# Il-Ġurnal Uffiċjali C 305/2008

| | ISSN 1725-5198 |
| --- | --- |
| Il-Ġurnal Uffiċjali
  ta’ l-Unjoni Ewropea | C 305 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5128 ta' Novembru 2008 |

ISSN 1725-5198

Il-Ġurnal Uffiċjali

ta’ l-Unjoni Ewropea

C 305

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5128 ta' Novembru 2008

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | II   Komunikazzjonijiet |
| | KOMUNIKAZZJONIJIET MINN ISTITUZZJONIJIET U KORPI TA' L-UNJONI EWROPEA |
| | Kummissjoni |
| 2008/C 305/01 | Ebda oppożizzjoni għal konċentrazzjoni notifikata (Każ COMP/M.5368 — MidAmerican/Constellation) (
  1
  ) | 1 |
| 2008/C 305/02 | Ebda oppożizzjoni għal konċentrazzjoni notifikata (Każ COMP/M.5334 — RICOH/IKON) (
  1
  ) | 1 |

Avviż Nru

Werrej

Paġna

II   Komunikazzjonijiet

KOMUNIKAZZJONIJIET MINN ISTITUZZJONIJIET U KORPI TA' L-UNJONI EWROPEA

Kummissjoni

2008/C 305/01

Ebda oppożizzjoni għal konċentrazzjoni notifikata (Każ COMP/M.5368 — MidAmerican/Constellation) (
  1
  )

1

1

2008/C 305/02

Ebda oppożizzjoni għal konċentrazzjoni notifikata (Każ COMP/M.5334 — RICOH/IKON) (
  1
  )

1

1

| | IV   Informazzjoni |
| --- | --- |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TA' L-UNJONI EWROPEA |
| | Kummissjoni |
| 2008/C 305/03 | Rata tal-kambju ta' l-euro | 2 |
| 2008/C 305/04 | Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta' prodotti mediċinali mill-1 ta' Ottubru 2008 sal-31 ta' Ottubru 2008 (Ppubblikat skond l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 3 |
| 2008/C 305/05 | Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta' prodotti mediċinali mill-1 ta' Ottubru 2008 sal-31 ta' Ottubru 2008 (Deċiżjonijiet meħuda skond 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) | 10 |

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TA' L-UNJONI EWROPEA

Kummissjoni

2008/C 305/03

Rata tal-kambju ta' l-euro

2

2008/C 305/04

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta' prodotti mediċinali mill-1 ta' Ottubru 2008 sal-31 ta' Ottubru 2008 (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

3

2008/C 305/05

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta' prodotti mediċinali mill-1 ta' Ottubru 2008 sal-31 ta' Ottubru 2008 (Deċiżjonijiet meħuda skond 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 skond 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

10

| | V   Avviżi |
| --- | --- |
| | PROĊEDURI GĦALL-IMPLIMENTAZZJONI TAL-POLITIKA TAL-KOMPETIZZJONI |
| | Kummissjoni |
| 2008/C 305/06 | Notifika minn qabel ta' konċentrazzjoni (Każ COMP/M.5398 — Hutchison/Evergreen) (
  1
  ) | 89 |
| 2008/C 305/07 | Notifika minn qabel ta' konċentrazzjoni (Każ COMP/M.5274 — NEWS CORP/Permira/NDS) — Każ li jista' jiġi kkunsidrat għal proċedura simplifikata (
  1
  ) | 90 |

V   Avviżi

PROĊEDURI GĦALL-IMPLIMENTAZZJONI TAL-POLITIKA TAL-KOMPETIZZJONI

Kummissjoni

2008/C 305/06

Notifika minn qabel ta' konċentrazzjoni (Każ COMP/M.5398 — Hutchison/Evergreen) (
  1
  )

1

89

2008/C 305/07

Notifika minn qabel ta' konċentrazzjoni (Każ COMP/M.5274 — NEWS CORP/Permira/NDS) — Każ li jista' jiġi kkunsidrat għal proċedura simplifikata (
  1
  )

1

90

| | |
| --- | --- |
| 2008/C 305/08 | Nota lill-qarrej(Ara paġna 3 tal-qoxra) | s3 |

2008/C 305/08

Nota lill-qarrej(Ara paġna 3 tal-qoxra)

Nota lill-qarrej

s3

| | |
| --- | --- |
| | (1)   Test b'rilevanza għaż-ŻEE |

---

(1)   Test b'rilevanza għaż-ŻEE

1

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

MT

---

II Komunikazzjonijiet

KOMUNIKAZZJONIJIET MINN ISTITUZZJONIJIET U KORPI TA' L-UNJONI EWROPEA

Kummissjoni

| 28.11.2008 | MT | Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea | C 305/1 |
| --- | --- | --- | --- |

28.11.2008

MT

Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea

C 305/1

---

Ebda oppożizzjoni għal konċentrazzjoni notifikata

(Każ COMP/M.5368 — MidAmerican/Constellation)

(Test b'rilevanza għaż-ŻEE)

(2008/C 305/01)

Fil-21 ta' Novembru 2008, il-Kummissjoni iddeċidiet li ma topponix il-konċentrazzjoni notifikata msemmija hawn fuq u li tiddikjaraha kompatibbli mas-suq komuni. Din id-deċiżjoni hi bbażata fuq l-Artikolu 6(1)(b) tar-Regolament tal-Kunsill (KE) Nru 139/2004. It-test kollu tad-deċiżjoni jinsab bl-Ingliż u se jkun ippubblikat wara li jkun meħlus minn kwalunkwe sigrieti tan-negozju li jista' jkun fih. Hu jinstab:

| — | mill-websajt tal-kompetizzjoni ta' l-Europa (http://ec.europa.eu/comm/competition/mergers/cases/). Dan il-websajt jipprovdi faċilitajiet varji biex jgħinu jinstabu deċiżjonijiet individwali ta' fużjoni, inklużi l-kumpanija, in-numru tal-każ, id-data u indiċi settorali, |
| --- | --- |

—

mill-websajt tal-kompetizzjoni ta' l-Europa (http://ec.europa.eu/comm/competition/mergers/cases/). Dan il-websajt jipprovdi faċilitajiet varji biex jgħinu jinstabu deċiżjonijiet individwali ta' fużjoni, inklużi l-kumpanija, in-numru tal-każ, id-data u indiċi settorali,

| — | f'forma elettronika fil-websajt EUR-Lex fid-dokument numru 32008M5368. EUR-Lex hu l-aċċess fuq l-internet għal-liġi Ewropea (http://eur-lex.europa.eu). |
| --- | --- |

—

f'forma elettronika fil-websajt EUR-Lex fid-dokument numru 32008M5368. EUR-Lex hu l-aċċess fuq l-internet għal-liġi Ewropea (http://eur-lex.europa.eu).

---

| 28.11.2008 | MT | Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea | C 305/1 |
| --- | --- | --- | --- |

28.11.2008

MT

Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea

C 305/1

---

Ebda oppożizzjoni għal konċentrazzjoni notifikata

(Każ COMP/M.5334 — RICOH/IKON)

(Test b'rilevanza għaż-ŻEE)

(2008/C 305/02)

Fl-24 ta' Ottubru 2008, il-Kummissjoni iddeċidiet li ma topponix il-konċentrazzjoni notifikata msemmija hawn fuq u li tiddikjaraha kompatibbli mas-suq komuni. Din id-deċiżjoni hi bbażata fuq l-Artikolu 6(1)(b) tar-Regolament tal-Kunsill (KE) Nru 139/2004. It-test kollu tad-deċiżjoni jinsab bl-Ingliż u se jkun ippubblikat wara li jkun meħlus minn kwalunkwe sigrieti tan-negozju li jista' jkun fih. Hu jinstab:

| — | mill-websajt tal-kompetizzjoni ta' l-Europa (http://ec.europa.eu/comm/competition/mergers/cases/). Dan il-websajt jipprovdi faċilitajiet varji biex jgħinu jinstabu deċiżjonijiet individwali ta' fużjoni, inklużi l-kumpanija, in-numru tal-każ, id-data u indiċi settorali, |
| --- | --- |

—

mill-websajt tal-kompetizzjoni ta' l-Europa (http://ec.europa.eu/comm/competition/mergers/cases/). Dan il-websajt jipprovdi faċilitajiet varji biex jgħinu jinstabu deċiżjonijiet individwali ta' fużjoni, inklużi l-kumpanija, in-numru tal-każ, id-data u indiċi settorali,

| — | f'forma elettronika fil-websajt EUR-Lex fid-dokument numru 32008M5334. EUR-Lex hu l-aċċess fuq l-internet għal-liġi Ewropea (http://eur-lex.europa.eu). |
| --- | --- |

—

f'forma elettronika fil-websajt EUR-Lex fid-dokument numru 32008M5334. EUR-Lex hu l-aċċess fuq l-internet għal-liġi Ewropea (http://eur-lex.europa.eu).

---

IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TA' L-UNJONI EWROPEA

Kummissjoni

| 28.11.2008 | MT | Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea | C 305/2 |
| --- | --- | --- | --- |

28.11.2008

MT

Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea

C 305/2

---

Rata tal-kambju ta' l-euro (1)

Is-27 ta' Novembru 2008

(2008/C 305/03)

1 euro=

| | Munita | Rata tal-kambju |
| --- | --- | --- |
| USD | Dollaru Amerikan | 1,29 |
| JPY | Yen Ġappuniż | 123,04 |
| DKK | Krona Daniża | 7,4521 |
| GBP | Lira Sterlina | 0,8358 |
| SEK | Krona Żvediża | 10,2543 |
| CHF | Frank Żvizzeru | 1,545 |
| ISK | Krona Iżlandiża | 280 |
| NOK | Krona Norveġiża | 8,88 |
| BGN | Lev Bulgaru | 1,9558 |
| CZK | Krona Ċeka | 25,18 |
| EEK | Krona Estona | 15,6466 |
| HUF | Forint Ungeriż | 261,65 |
| LTL | Litas Litwan | 3,4528 |
| LVL | Lats Latvjan | 0,7095 |
| PLN | Zloty Pollakk | 3,7745 |
| RON | Leu Rumen | 3,8688 |
| SKK | Krona Slovakka | 30,334 |
| TRY | Lira Turka | 2,0329 |
| AUD | Dollaru Awstraljan | 1,9689 |
| CAD | Dollaru Kanadiż | 1,5937 |
| HKD | Dollaru ta' Hong Kong | 10,0007 |
| NZD | Dollaru tan-New Zealand | 2,3399 |
| SGD | Dollaru tas-Singapor | 1,9501 |
| KRW | Won tal-Korea t'Isfel | 1 903,4 |
| ZAR | Rand ta' l-Afrika t'Isfel | 12,7107 |
| CNY | Yuan ren-min-bi Ċiniż | 8,8081 |
| HRK | Kuna Kroata | 7,1299 |
| IDR | Rupiah Indoneżjan | 15 963,75 |
| MYR | Ringgit Malażjan | 4,6666 |
| PHP | Peso Filippin | 63,03 |
| RUB | Rouble Russu | 35,3902 |
| THB | Baht Tajlandiż | 45,679 |
| BRL | Real Brażiljan | 2,9077 |
| MXN | Peso Messikan | 17,0022 |

Munita

Rata tal-kambju

USD

Dollaru Amerikan

1,29

JPY

Yen Ġappuniż

123,04

DKK

Krona Daniża

7,4521

GBP

Lira Sterlina

0,8358

SEK

Krona Żvediża

10,2543

CHF

Frank Żvizzeru

1,545

ISK

Krona Iżlandiża

280

NOK

Krona Norveġiża

8,88

BGN

Lev Bulgaru

1,9558

CZK

Krona Ċeka

25,18

EEK

Krona Estona

15,6466

HUF

Forint Ungeriż

261,65

LTL

Litas Litwan

3,4528

LVL

Lats Latvjan

0,7095

PLN

Zloty Pollakk

3,7745

RON

Leu Rumen

3,8688

SKK

Krona Slovakka

30,334

TRY

Lira Turka

2,0329

AUD

Dollaru Awstraljan

1,9689

CAD

Dollaru Kanadiż

1,5937

HKD

Dollaru ta' Hong Kong

10,0007

NZD

Dollaru tan-New Zealand

2,3399

SGD

Dollaru tas-Singapor

1,9501

KRW

Won tal-Korea t'Isfel

1 903,4

ZAR

Rand ta' l-Afrika t'Isfel

12,7107

CNY

Yuan ren-min-bi Ċiniż

8,8081

HRK

Kuna Kroata

7,1299

IDR

Rupiah Indoneżjan

15 963,75

MYR

Ringgit Malażjan

4,6666

PHP

Peso Filippin

63,03

RUB

Rouble Russu

35,3902

THB

Baht Tajlandiż

45,679

BRL

Real Brażiljan

2,9077

MXN

Peso Messikan

17,0022

---

(1)

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

---

| 28.11.2008 | MT | Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea | C 305/3 |
| --- | --- | --- | --- |

28.11.2008

MT

Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea

C 305/3

---

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta' prodotti mediċinali mill-1 ta' Ottubru 2008 sal-31 ta' Ottubru 2008

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

(2008/C 305/04)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.10.2008 | Tadalafil Lilly | Tadalafil | Eli Lilly Nederlan B.V. |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nederland |

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

1.10.2008

Tadalafil Lilly

Tadalafil

Eli Lilly Nederlan B.V.

Grootslag 1-5

3991 RA Houten

Nederland

EU/1/08/476/001-004

Pillola miksija b'rita

G04B E08

3.10.2008

6.10.2008

EVICEL

Fibrinoġena umana/trombina umana

| OMRIX biopharmaceuticals S.A./N.V. |
| --- |
| 200 Chaussée de Waterloo/Waterloosesteenweg 200 |
| B-1640 Rhode-St-Genèse/Sint-Genesius-Rode |

OMRIX biopharmaceuticals S.A./N.V.

200 Chaussée de Waterloo/Waterloosesteenweg 200

B-1640 Rhode-St-Genèse/Sint-Genesius-Rode

EU/1/08/473/001-003

Soluzzjonijiet għal siġill

B02BC

9.10.2008

6.10.2008

Fluticasone furoate GSK

Fluticasone furoate

| Glaxo Group Ltd |
| --- |
| Greenford |
| Middlesex UB6 ONN |
| United Kingdom |

Glaxo Group Ltd

Greenford

Middlesex UB6 ONN

United Kingdom

EU/1/08/474/001-003

Imnieħer, suspensjoni

R01AD12

8.10.2008

7.10.2008

Olanzapine Mylan

Olanzapine

| Generics [UK] Limited |
| --- |
| Station Close |
| Potters Bar |
| Hertfordshire EN6 1TL |
| United Kingdom |

Generics [UK] Limited

Station Close

Potters Bar

Hertfordshire EN6 1TL

United Kingdom

EU/1/08/475/001-034

Pillola miksija b'lega

N05AH03

9.10.2008

7.10.2008

Ceplene

Histamine dihydrochloride

| EpiCept GmbH |
| --- |
| Goethestraße 4 |
| D-80336 München |

EpiCept GmbH

Goethestraße 4

D-80336 München

EU/1/08/477/001

Soluzzjoni għal injezzjoni

L03AX14

9.10.2008

8.10.2008

Duloxetine Boehringer Ingelheim

Duloxetine

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/08/471/001-012

Kapsula gastro-reżistenti, iebsa

N06AX21

10.10.2008

—   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 |
| --- | --- | --- | --- | --- |
| 1.10.2008 | Karvezide | Bristol-Myers Squibb Pharma EEIG |
| Uxbridge Business Park |
| Sanderson Road |
| Uxbridge UB8 1DH |
| United Kingdom |

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

1.10.2008

Karvezide

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park

Sanderson Road

Uxbridge UB8 1DH

United Kingdom

EU/1/98/085/001-034

3.10.2008

1.10.2008

CoAprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174, avenue de France |
| F-75013 Paris |

Sanofi Pharma Bristol-Myers Squibb SNC

174, avenue de France

F-75013 Paris

EU/1/98/086/001-034

3.10.2008

8.10.2008

Simulect

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/98/084/001-002

10.10.2008

9.10.2008

Tasmar

| Valeant Pharmaceuticals Limited |
| --- |
| Cedarwood |
| Chineham Business Park |
| Crockford lane |
| Basingstoke RG24 8WD |
| United Kingdom |

Valeant Pharmaceuticals Limited

Cedarwood

Chineham Business Park

Crockford lane

Basingstoke RG24 8WD

United Kingdom

EU/1/97/044/001-008

14.10.2008

13.10.2008

Yondelis

| Pharma Mar, S.A. |
| --- |
| Avda. de los Reyes 1 |
| Polígono Industrial La Mina |
| E-28770 Colmenar Viejo (Madrid) |

Pharma Mar, S.A.

