Hidrasec

Medicinal product

(Invented) name

Hidrasec

Active substance (s)

Racekadotrilis

Strength

30 mg

Pharmaceutical form

granulės geriamajai suspensijai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A07XA04, Racecadotril

Marketing authorisation holder

Bioprojet Europe Ltd., Airija

Date of authorisation

2012-02-14

Date of renewal

2022-12-29

Documents

2804 Hidrasec 30mg gran PCS PL 2024 11 14.docx

2804 Pakuotės lapelis 30mg gran 2024 11 14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1342/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kiekviename paketėlyje yra	1 vnt.
Racekadotrilis	30 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
45433	59232	1059232	paketėlis	N10		Receptinis	LT/1/12/2804/007	Netiekiama	-	-	No	-	-
51199	65091	1065091	paketėlis	N16		Receptinis	LT/1/12/2804/008	Netiekiama	-	-	No	-	-	Download
51200	65092	1065092	paketėlis	N20		Receptinis	LT/1/12/2804/009	Netiekiama	-	-	No	-	-
51201	65093	1065093	paketėlis	N30		Receptinis	LT/1/12/2804/010	Netiekiama	-	-	No	-	-
51202	65094	1065094	paketėlis	N50		Receptinis	LT/1/12/2804/011	Netiekiama	-	-	No	-	-
51203	65095	1065095	paketėlis	N100		Receptinis	LT/1/12/2804/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-12-29	Perregistruotas
2012-02-14	Registruotas