Bimatoprost/Timolol Viatris [Bimatoprost/Timolol Mylan]

Medicinal product

(Invented) name

Active substance (s)

Bimatoprostas/Timololis

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)

ATC code (s)

S01ED51, Timolol, combinations

Marketing authorisation holder

Viatris Limited, Airija

Date of authorisation

2017-09-05

Date of renewal

2022-03-17

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10(3)

Procedure number

NL/H/3812/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Bimatoprostas	0,3 mg
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
97668	83763	1083763	buteliukas	3 ml N1		Receptinis	LT/1/17/4123/001	Tiekiama	-	-	No	-	-	Download
97669	83764	1083764	buteliukas	3 ml N3		Receptinis	LT/1/17/4123/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-03-17	Perregistruotas
2017-09-05	Registruotas