# Euroopan unionin C 56/2012

| | ISSN 1977-1053
  doi:10.3000/19771053.C_2012.056.fin |
| --- | --- |
| Euroopan unionin
  virallinen lehti | C 56 |
| | |
| Suomenkielinen laitos | Tiedonantoja ja ilmoituksia | 55. vuosikerta24. helmikuu 2012 |

ISSN 1977-1053

doi:10.3000/19771053.C_2012.056.fin

Euroopan unionin

virallinen lehti

C 56

Suomenkielinen laitos

Tiedonantoja ja ilmoituksia

55. vuosikerta24. helmikuu 2012

---

| Ilmoitusnumero | Sisältö | Sivu |
| --- | --- | --- |
| | IV   Tiedotteet |
| | EUROOPAN UNIONIN TOIMIELINTEN, ELINTEN, TOIMISTOJEN JA VIRASTOJEN TIEDOTTEET |
| | Euroopan komissio |
| 2012/C 056/01 | Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä marraskuuta 2011–31 päivänä joulukuuta 2011(Julkaistu Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 tai 38 artiklan nojalla) | 1 |
| 2012/C 056/02 | Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä marraskuuta 2011–31 päivänä joulukuuta 2011(Päätökset, jotka on tehty direktiivin 2001/83/EY 34 artiklan tai direktiivin 2001/82/EY 38 artiklan nojalla) | 26 |

Ilmoitusnumero

Sisältö

Sivu

IV   Tiedotteet

EUROOPAN UNIONIN TOIMIELINTEN, ELINTEN, TOIMISTOJEN JA VIRASTOJEN TIEDOTTEET

Euroopan komissio

2012/C 056/01

Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä marraskuuta 2011–31 päivänä joulukuuta 2011(Julkaistu Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 tai 38 artiklan nojalla)

(Julkaistu Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 tai 38 artiklan nojalla)

1

2012/C 056/02

Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä marraskuuta 2011–31 päivänä joulukuuta 2011(Päätökset, jotka on tehty direktiivin 2001/83/EY 34 artiklan tai direktiivin 2001/82/EY 38 artiklan nojalla)

(Päätökset, jotka on tehty direktiivin 2001/83/EY 34 artiklan tai direktiivin 2001/82/EY 38 artiklan

)

26

| FI | |
| --- | --- |

FI

---

IV Tiedotteet

EUROOPAN UNIONIN TOIMIELINTEN, ELINTEN, TOIMISTOJEN JA VIRASTOJEN TIEDOTTEET

Euroopan komissio

| 24.2.2012 | FI | Euroopan unionin virallinen lehti | C 56/1 |
| --- | --- | --- | --- |

24.2.2012

FI

Euroopan unionin virallinen lehti

C 56/1

---

Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä marraskuuta 2011–31 päivänä joulukuuta 2011

(Julkaistu Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 tai 38 artiklan nojalla
   (1)
  )

2012/C 56/01

—   Myyntiluvan myöntäminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 artikla): Hyväksytyt

| Päätöksen päivämäärä | Lääkkeen nimi | INN-nimi (kansainvälinen yleisnimi) | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Lääkemuoto | ATC-koodi
  (anatomis-terapeuttis-kemiallinen koodi) | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.11.2011 | Plenadren | hydrokortisoni | DuoCort Pharma AB |
| Kullagatan 8-10, |
| S-252 20 Helsingborg, |
| Sveridge |

Päätöksen päivämäärä

Lääkkeen nimi

INN-nimi (kansainvälinen yleisnimi)

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Lääkemuoto

ATC-koodi

(anatomis-terapeuttis-kemiallinen koodi)

Ilmoituksen päivämäärä

3.11.2011

Plenadren

hydrokortisoni

DuoCort Pharma AB

Kullagatan 8-10,

S-252 20 Helsingborg,

Sveridge

EU/1/11/715/001-002

Depottabletti

H02AB09

14.11.2011

16.11.2011

IOA

Nomegestroli / estradioli

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

N.V. Organon

Kloosterstraat 6,

5349 AB Oss,

Nederland

EU/1/11/689/001-002

Kalvopäällysteinen tabletti

G03AA14

18.11.2011

16.11.2011

Vyndaqel

tafamidiisi

| 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

Pehmeä kapseli

N07XX08

18.11.2011

22.11.2011

Rasitrio

aliskireeni / amlodipiini / hydroklooritiatsidi

| 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

Kalvopäällysteinen tabletti

C09XA54

24.11.2011

24.11.2011

Desloratadine Teva

desloratadiini

| 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

Kalvopäällysteinen tabletti

R06AX27

29.11.2011

24.11.2011

Komboglyze

saksagliptiini / metformiini

| 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

Kalvopäällysteinen tabletti

A10BD

28.11.2011

24.11.2011

Onduarp

Telmisartaani / Amlodipiini

| 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

Tabletti

C09DB04

28.11.2011

28.11.2011

Dasselta

desloratadiini

| 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

Kalvopäällysteinen tabletti

R06AX27

30.11.2011

28.11.2011

EDURANT

rilpiviriini

| 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

Kalvopäällysteinen tabletti

J05AG05

30.11.2011

28.11.2011

Eviplera

emtrisitabiininä / rilpiviriinia (hydrokloridina) / tenofoviiridisoproksiilia (fumaraattina)

