Bilastine Polpharma

Medicinal product

(Invented) name

Bilastine Polpharma

Active substance (s)

Bilastinas

Strength

20 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis/Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R06AX29, Bilastine

Marketing authorisation holder

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

2025-04-24

Date of renewal

Documents

5757_Bilastine Polpharma_Rp.docx

5757_Bilastine Polpharma_Nerp.docx

5757_pakuotes lapelis_2025-04-24_Nerp.docx

5757_pakuotes lapelis_2025-04-24_Rp.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2535/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Bilastinas	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
117253	103353	1103353	lizdinė plokštelė	N10		Nereceptinis	LT/1/25/5757/001	Netiekiama	-	-	No	-	-
117254	103354	1103354	lizdinė plokštelė	N20		Receptinis	LT/1/25/5757/002	Netiekiama	-	-	No	-	-
117255	103355	1103355	lizdinė plokštelė	N30		Receptinis	LT/1/25/5757/003	Netiekiama	-	-	No	-	-
117256	103356	1103356	lizdinė plokštelė	N50		Receptinis	LT/1/25/5757/004	Netiekiama	-	-	No	-	-
117257	103357	1103357	lizdinė plokštelė	N100		Receptinis	LT/1/25/5757/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-24	Registruotas