemol

100 mg

Sachet

Oral use

Sachet

30

Nidemol

200 mg

Suppository

Rectal use

Strip

10

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

Polifarma SpA

Via Tor Sapienza 138 - I-00155 Roma

Tel. +39 06 227420 - Fax. +39 06 227 422 61

Nimesulide

100 mg

Tablet

Oral use

Blister

30

Nimesulide

100 mg

Granules for oral suspension

Oral use

Sachet

30

| 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 |

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

Nimesulide

100 mg

Tablet

Oral use

Blister

30

Nimesulide

100 mg

Granules for oral suspension

Oral use

Sachet

30

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

Prodotti Formenti SRL

Via Coreggio 43 – I-20149 Milano

Tel. +39 02 43051- Fax. +39 02 430555

FLAMINIDE

100 mg

Tablet

Oral use

Blister

30

FLAMINIDE

100 mg

Granules for oral suspension

Oral use

Sachet

30

| 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 |

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

Reumalide

100 mg

Granules for oral suspension

Oral use

Sachet

30

Reumalide

200 mg

Suppository

Rectal use

Strip

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 |

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

blister

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

Mesulid

100 mg

Granules

Oral use

sachet

14,30,60

Mesulid

3%

Gel

Cutaneous use

Tube

30g, 50g, 100g

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 |

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 |

Angelini Farmacêutica, Lda.

Rua João Chagas n. 53

3° Piso

P- 1495-072 Algés- Portugal

T: 00351214148300 F: 00351214142981

Aulin

100 mg

Tablet

Oral use

Blister

14; 30 and 60

Aulin

200 mg

Suppository

Rectal use

Strip

10 and 12

Aulin

100mg

Granules for oral solution

Oral use

Sachet

14; 30 and 60

Aulin Gel

30 mg/g

Gel

Cutaneous use

Tube

30; 50 and 100g

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

Wyeth Lederle Portugal (Farma), Lda.

PRT

Rua Dr. António Loureiro Borges, 2 - Arquiparque

Miraflores Algés 1495-131

T: 00351214128200 F: 00351214120111

Donulide

100 mg

Tablet

Oral use

Blister

14; 20; 30 and 60

Donulide

100 mg

Granules for oral solution

Oral use

Sachet

14; 20; 30 and 60

Donulide Gel

30 mg/g

Gel

Cutaneous use

Tube

30; 50 and 100g

| 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 |

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

Flamisul

100 mg

Tablet

Oral use

Blister

10; 30 and 60

Flamisul

100 mg

Granules

Oral use

Sachet

10; 20; 30 and 60

| 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 |

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

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

| 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 |

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

Isartrox

100mg

Tablet

Oral use

Blister

10; 12; 20; 30 and 60

Isartrox

100mg

Granules

Oral use

Sachet

10; 12; 20; 30 and 60

| 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 |

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

Jabasulide

100mg

Tablet

Oral use

Blister

10;

, 30 and 60

Jabasulide

100mg

Granules for oral solution

Oral use

Sachet

10; 30 and 60

| 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 |

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

Neuride

100mg

Tablet

Oral use

Blister

10; 30 and 60

Neuride

100mg

Granules

Oral use

Sachet

10; 20; 30 and 60

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

Labesfal - Laboratórios Almiro, SA

P-3465-051 Campo de Besteiros

T: 00351232831100 F: 00351232831112

Alda Rodrigues - labesfal@mail.telepac.pt

Nimalge

100mg

Granules for oral suspension

Oral use

Sachet

10; 20; 30 and 60

Nimalge

200mg

Suppository

Rectal use

Strip

10

Nimalge

100mg

Tablet

Oral use

Blister

10; 20; 30 and 60

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

Mediquímica - Produtos Químicos, Especialidades Farmacêuticas, Lda.

Vala do Carregado

P-2600-726 Castanheira do Ribatejo

T: 0351263856800 F: 0351263855020

Nimartin

100mg

Coated Tablet

Oral use

Blister

10; 20; 30 and 60

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

Aventis Pharma, Lda.

Estrada Nacional 249

Po Doos 39 Km 15 Mem Martins 2726-922

T: 00351219269540 F: 00351219269696

Nimed

200 mg

Suppository

Rectal use

Strip

10

Nimed

100mg

Coated Tablet

Oral use

Blister

14; 20; 30 and 60

Nimed

100mg

Granules

Oral use

Sachet

14; 20; 30 and 60

Nimed Gel

30 mg/g

Gel

Cutaneous use

Tube

30; 50 and 100g

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

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 |

Clintex - Produtos Farmacêuticos, Lda.

Rua João de Deus 19, Venda Nova P-2700487 Amadora

T.00351214998933 F: 00351214998932

Nimesulida

100mg

Granules for oral suspension

Oral use

Sachet

10; 20; 30 and 60

Nimesulida Clintex

200 mg

Suppository

Rectal use

Strip

10

Nimesulida Clintex

100mg

Tablet

Oral use

Blister

10; 20; 30 and 60

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

Angelini Farmacêutica, Lda.

Rua João Chagas n. 53, 3° Piso

P- 1495-072 Algés

T: 00351214148300 F: 00351214142981

Nimesulide HPF

200mg

Suppository

Rectal use

Strip

12

Nimesulide HPF

100mg

Granules for oral suspension

Oral use

Sachet

14, 30, 60

Nimesulide HPF

100mg

Tablet

Oral use

Blister

14, 30, 60

Nimesulide HPF Gel

30 mg/g

Gel

Cutaneous use

Tube

30, 50 and 100g

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

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

Blister

10, 20, 30 e 60

| 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 |

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

100mg

Tablet

Oral use

Blister

10, 20; 30 and 60

Polyfen

100mg

Granules for oral suspension

Oral use

Sachet

10, 20; 30 and 60

Polyfen

200mg

Suppository

Rectal use

Strip

10

Pronidal - 100

100mg

Tablet

Oral use

Blister

10, 20; 30 and 60

Pronidal - 100

100mg

Granules for oral suspension

Oral use

Sachet

10, 20; 30 and 60

Pronidal - 200

200 mg

Suppository

Rectal use

Strip

10

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

Farmácia Nova Rua Elias Garcia

10-G Venda Nova

P- 2700 Amadora

T: 00351 2638 56800 F: 0351263855020/1

Ribantil

100mg

Coated Tablet

Oral use

Blister

10; 20; 30 and 60

| 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 |

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

Sulimed

100mg

Tablet

Oral use

Blister

10; 30 and 60

| 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 |

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

Sulinime

100 mg

Tablet

Oral use

Blister

10 ;12 ;20 ; 30; 60

Sulinime

100mg

Granules

Oral use

Sachet

10; 12; 20; 30 and 60

| 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 |

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

Vitolide

100mg

Tablet

Oral use

Blister

10 and 30

| 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 |

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

Zulide

100mg

Tablet

Oral use

Blister

10, 30 and 60

Zulide

100 mg

Granules for oral solution

Oral use

Sachets

10, 30 and 60

Spain

| 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 |

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

Guaxan

100 mg

Granules

Oral use

Sachet

30, 500

Guaxan

100 mg

Tablet

Oral use

Blister

30, 500

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

Laboratorios Alter SA

Mateo Inurria, 30 - E-28036 Madrid

Tel. +34 91 35 92 000 - Fax. +34 91 35 01 165

Antifloxil

100 mg

Tablet

Oral use

Blister

30

Antifloxil

100 mg

Granules

Oral use

Sachet

30

Belgium

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

P.S.I. NV Kraanlei 27-29 9000 Gent

Tel. +32 9233 1404

Fax. +32 92 33 00 16

NIMESULIDE/SI

100 mg

ZAKJES

100 mg

Granules for oral suspension

Oral use

Sachet

30

NIMESULIDE/ SI

100 mg

Tabletten

100 mg

Tablet

Oral use

Blister

France

| 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 |

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

Nimesulide Arrow

100 mg

Tablet

Oral use

Blister

Merck Generiques

| 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 |

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

Nimesulide Merck

100 mg

Tablet

Oral use

Blister

Greece

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

Rafarm Aebe

Kirinthou 12 - 15451, N. Psyhiko

Tel. +30 10 677 65 50/ Fax. +30 10 677 65 52

Ventor

50 mg/ 5 ml

Oral Suspension

Oral use

Sachet

Kleva Epe

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

L. Parnithos 189- Aharne Attikis

Tel. +30 10 24 63 737 / Fax. +30 10 24 60 206

Elinap

3%

Cream

Cutaneous use

Tube

Elinap

3%

Gel

Cutaneous use

Tube

Pharmacypria Hellas

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

Paster 6 - Ampelokipoi GR-11521

Tel. +30 10 65 13 436/ Fax. +30 10 644 5375

Lalide

100 mg/ 5ml

Oral Suspension

Oral use

Sachet

Lalide

3%

Gel

Cutaneous use

Tube

30g;50g; 100g.

| 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 |

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

Lasazin

100 mg

Tablet

Oral use

Blister

2X10

3X10

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

Pharmachem Epe

Imitou 73 - Vrilissia Attikis - GR-15235

Tel. +30 210 524 74 08/ Fax. +30 210 5244847

Nimesulide

Pharmakem

100 mg

Tablet

Oral use

Blister

Antonios Polixronis Tou Marinou

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

Thivon 3 / GR-15562 Holargos

Tel. +30 10 65 42 360/ Fax. +30 10 6561006

Omnibus

100 mg

Tablet

Oral use

Blister

1X20

1X30

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

Zwitter Pharmaceuticals Ltd.

L. Pentelis 34-36 - Athens GR-15234

Tel. +30 210 6821098/ Fax.. +30 210 6821098

zwitter@hol.gr

Rhemid

100 mg

Tablet

Oral use

Blister

1X20

1X30

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

Med-One SA

211 Parnithos Avenue - GR-13671 Acharnai - Attiki

Tel. +30 210240 24 05/ Fax. +30 2102 46 02 06

Polydefkidoy Eleni

Algosulid

3%

Cream

Cutaneous use

Tube

Algosulid

100 mg

Tablet

Oral use

Blister

Lamda Pharmaceutical AE

| 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 |

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

Nimesoral

50 mg/ 5ml

Oral Suspension

Oral use

Bottle

1X100ml

Nimegel

3%

Gel

Cutaneous use

Tube

1x30g

1x50g

1x100g

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

Medicon Pharmaceutical SA

Karaiskaki 115°A/ GR-26500 Aktaio –Rio Patron

Tel.: +30 6932200188 - Fax. +30 2610 99 38 08

chrodopoulos@yahoo.gr

Nimesulide Medicon

100 mg

Tablet

Oral use

Blister

2x10

3x10

| Farmamust Epe |
| --- |
| Plateia Pantazopoulou 7/ GR-10443 Kolonos Attikis |

Farmamust Epe

Plateia Pantazopoulou 7/ GR-10443 Kolonos Attikis

Lovirem

100 mg

Tablet

Oral use

Blister

Spanje

| 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 |

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

Italy

| 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 |

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

ANNEX II

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

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Sweden | Perivita A/S
  Håndverksveien 2
  N-1403, Langhus
  Norway | | Amlovita | 5 mg | Tablet | oral use |
| Amlovita | 10 mg | Tablet | oral use |
| Germany | | Perivita A/S
  Håndverksveien 2
  N-1403, Langhus
  Norway | Amlovita | 5 mg | Tablet | oral use |
| Amlovita | 10 mg | Tablet | oral use |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Sweden

Perivita A/S

Håndverksveien 2

N-1403, Langhus

Norway

Amlovita

5 mg

Tablet

oral use

Amlovita

10 mg

Tablet

oral use

Germany

Perivita A/S

Håndverksveien 2

N-1403, Langhus

Norway

Amlovita

5 mg

Tablet

oral use

Amlovita

10 mg

Tablet

oral use

ANNEX III

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

| Member State | Marketing Authorisation Holder | Applicant | Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Sweden | Wörwag Pharma GmbH & Co. KG |
| Calwer Str. 7 |
| 71034 Böblingen |
| Germany |

Member State

Marketing Authorisation Holder

Applicant

Name

Strength

Pharmaceutical Form

Route of administration

Sweden

Wörwag Pharma GmbH & Co. KG

Calwer Str. 7

71034 Böblingen

Germany

Amlodipin Wörwag

5 mg

Tablet

oral use

Amlodipin Wörwag

10 mg

Tablet

oral use

Germany

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

Wörwag Pharma GmbH & Co. KG

Calwer Str. 7

71034 Böblingen

Germany

Amlodipin Wörwag

5 mg

Tablet

oral use

Amlodipin Wörwag

10 mg

Tablet

oral use

ANNEX IV

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

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Sweden | Laboratoires Delbert |
| 56, Quai A. Le Gallo 92100 Boulogne |
| Billancourt |
| France |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Sweden

Laboratoires Delbert

56, Quai A. Le Gallo 92100 Boulogne

Billancourt

France

Talam

5 mg

Tablet

oral use

Talam

10 mg

Tablet

oral use

Germany

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

Laboratoires Delbert

56, Quai A. Le Gallo 92100 Boulogne

Billancourt

France

Talam

5 mg

Tablet

oral use

Talam

10 mg

Tablet

oral use

ANNEX V

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

| Member State | Marketing Authorisation Holder | Applicant | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Sweden | Laboratoires Delbert |
| 56, Quai A. Le Gallo 92100 Boulogne |
| Billancourt |
| France |

Member State

Marketing Authorisation Holder

Applicant

Invented name

Strength

Pharmaceutical Form

Route of administration

Sweden

Laboratoires Delbert

56, Quai A. Le Gallo 92100 Boulogne

Billancourt

France

Pidolma

5 mg

Tablet

oral use

Pidolma

10 mg

Tablet

oral use

Germany

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

Laboratoires Delbert

56, Quai A. Le Gallo 92100 Boulogne

Billancourt

France

Pidolma

5 mg

Tablet

oral use

Pidolma

10 mg

Tablet

oral use

ANNEX VI

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

| 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 |

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

25 mg

Tablet

Oral use

Ceoxx 50 mg tabletten

50 mg

Tablet

Oral use

Coxxil 12, 5 mg/5 ml orale suspension

12, 5 mg/5 ml

Oral suspension

Oral use

Coxxil 25 mg/5 ml orale suspension

25 mg/5 ml

Oral suspension

Oral use

Coxxil 12, 5 mg tabletten

12, 5 mg

Tablet

Oral use

Coxxil 25 mg tabletten

25 mg

Tablet

Oral use

Vioxx 12,5 mg tabletten

12,5 mg

Tablet

Oral use

Vioxx 25 mg tabletten

25 mg

Tablet

Oral use

Vioxx 12, 5 mg/5 ml orale suspension

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx 25 mg/5 ml orale suspension

25 mg/5 ml

Oral suspension

Oral use

Vioxx Dolor 25 mg tabletten

25 mg

Tablet

Oral use

Vioxx Dolor 50 mg tabletten

50 mg

Tablet

Oral use

Belgium

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

Merck Sharp & Dohme, B.V.

