TAFLOTAN

Medicinal product

(Invented) name

TAFLOTAN

Active substance (s)

Tafluprostas

Strength

15 µg/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)

S01EE05, Tafluprost

Marketing authorisation holder

Santen Oy, Suomija

Date of authorisation

2018-11-29

Date of renewal

2023-07-26

Documents

4301 Taflotan_perr2023-07-26.docx

4301 pakuotes lapelis_2023-07-26.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/5250/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo 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
100574	86684	1086684	buteliukas	3 ml N1		Receptinis	LT/1/18/4301/001	Tiekiama	-	-	No	-	-	Download
100575	86685	1086685	buteliukas	3 ml N3		Receptinis	LT/1/18/4301/002	Netiekiama	-	-	No	-	-
107822	93927	1093927	buteliukas	5 ml N1		Receptinis	LT/1/18/4301/003	Netiekiama	-	-	No	-	-
107823	93928	1093928	buteliukas	7 ml N1		Receptinis	LT/1/18/4301/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-26	Perregistruotas
2018-11-29	Registruotas