# Il-Ġurnal Uffiċjali C 56/2012

| | ISSN 1977-0987
  doi:10.3000/19770987.C_2012.056.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 56 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5524 ta' Frar 2012 |

ISSN 1977-0987

doi:10.3000/19770987.C_2012.056.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 56

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5524 ta' Frar 2012

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2012/C 056/01 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Novembru 2011 sa 31 Dicembru 2011(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2012/C 056/02 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Novembru 2011 sa 31 Dicembru 2011(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 26 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2012/C 056/01

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Novembru 2011 sa 31 Dicembru 2011(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

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

1

2012/C 056/02

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Novembru 2011 sa 31 Dicembru 2011(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

26

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

MT

---

IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 24.2.2012 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 56/1 |
| --- | --- | --- | --- |

24.2.2012

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 56/1

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Novembru 2011 sa 31 Dicembru 2011

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

2012/C 56/01

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC
  (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.11.2011 | Plenadren | hydrocortisone | DuoCort Pharma AB |
| Kullagatan 8-10, |
| S-252 20 Helsingborg, |
| Sveridge |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC

(Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

3.11.2011

Plenadren

hydrocortisone

DuoCort Pharma AB

Kullagatan 8-10,

S-252 20 Helsingborg,

Sveridge

EU/1/11/715/001-002

Pillola li terħi il-mediċina b'mod modifikat

H02AB09

14.11.2011

16.11.2011

IOA

Nomegestrol / estradiol

| N.V. Organon |
| --- |
| Kloosterstraat 6, |
| 5349 AB Oss, |
| Nederland |

N.V. Organon

Kloosterstraat 6,

5349 AB Oss,

Nederland

EU/1/11/689/001-002

Pillola miksija b’rita

G03AA14

18.11.2011

16.11.2011

Vyndaqel

tafamidis

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

Pfizer Specialty UK Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/1/11/717/001

Kapsula, ratba

N07XX08

18.11.2011

22.11.2011

Rasitrio

aliskiren / amlodipine / hydrochlorothiazide

| 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/1/11/730/001-060

Pillola miksija b’rita

C09XA54

24.11.2011

24.11.2011

Desloratadine Teva

desloratadine

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/11/732/001-013

Pillola miksija b’rita

R06AX27

29.11.2011

24.11.2011

Komboglyze

saxagliptin / metformin

| Bristol Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, |
| Uxbridge Business Park, |
| Sanderson Road, |
| Uxbridge, |
| Middlesex |
| UB8 1DH, |
| United Kingdom |

Bristol Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House,

Uxbridge Business Park,

Sanderson Road,

Uxbridge,

Middlesex

UB8 1DH,

United Kingdom

EU/1/11/731/001-012

Pillola miksija b’rita

A10BD

28.11.2011

24.11.2011

Onduarp

Telmisartan / Amlodipine

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Str. 173, |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim International GmbH

Binger Str. 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/11/729/001-006

Pillola

C09DB04

28.11.2011

28.11.2011

Dasselta

desloratadine

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

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/11/739/001-008

Pillola miksija b’rita

R06AX27

30.11.2011

28.11.2011

EDURANT

rilpivirine

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

Janssen Cilag International NV

Turnhoutseweg 30,

B 2340 Beerse,

België

EU/1/11/736/001

Pillola miksija b’rita

J05AG05

30.11.2011

28.11.2011

Eviplera

emtricitabine / rilpivirine (bħala hydrochloride) / tenofovir disoproxil (bħala fumarate)

| Gilead Sciences International Limited |
| --- |
| Cambridge, |
| CB21 6GT, |
| United Kingdom |

Gilead Sciences International Limited

Cambridge,

CB21 6GT,

United Kingdom

EU/1/11/737/001-002

Pillola miksija b’rita

J05AR08

28.11.2011

5.12.2011

Dificlir

fidaxomicin

| FGK Representative Service GmbH |
| --- |
| Heimeranstrasse 35, |
| 80339 München, |
| Deutschland |

FGK Representative Service GmbH

Heimeranstrasse 35,

80339 München,

Deutschland

EU/1/11/733/001-004

Pillola miksija b’rita

Pending

7.12.2011

5.12.2011

Levetiracetam Actavis Group

Levetiracetam

| Actavis Group PTC ehf. |
| --- |
| ReykjavÍkurvegur 76-78, |
| Hafnarfjörður 220, |
| Iceland |

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78,

Hafnarfjörður 220,

Iceland

EU/1/11/738/001-003

Soluzzjoni orali

N03AX14

7.12.2011

7.12.2011

Edarbi

azilsartan medoxomil

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/11/734/001-011

Pillola

C09CA09

9.12.2011

7.12.2011

Ipreziv

azilsartan medoxomil

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/11/735/001-011

Pillola

C09CA09

9.12.2011

14.12.2011

Ameluz

5-Aminolaevulinic acid

| Biofrontera Bioscience GmbH |
| --- |
| Hemmelrather Weg 201, |
| 51377 Leverkusen, |
| Deutschland |

Biofrontera Bioscience GmbH

Hemmelrather Weg 201,

51377 Leverkusen,

Deutschland

EU/1/11/740/001

Ġel

L01XD04

19.12.2011

14.12.2011

Levetiracetam SUN

Levetiracetam

| Sun Pharmaceutical Industries Europe BV |
| --- |
| Polarisavenue 87, |
| 2132 JH Hoofddorp, |
| Nederland |

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87,

2132 JH Hoofddorp,

Nederland

EU/1/11/741/001

Konċentrat għal soluzzjoni għal infużjoni

N03AX14

19.12.2011

22.12.2011

Repaglinide Accord

Repaglinide

| Accord Healthcare Limited |
| --- |
| Sage house, |
| 319 Pinner road, |
| Harrow, |
| HA1 4HF |
| United Kingdom |

Accord Healthcare Limited

Sage house,

319 Pinner road,

Harrow,

HA1 4HF

United Kingdom

EU/1/11/743/001-015

Pillola

A10BX02

28.12.2011

22.12.2011

Topotecan Eagle

topotecan

| Eagle Laboratories Limited |
| --- |
| The Clock House, |
| Station Approach, |
| Marlow, |
| Bucks |
| SL7 1NT, |
| UNITED KINGDOM |

Eagle Laboratories Limited

The Clock House,

Station Approach,

Marlow,

Bucks

SL7 1NT,

UNITED KINGDOM

EU/1/11/744/001-002

Konċentrat għal soluzzjoni għal infużjoni

L01XX17

29.12.2011

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 3.11.2011 | Clopidogrel Krka | KRKA, d. d., Novo mesto |
| Šmarješka cesta 6, |
| 8501 Novo mesto, |
| Slovenija |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

3.11.2011

Clopidogrel Krka

KRKA, d. d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/09/556/001-011

7.11.2011

3.11.2011

Clopidogrel TAD

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Straße 5, |
| 27472 Cuxhaven, |
| Deutschland |

TAD Pharma GmbH

Heinz-Lohmann-Straße 5,

27472 Cuxhaven,

Deutschland

EU/1/09/555/001-009

7.11.2011

3.11.2011

Ozurdex

| Allergan Pharmaceuticals (Ireland) Ltd, |
| --- |
| Castlebar Road, Westport, |
| Co. Mayo, |
| Ireland |

Allergan Pharmaceuticals (Ireland) Ltd,

Castlebar Road, Westport,

Co. Mayo,

Ireland

EU/1/10/638/001

7.11.2011

3.11.2011

Pandemrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| B-1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

B-1330 Rixensart,

Belgique

EU/1/08/452/001

7.11.2011

3.11.2011

Protaphane

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/234/010-012

7.11.2011

3.11.2011

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

7.11.2011

10.11.2011

Actraphane

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/229/030-032

15.11.2011

10.11.2011

Actrapid

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/230/010-012

15.11.2011

10.11.2011

Arava

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/99/118/001-010

15.11.2011

10.11.2011

Avamys

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

Glaxo Group Ltd

Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/07/434/001-003

15.11.2011

10.11.2011

Clopidogrel Mylan

| Mylan S.A.S |
| --- |
| 117 allée des Parcs, |
| 69 800 Saint Priest, |
| France |

Mylan S.A.S

117 allée des Parcs,

69 800 Saint Priest,

France

EU/1/09/559/001-016

15.11.2011

10.11.2011

Clopidogrel Teva

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/540/001-016

15.11.2011

10.11.2011

Clopidogrel Zentiva

| Sanofi-Aventis |
| --- |
| 174, avenue de France, |
| F-75013 Paris, |
| France |

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/08/465/001-020

15.11.2011

10.11.2011

Conbriza

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/1/09/511/001-005

15.11.2011

10.11.2011

Cyanokit

| Merck Santé s.a.s. |
| --- |
| 37, rue Saint-Romain, |
| 69379 Lyon Cedex 08, |
| France |

Merck Santé s.a.s.

37, rue Saint-Romain,

69379 Lyon Cedex 08,

France

EU/1/07/420/001-002

15.11.2011

10.11.2011

ellaOne

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

Laboratoire HRA Pharma

15, rue Béranger,

75003 Paris,

France

EU/1/09/522/001

15.11.2011

10.11.2011

Helixate NexGen

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Schering Pharma AG

13342 Berlin,

Deutschland

EU/1/00/144/001-005

15.11.2011

10.11.2011

Javlor

| Pierre Fabre Médicament |
| --- |
| 45, place Abel Gance, |
| F-92100 Boulogne, |
| France |

Pierre Fabre Médicament

45, place Abel Gance,

F-92100 Boulogne,

France

EU/1/09/550/001-012

15.11.2011

10.11.2011

Kogenate Bayer

| Bayer Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/00/143/004-013

15.11.2011

10.11.2011

Levitra

| Bayer Pharma AG |
| --- |
| Berlin 13342, |
| Deutschland |

Bayer Pharma AG

Berlin 13342,

Deutschland

EU/1/03/248/001-023

15.11.2011

10.11.2011

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/1/06/358/001-008

EU/1/06/358/018-021

15.11.2011

10.11.2011

Vectibix

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/07/423/001-003

15.11.2011

10.11.2011

Vfend

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

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/02/212/025

15.11.2011

10.11.2011

Victoza

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/09/529/001-005

15.11.2011

10.11.2011

Zebinix

| BIAL - Portela & Ca, SA |
| --- |
| A Av. da Siderurgia Nacional 4745-457 S. |
| Mamede do Coronado - |
| Portugal |

BIAL - Portela & Ca, SA

A Av. da Siderurgia Nacional 4745-457 S.

