Hidrasec

Medicinal product

(Invented) name

Hidrasec

Active substance (s)

Racekadotrilis

Strength

10 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 10mg gran PCS PL 2024 11 14.docx

2804 Pakuotės lapelis 10mg gran 2024 11 14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/1342/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Kiekviename paketėlyje yra	1 vnt.
Racekadotrilis	10 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
45437	59236	1059236	paketėlis	N10		Receptinis	LT/1/12/2804/001	Netiekiama	-	-	No	-	-
51194	65086	1065086	paketėlis	N16		Receptinis	LT/1/12/2804/002	Netiekiama	-	-	No	-	-	Download
51195	65087	1065087	paketėlis	N20		Receptinis	LT/1/12/2804/003	Netiekiama	-	-	No	-	-
51196	65088	1065088	paketėlis	N30		Receptinis	LT/1/12/2804/004	Netiekiama	-	-	No	-	-
51197	65089	1065089	paketėlis	N50		Receptinis	LT/1/12/2804/005	Netiekiama	-	-	No	-	-
51198	65090	1065090	paketėlis	N100		Receptinis	LT/1/12/2804/006	Netiekiama	-	-	No	-	-

Stadijos

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