EN Official Journal of the European Union C 146/15

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2009 to 31 May 2009

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

2009/C 146/04

— 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 5.5.2009 Unisol 10 % Oral Solution See Annex I See Annex I 6.5.2009 5.5.2009 Enro-K 10 % Oral Solution See Annex II See Annex II 6.5.2009 7.5.2009 Budesonide Sandoz See Annex III See Annex III 8.5.2009 11.5.2009 Atifor Chiesi 12 mcg See Annex IV See Annex IV 12.5.2009 11.5.2009 Forair Chiesi 12 mcg See Annex V See Annex V 12.5.2009 15.5.2009 Qutenza NeurogesX UK Limited 265 Strand London WC2R 1BH UNITED KINGDOM This Decision is addressed to the Member States 18.5.2009 27.5.2009 Methylphenidate See Annex VI See Annex VI 28.5.2009 28.5.2009 Soliris Alexion Europe SAS 54-56 Avenue Hoche 75008 Paris FRANCE This Decision is addressed to the Member States 2.6.2009 29.5.2009 GLUSCAN 500 See Annex VII See Annex VII 2.6.2009

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

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

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES Member State Applicant Invented name Pharmaceutical form Strength Animal species Recommended dose Belgium Universal Farma, S.L. Gran Vía Carlos III, 98 — 7a 08028 Barcelona SPAIN Unisol 10 % Oral solution Oral solution 100 mg/ml Chickens and turkeys 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. The treatment should continue for a minimum of 3 days. For the treatment of salmonellosis treatment should be extended to 5 days. Czech Republic Universal Farma, S.L. Gran Vía Carlos III, 98 — 7a 08028 Barcelona SPAIN Unisol 10 % Oral solution Oral solution 100 mg/ml Chickens and turkeys 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. The treatment should continue for a minimum of 3 days. For the treatment of salmonellosis treatment should be extended to 5 days. Germany Universal Farma, S.L. Gran Vía Carlos III, 98 — 7a 08028 Barcelona SPAIN Unisol 10 % Oral solution Oral solution 100 mg/ml Chickens and turkeys 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. The treatment should continue for a minimum of 3 days. For the treatment of salmonellosis treatment should be extended to 5 days. Ireland Universal Farma, S.L. Gran Vía Carlos III, 98 — 7a 08028 Barcelona SPAIN Unisol 10 % Oral solution Oral solution 100 mg/ml Chickens and turkeys 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. The treatment should continue for a minimum of 3 days. For the treatment of salmonellosis treatment should be extended to 5 days. Poland Universal Farma, S.L. Gran Vía Carlos III, 98 — 7a 08028 Barcelona SPAIN Unisol 10 % Oral solution Oral solution 100 mg/ml Chickens and turkeys 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. The treatment should continue for a minimum of 3 days. For the treatment of salmonellosis treatment should be extended to 5 days.

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES Member State Applicant Invented name Pharmaceutical form Strength Animal species Recommended dose Belgium Laboratorios Karizoo S.A. Mas Pujades 11-12 Pol. Ind. La Borda 08140 Caldes de Montbui SPAIN Enro-K 10 % Oral Solution Oral solution 100 mg/ml Chickens and turkeys 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. The treatment should continue for a minimum of 3 days. For the treatment of salmonellosis treatment should be extended to 5 days. Czech Republic Laboratorios Karizoo S.A. Mas Pujades 11-12 Pol. Ind. La Borda 08140 Caldes de Montbui SPAIN Enro-K 10 % Oral Solution Oral solution 100 mg/ml Chickens and turkeys 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. The treatment should continue for a minimum of 3 days. For the treatment of salmonellosis treatment should be extended to 5 days. Germany Laboratorios Karizoo S.A. Mas Pujades 11-12 Pol. Ind. La Borda 08140 Caldes de Montbui SPAIN Enro-K 10 % Oral Solution Oral solution 100 mg/ml Chickens and turkeys 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. The treatment should continue for a minimum of 3 days. For the treatment of salmonellosis treatment should be extended to 5 days. Ireland Laboratorios Karizoo S.A. Mas Pujades 11-12 Pol. Ind. La Borda 08140 Caldes de Montbui SPAIN Enro-K 10 % Oral Solution Oral solution 100 mg/ml Chickens and turkeys 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. The treatment should continue for a minimum of 3 days. For the treatment of salmonellosis treatment should be extended to 5 days. Poland Laboratorios Karizoo S.A. Mas Pujades 11-12 Pol. Ind. La Borda 08140 Caldes de Montbui SPAIN Enro-K 10 % Oral Solution Oral solution 100 mg/ml Chickens and turkeys 50 ml of product per 100 litres water or 10 mg of the active ingredient per kg bodyweight per day. The treatment should continue for a minimum of 3 days. For the treatment of salmonellosis treatment should be extended to 5 days.

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES Member State EU/EEA Marketing Authorisation Holder Applicant (Invented) Name Strength Pharmaceutical Form Route of administration Content (concentration) Czech Republic Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 83607 Holzkirchen GERMANY Tafen Aqua 32 μg nosní spray Tafen Aqua 64 μg nosní spray 32 mcg/dose 64 mcg/dose Nasalspray, suspension Nasal use 0,64 mg/ml 1,28 mg/ml Denmark Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 83607 Holzkirchen GERMANY Budesonid Sandoz 32 mcg/dose 64 mcg/dose Nasalspray, suspension Nasal use 0,64 mg/ml 1,28 mg/ml France Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 83607 Holzkirchen GERMANY BUDESONIDE SANDOZ 64 μg/dose, suspension pour pulvérisation nasale 64 mcg/dose Nasalspray, suspension Nasal use 1,28 mg/ml Germany Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 83607 Holzkirchen GERMANY Budesonid Sandoz 32 Mikrogramm/Sprühstoß Nasenspray, Suspension Budesonid Sandoz 64 Mikrogramm/Sprühstoß Nasenspray, Suspension 32 mcg/dose 64 mcg/dose Nasalspray, suspension Nasal use 0,64 mg/ml 1,28 mg/ml Netherlands Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 83607 Holzkirchen GERMANY Budesonide Sandoz 32 microgram/dosis, neusspray, suspensie Budesonide Sandoz 64 microgram/dosis, neusspray, suspensie 32 mcg/dose 64 mcg/dose Nasalspray, suspension Nasal use 0,64 mg/ml 1,28 mg/ml Norway Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 83607 Holzkirchen GERMANY Budesonid Sandoz 32 mcg/dose 64 mcg/dose Nasalspray, suspension Nasal use 0,64 mg/ml 1,28 mg/ml Poland Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 83607 Holzkirchen GERMANY Tafen Nasal 32 Tafen Nasal 64 32 mcg/dose 64 mcg/dose Nasalspray, suspension Nasal use 0,64 mg/ml 1,28 mg/ml Sweden Sandoz A/S C.F. Tietgens Boulevard 40 5220 Odense SØ DANMARK Desonix 32 mcg/dose 64 mcg/dose Nasalspray, suspension Nasal use 0,64 mg/ml 1,28 mg/ml United Kingdom Sandoz B.V. Veluwezoom 22 1327 AH Almere NETHERLANDS Budesonide Aqua 64 micrograms Nasal Spray 32 mcg/dose 64 mcg/dose Nasalspray, suspension Nasal use 1,28 mg/ml

