Elymbus

Medicinal product

(Invented) name

Elymbus

Active substance (s)

Bimatoprostas

Strength

0,1 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)

S01EE03, Bimatoprost

Marketing authorisation holder

Laboratoires THEA, Prancūzija

Date of authorisation

2023-07-05

Date of renewal

Documents

5196_Elymbus.docx

5196_pakuotes lapelis_2023-07-05.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DK/H/3312/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 g gelio yra:	1 g
Bimatoprostas	0,1 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
111215	97328	1097328	vienadozė talpyklė	0,3 g N10 (1×10)		Receptinis	LT/1/23/5196/001	Netiekiama	-	-	No	-	-
111216	97329	1097329	vienadozė talpyklė	0,3 g N30 (3×10)		Receptinis	LT/1/23/5196/002	Netiekiama	-	-	No	-	-
111217	97330	1097330	vienadozė talpyklė	0,3 g N90 (9×10)		Receptinis	LT/1/23/5196/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-07-05	Registruotas