Cystadrops

Medicinal product

(Invented) name

Cystadrops

Active substance (s)

Merkaptaminas

Strength

3,8 mg/ml

Pharmaceutical form

akių lašai (tirpalas)

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01XA21, Mercaptamine

Marketing authorisation holder

Recordati Rare Diseases, Prancūzija

Date of authorisation

2017-01-19

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

Eye drops, solution	1 ml
Merkaptaminas	3,8 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
67455	82007	1082007	flakonas	5 ml ir antgalis su lašintuvu N1		Receptinis	EU/1/15/1049/001	Netiekiama	-	-	No	-	-
105170	91272	1091272	flakonas	5 ml N4 (4×1) + 4 (4×1) antgalis su lašintuvu		Receptinis	EU/1/15/1049/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-01-19	Registruotas