TAFLOTAN

Medicinal product

(Invented) name

TAFLOTAN

Active substance (s)

Tafluprostas

Strength

15 µg/ml

Pharmaceutical form

akių lašai (tirpalas vienadozėje talpyklėje)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01EE05, Tafluprost

Marketing authorisation holder

Santen Oy, Suomija

Date of authorisation

2009-06-10

Date of renewal

2013-10-31

Documents

1603 Pakuotės lapelis 2021 07 15.docx

1603 TAFLOTAN vienadozeje II PL 2021 07 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0991/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Tafluprostas	15 µg

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
31784	34197	1034197	vienadozė talpyklė	0,3 ml N30		Receptinis	LT/1/09/1603/001	Netiekiama	2023-01-18	2025-12-01	No	-	-	Download
35863	38195	1038195	vienadozė talpyklė	0,3 ml N90		Receptinis	LT/1/09/1603/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-10-31	Perregistruotas
2009-06-10	Registruotas