BIMATOPROST TIEFENBACHER

Medicinal product

(Invented) name

BIMATOPROST TIEFENBACHER

Active substance (s)

Bimatoprostas

Strength

0,3 mg/ml

Pharmaceutical form

akių lašai (tirpalas)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01EE03, Bimatoprost

Marketing authorisation holder

Alfred E. Tiefenbacher (GmbH & Co. KG), Vokietija

Date of authorisation

2013-10-31

Date of renewal

Documents

3414_1-4 BIMATOPROST_Tief_DP.doc

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/2785/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename ml tirpalo yra	1 ml
Bimatoprostas	0,3 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
53106	67048	1067048	buteliukas	2,5 ml N1		Receptinis	LT/1/13/3414/001	Netiekiama	-	-	No	-	-
53107	67049	1067049	buteliukas	2,5 ml N3		Receptinis	LT/1/13/3414/002	Netiekiama	-	-	No	-	-
57730	71850	1071850	buteliukas	3 ml N1		Receptinis	LT/1/13/3414/003	Netiekiama	-	-	No	-	-
57731	71851	1071851	buteliukas	3 ml N3		Receptinis	LT/1/13/3414/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-09-02	Išregistruotas
2013-10-31	Registruotas