Chaussée de Waterloo

Waterloosesteenweg, 1135

B-1180 Bruxelles

Belgium

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx

25 mg/ 5 ml

Oral suspension

Oral use

Vioxx

25 mg

Tablet

Oral use

Flogoxxa

25 mg

Tablet

Oral use

Flogoxxa

50 mg

Tablet

Oral use

Foldoxx

12, 5 mg

Tablet

Oral use

Foldoxx

25 mg

Tablet

Oral use

Foldoxx

12, 5 mg/5 ml

Oral suspension

Oral use

Foldoxx

25 mg/5 ml

Oral suspension

Oral use

Vioxxdolor

25 mg

Tablet

Oral use

Vioxxdolor

50 mg

Tablet

Oral use

Denmark

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

Merck Sharp & Dohme B.V.

Waarderweg 39, Post Bus 581

2003 PC Haarleem

The Netherlands

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Vioxx

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx

25 mg/5 ml

Oral suspension

Oral use

Meroxx

12, 5 mg

Tablet

Oral use

Meroxx

25 mg

Tablet

Oral use

Meroxx

12, 5 ml/5 ml

Oral suspension

Oral use

Meroxx

25 ml/5 ml

Oral suspension

Oral use

Vioxxalt

25 mg

Tablet

Oral use

Vioxxalt

50 mg

Tablet

Oral use

Rofecoxib, MSD

25 mg

Tablet

Oral use

Rofecoxib, MSD

50 mg

Tablet

Oral use

Finland

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

Merck Sharp & Dohme B.V. Waarderweg 39, Post Bus 581

2003 PC Haarleem

The Netherlands

Ceoxxa

25 mg

Tablet

Oral use

Ceoxxa

50 mg

Tablet

Oral use

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Vioxx

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx

25 mg/5 ml

Oral suspension

Oral use

Vioxxakut

25 mg

Tablet

Oral use

Vioxxakut

50 mg

Tablet

Oral use

France

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

Laboratoires Merck Sharp & Dohme – Chibret

3, avenue Hoche

75114 Paris cedex 08

France

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx

25 mg

Tablet

Oral use

Vioxx

25 mg/5 ml

Oral suspension

Oral use

Meoroxx

12, 5 mg

Tablet

Oral use

Meoroxx

12, 5 mg/5 ml

Oral suspension

Oral use

Meoroxx

25 mg

Tablet

Oral use

Meoroxx

25 mg/5 ml

Oral suspension

Oral use

Germany

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

MSD Sharp & Dohme GmbH

Lindenplatz 1

D-85540 Haar

Germany

Vioxx Dolor 25 mg Tabletten

25 mg

Tablet

Oral use

Vioxx Dolor 50 mg Tabletten

50 mg

Tablet

Oral use

Ceoxx 25 mg Tabletten

25 mg

Tablet

Oral use

Ceoxx 50 mg Tabletten

50 mg

Tablet

Oral use

Rofecoxib MSD

12,5 mg/5 ml Suspension zum Einnehmen

12,5 mg/5 ml

Oral suspension

Oral use

Rofecoxib MSD

25 mg/5 ml Suspension zum Einnehmen

25 mg/5 ml

Oral suspension

Oral use

Rofecoxib MSD

12, 5 mg Tabletten

12, 5 mg

Tablet

Oral use

Rofecoxib MSD

25 mg Tabletten

25 mg

Tablet

Oral use

Vioxx 12,5 mg/5 ml Suspension zum Einnehmen

12,5 mg/5 ml

Oral suspension

Oral use

Vioxx 25 mg/5 ml Suspension zum Einnehmen

25 mg/5 ml

Oral suspension

Oral use

Vioxx 12, 5 mg Tabletten

12, 5 mg

Tablet

Oral use

Vioxx 25 mg Tabletten

25 mg

Tablet

Oral use

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 |

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

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Vioxx

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx

25 mg/5 ml

Oral suspension

Oral use

Peroxx

12, 5 mg

Tablet

Oral use

Peroxx

25 mg

Tablet

Oral use

Peroxx

12, 5 mg/5 ml

Oral suspension

Oral use

Peroxx

25 mg/5 ml

Oral suspension

Oral use

Iceland

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

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

The Netherlands

Vioxx

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx

25 mg/5 ml

Oral suspension

Oral use

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Vioxxakut

25 mg

Tablet

Oral use

Vioxxakut

50 mg

Tablet

Oral use

Ceoxx

25 mg

Tablet

Oral use

Ceoxx

50 mg

Tablet

Oral use

Ireland

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

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

United Kingdom

Ceoxx

25 mg

Tablet

Oral use

Ceoxx

50 mg

Tablet

Oral use

Vioxx

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx

25 mg/5 ml

Oral suspension

Oral use

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Italy

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

Merck Sharp E Dohme (Italia) S.p.A.

Via G. Fabbroni, 6

00191 Rome

Italy

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Vioxx

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx

25 mg/5 ml

Oral suspension

Oral use

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

Neopharmed S.p.A.

Via G. Fabbroni, 6

00191 Rome

Italy

Arofexx

12, 5 mg

Tablet

Oral use

Arofexx

25 mg

Tablet

Oral use

Arofexx

12, 5 mg/5 ml

Oral suspension

Oral use

Arofexx

25 mg/5 ml

Oral suspension

Oral use

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

Istituto Gentili S.p.A.

Via Mazzini, 112

56125 Pisa

Italy

Coxxil

12, 5 mg

Tablet

Oral use

Coxxil

25 mg

Tablet

Oral use

Coxxil

12, 5 mg/5 ml

Oral suspension

Oral use

Coxxil

25 mg/5 ml

Oral suspension

Oral use

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

Merck Sharp E Dohme (Italia) S.p.A.

Via G. Fabbroni, 6

00191 Rome

Italy

Dolcoxx

25 mg

Tablet

Oral use

Dolcoxx

50 mg

Tablet

Oral use

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

Neopharmed S.p.A.

Via G. Fabbroni, 6

00191 Rome

Italy

Miraxx

25 mg

Tablet

Oral use

Miraxx

50 mg

Tablet

Oral use

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

Istituto Gentili S.p.A.

Via Mazzini, 112

I-56100 Pisa

Italy

Dolostop

25 mg

Tablet

Oral use

Dolostop

50 mg

Tablet

Oral use

Luxembourg

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

Merck Sharp & Dohme B.V.

Chaussée de Waterloo

Waterloosesteenweg 1135

B-1180 Brussels

Belgium

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Vioxx

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx

25 mg/5 ml

Oral suspension

Oral use

Foldoxx

12, 5 mg

Tablet

Oral use

Foldoxx

25 mg

Tablet

Oral use

Foldoxx

12, 5 mg/5 ml

Oral suspension

Oral use

Foldoxx

25 mg/5 ml

Oral suspension

Oral use

Flogoxxa

25 mg

Tablet

Oral use

Flogoxxa

50 mg

Tablet

Oral use

Vioxxdolor

25 mg

Tablet

Oral use

Vioxxdolor

50 mg

Tablet

Oral use

The Netherlands

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

Merck Sharp & Dohme BV, Waarderweg 39, Post Bus 581

2003 P.C. Haarlem

The Netherlands

Vioxx 12, 5 mg tabletten

12, 5 mg

Tablet

Oral use

Vioxx 25 mg tabletten

25 mg

Tablet

Oral use

Vioxx 12, 5 mg/5 ml suspensie

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx 25 mg/5 ml suspensie

25 mg/5 ml

Oral suspension

Oral use

Balasys 12, 5 mg tabletten

12, 5 mg

Tablet

Oral use

Balasys 25 mg tabletten

25 mg

Tablet

Oral use

Balasys 12, 5 mg/5 ml suspensie

12, 5 mg/5 ml

Oral suspension

Oral use

Balasys 25 mg/5 ml suspensie

25 mg/5 ml

Oral suspension

Oral use

Ceoxx 25 mg tabletten

25 mg

Tablet

Oral use

Ceoxx 50 mg tabletten

50 mg

Tablet

Oral use

Vioxx acute pijn 25 mg tabletten

25 mg

Tablet

Oral use

Vioxx acute pijn 50 mg tabletten

50 mg

Tablet

Oral use

Norway

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

Merck Sharp & Dohme BV, Waarderweg 39, Post Bus 581

2003 P.C. Haarlem

The Netherlands

Vioxx

12, 5 mg/ml

Oral suspension

Oral use

Vioxx

25 mg/ml

Oral suspension

Oral use

Vioxx

12,5 mg

Tablet

Oral use

Vioxx

12,5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Ceoxx

25 mg

Tablet

Oral use

Ceoxx

50 mg

Tablet

Oral use

Vioxx AC

25 mg

Tablet

Oral use

Vioxx AC

50 mg

Tablet

Oral use

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 |

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

Acoxxin

12, 5 mg

Tablet

Oral use

Acoxxin

25 mg

Tablet

Oral use

Acoxxin

12, 5 mg/ml

Oral suspension

Oral use

Acoxxin

25 mg/ml

Oral suspension

Oral use

| Merck Sharp & Dohme, 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

Ceoxx

25 mg

Tablet

Oral use

Ceoxx

50 mg

Tablet

Oral use

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

Ferraz Lynce, S.A.

Rua Consiglieri Pedroso, 123 Queluz de Baixo

P.O Box 1001

2745-557 Barcarena

Portugal

Coxxil

12, 5 mg

Tablet

Oral use

Coxxil

25 mg

Tablet

Oral use

| 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 |

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

Coxxil

12, 5 mg/ml

Oral suspension

Oral use

Coxxil

25 mg/ml

Oral suspension

Oral use

Dolocoxx

25 mg

Tablet

Oral use

Dolocoxx

50 mg

Tablet

Oral use

| Farmacox - Companhia Farmacêutica, 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

Trioxx

25 mg

Tablet

Oral use

Trioxx

50 mg

Tablet

Oral use

| Merck Sharp & Dohme, 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

Vioxx

12, 5 mg/ml

Oral suspension

Oral use

Vioxx

25 mg/ml

Oral suspension

Oral use

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

12, 5 mg

Tablet

Oral use

Spain

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

Laboratorios Abello S.A

Josefa Valcarcel, 38

28027 Madrid

Spain

Movtor 25 mg

25 mg

Tablet

Oral use

Movtor 50 mg

50 mg

Tablet

Oral use

Ceoxx 25 mg

25 mg

Tablet

Oral use

Ceoxx 50 mg

50 mg

Tablet

Oral use

Vioxx 12, 5 mg/5 ml

12, 5 mg/5 ml

Oral suspension

Oral use

Vioxx 25 mg/5 ml

25 mg/5 ml

Oral suspension

Oral use

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Recox 12, 5 mg

12, 5 mg

Tablet

Oral use

Recox 25 mg

25 mg

Tablet

Oral use

Recox 12, 5 mg/5ml

12, 5 mg/5 ml

Oral suspension

Oral use

Recox 25 mg/5ml

25 mg/5 ml

Oral suspension

Oral use

Sweden

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

Merck Sharp & Dohme B.V.

Waarderweg 39, Post Bus 581

2003 P.C. Haarlem

The Netherlands

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Vioxx

12,5 mg/ml

Oral suspension

Oral use

Vioxx

25 mg/ml

Oral suspension

Oral use

Ceoxx

25 mg

Tablet

Oral use

Ceoxx

50 mg

Tablet

Oral use

Vioxxakut

25 mg

Tablet

Oral use

Vioxxakut

50mg

Tablet

Oral use

United Kingdom

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

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

United Kingdom

Axxelor

12,5 mg

Tablet

Oral use

Axxelor

25 mg

Tablet

Oral use

Axxelor

12,5 mg/5 ml

Oral suspension

Oral use

Axxelor

25 mg/5 ml

Oral suspension

Oral use

Coxxid

12, 5 mg

Tablet

Oral use

Coxxid

25 mg

Tablet

Oral use

Coxxid

12,5 mg/5 ml

Oral suspension

Oral use

Coxxid

25 mg/5 ml

Oral suspension

Oral use

Ceoxx

25 mg

Tablet

Oral use

Ceoxx

50 mg

Tablet

Oral use

Movtor

25 mg

Tablet

Oral use

Movtor

50 mg

Tablet

Oral use

Vioxx

12,5 mg/5 ml

Oral suspension

Oral use

Vioxx

25 mg/5 ml

Oral suspension

Oral use

Vioxx

12, 5 mg

Tablet

Oral use

Vioxx

25 mg

Tablet

Oral use

Vioxxacute

25 mg

Tablet

Oral use

ANNEX VII

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

| 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 |

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

Arcoxia

60 mg

Film-coated tablets

Oral use

Arcoxia

90 mg

Film-coated tablets

Oral use

Arcoxia

120 mg

Film-coated tablets

Oral use

Auxib

60 mg

Film-coated tablets

Oral use

Auxib

90 mg

Film-coated tablets

Oral use

Auxib

120 mg

Film-coated tablets

Oral use

Belgium

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

Merck Sharp & Dohme B.V.

