EN Official Journal of the European Union C 386/14

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014

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

2014/C 386/03

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorisation Member State concerned Date of notification 1.9.2014 Domperidone See Annex I See Annex I See Annex I 2.9.2014 4.9.2014 Diacerein See Annex II See Annex II See Annex II 8.9.2014 18.9.2014 Anagrelide anagrelide Not applicable Not applicable 19.9.2014 30.9.2014 Emergency contraceptives — levonorgestrel See Annex III See Annex III See Annex III 1.10.2014 1.9.2014 Baytril (Art. 34) See Annex IV See Annex IV See Annex IV 2.9.2014 1.9.2014 Baytril (Art. 35) See Annex V See Annex V See Annex V 2.9.2014

— Revocation of a national marketing authorisation

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorisation Member State concerned Date of notification 1.9.2014 Domperidone See Annex I See Annex I See Annex I 2.9.2014

(1) OJ L 311, 28.11.01, p. 67.

(2) OJ L 311, 28.11.01, p. 1.

ANNEX I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States Member State (in EEA) Marketing authorisation holder INN Invented name Strength Pharmaceutical form Route of administration Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria Domperidone Motilium 10 mg — Filmtabletten 10 mg film-coated tablet oral use Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria Domperidone Motilium 1 mg/ml — Suspension zum Einnehmen 1 mg/ml oral suspension oral use Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria Domperidone Motilium 10 mg — Zäpfchen 10 mg suppository rectal use Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria Domperidone Motilium 30 mg — Zäpfchen 30 mg suppository rectal use Austria Janssen-Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien Austria Domperidone Motilium 60 mg — Zäpfchen 60 mg suppository rectal use Belgium Teva Pharma Belgium N.V. Laarstraat 16 2610 Wilrijk Belgium Domperidone maleate Domperidon teva 10 mg film-coated tablet oral use Belgium Eurogenerics N.V. Heizel Esplanade b22 1020 Brussels Belgium Domperidone maleate Domperidone EG 10 mg tablet oral use Belgium Eurogenerics N.V. Heizel Esplanade b22 1020 Brussels Belgium Domperidone Domperidone instant EG 10 mg orodispersible tablet oral use Belgium Mylan BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium Domperidone maleate Domperidone mylan 10 mg film-coated tablet oral use Belgium Apotex NV Av Etienne Demunter 5/8 1090 Brussels Belgium Domperidone maleate Domperitop 10 mg film-coated tablet oral use Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone maleate Motilium 1 mg/ml oral suspension oral use Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone maleate Motilium 10 mg film-coated tablet oral use Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium 10 mg suppository rectal use Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium 10 mg effervescent granules oral use Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium 10 mg film-coated tablet oral use Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium 1 mg/ml oral suspension oral use Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium 30 mg suppository rectal use Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium 60 mg suppository rectal use Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium instant 10 mg orodispersible tablet oral use Belgium Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone Oroperidys 10 mg orodispersible tablet oral use Belgium Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Cinnarizine/ Domperidone maleate Touristil 20 mg/ 19 mg tablet oral use Belgium Kela Pharma nv Industriepark 68 9100 Sint-Niklaas Belgium Domperidone maleate Zilium 10 mg tablet oral use Bulgaria Johnson & Johnson D.O.O Smartinska cesta 53 1000 Ljubljana Slovenia Domperidone Motilium 10 mg film-coated tablet oral use Bulgaria Medochemie Ltd. 1-10 Astronafton Str.+ Limassol 3505 Cyprus Domperidone Costi 10 mg tablet oral use Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos Str, P.O.Box 51409, Lemesos Cyprus Domperidone COSTI TABLETS 10 MG 10 mg tablet oral use Cyprus Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium Domperidone MOTILIUM ORAL SUSPENSION 1 MG/ML 1 mg/ml oral suspension oral use Cyprus Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium Domperidone MOTILIUM SUPPOSITORY 30 MG 30 mg suppository rectal use Cyprus Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium Domperidone MOTILIUM TABLETS 10 MG 10 mg tablet oral use Cyprus Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone OROPERIDYS ORODISPERSIBLE TABLETS 10 MG 10 mg orodispersible tablet oral use Cyprus REMEDICA LTD, Aharnon str. P.O.box 51706, Lemesos, Cyprus Domperidone PEPTOMET FILM COATED TABLETS 10 MG 10 mg tablet oral use Czech Republic Janssen-Cilag s.r.o. Karla Engliše 3201/6 150 00 Praha 5 — Smíchov Czech Republic Domperidone Motilium 10 mg film-coated tablet oral use Czech Republic Pierre Fabre Médicament 45 Place Abel Gance 92654 Boulogne Cedex France Domperidone Oroperidys 10 mg 10 mg orodispersible tablet oral use Denmark Janssen-Cilag (TIBOTEC) Hammerbakken 19 3460 Birkeroed Denmark Domperidone Motilium 10 mg film-coated tablet oral use Denmark Janssen-Cilag (TIBOTEC) Hammerbakken 19 3460 Birkeroed Denmark Domperidone Motilium 30 mg suppository rectal use Denmark Alternova A/S Lodhusvej 11 4230 Skaelskoer Denmark Domperidone Domperidon ‘Alternova’ 10 mg tablet oral use Estonia Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland Domperidone Domperidon Actavis 10 mg tablet oral use Estonia Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone Oroperidys 10 mg 10 mg orodispersible tablet oral use France Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone BIPERIDYS 20 mg, comprimé pelliculé sécable 20 mg film-coated tablet oral use France Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone BIPERIDYSFLASH 20 mg, comprimé orodispersible 20 mg orodispersible tablet oral use France ACTAVIS FRANCE La Boursidière Centre d'Affaires 92357 Le Plessis Robinson France Domperidone DOMPERIDONE ACTAVIS 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France Domperidone DOMPERIDONE ALMUS 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette FRANCE Domperidone DOMPERIDONE ALTER 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France Domperidone DOMPERIDONE ARROW 1 mg/ml, suspension buvable 1 mg/ml oral suspension oral use France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France Domperidone DOMPERIDONE ARROW 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France Domperidone DOMPERIDONE ARROW 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France AUROBINDO PHARMA FRANCE 22-26 rue des Gaudines 78100 Saint-Germain-en-Laye France Domperidone DOMPERIDONE AUROBINDO 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France Domperidone DOMPERIDONE BIOGARAN 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France Domperidone DOMPERIDONE BIOGARAN 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France Domperidone DOMPERIDONE BIOGARAN 20 mg, comprimé pelliculé sécable. 20 mg film-coated tablet oral use France CRISTERS 22 quai Gallieni 92150 Suresnes France Domperidone DOMPERIDONE CRISTERS 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France EG LABO — LABORATOIRES EUROGENERICS ‘Le Quintet’ — bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France Domperidone DOMPERIDONE EG 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France EG LABO — LABORATOIRES EUROGENERICS ‘Le Quintet’ — bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France Domperidone DOMPERIDONE EG 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France EG LABO — LABORATOIRES EUROGENERICS ‘Le Quintet’ — bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France Domperidone DOMPERIDONE EG 20 mg, comprimé pelliculé sécable. 20 mg film-coated tablet oral use France SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris France Domperidone DOMPERIDONE GENODEX 20 mg, comprimé pelliculé sécable. 