Mamede do Coronado -

Portugal

EU/1/09/514/001-020

15.11.2011

10.11.2011

Zevalin

| Bayer Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/03/264/001

15.11.2011

10.11.2011

Zoely

| Merck Serono Europe Limited |
| --- |
| 56 Marsh Wall, |
| London |
| E14 9TP, |
| United Kingdom |

Merck Serono Europe Limited

56 Marsh Wall,

London

E14 9TP,

United Kingdom

EU/1/11/690/001-002

15.11.2011

10.11.2011

Zomarist

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/483/001-018

15.11.2011

10.11.2011

Zylagren

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

KRKA, d. d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/09/558/001-010

16.11.2011

16.11.2011

Exelon

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/98/066/013

EU/1/98/066/018

18.11.2011

16.11.2011

Gardasil

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/357/001-008

EU/1/06/357/018-021

18.11.2011

16.11.2011

Vivanza

| Bayer Pharma AG |
| --- |
| Berlin 13342, |
| Deutschland |

Bayer Pharma AG

Berlin 13342,

Deutschland

EU/1/03/249/001-015

18.11.2011

21.11.2011

Adrovance

| 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/1/06/364/001-004

EU/1/06/364/006-008

23.11.2011

21.11.2011

Aldurazyme

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

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/03/253/001-003

23.11.2011

21.11.2011

Celsentri

| ViiV Healthcare UK Ltd |
| --- |
| 980 Great West Road, |
| Brentford, |
| Middlesex, |
| TW8 9GS, |
| United Kingdom |

ViiV Healthcare UK Ltd

980 Great West Road,

Brentford,

Middlesex,

TW8 9GS,

United Kingdom

EU/1/07/418/001-010

23.11.2011

21.11.2011

Champix

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

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/06/360/001-013

23.11.2011

21.11.2011

Copalia

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/06/372/001-039

22.11.2011

21.11.2011

Dafiro

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/06/371/001-039

22.11.2011

21.11.2011

Evoltra

| Genzyme Europe BV |
| --- |
| Gooimeer 10, |
| 1411 DD Naarden, |
| Nederland |

Genzyme Europe BV

Gooimeer 10,

1411 DD Naarden,

Nederland

EU/1/06/334/001-005

23.11.2011

21.11.2011

Firdapse

| BioMarin Europe Ltd |
| --- |
| 164 Shaftesbury Avenue, |
| London |
| WC2H 8HL, |
| United Kingdom |

BioMarin Europe Ltd

164 Shaftesbury Avenue,

London

WC2H 8HL,

United Kingdom

EU/1/09/601/001

23.11.2011

21.11.2011

Inovelon

| Eisai Limited |
| --- |
| European Knowledge Centre, |
| Mosquito Way, |
| Hatfield, |
| Hertfordshire, |
| AL10 9SN, |
| United Kingdom |

Eisai Limited

European Knowledge Centre,

Mosquito Way,

Hatfield,

Hertfordshire,

AL10 9SN,

United Kingdom

EU/1/06/378/001-017

23.11.2011

21.11.2011

Insulin Human Winthrop

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main,

Deutschland

EU/1/06/368/001-168

23.11.2011

21.11.2011

Isentress

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, |
| Hoddesdon, |
| Hertfordshire |
| EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road,

Hoddesdon,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/07/436/001-002

23.11.2011

21.11.2011

Rilonacept Regeneron

| Regeneron UK Limited |
| --- |
| 40 Bank Street, |
| E14 5DS |
| London, |
| United Kingdom |

Regeneron UK Limited

40 Bank Street,

E14 5DS

London,

United Kingdom

EU/1/09/582/001

23.11.2011

21.11.2011

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

23.11.2011

22.11.2011

Advagraf

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

Astellas Pharma Europe B.V.

Elisabethhof 19,

NL-2353 EW Leiderdorp,

Nederland

EU/1/07/387/001-026

24.11.2011

22.11.2011

Afinitor

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/09/538/001-008

24.11.2011

22.11.2011

Atripla

| Bristol-Myers Squibb and Gilead Sciences Limited |
| --- |
| IDA Business & Technology Park, |
| Carrigtohill, |
| Co. Cork, |
| Ireland |

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park,

Carrigtohill,

Co. Cork,

Ireland

EU/1/07/430/001-002

24.11.2011

22.11.2011

Dynastat

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

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/02/209/001-008

24.11.2011

22.11.2011

Effentora

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

Cephalon Europe

5 Rue Charles Martigny,

Maisons-Alfort 94700,

France

EU/1/08/441/001-010

24.11.2011

22.11.2011

Exforge

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/06/370/001-039

24.11.2011

22.11.2011

Fabrazyme

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

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/01/188/001-006

25.11.2011

22.11.2011

Grepid

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, |
| 15351 Pallini Attiki, |
| Ελλάδα |

Pharmathen S.A.

6 Dervenakion,

15351 Pallini Attiki,

Ελλάδα

EU/1/09/535/001-016

24.11.2011

22.11.2011

Imprida

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/06/373/001-039

24.11.2011

22.11.2011

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

24.11.2011

22.11.2011

Levemir

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/04/278/001-016

24.11.2011

22.11.2011

Lyrica

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

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/04/279/001-044

24.11.2011

22.11.2011

Myozyme

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

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/06/333/001-003

24.11.2011

22.11.2011

Norvir

| Abbott Laboratories Ltd |
| --- |
| Abbott House, |
| Vanwall Business Park, |
| Vanwall Road, |
| Maidenhead, |
| Berkshire |
| SL6 4XE, |
| United Kingdom |

Abbott Laboratories Ltd

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead,

Berkshire

SL6 4XE,

United Kingdom

EU/1/96/016/001

EU/1/96/016/003-008

24.11.2011

22.11.2011

Onglyza

| Bristol Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, |
| Uxbridge Business Park, |
| Sanderson Road, |
| Uxbridge, |
| Middlesex |
| UB8 1DH, |
| United Kingdom |

Bristol Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House,

Uxbridge Business Park,

Sanderson Road,

Uxbridge,

Middlesex

UB8 1DH,

United Kingdom

EU/1/09/545/001-015

24.11.2011

22.11.2011

Optaflu

| Novartis Vaccines and Diagnostics GmbH |
| --- |
| Emil-von-Behring-Strasse 76, |
| D-35041 Marburg, |
| Deutschland |

Novartis Vaccines and Diagnostics GmbH

Emil-von-Behring-Strasse 76,

D-35041 Marburg,

Deutschland

EU/1/07/394/001-009

24.11.2011

22.11.2011

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/09/578/001

24.11.2011

22.11.2011

PecFent

| Archimedes Development Ltd |
| --- |
| Nottingham, |
| NGT7 2TN, |
| United Kingdom |

Archimedes Development Ltd

Nottingham,

NGT7 2TN,

United Kingdom

EU/1/10/644/001-006

24.11.2011

22.11.2011

Prepandrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| B-1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

B-1330 Rixensart,

Belgique

EU/1/08/453/002

24.11.2011

22.11.2011

Rasilez

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/405/001-040

24.11.2011

22.11.2011

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/1/03/267/001-006

EU/1/03/267/008-010

24.11.2011

22.11.2011

Riprazo

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/409/001-040

24.11.2011

22.11.2011

Riprazo HCT

| 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/1/11/680/001-080

24.11.2011

22.11.2011

Sprimeo

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/407/001-040

24.11.2011

22.11.2011

Tasigna

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/422/001-012

24.11.2011

22.11.2011

Thalidomide Celgene

| Celgene Europe Limited |
| --- |
| 1 Longwalk Road, |
| Stockley Park, |
| Uxbridge |
| UB11 1DB, |
| United Kingdom |

Celgene Europe Limited

1 Longwalk Road,

Stockley Park,

Uxbridge

UB11 1DB,

United Kingdom

EU/1/08/443/001

24.11.2011

22.11.2011

Trisenox

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

Cephalon Europe

5 Rue Charles Martigny,

94700 Maisons Alfort, Cedex,

France

EU/1/02/204/001

24.11.2011

22.11.2011

Victoza

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/09/529/001-005

25.11.2011

24.11.2011

Adenuric

| Menarini International Operations Luxembourg S.A. |
| --- |
| 1, Avenue de la Gare, |
| L-1611 Luxembourg, |
| Luxembourg |

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare,

L-1611 Luxembourg,

Luxembourg

EU/1/08/447/001-012

29.11.2011

24.11.2011

Atriance

| Glaxo Group Limited |
| --- |
| Berkeley Avenue, |
| Greenford, |
| Middlesex |
| UB6 0NN, |
| United Kingdom |

Glaxo Group Limited

Berkeley Avenue,

Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/07/403/001

1.12.2011

24.11.2011

Avastin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, |
| Shire Park, |
| Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/04/300/001-002

30.11.2011

24.11.2011

Clopidogrel HCS

| HCS bvba |
| --- |
| H. Kennisstraat 53, |
| B 2650 Edegem, |
| Belgïe |

HCS bvba

H. Kennisstraat 53,

B 2650 Edegem,

Belgïe

EU/1/10/651/001-015

29.11.2011

24.11.2011

Clopidogrel Teva Generics B.V.

| Teva Generics B.V. |
| --- |
| Computerweg 10, |
| 3542 DR Utrecht, |
| Nederland |

Teva Generics B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/10/650/001-015

29.11.2011

24.11.2011

Eucreas

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/425/001-018

28.11.2011

24.11.2011

Galvus

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/414/001-010

EU/1/07/414/018

29.11.2011

24.11.2011

Icandra

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/484/001-018

30.11.2011

24.11.2011

Intelence

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

Janssen-Cilag International NV

Turnhoutseweg, 30 -

2340 Beerse -

België

EU/1/08/468/001-002

29.11.2011

24.11.2011

Jalra

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/485/001-011

29.11.2011

24.11.2011

ReFacto AF

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/1/99/103/001-008

29.11.2011

24.11.2011

Soliris

| Alexion Europe S.A.S. |
| --- |
| 25, boulevard de l'Amiral Bruix, |
| 75016 Paris, |
| France |

Alexion Europe S.A.S.

25, boulevard de l'Amiral Bruix,

75016 Paris,

France

EU/1/07/393/001

29.11.2011

24.11.2011

Vimpat

| UCB Pharma SA. |
| --- |
| Allée de la Recherche 60, |
| 1070 Bruxelles, |
| Belgique/Researchdreef, 60, |
| Brussel 1070, |
| België |

UCB Pharma SA.

