Opexa

Medicinal product

(Invented) name

Opexa

Active substance (s)

Bilastinas

Strength

10 mg

Pharmaceutical form

burnoje disperguojamos tabletės

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 10mg disperg 2025 04 11.docx

2241 Opexa 10mg disperg 2025 04 11.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/2300/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Bilastinas	10 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
97499	83593	1083593	lizdinė plokštelė	N10		Receptinis	LT/1/10/2241/006	Tiekiama	-	-	No	-	-	Download
97500	83594	1083594	lizdinė plokštelė	N20		Receptinis	LT/1/10/2241/007	Netiekiama	-	-	No	-	-
97501	83595	1083595	lizdinė plokštelė	N30		Receptinis	LT/1/10/2241/008	Netiekiama	-	-	No	-	-
97502	83596	1083596	lizdinė plokštelė	N50		Receptinis	LT/1/10/2241/009	Netiekiama	-	-	No	-	-

Stadijos

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