# Il-Ġurnal Uffiċjali C 146/2009

| | ISSN 1725-5198
  doi:10.3000/17255198.C_2009.146.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 146 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5226 ta' Ġunju 2009 |

ISSN 1725-5198

doi:10.3000/17255198.C_2009.146.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 146

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5226 ta' Ġunju 2009

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | II   Komunikazzjonijiet |
| | KOMUNIKAZZJONIJIET MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni |
| 2009/C 146/01 | Awtorizzazzjoni tal-għajnuna Statali fil-qafas tad-Dispożizzjonijiet tal-Artikoli 87 u 88 tat-Trattat tal-KEi – Fir-rigward ta' dawn il-każijiet il-Kummissjoni ma tqajjimx oġġezzjonijiet (
  1
  ) | 1 |

Avviż Nru

Werrej

Paġna

II   Komunikazzjonijiet

KOMUNIKAZZJONIJIET MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA

Il-Kummissjoni

2009/C 146/01

Awtorizzazzjoni tal-għajnuna Statali fil-qafas tad-Dispożizzjonijiet tal-Artikoli 87 u 88 tat-Trattat tal-KEi – Fir-rigward ta' dawn il-każijiet il-Kummissjoni ma tqajjimx oġġezzjonijiet (
  1
  )

1

1

| | IV   Informazzjoni |
| --- | --- |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni |
| 2009/C 146/02 | Rata tal-kambju tal-euro | 5 |
| 2009/C 146/03 | Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta’ Mejju 2009 sal-31 ta’ Mejju 2009(Ppubblikat skond l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
  ) | 6 |
| 2009/C 146/04 | Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta' Mejju 2009 sal-31 ta' Mejju 2009(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE tal-Parlament Ewropew u tal-Kunsill
  jew Artikolu 38 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill
  ) | 15 |

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA

Il-Kummissjoni

2009/C 146/02

Rata tal-kambju tal-euro

5

2009/C 146/03

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta’ Mejju 2009 sal-31 ta’ Mejju 2009(Ppubblikat skond l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
  )

(Ppubblikat skond l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill

)

6

2009/C 146/04

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta' Mejju 2009 sal-31 ta' Mejju 2009(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE tal-Parlament Ewropew u tal-Kunsill
  jew Artikolu 38 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill
  )

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE tal-Parlament Ewropew u tal-Kunsill

jew Artikolu 38 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill

)

15

| | V   Avviżi |
| --- | --- |
| | PROĊEDURI GĦALL-IMPLIMENTAZZJONI TAL-POLITIKA TAL-KOMPETIZZJONI |
| | Il-Kummissjoni |
| 2009/C 146/05 | Notifika minn qabel ta' konċentrazzjoni (Każ COMP/M.5522 – Mitsubishi Corporation/Acciona Energia Internacional/Amper) – Każ li jista' jiġi kkunsidrat għal proċedura simplifikata (
  1
  ) | 60 |

V   Avviżi

PROĊEDURI GĦALL-IMPLIMENTAZZJONI TAL-POLITIKA TAL-KOMPETIZZJONI

Il-Kummissjoni

2009/C 146/05

Notifika minn qabel ta' konċentrazzjoni (Każ COMP/M.5522 – Mitsubishi Corporation/Acciona Energia Internacional/Amper) – Każ li jista' jiġi kkunsidrat għal proċedura simplifikata (
  1
  )

1

60

| | |
| --- | --- |
| | (1)   Test b’relevanza għaż-ŻEE |

---

(1)   Test b’relevanza għaż-ŻEE

1

| MT | |
| --- | --- |

MT

---

II Komunikazzjonijiet

KOMUNIKAZZJONIJIET MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA

Il-Kummissjoni

| 26.6.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 146/1 |
| --- | --- | --- | --- |

26.6.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 146/1

---

Awtorizzazzjoni tal-għajnuna Statali fil-qafas tad-Dispożizzjonijiet tal-Artikoli 87 u 88 tat-Trattat tal-KEi

Fir-rigward ta' dawn il-każijiet il-Kummissjoni ma tqajjimx oġġezzjonijiet

(Test b’relevanza għaż-ŻEE)

2009/C 146/01

| Data tal-adozzjoni tad-deċiżjoni | 19.3.2009 |
| --- | --- |
| In-numru ta' referenza tal-għajnuna | N 348/08 |
| Stat Membru | Spanja |
| Reġjun | — |
| Titolu (u/jew isem tal-benefiċjarju) | Programa de Ayudas de IDAE a la financiación de proyectos estratégicos de inversión en Ahorro y Eficiencia Energética |
| Il-bażi legali | Resolución del Consejo de Administración del Instituto para la Diversificación y Ahorro de la Energía (IDAE) de 29/5/2008 por la que se establecen las Bases Reguladoras, en adelante «Bases Reguladoras», para la convocatoria 2008 del programa de ayudas IDAE a la financiación de proyectos estratégicos de inversión en ahorro y eficiencia energética dentro del Plan de Acción 2008-2012 de la Estrategia de Ahorro y Eficiencia Energética en España (E4). Publicada en el BOE núm. 138 de 7/6/2008. |
| It-tip tal-miżura | Skema ta' għajnuna |
| L-għan | Il-ħarsien tal-ambjent, L-iffrankar tal-enerġija |
| Il-forma tal-għajnuna | Għotja diretta |
| L-Estimi | Baġit annwali: 60 miljun EUR; Baġit globali: 380 miljun EUR |
| L-intensità | 50-80 % |
| It-tul ta' żmien | 1.12.2008-31.12.2012 |
| Setturi ekonomiċi | L-enerġija |
| Isem u indirizz tal-awtorità responsabbli mill-għajnuna | Instituto para la Diversificación y Ahorro de la Energía (IDAE) C/Madera, 8 |
| 28004 Madrid |
| ESPAÑA |

Data tal-adozzjoni tad-deċiżjoni

19.3.2009

In-numru ta' referenza tal-għajnuna

N 348/08

Stat Membru

Spanja

Reġjun

—

Titolu (u/jew isem tal-benefiċjarju)

Programa de Ayudas de IDAE a la financiación de proyectos estratégicos de inversión en Ahorro y Eficiencia Energética

Il-bażi legali

Resolución del Consejo de Administración del Instituto para la Diversificación y Ahorro de la Energía (IDAE) de 29/5/2008 por la que se establecen las Bases Reguladoras, en adelante «Bases Reguladoras», para la convocatoria 2008 del programa de ayudas IDAE a la financiación de proyectos estratégicos de inversión en ahorro y eficiencia energética dentro del Plan de Acción 2008-2012 de la Estrategia de Ahorro y Eficiencia Energética en España (E4). Publicada en el BOE núm. 138 de 7/6/2008.

It-tip tal-miżura

Skema ta' għajnuna

L-għan

Il-ħarsien tal-ambjent, L-iffrankar tal-enerġija

Il-forma tal-għajnuna

Għotja diretta

L-Estimi

Baġit annwali: 60 miljun EUR; Baġit globali: 380 miljun EUR

L-intensità

50-80 %

It-tul ta' żmien

1.12.2008-31.12.2012

Setturi ekonomiċi

L-enerġija

Isem u indirizz tal-awtorità responsabbli mill-għajnuna

Instituto para la Diversificación y Ahorro de la Energía (IDAE) C/Madera, 8

28004 Madrid

ESPAÑA

Aktar informazzjoni

—

It-test tad-deċiżjoni fil-lingwa jew lingwi awtentika/awtentiċi, li minnu tneħħew il-partijiet kunfidenzjali kollha, jinsab fuq is-sit:

http://ec.europa.eu/community_law/state_aids/index.htm

| Data tal-adozzjoni tad-deċiżjoni | 1.4.2009 |
| --- | --- |
| In-numru ta' referenza tal-għajnuna | N 573/08 |
| Stat Membru | L-Italja |
| Reġjun | Toscana |
| Titolu (u/jew isem tal-benefiċjarju) | Istituzione di un regime di aiuti di stato agli investimenti in materia di fonti energetiche rinnovabili, risparmio energetico, cogenerazione e teleriscaldamento |
| Il-bażi legali | Decreto Dirigenziale no 2450/2008, Decreto Dirigenziale no 2773/2008 e Decreto Dirigenziale no 4852/2008 |
| It-tip tal-miżura | Skema ta' għajnuna |
| L-għan | Il-ħarsien tal-ambjent, L-iffrankar tal-enerġija |
| Il-forma tal-għajnuna | Għotja diretta |
| L-Estimi | Baġit globali: 53 miljun EUR |
| L-intensità | 50-80 % |
| It-tul ta' żmien | 1.1.2009-31.12.2013 |
| Setturi ekonomiċi | L-enerġija |
| Isem u indirizz tal-awtorità responsabbli mill-għajnuna | Regione Toscana |
| Settore Miniere e Energia |
| Via R. Bardazzi, 19/21 |
| 50127 Firenze |
| ITALIA |

Data tal-adozzjoni tad-deċiżjoni

1.4.2009

In-numru ta' referenza tal-għajnuna

N 573/08

Stat Membru

L-Italja

Reġjun

Toscana

Titolu (u/jew isem tal-benefiċjarju)

Istituzione di un regime di aiuti di stato agli investimenti in materia di fonti energetiche rinnovabili, risparmio energetico, cogenerazione e teleriscaldamento

Il-bażi legali

Decreto Dirigenziale no 2450/2008, Decreto Dirigenziale no 2773/2008 e Decreto Dirigenziale no 4852/2008

It-tip tal-miżura

Skema ta' għajnuna

L-għan

Il-ħarsien tal-ambjent, L-iffrankar tal-enerġija

Il-forma tal-għajnuna

Għotja diretta

L-Estimi

Baġit globali: 53 miljun EUR

L-intensità

50-80 %

It-tul ta' żmien

1.1.2009-31.12.2013

Setturi ekonomiċi

L-enerġija

Isem u indirizz tal-awtorità responsabbli mill-għajnuna

Regione Toscana

Settore Miniere e Energia

Via R. Bardazzi, 19/21

50127 Firenze

ITALIA

Aktar informazzjoni

—

It-test tad-deċiżjoni fil-lingwa jew lingwi awtentika/awtentiċi, li minnu tneħħew il-partijiet kunfidenzjali kollha, jinsab fuq is-sit:

http://ec.europa.eu/community_law/state_aids/index.htm

| Data tal-adozzjoni tad-deċiżjoni | 30.3.2009 |
| --- | --- |
| In-numru ta' referenza tal-għajnuna | N 140/09 |
| Stat Membru | Spanja |
| Reġjun | — |
| Titolu (u/jew isem tal-benefiċjarju) | Plan de competitividad del Sector automoción. Actuaciones para la inversión destinada a la producción de productos más respetuosos con el medio ambiente |
| Il-bażi legali | Orden ITC/21/23009, de 16 de enero, por la que se establecen las bases reguladoras, y se efectúa la convocatoria de las ayudas para la realización de actuaciones en le marco del Plan de Competitividad del Sector Automoción |
| It-tip tal-miżura | Skema ta' għajnuna |
| L-għan | Għajnuna biex tirrimedja tfixkil serju fl-ekonomija |
| Il-forma tal-għajnuna | Sussidju fuq l-imgħax |
| L-Estimi | Baġit globali: 300 miljun EUR |
| L-intensità | — |
| It-tul ta' żmien | sal-31.12.2009 |
| Setturi ekonomiċi | Vetturi bil-mutur |
| Isem u indirizz tal-awtorità responsabbli mill-għajnuna | Ministerio de Industria, Turismo y Comercio |
| Po de la Castellana 160, 4a Pl, 21a |
| 28070 Madrid |
| ESPAÑA |

Data tal-adozzjoni tad-deċiżjoni

30.3.2009

In-numru ta' referenza tal-għajnuna

N 140/09

Stat Membru

Spanja

Reġjun

—

Titolu (u/jew isem tal-benefiċjarju)

Plan de competitividad del Sector automoción. Actuaciones para la inversión destinada a la producción de productos más respetuosos con el medio ambiente

Il-bażi legali

Orden ITC/21/23009, de 16 de enero, por la que se establecen las bases reguladoras, y se efectúa la convocatoria de las ayudas para la realización de actuaciones en le marco del Plan de Competitividad del Sector Automoción

It-tip tal-miżura

Skema ta' għajnuna

L-għan

Għajnuna biex tirrimedja tfixkil serju fl-ekonomija

Il-forma tal-għajnuna

Sussidju fuq l-imgħax

L-Estimi

Baġit globali: 300 miljun EUR

L-intensità

—

It-tul ta' żmien

sal-31.12.2009

Setturi ekonomiċi

Vetturi bil-mutur

Isem u indirizz tal-awtorità responsabbli mill-għajnuna

Ministerio de Industria, Turismo y Comercio

Po de la Castellana 160, 4a Pl, 21a

28070 Madrid

ESPAÑA

Aktar informazzjoni

—

It-test tad-deċiżjoni fil-lingwa jew lingwi awtentika/awtentiċi, li minnu tneħħew il-partijiet kunfidenzjali kollha, jinsab fuq is-sit:

http://ec.europa.eu/community_law/state_aids/index.htm

| Data tal-adozzjoni tad-deċiżjoni | 29.4.2009 |
| --- | --- |
| In-numru ta' referenza tal-għajnuna | N 222/09 |
| Stat Membru | Is-Slovakkja |
| Reġjun | — |
| Titolu (u/jew isem tal-benefiċjarju) | Limited amount of compatible aid |
| Il-bażi legali | Schéma pre dočasné poskytovanie malej pomoci v Slovenskej republike počas trvania finančnej a hospodárskej krízy
  Z.z. c. 523/ 2004, v znení neskorších predpisov
  Z.z. c. 511/1992 v znení neskorších predpisov,
  Z.z. c. 231/1999 v znení neskorších predpisov, |
| It-tip tal-miżura | Skema ta' għajnuna |
| L-għan | Għajnuna biex tirrimedja tfixkil serju fl-ekonomija |
| Il-forma tal-għajnuna | Għotja diretta, Għotja rimborsabbli, Sussidju fuq l-imgħax |
| L-Estimi | Baġit globali: 400 miljun EUR |
| L-intensità | — |
| It-tul ta' żmien | 1.5.2009-31.12.2010 |
| Setturi ekonomiċi | Is-setturi kollha |
| Isem u indirizz ta' l-awtorità responsabbli mill-għajnuna | — |
| Aktar informazzjoni | — |