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

Gilead Sciences International Limited

Cambridge,

CB21 6GT,

United Kingdom

EU/1/11/737/001-002

Kalvopäällysteinen tabletti

J05AR08

28.11.2011

5.12.2011

Dificlir

fidaksomisiinia

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

FGK Representative Service GmbH

Heimeranstrasse 35,

80339 München,

Deutschland

EU/1/11/733/001-004

Kalvopäällysteinen tabletti

Pending

7.12.2011

5.12.2011

Levetiracetam Actavis Group

Levetirasetaami

| 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

Oraaliliuos

N03AX14

7.12.2011

7.12.2011

Edarbi

atsilsartaanimedoksomiili

| 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

Tabletti

C09CA09

9.12.2011

7.12.2011

Ipreziv

atsilsartaanimedoksomiili

| 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

Tabletti

C09CA09

9.12.2011

14.12.2011

Ameluz

5-aminolevuliinihappo

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

Biofrontera Bioscience GmbH

Hemmelrather Weg 201,

51377 Leverkusen,

Deutschland

EU/1/11/740/001

Geeli

L01XD04

19.12.2011

14.12.2011

Levetiracetam SUN

Levetirasetaami

| 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

Infuusiokonsentraatti, liuosta varten

N03AX14

19.12.2011

22.12.2011

Repaglinide Accord

repaglinidi

| 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

Tabletti

A10BX02

28.12.2011

22.12.2011

Topotecan Eagle

topotekaani

| 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

Infuusiokonsentraatti, liuosta varten

L01XX17

29.12.2011

—   Myyntiluvan muuttaminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 artikla): Hyväksytyt

| Päätöksen päivämäärä | Lääkkeen nimi | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 3.11.2011 | Clopidogrel Krka | KRKA, d. d., Novo mesto |
| Šmarješka cesta 6, |
| 8501 Novo mesto, |
| Slovenija |

Päätöksen päivämäärä

Lääkkeen nimi

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Ilmoituksen päivämäärä

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, |
| London, |
| E14 5DS |
| United Kingdom |

Regeneron UK Limited

40 Bank Street,

London,

E14 5DS

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

—   Myyntiluvan peruuttaminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 13 artikla)

| Päätöksen päivämäärä | Lääkkeen nimi | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 28.11.2011 | Xigris | Eli Lilly Nederland B.V. |
| Grootslag 1-5, |
| 3991 RA Houten, |
| Nederland |

Päätöksen päivämäärä

Lääkkeen nimi

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Ilmoituksen päivämäärä

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

—   Myyntiluvan keskeyttäminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 20 artikla)

| Päätöksen päivämäärä | Lääkkeen nimi | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 24.11.2011 | Busilvex | Pierre Fabre Médicament |
| 45, Place Abel Gance, |
| 92654 Boulogne Billancourt Cedex, |
| France |

Päätöksen päivämäärä

Lääkkeen nimi

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Ilmoituksen päivämäärä

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

—   Myyntiluvan myöntäminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 38 artikla
   (2)): Hyväksytyt

| Päätöksen päivämäärä | Lääkkeen nimi | INN-nimi (kansainvälinen yleisnimi) | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Lääkemuoto | ATC-koodi
  (anatomis-terapeuttis-kemiallinen koodi) | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.12.2011 | Inflacam | Meloksikaami | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, |
| Co. Galway, |
| IRELAND |

Päätöksen päivämäärä

Lääkkeen nimi

INN-nimi (kansainvälinen yleisnimi)

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Lääkemuoto

ATC-koodi

(anatomis-terapeuttis-kemiallinen koodi)

Ilmoituksen päivämäärä

9.12.2011

Inflacam

Meloksikaami

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea,

Co. Galway,

IRELAND

EU/2/11/134/001-014

Injektioneste, liuos

Oraalisuspensio

Purutabletti

QM01AC06

13.12.2011

9.12.2011

Panacur AquaSol

Fenbendatsoli

| 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

Oraalisuspensio

QP52AC13

13.12.2011

14.12.2011

TruScient

Dibotermiini alfaa

| 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

Valmisteyhdistelmä implantaatiota varten

QM05BC01

19.12.2011

—   Myyntiluvan muuttaminen (Euroopan parlamentin ja neuvoston asetuksen (EY) N:o 726/2004 38 artikla): Hyväksytyt

| Päätöksen päivämäärä | Lääkkeen nimi | Myyntiluvan haltija | Yhteisön rekisteriin merkitty numero | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 10.11.2011 | ProMeris | Pfizer Limited |
| Ramsgate Road, |
| Sandwich, |
| Kent |
| CT13 9NJ |
| United Kingdom |

Päätöksen päivämäärä

Lääkkeen nimi

Myyntiluvan haltija

Yhteisön rekisteriin merkitty numero

Ilmoituksen päivämäärä

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

Kyseisten lääkkeiden julkiseen arviointilausuntoon ja siihen liittyviin päätöksiin voi tutustua ottamalla yhteyttä seuraavaan osoitteeseen:

| 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)  EUVL L 136, 30.4.2004, s. 1.