20 mg film-coated tablet oral use France SUBSTIPHARM 8, rue Bellini 75116 Paris France Domperidone DOMPERIDONE GERDA 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France Domperidone DOMPERIDONE MYLAN 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France Domperidone DOMPERIDONE MYLAN 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France Domperidone DOMPERIDONE MYLAN 20 mg, comprimé pelliculé sécable. 20 mg film-coated tablet oral use France Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone DOMPERIDONE PIERRE FABRE 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone DOMPERIDONE PIERRE FABRE 20 mg, comprimé pelliculé sécable 20 mg film-coated tablet oral use France Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone DOMPERIDONE PIERRE FABRE MEDICAMENT 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France Domperidone DOMPERIDONE QUALIMED 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 89079 Ulm Germany Domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 89079 Ulm Germany Domperidone DOMPERIDONE RATIOPHARM 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton 92800 Puteaux France Domperidone DOMPERIDONE RPG 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France Domperidone DOMPERIDONE SANDOZ 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France Domperidone DOMPERIDONE SANDOZ 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France Domperidone DOMPERIDONE SANDOZ 20 mg, comprimé pelliculé sécable. 20 mg film-coated tablet oral use France SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris France Domperidone DOMPERIDONE SG-PHARM 20 mg, comprimé pelliculé sécable. 20 mg film-coated tablet oral use France SUBSTIPHARM DEVELOPPEMENT 8, rue Bellini 75116 Paris France Domperidone DOMPERIDONE SUBSTIPHARM 20 mg, comprimé pelliculé sécable 20 mg film-coated tablet oral use France TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France Domperidone DOMPERIDONE TEVA 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France Domperidone DOMPERIDONE TEVA 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France Domperidone DOMPERIDONE TEVA 20 mg, comprimé pelliculé sécable 20 mg film-coated tablet oral use France Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris France Domperidone DOMPERIDONE ZENTIVA 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris France Domperidone DOMPERIDONE ZENTIVA 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France Sanofi-Aventis France 1-13, boulevard Romain Rolland 75014 Paris France Domperidone DOMPERIDONE ZENTIVA 20 mg, comprimé pelliculé sécable. 20 mg film-coated tablet oral use France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers 92000 Nanterre France Domperidone DOMPERIDONE ZYDUS 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France Janssen-Cilag 1, rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux Cedex 9 France Domperidone MOTILIUM 1 mg/ml, suspension buvable 1 mg/ml oral suspension oral use France Janssen-Cilag 1, rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux Cedex 9 France Domperidone MOTILIUM 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use France Janssen-Cilag 1, rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux Cedex 9 France Domperidone MOTILIUM 10 mg, granulés effervescents en sachet-dose 10 mg effervescent granules oral use France Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone OROPERIDYS 10 mg, comprimé orodispersible 10 mg orodispersible tablet oral use France Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone PERIDYS 1 mg/ml, suspension buvable 1 mg/ml oral suspension oral use France Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone PERIDYS 10 mg, comprimé pelliculé 10 mg film-coated tablet oral use Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany Domperidonemaleat Domperidon — 1 A Pharma 10 mg Tabletten 12,72 mg tablet oral use Germany AbZ Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany Domperidonemaleat Domperidon-CT 10 mg Filmtabletten 12,73 mg film-coated tablet oral use Germany AbZ Pharma GmbH Graf-Arco-Str. 3 89079 Ulm Germany Domperidonemaleat Domperidon AbZ 10 mg Filmtabletten 12,73 mg film-coated tablet oral use Germany Accord Healthcare Limited Sage House, 319, Pinner Road HA1 4HF North Harrow, Middlesex United Kingdom Domperidonemaleat Domperidon Accord 10 mg Tabletten 12,72 mg tablet oral use Germany ALIUD PHARMA GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Germany Domperidonemaleat Domperidon AL 10 mg Tabletten 12,72 mg tablet oral use Germany Betapharm Arzneimittel GmbH Kobelweg 95 86156 Augsburg Germany Domperidonemaleat Domperidon beta 10 mg Tabletten 12,72 mg tablet oral use Germany HEXAL AG Industriestr. 25 83607 Holzkirchen Germany Domperidonemaleat Domperidom Hexal 10 mg Tabletten 12,72 mg tablet oral use Germany RATIOPHARM GmbH Graf Arco Strasse 3 89079 Ulm Germany Domperidonemaleat Domperidon-ratiopharm 10 mg Filmtabletten 12,73 mg film-coated tablet oral use Germany Stadapharm GmbH Stadastr. 2-18 61118 Bad Vilbel Germany Domperidonemaleat Domperidon STADA 10 mg Tabletten 12,72 mg tablet oral use Germany Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany Domperidone Motilium Tropfen 10 mg oral drops, suspension oral use Germany Takeda GmbH Byk-Gulden-Str. 2 78467 Konstanz Germany Domperidone Motilium 10 mg tablet oral use Germany TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany Domperidonemaleat Domperidon-TEVA 10 mg Filmtabletten 12,73 mg film-coated tablet oral use Germany TEVA GmbH Graf-Arco-Str. 3 89079 Ulm Germany Domperidonemaleat Domidon 10 mg Filmtabletten 12,73 mg film-coated tablet oral use Greece JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA Epidarvou 4 & Aigialeias Maroussi 15125 Athens, Greece Domperidone CILROTON 10 mg film-coated tablet oral use Greece JOHNSON & JOHNSON ΗΕΛΛΑΣ CONSUMER SA Epidarvou 4 & Aigialeias Maroussi 15125 Athens, Greece Domperidone CILROTON 5 mg/5 ml oral solution oral use Greece PIERRE FABRE MEDICINES SA Messogeion 350, Agia Paraskevi 15341 Athens, Greece Domperidone OROPERIDYS 10 mg orodispersible tablet oral use Hungary Extractum Pharma zRT. Megyeri út 64. Budapest H-1044 Hungary Domperidone Domperidon-EP 10 mg tabletta 10 mg tablet oral use Hungary Janssen-Cilag Kft. Tó park H-2045 Törökbálint Hungary Domperidone Motilium 10 mg filmtabletta 10 mg film-coated tablet oral use Ireland McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland Domperidone Motilium Fastmelts 10 mg Tablets 10 mg tablet oral use Ireland McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland Domperidone Motilium 10 mg Film-Coated Tablets 10 mg tablet oral use Ireland McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland Domperidone Motilium 10 mg Suppositories 10 mg suppository rectal use Ireland McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland Domperidone Motilium 30 mg Suppositories 30 mg suppository rectal use Ireland McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland Domperidone Motilium 60 mg Suppositories 60 mg suppository rectal use Ireland McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland Domperidone Motilium 1 mg/ml Oral Suspension 1 mg/ml oral suspension oral use Ireland McNeil Healthcare (Ireland) Limited Airton Road Tallaght Dublin 24 Ireland Domperidone Motilium Rx 10 mg Film-coated Tablets 10 mg film-coated tablet oral use Ireland Rowex Ltd Bantry Co Cork Ireland Domperidone DOMERID 10 mg Tablets. 10 mg tablet oral use Ireland Rowex Ltd Bantry Co Cork Ireland Domperidone Domerid Relief 10 mg Tablets. 