ANNEX IV LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Atifor chiesi 12 mcg and associated names with marketing authorisation in the European Union Member State (EU/EEA) Marketing Authorisation Holder Invented Name Strength Pharmaceutical Form Route of administration Austria Novartis Pharma GmBH Brunner Strasse 59 1235 Wien AUSTRIA FORADIL 12 mcg/actuation Pressurised inhalation, solution Inhalation use Belgium Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use Czech Republic Torrex Chiesi Pharma s.r.o. CZ Na Kvetnici 33 140 00 Praha 4 CZECH REPUBLIC ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use Estonia Torrex Chiesi Pharma GmbH Gonzagagasse 16/16 1010 Vienna AUSTRIA ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use France Chiesi S.A. Immeuble le Doublon 11 Avenue Dubonnet 92400 Courbevoie FRANCE ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use Germany Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY ATIFOR CHIESI 12 mcg/actuation Pressurised inhalation, solution Inhalation use Greece Novartis (Hellas) S.A.C.I. 12 klm National Road No 1 Athens-Lamia 14453 – Metamorphosis GREECE FORADIL 12 mcg/actuation Pressurised inhalation, solution Inhalation use Hungary Torrex Chiesi Kft. Kristóf tér 4. 1052 Budapest HUNGARY ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use Latvia Torrex Chiesi Pharma GmbH Gonzagagasse 16/16 1010 Vienna AUSTRIA ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use Lithuania Torrex Chiesi Pharma GmbH Gonzagagasse 16/16 1010 Vienna AUSTRIA ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use Poland Torrex Chiesi Polska Sp. z o.o. ul. Biala 3 00-895 Warszawa POLAND ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use Portugal Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use Slovakia Torrex Chiesi Slovakia s.r.o. Sulekova 14 811 06 Bratislava SLOVAK REPUBLIC ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use Slovenia Torrex Chiesi Slovenija, d.o.o. Trdinova ulica 4 1000 Ljubljana SLOVENIJA ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use Spain Chiesi España S.A. Berlín 38-48 7a planta 08029 Barcelona SPAIN BRONCORAL NEO 12 mcg/actuation Pressurised inhalation, solution Inhalation use The Netherlands Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY ATIMOS 12 mcg/actuation Pressurised inhalation, solution Inhalation use United Kingdom Trinity-Chiesi Pharmaceuticals Ltd. Cheadle Royal Business Park Highfield, Cheadle SK8 3GY UNITED KINGDOM ATIMOS MODULITE 12 mcg/actuation Pressurised inhalation, solution Inhalation use

ANNEX V LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Forair Chiesi 12 mcg and associated names with marketing authorisation in the European Union Member State (EU/EAA) Marketing Authorisation Holder Invented Name Strength Pharmaceutical Form Route of administration Austria Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY FORAIR 12 mcg/actuation Pressurised inhalation, solution Inhalation use Belgium Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY FORMOAIR 12 mcg/actuation Pressurised inhalation, solution Inhalation use Czech Republic Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY FORAIR 12 mcg/actuation Pressurised inhalation, solution Inhalation use Denmark Novartis Healthcare A/S Lyngbyvej 172 2100 Copenhagen DENMARK FORADIL HFA 12 mcg/actuation Pressurised inhalation, solution Inhalation use France Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY FORMOAIR 12 mcg/actuation Pressurised inhalation, solution Inhalation use Germany Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY FORAIR CHIESI 12 mcg/actuation Pressurised inhalation, solution Inhalation use Greece Chiesi Hellas S.A. Anapafseos 30 15235 Vrilissia, Athens GREECE FORAIR 12 mcg/actuation Pressurised inhalation, solution Inhalation use Hungary Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY FORAIR 12 mcg/actuation Pressurised inhalation, solution Inhalation use Portugal Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY FORAIR 12 mcg/actuation Pressurised inhalation, solution Inhalation use Spain Novartis Faramceutica S.A. Apartado 708 08080 Barcelona SPAIN FORADIL NEO 12 mcg/actuation Pressurised inhalation, solution Inhalation use Slovakia Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY FORAIR 12 mcg/actuation Pressurised inhalation, solution Inhalation use The Netherlands Novartis Pharma B.V. Postbus 241 6800 LZ Arnhem NETHERLANDS FORADIL 12 mcg/actuation Pressurised inhalation, solution Inhalation use United Kingdom Chiesi Farmaceutici S.p.A. Via Palermo 26/A 43100 Parma ITALY FORAIR MODULITE 12 mcg/actuation Pressurised inhalation, solution Inhalation use

