EN Official Journal of the European Union 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 (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

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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- 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 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-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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 LEDOREN 100 mg Tablet Oral use Blister 30 LEDOREN 100 mg Granules Oral use Sachet 30 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 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 SULIDAMOR 200 mg Suppository Rectal use Strip 10 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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) 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 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 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 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 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 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 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 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 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 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 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 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. 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 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 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 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 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 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 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 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 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 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 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 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 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 Nimesulida Jaba 100 mg granulado para solução oral 100 mg Granules for oral solution Oral use Sachet 10; 30 and 60 Angelini Farmacêutica, Lda. Rua João Chagas n. 53 3° Piso P- 1495-072 Algés- Portugal T: 00351214148300 F: 00351214142981 Aulin 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Nimesulide Arrow 100 mg Tablet Oral use Blister 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 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 Ventor 50 mg/ 5 ml Oral Suspension Oral use Sachet Kleva Epe 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 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 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 Nimesulide Pharmakem 100 mg Tablet Oral use Blister Antonios Polixronis Tou Marinou 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 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 Algosulid 3% Cream Cutaneous use Tube Algosulid 100 mg Tablet Oral use Blister 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 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 Nimesulide Medicon 100 mg Tablet Oral use Blister 2x10 3x10 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 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

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

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 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 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 Talam 5 mg Tablet oral use Talam 10 mg Tablet oral use Germany 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 Pidolma 5 mg Tablet oral use Pidolma 10 mg Tablet oral use Germany 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 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 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 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 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 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 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 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 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 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 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 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 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 Dolcoxx 25 mg Tablet Oral use Dolcoxx 50 mg Tablet Oral use 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Chemotadin 10 mg - Tabletten 10 mg Tablet Oral use Blister 7, 10, 20, 30, 50, 100 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 Loratadin ratiopharm 10 mg - Tabletten 10 mg Tablet Oral use Blister 7, 20, 50, 100 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 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 Loratadin Genericon 10 mg – Tabletten 10 mg Tablet Oral use Blister 10 BE 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 Loratadine irex 10 mg Tablet Oral use Blister (PVC/Alu) 7, 20, 30, 50, 100 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 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 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 Geklimon 10 mg Tablet Oral use Blister 10, 30, 100 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 Oratyn 10 mg Tablet Oral use Blister 5, 10, 30, 100 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 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 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 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 Loratadin "NM" 10 mg Film-coated tablet Oral use Blister 10, 30 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 Loratadin Ratiopharm 10 mg Tablet Oral use Blister 10, 30, 100 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 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 Versal 10 mg Tablet Oral use Blister Not marketed at the moment 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 Lorafile 10 mg Tablet Oral use Blister Not marketed at the moment 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 Geklimon 10 mg Tablet Oral use Blister 7, 10, 20, 21, 30, 100 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 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 Histadin 10 mg Tablet Oral use Blister 10, 30, 100 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 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 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 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 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 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 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 LORATADINE MADAUS 10 mg Tablets Oral use Blister (PVC/Alu) 15, 28, 30 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 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 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 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 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 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 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 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 Loralerg 10 mg Tablet Oral use Blister (PVC/Alu) 7, 20, 50, 100, 500 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 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 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 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 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 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 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 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 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 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 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 Loratadin 10 Heumann 10 mg Tablet Oral use Blister (PVC/Alu) 7, 20, 50, 100, 500 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 Loraclar 10 mg Tablet Oral use Blister (PVC/Alu) 7, 20, 50, 100, 500 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 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 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 Alerisa 10 mg Tablet Oral use Blister (PVC/Alu) 7, 10, 14, 20, 50, 100 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 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 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 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 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 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 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 Latoren 10 mg Tablet Oral use Blister 14, 28 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 Loratab 10 mg Tablet Oral use Blister 14, 21, 42 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 Allergofact 10 mg Tablet Oral use Blister 14, 20 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 Lora 10 mg Tablet Oral use Blister 14, 21, 28 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 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 Loralerg 10 mg Effervescent tablet Oral use Blister 21 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 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 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 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 Novacloxab 10 mg Tablet Oral use Blister 10, 14 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 Igir 10 mg Tablet Oral use Blister 21 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 Biliranin 10 mg Tablet Oral use Blister 14 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 Lóritín 10 mg Tablet Oral use Blister 10, 30, 100 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 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 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 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 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 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 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 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 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-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 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 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 Loratadine B.C. 10 mg Tablet Oral use Blister 7, 21 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 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 Loratadine Disphar 10 10 mg Tablet Oral use Blister 30 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 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 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 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 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 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 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 Loratadin Gea 10 mg Tablet Oral use Blister 7, 10, 20, 21, 30, 100 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 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 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 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 Versal 10 mg Tablet Oral use Blister 10, 30, 60, 100 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Loratadina Bexal 10 mg Tablet Oral use Blister 20 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 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 Loratadina Lasa 10 mg Tablet Oral use Blister 20 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 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 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 Loratadina Davur 10 mg Tablet Oral use Blister 20 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 Civeran Flas 10 mg Oral lyophilisate Oral use Blister 30 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 Loratadina Rimafar 10 mg Tablet Oral use Blister 20 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 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 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 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 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 Loratadina Merk 10 mg Tablet Oral use Blister 20 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 Loratadina Agen 10 mg Tablet Oral use Blister 20 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 Loramed 10 mg Tablet Oral use Blister PVC/AL 7, 20, 100 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 Loratadin GEA 10 mg Tablet Oral use Blister 7, 10, 20, 21, 30, 100 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 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 Versal 10 mg Tablet Oral use Blister 7, 14 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 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 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 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 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 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 Loratadine 10 mg Tablets 10 mg Tablet Oral use Blister 30 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 Loratadine 10 mg tablets 10 mg Tablet Oral use Blister 7, 10, 30 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 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 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 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 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 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 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 Loratadine Tablets 10 mg Tablet Oral use Blister 30 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 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 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 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 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 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 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 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 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 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 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 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 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 75