Allée de la Recherche 60,

1070 Bruxelles,

Belgique/Researchdreef, 60,

Brussel 1070,

België

EU/1/08/470/001-017

29.11.2011

24.11.2011

Xiliarx

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/486/001-011

29.11.2011

24.11.2011

Zomarist

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/08/483/001-018

29.11.2011

24.11.2011

Zypadhera

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, |
| NL-3991 RA Houten, |
| Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5,

NL-3991 RA Houten,

Nederland

EU/1/08/479/001-003

28.11.2011

24.11.2011

Zyprexa

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, |
| 3991 RA Houten, |
| Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/96/022/002

EU/1/96/022/004

EU/1/96/022/006

EU/1/96/022/009-012

EU/1/96/022/014

EU/1/96/022/016-017

EU/1/96/022/019-040

28.11.2011

24.11.2011

Zyprexa Velotab

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, |
| 3991 RA Houten, |
| Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/99/125/001-020

28.11.2011

28.11.2011

Emend

| 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/1/03/262/001-010

30.11.2011

28.11.2011

Pradaxa

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173, |
| D-55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/08/442/001-014

1.12.2011

28.11.2011

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/1/02/222/001-005

30.11.2011

28.11.2011

Zutectra

| Biotest Pharma GmbH |
| --- |
| Landsteinerstr.5, |
| 63303 Dreieich, |
| Deutschland |

Biotest Pharma GmbH

Landsteinerstr.5,

63303 Dreieich,

Deutschland

EU/1/09/600/001

30.11.2011

28.11.2011

Zyllt

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

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/09/553/001-010

30.11.2011

5.12.2011

Aranesp

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

Amgen Europe B.V.

Minervum 7061,

NL-4817 ZK Breda,

Nederland

EU/1/01/185/001-022

EU/1/01/185/031-111

7.12.2011

5.12.2011

Cervarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/07/419/001-012

7.12.2011

5.12.2011

Clopidogrel Acino

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/532/001-007

7.12.2011

5.12.2011

Clopidogrel Hexal

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/534/001-007

7.12.2011

5.12.2011

Controloc Control

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, |
| D-78467 Konstanz, |
| Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2,

D-78467 Konstanz,

Deutschland

EU/1/09/515/001-004

7.12.2011

5.12.2011

Pantozol Control

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, |
| D-78467 Konstanz, |
| Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2,

D-78467 Konstanz,

Deutschland

EU/1/09/517/001-004

7.12.2011

5.12.2011

Somac Control

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, |
| D-78467 Konstanz, |
| Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2,

D-78467 Konstanz,

Deutschland

EU/1/09/516/001-004

7.12.2011

5.12.2011

Xenical

| 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/1/98/071/001-006

7.12.2011

7.12.2011

Clopidogrel Teva Pharma

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

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/09/561/001-011

9.12.2011

7.12.2011

Pantecta Control

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, |
| D-78467 Konstanz, |
| Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2,

D-78467 Konstanz,

Deutschland

EU/1/09/518/001-004

9.12.2011

7.12.2011

Pantoloc Control

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, |
| D-78467 Konstanz, |
| Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2,

D-78467 Konstanz,

Deutschland

EU/1/09/519/001-004

9.12.2011

7.12.2011

Prometax

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/98/092/013

EU/1/98/092/018-026

12.12.2011

7.12.2011

Torisel

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/1/07/424/001

9.12.2011

8.12.2011

Ceplene

| EpiCept GmbH |
| --- |
| Goethestrasse 4, |
| D-80336 München, |
| Deutschland |

EpiCept GmbH

Goethestrasse 4,

D-80336 München,

Deutschland

EU/1/08/477/001

12.12.2011

9.12.2011

Rasilamlo

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex,

RH12 5AB,

United Kingdom

EU/1/11/686/001-056

13.12.2011

9.12.2011

Xarelto

| Bayer Pharma AG |
| --- |
| 13342 Berlin, |
| Deutschland |

Bayer Pharma AG

13342 Berlin,

Deutschland

EU/1/08/472/001-021

20.12.2011

9.12.2011

Zeffix

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

Glaxo Group Ltd.

Greenford Road,

Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/99/114/003

13.12.2011

14.12.2011

Clopidogrel ratiopharm

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/554/001-008

19.12.2011

14.12.2011

Emselex

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/04/294/001-028

19.12.2011

14.12.2011

GILENYA

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/11/677/001-005

20.12.2011

14.12.2011

Glivec

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/01/198/001-013

19.12.2011

14.12.2011

Insulatard

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/02/233/010-012

21.12.2011

14.12.2011

Lucentis

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/06/374/001

19.12.2011

14.12.2011

Mabthera

| 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/1/98/067/001-002

19.12.2011

14.12.2011

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/1/02/221/001-016

19.12.2011

14.12.2011

Simulect

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/98/084/001-002

19.12.2011

14.12.2011

Vfend

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

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/02/212/001-026

19.12.2011

14.12.2011

Viread

| Gilead Sciences International Limited |
| --- |
| Cambridge |
| CB21 6GT |
| United Kingdom |

Gilead Sciences International Limited

Cambridge

CB21 6GT

United Kingdom

EU/1/01/200/001-002

19.12.2011

14.12.2011

Volibris

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

Glaxo Group Ltd

Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/08/451/001-004

19.12.2011

19.12.2011

Advate

| Baxter AG |
| --- |
| Industriesstrasse 67, |
| 1221 Vienna, |
| Österreich |

Baxter AG

Industriesstrasse 67,

1221 Vienna,

Österreich

EU/1/03/271/001-010

21.12.2011

19.12.2011

APTIVUS

| Boehringer Ingelheim International GmbH |
| --- |
| Binger Strasse 173- |
| D - 55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim International GmbH

Binger Strasse 173-

D - 55216 Ingelheim am Rhein,

Deutschland

EU/1/05/315/001-002

21.12.2011

19.12.2011

Avastin

| Roche Registration Limited |
| --- |
| 6 Falcon Way, |
| Shire Park, |
| Welwyn Garden City, |
| AL7 1TW, |
| United Kingdom |

Roche Registration Limited

6 Falcon Way,

Shire Park,

Welwyn Garden City,

AL7 1TW,

United Kingdom

EU/1/04/300/001-002

21.12.2011

19.12.2011

Clopidogrel Acino Pharma GmbH

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, |
| 83714 Miesbach, |
| Deutschland |

Acino Pharma GmbH

Am Windfeld 35,

83714 Miesbach,

Deutschland

EU/1/09/548/001-007

21.12.2011

19.12.2011

Emend

| 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/1/03/262/001-008

21.12.2011

19.12.2011

Exjade

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/06/356/001-009

21.12.2011

19.12.2011

Fendrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| B-1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

B-1330 Rixensart,

Belgique

EU/1/04/299/001-003

21.12.2011

19.12.2011

Gardasil

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk,

69007 Lyon,

France

EU/1/06/357/001-008

EU/1/06/357/018-021

21.12.2011

19.12.2011

Herceptin

| 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/1/00/145/001

21.12.2011

19.12.2011

Humira

| Abbott Laboratories Ltd |
| --- |
| Abbott House, |
| Vanwall Business Park, |
| Vanwall Road, |
| Maidenhead, Berkshire |
| SL6 4XE, |
| United Kingdom |

Abbott Laboratories Ltd

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead, Berkshire

SL6 4XE,

United Kingdom

EU/1/03/256/001-010

21.12.2011

19.12.2011

Kentera

| Nicobrand Limited |
| --- |
| 189 Castleroe Road, |
| Coleraine, |
| BT51 3 RP |
| Northern Ireland |

Nicobrand Limited

189 Castleroe Road,

Coleraine,

BT51 3 RP

Northern Ireland

EU/1/03/270/001-005

21.12.2011

19.12.2011

Levemir

| Novo Nordisk A/S |
| --- |
| Novo Allé, |
| DK-2880 Bagsvaerd, |
| Danmark |

Novo Nordisk A/S

Novo Allé,

DK-2880 Bagsvaerd,

Danmark

EU/1/04/278/001-016

21.12.2011

19.12.2011

Noxafil

| 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/1/05/320/001

21.12.2011

19.12.2011

Pandemic influenza vaccine H5N1 BAXTER

| Baxter AG |
| --- |
| Industriestraße 67, |
| A - 1221 Wien, |
| Österreich |

Baxter AG

Industriestraße 67,

A - 1221 Wien,

Österreich

EU/1/09/571/001

21.12.2011

19.12.2011

Pandemrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| B-1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

B-1330 Rixensart,

Belgique

EU/1/08/452/001

21.12.2011

19.12.2011

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/1/06/358/001-008

EU/1/06/358/018-021

21.12.2011

19.12.2011

Somavert

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

Pfizer Ltd

Ramsgate Road,

Sandwich,

Kent

CT 13 9NJ,

United Kingdom

EU/1/02/240/001-004

21.12.2011

19.12.2011

Synagis

| Abbott Laboratories Ltd |
| --- |
| Abbott House, |
| Vanwall Business Park, |
| Vanwall Road, |
| Maidenhead, |
| Berkshire |
| SL6 4XE, |
| United Kingdom |

Abbott Laboratories Ltd

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead,

Berkshire

SL6 4XE,

United Kingdom

EU/1/99/117/001-002

21.12.2011

19.12.2011

Tasigna

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

Novartis Europharm Ltd

Wimblehurst Road,

Horsham,

West Sussex

RH12 5AB,

United Kingdom

EU/1/07/422/001-012

21.12.2011

19.12.2011

Tesavel

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, |
| Hoddesdon, |
| Hertfordshire |
| EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/07/435/001-018

21.12.2011

19.12.2011

Tracleer

| 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/1/02/220/001-006

21.12.2011

22.12.2011

Actos

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/00/150/001-030

29.12.2011

22.12.2011

Actos

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/00/150/001-030

29.12.2011

22.12.2011

Ambirix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| B-1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

B-1330 Rixensart,

Belgique

EU/1/02/224/001-005

27.12.2011

22.12.2011

Arzerra

| Glaxo Group Ltd |
| --- |
| Glaxo Wellcome House, |
| Berkeley Avenue, |
| Greenford, |
| Middlesex |
| UB6 0NN, |
| United Kingdom |