(2)  EUVL L 136, 30.4.2004, s. 1.

---

| 24.2.2012 | FI | Euroopan unionin virallinen lehti | C 56/26 |
| --- | --- | --- | --- |

24.2.2012

FI

Euroopan unionin virallinen lehti

C 56/26

---

Tiivistelmä lääkkeiden myyntilupia koskevista Euroopan unionin päätöksistä ajanjaksolla 1 päivänä marraskuuta 2011–31 päivänä joulukuuta 2011

(Päätökset, jotka on tehty direktiivin 2001/83/EY 34 artiklan
   (1)
  tai direktiivin 2001/82/EY 38 artiklan
   (2) nojalla)

2012/C 56/02

—   Kansallisen myyntiluvan myöntäminen, voimassapito tai muuttaminen

| Päätöksen päivämäärä | Lääkkeen nimi (nimet) | Myyntiluvan haltija(t) | Asianomainen jäsenvaltio | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 16.12.2011 | Dianeal, Extraneal, Nutrineal, Monosol and sodium chloride 0,9% solution for haemodialysis
  (Baxter) | Katso liite I | Katso liite I | 19.12.2011 |

Päätöksen päivämäärä

Lääkkeen nimi (nimet)

Myyntiluvan haltija(t)

Asianomainen jäsenvaltio

Ilmoituksen päivämäärä

16.12.2011

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

(Baxter)

Katso liite I

Katso liite I

19.12.2011

—   Kansallisen myyntiluvan keskeyttäminen

| Päätöksen päivämäärä | Lääkkeen nimi (nimet) | Myyntiluvan haltija(t) | Asianomainen jäsenvaltio | Ilmoituksen päivämäärä |
| --- | --- | --- | --- | --- |
| 3.11.2011 | HIPRABOVIS PNEUMOS Emulsion for injection for cattle | Katso liite II | Katso liite II | 7.11.2011 |

Päätöksen päivämäärä

Lääkkeen nimi (nimet)

Myyntiluvan haltija(t)

Asianomainen jäsenvaltio

Ilmoituksen päivämäärä

3.11.2011

HIPRABOVIS PNEUMOS Emulsion for injection for cattle

Katso liite II

Katso liite II

7.11.2011

---

(1)  EUVL L 311, 28.11.01, s. 67.

(2)  EUVL L 311, 28.11.01, s. 1.

---

LIITE I

LUETTELO LÄÄKEVALMISTEEN NIMISTÄ, LÄÄKEMUODOSTA, VAHVUUDESTA, ANTOREITISTÄ JA MYYNTILUVAN HALTIJOISTA JÄSENVALTIOISSA

| Jäsenvaltio | Myyntiluvan haltija | Kauppanimi | Vahvuus | Lääkemuoto | Antoreitti |
| --- | --- | --- | --- | --- | --- |
| Itävalta | Baxter Healthcare GmbH |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Jäsenvaltio

Myyntiluvan haltija

Kauppanimi

Vahvuus

Lääkemuoto

Antoreitti

Itävalta

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

EXTRANEAL- Peritonealdialyselösung

75 g/L

Peritoneaalidialyysineste

Vatsaonteloon

Itävalta

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

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

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

Vedetön glukoosi 13,6 g/L, Natriumkloridi 5,38 g/L, Natrium-(S)-laktaatti 4,48 g/L, Kalsiumkloridi 0,184 g/L, Magnesiumkloridi 0,051 g/L

Peritoneaalidialyysineste

Vatsaonteloon

Itävalta

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

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

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

Vedetön glukoosi 22,7 g/L, Natriumkloridi 5,38 g/L, Natrium-(S)-laktaatti 4,48 g/L, Kalsiumkloridi 0,184 g/L, Magnesiumkloridi 0,051 g/L

Peritoneaalidialyysineste

Vatsaonteloon

Itävalta

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

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

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

Vedetön glukoosi 38,6 g/L, Natriumkloridi 5,38 g/L, Natrium-(S)-laktaatti 4,48 g/L, Kalsiumkloridi 0,184 g/L, Magnesiumkloridi 0,051 g/L