10 mg tablet oral use Italy ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy Domperidone PERIDON 10 mg film-coated tablet oral use Italy ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy Domperidone PERIDON 60 mg suppository rectal use Italy ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy Domperidone PERIDON 30 mg suppository rectal use Italy ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy Domperidone PERIDON 10 mg effervescent granules oral use Italy ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy Domperidone PERIDON 1 mg/ml suspension oral use Italy ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy Domperidone PERIDON 20 mg film-coated tablet oral use Italy ITALCHIMICI SpA Via Pontina, 5 km 29 — 00040 Pomezia — Roma — Italy Domperidone PERIDON 20 mg effervescent granules oral use Italy Janssen-Cilag SpA Via Michelangelo buonarroti 23 20093 Cologno Monzese — Milano Italy Domperidone MOTILIUM 1 mg/ml suspension oral use Italy Janssen-Cilag SpA Via Michelangelo buonarroti 23 20093 Cologno Monzese — Milano Italy Domperidone MOTILIUM 10 mg film-coated tablet oral use Italy Janssen-Cilag SpA Via Michelangelo buonarroti 23 20093 Cologno Monzese — Milano Italy Domperidone MOTILIUM 10 mg effervescent granules oral use Italy DR. REDDY'S S.R.L. Via Fernanda Wittgens 3 — 20123 Milano Italy Domperidone DOMPERIDONE DR. REDDY'S 10 mg tablet oral use Italy DR. REDDY'S S.R.L. Via Fernanda Wittgens 3 — 20123 Milano Italy Domperidone DOMPERIDONE DR. REDDY'S 100 mg/100 ml syrup oral use Italy GIULIANI S.P.A Via Palagi 2 20129 Milano Italy Domperidone DIGESTIVO GIULIANI 5 mg effervescent granules oral use Italy GIULIANI S.P.A Via Palagi 2 20129 Milano Italy Domperidone DIGESTIVO GIULIANI 5 mg chewable tablet oral use Italy GIULIANI S.P.A Via Palagi 2 20129 Milano Italy Domperidone DIGESTIVO GIULIANI 10 mg film-coated tablet oral use Italy TEVA ITALIA S.R.L. Via Messina 38 20154 Milano Italy Domperidone DOMPERIDONE TEVA 10 mg film-coated tablet oral use Italy GERMED PHARMA SpA Via Cantù 11 20092 Cinisello Balsamo — Milano — Italy Domperidone DOMPERIDONE GERMED 10 mg film-coated tablet oral use Italy GERMED PHARMA SpA Via Cantù 11 20092 Cinisello Balsamo — Milano — Italy Domperidone DOMPERIDONE GERMED 10 mg/10 ml suspension oral use Italy ABC FARMACEUTICI SpA, Corso Vittorio Emanuele II 72, 10121 Torino Italy Domperidone DOMPERIDONE ABC 10 mg tablet oral use Italy MYLAN SpA Via Vittor Pisani 20 20124 Milano Italy Domperidone DOMPERIDONE MYLAN GENERICS 10 mg tablet oral use Italy FG S.R.L. Via San Rocco 6 - 85033 Episcopia Potenza Italy Domperidone DOMPERIDONE FG 10 mg tablet oral use Italy EG SpA Via Domenico Scarlatti 31 20124 Milano Italy Domperidone DOMPERIDONE EG 10 mg tablet oral use Italy LABORATORI ALTER S.R.L. Via Egadi 7 20144 Milano Italy Domperidone DOMPERIDONE ALTER 10 mg tablet oral use Italy CRINOS SpA Via Pavia 6 20136 Milano Italy Domperidone RIGES 10 mg tablet oral use Italy SANDOZ SpA Largo Umberto Boccioni 1 21040 Origgio — Varese Italy Domperidone PYNINAT 10 mg tablet oral use Italy DOC GENERICI S.R.L. Via Manunzio 7 20124 Milano Italy Domperidone DOMPERIDONE DOC GENERICI 10 mg tablet oral use Italy ALMUS S.R.L. Via Cesarea 11/10 16121 Genova Italy Domperidone DOMPERIDONE ALMUS 10 mg tablet oral use Italy FARMAKOPEA S.P.A Via Cavriana 14 20134 Milano Italy Domperidone DALIA 10 mg effervescent tablet oral use Italy SANDOZ SpA Largo Umberto Boccioni 1 21040 Origgio — Varese Italy Domperidone DOMPERIDONE SANDOZ 10 mg tablet oral use Italy PENSA PHARMA SpA Via Ippolito Rossellini 12 20124 Milano Italy Domperidone DOMPERIDONE PENSA 10 mg effervescent tablet oral use Italy FARMAKOPEA S.P.A Via Cavriana 14 20134 Milano Italy Domperidone GERDI 5 mg effervescent tablet oral use Italy FARMAKOPEA S.P.A Via Cavriana 14 20134 Milano Italy Domperidone GERDI 5 mg effervescent granules oral use Italy CRINOS SpA Via Pavia 6 20136 Milano Italy Domperidone RAXAR 10 mg orodispersible tablet oral use Italy PIERRE FABRE PHARMA S.R.L. Via Winckelmann 1 20146 Milano Italy Domperidone NEOPERIDYS 10 mg orodispersible tablet oral use Italy SOFAR S.p.a. Via Firenze, 40 20060 Trezzano Rosa — Milano Italy Domperidone Maleato PERMOTIL 10 mg tablet oral use Italy ANGENERICO S.p.a. Via Nocera Umbra 75, 00181 Roma Italy Domperidone Maleato DOMPERIDONE ANGENERICO 10 mg tablet oral use Latvia Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone Oroperidys 10 mg orodispersible tablets 10 mg orodispersible tablet oral use Latvia UAB ‘Johnson & Johnson’ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania Domperidone Motilium 10 mg film-coated tablets 10 mg film-coated tablet oral use Latvia Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland Domperidone Domperidon Actavis 10 mg tablets 10 mg tablet oral use Lithuania Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland Domperidone Domperidon Actavis 10 mg tablet oral use Lithuania Torrent Pharma GmbH Sudwestpark 50 Nurnberg D-90449 Germany Domperidone Domstal 10 mg tablet oral use Lithuania UAB ‘Johnson & Johnson’ Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania Domperidone Motilium 10 mg film-coated tablet oral use Lithuania Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone Oroperidys 10 mg orodispersible tablet oral use Luxembourg Eurogenerics SA esplanade heysel b22 1020 bruxelles Belgium Domperidone (maleate) Domperidone EG-10 10 mg tablet oral use Luxembourg Eurogenerics SA esplanade heysel b22 1020 bruxelles Belgium Domperidone Domperidone EG-10 10 mg orodispersible tablet oral use Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium Domperidone Base 10 mg coated tablet oral use Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium Instant-10 10 mg orodispersible tablet oral use Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone (maleate) Motilium-10 10 mg coated tablet oral use Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium pediatrie 1 mg/ml oral suspension oral use Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium-1 mg/ml 1 mg/ml oral suspension oral use Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium-10 supp 10 mg suppository rectal use Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium-30 supp 30 mg suppository rectal use Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Domperidone Motilium-60 supp 60 mg suppository rectal use Luxembourg Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone Oroperidys 10 mg orodispersible tablet oral use Luxembourg Johnson & Johnson Consumer N.V. Antwerpseweg 15-17 2340 Beerse Belgium Cinnarizine/Domperidone (maleate) Touristil 20 mg/ 15 mg tablet oral use Malta Actavis Group Hf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland Domperidone Domperidon Actavis 10 mg tablet oral use Malta Medochemie Limited PO Box 51409 Limassol CY-3505 Cyprus Domperidone Costi 10 mg Film coated tablets 10 mg film-coated tablet oral use Malta Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium Domperidone motilium 1 mg/ml oral suspension 1 mg/ml oral suspension oral use Malta Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium Domperidone motilium 10 mg film coated tablets 10 mg film-coated tablet oral use Malta Janssen-Cilag International NV Turnhoutseweg 30 B-2340, Beerse Belgium Domperidone motilium 30 mg Suppositories 30 mg suppository rectal use Poland Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France Domperidone Oroperidys 10 mg orodispersible tablet oral use Portugal Laboratório Medinfar — Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova 2700-547 Amadora Portugal Domperidone Cinet 10 mg tablet oral use Portugal Laboratório Medinfar — Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova 2700-547 Amadora Portugal Domperidone Cinet 10 mg dispersible tablet oral use Portugal Laboratório Medinfar — Produtos Farmacêuticos, S.A. Rua Manuel Ribeiro de Pavia, 1 — 1o — Venda Nova 2700-547 Amadora Portugal Domperidone Cinet 1 mg/ml oral suspension oral use Portugal Actavis A/S Sucursal Rua Virgílio Correia, 11 — A 1600-219 Lisboa Portugal Domperidone Domperidona Actavis 10 mg tablet oral use Portugal Baldacci — Portugal, S.A. Rua Cândido de Figueiredo, 84-B 1549-005 Lisboa Portugal Domperidone Domperidona Baldacci 10 mg film-coated tablet oral use Portugal Ciclum Farma Unipessoal, Lda. Quinta da Fonte, Rua Vitor Câmara, 2 — Edifício D. Amélia, Piso 1, Ala B 2770-229 Paço de Arcos Portugal Domperidone Domperidona Ciclum 10 mg tablet oral use Portugal GP — Genéricos Portugueses, Lda. Rua Henrique Paiva Couceiro, 29 — Venda Nova 2700-451 Amadora Portugal Domperidone Domperidona GP 10 mg tablet oral use Portugal Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal Domperidone Domperidona Generis 10 mg film-coated tablet oral use Portugal Germed Farmacêutica, Lda. Rua Alto do Montijo, 13 — 1o Dto — Edifício Monsanto 2790-012 Portela de Carnaxide Portugal Domperidone Domperidona Germed 10 mg film-coated tablet oral use Portugal Labesfal Genéricos, S.A. Avenida Dr. Afonso Costa, 1370 3465-051 Campo de Besteiros Portugal Domperidone Domperidona Labesfal 10 mg tablet oral use Portugal Mylan, Lda. Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C — 7.3 e 7.4 1990-095 Lisboa Portugal Domperidone Domperidona Mylan 10 mg film-coated tablet oral use Portugal Ratiopharm — Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245 Porto Salvo Portugal Domperidone Domperidona Ratiopharm 10 mg film-coated tablet oral use Portugal ToLife — Produtos Farmacêuticos, S.A. Avenida do Forte, 3 — Edificio Suécia III, Piso 1 2794-093 Carnaxide Portugal Domperidone Domperidona ToLife 10 mg tablet oral use Portugal Wynn Industrial Pharma, S.A. Rua Tierno Galvan, Torre 3, 16o Piso, Amoreiras 1070-274 Lisboa Portugal Domperidone Domperidona Wynn 10 mg tablet oral use Portugal Johnson & Johnson, Lda. Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo 2730-055 Barcarena Portugal Domperidone Motilium 1 mg/ml oral suspension oral use Portugal Johnson & Johnson, Lda. Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo 2730-055 Barcarena Portugal Domperidone Motilium 10 mg film-coated tablet oral use Portugal Johnson & Johnson, Lda. Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo 2730-055 Barcarena Portugal Domperidone Motilium 10 mg effervescent granules oral use Portugal Johnson & Johnson, Lda. Estrada Consiglieri Pedroso, 69 A — Queluz de Baixo 2730-055 Barcarena Portugal Domperidone Motilium Rapid 10 mg orodispersible tablet oral use Portugal Laboratórios Azevedos — Indústria Farmacêutica, S.A. Edifícios Azevedos — Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal Domperidone Remotil 10 mg tablet oral use Romania S.C. TERAPIA S.A. Str. Fabricii nr. 124, Cluj Napoca, Romania DOMPERIDONE MOTILIUM 10 mg 10 mg film-coated tablet oral use Romania Pierre Fabre Médicament 45 place Abel Gance 92100 Boulogne France DOMPERIDONE OROPERIDYS 10 mg 10 mg orodispersible tablet oral use Slovak Republic Pierre Fabre Médicament 45 Place Abel Gance 92654 Boulogne Cedex France Domperidone OROPERIDYS 10 mg 10 mg tablet oral use Slovak Republic Medochemie Ltd. 1-10 Constantinoupoleos St. P.O. Box: 51409 3505 Limassol Cyprus Domperidone COSTI 10 mg tablet oral use Slovenia KRKA, tovarna zdravil, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia Domperidone Tametil 10 mg filmsko obložene tablete 10 mg film-coated tablet oral use Spain LABORATORIOS DR. ESTEVE, S.A. Avda. Mare de Déu de Montserrat, 221 08041 Barcelona Spain Domperidone Motilium 30 mg supositorios niños 30 mg suppository rectal use Spain LABORATORIOS DR. ESTEVE, S.A. Avda. Mare de Déu de Montserrat, 221 08041 Barcelona Spain Domperidone Motilium 10 mg comprimidos recubiertos con película 10 mg film-coated tablet oral use Spain LABORATORIOS DR. ESTEVE, S.A. Avda. Mare de Déu de Montserrat, 221 08041 Barcelona Spain Domperidone Motilium 1 mg/ml suspensión oral 1 mg/ml oral suspension oral use Spain Janssen-Cilag, S.A. Po de Las Doce Estrellas, 5-7 28042 Madrid Spain Domperidone Nauzelin 1 mg/ml suspensión oral 1 mg/ml oral suspension oral use Spain Janssen-Cilag, S.A. Po de Las Doce Estrellas, 5-7 28042 Madrid Spain Domperidone Nauzelin 10 mg comprimidos recubiertos con película 10 mg film-coated tablet oral use Spain ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain Domperidone Domperidona Gamir 10 mg cápsulas duras 10 mg capsule, hard oral use Spain ROTTAPHARM, S.L. Avda. Diagonal, 67-69 Barcelona 08019 Spain Domperidone Domperidona Gamir 1 mg/ml suspensión oral 1 mg/ml oral suspension oral use Spain PENSA PHARMA, S.A.U. Jorge Comín (médico pediatra), 3-bajos Valencia 46015 Spain Domperidone maleate Domperidona Pensa 10 mg comprimidos EFG 12,72 mg tablet oral use Spain Pierre Fabre Médicament 45 place Abel Gance F-92100 Boulogne France Domperidone Orosperidys 10 mg comprimidos bucodispersables 10 mg orodispersible tablet oral use The Netherlands Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands Domperidone Motilium filmomhulde tabletten 10 mg 10 mg film-coated tablet oral use The Netherlands Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands Domperidone Motilium suspensie voor oraal gebruik 1 mg/ml 1 mg/ml oral suspension oral use The Netherlands Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands Domperidone Motilium zetpillen voor zuigelingen 10 mg 10 mg suppository rectal use The Netherlands Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands Domperidone Motilium zetpillen voor kinderen 30 mg 30 mg suppository rectal use The Netherlands Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands Domperidone Motilium zetpillen voor volwassenen 60 mg 60 mg suppository rectal use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands Domperidone Domperidon 10 PCH voor zuigelingen, zetpillen 10 mg 10 mg suppository rectal use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands Domperidone Domperidon 30 PCH voor kinderen, zetpillen 30 mg 30 mg suppository rectal use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands Domperidone Domperidon 60 PCH voor volwassenen, zetpillen 60 mg 60 mg suppository rectal use The Netherlands Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands Domperidone Domperidon JJC filmomhulde tabletten 10 mg 10 mg film-coated tablet oral use The Netherlands Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands Domperidone Domperidon JJC zetpillen voor volwassenen 60 mg 60 mg suppository rectal use The Netherlands Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands Domperidone Domperidon JJC zetpillen voor kinderen 30 mg 30 mg suppository rectal use The Netherlands Johnson & Johnson Consumer B.V. Rooseveltweg 15 1314 SJ Almere The Netherlands Domperidone Domperidon JJC zetpillen voor zuigelingen 10 mg 10 mg suppository rectal use The Netherlands Samenwerkende Apothekers Nederland B.V. Kralingseweg 201 3062 CE Rotterdam The Netherlands Domperidone Domperidon 30 mg zetpillen Samenwerkende Apothekers 30 mg suppository rectal use The Netherlands Samenwerkende Apothekers Nederland B.V. Kralingseweg 201 3062 CE Rotterdam The Netherlands Domperidone Domperidon 60 mg zetpillen Samenwerkende Apothekers, zetpillen 60 mg suppository rectal use The Netherlands Mylan B.V. Dieselweg 25 3752 LB Bunschoten The Netherlands Domperidone Domperidon Mylan 10 mg, tabletten 10 mg tablet oral use The Netherlands Pharmacin B.V. Molenvliet 103 3335 LH Zwijndrecht The Netherlands Domperidone Domperidon Pharmacin 10 mg, tabletten 10 mg tablet oral use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands Domperidone Domperidon 10 PCH, filmomhulde tabletten 10 mg 10 mg film-coated tablet oral use The Netherlands Accord Healthcare Ltd Sage House, 319 Pinner Road HA1 4 HF North Harrow, Middlesex United Kingdom Domperidone Domperidon Accord 10 mg, tabletten 10 mg tablet oral use The Netherlands Healthypharm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands Domperidone Tabletten bij maagklachten en misselijkheid domperidon 10 mg, tabletten 10 mg tablet oral use The Netherlands Leidapharm B.V. Archimedesweg 2 2333 CN Leiden The Netherlands Domperidone Domperidon 10 mg, tabletten 10 mg tablet oral use The Netherlands Stada Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany Domperidone Domperidon STADA 10 mg tabletten 10 mg tablet oral use The Netherlands Actavis B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands Domperidone Domperidon Actavis 10 mg, omhulde tabletten 10 mg coated tablet oral use The Netherlands Centrafarm B.V. Nieuwe Donk 3 4879 AC Etten-Leur The Netherlands Domperidone Domperidon CF 10 mg, tabletten 10 mg tablet oral use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands Domperidone Domperidon PCH 10, filmomhulde tabletten 10 mg 10 mg film-coated tablet oral use The Netherlands Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No7, Hardicker Street M19 2RB Manchester United Kingdom Domperidone Domperidon 10 mg, tabletten 10 mg tablet oral use The Netherlands Marel B.V. Archimedesweg 2 2333 CN Leiden The Netherlands Domperidone Kruidvat Domperidon 10 mg, tabletten 10 mg tablet oral use The Netherlands Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands Domperidone Domperidon Sandoz 10 mg, tabletten 10 mg tablet oral use The Netherlands Sofar S.p.A. Via Firenze 40 20060 Trezzano Rosa (MI) Italy Domperidone Domperidon Sofar 10 mg, tabletten 10 mg tablet oral use The Netherlands Bellwood Pharmaceuticals Ltd. First Floor 69, St. Patricks