Glaxo Group Ltd

Glaxo Wellcome House,

Berkeley Avenue,

Greenford,

Middlesex

UB6 0NN,

United Kingdom

EU/1/10/625/001

EU/1/10/625/003

28.12.2011

22.12.2011

Competact

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/06/354/001-012

29.12.2011

22.12.2011

Competact

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/06/354/001-012

3.1.2012

22.12.2011

Glubrava

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/07/421/001-009

29.12.2011

22.12.2011

Glubrava

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/07/421/001-009

29.12.2011

22.12.2011

Glustin

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/00/151/001-024

29.12.2011

22.12.2011

Glustin

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/00/151/001-024

29.12.2011

22.12.2011

Invanz

| 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/1/02/216/001-002

3.1.2012

22.12.2011

Ivemend

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, |
| Hodderson, |
| Hertfordshire |
| EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road,

Hodderson,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/07/437/001-004

3.1.2012

22.12.2011

Januvia

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, |
| Hoddesdon, |
| Hertfordshire |
| EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/07/383/001-018

5.1.2012

22.12.2011

Multaq

| Sanofi-Aventis |
| --- |
| 174, avenue de France, |
| F-75013 Paris, |
| France |

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/09/591/001-004

28.12.2011

22.12.2011

Multaq

| Sanofi-Aventis |
| --- |
| 174, avenue de France, |
| F-75013 Paris, |
| France |

Sanofi-Aventis

174, avenue de France,

F-75013 Paris,

France

EU/1/09/591/001-004

29.12.2011

22.12.2011

Nevanac

| Alcon Laboratories (UK) Ltd. |
| --- |
| Boundary Way, |
| Hemel Hempstead, |
| Herts |
| HP2 7UD, |
| United Kingdom |

Alcon Laboratories (UK) Ltd.

Boundary Way,

Hemel Hempstead,

Herts

HP2 7UD,

United Kingdom

EU/1/07/433/001

3.1.2012

22.12.2011

Norvir

| Abbott Laboratories Ltd |
| --- |
| Abbott House, |
| Vanwall Business Park, |
| Vanwall Road, |
| Maidenhead, |
| Berkshire |
| SL6 4XE, |
| United Kingdom |

Abbott Laboratories Ltd

Abbott House,

Vanwall Business Park,

Vanwall Road,

Maidenhead,

Berkshire

SL6 4XE,

United Kingdom

EU/1/96/016/001

EU/1/96/016/003-008

28.12.2011

22.12.2011

Onglyza

| Bristol Myers Squibb/AstraZeneca EEIG |
| --- |
| Bristol Myers Squibb House, |
| Uxbridge Business Park, |
| Sanderson Road, |
| Uxbridge, |
| Middlesex |
| UB8 1DH, |
| United Kingdom |

Bristol Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House,

Uxbridge Business Park,

Sanderson Road,

Uxbridge,

Middlesex

UB8 1DH,

United Kingdom

EU/1/09/545/001-015

3.1.2012

22.12.2011

Ozurdex

| Allergan Pharmaceuticals Ireland |
| --- |
| Castlebar Road, |
| Westport, |
| Co. Mayo, |
| Ireland |

Allergan Pharmaceuticals Ireland

Castlebar Road,

Westport,

Co. Mayo,

Ireland

EU/1/10/638/001

4.1.2012

22.12.2011

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| 1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

1330 Rixensart,

Belgique

EU/1/09/578/001

27.12.2011

22.12.2011

Prepandrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, |
| B-1330 Rixensart, |
| Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89,

B-1330 Rixensart,

Belgique

EU/1/08/453/002

27.12.2011

22.12.2011

Renagel

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

Genzyme Europe B.V.

Gooimeer 10,

NL-1411 DD Naarden,

Nederland

EU/1/99/123/005-013

27.12.2011

22.12.2011

Renvela

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

Genzyme Europe B.V.

Gooimeer 10,

1411 DD Naarden,

Nederland

EU/1/09/521/001-007

27.12.2011

22.12.2011

Ristaben

| 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/1/10/621/001-018

3.1.2012

22.12.2011

Tandemact

| Takeda Global Research and Development Centre (Europe) Ltd. |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd.

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/06/366/005-022

29.12.2011

22.12.2011

Tandemact

| Takeda Global Research and Development Centre (Europe) Ltd. |
| --- |
| 61 Aldwych, |
| London |
| WC2B 4AE, |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd.

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/06/366/005-022

28.12.2011

22.12.2011

Vidaza

| Celgene Europe Ltd |
| --- |
| 1 Longwalk Road, |
| Stockley Park, |
| Uxbridge, |
| UB11 1DB, |
| United Kingdom |

Celgene Europe Ltd

1 Longwalk Road,

Stockley Park,

Uxbridge,

UB11 1DB,

United Kingdom

EU/1/08/488/001

28.12.2011

22.12.2011

Xelevia

| Merck Sharp & Dohme Ltd |
| --- |
| Hertford Road, |
| Hoddesdon, |
| Hertfordshire |
| EN11 9BU, |
| United Kingdom |

Merck Sharp & Dohme Ltd

Hertford Road,

Hoddesdon,

Hertfordshire

EN11 9BU,

United Kingdom

EU/1/07/382/001-018

3.1.2012

22.12.2011

Zavesca

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor, |
| 389 Chiswick High Road, |
| London |
| W4 4AL, |
| United Kingdom |

Actelion Registration Ltd

BSI Building 13th Floor,

389 Chiswick High Road,

London

W4 4AL,

United Kingdom

EU/1/02/238/001

28.12.2011

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

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 28.11.2011 | Xigris | Eli Lilly Nederland B.V. |
| Grootslag 1-5, |
| 3991 RA Houten, |
| Nederland |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

28.11.2011

Xigris

Eli Lilly Nederland B.V.

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/02/225/001-002

30.11.2011

—   Sospensjoni ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 20 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 24.11.2011 | Busilvex | Pierre Fabre Médicament |
| 45, Place Abel Gance, |
| 92654 Boulogne Billancourt Cedex, |
| France |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

24.11.2011

Busilvex

Pierre Fabre Médicament

45, Place Abel Gance,

92654 Boulogne Billancourt Cedex,

France

EU/1/03/254/002

28.11.2011

24.11.2011

Caelyx

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/96/011/001-004

28.11.2011

24.11.2011

VELCADE

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

Janssen-Cilag International NV

Turnhoutseweg 30,

B-2340 Beerse,

België

EU/1/04/274/001-002

28.11.2011

24.11.2011

Vidaza

| Celgene Europe Ltd |
| --- |
| 1 Longwalk Road, |
| Stockley Park, |
| Uxbridge, |
| UB11 1DB, |
| United Kingdom |

Celgene Europe Ltd

1 Longwalk Road,

Stockley Park,

Uxbridge,

UB11 1DB,

United Kingdom

EU/1/08/488/001

25.11.2011

7.12.2011

Ecalta

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/1/07/416/001-002

9.12.2011

7.12.2011

Luminity

| Lantheus MI UK Limited |
| --- |
| Festival House - |
| 39 Oxford Street - |
| Newbury - |
| Berkshire |
| RG14 1JG - |
| United Kingdom |

Lantheus MI UK Limited

Festival House -

39 Oxford Street -

Newbury -

Berkshire

RG14 1JG -

United Kingdom

EU/1/06/361/001-002

12.12.2011

12.12.2011

Vistide

| Gilead Sciences International Limited |
| --- |
| Cambridge, |
| CB21 6GT, |
| United Kingdom |

Gilead Sciences International Limited

Cambridge,

CB21 6GT,

United Kingdom

EU/1/97/037/001

14.12.2011

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

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC
  (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.12.2011 | Inflacam | Meloxicam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, |
| Co. Galway, |
| IRELAND |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN (Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC

(Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

9.12.2011

Inflacam

Meloxicam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea,

Co. Galway,

IRELAND

EU/2/11/134/001-014

Pilloli li tomgħodhom

Soluzzjoni għall-injezzjoni

Suspensjoni Orali

QM01AC06

13.12.2011

9.12.2011

Panacur AquaSol

Fenbendazole

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/11/135/001-003

Suspensjoni Orali

QP52AC13

13.12.2011

14.12.2011

TruScient

Dibotermin alfa

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/2/11/136/001

Kit għall-impjantazzjoni

QM05BC01

19.12.2011

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

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 10.11.2011 | ProMeris | Pfizer Limited |
| Ramsgate Road, |
| Sandwich, |
| Kent |
| CT13 9NJ |
| United Kingdom |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

10.11.2011

ProMeris

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ

United Kingdom

EU/2/06/064/001-004

15.11.2011

10.11.2011

ProMeris Duo

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/2/06/065/001-010

15.11.2011

10.11.2011

Zulvac 8 Bovis

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/2/09/105/001-002

15.11.2011

10.11.2011

Zulvac 8 Ovis

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/2/09/104/001-002

15.11.2011

16.11.2011

Prac-Tic

| Novartis Sanidad Animal S.L. |
| --- |
| Calle de la Marina, 206, |
| E - Barcelona 08013, |
| ESPANA |

Novartis Sanidad Animal S.L.

Calle de la Marina, 206,

E - Barcelona 08013,

ESPANA

EU/2/06/066/001-012

18.11.2011

24.11.2011

Coxevac

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, |
| 33500 Libourne, |
| France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière,

33500 Libourne,

France

EU/2/10/110/001-002

29.11.2011

24.11.2011

Ingelvac CircoFLEX

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, |
| Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein,

Deutschland

EU/2/07/079/001-008

29.11.2011

28.11.2011

Melosus

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13, |
| D-31303 Burgdorf, |
| Deutschland |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13,

D-31303 Burgdorf,

Deutschland

EU/2/10/116/004-006

30.11.2011

5.12.2011

Porcilis Porcoli

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35, |
| 5831 AN Boxmeer, |
| Nederland |

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/96/001/001-010

7.12.2011

9.12.2011

Masivet

| AB Science S.A. |
| --- |
| 3 avenue George V, |
| 75008 Paris, |
| France |

AB Science S.A.

