Gammaplex

Medicinal product

(Invented) name

Gammaplex

Active substance (s)

Žmogaus normalusis imunoglobulinas

Strength

100 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BA02, Immunoglobulins, normal human, for intravascular adm.

Marketing authorisation holder

BPL Bioproducts Laboratory GmbH, Vokietija

Date of authorisation

2020-01-24

Date of renewal

Documents

4503_01-03 pakuotes lapelis_2020-01-24.docx

4503_1_3 Gammaplex inf PCS 200312.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/4909/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Žmogaus normalusis imunoglobulinas	100 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
103123	89224	1089224	flakonas	50 ml N1		Receptinis	LT/1/20/4503/001	Netiekiama	-	-	No	-	-
103124	89225	1089225	flakonas	100 ml N1		Receptinis	LT/1/20/4503/002	Netiekiama	-	-	No	-	-
103125	89226	1089226	flakonas	200 ml N1		Receptinis	LT/1/20/4503/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-03-29	Išregistruotas
2020-01-24	Registruotas