Chaussée de Waterloo, 1135

B- 1180 Bruxelles

Belgium

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

Ranacox

60 mg

Film-coated tablet

Oral use

Ranacox

90 mg

Film-coated tablet

Oral use

Ranacox

120 mg

Film-coated tablet

Oral use

Denmark

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

Merck Sharp & Dohme B.V. Waarderweg 39, Post Bus 581

2003 PC Haarleem

The Netherlands

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

Finland

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

Merck Sharp & Dohme B.V. Waarderweg 39, Post Bus 581

2003 P.C. Haarlem

The Netherlands

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

Turox

60 mg

Film-coated tablet

Oral use

Turox

90 mg

Film-coated tablet

Oral use

Turox

120 mg

Film-coated tablet

Oral use

Greece

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

Vianex S.A.

Pharmaceuticals & Cosmetic Industry Licensee/Distributor of Merck Sharp & Dohme

Tatoiou Street. 18th Km Athens-Lamia National Road

14671Nea Erythrea, Athens

Greece

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

Turox

60 mg

Film-coated tablet

Oral use

Turox

90 mg

Film-coated tablet

Oral use

Turox

120 mg

Film-coated tablet

Oral use

Iceland

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

Merck Sharp & Dohme B.V., Waaderweg 39, Post Bus 581

2003 P.C. Haarlem

The Netherlands

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

Ireland

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

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon Hertfordshire

EN11 9BU

United Kingdom

Arcoxia

60 mg

Tablet

Oral use

Arcoxia

90 mg

Tablet

Oral use

Arcoxia

120 mg

Tablet

Oral use

Italy

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

Merck Sharp & Dohme Italia S.p.A.

Via G. Fabbroni, 6

I-00191 Roma

Italy

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

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

Istituto Gentili S.p.A.

Via Mazzini, 112

I-56125 Pisa

Italy

Algix

60 mg

Film-coated tablet

Oral use

Algix

90mg

Film-coated tablet

Oral use

Algix

120 mg

Film-coated tablet

Oral use

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

Neopharmed S.p.A.

Via G. Fabbroni, 6

I-00191 Roma

Italy

Recoxib

60 mg

Film-coated tablet

Oral use

Recoxib

90mg

Film-coated tablet

Oral use

Recoxib

120 mg

Film-coated tablet

Oral use

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

Addenda Pharma S.r.l.

Viale Shakespeare, 47

00100 Roma

Italy

Tauxib

60 mg

Film-coated tablet

Oral use

Tauxib

90 mg

Film-coated tablet

Oral use

Tauxib

120 mg

Film-coated tablet

Oral use

Luxembourg

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

Merck Sharp & Dohme B.V.

Chaussée de Waterloo 1135

B-1180 Bruxelles

Belgium

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

Ranacox

60 mg

Film-coated tablet

Oral use

Ranacox

90 mg

Film-coated tablet

Oral use

Ranacox

120 mg

Film-coated tablet

Oral use

The Netherlands

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

Merck Sharp & Dohme BV Waarderweg 39

P.O. Box 581

2003 PC Haarlem

Netherlands

Arcoxia 60

60 mg

Film-coated tablet

Oral use

Arcoxia 90

90mg

Film-coated tablet

Oral use

Arcoxia 120

120 mg

Film-coated tablet

Oral use

Auxib 60

60 mg

Film-coated tablet

Oral use

Auxib 90

90 mg

Film-coated tablet

Oral use

Auxib 120

120 mg

Film-coated tablet

Oral use

Norway

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

Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581

2003 PC Haarlem

The Netherlands

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

Portugal

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

Merck Sharp & Dohme, (Portugal) Lda. Quinta da Fonte, Edifício Vasco da Gama n.o 19, Porto Salvo

2780-730 Paço d' Arcos

Portugal

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

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

Laboratórios BIA-Portela S.A.

Av. Da Siderurgia Nacional, 4745-457 S. Mamede do Coronado

Portugal

Exxiv

60 mg

Film-coated tablet

Oral use

Exxiv

90 mg

Film-coated tablet

Oral use

Exxiv

120 mg

Film-coated tablet

Oral use

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

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

Portugal

Turox

60 mg

Film-coated tablet

Oral use

Turox

90mg

Film-coated tablet

Oral use

Turox

120 mg

Film-coated tablet

Oral use

Spain

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

Merck Sharp & Dohme de Espana, S.A.

c/ Josefa Valcarcel 38

28027 Madrid

Spain

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

| Laboratorios Abello |
| --- |
| c/ Josefa Valcarcel 38 |
| 28027 Madrid |
| Spain |

Laboratorios Abello

c/ Josefa Valcarcel 38

28027 Madrid

Spain

Exxiv

60 mg

Film-coated tablet

Oral use

Exxiv

90 mg

Film-coated tablet

Oral use

Exxiv

120 mg

Film-coated tablet

Oral use

Sweden

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

Merck Sharp & Dohme BV Waarderweg 39, Post Bus 581

2003 PC Haarlem

The Netherlands

Arcoxia

60 mg

Film-coated tablet

Oral use

Arcoxia

90 mg

Film-coated tablet

Oral use

Arcoxia

120 mg

Film-coated tablet

Oral use

Turox

60 mg

Film-coated tablet

Oral use

Turox

90 mg

Film-coated tablet

Oral use

Turox

120 mg

Film-coated tablet

Oral use

United Kingdom

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

Merck, Sharp & Dohme Ltd

Hertford Road, Hoddesdon Hertfordshire EN11 9BU

United Kingdom

Arcoxia

60 mg

Tablet

Oral use

Arcoxia

90 mg

Tablet

Oral use

Arcoxia

120 mg

Tablet

Oral use

Auxib

60 mg

Tablet

Oral use

Auxib

90 mg

Tablet

Oral use

Auxib

120 mg

Tablet

Oral use

Exxiv

60 mg

Tablet

Oral use

Exxiv

90 mg

Tablet

Oral use

Exxiv

120 mg

Tablet

Oral use

Turox

60 mg

Tablet

Oral use

Turox

90 mg

Tablet

Oral use

Turox

120 mg

Tablet

Oral use

ANNEX VIII

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

| Member State | Marketing Authorisation Holder | Invented Name | Strength | Pharmaceutical Form | Route of administration | Packaging | Package size |
| --- | --- | --- | --- | --- | --- | --- | --- |
| AU | Aesca chem.pharm. Fabrik GmbH., |
| Badner Straße 23, |
| A-2514 Traiskirchen, |
| Austria |

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Package size

AU

Aesca chem.pharm. Fabrik GmbH.,

Badner Straße 23,

A-2514 Traiskirchen,

Austria

Clarinase - Manteldragees

5 mg

loratadine +120 mg pseudoephedrine

Coated tablet

Oral use

Blister

10

Clarinase retard Dragees

10 mg loratadine + 240 mg psuedoephedrine

Coated tablet

Oral use

Blister

10

BE

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

Schering Plough N.V.

Rue de Stalle 73

B-1180 Brussels

Belgium

Clarinase 120/5

(Repetabs)

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

Prolonged-release tablet

Oral use

Blister

14

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

Clarinase 240/10 once daily

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

Prolonged-release tablet

Oral use

Blister

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

Prospel

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

Prolonged-release tablet

Oral use

Blister

10, 14,

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

FI

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

Schering-Plough Europe,

73, Rue De Stalle,

B-1180 Brussels,

Belgium

Clarinase

10 mg loratadine/

240 mg pseudoeph-edrine

Prolonged-release tablet

Oral use

Blister

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

FR

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

Schering Plough

92, rue Baudin

F-92307 Levallois Perret Cedex,

France

CLARINASE

10 mg loratadine + 240 mg pseudo-ephedrine sulphate

Prolonged-release tablet

Oral use

Blister

(PVC/Alu)

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

CLARINASE REPETABS

5 mg loratadine + 120 mg pseudoephedrine

Modified-release tablet

Oral use

Blister

(PVC/Alu)

10, 14, 20

LORATADINE/SULFATE de PSEUDOEPHEDRINE

5 mg loratadine + 120 mg pseudoephedrine

Modified-release tablet

Oral use

Blister

(PVC/Alu)

10, 14, 20

GR

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

Schering Plough A.Φ.B.E.E.

63 Agiou Dimitriou

GR-17456 Alimos

Greece

Clarityne D

5 + 120 mg

pseudoe-phine phri-nesulphate

Modified-release tablet

Oral use

Blister

14

Clarityne-D

10 + 240 mg pseudo-epinephrine sulphate

Prolonged-release tablet

Oral use

Blister

7, 14

IC

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

Schering-Plough Europe,

Rue de Stalle,

B-1180 Brussels

Belgium

Clarinase

10 mg loratadine + 240 mg pseudoephedrine

Prolonged-release tablet

Oral use

Blister

10

IT

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

Italfarmaco SPA

Via Dei Lavoratori, 54

I-20092 Cinisello Balsamo

Milano

Italy

Frinase

Loratadine 5

mg/pseudoephedrine sulph 120 mg

Modified-release coated tablet

Oral use

Blister

20

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

Schering Plough SPA

Via Ripamonti, 89

I-20141 Milano,

Italy

Clarinase

Loratadine 5

mg/pseudoephedrine sulph 120 mg

Modified-release coated tablet

Oral use

Blister

20

Narinex

Loratadine 10 mg/pseudoephedrine sulph 240 mg

Prolonged-release tablet

Oral use

Blister (ACLAR/PE/PVC)

100

Narinex

Loratadine 10 mg/pseudoephedrine sulph 240 mg

Prolonged-release tablet

Oral use

Blister (ACLAR/PE/PVC)

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

LU

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

SCHERING-PLOUGH s.a.

73, Rue de Stalle

B-1180 Brussels

Belgium

Clarinase 120/5

5 mg + 120 mg pseudoephedrine

Prolonged-release tablet

Oral use

Blister

14

Clarinase 240/10 once daily

10 mg + 240 mg pseudoephedrine

Prolonged-release tablet

Oral use

Blister

7, 10, 20

PT

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

Schering-Plough Farma, Lda.

Rua Agualva dos Açores 16

P-2735-557 Agualva- Cacém

Portugal

Claridon

5 mg loratadine + 120 mg pseudo-ephedrine

Modified-release tablet

Oral use

Blister

14, 20

Claridon QD

10 mg loratadine + 240 mg pseudo-ephedrine

Prolonged-release tablet

Oral use

Blister

7, 14

SP

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

Laboratorios Lesvi S.A.

C/Argent 1. Pol. Ind. Can Pelegri

ES-08755 Castellbisbal, Barcelona,

Spain

Rinociveran

Loratadine10 mg/ pseudoephedrine sulphate 240 mg

Prolonged-release tablet

Oral use

Blister (PVC/AL)

10

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

Schering-Plough S.A.

Km 36 Carret Nacional 1

ES-28750 San Agustin de Guadalix

Madrid,

Spain

Narine Repetabs

Loratadina 5 mg/pseudoephedrine sulphate 120 mg

Modified-release tablet

Oral use

Blister

20

Narine Retard

Loratadina 10 mg/ pseudoephedrine 240 mg

Prolonged-release tablet

Oral use

Blister

10

ANNEX IX

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

| Member State | Marketing Authorisation Holder | Applicant | Invented Name | Strength | Pharmaceutical Form | Route of administration | Packaging | Package size |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| AU | Aesca chem.pharm. Fabrik GmbH., |
| Badner Straße 23, |
| A-2514 Traiskirchen, |
| Austria |

Member State

Marketing Authorisation Holder

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Packaging

Package size

AU

Aesca chem.pharm. Fabrik GmbH.,

Badner Straße 23,

A-2514 Traiskirchen,

Austria

Clarityn 10 mg - lösliche Tabletten

10 mg

Soluble tablet

Oral use

Tablet container

10, 30

Clarityn 10 mg - Lyotabletten

10 mg

Oral lyophilisate

Oral use

Blister

10, 30

Clarityn 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

10, 30

Clarityn 5mg/5ml – Sirup

5 mg/5 ml

Syrup

Oral use

Bottle (glass)

60 ml

Loratadin Aesca 10mg - Tabletten

10 mg

Tablet

Oral use

Blister

10, 30

Loratadin Aesca 5mg/5ml - Sirup

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

Blister

10, 30

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

Arcana Arzneimittel GmbH.,

Zimbagasse 5,

A-1147 Wien

Austria

Loratadin arcana 10 mg- Filmtabletten

10 mg

Film-coated tablet

Oral use

Blister

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

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

Lannacher Heilmittelwerke GmbH, Schloßplatz 1,

A-8502 Lannach

Austria

Lorat 10 mg - Tabletten

10 mg

Tablet

Oral use

Blister

7, 10, 20, 30, 50, 100

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

Liconsa S.A. Gran Via Carlos III, 98

ES-08028 Barcelona

Spain

Chemotadin 10 mg - Tabletten

10 mg

Tablet

Oral use

Blister

7, 10, 20, 30, 50, 100

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

Lindopharm GmbH.,

Neustraße 82,

D-40721 Hilden

Germany

Loratadin Lindopharm 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

7, 10, 20, 30, 50, 100

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

Ratiopharm Arzneimittel Vertriebs-GmbH, Alöbert Schweitzer Gasse 3,

A-1147 Wien

Austria

Loratadin ratiopharm 10 mg - Tabletten

10 mg

Tablet

Oral use

Blister

7, 20, 50, 100

| Sandoz GmbH., |
| --- |
| A-6250 Kundl/Tirol |
| Austria |

Sandoz GmbH.,

A-6250 Kundl/Tirol

Austria

Lictyn 10 mg - Tabletten

10 mg

Tablet

Oral use

Blister

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

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

Stada Arzneimittel GmbH, Heiligenstädterstraße 52/8,

A-1190 Wien,

Austria

Loratadine “Stada” 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

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

Loratadine “Stada” 1 mg/ml Sirup

5mg/5 ml

Syrup

Oral use

Bottle (glass)

50, 60, 100, 120, 150ml

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

Genericon Pharma GesmbH,

Schloßplatz 1,

A-8502 Lannach

Austria

Loratadin Genericon 10 mg – Tabletten

10 mg

Tablet

Oral use

Blister

10

BE

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

Omega Pharma N.V.