3 avenue George V,

75008 Paris,

France

EU/2/08/087/001-002

13.12.2011

9.12.2011

Zulvac 1 Ovis

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/2/11/131/001-006

13.12.2011

14.12.2011

Trocoxil

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ

United Kingdom

EU/2/08/084/001-005

19.12.2011

14.12.2011

Zulvac 1 Bovis

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/2/11/130/001-003

19.12.2011

19.12.2011

Meloxidyl

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, |
| 33500 Libourne, |
| France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière,

33500 Libourne,

France

EU/2/06/070/001-008

21.12.2011

19.12.2011

Ypozane

| VIRBAC S.A. |
| --- |
| 1ère Avenue 2065 m L.I.D. - |
| 06516 Carros - |
| France |

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. -

06516 Carros -

France

EU/2/06/068/001-004

21.12.2011

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

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK - LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK - LONDON E14 4H

---

(1)  ĠU L 136, 30.4.2004, p. 1.

(2)  ĠU L 136, 30.4.2004, p. 1.

---

| 24.2.2012 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 56/26 |
| --- | --- | --- | --- |

24.2.2012

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 56/26

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Novembru 2011 sa 31 Dicembru 2011

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

2012/C 56/02

—   Ħruġ, manteniment jew modifika ta' awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 16.12.2011 | Dianeal, Extraneal, Nutrineal, Monosol and sodium chloride 0,9% solution for haemodialysis
  (Baxter) | Ara l-Anness I | Ara l-Anness I | 19.12.2011 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

16.12.2011

Dianeal, Extraneal, Nutrineal, Monosol and sodium chloride 0,9% solution for haemodialysis

(Baxter)

Ara l-Anness I

Ara l-Anness I

19.12.2011

—   Sospensjoni ta' awtorizzazzjoni nazzjonali għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 3.11.2011 | HIPRABOVIS PNEUMOS Emulsion for injection for cattle | Ara l-Anness II | Ara l-Anness II | 7.11.2011 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

3.11.2011

HIPRABOVIS PNEUMOS Emulsion for injection for cattle

Ara l-Anness II

Ara l-Anness II

7.11.2011

---

(1)  ĠU L 311, 28.11.01, p. 67.

(2)  ĠU L 311, 28.11.01, p. 1.

---

ANNESS I

Lista tal-ismijiet, għamla farmaċewtika, qawwiet tal-prodotti mediċinali, mnejn jingħata, applikanti / detenturi tal-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 |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Baxter Healthcare GmbH |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| L- Awstrija |

Stat Membru

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

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

L- Awstrija

EXTRANEAL- Peritonealdialyselösung

75 g/L

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Awstrija

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| L-Awstrija |

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

L-Awstrija

Dianeal PD4 Glucose 1,36% w/v/13,6 mg/ml- Peritonealdialyselösung

Anhydrous glucose 13,6 g/L, sodium chloride 5,38 g/L, sodium-L (+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, Magnesium chloride hexahydrate 0,051 g/L

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Awstrija

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| L- Awstrija |

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

L- Awstrija

Dianeal PD4 Glucose 2,27% w/v/22,7 mg/ml- Peritonealdialyselösung

Anhydrous glucose 22,7 g/L, sodium chloride 5,38 g/L, sodium-L (+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, Magnesium chloride hexahydrate 0,051 g/L

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol- peritonew

L-Awstrija

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| L-Awstrija |

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

L-Awstrija

Dianeal PD4 Glucose 3,86% w/v/38,6 mg/ml- Peritonealdialyselösung

Anhydrous glucose 38,6 g/L, sodium chloride 5,38 g/L, sodium-L (+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, Magnesium chloride hexahydrate 0,051 g/L

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Awstrija

| Baxter Healthcare GmbH |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| L-Awstrija |

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

L-Awstrija

Nutrineal PD4 mit 1,1 % Aminosäuren - Peritonealdialyselösung

alanine 951 mg/L, arginine 1 071 mg/L, glycine 510 mg/L, histidine 714 mg/L, isoleucine 850 mg/L, leucine 1 020 mg/L, Iysine hydrochloride 955 mg/L, methionine 850 mg/L, phenylalanine 570 mg/L, proline 595 mg/L, serine 510 mg/L, threonine 646 mg/L, tryptophan 270 mg/L, tyrosine 300 mg/L, valine 1 393 mg/L, sodium chloride 5 380 mg/L, calcium chloride dihydrate 184 mg/L, magnesium chloride hexahydrate 51 mg/L, sodium(s)-lactate 4 480 mg/L

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Awstrija

| Baxter Healthcare GmbH, |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| L-Awstrija |

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

L-Awstrija

Monosol Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung

Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L

soluzzjoni g=al emodijalisi, emodijafiltrazzjoni u emofiltrazzjoni

użu ġol arterji, Użu ġol-vini, emodijalisi

L-Awstrija

| Baxter Healthcare GmbH, |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| L-Awstrija |

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

L-Awstrija

Monosol-K mit 2mEq Kalium/l Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung

Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L, potassium chloride 0,149 g/L

soluzzjoni għal emodijalisi, emodijafiltrazzjoni u emofiltrazzjoni

użu ġol arterji, Użu ġol-vini, emodijalisi

L-Awstrija

| Baxter Healthcare GmbH, |
| --- |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| L-Awstrija |

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

L-Awstrija

Monosol-K mit 4mEq Kalium/l Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung

Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L, potassium chloride 0,298 g/L

soluzzjoni għal emodijalisi, emodijafiltrazzjoni u emofiltrazzjoni

Użu ġol arterji, Użu ġol-vini, emodijalisi

Il-Belġju

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Il-Belġju |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Il-Belġju

Extraneal 7,5 % solution pour dialyse péritonéale

75,00 g/l Icodextrin

Soluzzjoni għad-dijalisi tal-peritenow

Użu għal ġol-peritenow

Il-Belġju

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Il-Belġju |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Il-Belġju

Dianeal PD1 Glucose 1,36% (13,6 mg/ml), solution pour dialyse péritonéale

13,60 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Belġju

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Il-Belġju |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Il-Belġju

Dianeal PD1 Glucose 2,27% (22,7 mg/ml). solution pour dialyse péritonéale

22,7 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Belġju

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Il-Belġju |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Il-Belġju

Dianeal PD1 Glucose 3,86% (38,6 mg/ml), solution pour dialyse péritonéale

38,6 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Belġju

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Il-Belġju |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Il-Belġju

Dianeal PD4 Glucose 1,36% (13,6 mg/ml), solution pour dialyse péritonéale

13,6 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Belġju

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Il-Belġju |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Il-Belġju

Dianeal PD4 Glucose 2,27% (22,7 mg/ml). solution pour dialyse péritonéale

22,7 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Belġju

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Il-Belġju |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Il-Belġju

Dianeal PD4 Glucose 3,86% (38,6 mg/ml), solution pour dialyse péritonéale

38,6 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Belġju

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Il-Belġju |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Il-Belġju

Nutrineal Peritoneal Dialysis 4 à 1,1 % d'acides aminés, solution pour dialyse péritonéale

4 to 1,1% amino acids

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Bulgarija

| BAXTER d.o.o., |
| --- |
| Zelezna cesta 18, |
| 1000 Ljubljana, |
| Slovenja |

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana,

Slovenja

Dianeal PD4 Glucose 1,36%

1,36% w/v/ 13,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Bulgarija

| BAXTER d.o.o., |
| --- |
| Zelezna cesta 18, |
| 1000 Ljubljana, |
| Slovenja |

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana,

Slovenja

Dianeal PD4 Glucose 2,27%

2,27% w/v/ 22,7 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Bulgarija

| BAXTER d.o.o., |
| --- |
| Zelezna cesta 18, |
| 1000 Ljubljana, |
| Slovenja |

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana,

Slovenja

Dianeal PD4 Glucose 3,86%

38,6% w/v/ 38,6mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Bulgarija

| BAXTER d.o.o., |
| --- |
| Zelezna cesta 18, |
| 1000 Ljubljana, |
| Slovenja |

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana,

Slovenja

Extraneal

7,50%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Bulgarija

| BAXTER d.o.o., |
| --- |
| Zelezna cesta 18, |
| 1000 Ljubljana, |
| Slovenja |

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana,

Slovenja

Nutrineal PD 4 with 1,1 % Amino Acids

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Ċeka

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

EXTRANEAL

7,5 % 75g/1 000 ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Ċeka

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose 1,36% w/v/13,6 mg/ml

1,36% w/v/13,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Ċeka

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose 2,27% w/v/22,7 mg/ml

2,27% w/v/22,7 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Ċeka

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose 3,86% w/v/38,6 mg/ml

3,86% w/v/38,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Ċeka

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

Nutrineal PD 4 with 1,1 % Amino Acids

1,1 % 300 mg/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Id-Danimarka

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Id-Danimarka |

Baxter A/S

Gydevang 43

3450 Allerød

Id-Danimarka

Natriumklorid Baxter 9 mg/ml

9 mg/ml

Soluzzjoni għall-infużjoni

Użu ġol-vina

Id-Danimarka

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Id-Danimarka |

Baxter A/S

Gydevang 43

3450 Allerød

Id-Danimarka

Dianeal PD4 med Glucos

13,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Id-Danimarka

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Id-Danimarka |

Baxter A/S

Gydevang 43

3450 Allerød

Id-Danimarka

Dianeal PD4 med Glucos

22,7 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Id-Danimarka

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Id-Danimarka |

Baxter A/S

Gydevang 43

3450 Allerød

Id-Danimarka

Dianeal PD4 med Glucos

38,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Id-Danimarka

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Id-Danimarka |

Baxter A/S

Gydevang 43

3450 Allerød

Id-Danimarka

Extraneal

75 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Id-Danimarka

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Id-Danimarka |

Baxter A/S

Gydevang 43

3450 Allerød

Id-Danimarka

Nutrineal PD4 med 1,1 % aminosyrer

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Estonja

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| 00381 Helsinski |
| Il-Finlandja |

Baxter Oy

P.O. Box 270

Valimotie 15A

00381 Helsinski

Il-Finlandja

EXTRANEAL

7,50%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Finlandja

| Baxter Healthcare S.A. |
| --- |
| Moneen Road, Castlebar |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road, Castlebar

County Mayo

L-Irlanda

Natriumklorid Baxter 9 mg/ml

9 mg/ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vina

Il-Finlandja

| Baxter Oy |
| --- |
| P.O. Box 270 Valimotie 15A |
| 00381 Helsinski |
| Il-Finlandja |

Baxter Oy

P.O. Box 270 Valimotie 15A

00381 Helsinski

Il-Finlandja

Extraneal

7,5%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Finlandja

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| CO. Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

CO. Mayo

L-Irlanda

Dianeal PD4 Glucose

13,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Finlandja

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| CO. Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

