Plerixafor Auxilia

Medicinal product

(Invented) name

Plerixafor Auxilia

Active substance (s)

Pleriksaforas

Strength

20 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L03AX16, Plerixafor

Marketing authorisation holder

Auxilia Pharma OÜ, Estija

Date of authorisation

2023-04-04

Date of renewal

Documents

5161 Pakuotės lapelis 2023 10 19.docx

5161 Plerixafor Auxilia PCS 2024 11 22.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/1193/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Pleriksaforas	20 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
110763	96874	1096874	flakonas	1,2 ml N1		Receptinis	LT/1/23/5161/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-04-04	Registruotas