Peritoneaalidialyysineste

Vatsaonteloon

Itävalta

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

Baxter Healthcare GmbH

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Nutrineal PD4 mit 1,1 % Aminosäuren - Peritonealdialyselösung

alaniinin 951 mg/L, arginiini 1 071 mg/L, glysiini 510 mg/L, histidiini 714 mg/L, isoleusiini 850 mg/L, leusiini 1 020 mg/L, Lysiinihydrokloridia 955 mg/L, metioniini 850 mg/L, fenyylialaniinia 570 mg/L, proline 595 mg/L, seriini 510 mg/L, treoniini 646 mg/L, tryptofaania 270 mg/L, tyrosiinin 300 mg/L, valiini 1 393 mg/L, Natriumkloridi 5 380 mg/L, Kalsiumkloridi 184 mg/L, Magnesiumkloridi 51 mg/L, Natrium-(S)-laktaatti 4 480 mg/L

Peritoneaalidialyysineste

Vatsaonteloon

Itävalta

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

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

Monosol Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung

glukoosimonohydraatti 1,1 g/L, natriumkloridi 6,43 g/L, natriumlaktaatti 3,36 g/L, kalsiumklorididihydraatti 0,257 g/L, magnesiumkloridiheksahydraatti 0,152 g/L

Hemodialyysi-, hemodiafiltraatio- ja hemofiltraationeste

Valtimoon, laskimoon, hemodialyysiin

Itävalta

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

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

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

glukoosimonohydraatti 1,1 g/L, natriumkloridi 6,43 g/L, natriumlaktaatti 3,36 g/L, kalsiumklorididihydraatti 0,257 g/L, magnesiumkloridiheksahydraatti 0,152 g/L, kaliumkloridi 0,149 g/L

Hemodialyysi-, hemodiafiltraatio- ja hemofiltraationeste

Valtimoon, laskimoon, hemodialyysiin

Itävalta

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

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

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

glukoosimonohydraatti 1,1 g/L, natriumkloridi 6,43 g/L, natriumlaktaatti 3,36 g/L, kalsiumklorididihydraatti 0,257 g/L, magnesiumkloridiheksahydraatti 0,152 g/L, kaliumkloridi 0,298 g/L

Hemodialyysi-, hemodiafiltraatio- ja hemofiltraationeste

Valtimoon, laskimoon, hemodialyysiin

Belgia

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

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

Extraneal 7,5 % solution pour dialyse péritonéale

75,00 g/l Ikodekstriini

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

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

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

13,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

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

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

22,7 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

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

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

38,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

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

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

13,60 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

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

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

22,7 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

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

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

38,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Belgia

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

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

4 to 1,1 % Aminohapot

Peritoneaalidialyysineste

Vatsaonteloon

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana,

Slovenia

Dianeal PD4 Glucose 1,36 %

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

Peritoneaalidialyysineste

Vatsaonteloon

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana,

Slovenia

Dianeal PD4 Glucose 2,27 %

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

Peritoneaalidialyysineste

Vatsaonteloon

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana,

Slovenia

Dianeal PD4 Glucose 3,86 %

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

Peritoneaalidialyysineste

Vatsaonteloon

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana,

Slovenia

Extraneal

7,50 %

Peritoneaalidialyysineste

Vatsaonteloon

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana,

Slovenia

Nutrineal PD 4 with 1,1 % Amino Acids

Peritoneaalidialyysineste

Vatsaonteloon

Tšekki

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

lreland

EXTRANEAL

7,5 % 75 g/1 000 ml

Peritoneaalidialyysineste

Vatsaonteloon

Tšekki

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

lreland

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Tšekki

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

lreland

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Tšekki

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

lreland

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Tšekki

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

lreland

Nutrineal PD 4 with 1,1 % Amino Acids

1,1 % 300 mg/l

Peritoneaalidialyysineste

Vatsaonteloon

Tanska

| Baxter A/S, |
| --- |
| Gydevang 43, |
| DK-3450 Allerød |
| Denmark |

Baxter A/S,

Gydevang 43,

DK-3450 Allerød

Denmark

Natriumklorid Baxter 9 mg/ml

9 mg/ml

Infuusioneste, liuos

Laskimoon

Tanska

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Tanska

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Tanska

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Dianeal PD4 med Glucos

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Tanska

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Extraneal

75 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Tanska

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| Denmark |

Baxter A/S

Gydevang 43

3450 Allerød

Denmark

Nutrineal PD4 med 1,1 % aminosyrer

Peritoneaalidialyysineste

Vatsaonteloon

Viro

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

Baxter Oy P.O.

Box 270

Valimotie 15A

00381 Helsinski

Finland

EXTRANEAL

7,50 %

Peritoneaalidialyysineste

Vatsaonteloon

Suomi

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

Baxter Healthcare S.A.

