# Official Journal C 56/2012

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2012.056.eng |
| --- | --- |
| Official Journal
  of the European Union | C 56 |
| | |
| English edition | Information and Notices | Volume 5524 February 2012 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2012.056.eng

Official Journal

of the European Union

C 56

English edition

Information and Notices

Volume 5524 February 2012

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2012/C 056/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2012/C 056/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 26 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2012/C 056/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

2012/C 056/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

26

| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 24.2.2012 | EN | Official Journal of the European Union | C 56/1 |
| --- | --- | --- | --- |

24.2.2012

EN

Official Journal of the European Union

C 56/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1)
  )

2012/C 56/01

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.11.2011 | Plenadren | hydrocortisone | DuoCort Pharma AB |
| Kullagatan 8-10, |
| S-252 20 Helsingborg, |
| Sveridge |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

3.11.2011

Plenadren

hydrocortisone

DuoCort Pharma AB

Kullagatan 8-10,

S-252 20 Helsingborg,

Sveridge

EU/1/11/715/001-002

Modified-release tablet

H02AB09

14.11.2011

16.11.2011

IOA

nomegestrol / estradiol

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

N.V. Organon

Kloosterstraat 6,

5349 AB Oss,

Nederland

EU/1/11/689/001-002

Film-coated tablet

G03AA14

18.11.2011

16.11.2011

Vyndaqel

tafamidis

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

Pfizer Specialty UK Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/1/11/717/001

Capsule, soft

N07XX08

18.11.2011

22.11.2011

Rasitrio

aliskiren / amlodipine / hydrochlorothiazide

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

Novartis Europharm Limited

Wimblehurst Road,

Horsham,

West Sussex,

RH12 5AB,

United Kingdom

EU/1/11/730/001-060

Film-coated tablet

C09XA54

24.11.2011

24.11.2011

Desloratadine Teva

desloratadine

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

Teva Pharma B.V

Computerweg 10,

3542 DR Utrecht,

Nederland

EU/1/11/732/001-013

Film-coated tablet

R06AX27

29.11.2011

24.11.2011

Komboglyze

saxagliptin / metformin

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

Bristol Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House,

Uxbridge Business Park,

Sanderson Road,

Uxbridge,

Middlesex

UB8 1DH,

United Kingdom

EU/1/11/731/001-012

Film-coated tablet

A10BD

28.11.2011

24.11.2011

Onduarp

telmisartan / amlodipine

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

Boehringer Ingelheim International GmbH

Binger Str. 173,

D-55216 Ingelheim am Rhein,

Deutschland

EU/1/11/729/001-006

Tablet

C09DB04

28.11.2011

28.11.2011

Dasselta

desloratadine

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

KRKA, d.d., Novo mesto

Šmarješka cesta 6,

8501 Novo mesto,

Slovenija

EU/1/11/739/001-008

Film-coated tablet

R06AX27

30.11.2011

28.11.2011

EDURANT

rilpivirine

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

Janssen Cilag International NV

Turnhoutseweg 30,

B 2340 Beerse,

België

EU/1/11/736/001

Film-coated tablet

J05AG05

30.11.2011

28.11.2011

Eviplera

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

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

Gilead Sciences International Limited

Cambridge,

CB21 6GT,

United Kingdom

EU/1/11/737/001-002

Film-coated tablet

J05AR08

28.11.2011

5.12.2011

Dificlir

fidaxomicin

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

FGK Representative Service GmbH

Heimeranstrasse 35,

80339 München,

Deutschland

EU/1/11/733/001-004

Film-coated tablet

Pending

7.12.2011

5.12.2011

Levetiracetam Actavis Group

levetiracetam

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

Actavis Group PTC ehf.

