Sapropterin Dipharma

Medicinal product

(Invented) name

Sapropterin Dipharma

Active substance (s)

Sapropterino dihidrochloridas

Strength

100 mg

Pharmaceutical form

tirpinamosios tabletės

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

Soluble tablet	1 vnt.
Sapropterino dihidrochloridas	100 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
108176	94280	1094280	buteliukas	N30		Receptinis	EU/1/21/1620/001	Netiekiama	-	-	No	-	-
108177	94281	1094281	buteliukas	N120		Receptinis	EU/1/21/1620/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-02-16	Registruotas