Brimonidine/Timolol PharmaSwiss

Medicinal product

(Invented) name

Brimonidine/Timolol PharmaSwiss

Active substance (s)

Brimonidino tartratas/Timololis

Strength

2 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

PharmaSwiss Česká republika s.r.o., Čekija

Date of authorisation

2016-11-22

Date of renewal

Documents

4001 pakuotes lapelis_2016-11-22.docx

4001 Brimonidine Timolol PharmaSwiss.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DK/H/2525/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Brimonidino tartratas	2 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
62001	76373	1076373	buteliukas	5 ml N1		Receptinis	LT/1/16/4001/001	Netiekiama	-	-	No	-	-
67147	81690	1081690	buteliukas	5 ml N3		Receptinis	LT/1/16/4001/002	Netiekiama	-	-	No	-	-
67148	81691	1081691	buteliukas	5 ml N6		Receptinis	LT/1/16/4001/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-31	Išregistruotas
2016-11-22	Registruotas