# Official Journal C 121/2013

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2013.121.eng |
| --- | --- |
| Official Journal
  of the European Union | C 121 |
| | |
| English edition | Information and Notices | Volume 5626 April 2013 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2013.121.eng

Official Journal

of the European Union

C 121

English edition

Information and Notices

Volume 5626 April 2013

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2013/C 121/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2013/C 121/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2013 to 31 March 2013(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 2 |
| 2013/C 121/03 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2013 to 31 March 2013(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 8 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2013/C 121/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013(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

2013/C 121/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2013 to 31 March 2013(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

)

2

2013/C 121/03

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2013 to 31 March 2013(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)

8

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 26.4.2013 | EN | Official Journal of the European Union | C 121/1 |
| --- | --- | --- | --- |

26.4.2013

EN

Official Journal of the European Union

C 121/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 2013

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

2013/C 121/01

—   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 |
| --- | --- | --- | --- | --- |
| 8.2.2013 | Novem | Boehringer Ingelheim Vetmedica GmbH |
| D-55216 Ingelheim am Rhein, Deutschland |

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

8.2.2013

Novem

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/04/042

12.3.2013

---

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

---

| 26.4.2013 | EN | Official Journal of the European Union | C 121/2 |
| --- | --- | --- | --- |

26.4.2013

EN

Official Journal of the European Union

C 121/2

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2013 to 31 March 2013

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

2013/C 121/02

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.3.2013 | Perjeta | pertuzumab | Roche Registration Limited |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

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

4.3.2013

Perjeta

pertuzumab

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/13/813

Concentrate for solution for infusion

L01XC13

6.3.2013

13.3.2013

Actelsar HCT

telmisartan/hydrochlorothiazide

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

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/13/817

Tablet

C09DA07

15.3.2013

13.3.2013

JETREA

OCRIPLASMIN

| ThromboGenics NV |
| --- |
| Gaston Geenslaan 1, B-3001 Leuven, België |

ThromboGenics NV

Gaston Geenslaan 1, B-3001 Leuven, België

EU/1/13/819

Concentrate for solution for injection

Pending

15.3.2013

13.3.2013

Tolucombi

telmisartan/hydrochlorothiazide

| 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/1/13/821

Tablet

C09DA07

15.3.2013

22.3.2013

Bexsero

Meningococcal group B Vaccine (rDNA, component, adsorbed)

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, 53100 Siena, Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

Suspension for injection

J07AH09

26.3.2013

27.3.2013

Bosulif

Bosutinib

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

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/13/818

Film-coated tablet

L01XE14

2.4.2013

—   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 |
| --- | --- | --- | --- | --- |
| 6.3.2013 | Byetta | Bristol-Myers Squibb/AstraZeneca EEIG |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, 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

6.3.2013

Byetta

Bristol-Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/06/362

8.3.2013

6.3.2013

Intelence

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/468

8.3.2013

6.3.2013

Ozurdex

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

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/10/638

8.3.2013

6.3.2013

Ranexa

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

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/08/462

8.3.2013

11.3.2013

Champix

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

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/06/360

13.3.2013

11.3.2013

Qutenza

| Astellas Pharma Europe B.V. |
| --- |
| Sylviusweg 62, NL-2333 BE Leiden, Nederland |

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/09/524

13.3.2013

11.3.2013

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

13.3.2013

13.3.2013

BYDUREON

| 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/1/11/696

15.3.2013

13.3.2013

Efficib

| 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/1/08/457

15.3.2013

13.3.2013

Firazyr

| Shire Orphan Therapies GmbH |
| --- |
| Friedrichstrasse 149, D-10117 Berlin, Deutschland |

Shire Orphan Therapies GmbH

Friedrichstrasse 149, D-10117 Berlin, Deutschland

EU/1/08/461

15.3.2013

13.3.2013

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

15.3.2013

13.3.2013

Ganfort

| Allergan Pharmaceuticals Ireland, (514125) |
| --- |
| Castlebar Road, Westport, County Mayo, Ireland |

Allergan Pharmaceuticals Ireland, (514125)

Castlebar Road, Westport, County Mayo, Ireland

EU/1/06/340

15.3.2013

13.3.2013

Iscover

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/070

15.3.2013

13.3.2013

Janumet

| 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/1/08/455

15.3.2013

13.3.2013

Optimark

| Mallinckrodt Deutschland GmbH |
| --- |
| Josef-Dietzgen-Strasse 1, 53773 Hennef, Deutschland |

Mallinckrodt Deutschland GmbH

Josef-Dietzgen-Strasse 1, 53773 Hennef, Deutschland

EU/1/07/398

15.3.2013

13.3.2013

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

15.3.2013

13.3.2013

Privigen

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland |

CSL Behring GmbH

Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland

EU/1/08/446

15.3.2013

13.3.2013

Velmetia

| 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/1/08/456

15.3.2013

13.3.2013

Vidaza

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

Celgene Europe Limited

1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom

EU/1/08/488

15.3.2013

22.3.2013

Daliresp

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

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/11/668

26.3.2013

22.3.2013

DaTSCAN

| GE Healthcare Limited |
| --- |
| Little Chalfont, Bucks HP7 9NA, United Kingdom |