Venecoweg 26

B-9810 Nazareth

Belgium

Sanelor

10 mg

Tablet

Oral use

Blister

10

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

Laboratoires Irex

Avenue galilee

F-92350 Le Plessis-Robinson, Cedex

France

Loratadine irex

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 30, 50, 100

| Merck NV |
| --- |
| Brusselsesteenweg 288 |
| B-3090 Overijse |
| Belgium |

Merck NV

Brusselsesteenweg 288

B-3090 Overijse

Belgium

Merck-loratadine

10 mg

Film-coated tablet

Oral use

Blister

(PVC/Alu)

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

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

Schering Plough N.V.

Rue de Stalle 73

B-1180 Brussels

Belgium

Claritine

10 mg

Tablet

Oral use

Blister

7, 21

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

Claritine

10 mg

Effervescent tablet

Oral use

Blister

10, 21

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

Claritine

1 mg/ml

Syrup

Oral use

Bottle

100 ml

50, 60, 100, 120, 150 ml – for export

Claritine Reditabs

10 mg

Oral Lyophilisate

Oral use

Blister

10, 20, 30

DK

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

1A Farma

Herstedøstervej 27-29

DK-2620 Albertslund.

Denmark

Loratadin 1A

Pharma

10 mg

Tablet

Oral use

Blister

10, 30, 100

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

A/S GEA Farmaceutiske Fabrik,

Holger Danskes Vej 89,

DK-2000 Frederiksberg,

Denmark

Geklimon

10 mg

Tablet

Oral use

Blister

10, 30, 100

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

Ct-Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Germany

Loratadin ct

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

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

Durascan Medicinal Products A/S

Svendborgvej 243,

DK-5260 Odense S,

Denmark

Oratyn

10 mg

Tablet

Oral use

Blister

5, 10, 30, 100

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Medallerg

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

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

Lichtenstein Pharmazeutica GmbH

Industriestrasse 10

D-56218 Mulheim-Karlich

Germany

Loratadin Lichtenstein

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

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

Linconsa SA.

Gran Via Carlos III 98, 7 Planta

ES-08028 Barcelona

Spain

Chemolorat

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

Chemotadin

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

Licatidin

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

Loralic

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

Lorat

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

Loratadin "Liconsa"

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

Tifitadin

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

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

Medis Danmark A/S

Havelse Mølle 14

DK-3600 Frederikssund

Denmark

Solamed

1 mg/ml

Oral solution

Oral use

Bottle

Not marketed at the moment

Delor

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

Loratadin Medis

1mg/ml

Oral suspension

Oral use

Bottle

Ongoing. Packsizes not decided

Loratabs

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

Loarev

1 mg/ml

Oral suspension

Oral use

Bottle

Not marketed at the moment

Lorafluid

1 mg/ml

Oral suspension

Oral use

Bottle

Not marketed at the moment

Loramix

1 mg/ml

Oral suspension

Oral use

Bottle

Not marketed at the moment

Lorfuse

1 mg/ml

Oral suspension

Oral use

Bottle

Not marketed at the moment

Lorasol

1 mg/ml

Oral suspension

Oral use

Bottle

Not marketed at the moment

Deloradin

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

Alerzid

1 mg/ml

Oral suspension

Oral use

Bottle

Not marketed at the moment

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

NM Pharma A/S.

Overgaden Neden Vandet 7,

DK-1414 København K

Denmark

Loratadin "NM"

10 mg

Film-coated tablet

Oral use

Blister

10, 30

| PharmaCo Dane |
| --- |
| Marielund vej 46A |
| DK-2730 Herlev |
| Denmark |

PharmaCo Dane

Marielund vej 46A

DK-2730 Herlev

Denmark

Loratadin "PCD"

1 mg/ml

Oral suspension

Oral use

Bottle

Not marketed at the moment

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

Ratiopharm GmbH,

Graf-Acro-Strasse 3,

D-89079 Ulm,

Germany

Loratadin

Ratiopharm

10 mg

Tablet

Oral use

Blister

10, 30, 100

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

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Loratadin

Biochemie

10 mg

Tablet

Oral use

Blister

10, 30, 100

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

Schering Plough Europe

Rue de Stalle 73

B-1180 Brussels

Belgium

Clarityn

10 mg

Tablet

Oral use

Blister

5, 10, 30, 100

Clarityn

1 mg/ml

Oral Solution

Oral use

Bottle

1 x 100 ml

Clarityn

10 mg

Effervescent tablet

Oral use

Blister

10

Clarityn

10 mg

Oral lyophilisate

Oral use

Blister

Not marketed at the moment

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

Schering-Plough A/S

Hvedemarken 12

DK-3520 Farum

Denmark

Versal

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

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

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Allergostad

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

Loratadin STADA

10 mg

Tablet

Oral use

Blister

10, 30, 50, 100

Loradis

10 mg

Tablet

Oral use

Blister

Not marked at the moment

Lorapharm

10 mg

Tablet

Oral use

Blister

Not marked at the moment

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

Sterwin Medicines Ltd

1 Onslow Street, Guildford

Surrey

GU1 4YS,

United Kingdom

Lorafile

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

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

Wörwag Pharma GmbH & Co. KG.

Calwerstrasse 7

D-71034 Böblingen,

Germany

LORATAGAMMA

10 mg

Tablet

Oral use

Blister

Not marketed at the moment

FI

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

A/S Gea Farmaceutisk Fabrik,

Holger Danskes Vej 89,

DK-2000 Frederiksberg,

Denmark

Geklimon

10 mg

Tablet

Oral use

Blister

7, 10, 20, 21, 30, 100

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

DuraScan Medical Products AS, Svendborgvej 243,

DK-5260 Odense S,

Denmark

Loratadin Durascan

10 mg

Tablet

Oral use

Blister

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

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

Generics (UK) Limited,

Station Close,

Potters Bar,

Herts EN6 1TL,

United Kingdom

Loratadin Generics

10 mg

Film-coated tablet

Oral use

Blister

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

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

Laboratoires SMB S.A.,

Rue de la Pastorale 26-28,

B-1080 Brussels,

Belgium

Histadin

10 mg

Tablet

Oral use

Blister

10, 30, 100

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

Ratiopharm GmbH,

Graf-Arco-Strasse 3,

D-89079 Ulm,

Germany

Loratadin-ratiopharm

10 mg

Tablet

Oral use

Blister

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

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

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl,

Austria

Loratadin Biochemie

10 mg

Tablet

Oral use

Blister and tablet container

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

100x1,250

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

Schering-Plough Europe,

73, Rue De Stalle,

B-1180 Brussels,

Belgium

Clarityn

1 mg/ml

Oral solution

Oral use

Bottle

120 ml

Clarityn

10 mg

Tablet

Oral use

Blister

10, 30, 100

Clarityn-S

10 mg

Oral lyophilisate

Oral use

Blister

8, 10, 30, 100,

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

STADA Arzneimittel AG,

Stadastrasse 2-18,

D-61118 Bad Vilbel,

Germany

Loratadin Stada

10 mg

Tablet

Oral use

Blister

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

Loratadin Stada

1 mg/ml

Oral solution

Oral use

Bottle

50, 60, 100, 120, 150 ml

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

Verman Oy Ab,

Vanhankyläntie 44 B,

FIN-04401 Järvenpää,

Finland

Tuulix

10 mg

Tablet

Oral use

Blister

1, 10, 30, 100

Tuulix

1 mg/ml

Oral solution

Oral use

Bottle

60, 100, 200 ml

FR

| ENDWELL |
| --- |
| Elm House |
| Ashbourne Industrial Estate |
| Ashbourne - County Meath |
| Ireland |

ENDWELL

Elm House

Ashbourne Industrial Estate

Ashbourne - County Meath

Ireland

LORATADINE ENDWELL

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

15, 28, 30, 100

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

Generics

28 Station Close

Potters Bar

EN6 1TL Hertfordshire,

United Kingdom

LORATADINE

10 mg

Film-coated tablet

Oral use

Blister

(PVC/Alu)

5, 7, 10, 14, 15

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

MADAUS

Immeuble Mercure III

55 bis, Quai de Grenelle

F-75015 Paris,

France

LORATADINE MADAUS

10 mg

Tablets

Oral use

Blister (PVC/Alu)

15, 28, 30

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

Schering Plough

92, rue Baudin

F-92307 Levallois Perret Cedex,

France

CLARITYNE

0.1 g/100ml

Syrup

Oral use

Glass

(brown)

60, 120 ml

CLARITYNE

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

10, 15, 20

CLARITYNE

10 mg

Effervescent tablet

Oral use

Blister

(Alu/Alu)

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

LORATADINE SCHERING PLOUGH

0.10 %

Syrup

Oral use

Bottle (glass)

60, 125ml

LORATADINE SCHERING PLOUGH

10 mg

Effervescent tablet

Oral use

Blister (Alu/Alu)

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

LORATADINE SCHERING PLOUGH

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

10, 15, 20

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 |

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

GE

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

1 A Pharma GmbH

Keltenring 1+3

D-82041 Oberaching

Germany

Loratad 10 mg

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

Loratad 10

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

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

Loratadin-1A Pharma

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

20, 30, 50, 100

| Acis Arzneimittel Vertrieb AG |
| --- |
| Bajuwarenring 14 |
| D-82041 Oberhachling |
| Germany |

Acis Arzneimittel Vertrieb AG

Bajuwarenring 14

D-82041 Oberhachling

Germany

Loratadin Acis 10 mg

10 mg

Tablet

Oral use

Blister

(PVC/PVDC/Alu)

20, 50, 100

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

Alfred E.Tiefenbacher GmbH & Co.

Van-der-Schmissen-Str 1

D-22767 Hamburg

Germany

Chemotadin 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 10, 20, 30, 50, 100

Lorat 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 10, 20, 30, 50, 100

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

Aliud Pharma GmbH & Co KG

Gottlieb-Daimler Str 19

D-89150 Laichingen

Germany

Loratadin AL 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

Loratadin AL 1 1 mg/ml saft

1 mg/1ml

Syrup

Oral use

Bottle

(PE)

50, 60, 100, 120, 150 ml

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

Alpharma-ISIS GmbH & Co KG

Elisabeth-Selbert-Str. 1

D-40764 Langenfeld

Germany

LORA-PUREN

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 10, 20, 50, 100, 500

| Altana Consumer Health GmbH |
| --- |
| Bargkoppelweg 66 |
| D-22145 Hamburg |
| Germany |

Altana Consumer Health GmbH

Bargkoppelweg 66

D-22145 Hamburg

Germany

Enatin

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

10, 20, 50, 100

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

AWD.pharma GmbH & Co. KG

Leipziger Str. 7-13

D-01097 Dresden

Germany

Loralerg

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100, 500

| Basics GmbH |
| --- |
| Hemmelrather Weg 201 |
| D-51377 Leverkusen |
| Germany |

Basics GmbH

Hemmelrather Weg 201

D-51377 Leverkusen

Germany

!LORA BASICS

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

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

Sandoz Pharmaceutical GmbH

Carl-Zeiss-Ring 3

D-85737 Ismaning

Germany

TRILOR 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

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

7, 10, 20, 50, 100

| Betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Germany |

Betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Germany

Betalora 10

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 10, 20, 30, 50, 100

Lobeta gegen Allergien

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

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

ct-Arzneimittel GmbH

Lengeder Str. 42a

D-13407 Berlin

Germany

Loratadin von ct

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

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

Dermapharm AG

Luise-Ullrich-Str. 6

D-82031 Gruenwald

Germany

Loraderm

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

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

Dr.August Wolff GmbH & Co. Arzneimittel

Sudbrackstr. 56

D-33611 Bielefeld

Germany

Loradino 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

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

Dr.Gerhard Mann Chem.-pharm.Fabrik GmbH

Brunsbuetteler Damm 165-173

D-13581 Berlin

Germany

Lora Rhinol 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

Vividrin Tabletten Wirkstoff Loratadin

10 mg

Tablet

Oral use

Blister

(Alu)

7, 14, 28, 56

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

Dr.R.Pfleger Chemische Fabrik GmbH

Emil-Kemmer-Str. 33

D-96103 Hallstadt

Germany

Lantamed 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

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

Essex Pharma GmbH

Thomas-Dehler-Str. 27

D-81737 Muenchen

Germany

Lisino

10 mg

Tablet

Oral use

Blister

20, 50, 100

Lisino Brause Brausetabletten

10 mg

Effervescent tablet

Oral use

Blister

10, 30

Lisino extra schnellaufloesende Tabletten

10 mg

Tablet

Oral use

Blister

8, 10, 20, 50, 60

Lisino S

10 mg

Tablet

Oral use

Blister

7

Loratadin Brause Brausetabletten

10 mg

Effervescent tablet

Oral use

Blister

10

| GALENpharma GmbH |
| --- |
| Wittland 13 |
| D-24109 Kiel |
| Germany |

GALENpharma GmbH

Wittland 13

D-24109 Kiel

Germany

LORAGALEN

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100, 500

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

Hermal Kurt Herrmann GmbH & Co.