Data tal-adozzjoni tad-deċiżjoni

29.4.2009

In-numru ta' referenza tal-għajnuna

N 222/09

Stat Membru

Is-Slovakkja

Reġjun

—

Titolu (u/jew isem tal-benefiċjarju)

Limited amount of compatible aid

Il-bażi legali

Schéma pre dočasné poskytovanie malej pomoci v Slovenskej republike počas trvania finančnej a hospodárskej krízy

Z.z. c. 523/ 2004, v znení neskorších predpisov

Z.z. c. 511/1992 v znení neskorších predpisov,

Z.z. c. 231/1999 v znení neskorších predpisov,

It-tip tal-miżura

Skema ta' għajnuna

L-għan

Għajnuna biex tirrimedja tfixkil serju fl-ekonomija

Il-forma tal-għajnuna

Għotja diretta, Għotja rimborsabbli, Sussidju fuq l-imgħax

L-Estimi

Baġit globali: 400 miljun EUR

L-intensità

—

It-tul ta' żmien

1.5.2009-31.12.2010

Setturi ekonomiċi

Is-setturi kollha

Isem u indirizz ta' l-awtorità responsabbli mill-għajnuna

—

Aktar informazzjoni

—

It-test tad-deċiżjoni fil-lingwa jew lingwi awtentika/awtentiċi, li minnu tneħħew il-partijiet kunfidenzjali kollha, jinsab fuq is-sit:

http://ec.europa.eu/community_law/state_aids/index.htm

| Data tal-adozzjoni tad-deċiżjoni | 8.6.2009 |
| --- | --- |
| In-numru ta' referenza tal-għajnuna | N 307/09 |
| Stat Membru | Spanja |
| Reġjun | — |
| Titolu (u/jew isem tal-benefiċjarju) | Regimen temporal de ayuda para conceder cantidades limitadas de ayuda compatible |
| Il-bażi legali | Acuerdo de la Comisión Delegada del Gobierno para Asuntos Económicos sobre el maco nacional transitorio de concesión de ayudas de importe limitado a empresas como consecuencia de la crisis económica y financiera |
| It-tip tal-miżura | Għajnuna individwali |
| L-għan | Għajnuna biex tirrimedja tfixkil serju fl-ekonomija |
| Il-forma tal-għajnuna | Għotja diretta |
| L-Estimi | Baġit globali: 1 400 miljun EUR |
| L-intensità | — |
| It-tul ta' żmien | 15.6.2009-31.12.2010 |
| Setturi ekonomiċi | Is-setturi kollha |
| Isem u indirizz tal-awtorità responsabbli mill-għajnuna | Todas las autoridades competentes en España |
| Aktar informazzjoni | — |

Data tal-adozzjoni tad-deċiżjoni

8.6.2009

In-numru ta' referenza tal-għajnuna

N 307/09

Stat Membru

Spanja

Reġjun

—

Titolu (u/jew isem tal-benefiċjarju)

Regimen temporal de ayuda para conceder cantidades limitadas de ayuda compatible

Il-bażi legali

Acuerdo de la Comisión Delegada del Gobierno para Asuntos Económicos sobre el maco nacional transitorio de concesión de ayudas de importe limitado a empresas como consecuencia de la crisis económica y financiera

It-tip tal-miżura

Għajnuna individwali

L-għan

Għajnuna biex tirrimedja tfixkil serju fl-ekonomija

Il-forma tal-għajnuna

Għotja diretta

L-Estimi

Baġit globali: 1 400 miljun EUR

L-intensità

—

It-tul ta' żmien

15.6.2009-31.12.2010

Setturi ekonomiċi

Is-setturi kollha

Isem u indirizz tal-awtorità responsabbli mill-għajnuna

Todas las autoridades competentes en España

Aktar informazzjoni

—

It-test tad-deċiżjoni fil-lingwa jew lingwi awtentika/awtentiċi, li minnu tneħħew il-partijiet kunfidenzjali kollha, jinsab fuq is-sit:

http://ec.europa.eu/community_law/state_aids/index.htm

---

IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA

Il-Kummissjoni

| 26.6.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 146/5 |
| --- | --- | --- | --- |

26.6.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 146/5

---

Rata tal-kambju tal-euro (1)

Il-25 ta’ Ġunju 2009

2009/C 146/02

1 euro =

| | Munita | Rata tal-kambju |
| --- | --- | --- |
| USD | Dollaru Amerikan | 1,3940 |
| JPY | Yen Ġappuniż | 134,34 |
| DKK | Krona Daniża | 7,4455 |
| GBP | Lira Sterlina | 0,85670 |
| SEK | Krona Żvediża | 11,0718 |
| CHF | Frank Żvizzeru | 1,5311 |
| ISK | Krona Iżlandiża | |
| NOK | Krona Norveġiża | 9,0760 |
| BGN | Lev Bulgaru | 1,9558 |
| CZK | Krona Ċeka | 26,080 |
| EEK | Krona Estona | 15,6466 |
| HUF | Forint Ungeriż | 277,10 |
| LTL | Litas Litwan | 3,4528 |
| LVL | Lats Latvjan | 0,6963 |
| PLN | Zloty Pollakk | 4,5160 |
| RON | Leu Rumen | 4,2232 |
| TRY | Lira Turka | 2,1691 |
| AUD | Dollaru Awstraljan | 1,7488 |
| CAD | Dollaru Kanadiż | 1,6200 |
| HKD | Dollaru ta' Hong Kong | 10,8037 |
| NZD | Dollaru tan-New Zealand | 2,1870 |
| SGD | Dollaru tas-Singapor | 2,0336 |
| KRW | Won tal-Korea t'Isfel | 1 794,95 |
| ZAR | Rand ta' l-Afrika t'Isfel | 11,2586 |
| CNY | Yuan ren-min-bi Ċiniż | 9,5276 |
| HRK | Kuna Kroata | 7,3105 |
| IDR | Rupiah Indoneżjan | 14 328,78 |
| MYR | Ringgit Malażjan | 4,9292 |
| PHP | Peso Filippin | 67,111 |
| RUB | Rouble Russu | 43,5400 |
| THB | Baht Tajlandiż | 47,570 |
| BRL | Real Brażiljan | 2,7368 |
| MXN | Peso Messikan | 18,4593 |
| INR | Rupi Indjan | 67,7520 |

Munita

Rata tal-kambju

USD

Dollaru Amerikan

1,3940

JPY

Yen Ġappuniż

134,34

DKK

Krona Daniża

7,4455

GBP

Lira Sterlina

0,85670

SEK

Krona Żvediża

11,0718

CHF

Frank Żvizzeru

1,5311

ISK

Krona Iżlandiża

NOK

Krona Norveġiża

9,0760

BGN

Lev Bulgaru

1,9558

CZK

Krona Ċeka

26,080

EEK

Krona Estona

15,6466

HUF

Forint Ungeriż

277,10

LTL

Litas Litwan

3,4528

LVL

Lats Latvjan

0,6963

PLN

Zloty Pollakk

4,5160

RON

Leu Rumen

4,2232

TRY

Lira Turka

2,1691

AUD

Dollaru Awstraljan

1,7488

CAD

Dollaru Kanadiż

1,6200

HKD

Dollaru ta' Hong Kong

10,8037

NZD

Dollaru tan-New Zealand

2,1870

SGD

Dollaru tas-Singapor

2,0336

KRW

Won tal-Korea t'Isfel

1 794,95

ZAR

Rand ta' l-Afrika t'Isfel

11,2586

CNY

Yuan ren-min-bi Ċiniż

9,5276

HRK

Kuna Kroata

7,3105

IDR

Rupiah Indoneżjan

14 328,78

MYR

Ringgit Malażjan

4,9292

PHP

Peso Filippin

67,111

RUB

Rouble Russu

43,5400

THB

Baht Tajlandiż

47,570

BRL

Real Brażiljan

2,7368

MXN

Peso Messikan

18,4593

INR

Rupi Indjan

67,7520

---

(1)  Sors: rata tal-kambju ta' referenza ppubblikata mill-Bank Ċentrali Ewropew.

---

| 26.6.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 146/6 |
| --- | --- | --- | --- |

26.6.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 146/6

---

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta’ Mejju 2009 sal-31 ta’ Mejju 2009

(Ppubblikat skond l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (1)
  )

2009/C 146/03

—   Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004): Aċċettat

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | INN
  (Isem internazzjonal Mhux Proprjetarju) | Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Forma Farmaċewtika | Kodiċi ATC
  (Kodiċi Anatomiku Terapewtiku Kimiku) | Data tan-notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.5.2009 | Nimvastid | rivastigmine | KRKA, d.d. |
| Novo mesto |
| Šmarješka cesta 6 |
| SI-8501Novo mesto |
| SLOVENIJA |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

INN

(Isem internazzjonal Mhux Proprjetarju)

Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Forma Farmaċewtika

Kodiċi ATC

(Kodiċi Anatomiku Terapewtiku Kimiku)

Data tan-notifika

11.5.2009

Nimvastid

rivastigmine

KRKA, d.d.

Novo mesto

Šmarješka cesta 6

SI-8501Novo mesto

SLOVENIJA

EU/1/09/525/001-025

EU/1/09/525/026-046

Kapsula, iebsa

Pillola li tinħall fil-ħalq

N06DA03

13.5.2009

15.5.2009

Modigraf

Tacrolimus

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19 |
| 2353 EW Leiderdorp |
| NEDERLAND |

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

NEDERLAND

EU/1/09/523/001-002

Granijiet għal suspensjoni orali

L04AD02

20.5.2009

15.5.2009

Ellaone

ulipristal acetate

| Laboratoire HRA Pharma |
| --- |
| 15, rue Béranger |
| 75003 Paris |
| FRANCE |

Laboratoire HRA Pharma

15, rue Béranger

75003 Paris

FRANCE

EU/1/09/522/001

Pillola

Mhux applikabbli

20.5.2009

15.5.2009

Qutenza

capsaicin

| NeurogesX UK Limited |
| --- |
| 265 Strand |
| London |
| WC2R 1BH |
| UNITED KINGDOM |

NeurogesX UK Limited

265 Strand

London

WC2R 1BH

UNITED KINGDOM

EU/1/09/524/001-002

Stikk għall-ġilda

N01BX04

20.5.2009

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004): Aċċettata

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 5.5.2009 | Kinzalkomb | Bayer Schering Pharma AG |
| 13342 Berlin |
| DEUTSCHLAND |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Data tan-notifika

5.5.2009

Kinzalkomb

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/02/214/001-015

8.5.2009

5.5.2009

Kinzalmono

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/98/091/001-014

7.5.2009

6.5.2009

Pritorplus

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/02/215/001-021

8.5.2009

6.5.2009

Pritor

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer HealthCare AG

51368 Leverkusen

DEUTSCHLAND

EU/1/98/089/001-022

8.5.2009

7.5.2009

Viramune

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/97/055/001-004

11.5.2009

7.5.2009

Privigen

| CSL Behring GmbH |
| --- |
| Emil von Behring Strasse 76 |
| 35041 Marburg |
| DEUTSCHLAND |

CSL Behring GmbH

Emil von Behring Strasse 76

35041 Marburg

DEUTSCHLAND

EU/1/08/446/001-004

11.5.2009

7.5.2009

Adenuric

| CSL Behring GmbH |
| --- |
| Emil von Behring Strasse 76 |
| 35041 Marburg |
| DEUTSCHLAND |

CSL Behring GmbH

Emil von Behring Strasse 76

35041 Marburg

DEUTSCHLAND

EU/1/08/447/001-004

11.5.2009

11.5.2009

Tamiflu

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| UNITED KINGDOM |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/02/222/001

EU/1/02/222/003-004

13.5.2009

15.5.2009

REYATAZ

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/03/267/001-010

20.5.2009

15.5.2009

Oprymea

| KRKA, d.d. |
| --- |
| Novo mesto |
| Šmarješka cesta 6 |
| SI-8501 Novo mesto |
| SLOVENIJA |

KRKA, d.d.

Novo mesto

Šmarješka cesta 6

SI-8501 Novo mesto

SLOVENIJA

EU/1/08/469/001-025

20.5.2009

15.5.2009

Telzir

| Glaxo Group Ltd. |
| --- |
| Greenford Road |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.

Greenford Road

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/04/282/001-002

20.5.2009

15.5.2009

Tredaptive

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/08/459/001-014

20.5.2009

15.5.2009

Pelzont

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/08/460/001-014

20.5.2009

15.5.2009

Trevaclyn

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/08/458/001-014

20.5.2009

19.5.2009

Adenuric

| Ipsen Pharma |
| --- |
| 65 quai Georges Gorse |
| 92100 Boulogne-Billancourt |
| FRANCE |

Ipsen Pharma

65 quai Georges Gorse

92100 Boulogne-Billancourt

FRANCE

| Beaufour Ipsen Pharma |
| --- |
| 24, rue Erlanger |
| 75781 Paris Cedex 16 |
| FRANCE |

Beaufour Ipsen Pharma

24, rue Erlanger

75781 Paris Cedex 16

FRANCE

EU/1/08/447/001-004

26.5.2009

20.5.2009

Pramipexole Teva

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| DR Utrecht 3542 |
| NEDERLAND |

Teva Pharma B.V.

