FOTIL

Medicinal product

(Invented) name

FOTIL

Active substance (s)

Timololis/Pilokarpino hidrochloridas

Strength

5 mg/20 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

Santen Oy, Suomija

Date of authorisation

1996-05-17

Date of renewal

2010-03-19

Documents

1924_1 Pakuotės lapelis 210315.docx

1924_1 FOTIL akiu lasai RPP 210315.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Timololis	5 mg
Pilokarpino hidrochloridas	20 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
2701	3025	1003025	buteliukas	5 ml N1		Receptinis	LT/1/96/1924/001	Netiekiama	2025-09-01	-	No	-	-

Stadijos

Data	Stadija
2010-03-19	Perregistruotas
1996-05-17	Registruotas