GE Healthcare Limited

Little Chalfont, Bucks HP7 9NA, United Kingdom

EU/1/00/135

26.3.2013

22.3.2013

Daxas

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

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/10/636

26.3.2013

22.3.2013

Emend

| 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/1/03/262

26.3.2013

22.3.2013

Ivemend

| 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/1/07/437

26.3.2013

22.3.2013

Libertek

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

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/11/666

26.3.2013

22.3.2013

Pixuvri

| CTI Life Sciences Ltd |
| --- |
| Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom |

CTI Life Sciences Ltd

Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom

EU/1/12/764

26.3.2013

26.3.2013

Combivir

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

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/98/058

28.3.2013

26.3.2013

Daliresp

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

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/11/668

28.3.2013

26.3.2013

Daxas

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

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/10/636

28.3.2013

26.3.2013

Epivir

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

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/96/015

28.3.2013

26.3.2013

Kivexa

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

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/04/298

28.3.2013

26.3.2013

Libertek

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

Takeda GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/11/666

28.3.2012

26.3.2013

Privigen

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland |

CSL Behring GmbH

Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland

EU/1/08/446

28.3.2013

26.3.2013

Telzir

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

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/04/282

28.3.2013

26.3.2013

Trizivir

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

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/00/156

28.3.2013

26.3.2013

Ziagen

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

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/99/112

28.3.2013

27.3.2013

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

29.3.2013

—   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 |
| --- | --- | --- | --- | --- |
| 27.3.2013 | Bondenza | Roche Registration Limited |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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

27.3.2013

Bondenza

Roche Registration Limited

6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/03/266

2.4.2013

27.3.2013

Possia

| AstraZeneca AB |
| --- |
| SE-151 85 Södertälje, Sverige |

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/10/656

2.4.2013

—   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 |
| --- | --- | --- | --- | --- |
| 22.3.2013 | Pelzont | Merck Sharp & Dohme Limited |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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

22.3.2013

Pelzont

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/460

26.3.2013

22.3.2013

Tredaptive

| 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/1/08/459

26.3.2013

22.3.2013

Trevaclyn

| 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/1/08/458

26.3.2013

—   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 |
| --- | --- | --- | --- | --- |
| 6.3.2013 | Loxicom | Norbrook Laboratories Ltd |
| Station Works, Newry, Co. Down, BT35 6JP, United Kindgom |

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

6.3.2013

Loxicom

Norbrook Laboratories Ltd

Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

EU/2/08/090

8.3.2013

6.3.2013

ProteqFlu

| Merial |
| --- |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/03/037

8.3.2013

6.3.2013

ProteqFlu-Te

| Merial |
| --- |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/03/038

8.3.2013

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.

---

| 26.4.2013 | EN | Official Journal of the European Union | C 121/8 |
| --- | --- | --- | --- |

26.4.2013

EN

Official Journal of the European Union

C 121/8

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2013 to 31 March 2013

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

2013/C 121/03

—   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 |
| --- | --- | --- | --- | --- |
| 15.3.2013 | Fibrinogen | See Annex I | See Annex I | 19.3.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

15.3.2013

Fibrinogen

See Annex I

See Annex I

19.3.2013

---

(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

Artiss and associated names; Tisseel and associated names; Tissucol and associated names

| Member State
  (in EEA) | Marketing Authorisation Holder | Invented name Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Baxter AG |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Member State

(in EEA)

Marketing Authorisation Holder

Invented name Name

Strength

Pharmaceutical Form

Route of administration

Austria

Baxter AG

Industriestraße 67

1221 Vienna

Austria

ARTISS – Lösungen für einen Gewebekleber

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Austria

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

ARTISS LYO – Pulver und Lösungsmittel für einen Gewebekleber

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIE/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Austria

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tisseel - Lösungen für einen Gewebekleber

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Austria

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tisseel Lyo - Pulver und Lösungsmittel für einen Gewebekleber

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Belgium

| Baxter SA |
| --- |
| Boulevard René |
| Branquart 80 |
| 7860 Lessines |
| Belgium |

Baxter SA

Boulevard René

Branquart 80

7860 Lessines

Belgium

Artiss

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Belgium

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tissucol Duo 500

Syringe TISSUCOL-APROTININ:

Total Proteins 100-130 mg/ml;

clottable protein 75-115 mg/ml,

of which fibrinogen 70-110 mg/ml and

plasmatic fibronectin 2-9 mg/ml:

Factor XIII 10-50 UI/ml;

Plasminogen 0,04-0,12 mg/ml;

Aprotinin 3 000 UIK/ml (1,67 UPE/ml);

Syringe THROMBIN-CALCIUM CHLORIDE:

Proteins 50 mg/ml;

Thrombin 500 UI/ml;

calcium chloride 40 μmol/ml

Solution for sealant

Epilesional use

Belgium

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tissucol Kit

Bottle 1: Total Proteins 100-130 mg/ml;

dont clottable protein 75-115 mg/ml,

Factor XIII 10-50 UI/ml;