Computerweg 10

DR Utrecht 3542

NEDERLAND

EU/1/08/490/001-016

26.5.2009

26.5.2009

TORISEL

| Wyeth Europa Ltd |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Wyeth Europa Ltd

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/07/424/001

28.5.2009

26.5.2009

Luveris

| Serono Europe Limited |
| --- |
| 56, Marsh Wall |
| London |
| E14 9TP |
| UNITED KINGDOM |

Serono Europe Limited

56, Marsh Wall

London

E14 9TP

UNITED KINGDOM

EU/1/00/155/001-006

28.5.2009

26.5.2009

Tysabri

| Elan Pharma International Ltd. |
| --- |
| Monksland, Athlone |
| County Westmeath |
| IRELAND |

Elan Pharma International Ltd.

Monksland, Athlone

County Westmeath

IRELAND

EU/1/06/346/001

28.5.2009

26.5.2009

Pritor

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/98/089/001-022

28.5.2009

26.5.2009

Zavesca

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor |
| 389 Chiswick High Road |
| London |
| W4 4AL |
| UNITED KINGDOM |

Actelion Registration Ltd

BSI Building 13th Floor

389 Chiswick High Road

London

W4 4AL

UNITED KINGDOM

EU/1/02/238/001

28.5.2009

27.5.2009

TRIZIVIR

| Glaxo Group Ltd. |
| --- |
| Greenford Road |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd.

Greenford Road

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/00/156/002-003

29.5.2009

27.5.2009

Ventavis

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

Müllerstrasse 170-178

13342 Berlin

DEUTSCHLAND

EU/1/03/255/001-008

29.5.2009

27.5.2009

Rilutek

| Aventis Pharma S.A. |
| --- |
| 20 avenue Raymond Aron |
| 92165 Antony Cedex |
| FRANCE |

Aventis Pharma S.A.

20 avenue Raymond Aron

92165 Antony Cedex

FRANCE

EU/1/96/010/001

29.5.2009

27.5.2009

PritorPlus

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/02/215/001-021

29.5.2009

28.5.2009

TESAVEL

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/435/001-018

1.6.2009

28.5.2009

ISENTRESS

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Limited

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/436/001-002

1.6.2009

28.5.2009

NovoSeven

| Novo Nordisk A/S |
| --- |
| Novo Allé |
| 2880 Bagsværd |
| DANMARK |

Novo Nordisk A/S

Novo Allé

2880 Bagsværd

DANMARK

EU/1/96/006/001-006

2.6.2009

28.5.2009

AVANDIA

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex |
| TW8 9GS |
| UNITED KINGDOM |

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

UNITED KINGDOM

EU/1/00/137/002-018

1.6.2009

28.5.2009

Soliris

| Alexion Europe SAS |
| --- |
| 54-56 Avenue Hoche |
| 75008 Paris |
| FRANCE |

Alexion Europe SAS

54-56 Avenue Hoche

75008 Paris

FRANCE

EU/1/07/393/001

2.6.2009

28.5.2009

Tarceva

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| UNITED KINGDOM |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/05/311/001-003

1.6.2009

28.5.2009

Insulin Human Winthrop

| Sanofi-Aventis Deutschland GmbH |
| --- |
| 65926 Frankfurt am Main |
| DEUTSCHLAND |

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/06/368/163-168

2.6.2009

28.5.2009

DepoCyte

| Pacira Limited |
| --- |
| West Forest Gate |
| Wellington Road |
| Wokingham |
| Berkshire |
| RG40 2AQ |
| UNITED KINGDOM |

Pacira Limited

West Forest Gate

Wellington Road

Wokingham

Berkshire

RG40 2AQ

UNITED KINGDOM

EU/1/01/187/001

1.6.2009

28.5.2009

Gardasil

| Sanofi Pasteur MSD SNC |
| --- |
| 8, rue Jonas Salk |
| 69007 Lyon |
| FRANCE |

Sanofi Pasteur MSD SNC

8, rue Jonas Salk

69007 Lyon

FRANCE

EU/1/06/357/001-021

2.6.2009

29.5.2009

Ebixa

| H. Lundbeck A/S |
| --- |
| Ottiliavej 9 |
| 2500 Valby |
| DANMARK |

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

DANMARK

EU/1/02/219/001-049

3.6.2009

29.5.2009

Micardis

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/98/090/001-020

3.6.2009

29.5.2009

SUTENT

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT 13 9NJ

UNITED KINGDOM

EU/1/06/347/007-008

3.6.2009

29.5.2009

Lyrica

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT 13 9NJ |
| UNITED KINGDOM |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent

CT 13 9NJ

UNITED KINGDOM

EU/1/04/279/001-043

3.6.2009

29.5.2009

MicardisPlus

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/02/213/001-023

3.6.2009

29.5.2009

Ziagen

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex |
| UB6 0NN |
| UNITED KINGDOM |

Glaxo Group Ltd

Greenford

Middlesex

UB6 0NN

UNITED KINGDOM

EU/1/99/112/001-002

3.6.2009

29.5.2009

CellCept

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| UNITED KINGDOM |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/96/005/001-006

3.6.2009

29.5.2009

Xelevia

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road |
| Hoddesdon |
| Hertfordshire |
| EN11 9BU |
| UNITED KINGDOM |

Merck Sharp & Dohme Ltd

Hertford Road

Hoddesdon

Hertfordshire

EN11 9BU

UNITED KINGDOM

EU/1/07/382/001-018

3.6.2009

29.5.2009

Viramune

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/97/055/001-004

3.6.2009

29.5.2009

Zostavax

| Sanofi Pasteur MSD SNC |
| --- |
| 8, rue Jonas Salk |
| Lyon 69007 |
| FRANCE |

Sanofi Pasteur MSD SNC

8, rue Jonas Salk

Lyon 69007

FRANCE

EU/1/06/341/001-013

3.6.2009

29.5.2009

Replagal

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D |
| SE-182 33 Danderyd |
| SVERIGE |

Shire Human Genetic Therapies AB

Svärdvägen 11D

SE-182 33 Danderyd

SVERIGE

EU/1/01/189/001-006

3.6.2009

29.5.2009

Velcade

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIË |

Janssen-Cilag International NV

Turnhoutseweg 30

2340 Beerse

BELGIË

EU/1/04/274/001-002

3.6.2009

29.5.2009

Aptivus

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173 |
| 55216 Ingelheim am Rhein |
| DEUTSCHLAND |

Boehringer Ingelheim International GmbH

Binger Strasse 173

55216 Ingelheim am Rhein

DEUTSCHLAND

EU/1/05/315/001

3.6.2009

29.5.2009

Kinzalkomb

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/02/214/001-015

3.6.2009

29.5.2009

ORENCIA

| Bristol-Myers Squibb Pharma EEIG |
| --- |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge |
| UB8 1DH |
| UNITED KINGDOM |

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge

UB8 1DH

UNITED KINGDOM

EU/1/07/389/001-003

3.6.2009

29.5.2009

Avastin

| Roche Registration Limited |
| --- |
| 6 Falcon Way |
| Shire Park |
| Welwyn Garden City |
| AL7 1TW |
| UNITED KINGDOM |

Roche Registration Limited

6 Falcon Way

Shire Park

Welwyn Garden City

AL7 1TW

UNITED KINGDOM

EU/1/04/300/001-002

3.6.2009

29.5.2009

Advate

| Baxter AG |
| --- |
| Industriesstrasse 67 |
| 1220 Vienna |
| ÖSTERREICH |

Baxter AG

Industriesstrasse 67

1220 Vienna

ÖSTERREICH

EU/1/03/271/001-006

3.6.2009

29.5.2009

Kinzalmono

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin |
| DEUTSCHLAND |

Bayer Schering Pharma AG

13342 Berlin

DEUTSCHLAND

EU/1/98/091/001-014

3.6.2009

29.5.2009

Enbrel

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire |
| SL6 0PH |
| UNITED KINGDOM |

Wyeth Europa Limited

Huntercombe Lane South

Taplow

Maidenhead

Berkshire

SL6 0PH

UNITED KINGDOM

EU/1/99/126/001-018

3.6.2009

29.5.2009

Insuman

| Sanofi-Aventis Deutschland GmbH |
| --- |
| 65926 Frankfurt am Main |
| DEUTSCHLAND |

Sanofi-Aventis Deutschland GmbH

65926 Frankfurt am Main

DEUTSCHLAND

EU/1/97/030/028-195

3.6.2009

—   Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill (2)
  Aċċettat

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | INN
  (Isem internazzjonal Mhux Proprjetarju) | Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Forma Farmaċewtika | Kodiċi ATC
  (Kodiċi Anatomiku Terapewtiku Kimiku) | Data tan-notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.5.2009 | Improvac | Peptajd sintetiku jixbaħ lil GnRF ikkonjugat ma’ proteina b’min. ta’ 300 μg f’kull doża ta’ 2 ml | PFIZER Limited |
| Ramsgate Road |
| Sandwich |
| Kent |
| CT13 9NJ |
| UNITED KINGDOM |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

INN

(Isem internazzjonal Mhux Proprjetarju)

Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Forma Farmaċewtika

Kodiċi ATC

(Kodiċi Anatomiku Terapewtiku Kimiku)

Data tan-notifika

11.5.2009

Improvac

Peptajd sintetiku jixbaħ lil GnRF ikkonjugat ma’ proteina b’min. ta’ 300 μg f’kull doża ta’ 2 ml

PFIZER Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

UNITED KINGDOM

EU/2/09/095/001-003

Soluzzjoni għall-injezzjoni

QI09AX

13.5.2009

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004): Aċċettata

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 8.5.2009 | Econor | Novartis Animal Health Austria GmbH |
| Biochemiestrasse 10 |
| 6250 Kundl |
| ÖSTERREICH |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Data tan-notifika

8.5.2009

Econor

Novartis Animal Health Austria GmbH

Biochemiestrasse 10

6250 Kundl

ÖSTERREICH

EU/2/98/010/004-006

EU/2/98/010/017-018

EU/2/98/010/021-024

12.5.2009

11.5.2009

Aivlosin

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey |
| KT3 4QS |
| UNITED KINGDOM |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey

KT3 4QS

UNITED KINGDOM

EU/2/04/044/009-010

13.5.2009

19.5.2009

Onsior

| Novartis Animal Health UK Ltd |
| --- |
| Frimley Business Park |
| Frimley/Camberley |
| Surrey |
| GU16 7SR |
| UNITED KINGDOM |

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley/Camberley

Surrey

GU16 7SR

UNITED KINGDOM

EU/2/08/089/001-020

21.5.2009

25.5.2009

Advocate

| Bayer Animal Health GmbH |
| --- |
| 51368 Leverkusen |
| DEUTSCHLAND |

Bayer Animal Health GmbH

51368 Leverkusen

DEUTSCHLAND

EU/2/03/039/001-002

EU/2/03/039/013

EU/2/03/039/019-020

27.5.2009

29.5.2009

Previcox

| Merial |
| --- |
| 29 Avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

Merial

29 Avenue Tony Garnier

69007 Lyon

FRANCE

EU/2/04/045/001-007

3.6.2009

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004): Rifjutata

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 7.5.2009 | Porcilis Porcoli | Intervet International B.V. (NL) |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| NEDERLAND |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Data tan-notifika

7.5.2009

Porcilis Porcoli

Intervet International B.V. (NL)

Wim de Körverstraat 35

5831 AN Boxmeer

NEDERLAND

EU/2/96/001/003-008

11.5.2009

Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika fuq il-prodotti mediċinali inkwistjoni u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| L-Aġenzija Ewropea tal-Mediċini |
| --- |
| 7, Westferry Circus |
| Canary Wharf |
| London |
| E14 4HB |
| UNITED KINGDOM |

L-Aġenzija Ewropea tal-Mediċini

7, Westferry Circus

Canary Wharf

London

E14 4HB

UNITED KINGDOM

---

(1)  ĠU L 136, 30.4.2004, p. 1

(2)  ĠU L 136, 30.4.2004, p. 1

---

| 26.6.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 146/15 |
| --- | --- | --- | --- |

26.6.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 146/15

---

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta' Mejju 2009 sal-31 ta' Mejju 2009

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE tal-Parlament Ewropew u tal-Kunsill
   (1)
  jew Artikolu 38 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill
   (2)
  )

2009/C 146/04

—   Ħruġ, manteniment jew modifikazzjoni tal- l-awtorizazzjonijiet nazzjonali tat-tqegħid fis-suq

| Data tad-Deċiżjoni | Isem(ijiet) tal-prodott mediċinali | Detentur(i) ta’ l-awtorizazzjoni għat-tqegħid fis-suq | Stat Membru konċernat | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 5.5.2009 | Unisol 10 % Oral Solution | Ara l-Anness I | Ara l-Anness I | 6.5.2009 |
| 5.5.2009 | Enro-K 10 % Oral Solution | Ara l-Anness II | Ara l-Anness II | 6.5.2009 |
| 7.5.2009 | Budesonide Sandoz | Ara l-Anness III | Ara l-Anness III | 8.5.2009 |
| 11.5.2009 | Atifor Chiesi 12 mcg | Ara l-Anness IV | Ara l-Anness IV | 12.5.2009 |
| 11.5.2009 | Forair Chiesi 12 mcg | Ara l-Anness V | Ara l-Anness V | 12.5.2009 |
| 15.5.2009 | Qutenza | NeurogesX UK Limited |
| 265 Strand |
| London |
| WC2R 1BH |
| UNITED KINGDOM |

Data tad-Deċiżjoni

Isem(ijiet) tal-prodott mediċinali

Detentur(i) ta’ l-awtorizazzjoni għat-tqegħid fis-suq

Stat Membru konċernat

Data tan-notifika

5.5.2009

Unisol 10 % Oral Solution

Ara l-Anness I

Ara l-Anness I

6.5.2009

5.5.2009

Enro-K 10 % Oral Solution

Ara l-Anness II

Ara l-Anness II

6.5.2009

7.5.2009

Budesonide Sandoz

Ara l-Anness III

Ara l-Anness III

8.5.2009

11.5.2009

Atifor Chiesi 12 mcg

Ara l-Anness IV

Ara l-Anness IV

12.5.2009

11.5.2009

Forair Chiesi 12 mcg

Ara l-Anness V

Ara l-Anness V

12.5.2009

15.5.2009

Qutenza

NeurogesX UK Limited

265 Strand

London

WC2R 1BH

UNITED KINGDOM

Din id-Deċiżjoni hija indirizzata lill-Istati Membri

18.5.2009

27.5.2009

Methylphenidate

Ara l-Anness VI

Ara l-Anness 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

Din id-Deċiżjoni hija indirizzata lill-Istati Membri

2.6.2009

29.5.2009

GLUSCAN 500

Ara l-Anness VII

Ara l-Anness VII

2.6.2009

---

(1)  ĠU L 311, 28.11.2001, p. 67

(2)  ĠU L 311, 28.11.2001, p. 1

---

ANNESS I

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI VETERINARJU, SPEĊI TA’ ANNIMALI, MNEJN JINGĦATA, APPLIKANT FL-ISTATI MEMBRI

| Stat Membru | Applikant | Isem ivvintat | Għamla farmaċewtika | Qawwa | Speċi ta’ annimali | Doża rakkomandata |
| --- | --- | --- | --- | --- | --- | --- |
| Il-Belġju | Universal Farma, S.L. |
| Gran Vía Carlos III, 98 — 7a |
| 08028 Barċellona |
| SPANJA |

Stat Membru

Applikant

Isem ivvintat

Għamla farmaċewtika

Qawwa

Speċi ta’ annimali

Doża rakkomandata

Il-Belġju

Universal Farma, S.L.

