Glypressin

Medicinal product

(Invented) name

Glypressin

Active substance (s)

Terlipresino acetatas

Strength

1 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

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

2006-03-31

Date of renewal

2008-02-08

Documents

0470 Glypressin milt inj tirp PCS PL 2024 05 15.docx

0470 Pakuotės lapelis milt 2024 05 15.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DK/H/0829/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Buteliuke yra	1 vnt.
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
15678	19805	1019805	buteliukas	milteliai ir ampulė tirpiklio (5 ml), N5		Receptinis	LT/1/05/0470/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-02-08	Perregistruotas
2006-03-31	Registruotas