Plasminogen 0,04-0,12 mg/ml;

Bottle 2: Aprotinin bovine 3 000 UIK/ml (1,67 UPE/ml);

Bottle 3: Human Thrombin 500 IU/ml;

Proteins 50 mg/ml;

Bottle 4: Human Thrombin 4 UI/ml;

Proteins 50 mg/ml;

Bottle 5: calcium chloride 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Belgium

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tissucol S/D

Human fibrinogen (clottable protein): 72-110 mg/ml

Factor XIII ≤ 10 UI/ml

Aprotinin: 3 000 UIK/ml

Human Thrombin: 500 UI/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Belgium

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tissucol S/D Kit

Human fibrinogen (clottable protein): 72-110 mg/ml

Factor XIII ≤ 10 UI/ml

Aprotinin: 3 000 UIK/ml

Human Thrombin: 500 UI/ml

Calcium chloride: 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Bulgaria

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

Baxter d.o.o.

Zelezna cesta 18

1000 Ljubljana

Slovenia

Artiss solution for sealant frozen

Human fibrinogen 91 mg/ml

Aprotinin 3 000 KIU/ml

Human Thrombin 4 IU/ml

Calcium Chloride 40 μmol/ml

Solution for sealant

Epilesional use

Bulgaria

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

Baxter d.o.o.

Zelezna cesta 18

1000 Ljubljana

Slovenia

Tisseel Lyo powders and solvents for sealant

Human fibrinogen 91 mg/ml

Aprotinin 3 000 KIU/ml

Human Thrombin 4 IU/ml

Calcium Chloride 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Bulgaria

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

Baxter d.o.o.

Zelezna cesta 18

1000 Ljubljana

Slovenia

Tisseel solutions for sealant

Human fibrinogen 72-110 mg/ml

Aprotinin 3 000 KIU/ml

Human Thrombin 500 IU/ml

Calcium Chloride 40 μmol/ml

Solution for sealant

Epilesional use

Czech Republic

| Baxter Czech spol. s r.o. |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |
| Czech Republic |

Baxter Czech spol. s r.o.

Karla Engliše 3201/6

150 00 Praha 5

Czech Republic

Artiss

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Czech Republic

| Baxter Czech spol. s r.o. |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |
| Czech Republic |

Baxter Czech spol. s r.o.

Karla Engliše 3201/6

150 00 Praha 5

Czech Republic

Tisseel

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Czech Republic

| Baxter Czech spol. s r.o. |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |
| Czech Republic |

Baxter Czech spol. s r.o.

Karla Engliše 3201/6

150 00 Praha 5

Czech Republic

Tisseel Lyo

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Denmark

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

Baxter A/S

Gydevang 43

DK-3450 Allerød

Denmark

Artiss

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Intralesional use

Denmark

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tisseel Duo Quick

Fibrinogen 90 mg/ml

Fibronectin 6 mg/ml

Aprotinin 3 000 KIE/ml

Coagulation Factor XIII 30 IE/ml

Plasminogen 80 μg/ml

Thrombin human 500 IE/ml

Calcium Chloride Dihydrate 40 μg/ml

Solution for sealant

Intralesional use

Denmark

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

Baxter A/S

Gydevang 43

DK-3450 Allerød

Denmark

Tissel

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Intralesional use

Finland

| Baxter Oy, |
| --- |
| PL 119, |
| 00181 Helsinki |
| Finland |

Baxter Oy,

PL 119,

00181 Helsinki

Finland

Artiss

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Topical

Finland

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tisseel

Fibrinogen 72-110 mg/ml

Factor XIII coagulationis humanus 10 IU/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Topical

Finland

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tisseel duo quick

Plasmaproteinum humanum 100-130 mg/ml: Fibrinogen 90 mg/ml

Plasmafibrinonectinum 5,5 mg/ml

Factor XIII coagulationis humanus 30 IU/ml

Aprotinin 1,67 Ph.Eur.U./ml

Coagulation Factor XIII 30IE/ml

Plasminogen 80 μg/ml

Thrombin human 500 IE/ml plasmaproteinum humanum 50 mg/ml

Calcium Chloride Dihydrate 40 μg/ml

Solution for sealant

Topical

France

| BAXTER SAS |
| --- |
| 6 Avenue Louis Pasteur |
| 78310 MAUREPAS |
| FRANCE |

BAXTER SAS

6 Avenue Louis Pasteur

78310 MAUREPAS

FRANCE

ARTISS solution for sealant

Fibrinogen 91 mg/ml

Aprotinin: 3 000 KIE/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

France

| BAXTER SAS |
| --- |
| 6 Avenue Louis Pasteur |
| 78310 MAUREPAS |
| FRANCE |

BAXTER SAS

6 Avenue Louis Pasteur

78310 MAUREPAS

FRANCE

TISSUCOL KIT

1st Component:

Fibrinogen human 90,00 mg/ml

Factor XIII: 10,00 UI/ml

Fibronectin: 5,50 mg/ml

Plasminogen: 0,08 mg/ml

Aprotinin 3 000,0 UIK***/ml

2nd Component:

