Spravato

Medicinal product

(Invented) name

Spravato

Active substance (s)

Esketaminas

Strength

28 mg

Pharmaceutical form

nosies purškalas (tirpalas)

Route (s) of administration

vartoti į nosį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N06AX27, esketamine

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2019-12-18

Date of renewal

Documents

Spravato mokomoji medziaga sveikatos prieziuros specialistams.pdf

Spravato mokomoji medziaga pacientams.pdf

Spravato kontrolinis sarasas sveikatos prieziuros specialistams.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Psichotropinis

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Nasal spray, solution, Each nasal spray device contains	1 vnt.
Esketaminas	28 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
102984	89085	1089085	nosies purškalo prietaisas	N1		Receptinis	EU/1/19/1410/001	Tiekiama	-	-	No	-	-
102985	89086	1089086	nosies purškalo prietaisas	N2		Receptinis	EU/1/19/1410/002	Netiekiama	2026-01-01	-	No	-	-
102986	89087	1089087	nosies purškalo prietaisas	N3		Receptinis	EU/1/19/1410/003	Netiekiama	-	-	No	-	-
102987	89088	1089088	nosies purškalo prietaisas	N6		Receptinis	EU/1/19/1410/004	Netiekiama	-	-	No	-	-
105714	91815	1091815	nosies purškalo prietaisas	N24 (8×3)		Receptinis	EU/1/19/1410/005	Netiekiama	-	-	No	-	-
109260	95366	1095366	nosies purškalo prietaisas	N12 (4×3)		Receptinis	EU/1/19/1410/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-12-18	Registruotas