CO. Mayo

L-Irlanda

Dianeal PD4 Glucose

22,7 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Finlandja

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| CO. Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

CO. Mayo

L-Irlanda

Dianeal PD4 Glucose

38,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Franza

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| Franza |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

Franza

DIANEAL PD1 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Franza

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| Franza |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

Franza

DIANEAL PD1 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Franza

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| Franza |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

Franza

DIANEAL PD4 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche

3,86%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Franza

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| Franza |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

Franza

DIANEAL PD1 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Franza

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| Franza |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

Franza

DIANEAL PD4 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche

2,27%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Franza

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| Franza |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

Franza

DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche

1,36%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Franza

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| Franza |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

Franza

EXTRANEAL, solution pour dialyse péritonéale

7,50%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Franza

| Baxter S.A.S |
| --- |
| Avenue louis Pasteur 78310 |
| ZA de Coigneres |
| 78310 Maurepas |
| Franza |

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

Franza

NUTRINEAL PD4 A 1,1 % D'ACIDES AMINES, solution pour dialyse péritonéale

1,10%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstraße 4 |
| 85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstraße 4

85716 Unterschleißheim

Il-Ġermanja

Dianeal PDl Glucose 1,36% w/v

13,6 g/l

5,67 g/l

3,92 g/l

0,257 g/l

0,152 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PDl Glucose 2,27% w/v

22,7 g/l

5,67 g/l

3,92 g/l

0,257 g/l

0,152 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PDl Glucose 3,86% w/v

38,6 g/l

5,67 g/l

3,92 g/l

0,257 g/l

0,152 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PD4 Glucose 1,36% w/v

13,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PD4 Glucose 2,27% w/v

22,7 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PD4 Glucose 3,86% w/v

38,6 g/l

5,4 g/l

4,5 g/l

0,184 g/l

0,051 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PDG1 1,36%

13,6 g/l

5,67 g/l

3,92 g/l

0,257 g/l

0,0152 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PDG1 2,27%

22,7 g/l

5,67 g/l

3,92 g/l

0,257 g/l

0,0152 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PDG1 3,86%

38,6 g/l

5,67 g/l

3,92 g/l

0,257 g/l

0,0152 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PDG4 1,36%

13,6 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PDG4 2,27%

22,7 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Dianeal PDG4 3,86%

38,6 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Extraneal

75 g/l

5,4 g/l

4,5 g/l

0,257 g/l

0,051 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Nutrineal PD4 mit 1,1 % Aminosauren

11,205 g/l

5,38 g/l

0,184 g/l

0,0508 g/l

4,48 g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Monosol

1,1 g / l

6,43 g / l

0,257 g / l

0,152 g / l

3,36 g / l

Soluzzjoni għal emodijalisi

emodijalisi

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Monosol-K mit 2 mmol Kalium/l

1,1 g / l

6,43 g / l

0,257 g / l

0,149 g / l

0,152 g / l

3,36 g / l

Soluzzjoni għal emodijalisi

emodijalisi

Il-Ġermanja

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Il-Ġermanja |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Il-Ġermanja

Monosol-K mit 4 mmol Kalium/l

1,1 g / l

6,43 g / l

0,257 g / l

0,298 g / l

0,152 g / l

3,36 g / l

Soluzzjoni għal emodijalisi

emodijalisi

Il-Greċja

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Il-Greċja |

Diophar SA

Kifissias 368

Halandri 15233

Il-Greċja

DIANEAL PD1

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Greċja

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Il-Greċja |

Diophar SA

Kifissias 368

Halandri 15233

Il-Greċja

DIANEAL PD4

1,36%

2,27% w/v

3,86%w/v

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Greċja

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Il-Greċja |

Diophar SA

Kifissias 368

Halandri 15233

Il-Greċja

Extraneal

(7,5+0,54+0,45+0,0257+0,0051)% w/v

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Greċja

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Il-Greċja |

Diophar SA

Kifissias 368

Halandri 15233

Il-Greċja

Nutrineal PD4

1,1%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Ungerija

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| L-Ungerija |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

L-Ungerija

EXTRANEAL peritoneális dializáló oldat

7,5% (icodextrin)

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Ungerija

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| L-Ungerija |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

L-Ungerija

DIANEAL PD 1 Glucose 1,36% peritoneális dializáló oldat

1,36%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Ungerija

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| L-Ungerija |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

L-Ungerija

DIANEAL PD 1 Glucose 2,27% peritoneális dializáló oldat

2,27%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Ungerija

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| L-Ungerija |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

L-Ungerija

DIANEAL PD 1 Glucose 3,86% peritoneális dializáló oldat

3,86%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Ungerija

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| L-Ungerija |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

L-Ungerija

DIANEAL PD 4 Glucose 1,36% peritoneális dializáló oldat

1,36%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Ungerija

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| L-Ungerija |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

L-Ungerija

DIANEAL PD 4 Glucose 2,27% peritoneális dializáló oldat

2,27%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Ungerija

| Baxter Hungary Kft. |
| --- |
| Népfürdö u. 22. |
| 1138, Budapest |
| L-Ungerija |

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

L-Ungerija

DIANEAL PD 4 Glucose 3,86% peritoneális dializáló oldat

3,86%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Islanda

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare SA

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose

13,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Islanda

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare SA

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose

22,7 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Islanda

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare SA

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose

38,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Irlanda

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

Ir-Renju Unit

Monosol, Solution for haemodialysis, haemodiafiltration and haemofiltration

Glucose Monohydrate Ph. Eur.1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur., 0,257, Magnesium Chloride Hexahydrate Ph. Eur.0,152, Sodium Lactate Ph. Eur. 3,36

soluzzjoni għal emodijalisi, emodijafiltrazzjoni u emofiltrazzjoni

emodijalisi

L-Irlanda

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Monosol-K with 2 mEq Potassium/l, Solution for haemodialysis, haemodiafiltration and haemofiltration

Glucose Monohydrate Ph. Eur. 1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur. 0,257, Magnesium Chloride Hexahydrate Ph. Eur. 0,152, Sodium Lactate Ph. Eur. 3,36, Potassium Chloride Ph. Eur. 0,149

soluzzjoni għal emodijalisi, emodijafiltrazzjoni u emofiltrazzjoni

emodijalisi

L-Irlanda

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Monosol-K with 4 mEq Potassium/l, Solution for haemodialysis, haemodiafiltration and haemofiltration

Glucose Monohydrate Ph. Eur. 1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur. 0,257, Magnesium Chloride Hexahydrate Ph. Eur. 0,152, Sodium Lactate Ph. Eur. 3,36, Potassium Chloride Ph. Eur. 0,298

soluzzjoni għal emodijalisi, emodijafiltrazzjoni u emofiltrazzjoni

emodijalisi

L-Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD1 Glucose 1,36% w/v (13,6 mg/ml) Solution for peritoneal dialysis

1,36% w/v

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD1 Glucose 3,86% w/v (38,6 mg/ml) Solution for peritoneal dialysis

3,86% w/v (38,6 mg/ml)

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD1 Glucose 2,27% w/v (22,7 mg/ml) Solution for peritoneal dialysis

2,27% w/v (22,7 mg/ml)

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 1,36% w/v (13,6 mg/ml) Solution for peritoneal dialysis

1,36% w/v (13,6 mg/ml)

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 2,27% w/v (22,7 mg/ml) Solution for peritoneal dialysis

2,27% w/v (22,7 mg/ml)

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Dianeal PD4 Glucose 3,86% w/v (38,6 mg/ml) Solution for peritoneal dialysis

3,86% w/v (38,6 mg/ml)

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Nutrineal Solution for Peritoneal Dialysis 4 with 1,1 % Amino Acids

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Irlanda

| Baxter Healthcare Limited |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| United Kingdom |

Baxter Healthcare Limited

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

EXTRANEAL Solution for peritoneal dialysis

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Italja

| Baxter S.p.A. |
| --- |
| Piazzale dell’Industria 20 |
| 00144 Roma |
| L-Italja |

Baxter S.p.A.

Piazzale dell’Industria 20

00144 Roma

L-Italja

EXTRANEAL

7,5%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Italja

| Baxter S.p.A. |
| --- |
| Piazzale dell’Industria 20 |
| 00144 Roma |
| L-Italja |

Baxter S.p.A.

Piazzale dell’Industria 20

00144 Roma

L-Italja

NUTRINEAL PD4

1,1%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Italja

| Baxter S.p.A. |
| --- |
| Piazzale dell’Industria 20 |
| 00144 Roma |
| L-Italja |

Baxter S.p.A.

Piazzale dell’Industria 20

00144 Roma

L-Italja

SOLUZIONI PER DIALISI PERITONEALE BAXTER

Range compositions

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Latvja

| Baxter Oy |
| --- |
| P.O. Box 270 Valimotie 15A |
| 00381 Helsinski |
| Il-Finlandja |

Baxter Oy

P.O. Box 270 Valimotie 15A

00381 Helsinski

Il-Finlandja

Extraneal solution for peritoneal dialysis

75g/L 5,4g/L 4,5g/L 0,257g/L 0,051g/L

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Latvja

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose 2,27% w/v/22,7 mg/ml- solution for peritoneal dialysis

2,27 % w/v

0,538% w/v 0,448% w/v

0,0184% w/v 0,0051% w/v

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Latvja

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose 3,86% w/v/38,6 mg/ml- solution for peritoneal dialysis

3,86% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Latvja

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose 1,36% w/v/13,6 mg/ml- solution for peritoneal dialysis

1,36% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Litwanja

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose

13,6g+5,38g+4,48g+0,184g+0,051g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Litwanja

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose

22,7g+5,38g+4,48g+0,184g+0,051g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Litwanja

| Baxter Healthcare S.A. |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| L-Irlanda |

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

L-Irlanda

Dianeal PD4 Glucose

38,6g+5,38g+4,48g+0,184g+0,051g/l

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Litwanja

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15 A |
| 00381 Helsinski |
| Il-Finlandja |

Baxter Oy

P.O. Box 270

Valimotie 15 A

00381 Helsinski

Il-Finlandja

EXTRANEAL

75g+5,4g+4,5g+0,257g+0,051g/1 000ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Lussemburgu

| Baxter S.A. |
| --- |
| Bd René Branquart 80 |
| B-7860 Lessines |
| Il-Belġju |