Thrombin 500 UI/ml

Powder, solution and solvent for sealant

Epilesional use

Germany

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

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Artiss

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Germany

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

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Tissucol-Duo S

0,5 ml/1 ml/2 ml Immuno

Component 1

Fibrinogen: 70-110 mg/ml

Coagulation factor XIII: 10-50 I.E./ml

Plasmafibronectin: 2-9 mg/ml

Aprotinin (bovin): 3 000 KIE/ml

Component 2

Thrombin (human) 500 I.E./ml

Calcium chloride: 5,88 mg/ml

Powder and solvent for sealant

Epilesional use

Germany

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

Baxter Deutschland GmbH

Edisonstr. 4

D-85716 Unterschleißheim

Germany

Tissucol-Kit 1,0/2,0/5,0 Immuno

Component 1: Fibrinogen: 70 - 110 mg/ml

Plasmafibronectin: 2 - 9 mg/ml

Coagulation factor XIII: 10 - 50 I.E/ml

Aprotininsolution: 3 000 KIE/ml

Component 2:

Thrombin S lyophilized: 500 I.E/ml Thrombin L lyophilized: 4 I.E/ml Calcium chloride: 5,88 mg/ml

Powder and solvent for sealant

Epilesional use

Greece

| BAXTER HELLAS LTD |
| --- |
| 3 Metsovou str, |
| 14121-N Irakleio, |
| Athens |
| Greece |

BAXTER HELLAS LTD

3 Metsovou str,

14121-N Irakleio,

Athens

Greece

ARTISS

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Greece

| BAXTER HELLAS LTD |
| --- |
| 3 Metsovou str, |
| 14121-N Irakleio, |
| Athens |
| Greece |

BAXTER HELLAS LTD

3 Metsovou str,

14121-N Irakleio,

Athens

Greece

TISSEEL

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Greece

| BAXTER HELLAS LTD |
| --- |
| 3 Metsovou str, |
| 14121-N Irakleio, |
| Athens |
| Greece |

BAXTER HELLAS LTD

3 Metsovou str,

14121-N Irakleio,

Athens

Greece

TISSEEL LYO

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Hungary

| Baxter Hungary Kft. |
| --- |
| Népfürdő u. 22. IX. em. |
| 1138 Budapest |
| Hungary |

Baxter Hungary Kft.

Népfürdő u. 22. IX. em.

1138 Budapest

Hungary

TISSEEL LYO por és oldószer szövetragasztóhoz

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Hungary

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

TISSUCOL Kit 1,0 kétkomponensű fibrinragasztó

1st Component:

Total Protein 100-130 mg;

Clottable protein: 75-115 mg, thereof Fibrinogen 70-110 mg;

Plasma Fibronectin 2-9 mg;

Factor XIII 10-50 UI;

Plasminogen 0,04-0,12 mg;

Aprotinin 3 000 KIU;

2nd Component:

Thrombin 500 IU or Thrombin 4 UI;

Calcium Chlorid Dihydrate 5,88 mg

Powder and solvent for sealant

Epilesional use

Hungary

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

TISSUCOL Kit 2,0 kétkomponensű fibrinragasztó

1st Component:

Total Protein 200-260 mg;

Clottable protein: 150-230 mg, thereof Fibrinogen 140-220 mg;

Plasma Fibronectin 4-18 mg;

Factor XIII 20-100 UI;

Plasminogen 0,08-0,24 mg;

Aprotinin 6 000 KIU;

2nd Component:

Thrombin 1 000 IU or Thrombin 8 UI;

Calcium Chlorid Dihydrate 11,76 mg

Powder and solvent for sealant

Epilesional use

Hungary

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

TISSUCOL Kit 5,0 kétkomponensű fibrinragasztó

1st Component:

Total Protein 500-650 mg;

Clottable protein: 375-575 mg, thereof Fibrinogen 350-550 mg;

Plasma Fibronectin 10-45 mg;

Factor XIII 50-250 UI;

Plasminogen 0,2-0,6 mg;

Aprotinin 15 000 KIU;

2nd Component:

Thrombin 2 500 IU or Thrombin 20 UI;

Calcium Chlorid Dihydrate 29,4 mg

Powder and solvent for sealant

Epilesional use

Iceland

| Baxter Medical AB, Isafjordstgatan 30B |
| --- |
| P.O. Box 63 |
| 164 94 Kista, |
| Sweden |

Baxter Medical AB, Isafjordstgatan 30B

P.O. Box 63

164 94 Kista,

Sweden

Artiss

Human Fibrinogen 91 mg/ml

Aprotinum INN 3 000 KIU/ml (bovine)

