Nplate

Medicinal product

(Invented) name

Nplate

Active substance (s)

Romiplostimas

Strength

250 µg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02BX04, Romiplostim

Marketing authorisation holder

Amgen Europe B.V., Nyderlandai

Date of authorisation

2010-01-11

Date of renewal

Documents

Nplate dozės skaičiuoklė.pdf

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

Powder and solvent for solution for injection	1 vnt.
Romiplostimas	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
39192	52875	1052875	flakonas	N1 (užpildytas švirkštas + adapteris + adata + švirkštas + 4 spiritiniai tamponai)		Receptinis	EU/1/08/497/005	Tiekiama	-	-	No	-	-
39193	52876	1052876	flakonas	N4 x (užpildytas švirkštas + adapteris + adata + švirkštas + 4 spiritiniai tamponai)		Receptinis	EU/1/08/497/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-01-11	Registruotas