Scholtzstr. 3

D-21465 Reinbek

Germany

Loratadindura 10 mg Filmtabletten

10 mg

Tablet

Oral use

Blister strips

(PVC/Alu)

7, 20, 50, 100

| Heumann Pharma GmbH |
| --- |
| Suedwestpark 50 |
| D-90449 Nuernberg |
| Germany |

Heumann Pharma GmbH

Suedwestpark 50

D-90449 Nuernberg

Germany

Loratadin 10 Heumann

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100, 500

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Loratadina 10 mg

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

Lorano

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 10, 20, 30, 50, 100

Lorano akut

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 14, 20, 50, 100

| Krewel Meuselbach GmbH |
| --- |
| Krewelstr. 25 |
| D-3783 Eitorf |
| Germany |

Krewel Meuselbach GmbH

Krewelstr. 25

D-3783 Eitorf

Germany

Loraclar

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100, 500

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

KSK – Pharma Vertriebs AG

Roggenbackstr. 4

D-76133 Karlsruhe

Germany

Loratadin KSK

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 30, 50, 100

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

Lichtenstein Pharmazeutica GmbH & Co.

Industriestr. 26

D-56218 Muelheim-Kaerlich

Germany

Lora-Lich 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

| Lindopharm GmbH |
| --- |
| Neustr. 82 |
| D-40721 Hilden |
| Germany |

Lindopharm GmbH

Neustr. 82

D-40721 Hilden

Germany

Loravis 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

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

Medis Danmark A/S

Havelse Mølle 14

DK-3600 Fredrikssund

Denmark

Alerisa

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 10, 14, 20, 50, 100

| PROMEDIPHARM GmbH |
| --- |
| Berliner Ring 89 |
| D-64625 Bensheim |
| Germany |

PROMEDIPHARM GmbH

Berliner Ring 89

D-64625 Bensheim

Germany

Lorasan

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100, 500

Loratadura 10mg

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100, 500

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

Ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Lora-ratiopharm 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

20, 50, 100

Loratadin-ratiopharm 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

Loratadin-ratiopharm (10 mg Tabletten) bei Allergien

10 mg

Tablet

Oral use

Blister

(PVC/PVDC/Alu)

20, 50, 100

Loratadinum von ratio 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/PVDC/Alu)

20, 50, 100

Loratadin-ratio 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/PVDC/Alu)

20, 50, 100

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

Sandoz Pharmaceutical GmbH

Carl-Zeiss-Ring

D-85737 Ismaning

Germany

Loratadin Azupharma 10mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 10, 20, 50, 100

Loratadine AZU 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

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

7, 10, 20, 50, 100

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

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Loratadin STADA allerg 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 20, 50, 100

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

Woelm Pharma GmbH & Co.

Rhoendorfer Str. 80

D-53604 Bad Honnef

Germany

Livotab direkt Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 10, 14, 28

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

Woerwag Pharma GmbH & Co.

Calwer Str. 7

D-71034 Boeblingen

Germany

Loragamma 10 mg Tabletten

10 mg

Tablet

Oral use

Blister

(PVC/Alu)

7, 10, 20, 50, 100

| PROMEDIPHARM GmbH |
| --- |
| Berliner Ring 89 |
| D-64625 Bensheim |
| Germany |

PROMEDIPHARM GmbH

Berliner Ring 89

D-64625 Bensheim

Germany

Lorasol Loesung

10 mg/10 ml

Oral solution

Oral use

Bottle (glass)

Packsize not determined yet

GR

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

ANΦΑΡΜ ΕΛΛΑΣ Α.Ε.

442 Acharnon Str

GR-11143 Athens

Greece

Latoren

10 mg

Tablet

Oral use

Blister

14, 28

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

Biomedica-Chemica S.A.

Liolios-Parodos G. Lyra

25-K. Kifisia,

Greece

Zelmar

10 mg

Tablet

Oral use

Blister

14, 21

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

BIOSPRAY ABEE

10, Aristotelous str.

GR-104 32 Athens

Greece

Loratab

10 mg

Tablet

Oral use

Blister

14, 21, 42

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

Coup OE

Kouparousos

Ag. Barbaras 53,

GR-172 35 Dafni

Greece

Ralinet

10 mg

Tablet

Oral use

Blister

14, 21

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

DOCTUM S.A.

5, Dorilaiou str.

GR-115 21 Athens

Greece

Allergofact

10 mg

Tablet

Oral use

Blister

14, 20

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

Faran ABEE

Ahaias kai Trizinias

145 64 N. Kifisia,

Greece

Difmedol

10 mg

Tablet

Oral use

Blister

14

| Finixfarm |
| --- |
| Ant. Polyxronis |
| Anabrytis 11 |
| Athens, |
| Greece |

Finixfarm

Ant. Polyxronis

Anabrytis 11

Athens,

Greece

Lora

10 mg

Tablet

Oral use

Blister

14, 21, 28

| HELP ABEE |
| --- |
| 4 Valaoritou Str |
| GR-14452 Metamorphosi |
| Greece |

HELP ABEE

4 Valaoritou Str

GR-14452 Metamorphosi

Greece

Helporigin

10 mg

Tablet

Oral use

Blister

14

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

KLEVA E.Π.E.

189 Parnithos Ave

GR-13671 Acharnai

Greece

Horestyl

10 mg

Tablet

Oral use

Blister

14, 21

Horestyl

5 mg/ 5 ml

Syrup

Oral use

Bottle

120 ml

| LAMDA PHARMACEUTICAL |
| --- |
| 6 Thermopilon str. |
| 152 33 Chalandri |
| Athens |
| Greece |

LAMDA PHARMACEUTICAL

6 Thermopilon str.

152 33 Chalandri

Athens

Greece

Loralerg

10 mg

Effervescent tablet

Oral use

Blister

21

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

LEOVAN

10, Chrisanthou Trapezountos str.

166 77 Elliniko

Athens

Greece

Ristotadin

10 mg

Tablet

Oral use

Blister

21

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

MED-ONE S.A.

ΕΛΛΑΣ

211 Parnithos Ave

GR-13671 Acharnal

Athens

Greece

Allerdrug

5 mg/5 ml

Syrup

Oral use

Bottle

120 ml

Allerdrug

10 mg

Tablet

Oral use

Blister

14

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

Novartis (Hellas) A.E.B.E

120 xlm Ethnikis Odou Athinon-Lamias

GR-14410 Metamorfosi

Greece

Loratadine/Biochemie

10 mg

Tablet

Oral use

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

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)

| Novexal Hellas |
| --- |
| 25 AgDimitriou Str |
| 174 55 Kalamaki, |
| Athens |
| Greece |

Novexal Hellas

25 AgDimitriou Str

174 55 Kalamaki,

Athens

Greece

Loratadine / Novexal

5 mg/5 ml

Syrup

Oral use

Bottle

120 ml

Loratadine / Novexal

10 mg

tablet

Oral use

Blister

14

| Relyo Hellas ΕΠΕ |
| --- |
| Pan. Kabbadas |
| Fabicrou 48 |
| Athens, |
| Greece |

Relyo Hellas ΕΠΕ

Pan. Kabbadas

Fabicrou 48

Athens,

Greece

Novacloxab

10 mg

Tablet

Oral use

Blister

10, 14

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

Schering Plough A.Φ.B.E.E.

63 Agiou Dimitriou

GR-17456 Alimos

Greece

Clarityne

10 mg

Tablet

Oral use

Blister

10, 14, 21

Clarityne

5 mg/5 ml

Syrup

Oral use

Bottle

120 ml

Clarityne

10 mg

Effervescent tablet

Oral use

Blister

10, 21

Clarityne

10 mg

Oral lyophilisate

Oral use

Blister

10, 20

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

VELKA HELLAS AEBE

12 Korinthou str.

154 51 Psychiko

Athens

Greece

Igir

10 mg

Tablet

Oral use

Blister

21

| VIOFAR EPE |
| --- |
| Terma Evaggelistrias |
| GR-136 71 Acharnai |
| Athens |
| Greece |

VIOFAR EPE

Terma Evaggelistrias

GR-136 71 Acharnai

Athens

Greece

Bollinol

10 mg

Tablet

Oral use

Blister

20

Bollinol

5 mg/5 ml

Syrup

Oral use

Bottle

120 ml

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

ΦΑΡΜΑΤΕΝ Ε.Π.Ε

68 Menandrou Str

GR-10432 Athens

Greece

Biliranin

10 mg

Tablet

Oral use

Blister

14

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

ΦΑΡΜΕΞ Α.Ε.

156 Aylonos Str

Sepolia GR-1044

Greece

Utel

10 mg

Tablet

Oral use

Blister

10, 14, 21

Utel

5 mg/5 ml

Syrup

Oral use

Bottle

120 ml

IC

| Delta hf. |
| --- |
| Reykjavíkurvegi 78 |
| IS-220 Hafnarfjörður |
| Ísland |

Delta hf.

Reykjavíkurvegi 78

IS-220 Hafnarfjörður

Ísland

Lóritín

10 mg

Tablet

Oral use

Blister

10, 30, 100

| NM Pharma, |
| --- |
| Reykjavíkurvegi 78 |
| IS-220 Hafnarfjörður |
| Ísland |

NM Pharma,

Reykjavíkurvegi 78

IS-220 Hafnarfjörður

Ísland

Loratadine NM Pharma

10 mg

Tablet

Oral use

Blister

10, 30, 100

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

Schering-Plough Europe,

Rue de Stalle,

B-1180 Brussels

Belgium

Clarityn

10 mg

Effervescent tablet

Oral use

Blister

10

Clarityn

1 mg/ml

Oral solution

Oral use

Bottle

100 ml

Clarityn

10 mg

Tablet

Oral use

Blister

10, 30, 100

IR

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

McDermott Laboratories Ltd

35 Baldoyle Industrial Estate,

Grange Road

Baldoyle

Dublin 13,

Ireland

Histaclar

10 mg

Tablet

Oral use

Blister

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

Histaclar Allergy Tablet

10 mg

Tablet

Oral use

Blister

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

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

Olinka UK Ltd

38-40 Chamberlayne Road

London, NW10 3JE,

United Kingdom

Loratadine

10 mg

Tablet

Oral use

Blister

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

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

Schering-Plough Ltd

Schering-Plough House

Shire Park

Welwyn Garden City

Hertfordshire, AL7 1TW,

United Kingdom

Clarityn

10 mg

Tablet

Oral use

Blister

5, 7, 10, 30

Clarityn

1 mg/ ml

Syrup

Oral use

Bottle (glass)

100, 200ml

Clarityn Rapide

10 mg

Tablet

Oral use

Strip

30

Clarityn Rapide Allergy Tablets

10 mg

Tablet

Oral use

Strip

7, 10

IT

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

Essex Italia SPA

Via Serio, 1

I-20139 Milano,

Italy

Alorin

10 mg

Tablet

Oral use

Blister

5, 7, 10, 20

Alorin

1 mg/ml

Oral solution

Oral use

Bottle

100 ml

Alorin

10 mg

Effervescent tablet

Oral use

Blister

20

Alorin

10 mg

Oral lyophilisate

Oral use

Blister

20

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

F.I.R.M.A. SPA

Via Dio Scandicci, 37

I-50143 Firenze,

Italy

Fristamin

10 mg

Tablet

Oral use

Blister

5, 7, 10, 20

Fristamin

1 mg/ml

Oral solution

Oral use

Bottle

100 ml

Fristamin

10 mg

Effervescent tablet

Oral use

Blister

20

Fristamin

10 mg

Oral lyophilisate

Oral use

Blister

20

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

Schering Plough SPA

Via Ripamonti, 89

I-20141 Milano,

Italy

Clarityn

10 mg

Tablet

Oral use

Blister

5, 7, 10, 20

Clarityn

1mg/ml

Oral Solution

Oral use

Bottle

100 ml

Clarityn

10 mg

Effervescent tablet

Oral use

Blister

20

Clarityn

10 mg

Oral lyophilisate

Oral use

Blister

20

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

Stada Arzneimittel AG

Stadastrasse 2-18

D-6118 Bad Vilbel

Germany

Lorastad 10 mg

10 mg

Tablet

Oral use

Blister

(PVC)

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

Lorastad 1mg/ml

1mg/ml

Syrup

Oral use

Bottle

(amber)

50, 60, 100, 120, 150 ml

LU

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

Merck s.a.,

Brusselsesteenweg 288,

B-3090 Overijse,

Belgium

Merck-Loratadine

10 mg

Tablet

Oral use

Blister

(PVC/AL)

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

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

Ratiopharm GmbH

Graf-Arco-Strasse 3

D-89079 Ulm,

Germany

Loratadine Ratiopharm

10 mg

Tablet

Oral use

Blister

(PVC/Al)

7, 20, 50, 100

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

SCHERING-PLOUGH s.a.

73, Rue de Stalle

B-1180 Brussels,

Belgium

Claritine

10 mg

Effervescent tablet

Oral use

Blister

10, 21

Claritine

10 mg

Tablet

Oral use

Blister

7, 21

Claritine Pédiatrique

1 mg/ ml

Syrup

Oral use

Bottle

100 ml

Sanelor

10 mg

Tablet

Oral use

Blister

10

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

Multipharma B.V.

Postbus 216

NL-1380 AE Weesp,

Netherlands

Loratadine B.C.

10 mg

Tablet

Oral use

Blister

7, 21

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

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

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

NL

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

Centrafarm Services B.V.

