# C_2009146EN.01001501.xml

| 26.6.2009 | EN | Official Journal of the European Union | C 146/15 |
| --- | --- | --- | --- |

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)
  )

(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

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 |

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 |

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.

1

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

2

---

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

Medice Arzneimittle

Kuhloweg 37-39

Iserlohn

GERMANY

Medikinet

5, 10, 20 mg

Tablets

Oral

Denmark

| Medice Arzneimittle |
| --- |
| Kuhloweg 37-39 |
| Iserlohn |
| GERMANY |

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 |

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 |

Novartis Healthcare

Lyngbyvej 172

2100 Københarn Ø

DENMARK

Ritalin

10 mg

Tablets

Oral

Denmark

| Novartis Healthcare |
| --- |
| Lyngbyvej 172 |
| 2100 Københarn Ø |
| 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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

Ratiopharm GmbH

Graf-Arco-Straße 3

GERMANY

Equasym

5 mg, 10 mg, 20 mg

Tablets

Oral

Ireland

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| GERMANY |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

Novartis Pharma GmbH

90327 Nuernberg

GERMANY

Ritalin

10 mg

Tablet

Oral

Germany

| Novartis Pharma GmbH |
| --- |
| 90327 Nuernberg |
| 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 |

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 |

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 |

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 |

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 |

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 |

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet 10 mg

11,56 mg

Tablet

Oral

Germany

| UCB GmbH |
| --- |
| Alfred-Nobel-Straße 10 |
| 40789 Monheim |
| 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 |

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 |

UCB GmbH

Alfred-Nobel-Straße 10

40789 Monheim

GERMANY

Equasym 20 mg Tabletten

20 mg

Tablet

Oral

Germany

| Medice |
| --- |
| Postfach 2063 |
| 58634 Iserlohn |
| 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 |

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 |

HEXAL AG

Postfach 1263

83602 Holzkirchen

GERMANY

Methylphenidat HEXAL 10 mg Tabletten

10 mg

Tablet

Oral

Germany

| Medice |
| --- |
| Postfach 2063 |
| 58634 Iserlohn |
| GERMANY |

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet 5 mg

5 mg

Tablet

Oral

Germany

| Medice |
| --- |
| Postfach 2063 |
| 58634 Iserlohn |
| 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 |

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 |

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 |

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 |

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 |

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet retard 10 mg

10 mg

Prolonged-release capsule, hard

Oral

Germany

| Medice |
| --- |
| Postfach 2063 |
| 58634 Iserlohn |
| 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 |

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 |

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 |

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 |

TAD Pharma GmbH

Postfach 720

27457 Cuxhaven

GERMANY

METHYLPHENI TAD 20 mg Tabletten

20 mg

Tablet

Oral

Germany

| ratiopharm GmbH |
| --- |
| 89070 Ulm |
| 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 |

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 |

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 |

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 |

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet retard 30 mg

30 mg

Prolonged-release capsule, hard

Oral

Germany

| Medice |
| --- |
| Postfach 2063 |
| 58634 Iserlohn |
| 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 |

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid 5 mg

5 mg

Tablet

Oral

Germany

| Medice |
| --- |
| Postfach 2063 |
| 58634 Iserlohn |
| GERMANY |

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid 20 mg

20 mg

Tablet

Oral

Germany

| Medice |
| --- |
| Postfach 2063 |
| 58634 Iserlohn |
| 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 |

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid retard 20 mg

20 mg

Prolonged-release capsule, hard

Oral

Germany

| Medice |
| --- |
| Postfach 2063 |
| 58634 Iserlohn |
| 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 |

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 |

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 |

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 |

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid retard 30 mg

30 mg

Prolonged-release capsule, hard

Oral

Germany

| Medice |
| --- |
| Postfach 2063 |
| 58634 Iserlohn |
| 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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

Novartis Pharma

Roonstraße 25

90429 Nűrnberg

GERMANY

Ritalin

10 mg

Tablets

Oral

Luxembourg

| Janssen Cilag N.V./S.A |
| --- |
| Roderveldlaan 1 |
| 2600 Berchem |
| BELGIUM |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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

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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 |