ANNEX VI LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA) Marketing authorisations for medicinal products containing methylphenidate Member State (EU/EEA) Marketing Authorisation Holder Invented Name Strength Pharmaceutical form Route of administration Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 1232 Wien AUSTRIA Concerta 18 mg Retardtabletten 18 mg Prolonged-release tablet Oral use Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 1232 Wien AUSTRIA Concerta 36 mg Retardtabletten 36 mg Prolonged-release tablet Oral use Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 1232 Wien AUSTRIA Concerta 54 mg Retardtabletten 54 mg Prolonged-release tablet Oral use Austria Janssen-Cilag Pharma GmbH Pfarrgasse 75 1232 Wien AUSTRIA Concerta 27 mg Retardtabletten 27 mg Prolonged-release tablet Oral use Austria UCB Pharma GmbH Jaquingasse 16-18/3 1030 Wien AUSTRIA Equasym retard 10 mg - Hartkapseln mit veränderter Wirkstofffreisetzung 10 mg Modified-release capsule, hard Oral use Austria UCB Pharma GmbH Jaquingasse 16-18/3 1030 Wien AUSTRIA Equasym retard 20 mg - Hartkapseln mit veränderter Wirkstofffreisetzung 20 mg Modified-release capsule, hard Oral use Austria UCB Pharma GmbH Jaquingasse 16-18/3 1030 Wien AUSTRIA Equasym retard 30 mg - Hartkapseln mit veränderter Wirkstofffreisetzung 30 mg Modified-release capsule, hard Oral use Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 10 mg - retardierte Hartkapseln 10 mg Prolonged-release capsule, hard Oral use Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 20 mg - retardierte Hartkapseln 20 mg Prolonged-release capsule, hard Oral use Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 30 mg - retardierte Hartkapseln 30 mg Prolonged-release capsule, hard Oral use Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 40 mg - retardierte Hartkapseln 40 mg Prolonged-release capsule, hard Oral use Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 5 mg - Tabletten 5 mg Tablet Oral use Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 10 mg - Tabletten 10 mg Tablet Oral use Austria Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 20 mg - Tabletten 20 mg Tablet Oral use Austria Novartis Pharma GmbH Brunner Straße 59 1235 Wien AUSTRIA Ritalin LA 20 mg - Kapseln 20 mg Modified-release capsule, hard Oral use Austria Novartis Pharma GmbH Brunner Straße 59 1235 Wien AUSTRIA Ritalin LA 30 mg - Kapseln 30 mg Modified-release capsule, hard Oral use Austria Novartis Pharma GmbH Brunner Straße 59 1235 Wien AUSTRIA Ritalin LA 40 mg - Kapseln 40 mg Modified-release capsule, hard Oral use Austria Novartis Pharma GmbH Brunner Straße 59 1235 Wien AUSTRIA Ritalin 10 mg - Tabletten 10 mg Tablet Oral use Austria Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert 08755 Castellbisbal (Barcelona) SPAIN RUBIFEN 5 mg - Tabletten 5 mg Tablet Oral use Austria Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert 08755 Castellbisbal (Barcelona) SPAIN RUBIFEN 10 mg - Tabletten 10 mg Tablet Oral use Austria Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert 08755 Castellbisbal (Barcelona) SPAIN RUBIFEN 20 mg - Tabletten 20 mg Tablet Oral use Belgium JANSSEN CILAG N.V. Roderveldlaan 1 2600 Berchem BELGIUM CONCERTA 18 mg 18 mg Prolonged-release tablet Oral use Belgium JANSSEN CILAG N.V. Roderveldlaan 1 2600 Berchem BELGIUM CONCERTA 36 mg 36 mg Prolonged-release tablet Oral use Belgium JANSSEN CILAG N.V. Roderveldlaan 1 2600 Berchem BELGIUM CONCERTA 54 mg 54 mg Prolonged-release tablet Oral use Belgium JANSSEN CILAG N.V. Roderveldlaan 1 2600 Berchem BELGIUM CONCERTA 27 mg 27 mg Prolonged-release tablet Oral use Belgium NOVARTIS PHARMA N.V. Medialaan 40 1800 Vilvoorde BELGIUM RILATINE 10 mg Tablet Oral use Belgium NOVARTIS PHARMA N.V. Medialaan 40 1800 Vilvoorde BELGIUM RILATINE MODIFIED RELEASE 20 mg 20 mg Modified-release capsule, hard Oral use Belgium NOVARTIS PHARMA N.V. Medialaan 40 1800 Vilvoorde BELGIUM RILATINE MODIFIED RELEASE 30 mg 30 mg Modified-release capsule, hard Oral use Belgium NOVARTIS PHARMA N.V. Medialaan 40 1800 Vilvoorde BELGIUM RILATINE MODIFIED RELEASE 40 mg 40 mg Modified-release capsule, hard Oral use Bulgaria Johnson & Johnson D.O.O. Smartinska 53 SI-1000 Ljubljana SLOVENIA Concerta 36 mg Prolonged-release tablet Oral use Bulgaria Johnson & Johnson D.O.O. Smartinska 53 SI-1000 Ljubljana SLOVENIA Concerta 18 mg Prolonged-release tablet Oral use Bulgaria Johnson & Johnson D.O.O. Smartinska 53 SI-1000 Ljubljana SLOVENIA Concerta 54 mg Prolonged-release tablet Oral use Cyprus Janssen-Cilag International N.V. Turnhoutseweg 30 2340 Beerse BELGIUM Concerta 18 mg Prolonged-release tablet Oral use Cyprus Janssen-Cilag International N.V. Turnhoutseweg 30 2340 Beerse BELGIUM Concerta 36 mg Prolonged-release tablet Oral use Cyprus Janssen-Cilag International N.V. Turnhoutseweg 30 2340 Beerse BELGIUM Concerta 54 mg Prolonged-release tablet Oral use Czech Republic Novartis s.r.o. Nagano III. U Nákladového nádraží 10 13000 Praha 3 CZECH REPUBLIC RITALIN 10 mg Tablet Oral use Czech Republic Janssen-Cilag s.r.o. Karla Engliše 3201/6 15000 Praha 5 — Smíchov CZECH REPUBLIC CONCERTA 18 mg 18 mg Prolonged-release tablet Oral use Czech Republic Janssen-Cilag s.r.o. Karla Engliše 3201/6 15000 Praha 5 — Smíchov CZECH REPUBLIC CONCERTA 36 mg 36 mg Prolonged-release tablet Oral use Czech Republic Janssen-Cilag s.r.o. Karla Engliše 3201/6 15000 Praha 5 — Smíchov CZECH REPUBLIC CONCERTA 54 mg 54 mg Prolonged-release tablet Oral use Denmark Janssen-Cilag A/S Hammerbakken 19 3460 Birkerød DENMARK CONCERTA 18 mg Prolonged-release tablet Oral use Denmark Janssen-Cilag A/S Hammerbakken 19 3460 Birkerød DENMARK CONCERTA 36 mg Prolonged-release tablet Oral use Denmark Janssen-Cilag A/S Hammerbakken 19 3460 Birkerød DENMARK CONCERTA 54 mg Prolonged-release tablet Oral use Denmark UCB Nordic A/S Arne Jacobsen Allé 15 2300 Kobenhavn S DENMARK Equasym 5 mg Tablets Oral Denmark UCB Nordic A/S Arne Jacobsen Allé 15 2300 Kobenhavn S DENMARK Equasym 10 mg Tablets Oral Denmark UCB Nordic A/S Arne Jacobsen Allé 15 2300 Kobenhavn S DENMARK Equasym 20 mg Tablets Oral Denmark UCB Nordic A/S Arne Jacobsen Allé 15 2300 Kobenhavn S DENMARK Equasym Depot 10, 20, 30 mg Modified-release capsules, hard Oral Denmark Medice Arzneimittle Kuhloweg 37-39 Iserlohn GERMANY Medikinet 5, 10, 20 mg Tablets Oral Denmark Medice Arzneimittle Kuhloweg 37-39 Iserlohn GERMANY Medikinet CR 10, 20, 30, 40 mg Hard capsules, modified release Oral Denmark Sandoz A/S C.F. Tietgens Boulevard 40 5220 Odense SØ DENMARK Motiron 5, 10, 20 mg Tablets Oral Denmark Novartis Healthcare Lyngbyvej 172 2100 Københarn Ø DENMARK Ritalin 10 mg Tablets Oral Denmark Novartis Healthcare Lyngbyvej 172 2100 Københarn Ø DENMARK Ritalin Uno 20, 30, 40 mg Hard capsules, modified release Oral Spain Laboratorios RUBIO, SA Industria 29 — Polígono industrial Comte de Sert 08755 Castellbisbal SPAIN RUBIFEN 10 mg comprimidos 10 mg Tablets Oral use Spain Laboratorios RUBIO, SA Industria 29 — Polígono industrial Comte de Sert 08755 Castellbisbal SPAIN RUBIFEN 20 mg comprimidos 20 mg Tablets Oral use Spain Laboratorios RUBIO, SA Industria 29 — Polígono industrial Comte de Sert 08755 