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)
Date: 2013-04-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013121EN.01000801.xml










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






(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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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