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 56
26 April 2013
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ISSN 1977-091X doi:10.3000/1977091X.C_2013.121.eng |
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Official Journal of the European Union |
C 121 |
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English edition |
Information and Notices |
Volume 56 |
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Notice No |
Contents |
page |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2013/C 121/01 |
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2013/C 121/02 |
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2013/C 121/03 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
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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
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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 |
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8.2.2013 |
Novem |
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EU/2/04/042 |
12.3.2013 |
(1) OJ L 136, 30.4.2004, p. 1.
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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
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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 |
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4.3.2013 |
Perjeta |
pertuzumab |
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EU/1/13/813 |
Concentrate for solution for infusion |
L01XC13 |
6.3.2013 |
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13.3.2013 |
Actelsar HCT |
telmisartan/hydrochlorothiazide |
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EU/1/13/817 |
Tablet |
C09DA07 |
15.3.2013 |
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13.3.2013 |
JETREA |
OCRIPLASMIN |
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EU/1/13/819 |
Concentrate for solution for injection |
Pending |
15.3.2013 |
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13.3.2013 |
Tolucombi |
telmisartan/hydrochlorothiazide |
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EU/1/13/821 |
Tablet |
C09DA07 |
15.3.2013 |
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22.3.2013 |
Bexsero |
Meningococcal group B Vaccine (rDNA, component, adsorbed) |
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EU/1/12/812 |
Suspension for injection |
J07AH09 |
26.3.2013 |
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27.3.2013 |
Bosulif |
Bosutinib |
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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
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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 |
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6.3.2013 |
Byetta |
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EU/1/06/362 |
8.3.2013 |
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6.3.2013 |
Intelence |
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EU/1/08/468 |
8.3.2013 |
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6.3.2013 |
Ozurdex |
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EU/1/10/638 |
8.3.2013 |
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6.3.2013 |
Ranexa |
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EU/1/08/462 |
8.3.2013 |
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11.3.2013 |
Champix |
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EU/1/06/360 |
13.3.2013 |
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11.3.2013 |
Qutenza |
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EU/1/09/524 |
13.3.2013 |
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11.3.2013 |
Victoza |
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EU/1/09/529 |
13.3.2013 |
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13.3.2013 |
BYDUREON |
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EU/1/11/696 |
15.3.2013 |
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13.3.2013 |
Efficib |
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EU/1/08/457 |
15.3.2013 |
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13.3.2013 |
Firazyr |
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EU/1/08/461 |
15.3.2013 |
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13.3.2013 |
Firdapse |
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EU/1/09/601 |
15.3.2013 |
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13.3.2013 |
Ganfort |
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EU/1/06/340 |
15.3.2013 |
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13.3.2013 |
Iscover |
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EU/1/98/070 |
15.3.2013 |
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13.3.2013 |
Janumet |
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EU/1/08/455 |
15.3.2013 |
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13.3.2013 |
Optimark |
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EU/1/07/398 |
15.3.2013 |
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13.3.2013 |
Pegasys |
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EU/1/02/221 |
15.3.2013 |
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13.3.2013 |
Privigen |
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EU/1/08/446 |
15.3.2013 |
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13.3.2013 |
Velmetia |
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EU/1/08/456 |
15.3.2013 |
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13.3.2013 |
Vidaza |
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EU/1/08/488 |
15.3.2013 |
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22.3.2013 |
Daliresp |
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EU/1/11/668 |
26.3.2013 |
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22.3.2013 |
DaTSCAN |
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EU/1/00/135 |
26.3.2013 |
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22.3.2013 |
Daxas |
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EU/1/10/636 |
26.3.2013 |
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22.3.2013 |
Emend |
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EU/1/03/262 |
26.3.2013 |
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22.3.2013 |
Ivemend |
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EU/1/07/437 |
26.3.2013 |
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22.3.2013 |
Libertek |
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EU/1/11/666 |
26.3.2013 |
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22.3.2013 |
Pixuvri |
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EU/1/12/764 |
26.3.2013 |
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26.3.2013 |
Combivir |
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EU/1/98/058 |
28.3.2013 |
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26.3.2013 |
Daliresp |
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EU/1/11/668 |
28.3.2013 |
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26.3.2013 |
Daxas |
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EU/1/10/636 |
28.3.2013 |
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26.3.2013 |
Epivir |
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EU/1/96/015 |
28.3.2013 |
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26.3.2013 |
Kivexa |
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EU/1/04/298 |
28.3.2013 |
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26.3.2013 |
Libertek |
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EU/1/11/666 |
28.3.2012 |
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26.3.2013 |
Privigen |
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EU/1/08/446 |
28.3.2013 |
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26.3.2013 |
Telzir |
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EU/1/04/282 |
28.3.2013 |
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26.3.2013 |
Trizivir |
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EU/1/00/156 |
28.3.2013 |
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26.3.2013 |
Ziagen |
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EU/1/99/112 |
28.3.2013 |
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27.3.2013 |
Cervarix |
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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)
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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 |
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27.3.2013 |
Bondenza |
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EU/1/03/266 |
2.4.2013 |
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27.3.2013 |
Possia |
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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)
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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 |
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22.3.2013 |
Pelzont |
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EU/1/08/460 |
26.3.2013 |
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22.3.2013 |
Tredaptive |
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EU/1/08/459 |
26.3.2013 |
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22.3.2013 |
Trevaclyn |
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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
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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 |
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6.3.2013 |
Loxicom |
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EU/2/08/090 |
8.3.2013 |
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6.3.2013 |
ProteqFlu |
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EU/2/03/037 |
8.3.2013 |
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6.3.2013 |
ProteqFlu-Te |
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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:
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The European Medicines Agency |
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7, Westferry Circus, |
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Canary Wharf |
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UK-LONDON E14 4H |
(1) OJ L 136, 30.4.2004, p. 1.