Castellbisbal SPAIN RUBIFEN 5 mg comprimidos 5 mg Tablets Oral use Spain JANSSEN CILAG, SA Paseo de las doce estrellas, 5-7 28042 Madrid SPAIN CONCERTA 27 mg comprimidos de liberación prolongada 27 mg Prolonged-release tablet Oral use Spain JANSSEN CILAG, SA Paseo de las doce estrellas, 5-7 28042 Madrid SPAIN CONCERTA 36 mg comprimidos de liberación prolongada 36 mg Prolonged-release tablet Oral use Spain JANSSEN CILAG, SA Paseo de las doce estrellas, 5-7 28042 Madrid SPAIN CONCERTA 54 mg comprimidos de liberación prolongada 54 mg Prolonged-release tablet Oral use Spain JANSSEN CILAG, SA Paseo de las doce estrellas, 5-7 28042 Madrid SPAIN CONCERTA 18 mg comprimidos de liberación prolongada 18 mg Prolonged-release tablet Oral use Spain Laboratorios RUBIO, SA Industria 29 — Polígono industrial Comte de Sert 08755 Castellbisbal SPAIN OMOZIN 5 mg comprimidos 5 mg Tablets Oral use Spain Laboratorios RUBIO, SA Industria 29 — Polígono industrial Comte de Sert 08755 Castellbisbal SPAIN OMOZIN 10 mg comprimidos 10 mg Tablets Oral use Spain Laboratorios RUBIO, SA Industria 29 — Polígono industrial Comte de Sert 08755 Castellbisbal SPAIN OMOZIN 20 mg comprimidos 20 mg Tablets Oral use Spain Medice Arznemitel Putter GmbH Kuhloweg 37 58638 Iselohon GERMANY MEDIKINET 5 mg comprimidos 5 mg Tablets Oral use Spain Medice Arznemitel Putter GmbH Kuhloweg 37 58638 Iselohon GERMANY MEDIKINET 10 mg comprimidos 10 mg Tablets Oral use Spain Medice Arznemitel Putter GmbH Kuhloweg 37 58638 Iselohon GERMANY MEDIKINET 20 mg comprimidos 20 mg Tablets Oral use Spain Medice Arznemitel Putter GmbH Kuhloweg 37 58638 Iselohon GERMANY MEDIKINET 10 mg cápsulas de liberación prolongada 10 mg Prolonged-release tablets Oral use Spain Medice Arznemitel Putter GmbH Kuhloweg 37 58638 Iselohon GERMANY MEDIKINET 20 mg cápsulas de liberación prolongada 20 mg Prolonged-release tablets Oral use Spain Medice Arznemitel Putter GmbH Kuhloweg 37 58638 Iselohon GERMANY MEDIKINET 30 mg cápsulas de liberación prolongada 30 mg Prolonged-release tablets Oral use Spain Medice Arznemitel Putter GmbH Kuhloweg 37 58638 Iselohon GERMANY MEDIKINET 40 mg cápsulas de liberación prolongada 40 mg Prolonged-release tablets Oral use Estonia Johnson & Johnson UAB Geležinio Vilko g. 18A LT-08104 Vilnius LITHUANIA CONCERTA 18 mg Prolonged-release tablet Oral use Estonia Johnson & Johnson UAB Geležinio Vilko g. 18A LT-08104 Vilnius LITHUANIA CONCERTA 36 mg Prolonged-release tablet Oral use Estonia Johnson & Johnson UAB Geležinio Vilko g. 18A LT-08104 Vilnius LITHUANIA CONCERTA 54 mg Prolonged-release tablet Oral use Finland Janssen-Cilag Oy Metsänneidonkuja 8 FI-02130 Espoo FINLAND Concerta 18 mg Prolonged-release tablet Oral Finland Janssen-Cilag Oy Metsänneidonkuja 8 FI-02130 Espoo FINLAND Concerta 27 mg Prolonged-release tablet Oral Finland Janssen-Cilag Oy Metsänneidonkuja 8 FI-02130 Espoo FINLAND Concerta 36 mg Prolonged-release tablet Oral Finland Janssen-Cilag Oy Metsänneidonkuja 8 FI-02130 Espoo FINLAND Concerta 54 mg Prolonged-release tablet Oral Finland UCB Pharma Oy Finland Malminkaari 5 FI-00700 Helsinki FINLAND Equasym Retard 10 mg Modified-release capsule, hard Oral Finland UCB Pharma Oy Finland Malminkaari 5 FI-00700 Helsinki FINLAND Equasym Retard 20 mg Modified-release capsule, hard Oral Finland UCB Pharma Oy Finland Malminkaari 5 FI-00700 Helsinki FINLAND Equasym Retard 30 mg Modified-release capsule, hard Oral Finland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 5 mg Tablet Oral Finland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 10 mg Tablet Oral Finland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 20 mg Tablet Oral Finland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 10 mg Prolonged-release capsule, hard Oral Finland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 20 mg Prolonged-release capsule, hard Oral Finland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 30 mg Prolonged-release capsule, hard Oral Finland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 40 mg Prolonged-release capsule, hard Oral France JANSSEN CILAG S.A. 1 rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux Cedex 9 FRANCE CONCERTA LP 18 mg Prolonged-release tablet Oral France JANSSEN CILAG S.A. 1 rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux Cedex 9 FRANCE CONCERTA LP 27 mg Prolonged-release tablet Oral France JANSSEN CILAG S.A. 1 rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux Cedex 9 FRANCE CONCERTA LP 36 mg Prolonged-release tablet Oral France JANSSEN CILAG S.A. 1 rue Camille Desmoulins TSA 91003 92787 Issy-les-Moulineaux Cedex 9 FRANCE CONCERTA LP 54 mg Prolonged-release tablet Oral France Laboratorios RUBIO SA c/ Industria 29, Pol.Ind.Comte de Sert 08755 Castellbisbal Barcelona SPAIN METHYLPHENIDATE RUBIO 10 mg Tablet Oral France Laboratorios RUBIO SA c/ Industria 29, Pol.Ind.Comte de Sert 08755 Castellbisbal Barcelona SPAIN METHYLPHENIDATE RUBIO 20 mg Tablet Oral France Laboratorios RUBIO SA c/ Industria 29, Pol.Ind.Comte de Sert 08755 Castellbisbal Barcelona SPAIN METHYLPHENIDATE RUBIO 5 mg Tablet Oral France UCB PHARMA S.A. 21 rue de Neuilly BP 314 92003 Nanterre FRANCE QUASYM L.P. 10 mg, GELULE A LIBERATION MODIFIÉE 10 mg Modified-release capsule, hard Oral France UCB PHARMA S.A. 21 rue de Neuilly BP 314 92003 Nanterre FRANCE QUASYM L.P. 20 mg, GELULE A LIBERATION MODIFIÉE 20 mg Modified-release capsule, hard Oral France UCB PHARMA S.A. 21 rue de Neuilly BP 314 92003 Nanterre FRANCE QUASYM L.P. 30 mg, GELULE A LIBERATION MODIFIÉE 30 mg Modified-release capsule, hard Oral France NOVARTIS PHARMA SAS 2-4 rue Lionel Terray 92500 Rueil-Malmaison FRANCE RITALINE 10 mg Tablet Oral France NOVARTIS PHARMA SAS 2-4 rue Lionel Terray 92500 Rueil-Malmaison FRANCE RITALINE L.P. 20 mg Modified-release capsule Oral France NOVARTIS PHARMA SAS 2-4 rue Lionel Terray 92500 Rueil-Malmaison FRANCE RITALINE L.P. 30 mg Modified-release capsule Oral France NOVARTIS PHARMA SAS 2-4 rue Lionel Terray 92500 Rueil-Malmaison FRANCE RITALINE L.P. 40 mg Modified-release capsule Oral Hungary JANSSEN-CILAG Kft. Törökbálint Tó Park 2045 HUNGARY CONCERTA 18 mg 18 mg Retard tablet Oral Hungary JANSSEN-CILAG Kft. Törökbálint Tó Park 2045 HUNGARY CONCERTA 36 mg 36 mg Retard tablet Oral Hungary JANSSEN-CILAG Kft. Törökbálint