Moneen Road, Castlebar

County Mayo

Ireland

Natriumklorid Baxter 9 mg/ml

9 mg/ml

Infuusioneste, liuos

Laskimoon

Suomi

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

Baxter Oy P.O. Box

270 Valimotie 15A

00381 Helsinski

Finland

Extraneal

7,5 %

Peritoneaalidialyysineste

Vatsaonteloon

Suomi

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

CO. Mayo

lreland

Dianeal PD4 Glucose

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Suomi

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

CO. Mayo

lreland

Dianeal PD4 Glucose

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Suomi

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

CO. Mayo

lreland

Dianeal PD4 Glucose

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

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

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

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

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

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

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

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

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

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

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

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

3,86 %

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

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

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

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

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

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

Baxter S.A.S

Avenue louis Pasteur

78310 ZA de Coigneres

78310 Maurepas

France

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

2,27 %

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

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

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

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

1,36 %

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

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

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

EXTRANEAL, solution pour dialyse péritonéale

7,50 %

Peritoneaalidialyysineste

Vatsaonteloon

Ranska

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

Baxter S.A.S

Avenue louis Pasteur 78310

ZA de Coigneres

78310 Maurepas

France

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

1,10 %

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstraße 4 |
| 85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstraße 4

85716 Unterschleißheim

Germany

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

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

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

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

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

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

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

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

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

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

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

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG1 1,36 %

13,6 g/l

5,67 g/l

3,92 g/l

0,257 g/l

0,0152 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG1 2,27 %

22,7 g/l

5,67 g/l

3,92 g/l

0,257 g/l

0,0152 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG1 3,86 %

38,6 g/l

5,67 g/l

3,92 g/l

0,257 g/l

0,0152 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 1,36 %

13,6 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 2,27 %

22,7 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 3,86 %

38,6 g/l

5,38 g/l

4,48 g/l

0,184 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Extraneal

75 g/l

5,4 g/l

4,5 g/l

0,257 g/l

0,051 g/l

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

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

Peritoneaalidialyysineste

Vatsaonteloon

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Monosol

1,1 g / l

6,43 g / l

0,257 g / l

0,152 g / l

3,36 g / l

Hemodialyysineste

Hemodialyysiin

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

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

Hemodialyysineste

Hemodialyysiin

Saksa

| Baxter Deutschland GmbH |
| --- |
| Edisonstr. 4 |
| D-85716 Unterschleißheim |
| Germany |

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

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

Hemodialyysineste

Hemodialyysiin

Kreikka

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Greece |

Diophar SA

Kifissias 368

Halandri 15233

Greece

DIANEAL PD1

Peritoneaalidialyysineste

Vatsaonteloon

Kreikka

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Greece |

Diophar SA

Kifissias 368

Halandri 15233

Greece

DIANEAL PD4

1,36 %

2,27 % w/v

3,86 % w/v

Peritoneaalidialyysineste

Vatsaonteloon

Kreikka

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Greece |

Diophar SA

Kifissias 368

Halandri 15233

Greece

Extraneal

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

Peritoneaalidialyysineste

Vatsaonteloon

Kreikka

| Diophar SA |
| --- |
| Kifissias 368 |
| Halandri 15233 |
| Greece |

Diophar SA

Kifissias 368

Halandri 15233

Greece

Nutrineal PD4

1,1 %

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

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

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

EXTRANEAL peritoneális dializáló oldat

7,5 % (Ikodekstriini)

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

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

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 1 Glucose 1,36 % peritoneális dializáló oldat

1,36 %

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

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

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 1 Glucose 2,27 % peritoneális dializáló oldat

2,27 %

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

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

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 1 Glucose 3,86 % peritoneális dializáló oldat

3,86 %

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

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

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 1,36 % peritoneális dializáló oldat

1,36 %

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

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

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 2,27 % peritoneális dializáló oldat

2,27 %

Peritoneaalidialyysineste

Vatsaonteloon

Unkari

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

Baxter Hungary Kft.

Népfürdö u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 3,86 % peritoneális dializáló oldat

3,86 %

Peritoneaalidialyysineste

Vatsaonteloon

Islanti

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| Ireland |

Baxter Healthcare SA

Moneen Road Castlebar,

County Mayo

Ireland

Dianeal PD4 Glucose

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Islanti

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| Ireland |

Baxter Healthcare SA

Moneen Road Castlebar,

County Mayo

Ireland

Dianeal PD4 Glucose

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Islanti

| Baxter Healthcare SA |
| --- |
| Moneen Road Castlebar, |
| County Mayo |
| Ireland |

Baxter Healthcare SA

Moneen Road Castlebar,

County Mayo

Ireland

Dianeal PD4 Glucose

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Monosol, Solution for haemodialysis, haemodiafiltration and haemofiltration

Glukoosimonohydraatti Ph. Eur.1,1, Natriumkloridin Ph. Eur. 6,43, Kalsiumklorididihydraatti Ph. Eur., 0,257, Magnesiumkloridiheksahydraatti Ph. Eur.0,152, Natriumlaktaatti Ph. Eur. 3,36

Hemodialyysi-, hemodiafiltraatio- ja hemofiltraationeste

Hemodialyysiin

Irlanti

| 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

Glukoosimonohydraatti Ph. Eur.1,1, Natriumkloridin Ph. Eur. 6,43, Kalsiumklorididihydraatti Ph. Eur., 0,257, Magnesiumkloridiheksahydraatti Ph. Eur.0,152, Natriumlaktaatti Ph. Eur. 3,36, Kaliumkloridi Ph. Eur. 0,149