Gran Vía Carlos III, 98 — 7a

08028 Barċellona

SPANJA

Unisol 10 % Soluzzjoni Orali

Soluzzjoni Orali

100 mg/ml

Tiġieġ u dundjani

50 ml tal-prodott għal kull 100 litru ta’ ilma jew 10 mg tas-sustanza attiva għal kull kg ta’ piż tal-ġisem kuljum. Il-kura għandha tibqa’ sejra għal massimu ta’ 3 ijiem. Għas-salmonellożi, il-kura għandha tiġi estiża għal 5 ijiem.

Ir-Repubblika Ċeka

| Universal Farma, S.L. |
| --- |
| Gran Vía Carlos III, 98 — 7a |
| 08028 Barċellona |
| SPANJA |

Universal Farma, S.L.

Gran Vía Carlos III, 98 — 7a

08028 Barċellona

SPANJA

Unisol 10 % Soluzzjoni Orali

Soluzzjoni Orali

100 mg/ml

Tiġieġ u dundjani

50 ml tal-prodott għal kull 100 litru ta’ ilma jew 10 mg tas-sustanza attiva għal kull kg ta’ piż tal-ġisem kuljum. Il-kura għandha tibqa’ sejra għal massimu ta’ 3 ijiem. Għas-salmonellożi, il-kura għandha tiġi estiża għal 5 ijiem.

Il-Ġermanja

| Universal Farma, S.L. |
| --- |
| Gran Vía Carlos III, 98 — 7a |
| 08028 Barċellona |
| SPANJA |

Universal Farma, S.L.

Gran Vía Carlos III, 98 — 7a

08028 Barċellona

SPANJA

Unisol 10 % Soluzzjoni Orali

Soluzzjoni Orali

100 mg/ml

Tiġieġ u dundjani

50 ml tal-prodott għal kull 100 litru ta’ ilma jew 10 mg tas-sustanza attiva għal kull kg ta’ piż tal-ġisem kuljum. Il-kura għandha tibqa’ sejra għal massimu ta’ 3 ijiem. Għas-salmonellożi, il-kura għandha tiġi estiża għal 5 ijiem.

L-Irlanda

| Universal Farma, S.L. |
| --- |
| Gran Vía Carlos III, 98 — 7a |
| 08028 Barċellona |
| SPANJA |

Universal Farma, S.L.

Gran Vía Carlos III, 98 — 7a

08028 Barċellona

SPANJA

Unisol 10 % Soluzzjoni Orali

Soluzzjoni Orali

100 mg/ml

Tiġieġ u dundjani

50 ml tal-prodott għal kull 100 litru ta’ ilma jew 10 mg tas-sustanza attiva għal kull kg ta’ piż tal-ġisem kuljum. Il-kura għandha tibqa’ sejra għal massimu ta’ 3 ijiem. Għas-salmonellożi, il-kura għandha tiġi estiża għal 5 ijiem.

Il-Polonja

| Universal Farma, S.L. |
| --- |
| Gran Vía Carlos III, 98 — 7a |
| 08028 Barċellona |
| SPANJA |

Universal Farma, S.L.

Gran Vía Carlos III, 98 — 7a

08028 Barċellona

SPANJA

Unisol 10 % Soluzzjoni Orali

Soluzzjoni Orali

100 mg/ml

Tiġieġ u dundjani

50 ml tal-prodott għal kull 100 litru ta’ ilma jew 10 mg tas-sustanza attiva għal kull kg ta’ piż tal-ġisem kuljum. Il-kura għandha tibqa’ sejra għal massimu ta’ 3 ijiem. Għas-salmonellożi, il-kura għandha tiġi estiża għal 5 ijiem.

---

ANNESS II

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI VETERINARJU, SPEĊI TA’ ANNIMALI, MNEJN JINGĦATA, APPLIKANT FL-ISTATI MEMBRI

| Stat Membru | Applikant | Isem ivvintat | Għamla farmaċewtika | Qawwa | Speċi ta’ annimali | Doża rakkomandata |
| --- | --- | --- | --- | --- | --- | --- |
| Il-Belġju | Laboratorios Karizoo S.A. |
| Mas Pujades |
| 11-12 Pol. Ind. La Borda |
| 08140 Caldes de Montbui |
| SPANJA |

Stat Membru

Applikant

Isem ivvintat

Għamla farmaċewtika

Qawwa

Speċi ta’ annimali

Doża rakkomandata

Il-Belġju

Laboratorios Karizoo S.A.

Mas Pujades

11-12 Pol. Ind. La Borda

08140 Caldes de Montbui

SPANJA

Enro-K 10 % Soluzzjoni Orali

Soluzzjoni Orali

100 mg/ml

Tiġieġ u dundjani

50 ml tal-prodott għal kull 100 litru ta’ ilma jew 10 mg tas-sustanza attiva għal kull kg ta’ piż tal-ġisem kuljum. Il-kura għandha tibqa’ sejra għal massimu ta’ 3 ijiem. Għas-salmonellożi, il-kura għandha tiġi estiża għal 5 ijiem.

Ir-Repubblika Ċeka

| Laboratorios Karizoo S.A. |
| --- |
| Mas Pujades |
| 11-12 Pol. Ind. La Borda |
| 08140 Caldes de Montbui |
| SPANJA |

Laboratorios Karizoo S.A.

Mas Pujades

11-12 Pol. Ind. La Borda

08140 Caldes de Montbui

SPANJA

Enro-K 10 % Soluzzjoni Orali

Soluzzjoni Orali

100 mg/ml

Tiġieġ u dundjani

50 ml tal-prodott għal kull 100 litru ta’ ilma jew 10 mg tas-sustanza attiva għal kull kg ta’ piż tal-ġisem kuljum. Il-kura għandha tibqa’ sejra għal massimu ta’ 3 ijiem. Għas-salmonellożi, il-kura għandha tiġi estiża għal 5 ijiem.

Il-Ġermanja

| Laboratorios Karizoo S.A. |
| --- |
| Mas Pujades |
| 11-12 Pol. Ind. La Borda |
| 08140 Caldes de Montbui |
| SPANJA |

Laboratorios Karizoo S.A.

Mas Pujades

11-12 Pol. Ind. La Borda

08140 Caldes de Montbui

SPANJA

Enro-K 10 % Soluzzjoni Orali

Soluzzjoni Orali

100 mg/ml

Tiġieġ u dundjani

50 ml tal-prodott għal kull 100 litru ta’ ilma jew 10 mg tas-sustanza attiva għal kull kg ta’ piż tal-ġisem kuljum. Il-kura għandha tibqa’ sejra għal massimu ta’ 3 ijiem. Għas-salmonellożi, il-kura għandha tiġi estiża għal 5 ijiem.

L-Irlanda

| Laboratorios Karizoo S.A. |
| --- |
| Mas Pujades |
| 11-12 Pol. Ind. La Borda |
| 08140 Caldes de Montbui |
| SPANJA |

Laboratorios Karizoo S.A.

Mas Pujades

11-12 Pol. Ind. La Borda

08140 Caldes de Montbui

SPANJA

Enro-K 10 % Soluzzjoni Orali

Soluzzjoni Orali

100 mg/ml

Tiġieġ u dundjani

50 ml tal-prodott għal kull 100 litru ta’ ilma jew 10 mg tas-sustanza attiva għal kull kg ta’ piż tal-ġisem kuljum. Il-kura għandha tibqa’ sejra għal massimu ta’ 3 ijiem. Għas-salmonellożi, il-kura għandha tiġi estiża għal 5 ijiem.

Il-Polonja

| Laboratorios Karizoo S.A. |
| --- |
| Mas Pujades |
| 11-12 Pol. Ind. La Borda |
| 08140 Caldes de Montbui |
| SPANJA |

Laboratorios Karizoo S.A.

Mas Pujades

11-12 Pol. Ind. La Borda

08140 Caldes de Montbui

SPANJA

Enro-K 10 % Soluzzjoni Orali

Soluzzjoni Orali

100 mg/ml

Tiġieġ u dundjani

50 ml tal-prodott għal kull 100 litru ta’ ilma jew 10 mg tas-sustanza attiva għal kull kg ta’ piż tal-ġisem kuljum. Il-kura għandha tibqa’ sejra għal massimu ta’ 3 ijiem. Għas-salmonellożi, il-kura għandha tiġi estiża għal 5 ijiem.

---

ANNESS III

LISTA TA’ L-ISMIJIET, GĦAMLA FARMAĊEWTIKA (GĦAMLIET FARMAĊEWTIĊI), QAWWA (QAWWIET) TAL-PRODOTT(I) MEDIĊINALI, MNEJN JINGĦATA(W), L-APPLIKANT(I) FL-ISTATI MEMBRI

| Stat Membru UE/ŻEE | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | L-Applikant | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnejn jingħata | Il-Kontenut
  (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Ir-Repubblika Ċeka | | Sandoz Pharmaceuticals GmbH |
| Raiffeisenstraße 11 |
| 83607 Holzkirchen |
| IL-ĠERMANJA |

Stat Membru UE/ŻEE

Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq

L-Applikant

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

Il-Kontenut

(Konċentrat)

Ir-Repubblika Ċeka

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11

83607 Holzkirchen

IL-ĠERMANJA

Tafen Aqua 32 μg nosní spray

Tafen Aqua 64 μg nosní spray

32 mcg/doża

64 mcg/doża

Sprej għall-imnieħer, suspensjoni

Użu għall-imnieħer

0,64 mg/ml

1,28 mg/ml

Id-Danimarka

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11 |
| 83607 Holzkirchen |
| IL-ĠERMANJA |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11

83607 Holzkirchen

IL-ĠERMANJA

Budesonid Sandoz

32 mcg/doża

64 mcg/doża

Sprej għall-imnieħer, suspensjoni

Użu għall-imnieħer

0,64 mg/ml

1,28 mg/ml

Franza

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11 |
| 83607 Holzkirchen |
| IL-ĠERMANJA |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11

83607 Holzkirchen

IL-ĠERMANJA

BUDESONIDE SANDOZ 64 μg/dose, suspension pour pulvérisation nasale

64 mcg/doża

Sprej għall-imnieħer, suspensjoni

Użu għall-imnieħer

1,28 mg/ml

Il-Ġermanja

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11 |
| 83607 Holzkirchen |
| IL-ĠERMANJA |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11

83607 Holzkirchen

IL-ĠERMANJA

Budesonid Sandoz 32 Mikrogramm/Sprühstoß Nasenspray, Suspension

Budesonid Sandoz 64 Mikrogramm/Sprühstoß Nasenspray, Suspension

32 mcg/doża

64 mcg/doża

Sprej għall-imnieħer, suspensjoni

Użu għall-imnieħer

0,64 mg/ml

1,28 mg/ml

L-Olanda

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11 |
| 83607 Holzkirchen |
| IL-ĠERMANJA |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11

83607 Holzkirchen

IL-ĠERMANJA

Budesonide Sandoz 32 microgram/dosis, neusspray, suspensie

Budesonide Sandoz 64 microgram/dosis, neusspray, suspensie

32 mcg/doża

64 mcg/doża

Sprej għall-imnieħer, suspensjoni

Użu għall-imnieħer

0,64 mg/ml

1,28 mg/ml

In-Norvegja

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11 |
| 83607 Holzkirchen |
| IL-ĠERMANJA |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11

83607 Holzkirchen

IL-ĠERMANJA

Budesonid Sandoz

32 mcg/doża

64 mcg/doża

Sprej għall-imnieħer, suspensjoni

Użu għall-imnieħer

0,64 mg/ml

1,28 mg/ml

Il-Polonja

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstraße 11 |
| 83607 Holzkirchen |
| IL-ĠERMANJA |

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11

83607 Holzkirchen

IL-ĠERMANJA

Tafen Nasal 32

Tafen Nasal 64

32 mcg/doża

64 mcg/doża

Sprej għall-imnieħer, suspensjoni

Użu għall-imnieħer

0,64 mg/ml

1,28 mg/ml

L-Isvezja

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40 |
| 5220 Odense SØ |
| ID-DANIMARKA |

