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Document 52021XC0730(06)

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2021 to 30 June 2021 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

PUB/2021/591

OJ C 307, 30.7.2021, p. 11–12 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

30.7.2021   

EN

Official Journal of the European Union

C 307/11


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2021 to 30 June 2021

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2021/C 307/02)

Issuing, maintenance or modification of a national marketing authorisation

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorisation

Member State concerned

Date of notification

21.6.2021

ifosfamide-containing solutions

ifosfamide-containing solutions

See Annex

See Annex

22.6.2021


(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX

List of medicinal products and presentations

Member State

EU/EEA

Marketing authorisation holder

Invented name

INN + Strength

Pharmaceutical form

Route of administration

France

Eg Labo Laboratoires Eurogenerics

Ifosfamide Eg

Ifosfamide 40 mg/ml

Solution for infusion

Intravenous use

Germany

Stadapharm GmbH

Ifo-Cell

Ifosfamide 200 mg/ml

Concentrate for solution for infusion

Intravenous use

Germany

Stadapharm GmbH

Ifo-Cell N

Ifosfamide 40 mg/ml

Solution for infusion

Intravenous use

Germany

Stadapharm GmbH

Ifo-Cell N 2000

Ifosfamide 40 mg/ml

Solution for infusion

Intravenous use


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