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, |
| --- | --- |

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

| | Water for injection — 1,00 g, |
| --- | --- |

Water for injection — 1,00 g,

| | Sodium citrate — 0,62 % (v/v), |
| --- | --- |

Sodium citrate — 0,62 % (v/v),

| | Sodium chloride — 0,41 % (v/v), |
| --- | --- |

Sodium chloride — 0,41 % (v/v),

| | Hydrochloric acid 0,39 % (v/v), |
| --- | --- |

Hydrochloric acid 0,39 % (v/v),

| | Ethanol 0,31 % (v/v) |
| --- | --- |

Ethanol 0,31 % (v/v)

| | Sodium hydroxide 0,24 % (v/v) |
| --- | --- |

Sodium hydroxide 0,24 % (v/v)

Germany

| Advanced Accelerator Applications |
| --- |
| 20 rue Diesel |
| 01630 Saint Genis Pouilly |
| 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, |
| --- | --- |

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

| | Water for injection — 1,00 g, |
| --- | --- |

Water for injection — 1,00 g,

| | Sodium citrate — 0,62 % (v/v), |
| --- | --- |

Sodium citrate — 0,62 % (v/v),

| | Sodium chloride — 0,41 % (v/v), |
| --- | --- |

Sodium chloride — 0,41 % (v/v),

| | Hydrochloric acid 0,39 % (v/v), |
| --- | --- |

Hydrochloric acid 0,39 % (v/v),

| | Ethanol 0,31 % (v/v) |
| --- | --- |

Ethanol 0,31 % (v/v)

| | Sodium hydroxide 0,24 % (v/v) |
| --- | --- |

Sodium hydroxide 0,24 % (v/v)

Poland

| Advanced Accelerator Applications |
| --- |
| 20 rue Diesel |
| 01630 Saint Genis Pouilly |
| FRANCE |

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, |
| --- | --- |

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

| | Water for injection — 1,00 g, |
| --- | --- |

Water for injection — 1,00 g,

| | Sodium citrate — 0,62 % (v/v), |
| --- | --- |

Sodium citrate — 0,62 % (v/v),

| | Sodium chloride — 0,41 % (v/v), |
| --- | --- |

Sodium chloride — 0,41 % (v/v),

| | Hydrochloric acid 0,39 % (v/v), |
| --- | --- |

Hydrochloric acid 0,39 % (v/v),

| | Ethanol 0,31 % (v/v) |
| --- | --- |

Ethanol 0,31 % (v/v)

| | Sodium hydroxide 0,24 % (v/v) |
| --- | --- |

Sodium hydroxide 0,24 % (v/v)

Portugal

| Advanced Accelerator Applications |
| --- |
| 20 rue Diesel |
| 01630 Saint Genis Pouilly |
| 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, |
| --- | --- |

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

| | Water for injection — 1,00 g, |
| --- | --- |

Water for injection — 1,00 g,

| | Sodium citrate — 0,62 % (v/v), |
| --- | --- |

Sodium citrate — 0,62 % (v/v),

| | Sodium chloride — 0,41 % (v/v), |
| --- | --- |

Sodium chloride — 0,41 % (v/v),

| | Hydrochloric acid 0,39 % (v/v), |
| --- | --- |

Hydrochloric acid 0,39 % (v/v),

| | Ethanol 0,31 % (v/v) |
| --- | --- |

Ethanol 0,31 % (v/v)

| | Sodium hydroxide 0,24 % (v/v) |
| --- | --- |

Sodium hydroxide 0,24 % (v/v)

Spain

| Advanced Accelerator Applications |
| --- |
| 20 rue Diesel |
| 01630 Saint Genis Pouilly |
| 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, |
| --- | --- |

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

| | Water for injection — 1,00 g, |
| --- | --- |

Water for injection — 1,00 g,

| | Sodium citrate — 0,62 % (v/v), |
| --- | --- |

Sodium citrate — 0,62 % (v/v),

| | Sodium chloride — 0,41 % (v/v), |
| --- | --- |

Sodium chloride — 0,41 % (v/v),

| | Hydrochloric acid 0,39 % (v/v), |
| --- | --- |

Hydrochloric acid 0,39 % (v/v),

| | Ethanol 0,31 % (v/v) |
| --- | --- |

Ethanol 0,31 % (v/v)

| | Sodium hydroxide 0,24 % (v/v) |
| --- | --- |

Sodium hydroxide 0,24 % (v/v)

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