AGAMREE

Medicinal product

(Invented) name

AGAMREE

Active substance (s)

Vamorolonas

Strength

40 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H02AB18, vamorolone

Marketing authorisation holder

Santhera Pharmaceuticals (Deutschland) GmbH, Vokietija

Date of authorisation

2023-12-14

Date of renewal

Documents

AGAMREE paciento kortele.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral suspension	1 ml
Vamorolonas	40 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
112349	98464	1098464	buteliukas	100 ml + adapteris ir 2 geriamieji švirkštai (8 ml) N1		Receptinis	EU/1/23/1776/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-14	Registruotas