Fixopost

Medicinal product

(Invented) name

Fixopost

Active substance (s)

Latanoprostas/Timololis

Strength

50 µg/5 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)

S01ED51, Timolol, combinations

Marketing authorisation holder

Laboratoires THEA, Prancūzija

Date of authorisation

2021-02-10

Date of renewal

2023-06-21

Documents

4683_Fixopost_perr2023-06-21.docx

4683_pakuotes lapelis_2023-06-21.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

SE/H/1602/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Latanoprostas	50 µg
Timololis	5 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
105930	92030	1092030	buteliukas	2,5 ml N1		Receptinis	LT/1/21/4683/001	Netiekiama	-	-	No	-	-
105931	92031	1092031	buteliukas	6 ml N1		Receptinis	LT/1/21/4683/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-28	Išregistruotas
2023-06-21	Perregistruotas
2021-02-10	Registruotas