Ultarcorlene

Medicinal product

(Invented) name

Ultarcorlene

Active substance (s)

Prednizolono pivalatas

Strength

5 mg/g

Pharmaceutical form

akių tepalas

Route (s) of administration

vartoti ant akių

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

S01BA04, Prednisolone

Marketing authorisation holder

AGEPHA Pharma s.r.o, Slovakija

Date of authorisation

2021-05-11

Date of renewal

Documents

4742 pakuotes lapelis_2021-05-11.docx

4742 Ultarcorlene PCS 2022 06 17.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

SE/H/1794/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

1 g tepalo yra:	1 g
Prednizolono pivalatas	5 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
106513	92614	1092614	tūbelė	5 g N1		Receptinis	LT/1/21/4742/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2021-05-11	Registruotas