Human Thrombin 4 ae^3/ml

Calcium Chloride 40 micromol/ml

Solution for sealant

Epilesional use

Iceland

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

TISSEEL

Human Fibrinogen 91 gm/ml

Human Factor XIII 10 IU/ml

Bovine Aprotinin 3 000 IU/ml

Human Thrombin 500 IU/ml

Calcium Chloride 40 micromol/ml

Solution for sealant

Epilesional use

Iceland

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tisseel Duo Quick

Tisseel solution Per ml -

Fibrinogen 90 mg

Fibronectin 5,5 mg

Factor XIII 30 a.e

Aprotinin (bovel) 3 000 KIU

Plasminogen 80 microgram

Thrombin solution per ml

Human thrombin 500 ae

Calcium chloridum 40 micromol

Solution for sealant

Epilesional use

Ireland

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfork

IP24 3SE,

United Kingdom

Artiss solutions for sealant, deep frozen

Human Fibrinogen: 72-110 mg/ml

Aprotinin: 3 000 KIU/ml

Human Thrombin: 4 IU/ml

Calcium Chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Ireland

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfork

IP24 3SE,

United Kingdom

Tiseel Ready to use Solutions for Sealant

Human Fibrinogen: 72/110 mg/ml

Aprotinin: 3 000 KIU/ml

Human Thrombin: 500 IU/ml

Calcium Chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Ireland

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfork

IP24 3SE,

United Kingdom

TISSEEL Lyo

Human Fibrinogen: 72/110 mg/ml

Aprotinin: 3 000 KIU/ml

Human Thrombin: 500 IU/ml

Calcium Chloride: 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Italy

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

Baxter S.p.A.

Piazzale dell'Industria, 20

00144 Roma

Italy

ARTISS

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium Chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Italy

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

TISSEEL

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU

Thrombin: 500 UI/ML

Calcium Chloride: 40 MMO LI/L

Factor XIII ≤ 10 UI/ml

Solution for sealant

Epilesional use

Luxembourg

| Baxter SA |
| --- |
| Boulevard René |
| Branquart 80 |
| 7860 Lessines |
| Belgium |

Baxter SA

Boulevard René

Branquart 80

7860 Lessines

Belgium

Artiss

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Luxembourg

| Baxter AG |
| --- |
| Industriestraße 67 |
| 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

1221 Vienna

Austria

Tissucol S/D Kit

Fibrinogene humain (proteines coagulables) 72-110 mg/ml

Facteur XIII ≤ 10 UI/ml

Aprotinine 3 000 UIK/ml

Thrombine humaine 500 UI/ml

Chlorure de calcium 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Malta

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfork IP24 3SE,

United Kingdom

TISSEEL KIT 2,0 ml, Two-Component Fibrin Sealant

Fibrinogen: 70-110 mg/ml

Plasmafibronectin (CIG): 2-9 mg/ml

Factor XIII: 10-50 U/ml

Plasminogen: 0,04 - 0,12 mg/ml

Powder and solvent for sealant

Cutaneous Use

Malta

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfork IP24 3SE,

United Kingdom

TISSEEL Lyo, Two-Component Fibrin Sealant

Fibrinogen: 72-110 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml in 45-55 mg total protein

Calcium chloride: 40 μmol/ml

Powder and solvent for sealant

Cutaneous Use

Norway

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

Baxter AS,

Gjerdrumsvei 11,

0484 Oslo,

Norway

Artiss

Human Fibrinogen: 91 mg1/ml

Aprotinin: 3 000 KIU2/ml

Human Thrombin: 4 IU3/ml

Calcium Chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Norway

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

Baxter AS,

Gjerdrumsvei 11,

0484 Oslo,

Norway

Tisseel

Human Fibrinogen: 91 mg1/ml

Aprotinin: 3 000 KIU2/ml

Human Thrombin: 500 IU3/ml

Calcium Chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Norway

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

Baxter AS,

Gjerdrumsvei 11,

0484 Oslo,

Norway

Tisseel

Human Fibrinogen: 91 mg1/ml

Aprotinin: 3 000 KIU2/ml

Human Thrombin: 500 IU3/ml

Calcium Chloride: 40 μmol/ml

Powder and solvent for sealant

Epilesional use

Poland

| Baxter Polska Sp. z o.o. |
| --- |
| ul. Kruczkowskiego 8 |
| 00-380 Warzawa |
| Poland |

Baxter Polska Sp. z o.o.

ul. Kruczkowskiego 8

00-380 Warzawa

Poland

Artiss

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Poland

| Baxter Polska Sp. z o.o. |
| --- |
| ul. Kruczkowskiego 8 |
| 00-380 Warzawa |
| Poland |

Baxter Polska Sp. z o.o.

ul. Kruczkowskiego 8

00-380 Warzawa

Poland

Tisseel

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Poland

| Baxter Polska Sp. z o.o. |
| --- |
| ul. Kruczkowskiego 8 |
| 00-380 Warzawa |
| Poland |

Baxter Polska Sp. z o.o.

ul. Kruczkowskiego 8

00-380 Warzawa

Poland

Tisseel Lyo

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Powder and solvent for sealant

