Pomalidomide Olpha

Medicinal product

(Invented) name

Pomalidomide Olpha

Active substance (s)

Pomalidomidas

Strength

1 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)

L04AX06, Pomalidomide

Marketing authorisation holder

Olpha AS, Latvija

Date of authorisation

2025-05-19

Date of renewal

Documents

5786-89 pakuotes lapelis_2025-05-19.docx

5786-5789_Pomalidomide Olpha.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/1246/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Pomalidomidas	1 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
117594	103697	1103697	lizdinė plokštelė	N14		Receptinis	LT/1/25/5786/001	Netiekiama	-	-	No	-	-
117595	103698	1103698	lizdinė plokštelė	N21		Receptinis	LT/1/25/5786/002	Netiekiama	-	-	No	-	-
117596	103699	1103699	dalomoji lizdinė plokštelė	N14×1		Receptinis	LT/1/25/5786/003	Netiekiama	-	-	No	-	-
117597	103700	1103700	dalomoji lizdinė plokštelė	N21×1		Receptinis	LT/1/25/5786/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-05-19	Registruotas