Lenalidomide STADA

Medicinal product

(Invented) name

Lenalidomide STADA

Active substance (s)

Lenalidomidas

Strength

5 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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2018-05-29

Date of renewal

2022-12-29

Documents

Lenalidomide STADA kontrolinis sarasas.pdf

Lenalidomide_STADA paciento brosiura.pdf

Lenalidomide STADA specialisto brosiura.pdf

Lenalidomide STADA paciento kortele.pdf

Lenalidomide_STADA pranesimo apie nestuma forma.pdf

4229 Pakuotės lapelis 2024 04 30.docx

4229 Lenalidomide STADA PCS PL 2024 04 30.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0275/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Lenalidomidas	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
99520	85628	1085628	lizdinė plokštelė	N7		Receptinis	LT/1/18/4229/001	Netiekiama	-	-	No	-	-
99521	85629	1085629	lizdinė plokštelė	N21		Receptinis	LT/1/18/4229/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Perregistruotas
2018-05-29	Registruotas