Avda. de los Reyes 1

Polígono Industrial La Mina

E-28770 Colmenar Viejo (Madrid)

EU/1/07/417/001-002

15.10.2008

13.10.2008

HBVAXPRO

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/01/183/030-032

15.10.2008

13.10.2008

Galvus

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/414/018

15.10.2008

14.10.2008

DepoCyte

| Pacira Limited MG House |
| --- |
| Rumbolds Hill |
| Midhurst |
| West Sussex GU29 9BY |
| United Kingdom |

Pacira Limited MG House

Rumbolds Hill

Midhurst

West Sussex GU29 9BY

United Kingdom

EU/1/01/187/001

16.10.2008

20.10.2008

Onsenal

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/03/259/001-006

22.10.2008

20.10.2008

Thalidomide Pharmion

| Celgene Europe Limited |
| --- |
| Riverside House |
| Riverside Walk |
| Windsor SL4 1NA |
| United Kingdom |

Celgene Europe Limited

Riverside House

Riverside Walk

Windsor SL4 1NA

United Kingdom

EU/1/08/443/001

22.10.2008

| Pharmion Ltd |
| --- |
| Riverside House |
| Riverside Walk |
| Windsor SL4 1NA |
| United Kingdom |

Pharmion Ltd

Riverside House

Riverside Walk

Windsor SL4 1NA

United Kingdom

21.10.2008

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

23.10.2008

21.10.2008

Aptivus

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Straße 173 |
| D-55216 Ingelheim am Rhein |

Boehringer Ingelheim International GmbH

Binger Straße 173

D-55216 Ingelheim am Rhein

EU/1/05/315/001

23.10.2008

22.10.2008

Abseamed

| Medice Arzneimittel Pütter GmbH & Co KG |
| --- |
| Kuhloweg 37 |
| D-58638 Iserlohn |

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37

D-58638 Iserlohn

EU/1/07/412/001-020

24.10.2008

23.10.2008

NeoRecormon

| 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/1/97/031/019-046

27.10.2008

23.10.2008

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

27.10.2008

24.10.2008

Prezista

| Janssen-Cilag International NV |
| --- |
| Turnhoutseweg, 30 |
| B-2340 Beerse |

Janssen-Cilag International NV

Turnhoutseweg, 30

B-2340 Beerse

EU/1/06/380/001

28.10.2008

24.10.2008

Vectibix

| Amgen Europe B.V. |
| --- |
| Minervum 7061 |
| 4817 ZK Breda |
| Nederland |

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Nederland

EU/1/07/423/001-003

28.10.2008

27.10.2008

Myocet

| Cephalon Europe |
| --- |
| 5, Rue Charles Martigny |
| F-94700 Maisons Alfort |

Cephalon Europe

5, Rue Charles Martigny

F-94700 Maisons Alfort

EU/1/00/141/001

29.10.2008

27.10.2008

Revlimid

| Celgene Europe Limited |
| --- |
| Riverside House |
| Riverside Walk |
| Windsor |
| Berkshire SL4 1NA |
| United Kingdom |

Celgene Europe Limited

Riverside House

Riverside Walk

Windsor

Berkshire SL4 1NA

United Kingdom

EU/1/07/391/001-004

29.10.2008

27.10.2008

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

29.10.2008

27.10.2008

Lucentis

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/06/374/001

29.10.2008

28.10.2008

Nespo

| Dompé Biotec S.p.A. |
| --- |
| Via San Martino, 12 |
| I-20122 Milano |

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/01/184/001-073

30.10.2008

28.10.2008

RotaTeq

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

Sanofi Pasteur MSD SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/348/001-002

30.10.2008

28.10.2008

CELSENTRI

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/07/418/001-010

30.10.2008

28.10.2008

Valtropin

| BioPartners GmbH |
| --- |
| Eisenstraße 3 |
| D-65428 Rüsselsheim |

BioPartners GmbH

Eisenstraße 3

D-65428 Rüsselsheim

EU/1/06/335/001

5.11.2008

28.10.2008

Revatio

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/05/318/001

30.10.2008

28.10.2008

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

30.10.2008

28.10.2008

Advagraf

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

Astellas Pharma Europe B.V.

Elisabethhof 19

2353 EW Leiderdorp

Nederland

EU/1/07/387/001-010

30.10.2008

28.10.2008

Agenerase

| Glaxo Group Ltd |
| --- |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

United Kingdom

EU/1/00/148/001-004

30.10.2008

28.10.2008

Ketek

| Aventis Pharma S.A. |
| --- |
| 20, avenue Raymond Aron |
| F-92160 Antony Cedex |

Aventis Pharma S.A.

20, avenue Raymond Aron

F-92160 Antony Cedex

EU/1/01/191/001-005

30.10.2008

28.10.2008

Aranesp

| Amgen Europe B.V. |
| --- |
| Minervum 7061 4817 ZK Breda |
| Nederland |

Amgen Europe B.V.

Minervum 7061 4817 ZK Breda

Nederland

EU/1/01/185/001-022

EU/1/01/185/031-073

30.10.2008

29.10.2008

Parareg

| Dompé Biotec S.p.A. |
| --- |
| Via San Martino, 12 |
| I-20122 Milano |

Dompé Biotec S.p.A.

Via San Martino, 12

I-20122 Milano

EU/1/04/293/001-012

31.10.2008

29.10.2008

Mimpara

| Amgen Europe B.V. |
| --- |
| Minervum 7061 4817 ZK Breda |
| Nederland |

Amgen Europe B.V.

Minervum 7061 4817 ZK Breda

Nederland

EU/1/04/292/001-012

31.10.2008

29.10.2008

Binocrit

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-Kundl 6250 |

Sandoz GmbH

Biochemiestrasse 10

A-Kundl 6250

EU/1/07/410/001-020

31.10.2008

29.10.2008

Betaferon

| Bayer Schering Pharma AG |
| --- |
| Müllerstraße 170-178 |
| D-13342 Berlin |

Bayer Schering Pharma AG

Müllerstraße 170-178

D-13342 Berlin

EU/1/95/003/003-008

31.10.2008

29.10.2008

Crixivan

| 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/1/96/024/001-005

EU/1/96/024/007-008

EU/1/96/024/010

31.10.2008

29.10.2008

Epoetin alfa Hexal

| HEXAL Biotech Forschungs GmbH |
| --- |
| Industriestraße 25 |
| D-83607 Holzkirchen |

HEXAL Biotech Forschungs GmbH

Industriestraße 25

D-83607 Holzkirchen

EU/1/07/411/001-020

31.10.2008

30.10.2008

Rapamune

| 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/1/01/171/001

EU/1/01/171/007-010

4.11.2008

30.10.2008

Kaletra

| Abbott Laboratories Ltd |
| --- |
| Queenborough |
| Kent ME11 5EL |
| United Kingdom |

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/1/01/172/001-006

4.11.2008

30.10.2008

Tysabri

| Elan Pharma International Ltd |
| --- |
| Monksland |
| Athlone |
| County Westmeath |
| Ireland |

Elan Pharma International Ltd

Monksland

Athlone

County Westmeath

Ireland

EU/1/06/346/001

4.11.2008

30.10.2008

Tygacil

| 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/1/06/336/001

4.11.2008

30.10.2008

Eucreas

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/425/001-018

4.11.2008

30.10.2008

PEGASYS

| 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/1/02/221/001-010

4.11.2008

30.10.2008

Infanrix Penta

| GlaxoSmithKline Biologicals s.a. |
| --- |
| rue de l'Institut, 89 |
| B-1330 Rixensart |

GlaxoSmithKline Biologicals s.a.

rue de l'Institut, 89

B-1330 Rixensart

EU/1/00/153/001-010

4.11.2008

30.10.2008

Hycamtin

| 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/1/96/027/001

EU/1/96/027/003-007

4.11.2008

30.10.2008

Myozyme

| Genzyme Europe B.V. |
| --- |
| Gooimeer 10 |
| 1411 DD Naarden |
| Nederland |

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

Nederland

EU/1/06/333/001-003

4.11.2008

30.10.2008

SUTENT

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/1/06/347/001-006

4.11.2008

31.10.2008

Sebivo

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/388/001-002

4.11.2008

31.10.2008

Gardasil

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk

F-69007 Lyon

EU/1/06/357/001-021

4.11.2008

31.10.2008

Silgard

| 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/1/06/358/001-021

4.11.2008

31.10.2008

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/1/02/222/001-004

4.11.2008

31.10.2008

Invirase

| 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/1/96/026/001-002

4.11.2008

31.10.2008

CELSENTRI

| Pfizer Limited |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT13 9NJ |
| United Kingdom |

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

EU/1/07/418/001-010

4.11.2008

31.10.2008

Xeloda

| 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/1/00/163/001-002

4.11.2008

31.10.2008

Rebetol

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73/Stallestraat, 73 |
| B-1180 Bruxelles/1180 Brussel |

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/1180 Brussel

EU/1/99/107/001-005

4.11.2008

31.10.2008

Galvus

| Novartis Europharm Limited |
| --- |
| Wimblehurst Road |
| Horsham |
| West Sussex RH12 5AB |
| United Kingdom |

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

United Kingdom

EU/1/07/414/001-010

EU/1/07/414/018

4.11.2008

31.10.2008

Infanrix hexa

| GlaxoSmithKline Biologicals s.a. |
| --- |
| rue de l'Institut, 89 |
| B-1330 Rixensart |

GlaxoSmithKline Biologicals s.a.

rue de l'Institut, 89

B-1330 Rixensart

EU/1/00/152/001-018

4.11.2008

31.10.2008

Insulin human Winthrop

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

EU/1/06/368/088-142

4.11.2008

31.10.2008

ViraferonPeg

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73/Stallestraat, 73 |
| B-1180 Bruxelles/1180 Brussel |

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/1180 Brussel

EU/1/00/132/001-050

4.11.2008

31.10.2008

PegIntron

| Schering Plough Europe |
| --- |
| Rue de Stalle, 73/Stallestraat, 73 |
| B-1180 Bruxelles/1180 Brussel |

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/1180 Brussel

EU/1/00/131/001-050

4.11.2008

—   Irtirar ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004)

| 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 |
| --- | --- | --- | --- | --- |
| 13.10.2008 | Viraferon | Schering Plough Europe |
| Rue de Stalle, 73/Stallestraat, 73 |
| B-1180 Bruxelles/1180 Brussel |

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

13.10.2008

Viraferon

Schering Plough Europe

Rue de Stalle, 73/Stallestraat, 73

B-1180 Bruxelles/1180 Brussel

EU/1/99/128/001-037

15.10.2008

29.10.2008

Forcaltonin

| Unigene UK Limited |
| --- |
| 191 Sparrows Herne |
| Bushey Heath |
| Hertfordshire WD23 1AJ |
| United Kingdom |

Unigene UK Limited

191 Sparrows Herne

Bushey Heath

Hertfordshire WD23 1AJ

United Kingdom

EU/1/98/093/002

3.11.2008

—   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 |
| --- | --- | --- | --- | --- |
| 9.10.2008 | SevoFlo | Abbott Laboratories Ltd |
| Queenborough |
| Kent ME11 5EL |
| United Kingdom |

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

9.10.2008

SevoFlo

Abbott Laboratories Ltd

Queenborough

Kent ME11 5EL

United Kingdom

EU/2/02/035/007

14.10.2008

13.10.2008

Vaxxitek HVT + IBD

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/02/032/001

15.10.2008

17.10.2008

Previcox

| Merial |
| --- |
| 29, Avenue Tony Garnier |
| F-69007 Lyon |

Merial

29, Avenue Tony Garnier

F-69007 Lyon

EU/2/04/045/001-006

21.10.2008

20.10.2008

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/2/04/044/001-002

22.10.2008

21.10.2008

Convenia

| Pfizer Ltd |
| --- |
| Ramsgate Road |
| Sandwich |
| Kent CT 13 9NJ |
| United Kingdom |

Pfizer Ltd

Ramsgate Road

Sandwich

Kent CT 13 9NJ

United Kingdom

EU/2/06/059/001

23.10.2008

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.

---

| 28.11.2008 | MT | Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea | C 305/10 |
| --- | --- | --- | --- |

28.11.2008

MT

Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea

C 305/10

---

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta' prodotti mediċinali mill-1 ta' Ottubru 2008 sal-31 ta' Ottubru 2008

(Deċiżjonijiet meħuda skond 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))

(2008/C 305/05)

—   Ħruġ, manteniment jew modifikazzjoni ta' 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 |
| --- | --- | --- | --- | --- |
| 6.10.2008 | Zyrtec | Ara l-Anness I | Ara l-Anness I | 7.10.2008 |
| 7.10.2008 | Risperdal | Ara l-Anness II | Ara l-Anness II | 10.10.2008 |
| 7.10.2008 | Risperdal Consta | Ara l-Anness III | Ara l-Anness III | 9.10.2008 |
| 7.10.2008 | Ciprofloxacin Bayer | Ara l-Anness IV | Ara l-Anness IV | 9.10.2008 |
| 24.10.2008 | Moxifloxacin | Ara l-Anness V | Ara l-Anness V | 27.10.2008 |

Data tad-Deċiżjoni

Isem(ijiet) tal-prodott mediċinali

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

Stat Membru konċernat

Data tan-notifika

6.10.2008

Zyrtec

Ara l-Anness I

Ara l-Anness I

7.10.2008

7.10.2008

Risperdal

Ara l-Anness II

Ara l-Anness II

10.10.2008

7.10.2008

Risperdal Consta

Ara l-Anness III

Ara l-Anness III

9.10.2008

7.10.2008

Ciprofloxacin Bayer

Ara l-Anness IV

Ara l-Anness IV

9.10.2008

24.10.2008

Moxifloxacin

Ara l-Anness V

Ara l-Anness V

27.10.2008

—   Revoka ta' l-awtorizzazzjoni nazzjonali għat-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 |
| --- | --- | --- | --- | --- |
| 24.10.2008 | Ribavirin iQur | Ara l-Anness VI | Ara l-Anness VI | 27.10.2008 |

Data tad-Deċiżjoni

Isem(ijiet) tal-prodott mediċinali

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

Stat Membru konċernat

Data tan-notifika

24.10.2008

Ribavirin iQur

Ara l-Anness VI

Ara l-Anness VI

27.10.2008

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS I

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnejn jingħata | Il-Kontenut
  (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | UCB Pharma GmbH (AT) |
| Jacquingasse 16-18/3.OG |
| A-1030 Wien |

Stat Membru

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

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

Il-Kontenut

(Konċentrat)

L-Awstrija

UCB Pharma GmbH (AT)

Jacquingasse 16-18/3.OG

A-1030 Wien

Zyrtec 10 mg — Filmtabletten

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Awstrija

| UCB Pharma GmbH (AT) |
| --- |
| Jacquingasse 16-18/3.OG |
| A-1030 Wien |

UCB Pharma GmbH (AT)

