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 or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council )
Date: 2009-06-26
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009146EN.01001501.xml










26.6.2009   


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







ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES













Member State EU/EEA


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration


Content
(concentration)




France


 







Advanced Accelerator Applications




20 rue Diesel




01630 Saint Genis Pouilly




FRANCE






GLUSCAN 500


500 MBq/ml at calibration time


Solution for injection


Intravenous use


For 1 ml of drug product:






 


Fludeoxyglucose (18F) — 500 MBq at calibration time,










 


Water for injection — 1,00 g,










 


Sodium citrate — 0,62 % (v/v),










 


Sodium chloride — 0,41 % (v/v),










 


Hydrochloric acid 0,39 % (v/v),










 


Ethanol 0,31 % (v/v)










 


Sodium hydroxide 0,24 % (v/v)








Germany


 







Advanced Accelerator Applications




20 rue Diesel




01630 Saint Genis Pouilly




FRANCE






GLUSCAN 500


500 MBq/ml at calibration time


Solution for injection


Intravenous use


For 1 ml of drug product:






 


Fludeoxyglucose (18F) — 500 MBq at calibration time,










 


Water for injection — 1,00 g,










 


Sodium citrate — 0,62 % (v/v),










 


Sodium chloride — 0,41 % (v/v),










 


Hydrochloric acid 0,39 % (v/v),










 


Ethanol 0,31 % (v/v)










 


Sodium hydroxide 0,24 % (v/v)








Poland


 







Advanced Accelerator Applications




20 rue Diesel




01630 Saint Genis Pouilly




FRANCE






GLUSCAN PL


500 MBq/ml at calibration time


Solution for injection


Intravenous use


For 1 ml of drug product:






 


Fludeoxyglucose (18F) — 500 MBq at calibration time,










 


Water for injection — 1,00 g,










 


Sodium citrate — 0,62 % (v/v),










 


Sodium chloride — 0,41 % (v/v),










 


Hydrochloric acid 0,39 % (v/v),










 


Ethanol 0,31 % (v/v)










 


Sodium hydroxide 0,24 % (v/v)








Portugal


 







Advanced Accelerator Applications




20 rue Diesel




01630 Saint Genis Pouilly




FRANCE






GLUSCAN 500


500 MBq/ml at calibration time


Solution for injection


Intravenous use


For 1 ml of drug product:






 


Fludeoxyglucose (18F) — 500 MBq at calibration time,










 


Water for injection — 1,00 g,










 


Sodium citrate — 0,62 % (v/v),










 


Sodium chloride — 0,41 % (v/v),










 


Hydrochloric acid 0,39 % (v/v),










 


Ethanol 0,31 % (v/v)










 


Sodium hydroxide 0,24 % (v/v)








Spain


 







Advanced Accelerator Applications




20 rue Diesel




01630 Saint Genis Pouilly




FRANCE






GLUSCAN 500


500 MBq/ml at calibration time


Solution for injection


Intravenous use


For 1 ml of drug product:






 


Fludeoxyglucose (18F) — 500 MBq at calibration time,










 


Water for injection — 1,00 g,










 


Sodium citrate — 0,62 % (v/v),










 


Sodium chloride — 0,41 % (v/v),










 


Hydrochloric acid 0,39 % (v/v),










 


Ethanol 0,31 % (v/v)










 


Sodium hydroxide 0,24 % (v/v)