ReykjavÍkurvegur 76-78,

Hafnarfjörður 220,

Iceland

EU/1/11/738/001-003

Oral solution

N03AX14

7.12.2011

7.12.2011

Edarbi

azilsartan medoxomil

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

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/11/734/001-011

Tablet

C09CA09

9.12.2011

7.12.2011

Ipreziv

azilsartan medoxomil

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

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych,

London

WC2B 4AE,

United Kingdom

EU/1/11/735/001-011

Tablet

C09CA09

9.12.2011

14.12.2011

Ameluz

5-Aminolaevulinic acid

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

Biofrontera Bioscience GmbH

Hemmelrather Weg 201,

51377 Leverkusen,

Deutschland

EU/1/11/740/001

Gel

L01XD04

19.12.2011

14.12.2011

Levetiracetam SUN

levetiracetam

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

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87,

2132 JH Hoofddorp,

Nederland

EU/1/11/741/001

Concentrate for solution for infusion

N03AX14

19.12.2011

22.12.2011

Repaglinide Accord

Repaglinide

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

Accord Healthcare Limited

Sage house,

319 Pinner road,

Harrow,

HA1 4HF

United Kingdom

EU/1/11/743/001-015

Tablet

A10BX02

28.12.2011

22.12.2011

Topotecan Eagle

topotecan

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

Eagle Laboratories Limited

The Clock House,

Station Approach,

Marlow,

Bucks

SL7 1NT,

UNITED KINGDOM

EU/1/11/744/001-002

Concentrate for solution for infusion

L01XX17

29.12.2011

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.11.2011 | Clopidogrel Krka | KRKA, d. d., Novo mesto |
| Šmarješka cesta 6, |
| 8501 Novo mesto, |
| Slovenija |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 28.11.2011 | Xigris | Eli Lilly Nederland B.V. |
| Grootslag 1-5, |
| 3991 RA Houten, |
| Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

—   Suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 24.11.2011 | Busilvex | Pierre Fabre Médicament |
| 45, Place Abel Gance, |
| 92654 Boulogne Billancourt Cedex, |
| France |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (2)): Accepted

| Date of the Décision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
  (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 9.12.2011 | Inflacam | Meloxicam | Chanelle Pharmaceuticals Manufacturing Limited |
| Loughrea, |
| Co. Galway, |
| IRELAND |

Date of the Décision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code

(Anatomical Therapeutic Chemical Code)

Date of notification

9.12.2011

Inflacam

Meloxicam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea,

Co. Galway,

IRELAND

EU/2/11/134/001-014

Chewable tablet

Oral suspension

Solution for injection

QM01AC06

13.12.2011

9.12.2011

Panacur AquaSol

Fenbendazole

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

Intervet International B.V.

Wim de Körverstraat 35,

5831 AN Boxmeer,

Nederland

EU/2/11/135/001-003

Oral suspension

QP52AC13

13.12.2011

14.12.2011

TruScient

Dibotermin alfa

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

Pfizer Limited

Ramsgate Road,

Sandwich,

Kent

CT13 9NJ,

United Kingdom

EU/2/11/136/001

Kit for implant

QM05BC01

19.12.2011

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 10.11.2011 | ProMeris | Pfizer Limited |
| Ramsgate Road, |
| Sandwich, |
| Kent |
| CT13 9NJ |
| United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| 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)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.

---

| 24.2.2012 | EN | Official Journal of the European Union | C 56/26 |
| --- | --- | --- | --- |

24.2.2012

EN

Official Journal of the European Union

C 56/26

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1)
  or Article 38 of Directive 2001/82/EC
   (2)
  )

2012/C 56/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 16.12.2011 | Dianeal, Extraneal, Nutrineal, Monosol and sodium chloride 0,9% solution for haemodialysis
  (Baxter) | See Annex I | See Annex I | 19.12.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

16.12.2011

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

(Baxter)

See Annex I

See Annex I

19.12.2011

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 3.11.2011 | HIPRABOVIS PNEUMOS Emulsion for injection for cattle | See Annex II | See Annex II | 7.11.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

3.11.2011

HIPRABOVIS PNEUMOS Emulsion for injection for cattle

See Annex II

See Annex II

7.11.2011

---

(1)  OJ L 311, 28.11.2001, p. 67.

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

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Baxter Healthcare GmbH, |
| Stella-Klein-Löw-Weg 15, |
| A-1020 Wien |
| Austria |