Jacquingasse 16-18/3.OG

A-1030 Wien

Zyrtec 10 mg/ml — Tropfen

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

L-Awstrija

| UCB Pharma GmbH (AT) |
| --- |
| Jacquingasse 16-18/3.OG |
| A-1030 Wien |

UCB Pharma GmbH (AT)

Jacquingasse 16-18/3.OG

A-1030 Wien

Zyrtec 1 mg/ml — orale Lösung

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Belġju

| McNeil |
| --- |
| Roderveld 1 |
| B-2600 Berchem |

McNeil

Roderveld 1

B-2600 Berchem

Reactine

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Belġju

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Cetirizine-ucb

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Belġju

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Cetirizine-ucb

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Belġju

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Virlix

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Belġju

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Belġju

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Belġju

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Bulgarija

| UCB Farchim S.A. (AG, Ltd) |
| --- |
| Z.I. de Planchy |
| Ch. de Croix-Blanche 10 |
| CH-1630 Bulle |

UCB Farchim S.A. (AG, Ltd)

Z.I. de Planchy

Ch. de Croix-Blanche 10

CH-1630 Bulle

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Bulgarija

| UCB Farchim S.A. (AG, Ltd) |
| --- |
| Z.I. de Planchy |
| Ch. de Croix-Blanche 10 |
| CH-1630 Bulle |

UCB Farchim S.A. (AG, Ltd)

Z.I. de Planchy

Ch. de Croix-Blanche 10

CH-1630 Bulle

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Ċipru

| Lifepharma (Z.A.M.) Ltd (CY) |
| --- |
| 8 Ayiou Nicolaou Street |
| P.O. Box 22679 |
| CY-1523 Nicosia |

Lifepharma (Z.A.M.) Ltd (CY)

8 Ayiou Nicolaou Street

P.O. Box 22679

CY-1523 Nicosia

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Ċipru

| Lifepharma (Z.A.M.) Ltd (CY) |
| --- |
| 8 Ayiou Nicolaou Street |
| P.O. Box 22679 |
| CY-1523 Nicosia |

Lifepharma (Z.A.M.) Ltd (CY)

8 Ayiou Nicolaou Street

P.O. Box 22679

CY-1523 Nicosia

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Ir-Repubblika Ċeka

| UCB Pharma S.A. (BRAINE) |
| --- |
| Chemin du Foriest |
| Braine-l'Alleud |
| B-1420 Belgique |

UCB Pharma S.A. (BRAINE)

Chemin du Foriest

Braine-l'Alleud

B-1420 Belgique

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Ir-Repubblika Ċeka

| UCB Pharma S.A. (BRAINE) |
| --- |
| Chemin du Foriest |
| Braine-l'Alleud |
| B-1420 Belgique |

UCB Pharma S.A. (BRAINE)

Chemin du Foriest

Braine-l'Alleud

B-1420 Belgique

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Id-Danimarka

| McNeil Denmark Aps |
| --- |
| Bregnerødvej 133 |
| DK-3460 Birkerød |

McNeil Denmark Aps

Bregnerødvej 133

DK-3460 Birkerød

Benaday

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Id-Danimarka

| McNeil Denmark Aps |
| --- |
| Bregnerødvej 133 |
| DK-3460 Birkerød |

McNeil Denmark Aps

Bregnerødvej 133

DK-3460 Birkerød

Benaday

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Id-Danimarka

| UCB Nordic A/S (DK) |
| --- |
| Arne Jacobsens Allé 15 |
| DK-2300 København S |

UCB Nordic A/S (DK)

Arne Jacobsens Allé 15

DK-2300 København S

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Id-Danimarka

| UCB Nordic A/S (DK) |
| --- |
| Arne Jacobsens Allé 15 |
| DK-2300 København S |

UCB Nordic A/S (DK)

Arne Jacobsens Allé 15

DK-2300 København S

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Id-Danimarka

| UCB Nordic A/S (DK) |
| --- |
| Arne Jacobsens Allé 15 |
| DK-2300 København S |

UCB Nordic A/S (DK)

Arne Jacobsens Allé 15

DK-2300 København S

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

L-Estonja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Estonja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

L-Estonja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Finlandja

| McNeil, a division of Janssen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

McNeil, a division of Janssen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Benaday

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Finlandja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Finlandja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Finlandja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Franza

| Pfizer Santé Grand Public (FR) |
| --- |
| 23-25, avenue du docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer Santé Grand Public (FR)

23-25, avenue du docteur Lannelongue

F-75668 Paris Cedex 14

Reactine

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Franza

| Sanofi Aventis France |
| --- |
| 9, Boulevard Romain Rolland |
| F-75159 Paris Cedex 14 |

Sanofi Aventis France

9, Boulevard Romain Rolland

F-75159 Paris Cedex 14

Virlix

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Franza

| Sanofi Aventis France |
| --- |
| 9, Boulevard Romain Rolland |
| F-75159 Paris Cedex 14 |

Sanofi Aventis France

9, Boulevard Romain Rolland

F-75159 Paris Cedex 14

Virlix

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Franza

| Sanofi Aventis France |
| --- |
| 9, Boulevard Romain Rolland |
| F-75159 Paris Cedex 14 |

Sanofi Aventis France

9, Boulevard Romain Rolland

F-75159 Paris Cedex 14

Virlix

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Franza

| UCB Pharma S.A. |
| --- |
| 21, Rue de Neuilly |
| F-92003 Nanterre |

UCB Pharma S.A.

21, Rue de Neuilly

F-92003 Nanterre

Cetirizine ucb 10 mg

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Franza

| UCB Pharma S.A. |
| --- |
| 21, Rue de Neuilly |
| F-92003 Nanterre |

UCB Pharma S.A.

21, Rue de Neuilly

F-92003 Nanterre

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Franza

| UCB Pharma S.A. |
| --- |
| 21, Rue de Neuilly |
| F-92003 Nanterre |

UCB Pharma S.A.

21, Rue de Neuilly

F-92003 Nanterre

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Franza

| UCB Pharma S.A. |
| --- |
| 21, Rue de Neuilly |
| F-92003 Nanterre |

UCB Pharma S.A.

21, Rue de Neuilly

F-92003 Nanterre

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Franza

| Pfizer Santé Grand Public (FR) |
| --- |
| 23-25, avenue du docteur Lannelongue |
| F-75668 Paris Cedex 14 |

Pfizer Santé Grand Public (FR)

23-25, avenue du docteur Lannelongue

F-75668 Paris Cedex 14

Actifed allergie cetirizine 10 mg

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Franza

| UCB Pharma S.A. |
| --- |
| 21, Rue de Neuilly |
| F-92003 Nanterre |

UCB Pharma S.A.

21, Rue de Neuilly

F-92003 Nanterre

Zyrtecset

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Ġermanja

| UCB GmbH |
| --- |
| Alfred-Nobel-Str. 10 |
| D-40789 Monheim |

UCB GmbH

Alfred-Nobel-Str. 10

D-40789 Monheim

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Ġermanja

| UCB GmbH |
| --- |
| Alfred-Nobel-Str. 10 |
| D-40789 Monheim |

UCB GmbH

Alfred-Nobel-Str. 10

D-40789 Monheim

Zyrtec p

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Ġermanja

| UCB GmbH |
| --- |
| Alfred-Nobel-Str. 10 |
| D-40789 Monheim |

UCB GmbH

Alfred-Nobel-Str. 10

D-40789 Monheim

Zyrtec p tropfen

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Ġermanja

| UCB GmbH |
| --- |
| Alfred-Nobel-Str. 10 |
| D-40789 Monheim |

UCB GmbH

Alfred-Nobel-Str. 10

D-40789 Monheim

Zyrtec saft

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Ġermanja

| UCB GmbH |
| --- |
| Alfred-Nobel-Str. 10 |
| D-40789 Monheim |

UCB GmbH

Alfred-Nobel-Str. 10

D-40789 Monheim

Zyrtec tropfen

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Ġermanja

| Pfizer Consumer Healthcare GmbH |
| --- |
| Pfizerstr. 1 |
| D-76139 Karlsruhe |

Pfizer Consumer Healthcare GmbH

Pfizerstr. 1

D-76139 Karlsruhe

Reactine

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Greċja

| UCB A.E. |
| --- |
| 580 Avenue Vouliagmenis |
| GR-16452 Argyroupoli |

UCB A.E.

580 Avenue Vouliagmenis

GR-16452 Argyroupoli

Ziptek

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Greċja

| UCB A.E. |
| --- |
| 580 Avenue Vouliagmenis |
| GR-16452 Argyroupoli |

UCB A.E.

580 Avenue Vouliagmenis

GR-16452 Argyroupoli

Ziptek

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

L-Ungerija

| UCB Magyarország Kft |
| --- |
| Árpád fejedelem útja 26-28 |
| H-1023 Budapest |

UCB Magyarország Kft

Árpád fejedelem útja 26-28

H-1023 Budapest

Zyrtec cseppek

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

L-Ungerija

| UCB Magyarország Kft |
| --- |
| Árpád fejedelem útja 26-28 |
| H-1023 Budapest |

UCB Magyarország Kft

Árpád fejedelem útja 26-28

H-1023 Budapest

Zyrtec filmtabletta

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Ungerija

| UCB Magyarország Kft |
| --- |
| Árpád fejedelem útja 26-28 |
| H-1023 Budapest |

UCB Magyarország Kft

Árpád fejedelem útja 26-28

H-1023 Budapest

Zyrtec oldat

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

L-Ungerija

| UCB Magyarország Kft |
| --- |
| Árpád fejedelem útja 26-28 |
| H-1023 Budapest |

UCB Magyarország Kft

Árpád fejedelem útja 26-28

H-1023 Budapest

Zyrtec start filmtabletta

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Irlanda

| UCB Pharma Ireland Limited |
| --- |
| United Drug House |
| Magna Drive |
| City West Road |
| Dublin 24 |
| Ireland |

UCB Pharma Ireland Limited

United Drug House

Magna Drive

City West Road

Dublin 24

Ireland

Zirtek oral solution 1 mg/ml

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

L-Irlanda

| UCB Pharma Ireland Limited |
| --- |
| United Drug House |
| Magna Drive |
| City West Road |
| Dublin 24 |
| Ireland |

UCB Pharma Ireland Limited

United Drug House

Magna Drive

City West Road

Dublin 24

Ireland

Zirtek tablets

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Italja

| Istituto Lusofarmaco |
| --- |
| Via Walter Tobagi 8 |
| I-20068 Peschiera Borromeo (MI) |

Istituto Lusofarmaco

Via Walter Tobagi 8

I-20068 Peschiera Borromeo (MI)

Formistin

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Italja

| Istituto Lusofarmaco |
| --- |
| Via Walter Tobagi 8 |
| I-20068 Peschiera Borromeo (MI) |

Istituto Lusofarmaco

Via Walter Tobagi 8

I-20068 Peschiera Borromeo (MI)

Formistin

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

L-Italja

| Pfizer Consumer Healthcare S.r.l. |
| --- |
| SS 156km 50 |
| I-04010 Borgo San Michele (LT) |

Pfizer Consumer Healthcare S.r.l.

SS 156km 50

I-04010 Borgo San Michele (LT)

Virlix

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Italja

| Pfizer Consumer Healthcare S.r.l. |
| --- |
| SS 156km 50 |
| I-04010 Borgo San Michele (LT) |

Pfizer Consumer Healthcare S.r.l.

SS 156km 50

I-04010 Borgo San Michele (LT)

Virlix

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

L-Italja

| UCB Pharma SpA |
| --- |
| Via Praglia, 15 |
| I-10044 Pianezza (Torino) |

UCB Pharma SpA

Via Praglia, 15

I-10044 Pianezza (Torino)

Zirtec 1 mg/ml soluzione orale

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

L-Italja

| UCB Pharma SpA |
| --- |
| Via Praglia, 15 |
| I-10044 Pianezza (Torino) |

UCB Pharma SpA

Via Praglia, 15

I-10044 Pianezza (Torino)

Zirtec 10 mg compresse rivestite con film

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Italja

| UCB Pharma SpA |
| --- |
| Via Praglia, 15 |
| I-10044 Pianezza (Torino) |

UCB Pharma SpA

Via Praglia, 15

I-10044 Pianezza (Torino)

Zirtec 10 mg/ml gocce orali soluzione

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Latvja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Latvja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Latvja

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

UCB Pharma Oy

Finland Malminkaari 5

FI-00700 Helsinki

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Litwanja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Litwanja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Litwanja

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

UCB Pharma Oy Finland

Malminkaari 5

FI-00700 Helsinki

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Lussemburgu

| McNeil |
| --- |
| Roderveld 1 |
| B-2600 Berchem |

McNeil

Roderveld 1

B-2600 Berchem

Reactine

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Lussemburgu

| McNeil |
| --- |
| Roderveld 1 |
| B-2600 Berchem |

McNeil

Roderveld 1

B-2600 Berchem

Sinutab Decongestif & Antihistaminicum

5 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Lussemburgu

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Virlix

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Lussemburgu

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Lussemburgu

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Lussemburgu

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Lussemburgu

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Cetirizine-ucb

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Lussemburgu

| UCB Pharma S.A. (Brussels) |
| --- |
| Allée de la Recherche, 60/Researchdreef, 60 |
| B-1070 Bruxelles/Brussel |

UCB Pharma S.A. (Brussels)

Allée de la Recherche, 60/Researchdreef, 60

B-1070 Bruxelles/Brussel

Cetirizine-ucb

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Malta

| Pharmasud Ltd |
| --- |
| 38 Triq l-Isturnell |
| San Gwann SGN02 |
| Malta |

Pharmasud Ltd

38 Triq l-Isturnell

San Gwann SGN02

Malta

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Malta

| Pharmasud Ltd |
| --- |
| 38 Triq l-Isturnell |
| San Gwann SGN02 |
| Malta |

Pharmasud Ltd

38 Triq l-Isturnell

San Gwann SGN02

Malta

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

L-Olanda

| Pfizer Consumer Healthcare BV |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJsel |
| Nederland |

Pfizer Consumer Healthcare BV

Rivium Westlaan 142

2909 LD Capelle a/d IJsel

Nederland

Reactine

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Olanda

| UCB Pharma B.V. |
| --- |
| Lage Mosten 33 |
| 4822 NK Breda |
| Nederland |

UCB Pharma B.V.

Lage Mosten 33

4822 NK Breda

Nederland

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Olanda

| UCB Pharma B.V. |
| --- |
| Lage Mosten 33 |
| 4822 NK Breda |
| Nederland |

UCB Pharma B.V.

