Roclanda

Medicinal product

(Invented) name

Roclanda

Active substance (s)

Latanoprostas/Netarsudilas

Strength

50 µg/200 µg/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)

S01EE51, latanoprost and netarsudil

Marketing authorisation holder

Santen Oy, Suomija

Date of authorisation

2021-01-07

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Latanoprostas	50 µg
Netarsudilas	200 µg

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
105638	91738	1091738	buteliukas	2,5 ml N1		Receptinis	EU/1/20/1502/001	Netiekiama	-	-	No	-	-
117700	103804	1103804	buteliukas	2.5 ml N3		Receptinis	EU/1/20/1502/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-07	Registruotas