Plenadren

Medicinal product

(Invented) name

Plenadren

Active substance (s)

Hidrokortizonas

Strength

5 mg

Pharmaceutical form

modifikuoto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

H02AB09, Hydrocortisone

Marketing authorisation holder

Takeda Pharmaceuticals International AG Ireland Branch, Airija

Date of authorisation

2011-11-03

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Modified-release tablet	1 vnt.
Hidrokortizonas	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
49864	63736	1063736	buteliukas	N50		Receptinis	EU/1/11/715/001	Netiekiama	-	-	No	-	-
57676	71795	1071795	buteliukas	N100 (2×50)		Receptinis	EU/1/11/715/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-11-03	Registruotas