Lage Mosten 33

4822 NK Breda

Nederland

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

In-Norveġja

| McNeil Sweden AB |
| --- |
| Sollentuna |
| Sweden |

McNeil Sweden AB

Sollentuna

Sweden

Reactine

10 mg

Pillola miksija b'rita

Użu mill-ħalq

In-Norveġja

| UCB Nordic A/S (DK) |
| --- |
| Arne Jacobsens Allé 15 |
| DK-2300 København S |

UCB Nordic A/S (DK)

Arne Jacobsens Allé 15

DK-2300 København S

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

In-Norveġja

| UCB Nordic A/S (DK) |
| --- |
| Arne Jacobsens Allé 15 |
| DK-2300 København S |

UCB Nordic A/S (DK)

Arne Jacobsens Allé 15

DK-2300 København S

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

In-Norveġja

| UCB Nordic A/S (DK) |
| --- |
| Arne Jacobsens Allé 15 |
| DK-2300 København S |

UCB Nordic A/S (DK)

Arne Jacobsens Allé 15

DK-2300 København S

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Polonja

| Pfizer Consumer Healthcare |
| --- |
| Walton Oaks Dorking Road |
| Walton on the Hill |
| Surrey KT 20 7 NS |
| United Kingdom |

Pfizer Consumer Healthcare

Walton Oaks Dorking Road

Walton on the Hill

Surrey KT 20 7 NS

United Kingdom

Reactine

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Polonja

| PLIVA Kraków Zakłady Farmaceutyczne S.A. |
| --- |
| ul. Mogilska 80 |
| PL-31-546 Krakow |

PLIVA Kraków Zakłady Farmaceutyczne S.A.

ul. Mogilska 80

PL-31-546 Krakow

Virlix

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Polonja

| PLIVA Kraków Zakłady Farmaceutyczne S.A. |
| --- |
| ul. Mogilska 80 |
| PL-31-546 Krakow |

PLIVA Kraków Zakłady Farmaceutyczne S.A.

ul. Mogilska 80

PL-31-546 Krakow

Virlix

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Polonja

| Vedim Sp. z.o.o. |
| --- |
| ul. Kruczkowskiego 8 |
| PL-00-380 Warszawa |

Vedim Sp. z.o.o.

ul. Kruczkowskiego 8

PL-00-380 Warszawa

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Polonja

| Vedim Sp. z.o.o. |
| --- |
| ul. Kruczkowskiego 8 |
| PL-00-380 Warszawa |

Vedim Sp. z.o.o.

ul. Kruczkowskiego 8

PL-00-380 Warszawa

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Polonja

| Vedim Sp. z.o.o. |
| --- |
| ul. Kruczkowskiego 8 |
| PL-00-380 Warszawa |

Vedim Sp. z.o.o.

ul. Kruczkowskiego 8

PL-00-380 Warszawa

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Polonja

| Vedim Sp. z.o.o. |
| --- |
| ul. Kruczkowskiego 8 |
| PL-00-380 Warszawa |

Vedim Sp. z.o.o.

ul. Kruczkowskiego 8

PL-00-380 Warszawa

Zyrtec ucb

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Portugall

| UCB Pharma |
| --- |
| Ed. Maria I |
| Q 60, piso 1 A |
| Quinta da Fonte |
| P-2770-229 Paço de Arcos |

UCB Pharma

Ed. Maria I

Q 60, piso 1 A

Quinta da Fonte

P-2770-229 Paço de Arcos

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Portugall

| UCB Pharma |
| --- |
| Ed. Maria I |
| Q 60, piso 1 A |
| Quinta da Fonte |
| P-2770-229 Paço de Arcos |

UCB Pharma

Ed. Maria I

Q 60, piso 1 A

Quinta da Fonte

P-2770-229 Paço de Arcos

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Il-Portugall

| UCB Pharma |
| --- |
| Ed. Maria I |
| Q 60, piso 1 A |
| Quinta da Fonte |
| P-2770-229 Paço de Arcos |

UCB Pharma

Ed. Maria I

Q 60, piso 1 A

Quinta da Fonte

P-2770-229 Paço de Arcos

Zyrtec

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Il-Portugall

| Vedim Pharma Lda |
| --- |
| Ed. D. Maria I |
| Piso 1 A |
| Quinta da Fonte |
| P-2770-229 Paço de Arcos |

Vedim Pharma Lda

Ed. D. Maria I

Piso 1 A

Quinta da Fonte

P-2770-229 Paço de Arcos

Virlix

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Il-Portugall

| Vedim Pharma Lda |
| --- |
| Ed. D. Maria I |
| Piso 1 A |
| Quinta da Fonte |
| P-2770-229 Paço de Arcos |

Vedim Pharma Lda

Ed. D. Maria I

Piso 1 A

Quinta da Fonte

P-2770-229 Paço de Arcos

Virlix

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Ir-Rumanija

| UCB GmbH |
| --- |
| Huttenstraße 205 |
| D-50170 Kerpen |

UCB GmbH

Huttenstraße 205

D-50170 Kerpen

Zyrtec

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Ir-Rumanija

| UCB GmbH |
| --- |
| Huttenstraße 205 |
| D-50170 Kerpen |

UCB GmbH

Huttenstraße 205

D-50170 Kerpen

Zyrtec

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Is-Slovakkja

| UCB S.A. Pharma Secteur |
| --- |
| Chemin du Foriest |
| B-1420 Braine l'Alleud |

UCB S.A. Pharma Secteur

Chemin du Foriest

B-1420 Braine l'Alleud

Zyrtec gtt por 10 mg/ml

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Is-Slovakkja

| UCB S.A. Pharma Secteur |
| --- |
| Chemin du Foriest |
| B-1420 Braine l'Alleud |

UCB S.A. Pharma Secteur

Chemin du Foriest

B-1420 Braine l'Alleud

Zyrtec tbl flm 10 mg

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Slovenja

| Medis – Podjetje za proizvodnjo in trženje d.o.o. (Slovenia) |
| --- |
| Brnčičeva 1 |
| SLO-1001 Ljubljana |

Medis – Podjetje za proizvodnjo in trženje d.o.o. (Slovenia)

Brnčičeva 1

SLO-1001 Ljubljana

Zyrtec 1 mg/ml peroralna raztopina

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Slovenja

| Medis – Podjetje za proizvodnjo in trženje d.o.o. (Slovenia) |
| --- |
| Brnčičeva 1 |
| SLO-1001 Ljubljana |

Medis – Podjetje za proizvodnjo in trženje d.o.o. (Slovenia)

Brnčičeva 1

SLO-1001 Ljubljana

Zyrtec 10 mg filmsko obložene tablete

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Slovenja

| Medis – Podjetje za proizvodnjo in trženje d.o.o. (Slovenia) |
| --- |
| Brnčičeva 1 |
| SLO-1001 Ljubljana |

Medis – Podjetje za proizvodnjo in trženje d.o.o. (Slovenia)

Brnčičeva 1

SLO-1001 Ljubljana

Zyrtec 10 mg/ml peroralne kapljice, raztopina

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Spanja

| Laboratorios Menarini S.A. |
| --- |
| Alfonso XII, 587 |
| E-08918 Badalona (Barcelona) |

Laboratorios Menarini S.A.

Alfonso XII, 587

E-08918 Badalona (Barcelona)

Alerlisin

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Spanja

| Laboratorios Menarini S.A. |
| --- |
| Alfonso XII, 587 |
| E-08918 Badalona (Barcelona) |

Laboratorios Menarini S.A.

Alfonso XII, 587

E-08918 Badalona (Barcelona)

Alerlisin

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Spanja

| Laboratorios Menarini S.A. |
| --- |
| Alfonso XII, 587 |
| E-08918 Badalona (Barcelona) |

Laboratorios Menarini S.A.

Alfonso XII, 587

E-08918 Badalona (Barcelona)

Alerlisin

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Spanja

| Lacer SA |
| --- |
| Sardenya 346-350 |
| E-08025 Barcelona |

Lacer SA

Sardenya 346-350

E-08025 Barcelona

Virdos

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Spanja

| Lacer SA |
| --- |
| Sardenya 346-350 |
| E-08025 Barcelona |

Lacer SA

Sardenya 346-350

E-08025 Barcelona

Virlix

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Spanja

| Lacer SA |
| --- |
| Sardenya 346-350 |
| E-08025 Barcelona |

Lacer SA

Sardenya 346-350

E-08025 Barcelona

Virlix

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Spanja

| Pfizer Consumer Healthcare |
| --- |
| Plaza Xavier Cugat, 2. Edificio D. |
| E-08174 Sant Cugat del Vallés |

Pfizer Consumer Healthcare

Plaza Xavier Cugat, 2. Edificio D.

E-08174 Sant Cugat del Vallés

Reactine

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Spanja

| Pfizer Consumer Healthcare |
| --- |
| Plaza Xavier Cugat, 2. Edificio D. |
| E-08174 Sant Cugat del Vallés |

Pfizer Consumer Healthcare

Plaza Xavier Cugat, 2. Edificio D.

E-08174 Sant Cugat del Vallés

Reactine 5 mg/5 ml solución oral

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Spanja

| UCB Pharma S.A. |
| --- |
| Avenida de Barcelona 239 |
| E-08750 Molins de Rei |

UCB Pharma S.A.

Avenida de Barcelona 239

E-08750 Molins de Rei

Zyrtec comprimidos recubiertos con pelicula

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Spanja

| UCB Pharma S.A. |
| --- |
| Avenida de Barcelona 239 |
| E-08750 Molins de Rei |

UCB Pharma S.A.

Avenida de Barcelona 239

E-08750 Molins de Rei

Zyrtec gotas orales en solución

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

Spanja

| UCB Pharma S.A. |
| --- |
| Avenida de Barcelona 239 |
| E-08750 Molins de Rei |

UCB Pharma S.A.

Avenida de Barcelona 239

E-08750 Molins de Rei

Zyrtec solución oral

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Spanja

| Vedim Pharma S.A. |
| --- |
| Avenida de Barcelona, 239 |
| E-08750 Molins de Rei (Barcelona) |

Vedim Pharma S.A.

Avenida de Barcelona, 239

E-08750 Molins de Rei (Barcelona)

Alerrid 10 mg comprimidos recubierto con pelicula

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Isvezja

| UCB Nordic A/S |
| --- |
| Arne Jacobsens Allé 15 |
| DK-2300 København S |

UCB Nordic A/S

Arne Jacobsens Allé 15

DK-2300 København S

Alerid

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Isvezja

| UCB Nordic A/S |
| --- |
| Arne Jacobsens Allé 15 |
| DK-2300 København S |

UCB Nordic A/S

Arne Jacobsens Allé 15

DK-2300 København S

Zyrlex

10 mg

Pillola miksija b'rita

Użu mill-ħalq

L-Isvezja

| UCB Nordic A/S |
| --- |
| Arne Jacobsens Allé 15 |
| DK-2300 København S |

UCB Nordic A/S

Arne Jacobsens Allé 15

DK-2300 København S

Zyrlex

10 mg/ml

Taqtir tal-ħalq, taħlita likwida

Użu mill-ħalq

10 mg/ml

L-Isvezja

| UCB Nordic A/S |
| --- |
| Arne Jacobsens Allé 15 |
| DK-2300 København S |

UCB Nordic A/S

Arne Jacobsens Allé 15

DK-2300 København S

Zyrlex

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Ir-Renju Unit

| McNeil Products Limited |
| --- |
| Foundation Park |
| Roxborough Way |
| Maidenhead |
| Berkshire SL6 3UG |
| United Kingdom |

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

Benadryl allergy oral syrup

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Ir-Renju Unit

| McNeil Products Limited |
| --- |
| Foundation Park |
| Roxborough Way |
| Maidenhead |
| Berkshire SL6 3UG |
| United Kingdom |

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

Benadryl for children allergy solution

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

Ir-Renju Unit

| McNeil Products Limited |
| --- |
| Walton Oaks |
| Dorking Road |
| Walton on the Hill |
| Surrey KT20 7NS |
| United Kingdom |

McNeil Products Limited

Walton Oaks

Dorking Road

Walton on the Hill

Surrey KT20 7NS

United Kingdom

Benadryl one a day

10 mg

Pillola miksija b'rita

Użu mill-ħalq

Ir-Renju Unit

| McNeil Products Limited |
| --- |
| Foundation Park |
| Roxborough way |
| Maidenhead |
| Berkshire SL6 3UG |
| United Kingdom |

McNeil Products Limited

Foundation Park

Roxborough way

Maidenhead

Berkshire SL6 3UG

United Kingdom

Benadryl one a day

10 mg

Pillola miksija b'rita

Użu mill-ħalq

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

Zirtek allergy relief for children

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

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

Zirtek allergy relief tablets

10 mg

Pillola miksija b'rita

Użu mill-ħalq

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

Zirtek allergy solution

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

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

Benadryl allergy solution

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

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

Benadryl allergy oral solution

1 mg/ml

Taħlita likwida li tittieħed mill-ħalq

Użu mill-ħalq

1 mg/ml

---

ANNESS II

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq | INN | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnejn jingħata | Il-Kontenut
  (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Janssen-Cilag Pharma GmbH |
| Pfarrgasse 75 |
| A-1232 Wien |

Stat Membru

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

INN

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

Il-Kontenut

(Konċentrat)

L-Awstrija

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal Quicklet 0,5 mg — Tabletten

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal Quicklet 1 mg — Tabletten

1 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal Quicklet 2 mg — Tabletten

2 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal Quicklet 3 mg — Tabletten

3 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal Quicklet 4 mg — Tabletten

4 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal 0,5 mg — Filmtabletten

0,5 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal 1 mg — Filmtabletten

1 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal 2 mg — Filmtabletten

2 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal 3 mg — Filmtabletten

3 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal 4 mg — Filmtabletten

4 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal 6 mg — Filmtabletten

6 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Risperdal 1 mg/ml — orale Lösung

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin Quicklet 0,5 mg — Tabletten

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin Quicklet 1 mg — Tabletten

1 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin Quicklet 2 mg — Tabletten

2 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin Quicklet 3 mg — Tabletten

3 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin Quicklet 4 mg — Tabletten

4 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin 0,5 mg — Filmtabletten

0,5 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin 1 mg — Filmtabletten

1 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin 2 mg — Filmtabletten

2 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin 3 mg — Filmtabletten

3 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin 4 mg — Filmtabletten

4 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin 6 mg — Filmtabletten

6 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperidon

Rispolin 1 mg/ml — orale Lösung

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C Instasolv

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

6 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal Instasolv

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal Instasolv

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal Instasolv

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

0,5 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

1 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

2 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

3 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

4 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

6 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C Instasolv

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C Instasolv

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Il- Bulgarija

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Rispolept

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il- Bulgarija

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Rispolept

1 mg

Pillola miksija b'rita

Użu orali

Il- Bulgarija

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Rispolept

2 mg

Pillola miksija b'rita

Użu orali

Il- Bulgarija

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Rispolept

3 mg

Pillola miksija b'rita

Użu orali

Il- Bulgarija

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Rispolept

4 mg

Pillola miksija b'rita

Użu orali

Ċipru

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Ċipru

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Ċipru

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Ċipru

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

Ċipru

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal

1 mg/ml

Soluzzjoni orali

Użu orali

1 mg/ 1 ml

Ir-Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperidonum

Risperdal 1 mg

1 mg

Pillola miksija b'rita

Użu orali

Ir-Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperidonum

Risperdal 2 mg

2 mg

Pillola miksija b'rita

Użu orali

Ir-Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperidonum

Risperdal 3 mg

3 mg

Pillola miksija b'rita

Użu orali

Ir-Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperidonum

Risperdal 4 mg

4 mg

Pillola miksija b'rita

Użu orali

Ir-Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperidonum

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ 1 ml

Ir-Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperidonum

Risperdal Quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Ir-Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperidonum

3 mg

Pillola li tinħall fil-ħalq

Użu orali

Ir-Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperidonum

Risperdal Quicklet

4 mg

Pillola li tinħall fil-ħalq

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Belivon

1 mg

Soluzzjoni orali

Użu orali

1 mg/ 1 ml

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Belivon

1 mg

Pillola miksija b'rita

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Belivon

2 mg

Pillola miksija b'rita

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Belivon

3 mg

Pillola miksija b'rita

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Belivon

4 mg

Pillola miksija b'rita

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ 1 ml

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Risperdal

0,5 mg

Lajofiliżejt orali

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Risperdal

1 mg

Lajofiliżejt orali

Użu orali

Danimarka

| Janssen-Cilag A/S |
| --- |
| Postboks 149 |
| Hammerbakken 19 |
| DK-3460 Birkerød |