Hemodialyysi-, hemodiafiltraatio- ja hemofiltraationeste

Hemodialyysiin

Irlanti

| 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

Glukoosimonohydraatti Ph. Eur.1,1, Natriumkloridin Ph. Eur. 6,43, Kalsiumklorididihydraatti Ph. Eur., 0,257, Magnesiumkloridiheksahydraatti Ph. Eur.0,152, Natriumlaktaatti Ph. Eur. 3,36, Kaliumkloridi Ph. Eur. 0,298

Hemodialyysi-, hemodiafiltraatio- ja hemofiltraationeste

Hemodialyysiin

Irlanti

| 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

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| 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)

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| 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)

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| 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)

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| 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)

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| 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)

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| 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

Peritoneaalidialyysineste

Vatsaonteloon

Irlanti

| 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

Peritoneaalidialyysineste

Vatsaonteloon

Italia

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

Baxter S.p.A.

Piazzale dell’Industria 20

00144 Roma

Italy

EXTRANEAL

7,5 %

Peritoneaalidialyysineste

Vatsaonteloon

Italia

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

Baxter S.p.A.

Piazzale dell’Industria 20

00144 Roma

Italy

NUTRINEAL PD4

1,1 %

Peritoneaalidialyysineste

Vatsaonteloon

Italia

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

Baxter S.p.A.

Piazzale dell’Industria 20

00144 Roma

Italy

SOLUZIONI PER DIALISI PERITONEALE BAXTER

Range compositions

Peritoneaalidialyysineste

Vatsaonteloon

Latvia

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

Baxter Oy P.O. Box 270

Valimotie 15A

00381 Helsinski

Finland

Extraneal solution for peritoneal dialysis

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

Peritoneaalidialyysineste

Vatsaonteloon

Latvia

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

Ireland

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

Peritoneaalidialyysineste

Vatsaonteloon

Latvia

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

Ireland

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

Peritoneaalidialyysineste

Vatsaonteloon

Latvia

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

Ireland

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

Peritoneaalidialyysineste

Vatsaonteloon

Liettua

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

Ireland

Dianeal PD4 Glucose

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

Peritoneaalidialyysineste

Vatsaonteloon

Liettua

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

Ireland

Dianeal PD4 Glucose

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

Peritoneaalidialyysineste

Vatsaonteloon

Liettua

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

County Mayo

Ireland

Dianeal PD4 Glucose

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

Peritoneaalidialyysineste

Vatsaonteloon

Liettua

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

Baxter Oy

P.O. Box 270

Valimotie 15A

00381 Helsinski

Finland

EXTRANEAL

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

Peritoneaalidialyysineste

Vatsaonteloon

Luxemburg

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

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Belgium

Nutrineal PD4+A.A.1,1 %

1,1 % Aminohapot

Peritoneaalidialyysineste

Vatsaonteloon

Luxemburg

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

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Belgium

Dianeal PD1 Glucose

1,36 %/2,27 %/3,86 % Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Luxemburg

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

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Belgium

Dianeal PD4 Glucose

1,36 %/2,27 %/3,86 % Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Luxemburg

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

Baxter S.A.

Bd René Branquart 80

B-7860 Lessines

Belgium

Extraneal

75,00 g/l Ikodekstriini

Peritoneaalidialyysineste

Vatsaonteloon

Malta

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

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Extraneal (Icodextrin 7,5 %)

N/A

Peritoneaalidialyysineste

Vatsaonteloon

Malta

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

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

Nutrineal PD4 with 1,1 % amino acids

N/A

Peritoneaalidialyysineste

Vatsaonteloon

Malta

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

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Malta

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

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Malta

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

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Malta

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

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Malta

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

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Malta

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

Baxter Healthcare Ltd

Caxton Way

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Malta

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE,

UK

Monosol

glukoosimonohydraatti 1,1 g/L,

natriumkloridi 6,43 g/L,

kalsiumklorididihydraatti 0,257 g/L,

magnesiumkloridiheksahydraatti 0,152 g/L,

natriumlaktaatti 3,36 g/L

Hemodialyysi-/hemofiltraationeste

Valtimoon, laskimoon

Malta

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE,

UK

Monosol-K with 2MEQ Potassium/L

glukoosimonohydraatti 1,1 g/L,

natriumkloridi 6,43 g/L,

kalsiumklorididihydraatti 0,257 g/L,

magnesiumkloridiheksahydraatti 0,152 g/L,

kaliumkloridi 0,149 g/l,

natriumlaktaatti 3,36 g/L

Hemodialyysi-/hemofiltraationeste

Valtimoon, laskimoon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

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

13,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

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

22,7 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

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

38,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

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

13,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

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

22,7 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

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

38,6 g/l Vedetön glukoosi

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

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

11 g/l Aminohapot & 1,25 mmol/l Ca.

