Bimatoprost/Timolol Zentiva

Medicinal product

(Invented) name

Bimatoprost/Timolol Zentiva

Active substance (s)

Bimatoprostas/Timololio maleatas

Strength

0,3 mg/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

Zentiva k.s., Čekija

Date of authorisation

2020-11-25

Date of renewal

Documents

4633 Bimatoprost_Timolol Zentiva PL 2021 08 29.docx

4633 Pakuotės lapelis 2021 08 29.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/4949/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Bimatoprostas	0,3 mg
Timololio maleatas	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
105316	91418	1091418	buteliukas	3 ml N1		Receptinis	LT/1/20/4633/001	Netiekiama	-	-	No	-	-
105317	91419	1091419	buteliukas	3 ml N3		Receptinis	LT/1/20/4633/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-29	Išregistruotas
2020-11-25	Registruotas