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

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© 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

tirofiban List of nationally authorised medicinal products PSUSA-2974 ...

Jan 12, 2017 - Send a question via our website www.ema.europa.eu/contact ... Product Name (in authorisation country). MRP/DCP .... not available. 99-0206.

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