Peritoneaalidialyysineste

Vatsaonteloon

Alankomaat

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| The Netherlands |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

The Netherlands

EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse

75 g/l Ikodekstriini

Peritoneaalidialyysineste

Vatsaonteloon

Norja

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo |
| Norway |

Baxter AS

Gjerdrumsvei 11

0484 Oslo

Norway

Natriumklorid Baxter 9 mg/ml

9 mg/ml

Infuusioneste, liuos

Laskimoon

Norja

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo, |
| Norway |

Baxter AS

Gjerdrumsvei 11

0484 Oslo,

Norway

Nutrineal PD4 amino Acids 1,1 %

1,10 %

Peritoneaalidialyysineste

Vatsaonteloon

Norja

| Baxter AS |
| --- |
| Gjerdrumsvei 11 |
| 0484 Oslo, |
| Norway |

Baxter AS

Gjerdrumsvei 11

0484 Oslo,

Norway

Extraneal

75 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Puola

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

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Poland

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

Peritoneaalidialyysineste

Vatsaonteloon

Puola

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

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Poland

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

Peritoneaalidialyysineste

Vatsaonteloon

Puola

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

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Poland

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

Peritoneaalidialyysineste

Vatsaonteloon

Puola

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

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Poland

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

Peritoneaalidialyysineste

Vatsaonteloon

Puola

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

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Poland

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

Peritoneaalidialyysineste

Vatsaonteloon

Puola

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

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Poland

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

Peritoneaalidialyysineste

Vatsaonteloon

Puola

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

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Poland

Extraneal Zestaw do dializy otrzewnowej

75 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Puola

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

Baxter Polska SP. z.o.o.

Kruczkowskiego 8 st.,

00-380 Warszawa,

Poland

Nutrineal PD4 (z 1,1 % roztworem aminokwasów)

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

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

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Extraneal

75 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

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

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd1

Association

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

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

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd1

Association

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

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

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd1

Association

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

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

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

Association

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

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

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

Association

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

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

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

Association

Peritoneaalidialyysineste

Vatsaonteloon

Portugali

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

Baxter Médico Farmacêutica Lda

Zona Industrial da Abrunheira,

Edificio 10 Sintra Business Park,

2710-089 Sintra

Portugal

Nutrineal PD4

Association

Peritoneaalidialyysineste

Vatsaonteloon

Romania

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

Baxter Healthcare Ltd

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom

EXTRANEAL

75 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Romania

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

Baxter Healthcare SA,

Moneen Road, Castlebar,

Co. Mayo,

Ireland

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

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Romania

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

Baxter Healthcare SA,

Moneen Road, Castlebar,

Co. Mayo,

Ireland

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

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Romania

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

Baxter Healthcare SA,

Moneen Road, Castlebar,

Co. Mayo,

Ireland

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

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Romania

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

BAXTER d.o.o.

Zelezna cesta 14,

SI-1000 Ljubljana,

Slovenia

NUTRINEAL PD4 cu 1,1 % aminoacizi

1,1 %

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavalta

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

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

Ireland

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

13,6 mg/1 ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavalta

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

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

Ireland

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

22,7 mg/1 ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavalta

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

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

Ireland

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

38,6 mg/1 ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavalta

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

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

Ireland

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

13,6 mg/1 ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavalta

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

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

Ireland

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

22,7 mg/1 ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavalta

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

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

Ireland

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

38,6 mg/1 ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavalta

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

Baxter Healthcare Ltd

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

EXTRANEAL

7,5 %

Peritoneaalidialyysineste

Vatsaonteloon

Slovakian tasavalta

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

Baxter Healthcare SA,

Moneen Rd, Castlebar,

Co. Mayo,

Ireland

Nutrineal PD4 with 1,1 % Amino Acids

1,1 %

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

Ljubljana, SI-1000,

Slovenia

Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo

75 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

Ljubljana, SI -1000,

Slovenia

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

11 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

Ljubljana, SI -1000,

Slovenia

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

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

Ljubljana, SI -1000,

Slovenia

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

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

Ljubljana, SI -1000,

Slovenia

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

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

Ljubljana, SI -1000,

Slovenia

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

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

Ljubljana, SI -1000,

Slovenia

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

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

Ljubljana, SI -1000,

Slovenia

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

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

EXTRANEAL

Solución para diálisis peritoneal

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

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

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

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

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD1 Glucosa 1,36 %

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

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

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD1 Glucosa 2,27 %

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

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

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD1 Glucosa 3,86 %

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

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

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 1,36 %

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

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

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 2,27 %

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

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

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

Dianeal PD4 Glucosa 3,86 %

Peritoneaalidialyysineste

Vatsaonteloon

Espanja

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

Baxter S.L

Pouet de Camilo, 2

Ribarroja del Turia (Valencia)