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Il-Belġju

Nutrineal PD4+A.A.1,1 %

1,1% amino acids

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Lussemburgu

| Baxter S.A. |
| --- |
| Bd René Branquart 80 |
| B-7860 Lessines |
| Il-Belġju |

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Il-Belġju

Dianeal PD1 Glucose

1,36%/2,27%/3,86% dextrose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Lussemburgu

| Baxter S.A. |
| --- |
| Bd René Branquart 80 |
| B-7860 Lessines |
| Il-Belġju |

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Il-Belġju

Dianeal PD4 Glucose

1,36%/2,27%/3,86% dextrose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Lussemburgu

| Baxter S.A. |
| --- |
| Bd René Branquart 80 |
| B-7860 Lessines |
| Il-Belġju |

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Il-Belġju

Extraneal

75,00 g/l Icodextrin

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

Ir-Renju Unit

Extraneal (Icodextrin 7,5%)

N/A

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

Ir-Renju Unit

Nutrineal PD4 with 1,1% amino acids

N/A

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

Ir-Renju Unit

Dianeal PD1 Glucose 1,36%w/v 13,6mg/ml

1,36%w/v 13,6mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

Ir-Renju Unit

Dianeal PD1 Glucose 2,27%w/v 22,7mg/ml

2,27%w/v 22,7mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

Ir-Renju Unit

Dianeal PD1 Glucose 3,86%w/v 38,6mg/ml

3,86%w/v 38,6mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

Ir-Renju Unit

Dianeal PD4 Glucose 1,36%w/v 13,6mg/ml

1,36%w/v 13,6mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

Ir-Renju Unit

Dianeal PD4 Glucose 2,27%w/v 22,7mg/ml

2,27%w/v 22,7mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Malta

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford, |
| Norfolk, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

Ir-Renju Unit

Dianeal PD4 Glucose 3,86%w/v 38,6mg/ml

3,86%w/v 38,6mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Malta

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk |
| IP24 3SE, |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE,

Ir-Renju Unit

Monosol

Glucose Monohydrate 1,1 g/l,

Sodium Chloride 6,43 g/l,

Calcium Chloride Dihydrate 0,257 g/l,

Magnesium Chloride Hexahydrate 0,152 g/l,

Sodium Lactate 3,36 g/l

Soluzzjoni għal emodijalisi emofiltrazzjoni

Użu ġol arterja, Użu ġol-vina

Malta

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk |
| IP24 3SE, |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE,

Ir-Renju Unit

Monosol-K with 2MEQ Potassium/L

Glucose Monohydrate 1,1 g/l,

Sodium Chloride 6,43 g/l,

Calcium Chloride Dihydrate 0,257 g/l,

Magnesium Chloride Hexahydrate 0,152 g/l,

Potassium Chloride 0,149 g/l,

Sodium Lactate 3,36 g/l

Soluzzjoni għal emodijalisi emofiltrazzjoni

Użu ġol arterja, Użu ġol-vina

L-Olanda

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| L-Olanda |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

L-Olanda

Dianeal PD1 Glucose 1,36%/13,6 mg/ml, peritoneaaldialysevloeist of

13,6 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Olanda

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| L-Olanda |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

L-Olanda

Dianeal PD1 Glucose 2,27%/22,7 mg/ml, peritoneaaldialysevloeist of

22,7 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Olanda

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| L-Olanda |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

L-Olanda

Dianeal PD1 Glucose 3,86%/38,6 mg/ml, peritoneaaldialysevloeist of

38,6 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Olanda

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| L-Olanda |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

L-Olanda

Dianeal PD4 Glucose 1,36%/13,6 mg/ml, peritoneaaldialysevloeist of

13,6 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Olanda

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| L-Olanda |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

L-Olanda

Dianeal PD4 Glucose 2,27%/22,7 mg/ml, peritoneaaldialysevloeist of

22,7 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Olanda

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| L-Olanda |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

L-Olanda

Dianeal PD4 Glucose 3,86%/38,6 mg/ml, peritoneaaldialysevloeist of

38,6 g/l glucose anhydrous

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Olanda

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| L-Olanda |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

L-Olanda

Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeist of

11 g/l amino acids and 1,25 mmol/l Ca.

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Olanda

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| L-Olanda |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

L-Olanda

EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse

75 g/l icodextrin

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

In-Norveġja

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo |
| In-Norveġja |

Baxter AS

Gjerdrumsvei 11

0484 Oslo

In-Norveġja

Natriumklorid Baxter 9 mg/ml

9 mg/ml

Soluzzjoni għall-infużjoni

Użu ġol-vina

In-Norveġja

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo, |
| In-Norveġja |

Baxter AS

Gjerdrumsvei 11

0484 Oslo,

In-Norveġja

Nutrineal PD4 amino Acids 1,1 %

1,10%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

In-Norveġja

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo, |
| In-Norveġja |

Baxter AS

Gjerdrumsvei 11

0484 Oslo,

In-Norveġja

Extraneal

75 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Polonja

| Baxter Polska SP. z.o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa, |
| Il-Polonja |

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Il-Polonja

Dianeal PD1 (glukoza 1,36%). Zestaw do dializy otrzewnowej

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Polonja

| Baxter Polska SP. z.o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa, |
| Il-Polonja |

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Il-Polonja

Dianeal PD1 (glukoza 2,27%). Zestaw do dializy otrzewnowej

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Polonja

| Baxter Polska SP. z.o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa, |
| Il-Polonja |

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Il-Polonja

Dianeal PD1 (glukoza 3,86%). Zestaw do dializy otrzewnowej

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Polonja

| Baxter Polska SP. z.o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa, |
| Il-Polonja |

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Il-Polonja

Dianeal PD4 (glukoza 1,36%). Zestaw do dializy otrzewnowej

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Polonja

| Baxter Polska SP. z.o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa, |
| Il-Polonja |

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Il-Polonja

Dianeal PD4 (glukoza 2,27%). Zestaw do dializy otrzewnowej

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Polonja

| Baxter Polska SP. z.o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa, |
| Il-Polonja |

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Il-Polonja

Dianeal PD4 (glukoza 3,86%). Zestaw do dializy otrzewnowej

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Polonja

| Baxter Polska SP. z.o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa, |
| Il-Polonja |

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Il-Polonja

Extraneal Zestaw do dializy otrzewnowej

75 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Polonja

| Baxter Polska SP. z.o.o. |
| --- |
| Kruczkowskiego 8 st., |
| 00-380 Warszawa, |
| Il-Polonja |

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Il-Polonja

Nutrineal PD4 (z 1,1% roztworem aminokwasów)

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Portugall

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Il-Portugall |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Il-Portugall

Extraneal

75 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Portugall

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Il-Portugall |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Il-Portugall

Dianeal Pd1

Association

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Portugall

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Il-Portugall |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Il-Portugall

Dianeal Pd1

Association

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Portugall

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Il-Portugall |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Il-Portugall

Dianeal Pd1

Association

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Portugall

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Il-Portugall |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Il-Portugall

Dianeal Pd4

Association

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Portugall

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Il-Portugall |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Il-Portugall

Dianeal Pd4

Association

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Portugall

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Il-Portugall |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Il-Portugall

Dianeal Pd4

Association

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Il-Portugall

| Baxter Médico Farmacêutica Lda |
| --- |
| Zona Industrial da Abrunheira, |
| Edificio 10 Sintra Business Park, |
| 2710-089 Sintra |
| Il-Portugall |

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Il-Portugall

Nutrineal PD4

Association

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Rumanija

| Baxter Healthcare Ltd |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| IP24 3SE, |
| Ir-Renju Unit |

Baxter Healthcare Ltd

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

Ir-Renju Unit

EXTRANEAL

75 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Rumanija

| Baxter Healthcare SA, |
| --- |
| Moneen Road, Castlebar, |
| Co. Mayo, |
| L-Irlanda |

Baxter Healthcare SA,

Moneen Road, Castlebar,

Co. Mayo,

L-Irlanda

DIANEAL PD4 GLUCOSE 1,36% m/v (13,6 mg/ml)

13,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Rumanija

| Baxter Healthcare SA, |
| --- |
| Moneen Road, Castlebar, |
| Co. Mayo, |
| L-Irlanda |

Baxter Healthcare SA,

Moneen Road, Castlebar,

Co. Mayo,

L-Irlanda

DIANEAL PD4 GLUCOSE 2,27% m/v (22,7 mg/ml)

22,7 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Rumanija

| Baxter Healthcare SA, |
| --- |
| Moneen Road, Castlebar, |
| Co. Mayo, |
| L-Irlanda |

Baxter Healthcare SA,

Moneen Road, Castlebar,

Co. Mayo,

L-Irlanda

DIANEAL PD4 GLUCOSE 3,86% m/v (38,6 mg/ml)

38,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Rumanija

| BAXTER d.o.o. |
| --- |
| Zelezna cesta 14, |
| SI-1000 Ljubljana, |
| Is-Slovenja |

BAXTER d.o.o.

Zelezna cesta 14,

SI-1000 Ljubljana,

Is-Slovenja

NUTRINEAL PD4 cu 1,1% aminoacizi

1,1%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Slovakka

| Baxter Healthcare SA, |
| --- |
| Moneen Rd, Castlebar, |
| Co. Mayo, |
| L-Irlanda |

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

L-Irlanda

Dianeal® PD1 glucose 1,36% w/v /13,6 mg/ml

13,6 mg/1 ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Slovakka

| Baxter Healthcare SA, |
| --- |
| Moneen Rd, Castlebar, |
| Co. Mayo, |
| L-Irlanda |

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

L-Irlanda

Dianeal® PD1 glucose 2,27% w/v /22,7 mg/ml

22,7 mg/1 ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Slovakka

| Baxter Healthcare SA, |
| --- |
| Moneen Rd, Castlebar, |
| Co. Mayo, |
| L-Irlanda |

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

L-Irlanda

Dianeal® PD1 glucose 3,86% w/v /38,6 mg/ml

38,6 mg/1 ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Slovakka

| Baxter Healthcare SA, |
| --- |
| Moneen Rd, Castlebar, |
| Co. Mayo, |
| L-Irlanda |

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

L-Irlanda

Dianeal® PD4 glucose 1,36% w/v /13,6 mg/ml

13,6 mg/1 ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Slovakka

| Baxter Healthcare SA, |
| --- |
| Moneen Rd, Castlebar, |
| Co. Mayo, |
| L-Irlanda |