Tó Park 2045 HUNGARY CONCERTA 54 mg 54 mg Retard tablet Oral Hungary Novartis Hungária Kft. Pharma Budapest Bartók Béla út 43-47 1114 HUNGARY RITALIN 10 mg Tablet Oral Hungary Novartis Hungária Kft. Pharma Budapest Bartók Béla út 43-47 1114 HUNGARY RITALIN 20 mg Prolonged-release capsules Oral Hungary Novartis Hungária Kft. Pharma Budapest Bartók Béla út 43-47 1114 HUNGARY RITALIN 30 mg Prolonged-release capsules Oral Hungary Novartis Hungária Kft.Pharma Budapest Bartók Béla út 43-47 1114 HUNGARY RITALIN 40 mg Prolonged-release capsules Oral Ireland Novartis Pharmaceuticals UK Ltd Frimley Business Park, Frimley Camberley GU16 7SR UNITED KINGDOM Ritalin 10 mg Tablet Oral Ireland Novartis Pharmaceuticals UK Ltd Frimley Business Park, Frimley Camberley GU16 7SR UNITED KINGDOM Ritalin LA 20 mg, 30 mg, 40 mg Capsules modified release Oral Ireland Janssen-Cilag Ltd Saunderton High Wycombe Buckinghamshire HP14 4HJ UNITED KINGDOM Concerta XL 18 mg, 27 mg, 36 mg, 54 mg Prolonged-release tablet Oral Ireland Ratiopharm GmbH Graf-Arco-Straße 3 GERMANY Equasym 5 mg, 10 mg, 20 mg Tablets Oral Ireland Ratiopharm GmbH Graf-Arco-Straße 3 GERMANY Equasym XL 10 mg, 20 mg, 30 mg Capsules modified release Oral Ireland UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road Dublin 24 IRELAND Equasym 5 mg tablets 5 mg Tablets Oral Ireland UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road Dublin 24 IRELAND Equasym 10 mg tablets 10 mg Tablets Oral Ireland UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road Dublin 24 IRELAND Equasym 20 mg tablets 30 mg Tablets Oral Ireland UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road Dublin 24 IRELAND Equasym XL 10 mg Modified-release capsules, hard 10 mg Modified-release capsules, hard Oral Ireland UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road Dublin 24 IRELAND Equasym XL 20 mg Modified-release capsules, hard 20 mg Modified-release capsules, hard Oral Ireland UCB (Pharma) Ireland Ltd Magna Drive, Magna Business Park Citywest Road Dublin 24 IRELAND Equasym XL 30 mg Modified-release capsules, hard 30 mg Modified-release capsules, hard Oral Latvia UAB Johnson & Johnson Geležinio Vilko g. 18A LT-08104 Vilnius LITHUANIA CONCERTA 18 mg Prolonged-release tablet Oral use Latvia UAB Johnson & Johnson Geležinio Vilko g. 18A LT-08104 Vilnius LITHUANIA CONCERTA 36 mg Prolonged-release tablet Oral use Latvia UAB Johnson & Johnson Geležinio Vilko g. 18A LT-08104 Vilnius LITHUANIA CONCERTA 54 mg Prolonged-release tablet Oral use Latvia Novartis Finland Oy Metsanneidonkuja 10 FI-02130 Espoo FINLAND Ritalin 10 mg 10 mg Tablets Oral Lithuania UAB ‘Johnson & Johnson’ Geležinio Vilko g. 18A LT-08104 Vilnius LITHUANIA CONCERTA 18 mg Prolonged-release tablet Oral use Lithuania UAB ‘Johnson & Johnson’ Geležinio Vilko g. 18A LT-08104 Vilnius LITHUANIA CONCERTA 36 mg Prolonged-release tablet Oral use Lithuania UAB ‘Johnson & Johnson’ Geležinio Vilko g. 18A LT-08104 Vilnius LITHUANIA CONCERTA 54 mg Prolonged-release tablet Oral use Italy Janssen-Cilag SpA via M. Buonarroti 23 20093 Cologno Monzese MI ITALY CONCERTA 18 mg, 36 mg, 54 mg Prolonged-release tablet Oral Portugal Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena PORTUGAL Concerta 18 mg Prolonged-release tablet Oral use Portugal Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena PORTUGAL Concerta 27 mg Prolonged-release tablet Oral use Portugal Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena PORTUGAL Concerta 36 mg Prolonged-release tablet Oral use Portugal Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena PORTUGAL Concerta 54 mg Prolonged-release tablet Oral use Portugal Novartis Farma — Produtos Farmacêuticos, S.A. Rua do Centro Empresarial, Edifício 8 Quinta da Beloura 2710-444 Sintra PORTUGAL Ritalina LA 20 mg Modified-release capsule, hard Oral use Portugal Novartis Farma — Produtos Farmacêuticos, S.A. Rua do Centro Empresarial, Edifício 8 Quinta da Beloura 2710-444 Sintra PORTUGAL Ritalina LA 30 mg Modified-release capsule, hard Oral use Portugal Novartis Farma — Produtos Farmacêuticos, S.A. Rua do Centro Empresarial, Edifício 8 Quinta da Beloura 2710-444 Sintra PORTUGAL Ritalina LA 40 mg Modified-release capsule, hard Oral use Portugal Laboratorios Rubió, S.A. Calle Industria, 29 Poligono Industrial Comte de Sert 08755 Castellbisbal — Barcelona SPAIN Rubifen 5 mg Tablet Oral use Portugal Laboratorios Rubió, S.A. Calle Industria, 29 Poligono Industrial Comte de Sert 08755 Castellbisbal — Barcelona SPAIN Rubifen 10 mg Tablet Oral use Portugal Laboratorios Rubió, S.A. Calle Industria, 29 Poligono Industrial Comte de Sert 08755 Castellbisbal — Barcelona SPAIN Rubifen 20 mg Tablet Oral use Romania Janssen-Pharmaceutica N.V. Tumhoutseweg 30 2340 Beerse BELGIUM Concerta XL 18 mg 18 mg Prolonged-release film-coated tablets Romania Janssen-Pharmaceutica N.V. Tumhoutseweg 30 2340 Beerse BELGIUM Concerta XL 36 mg 36 mg Prolonged-release film-coated tablets Romania Janssen-Pharmaceutica N.V. Tumhoutseweg 30 2340 Beerse BELGIUM Concerta XL 54 mg 54 mg Prolonged-release film-coated tablets Oral Sweden Janssen-Cilag AB Box 7073 SE-192 07 Sollentuna SWEDEN Concerta 18, 27, 36, 54 mg Prolonged-release tablet Oral Sweden UCB Nordic A/S Arne Jacobsens Allé 15 2300 Kobenhavn S DENMARK Equasym Depot 10, 20, 30 mg Modified-release capsules, hard Oral Sweden Novartis Sverige AB Box 1150 SE-183 11 Täby SWEDEN Ritalin 10, 20, 30, 40 mg 10 mg — tablet 20, 30, 40 mg — modified-release capsule, hard Oral Sweden UCB Nordic A/S Arne Jacobsens Allé 15 2300 Kobenhavn S DENMARK Equasym 5, 10, 20 mg Tablet Oral Sweden Medice Arzneimittel Pütter & Co. KG Kuhloweg 37-39 58638 Iserlohn GERMANY Medikinet 5, 10, 20, 30, 40 mg 5, 10, 20 mg — tablet 10, 20, 30, 40 — prolonged-release capsule, hard Oral United Kingdom UCB PHARMA LIMITED 208 Bath Road, Slough Berkshire SL1 3WE UNITED KINGDOM EQUASYM 10 MG TABLETS 10 mg Tablet Oral use United Kingdom UCB PHARMA LIMITED 208 Bath Road, Slough Berkshire SL1 3WE UNITED KINGDOM EQUASYM 5 MG TABLETS 5 mg Tablet Oral use United Kingdom UCB PHARMA LIMITED 208 Bath Road, Slough Berkshire SL1 3WE UNITED KINGDOM EQUASYM 20 MG TABLETS 20 mg Tablet Oral use United Kingdom UCB PHARMA LIMITED 208 Bath Road, Slough Berkshire SL1 3WE UNITED KINGDOM EQUASYM XL 10 MG CAPSULES 