Member State EU/EEA

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Route of administration

Austria

Baxter Healthcare GmbH,

Stella-Klein-Löw-Weg 15,

A-1020 Wien

Austria

EXTRANEAL - Peritonealdialyselösung

75 g/L

solution for peritoneal dialysis

intraperitoneal use

Austria

| 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

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

solution for peritoneal dialysis

intraperitoneal use

Austria

| 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

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

solution for peritoneal dialysis

intraperitoneal use

Austria

| 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

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

solution for peritoneal dialysis

intraperitoneal use

Austria

| 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

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

solution for peritoneal dialysis

intraperitoneal use

Austria

| 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

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

solution for haemodialysis, haemodiafiltration and haemofiltration

intraarterial use, intravenous use, hemodialysis

Austria

| 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

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

solution for haemodialysis, haemodiafiltration and haemofiltration

intraarterial use, intravenous use, hemodialysis

Austria

| 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

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

solution for haemodialysis, haemodiafiltration and haemofiltration

intraarterial use, intravenous use, hemodialysis

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

EXTRANEAL 7,5 %, solution pour dialyse péritonéale

75,00 g/l Icodextrine

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

13,60 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

22,7 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

38,6 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

13,6 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

22,7 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

Boulevard R. Branquart 80

7680 Lessines

Belgium

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

38,6 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Belgium

| Baxter SA |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| Belgium |

Baxter SA

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% acides aminés

solution for peritoneal dialysis

intraperitoneal use

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% w/v/ 13,6mg/ml

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

solution for peritoneal dialysis

intraperitoneal use

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% w/v/ 22,7mg/ml

solution for peritoneal dialysis

intraperitoneal use

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% w/v/ 38,6mg/ml

solution for peritoneal dialysis

intraperitoneal use

Bulgaria

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

BAXTER d.o.o.,

Zelezna cesta 18,

1000 Ljubljana

Slovenia

Extraneal

7,50%

solution for peritoneal dialysis

intraperitoneal use

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

solution for peritoneal dialysis

intraperitoneal use

Czech Republic

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

Co. Mayo

Ireland

EXTRANEAL

7,5 % 75 g / 1 000 ml

solution for peritoneal dialysis

peritoneal use

Czech Republic

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

Co. Mayo

Ireland

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

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

solution for peritoneal dialysis

peritoneal use

Czech Republic

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

Co. Mayo

Ireland

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

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

solution for peritoneal dialysis

peritoneal use

Czech Republic

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

Co. Mayo

Ireland

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

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

solution for peritoneal dialysis

peritoneal use

Czech Republic

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

Baxter Healthcare S.A.

Moneen Road Castlebar,

Co. Mayo

Ireland

NUTRINEAL PD4 WITH 1,1% AMINOACIDS

1,10%

solution for peritoneal dialysis

peritoneal use

Denmark

| 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

solution for infusion

intravenous use

Denmark

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

Baxter A/S,

Gydevang 43,

DK-3450 Allerød

Denmark

Dianeal PD4 med Glucos

13,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Denmark

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

Baxter A/S,

Gydevang 43,

DK-3450 Allerød

Denmark

Dianeal PD4 med Glucos

22,7 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Denmark

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

Baxter A/S,

Gydevang 43,

DK-3450 Allerød

Denmark

Dianeal PD4 med Glucos

38,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Denmark

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

Baxter A/S,

Gydevang 43,

DK-3450 Allerød

Denmark

Extraneal

75 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Denmark

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

Baxter A/S,

Gydevang 43,

DK-3450 Allerød

Denmark

Nutrineal PD4 med 1,1 % aminosyrer

1,1 %/1 000 ml

solution for peritoneal dialysis

intraperitoneal use

Estonia

| Baxter OY |
| --- |
| P.O box 270, |
| Valimotie 15A, |
| Helsinki 00381 |
| Finland |

Baxter OY

P.O box 270,

Valimotie 15A,

Helsinki 00381

Finland

EXTRANEAL

7,50%

solution for peritoneal dialysis

intraperitoneal use

Finland

| 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

solution for infusion

intravenous use

Finland

| Baxter Oy |
| --- |
| Valimotie 15 A |
| 00380 Helsinki |
| Finland |

Baxter Oy

Valimotie 15 A

00380 Helsinki

Finland

Extraneal

7,50%

solution for peritoneal dialysis

intraperitoneal use

Finland

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

Baxter Healthcare S.A.

Moneen Road, Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

13,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Finland

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

Baxter Healthcare S.A.

Moneen Road, Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

22,7 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Finland

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

Baxter Healthcare S.A.

Moneen Road, Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

38,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

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

1,36%

solution for peritoneal dialysis

intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

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

3,86%

solution for peritoneal dialysis

intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

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

3,86%

solution for peritoneal dialysis

intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

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

2,27%

solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

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

2,27%

solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

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

1,36%

solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

EXTRANEAL, solution pour dialyse péritonéale

7,50%

solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter SAS |
| --- |
| Avenue louis Pasteur |
| ZA de Coignères Maurepas |
| 78310 Maurepas |
| France |

Baxter SAS

Avenue louis Pasteur

ZA de Coignères Maurepas

78310 Maurepas

France

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

1,10%

solution for peritoneal dialysis

Intraperitoneal use

Germany

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

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD1 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

solution for peritoneal dialysis

Intraperitoneal use

Germany

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

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD1 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

solution for peritoneal dialysis

Intraperitoneal use

Germany

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

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PD1 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

solution for peritoneal dialysis

Intraperitoneal use

Germany

| 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

solution for peritoneal dialysis

Intraperitoneal use

Germany

| 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

solution for peritoneal dialysis

intraperitoneal use

Germany

| 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

solution for peritoneal dialysis

intraperitoneal use

Germany

| 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

solution for peritoneal dialysis

intraperitoneal use

Germany

| 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

solution for peritoneal dialysis

intraperitoneal use

Germany

| 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

solution for peritoneal dialysis

intraperitoneal use

Germany

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

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Dianeal PDG4 1,36 %

13,6g / l

5,38 g / l

4,48 g/ l

0,184 g / l

0,051 g / l

solution for peritoneal dialysis

intraperitoneal use

Germany

| 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

solution for peritoneal dialysis

intraperitoneal use

Germany

| 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

solution for peritoneal dialysis

intraperitoneal use

Germany

| 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

solution for peritoneal dialysis

intraperitoneal use

Germany

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

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Nutrineal PD4 mit 1,1 % Aminosäuren