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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
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Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
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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
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Member State (in EEA) |
Marketing Authorisation Holder |
Invented name Name |
Strength |
Pharmaceutical Form |
Route of administration |
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Austria |
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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 |
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Austria |
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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 |
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Austria |
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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 |
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Austria |
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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 |
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Belgium |
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Artiss |
Fibrinogen: 91 mg/ml Aprotinin: 3 000 KIU/ml Thrombin: 4 IU/ml Calcium chloride: 40 μmol/ml |
Solution for sealant |
Epilesional use |
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Belgium |
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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 |
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Belgium |
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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 |
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Belgium |
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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 |
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Belgium |
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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 |
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Bulgaria |
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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 |
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Bulgaria |
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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 |
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Bulgaria |
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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 |
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Czech Republic |
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Artiss |
Fibrinogen: 91 mg/ml Aprotinin: 3 000 KIU/ml Thrombin: 4 IU/ml Calcium chloride: 40 μmol/ml |
Solution for sealant |
Epilesional use |
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Czech Republic |
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Tisseel |
Fibrinogen: 91 mg/ml Aprotinin: 3 000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 μmol/ml |
Solution for sealant |
Epilesional use |
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Czech Republic |
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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 |
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Denmark |
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Artiss |
Fibrinogen: 91 mg/ml Aprotinin: 3 000 KIU/ml Thrombin: 4 IU/ml Calcium chloride: 40 μmol/ml |
Solution for sealant |
Intralesional use |
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Denmark |
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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 |
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Denmark |
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Tissel |
Fibrinogen: 91 mg/ml Aprotinin: 3 000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 μmol/ml |
Solution for sealant |
Intralesional use |
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Finland |
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Artiss |
Fibrinogen: 91 mg/ml Aprotinin: 3 000 KIU/ml Thrombin: 4 IU/ml Calcium chloride: 40 μmol/ml |
Solution for sealant |
Topical |
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Finland |
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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 |
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Finland |
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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 |
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France |
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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 |
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France |
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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 |
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Germany |
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Artiss |
Fibrinogen: 91 mg/ml Aprotinin: 3 000 KIU/ml Thrombin: 4 IU/ml Calcium chloride: 40 μmol/ml |
Solution for sealant |
Epilesional use |
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Germany |
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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 |
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Germany |
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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 |
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Greece |
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ARTISS |
Fibrinogen: 91 mg/ml Aprotinin: 3 000 KIU/ml Thrombin: 4 IU/ml Calcium chloride: 40 μmol/ml |
Solution for sealant |
Epilesional use |
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Greece |
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TISSEEL |
Fibrinogen: 91 mg/ml Aprotinin: 3 000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 μmol/ml |
Solution for sealant |
Epilesional use |
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Greece |
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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 |
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Hungary |
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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 |
||||||
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Hungary |
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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 |
||||||
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Hungary |
|
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 |
||||||
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Hungary |
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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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
Sweden |
|
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 |
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|
Sweden |
|
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 |
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|
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 |
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|
The Netherlands |
|
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 |
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|
The Netherlands |
|
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 |
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|
The Netherlands |
|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
Austria |
|
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 |
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|
France |
|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
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 |
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|
Hungary |
|
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 |
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|
Hungary |
|
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 |
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|
Italy |
|
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 |
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|
The Netherlands |
|
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 |
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|
Slovak Republic |
|
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 |
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|
Slovenia |
|
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 |
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|
Slovenia |
|
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 |
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|
Spain |
|
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 |
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|
Spain |
|
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 |
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|
Spain |
|
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 |