Buprenorphine Neuraxpharm

Medicinal product

(Invented) name

Buprenorphine Neuraxpharm

Active substance (s)

Buprenorfinas

Strength

8 mg

Pharmaceutical form

poliežuvinė plėvelė

Route (s) of administration

vartoti po liežuviu

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07BC01, Buprenorphine

Marketing authorisation holder

Neuraxpharm Pharmaceuticals, S.L., Ispanija

Date of authorisation

2024-12-19

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

Plėvelėje yra:	1 vnt.
Buprenorfinas	8 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
116090	102191	1102191	paketėlis	N7×1		Receptinis	EU/1/24/1809/010	Netiekiama	-	-	No	-	-
116091	102192	1102192	paketėlis	N28×1		Receptinis	EU/1/24/1809/011	Netiekiama	-	-	No	-	-
116092	102193	1102193	paketėlis	N56×1		Receptinis	EU/1/24/1809/012	Netiekiama	-	-	No	-	-
117614	103717	1103717	paketėlis	N49×1		Receptinis	EU/1/24/1809/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-12-19	Registruotas