Betoptic S

Medicinal product

(Invented) name

Betoptic S

Active substance (s)

Betaksololis

Strength

2,5 mg/ml

Pharmaceutical form

akių lašai (suspensija)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01ED02, Betaxolol

Marketing authorisation holder

Immedica Pharma AB, Švedija

Date of authorisation

1998-06-02

Date of renewal

2012-10-12

Documents

0089 Pakuotės lapelis 2025 04 14.docx

0089 Betoptic S RPP 2025 04 14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml suspensijos yra	1 ml
Betaksololis	2,5 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
6453	2498	1002498	buteliukas	5 ml su lašinimo kamščiu N1		Receptinis	LT/1/92/0089/001	Tiekiama	2025-07-07	-	No	-	-	Download

Stadijos

Data	Stadija
2012-10-12	Perregistruotas
1998-06-02	Registruotas