Janssen-Cilag A/S

Postboks 149

Hammerbakken 19

DK-3460 Birkerød

Risperidone

Risperdal

2 mg

Lajofiliżejt orali

Użu orali

L-Estonja

| Johnson & Johnson UAB |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

Johnson & Johnson UAB

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

1 mg

Pillola miksija b'rita

Użu orali

L-Estonja

| Johnson & Johnson UAB |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

Johnson & Johnson UAB

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

2 mg

Pillola miksija b'rita

Użu orali

L-Estonja

| Johnson & Johnson UAB |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

Johnson & Johnson UAB

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

3 mg

Pillola miksija b'rita

Użu orali

L-Estonja

| Johnson & Johnson UAB |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

Johnson & Johnson UAB

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

4 mg

Pillola miksija b'rita

Użu orali

L-Estonja

| Johnson & Johnson UAB |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

Johnson & Johnson UAB

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

1 mg/ml

Soluzzjoni orali

Użu orali

1 mg/ml

L-Estonja

| Johnson & Johnson UAB |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

Johnson & Johnson UAB

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept Quicklet

1 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Estonja

| Johnson & Johnson UAB |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

Johnson & Johnson UAB

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept Quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal

0,25 mg

Pillola miksija b'rita

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal

6 mg

Pillola miksija b'rita

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal Instasolv

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal Instasolv

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal Instasolv

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal Instasolv

3 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperidone

Risperdal Instasolv

4 mg

Pillola li tinħall fil-ħalq

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Belivon

1 mg

Pillola mnaqqxa

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Belivon

2 mg

Pillola mnaqqxa

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Belivon

3 mg

Pillola mnaqqxa

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Belivon

4 mg

Pillola mnaqqxa

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdal

1 mg

Pillola mnaqqxa minn fejn tinqasam fin-nofs

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdal

2 mg

Pillola mnaqqxa minn fejn tinqasam fin-nofs

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdal

3 mg

Pillola mnaqqxa minn fejn tinqasam fin-nofs

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdal

4 mg

Pillola mnaqqxa minn fejn tinqasam fin-nofs

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdal

1 mg/ml

Soluzzjoni orali

Użu orali

1 mg/ml

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdaloro

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdaloro

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdaloro

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdaloro

3 mg

Pillola li tinħall fil-ħalq

Użu orali

Franza

| Laboratoires Janssen-Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Laboratoires Janssen-Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperidone

Risperdaloro

4 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal 1 mg

1 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal 2 mg

2 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal 3 mg

3 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal 4 mg

4 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal Filmtabletten 0,25 mg

0,25 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal Filmtabletten 0,5 mg

0,5 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal Filmtabletten 6 mg

6 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal Lösung 1 mg/ml

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal Quicklet 1 mg

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal Quicklet 2 mg

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal Quicklet 3 mg

3 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperdal Quicklet 4 mg

4 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperidon-Janssen Filmtabletten 6 mg

6 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Risperidon-Janssen Loesung 1 mg/ml

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Belivon 0,5 mg Filmtabletten

0,5 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Belivon 1 mg Filmtabletten

1 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Belivon 1 mg/ml Lösung

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Belivon 2 mg Filmtabletten

2 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Belivon 3 mg Filmtabletten

3 mg

Pillola miksija b'rita

Użu jewali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Belivon 4 mg Filmtabletten

4 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Belivon 6 mg Filmtabletten

6 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Rehablit 1 mg

1 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss. |

Janssen-Cilag GmbH

Raiffeisenstr. 8

41470 Neuss.

Risperidon

Rehablit 2 mg

2 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Rehablit 3 mg

3 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Rehablit 4 mg

4 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Rehablit Filmtabletten 6 mg

6 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Janssen-Cilag GmbH |
| --- |
| D-41457 Neuss |

Janssen-Cilag GmbH

D-41457 Neuss

jew

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon

Rehablit Lösung 1 mg/ml

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal

6 mg

Pillola miksija b'rita

Użu orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal

8 mg

Pillola miksija b'rita

Użu orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal

1 mg/1 ml

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal Quicklet

0,5 mg

Pillola għall-ilsien

Użu orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal Quicklet

1 mg

Pillola għall-ilsien

Użu orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal Quicklet

2 mg

Pillola għall-ilsien

Użu orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal Quicklet

3 mg

Pillola għall-ilsien

Użu orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I |
| --- |
| 56 Eirinis Avenue |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical S.A.C.I

56 Eirinis Avenue

GR-15121 Pefki

Risperidone

Risperdal Quicklet

4 mg

Pillola għall-ilsien

Użu orali

L-Ungerija

| Janssen-Cilag Kft. |
| --- |
| H-2045 Törökbálint, Tó park |

Janssen-Cilag Kft.

H-2045 Törökbálint, Tó park

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

L-Ungerija

| Janssen-Cilag Kft. |
| --- |
| Tó park |
| H-2045 Törökbálint |

Janssen-Cilag Kft.

Tó park

H-2045 Törökbálint

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

L-Ungerija

| Janssen-Cilag Kft. |
| --- |
| Tó park |
| H-2045 Törökbálint |

Janssen-Cilag Kft.

Tó park

H-2045 Törökbálint

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

L-Ungerija

| Janssen-Cilag Kft. |
| --- |
| Tó park |
| H-2045 Törökbálint |

Janssen-Cilag Kft.

Tó park

H-2045 Törökbálint

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

L-Ungerija

| Janssen-Cilag Kft. |
| --- |
| Tó park |
| H-2045 Törökbálint |

Janssen-Cilag Kft.

Tó park

H-2045 Törökbálint

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

L-Ungerija

| Janssen-Cilag Kft. |
| --- |
| Tó park |
| H-2045 Törökbálint |

Janssen-Cilag Kft.

Tó park

H-2045 Törökbálint

Risperidone

Risperdal Quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Ungerija

| Janssen-Cilag Kft. |
| --- |
| Tó park |
| H-2045 Törökbálint |

Janssen-Cilag Kft.

Tó park

H-2045 Törökbálint

Risperidone

Risperdal Quicklet

3 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Ungerija

| Janssen-Cilag Kft. |
| --- |
| Tó park |
| H-2045 Törökbálint |

Janssen-Cilag Kft.

Tó park

H-2045 Törökbálint

Risperidone

Risperdal Quicklet

4 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

0,5 mg

Lajofiliżejt orali

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

1 mg

Lajofiliżejt orali

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

2 mg

Lajofiliżejt orali

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

3 mg

Lajofiliżejt orali

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

4 mg

Lajofiliżejt orali

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

L-Islanda

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidonum

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal liquid

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal

6 mg

Pillola miksija b'rita

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal

0,25 mg

Pillola miksija b'rita

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal quicklet

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal quicklet

1 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal quicklet

3 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperidone

Risperdal quicklet

4 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

0,5 mg

Pillola

Użu orali

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

0,25 mg

Pillola

Użu orali

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

6 mg

Pillola miksija b'rita

Użu orali

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

0,5 mg

Pillola li tinħall fil-ħalq

Oral

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

1 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Risperdal

2 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Italja

| J.C. Healthcare Srl |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

J.C. Healthcare Srl

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Belivon

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

L-Italja

| J.C. Healthcare Srl |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

J.C. Healthcare Srl

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Belivon

1 mg

Pillola miksija b'rita

Użu orali

L-Italja

| J.C. Healthcare Srl |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

J.C. Healthcare Srl

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Belivon

2 mg

Pillola miksija b'rita

Użu orali

L-Italja

| J.C. Healthcare Srl |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

J.C. Healthcare Srl

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Belivon

3 mg

Pillola miksija b'rita

Użu orali

L-Italja

| J.C. Healthcare Srl |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

J.C. Healthcare Srl

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Belivon

4 mg

Pillola miksija b'rita

Użu orali

L-Italja

| J.C. Healthcare Srl |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

J.C. Healthcare Srl

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Actase

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

L-Italja

| J.C. Healthcare Srl |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

J.C. Healthcare Srl

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Actase

1 mg

Pillola miksija b'rita

Użu orali

L-Italja

| J.C. Healthcare Srl |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

J.C. Healthcare Srl

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Actase

2 mg

Pillola miksija b'rita

Użu orali

L-Italja

| J.C. Healthcare Srl |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

J.C. Healthcare Srl

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Actase

3 mg

Pillola miksija b'rita

Użu orali

L-Italja

| J.C. Healthcare Srl |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

J.C. Healthcare Srl

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperidone

Actase

4 mg

Pillola miksija b'rita

Użu orali

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

1 mg

Pilloli

Użu orali

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

2 mg

Pilloli

Użu orali

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

3 mg

Pilloli

Użu orali

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

4 mg

Pilloli

Użu orali

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Risperdal Quicklet

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Risperdal Quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Risperdal Quicklet

4 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

1 mg

Pillola miksija b'rita

Użu orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

2 mg

Pillola miksija b'rita

Użu orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

3 mg

Pillola miksija b'rita

Użu orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

4 mg

Pillola miksija b'rita

Użu orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept Quicklet

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Risperidone

Rispolept Quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C Instasolv

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal

6 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal Instasolv

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal Instasolv

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperdal Instasolv

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

0,5 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

1 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

2 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

3 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

4 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C

6 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C Instasolv

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Lussemburgu

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperidone

Risperidone J-C Instasolv

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Malta

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal

1 mg

Pilloli

Użu orali

Malta

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal

2 mg

Pilloli

Użu orali

Malta

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal

3 mg

Pilloli

Użu orali

Malta

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Malta

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal Quicklets

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Malta

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal Quicklets

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Malta

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Risperdal Quicklets

2 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Risperdal

Risperdal omhulde tabletten 0,5 mg

0,5 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Risperdal

Risperdal omhulde tabletten 1 mg

1 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag BV |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag BV

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Risperdal

Risperdal omhulde tabletten 2 mg

2 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Risperdal

Risperdal omhulde tabletten 3 mg

3 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Risperdal

Risperdal omhulde tabletten 4 mg

4 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Risperdal

Risperdal omhulde tabletten 6 mg

6 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Risperdal

Risperdal omhulde tabletten 8 mg

8 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Belivon

Belivon omhulde tabletten 1 mg

1 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Belivon

Belivon omhulde tabletten 2 mg

2 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Belivon

Belivon omhulde tabletten 3 mg

3 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Belivon

4 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Risperdal

Risperdal 1 mg/ml, drank

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

L-Olanda

| Janssen-Cilag N.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag N.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperidon

Belivon

Belivon 1 mg/ml

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Belivon

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Belivon

1 mg

Pillola miksija b'rita

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Belivon

2 mg

Pillola miksija b'rita

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Belivon

3 mg

Pillola miksija b'rita

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Belivon

4 mg

Pillola miksija b'rita

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

3 mg

Pillola li tinħall fil-ħalq

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

4 mg

Pillola li tinħall fil-ħalq

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Polonja

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Polonja

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept

1 mg

Pillola miksija b'rita

Użu orali

Il-Polonja

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept

2 mg

Pillola miksija b'rita

Użu orali

Il-Polonja

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept

3 mg

Pillola miksija b'rita

Użu orali

Il-Polonja

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept

4 mg

Pillola miksija b'rita

Użu orali

Il-Polonja

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept Quicklet

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Polonja

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept Quicklet

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Polonja

| Jansen Cilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Jansen Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept Quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal

0,25 mg

Pillola miksija b'rita

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal Quicklet

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal Quicklet

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal Quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal Quicklet

3 mg

Pillola li tinħall fil-ħalq

Użu orali

Il-Portugall

| Janssen Farmacêutica Portugal, Lda |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperidona

Risperdal Quicklet

4 mg

Pillola li tinħall fil-ħalq

Użu orali

Ir-Rumanija

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept 1 mg

1 mg

Pillola miksija b'rita

Użu orali

Ir-Rumanija

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept 2 mg

2 mg

Pillola miksija b'rita

Użu orali

Ir-Rumanija

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept 3 mg

3 mg

Pillola miksija b'rita

Użu orali

Ir-Rumanija

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept 4 mg

4 mg

Pillola miksija b'rita

Użu orali

Ir-Rumanija

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Ir-Rumanija

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept Quicklet

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Ir-Rumanija

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperidone

Rispolept Quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperidone

Risperdal Quicklet

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperidone

Risperdal Quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperidone

Risperdal Quicklet

3 mg

Pillola li tinħall fil-ħalq

Użu orali

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperidone

Risperdal Quicklet

4 mg

Pillola li tinħall fil-ħalq

Użu orali

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Risperdal 1 mg filmsko obložene tablete

1 mg

Pillola miksija b'rita

Użu orali

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Risperdal 2 mg filmsko obložene tablete

2 mg

Pillola miksija b'rita

Użu orali

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Risperdal 3 mg filmsko obložene tablete

3 mg

Pillola miksija b'rita

Użu orali

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Risperdal 4 mg filmsko obložene tablete

4 mg

Pillola miksija b'rita

Użu orali

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Risperdal 1 mg/ml peroralna raztopina

1 mg/ml

Soluzzjoni orali

Użu orali

1 mg/ml

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Risperdal Quicklet 0,5 mg orodisperzibilna tableta

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Risperdal Quicklet 1 mg orodisperzibilna tableta

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperidone

Risperdal Quicklet 2 mg orodisperzibilna tableta

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las Doce Estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Risperidone

Risperdal flas

3 mg

Pillola li tinħall fil-ħalq

Użu orali

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las Doce Estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Risperidone

Risperdal flas

4 mg

Pillola li tinħall fil-ħalq

Użu orali

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las Doce Estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Risperidone

Risperdal flas

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las Doce Estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Risperidone

Risperdal flas

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las Doce Estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Risperidone

Risperdal flas

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las Doce Estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las Doce Estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las Doce Estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las Doce Estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Risperidone

Risperdal

6 mg

Pillola miksija b'rita

Użu orali

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las Doce Estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las Doce Estrellas, 5-7

E-28042 Madrid

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Belivon

1 mg

Pillola miksija b'rita

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Belivon

2 mg

Pillola miksija b'rita

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Belivon

3 mg

Pillola miksija b'rita

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Belivon

4 mg

Pillola miksija b'rita

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Belivon

6 mg

Pillola miksija b'rita

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Belivon

1 mg

Soluzzjoni orali

Użu orali

1 mg/1ml

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

0,5 mg

Lajofiliżejt orali

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

1 mg

Lajofiliżejt orali

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

2 mg

Lajofiliżejt orali

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

3 mg

Lajofiliżejt orali

Użu orali

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperidone

Risperdal

4 mg

Lajofiliżejt orali

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal

0,25 mg

Pillola miksija b'rita

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal

0,5 mg

Pillola miksija b'rita

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal

1 mg

Pillola miksija b'rita

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal

2 mg

Pillola miksija b'rita

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal

3 mg

Pillola miksija b'rita

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal

4 mg

Pillola miksija b'rita

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal

6 mg

Pillola miksija b'rita

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal liquid

1 mg

Soluzzjoni orali

Użu orali

1 mg/ml

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal quicklet

0,5 mg

Pillola li tinħall fil-ħalq

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal quicklet

1 mg

Pillola li tinħall fil-ħalq

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal quicklet

2 mg

Pillola li tinħall fil-ħalq

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal quicklet

3 mg

Pillola li tinħall fil-ħalq

Użu orali

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperidone

Risperdal quicklet

4 mg

Pillola li tinħall fil-ħalq

Użu orali

---

ANNESS III

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnejn jingħata | Il-Kontenut
  (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Janssen-Cilag Pharma GmbH |
| Pfarrgasse 75 |
| A-1232 Wien |

Stat Membru

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

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

Il-Kontenut

(Konċentrat)

L-Awstrija

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperdal Consta

12,5 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

12,5 mg/2 ml

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperdal Consta

25 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperdal Consta

37,5 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Risperdal Consta

50 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Rispolin Consta

12,5 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

12,5 mg/2ml

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Rispolin Consta

25 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

25 mg/2ml

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Rispolin Consta

37,5 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

L-Awstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75

A-1232 Wien

Rispolin Consta

50 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Belivon Consta

25 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Belivon Consta

37,5 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Belivon Consta

50 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperdal Consta

25 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperdal Consta

37,5 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Il-Belġju

| Janssen Cilag N.V. |
| --- |
| Roderveldlaan 1 |
| B-2600 Berchem |

Janssen Cilag N.V.