Postbus 289

NL-4870 AG Ehen-Leur

Netherlands

Loratadine CF

1 mg/ml

1 mg/ml

Syrup

Oral use

Bottle

50, 60, 100, 120, 150 ml

Loratadine CF 10 mg

10 mg

Tablet

Oral use

Blister

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

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

Disphar International B.V.

Postbus 100

NL-7255 ZK Hengelo (Gld),

Netherlands

Loratadine Disphar 10

10 mg

Tablet

Oral use

Blister

30

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

Genfarma B.V.

P.O. Box 2062

NL-1500 GB Zaandam

Netherlands

Loratadine Gf 10 mg

10 mg

Tablet

Oral use

Blister

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

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

Hexal Pharma Nederland B.V.

Postbus 251

NL-2180 AG Hillegom,

Netherlands

Loratadine 10 mg Hexal

10 mg

Tablet

Oral use

Blister

7, 10, 20, 21, 30, 100

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

Katwijk Farma B.V.

Postbus 408

NL-2300 AK Leiden,

Netherlands

Loratadine 1mg/ml Katwijk

1 mg/ml

Syrup

Oral use

Bottle

60, 120 ml

Loratadine 10 mg Katwijk

10 mg

Tablet

Oral use

Blister

10, 30, 250

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

Merck Generics B.V.

Dieselweg 26

NL 3752 LB Bunschoten

Netherlands

Loratadine Merck 10 mg

10 mg

Tablet

Oral use

Blister

5, 7, 10, 14,

15, 20, 21, 30, 50, 100

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

Multipharma B.V.

Postbus 216

NL-1380 AE Weesp,

Netherlands

Loratadine 10

10 mg

Tablet

Oral use

Blister

7, 10, 20, 50, 100, 250

MP-Loratadine

10 mg

Tablet

Oral use

Blister

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

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

Schering-Plough B.V.

Postbus 1364

NL-3600 BJ Maarssen,

Netherlands

Claritine

Reditabs

10 mg

Oral Lyophilisate

Oral use

Blister

10, 20, 30

Claritine

1 mg/ml

Syrup

Oral use

Bottle

60, 120 ml

Claritine

10 mg

Tablet

Oral use

Blister

2, 5, 7, 10, 30

Claritine

10 mg

Effervescent

tablet

Oral use

Blister

7, 10, 30

Sanelor

10 mg

Tablet

Oral use

Blister

10

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

Stada Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel,

Germany

Lorastad

1 mg/ml

1 mg/ml

Syrup

Oral use

Bottle

50, 60, 100, 120, 150 ml

Lorastad 10 mg

10 mg

Tablet

Oral use

Blister

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

NO

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

A/S GEA Farmaceutisk Fabrik,

Holger Danskes vej 89,

DK-2000 Frederiksberg,

Denmark

Loratadin Gea

10 mg

Tablet

Oral use

Blister

7, 10, 20, 21, 30, 100

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

Sandoz GmbH,

Biochemiestrasse 10,

A-6250 Kundl,

Austria

Loraratidin Biochemie

10 mg

Tablet

Oral use

Blister

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

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

Duranor AS,

Hoffsv. 70 B,

N-0319 Oslo,

Norway

Loratadin Duranor

10 mg

Tablet

Oral use

Blister

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

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

NM Pharma AS,

Lilleakerv. 2 B,

N-0283 Oslo,

Norway

Loratadin

10 mg

Tablet

Oral use

Blister

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

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

Ratiopharm GmbH,

Graf-Arco-Str 3,

DE-89079 Ulm,

Germany

Loratadin Ratiopharm

10 mg

Tablet

Oral use

Blister

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

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

Schering-Plough AS,

Ankerveien 209,

N-1359 Eiksmarka,

Norway

Versal

10 mg

Tablet

Oral use

Blister

10, 30, 60, 100

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

Schering-Plough Europe,

73, Rue de Stalle,

B-1180 Brussels,

Belgium

Clarityn

1 mg/ml

Oral solution

Oral use

Bottle

120 ml

Clarityn

10 mg

Tablet

Oral use

Blister

7, 30, 100

Clarityn-S

10 mg

Oral lyophilisate

Oral use

Blister

10, 30, 100

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

Stada Arzneimittel AG,

Stadastrasse 2-18.

D-61118 Bad Vilbel,

Germany

Loratadin Stada

1 mg/ml

Oral solution

Oral use

Bottle

50, 60, 100, 120, 150 ml

Loratadin Stada

10 mg

Tablet

Oral use

Blister

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

PT

| Sandoz, GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |
| Austria |

Sandoz, GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

Loratadina Biochemie 10 mg Comprimidos

10 mg

Tablet

Oral use

Blister

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

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

Decomed Farmacêutica,

S.A. Rua Sebastião e Silva, 56

P-2745-838 Massamá

Portugal

Loratin

10 mg

Tablet

Oral use

Blister

20

| 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 |

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

Loristine

10 mg

Tablet

Oral use

Blister

20

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

Farmalavi - Produtos Farmacêuticos, Sociedade Unipessoal,

Lda. Rua Elias Garcia,

28 Venda Nova

P-2700-327 Amadora

Portugal

Loratadina Farmalavi 10 mg comprimidos

10 mg

Tablet

Oral use

Blister

20

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

Farmoz - Sociedade Técnico-Medicinal, S.A. Rua Prof. Henrique de Barros, Edifício Sagres, 3oA

P-2685-338 Prior Velho

Portugal

Evertine

10 mg

Tablet

Oral use

Blister

10, 20

Evertine

1 mg/ml

Syrup

Oral use

Bottle

100ml

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

Generis Farmacêutica, S.A. Rua José Galhardo, n.o 3

P-1750-131 Lisboa

Portugal

Loratadina Generis 10 mg Comprimidos

10 mg

Tablet

Oral use

Blister

20

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

Irex - Promoção e Comercialização de Produtos Farmacêuticos, Lda

Praça Duque de Saldanha n° 1-4°E

P-1050-094 Lisboa

Portugal

Loratadina Irex 10 mg comprimidos

10 mg

Tablet

Oral use

Blister

7, 20, 50, 100

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

Labesfal - Laboratórios Almiro,

S.A. , Avenida Dr Afonso Costa

P-3465-051 Campo de Besteiros

Portugal

Loratadina Labesfal 10 mg Comprimidos

10 mg

Tablet

Oral use

Blister

20

Crizin

10 mg

Tablet

Oral use

Blister

20

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

Merck Genéricos - Produtos Farmacêuticos, Lda. Rua Alfredo da Silva, 3 - C - 4o

P-1300-040 Lisboa

Portugal

Loratadina Merck Genéricos 10 mg Comprimidos Revestidos

10 mg

Coated tablet

Oral use

Blister

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

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

Pentafarma - Sociedade Técnico-Medicinal, S.A. Rua Prof. Henrique de Barros, Edif. Sagres, 5oA

P-2685-338 Prior Velho

Portugal

Zolargene

10 mg

Tablet

Oral use

Blister

10, 20

Zolargene

1 mg/ml

Syrup

Oral use

Bottle

100 ml

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

Plough Farma, Lda.

Rua Agualva dos Açores no 16

P-2735-557 Agualva - Cacém

Portugal

Alertrin

10 mg

Tablet

Oral use

Blister

10, 20

Alertrin

10 mg

Effervescent tablet

Oral use

Blister

10, 20

Alertrin Zydis

10 mg

Oral lyophilisate

Oral use

Blister

10, 20

Alertrin

1mg/ml

Syrup

Oral use

Bottle

100, 200ml

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

Produfarma, Lda. (Laboratório Scientia) Estrada de Benfica, 403-B

P-1500-077 Lisboa

Portugal

Alerdaune

10 mg

Tablet

Oral use

Blister

20

Alerdaune

1 mg/ml

Oral Suspension

Oral use

Bottle

100ml

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

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

P-2790-145 Carnaxide

Portugal

Loratadina Ratiopharm 10 mg Comprimidos

10 mg

Tablet

Oral use

Blister

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

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

Schering-Plough Farma, Lda.

Rua Agualva dos Açores 16

P-2735-557 Agualva- Cacém

Portugal

Claritine

10 mg

Tablet

Oral use

Blister

20

Claritine

10 mg

Effervescent tablet

Oral use

Blister

10, 20

Claritine

1 mg/ml

Syrup

Oral use

Bottle

100, 200ml

Claritine Zydis

10 mg

Oral lyophilisate

Oral use

Blister

10, 20

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

Stada Arzneimittel A.G.

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Loratadina Stada 1 mg/ml Xarope

1 mg/ml

Syrup

Oral use

Bottle

50, 60, 100, 120, 150 ml

Loratadina Stada 10 mg Comprimidos

10 mg

Tablet

Oral use

Blister

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

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

Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua Prof. Henrique de Barros - Edf. Sagres, 3o A

P-2685-338 Prior Velho

Portugal

Profenox

10 mg

Tablet

Oral use

Blister

10, 20

Profenox

1 mg/ml

Syrup

Oral use

Bottle

100 ml

SP

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

Bexal Farmaceutica S.A.

Ventura Rodriguez 7

5a Plta,

ES-28008 Madrid,

Spain

Loratadina Bexal

10 mg

Tablet

Oral use

Blister

20

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

Combino Pharma

Fructuoso Gelabert 6-8

ES-08970 San Juan Despi

Barcelona,

Spain

Loratadine Combino Pharm

10 mg

Tablet

Oral use

Blister

20

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

Industrial Farmacéutica Cantabria

Carretera Cazoña-Ardazo s/n

ES-39011 Santander,

Spain

Fadina

10 mg

Tablet

Oral use

Blister

20

Loratadina UR

10 mg

Tablet

Oral use

Blister

20

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

Ipsen Pharma S.A.

Ctra. Laureà Miró 395

ES-08980 Sant Feliu de Llobregat

Barcelona,

Spain

Loratadina Lasa

10 mg

Tablet

Oral use

Blister

20

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

Kern Pharma S.L.

Pol. Ind. Colon II

Venus 72,

ES-08228 Terrassa

Barcelona,

Spain

Loratadina Kern

10 mg

Tablet

Oral use

Blister

20

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

Laboratorio Bayvit

Av. Frederic Mompou 5

ES-08960 Sant Just Desvern

Barcelona,

Spain

Loratadina Bayvit

10 mg

Coated tablet

Oral use

Blister

20

Loratadina Bayvit

1 mg/ml

Syrup

Oral use

Bottle

120 ml

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

Laboratorios Cinfa

C/ Olaz-Chipi 10

ES-31620 Huarte, Pamplona,

Spain

Loratadina Cinfa

10 mg

Coated tablet

Oral use

Blister

20

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

Laboratorios Davur S.L.

C/ Teide, 4

Parque Empresarial “La Marina”

ES-28700 San Sebastian de los Reyes

Madrid,

Spain

Loratadina Davur

10 mg

Tablet

Oral use

Blister

20

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

Laboratorios Geminis S.A.

Gran Via de Les Cortes Catalanes 7674

ES-08013 Barcelona,

Spain

Loratadina Geminis

10 mg

Tablet

Oral use

Blister

20

Loratadine Genpril

10 mg

Tablet

Oral use

Blister (PVC/AL)

20

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

Laboratorios Lesvi S.A.

C/ Argent, 1

Pol. Ind. Can Pelegri

ES-08755 Castellbisbal, Barcelona,

Spain

Civeran Flas

10 mg

Oral lyophilisate

Oral use

Blister

30

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

Laboratorios Normon S.A.

Nieremberg 10

ES-28002 Madrid,

Spain

Loratadina Normon

10 mg

Tablet

Oral use

Blister

20

Loratadina Normon

1 mg/ml

Syrup

Oral use

Bottle

120 ml

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

Laboratorios Rimafar S.L.

Poligono Malpica c/C 4

ES-50016 Zaragoza,

Spain

Loratadina Rimafar

10 mg

Tablet

Oral use

Blister

20

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

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

Velodan

1 mg/ml

Syrup

Oral use

Bottle

120 ml

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

Pharmagenus S.A.

Paseo de Gracia 55 1a

ES-08007 Barcelona,

Spain

Loratadina Pharmagenus

10 mg

Tablet

Oral use

Blister

20

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

PLIVA Pharma Iberia, S.A.

c/Geológicas 72, Pol. Ind.,

Urtinsa II,

ES-28923 Alcorcón,

Spain

Loratadine Pliva

10 mg

Tablet

Oral use

Blister

20

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

Schering-Plough S.A.

Km 36 Carret Nacional 1

ES-28750 San Agustin de Guadalix

Madrid,

Spain

Claritine Flas

10 mg

Oral lyophilisate

Oral use

Blister

30

Clarityne

10 mg

Tablet

Oral use

Blister

20

Clarityne

1 mg/ml

Syrup

Oral use

Bottle

120 ml

Optimin

10 mg

Tablet

Oral use use

Blister

20

Optimin

1 mg/ml

Syrup

Oral use

Bottle

120 ml

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

Tamarang S.A.

Balmes 84 4o 2a

ES-08008 Barcelona,

Spain

Loratadina Tamarang

1 mg/ml

Syrup

Oral use

Bottle

120 ml

Loratadina Tamarang

10 mg

Tablet

Oral use

Blister

20

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

Universal Farma S.L.

Gran Via Carlos III, 98

7a planta

ES-08028 Barcelona,

Spain

Loratadina Merk

10 mg

Tablet

Oral use

Blister

20

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

Vegal Farmacéutica

S.L. Tramontana, 44

ES-28223 Pozuelo de Alarcon

Madrid,

Spain

Loratadina Vegal

1 mg/ ml

Syrup

Oral use

Bottle

120 ml

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

Agen Genéricos Farmacéuticos S.L.

