Zubsolv

Medicinal product

(Invented) name

Zubsolv

Active substance (s)

Buprenorfinas/Naloksonas

Strength

11,4 mg/2,9 mg

Pharmaceutical form

poliežuvinės tabletės

Route (s) of administration

vartoti po liežuviu

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07BC51, Buprenorphine, combinations

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2017-11-10

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Sublingual tablets	1 vnt.
Buprenorfinas	11,4 mg
Naloksonas	2,9 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
98374	84476	1084476	lizdinė plokštelė	N30		Receptinis	EU/1/17/1233/006	Netiekiama	-	-	No	-	-
99130	85236	1085236	lizdinė plokštelė	N7		Receptinis	EU/1/17/1233/017	Netiekiama	-	-	No	-	-
99131	85237	1085237	lizdinė plokštelė	N28		Receptinis	EU/1/17/1233/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-10	Registruotas