Roderveldlaan 1

B-2600 Berchem

Risperdal Consta

50 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Il-Bulgarija

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Rispolept Consta

25 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Il-Bulgarija

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Rispolept Consta

37,5 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Il-Bulgarija

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Rispolept Consta

50 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Ċipru

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperdal Consta

25 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Ċipru

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperdal Consta

37,5 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Ċipru

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperdal Consta

50 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperdal Consta 25 mg

25 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperdal Consta 37,5 mg

37,5 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2ml

Repubblika Ċeka

| Janssen-Cilag s. r. o. |
| --- |
| Karla Engliše 3201/6 |
| CZ-150 00 Praha 5 |

Janssen-Cilag s. r. o.

Karla Engliše 3201/6

CZ-150 00 Praha 5

Risperdal Consta 50 mg

50 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

L-Estonja

| Johnson & Johnson UAB |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

Johnson & Johnson UAB

Šeimyniškių g. 1A

LT-09312 Vilnius

Rispolept Consta

25 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25mg/2ml

L-Estonja

| Johnson & Johnson UAB |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

Johnson & Johnson UAB

Šeimyniškių g. 1A

LT-09312 Vilnius

Rispolept Consta

37,5 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5mg/2ml

L-Estonja

| Johnson & Johnson UAB |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

Johnson & Johnson UAB

Šeimyniškių g. 1A

LT-09312 Vilnius

Rispolept Consta

50 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50mg/2ml

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperdal Consta

12,5 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

12,5 mg/2ml

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperdal Consta

25 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

25mg/2ml

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperdal Consta

37,5 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Il-Finlandja

| Jansen-Cilag Oy |
| --- |
| Metsänneidonkuja 8 |
| FI-02130 Espoo |

Jansen-Cilag Oy

Metsänneidonkuja 8

FI-02130 Espoo

Risperdal Consta

50 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Franza

| Janssen Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Janssen Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperdalconsta LP

25 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Franza

| Janssen Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Janssen Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperdalconsta LP

37,5 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Franza

| Janssen Cilag |
| --- |
| 1, rue Desmoulins |
| TSA 91003 |
| F-92787 Issy-les-Moulineaux Cedex 9 |

Janssen Cilag

1, rue Desmoulins

TSA 91003

F-92787 Issy-les-Moulineaux Cedex 9

Risperdalconsta LP

50 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Ġermanja

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperdal Consta

25 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Ġermanja

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperdal Consta

37,5 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Ġermanja

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperdal Consta

50 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Ġermanja

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon-Janssen Consta

25 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Ġermanja

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon-Janssen Consta

37,5 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Ġermanja

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Risperidon-Janssen Consta

50 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Ġermanja

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Rispon-Janssen Consta

25 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Ġermanja

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Rispon-Janssen Consta

37,5 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Ġermanja

| Janssen-Cilag GmbH |
| --- |
| Raiffeisenstr. 8 |
| D-41470 Neuss |

Janssen-Cilag GmbH

Raiffeisenstr. 8

D-41470 Neuss

Rispon-Janssen Consta

50 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Il-Greċja

| Janssen-Cilag Pharmaceutical |
| --- |
| Aebe Eirinis Avenue 56 |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical

Aebe Eirinis Avenue 56

GR-15121 Pefki

Risperdal Consta

25 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Il-Greċja

| Janssen-Cilag Pharmaceutical |
| --- |
| Aebe Eirinis Avenue 56 |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical

Aebe Eirinis Avenue 56

GR-15121 Pefki

Risperdal Consta

37,5 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Il-Greċja

| Janssen-Cilag Pharmaceutical |
| --- |
| Aebe Eirinis Avenue 56 |
| GR-15121 Pefki |

Janssen-Cilag Pharmaceutical

Aebe Eirinis Avenue 56

GR-15121 Pefki

Risperdal Consta

50 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

L-Islanda

| Janssen-Cilag AB |
| --- |
| c/o Vistor hf.Hörgatúni 2 |
| Garðabær |
| Iceland |

Janssen-Cilag AB

c/o Vistor hf.Hörgatúni 2

Garðabær

Iceland

Risperdal Consta

50 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

L-Islanda

| Janssen-Cilag AB |
| --- |
| c/o Vistor hf.Hörgatúni 2 |
| Garðabær |
| Iceland |

Janssen-Cilag AB

c/o Vistor hf.Hörgatúni 2

Garðabær

Iceland

Risperdal Consta

37,5 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

L-Islanda

| Janssen-Cilag AB |
| --- |
| c/o Vistor hf.Hörgatúni 2 |
| Garðabær |
| Iceland |

Janssen-Cilag AB

c/o Vistor hf.Hörgatúni 2

Garðabær

Iceland

Risperdal Consta

25 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperdal Consta

25 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperdal Consta

37,5 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

L-Irlanda

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

Risperdal Consta

50 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperdal

25 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperdal

37,5 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

L-Italja

| Janssen Cilag Spa |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese |
| I-20093 Milano |

Janssen Cilag Spa

Via Michelangelo Buonarroti n. 23

Cologno Monzese

I-20093 Milano

Risperdal

50 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Rispolept Consta

25 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Rispolept Consta

50 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

Il-Latvja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Rispolept Consta

37,5 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Rispolept Consta

25 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Rispolept Consta

37,5 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A |
| LT-09312 Vilnius |

UAB Johnson & Johnson

Šeimyniškių g. 1A

LT-09312 Vilnius

Rispolept Consta

50 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

Malta

| JansenCilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

JansenCilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperdal Consta

25 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Malta

| JansenCilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

JansenCilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperdal Consta

37,5 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Malta

| JansenCilag International N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

JansenCilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Risperdal Consta

50 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

L-Olanda

| Janssen-Cilag B.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperdal Consta

12,5 mg

Trab u soluzzjoni għal suspenzjoni u injezzjoni

Użu għal ġol-muskoli

12,5 mg/2 ml

L-Olanda

| Janssen-Cilag B.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperdal Consta

25 mg

Trab u soluzzjoni għal suspenzjoni u injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

L-Olanda

| Janssen-Cilag B.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperdal Consta

37,5 mg

Trab u soluzzjoni għal suspenzjoni u injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

L-Olanda

| Janssen-Cilag B.V. |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nederland |

Janssen-Cilag B.V.

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nederland

Risperdal Consta

50 mg

Trab u soluzzjoni għal suspenzjoni u injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

In-Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperdal Consta

25 mg

Trab li jerħi bil-mod (mikrosferi) u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

In-Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperdal Consta

37,5 mg

Trab li jerħi bil-mod (mikrosferi) u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

In-Norveġja

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

Janssen-Cilag AS

Hoffsveien 1D

N-0275 Oslo

Risperdal Consta

50 mg

Trab li jerħi bil-mod (mikrosferi) u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

Il-Polonja

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Rispolept Consta

25 mg

Mikrokapsula li terħi bil-mod il- mediċina u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Il-Polonja

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Rispolept Consta

37,5 mg

Mikrokapsula li terħi bil-mod il- mediċina u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Il-Polonja

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

Janssen-Cilag International N.V.

Turnhoutseweg 30

B-2340 Beerse

Rispolept Consta

50 mg

Mikrokapsula li terħi bil-mod il- mediċina u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

Il-Portugall

| Janssen Farmacêutica Portugal, Lda. |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperdal Consta

25 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Il-Portugall

| Janssen Farmacêutica Portugal, Lda. |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperdal Consta

37,5 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Il-Portugall

| Janssen Farmacêutica Portugal, Lda. |
| --- |
| Estrada Consiglieri Pedroso, 69 A |
| Queluz de Baixo |
| P-2734-503 Barcarena |

Janssen Farmacêutica Portugal, Lda.

Estrada Consiglieri Pedroso, 69 A

Queluz de Baixo

P-2734-503 Barcarena

Risperdal Consta

50 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

Ir-Rumanija

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

B-2340 Beerse

Rispolept Consta

25 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Ir-Rumanija

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

B-2340 Beerse

Rispolept Consta

37,5 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2ml

Ir-Rumanija

| Janssen Pharmaceutica N.V. |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |

Janssen Pharmaceutica N.V.

Turnhoutseweg 30

B-2340 Beerse

Rispolept Consta

50 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperdal Consta

25 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperdal Consta

37,5 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Is-Slovakkja

| Johnson & Johnson s. r. o. |
| --- |
| Plynárenská 7/B |
| SK-824 78 Bratislava |

Johnson & Johnson s. r. o.

Plynárenská 7/B

SK-824 78 Bratislava

Risperdal Consta

50 mg

Trab u solvent għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperdal Consta

25 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperdal Consta

37,5 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2ml

Slovenja

| Johnson & Johnson d.o.o. |
| --- |
| Šmartinska cesta 53 |
| SLO-1000 Ljubljana |

Johnson & Johnson d.o.o.

Šmartinska cesta 53

SLO-1000 Ljubljana

Risperdal Consta

50 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las 12 estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las 12 estrellas, 5-7

E-28042 Madrid

Risperdal Consta

25 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2ml

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las 12 estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las 12 estrellas, 5-7

E-28042 Madrid

Risperdal Consta

37.5 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Spanja

| Janssen Cilag, SA |
| --- |
| Paseo de las 12 estrellas, 5-7 |
| E-28042 Madrid |

Janssen Cilag, SA

Paseo de las 12 estrellas, 5-7

E-28042 Madrid

Risperdal Consta

50 mg

Trab u solvent għal soluzzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperdal Consta

25 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperdal Consta

37,5 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2ml

L-Isvezja

| Janssen-Cilag AB |
| --- |
| Box 7073 |
| S-192 07 Sollentuna |

Janssen-Cilag AB

Box 7073

S-192 07 Sollentuna

Risperdal Consta

50 mg

Trab u solvent għal suspenzjoni li terħi l-mediċina bil- mod għall injezzjoni

Użu għal ġol-muskoli

50 mg/2ml

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperdal Consta

25 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

25 mg/2 ml

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperdal Consta

37,5 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

37,5 mg/2 ml

Ir-Renju Unit

| Janssen-Cilag Ltd |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP 14 4HJ |
| United Kingdom |

Janssen-Cilag Ltd

Saunderton

High Wycombe

Buckinghamshire HP 14 4HJ

United Kingdom

Risperdal Consta

50 mg

Trab għal suspenzjoni għall injezzjoni

Użu għal ġol-muskoli

50 mg/2 ml

---

ANNESS IV

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Kontenut
  (konċentrazzjoni) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Bayer Austria GmbH |
| Herbststraße 6-10 |
| A-1160 Wien |

Stat Membru

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

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Kontenut

(konċentrazzjoni)

L-Awstrija

Bayer Austria GmbH

Herbststraße 6-10

A-1160 Wien

Ciproxin

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxin

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciproxin

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprofloxacine “BAYER”

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprofloxacine “BAYER”

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

5 %

Suspensjoni orali

Użu orali

5 %

Ciproxin

10 %

Suspensjoni orali

Użu orali

10 %

Il-Belġju

| Bayer S.A.-N.V. |
| --- |
| Avenue Louise 143/Louizalaan 143 |
| B-1050 Bruxelles/Brussel |

Bayer S.A.-N.V.

Avenue Louise 143/Louizalaan 143

B-1050 Bruxelles/Brussel

Ciproxine

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxine

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxine

100 mg

Pilloli miksija b'rita

Użu orali

100 mg

Ciproxine

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxine

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxine

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciproxine

5 g/100 ml

Suspensjoni orali

Użu orali

50 mg/ ml

Ciproxine

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxine

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Il-Bulgarija

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Ciprobay

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciprobay

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciprobay

200 mg /100ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay XR

500 mg

Pilloli li jerħu l-mediċina b'mod modifikat

Użu orali

500 mg

Ċipru

| Bayer Hellas Abee |
| --- |
| 18-20 Sorou Street |
| GR-15125 Marousi Athens |

Bayer Hellas Abee

18-20 Sorou Street

GR-15125 Marousi Athens

Ciproxin

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ir-Repubblika Ċeka

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Ciprobay

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay Uro

100 mg

Pilloli miksija b'rita

Użu orali

100 mg

Ciprobay

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciprobay

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciprobay

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Id-Danimarka

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Ciproxin

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxin

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

50 mg/ml

Suspensjoni orali

Użu orali

50 mg/ml

Ciproxin

100 mg/ml

Suspensjoni orali

Użu orali

100 mg/ml

L-Estonja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Ciproxin

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Il-Finlandja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Ciproxin

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxin

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Franza

| Bayer Santé |
| --- |
| 13, rue Jean Jaurès |
| F-92807 Puteaux Cedex |

Bayer Santé

13, rue Jean Jaurès

F-92807 Puteaux Cedex

Ciflox

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciflox

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Uniflox

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciflox

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciflox

250 mg/5 ml

Suspensjoni orali

Użu orali

50 mg/ml

Ciflox

500 mg/5 ml

Suspensjoni orali

Użu orali

100 mg/ml

Ciflox

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciflox

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |

Bayer Vital GmbH

D-51368 Leverkusen

CIPROBAY

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

CIPROBAY

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

CIPROBAY

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

CIPROBAY URO

100 mg

Pilloli miksija b'rita

Użu orali

100 mg

CIPROBAY

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

CIPROBAY

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

CIPROBAY

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

CIPROBAY

5 g/100 ml

Suspensjoni orali

Użu orali

50 mg/ml

CIPROBAY

10 g/100 ml

Suspensjoni orali

Użu orali

100 mg/ml

| Bayer Healthcare AG |
| --- |
| D-51368 Leverkusen |

Bayer Healthcare AG

D-51368 Leverkusen

Ciprofloxacin ANTIBAC

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciprofloxacin ANTIBAC

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciprofloxacin ANTIBAC

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciprofloxacin ANTIBAC

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprofloxacin ANTIBAC

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprofloxacin ANTIBAC

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprofloxacin BAYER

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprofloxacin BAYER

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprofloxacin BAYER

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprofloxacin VITAL

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprofloxacin VITAL

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprofloxacin VITAL

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Il-Greċja

| Bayer Hellas Abee |
| --- |
| 18-20 Sorou Street |
| GR-15125 Marousi Athens |

Bayer Hellas Abee

18-20 Sorou Street

GR-15125 Marousi Athens

CIPROXIN

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

CIPROXIN

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

CIPROXIN

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

CIPROXIN

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

CIPROXIN

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

CIPROXIN

250 mg/5 ml

Suspensjoni orali

Użu orali

50 mg/ml

CIPROXIN

500 mg/5 ml

Suspensjoni orali

Użu orali

100 mg/ml

CIPROXIN XR

500 mg

Pilloli li jerħu l-mediċina b'mod modifikat

Użu orali

500 mg

CIPROXIN XR

1 000 mg

Pilloli li jerħu l-mediċina b'mod modifikat

Użu orali

1 000 mg

L-Ungerija

| Bayer Hungária Kft. |
| --- |
| Alkotás u. 50. |
| H-1123 Budapest |

Bayer Hungária Kft.

Alkotás u. 50.