46394

Spain

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

Peritoneaalidialyysineste

Vatsaonteloon

Ruotsi

| 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

Infuusioneste, liuos

Laskimoon

Ruotsi

| Baxter Healthare SA |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Irland |

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Irland

Dianeal PD4 med glucos 13,6 mg/ml

13,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Ruotsi

| Baxter Healthare SA |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Irland |

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Irland

Dianeal PD4 med glucos 22,7 mg/ml

22,7 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Ruotsi

| Baxter Healthare SA |
| --- |
| Moneen Road Castlebar |
| County Mayo |
| Irland |

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Irland

Dianeal PD4 med glucos 38,6 mg/ml

38,6 mg/ml

Peritoneaalidialyysineste

Vatsaonteloon

Ruotsi

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

Baxter Medical AB

Box 63

16494 Kista

Sverige

Extraneal

7,5 %

Peritoneaalidialyysineste

Vatsaonteloon

Ruotsi

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

Baxter Medical AB

Box 63

16494 Kista

Sverige

Nutrineal PD4 1,1 % Aminosyror

1,10 %

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

Monosol

kalsiumkloridi: 0,026 % w/v; glukoosi 0,110 %w/v; natriumlaktaatti 0,336 %w/v; natriumkloridi 0,643 %w/v; magnesiumkloridi 0,015 %w/v

Hemodialyysi/hemofiltraationeste

Valtimoon, laskimoon

Iso-Britannia

| 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 2MEQ Potassium/L

natriumkloridi 0,643 %w/v; magnesiumkloridi 0,015 %w/v; kalsiumkloridi 0,026 %w/v; glukoosi 0,110 %w/v; kaliumkloridi 0,015 %w/v; natriumlaktaatti 0,336 %w/v

Hemodialyysi/hemofiltraationeste

Valtimoon, laskimoon

Iso-Britannia

| 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 4MEQ Potassium/L

magnesiumkloridi 0,015 %w/v; kaliumkloridi 0,029 %w/v; kalsiumkloridi 0,026 %w/v; natriumlaktaatti 0,336 %w/v; natriumkloridi 0,643 %w/v; glukoosi 0,110 %w/v

Hemodialyysi/hemofiltraationeste

Valtimoon, laskimoon

Iso-Britannia

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

Baxter Healthcare Limited

Caxton Way,

Thetford

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

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

Baxter Healthcare Limited

Caxton Way,

Thetford

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

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

Baxter Healthcare Limited

Caxton Way,

Thetford

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

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

Baxter Healthcare Limited

Caxton Way,

Thetford

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

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

Baxter Healthcare Limited

Caxton Way,

Thetford

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

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

Baxter Healthcare Limited

Caxton Way,

Thetford

IP24 3SE

United Kingdom

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

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

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

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

Baxter Healthcare Limited

Caxton Way,

Thetford

IP24 3SE

United Kingdom

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

Peritoneaalidialyysineste

Vatsaonteloon

Iso-Britannia

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

Baxter Healthcare Limited

Caxton Way,

Thetford

IP24 3SE

United Kingdom

Nutrineal PD4 with 1,1 % Amino Acids

Peritoneaalidialyysineste

Vatsaonteloon

---

LIITE II

LUETTELO ELÄINLÄÄKEVALMISTEEN NIMISTÄ, LÄÄKEMUODOSTA, VAHVUUDESTA, KOHDE-ELÄINLAJEISTA JA MYYNTILUVAN HALTIJOISTA JÄSENVALTIOISSA

| Jäsenvaltio EU/ETA | Myyntiluvan haltija | Kauppanimi | Vahvuus | Lääkemuoto | Kohde-eläinlajit |
| --- | --- | --- | --- | --- | --- |
| Itävalta | LABORATORIOS HIPRA, S.A. |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| ESPANJA |

Jäsenvaltio EU/ETA

Myyntiluvan haltija

Kauppanimi

Vahvuus

Lääkemuoto

Kohde-eläinlajit

Itävalta

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS -

Emulsion zur Injektion für Rinder

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Belgia

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Tšekki

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Injekční emulze pro skot

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Tanska

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Ranska

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS EMULSION INJECTABLE POUR BOVINS

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Saksa

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Kreikka

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Unkari

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

vakcina A.U.V.

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Irlanti

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Emulsion for injection for cattle

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Italia

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Emulsion for injection for cattle

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Puola

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

emulsja do wstrzykiwań dla bydła

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Portugali

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Emulsão para injecção para bovinos

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Slovakia

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

injekčná emulzia pre dobytok

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Espanja

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Alankomaat

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

Yhdistynyt kuningaskunta

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

ESPANJA

HIPRABOVIS PNEUMOS

Emulsion for Injection for Cattle

Inaktivoitu ja soluton Mannheimia haemolytica (biotyyppi A, serotyyppi A1) -suspensio, joka sisältää leukotoksoidia (Ph. Eur). Inaktivoitu Histophilus somnin Bailie-kanta

Injektioneste, emulsio

Naudalle 2 kuukauden iästä alkaen

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