Sandoz A/S

C.F. Tietgens Boulevard 40

5220 Odense SØ

ID-DANIMARKA

Desonix

32 mcg/doża

64 mcg/doża

Sprej għall-imnieħer, suspensjoni

Użu għall-imnieħer

0,64 mg/ml

1,28 mg/ml

Ir-Renju Unit

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| L-OLANDA |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

L-OLANDA

Budesonide Aqua 64 micrograms Nasal Spray

32 mcg/doża

64 mcg/doża

Sprej għall-imnieħer, suspensjoni

Użu għall-imnieħer

1,28 mg/ml

---

ANNESS IV

LISTA TAL- ISMIJIET IVVINTATI, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA U D-DETENTURI TAL- AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

Atifor chiesi 12 mcg u ismijiet assoċjati miegħu b’awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropeja

| Stat Membru (EU/EAA) | Id-Detentur tal- Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Novartis Pharma GmBH |
| Brunner Strasse 59 |
| 1235 Wien |
| L-AWSTRIJA |

Stat Membru (EU/EAA)

Id-Detentur tal- Awtorizzazzjoni għat-tqegħid fis-suq

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Novartis Pharma GmBH

Brunner Strasse 59

1235 Wien

L-AWSTRIJA

FORADIL

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-Belġju

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Ir-Republika Ċeka

| Torrex Chiesi Pharma s.r.o. CZ |
| --- |
| Na Kvetnici 33 |
| 140 00 Praha 4 |
| IR-REPUBLIKA ĊEKA |

Torrex Chiesi Pharma s.r.o. CZ

Na Kvetnici 33

140 00 Praha 4

IR-REPUBLIKA ĊEKA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

L-Estonja

| Torrex Chiesi Pharma GmbH |
| --- |
| Gonzagagasse 16/16 |
| 1010 Vienna |
| L-AWSTRIJA |

Torrex Chiesi Pharma GmbH

Gonzagagasse 16/16

1010 Vienna

L-AWSTRIJA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Franza

| Chiesi S.A. Immeuble le Doublon |
| --- |
| 11 Avenue Dubonnet |
| 92400 Courbevoie |
| FRANZA |

Chiesi S.A. Immeuble le Doublon

11 Avenue Dubonnet

92400 Courbevoie

FRANZA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-ĠERMANJA

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

ATIFOR CHIESI

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12 klm National Road No 1 Athens-Lamia |
| 14453 – Metamorphosis |
| IL-GREĊJA |

Novartis (Hellas) S.A.C.I.

12 klm National Road No 1 Athens-Lamia

14453 – Metamorphosis

IL-GREĊJA

FORADIL

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

L-Ungerija

| Torrex Chiesi Kft. |
| --- |
| Kristóf tér 4. |
| 1052 Budapest |
| L-UNGERIJA |

Torrex Chiesi Kft.

Kristóf tér 4.

1052 Budapest

L-UNGERIJA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-Latvja

| Torrex Chiesi Pharma GmbH |
| --- |
| Gonzagagasse 16/16 |
| 1010 Vienna |
| L-AWSTRIJA |

Torrex Chiesi Pharma GmbH

Gonzagagasse 16/16

1010 Vienna

L-AWSTRIJA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-Litwanja

| Torrex Chiesi Pharma GmbH |
| --- |
| Gonzagagasse 16/16 |
| 1010 Vienna |
| L-AWSTRIJA |

Torrex Chiesi Pharma GmbH

Gonzagagasse 16/16

1010 Vienna

L-AWSTRIJA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-Polonja

| Torrex Chiesi Polska Sp. z o.o. |
| --- |
| ul. Biala 3 |
| 00-895 Warszawa |
| IL-POLONJA |

Torrex Chiesi Polska Sp. z o.o.

ul. Biala 3

00-895 Warszawa

IL-POLONJA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-Portugall

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A,

43100 Parma

L-ITALJA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

ls-Slovakkja

| Torrex Chiesi Slovakia s.r.o. |
| --- |
| Sulekova 14 |
| 811 06 Bratislava |
| IR-REPUBLIKA SLOVAKKA |

Torrex Chiesi Slovakia s.r.o.

Sulekova 14

811 06 Bratislava

IR-REPUBLIKA SLOVAKKA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Is-Slovenja

| Torrex Chiesi Slovenija, d.o.o. |
| --- |
| Trdinova ulica 4 |
| 1000 Ljubljana |
| IS-SLOVENJA |

Torrex Chiesi Slovenija, d.o.o.

Trdinova ulica 4

1000 Ljubljana

IS-SLOVENJA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Spanja

| Chiesi España S.A. |
| --- |
| Berlín, 38-48 7a planta |
| 08029 Barcelona |
| SPANJA |

Chiesi España S.A.

Berlín, 38-48 7a planta

08029 Barcelona

SPANJA

BRONCORAL NEO

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

L-Olanda

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A, |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A,

43100 Parma

L-ITALJA

ATIMOS

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Ir-Renju Unit

| Trinity-Chiesi Pharmaceuticals Ltd. |
| --- |
| Cheadle Royal Business Park, |
| Highfield, Cheadle |
| SK8 3GY |
| IR-RENJU UNIT |

Trinity-Chiesi Pharmaceuticals Ltd.

Cheadle Royal Business Park,

Highfield, Cheadle

SK8 3GY

IR-RENJU UNIT

ATIMOS MODULITE

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

---

ANNESS V

LISTA TAL-ISMIJIET IVVINTATI, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA U D-DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

Forair chiesi 12 mcg u ismijiet assoċjati miegħu b’awtorizzazzjoni għat-tqegħid fis-suq fl-unjoni ewropeja

| Stat Membru (EU/EAA) | Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Chiesi Farmaceutici S.p.A. |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Stat Membru (EU/EAA)

Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

FORAIR

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-Belġju

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

FORMOAIR

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Ir-Republika Ċeka

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

FORAIR

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Id-Danimarka

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Copenhagen |
| ID-DANIMARKA |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Copenhagen

ID-DANIMARKA

FORADIL HFA

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Franza

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

FORMOAIR

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-Ġermanja

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

FORAIR CHIESI

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-Greċja

| Chiesi Hellas S.A. |
| --- |
| Anapafseos 30 |
| 15235 Vrilissia - Athens |
| IL-GREĊJA |

Chiesi Hellas S.A.

Anapafseos 30

15235 Vrilissia - Athens

IL-GREĊJA

FORAIR

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

L-Ungerija

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

FORAIR

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Il-Portugall

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

FORAIR

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Spanja

| Novartis Faramceutica S.A. |
| --- |
| Apartado 708 |
| 08080 Barcelona |
| SPANJA |

Novartis Faramceutica S.A.

Apartado 708

08080 Barcelona

SPANJA

FORADIL NEO

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

ls-Slovakkja

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

FORAIR

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

L-Olanda

| Novartis Pharma B.V. |
| --- |
| Postbus 241 |
| NL-6800 LZ Arnhem |
| L-OLANDA |

Novartis Pharma B.V.

Postbus 241

NL-6800 LZ Arnhem

L-OLANDA

FORADIL

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

Ir-Renju Unit

| Chiesi Farmaceutici S.p.A. |
| --- |
| Via Palermo 26/A |
| 43100 Parma |
| L-ITALJA |

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A

43100 Parma

L-ITALJA

FORAIR MODULITE

12 mcg/attwazzjoni

Sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni

Użu biex jittieħed man-nifs

---

ANNESS VI

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, SIDIEN TAL-AWTORIZZAZZJONI TAL- KUMMERĊ TAL-APPLIKANT FL-ISTATI MEMBRI

Awtorizzazzjonijiet għat-Tqegħid fis-Suq għal prodotti mediċinali li fihom il-Methylphenidate (metilfenidat)

| Stat Membru (UE/ŻEE) | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem ivvintat | Qawwa | Għamla farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| AT – L-Awstrija | Janssen-Cilag Pharma GmbH |
| Pfarrgasse 75 |
| 1232 Wien |
| AUSTRIA |

Stat Membru (UE/ŻEE)

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem ivvintat

Qawwa

Għamla farmaċewtika

Mnejn jingħata

AT – L-Awstrija

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

1232 Wien

AUSTRIA

Concerta 18 mg Retardtabletten

18 mg

pilloli b’rilaxx imtawwal

użu orali

AT – L-Awstrija

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 |
| 1232 Wien |
| AUSTRIA |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

1232 Wien

AUSTRIA

Concerta 36 mg Retardtabletten

36 mg

pilloli b’rilaxx imtawwal

użu orali

AT – L-Awstrija

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 |
| 1232 Wien |
| AUSTRIA |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

1232 Wien

AUSTRIA

Concerta 54 mg Retardtabletten

54 mg

pilloli b’rilaxx imtawwal

użu orali

AT – L-Awstrija

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 |
| 1232 Wien |
| AUSTRIA |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

1232 Wien

AUSTRIA

Concerta 27 mg Retardtabletten

27 mg

pilloli b’rilaxx imtawwal

użu orali

AT – L-Awstrija

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

AT – L-Awstrija

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

AT – L-Awstrija

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

AT – L-Awstrija

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

AT – L-Awstrija

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

AT – L-Awstrija

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

AT – L-Awstrija

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

AT – L-Awstrija

| 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

pilloli

użu orali

AT – L-Awstrija

| 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

pilloli

użu orali

AT – L-Awstrija

| 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

pilloli

użu orali

AT – L-Awstrija

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

AT – L-Awstrija

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

AT – L-Awstrija

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

AT – L-Awstrija

| Novartis Pharma GmbH |
| --- |
| Brunner Straße 59 |
| 1235 Wien |
| AUSTRIA |

Novartis Pharma GmbH

Brunner Straße 59

1235 Wien

AUSTRIA

Ritalin 10 mg - Tabletten

10 mg

pilloli

użu orali

AT – L-Awstrija

| 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

pilloli

użu orali

AT – L-Awstrija

| 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

pilloli

użu orali

AT – L-Awstrija

| 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

pilloli

użu orali

BE – Il-Belġju

| JANSSEN CILAG N.V. |
| --- |
| Roderveldlaan 1 |
| 2600 Berchem |
| BELGIUM |

JANSSEN CILAG N.V.

Roderveldlaan 1

2600 Berchem

BELGIUM

CONCERTA 18 MG

18 mg

pilloli b’rilaxx imtawwal

użu orali

BE – Il-Belġju

| JANSSEN CILAG N.V. |
| --- |
| Roderveldlaan 1 |
| 2600 Berchem |
| BELGIUM |

JANSSEN CILAG N.V.

Roderveldlaan 1

2600 Berchem

BELGIUM

CONCERTA 36 MG

36 mg

pilloli b’rilaxx imtawwal

użu orali

BE – Il-Belġju

| JANSSEN CILAG N.V. |
| --- |
| Roderveldlaan 1 |
| 2600 Berchem |
| BELGIUM |

JANSSEN CILAG N.V.

Roderveldlaan 1

2600 Berchem

BELGIUM

CONCERTA 54 MG

54 mg

pilloli b’rilaxx imtawwal

użu orali

BE – Il-Belġju

| JANSSEN CILAG N.V. |
| --- |
| Roderveldlaan 1 |
| 2600 Berchem |
| BELGIUM |

JANSSEN CILAG N.V.

Roderveldlaan 1

2600 Berchem

BELGIUM

CONCERTA 27 MG

27 mg

pilloli b’rilaxx imtawwal

użu orali

BE – Il-Belġju

| NOVARTIS PHARMA N.V. |
| --- |
| Medialaan 40 |
| 1800 Vilvoorde |
| BELGIUM |

NOVARTIS PHARMA N.V.

Medialaan 40

1800 Vilvoorde

BELGIUM

RILATINE

10 mg

pilloli

użu orali

BE – Il-Belġju

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

BE – Il-Belġju

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

BE – Il-Belġju

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

BG – Il-Bulgarija

| 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

pilloli b’rilaxx imtawwal

użu orali

BG – Il-Bulgarija

| 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

pilloli b’rilaxx imtawwal

użu orali

BG – Il-Bulgarija

| 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

pilloli b’rilaxx imtawwal

użu orali

CY – Ċipru

| Janssen-Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Cilag International N.V.

Turnhoutseweg 30

2340 Beerse

BELGIUM

Concerta

18 mg

pilloli b’rilaxx imtawwal

użu orali

CY – Ċipru

| Janssen-Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Cilag International N.V.

Turnhoutseweg 30

2340 Beerse

BELGIUM

Concerta

36 mg

pilloli b’rilaxx imtawwal

użu orali

CY – Ċipru

| Janssen-Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Cilag International N.V.

