Sibnayal

Medicinal product

(Invented) name

Sibnayal

Active substance (s)

Kalio citratas/Kalio-vandenilio karbonatas

Strength

8 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	8 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
106469	92570	1092570	paketėlis	N60		Receptinis	EU/1/20/1517/001	Netiekiama	-	-	No	-	-
106470	92571	1092571	paketėlis	N120 (2x60)		Receptinis	EU/1/20/1517/002	Netiekiama	-	-	No	-	-
106471	92572	1092572	paketėlis	N180 (3x60)		Receptinis	EU/1/20/1517/003	Netiekiama	-	-	No	-	-
106472	92573	1092573	paketėlis	N240 (4x60)		Receptinis	EU/1/20/1517/004	Netiekiama	-	-	No	-	-
106473	92574	1092574	paketėlis	N300 (5x60)		Receptinis	EU/1/20/1517/005	Netiekiama	-	-	No	-	-
106474	92575	1092575	paketėlis	N360 (6x60)		Receptinis	EU/1/20/1517/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-30	Registruotas