Polalid

Medicinal product

(Invented) name

Polalid

Active substance (s)

Lenalidomidas

Strength

10 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AX04, Lenalidomide

Marketing authorisation holder

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

2022-06-21

Date of renewal

Documents

Paciento kortele ir mokomoji medziaga pacientams.pdf

4968-4974_Polalid.docx

Nestumo prevencijos programa.pdf

Užsakymo forma.pdf

4968-4974_pakuotes lapelis_2022-06-21.docx

Mokomoji medziaga sveikatos prieziuros specialistams.pdf

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PL/H/0741/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Lenalidomidas	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
108881	94987	1094987	lizdinė plokštelė	N21		Receptinis	LT/1/22/4971/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-27	Išregistruotas
2023-04-27	Išregistruotas
2022-06-21	Registruotas