11,205 g / l

5,38 g / l

0,184 g / l

0,0508 g / l

4,48 g / l

solution for peritoneal dialysis

intraperitoneal use

Germany

| 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

solution for haemodialysis

hemodialysis

Germany

| 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

solution for haemodialysis

hemodialysis

Germany

| 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

solution for haemodialysis

hemodialysis

Greece

| DIOPHAR S.A. |
| --- |
| Kifissias Avenue 368, |
| Halandri, 152 33 |
| Greece |

DIOPHAR S.A.

Kifissias Avenue 368,

Halandri, 152 33

Greece

DIANEAL PD1

1,36% W/V

2,27% W/V

3,86% W/V

solution for peritoneal dialysis

Intraperitoneal use

Greece

| DIOPHAR S.A. |
| --- |
| Kifissias Avenue 368, |
| 152 33 Halandri, |
| Greece |

DIOPHAR S.A.

Kifissias Avenue 368,

152 33 Halandri,

Greece

DIANEAL PD4

1,36%

2,27% W/V

3,86% W/V

solution for peritoneal dialysis

intraperitoneal use

Greece

| DIOPHAR S.A. |
| --- |
| Kifissias Avenue 368, |
| 152 33 Halandri, |
| Greece |

DIOPHAR S.A.

Kifissias Avenue 368,

152 33 Halandri,

Greece

EXTRANEAL

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

solution for peritoneal dialysis

intraperitoneal use

Greece

| DIOPHAR S.A. |
| --- |
| Kifissias Avenue 368, |
| 152 33 Halandri, |
| Greece |

DIOPHAR S.A.

Kifissias Avenue 368,

152 33 Halandri,

Greece

Nutrineal PD4

1,1%

solution for peritoneal dialysis

intraperitoneal use

Hungary

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

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

EXTRANEAL peritoneális dializáló oldat

7,5% (icodextrin)

solution for peritoneal dialysis

intraperitoneal use

Hungary

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

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 1 Glucose 1,36% peritoneális dializáló oldat

1,36%

solution for peritoneal dialysis

intraperitoneal use

Hungary

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

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 1 Glucose 2,27% peritoneális dializáló oldat

2,27%

solution for peritoneal dialysis

intraperitoneal use

Hungary

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

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 1 Glucose 3,86% peritoneális dializáló oldat

3,86%

solution for peritoneal dialysis

intraperitoneal use

Hungary

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

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 1,36% peritoneális dializáló oldat

1,36%

solution for peritoneal dialysis

intraperitoneal use

Hungary

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

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 2,27% peritoneális dializáló oldat

2,27%

solution for peritoneal dialysis

intraperitoneal use

Hungary

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

Baxter Hungary Kft.

Népfürdő u. 22.

1138, Budapest

Hungary

DIANEAL PD 4 Glucose 3,86% peritoneális dializáló oldat

3,86%

solution for peritoneal dialysis

intraperitoneal use

Iceland

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

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

13,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Iceland

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

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

22,7 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Iceland

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

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 Glucose

38,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Ireland

| 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

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

solution for haemodialysis, haemodiafiltration and haemofiltration

hemodialysis

Ireland

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

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

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

solution for haemodialysis, haemodiafiltration and haemofiltration

hemodialysis

Ireland

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE,

United Kingdom

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

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

solution for haemodialysis, haemodiafiltration and haemofiltration

hemodialysis

Ireland

| 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 (13,6mg/ml) Solution for Peritoneal Dialysis

1,36% w/v

solution for peritoneal dialysis

intraperitoneal use

Ireland

| 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)

solution for peritoneal dialysis

intraperitoneal use

Ireland

| 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)

solution for peritoneal dialysis

intraperitoneal use

Ireland

| 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)

solution for peritoneal dialysis

intraperitoneal use

Ireland

| 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)

solution for peritoneal dialysis

intraperitoneal use

Ireland

| 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)

solution for peritoneal dialysis

intraperitoneal use

Ireland

| 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

solution for peritoneal dialysis

intraperitoneal use

Ireland

| 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

solution for peritoneal dialysis

intraperitoneal use

Italy

| Baxter SPA |
| --- |
| piazzale dell' industria 20 - |
| 00144 Roma, |
| Italy |

