Sibnayal

Medicinal product

(Invented) name

Sibnayal

Active substance (s)

Kalio citratas/Kalio-vandenilio karbonatas

Strength

24 mEq

Pharmaceutical form

pailginto atpalaidavimo granulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A12BA30, potassium (different salts in combination

Marketing authorisation holder

ADVICENNE, Prancūzija

Date of authorisation

2021-04-30

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Prolonged-release granules	1 vnt.
Kalio citratas/Kalio-vandenilio karbonatas	24 mEq

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
106475	92576	1092576	paketėlis	N60		Receptinis	EU/1/20/1517/007	Netiekiama	-	-	No	-	-
106476	92577	1092577	paketėlis	N120 (2x60)		Receptinis	EU/1/20/1517/008	Netiekiama	-	-	No	-	-
106477	92578	1092578	paketėlis	N180 (3x60)		Receptinis	EU/1/20/1517/009	Netiekiama	-	-	No	-	-
106478	92579	1092579	paketėlis	N240 (4x60)		Receptinis	EU/1/20/1517/010	Netiekiama	-	-	No	-	-
106479	92580	1092580	paketėlis	N300 (5x60)		Receptinis	EU/1/20/1517/011	Netiekiama	-	-	No	-	-
106480	92581	1092581	paketėlis	N360 (6x60)		Receptinis	EU/1/20/1517/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-30	Registruotas