Epilesional 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

Artiss

Human fibrinogen: 91 mg/ml

Aprotinin: 3 000 KUI2/ml

Human thrombin: 4 UI3/ml

Calcium chloride: 40 mmol/ml

Solvent for sealant

Epilesional 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

Tisseel

Human fibrinogen: 72-110 mg/ml

Factor xiii: ≤ 10 UI

Aprotinin: 3 000 KU12/ml

Human thrombin: 500 UI3/ml

Calcium chloride: 40 micromol/ml

Sealant

Epilesional 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

Tisseellyo

Human fibrinogen (72-110 mg/ml)

Factor xiii (≤ 10 UI)

Aprotinin (3 000 KUI2/ml)

Human thrombin (500 UI3/ml)

Calcium chloride (40 micromol/ml)

Powder and solvent for sealant

Epilesional use

Spain

| BAXTER, S.L. |
| --- |
| Polígono Industrial Sector 14 |
| Pouet de Camilo, 246394 |
| Ribarroja del |
| Turia Valencia |
| Spain |

BAXTER, S.L.

Polígono Industrial Sector 14

Pouet de Camilo, 246394

Ribarroja del

Turia Valencia

Spain

ARTISS soluciones para adhesivo tisular Ultracongeladas

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Intralesional use

Spain

| BAXTER, S.L. |
| --- |
| Polígono Industrial Sector 14 |
| Pouet de Camilo, 2 46394 |
| Ribarroja del |
| Turia Valencia |
| Spain |

BAXTER, S.L.

Polígono Industrial Sector 14

Pouet de Camilo, 2 46394

Ribarroja del

Turia Valencia

Spain

TISSUCOL DUO 2,0 ml

Syringe TISSUCOL-APROTININ:

Total Proteins 100-130 mg/ml;

clottable protein 75-115 mg/ml,

of which fibrinogen 70-110 mg/ml and

plasmatic fibronectin 2-9 mg/ml:

Factor XIII 10-50 UI/ml;

Plasminogen 0,04-0,12 mg/ml;

Aprotinin 3 000 UIK/ml (1,67 UPE/ml);

Syringe THROMBIN-CALCIUM CHLORIDE:

Proteins 50 mg/ml;

Thrombin 500 UI/ml;

calcium chloride 40 μmol/ml

Solution for sealant

Epilesional use

Spain

| BAXTER, S.L. |
| --- |
| Polígono Industrial Sector 14 |
| Pouet de Camilo, 2 46394 |
| Ribarroja del |
| Turia Valencia |
| Spain |

BAXTER, S.L.

Polígono Industrial Sector 14

Pouet de Camilo, 2 46394

Ribarroja del

Turia Valencia

Spain

TISSUCOL DUO 5,0 ml

Syringe TISSUCOL-APROTININ:

Total Proteins 100-130 mg/ml;

clottable protein 75-115 mg/ml,

of which fibrinogen 70-110 mg/ml and

plasmatic fibronectin 2-9 mg/ml:

Factor XIII 10-50 UI/ml;

Plasminogen 0,04-0,12 mg/ml;

Aprotinin 3 000 UIK/ml (1,67 UPE/ml);

Syringe THROMBIN-CALCIUM CHLORIDE:

Proteins 50 mg/ml;

Thrombin 500 UI/ml;

calcium chloride 40 μmol/ml

Solution for sealant

Epilesional use

Sweden

| Baxter Medical AB, Isafjordstgatan 30B |
| --- |
| P.O. Box 63 |
| 164 94 Kista, |
| Sweden |

Baxter Medical AB, Isafjordstgatan 30B

P.O. Box 63

164 94 Kista,

Sweden

Artiss

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

Sweden

| Baxter AG |
| --- |
| Industriestraße 67 |
| A- 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

A- 1221 Vienna

Austria

Tisseel

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Factor XIII: 10 IU/ml

Solution for sealant

Epilesional use

Sweden

| Baxter AG |
| --- |
| Industriestraße 67 |
| A- 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

A- 1221 Vienna

Austria

Tisseel Duo Quick

Fibrinogen: 90 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Factor XIII: 30 IU/ml

Plasminogen: 0,08 mg/ml

Fibronectin: 5,5 mg/ml

Solution for sealant

Epilesional use

The Netherlands

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

Baxter B.V.

Kobaltweg 49, Utrecht

3542 CE

The Netherlands

ARTISS, oplossingen voor weefsellijm (RVG 100631)

Fibrinogen: 91 mg/ml

Aprotinin: 3 000 KIU/ml

Thrombin: 4 IU/ml

Calcium chloride: 40 μmol/ml

Solution for sealant

Epilesional use

The Netherlands

| Baxter AG |
| --- |
| Industriestraße 67 |
| A- 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

A- 1221 Vienna

Austria

Tisseel (RVG 35050/1/2)

Fibrinogen: 91 mg/ml

Aprotinin (synthetic): 3 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Factor XIII: ≤ 10 IU/ml

Solution for sealant

Epilesional use

The Netherlands

| Baxter AG |
| --- |
| Industriestraße 67 |
| A- 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

A- 1221 Vienna

Austria

Tissucol Duo (RVG 17099)

Fibrinogen: 70 - 110 mg/ml

Fibronectine 2 - 9 mg/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Factor XIII: 10-50 IU/ml