10 mg Modified-release capsule, hard Oral use United Kingdom UCB PHARMA LIMITED 208 Bath Road, Slough Berkshire SL1 3WE UNITED KINGDOM EQUASYM XL 20 MG CAPSULES 20 mg Modified-release capsule, hard Oral use United Kingdom UCB PHARMA LIMITED 208 Bath Road, Slough Berkshire SL1 3WE UNITED KINGDOM EQUASYM XL 30 MG CAPSULES 30 mg Modified-release capsule, hard Oral use United Kingdom NOVARTIS PHARMACEUTICALS UK LIMITED Frimley Business Park Frimley, Camberley. Surrey GU16 7SR UNITED KINGDOM RITALIN 10 mg Tablet Oral use United Kingdom JANSSEN-CILAG LIMITED Saunderton, High Wycombe Buckinghamshire HP14 4HJ UNITED KINGDOM CONCERTA® XL 18 mg Prolonged-release tablet Oral use United Kingdom JANSSEN-CILAG LIMITED Saunderton, High Wycombe Buckinghamshire HP14 4HJ UNITED KINGDOM CONCERTA® XL 36 mg Prolonged-release tablet Oral use United Kingdom JANSSEN-CILAG LIMITED Saunderton, High Wycombe Buckinghamshire HP14 4HJ UNITED KINGDOM CONCERTA® XL 54 mg Prolonged-release tablet Oral use United Kingdom JANSSEN-CILAG LIMITED Saunderton, High Wycombe Buckinghamshire HP14 4HJ UNITED KINGDOM CONCERTA® XL 27 mg Prolonged-release tablet Oral use United Kingdom MEDICE ARZNEIMITTEL PUTTER GMBH & CO KG Kuhloweg 37 58638 Iserlohn GERMANY MEDIKINET 5 mg Tablet Oral use United Kingdom MEDICE ARZNEIMITTEL PUTTER GmbH & CO KG Kuhloweg 37 58638 Iserlohn GERMANY MEDIKINET 10 mg Tablet Oral use United Kingdom MEDICE ARZNEIMITTEL PUTTER GmbH & CO KG Kuhloweg 37 58638 Iserlohn GERMANY MEDIKINET 20 mg Tablet Oral use United Kingdom MEDICE ARZNEIMITTEL PUTTER GmbH & CO KG Kuhloweg 37 58638 Iserlohn GERMANY MEDIKINET XL 10 mg Prolonged-release capsule, hard Oral use United Kingdom MEDICE ARZNEIMITTEL PUTTER GmbH & CO KG Kuhloweg 37 58638 Iserlohn GERMANY MEDIKINET XL 20 mg Prolonged-release capsule, hard Oral use United Kingdom MEDICE ARZNEIMITTEL PUTTER GmbH & CO KG Kuhloweg 37 58638 Iserlohn GERMANY MEDIKINET XL 30 mg Prolonged-release capsule, hard Oral use United Kingdom MEDICE ARZNEIMITTEL PUTTER GmbH & CO KG Kuhloweg 37 58638 Iserlohn GERMANY MEDIKINET XL 40 mg Prolonged-release capsule, hard Oral use United Kingdom ALFRED E TIEFENBACHER GmbH & CO Van-der-Smissen-Straße 1 22767 Hamburg GERMANY ELMIFITEN 10 mg Tablet Oral use United Kingdom ALFRED E TIEFENBACHER GmbH & CO Van-der-Smissen-Straße 1 22767 Hamburg GERMANY TIFINIDAT 10 mg Tablet Oral use United Kingdom LABORATORIOS RUBIÓ SA C/Industrial 29, Poligono Industrial Comte de Sert 08755 Castellbisbal, Barcelona SPAIN TRANQUILYN 5 mg Tablet Oral use United Kingdom LABORATORIOS RUBIÓ SA C/Industrial 29, Poligono Industrial Comte de Sert 08755 Castellbisbal, Barcelona SPAIN TRANQUILYN 10 mg Tablet Oral use United Kingdom LABORATORIOS RUBIÓ SA C/Industrial 29, Poligono Industrial Comte de Sert 08755 Castellbisbal, Barcelona SPAIN TRANQUILYN 20 mg Tablet Oral use Iceland UCB Nordic A/S c/o Vistor hf. Hörgatúni 2 212 Garðabær ICELAND Equasym Depot 30 mg Modified-release capsule, hard Oral Iceland UCB Nordic A/S c/o Vistor hf. Hörgatúni 2 212 Garðabær ICELAND Equasym Depot 20 mg Modified-release capsule, hard Oral Iceland UCB Nordic A/S c/o Vistor hf. Hörgatúni 2 212 Garðabær ICELAND Equasym Depot 10 mg Modified-release capsule, hard Oral Iceland Janssen-Cilag AB c/o Vistor hf. Hörgatún 2 212 Garðabær ICELAND Concerta 54 mg Prolonged-release tablet Oral Iceland Janssen-Cilag AB c/o Vistor hf. Hörgatún 2 212 Garðabær ICELAND Concerta 27 mg Prolonged-release tablet Oral Iceland Janssen-Cilag AB c/o Vistor hf. Hörgatún 2 212 Garðabær ICELAND Concerta 36 mg Prolonged-release tablet Oral Iceland Janssen-Cilag AB c/o Vistor hf. Hörgatún 2 212 Garðabær ICELAND Concerta 18 mg Prolonged-release tablet Oral Iceland UCB Nordic A/S, c/o Vistor hf. Hörgatúni 2 212 Garðabær ICELAND Equasym 20 mg Tablet Oral Iceland UCB Nordic A/S, c/o Vistor hf. Hörgatúni 2 212 Garðabær ICELAND Equasym 10 mg Tablet Oral Iceland UCB Nordic A/S, c/o Vistor hf. Hörgatúni 2 212 Garðabær ICELAND Equasym 5 mg Tablet Oral Iceland Novartis Healthcare A/S, c/o Vistor hf. Hörgatún 2 212 Garðabær ICELAND Ritalin 10 mg Tablet Oral Iceland Novartis Healthcare A/S, c/o Vistor hf. Hörgatún 2 212 Garðabær ICELAND Ritalin Uno 40 mg Modified-release capsule, hard Oral Iceland Novartis Healthcare A/S, c/o Vistor hf. Hörgatún 2 212 Garðabær ICELAND Ritalin Uno 20 mg Modified-release capsule, hard Oral Iceland Novartis Healthcare A/S, c/o Vistor hf. Hörgatún 2 212 Garðabær ICELAND Ritalin Uno 30 mg Modified-release capsule, hard Oral Germany Novartis Pharma GmbH 90327 Nuernberg GERMANY Ritalin 10 mg Tablet Oral Germany Novartis Pharma GmbH 90327 Nuernberg GERMANY MPH Novartis 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung 20 mg Modified-release capsule, hard Oral Germany Novartis Pharma GmbH 90327 Nuernberg GERMANY MPH Novartis 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung 30 mg Modified-release capsule, hard Oral Germany Novartis Pharma GmbH 90327 Nuernberg GERMANY MPH Novartis 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung 40 mg Modified-release capsule, hard Oral Germany Novartis Pharma GmbH 90327 Nuernberg GERMANY Ritalin LA 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung 20 mg Modified-release capsule, hard Oral Germany Novartis Pharma GmbH 90327 Nuernberg GERMANY Ritalin LA 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung 30 mg Modified-release capsule, hard Oral Germany Novartis Pharma GmbH 90327 Nuernberg GERMANY Ritalin LA 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung 40 mg Modified-release capsule, hard Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikinet 10 mg 11,56 mg Tablet Oral Germany UCB GmbH Alfred-Nobel-Straße 10 40789 Monheim GERMANY Equasym 5 mg Tabletten 5 mg Tablet Oral Germany UCB GmbH Alfred-Nobel-Straße 10 40789 Monheim GERMANY Equasym 10 mg Tabletten 10 mg Tablet Oral Germany UCB GmbH Alfred-Nobel-Straße 10 40789 Monheim GERMANY Equasym 20 mg Tabletten 20 mg Tablet Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikid 10 mg 11,56 mg Tablet Oral Germany Alfred E. Tiefenbacher GmbH & Co. KG Van-der-Smissen-Straße. 