Road Dalkey, Co. Dublin Ireland Domperidone Domperidon Bellwood 10 mg, tabletten 10 mg tablet oral use The Netherlands Faribérica, Productos Farmacêuticos, SA Estrada da Luz, 90-9o CDE 1600-160 Lissabon Portugal Domperidone Domperidon Faribérica 10 mg, tabletten 10 mg tablet oral use The Netherlands Actavis Nordic A/S Ornegardsvej 16 2820 Gentofte Denmark Domperidone Domperidon Actavis 10 mg, tabletten 10 mg tablet oral use The Netherlands Mediq Farma B.V. Hertogswetering 159 3543 AS Utrecht The Netherlands Domperidone Domperidon Mdq 10 mg, tabletten 10 mg tablet oral use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands Domperidone Domperidon 10 mg PCH, tabletten 10 mg tablet oral use The Netherlands Samenwerkende Apothekers Nederland B.V. Kralingseweg 201 3062 CE Rotterdam The Netherlands Domperidone Domperidon 10 mg tabletten Samenwerkende Apothekers 10 mg tablet oral use The Netherlands Pharmachemie B.V. Swensweg 5 2031 GA Haarlem The Netherlands Domperidone Domperidon 10 mg Pharmachemie, tabletten 10 mg tablet oral use The Netherlands KELA Pharma nv Industriepark West 68 9100 Sint-Niklaas Belgium Domperidone Domperidon Kela 10 mg, tabletten 10 mg tablet oral use United Kingdom Co-operative Pharmacy National Distribution Centre Limited, Enterprose Way, Meir Park, Stoke-on-Trent, Staffordshire ST3 7UN United Kingdom Domperidone maleate Domperidone 10 mg Tablets 10 mg tablet oral use United Kingdom Generics (UK) Limited, T/A Mylan, Albany Gate, Potters Bar, Hertfordshire EN6 1AG, United Kingdom Domperidone maleate Domperidone Tablets 10 mg 10 mg coated tablet oral use United Kingdom Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom Domperidone maleate Domperidone 10 mg Tablets 10 mg tablet oral use United Kingdom Manx Healthcare Limited Taylor Group House Wedgnock Lane Warwick CV34 5YA United Kingdom Domperidone maleate Domperidone 10 mg Tablets 10 mg tablet oral use United Kingdom McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom Domperidone maleate Motilium 10 10 mg tablet oral use United Kingdom McNeil Products Limited, Johnson & Johnson Ltd, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom Domperidone maleate Motilium Instants 10 mg orodispersible tablet oral use United Kingdom Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip, HA4 6QD, United Kingdom Domperidone maleate Domperidone 10 mg Tablets 10 mg tablet oral use United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom Domperidone Domperidone 1 mg/ml Oral Suspension 5 mg oral suspension oral use United Kingdom Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS United Kingdom Domperidone maleate Motilium 10 mg Film-coated Tablets 10 mg film-coated tablet oral use United Kingdom Bristol Laboratories Limited Unit 3, Canalside Northbridge Road, Berkhamsted Hertfordshire HP4 1EG United Kingdom Domperidone maleate Domperidone 10 mg Tablets 10 mg tablet oral use United Kingdom Focus Pharmaceuticals Limited Unit 5, Faraday Court First Avenue, Centrum 100 Burton Upon Trent, Staffordshire DE14 2WX United Kingdom Domperidone maleate Domperidone 10 mg Tablets 10 mg tablet oral use United Kingdom Medreich plc, Warwick House, Plane Tree Crescent, Feltham TW13 7HF United Kingdom Domperidone maleate Domperidone 10 mg Tablets 10 mg tablet oral use United Kingdom Wockhardt UK Limited Ash Road North Wrexham Industrial Estate Wrexham LL13 9UF United Kingdom Domperidone maleate Domperidone 10 mg Tablets 10 mg film-coated tablet oral use United Kingdom Athlone Pharmaceuticals Limited, Ballymurray, Roscommon, Co. Roscommon, Ireland Domperidone maleate Domperidone 10 mg Tablets 10 mg film-coated tablet oral use

ANNEX II List of the names, pharmaceutical form, strength of the medicinal products, route of administration, marketing authorisation holders in the Member States Member State (in EEA) Marketing authorisation holder Invented name Strength Pharmaceutical form Route of administration Austria TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria ARTROLYT 50 mg Kapseln 50 mg capsule, hard oral use Austria TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria VERBORIL 50 mg Kapseln 50 mg capsule, hard oral use Czech Republic TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria ARTRODAR 50 mg capsule, hard oral use France NEGMA 10, rue Paul Dautier 78140 Vélizy Villacoublay France ART 50 mg, gélule 50 mg capsule, hard oral use France ACTAVIS GROUP (ISLANDE) Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland DIACEREINE ACTAVIS 50 mg, gélule 50 mg capsule, hard oral use France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France DIACEREINE ARROW 50 mg, gélule 50 mg capsule, hard oral use France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France DIACEREINE BIOGARAN 50 mg, gélule 50 mg capsule, hard oral use France CRISTERS 22 quai Gallieni 92150 Suresnes France DIACEREINE CRISTERS 50 mg, gélule 50 mg capsule, hard oral use France EG LABO — LABORATOIRES EUROGENERICS ‘Le Quintet’ — bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex France DIACEREINE EG 50 mg, gélule 50 mg capsule, hard oral use France EVOLUPHARM rue Irène Caron Zone Industrielle d'Auneuil 60390 Auneuil France DIACEREINE EVOLUGEN 50 mg, gélule 50 mg capsule, hard oral use France MAZAL PHARMACEUTIQUE 11, rue Rontgen BP 1309 29103 Quimper France DIACEREINE MAZAL 50 mg, gélule 50 mg capsule, hard oral use France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France DIACEREINE MYLAN 50 mg, gélule 50 mg capsule, hard oral use France NEGMA 10, rue Paul Dautier 78140 Vélizy Villacoublay France DIACEREINE NEGMA 50 mg, gélule 50 mg capsule, hard oral use France LABORATOIRES PHARMA 2000 10 rue Paul Dautier 78140 Vélizy Villacoublay France DIACEREINE PHARMA 2000 50 mg, gélule 50 mg capsule, hard oral use France RANBAXY PHARMACIE GENERIQUES 11-15 Quai de Dion Bouton 92800 Puteaux France DIACEREINE RANBAXY 50 mg, gélule 50 mg capsule, hard oral use France TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France DIACEREINE RATIOPHARM 50 mg, gélule 50 mg capsule, hard oral use France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France DIACEREINE REF 50 mg, gélule 50 mg capsule, hard oral use France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France DIACEREINE SANDOZ 50 mg, gélule 50 mg capsule, hard oral use France SUBSTIPHARM DEVELOPPEMENT 24, rue Erlanger 75016 Paris FRANCE DIACEREINE SUBSTIPHARM 50 mg, gélule 50 mg capsule, hard oral use France TEVA SANTE 110, Esplanade du Général de Gaulle 92931 Paris La Défense Cedex France DIACEREINE TEVA 50 mg, gélule 50 mg capsule, hard oral use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France DIACEREINE ZENTIVA 50 mg, gélule 50 mg capsule, hard oral use France ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures — Parc d’Activités des Peupliers 92000 Nanterre France DIACEREINE ZYDUS 50 mg, gélule 50 mg capsule, hard oral use France MAZAL PHARMACEUTIQUE 11, rue Rontgen BP 1309 29103 Quimper France MAZART 50 mg, gélule 50 mg capsule, hard oral use France NIVERPHARM 10 rue Paul Dautier 78140 Vélizy Villacoublay France ZONDAR 50 mg, gélule 50 mg capsule, hard oral use Greece ANGELINI PHARMA HELLAS Achaias and Troizinias, Nea Kifissia 14564, Athens Greece VERBORIL 50 mg capsule, hard oral use Greece AURORA PHARMACEUTICALS S.A. Evrou 4 and Messinias 2, Gerakas 15344 Greece ARTHROREIN 50 mg capsule, hard oral use Greece VOCATE Pharmaceuticals S.A., Gounari 150, Glyfada 16674 Athens Greece ARTHROFAR 50 mg capsule, hard oral use Greece RAFARM AEBE korinthou 12, Neo Psychiko, 15451 Greece IDEALITE 50 mg capsule, hard oral use Greece HELP ABEE Valaoritou 10, Metamorfosi, Attikis, 14452 Greece INFLABION 50 mg capsule, hard oral use Greece BROS EPE Avgis & Gallinis 15, n. Kifissia, 14564 Greece REUMANISAL 50 mg capsule, hard oral use Greece FARMEDIA A.E. Athinas 22 & Apollonos Gerakas, Attikis, 15344 Greece OSTIREIN 50 mg capsule, hard oral use Greece GENEPHARM A.E. 18th km Marathonos Avenue, Pallini, Attikis, 15351 Greece MYOBLOC 50 mg capsule, hard oral use Greece PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS Dilou 9, Peristeri, Attikis, 12134 Greece DIACEREIN/PROEL 50 mg capsule, hard oral use Greece NORMA HELLAS A.E. Menandrou 54, Athens, 10431 Greece DIACEREIN/NORMA 50 mg