Pedea

Medicinal product

(Invented) name

Pedea

Active substance (s)

Ibuprofenas

Strength

5 mg/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

C01EB16, Ibuprofen

Marketing authorisation holder

Recordati Rare Diseases, Prancūzija

Date of authorisation

2004-07-29

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

solution for injection	1 ml
Ibuprofenas	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
27644	30196	1030196	ampulė	2 ml N4		Receptinis	EU/1/04/284/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-07-29	Registruotas