Loargys

Medicinal product

(Invented) name

Loargys

Active substance (s)

Pegzilarginazė

Strength

5 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AB24, pegzilarginase

Marketing authorisation holder

Immedica Pharma AB, Švedija

Date of authorisation

2023-12-15

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

Solution for injection or infusion	1 ml
Pegzilarginazė	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
112350	98465	1098465	flakonas	0,4 ml N1		Receptinis	EU/1/23/1774/001	Netiekiama	-	-	No	-	-
112351	98466	1098466	flakonas	1 ml N1		Receptinis	EU/1/23/1774/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-15	Registruotas