capsule, hard oral use Greece S.M. Pharmaceutical Products Ltd, Agiou Orous 43-45 Piraeus 18545 Greece DESEREIN 50 mg capsule, hard oral use Greece PROTON PHARMA Achaias 4 and Trizoinias, Nea Kifissia 14564 Greece DIACERIL 50 mg capsule, hard oral use Italy ABIOGEN PHARMA S.p.A. Via Meucci 36 56121 Ospedaletto — Pisa Italy FISIODAR 50 mg capsule, hard oral use Portugal Neo-Farmacêutica, S.A. Av. D. João II, Lote 1.02.2.1 D-2o 1990-090 Lisboa Portugal Artrolyt 50 mg capsule, hard oral use Slovak Republic TRB Chemedica (Austria) GmbH IZ NOE-Sued, Straße 7, Obj.58D/1/2.OG 2355 Wiener Neudorf Austria ARTRODAR 50 mg capsule, hard oral use Spain ROTTAPHARM S.L. Avda. Diagonal, 67-69 08019 Barcelona ESPAÑA GLIZOLAN 50 mg cápsulas 50 mg capsule, hard Oral use Spain NEGMA-LERADS Immeuble Strasbourg Avenue de L'Europe Toussus-le-Noble Magny-les Hameaux Cedex F-78771 France ARTRIZAN 50 mg cápsulas 50 mg capsule, hard Oral use Spain LACER S.A. Sardenya, 350 08025 Barcelona Spain GALAXDAR 50 mg cápsulas 50 mg capsule, hard Oral use Spain LABORATORIOS NORMON S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain DIACEREINA NORMON 50 mg cápsulas duras EFG 50 mg capsule, hard Oral use Spain IBERMEDGEN S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain DIACEREINA PANLUETOL 50 mg cápsulas duras EFG 50 mg capsule, hard Oral use Spain MG PHARMA 8, Rue Bellini 75116 Paris France REINART 50 mg cápsulas duras EFG 50 mg capsule, hard Oral use

ANNEX III List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States Levonorgestrel-containing emergency contraceptive medicinal products Member State (in EEA) Marketing Authorisation Holder Invented name Strength Pharmaceutical Form Route of administration Austria Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 1 500 Mikrogramm-Tablette 1,5 mg Tablet Oral use Austria Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Vikela 750 Mikrogramm- Tabletten 0,75 mg Tablet Oral use Austria Laboratoire HRA Pharma 15. rue Béranger FR-75003 Paris France Vikela 1,5 Milligramm-Tablette 1,5 mg Tablet Oral use Austria Velvian Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany Velafam 1,5 mg Tabletten 1,5 mg Tablet Oral use Austria Velvian Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany Velafam 750 Mikrogramm Tabletten 0,75 mg Tablet Oral use Belgium Sandoz N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium Levodonna 1,5 mg Tablet Oral use Belgium Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 0,75 mg Tablet Oral use Belgium Laboratoire HRA Pharma 15. rue Béranger FR-75003 Paris France Norlevo 1,5 mg Tablet Oral use Belgium Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 1,5 mg Tablet Oral use Belgium Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 0,75 mg Tablet Oral use Bulgaria Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Escapelle 1,5 mg Tablet Oral use Bulgaria Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Ramonna 1,5 mg Tablet Oral use Bulgaria Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Postinor-Duo 0,75 mg Tablet Oral use Bulgaria Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre, Leon Spain Etiyone 1,5 mg Tablet Oral use Bulgaria Laboratorios Leon Farma SA Poligono Industrial Navatejera, La Vallina s/n, 24008 Villaquilambre, Leon Spain Melkidos 0,75 mg Tablet Oral use Croatia Arenda d.o.o., Medarska ulica 56b Zagreb 10090 Croatia Vikela 1,5 mg tableta 1,5 mg Tablet Oral use Croatia Sandoz d.o.o. Maksimirska 120 Zagreb 10000 Croatia Escapelle 1,5 mg Tablet Oral use Cyprus Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 0,75 mg Tablet Oral use Cyprus Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 1,5 mg Tablet Oral use Czech Republic Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Escapelle 1,5 mg Tablet Oral use Czech Republic Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Postinor-2 0,75 mg Tablet Oral use Czech Republic Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Ramonna 1,5 mg Tablet Oral use Czech Republic Egis Pharmaceuticals PLC Keresztúri út 30-38 H-1106 Budapest Hungary Egianti 0,75 mg 0,75 mg Tablet Oral use Czech Republic Laboratorios León Farma S.A. Calle La Vallina s/n Polígono Industrial Navatejera 24008 — Navatejera — León Spain Nopregy 1,5 mg tablety 1,5 mg Tablet Oral use Denmark Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 0,75 mg Tablet Oral use Denmark Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 1,5 mg Tablet Oral use Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Levodonna 1,5 mg Tablet Oral use Estonia Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary RAMONNA 1,5 mg Tablet Oral use Estonia Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary ESCAPELLE 1,5 mg Tablet Oral use Estonia Orivas UAB J.Jasinskio 16B LT-01112 Vilnius Lithuania LEVIDON 0,75 mg Tablet Oral use Estonia Sandoz Pharmaceuticals Verovškova 57 1000 Ljubljana Slovenia LEVODONNA 1,5 mg Tablet Oral use Estonia Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland LEVONORGESTREL ACTAVIS 0,75 mg Tablet Oral use Estonia Orivas UAB J.Jasinskio 16B LT-01112 Vilnius Lithuania ELISTREL 1,5 mg Tablet Oral use Finland Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 0,75 mg Tablet Oral use Finland Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 1,5 mg Tablet Oral use France Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom ANTHIA 750 microgrammes, comprimé 0,75 mg Tablet Oral use France Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom LEVONORGESTREL BIOGARAN 1 500 microgrammes, comprimé 1,5 mg Tablet Oral use France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France LEVONORGESTREL MYLAN 1,5 mg, comprimé 1,5 mg Tablet Oral use France Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 1,5 mg, comprimé 1,5 mg Tablet Oral use France Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 750 microgrammes, comprimé 0,75 mg Tablet Oral use France Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France VIKELA 1,5 mg, comprimé 1,5 mg Tablet Oral use France Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France VIKELA 750 microgrammes, comprimé 0,75 mg Tablet Oral use Germany VELVIAN Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany Navela 0,75 mg Tabletten 0,75 mg Tablet Oral use Germany VELVIAN Germany GmbH Carl-Zeiss-Ring 9 85737 Ismaning Germany Navela 1,5 mg Tabletten 1,5 mg Tablet Oral use Germany Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France PiDaNa 1,5 mg Tablette 1,5 mg Tablet Oral use Germany Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 1 500 Mikrogramm Tablette 1,5 mg Tablet Oral use Germany Hexal Aktiengesellschaft Industriestr. 25 83607 Holzkirchen Germany unofem HEXAL 1,5 mg Tabletten 1,5 mg Tablet Oral use Germany Laboratorios Leon Farma, SA Poligono Industrial Navatejera C/La Vallina s/n 24008 Navatejera — Villaquilambre Spain Etiyone 1 500 Mikrogramm Tabletten 1,5 mg Tablet Oral use Greece Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 0,75 mg Tablet Oral use Greece Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 1,5 mg Tablet Oral use Greece Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom POSTINOR 1,5 mg Tablet Oral use Hungary Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Escapelle 1,5 mg Tablet Oral use Hungary Egis Pharmaceuticals PLC Keresztúri út 30-38 H-1106 Budapest Hungary Empil 0,75 mg tabletta 0,75 mg Tablet Oral use Hungary Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland Helibona 1,5 mg Tablet Oral use Hungary Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Rigesoft 0,75 mg Tablet Oral use Iceland Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 1,5 mg Tablet Oral use Iceland Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 0,75 mg Tablet Oral use Iceland Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 1,5 mg Tablet Oral use Ireland Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Levonelle 1 500 microgram Tablet 1,5 mg Tablet Oral use Ireland Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 750 micrograms tablet 0,75 mg Tablet Oral use Ireland Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 1,5 mg tablet 1,5 mg Tablet Oral use Ireland Laboratorios Leon Farma, S.A. C/Roa de la Vega 15, 1 24008 Leon Spain Tyedra 1 500 micrograms tablet 1,5 mg Tablet Oral use