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

L-Irlanda

Dianeal® PD4 glucose 2,27% w/v /22,7 mg/ml

22,7 mg/1 ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Slovakka

| Baxter Healthcare SA, |
| --- |
| Moneen Rd, Castlebar, |
| Co. Mayo, |
| L-Irlanda |

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

L-Irlanda

Dianeal® PD4 glucose 3,86% w/v /38,6 mg/ml

38,6 mg/1 ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Slovakka

| Baxter Healthcare Ltd |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| IP24 3SE |

Baxter Healthcare Ltd

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

EXTRANEAL

7,5%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Repubblika Slovakka

| Baxter Healthcare SA, |
| --- |
| Moneen Rd, Castlebar, |
| Co. Mayo, |
| L-Irlanda |

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

L-Irlanda

Nutrineal PD4 with 1,1 % Amino Acids

1,1%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Is-Slovenja

| Baxter d.o.o., |
| --- |
| Zelezna cesta 18, |
| Ljubljana, SI-1000, |
| Is-Slovenja |

Baxter d.o.o.,

Zelezna cesta 18,

Ljubljana, SI-1000,

Is-Slovenja

Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo

75 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Is-Slovenja

| Baxter d.o.o., |
| --- |
| Zelezna cesta 18 , |
| Ljubljana, SI -1000, |
| Is-Slovenja |

Baxter d.o.o.,

Zelezna cesta 18 ,

Ljubljana, SI -1000,

Is-Slovenja

Nutrineal PD4 11 mg/ml amino kislin raztopina za peritonealno dializo

11 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Is-Slovenja

| Baxter d.o.o., |
| --- |
| Zelezna cesta 18 , |
| Ljubljana, SI -1000, |
| Is-Slovenja |

Baxter d.o.o.,

Zelezna cesta 18 ,

Ljubljana, SI -1000,

Is-Slovenja

Dianeal PD1 13,6 mg/ml glukoze raztopina za peritonelano dializo

13,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Is-Slovenja

| Baxter d.o.o., |
| --- |
| Zelezna cesta 18 , |
| Ljubljana, SI -1000, |
| Is-Slovenja |

Baxter d.o.o.,

Zelezna cesta 18 ,

Ljubljana, SI -1000,

Is-Slovenja

Dianeal PD1 22,7 mg/ml glukoze raztopina za peritonelano dializo

22,7 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Is-Slovenja

| Baxter d.o.o., |
| --- |
| Zelezna cesta 18 , |
| Ljubljana, SI -1000, |
| Is-Slovenja |

Baxter d.o.o.,

Zelezna cesta 18 ,

Ljubljana, SI -1000,

Is-Slovenja

Dianeal PD1 38,6 mg/ml glukoze raztopina za peritonelano dializo

38,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Is-Slovenja

| Baxter d.o.o., |
| --- |
| Zelezna cesta 18 , |
| Ljubljana, SI -1000, |
| Is-Slovenja |

Baxter d.o.o.,

Zelezna cesta 18 ,

Ljubljana, SI -1000,

Is-Slovenja

Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo

13,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Is-Slovenja

| Baxter d.o.o., |
| --- |
| Zelezna cesta 18 , |
| Ljubljana, SI -1000, |
| Is-Slovenja |

Baxter d.o.o.,

Zelezna cesta 18 ,

Ljubljana, SI -1000,

Is-Slovenja

Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo

22,7 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Is-Slovenja

| Baxter d.o.o., |
| --- |
| Zelezna cesta 18 , |
| Ljubljana, SI -1000, |
| Is-Slovenja |

Baxter d.o.o.,

Zelezna cesta 18 ,

Ljubljana, SI -1000,

Is-Slovenja

Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo

38,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

EXTRANEAL

Solución para diálisis peritoneal

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Nutrineal PD4 con 1,1% de aminoácidos. Solución para diálisis peritoneal

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Nutrineal PD4 con 1,1% de aminoácidos. Con sistema de desconexión integrado Solución para diálisis peritoneal

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD1 Glucosa 1,36%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD1 Glucosa 1,36% con sistema de desconexión integrado

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD1 Glucosa 2,27%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD1 Glucosa 2,27% con sistema de desconexión integrado

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD1 Glucosa 3,86%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD1 Glucosa 3,86% con sistema de desconexión integrado

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD4 Glucosa 1,36%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD4 Glucosa 1,36% con sistema de desconexión integrado

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD4 Glucosa 2,27%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD4 Glucosa 2,27% con sistema de desconexión integrado

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD4 Glucosa 3,86%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Spanja

| Baxter S.L |
| --- |
| Pouet de Camilo, 2 |
| Ribarroja del Turia (Valencia) |
| 46394 |
| Spanja |

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spanja

Dianeal PD4 Glucosa 3,86% con sistema de desconexión integrado

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Iżvezja

| Baxter Medical AB |
| --- |
| Box 63 |
| 164 94 Kista |
| Sweden |

Baxter Medical AB

Box 63

164 94 Kista

Sweden

Natriumklorid Baxter 9 mg/ml

9 mg/ml

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Iżvezja

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| L-Irlanda |

Baxter Healthcare SA

Moneen Road Castlebar

County Mayo

L-Irlanda

Dianeal PD4 med glucos 13,6 mg/ml

13,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Iżvezja

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| L-Irlanda |

Baxter Healthcare SA

Moneen Road Castlebar

County Mayo

L-Irlanda

Dianeal PD4 med glucos 22,7 mg/ml

22,7 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Iżvezja

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| L-Irlanda |

Baxter Healthcare SA

Moneen Road Castlebar

County Mayo

L-Irlanda

Dianeal PD4 med glucos 38,6 mg/ml

38,6 mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Iżvezja

| Baxter Medical AB |
| --- |
| Box 63 |
| 16494 Kista |
| Sverige |

Baxter Medical AB

Box 63

16494 Kista

Sverige

Extraneal

7,5%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

L-Iżvezja

| Baxter Medical AB |
| --- |
| Box 63 |
| 16494 Kista |
| Sverige |

Baxter Medical AB

Box 63

16494 Kista

Sverige

Nutrineal PD4 1,1 % Aminosyror

1,10%

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

Ir-Renju Unit

Monosol

Calcium Chloride: 0,026% w/v. glucose 0,110%w/v; sodium lactate 0,336%w/v; sodium chloride 0,643%w/v; magnesium chloride 0,015%w/v

Soluzzjoni għal Emodijalisi/e mofiltrazzjoni

Użu ġol-arterja, Użu ġol-vina

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

Ir-Renju Unit

Monosol-K with 2MEQ Potassium/L

sodium chloride 0,643%w/v; magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucoae 0,110%w/v; potassium hloride 0,015%w/v; sodium lactate 0,336%w/v

Soluzzjoni għal Emodijalisi/e mofiltrazzjoni

Użu ġol-arterja, Użu ġol-vina

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

Ir-Renju Unit

Monosol-K with 4MEQ Potassium/L

magnesium chloride 0,015%w/v; potassium chloride 0,029%w/v; calcium chloride 0,026%w/v; sodium lactate 0,336%w/v; sodium chloride 0,643%w/v; glucose 0,110%w/v

Soluzzjoni għal Emodijalisi/e mofiltrazzjoni

Użu ġol-arterja, Użu ġol-vina

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

IP24 3SE

Ir-Renju Unit

Dianeal PD1 Glucose 1,36% w/v /13,6mg/ml

1,36% w/v /13,6mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

IP24 3SE

Ir-Renju Unit

Dianeal PD1 Glucose 3,86% w/v /38,6mg/ml

3,86% w/v /38,6mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

IP24 3SE

Ir-Renju Unit

Dianeal PD1 Glucose 2,27% w/v /22,7mg/ml

2,27% w/v /22,7mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

IP24 3SE

Ir-Renju Unit

Dianeal PD4 Glucose 1,36% w/v /13,6mg/ml

1,36% w/v /13,6mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

IP24 3SE

Ir-Renju Unit

Dianeal PD4 Glucose 2,27% w/v /22,7mg/ml

2,27% w/v /22,7mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

IP24 3SE

Ir-Renju Unit

Dianeal PD4 Glucose 3,86% w/v /38,6mg/ml

3,86% w/v /38,6mg/ml

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

IP24 3SE

Ir-Renju Unit

Extraneal (lcodextrin 7,5%) Solution for peritoneal dialysis

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

Ir-Renju Unit

| Baxter Healthcare Limited, |
| --- |
| Caxton Way, |
| Thetford, |
| IP24 3SE |
| Ir-Renju Unit |

Baxter Healthcare Limited,

Caxton Way,

Thetford,

IP24 3SE

Ir-Renju Unit

Nutrineal PD4 with 1,1% Amino Acids

Soluzzjoni għad-dijalisi tal-peritonew

Użu għal ġol-peritonew

---

ANNESS II

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI VETERINARJU, SPEĊI LI FUQHOM GĦANDU JINTUŻA L-PRODOTT U DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/ŻEE | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Isem inventat | Qawwa | Għamla Farmaċewtika | Speċi li fuqhom għandu jintuża l-prodott |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | LABORATORIOS HIPRA, S.A. |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

Stat Membru UE/ŻEE

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Isem inventat

Qawwa

Għamla Farmaċewtika

Speċi li fuqhom għandu jintuża l-prodott

L-Awstrija

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS -

Emulsion zur Injektion für Rinder

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Il-Belġju

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Ir-Repubblika Ċeka

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Injekční emulze pro skot

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Id-Danimarka

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Franza

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS EMULSION INJECTABLE POUR BOVINS

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Il-Ġermanja

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Il-Greċja

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

L-Ungerija

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

vakcina A.U.V.

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

L-Irlanda

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Emulsion for injection for cattle

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

L-Italja

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Emulsion for injection for cattle

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Il-Polonja

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

emulsja do wstrzykiwań dla bydła

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Il-Portugall

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Emulsão para injecção para bovinos

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Ir-Repubblika Slovakka

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

injekčná emulzia pre dobytok

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Spanja

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Il-Pajjiżi l-Baxxi

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

Ir-Renju Unit

| LABORATORIOS HIPRA, S.A. |
| --- |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPANJA |

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPANJA

HIPRABOVIS PNEUMOS

Emulsion for Injection for Cattle

Mannheimia haemolytica Sospensjoni libera biċ-ċelloli inattivati ta’ Bijotip A sertip A1, li fiha r-razza Bailie Histophilus somni Inattivata Ph. Eur. lewkotossojde

Emulsjoni għal injezzjoni

Frat minn età ta’ xahrejn

---