Aprotinine (bovine): 3 000 KIU/ml

Solution for sealant

Epilesional use

The Netherlands

| Baxter AG |
| --- |
| Industriestraße 67 |
| A- 1221 Vienna |
| Austria |

Baxter AG

Industriestraße 67

A- 1221 Vienna

Austria

Tissucol, Kit (RVG 17100/1/2/3)

Fibrinogen: 70 - 110 mg/ml

Fibronectine 2 - 9 mg/ml

Thrombin: 500 IU/ml

Calcium chloride: 40 μmol/ml

Factor XIII: 10 - 50 IU/ml

Aprotinine (bovine): 3 000 KIU/ml

Powder and solvent for sealant

Epilesional use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfork IP24 3SE,

United Kingdom

Artiss, solution for sealant deep frozen

Human fibrinogen: 110 mg/ml

Aprotinin: 3 750 KIU/ml

Human thrombin: 6,5 IU/ml

Calcium chloride: 44 mcmol/ml

Solution for sealant

Epilesional use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfork IP24 3SE,

United Kingdom

Tisseel Lyo Two-component Fibrin Sealant

Fibrinogen: 75 mg

Human thrombin: 500 IU

Aprotinin: 3 000 KIU

Calcium chloride: 40 mcmol/ml

Powder for sealant and Solution for sealant

Epilesional use

United Kingdom

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

Baxter Healthcare Limited,

Caxton Way,

Thetford,

Norfork IP24 3SE,

United Kingdom

Tisseel Ready to use Solutions for Sealant

Human fibrinogen: 110 mg/ml

Aprotinin: 3 000 KU/ml

Human thrombin: 500 iu/ml

Calcium chloride: 40 mcmol/ml

Solution for sealant

Epilesional use

Beriplast and associated names

| Member State
  (in EEA) | Marketing Authorisation Holder | Invented name Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | CSL Behring GmbH |
| Emil-von-Behring-Straße 76 |
| D-35041 Marburg |
| Germany |

Member State

(in EEA)

Marketing Authorisation Holder

Invented name Name

Strength

Pharmaceutical Form

Route of administration

Austria

CSL Behring GmbH

Emil-von-Behring-Straße 76

D-35041 Marburg

Germany

Beriplast P Combi-Set Pulver und Lösungsmittel für einen Gewebekleber

Fibrinogen: 90 mg/ml

Coagulation factor XIII: 60 U/ml

Aprotinin: 1 000 KIU = 0,56 EPU

Thrombin: 500 IU/ml

Calcium chloride (dihydrate): 5,9 mg/ml

Powder and solvent for sealant

Epilesional use

France

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76 |
| D-35041 Marburg |
| Germany |

CSL Behring GmbH

Emil-von-Behring-Straße 76

D-35041 Marburg

Germany

BERIPLAST P 0,5 ml, 1 ml, 3 ml, powders and solvents for sealant

Combi-Set

Fibrinogen: 90 mg/ml

Coagulation factor XIII: 60 U/ml

Aprotinin: 1 000 KIU = 0,56 EPU

Thrombin: 500 IU/ml

Calcium chloride (dihydrate): 5,9 mg/ml

Powder and solvent for sealant

Epilesional use

Germany

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76 |
| D-35041 Marburg |
| Germany |

CSL Behring GmbH

Emil-von-Behring-Straße 76

D-35041 Marburg

Germany

Beriplast P Combi-Set 0,5 ml/1 ml/3 ml

Combi-Set 1:

Fibrinogen: 90 mg/ml

Coagulation factor XIII: 60 U/ml

Aprotinin: 1 000 KIU/ml = 0,56 PEU/ml

Combi-Set 2:

Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml

Powder and solvent for sealant

Epilesional use

Greece

| CSL BEHRING |
| --- |
| 5 Hadjiyianni Mexi str, |
| 11528-Athens |
| Greece |

CSL BEHRING

5 Hadjiyianni Mexi str,

11528-Athens

Greece

BERIPLAST P

Fibrinogen: 90 mg/ml

Factor XIII: 60 U/ml

Aprotinin: 1 000 UIC/ml

Thrombin: 500 UI/ml

Calcium chloride dihydrate: 5,9 mg/ml

Powder and solvent for sealant

Epilesional use

Greece

| CSL BEHRING |
| --- |
| 5 Hadjiyianni Mexi str, |
| 11528-Athens |
| Greece |

CSL BEHRING

5 Hadjiyianni Mexi str,

11528-Athens

Greece

BERIPLAST P

Fibrinogen: 90 mg/ml

Factor XIII: 60 U/ml

Aprotinin: 1 000 UIC/ml

Thrombin: 500 UI/ml

Calcium chloride dihydrate: 5,9 mg/ml

Powder and solvent for sealant

Epilesional use

Greece

| CSL BEHRING |
| --- |
| 5 Hadjiyianni Mexi str, |
| 11528-Athens |
| Greece |

CSL BEHRING

5 Hadjiyianni Mexi str,

11528-Athens

Greece

BERIPLAST P

Fibrinogen: 90 mg/ml

Factor XIII: 60 U/ml

Aprotinin: 1 000 UIC/ml

Thrombin: 500 UI/ml

Calcium chloride dihydrate: 5,9 mg/ml

Powder and solvent for sealant

Epilesional use

Hungary

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76 |
| D-35041 Marburg |
| Germany |