1 22767 Hamburg GERMANY Methylphenidat TB 11.56 mg Tablet Oral Germany HEXAL AG Postfach 1263 83602 Holzkirchen GERMANY Methylphenidat HEXAL 10 mg Tabletten 10 mg Tablet Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikinet 5 mg 5 mg Tablet Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikinet 20 mg 20 mg Tablet Oral Germany Janssen-Cilag GmbH 41457 Neuss or Janssen Cilag GmbH Raiffeisenstraße 8 41470 Neuss GERMANY CONCERTA 18 mg Retardtabletten 18 mg Prolonged-release tablet Oral Germany Janssen-Cilag GmbH 41457 Neuss or Janssen Cilag GmbH Raiffeisenstraße 8 41470 Neuss GERMANY CONCERTA 27 mg Retardtabletten 27 mg Prolonged-release tablet Oral Germany Janssen-Cilag GmbH 41457 Neuss or Janssen Cilag GmbH Raiffeisenstraße 8 41470 Neuss GERMANY CONCERTA 36 mg Retardtabletten 36 mg Prolonged-release tablet Oral Germany Janssen-Cilag GmbH 41457 Neuss or Janssen Cilag GmbH Raiffeisenstraße 8 41470 Neuss GERMANY CONCERTA 54 mg Retardtabletten 54 mg Prolonged-release tablet Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikinet retard 10 mg 10 mg Prolonged-release capsule, hard Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikinet retard 20 mg 20 mg Prolonged-release capsule, hard Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikinet retard 5 mg 5 mg Prolonged-release capsule, hard Oral Germany TAD Pharma GmbH Postfach 720 27457 Cuxhaven GERMANY METHYLPHENI TAD 5 mg Tabletten 5 mg Tablet Oral Germany TAD Pharma GmbH Postfach 720 27457 Cuxhaven GERMANY METHYLPHENI TAD 10 mg Tabletten 10 mg Tablet Oral Germany TAD Pharma GmbH Postfach 720 27457 Cuxhaven GERMANY METHYLPHENI TAD 20 mg Tabletten 20 mg Tablet Oral Germany ratiopharm GmbH 89070 Ulm GERMANY Methylphenidat-ratiopharm 10 mg Tabletten 10 mg Tablet Oral Germany Alfred E. Tiefenbacher GmbH & Co. KG Van-der-Smissen-Straße 1 22767 Hamburg GERMANY Elmifiten 10 mg Tabletten 10 mg Tablet Oral Germany 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching GERMANY Methylphenidat - 1 A Pharma 10 mg Tabletten 10 mg Tablet Oral Germany Alfred E. Tiefenbacher GmbH & Co. KG Van-der-Smissen-Straße 1 22767 Hamburg GERMANY Tifinidat 10 mg Tabletten 10 mg Tablet Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikinet retard 30 mg 30 mg Prolonged-release capsule, hard Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikinet retard 40 mg 40 mg Prolonged-release capsule, hard Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikid 5 mg 5 mg Tablet Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikid 20 mg 20 mg Tablet Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikid retard 10 mg 10 mg Prolonged-release capsule, hard Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikid retard 20 mg 20 mg Prolonged-release capsule, hard Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikid retard 5 mg 5 mg Prolonged-release capsule, hard Oral Germany UCB GmbH Alfred-Nobel-Straße 10 40789 Monheim GERMANY Equasym retard 10 mg Hartkapseln mit veränderter Wirkstofffreisetzung 10 mg Modified-release capsule, hard Oral Germany UCB GmbH Alfred-Nobel-Straße 10 40789 Monheim GERMANY Equasym retard 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung 20 mg Modified-release capsule, hard Oral Germany UCB GmbH Alfred-Nobel-Straße 10 40789 Monheim GERMANY Equasym retard 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung 30 mg Modified-release capsule, hard Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikid retard 30 mg 30 mg Prolonged-release capsule, hard Oral Germany Medice Postfach 2063 58634 Iserlohn GERMANY Medikid retard 40 mg 40 mg Prolonged-release capsule, hard Oral Greece JANSSEN-CILAG PHARMACEUTICAL S.A.C.I Eirinis Avenue 56 151 21 Pefki GREECE Tel. +30 2106140061 Fax +30 2106140072 CONCERTA® 18 mg, 36 mg, 54 mg Prolonged-release tablets Oral Greece LABORATORIOS RUBIO S.A. C/Industria 29 Pol. Compte de Sert 08755 Castellbisbal (Barcelona) SPAIN Tel. +34 937722509 Fax +34 937722501 METHYLPHENIDATE/RUBIO 5 mg/tab, 10 mg/tab, 20 mg/tab Tablets Oral Greece UCB A.E. Vouliagmenis Avenue 580 164 52 Argyroupolis GREECE EQUASYM XR 10, 20, 30 mg Modified-release capsules, hard Oral Italy NOVARTIS FARMA S.P.A. Largo Umberto Boccioni 1 21040 Varese VA ITALY RITALIN 10 mg Tablet 30 Oral Italy NOVARTIS FARMA S.P.A. Largo Umberto Boccioni 1 21040 Varese VA ITALY RITALIN 20 mg Tablet prolonged release 30 Oral Italy NOVARTIS FARMA S.P.A. Largo Umberto Boccioni 1 21040 Varese VA ITALY RITALIN 20 mg Tablet prolonged release 100 Oral Malta Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley Camberley, Surrey GU16 7SR UNITED KINGDOM Ritalin 10 mg Tablet Oral Malta UCB Pharma Limited 208, Bath Road, Slough Berkshire SL1 3WE UNITED KINGDOM Equasym XL 10 mg Modified-release capsule, hard Oral Malta UCB Pharma Limited 208, Bath Road, Slough Berkshire SL1 3WE UNITED KINGDOM Equasym XL 20 mg Modified-release capsule, hard Oral Malta UCB Pharma Limited 208, Bath Road, Slough Berkshire SL1 3WE UNITED KINGDOM Equasym XL 30 mg Modified-release capsule, hard Oral Malta Janssen-Cilag International N.V. Turnhoutseweg 30 2340 Beerse BELGIUM Concerta® 18 mg Prolonged-release tablet Oral use Malta Janssen-Cilag International N.V. Turnhoutseweg 30 2340 Beerse BELGIUM Concerta® 36 mg Prolonged-release tablet Oral use Malta Janssen-Cilag International N.V. Turnhoutseweg 30 2340 Beerse BELGIUM Concerta® 54 mg Prolonged-release tablet Oral use Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem NETHERLANDS Ritalin 10 mg Tablets Oral Netherlands Ratiopharm Nederland BV Ronde Tocht 11 1507 CC Zaandam NETHERLANDS Methylfenidaat HCl ratiopharm 10 mg 10 mg Tablets Oral Netherlands U.C.B. Pharma B.V. Lage Mosten 33 4822 NK Breda NETHERLANDS Equasym 5 mg Tabletten 5 mg Tablets Oral Netherlands U.C.B. Pharma B.V. Lage Mosten 33 4822 NK Breda NETHERLANDS Equasym 10 mg Tabletten 10 mg Tablets Oral Netherlands U.C.B. Pharma B.V. Lage Mosten 33 4822 NK Breda NETHERLANDS Equasym XL 10 mg Capsule 10 mg Modified-release capsules Oral Netherlands U.C.B. Pharma B.V. Lage Mosten 33 4822 NK Breda NETHERLANDS Equasym XL 20 mg Capsule 20 mg Modified-release capsules Oral Netherlands U.C.B. Pharma B.V. Lage Mosten 33 4822 NK Breda NETHERLANDS Equasym XL 30 mg Capsule 30 mg Modified-release capsules Oral Netherlands Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smisse-Straße 1 22767 Hamburg GERMANY Methylfenidaat HCl AET 10 mg 10 mg Tablets Oral Netherlands Pharmachemie B.V. Swensweg 5 2003 RN Haarlem NETHERLANDS Methylfenidaat HCl 10 mg PCH 10 mg Tablets Oral Netherlands Hexal