Opexa

Medicinal product

(Invented) name

Opexa

Active substance (s)

Bilastinas

Strength

2,5 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R06AX29, Bilastine

Marketing authorisation holder

Menarini International Operations Luxembourg S.A., Liuksemburgas

Date of authorisation

2017-07-27

Date of renewal

2022-07-08

Documents

2241 Pakuotės lapelis 2025 07 17.docx

2241 Opexa 2,5mg ger tirp II PL 2025 07 17.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/2300/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Bilastinas	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
97503	83597	1083597	buteliukas	120 ml ir taurelė N1		Receptinis	LT/1/10/2241/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-07-08	Perregistruotas
2017-07-27	Registruotas