Imreplys

Medicinal product

(Invented) name

Imreplys

Active substance (s)

Sargramostimas

Strength

250 µg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L03AA09, Sargramostim

Marketing authorisation holder

Partner Therapeutics Ltd., Airija

Date of authorisation

2025-08-21

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Flakone yra	1 vnt.
Sargramostimas	250 µg

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
118624	104728	1104728	flakonas	N5		Receptinis	EU/1/25/1924/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-21	Registruotas