Udenyca

Medicinal product

(Invented) name

Udenyca

Active substance (s)

Pegfilgrastimas

Strength

6 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L03AA13, Pegfilgrastim

Marketing authorisation holder

ERA Consulting GmbH, Vokietija

Date of authorisation

2018-09-21

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	0.6 ml
Pegfilgrastimas	6 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
100312	86421	1086421	užpildytas švirkštas	0,6 ml N1		Receptinis	EU/1/18/1303/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-04	Išregistruotas
2018-09-21	Registruotas