Baxter SPA

piazzale dell' industria 20 -

00144 Roma,

Italy

EXTRANEAL

7,5%

solution for dialysis peritoneal

intraperitoneal use

Italy

| Baxter SPA |
| --- |
| piazzale dell' industria 20 – |
| 00144 Roma, |
| Italy |

Baxter SPA

piazzale dell' industria 20 –

00144 Roma,

Italy

NUTRINEAL PD4

1,1%

solution for dialysis peritoneal

intraperitoneal use

Italy

| Baxter SPA |
| --- |
| piazzale dell' industria 20 – |
| 00144 Roma, |
| Italy |

Baxter SPA

piazzale dell' industria 20 –

00144 Roma,

Italy

SOLUZIONI PER DIALISI PERITONEALE BAXTER

4,95 g/l - 49,54 g/l;

solution for dialysis peritoneal

intraperitoneal use

Latvia

| Baxter Oy |
| --- |
| Valimotie 15 A |
| 00381 Helsinki |
| Finland |

Baxter Oy

Valimotie 15 A

00381 Helsinki

Finland

Extraneal solution for peritoneal dialysis

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

solution for peritoneal dialysis

intraperitoneal use

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

solution for peritoneal dialysis

intraperitoneal use

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

solution for peritoneal dialysis

intraperitoneal use

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

solution for peritoneal dialysis

intraperitoneal use

Lithuania

| 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

solution for peritoneal dialysis

intraperitoneal use

Lithuania

| 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

solution for peritoneal dialysis

intraperitoneal use

Lithuania

| 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

solution for peritoneal dialysis

intraperitoneal use

Lithuania

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

Baxter Oy,

P.O. Box 270

Valimotie 15A

00381 Helsinki

Finland

EXTRANEAL

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

solution for peritoneal dialysis

intraperitoneal use

Luxembourg

| Baxter SA, |
| --- |
| Bd René Branquart 80, |
| B-7860 Lessines |
| Belgium |

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Nutrineal PD4+A.A.1,1%

1,1% amino acids

solution for peritoneal dialysis

intraperitoneal use

Luxembourg

| Baxter SA, |
| --- |
| Bd René Branquart 80, |
| B-7860 Lessines |
| Belgium |

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Dianeal PD1 Glucose

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

solution for peritoneal dialysis

intraperitoneal use

Luxembourg

| Baxter SA, |
| --- |
| Bd René Branquart 80, |
| B-7860 Lessines |
| Belgium |

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Dianeal PD4 Glucose

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

solution for peritoneal dialysis

intraperitoneal use

Luxembourg

| Baxter SA, |
| --- |
| Bd René Branquart 80, |
| B-7860 Lessines |
| Belgium |

Baxter SA,

Bd René Branquart 80,

B-7860 Lessines

Belgium

Extraneal

75,00 g/l Icodextrine

solution for peritoneal dialysis

intraperitoneal use

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%)

Icodextrin (75 g/l), Sodium chloride (5,4 g/l),

Calcium chloride (0,257 g/l), Magnesium chloride

(0,051 g/l), Sodium lactate solution (4,5 g/l)

