Cystadane

Medicinal product

(Invented) name

Cystadane

Active substance (s)

Betainas, bevandenis

Strength

1 g

Pharmaceutical form

geriamieji milteliai

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AA06, Betaine

Marketing authorisation holder

Recordati Rare Diseases, Prancūzija

Date of authorisation

2007-02-15

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Oral powder	1 g
Betainas, bevandenis	1 g

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
25767	28362	1028362	buteliukas	180 g ir 3 matavimo šaukšteliai (1 g, 150 mg, 100 mg) N1		Receptinis	EU/1/06/379/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-02-15	Registruotas