Revestive

Medicinal product

(Invented) name

Revestive

Active substance (s)

Tedugliutidas

Strength

5 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

A16AX08, Teduglutide

Marketing authorisation holder

Takeda Pharmaceuticals International AG Ireland Branch, Airija

Date of authorisation

2012-08-30

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection	1 vnt.
Tedugliutidas	5 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
53375	67357	1067357	flakonas	milteliai, užpildytas švirkštas (0,5 ml) N28		Receptinis	EU/1/12/787/001	Tiekiama	-	-	No	-	-
97626	83720	1083720	flakonas	milteliai, užpildytas švirkštas (0,5 ml) N1		Receptinis	EU/1/12/787/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-08-30	Registruotas