Hydrocortisone Orifarm

Medicinal product

(Invented) name

Hydrocortisone Orifarm

Active substance (s)

Hidrokortizonas

Strength

10 mg/g

Pharmaceutical form

gelis

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis/Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

D07AA02, Hydrocortisone

Marketing authorisation holder

Orifarm Healthcare A/S, Danija

Date of authorisation

1995-10-04

Date of renewal

2008-05-12

Documents

1147 Pakuotės lapelis OTC 20024 01 19.docx

1147 Pakuotės lapelis Rp 2024 01 19.docx

1147 Hydrocortisone Orifarm OTC RPP 2024 01 19.docx

1147 Hydrocortisone Orifarm Rp RPP 2024 01 19.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 g gelio yra	1 g
Hidrokortizonas	10 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
9539	14181	1014181	tūbelė	30 g, N1		Receptinis	LT/1/95/1147/001	Netiekiama	2025-01-01	2025-05-01	No	-	-	Download
61097	75410	1075410	tūbelė	10 g, N1		Nereceptinis	LT/1/95/1147/002	Netiekiama	2025-01-01	2025-04-30	No	-	-	Download

Stadijos

Data	Stadija
2008-05-12	Perregistruotas
1995-10-04	Registruotas