Italy Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 0,75 mg Tablet Oral use Italy Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 1,5 mg Tablet Oral use Italy Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom LONEL 1,5 mg Tablet Oral use Latvia Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Escapelle 1,5 mg tablets 1,5 mg Tablet Oral use Latvia Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Ramonna 1 500micrograms tablets 1,5 mg Tablet Oral use Latvia Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Postinor-Duo 750 micrograms tablets 0,75 mg Tablet Oral use Latvia UAB ‘Orivas’ J. Jasinskio g. 16B LT- 01112 Vilnius Lithuania Elistrel 1 500 micrograms tablets 1,5 mg Tablet Oral use Latvia UAB ‘Orivas’ J. Jasinskio g. 16B LT- 01112 Vilnius Lithuania Levidon 750 micrograms tablets 0,75 mg Tablet Oral use Latvia Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland Levonorgestrel Actavis 750 micrograms tablets 0,75 mg Tablet Oral use Lithuania Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary ESCAPELLE 1,5 mg Tablet Oral use Lithuania Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary RAMONNA 1,5 mg Tablet Oral use Lithuania UAB ‘Orivas’ J. Jasinskio g. 16B LT- 01112 Vilnius Lithuania Elistrel 1,5 mg Tablet Oral use Lithuania UAB ‘Orivas’ J. Jasinskio g. 16B LT- 01112 Vilnius Lithuania Levidon 0,75 mg Tablet Oral use Lithuania UAB Inteli Generics Nord Šeimyniškių 3 LT-09312 Vilnius Lithuania Avodele 0,75 mg Tablet Oral use Lithuania UAB Inteli Generics Nord Šeimyniškių 3 LT-09312 Vilnius Lithuania Avodele 1,5 mg Tablet Oral use Lithuania Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary POSTINOR-DUO 0,75 mg Tablet Oral use Luxembourg Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 0,75 mg Tablet Oral use Luxembourg Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 1,5 mg Tablet Oral use Luxembourg Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 0,75 mg Tablet Oral use Luxembourg Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 1,5 mg Tablet Oral use Norway Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 0,75 mg Tablet Oral use Norway Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 1,5 mg Tablet Oral use Norway Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom POSTINOR 1,5 mg Tablet Oral use Norway Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Isteranda 1,5 mg Tablet Oral use Poland Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Escapelle tabletka 1 500 mikrogramów 1,5 mg Tablet Oral use Poland Gedeon Richter Polska Sp. z o.o. 5 Ks. J. Poniatowskiego Street 05-825 Grodzisk Mazowiecki Poland Ramonna 1,5 mg Tablet Oral use Portugal Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 0,75 mg Tablet Oral use Portugal Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 1,5 mg Tablet Oral use Portugal Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 1,5 mg Tablet Oral use Romania Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary ESCAPELLE 1,5 mg Tablet Oral use Romania Gedeon Richter Romania S.A. Str. Cuza-Vodă nr. 99-105 Târgu Mureş 540306 Romania RAMONNA 1,5 mg Tablet Oral use Romania Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary POSTINOR-2 750 micrograme 0,75 mg Tablet Oral use Slovak Republic Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary ESCAPELLE 1,5 mg Tablet Oral use Slovak Republic Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Ramona 1,5 mg Tablet Oral use Slovak Republic Egis Pharmaceuticals PLC Keresztúri út 30-38 H-1106 Budapest Hungary EGIANTI 0,75 mg tablety 0,75 mg Tablet Oral use Slovak Republic Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland Helibona 1,5 mg 1,5 mg Tablet Oral use Slovenia Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Hungary Escapelle 1,5 mg tableta 1,5 mg Tablet Oral use Slovenia Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France NORLEVO 1,5 mg tableta 1,5 mg Tablet Oral use Slovenia Gedeon Richter Plc. Gyömrői út 19-21. H-1103 Budapest Hungary Ramonna 1,5 mg tableta 1,5 mg Tablet Oral use Spain CHIESI ESPAÑA, S.A. Plaça d'Europa, 41-43 planta 10 08908 L'Hospitalet de Llobregat (Barcelona) Spain Norlevo 750 microgramos comprimidos 0,75 mg Tablet Oral use Spain CHIESI ESPAÑA, S.A. Plaça d'Europa, 41-43 planta 10 08908 L'Hospitalet de Llobregat (Barcelona) Spain Norlevo 1 500 microgramos comprimido 1,5 mg Tablet Oral use Spain Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 1 500 microgramos comprimido 1,5 mg Tablet Oral use Spain Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Iceland Julirona 1,5 mg comprimido EFG 1,5 mg Tablet Oral use Sweden Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 0,75 mg Tablet Oral use Sweden Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 1,5 mg Tablet Oral use Sweden Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Levodonna 1,5 mg Tablet Oral use Sweden Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 1,5 mg Tablet Oral use The Netherlands Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo, tabletten 0,75 mg 0,75 mg Tablet Oral use The Netherlands Laboratoire HRA Pharma 15, rue Béranger FR-75003 Paris France Norlevo 1,5 mg, tabletten 1,5 mg Tablet Oral use The Netherlands Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Postinor 1 500 microgram, tablet 1,5 mg Tablet Oral use The Netherlands Perryment Ltd 42-46 High street Esher, KT10 9QY Surrey United Kingdom Vikela, tabletten 750 microgram 0,75 mg Tablet Oral use United Kingdom Sandoz Limited Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Isteranda 1,5 mg Tablets 1,5 mg Tablet Oral use United Kingdom Gedeon Richter Plc. Gyömröí út 19-21 HU-1103 Budapest Hungary Upostelle 1 500 Microgram Tablets 1,5 mg Tablet Oral use United Kingdom Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Levonelle-2 750 Microgram Tablet 0,75 mg Tablet Oral use United Kingdom Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Levonelle 1 500Microgram Tablet 1,5 mg Tablet Oral use United Kingdom Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom Levonelle One Step 1 500 Microgram Tablet/Boots Emergency Contraceptive 1,5 mg Tablet 1,5 mg Tablet Oral use United Kingdom Laboratorios Leon Farma SA Calle La Vallina S/N Poligono Industrial Navatejera Navatejera, Leon E-24008 Spain Melkine 1,5 mg Tablet 1,5 mg Tablet Oral use

ANNEX IV List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States Member State EU/EEA Marketing authorisation holder Product name INN Strength Pharmaceutical form Animal species Austria Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria Baytril 25 mg/ml — Injektionslösung für Tiere Enrofloxacin 25 mg/ml Solution for injection Dogs, cats, rabbits, rodents (excluded: guinea pigs, hamster), exotic animals (reptiles, avian species), pigs (piglet, pigs < 30 kg bw) Austria Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria Baytril 50 mg/ml — Injektionslösung für Tiere Enrofloxacin 50 mg/ml Solution for injection Dogs, pigs, calves Austria Bayer Austria GmbH Herbststraße 6-10 1160 Wien Austria Baytril 100 mg/ml — Injektionslösung für Rinder und Schweine Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs Belgium Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium Baytril 2,5 % Enrofloxacin 25 mg/ml Solution for injection Cats, dogs Belgium Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium Baytril Piglet Enrofloxacin 25 mg/ml Solution for injection Pigs Belgium Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium Baytril 5 % Enrofloxacin 50 mg/ml Solution for injection Cattle, pigs Belgium Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium Baytril 10 % Enrofloxacin 100 mg/ml Solution for injection Cattle Belgium Bayer SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) Belgium Baytril Swine Enrofloxacin 100 mg/ml Solution for injection Pigs Bulgaria Bayer Animal Health GmbH D-51368 Leverkusen Germany Байтрил 5 % инжективен разтвор Enrofloxacin 50 mg/ml Solution for injection Calves, pigs, dogs Cyprus Bayer Animal Health GmbH D-51368 Leverkusen Germany BAYTRIL INJECTION 5 % Enrofloxacin 50 mg/ml Solution for injection Calves, pigs, dogs Czech Republic BAYER s.r.o. Siemensova 2717/4 155 00 Praha 5 Czech Republic BAYTRIL 2,5 % (w/v) injekční roztok Enrofloxacin 25 mg/ml Solution for injection Dogs, cats Czech