Eptifibatide Mylan [Eptifibatide Strides]

Medicinal product

(Invented) name

Eptifibatide Mylan [Eptifibatide Strides]

Active substance (s)

Eptifibatidas

Strength

0,75 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B01AC16, Eptifibatide

Marketing authorisation holder

Mylan S.A.S., Prancūzija

Date of authorisation

2013-09-24

Date of renewal

Documents

3370_1 Eptifibatide Mylan 0,75mg_ml RPP keit.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0440/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Eptifibatidas	0,75 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
50417	64302	1064302	flakonas	100 ml N1		Receptinis	LT/1/13/3370/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-09	Išregistruotas
2013-09-24	Registruotas