B.V. Pastoorslaan 28 2182 BX Hillegom NETHERLANDS Methylfenidaat HCl 10 mg tabletten 10 mg Tablets Oral Netherlands Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smisse-Straße 1 22767 Hamburg GERMANY Tifinidat 10 mg Tablets Oral Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg NETHERLANDS Concerta 18 mg 18 mg Prolonged-release tablets Oral Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg NETHERLANDS Concerta 27 mg 27 mg Prolonged-release tablets Oral Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg NETHERLANDS Concerta 36 mg 36 mg Prolonged-release tablets Oral Netherlands Janssen-Cilag B.V. Dr. Paul Janssenweg 150 5026 RH Tilburg NETHERLANDS Concerta 54 mg 54 mg Prolonged-release tablets Oral Netherlands Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert 08755 Castellbisbal, Barcelona SPAIN Methylfenidaat HCl 5 mg 5 mg Tablets Oral Netherlands Laboratorios Rubio SA C/Industria 29, Poligon Industrial Compte de Sert 08755 Castellbisbal, Barcelona SPAIN Methylfenidaat HCl 10 mg 10 mg Tablets Oral Netherlands Medice Arzneimittel Pütter GmbH Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 5 mg 5 mg Tablets Oral Netherlands Medice Arzneimittel Pütter GmbH Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 10 mg 10 mg Tablets Oral Netherlands Medice Arzneimittel Pütter GmbH Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 20 mg 20 mg Tablets Oral Netherlands Medice Arzneimittel Pütter GmbH Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 10 mg 10 mg Modified-release capsules Oral Netherlands Medice Arzneimittel Pütter GmbH Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 20 mg 20 mg Modified-release capsules Oral Netherlands Medice Arzneimittel Pütter GmbH Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 30 mg 30 mg Modified-release capsules Oral Netherlands Medice Arzneimittel Pütter GmbH Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 40 mg 40 mg Modified-release capsules Oral Norway Janssen-Cilag AS Hoffsveien 1D 0275 Oslo NORWAY Concerta 18 mg, 36 mg, 54 mg Prolonged-release tablet Oral Norway UCB Nordic A/S Arne Jacobsens Allé 15 2300 Köbenhavn S DENMARK Equasym tabletter 5 mg 5 mg Tablet Oral Norway UCB Nordic A/S Arne Jacobsens Allé 15 2300 Köbenhavn S DENMARK Equasym tabletter 10 mg 10 mg Tablet Oral Norway UCB Nordic A/S Arne Jacobsens Allé 15 2300 Köbenhavn S DENMARK Equasym tabletter 20 mg 20 mg Tablet Oral Norway UCB Nordic A/S Arne Jacobsens Allé 15 2300 Köbenhavn S DENMARK Equasym Depot 10 mg, 20 mg, 30 mg Modified-release capsule, hard Oral Norway Novartis Norge AS Brynsalleèn 4 0667 Oslo NORWAY Ritalin 10 mg, 20 mg, 30 mg, 40 mg (10 mg — tablet) (20 mg, 30 mg, 40 mg — modified-release capsule, hard) Oral Norway Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn, Nordrhein-Westfalen GERMANY Medikinet 10 mg, 20 mg, 30 mg, 40 mg Prolonged-release tablet Oral Norway Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn, Nordrhein-Westfalen GERMANY Medikinet 5 mg, 10 mg, 20 mg Tablet Oral Poland Janssen-Cilag International N.V. Turnhoutseweg 30 2340 Beerse BELGIUM Concerta® 18 mg Prolonged-release tablet Oral use Poland Janssen-Cilag International N.V. Turnhoutseweg 30 2340 Beerse BELGIUM Concerta® 36 mg Prolonged-release tablet Oral use Poland Janssen-Cilag International N.V. Turnhoutseweg 30 2340 Beerse BELGIUM Concerta® 54 mg Prolonged-release tablet Oral use Poland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 5 mg 5 mg Tablet Oral use Poland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 10 mg 10 mg Tablet Oral use Poland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 20 mg 20 mg Tablet Oral use Poland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 10 mg 10 mg Prolonged-release capsule Oral use Poland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 20 mg 20 mg Prolonged-release capsule Oral use Poland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 30 mg 30 mg Prolonged-release capsule Oral use Poland Medice Arzneimittel Pütter GmbH & Co. KG Kuhloweg 37 58638 Iserlohn GERMANY Medikinet CR 40 mg 40 mg Prolonged-release capsule Oral use Luxembourg Novartis Pharma Roonstraße 25 90429 Nűrnberg GERMANY Ritalin 10 mg Tablets Oral Luxembourg Janssen Cilag N.V./S.A Roderveldlaan 1 2600 Berchem BELGIUM Concerta 18 mg Prolonged-release tablets Oral use Luxembourg Janssen Cilag N.V./S.A Roderveldlaan 1 2600 Berchem BELGIUM Concerta 27 mg Prolonged-release tablets Oral use Luxembourg Janssen Cilag N.V./S.A Roderveldlaan 1 2600 Berchem BELGIUM Concerta 36 mg Prolonged-release tablets Oral use Luxembourg Janssen Cilag N.V./S.A Roderveldlaan 1 2600 Berchem BELGIUM Concerta 54 mg Prolonged-release tablets Oral use Luxembourg Medice Arzneimittel Pűtter GmbH & Co Kuhloweg 37 58638 Iserlohn GERMANY Medikinet 5 mg Tablets Oral Luxembourg Medice Arzneimittel Pűtter GmbH & Co Medikinet 10 mg Tablets Oral Luxembourg Medice Arzneimittel Pűtter GmbH & Co Medikinet 20 mg Tablets Oral Luxembourg Medice Arzneimittel Pűtter GmbH & Co Medikinet retard 10 mg Capsules Oral Luxembourg Medice Arzneimittel Pűtter GmbH & Co Medikinet retard 20 mg Capsules Oral Luxembourg Medice Arzneimittel Pűtter GmbH & Co Medikinet retard 30 mg Capsules Oral Luxembourg Medice Arzneimittel Pűtter GmbH & Co Medikinet retard 40 mg Capsules Oral Slovenia Johnson & Johnson d.o.o. Smartinska 53 SI-1000 Ljubljana SLOVENIA Concerta 18 mg tablete s podaljšanim sproščanjem 18 mg Prolonged-release tablets Oral use Slovenia Johnson & Johnson d.o.o. Smartinska 53 SI-1000 Ljubljana SLOVENIA Concerta 36 mg tablete s podaljšanim sproščanjem 36 mg Prolonged-release tablets Oral use Slovenia Johnson & Johnson d.o.o. Smartinska 53 SI-1000 Ljubljana SLOVENIA Concerta 54 mg tablete s podaljšanim sproščanjem 54 mg Prolonged-release tablets Oral use Slovakia Johnson & Johnson, s.r.o. Plynárenská 7/B 824 78 Bratislava SLOVAK REPUBLIC Concerta 18 mg tablety s predĺženým uvoľňovaním 18 mg Prolonged-release tablet Oral use Slovakia Johnson & Johnson, s.r.o. Plynárenská 7/B 824 78 Bratislava SLOVAK REPUBLIC Concerta 36 mg tablety s predĺženým uvoľňovaním 36 mg Prolonged-release tablet Oral use Slovakia Johnson & Johnson, s.r.o. Plynárenská 7/B 824 78 Bratislava SLOVAK REPUBLIC Concerta 54 mg tablety s predĺženým uvoľňovaním 54 mg Prolonged-release tablet Oral use