Cymvigo

Medicinal product

(Invented) name

Cymvigo

Active substance (s)

Žmogaus citomegalo viruso imunoglobulinas

Strength

100 V/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)

J06BB09, Cytomegalovirus immunoglobulin

Marketing authorisation holder

Biotest Pharma GmbH, Vokietija

Date of authorisation

2022-11-29

Date of renewal

2023-06-08

Documents

5073_pakuotes lapelis_2023-06-08.docx

5073_Cymvigo_perr2023-06-08.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/4905/001/E002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Žmogaus citomegalo viruso imunoglobulinas	100 V

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
109879	95986	1095986	flakonas	10 ml N1		Receptinis	LT/1/22/5073/001	Netiekiama	-	-	No	-	-	Download
109880	95987	1095987	flakonas	50 ml N1		Receptinis	LT/1/22/5073/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2023-06-08	Perregistruotas
2022-11-29	Registruotas