Prelum

Medicinal product

(Invented) name

Prelum

Active substance (s)

Lacidipinas

Strength

4 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C08CA09, Lacidipine

Marketing authorisation holder

UAB SanoSwiss, Lietuva

Date of authorisation

2015-06-16

Date of renewal

2020-06-29

Documents

3741 Pakuotės lapelis 2mg, 4mg, 6mg 2023 02 06.docx

3741 Prelum 4mg RPP 2023 02 06.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/2992/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Lacidipinas	4 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
56759	70865	1070865	lizdinė plokštelė	N28		Receptinis	LT/1/15/3741/004	Netiekiama	-	-	No	-	-
62495	76904	1076904	lizdinė plokštelė	N56		Receptinis	LT/1/15/3741/005	Tiekiama	-	-	No	-	-	Download
62496	76905	1076905	lizdinė plokštelė	N98		Receptinis	LT/1/15/3741/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-06-29	Perregistruotas
2015-06-16	Registruotas