CSL Behring GmbH

Emil-von-Behring-Straße 76

D-35041 Marburg

Germany

BERIPLAST P COMBI-SET 1 ml szövetragasztó készlet

Combi-Set 1:

fibrinogen: 90 mg/ml

coagulation factor XIII: 60 U/ml

aprotinin: 1 000 KIU/ml = 0,56 PEU/ml

Combi-Set 2:

thrombin: 500 IU/ml

Powder and solvent for sealant

Epilesional use

Hungary

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76 |
| D-35041 Marburg |
| Germany |

CSL Behring GmbH

Emil-von-Behring-Straße 76

D-35041 Marburg

Germany

BERIPLAST P COMBI-SET 3 ml szövetragasztó készlet

Combi-Set 1:

fibrinogen: 90 mg/ml

coagulation factor XIII: 60 U/ml

aprotinin: 1 000 KIU/ml = 0,56 PEU/ml

Combi-Set 2:

thrombin: 500 IU/ml

Powder and solvent for sealant

Epilesional use

Italy

| CSL Behring GmbH |
| --- |
| Emil-von-Behring-Straße 76 |
| D-35041 Marburg |
| Germany |

CSL Behring GmbH

Emil-von-Behring-Straße 76

D-35041 Marburg

Germany

BERIPLAST P

Fibrinogen: 90 mg/ml

Factor XIII: 60 U/ml

Aprotinin: 1 000 KIU/ml

Thrombin: 500 IU/ml

Calcium Chloride: 5,9 mg/ml

Powder and solvent for sealant

Epilesional use

The Netherlands

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Strasse 76 |
| 35041 Marburg |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

Beriplast P Combi-Set, weefsellijm - 26655/6/7

Fibrinogen: 90 mg/ml

Aprotinin (bovine): 1 000 KIU/ml

Thrombin: 500 IU/ml

Calcium chloride: 5,9 mg/ml

Factor XIII: 60 U/ml

Powder and solvent for sealant

Epilesional use

Slovak Republic

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Strasse 76 |
| 35041 Marburg |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

Beriplast P Combi-Set 0,5 ml, Beriplast P Combi-Set 1 ml, Beriplast P Combi-Set 3 ml

Human fibrinogen: 90 mg

Coagulation factor XIII: 60 UI

Aprotinin: 1 000 KUI

Trombin: 7,6 mg

Calcium chloride: 5,9 mg

Powder and solvent for tissue sealant

Epilesional use

Slovenia

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Strasse 76 |
| 35041 Marburg |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

Beriplast P Combi-Set 1 ml prašek in vehikel za lepilo za tkiva

Human fibrinogen: 90 mg/ml

Coagulation factor XIII: 60 e/ml

Aprotinin: 1 000 EIK/ml

Thrombin: 7,6 mg/ml

Calcium chloride: 5,9 mg/ml

Powder and solvent for tissue sealant

Epilesional use

Slovenia

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Strasse 76 |
| 35041 Marburg |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

Beriplast P Combi-Set 3 ml prašek in vehikel za lepilo za tkiva

Human fibrinogen: 90 mg/ml

Coagulation factor XIII: 60 e/ml

Aprotinin: 1 000 EIK/ml

Thrombin: 7,6 mg/ml

Calcium chloride: 5,9 mg/ml

Powder and solvent for tissue sealant

Epilesional use

Spain

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Strasse 76 |
| 35041 Marburg |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

BERIPLAST P COMBI-SET 0,5 ml

Fibrinogen: 90 mg/ml

Coagulation factor XIII: 60 U/ml

Aprotinin: 1 000 KIU = 0,56 EPU

Thrombin: 500 IU/ml

Calcium chloride (dihydrate): 5,9 mg/ml

Powder and solvent for sealant

Epilesional use

Spain

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Strasse 76 |
| 35041 Marburg |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

BERIPLAST P COMBI-SET 1 ml

Fibrinogen: 90 mg/ml

Coagulation factor XIII: 60 U/ml

Aprotinin: 1 000 KIU = 0,56 EPU

Thrombin: 500 IU/ml

Calcium chloride (dihydrate): 5,9 mg/ml

Powder and solvent for sealant

Epilesional use

Spain

| CSL Behring GmbH, |
| --- |
| Emil-von-Behring-Strasse 76 |
| 35041 Marburg |
| Germany |

CSL Behring GmbH,

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

BERIPLAST P COMBI-SET 3 ml

Fibrinogen: 90 mg/ml

Coagulation factor XIII: 60 U/ml

Aprotinin: 1 000 KIU = 0,56 EPU

Thrombin: 500 IU/ml

Calcium chloride (dihydrate): 5,9 mg/ml

Powder and solvent for sealant

Epilesional use

---