Avda. Conde de Guadalhorce no 43

Nave 2

Avilés,

Spain

Loratadina Agen

10 mg

Tablet

Oral use

Blister

20

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

Multipharma B.V.

Gemeen schapspolder weg 28

1382 GR Weesp,

Netherlands

Loratadina Multipharma

10 mg

Tablet

Oral use

Blister PVC/AL

20

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

Ratiopharma GmbH

Graf-Arco Str. 3

D-89079 ULM,

Germany

Loramed

10 mg

Tablet

Oral use

Blister PVC/AL

7, 20, 100

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

RCA S.L.

C/ Pez Volador no15 1oB

28007 Madrid,

Spain

Loratadina RCA

10 mg

Tablet

Oral use

Blister

20

SW

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

A/S GEA Farmaceutisk Fabrik

Holger Danskes Vej 89

DK-2000 Fredriksberg

Denmark

Loratadin GEA

10 mg

Tablet

Oral use

Blister

7, 10, 20, 21, 30, 100

| Astra Zeneca AB |
| --- |
| S-151 85 Södertälje |
| Sweden |

Astra Zeneca AB

S-151 85 Södertälje

Sweden

Loratadin Astra Zeneca

10 mg

Tablet

Oral use

Blister

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

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

Generics (UK) Ltd

12 Station Close

Potters Bar

Herts

EN6 1TL

United Kingdom

Loratadin NM Pharma

10 mg

Film-coated tablet

Oral use

Blister

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

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

Pro Medica AB

Box 271 90

S-10252 Stockholm,

Sweden

Versal

10 mg

Tablet

Oral use

Blister

7, 14

| Sandoz GmbH |
| --- |
| Biochemiestraße 10 |
| A-6250 Kundl |
| Austria |

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

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

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

Schering-Plough Europe

Rue de Stalle 73

B-1180 Brussels,

Belgium

Clarityn

10 mg

Tablet

Oral use

Blister

10, 14, 28, 30 and 100

Clarityn

1mg/ml

Oral solution

Oral use

Bottle

120 ml

Clarityn

10 mg

Effervescent tablet

Oral use

Tube

10, 100

Clarityn-S

10 mg

Oral lyophilisate

Oral use

Blister

12, 30, 100

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

Stada Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vibel

Germany

Loratadin Stada

10 mg

Tablet

Oral use

Blister

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

Loratadin Stada

1 mg/ml

Syrup

Oral use

Bottle (glass)

50, 60, 100, 120, 150 ml

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

Ratiopharm GmbH

Graf-Arco-Straße 3

D-89079 Ulm

Germany

Loratadin ratiopharm

10 mg

Tablet

Oral use

Blister

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

UK

| Alpharma Limited |
| --- |
| Whiddon Valley |
| Barnstaple |
| EX32 8NS |
| UK |

Alpharma Limited

Whiddon Valley

Barnstaple

EX32 8NS

UK

Alpharma Loratadine Tablets

10 mg

Tablet

Oral use

Blister

Strip

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

Loratadine 5mg/5ml Syrup

1mg/ml

Oral solution

Oral use

Bottle

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

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

Approved Prescription Services Ltd

41 Brampton Road

Hampden Park, Eastbourne

East Sussex, BN22 9AG,

UK

Loratadine 10 mg

Tablets

10 mg

Tablet

Oral use

Blister

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

Loratadine 1mg/1ml Oral Solution

1 mg/ml

Syrup

Oral use

Bottle

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

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

Egis Pharmaceuticals UK Limited

127 Shirland Road

London

W9 2EP,

UK

Loratadine

10 mg Tablets

10 mg

Tablet

Oral use

Blister

30

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

Generics (UK) Limited

Station Close

Potters Bar

EN6 1TL

UK

Loratadine 10 mg film-coated Tablets

10 mg

Film-coated Tablets

Oral use

Blister

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

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

Lagap Pharmaceuticals Limited

Unit 37, Woolmer Way

Bordon, Hampshire,

GU35 9QE,

UK

Loratadine 10 mg tablets

10 mg

Tablet

Oral use

Blister

7, 10, 30

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

Medis Danmark A/S

Havelse Mølle 14

DK-3600 Frederikssund

Denmark

Loratadine 10 mg tablets

10 mg

Tablet

Oral use

Blister

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

| Niche Generics Limitd |
| --- |
| Waterford Road |
| Clonmel |
| Co. Tipperary, |
| Ireland |

Niche Generics Limitd

Waterford Road

Clonmel

Co. Tipperary,

Ireland

Bioglan Generics Loratadin Tablets

10 mg

Tablet

Oral use

Blister

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

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

Norton Healthcare Limited

Ivax Quays, Albert Basin

Armada Way, Royal Docks

London, E16 2QJ

UK

Hay-Rite Allergy Tablets

10 mg

Tablet

Oral use

Blister

7

Hayrite Tablets

10 mg

Tablet

Oral use

Blister

20, 30

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

Rockspring Healthcare Ltd

Nerin House

26 Bridgeway Street

Douglas

IM1 1EL – Isle of Man

UK

Loratadine 10 mg tablets

10 mg

Tablet

Oral use

Blister

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

Loratadine 10 mg tablets

10 mg

Tablet

Oral use

Blister

7

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

Schering Plough Ltd

Shire Park

Welwyn Garden City

AL7 1TW

UK

Clarityn Rapide Tablets

10 mg

Tablet

Oral use

Blister

1, 7, 8, 10, 30

Clarityn Syrup

1 mg/ml

Oral solution

Oral use

Bottle

50, 60, 100, 200 ml

Clarityn Tablets

10 mg

Tablet

Oral use

Blister

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

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

Sterwin Medicines Limited

One Onslow Street

Guilford

Surrey GU1 4YW

UK

Loratadine 10 mg Tablets

10 mg

Tablet

Oral use

Blister

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

Allergy and Hayfever Relief tablets

10 mg

Tablet

Oral use

Blister

7

Loratadine 10 mg Tablets

10 mg

Tablet

Oral use

Blister

7, 20, 30, 50, 100

| Teva Pharma BV |
| --- |
| 3640 AE Mijdrecht |
| Netherlands |

Teva Pharma BV

3640 AE Mijdrecht

Netherlands

Teva Loratadine Tablets

10 mg

Tablet

Oral use

Blister

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

Teva Pharma

Loratadine

Syrup

1 mg/ml

Syrup

Oral use

Bottle

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

| Waymade Plc |
| --- |
| Miles Gray Road |
| Basildon |
| SS14 3FR |
| UK |

Waymade Plc

Miles Gray Road

Basildon

SS14 3FR

UK

Waymade Loratadine Tablets

10 mg

Tablet

Oral use

Blister

30

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

Calao s.r.l.

Via Grassi, 15

I-20157 Milano

Italy

Tractyn Tablets

10 mg

Tablet

Oral use

Blister

7, 28, 30

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

Co-Pharma Limited

Unit 4, Metro Centre

Tolpits Lane

Watford

Hertfordshire

WD1 8SS

UK

Loratadine

10 mg Tablets

10 mg

Film-coated tablet

Oral use

Blister

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

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

Generics UK Ltd

Station Close

Potters Bar

Herts, EN6 1TL,

UK

Loratadine 1mg/1ml Syrup

1 mg/ml

Syrup

Oral use

Bottle

120 ml

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

Karib Kemi-Pharm Limited

63-65 Imperial Way,

Croydon, Surrey, CR0 4RR

UK

Loratadine

10 mg Tablets

10 mg

Tablet

Oral use

Blister

7, 10, 30

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

Norton Healthcare Limited

Ivax Quays, Albert Basin

Armada Way, Royal Docks

London, E16 2QJ

UK

Hay-Rite Allergy Syrup

1mg/ml

Syrup

Oral use

Bottle

50, 100 ml

Loratadine Syrup

1mg/ml

Syrup

Oral use

Bottle

120, 200ml

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

Ratiopharm GmbH

Graf-Arco Strasse 3

D-89079 Ulm,

Germany

Loratadine

10 mg Tablets

10 mg

Tablet

Oral use

Blister

7, 20, 50, 100

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

Stada Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

Loratadine

10 mg Tablets

10 mg

Tablet

Oral use

Blister

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

Loratadine

5mg/5ml Syrup

1 mg/ml

Syrup

Oral use

Bottle

50, 60, 100, 120, 150

| Ranbaxy UK Ltd |
| --- |
| 97-107 Uxbridge Road |
| Ealing London |
| UK |

Ranbaxy UK Ltd

97-107 Uxbridge Road

Ealing London

UK

Loratadine

10 mg Tablets

10 mg

Tablet

Oral use

Blister

Strip

7, 30

Loratadine

10 mg Tablets

10 mg

Tablet

Oral use

Blister

Strip

7, 10, 14, 21

ANNEX X

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

| Member State | Marketing Authorisation
  Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Merck Sharp & Dohme G.m.b.H. |
| Donau-City Strasse 6 |
| 1220 - Wien, Austria |

Member State

Marketing Authorisation

Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Merck Sharp & Dohme G.m.b.H.

Donau-City Strasse 6

1220 - Wien, Austria

ZOCORD

5 mg

film coated tablets

oral use

ZOCORD

10 mg

film coated tablets

oral use

ZOCORD

20 mg

film coated tablets

oral use

ZOCORD

40 mg

film coated tablets

oral use

ZOCORD

80 mg

film coated tablets

oral use

Belgium

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

Merck Sharp & Dohme B.V.

Succursale belge

Chaussée de Waterloo 1135

1180 Bruxelles

Belgique

ZOCOR

5 mg

tablets

oral use

ZOCOR

10 mg

tablets

oral use

ZOCOR

20 mg

tablets

oral use

ZOCOR

40 mg

tablets

oral use

ZOCOR

80 mg

tablets

oral use

Denmark

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

Merck Sharp & Dohme B.V.

P.O. Box 581

2003PC Haarlem, The Netherlands

ZOCOR

5 mg

film coated tablets

oral use

ZOCOR

10 mg

film coated tablets

oral use

ZOCOR

20 mg

film coated tablets

oral use

ZOCOR

40 mg

film coated tablets

oral use

ZOCOR

80 mg

film coated tablets

oral use

Finland

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

Merck Sharp & Dohme B.V.

P.O. Box 581

2003 PC Haarlem, The Netherlands

ZOCOR

10 mg

film coated tablets

oral use

ZOCOR

20 mg

film coated tablets

oral use

ZOCOR

40 mg

film coated tablets

oral use

ZOCOR

80 mg

film coated tablets

oral use

| Oy Leiras Finland Ab |
| --- |
| Yliopistonkatu 34 A |
| 20100 Turku, Finland |

Oy Leiras Finland Ab

Yliopistonkatu 34 A

20100 Turku, Finland

COROLIN

10 mg

film coated tablets

oral use

COROLIN

20 mg

film coated tablets

oral use

COROLIN

40 mg

film coated tablets

oral use

France

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

Laboratoires Merck Sharp & Dohme Chibret

3, Avenue Hoche

75008 Paris, France

ZOCOR

5 mg

tablets

oral use

ZOCOR

10 mg

tablets

oral use

ZOCOR

20 mg

tablets

oral use

ZOCOR

40 mg

tablets

oral use

ZOCOR

80 mg

tablets

oral use

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

Laboratoires SANOFI-SYNTHELABO FRANCE

174, Avenue de France

75013 Paris, France

LODALES

5 mg

tablets

oral use

LODALES

10 mg

tablets

oral use

LODALES

20 mg

tablets

oral use

LODALES

40 mg

tablets

oral use

LODALES

80 mg

tablets

oral use

Germany

| Dieckmann Arzneimittel GmBH |
| --- |
| Lindenplatz 1 |
| 85540 Haar, Germany |

Dieckmann Arzneimittel GmBH

Lindenplatz 1

85540 Haar, Germany

ZOCOR

5 mg

film coated tablets

oral use

ZOCOR

10 mg

film coated tablets

oral use

ZOCOR

20 mg

film coated tablets

oral use

ZOCOR FORTE

40 mg

film coated tablets

oral use

ZOCOR FORTE XL

80 mg

film coated tablets

oral use

| MSD Sharp & Dohme GmbH |
| --- |
| Lindenplatz 1 |
| 85540 Haar, Germany |

MSD Sharp & Dohme GmbH

Lindenplatz 1

85540 Haar, Germany

LIPOCARD

5 mg

film coated tablets

oral use

LIPOCARD

10 mg

film coated tablets

oral use

LIPOCARD

20 mg

film coated tablets

oral use

LIPOCARD

40 mg

film coated tablets

oral use

ZEMOX

5 mg

film coated tablets

oral use

ZEMOX

10 mg

film coated tablets

oral use

ZEMOX

20 mg

film coated tablets

oral use

ZEMOX

40 mg

film coated tablets

oral use

ZEMOX

80 mg

film coated tablets

oral use

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

Boehringer Ingelheim Pharma KG

Binger Strasse 173

55216 Ingelheim am Rhein, Germany

DENAN

5 mg

film coated tablets

oral use

DENAN

10 mg

film coated tablets

oral use

DENAN

20 mg

film coated tablets

oral use

DENAN

40 mg

film coated tablets

oral use

DENAN

80 mg

film coated tablets

oral use

Greece

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

Marketing Authorization Holder

Merck & Co., INC

Whitehouse Station, N.J.

USA

ZOCOR

5 mg

tablets

oral use

ZOCOR

10 mg

tablets

oral use

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

VIANEX S.A.

Tatoioy Street

P.O. Box 52894

146 10N. Erithrea, Greece

ZOCOR

20 mg

tablets

oral use

ZOCOR

40 mg

tablets

oral use

ZOCOR

80 mg

tablets

oral use

Iceland

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

Merck Sharp & Dohme B.V.