Turnhoutseweg 30

2340 Beerse

BELGIUM

Concerta

54 mg

pilloli b’rilaxx imtawwal

użu orali

CZ – Ir-Repubblika Ċeka

| 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

pilloli

użu orali

CZ – Ir-Repubblika Ċeka

| 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

pilloli b’rilaxx imtawwal

użu orali

CZ – Ir-Repubblika Ċeka

| 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

pilloli b’rilaxx imtawwal

użu orali

CZ – Ir-Repubblika Ċeka

| 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

pilloli b’rilaxx imtawwal

użu orali

DK – Id-Danimarka

| Janssen-Cilag A/S |
| --- |
| Hammerbakken 19 |
| 3460 Birkerød |
| DENMARK |

Janssen-Cilag A/S

Hammerbakken 19

3460 Birkerød

DENMARK

CONCERTA

18 mg

pilloli b’rilaxx imtawwal

użu orali

DK – Id-Danimarka

| Janssen-Cilag A/S |
| --- |
| Hammerbakken 19 |
| 3460 Birkerød |
| DENMARK |

Janssen-Cilag A/S

Hammerbakken 19

3460 Birkerød

DENMARK

CONCERTA

36 mg

pilloli b’rilaxx imtawwal

użu orali

DK – Id-Danimarka

| Janssen-Cilag A/S |
| --- |
| Hammerbakken 19 |
| 3460 Birkerød |
| DENMARK |

Janssen-Cilag A/S

Hammerbakken 19

3460 Birkerød

DENMARK

CONCERTA

54 mg

pilloli b’rilaxx imtawwal

użu orali

DK – Id-Danimarka

| 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

pilloli

użu orali

DK – Id-Danimarka

| 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

pilloli

użu orali

DK – Id-Danimarka

| 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

pilloli

użu orali

DK – Id-Danimarka

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

DK – Id-Danimarka

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

Medice Arzneimittle

Kuhloweg 37-39

Iserlohn

GERMANY

Medikinet

5, 10, 20 mg

pilloli

użu orali

DK – Id-Danimarka

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

Medice Arzneimittle

Kuhloweg 37-39

Iserlohn

GERMANY

Medikinet CR

10, 20, 30, 40 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

DK – Id-Danimarka

| 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

pilloli

użu orali

DK – Id-Danimarka

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

Novartis Healthcare

Lyngbyvej 172

2100 Københarn Ø

DENMARK

Ritalin

10 mg

pilloli

użu orali

DK – Id-Danimarka

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

Novartis Healthcare

Lyngbyvej 172

2100 Københarn Ø

DENMARK

Ritalin Uno

20, 30, 40 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

ES – Spanja

| 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

pilloli

użu orali

ES – Spanja

| 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

pilloli

użu orali

ES – Spanja

| 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

pilloli

użu orali

ES – Spanja

| 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

pilloli b’rilaxx imtawwal

użu orali

ES – Spanja

| 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

pilloli b’rilaxx imtawwal

użu orali

ES – Spanja

| 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

pilloli b’rilaxx imtawwal

użu orali

ES – Spanja

| 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

pilloli b’rilaxx imtawwal

użu orali

ES – Spanja

| 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

pilloli

użu orali

ES – Spanja

| 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

pilloli

użu orali

ES – Spanja

| 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

pilloli

użu orali

ES – Spanja

| Medice Arznemitel Putter GmbH |
| --- |
| Kuhloweg 37 |
| 58638 Iselohon |
| GERMANY |

Medice Arznemitel Putter GmbH

Kuhloweg 37

58638 Iselohon

GERMANY

MEDIKINET 5 mg comprimidos

5 mg

pilloli

użu orali

ES – Spanja

| Medice Arznemitel Putter GmbH |
| --- |
| Kuhloweg 37 |
| 58638 Iselohon |
| GERMANY |

Medice Arznemitel Putter GmbH

Kuhloweg 37

58638 Iselohon

GERMANY

MEDIKINET 10 mg comprimidos

10 mg

pilloli

użu orali

ES – Spanja

| Medice Arznemitel Putter GmbH |
| --- |
| Kuhloweg 37 |
| 58638 Iselohon |
| GERMANY |

Medice Arznemitel Putter GmbH

Kuhloweg 37

58638 Iselohon

GERMANY

MEDIKINET 20 mg comprimidos

20 mg

pilloli

użu orali

ES – Spanja

| 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

pilloli b’rilaxx imtawwal

użu orali

ES – Spanja

| 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

pilloli b’rilaxx imtawwal

użu orali

ES – Spanja

| 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

pilloli b’rilaxx imtawwal

użu orali

ES – Spanja

| 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

pilloli b’rilaxx imtawwal

użu orali

ET – L-Estonja

| 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

pilloli b’rilaxx imtawwal

użu orali

ET – L-Estonja

| 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

pilloli b’rilaxx imtawwal

użu orali

ET – L-Estonja

| 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

pilloli b’rilaxx imtawwal

użu orali

FI – Il-Finlandja

| Janssen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |
| FINLAND |

Janssen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

FINLAND

Concerta

18 mg

pilloli b’rilaxx imtawwal

użu orali

FI – Il-Finlandja

| Janssen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |
| FINLAND |

Janssen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

FINLAND

Concerta

27 mg

pilloli b’rilaxx imtawwal

użu orali

FI – Il-Finlandja

| Janssen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |
| FINLAND |

Janssen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

FINLAND

Concerta

36 mg

pilloli b’rilaxx imtawwal

użu orali

FI – Il-Finlandja

| Janssen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |
| FINLAND |

Janssen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

FINLAND

Concerta

54 mg

pilloli b’rilaxx imtawwal

użu orali

FI – Il-Finlandja

| UCB Pharma Oy Finland |
| --- |
| Malminkaari 5 |
| FI-00700 Helsinki |
| FINLAND |

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

FINLAND

Equasym Retard

10 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

FI – Il-Finlandja

| UCB Pharma Oy Finland |
| --- |
| Malminkaari 5 |
| FI-00700 Helsinki |
| FINLAND |

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

FINLAND

Equasym Retard

20 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

FI – Il-Finlandja

| UCB Pharma Oy Finland |
| --- |
| Malminkaari 5 |
| FI-00700 Helsinki |
| FINLAND |

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

FINLAND

Equasym Retard

30 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

FI – Il-Finlandja

| 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

pilloli

użu orali

FI – Il-Finlandja

| 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

pilloli

użu orali

FI – Il-Finlandja

| 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

pilloli

użu orali

FI – Il-Finlandja

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

FI – Il-Finlandja

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

FI – Il-Finlandja

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

FI – Il-Finlandja

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

FR – Franza

| 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

pilloli b’rilaxx imtawwal

użu orali

FR – Franza

| 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

pilloli b’rilaxx imtawwal

użu orali

FR – Franza

| 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

pilloli b’rilaxx imtawwal

użu orali

FR – Franza

| 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

pilloli b’rilaxx imtawwal

użu orali

FR – Franza

| 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

pilloli

użu orali

FR – Franza

| 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

pilloli

użu orali

FR – Franza

| 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

pilloli

użu orali

FR – Franza

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

FR – Franza

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

FR – Franza

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

FR – Franza

| 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

pilloli

użu orali

FR – Franza

| 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

kapsuli b’rilaxx modifikat

użu orali

FR – Franza

| 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

kapsuli b’rilaxx modifikat

użu orali

FR – Franza

| 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

kapsuli b’rilaxx modifikat

użu orali

HU – L-Ungerija

| JANSSEN-CILAG Kft. |
| --- |
| Törökbálint |
| Tó Park 2045 |
| HUNGARY |

JANSSEN-CILAG Kft.

Törökbálint

Tó Park 2045

HUNGARY

CONCERTA 18 mg

18 mg

retard pilloli

użu orali

HU – L-Ungerija

| JANSSEN-CILAG Kft. |
| --- |
| Törökbálint |
| Tó Park 2045 |
| HUNGARY |

JANSSEN-CILAG Kft.

Törökbálint

Tó Park 2045

HUNGARY

CONCERTA 36 mg

36 mg

retard pilloli

użu orali

HU – L-Ungerija

| JANSSEN-CILAG Kft. |
| --- |
| Törökbálint |
| Tó Park 2045 |
| HUNGARY |

JANSSEN-CILAG Kft.

Törökbálint

Tó Park 2045

HUNGARY

CONCERTA 54 mg

54 mg

retard pilloli

użu orali

HU – L-Ungerija

| 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

pilloli

użu orali

HU – L-Ungerija

| 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

kapsuli b’rilaxx imtawwal

użu orali

HU – L-Ungerija

| 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

kapsuli b’rilaxx imtawwal

użu orali

HU – L-Ungerija

| 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

kapsuli b’rilaxx imtawwal

użu orali

IE – L-Irlanda

| 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

pilloli

użu orali

IE – L-Irlanda

| 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

kapsuli b’rilaxx moodifikat

użu orali

IE – L-Irlanda

| 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

pilloli b’rilaxx imtawwal

użu orali

IE – L-Irlanda

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

Ratiopharm GmbH

Graf-Arco-Straße 3

GERMANY

Equasym

5 mg, 10 mg, 20 mg

pilloli

użu orali

IE – L-Irlanda

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

Ratiopharm GmbH

Graf-Arco-Straße 3

GERMANY

Equasym XL

10 mg, 20 mg, 30 mg

kapsuli b’rilaxx moodifikat

użu orali

IE – L-Irlanda

| 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

pilloli

użu orali

IE – L-Irlanda

| 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

pilloli

użu orali

IE – L-Irlanda

| 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

pilloli

użu orali

IE – L-Irlanda

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

IE – L-Irlanda

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

IE – L-Irlanda

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

LV – Il-Latvja

| 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

pilloli b’rilaxx imtawwal

użu orali

LV – Il-Latvja

| 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

pilloli b’rilaxx imtawwal

użu orali

LV – Il-Latvja

| 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

pilloli b’rilaxx imtawwal

użu orali

LV – Il-Latvja

| Novartis Finland Oy |
| --- |
| Metsanneidonkuja 10 |
| FI-02130 Espoo |
| FINLAND |

Novartis Finland Oy

Metsanneidonkuja 10

FI-02130 Espoo

FINLAND

Ritalin 10 mg

10 mg

pilloli

użu orali

LT – Il-Litwanja

| 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

pilloli b’rilaxx imtawwal

użu orali

LT – Il-Litwanja

| 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

pilloli b’rilaxx imtawwal

użu orali

LT – Il-Litwanja

| 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

pilloli b’rilaxx imtawwal

użu orali

IT – L-Italja

| 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

pilloli b’rilaxx imtawwal

użu orali

PT – Il-Portugall

| 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

pilloli b’rilaxx imtawwal

użu orali

PT – Il-Portugall

| 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

pilloli b’rilaxx imtawwal

użu orali

PT – Il-Portugall

| 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

pilloli b’rilaxx imtawwal

użu orali

PT – Il-Portugall

| 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

pilloli b’rilaxx imtawwal

użu orali

PT – Il-Portugall

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

PT – Il-Portugall

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

PT – Il-Portugall

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

PT – Il-Portugall

| 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

pilloli

użu orali

PT – Il-Portugall

| 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

pilloli

użu orali

PT – Il-Portugall

| 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

pilloli

użu orali

RO – Ir-Rumanija

| Janssen-Pharmaceutica N.V. |
| --- |
| Tumhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Pharmaceutica N.V.

Tumhoutseweg 30

2340 Beerse

BELGIUM

Concerta XL 18 mg

18 mg

pilloli b’rilaxx imtawwal miksija b’rita

RO – Ir-Rumanija

| Janssen-Pharmaceutica N.V. |
| --- |
| Tumhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Pharmaceutica N.V.

Tumhoutseweg 30

2340 Beerse

BELGIUM

Concerta XL 36 mg

36 mg

pilloli b’rilaxx imtawwal miksija b’rita

RO – Ir-Rumanija

| Janssen-Pharmaceutica N.V. |
| --- |
| Tumhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Pharmaceutica N.V.

Tumhoutseweg 30

2340 Beerse

BELGIUM

Concerta XL 54 mg

54 mg

pilloli b’rilaxx imtawwal miksija b’rita

użu orali

SE – L-Iżvezja

| 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

pilloli b’rilaxx imtawwal

użu orali

SE – L-Iżvezja

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

SE – L-Iżvezja

| 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 — pilloli 20, 30, 40 mg — kapsuli iebsa b’rilaxx modifikat

użu orali

SE – L-Iżvezja

| 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

pilloli

użu orali

SE – L-Iżvezja

| 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 — pilloli 10, 20, 30, 40 — kapsuli iebsa b’rilaxx modifikat

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

UK – Ir-Renju Unit

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

UK – Ir-Renju Unit

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

pilloli b’rilaxx imtawwal

użu orali

UK – Ir-Renju Unit

| 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

pilloli b’rilaxx imtawwal

użu orali

UK – Ir-Renju Unit

| 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

pilloli b’rilaxx imtawwal

użu orali

UK – Ir-Renju Unit

| 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

pilloli b’rilaxx imtawwal

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

UK – Ir-Renju Unit

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

UK – Ir-Renju Unit

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

UK – Ir-Renju Unit

| 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

kapsuli iebsa b’rilaxx imtawwal

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

UK – Ir-Renju Unit

| 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

pilloli

użu orali

IS – L-Iżlanda

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

IS – L-Iżlanda

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

IS – L-Iżlanda

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

IS – L-Iżlanda

| 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

pilloli b’rilaxx imtawwal

użu orali

IS – L-Iżlanda

| 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

pilloli b’rilaxx imtawwal

użu orali

IS – L-Iżlanda

| 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

pilloli b’rilaxx imtawwal

użu orali

IS – L-Iżlanda

| 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

pilloli b’rilaxx imtawwal

użu orali

IS – L-Iżlanda

| 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

pilloli

użu orali

IS – L-Iżlanda

| 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

pilloli

użu orali

IS – L-Iżlanda

| 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

pilloli

użu orali

IS – L-Iżlanda

| 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

pilloli

użu orali

IS – L-Iżlanda

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

IS – L-Iżlanda

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

IS – L-Iżlanda

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

DE – Il-Ġermanja

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

Novartis Pharma GmbH

90327 Nuernberg

GERMANY

Ritalin

10 mg

pilloli

użu orali

DE – Il-Ġermanja

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

Novartis Pharma GmbH

90327 Nuernberg

GERMANY

MPH Novartis 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung

20 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

DE – Il-Ġermanja

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

Novartis Pharma GmbH

90327 Nuernberg

GERMANY

MPH Novartis 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung

30 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

DE – Il-Ġermanja

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

Novartis Pharma GmbH

90327 Nuernberg

GERMANY

MPH Novartis 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung

40 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

DE – Il-Ġermanja

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

Novartis Pharma GmbH

90327 Nuernberg

GERMANY

Ritalin LA 20 mg Hartkapseln mit veränderter Wirkstofffreisetzung

20 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

DE – Il-Ġermanja

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

Novartis Pharma GmbH

90327 Nuernberg

GERMANY

Ritalin LA 30 mg Hartkapseln mit veränderter Wirkstofffreisetzung

30 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

DE – Il-Ġermanja

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

Novartis Pharma GmbH

90327 Nuernberg

GERMANY

Ritalin LA 40 mg Hartkapseln mit veränderter Wirkstofffreisetzung

40 mg

kapsuli iebsa b’rilaxx modifikat

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet 10 mg

11,56 mg

pilloli

użu orali

DE – Il-Ġermanja

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

UCB GmbH

Alfred-Nobel-Straße 10

40789 Monheim

GERMANY

Equasym 5 mg Tabletten

5 mg

pilloli

użu orali

DE – Il-Ġermanja

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

UCB GmbH

Alfred-Nobel-Straße 10

40789 Monheim

GERMANY

Equasym 10 mg Tabletten

10 mg

pilloli

użu orali

DE – Il-Ġermanja

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

UCB GmbH

Alfred-Nobel-Straße 10

40789 Monheim

GERMANY

Equasym 20 mg Tabletten

20 mg

pilloli

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid 10 mg

11,56 mg

pilloli

użu orali

DE – Il-Ġermanja

| 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

pilloli

użu orali

DE – Il-Ġermanja

| HEXAL AG |
| --- |
| Postfach 1263 |
| 83602 Holzkirchen |
| GERMANY |

HEXAL AG

Postfach 1263

83602 Holzkirchen

GERMANY

Methylphenidat HEXAL 10 mg Tabletten

10 mg

pilloli

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet 5 mg

5 mg

pilloli

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet 20 mg

20 mg

pilloli

użu orali

DE – Il-Ġermanja

| 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

pilloli b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

| 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

pilloli b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

| 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

pilloli b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

| 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

pilloli b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet retard 10 mg

10 mg

kapsuli iebsa b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet retard 20 mg

