Jan 12, 2017 - Send a question via our website www.ema.europa.eu/contact ... Product Name (in authorisation country). MR
12 January 2017 EMA/77788/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products Active substance(s): tirofiban Procedure No.: PSUSA/00002974/201605
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country) Aggrastat 250 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung Aggrastat 250 mikrog/ml infuusiokonsentraatti, liuosta varten Aggrastat 250 Mikrogramm/ml Konzentrat|zur Herstellung einer Infusionslösung Aggrastat (250 mikrogram/ml) koncentrat till infusionsvätska, lösning AGRASTAT 250 microgrammes/ml, solution à diluer pour perfusion AGGRASTAT 250 microgrammi/ml concentrato per soluzione per infusione Aggrastat 0,25 mg/ml concentraat, concentraat voor oplossing voor intraveneuze infusie AGRASTAT 0,25 mg/ml, concentrado para solución para perfusión Aggrastat 250 mikrogram/ml koncentrat till infusionsvätska, lösning AGGRASTAT (250 micrograms/ml) concentrate for solution for infusion Aggrastat 0,25 mg/ml, concentraat voor oplossing voor infusie AGGRASTAT 250 microgrammes/ml, solution à diluer pour perfusion Aggrastat 250 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung AGGRASTAT 250 microgrammes/ml, solution à diluer pour perfusion Aggrastat 250 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung AGGRASTAT (250 micrograms/ml) πυκνό διάλυμα για παρασκευή διαλύματος πρoς έγχυση. Aggrastat 50 Mikrogramm/ml Infusionslösung
MRP/DCP Authorisation number
National Authorisation Number
DE/H/0141/002
1-23140
DE/H/0141/002
13763
DE/H/0141/002
42618.00.00
DE/H/0141/002
13763
DE/H/0141/002
34009 562 162 5-8
DE/H/0141/002
034357018
DE/H/0141/002
RVG 23380
DE/H/0141/002
62.714
DE/H/0141/002
14828
DE/H/0141/002
PL 35173/0001
DE/H/0141/002
BE 205247
DE/H/0141/002
BE 205247
DE/H/0141/002
BE205247
DE/H/0141/002
0483/99/09/0031
DE/H/0141/002
0483/99/09/0031
CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED
DE/H/0141/02 DE/H/0141/001
38212 1-23141
VIANEX S.A. CORREVIO (UK)
MAH of product in the member state (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK)
Member State where product is authorised AT FI DE FI FR IT NL ES SE UK BE BE BE LU LU GR AT
MRP/DCP Authorisation number
National Authorisation Number
Aggrastat 50 mikrog/ml infuusioneste, liuos
DE/H/0141/001
13764
Aggrastat 50Mikrogramm/ml Infusionslösung AGGRASTAT (50 mikrogram/ml) infusionsvätska, lösning AGRASTAT 50 microgrammes/ml, solution pour perfusion Aggrastat 0,05 mg/ml oplossing, oplossing voor intraveneuze infusie
DE/H/0141/001
42618.00.01
DE/H/0141/001
13764
DE/H/141/01
34009 563 233 1 9
DE/H/0141/001
RVG 23381
AGRASTAT 0,05 mg/ml solución para perfusión Aggrastat 50 mikrogram/ml, infusionsvätska, lösning AGGRASTAT (50 micrograms/ml) solution for infusion AGGRASTAT (50 microgram/ml), oplossing voor infusie AGGRASTAT 50 microgrammes/ml, solution pour perfusion
DE/H/0141/001
62.713
DE/H/0141/001
14829
DE/H/0141/001
PL 35173/0002
DE/H/0141/001
BE 218057
DE/H/0141/001
BE 218057
Aggrastat 50 Mikrogramm/ml Infusionslösung AGGRASTAT 50 microgrammes/ml, solution pour perfusion
DE/H/0141/001
BE218057
DE/H/0141/001
0483/99/09/0131
Aggrastat 50 Mikrogramm/ml Infusionslösung AGGRASTAT (50 micrograms/ml) Διάλυμα για ενδοφλέβια έγχυση Aggrastat 250 mikrogrami/ml koncentrāts infūziju šķīduma pagatavošanai АГРАСТАТ 250 микрограма/ml концентрат за инфузионен разтвор AGGRASTAT (250 micrograms/ml) concentrate for solution for infusion AGGRASTAT (250 micrograms/ml) concentrate for solution for infusion AGGRASTAT 250 mikrogramų/ml koncentratas
DE/H/0141/001
0483/99/09/0131
DE/H/0141/01
38210
not available
99-0206
not available
9900200
not available
18260
not available not available
MA931/00101 LT/1/98/0081/001
Product Name (in authorisation country)
MAH of product in the member state LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED CORREVIO LIMITED
(UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK) (UK)
VIANEX S.A. CORREVIO (UK) LIMITED CORREVIO (UK) LIMITED CORREVIO (UK) LIMITED CORREVIO (UK) LIMITED CORREVIO (UK)
Member State where product is authorised
FI DE FI FR NL ES SE UK BE BE BE LU LU GR LV BG CY MT LT
Product Name (in authorisation country) infuziniam tirpalui AGGRASTAT, 250 mikrogrammi/ml infusioonilahuse kontsentraat Aggrastat 0,25 mg/ml koncentrátum oldatos infúzióhoz
MRP/DCP Authorisation number
National Authorisation Number
not available
238398
not available
OGYI-T-6734/01
MAH of product in the member state
Member State where product is authorised
LIMITED CORREVIO (UK) LIMITED CORREVIO (UK) LIMITED
EE HU