H-1123 Budapest

Ciprobay

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciprobay

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciprobay

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

L-Islanda

| Bayer Healthcare AG |
| --- |
| D-51368 Leverkusen |

Bayer Healthcare AG

D-51368 Leverkusen

Ciproxin

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxin

750 mg

Pilloli miksija b'rita

Użu orali

750mg

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

L-Irlanda

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Ciproxin

100 mg

Pilloli miksija b'rita

Użu orali

100 mg

Ciproxin

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxin

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciproxin

250 mg/5 ml

Suspensjoni orali

Użu orali

50 mg/ml

Ciproxin

500 mg/5 ml

Suspensjoni orali

Użu orali

100 mg/ml

Ciproxin

100 mg/50ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

200 mg/100ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

L-Italja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

CIFLOX

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

CIFLOX

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

| Bayer Spa |
| --- |
| Viale Certosa 130 |
| I-20156 Milano |

Bayer Spa

Viale Certosa 130

I-20156 Milano

CIPROXIN

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

CIPROXIN

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

CIPROXIN

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

CIPROXIN

500 mg

Pilloli li jerħu l-mediċina b'mod modifikat

Użu orali

500 mg

CIPROXIN

1 000 mg

Pilloli li jerħu l-mediċina b'mod modifikat

Użu orali

1 000 mg

CIPROXIN

250 mg

Suspensjoni orali

Użu orali

50 mg/ml

CIPROXIN

500 mg

Suspensjoni orali

Użu orali

100 mg/ml

CIPROXIN

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

CIPROXIN

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

CIPROXIN

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Il-Latvja

Mhux awtorizzat

Il-Litwanja

Mhux awtorizzat

Il-Lussemburgu

| Bayer S.A.-N.V. |
| --- |
| Avenue Louise 143 |
| B-1050 Bruxelles |

Bayer S.A.-N.V.

Avenue Louise 143

B-1050 Bruxelles

Ciproxine

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxine

100 mg

Pilloli miksija b'rita

Użu orali

100 mg

Ciproxine

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxine

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxine

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciproxine

5 g/100 ml

Suspensjoni orali

Użu orali

250 mg/5 ml

Ciproxine

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxine

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Malta

| Bayer Plc |
| --- |
| Bayer House |
| Newbury |
| Berkshire RG14 1JA |
| United Kingdom |
| Trading as: Bayer plc |
| Bayer Schering Pharma |

Bayer Plc

Bayer House

Newbury

Berkshire RG14 1JA

United Kingdom

Trading as: Bayer plc

Bayer Schering Pharma

Ciproxin

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxin

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

L-Olanda

| Bayer BV |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| Nederland |

Bayer BV

Energieweg 1

3641 RT Mijdrecht

Nederland

Ciproxin

100 mg

Pilloli miksija b'rita

Użu orali

100 mg

Ciproxin

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxin

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciproxin

5 g/100 ml

Suspensjoni orali

Użu orali

50 mg/ml

Ciproxin

10 g/100 ml

Suspensjoni orali

Użu orali

100 mg/ml

Ciproxin

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

In-Norveġja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Ciproxin

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxin

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Il-Polonja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Ciprobay Uro

100 mg

Pillola miksija b'rita

Użu orali

100 mg

Ciprobay

250 mg

Pillola miksija b'rita

Użu orali

250 mg

Ciprobay

500 mg

Pillola miksija b'rita

Użu orali

500 mg

Ciprobay

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Il-Portugall

| Bayer Portugal S.A. |
| --- |
| Rua Quinta do |
| Pinheiro 5 |
| P-2794-003 Carnaxide |

Bayer Portugal S.A.

Rua Quinta do

Pinheiro 5

P-2794-003 Carnaxide

Ciproxina

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

Ciproxina

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciproxina

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

Ciproxina OD

500 mg

Pilloli li jerħu l-mediċina b'mod modifikat

Użu orali

500 mg

Ciproxina OD

1 000 mg

Pilloli li jerħu l-mediċina b'mod modifikat

Użu orali

1 000 mg

Ciproxina

10 g/100 ml

Suspensjoni orali

Użu orali

100 mg/ ml

Ciproxina

5 g/100 ml

Suspensjoni orali

Użu orali

50 mg/ml

Ciproxina

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxina

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ir-Rumanija

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Ciprobay

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

Ciprobay

200 mg/ 100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

400 mg/ 200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay XR

500 mg

Pilloli li jerħu l-mediċina b'mod modifikat

Użu orali

500 mg

Ciprobay XR

1 000 mg

Pilloli li jerħu l-mediċina b'mod modifikat

Użu orali

1 000 mg

Ciproxin

5 g/100 ml

Suspensjoni orali

Użu orali

50 mg/ml

Ciproxin

10 g/100 ml

Suspensjoni orali

Użu orali

100 mg/ml

Is-Slovakkja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Ciprobay

250 mg

Pillola miksija b'rita

Użu orali

250 mg

Ciprobay

500 mg

Pillola miksija b'rita

Użu orali

500 mg

Ciprobay

750 mg

Pillola miksija b'rita

Użu orali

750 mg

Ciprobay

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Is-Slovenja

| Bayer Pharma d.o.o. |
| --- |
| Bravničarjeva 13 |
| SLO-1000 Ljubljana |

Bayer Pharma d.o.o.

Bravničarjeva 13

SLO-1000 Ljubljana

Ciprobay

250 mg

Pillola miksija b'rita

Użu orali

250 mg

Ciprobay

500 mg

Pillola miksija b'rita

Użu orali

500 mg

Ciprobay

750 mg

Pillola miksija b'rita

Użu orali

750 mg

Ciprobay

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciprobay

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Spanja

| Quimica farmacéutica Bayer, S.L. |
| --- |
| Av. Baix Llobregat, 3-5 |
| E-08970 Sant Joan Despí Barcelona |

Quimica farmacéutica Bayer, S.L.

Av. Baix Llobregat, 3-5

E-08970 Sant Joan Despí Barcelona

BAYCIP

250 mg

Pilloli miksija b'rita

Użu orali

250 mg

BAYCIP

500 mg

Pilloli miksija b'rita

Użu orali

500 mg

BAYCIP

750 mg

Pilloli miksija b'rita

Użu orali

750 mg

BAYCIP

250 mg

Suspensjoni orali (fi qratas b'doża waħda)

Użu orali

250 mg

BAYCIP

500 mg

Suspensjoni orali (fi qratas b'doża waħda)

Użu orali

500 mg

BAYCIP

10 g/100 ml

Suspensjoni orali

Użu orali

100 mg/ml

L-Isvezja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Ciproxin

250 mg

Pillola miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pillola miksija b'rita

Użu orali

500 mg

Ciproxin

750 mg

Pillola miksija b'rita

Użu orali

750 mg

Ciproxin

5 g/100 ml

Suspensjoni orali

Użu orali

50 mg/ml

Ciproxin

10 g/100 ml

Suspensjoni orali

Użu orali

100 mg/ml

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ir-Renju Unit

| Bayer Plc |
| --- |
| Bayer House. |
| Newbury |
| Berkshire RG14 1JA |
| Ir-Renju Unit |

Bayer Plc

Bayer House.

Newbury

Berkshire RG14 1JA

Ir-Renju Unit

Għall-kummerċ bħala: Bayer plc

Bayer Schering Pharma

Ciproxin

100 mg

Pillola miksija b'rita

Użu orali

100 mg

Ciproxin

250 mg

Pillola miksija b'rita

Użu orali

250 mg

Ciproxin

500 mg

Pillola miksija b'rita

Użu orali

500 mg

Ciproxin

750 mg

Pillola miksija b'rita

Użu orali

750 mg

Ciproxin

250 mg/5 ml

Suspensjoni orali

Użu orali

50 mg/ml

Ciproxin

500 mg/5 ml

Suspensjoni orali

Użu orali

100 mg/ml

Ciproxin

100 mg/50 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

200 mg/100 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

Ciproxin

400 mg/200 ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 mg/ml

---

ANNESS V

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI U TA' L-ISLANDA

| Stat Membru | Isem u indirizz tad-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq | INN | Isem tal-prodott | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Bayer HealthCare AG |
| D-51368 Leverkusen |

Stat Membru

Isem u indirizz tad-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-suq

INN

Isem tal-prodott

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Actira 400 mg — Filmtabletten

400 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Octegra 400 mg — Filmtabletten

400 mg

Pillola miksija b'rita

Użu orali

L-Awstrija

| Bayer Austria GmbH |
| --- |
| Herbststraße 6-10 |
| A-1160 Wien |

Bayer Austria GmbH

Herbststraße 6-10

A-1160 Wien

Moxifloxacin hydrochloride

Avelox 400 mg — Filmtabletten

400 mg

Pillola miksija b'rita

Użu orali

Il-Bulgarija

| Bayer AG |
| --- |
| D-51368 Leverkusen |

Bayer AG

D-51368 Leverkusen

Moxifloxacin

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Bayer AG |
| --- |
| D-51368 Leverkusen |

Bayer AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Actira 400 mg

400 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Bayer S.A.-N.V. |
| --- |
| Avenue Louise 143/Louizalaan 143 |
| B-1050 Bruxelles/Brussel |

Bayer S.A.-N.V.

Avenue Louise 143/Louizalaan 143

B-1050 Bruxelles/Brussel

Moxifloxacin hydrochloride

Avelox 400 mg

400 mg

Pillola miksija b'rita

Użu orali

Il-Belġju

| Therabel Pharma S.A. |
| --- |
| Rue Egide Van Ophem 108 |
| B-1180 Bruxelles |

Therabel Pharma S.A.

Rue Egide Van Ophem 108

B-1180 Bruxelles

Moxifloxacin hydrochloride

Proflox 400 mg

400 mg

Pillola miksija b'rita

Użu orali

Ċipru

| Bayer Hellas S.A. |
| --- |
| Sorou 18-20 |
| GR-151 25 Marousi — Athens |

Bayer Hellas S.A.

Sorou 18-20

GR-151 25 Marousi — Athens

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Ir-Repubblika Ċeka

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |

Bayer Vital GmbH

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avalox 400 mg Filmtabletten

400 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Octegra 400 mg Filmtabletten

400 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Actira 400 mg Filmtabletten

400 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Actimax 400 mg Filmtabletten

400 mg

Pillola miksija b'rita

Użu orali

Id-Danimarka

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Actira

400 mg

Pillola miksija b'rita

Użu orali

Id-Danimarka

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Id-Danimarka

| Teva Denmark A/S |
| --- |
| Parallelvej 10 |
| DK-2800 Kongens Lyngby |

Teva Denmark A/S

Parallelvej 10

DK-2800 Kongens Lyngby

Moxifloxacin

Infekt

400 mg

Pillola miksija b'rita

Użu orali

Id-Danimarka

| Teva UK limited |
| --- |
| Brampton Road |
| Eastbourne |
| East Sussex BN22 9AG |
| United Kingdom |

Teva UK limited

Brampton Road

Eastbourne

East Sussex BN22 9AG

United Kingdom

Moxifloxacin

Moxiflaxacine “Teva”

400 mg

Pillola miksija b'rita

Użu orali

L-Estonja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Il-Greċja

| Elpen SA Pharmaceutical Industry |
| --- |
| 95, Marathonos Avenue |
| GR-19009 Pikermi |

Elpen SA Pharmaceutical Industry

95, Marathonos Avenue

GR-19009 Pikermi

Moxifloxacin

Octegra

400 mg

Pillola miksija b'rita

Użu orali

Il-Greċja

| Bayer Hellas Abee |
| --- |
| Sorou 18-20 |
| GR-15125 Maroussi — Athens |

Bayer Hellas Abee

Sorou 18-20

GR-15125 Maroussi — Athens

Moxifloxacin

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Il-Greċja

| Bayer plc, Pharmaceutical |
| --- |
| Bayer House |
| Strawberry Hill |
| Newbury |
| Berkshire RG14 1JA |
| United Kingdom |

Bayer plc, Pharmaceutical

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

Moxifloxacin

Proflox

400 mg

Pillola miksija b'rita

Użu orali

Spanja

| Química Farmaceutica Bayer, S.A. |
| --- |
| Av. Baix Llobregat, 3-5 |
| E-08970 Sant Joan Despi, Barcelona |

Química Farmaceutica Bayer, S.A.

Av. Baix Llobregat, 3-5

E-08970 Sant Joan Despi, Barcelona

Moxifloxacin hydrochloride

Actira 400 mg comprimidos recubiertos con película

400 mg

Pillola miksija b'rita

Użu orali

Spanja

| Procter and Gamble Pharmaceuticals Iberia, SL |
| --- |
| WTC Almeda park, Edif 1, 2a planta |
| E-08940 Cornellá de Llobregat, Barcelona |

Procter and Gamble Pharmaceuticals Iberia, SL

WTC Almeda park, Edif 1, 2a planta

E-08940 Cornellá de Llobregat, Barcelona

Moxifloxacin hydrochloride

Octegra 400 mg comprimidos recubiertos con película

400 mg

Pillola miksija b'rita

Użu orali

Spanja

| Recordati Espaňa, SL |
| --- |
| Carretera De Zeneta, 149 |
| E-30588 Beniel (Murcia) |

Recordati Espaňa, SL

Carretera De Zeneta, 149

E-30588 Beniel (Murcia)

Moxifloxacin hydrochloride

Havelox 400 mg comprimidos recubiertos con película

400 mg

Pillola miksija b'rita

Użu orali

Spanja

| Laboratorios Dr Esteve, SA |
| --- |
| Avda. Mare de Déu de Montserrat, 221 |
| E-08041 Barcelona |

Laboratorios Dr Esteve, SA

Avda. Mare de Déu de Montserrat, 221

E-08041 Barcelona

Moxifloxacin hydrochloride

Proflox 400 mg comprimidos recubiertos con película

400 mg

Pillola miksija b'rita

Użu orali

Finland

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Actira

400 mg

Pillola miksija b'rita

Użu orali

Il-Finlandja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Franza

| Bayer Santé |
| --- |
| 13, rue Jean Jaurès |
| F-92807 Puteaux Cedex |

Bayer Santé

13, rue Jean Jaurès

F-92807 Puteaux Cedex

Moxifloxacin hydrochloride

Izilox 400 mg, comprimé pelliculé

400 mg

Pillola miksija b'rita

Użu orali

Franza

| Bayer Healthcare AG |
| --- |
| D-51368 Leverkusen |

Bayer Healthcare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Octegra 400 mg, comprimé pelliculé

400 mg

Pillola miksija b'rita

Użu orali

L-Ungerija

| Bayer Hungária Kft |
| --- |
| Alkotás u.50. |
| H-1123 Budapest |

Bayer Hungária Kft

Alkotás u.50.

H-1123 Budapest

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

I-Islanda

| Bayer Healthcare AG |
| --- |
| D-51368 Leverkusen |

Bayer Healthcare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

I-Italja

| Bayer Spa |
| --- |
| Viale Certosa 130 |
| I-20156 Milano |

Bayer Spa

Viale Certosa 130

I-20156 Milano

Moxifloxacin hydrochloride

Avalox

400 mg

Pillola miksija b'rita

Użu orali

I-Italja

| Bayer AG |
| --- |
| D-51368 Leverkusen |

Bayer AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Proflox

400 mg

Pillola miksija b'rita

Użu orali

I-Italja

| Innova pharma Spa |
| --- |
| Via M. Civitali 1 |
| I-20148 Milano |

Innova pharma Spa

Via M. Civitali 1

I-20148 Milano

Moxifloxacin hydrochloride

Octegra

400 mg

Pillola miksija b'rita

Użu orali

I-Italja

| Sigma-Tau Industrie Farmaceutiche Riunite Spa |
| --- |
| Viale Shakespeare 47 |
| I-00144 Roma |

Sigma-Tau Industrie Farmaceutiche Riunite Spa

Viale Shakespeare 47

I-00144 Roma

Moxifloxacin hydrochloride

Actira

400 mg

Pillola miksija b'rita

Użu orali

I-Irlanda

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Moxafloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Il-Litwanja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Actira

400 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Bayer S.A.-N.V. |
| --- |
| Avenue Louise 143/Louizalaan 143 |
| B-1050 Bruxelles/Brussel |

Bayer S.A.-N.V.