solution for peritoneal dialysis

intraperitoneal use

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

L-Tyrosine 0,300 g/l

L-Tryptophan 0,270 g/l

L-Phenylalanine 0,570 g/l

L-Threonine 0,646 g/l

L-Serine 0,510 g/l

L-Proline 0,595 g/l

Glycine 0,510 g/l

L-Alanine 0,951 g/l

L-Valine 1,393 g/l

L-Methionine 0,850 g/l

L-Isoleucine 0,850 g/l

L-Leucine 1,020 g/l

L-Lysine (chlorhydrate) 0,955 g/l

L-Histidine 0,714 g/l

L-Arginine 1,071 g/l

Calcium chloride dihydrate 0,184 g/l

Magnesium chloride hexahydrate 0,051 g/l

Sodium Lactate 4,48 g/l

Sodium Chloride 5,38 g/l

Quantitative Composition of Sodium Lactate

Lactic Acid 139 g

Sodium Hydroxide 52,25 g

Water for Injections to 100 ml

solution for peritoneal dialysis

intraperitoneal use

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

Anhydrous Glucose Ph.Eur. 1,36 % w/v

or Glucose Monohydrate Ph.Eur. 1,50 % w/v

Sodium Chloride Ph.Eur. 0,57 % w/v

Sodium Lactate Ph.Eur. 0,39 % w/v

Calcium Chloride Ph.Eur. 0,0257 % w/v

Magnesium Chloride Ph.Eur. 0,0152 % w/v

solution for peritoneal dialysis

intraperitoneal use

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

Anhydrous Glucose Ph.Eur. 2,27 % w/v

or Glucose Monohydrate Ph.Eur. 2,50 % w/v

Sodium Chloride Ph.Eur. 0,57 % w/v

Sodium Lactate Ph.Eur. 0,39 % w/v

Calcium Chloride Ph.Eur. 0,0257 % w/v

Magnesium Chloride Ph.Eur. 0,0152 % w/v

solution for peritoneal dialysis

intraperitoneal use

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

Anhydrous Glucose Ph.Eur. 3,86 % w/v

or Glucose Monohydrate Ph.Eur. 4,25 % w/v

Sodium Chloride Ph.Eur. 0,57 % w/v

Sodium Lactate Ph.Eur. 0,39 % w/v

Calcium Chloride Ph.Eur. 0,0257 % w/v

Magnesium Chloride Ph.Eur. 0,0152 % w/v

solution for peritoneal dialysis

intraperitoneal use

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

Anhydrous Glucose Ph.Eur. 1,36 % w/v

or Glucose Monohydrate Ph.Eur. 1,50 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

solution for peritoneal dialysis

intraperitoneal use

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

Anhydrous Glucose Ph.Eur. 2,27 % w/v

or Glucose Monohydrate Ph.Eur. 2,50 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

solution for peritoneal dialysis

intraperitoneal use

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

Anhydrous Glucose Ph.Eur. 3,86 % w/v

or Glucose Monohydrate Ph.Eur. 4,25 % w/v

Sodium Chloride Ph.Eur. 0,538 % w/v

Sodium Lactate Ph.Eur. 0,448 % w/v

Calcium Chloride Ph.Eur. 0,0184 % w/v

Magnesium Chloride Ph.Eur. 0,0051 % w/v

solution for peritoneal dialysis

intraperitoneal use

Malta

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE,

UK

Monosol

Glucose Monohydrate 1,1 g/l,

Sodium Chloride 6,43 g/l,

Calcium Chloride Dihydrate 0,257 g/l,

Magnesium Chloride Hexahydrate 0,152 g/l,

Sodium Lactate 3,36 g/l

solution for haemodialysis/haemofiltration

intraarterial use, intravenous use

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

Glucose Monohydrate 1,1 g/l,

Sodium Chloride 6,43 g/l,

Calcium Chloride Dihydrate 0,257 g/l,

Magnesium Chloride Hexahydrate 0,152 g/l,

Potassium Chloride 0,149 g/l,

Sodium Lactate 3,36 g/l

solution for haemodialysis/haemofiltration

intra-arterial use, intravenous use

Netherlands

| 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, peritoneaaldialysevloeistof

13,6 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| 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, peritoneaaldialysevloeistof

22,7 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| 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, peritoneaaldialysevloeistof

38,6 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| 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, peritoneaaldialysevloeistof

13,6 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| 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, peritoneaaldialysevloeistof

22,7 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| 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, peritoneaaldialysevloeistof

38,6 g/l glucose anhydrate

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| 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, peritoneaaldialysevloeistof

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

solution for peritoneal dialysis

intraperitoneal use

Netherlands

| 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 icodextrine

solution for peritoneal dialysis

intraperitoneal use

Norway

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

Baxter AS

Gjerdrumsvei 11

0484 Oslo

Norway

Natriumklorid Baxter 9 mg/ml

9 mg/ml

solution for infusion

intravenous use

Norway

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

Baxter AS

Gjerdrumsvei 11

0484 Oslo

Norway

Nutrineal PD4 amino Acids 1,1 %

1,10%

solution for peritoneal dialysis

intraperitoneal use

Norway

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

Baxter AS

Gjerdrumsvei 11

0484 Oslo

Norway

Extraneal

75 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Poland

| 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

15 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Poland

| 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

25 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Poland

| 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

42,5 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 2,57 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Poland

| 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

15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Poland

| 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

25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Poland

| 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

42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Poland

| 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

solution for peritoneal dialysis

intraperitoneal use

Poland

| 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)

1,071 mg/ml Arginine; 0,714 mg/ml Histine; 0,955 mg/ml Lysine hydrochloride; 1,02 mg/ml Leucine; 0,85 mg/ml Isoleucine; 0,85 mg/ml Methionine; 1,393 mg/ml Valine; 0,951 mg/ml Alanine; 0,51 mg/ml Glycine; 0,595 mg/ml Proline; 0,51 mg/ml Serine; 0,646 mg/ml Threonine; 0,57 mg/ml Phenylalanine; 0,27 mg/ml Tryptophan; 0,3 mg/ml Tyrosine; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 5,38 mg/ml Sodium Chloride; 4,48 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Portugal

