Diclofenac Mylan

Medicinal product

(Invented) name

Diclofenac Mylan

Active substance (s)

Diklofenako epolaminas

Strength

180 mg

Pharmaceutical form

vaistinis pleistras

Route (s) of administration

vartoti ant odos

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M02AA15, Diclofenac

Marketing authorisation holder

Mylan Ireland Limited, Airija

Date of authorisation

2020-09-30

Date of renewal

2025-04-14

Documents

4605 pakuotes lapelis_2025-04-14.docx

4605 Diclofenac Mylan_perr2025-04-14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

HU/H/0626/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Vaistiniame pleistre yra:	1 vnt.
Diklofenako epolaminas	180 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
105028	91130	1091130	paketėlis	N5		Nereceptinis	LT/1/20/4605/001	Netiekiama	-	-	No	-	-	Download
105029	91131	1091131	paketėlis	N10		Nereceptinis	LT/1/20/4605/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-04-14	Perregistruotas
2020-09-30	Registruotas