Avenue Louise 143/Louizalaan 143

B-1050 Bruxelles/Brussel

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Il-Lussemburgu

| Therabel Pharma |
| --- |
| Rue Egide Van Ochem 110 |
| B-1180 Bruxelles |

Therabel Pharma

Rue Egide Van Ochem 110

B-1180 Bruxelles

Moxifloxacin hydrochloride

Proflox

400 mg

Pillola miksija b'rita

Użu orali

Il-Latvja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Malta

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |

Bayer Vital GmbH

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avalox

400 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Bayer BV |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| Nederland |

Bayer BV

Energieweg 1

3641 RT Mijdrecht

Nederland

Moxifloxacin hydrochloride

Avelox 400 mg tabletten

400 mg

Pillola miksija b'rita

Użu orali

L-Olanda

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Octegra 400 mg tabletten

400 mg

Pillola miksija b'rita

Użu orali

Il-Polonja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Il-Portugall

| Bayer AG |
| --- |
| D-51368 Leverkusen |

Bayer AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Actira

400 mg

Pillola miksija b'rita

Użu orali

Il-Portugall

| BayHealth |
| --- |
| Comercialização de Produtos Farmacêuticos Unipessoal, Lda. |
| Rua Quinta do Pinheiro, 5 |
| P-2794-003 Carnaxide |

BayHealth

Comercialização de Produtos Farmacêuticos Unipessoal, Lda.

Rua Quinta do Pinheiro, 5

P-2794-003 Carnaxide

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

Il-Portugall

| Bialfar-Produtos |
| --- |
| A Av. da Siderurgia Nacional |
| P.O. Box 56 |
| P-4745-457 S. Mamede do Coronado |

Bialfar-Produtos

A Av. da Siderurgia Nacional

P.O. Box 56

P-4745-457 S. Mamede do Coronado

Moxifloxacin hydrochloride

Proflox

400 mg

Pillola miksija b'rita

Użu orali

Ir-Rumanija

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

l-Isvezja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox

400 mg

Pillola miksija b'rita

Użu orali

l-Isvezja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Actira

400 mg

Pillola miksija b'rita

Użu orali

l-Isvezja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Octegra

400 mg

Pillola miksija b'rita

Użu orali

Is-Slovenja

| Bayer d.o.o. |
| --- |
| Bravničarjeva 13 |
| SLO-1000 Ljubljana |

Bayer d.o.o.

Bravničarjeva 13

SLO-1000 Ljubljana

Moxifloxacin hydrochloride

Avelox 400 mg filmsko obložene tablete

400 mg

Pillola miksija b'rita

Użu orali

Is-Slovakkja

| Bayer HealthCare AG |
| --- |
| D-51368 Leverkusen |

Bayer HealthCare AG

D-51368 Leverkusen

Moxifloxacin hydrochloride

Avelox 400

400 mg

Pillola miksija b'rita

Użu orali

Ir-Renju Unit

| Bayer plc, Pharmaceutical |
| --- |
| Bayer House |
| Strawberry Hill |
| Newbury |
| Berkshire RG14 1JA |
| United Kingdom |

Bayer plc, Pharmaceutical

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

Moxifloxacin hydrochloride

Avelox 400 mg tablets

400 mg

Pillola miksija b'rita

Użu orali

---

ANNESS VI

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATAW, APPLIKANT FL-ISTATI MEMBRI

| Stat Membru | Detentur tal-Awtorizzazzjoni Għat-Tqegħid fis-Suq | Applikant | Isem | Qawwa | Għamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| Id-Danimarka | | iQur Pharmaceuticals Ltd |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

Stat Membru

Detentur tal-Awtorizzazzjoni Għat-Tqegħid fis-Suq

Applikant

Isem

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

Id-Danimarka

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR Capsules

200 mg

Kapsula, iebsa

Użu orali

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR Tablets

200/400/600 mg

Pillola miksija b'rita

Użu orali

Franza

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR Capsules

200 mg

Kapsula, iebsa

Użu orali

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR Tablets

200/400/600 mg

Pillola miksija b'rita

Użu orali

Il-Ġermanja

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR Capsules

200 mg

Kapsula, iebsa

Użu orali

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR Tablets

200/400/600 mg

Pillola miksija b'rita

Użu orali

Il-Greċja

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR Capsules

200 mg

Kapsula, iebsa

Użu orali

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR Tablets

200/400/600 mg

Pillola miksija b'rita

Użu orali

L-Irlanda

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR capsules

200 mg

Kapsula, iebsa

Użu orali

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR tablets

200/400/600 mg

Pillola miksija b'rita

Użu orali

L-Italja

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR

200 mg

Kapsula, iebsa

Użu orali

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR

200/400/600 mg

Pillola miksija b'rita

Użu orali

Il-Polonja

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR

200 mg

Kapsula, iebsa

Użu orali

| iQur Pharmaceuticals Ltd |
| --- |
| 20-22 Bedford Row |
| London WC1R 4JS |
| United Kingdom |

iQur Pharmaceuticals Ltd

20-22 Bedford Row

London WC1R 4JS

United Kingdom

Ribavirin IQUR

200/400/600 mg

Pillola miksija b'rita

Użu orali

---

V Avviżi

PROĊEDURI GĦALL-IMPLIMENTAZZJONI TAL-POLITIKA TAL-KOMPETIZZJONI

Kummissjoni

| 28.11.2008 | MT | Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea | C 305/89 |
| --- | --- | --- | --- |

28.11.2008

MT

Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea

C 305/89

---

Notifika minn qabel ta' konċentrazzjoni

(Każ COMP/M.5398 — Hutchison/Evergreen)

(Test b'rilevanza għaż-ŻEE)

(2008/C 305/06)

| 1. | Fit-18 ta' Novembru 2008, il-Kummissjoni rċeviet notifika ta' proposta ta' konċentrazzjoni skont l-Artikolu 4 tar-Regolament tal-Kunsill (KE) Nru 139/2004 (1), li permezz tagħha Hutchison Ports Taranto B.V. c/o (“HPT”, r-Renju Unit), proprjetà ta' Hutchison Whampoa Limited Group (“Hutchison Group”, Hong Kong) u Evergreen Marine Corporation (it-Tajwan) Limited (“EMC”, ir-Repubblika taċ-Ċina), li hi parti mill-Evergreen Group (“Evergreen Group”, it-Tajwan) jakkwistaw, skont it-tifsira tal-Artikolu 3(1)(b) tar-Regolament tal-Kunsill, il-kontroll konġunt ta' Taranto Container Terminal S.p.A. (“TCT”, l-Italja) permezz ta' tpartit ta' azzjonijiet. |
| --- | --- |

1.

Fit-18 ta' Novembru 2008, il-Kummissjoni rċeviet notifika ta' proposta ta' konċentrazzjoni skont l-Artikolu 4 tar-Regolament tal-Kunsill (KE) Nru 139/2004 (1), li permezz tagħha Hutchison Ports Taranto B.V. c/o (“HPT”, r-Renju Unit), proprjetà ta' Hutchison Whampoa Limited Group (“Hutchison Group”, Hong Kong) u Evergreen Marine Corporation (it-Tajwan) Limited (“EMC”, ir-Repubblika taċ-Ċina), li hi parti mill-Evergreen Group (“Evergreen Group”, it-Tajwan) jakkwistaw, skont it-tifsira tal-Artikolu 3(1)(b) tar-Regolament tal-Kunsill, il-kontroll konġunt ta' Taranto Container Terminal S.p.A. (“TCT”, l-Italja) permezz ta' tpartit ta' azzjonijiet.

| 2. | L-attivitajiet ta' negozju tal-impriżi kkonċernati huma:






  — | għal HPT: proviżjon ta' servizzi ta' burdnara għal kontenituri għal baħar fond, |
| --- | --- | --- |

2.

L-attivitajiet ta' negozju tal-impriżi kkonċernati huma:

—

għal HPT: proviżjon ta' servizzi ta' burdnara għal kontenituri għal baħar fond,

| — | għal EMC: servizzi tal-bastimenti tal-linja, |
| --- | --- |

—

għal EMC: servizzi tal-bastimenti tal-linja,

| — | għal TCT: proviżjon ta' servizzi fit-terminal fil-Port ta' Taranto. |
| --- | --- |

—

għal TCT: proviżjon ta' servizzi fit-terminal fil-Port ta' Taranto.

| 3. | Wara eżaminazzjoni preliminari, il-Kummissjoni ssib li l-operazzjoni notifikata tista' taqa' fl-ambitu tar-Regolament (KE) Nru 139/2004 Madankollu, id-deċiżjoni finali dwar dan il-punt hija riżervata. |
| --- | --- |

3.

Wara eżaminazzjoni preliminari, il-Kummissjoni ssib li l-operazzjoni notifikata tista' taqa' fl-ambitu tar-Regolament (KE) Nru 139/2004 Madankollu, id-deċiżjoni finali dwar dan il-punt hija riżervata.

| 4. | Il-Kummissjoni tistieden lill-partijiet interessati biex jissottomettu lill-Kummissjoni l-kummenti li jista' jkollhom dwar l-operazzjoni proposta.
  Il-Kummenti għandhom 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 (nru tal-faks (32-2) 296 43 01 jew 296 72 44) jew bil-posta, bin-numru ta' referenza COMP/M.5398 — Hutchison/Evergreen, fl-indirizz li ġej:





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

4.

Il-Kummissjoni tistieden lill-partijiet interessati biex jissottomettu lill-Kummissjoni l-kummenti li jista' jkollhom dwar l-operazzjoni proposta.

Il-Kummenti għandhom 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 (nru tal-faks (32-2) 296 43 01 jew 296 72 44) jew bil-posta, bin-numru ta' referenza COMP/M.5398 — Hutchison/Evergreen, fl-indirizz li ġej:

Il-Kummissjoni Ewropea

Direttorat Ġenerali għall-Kompetizzjoni

Reġistru tal-Amalgamazzjonijiet

J-70

B-1049 Bruxelles/Brussel

---

(1)  ĠU L 24, 29.1.2004, p. 1.

---

| 28.11.2008 | MT | Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea | C 305/90 |
| --- | --- | --- | --- |

28.11.2008

MT

Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea

C 305/90

---

Notifika minn qabel ta' konċentrazzjoni

(Każ COMP/M.5274 — NEWS CORP/Permira/NDS)

Każ li jista' jiġi kkunsidrat għal proċedura simplifikata

(Test b'rilevanza għaż-ŻEE)

(2008/C 305/07)

| 1. | Fl-20 ta' Novembru 2008, il-Kummissjoni rċeviet notifika ta' proposta ta' konċentrazzjoni skont l-Artikolu 4 tar-Regolament tal-Kunsill (KE) Nru 139/2004 (1) li permezz tagħha l-impriżi Nuclobel Lux 1 S.à.r.l. u Nuclobel Lux 2 S.à.r.l. (il-Lussemburgu), li fl-aħħar hi kkontrollata mill-Permira Holdings LLP (ir-Renju Unit), jakkwistaw fi ħdan it-tifsira tal-Artikolu 3(1)(b) tar-Regolament tal-Kummissjoni l-kontoll konġunt tal-impriża NDS (ir-Renju Unit), li bħalissa hi kkontrollata min-News Corporation (l-Istati Uniti tal-Amerika), permezz ta' xiri ta' ishma. |
| --- | --- |

1.

Fl-20 ta' Novembru 2008, il-Kummissjoni rċeviet notifika ta' proposta ta' konċentrazzjoni skont l-Artikolu 4 tar-Regolament tal-Kunsill (KE) Nru 139/2004 (1) li permezz tagħha l-impriżi Nuclobel Lux 1 S.à.r.l. u Nuclobel Lux 2 S.à.r.l. (il-Lussemburgu), li fl-aħħar hi kkontrollata mill-Permira Holdings LLP (ir-Renju Unit), jakkwistaw fi ħdan it-tifsira tal-Artikolu 3(1)(b) tar-Regolament tal-Kummissjoni l-kontoll konġunt tal-impriża NDS (ir-Renju Unit), li bħalissa hi kkontrollata min-News Corporation (l-Istati Uniti tal-Amerika), permezz ta' xiri ta' ishma.

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






  — | għal Permira Holdings LLP: fond ta' ekwità privata, |
| --- | --- | --- |

2.

L-attivitajiet kummerċjali tal-impriżi kkonċernati huma:

—

għal Permira Holdings LLP: fond ta' ekwità privata,

| — | għal NDS: il-fornitura tas-servizzi tekniċi lix-xandara tat-televiżjoni bi ħlas, |
| --- | --- |

—

għal NDS: il-fornitura tas-servizzi tekniċi lix-xandara tat-televiżjoni bi ħlas,

| — | għal News Corporation: kumpanija diversifikata tad-divertiment b'operazzjonijiet fi tmien setturi tal-industrija tal-midja, inklużi (i) id-divertiment iffilmjat; (ii) it-televiżjoni; (iii) programmi fuq in-netwerk tal-kejbil; (iv) televiżjoni b'xandir dirett bis-satellita; (v) ġurnali u fuljetti; (vi) gazzetti; (vii) pubblikazzjoni tal-kotba; u (viii) negozji oħra. |
| --- | --- |

—

għal News Corporation: kumpanija diversifikata tad-divertiment b'operazzjonijiet fi tmien setturi tal-industrija tal-midja, inklużi (i) id-divertiment iffilmjat; (ii) it-televiżjoni; (iii) programmi fuq in-netwerk tal-kejbil; (iv) televiżjoni b'xandir dirett bis-satellita; (v) ġurnali u fuljetti; (vi) gazzetti; (vii) pubblikazzjoni tal-kotba; u (viii) negozji oħra.

| 3. | Wara eżami preliminari, il-Kummissjoni ssib li l-operazzjoni notifikata tista' taqa' fl-ambitu tar-Regolament (KE) Nru 139/2004. Madankollu, id-deċiżjoni finali dwar dan il-punt hija rriżervata. 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 notifikata tista' taqa' fl-ambitu tar-Regolament (KE) Nru 139/2004. Madankollu, id-deċiżjoni finali dwar dan il-punt hija rriżervata. 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 sabiex iressqu l-kummenti li jista' jkollhom dwar l-operazzjoni proposta lill-Kummissjoni.
  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 (nru tal-faks (32-2) 296 43 01 jew 296 72 44) jew bil-posta, taħt in-numru ta' referenza COMP/M.5274 — NEWS CORP/Permira/NDS, fl-indirizz li ġej:





  Il-Kummissjoni Ewropea |
| --- | --- |
| Direttorat Ġenerali għall-Kompetizzjoni |
| Reġistru tal-Amalgamazzjonijiet |
| J-70 |
| B-1049 Bruxelles/Brussell |

4.

Il-Kummissjoni tistieden lill-partijiet terzi interessati sabiex iressqu l-kummenti li jista' jkollhom dwar l-operazzjoni proposta lill-Kummissjoni.

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 (nru tal-faks (32-2) 296 43 01 jew 296 72 44) jew bil-posta, taħt in-numru ta' referenza COMP/M.5274 — NEWS CORP/Permira/NDS, fl-indirizz li ġej:

Il-Kummissjoni Ewropea

Direttorat Ġenerali għall-Kompetizzjoni

Reġistru tal-Amalgamazzjonijiet

J-70

B-1049 Bruxelles/Brussell

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(1)  ĠU L 24, 29.1.2004, p. 1.

(2)  ĠU C 56, 5.3.2005, p. 32.

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28.11.2008

| 28.11.2008 | MT | Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea | C 305/s3 |
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MT

Il-Ġurnal Uffiċjali ta’ l-Unjoni Ewropea

C 305/s3

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NOTA LILL-QARREJ

L-istituzzjonijiet iddeċidew li ma jikkwotawx aktar fit-testi tagħhom l-aħħar emenda ta' l-atti kkwotati.

Sakemm mhux indikat mod ieħor, l-atti mmsemija fit-testi ppubblikati hawn jirreferu għall-atti li bħalissa huma fis-seħħ.

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