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

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Extraneal

75 mg/ml Icodextrin; 5,4 mg/ml Sodium Chloride; 4,5 mg/ml Sodium (S) - lactate solution; 0,051 mg/ml Magnesium Chloride; 0,257 mg/ml Calcium Chloride

solution for peritoneal dialysis

intraperitoneal use

Portugal

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

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd1

42,5 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 2,57 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Portugal

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

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd1

25 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Portugal

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

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd1

15 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Hydroxide; 3,92 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Portugal

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

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Portugal

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

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Portugal

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

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Dianeal Pd4

15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Portugal

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

Baxter Médico-Farmacêutica, Lda.

Zona Industrial da Abrunheira –

Edifício 10 - Sintra Business Park,

2710-089 Sintra

Portugal

Nutrineal PD4

1,071 mg/ml Arginine; 0,714 mg/ml Histine; 0,955 mg/ml Lysine hydrochloride; 1,02 mg/ml Leucine; 0,85 mg/ml Isoleucine; 0,85 mg/ml Methionine; 1,393 mg/ml Valine; 0,951 mg/ml Alanine; 0,51 mg/ml Glycine; 0,595 mg/ml Proline; 0,51 mg/ml Serine; 0,646 mg/ml Threonine; 0,57 mg/ml Phenylalanine; 0,27 mg/ml Tryptophan; 0,3 mg/ml Tyrosine; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 5,38 mg/ml Sodium Chloride; 4,48 mg/ml Sodium Lactate

solution for peritoneal dialysis

intraperitoneal use

Romania

| BAXTER HEALTHCARE Ltd., |
| --- |
| Caxton Way, |
| Thetford, |
| Norfolk, |
| 1P24 3SE, Thetford, |
| United Kingdom |

BAXTER HEALTHCARE Ltd.,

Caxton Way,

Thetford,

Norfolk,

1P24 3SE, Thetford,

United Kingdom

EXTRANEAL

75 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Romania

| BAXTER HEALTHCARE S.A. |
| --- |
| Moneen Road, Castelbar, |
| County Mayo |
| Ireland |

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar,

County Mayo

Ireland

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

13,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Romania

| BAXTER HEALTHCARE S.A. |
| --- |
| Moneen Road, Castelbar, |
| County Mayo |
| Ireland |

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar,

County Mayo

Ireland

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

22,7 mg/ml

solution for peritoneal dialysis

Intraperitoneal use

Romania

| BAXTER HEALTHCARE S.A. |
| --- |
| Moneen Road, Castelbar, |
| County Mayo |
| Ireland |

BAXTER HEALTHCARE S.A.

Moneen Road, Castelbar,

County Mayo

Ireland

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

38,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

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%

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| 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

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| 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

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| 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

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| 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

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| 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

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| 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

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

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

Baxter Healthcare Ltd.

Caxton Way

Thetford

Norfolk

IP24 3SE

United Kingdom

EXTRANEAL

7,5%

solution for peritoneal dialysis

intraperitoneal use

Slovak Republic

| 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%

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo

75 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

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

11 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

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

13,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

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

22,7 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

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

38,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

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

13,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

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

22,7 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Slovenia

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

Baxter d.o.o.,

Zelezna cesta 18,

SI-1000 Ljubljana,

Slovenia

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

38,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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

75 g/l; 5,4 g/l; 4,5 g/l; 0,257 g/l; 0,051 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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

951 mg/l; 1 071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1 020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 270 mg/l; 300 mg/l; 393 mg/l; 5 380 mg/l; 184 mg/l; 51 mg/l; 4 480 mg/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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

951 mg/l; 1 071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1 020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 720 mg/l; 300 mg/l; 1 393 mg/l; 5 380 mg/l; 184 mg/l; 51 mg/l; 4 480 mg/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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% solución para diálisis peritoneal

15 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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 solución para diálisis peritoneal.

15 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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% solución para diálisis peritoneal

25,0 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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 solución para diálisis peritoneal

25,0 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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% solución para diálisis peritoneal

42,50 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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 solución para diálisis peritoneal

42,50 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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% solución para diálisis peritoneal

15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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 solución para diálisis peritoneal.

