Sapropterin Dipharma

Medicinal product

(Invented) name

Sapropterin Dipharma

Active substance (s)

Sapropterino dihidrochloridas

Strength

500 mg

Pharmaceutical form

milteliai geriamajam tirpalui

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AX07, Sapropterin

Marketing authorisation holder

Dipharma Arzneimittel GmbH, Vokietija

Date of authorisation

2022-02-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for oral solution	1 vnt.
Sapropterino dihidrochloridas	500 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
108179	94283	1094283	paketėlis	N30		Receptinis	EU/1/21/1620/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-02-16	Registruotas