20 mg

kapsuli iebsa b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet retard 5 mg

5 mg

kapsuli iebsa b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| 27457 Cuxhaven |
| GERMANY |

TAD Pharma GmbH

Postfach 720

27457 Cuxhaven

GERMANY

METHYLPHENI TAD 5 mg Tabletten

5 mg

pilloli

użu orali

DE – Il-Ġermanja

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| 27457 Cuxhaven |
| GERMANY |

TAD Pharma GmbH

Postfach 720

27457 Cuxhaven

GERMANY

METHYLPHENI TAD 10 mg Tabletten

10 mg

pilloli

użu orali

DE – Il-Ġermanja

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| 27457 Cuxhaven |
| GERMANY |

TAD Pharma GmbH

Postfach 720

27457 Cuxhaven

GERMANY

METHYLPHENI TAD 20 mg Tabletten

20 mg

pilloli

użu orali

DE – Il-Ġermanja

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

ratiopharm GmbH

89070 Ulm

GERMANY

Methylphenidat-ratiopharm 10 mg Tabletten

10 mg

pilloli

użu orali

DE – Il-Ġermanja

| 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

pilloli

użu orali

DE – Il-Ġermanja

| 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

pilloli

użu orali

DE – Il-Ġermanja

| 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

pilloli

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet retard 30 mg

30 mg

kapsuli iebsa b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikinet retard 40 mg

40 mg

kapsuli iebsa b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid 5 mg

5 mg

pilloli

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid 20 mg

20 mg

pilloli

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid retard 10 mg

10 mg

kapsuli iebsa b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid retard 20 mg

20 mg

kapsuli iebsa b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid retard 5 mg

5 mg

kapsuli iebsa b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

DE – Il-Ġermanja

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

DE – Il-Ġermanja

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid retard 30 mg

30 mg

kapsuli iebsa b’rilaxx imtawwal

użu orali

DE – Il-Ġermanja

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

Medice

Postfach 2063

58634 Iserlohn

GERMANY

Medikid retard 40 mg

40 mg

kapsuli iebsa b’rilaxx imtawwal

użu orali

EL – Il-Greċja

| 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

pilloli b’rilaxx imtawwal

użu orali

EL – Il-Greċja

| 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

pilloli

użu orali

EL – Il-Greċja

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

IT – L-Italja

| 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

pilloli 30

użu orali

IT – L-Italja

| 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

pilloli b’rilaxx imtawwal 30

użu orali

IT – L-Italja

| 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

pilloli b’rilaxx imtawwal 100

użu orali

MT – 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

pilloli

użu orali

MT – 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

kapsuli iebsa b’rilaxx modifikat

użu orali

MT – 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

kapsuli iebsa b’rilaxx modifikat

użu orali

MT – 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

kapsuli iebsa b’rilaxx modifikat

użu orali

MT – Malta

| Janssen-Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Cilag International N.V.

Turnhoutseweg 30

2340 Beerse

BELGIUM

Concerta®

18 mg

pilloli b’rilaxx imtawwal

użu orali

MT – Malta

| Janssen-Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Cilag International N.V.

Turnhoutseweg 30

2340 Beerse

BELGIUM

Concerta®

36 mg

pilloli b’rilaxx imtawwal

użu orali

MT – Malta

| Janssen-Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Cilag International N.V.

Turnhoutseweg 30

2340 Beerse

BELGIUM

Concerta®

54 mg

pilloli b’rilaxx imtawwal

użu orali

NL – L-Olanda

| Novartis Pharma B.V. |
| --- |
| Raapopseweg 1 |
| 6824 DP Arnhem |
| NETHERLANDS |

Novartis Pharma B.V.

Raapopseweg 1

6824 DP Arnhem

NETHERLANDS

Ritalin

10 mg

pilloli

użu orali

NL – L-Olanda

| 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

pilloli

użu orali

NL – L-Olanda

| 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

pilloli

użu orali

NL – L-Olanda

| 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

pilloli

użu orali

NL – L-Olanda

| 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

kapsuli b’rilaxx modifikat

użu orali

NL – L-Olanda

| 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

kapsuli b’rilaxx modifikat

użu orali

NL – L-Olanda

| 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

kapsuli b’rilaxx modifikat

użu orali

NL – L-Olanda

| 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

pilloli

użu orali

NL – L-Olanda

| 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

pilloli

użu orali

NL – L-Olanda

| 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

pilloli

użu orali

NL – L-Olanda

| 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

pilloli

użu orali

NL – L-Olanda

| 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

pilloli b’rilaxx imtawwal

użu orali

NL – L-Olanda

| 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

pilloli b’rilaxx imtawwal

użu orali

NL – L-Olanda

| 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

pilloli b’rilaxx imtawwal

użu orali

NL – L-Olanda

| 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

pilloli b’rilaxx imtawwal

użu orali

NL – L-Olanda

| 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

pilloli

użu orali

NL – L-Olanda

| 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

pilloli

użu orali

NL – L-Olanda

| Medice Arzneimittel Pütter GmbH |
| --- |
| Kuhloweg 37 |
| 58638 Iserlohn |
| GERMANY |

Medice Arzneimittel Pütter GmbH

Kuhloweg 37

58638 Iserlohn

GERMANY

Medikinet 5 mg

5 mg

pilloli

użu orali

NL – L-Olanda

| Medice Arzneimittel Pütter GmbH |
| --- |
| Kuhloweg 37 |
| 58638 Iserlohn |
| GERMANY |

Medice Arzneimittel Pütter GmbH

Kuhloweg 37

58638 Iserlohn

GERMANY

Medikinet 10 mg

10 mg

pilloli

użu orali

NL – L-Olanda

| Medice Arzneimittel Pütter GmbH |
| --- |
| Kuhloweg 37 |
| 58638 Iserlohn |
| GERMANY |

Medice Arzneimittel Pütter GmbH

Kuhloweg 37

58638 Iserlohn

GERMANY

Medikinet 20 mg

20 mg

pilloli

użu orali

NL – L-Olanda

| Medice Arzneimittel Pütter GmbH |
| --- |
| Kuhloweg 37 |
| 58638 Iserlohn |
| GERMANY |

Medice Arzneimittel Pütter GmbH

Kuhloweg 37

58638 Iserlohn

GERMANY

Medikinet CR 10 mg

10 mg

kapsuli b’rilaxx modifikat

użu orali

NL – L-Olanda

| Medice Arzneimittel Pütter GmbH |
| --- |
| Kuhloweg 37 |
| 58638 Iserlohn |
| GERMANY |

Medice Arzneimittel Pütter GmbH

Kuhloweg 37

58638 Iserlohn

GERMANY

Medikinet CR 20 mg

20 mg

kapsuli b’rilaxx modifikat

użu orali

NL – L-Olanda

| Medice Arzneimittel Pütter GmbH |
| --- |
| Kuhloweg 37 |
| 58638 Iserlohn |
| GERMANY |

Medice Arzneimittel Pütter GmbH

Kuhloweg 37

58638 Iserlohn

GERMANY

Medikinet CR 30 mg

30 mg

kapsuli b’rilaxx modifikat

użu orali

NL – L-Olanda

| Medice Arzneimittel Pütter GmbH |
| --- |
| Kuhloweg 37 |
| 58638 Iserlohn |
| GERMANY |

Medice Arzneimittel Pütter GmbH

Kuhloweg 37

58638 Iserlohn

GERMANY

Medikinet CR 40 mg

40 mg

kapsuli b’rilaxx modifikat

użu orali

NO – In-Norveġja

| Janssen-Cilag AS |
| --- |
| Hoffsveien 1D |
| 0275 Oslo |
| NORWAY |

Janssen-Cilag AS

Hoffsveien 1D

0275 Oslo

NORWAY

Concerta

18 mg, 36 mg, 54 mg

pilloli b’rilaxx imtawwal

użu orali

NO – In-Norveġja

| 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

pilloli

użu orali

NO – In-Norveġja

| 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

pilloli

użu orali

NO – In-Norveġja

| 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

pilloli

użu orali

NO – In-Norveġja

| 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

kapsuli iebsa b’rilaxx modifikat

użu orali

NO – In-Norveġja

| 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 — pilloli) (20 mg, 30 mg, 40 mg — kapsuli iebsa b’rilaxx modifikat)

użu orali

NO – In-Norveġja

| 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

pilloli b’rilaxx imtawwal

użu orali

NO – In-Norveġja

| 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

pilloli

użu orali

PL – Il-Polonja

| Janssen-Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Cilag International N.V.

Turnhoutseweg 30

2340 Beerse

BELGIUM

Concerta®

18 mg

pilloli b’rilaxx imtawwal

użu orali

PL – Il-Polonja

| Janssen-Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Cilag International N.V.

Turnhoutseweg 30

2340 Beerse

BELGIUM

Concerta®

36 mg

pilloli b’rilaxx imtawwal

użu orali

PL – Il-Polonja

| Janssen-Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| 2340 Beerse |
| BELGIUM |

Janssen-Cilag International N.V.

Turnhoutseweg 30

2340 Beerse

BELGIUM

Concerta®

54 mg

pilloli b’rilaxx imtawwal

użu orali

PL – Il-Polonja

| 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

pilloli

użu orali

PL – Il-Polonja

| 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

pilloli

użu orali

PL – Il-Polonja

| 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

pilloli

użu orali

PL – Il-Polonja

| 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

kapsuli b’rilaxx imtawwal

użu orali

PL – Il-Polonja

| 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

kapsuli b’rilaxx imtawwal

użu orali

PL – Il-Polonja

| 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

kapsuli b’rilaxx imtawwal

użu orali

PL – Il-Polonja

| 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

kapsuli b’rilaxx imtawwal

użu orali

LU – Il-Lussemburgu

| Novartis Pharma |
| --- |
| Roonstraße 25 |
| 90429 Nűrnberg |
| GERMANY |

Novartis Pharma

Roonstraße 25

90429 Nűrnberg

GERMANY

Ritalin

10 mg

pilloli

użu orali

LU – Il-Lussemburgu

| 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

pilloli b’rilaxx imtawwal

użu orali

LU – Il-Lussemburgu

| 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

pilloli b’rilaxx imtawwal

użu orali

LU – Il-Lussemburgu

| 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

pilloli b’rilaxx imtawwal

użu orali

LU – Il-Lussemburgu

| 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

pilloli b’rilaxx imtawwal

użu orali

LU – Il-Lussemburgu

| Medice Arzneimittel Pűtter GmbH & Co |
| --- |
| Kuhloweg 37 |
| 58638 Iserlohn |
| GERMANY |

Medice Arzneimittel Pűtter GmbH & Co

Kuhloweg 37

58638 Iserlohn

GERMANY

Medikinet

5 mg

pilloli

użu orali

LU – Il-Lussemburgu

Medice Arzneimittel Pűtter GmbH & Co

Medikinet

10 mg

pilloli

użu orali

LU – Il-Lussemburgu

Medice Arzneimittel Pűtter GmbH & Co

Medikinet

20 mg

pilloli

użu orali

LU – Il-Lussemburgu

Medice Arzneimittel Pűtter GmbH & Co

Medikinet retard

10 mg

kapsuli

użu orali

LU – Il-Lussemburgu

Medice Arzneimittel Pűtter GmbH & Co

Medikinet retard

20 mg

kapsuli

użu orali

LU – Il-Lussemburgu

Medice Arzneimittel Pűtter GmbH & Co

Medikinet retard

30 mg

kapsuli

użu orali

LU – Il-Lussemburgu

Medice Arzneimittel Pűtter GmbH & Co

Medikinet retard

40 mg

kapsuli

użu orali

SI – Is-Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Smartinska 53 |
| 1000 Ljubljana |
| SLOVENIA |

Johnson & Johnson d.o.o.

Smartinska 53

1000 Ljubljana

SLOVENIA

Concerta 18 mg tablete s podaljšanim sproščanjem

18 mg

pilloli b’rilaxx imtawwal

użu orali

SI – Is-Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Smartinska 53 |
| 1000 Ljubljana |
| SLOVENIA |

Johnson & Johnson d.o.o.

Smartinska 53

1000 Ljubljana

SLOVENIA

Concerta 36 mg tablete s podaljšanim sproščanjem

36 mg

pilloli b’rilaxx imtawwal

użu orali

SI – Is-Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Smartinska 53 |
| 1000 Ljubljana |
| SLOVENIA |

Johnson & Johnson d.o.o.

