Glypressin

Medicinal product

(Invented) name

Glypressin

Active substance (s)

Terlipresino acetatas

Strength

1 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

H01BA04, Terlipressin

Marketing authorisation holder

Ferring GmbH, Vokietija

Date of authorisation

2011-01-26

Date of renewal

2015-01-27

Documents

0470 Pakuotės lapelis inj 2024 05 15.docx

0470 Glypressin inj PCS PL 2024 05 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/0829/002/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Vienoje ampulėje (8,5 ml tirpalo) yra	8.5 ml
Terlipresino acetatas	1 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
41014	54751	1054751	ampulė	8,5 ml N5		Receptinis	LT/1/05/0470/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-01-27	Perregistruotas
2011-01-26	Registruotas