BYANNLI

Medicinal product

(Invented) name

BYANNLI

Active substance (s)

Paliperidonas

Strength

1000 mg

Pharmaceutical form

pailginto atpalaidavimo injekcinė suspensija užpildytame švirkšte

Route (s) of administration

leisti į sėdmens raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

N05AX13, Paliperidone

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2020-06-18

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10c

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Prolonged-release suspension for injection in pre-filled syringe	1 vnt.
Paliperidonas	1000 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
107665	93770	1093770	užpildytas švirkštas	N1 (ir adata)		Receptinis	EU/1/20/1453/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-06-18	Registruotas