Republic BAYER s.r.o. Siemensova 2717/4 155 00 Praha 5 Czech Republic BAYTRIL 5 % (w/v) injekční roztok Enrofloxacin 50 mg/ml Solution for injection Dogs, pigs, calves Denmark Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril Vet. Enrofloxacin 50 mg/ml Solution for injection Dogs, cats, cattle, poultry, pigs Denmark Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril Vet. Enrofloxacin 100 mg/ml Solution for injection Dogs, cats, cattle poultry, pigs Finland Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril 5 % inj. Enrofloxacin 50 mg/ml Solution for injection Cats, dogs, sheep, cattle, pigs, goats Finland Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril 10 % inj. Enrofloxacin 100 mg/ml Solution for injection Sheep, cattle, pigs, goats France Bayer Sante 220 Avenue de la Recherche 59120 Loos France BAYTRIL 2,5 % Enrofloxacin 25 mg/ml Solution for injection Pigs France Bayer Sante 220 Avenue de la Recherche 59120 Loos France BAYTRIL 5 % Enrofloxacin 50 mg/ml Solution for injection Cattle, pigs, dogs France Bayer Sante 220 Avenue de la Recherche 59120 Loos France BAYTRIL 10 % Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany Baytril — Das Original - 2,5 % Injektionslösung für Hunde, Katzen, Schweine und Kaninchen Enrofloxacin 25 mg/ml Solution for injection Pig, rabbits, dogs, cats Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany Baytril — Das Original — 5 % Injektionslösung Enrofloxacin 50 mg/ml Solution for injection Cattle (calves), pigs, dogs Germany Bayer Vital GmbH Kaiser-Wilhelm-Allee D-51373 Leverkusen Germany Baytril — Das Original — 10 % Injektionslösung für Rinder und Schweine Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs Greece Bayer Animal Health GmbH D-51368 Leverkusen Germany BAYTRIL 2,5 % inj.sol Enrofloxacin 25 mg/ml Solution for injection Dogs Greece Bayer Animal Health GmbH D-51368 Leverkusen Germany BAYTRIL 5 % inj.sol Enrofloxacin 50 mg/ml Solution for injection Calves, cattle, pigs, dogs Hungary Bayer Hungária Kft. Alkotás u. 50 1123 Budapest Hungary Baytril 2,5 % injekció A.U.V. Enrofloxacin 25 mg/ml Solution for injection Pigs, rabbit, dogs, cats, exotic animals (mammals, birds, reptiles) Hungary Bayer Hungária Kft. Alkotás u. 50 1123 Budapest Hungary Baytril 5 % injekció A.U.V. Enrofloxacin 50 mg/ml Solution for injection Cattle, pigs, dogs Hungary Bayer Hungária Kft. Alkotás u. 50 1123 Budapest Hungary Baytril 10 % injekció A.U.V. Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs Iceland Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril vet Enrofloxacin 50 mg/ml Solution for injection Calves, pigs, poultry, dogs, cats Iceland Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril vet Enrofloxacin 100 mg/ml Solution for injection Calves, pigs, poultry, dogs, cats Ireland Bayer Limited Animal Health Division The Atrium Blackthorn Road Dublin 18 Ireland Baytril 2,5 % Solution for Injection Enrofloxacin 25 mg/ml Solution for injection Dogs, cats, exotic animals (small mammals, reptiles and avian species) Ireland Bayer Limited Animal Health Division The Atrium Blackthorn Road Dublin 18 Ireland Baytril 5 % Solution for Injection Enrofloxacin 50 mg/ml Solution for injection Cattle, pigs, dogs, cats Ireland Bayer Limited Animal Health Division The Atrium Blackthorn Road Dublin 18 Ireland Baytril 10 % Solution for Injection Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs Italy Bayer S.p.A. Viale Certosa, 130 20156 Milano Italy Baytril Enrofloxacin 25 mg/ml and 50 mg/ml Solution for injection Cattle, dogs, sheep, goats, cats, rabbits, pigs Italy Bayer S.p.A. Viale Certosa, 130 20156 Milano Italy Baytril 10 % Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs, sheep, goats Norway Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril vet Enrofloxacin 25 mg/ml Solution for injection Pigs, cattle, dogs, cats Norway Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril vet Enrofloxacin 100 mg/ml Solution for injection Pigs, cattle, dogs, cats Poland Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril 2,5 % inj., 25 mg/ml roztwór do wstrzykiwań dla psów i kotów Enrofloxacin 25 mg/ml Solution for injection Dogs, cats Poland Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril 5 % inj., enrofloksacyna 50 mg/ml, roztwór do wstrzykiwań dla bydła i świń Enrofloxacin 50 mg/ml Solution for injection Cattle, pigs Portugal Bayer Portugal S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal BAYTRIL 2,5 % solução injectável Enrofloxacin 25 mg/ml Solution for injection Dogs, cats Portugal Bayer Portugal S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal Baytril 5 % solução injectável Enrofloxacin 50 mg/ml Solution for injection Dogs, cattle, pigs Portugal Bayer Portugal S.A. Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal Baytril 10 % solução injectável Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs Romania Bayer Health Care AG D-51368 Leverkusen Germany Baytril 5 % Enrofloxacin 50 mg/ml solution for injection Calves, pigs, dogs Romania Bayer Health Care AG D-51368 Leverkusen Germany Baytril 10 % Enrofloxacin 100 mg/ml solution for injection Cattle, pigs Slovakia Bayer s.r.o. Litvínovská 609/3 190 21 Praha 9 Czech Republic Baytril 2,5 % Enrofloxacin 25 mg/ml Solution for injection Dogs, cats Slovakia Bayer s.r.o. Litvínovská 609/3 190 21 Praha 9 Czech Republic Baytril 5 % Enrofloxacin 50 mg/ml Solution for injection Dogs, pigs, calves Slovenia Bayer d.o.o. Bravničarjeva 13 Ljubljana Slovenia Baytril® 5 % raztopina za injiciranje Enrofloxacin 50 mg/ml Solution for injection Calves, pigs, dogs Slovenia Bayer d.o.o. Bravničarjeva 13 Ljubljana Slovenia Baytril® 10 % raztopina za injiciranje Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs Spain Bayer Hispania S.L. Avda Baix LLObregat, 3-5 08970, Saint Joan Despí Barcelona Spain Baytril 2,5 % solución inyectable Enrofloxacin 25 mg/ml Solution for injection Dogs, cats and other exotic species (rodents, rabbits, cage birds and reptiles (snakes, turtles and iguana)) Spain Bayer Hispania S.L. Avda Baix LLObregat, 3-5 08970, Saint Joan Despí Barcelona Spain Baytril 5 % solución inyectable Enrofloxacin 50 mg/ml Solution for injection Dogs, cattle, pigs Spain Bayer Hispania S.L. Avda Baix LLObregat, 3-5 08970, Saint Joan Despí Barcelona Spain Baytril 10 % solución inyectable Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs Sweden Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril®vet Enrofloxacin 25 mg/ml Solution for injection Dogs, pigs, cattle, cats Sweden Bayer Animal Health GmbH D-51368 Leverkusen Germany Baytril®vet Enrofloxacin 100 mg/ml Solution for injection Dogs, pigs, cattle, cats The Netherlands Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands Baytril Piglet 25 mg/ml inspuitbare oplossing Enrofloxacin 25 mg/ml Solution for injection Pigs The Netherlands Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands BAYTRIL 2,5 % INJEKTIEVLOEISTOF Enrofloxacin 25 mg/ml Solution for injection Dogs, cats The Netherlands Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands BAYTRIL 5 % INJECTIEOPLOSSING Enrofloxacin 50 mg/ml Solution for injection Cattle, pigs, dogs The Netherlands Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands BAYTRIL 5 % INJEKTIEVLOEISTOF Enrofloxacin 50 mg/ml Solution for injection Cattle, pigs, dogs The Netherlands Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands BAYTRIL 10 % INJECTIEOPLOSSING Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs The Netherlands Bayer BV Energieweg 1 3641 RT Mijdrecht The Netherlands BAYTRIL INJEKTIEVLOEISTOF 10 % Enrofloxacin 100 mg/ml Solution for injection Pigs, cattle United Kingdom Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA United Kingdom Baytril 2,5 % Solution for Injection Enrofloxacin 25 mg/ml Solution for injection Dogs, cats and exotic animals (small mammals, reptiles and avian species) United Kingdom Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA United Kingdom Baytril 5 % Solution for Injection Enrofloxacin 50 mg/ml Solution for injection Cattle, pigs, dogs, cats United Kingdom Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury, Berkshire RG14 1JA United Kingdom Baytril 10 % Solution for Injection Enrofloxacin 100 mg/ml Solution for injection Cattle, pigs