Smartinska 53

1000 Ljubljana

SLOVENIA

Concerta 54 mg tablete s podaljšanim sproščanjem

54 mg

pilloli b’rilaxx imtawwal

użu orali

SK – Is-Slovakkja

| 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

pilloli b’rilaxx imtawwal

użu orali

SK – Is-Slovakkja

| 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

pilloli b’rilaxx imtawwal

użu orali

SK – Is-Slovakkja

| 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

pilloli b’rilaxx imtawwal

użu orali

---

ANNESS VII

LISTA TAL-ISMIJIET, L-GĦAMLIET FARMAĊEWTIĊI, IL-QAWWIET TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, APPLIKANTI/DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/ŻEE | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | L-Applikant | Isem Ivvintat Isem | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Il-Kontenut
  (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Franza | | Advanced Accelerator Applications |
| 20 rue Diesel |
| 01630 Saint Genis Pouilly |
| FRANZA |

Stat Membru UE/ŻEE

Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq

L-Applikant

Isem Ivvintat Isem

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Il-Kontenut

(Konċentrat)

Franza

Advanced Accelerator Applications

20 rue Diesel

01630 Saint Genis Pouilly

FRANZA

GLUSCAN 500

500 MBq/ml f’ħin ta’ kalibrazzjoni

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Għal 1 ml tal-prodott mediċinali:

| | Fludeoxyglukosju (18F) – 500 MBq f’ħin ta’ kalibrazzjoni, |
| --- | --- |

Fludeoxyglukosju (18F) – 500 MBq f’ħin ta’ kalibrazzjoni,

| | Ilma għal injezzjoni – 1,00 g, |
| --- | --- |

Ilma għal injezzjoni – 1,00 g,

| | Ċitrat tas-sodju – 0,62 % (v/v), |
| --- | --- |

Ċitrat tas-sodju – 0,62 % (v/v),

| | Klorur tas-sodju – 0,41 % (v/v), |
| --- | --- |

Klorur tas-sodju – 0,41 % (v/v),

| | Aċidu idrokloriku 0,39 % (v/v), |
| --- | --- |

Aċidu idrokloriku 0,39 % (v/v),

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

Etanol 0,31 % (v/v)

| | Sodju idrossidu 0,24 % (v/v) |
| --- | --- |

Sodju idrossidu 0,24 % (v/v)

Ġermanja

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

Advanced Accelerator Applications

20 rue Diesel

01630 Saint Genis Pouilly

FRANZA

GLUSCAN 500

500 MBq/ml f’ħin ta’ kalibrazzjoni

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Għal 1 ml tal-prodott mediċinali:

| | Fludeoxyglukosju (18F) – 500 MBq f’ħin ta’ kalibrazzjoni, |
| --- | --- |

Fludeoxyglukosju (18F) – 500 MBq f’ħin ta’ kalibrazzjoni,

| | Ilma għal injezzjoni – 1,00 g, |
| --- | --- |

Ilma għal injezzjoni – 1,00 g,

| | Ċitrat tas-sodju – 0,62 % (v/v), |
| --- | --- |

Ċitrat tas-sodju – 0,62 % (v/v),

| | Klorur tas-sodju – 0,41 % (v/v), |
| --- | --- |

Klorur tas-sodju – 0,41 % (v/v),

| | Aċidu idrokloriku 0,39 % (v/v), |
| --- | --- |

Aċidu idrokloriku 0,39 % (v/v),

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

Etanol 0,31 % (v/v)

| | Sodju idrossidu 0,24 % (v/v) |
| --- | --- |

Sodju idrossidu 0,24 % (v/v)

Polonja

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

Advanced Accelerator Applications

20 rue Diesel

01630 Saint Genis Pouilly

FRANZA

GLUSCAN PL

500 MBq/ml f’ħin ta’ kalibrazzjoni

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Għal 1 ml tal-prodott mediċinali:

| | Fludeoxyglukosju (18F) – 500 MBq f’ħin ta’ kalibrazzjoni, |
| --- | --- |

Fludeoxyglukosju (18F) – 500 MBq f’ħin ta’ kalibrazzjoni,

| | Ilma għal injezzjoni – 1,00 g, |
| --- | --- |

Ilma għal injezzjoni – 1,00 g,

| | Ċitrat tas-sodju – 0,62 % (v/v), |
| --- | --- |

Ċitrat tas-sodju – 0,62 % (v/v),

| | Klorur tas-sodju – 0,41 % (v/v), |
| --- | --- |

Klorur tas-sodju – 0,41 % (v/v),

| | Aċidu idrokloriku 0,39 % (v/v), |
| --- | --- |

Aċidu idrokloriku 0,39 % (v/v),

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

Etanol 0,31 % (v/v)

| | Sodju idrossidu 0,24 % (v/v) |
| --- | --- |

Sodju idrossidu 0,24 % (v/v)

Portugall

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

Advanced Accelerator Applications

20 rue Diesel

01630 Saint Genis Pouilly

FRANZA

GLUSCAN 500

500 MBq/ml f’ħin ta’ kalibrazzjoni

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Għal 1 ml tal-prodott mediċinali:

| | Fludeoxyglukosju (18F) – 500 MBq f’ħin ta’ kalibrazzjoni, |
| --- | --- |

Fludeoxyglukosju (18F) – 500 MBq f’ħin ta’ kalibrazzjoni,

| | Ilma għal injezzjoni – 1,00 g, |
| --- | --- |

Ilma għal injezzjoni – 1,00 g,

| | Ċitrat tas-sodju – 0,62 % (v/v), |
| --- | --- |

Ċitrat tas-sodju – 0,62 % (v/v),

| | Klorur tas-sodju – 0,41 % (v/v), |
| --- | --- |

Klorur tas-sodju – 0,41 % (v/v),

| | Aċidu idrokloriku 0,39 % (v/v), |
| --- | --- |

Aċidu idrokloriku 0,39 % (v/v),

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

Etanol 0,31 % (v/v)

| | Sodju idrossidu 0,24 % (v/v) |
| --- | --- |

Sodju idrossidu 0,24 % (v/v)

Spanja

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

Advanced Accelerator Applications

20 rue Diesel

01630 Saint Genis Pouilly

FRANZA

GLUSCAN 500

500 MBq/ml f’ħin ta’ kalibrazzjoni

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Għal 1 ml tal-prodott mediċinali:

| | Fludeoxyglukosju (18F) – 500 MBq f’ħin ta’ kalibrazzjoni, |
| --- | --- |

Fludeoxyglukosju (18F) – 500 MBq f’ħin ta’ kalibrazzjoni,

| | Ilma għal injezzjoni – 1,00 g, |
| --- | --- |

Ilma għal injezzjoni – 1,00 g,

| | Ċitrat tas-sodju – 0,62 % (v/v), |
| --- | --- |

Ċitrat tas-sodju – 0,62 % (v/v),

| | Klorur tas-sodju – 0,41 % (v/v), |
| --- | --- |

Klorur tas-sodju – 0,41 % (v/v),

| | Aċidu idrokloriku 0,39 % (v/v), |
| --- | --- |

Aċidu idrokloriku 0,39 % (v/v),

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

Etanol 0,31 % (v/v)

| | Sodju idrossidu 0,24 % (v/v) |
| --- | --- |

Sodju idrossidu 0,24 % (v/v)

---

V Avviżi

PROĊEDURI GĦALL-IMPLIMENTAZZJONI TAL-POLITIKA TAL-KOMPETIZZJONI

Il-Kummissjoni

| 26.6.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 146/60 |
| --- | --- | --- | --- |

26.6.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 146/60

---

Notifika minn qabel ta' konċentrazzjoni

(Każ COMP/M.5522 – Mitsubishi Corporation/Acciona Energia Internacional/Amper)

Każ li jista' jiġi kkunsidrat għal proċedura simplifikata

(Test b’relevanza għaż-ŻEE)

2009/C 146/05

| 1. | Fit-18 ta’ Ġunju 2009 il-Kummissjoni rċeviet notifika ta' proposta għal konċentrazzjoni skont l-Artikolu 4 tar-Regolament tal-Kunsill (KE) Nru 139/2004 (1) li permezz tagħha l-impriża Acciona Energia Internacional S.A.U. (“Acciona”, Spanja), li hi propjetà ta' Acciona Group u Mitsubishi Corporation (“MC”, il-Ġappun), takkwista skont it-tifsira tal-Artikolu 3(1)(b) tar-Regolament tal-Kunsill il-kontroll konġunt tal-impriża Amper Central Solar, S.A. (“Amper”, il-Portugall), kumpanija li hija impriża konġunta, permezz tax-xiri ta' ishma. |
| --- | --- |

1.

Fit-18 ta’ Ġunju 2009 il-Kummissjoni rċeviet notifika ta' proposta għal konċentrazzjoni skont l-Artikolu 4 tar-Regolament tal-Kunsill (KE) Nru 139/2004 (1) li permezz tagħha l-impriża Acciona Energia Internacional S.A.U. (“Acciona”, Spanja), li hi propjetà ta' Acciona Group u Mitsubishi Corporation (“MC”, il-Ġappun), takkwista skont it-tifsira tal-Artikolu 3(1)(b) tar-Regolament tal-Kunsill il-kontroll konġunt tal-impriża Amper Central Solar, S.A. (“Amper”, il-Portugall), kumpanija li hija impriża konġunta, permezz tax-xiri ta' ishma.

| 2. | L-attivitajiet kummerċjali tal-impriżi kkonċernati huma:






  — | għal Acciona: l-iżvilupp u l-ġestjoni ta' proġetti ta' infrastruttura u beni immobbli, il-provvista ta' servizzi ta' trasport, servizzi urbani u servizzi ambjentali, kif ukoll l-iżvilupp u l-operazzjoni ta' enerġiji li jiġġeddu, |
| --- | --- | --- |

2.

L-attivitajiet kummerċjali tal-impriżi kkonċernati huma:

—

għal Acciona: l-iżvilupp u l-ġestjoni ta' proġetti ta' infrastruttura u beni immobbli, il-provvista ta' servizzi ta' trasport, servizzi urbani u servizzi ambjentali, kif ukoll l-iżvilupp u l-operazzjoni ta' enerġiji li jiġġeddu,

| — | għal MC: negozju f'numru kbir ta' industriji, inklużi l-enerġija, il-metalli, il-makkinarju, il-kimika, l-ikel u prodotti ġenerali, |
| --- | --- |

—

għal MC: negozju f'numru kbir ta' industriji, inklużi l-enerġija, il-metalli, il-makkinarju, il-kimika, l-ikel u prodotti ġenerali,

| — | għal Amper: il-produzzjoni u l-bejgħ bl-ingrossa tal-elettriku. |
| --- | --- |

—

għal Amper: il-produzzjoni u l-bejgħ bl-ingrossa tal-elettriku.

| 3. | Wara eżami preliminari, il-Kummissjoni ssib li l-operazzjoni nnotifikata tista' taqa' fl-ambitu tar-Regolament (KE) Nru 139/2004. Madankollu, id-deċiżjoni finali dwar dan il-punt hija riżervata. Skont l-Avviż tal-Kummissjoni dwar proċedura simplifikata għat-trattament ta' ċerti konċentrazzjonijiet taħt ir-Regolament tal-Kunsill (KE) Nru 139/2004 (2) ta' min jinnota li dan il-każ jista' jiġi kkunsidrat għat-trattament taħt il-proċedura stipulata fl-Avviż. |
| --- | --- |

3.

Wara eżami preliminari, il-Kummissjoni ssib li l-operazzjoni nnotifikata tista' taqa' fl-ambitu tar-Regolament (KE) Nru 139/2004. Madankollu, id-deċiżjoni finali dwar dan il-punt hija riżervata. Skont l-Avviż tal-Kummissjoni dwar proċedura simplifikata għat-trattament ta' ċerti konċentrazzjonijiet taħt ir-Regolament tal-Kunsill (KE) Nru 139/2004 (2) ta' min jinnota li dan il-każ jista' jiġi kkunsidrat għat-trattament taħt il-proċedura stipulata fl-Avviż.

| 4. | Il-Kummissjoni tistieden lill-partijiet terzi interessati biex iressqu kwalunkwe kummenti li jistgħu jkollhom dwar it-tranżizzjoni proposta.
  Il-kummenti jridu jaslu għand il-Kummissjoni mhux aktar tard minn għaxart ijiem wara d-data ta' din il-pubblikazzjoni. Il-kummenti jistgħu jintbagħtu lill-Kummissjoni bil-faks (+32 2 2964301 jew 2967244) jew bil-posta, taħt in-numru ta' referenza COMP/M.5522 – Mitsubishi Corporation/Acciona Energia Internacional/Amper, fl-indirizz li ġej:





  Il-Kummissjoni Ewropea |
| --- | --- |
| Direttorat Ġenerali għall-Kompetizzjoni |
| Reġistru tal-Amalgamazzjonijiet |
| J-70 |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

4.

Il-Kummissjoni tistieden lill-partijiet terzi interessati biex iressqu kwalunkwe kummenti li jistgħu jkollhom dwar it-tranżizzjoni proposta.

Il-kummenti jridu jaslu għand il-Kummissjoni mhux aktar tard minn għaxart ijiem wara d-data ta' din il-pubblikazzjoni. Il-kummenti jistgħu jintbagħtu lill-Kummissjoni bil-faks (+32 2 2964301 jew 2967244) jew bil-posta, taħt in-numru ta' referenza COMP/M.5522 – Mitsubishi Corporation/Acciona Energia Internacional/Amper, fl-indirizz li ġej:

Il-Kummissjoni Ewropea

Direttorat Ġenerali għall-Kompetizzjoni

Reġistru tal-Amalgamazzjonijiet

J-70

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  ĠU L 24, 29.1.2004, p. 1.

(2)  ĠU C 56, 5.3.2005, p. 32.

---