Eduelym

Medicinal product

(Invented) name

Eduelym

Active substance (s)

Bimatoprostas/Timololis

Strength

0,1 mg/1 mg/g

Pharmaceutical form

akių gelis vienadozėje talpyklėje

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

Laboratoires THEA, Prancūzija

Date of authorisation

2025-11-11

Date of renewal

Documents

5885_pakuotes lapelis_2025-11-11.docx

5885_Eduelym.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/3500/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g gelio yra	1 g
Bimatoprostas	0,1 mg
Timololis	1 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
119055	105160	1105160	vienadozė talpyklė	0,3 g N10 (1×10)		Receptinis	LT/1/25/5885/001	Netiekiama	-	-	No	-	-
119056	105161	1105161	vienadozė talpyklė	0,3 g N30 (3×10)		Receptinis	LT/1/25/5885/002	Netiekiama	-	-	No	-	-
119057	105162	1105162	vienadozė talpyklė	0,3 g N90 (9×10)		Receptinis	LT/1/25/5885/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-11-11	Registruotas