15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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% solución para diálisis peritoneal

25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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 solución para diálisis peritoneal

25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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% solución para diálisis peritoneal

42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

solution for peritoneal dialysis

intraperitoneal use

Spain

| 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 solución para diálisis peritoneal

42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l

solution for peritoneal dialysis

intraperitoneal use

Sweden

| 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

solution for infusion

intravenous use

Sweden

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

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 med glucos 13,6 mg/ml

13,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Sweden

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

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 med glucos 22,7 mg/ml

22,7 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Sweden

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

Baxter Healthare SA

Moneen Road Castlebar

County Mayo

Ireland

Dianeal PD4 med glucos 38,6 mg/ml

38,6 mg/ml

solution for peritoneal dialysis

intraperitoneal use

Sweden

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

Baxter Medical AB

Box 63

164 94 Kista

Sweden

Extraneal

7,5%

solution for peritoneal dialysis

intraperitoneal use

Sweden

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

Baxter Medical AB

Box 63

164 94 Kista

Sweden

Nutrineal PD4 1,1 % Aminosyror

1,10%

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

Monosol

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

solution for haemodialysis/haemofiltration

intraarterial use, intravenous use

United Kingdom

| 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

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

solution for haemodialysis/haemofiltration

intraarterial use, intravenous use

United Kingdom

| 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

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

solution for haemodialysis/haemofiltration

intraarterial use, intravenous use

United Kingdom

| 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 /13,6mg/ml

magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucose 1,36%w/v; sodium lactate 0,39%w/v; sodium chloride 0,57%w/v

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

| 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 /38,6mg/ml

magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucose 3,86%w/v; sodium lactate 0,39%w/v; sodium chloride 0,57%w/v

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

| 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 /22,7mg/ml

sodium chloride 0,57%w/v; glucose 2,27%w/v; magnesium chloride 0,015%w/v; sodium lactate 0,39%w/v; calcium chloride 0,026%w/v

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

| 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 /13,6mg/ml

magnesium chloride 0,005%w/v; glucose 1,36%w/v; sodium lactate 0,45%w/v; calcium chloride 0,018%w/v; sodium chloride 0,54%w/v

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

| 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 /22,7mg/ml

magnesium chloride 0,005%w/v; glucose 2,27%w/v; sodium lactate 0,45%w/v; calcium chloride 0,018%w/v; sodium chloride 0,54%w/v

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

| 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 /38,6mg/ml

magnesium chloride 0,005%w/v; glucose 3,86%w/v; sodium lactate 0,45%w/v; calcium chloride 0,018%w/v; sodium chloride 0,54%w/v

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

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

icodextrin 75g/l; sodium chloride 5,4g/l; calcium chloride 0,257g/l; magnesium chloride 0,051g/l; sodium s-lactate 4,5g/l

solution for peritoneal dialysis

intraperitoneal use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfolk

IP24 3SE

United Kingdom

Nutrineal PD4 with 1,1% Amino Acids

tyrosine 0,03%w/v; tryptophan 0,027%w/v; phenylalanine 0,057%w/v; threonine 0,064%w/v; L-serine 0,051%w/v; L-proline 0,058%w/v; glycine 0,.051%w/v; L-alanine 0,095%w/v; valine 0,139%w/v; methionine 0,085%w/v; isoleucine 0,085%w/v; leucine 0,102%w/v; lysine 0,095%w/v; histidine 0/071%w/v; arginine 0,107%w/v; calcium chloride 0,018%w/v; magnesium chloride 0,005%w/v; sodium chloride 0,538%w/v; sodium s-lactate 0,448%w/v

solution for peritoneal dialysis

intraperitoneal use

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ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing authorisation holder | Invented name | Strength | Pharmaceutical form | Animal species |
| --- | --- | --- | --- | --- | --- |
| Austria | LABORATORIOS HIPRA, S.A. |
| Avda. la Selva, 135 |
| 17170- AMER (Girona) |
| SPAIN |

Member State EU/EEA

Marketing authorisation holder

Invented name

Strength

Pharmaceutical form

Animal species

Austria

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS -

Emulsion zur Injektion für Rinder

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Belgium

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Czech Republic

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Injekční emulze pro skot

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Denmark

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

France

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS EMULSION INJECTABLE POUR BOVINS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Germany

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Greece

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Hungary

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

vakcina A.U.V.

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Ireland

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Emulsion for injection for cattle

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Italy

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Emulsion for injection for cattle

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Poland

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

emulsja do wstrzykiwań dla bydła

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Portugal

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Emulsão para injecção para bovinos

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Slovak Republic

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

injekčná emulzia pre dobytok

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

Spain

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

The Netherlands

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

United Kingdom

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

LABORATORIOS HIPRA, S.A.

Avda. la Selva, 135

17170- AMER (Girona)

SPAIN

HIPRABOVIS PNEUMOS

Emulsion for Injection for Cattle

Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain

Emulsion for injection

Cattle from 2 months of age

---