# C_2013121EN.01000801.xml

| 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)
  )

(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

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.

1

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

2

---

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

---