P.O. Box 581

2003 PC Haarlem, The Netherlands

ZOCOR

10 mg

tablets

oral use

ZOCOR

20 mg

tablets

oral use

ZOCOR

40 mg

tablets

oral use

ZOCOR

80 mg

tablets

oral use

Ireland

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

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon

Herts EN11 9BU

United Kingdom

ZOCOR

5 mg

tablets

oral use

ZOCOR

10 mg

tablets

oral use

ZOCOR

20 mg

tablets

oral use

ZOCOR

40 mg

tablets

oral use

ZOCOR

80 mg

tablets

oral use

Italy

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

Merck Sharp & Dohme (Italia) SpA.

Via G. Fabbroni 6

00191 Rome, Italy

SINVACOR

10 mg

film coated tablets

oral use

SINVACOR

20 mg

film coated tablets

oral use

SINVACOR

40 mg

film coated tablets

oral use

| Neopharmed SpA |
| --- |
| Via G. Fabbroni 6 |
| 00191 Rome, Italy |

Neopharmed SpA

Via G. Fabbroni 6

00191 Rome, Italy

ZOCOR

10 mg

film coated tablets

oral use

ZOCOR

20 mg

film coated tablets

oral use

ZOCOR

40 mg

film coated tablets

oral use

| Istituto Gentili SpA. |
| --- |
| Via Mazzini 112 |
| 56125 Pisa, Italy |

Istituto Gentili SpA.

Via Mazzini 112

56125 Pisa, Italy

LIPONORM

10 mg

film coated tablets

oral use

LIPONORM

20 mg

film coated tablets

oral use

LIPONORM

40 mg

film coated tablets

oral use

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

Sigma Tau SpA

Via Pontina Km 30, 400

Pomezia (Rome) Italy

SIVASTIN

10 mg

film coated tablets

oral use

SIVASTIN

20 mg

film coated tablets

oral use

SIVASTIN

40 mg

film coated tablets

oral use

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

Mediolanum SpA

Via S.G. Cottolengo 15

20143 Milano, Italy

MEDIPO

10 mg

film coated tablets

oral use

MEDIPO

20 mg

film coated tablets

oral use

MEDIPO

40 mg

film coated tablets

oral use

Luxembourg

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

Merck Sharp & Dohme B.V.

Succursale belge

Chaussée de Waterloo 1135

1180 Bruxelles/Brussel, Belgique

ZOCOR

5 mg

tablets

oral use

ZOCOR

10 mg

tablets

oral use

ZOCOR

20 mg

tablets

oral use

ZOCOR

40 mg

tablets

oral use

ZOCOR

80 mg

tablets

oral use

Netherlands

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

Merck Sharp & Dohme B.V.

P.O. Box 581

2003 PC Haarlem, The Netherlands

ZOCOR

5 mg

tablets

oral use

ZOCOR

10 mg

tablets

oral use

ZOCOR

20 mg

tablets

oral use

ZOCOR

40 mg

tablets

oral use

ZOCOR

80 mg

tablets

oral use

ZOCOR

5 mg

tablets

oral use

BOZARA

10 mg

tablets

oral use

BOZARA

20 mg

tablets

oral use

BOZARA

40 mg

tablets

oral use

Norway

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

Merck Sharp & Dohme B.V.

P.O. Box 581

2003 PC Haarlem, The Netherlands

ZOCOR

10 mg

tablets

oral use

ZOCOR

20 mg

tablets

oral use

ZOCOR

40 mg

tablets

oral use

ZOCOR

80 mg

tablets

oral use

Portugal

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

Merck Sharp & Dohme, Lda,

Quinta da Fonte

Edifício Vasco da Gama, 19

P.O. Box 214

Porto Salvo

2780-730 Paço de Arcos, Portugal

ZOCOR

10 mg

film-coated tablets

oral use

ZOCOR

20 mg

film-coated tablets

oral use

ZOCOR

40 mg

film-coated tablets

oral use

| 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 |

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

VACOLEST

10 mg

film-coated tablets

oral use

VACOLEST

20 mg

film-coated tablets

oral use

Spain

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

Merck Sharp & Dohme de España SA

C/Josefa Valcárcel, 38

28027 Madrid, Spain

ZOCO

10 mg

film-coated tablets

oral use

ZOCOR

20 mg

film-coated tablets

oral use

ZOCOR

40 mg

film-coated tablets

oral use

| LACER, SA |
| --- |
| Sardenya, 350 |
| 080254 Barcelona, Spain |

LACER, SA

Sardenya, 350

080254 Barcelona, Spain

PANTOK

10 mg

film-coated tablets

oral use

PANTOK

20 mg

film-coated tablets

oral use

PANTOK

40 mg

film-coated tablets

oral use

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

J. Uriach & Cia SA

Avda Camí Reial, 51-57

08184 Palau-solitá I Plegamans-Barcelona, Spain

COLEMIN

10 mg

film-coated tablets

oral use

COLEMIN

20 mg

film-coated tablets

oral use

COLEMIN

40 mg

film-coated tablets

oral use

Sweden

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

Merck Sharp & Dohme B.V.

P.O. Box 581

2003 PC Haarlem, The Netherlands

ZOCORD

10 mg

tablets

oral use

ZOCORD

20 mg

tablets

oral use

ZOCORD

40 mg

tablets

oral use

ZOCORD

80 mg

tablets

oral use

United Kingdom

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

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon Herts EN11 9BU

United Kingdom

ZOCOR

5 mg

tablets

oral use

ZOCOR

10 mg

tablets

oral use

ZOCOR

20 mg

tablets

oral use

ZOCOR

40 mg

tablets

oral use

ZOCOR

80 mg

tablets

oral use

ANNEX XI

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

| Member State | Marketing Authorisation
  Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Pharmacia Austria Ges.m.b.H., |
| Oberlaaerstraße 247-251 |
| A-1100 Wien |
| AUSTRIA |

Member State

Marketing Authorisation

Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Pharmacia Austria Ges.m.b.H.,

Oberlaaerstraße 247-251

A-1100 Wien

AUSTRIA

Celebrex 100 mg Hartkapseln

100 mg

Capsule, hard

Oral use

Celebrex 200 mg Hartkapseln

200 mg

Capsule, hard

Oral use

Solexa 100 mg Hartkapseln

100 mg

Capsule, hard

Oral use

Solexa 200 mg Hartkapseln

200 mg

Capsule, hard

Oral use

Belgium

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

Pharmacia Twin Squares Culliganllaan, 1 c

B-1831 DIEGEM

Belgium

Celebrex

100 mg

Capsule, hard

Oral use

Celebrex

200 mg

Capsule, hard

Oral use

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

Pharmacia S.A.

Rijksweg 12

B-2870 Puurs

Belgium

Solexa

100 mg

Capsule, hard

Oral use

Solexa

200 mg

Capsule, hard

Oral use

Denmark

| Pfizer Aps |
| --- |
| Lautrupvang 8 |
| DK-2750 Ballerup |
| Denmark |

Pfizer Aps

Lautrupvang 8

DK-2750 Ballerup

Denmark

Celebra

100 mg

Capsule, hard

Oral use

Celebra

200 mg

Capsule, hard

Oral use

Solexa

100 mg

Capsule, hard

Oral use

Solexa

200 mg

Capsule, hard

Oral use

Finland

| Pharmacia Oy |
| --- |
| P.O Box 45 |
| 02601 ESPOO |
| FINLAND |

Pharmacia Oy

P.O Box 45

02601 ESPOO

FINLAND

Celebra

100 mg

Capsule Hard

Oral use

Celebra

200 mg

Capsule Hard

Oral use

Solexa

100 mg

Capsule Hard

Oral use

Solexa

200 mg

Capsule Hard

Oral use

France

| PHARMACIA SAS |
| --- |
| 1 rue Antoine Lavoisier |
| F-78280 GUYANCOURT |
| FRANCE |

PHARMACIA SAS

1 rue Antoine Lavoisier

F-78280 GUYANCOURT

FRANCE

Celebrex

100 mg

Capsule

Oral use

Celebrex

200 mg

Capsule

Oral use

| CARDEL |
| --- |
| 1 rue Antoine Lavoisier |
| F-78280 GUYANCOURT |
| France |

CARDEL

1 rue Antoine Lavoisier

F-78280 GUYANCOURT

France

Solexa

100 mg

Capsule

Oral use

Solexa

200 mg

Capsule

Oral use

Germany

| Pharmacia GmbH |
| --- |
| Am Wolfsmantel 46 |
| D-91059 Erlangen |
| GERMANY |

Pharmacia GmbH

Am Wolfsmantel 46

D-91059 Erlangen

GERMANY

Celebra 100 mg Hartkapseln

100

Capsule Hard

Oral use

Celebra 200 mg Hartkapseln

200

Capsule Hard

Oral use

Celebrex 100 mg Hartkapseln

100

Capsule Hard

Oral use

Celebrex 200 mg Hartkapseln

200

Capsule Hard

Oral use

Greece

| Pfizer Hellas AE |
| --- |
| 5 Alketou St |
| 116 33 Athens |
| GREECE |

Pfizer Hellas AE

5 Alketou St

116 33 Athens

GREECE

Aclarex

100 mg

Capsule hard

Oral use

Aclarex

200 mg

Capsule hard

Oral use

| Pharmacia hellas |
| --- |
| 2 Kalavriton |
| 145 62 Nea kifisia |
| Athens |
| GREECE |

Pharmacia hellas

2 Kalavriton

145 62 Nea kifisia

Athens

GREECE

Celebrex

100 mg

Capsule hard

Oral use

Celebrex

200 mg

Capsule hard

Oral use

Ireland

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

Monsanto Plc

PO Box 53

Lane End Road

High Wycombe

Buckinghamshire

HP12 4 HL

UNITED KINGDOM

Celebrex

100 mg

Capsule hard

Oral use

Celebrex

200 mg

Capsule hard

Oral use

Solexa

100 mg

Capsule hard

Oral use

Solexa

200 mg

Capsule hard

Oral use

Italy

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

Pharmacia Italia S.p.A.

Via Robert Kock, 1-2

I-20152 Milano

ITALY

Artilog

100 mg

Capsule, hard

Oral use

Artilog

200 mg

Capsule, hard

Oral use

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

Sefarma S.r.l.

Via Robert Kock, 1-2

I-20152 Milano

ITALY

Artrid

200 mg

Capsule, hard

Oral use

Artrid

100 mg

Capsule, hard

Oral use

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

Pharmacia Italia S.p.A.

Via Robert Kock, 1-2

I-20152 Milano

ITALY

Celebrex

100 mg

Capsule, hard

Oral use

Celebrex

200 mg

Capsule, hard

Oral use

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

Pfizer Italiana S.p.A.

Via Valbondione, 113

I-00188 Roma

ITALY

Solexa

100 mg

Capsule, hard

Oral use

Solexa

200 mg

Capsule, hard

Oral use

Luxembourg

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

Pharmacia S.A.

Rijksweg 12

B-2870 Puurs

BELGIUM

Celebrex

100 mg

Capsule

Oral use

Celebrex

200 mg

Capsule

Oral use

Solexa

100 mg

Capsule

Oral use

Solexa

200 mg

Capsule

Oral use

The Netherlands

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

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Celebrex 100 mg

100 mg

Capsule

Oral use

Celebrex 200 mg

200 mg

Capsule

Oral use

Solexa

100 mg

Capsule

Oral use

Solexa

200 mg

Capsule

Oral use

Norway

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

Pharmacia Norge AS

Lilleakerveien. 2 B

N-0283 Oslo

NORWAY

Celebra

100 mg

Capsule, hard

Oral use

Celebra

200 mg

Capsule, hard

Oral use

Portugal

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

Laboratórios Pfizer, Lda.

Estrada Nacional 10, Km 16,Porto Zemouto

2830-411 Coina

Portugal

Celebrex 100 mg

100 mg

Capsule, hard

Oral use

Celebrex 200 mg

200 mg

Capsule, hard

Oral use

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

Laboratório Medinfar - Produtos Farmacêuticos, S.A.

Rua Manuel Ribeiro de Pavia, 1

1o - Venda Nova

2700-547 Amadora

PORTUGAL

Solexa 100 mg

100 mg

Capsule, hard

Oral use

Solexa 200 mg

200 mg

Capsule, hard

Oral use

Spain

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

Pharmacia Spain S.A.

Avda. de Europa 20-B

Parque Empresarial La Moraleja

E-28108 Alcobendas, Madrid

SPAIN

Artilog 100 mg

100 mg

Capsule

Oral use

Artilog 200 mg

200 mg

Capsule

Oral use

Celebrex 100 mg

100 mg

Capsule

Oral use

Celebrex 200 mg

200 mg

Capsule

Oral use

Sweden

| Pharmacia Sverige AB |
| --- |
| S-112 87 Stockholm |
| SWEDEN |

Pharmacia Sverige AB

S-112 87 Stockholm

SWEDEN

Aclarix

100 mg

Capsule

Oral use

Aclarix

200 mg

Capsule

Oral use

Celebra

100 mg

Capsule

Oral use

Celebra

200 mg

Capsule

Oral use

Celora

100 mg

Capsule

Oral use

Celora

200 mg

Capsule

Oral use

Solexa

100 mg

Capsule

Oral use

Solexa

200 mg

Capsule

Oral use

United Kingdom

| Pharmacia Ltd |
| --- |
| Davy Avenue |
| Milton Keynes |
| Buckinghamshire MK5 8PH |
| UK |

Pharmacia Ltd

Davy Avenue

Milton Keynes

Buckinghamshire MK5 8PH

UK

Celebrex

100 mg

Capsule

Oral use

Celebrex

200 mg

Capsule

Oral use

Solexa

100 mg

Capsule

Oral use

Solexa

200 mg

Capsule

Oral use

---

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

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

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